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Human Tissue (Authorisation) (Scotland) Bill

Overview

This Bill proposes to change the system for organ and tissue donation in Scotland. 

Currently, donations can be taken if:

  • the person has authorised this before they die, or
  • their nearest relative authorises the donation after they die 

This is known as an ‘opt-in’ system.  

The Bill proposes a new category of ‘deemed authorisation’. This is also known as ‘presumed consent’.

This means when someone dies without having made their wishes known, it’d be assumed they’d agree to donate their organs. Unless family members have evidence that it would be against their dead relative's wishes, they can’t override the donation.

This proposed system is known as a ‘soft opt-out’.

It would not apply to people:

  • under 16
  • without the capacity to understand ‘deemed authorisation’
  • who have been living in Scotland for less than 12 months

The main aim of the Bill is to increase the organ donation rates and the number of transplants carried out.

You can find out more in the Scottish Government document that explains the bill.

Why the Bill was created

Between 40 and 60 people will die each year while waiting for a transplant.

Opinion polls tend to show most people are in favour of having to opt-out. The move to an opt-out system got 82% support from respondents in a public consultation in 2017.

Part of the logic of the bill is that by presuming consent, there will be fewer times that the family would need to consent to donation. This would limit the potential for refusals and so increase donations.

Around 40% of families do not agree to donate their loved one’s organs. This means the loss of around 100 potential donors each year.

Reasons for lack of transplants

Organ donation and transplant rates have been increasing over the last 10 years. But there are still over 500 people waiting for a transplant in Scotland at any one time. 

Transplants are made harder because less than 1% of people die in circumstances that allow organ donation to proceed. 

You can find out more in the Scottish Government document that explains the bill.

The Bill at different stages

'Bills' are proposed laws. Members of the Scottish Parliament (MSPs) discuss them to decide if they should become law.

Here are the different versions of the Bill:

The Bill as introduced

Human Tissue (Authorisation)(Scotland) Bill as introduced

The Scottish Government sends the Bill and the related documents to the Scottish Parliament.

Bill is at ScottishParliament.SC.Feature.BillComponents.Models.BillStageModel?.DefaultBillStage?.Stage_Name stage.

Stage 2 – Changes to detail

Human Tissue (Authorisation)(Scotland) Bill with Stage 2 changes

Second version of the proposed law with changes from Members of Scottish Parliament (MSPs).

Bill is at ScottishParliament.SC.Feature.BillComponents.Models.BillStageModel?.DefaultBillStage?.Stage_Name stage.

Stage 3 – Final changes and vote

Human Tissue (Authorisation)(Scotland) Bill as passed

Third version of the proposed law that the MSPs voted on and passed.

Bill is at ScottishParliament.SC.Feature.BillComponents.Models.BillStageModel?.DefaultBillStage?.Stage_Name stage.

Where do laws come from?

The Scottish Parliament can make decisions about many things like:

  • agriculture and fisheries
  • education and training
  • environment
  • health and social services
  • housing
  • justice and policing
  • local government
  • some aspects of tax and social security

These are 'devolved matters'.

Laws that are decided by the Scottish Parliament come from:

Government Bills

These are Bills that have been introduced by the Scottish Government. They are sometimes called 'Executive Bills'.

Most of the laws that the Scottish Parliament looks at are Government Bills.

Hybrid Bills

These Bills are suggested by the Scottish Government.

As well as having an impact on a general law, they could also have an impact on organisations' or the public's private interests.

The first Hybrid Bill was the Forth Crossing Bill.

Members' Bill

These are Bills suggested by MSPs. Every MSP can try to get 2 laws passed in the time between elections. This 5-year period is called a 'parliamentary session'.

To do this, they need other MSPs from different political parties to support their Bills.

Committee Bills

These are Bills suggested by a group of MSPs called a committee.

These are Public Bills because they will change general law.

Private Bills

These are Bills suggested by a person, group or company. They usually:

  • add to an existing law
  • change an existing law

A committee would be created to work on a Private Bill.

Becomes Law

The Human Tissue (Authorisation) (Scotland) Bill passed by a vote of 116 for, 3 against, 2 abstentions. The Bill became law on 18 July 2019.

Introduced

The Scottish Government sends the Bill and related documents to the Parliament.

Human Tissue (Authorisation) (Scotland) Bill as introduced

Related information from the Scottish Government on the Bill

Scottish Parliament research on the Bill 

Stage 1 - General principles

Committees examine the Bill. Then MSPs vote on whether it should continue to Stage 2.

The deadline for sharing your views on this Bill has passed. Read the views that were given.

Committees involved in this Bill

Who examined the Bill

Each Bill is examined by a 'lead committee'. This is the committee that has the subject of the Bill in its remit.

It looks at everything to do with the Bill.

Other committees may look at certain parts of the Bill if it covers subjects they deal with.

Who spoke to the lead committee about the Bill

Video Thumbnail Preview PNG

First meeting transcript

The Convener

The next item is the first of our public evidence sessions on the Human Tissue (Authorisation) (Scotland) Bill. As everyone in the room I think will know, the bill proposes to introduce a system of deemed authorisation for organ donation in Scotland. We have two sessions today to hear from patient and public representative groups.

I welcome to the committee David McColgan, the senior policy and public affairs manager for devolved nations with the British Heart Foundation; Harpreet Brrang, the information and research hub manager with the Children’s Liver Disease Foundation; and Gillian Hollis, who is attending in a personal capacity as a lung transplant recipient. I welcome you all to the committee and thank you very much for offering to give evidence today, and indeed for your written evidence, which I know colleagues have found very informative.

I start by asking members of the panel what the need for legislative change in this area is. Do you think that deemed authorisation under the bill will result in a marked difference in practice?

David McColgan (British Heart Foundation Scotland)

Thanks for inviting us to the committee. It is great to see this bill coming back to the Scottish Parliament.

The British Heart Foundation has been pretty clear in our support for opt-out over the past several years. Our biggest concern is the gap between the number of organs that are needed and the number of organs that become available. The biggest challenge for anybody looking at organ donation is the gap between the number of people who are willing to donate after death and the number of people who get around to donating. A number of polls have shown that, in the UK, about 80 per cent of the population would be willing to donate their organs, but only 51 per cent of people in Scotland get around to registering their wishes. That gap is a challenge.

One of the other big challenges is the number of people who register their willingness to donate but do not follow through to donation. The committee will be aware that family consent rates in Scotland are the lowest in the UK, and that has been the case since 2014. One of the challenges is how we increase family consent. I think that the experience in Wales is crucial. In Wales since 2015, when opt-out was put into operation, there has been a 50 per cent increase in family consent rates, up to about 72 per cent currently. There have been a lot of myths about follow-through to donation in Wales, but what we are really interested in is the family consent rate. I think that soft opt-out is a very good way of increasing family consent rates, and the evidence is there to show that.

10:15  



Harpreet Brrang (Children’s Liver Disease Foundation)

I completely agree with all those points. I also think that the bill is trying to encourage people to make a choice. It is not saying, as some members of the public might think, that they are being forced into donating the organs of a family member. It is encouraging people to make a choice about it. That is another opportunity with the bill.

Many of the families we work with, who are the families of children with a liver condition, say that, until their child was going through the treatment and needed a transplant, it had not come into their minds to consider organ donation and then, as soon as their child needed a transplant, they registered as soon as possible. Often it is the fact that people do not think about it beforehand that leads to them not taking action to sign up. This pushes them to make a decision either way.

The Convener

Thank you.

I know that Gillian Hollis is here in a personal capacity rather than as a member of the Scottish donation and transplant group. Feel free to answer and we are certainly interested in hearing your views.

Gillian Hollis

Like everyone else around this table, I am very pro any means to increase the number of organ transplants that take place each year. I have seen the benefits myself. There have been 15 fantastic years. Over those 15 years, the Scottish Government, NHS Blood and Transplant and the national health service have done a lot of things to increase the number of transplants that take place. First, I think that we should be celebrating that and the achievements of the past 15 years, because there have been real inroads made.

Immediately after my transplant, I was completely in favour of opt-out; I thought that it was a no brainer. Why would you not? I have been working on committees and groups associated with transplantation for the past six years in particular and I have found that my view has changed a bit. I am not convinced that moving to an opt-out system is the right means of increasing the number of organ transplants. I think that the situation is far more nuanced, and I can see from the briefing note, the submissions that have come in and the comments that people have made that we will be talking about some of those nuances in this session.

The Convener

Indeed.

An aspect of both the current law—the Human Tissue (Scotland) Act 2006—and the bill is that neither formally provides for family objection, but I think that it is fair to say that they are both designed in the expectation that, if a family is not content, a transplant will not proceed. Do witnesses feel that not explicitly referring to that in the bill is appropriate, or should there be an explicit reference to it in the bill?

Harpreet Brrang

There might be a lot of backlash from not making it clear to people what the family’s role is. I noticed in the briefing notes that there was a discussion of the fact that families can provide information in relation to deemed authorisation to say whether their family member would have changed their mind or not agreed with the decision to take their organs, but it might not be overly clear what information they need to provide and how to provide it. As long as that is made clear enough, and it is clear that they still have a say and are still involved in that process, I think that the opt-out approach could still work. I think that it is about changing people’s perceptions of what it is.

Gillian Hollis

I think that it is a hard thing. Certainly, the idea of the 2006 act was to try to take away the right of veto of relatives, but my experience of speaking to medical professionals on this issue is that, when a relative is saying, “I do not want this to go ahead,” it is the front page of the newspaper scenario, and no doctor is going to go ahead against the vehement reluctance or prohibition of the relative.

My experience on this was coloured somewhat by taking part in a BBC Radio 4 discussion on opt-out a few years back. I went in very naive, I suppose, and very positive, and I was quite taken aback. There were a lot of very strong views on this in the phone-in, and relatives felt very strongly that they should play a part as well.

Alex Cole-Hamilton

It is remarkable to hear your story. My interest in this area comes from personal experience as well. My close childhood friend needed a transplant during the 30 years of his short life. He got that but, sadly, he died very shortly after because of complications. He drove my interest in this in favour of an opt-out. I am interested to hear you unpack the journey as to why you were very in favour of that and now are less so.

Gillian Hollis

When I was reading the transcripts of the House of Commons meetings at which the English bill—the Organ Donation (Deemed Consent) Bill—was discussed last week, I was very struck by the fact that it is a really feel-good bill and a good thing to do; it feels like the right thing to do to move to an opt-out system. It was only when I looked at some of the implications, talked to some of the specialist nurses about the discussions that they have and heard the views of members of the public who got quite upset about the idea of the state having some control over their body that I realised that the issue is so nuanced and not as straightforward as I had thought.

My background is that I did a law degree and, ironically—this is before I was ill—medical jurisprudence and ethics was one of my subjects, so this is the kind of thing that I studied as a student and then have come back to and am actually seeing. I am intellectually interested in it, but I have found that I am less enthusiastic about the move to opt-out than I was 10 years ago. It is not because I do not believe in increasing organ donation. I just feel that there is the potential for a bit of a backlash.

David Stewart

What assessment have you made of the element of gift in the current system? I will start with Gillian Hollis, because her submission was very interesting on that point.

Gillian Hollis

I think that the fact that an organ donation is a gift is very important. I owe my life to my donor and their family, and the fact that they took an active decision to give a lung to me and a heart to the girl who had a transplant the same night as me in the same hospital and who I have kept in close contact with. We really appreciate that gift and it is a very important part of the process for both sides. Should the bill go through, it is very important that that element of gift is retained as much as possible, because it is people helping other people. A donation is a true gift.

David McColgan

The point about organ donation being a gift, which Gillian Hollis raised in her submission, is very important. The British Heart Foundation does not see moving to a soft opt-out system as removing that choice to make a gift. All we see it as is a change in the initial conversation. People will still be perfectly within their rights to opt out. People will be able to register their objections much more strongly and legally than they currently can.

Also, there is a reason why the British Heart Foundation does not support a hard opt-out that does not involve the family, as opposed to the soft opt-out. A big part of that is maintaining the positive choice to donate rather than a state-sanctioned donation, which a soft opt-out absolutely is not. We do not see the concept of gift being removed through a soft opt-out. We just see it changing the initial conversation.

Harpreet Brrang

In a conversation that I recently had with one of our Scottish families, the idea of a gift was something that the mother explicitly said was a reason why she was completely in support of a soft opt-out approach. She said that, when her daughter received a split liver transplant, they were ecstatic, because if they had not received it at that time, their daughter would not be alive right now, but then she remembered that, for her daughter to get that liver transplant, someone else had passed away. They saw it as a gift, because someone chose to donate that liver. She said that she would feel slightly more uncomfortable about it if she thought that it had not been an active choice. With the soft opt-out approach, people are still given a choice. As Gillian Hollis said, the idea of a gift needs to be retained, for both sides.

David Stewart

How important is simplicity of message in the bill? In Gillian Hollis’s submission, she said that it is

“quite a complicated language. Tell us if you want to donate. Tell us if you do not want to donate, and if you do not tell us anything we will presume you have got an authorised donation”.

That seems complicated to me as a layman.

Gillian Hollis

That is what I feel from talking to people. There is work going on about the opt-out bill and people say, “Oh, I thought that that had gone through already.” People are not aware generally of what is happening. I think that it is a complicated message and some of the terminology does not help. The term “deemed authorisation” is quite obscure. As I said in the submission, there are lots of double negatives possible with the terms “opt-in” and “opt-out”.

I think that it will be challenging, but it is very important that the message is clear, because all of us want to do a good thing. We need to make sure that we convey that message as positively as possible but as simply as possible, so that we get it across. Especially when we are moving to a default position that the organs would go to donation anyway, it has to be simple.

David McColgan

It is interesting that when we had the debate about opt-in and opt-out when Anne McTaggart introduced her member’s bill, we kind of defaulted to the position in Wales, where there was quite a movement during consideration of the Welsh Government legislation to retain the opt-in. The original Welsh Government legislation was going to get rid of the opportunity to opt in, but many people still want to make that positive choice while they are alive and many people are quite proud of carrying an organ donor card. That was one of the reasons why we retained opt-in.

I do not dispute Gillian Hollis’s point about confusion about that, but we have to look at organ donation campaigns that have happened up until now. None of them has spoken about opt-out. We should learn from the experience in Wales, where there was an 18-month campaign and the vast majority—over 80 per cent of the population—understood the legislation. There is not much legislation that comes out of the Scottish Parliament that has that level of understanding. One of the reasons why the BHF really likes this bill compared to the English bill is that it puts a duty on ministers to communicate the legislation. That will be very important in the run-up to its implementation. Although the legislation may be confusing right now—and that can be said for any piece of legislation—what is important is the communication from the Scottish Government if the bill is successfully passed.

Gillian Hollis

I have a quick supplementary point just to say that we are unusual in Scotland in having the money that has been devoted to organ donation campaigns over the past few years. I think that all of us really appreciate that, as it has made a huge difference in getting the number of people on the organ donor register higher in Scotland than it is anywhere else in the UK. What is happening is against that background of getting money for campaigns and having good campaigns. I really appreciate that.

Harpreet Brrang

This is an opportunity to shift people’s attitudes as well as the perceptions and the culture surrounding organ donations. The simpler you can make it—and it needs to be very, very simple—and the more effort and investment you put into raising awareness, the more effective this bill will be in increasing the number of organ donations.

David Stewart

My final question is a very general one. What is your assessment of the issue of deemed authorisation? Will it increase donation rates and save lives?

10:30  



David McColgan

To expand on what I said in my introduction, nine of the top 10 countries in the world on donation rates use an opt-out system. The only one that does not is the United States. When we considered the Transplantation (Authorisation of Removal of Organs etc) (Scotland) Bill a few years ago, many people wanted to see what happened in Wales, because it has a similar healthcare system and a similar culture. The evidence there has shown that there has been a significant increase in family consent rates. Gillian Hollis touched on the issue of specialist nurses. The Young et al analysis of the Welsh experience said that specialist nurses found conversations to be much easier and families to be much more informed.

There has been an element of smoke and mirrors with what has happened in Wales. Organ donations have not increased massively—it is estimated that they have increased by 20 per cent—but Madden’s analysis of the legislation put that down to people’s eligibility as donors. We cannot predict people’s eligibility as donors, but we can try to shift the family consent rate. Countries that have high donation rates have high family consent rates. Scotland has the highest percentage of the population who are opted in to organ donation, but we are the lowest when it comes to the family consent rate. I think that that is where culture change is necessary. From the international experience and the Welsh example, we believe that we can shift family consent rates by using an opt-out system.

Emma Harper (South Scotland) (SNP)

I should begin by reminding folk that I was a member of a liver transplant team when I worked in Los Angeles. I am interested in increasing donation rates. As you mentioned, that will involve a culture change. No single measure will increase the number of donors. You have already said that the Government has a duty to communicate with people. How do you expect that communication to be delivered?

David McColgan

As I said earlier, the lead-up to the implementation of the legislation in Wales involved a highly effective 18-month communication campaign. It is also interesting that, since the introduction of the opt-out legislation in Wales, there has been an increase in the number of people who have decided to opt in—more people have got round to doing it.

I think that communication is key. The Welsh Government used a multichannel approach: it did TV and bus stop adverts, it had a great radio campaign and there was a whole raft of literature that was used by the NHS and organisations such as the BHF in Wales. We must understand that we live in a multicultural, multilingual Scotland, so we need to make sure that any legislation or campaign is targeted at all the communities in Scotland. I think that the Scottish Government’s recent seven words to save seven lives campaign was really good. It is clear that the Scottish Government has something that is working for it when it comes to getting people to opt in. What we now need to look at is how we achieve a shift on family consent. I think that any sustained campaign will be effective, given the Scottish Government’s experience, historically.

Harpreet Brrang

Deemed authorisation on its own does not necessarily mean that organ donation rates will increase. It is necessary to take a holistic approach, as part of which communications with the public should start as soon as possible. For example, as I mentioned, many of our families do not join the organ donation register until they are affected by the issue or understand what the register is there for. We could promote organ donation by showing people the effect that it has and how it can save lives, because many people—especially in certain cultures—do not like to talk about death or to think about that stage of their life. We should start the communication process as early as possible. Certain groups—older generations, for example—do not like to talk about that stage because of the fear of it. We need to enable people to talk about the issue more openly. That is partly about the language that we use and the routes that we provide. We should offer different routes of communication rather than always communicating through online portals.

Gillian Hollis

There needs to be a continuation of what is going on at the moment, whereby there is increasing acceptance of talking about organ donation publicly. The whole-hospital approach involves all the staff, regardless of which department they are in, being encouraged to think about organ donation rather than it just being an issue for intensive care or accident and emergency departments. There has been a shift towards having discussions about organ donation as a usual part of end-of-life care, which has been important. Such smaller cultural changes will make a difference. The more regular on-going education campaign that starts at school age is very positive and helpful.

Miles Briggs

I would like to follow up on Emma Harper’s question. I notice from the submissions that countries that have a soft opt-out, such as Israel, Belgium, Norway, Spain and Sweden, have higher donation rates. That is particularly true of Spain, which introduced its system in 1979. Is there anything that Spain has done differently, or has there simply been a cultural shift over time?

Gillian Hollis

I suspect that the committee will have a bit more information on Spain, as it is held up as the model for organ donation and how to get organ donation rates up. If we look more closely at the figures, we find that it was not until 10 years after the opt-out was brought in that there was a big increase, and that was the result of infrastructure changes to do with how the teams were organised and the availability of retrieval teams and operating theatres. A lot of developments took place. In our submissions, all of us have talked about the need for a raft of proposals and new infrastructure to come in at the same time in order to make a difference in the organ donation rates.

David McColgan

There is a range of opt-out systems in the international evidence. Every country that runs an opt-out system has brought in legislation. Opt-out legislation is the first of the three pillars that the BHF looks at. Pillar 2 is continued infrastructure investment. Countries that run an opt-out system have high availability of intensive care unit beds, which is very important. Pillar 3 is staff training, which involves continued investment. Spain is a very good example. It brought in legislation in 1979 but did not create a national co-ordinating body until 1989. It ran a big media campaign in the early 1990s, which is when the climb became evident. I think that it was Harpreet Brrang who said that legislation will not be the magic bullet and that a whole package of measures need to be taken. We need to continue to invest and to train staff, as well as starting on the process of cultural change in Scotland.

Keith Brown

I thank the panellists for their submissions and for coming along today. In particular, I thank Gillian Hollis—the clarity and brevity of her submission was great. I very much agree with her point that the message that we are trying to send is complicated. I also agree with what she said about how well things have been done over the past 15 years and the dedicated resource that she mentioned.

My particular interest is in the rights of the individual. If an adult takes a decision that they want to donate, do other family members have the right to override that? A related issue with presumed consent or deemed authorisation is whether the state has the right to say that it will take control of a person’s body unless they have expressed a wish otherwise. If we continue to allow family overrides, is there a danger that that is more likely to happen in a situation in which a family is trying to override deemed consent than it is in a situation in which explicit consent has been given?

The Convener

Who would like to start? Mr Brown has asked a number of important questions.

Gillian Hollis

I think that that gets to the nub of an extremely difficult issue, on which we will not get consensus. In theory, the 2006 legislation allowed doctors to override the relatives’ consent, but many people still said, “We do not want that.” There are very strong views on both sides. On one side, people think, “If I make a decision, I want that decision to be carried out; I don’t want my relative to be able to do that.” On the other side, there is the relative at the bedside on the day who says, “You’re not going to take the organs away from my loved one”. It is a very personal issue. I would probably sit on the fence a bit; I am not sure what the correct answer is.

Harpreet Brrang

It is a difficult situation, as Gillian Hollis said. If family members have a very strong opinion, they might see deemed authorisation as the state taking control, but that comes back to the need for education. It is a difficult issue. How it is perceived is a matter of opinion; it also depends on how the medical professionals deal with it at the time. The training that staff have should encourage them to take a cohesive, collaborative approach with the family members. That might ease the tension a little, but I think that it will always be there.

David McColgan

To reiterate what Gillian Hollis said, our experience of working with clinicians on the issue is that no clinician will ever go against a family’s wishes. Gillian Hollis mentioned the front page of the newspaper scenario—we might have spoken to the same person. Doctors will never override a family who says no on the ground that, “The law says we can do it.” When it comes to deemed authorisation, state ownership and the right of the individual, the family’s role in the process is made significantly easier when the wishes of the individual are known. We know that families are less likely to object to donation if they know that their loved one wanted to donate. It would be the same with the flipside. If the family knew that their loved one had opted out, their role would become much easier—it would just be a case of confirming their wishes.

Through the consultation on Anne McTaggart’s bill, we met families in which the children were all for organ donation, but the parents said that they would not do it. That is a challenging conversation to have as a family, but we want to make such conversations easier and more likely by having an opt-out system. That will help to take out the challenge of the legalese around state ownership, because the family will understand its role in the process. In the current system, I am not sure that it is understood how often the family is involved.

Keith Brown

From my reading of the bill, what is proposed does not make the family’s role any clearer. There is nothing explicit in the bill on the role of the family. I am interested in what you think allows the rights or views of the family to supersede the expressed wish of the potential donor either not to donate or to donate. I understand your point about medical professionals—perhaps it would be easier if the law set out the position—but what is your understanding of what gives the family that right? Obviously, there is the family nature, but what if that person has made a decision?

The other point that I tried to make is that, if the bill goes ahead as planned and families continue to have that non-legally acknowledged right, are they not more likely to challenge it when there is deemed consent than when someone has explicitly consented? The family might think, “They never agreed to this; it’s just because it is the law, and we are going to object for that reason.” Where do the family’s rights derive from? Will the bill be counterproductive as a result of the family veto?

10:45  



David McColgan

On the point about deemed consent, the bill is clear that, if someone has not opted in or opted out—if they have not made the explicit statement, “I do not want to donate”—they are in to donate. The person might have said to family members, “I don’t want to donate, but I have never got around to opting out,” and those cases are written in. I completely agree that there is a challenge around deciding when the family has the right to overrule. If someone has opted out, we would argue that the person is out and the family should not override their decision, and the same applies if someone has opted in. However, we know that that already happens, for a number of reasons. I would never want to find myself in a position where I have to make the decision to donate someone’s organs if they had opted out or even if they had opted in, because it is a high-stress situation.

There will always be cases in which family members feel that they want to go against the wishes of their loved one. The Parliament may decide whether to make it possible to do that, but BHF does not have a view on that. You will probably find that there are views on both sides of the aisle on that issue as you go through the evidence sessions and among the public.

Brian Whittle

I want to pick up on David McColgan’s point that a healthcare professional will never go against the will of the family. That is a dangerous statement, and I do not agree with it. We should not be putting those kind of decisions on to healthcare professionals. On Keith Brown’s point, do you not agree that the bill, if it goes forward, must have absolute clarity so that there is no wriggle room and we do not put those kinds of decisions on healthcare professionals? I am not convinced of your argument on that.

David McColgan

The point on healthcare professionals is purely anecdotal. I have not polled all healthcare professionals, but that is a common message that is given to us. It is a message that we wrangle with when we are thinking about legislation on the topic. On the point about clarity, the clearer the bill is, the better for me and for everyone, and the panel has said that. The less complicated it is the better, and the easier it is to communicate the better. That is important.

I do not have the figures to hand, but we have only five, six, seven or eight cases where families have objected to their loved one donating even though they had opted in. It is interesting to go back and understand what those conversations were like and why, under the current legislation, the clinicians did not say, “We have the right to do this because your loved one has opted in.” It is interesting to look at why that happens now and in what percentage of donations clinicians say, “We’re going to do it.” I think that it is a very small percentage, although I do not have any evidence to back that. Our Welsh colleagues have been running this system for two years. I am not sure whether the committee will hear from anyone from Wales, but there will be a wealth of experience there already about how those conversations have gone and what the system is like.

Gillian Hollis

That is where the bill proposes a very big change in the default position. The deemed authorisation when someone has not recorded an opt-in or an opt-out has to be made clear to people before you can enforce it. It must be clear that that is what will happen and that relatives should not be able to override that. That is a very big change and will need to be communicated. If it is communicated properly, it will be all right not to accept relative overrides.

Harpreet Brrang

The bill says that relatives would need to provide evidence or information. If the bill is very clear about what that is, that will make it not easier, but a little clearer for the professionals who are involved in the process. At the moment, that might not be clear and it would just be interpretation.

Alex Cole-Hamilton

I, too, would like to ask about the family override. In our informal evidence session with specialist nurses, they talked us through the process by which that conversation happens currently. They revealed to us that literally hundreds of questions are asked of families at the most difficult time when they are coming to terms with the sometimes very sudden loss of a loved one. We were told that that is a demonstrable deterrent to families allowing consent. Families will often bail on that process, because it becomes too long and drawn out and they need to collect themselves. Can we do something in the bill to reduce that bureaucratic pressure or are we, by necessity, going to create further bureaucracy in the process?

Gillian Hollis

You are absolutely right. My understanding from the specialist nurses and from reading papers on why donations did not go ahead is that the length of time in the process, the number of questions that had to be answered and the bureaucracy that had to be gone through were very big factors behind that. Fifteen years ago, my husband’s cousin’s husband died in a motorcycle accident. She went through the donation process for her husband and was horrified by the number of questions that she had to answer. She said, “Frankly, I got halfway down the first page and then said, ‘I can’t do any more of this.’” That was because, as Alex Cole-Hamilton pointed out, the circumstances were so difficult. I am not sure of the extent to which the bureaucracy is giving a better understanding of what can and cannot be transplanted. We can do more and we can transplant more organs now and I am not sure whether the extra bureaucracy is essential, but I would certainly welcome anything that reduced it.

From a patient recipient point of view, the forms that we are being asked to sign are now a lot more bureaucratic and longer than ever. I just signed a one-page form saying, “I will accept any organ and the risks that come with it.” People who go on the transplant list are now asked to sign pages of forms that go through the different types of donors and different risks that might associate with each of them. It is a very difficult position. I do not know how much of that bureaucracy is necessary but, if it can be reduced, I would welcome that.

David McColgan

BHF does not have an opinion on the issue, but I think that we would agree with anything that makes the process easier and more streamlined for families, as long as it is still clinically and medically safe. We defer to our specialist nurse colleagues who operate that.

Alex Cole-Hamilton

We were told by the specialist nurses that the questions very much mirror those that people answer when donating blood. I understand that there is a need for clinical surety about what is coming in. However, that is not done in isolation. With blood, as with organs, tests are done to check that it is clean and that there are no contaminants or diseases. We are asking very vulnerable families very intimate questions to which they may not be able to give an accurate answer. If the questions are about sexually transmitted disease or lifestyle factors, the family may not want to reveal something that was going on in their family member’s life or they may not know. I do not think that much surety can be derived at that time, so I wonder whether we can dispense with part of that to give families comfort and respite from fairly arduous questioning. Is it still clinically necessary to probe those areas?

Gillian Hollis

Wearing another hat, I sit on the Advisory Committee on the Safety of Blood, Tissues and Organs, which advises the UK and devolved Governments on matters to do with the safety of blood, tissues and organs for transplant. We are doing quite a lot of work in that group to increase organ donation by looking at organs from people who might previously have been considered too high risk or whose particular organs might have a risk attached to them. We have been doing a lot of work on categorising different risks and how the organs might be utilised safely. That has been very successful in increasing the number of organs that are becoming available and that can be used for transplant and increasing the number of transplants. There is a balance between getting the safety part right and not doing things that make it far more difficult for the relatives to say yes to organ donation in the first place.

Harpreet Brrang

It would be fantastic if the bill could be used as an opportunity to cut down on the bureaucracy and the number of questions that people are asked at such a difficult and sensitive time. We cannot comment on how clinically safe it is, because we at the Children’s Liver Disease Foundation are not medical professionals, but the bill might be the ideal time to consider that opportunity.

Sandra White

Gillian Hollis has answered some of my questions, and she is obviously involved in the matter. Have any organisations or groups been asked or consulted about the questions that are asked? Should the bill process be in part a consultation on that issue? Alex Cole-Hamilton is absolutely right that some of the questions that are asked are so intimate and people do not know anything about them. As part of the bill process, should we look at reducing the questions? Should that go out to consultation or should organisations such as yours be asked? I think that around 300 questions are asked.

Harpreet Brrang

Absolutely. We are all about advocating the patient’s voice and speaking on behalf of the public and getting their opinions and views on things because, at the end of the day, it affects them. If you speak to family members who might have been asked those questions, you can derive from them what the most sensitive questions are and then work alongside medical professionals who know which ones are absolutely necessary. You have to involve a lot of stakeholders in that to come to the right approach.

David McColgan

My question back to Sandra White is whether we need legislation for those questions to be written or whether a recommendation can be made to NHSBT to look at the matter. We have to remember that the organ donation framework is not just in Scotland, England, Wales or Northern Ireland; it is a UK-wide framework. We need to work with colleagues across the UK on what questions would be appropriate across the UK and to understand the current set-up. I do not know when the issue was last reviewed, but I think that it is worth looking at. The committee has identified the issue, and it was identified a number of years ago when a former MSP spoke about his personal experience. Harpreet Brrang is absolutely right that there should be patient involvement and involvement of families that have been through the process. It would certainly be worth while taking that kind of approach to get the best answer.

Gillian Hollis

That recommendation would go to NHSBT, which deals with the questions on a UK-wide basis. As David McColgan said, it operates not just in Scotland. I agree with David that it probably should not be in the bill, but a strong recommendation could be made to review the questions. However, I believe that the matter is being reviewed by NHSBT, because it is seen as a hurdle to increasing donor numbers.

11:00  



David Torrance (Kirkcaldy) (SNP)

Good morning. In Wales, deemed consent applies to people aged 18 and over, whereas in Scotland, deemed authorisation will apply to people aged 16 and over. Do you agree with 16 as the age at which deemed authorisation should apply?

David McColgan

We are happy with 16, because when we looked at this issue during the consideration of the previous bill, we saw that the legal age of consent in Scotland differed from that in the rest of the UK. However, if the consensus is that it should be moved to 18, BHF will not have any major opposition to that. The age of 16 was set in order to tie in with the age of legal consent.

David Torrance

I asked the question, because it can sometimes be very hard to engage with the 16-and-under age group. How can we give young people sufficient opportunity to express their wishes in advance of their reaching the age of 16?

Gillian Hollis

I think that it can be part of education in schools. I have done quite a lot of talks in schools, sometimes as part of the personal and social responsibility curriculum, and I know that the issue is being covered by at least some—and, I hope, a lot of—pupils. When I speak to pupils, the first thing that I stress is that I am not there to convince them all to sign up to the organ donor register. However, I do ask them to go home, discuss the issue with their families and find out their views. The discussion on organ donation can start early, and it probably has a place in the school curriculum.

Harpreet Brrang

I completely agree. The discussion can start in schools—and the earlier, the better. As Gillian Hollis has said, a lot of schoolchildren will go home and discuss the issue with their families. As a result, you can target family members as well as the children. If you educate people at a very early stage, the culture change can happen from that age range.

Keith Brown

I want to go back to David McColgan’s point about the UK operating as one on this. If the bill were to be passed with 16 as the age limit for deemed authorisation in Scotland—the point that David Torrance made—would that introduce legal complications with regard to where organs could go in the UK?

The Convener

That is a good question to which there appears to be no immediate answer.

Gillian Hollis

It is a very good question—and it has me completely stumped. Although I live in Scotland, I had my transplant in England because the Freeman hospital in Newcastle is the nearest lung transplant centre, but I think that my lung came from another part of the UK that was neither England nor Scotland. I do not know the ins and outs of how the system would work.

David McColgan

We already have two systems in the UK: a soft opt-out in Wales and an opt-in in the rest of the UK. As a frequent traveller to Cardiff, I like to keep a note of this. Under the Welsh legislation, there is a residency period before the provisions apply—I believe that, in the Scottish legislation, the period is a year—and it means that if something were to happen to me in Wales, I would be treated under the opt-in system, not the opt-out system. I imagine that there is precedent with regard to, say, an English family visiting Scotland. If the person in question was under 18, the age would not default to 16; it would stay at the 18 age limit that operates across the rest of the UK, unless it was decided that that should be lowered, too. I think that there is precedent in the way that Wales operates its system, and we should look at that.

Keith Brown

My question was more about a 16-year-old in Scotland being a donor. Would there be a restriction on where their organs could go in the UK, given the presumption elsewhere that the donor must be 18 and over?

The Convener

I have a feeling that that is a question that we will have to put to the Government in due course.

Sandra White

I want to touch on pre-death procedures. When we spoke to individuals—we also had a private evidence session on the matter—we found that the issue was causing great concern in relation to situations in which a person might be deemed to be brain dead or their heart might have failed. Basically, they were asking whether the procedures would cause pain to a patient whose heart might have stopped, but whose brain had not. What is your view on a decision to carry out PDPs on patients who are not deemed to be dead? Obviously the issue will be—or might be—set out in regulations, but do you have concerns in that regard? Families and other people certainly have.

Gillian Hollis

This is another area that I have a better—though not perfect—understanding of. At one organ donation conference I attended, a doctor’s whole talk was on the question, “When is somebody actually dead?”, and he talked about the difficulties with the different definitions of death. It was an eye opener for me, because I had just thought that people were at one stage or the other. As far as pre-death procedures are concerned, it can be quite hard for a layperson to understand that there are some criteria under which someone might be deemed to be dead, but there are things that can be done to make organ donation better in the circumstances.

I note from the Scottish Parliament information centre briefing that some people felt “distaste” for the phrase “pre-death procedures”. It is definitely an issue, because the term sounds awkward and, indeed, quite nasty. However, it is not just a matter of giving something a different name. You have to be clear with relatives to ensure that they understand what is going to happen—and why it is going to happen—and that might involve having a discussion about the definition of death itself.

Sandra White

As a layperson myself, I did not realise that this was an issue. If something happens, certain organs will not survive if they are not transplanted. Quite apart from the fact that you would not want to ask anyone about anything that is called a “pre-death procedure”, the issue that worried a lot of people was deemed consent or authorisation. They thought that, if there was deemed authorisation, the pre-death procedure could go ahead to get the organs. Can we include something in the bill to explain to people that that would not necessarily happen? Can we do something about the language, for example, or do something to educate people—me included—about these things?

Harpreet Brrang

It needs to be made very clear to the public and family members that pre-death procedures could take place. At the moment, they might not be aware of what they mean. The first thing that people will say when you bring the issue up with them in the initial organ donation conversation is, “What are they?” As far as organ donation is concerned, people think that, once everything is switched off, the person is no longer there. That is probably the starting point for this particular conversation, because there is complete lack of understanding in this respect.

Emma Harper

I am itching to get in here, because I want to clarify what the pre-death procedures are. Are we talking about extra intravenous lines, arterial lines, central venous access or changing medication to improve renal function? Some meds might improve renal function, but they will also compromise liver function. Is that what we mean when we are talking about pre-death procedures? Are we talking about optimising organs in preparation for a donation process that we know we are moving forward with? Is this not about preparing for donation in the most optimal way instead of doing things without consent?

The Convener

Again, those are very good questions. Perhaps we will have other witnesses who will have a more medical perspective on that, but I see that Gillian Hollis wants to respond.

Gillian Hollis

It is exactly as Emma Harper has set out. It is based on the understanding that the person is about to become an organ donor and that, as a result, some procedures need to be carried out to ensure that the organs are working as efficiently as possible. These procedures would not be carried out if the person was not going to become an organ donor.

The Convener

Essentially, then, it is a clinical judgment. Alex Cole-Hamilton has a supplementary.

Alex Cole-Hamilton

I want to ask about the financial memorandum and capacity. If the bill is a success, it will lead to a greater number of organ transplants happening in this country than might otherwise be the case. Is there sufficient capacity in the bill, particularly the financial memorandum, to deal with the increase in workforce—both specialist nurses and surgical capacity—that will be required? Will we be ready for this if we pass the bill as it stands?

David McColgan

According to the Scottish Parliament information centre briefing, the Scottish Government has said that it is already funding to 2020 capacity levels. That target has been set, but it is not being met at the minute, so there will be funding to meet the extra positive impact that the bill will have.

The other point that I would make—and which came out in the previous member’s bill—is about putting pounds and pence on a person’s life. What we are talking about here, certainly as far as heart donations are concerned, is someone surviving or not surviving. The number of people in the UK who are waiting for a heart transplant has trebled in the last 10 years; in Scotland, it is 150 per cent higher that it was four years ago. We therefore need more transplants.

However, that will come with a cost. Somebody might have the exact figures, but when Kidney Research UK carried out an analysis of how much it cost to keep someone on dialysis instead of giving them a transplant, it found that the costs of giving them a transplant and bringing them off dialysis were significantly lower. The issue might come up again later, but if it does not, I can send the committee the figures.

The Scottish Government has made it clear that, with the 2020 target, money is there, but I would also point out that we are talking about people who are waiting for a second chance of life.

Alex Cole-Hamilton

Do not get me wrong—I am not concerned about the need to spend more money on this. I absolutely get the preventative agenda that you have described. I just want to be sure that we are ready with regard to the workforce and financial aspects and that we will be able to absorb the additional demand that the bill will create.

Gillian Hollis

At one of our commissioning meetings, we looked at the finances of transplantation, and I learned a lesson: as a lung transplant recipient, I had been, in effect, funded by all the kidney transplants. We lucky heart and lung transplantees have benefited from the kidney transplant programme being so successful financially versus the cost of dialysis.

Let me leave finance to one side and talk about the practical implications. Our local Lothian organ donation committee is having quite a big discussion about theatre capacity. At the moment, most transplants are done in the evenings. Obviously, these procedures are unscheduled, and because they cannot be scheduled in the way that other elective surgery can be, they usually happen at night. I am aware of discussions happening locally about the pressure on theatres as a result of transplants. A number of resource issues need to be followed through. Again, it might be best to speak to the witnesses who know the area, but I think that if the numbers increase past the 2020 levels, the issue will have to be considered.

The Convener

I want to thank all our witnesses for their very helpful evidence to the committee. One or two questions were asked for which you had no immediate answers or on which you might need to reflect, and if you feel that there is something else that you want to say or draw to our attention, please feel free to make a post-appearance submission.

I suspend the meeting for five minutes to allow a changeover of panels.

11:14 Meeting suspended.  



11:19 On resuming—  



The Convener

I welcome to the committee Shaben Begum, director of the Scottish Independent Advocacy Alliance; Fiona Loud, policy director at Kidney Care UK; and Dr Gordon Macdonald, parliamentary officer for Scotland at Christian Action Research and Education. Thank you for coming to join us this morning.

I know that some of you sat in on at least some of the previous evidence session, so you will not be surprised that I will start with a general question. Do you believe that there is a need for the Human Tissue (Authorisation) (Scotland) Bill and that it will result in a marked difference in practice?

Fiona Loud (Kidney Care UK)

Thank you for the invitation to speak today. Kidney Care UK is the national kidney patient support charity, and we welcome the opportunity to increase the number of transplants in Scotland, and across the whole country as a consequence of that.

People are dying every day while waiting for a transplant, and many of them are waiting for a kidney. We know that more can be done, and we absolutely believe that changing the rules so that it is presumed that a person will be a donor unless they have said otherwise in life is the right thing to do. However, it is not the only thing to do. It will work only if we take account of the views of the public, so we are very careful and clear about the need for education and promotion. A continuous and consistent message is needed across the country about what the bill aims to do, what it means and people’s rights under it. We also believe that the change must be supported by the right capacity in the health service.

However, we certainly believe that the bill has the opportunity to transform lives, and it gives many kidney patients, who feel very strongly about this, some hope for a far better future and a life that is transformed through a transplant.

Shaben Begum (Scottish Independent Advocacy Alliance)

We support the bill, but our main motivation for responding to the consultation was that we feel that the bill needs to be strengthened to consider the needs of people who have limited capacity or limitations on their ability to communicate and other marginalised groups. That is what we are interested in.

Dr Gordon Macdonald (Christian Action Research and Education)

We would say that the answer to the question is no. What is needed is improvements to the administrative system around organ donation. The evidence from Spain suggests that what matters is not a legislative change that introduces presumed consent, but improvements to the administrative system and, in particular, specialist organ donation nurses. We suggest that it would be better to invest the money in that. The Nuffield Council on Bioethics found that, where specialist organ donation nurses exist, the donation rates increased from 27.5 per cent to 68.6 per cent. I think that that speaks for itself.

The Convener

We have met several specialist organ donation nurses. Is your point that there should be more of them rather than a change in the law?

Dr Macdonald

Yes.

The Convener

Thank you. It is clear that you all come from different perspectives. A key question that has arisen is that of the wishes of family members. There is no formal place for them under either the current legislation or the bill. Should that change? Should the wishes of family members be written into the legislation in some way?

Dr Macdonald

It is very difficult for a clinician to go against the family’s wishes at what is a particularly difficult and sensitive time. Whether they are written into the bill or not, I think that the practice will be, as seems to be the case in Wales, that clinicians will not go against the family’s wishes. There is a dangerous precedent in allowing clinicians to override the family, particularly where there has been no opt-in on the part of the deceased. I am sure that clinicians are very conscious of that, but you will, obviously, have to speak to them.

We do not wish to see presumed consent being introduced in any case, but we would certainly want families to have a strong say as to whether it should happen and to be involved in the process. The evidence from Spain and other places seems to be that the key thing is dialogue and communication with families, rather than passing bits of legislation.

Shaben Begum

We need the bill to be really clear about rights. If it does not say anything about the rights of the family, that will be a potential barrier to its success. There needs to be that consideration. We need the bill to put in place safeguards for potential donors, family members and clinicians.

The previous panel gave evidence on the lack of clarity for clinicians and how it would be difficult for a clinician to go against the wishes of a family member. I agree that we should not put individual clinicians or teams in a position of having to be in dispute with family members. I carry a donor card, and if something happened to me and my family was in that situation, parts of my family would want to support my wishes and other family members would not. Good, robust legislation will need to take such nuances into consideration in order to safeguard everyone and protect my right to make that decision.

Fiona Loud

We believe that a soft opt-out is the right thing to introduce. That allows the family to present evidence as to why their loved one would not have wished to become a donor. We believe that, as we heard earlier, it is important to encourage people to have the conversation with family members all the time. If anyone takes the option to opt in, that is great. We would say to people, “Please let your family members know what your wishes are”, but even if people do not take that option but are content to have their consent deemed, we would still like people to be encouraged to have that conversation. Having the conversation and knowing what your loved one’s wishes are will make decisions much easier.

We should look at what has happened in Wales, with the right to a soft opt-out remaining, and what is proposed in England so that we can have some consistency. It is also important to train staff so that they understand the approach. If we look at Wales as an example, we can see what staff there learned about how to present the new rules and how they matured over time and became more confident about saying, “These are the rules and this is the law, but we would like to work with you as a family around the donation.” I have heard family members from Wales speak about that and speak approvingly about the way in which deemed authorisation was introduced to them.

David Stewart

Good morning, panel. What assessment have you made of the strengths of the gift concept in the current legislation?

Fiona Loud

I will speak from the recipients’ point of view first. There are about 464 kidney patients waiting or hoping for a transplant in this country at the moment. Any kidney patient who receives a transplant has the greatest respect for their donor and never forgets them. They remember the donor and speak of them with huge respect all the time. Recipients see the donation as a gift and will be forever grateful for the life transformation that the donor and their family have been able to grant them.

Turning to the point of view of donor families, we have spoken to many of them and they see the donation as their gift as well. The ones that we have spoken to are very proud to say that. I appreciate that they are only a selection, so I am presenting this as a story rather than as factual evidence, but they have also said that, provided that their wishes are still considered in the way that I described, with a soft opt-out, and their donations continue to be respected, spoken of in the highest possible terms and accepted as a vital part of what we are doing, they will be supportive and will still see it as a gift. They do not see that being taken away. I appreciate that not everybody feels that way, but that is the evidence that we have heard from the folk that we work with.

Shaben Begum

One of the strengths of the bill is that we have the concept of donation being a gift. It would be dangerous to squander that and introduce an element of compulsion or a notion that the state had certain rights over the bodies of individuals that would marginalise or sideline the wishes of the family. The packaging of the bill as people being able to provide a gift to other people in society is a really powerful message, and I think that the public will be open and amenable to that rather than to the idea that, if something happens to me, the state should be able to do whatever it likes with my body.

11:30  



Dr Macdonald

The gift element is very important. As I am sure you are well aware, when the organ donation task force did its study in 2008, it found that the gift element was important not just to donors but to recipients.

There is a danger in moving away from the gift element. That is precisely the point that has just been made. If there is a perception that it is no longer a gift and the state is claiming a right, there is a danger that people will choose to opt out of the system, which seems to have happened in Wales. The number of people opting out has gone up to 182,000, or maybe 187,000—I cannot remember the exact figure—which is about 6 per cent of the Welsh population. In the other constituent parts of the UK, it is less than 1 per cent of the population. The effect is that, rather than 99 per cent of the population being potential donors—I have opted in to the donor register, but if I had not done so and something happened to me, my wife could still donate my organs—we have 94 per cent being potential donors in Wales.

We need to think about the potential negative consequences of moving away from the gift element towards—even if it does not exist in practice—the possible perception of a formal compulsion approach in law.

David Stewart

My next question relates to that. How important is simplicity of language in the bill?

Dr Macdonald

The bill and any associated documentation should be clear and honest. Part of the problem in Wales was that there was a fundamental misconception at the core of the debate, which was that the Spanish system was essentially a presumed consent system, whereas in practice it is an informed consent system because there is no opt-out register. A study in The BMJ by Professor Fabre and others including the leading Spanish clinician in the area argued that that was the case—that it was not in practice a deemed authorisation or presumed consent system; it was the system that we have in practice.

When the Health and Sport Committee previously considered the matter—I gave evidence on that occasion, too—some members went to Spain and spoke to the Spanish authorities. I would recommend that you do that as well.

Fiona Loud

There has been a great deal of debate about why Spain has been so successful in achieving world-leader status in organ donation and transplantation. Spain has done all the things that we would like to see. It has built its base in terms of capacity and training its staff as well as having a default that people are considered to be donors unless a different conversation goes on with the person and their family.

When the organ donation task force reported in 2008, it recommended a number of things based on the Spanish experience. It recommended the implementation of organ donation committees, trained staff and clinical leads, the embedding of specialist nurses in hospitals and a range of public education initiatives, but it did not recommend, as we know, that we should go with the presumed consent approach.

We are 10 years on and many of those things have been put in place, although there is still more to do on some of them. The one thing that we have not yet done is the thing that Spain and other successful countries such as Croatia have done, which is to change the law to go along with that. We believe that the combination of all those things is the right approach, and we hope that the Scottish Government is planning that.

Dr Macdonald

Croatia is an interesting case study. It now sits at the same rate as Spain, but what happened in Croatia was that it introduced presumed consent in legislation first, and it did not make any difference to the rates. It was only after Croatia did all the other things that the rates started to increase, which suggests that there is no direct link between the introduction of the legislation and the system and rates increasing. It is the other things that make the difference.

The Convener

Unless, I suppose, the change in legislation changed the context and made the other changes easier to deliver.

Dr Macdonald

Yes, but it was some years later. We can send you further evidence on that.

The Convener

That would be appreciated.

Fiona Loud

Changing the context and the national conversation alongside all those things is the thing that will make the difference, and that is why I quoted that country. It is all those things together. It is about changing the default and changing the support system alongside that.

Emma Harper

When we first started taking evidence, more than 80 per cent of Scots said they would donate their organs. I have had conversations with people who think that deemed authorisation is a way of allowing folk who just have not got around to putting their names on the organ donor register to donate. What is your response to that?

Dr Macdonald

It is the same as the point I made earlier, which is that we are talking about more than 99 per cent of potential donors in Scotland who have not opted out. I take your point about the 50 per cent of people who have opted in, which is very good compared with the rest of the UK. You quoted 80 per cent and a good 30 per cent of those people are realistically potential donors.

The key thing in relation to that will be the conversations that are had with the family around the time of death. That is where I come back to our point that the best thing to do, and the best way of using the resource well, is to invest in organ donation nurses. Certainly the UK Government’s figures are £45 million start-up costs, £2 million a year to run the system, and then another £5 million or so every five years to run a publicity campaign. I do not know what the figures are for Scotland, but that money could certainly be better spent by investing in staff and in family communication.

Fiona Loud

Could I just comment on the point about eight out of 10 supporting organ donation, but only about half the population, for which Scotland is to be absolutely congratulated, being on the organ donor register? What we have is a group of up to 80 per cent of people who say that they would support donation and would be willing to donate who would be covered by the deemed authorisation bill. That is where there would be gains because there will always be people who will not wish to donate and having that right to opt out is incredibly important as part of the democratic work with the bill.

Emma Harper

Will the bill itself increase donation rates? That would be good, but if not, what areas will need to be invested in—you have mentioned some already—to increase donation among people who are on the organ donor register?

Shaben Begum

Your earlier point was a good illustration of the lack of awareness and understanding of a complicated area. It is so emotive. People think that if they are carrying a donor card that is the end of the story and their wishes will be safeguarded.

We need to have a bigger conversation within society. We do not talk about mortality. Lots of us do not have wills. Lots of people do not have advance statements, which is something that the Mental Health (Scotland) Act 2015 allows for. All sorts of things need to happen with infrastructure and finances, but we also need to have a conversation within society on a bigger level about what happens when we die and what we would like to see happen.

Dr Macdonald

It will be key to look at what has happened in Wales during the past four years or so. Everybody, including the Welsh Government, acknowledges that the evidence from Wales is inconclusive at the moment. However, certainly from looking at the stats, which I included in our submission, there is no clear link in terms of improving the figures.

In fact, what struck me when I looked at the NHSBT figures was that the deceased donor rate is increasing in all the other three jurisdictions in the UK, but in Wales it is not on a steadily increasing trajectory. It goes up and down each year, which is why it is quite difficult to just take a few years and make an assessment. More time needs to be given to see what happens in Wales before the Scottish Government and Scottish Parliament legislate in this area.

Fiona Loud

This is a national conversation and it is almost a once-in-a-lifetime opportunity for the whole country to raise our game and have that open national conversation that Shaben Begum just spoke so clearly about. The numbers of deceased donations that we are seeing are probably rising because we are having this national conversation in most of our countries about what is going to happen next and where we will go. However, we have to be careful—as one of the earlier witnesses said—because many people think the bill has already gone through. We have heard on the news that it has already happened, but it is still going through.

As a simple response to Emma Harper’s original question about whether we think the numbers will go up over time, yes, we do think they will go up over time. However, we should be looking at the consent rate. In Wales, it is now something like 72 or 73 per cent. I think that it was at about 40 per cent or so when the scheme started, so there has been an enormous increase in consent rates. Family consent to donate rates are probably the best thing to look at because numbers will vary from year to year with what might be a relatively small number of donors, and one or two additional donors can make all the difference to the number of transplants. That is incredibly encouraging.

Brian Whittle

Good morning to the panel. Fiona Loud has partly answered the question that I was going to ask about evidence that we have heard many times that family consent is probably one of the major issues that has to be tackled within organ donation.

My question is specifically for Dr Macdonald. Do you acknowledge that Wales’s success in raising the family consent rate is probably a more important indicator of success than the number of people who have opted out?

Dr Macdonald

We do not know what the reasons are. That is the key point. Is Wales’s success to do with passing legislation on presumed consent, or is it to do with all the discussion that has been taking place in the media, including the information campaigns that have been funded, or is it to do with investment in specialist staff and improving communication with families? It is not clear. There needs to be some sort of bottoming out of what has caused Wales’s success rather than assuming that it is just to do with the legislation.

You can certainly have a national conversation and invest in publicity campaigns without passing this legislation, and we would certainly support both those things.

Brian Whittle

Do you agree that the fact that we are having this discussion about the legislation is having an impact?

Dr Macdonald

It might be having an impact but the danger is that it is a negative impact. As we saw in Wales, a significant percentage of the population said, “I would not have minded in the past donating my organs, but if the Government is going to claim them then you can get lost”. That is the real danger.

Brian Whittle

Your focus is very much on the opt-out there. Surely the outcome should be about the number of organ donations that are made rather than who is opting out.

Dr Macdonald

Indeed, but that is the point. The number of deceased organ donations has increased in other parts of the UK, but it does not seem to be increasing steadily in Wales. We need to get to the bottom of the reasons for that. The Welsh Government made all sorts of claims based on an academic study that there would be an increase of 25 to 30 per cent. We have to give it a bit longer to see how things develop, but the evidence to date suggests that that increase is not happening. That being the case, the danger is that you have an adverse impact rather than the positive impact that you were hoping to have, whereas if you did other things you could have that positive impact.

To be fair to the Scottish Government, that is what it has been doing. It has been putting a lot of effort into improving communication and putting extra resources into organ donation, which is why we have seen the rates, the number of donors and the number of people who are opting in rising steadily in Scotland.

11:45  



Fiona Loud

I go back to what we can learn from Wales; I have no doubt that the committee will also take evidence from folk in Wales. To turn it around the other way, the startling increase in consent is a strong result of the impact of the work they have done there. It is also about learning from what they learnt in Wales about the importance of training staff—they knew about that but it was important to see it in action—and also of keeping families and family members informed on what the new rules are and what the law means. If we turn it around that way, far more members of the public in Wales know about organ donation and, as a consequence, more families have agreed to donate, through whichever route they have gone.

We would far rather have 80 per cent of the population be willing to donate, with the option for those who do not wish to donate, for whatever reason. I am not sure that we know enough about why people would have taken the option to opt out already, but that might be something to look at in the future. It is their right and there is no way that any of this is about a compulsion. It is about changing the default position so that Scotland is a country that accepts that organ donation is the natural thing to do with all the safeguards that I know we are discussing.

Keith Brown

I am fascinated by the evidence so far. I think that Fiona Loud referred to the person being content to have given their deemed consent; of course, the bill makes no provision for that. Shaben Begum, quite rightly, mentioned a scenario in which family members might have different views. Gordon Macdonald mentioned the fact that clinicians will have an obligation to listen to the families, although I would have thought that they would have an obligation to the person. The individual may or may not be a patient, as they could be deceased; I do not know what their legal standing would be.

It strikes me that, in such scenarios, the individual whose body it is could come third or fourth after the state, after the family, and potentially after the interest of the clinicians. Surely there must be some recognition of the rights of the individual—we have heard very little about that so far—especially if they have expressed a wish either to donate or not to donate.

Rather than asking a direct question, I am interested in hearing the witnesses’ views on the rights of the individual whose body it is.

Shaben Begum

The individual’s rights are paramount. The issue that I touched on earlier is that we cannot have a situation in which there is even a perception of compulsion in the bill.

It is interesting that you mentioned the state having rights. There could be a tricky situation of balancing the rights of different groups—that is always tricky—and the individual’s rights need to be paramount. We cannot have a situation in which clinicians know that there are other patients waiting for organs—for a kidney or whatever—and that that is their motivation for carrying out a procedure. The wishes of the individual should be given the highest consideration.

Dr Macdonald

The heart of the debate is that the view of the individual who is the donor, if it has been expressed, should be respected. There is no question about that. Clearly, in some situations families have overruled that. That is a difficult scenario for clinical staff and more work needs to be done with families in order to reduce the risk of that happening. The autonomy of people who are mentally competent and who have made a decision must be respected.

The issue that arises concerns the people who have not expressed a view one way or the other. The majority of those people would probably be content to donate, but some of them would not be content to donate; in those situations the state would be claiming a right that overrules that individual’s right. Under the present system, in essence the family makes the decision. The family says, “They haven’t made a decision, but we think that it would have been—”. The family might be reflecting the deceased’s view or it might be reflecting its own view, but in a sense that is the best that we can do in trying to get consent.

It is important philosophically for us to understand that the state does not have rights over us. The state has responsibilities to respect our rights—that is how human rights work. The duty is on the state to respect our rights and the rights are not given to us by the state but are inherent. Human rights legislation is about recognising the fact that we have inherent human rights.

When we get into a discussion that implies that the state somehow or other has rights over our bodies or other parts of our person—I am sure that that is not what Keith Brown intended—that is quite a dangerous philosophical step for us to take as a society. We need to be very careful not to be so focused on the pragmatism of trying to increase the number of donations, and on doing anything to achieve that, that we end up crossing a red line in the relationship between the state and the individual.

Fiona Loud

If an individual has expressed a wish to opt in or opt out, it is absolutely right that that should be honoured. We have worked with many patients who have said that they want to donate and that they do not want anyone to be able to override that. In practice, we know that the views of someone who has opted in are occasionally overridden because currently the family has to make the final decision. If the rules are to change, we must have a very careful and nuanced conversation about where that goes and what that means, in order to provide the patient’s family with the opportunity to say, “That person has changed their mind and we know they have changed their mind,” because people might change their minds.

We heard earlier from Gillian Hollis, who said she had changed her mind about how these things will work; others may do that, too. It is important that we provide that opportunity and that the safeguard is there, but that we honour the right of the individual when they have expressed their view. There are people who have not expressed a view, and for whom no other view is known, and that is the situation that the communication, the discussion and all those other things should be addressing. That is why it is very important that we are as clear as we possibly can be on what the new rules are, should the rules change.

Miles Briggs

I want to come back to the rights of families in a soft opt-out, because that is where the committee has focused some attention. Dr Macdonald, you were involved with a past bill; I think that this is the third bill on the subject that Parliament has considered. Has the current bill addressed some of the concerns? Have you seen some positive steps forward?

Dr Macdonald

I will need to rack my brains as to what the details were in the past bill. As I recall, there were concerns last time about the practical procedures and that was one of the main reasons why the committee rejected the bill.

I was interested to read in the SPICe briefing that the majority of committee members also rejected the bill because they were not convinced that it would make any difference to the numbers. I gave evidence as part of a private and informal consultation, at which two MSPs and a whole bunch of people were sitting round the table and it was very noticeable that everybody, from a variety of faith perspectives, had reservations. I do not know whether that had an impact on the committee’s decision, given that only two MSPs were there. Somewhat ironically, there was more unanimity on this issue than there is on many issues between different people from different faith traditions.

Fiona Loud

I understood that the concern was to do with the practicalities and perhaps with the bill being a little bit overcomplex. This bill is more straightforward, and perhaps there are more things that we can discuss about making it as straightforward as possible. Some of the previous witnesses discussed that.

Shaben Begum

Quite often, legislation is not that accessible. Perhaps the challenge this time round is to make the bill as accessible as possible, and to engage the public in the consultation.

Brian Whittle

My question is on the idea that, if this legislation goes through, all of a sudden that will make a huge impact on the number of donors. Do you accept that a period of time will be required for the legislation to cascade down, and that there might be an increase in family consent that might lead to an increase in donation somewhere down the line? Are there examples from around the world in which such an increase has been seen over a period of time? I wonder whether there is a period of time that we should expect, or that we should at least be willing to work towards, that would help in that conversation.

Fiona Loud

Absolutely. There is not a magic wand that we can just wave and suddenly everything will be marvellous; if there was, we would probably have changed the system an awful long time ago.

Wales made the change three years ago, in December 2015, and it is still learning. Work is still being done there and I believe that the Welsh Government is looking at a period of up to 10 years before it does a final evaluation. In other countries that have been quoted, such as Spain and Croatia, again it has taken a number of years before the big changes have started to come into play.

Please correct me if I am wrong, but I think that the financial memorandum to the bill says that we should not expect increased capacity for transplantation until something like year 4. In other words, there is already a realisation that there will be a period of time before we get the uptake. It could take five to 10 years, because it is a whole lifetime change. It will also take time for the message to come through and be taken up by many of the younger generation—we know that they tend to sign up and opt in quite willingly—in the education system, as well as for those people to mature in their own lives. That is my suggestion, based on that evidence.

Dr Macdonald

The figures from Wales are interesting. In 2014-15, there were 128 deceased donor transplants. The legislation changed in 2015-16, as we heard, and the figure was 168. However, in 2016-17 the figure was 135 and for 2017-18 it was 139. We do not have data from Wales for a long period, but the limited data that we have does not suggest that the new system has made a spectacular difference. In fact, it might have reduced the figures compared with those for the 2015-16 period, but that is speculation because ultimately the biggest impact on the figures is the number of people who are dying in the appropriate circumstances. Again, there is sometimes a misconception that there will be a huge increase in the number of organs available, because only 1 per cent of deaths happen in the appropriate circumstances in which a donation can take place. That is the key factor in donor rates.

Alex Cole-Hamilton

Good morning, panel. Dr Macdonald, I know that you are not in favour of the bill, but I was struck by what you said about how we could improve organ donations; it was about dealing with administration. My question—particularly to Dr Macdonald and Shaben Begum—arises from what we do at the moment when we are consulting families and what we might do in the context of the bill. We met specialist nurses, who took us through the process, which revealed that something like 300 questions are put to grieving families at their most vulnerable time. That leads to many families overriding their family member’s wishes and just saying, “Listen, I do not want to be part of this anymore.”

Obviously, advocacy and getting people’s views are important. However, could we use the bill to simplify that process so that people can express their views without having to go into intimate detail around their partner, or their son or daughter’s lifestyle, and their suitability for transplant?

12:00  



Shaben Begum

I was a little bit taken aback by the fact that there are 300 questions. I think that that will be a barrier if family members are in an emotional situation and cannot think that clearly, especially when there is a dispute.

I spoke about my family being in that scenario. I would completely support a reduction in the number of questions, and in their significance and intrusive nature. The intrusive nature of the questions was mentioned earlier.

Advocacy would work well in those situations. People could plan ahead and help others to think about what it would mean to opt in. It would also give the individual the strength and courage to have those conversations with their family members. Advocacy might help people who have capacity issues or communication difficulties, but I think that non-instructed advocacy would work well in those situations. We talked earlier about the pre-death situation. I might not be able to speak for myself, but a non-instructed advocate might be able to safeguard my wishes in that situation.

We were asked earlier whether the bill will make a difference straight away. I think that the bill is an example of a cultural shift that we need to have. It is not a panacea, and it will not sort everything out immediately. It is about changing our culture around these issues. Advocacy would play a key role in different situations for different people.

Dr Macdonald

If the problem is with the administrative system, legislation is unlikely to make a difference. The key thing that will make a difference is reviewing the administrative system.

I was surprised to hear the figure of 300 questions; I find that astonishing. If we are talking about 300 questions being asked in the current system—in which people have opted in—putting people into a situation of presumed consent, and putting relatives through such an onerous process, is likely to cause great angst if the relatives are not convinced of the person’s wishes. That needs to be thought about.

Clearly, the system should be reviewed to see whether we can reduce the number of questions. You would need to talk to clinicians to see how that could be done. If the system is so burdensome, I would caution against creating a situation in which relatives, at a very difficult time, are put in the position of having to answer 300 questions when they are not convinced in the first place that the deceased or the dying person would have wanted it.

The Convener

In fact, up to 350 questions might be asked. However, some of those questions are asked during particular lines of questioning in response to an earlier answer, so by no means everyone is answering 300 questions.

Fiona Loud

That is a helpful clarification.

At the moment, the specialist nurses will be asking a whole range of questions, which will be necessary. I cannot comment on the questions themselves, because they will be to do with safeguarding and that side of things. In England, I believe that rather than writing the questions, or the need to ask them, into the law the plan is for them to be covered by the code of practice, so that it can be consulted on separately through the Human Tissue Authority. In order to keep the bill as simple as possible, I suggest that that side of things could be covered in the code of practice; it would still be absolutely and correctly dealt with, but it would perhaps not come up as a potential barrier to the law being introduced.

That is one suggestion, alongside the fact that there are already a range of questions that will be asked very sensitively by well-trained specialist nurses. We have heard from families who find those questions distressing, but the families that we have heard from have also said that they appreciate why the questions are being asked, because if they are in favour of donation they want it to go through. Keeping the process simple and perhaps removing it from the law but including it in the code of practice would be a different approach.

Dr Macdonald

If there are good clinical safety reasons why questions need to be asked, presumably those questions will still need to be asked even under a system of presumed consent. That is the key point that I am trying to make.

The Convener

It is a fair point.

David Torrance

In Wales, deemed consent applies to people aged 18 and over. In Scotland, deemed authorisation would apply to potential donors aged 16 and over. Do you agree with 16 being the age at which deemed authorisation would apply?

Dr Macdonald

We do not agree in principle anyway, but the point that you make is valid and needs to be looked into because, if legislation was different on either side of the border, there is a danger that there could be some sort of judicial review of a particular case.

Fiona Loud

The messaging would have to be very careful if the age threshold was different here. I also think that the implications of there being a difference should be considered further, with regard to whether it would be better to be harmonious with the rest of the country or to stay with the proposed age threshold.

Shaben Begum

We support 16 being the age at which deemed authorisation would apply, but I point out that there are a lot of anomalies in different pieces of legislation with regard to when someone is considered to be a child. For example, the age of consent is 16, but young people are considered to be adults at other ages in other legislation. This would be another such anomaly.

David Torrance

As we have heard, the 16-and-under age group is sometimes a difficult one to engage with—it is especially difficult to get them to engage with their parents. How can we provide sufficient opportunity for young people in that age group to express their wishes?

Fiona Loud

I am going to say education, education, education. In terms of the school curriculum, I know that there are some excellent tools already out there that are aimed at secondary schools and particularly at people of 15 and 16—not just the slightly older younger people, if that makes sense.

It is also important to encourage people to have those conversations with their families, because, as we often say, children are the change makers. If we give children a good amount of education on the issues—not in terms of what they must or must not do, but as part of the education that they receive on health and being a part of society—we can ensure that they receive unbiased information about what it might mean and can be encouraged to talk it through with their families.

Shaben Begum

The dealings that I have personally and professionally with young people suggest to me that some of them are much more enlightened and open-minded than lots of older people or adults. I completely support Fiona Loud’s point about education and awareness raising, but I think that there would be examples of young people changing the minds of their family members and parents as well.

Fiona Loud

I agree. That is why I made the comment about children as change makers.

Dr Macdonald

I signed up to the organ donor register when I was renewing my car tax—I was offered the option as part of the process and I thought, “Well, okay”. It would seem to me that there are opportunities in the system to engage young people—for example, when people sit their driving test or apply for a driving licence, although maybe not when they apply for their Young Scot card, as that involves people of a younger age. Those opportunities could be taken, and there could even be opportunities to allow people who are younger than 16 to express a view without necessarily making a commitment.

Fiona Loud

Social media are, obviously, incredibly important to young people, most of whom will be world experts in them before they get anywhere near 16. It is important to use that approach.

Sandra White

Good morning. I will ask this panel the question that I asked the previous panel about pre-death procedures—the name is bad enough anyway. Concerns about the procedures have been raised with us. Basically, legislation for the procedures is being considered, but the detail of those procedures is not yet in place. Other people have raised concerns about pre-death procedures going ahead under deemed authorisation. What are your thoughts on the pre-death procedures? Shaben Begum talked about advocacy, and perhaps that should be included before someone gets to that stage.

Shaben Begum

In relation to advocacy, the constituency that we are interested in in this context would be people who have limited capacity with regard to communication, and people who are covered by the 2015 act, because I would not want to see the legislation discriminating against a group of people and saying that they cannot donate their organs.

Capacity is not a black and white issue. Someone who can make decisions about certain aspects of their life might be deemed not to be able to do so in relation to other aspects, such as their finances. We have safeguards such as guardianship and power of attorney, and those are the places where I think that there needs to be consideration with regard to organ donation. That would be part of a national conversation around donation.

The situations that we are talking about are not scheduled—they cannot be planned for. In those situations, non-instructed advocacy might play a crucial role in ensuring that the rights and wishes of the person are respected. Earlier, we raised the issue of balancing the rights of the family, the state and the individual, and advocacy plays a crucial role in redressing the inherent imbalances of power and dynamics within relationships. The issue that we are discussing would be a prime example of that. There needs to be somebody there who is independent and does not have any agenda within the situation but is there to safeguard an individual’s wishes and reinforce their rights and ensure that their rights and wishes are being listened to appropriately.

Other people within that dynamic and within that situation will have their own agendas and their own wishes, but especially when an individual does not have a physical voice, it is important that there is a mechanism for ensuring that their views are heard.

Dr Macdonald

One can understand why pre-death procedures would take place. As we heard earlier, the idea is to maximise the likelihood of the success of a donation. Where I think there might be a concern would be if there was any impact upon the care of a person who would otherwise not be dying, for example—we cited the UK Supreme Court’s recent judgment in relation to people with severe neurological conditions and so on. You also raised in the earlier session the issue of people whose brain might still be functioning even though their heart has stopped beating. Certainly, I have heard people express concerns about organ donation on that basis in the past. Those issues need to be carefully considered.

Fiona Loud

The concept of an advocate could be helpful in some situations, as Shaben Begum said. It is important to be clear and transparent, and we should look to do that, but we must also be sensitive to the fact that not all families want to know all the details, by any means. They want to know what is going to happen, how long it is going to take and so on, but they do not necessarily want to know everything. They have a right to be supported through the donation process by a well-trained member of staff.

12:15  



Emma Harper

Sandra White brought up pre-death procedures, and Shaben Begum mentioned incapacity. Does the bill adequately cover people who might have communication difficulties or incapacity difficulties, and should the language in the bill be widened to cover that?

Shaben Begum

Our feeling was that it does not adequately cover those groups of people, and that it needs to be strengthened.

Alex Cole-Hamilton

I have a question about capacity and the financial memorandum. I am conscious that none of you are clinicians, but you may have a view. From your experience of working in the transplant world—I direct this part of the question to Fiona Loud in particular—do you think that there is going to be sufficient capacity built in after the legislation is passed to meet any increased demand, and are we making enough money available to that end in terms of workforce planning?

Fiona Loud

I welcome the fact that the financial memorandum contains an estimate of when numbers of staff need to go up to support the anticipated increase in transplantation—I believe that it says that that will be in year 4. I think that that is the right thing to do, but we need to watch very carefully and evaluate how things are working as we go along, because we do not want families who wish to donate being put off by delays in the system. Recently, I asked about this issue in Wales, following some work that had been done there. They did not feel that the issue had been a problem, but they were aware that it might become one.

With a different hat on, I am a chair of an organ donation committee at my local hospital, and I am quite aware of the need to be able to make theatre space available in order to go forward with a donation from a family. From my experience there and in other hospitals, I know that chief executives of trusts are very supportive of that and understand the issue. However, we need to be cognisant of the fact that, as I said earlier, these circumstances are not always planned, and, often, the donations will take place in the middle of the night. It is important to ensure that appropriately trained surgical staff are available, as well as an adequate space. We need to have put some plans in place in that regard and we must watch very carefully how things develop to ensure that we can continue to do the right thing.

Shaben Begum

In addition to the points that Fiona Loud has made, there needs to be proper training around capacity. There is a danger that we think only about the capacity of the person who is going to be the organ donor, but there needs to be proper consideration of the capacity of the family who might be making a decision and who might all disagree with or support the decision and so on. There needs to be proper training for staff around that as well.

Dr Macdonald

I come back to my earlier point. I cannot comment on whether the Government’s planning in relation to the financial aspects of the legislation is accurate or sufficient, but we think that it would be better to use the resource that has been committed to this in other ways.

The Convener

I thank all of our witnesses once again. The session has been helpful. As I said to the previous panel, if you have any questions for us or further information that would be helpful to the committee, feel free to get in touch.

12:19 Meeting continued in private until 12:52.  



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Second meeting transcript

The Convener (Lewis Macdonald)

Welcome to the 29th meeting in 2018 of the Health and Sport Committee. I ask everyone in the room to ensure that mobile phones are off or switched to silent. Although you are very welcome to use devices for social media purposes, please do not film or record proceedings, because that will be done for us by Parliament staff.

The first item of business is consideration of evidence on the Human Tissue (Authorisation) (Scotland) Bill that we heard today in informal sessions. I am delighted that a number of those who gave that evidence are in the gallery.

The committee heard from three groups: people who have received donated organs, family members who have authorised the donation of organs, and people who are currently on the organ transplant waiting list. Before we take formal evidence, I ask colleagues, starting with Emma Harper, to feed back on those informal sessions.

Emma Harper (South Scotland) (SNP)

Brian Whittle and I had an interesting session. A theme that came out of it was that education is critical for engaging families and potential donors and for getting them to record their wishes on the organ donation register. People are generally supportive of presumed consent, but the critical goal would be to engage people as early as possible and in certain ways so that they express their wishes.

We had some discussion of economic arguments about the costs and benefits of organ donation versus dialysis. That was an interesting side topic.

We also discussed how important it is for a person to know that an organ has been donated as a gift rather than through presumed consent. The feeling is that it is an amazing thing to be given an organ, although donor information is not often sought. However, any available organ is welcome.

Brian Whittle (South Scotland) (Con)

The overwhelming message for me was that the public’s understanding of organ donation—what is involved in it and what the lifespan of an organ is when it is donated—is very poor. If the person who receives the organ is a young person, the likelihood is that they will need two or even three organs throughout their lifetime. As Emma Harper said, it is about education.

One thing that jumped out in response to one of my questions, which I was not quite expecting, was about where the tension would lie if we had presumed consent and an opt-in. That was quite an interesting discussion.

Miles Briggs (Lothian) (Con)

I will not repeat points that Emma Harper described that our group also made. I record our thanks to the individuals and the families who came to speak to us.

I picked up specific points about conversations with families and people across Scotland, which I hope can be taken forward in the bill. It is important that we try to have these conversations with our loved ones and express our wishes.

Key points were made about the public information campaign that will be needed. As Emma Harper mentioned, two key principles were highlighted: one was about the gift of life and the other was that family decision making should be included.

A few points are worth developing. One was about people using advance directives to make known their view. We have not looked at that in as much detail as we should. In addition to that, because of complex relationships and changing family types across Scotland, it might in the future not be clear who the next of kin is. We need to look at that.

It is worth putting it on the record that people’s experience of key professionals and organ donor nurse teams is absolutely excellent. Everyone to whom we spoke today outlined how good those people and the support that they provided had been.

The Convener

Thank you very much. Was the group that you talked to made up of families who had authorised donation of organs?

Miles Briggs

Yes.

The Convener

Were other members in that group?

Keith Brown (Clackmannanshire and Dunblane) (SNP)

Yes. It was interesting; I thank those who came along. It was quite a difficult session, but it was really helpful. I will talk about some of the issues that were raised.

One issue was the possibility that families could be divided on the question when they are put in that position. Where do the donor’s interests lie in those circumstances?

The burden of the extra 24 hours was mentioned by a number of people. Pre-death procedures have to happen. One woman in particular spoke about being put in that situation when you are in a bit of a dwam—that is the best way to describe it. People have to deal with so much at that time, so is it fair to put people in that situation?

There is also the idea of the organ as a gift. Is it a gift if the state has a pre-emptive right to organs? Is it a gift if it is given by somebody other than the person to whom the organs belong? Those are really interesting questions. It was obviously difficult for the families. My last point about the gift is that the way that it is currently done—with the medal, the recognition and the information that is passed to donors’ families about where organs have gone—is really appreciated. That should not be lost, no matter what happens with the bill.

Sandra White (Glasgow Kelvin) (SNP)

Miles Briggs and Keith Brown have covered the issues very well, particularly the idea of the gift, which came across strongly.

One of the areas I explored was pre-death procedures. The 24 to 36 hours was quite a harrowing time for the families of the people. I did not realise that in some cases, people who were brain dead were actually still breathing. The evidence that was given was very moving, and I thank the families very much. We need to explore pre-death procedures. People are not educated enough about the different ways in which organs have to be preserved. That issue stood out for me. Keith Brown and Miles Briggs have also raised some really good points.

The Convener

The third group to whom members talked were people who had received donations of organs; I was privileged to be part of that discussion. It was another very moving discussion that put a clear focus on the lived experience of patients who have waited—sometimes for a long time and sometimes for a short time—in intensive care for an organ donation, and the different ways in which individuals respond to those circumstances. There is no right way to deal with that; clearly, people respond in a variety of ways. It was a very useful and informative session.

Alex Cole-Hamilton (Edinburgh Western) (LD)

It was very moving and, equally, inspiring. The takeaway for me was definitely the lived experience, as you described, convener. The reality of how little support we offer transplant patients, either pre-op or post-op, particularly in respect of mental health, was quite stark. People are dealing with a challenging and unique set of circumstances. It was described as a “rollercoaster” of emotion, particularly when the person gets a call in the middle of the night to come for their transplant, only to be told when they do that it is not going to happen. The problem also applies in respect of recovery. That, for me, is where there is a real gap. If we do nothing about it in the bill, we will have failed.

I was touched by the fact that all the transplant patients whom we met have been giving back in some way—for example, through meeting transplant patients who are waiting for operations and talking about their experience to help those patients along.

There is anxiety around medication and the fact that we are asking transplant patients to run down their supplies of anti-rejection medication right to the end before they get their repeat prescription. Brexit is a concern, in that anti-rejection medication might be among the medicines that we will struggle to get if we crash out of the European Union with no deal.

David Torrance (Kirkcaldy) (SNP)

I record my thanks to individuals who came along today to give evidence. Education will play a key role in our engagement with the younger generation, if the deemed age of consent is going to be 16. The evidence that we took this morning highlighted the lack of support, especially for mental health issues, and it highlighted that it is important that a donated organ is a gift.

The Convener

That is right. The significance of an organ being a gift was fed back in different ways from all the groups.

One of my overall conclusions was about the value of networks. The transplant games were mentioned in our discussions, as was the family donor network. The networks are important, and I am glad that in some way our evidence sessions have allowed more network building to be done by people who are involved.

I repeat the thanks of all my colleagues to all those who provided evidence this morning. It was extremely valuable and will certainly inform our further proceedings.

We move to the first formal session of evidence on the bill. I welcome to the committee Dr Sue Robertson, who is the deputy chair of the British Medical Association Scotland; Rachel Cackett, who is a policy adviser at the Royal College of Nursing Scotland; and Mary Agnew, who is assistant director for standards and ethics at the General Medical Council. Thank you for your patience.

We will go straight to the heart of the matter, which is whether deemed authorisation will achieve the objective that everyone has set for it—that is, to increase donations—or have perverse negative effects. I ask that as a general opening question about the fundamental principle of the bill and because of its being the fundamental tool within the bill for achieving change. Is the bill fit for purpose?

Dr Sue Robertson (British Medical Association)

Before I speak on behalf of the BMA, I should mention, so that you know my background, that I am a doctor who looks after patients who are waiting for transplants and patients who have received transplants.

The Convener

That is helpful. Thank you.

Dr Robertson

Today, I speak on behalf of the BMA, and not personally. We have long supported a move to a soft opt-out system as part of a package to deliver more transplants for patients who need them. We do not think that such a system can be a stand-alone thing. It will not help our patients unless it is part of an investment in infrastructure to support delivery of that ethos, and to make available more organs for donation. However, we definitely support the move: we have done for a long time.

Rachel Cackett (Royal College of Nursing Scotland)

Thank you for giving the RCN the opportunity to come. It was great to sit and listen to the feedback from your session with patients and families this morning.

As we said in our evidence, the RCN consulted our membership back at the start of the year on a position on consent for organ and tissue donation. Overwhelmingly, our members support a move to an opt-out. Our Welsh members support the existing legislation in Wales: the Human Transplantation (Wales) Act 2013.

That support for an opt-out came with a series of conditions attached, which we have detailed in our response. I am happy to talk about any of those in the context of how they are reflected in the bill.

You have been talking in your feedback from your informal sessions this morning about education being mentioned a lot. The figures that really struck us from our consultation were that, of our members who responded, only 25 per cent felt that they could speak with confidence about organ donation, only 22 per cent felt that they could speak with confidence about tissue donation and only 10 per cent felt that patients and their families had had much discussion of the topic.

Although we are clear that those who get into the details of authorisation should be specialist nurses in organ donation—the expertise to do that sits with them—wider discussions need to happen at other points to support families and individuals to make an informed choice, and we need to come back to those in the support mechanism.

There are many other things that need to be in place to make sure that the bill supports an increase in successful donation.

10:45  



Mary Agnew (General Medical Council)

Thank you very much for giving the GMC the opportunity to contribute to the discussion. We are extremely supportive of the bill’s underlying aim to increase donation rates. In our written submission we have not taken a formal position on whether the bill is the best way to achieve it. That is because, in our role as the medical regulator, we think that that is a matter that is rightly for discussion in Parliament, with the public, rather than one on which we would take a position.

The points that we have made are about where we think there could be more clarity on how the bill will work in practice to support health professionals to act ethically in partnership with patients and their families. I strongly underline the theme that has been coming out already of the importance of education, in terms of public understanding and support for health professionals in what can be very difficult circumstances and sensitive conversations.

The Convener

Thank you very much—I appreciate that.

The committee has conducted a survey in order to try to gauge what the impact of the bill might be and to gather some public opinion. Deemed authorisation clearly creates a presumption in favour of transplant for people who do not opt out, but we found that the number of people who would opt out increased, and that most of those who would were people who had no particular opinion beforehand. My question is for the witnesses who have said that deemed authorisation is a good thing and for whom it is a policy position. Is there a danger of a backlash—of losing on the swings what you gain on the roundabouts—from people who have no particular view at the moment being encouraged to come to a view and taking a negative position?

Dr Robertson

Internationally, there is no evidence that the policy is likely to reduce consent rates; in fact, it tends to have a positive effect if it is done in association with other measures to support it. Wales is the closest country to us in terms of the policy. There, there has been similar legislative change in the past couple of years and there is no evidence that consent rates have gone down. Family consent rates have probably gone up. That is, to a great extent, a result of public information and education of families: the subject has become a conversation that people are much more likely to have in the cold light of day, when everybody is well, rather than on the most distressing day of their lives.

We think that the policy is unlikely to reduce consent rates and that it will, if anything, enhance them. We also think that it is really important that individuals who do not wish their organs to be used for transplant have the opportunity to register that wish.

Rachel Cackett

I agree with much of what Dr Robertson has just said. From talking to colleagues in Wales, I think that the important thing has been that the conversation has been supported by other changes. The conversation is important, so that people get to the point of informed choice. For families, for patients and for staff who support discussions at the end of life, it is important that there is informed choice, whatever that choice is. The college’s experience to date has been that the conversation is what matters, which is why we keep coming back to education.

Mary Agnew

I agree with that sentiment about informed consent; early and wide discussion is really helpful.

Keith Brown

Dr Robertson mentioned family consent. My concern is that if the bill is passed, presumed consent will mean that the rights of the state will supersede those of individuals who have not expressed a preference. I am also concerned that families’ rights might, in some circumstances, supersede the rights of individuals. We have heard evidence today that family members who are consulted—although there is priority attached to family members depending on their status—might disagree with donation, which can put them in a difficult position.

An example is the lady who mentioned that she had given consent but not for all organs, and regretted having not done so. I am interested to hear where you believe the rights of the donor—whose organs would be used—come in relation to the rights of the state, as expressed through the bill, of families and of the medical profession.

Dr Robertson

That is a very difficult issue. Again, we come back to the need to have the conversation early, which is one of the main thrusts of this. If people have the conversation with their loved ones about what they wish to happen to their organs in the event of their death, their loved ones will know that that is their wish.

Sometimes, obviously, family members disagree. That is very difficult and very distressing and—as I have already said—it can happen on the worst day of their lives. Families would not be asked for consent: they would be asked for information about their relative’s wishes. That is, perhaps, an easier conversation for a family to have than the one that they have at present.

As a doctor, I feel that under the soft opt-out, if the healthcare professionals felt that the situation would cause undue distress to the family, we have a duty of care to them, as well, so in such cases authorisation should not go ahead.

Mary Agnew

A doctor’s duty is, first and foremost, to the patient. We welcome the principle in the bill of doing what can be done to establish what the patient’s wishes are. A principle in terms of the family’s involvement would be about being considerate, sensitive and responsive to the people who are close to the patient.

The reasons for refusal are interesting—often, it has been because the patient’s wishes were not known, so in the context of a wider system, in which everyone is being encouraged to state their reasons and is given the choice to opt in or opt out, perhaps the conversations will become a little easier.

I very much agree with Dr Robertson that, in situations of extreme distress to the family, you would not want to put professionals in a position in which it was felt that they had somehow to override the family.

Rachel Cackett

Obviously the RCN’s position is that we support deemed consent, but as I said, the college has taken the position that safeguards need to be put in place. There are two that are really important in the context of the question that Keith Brown asked.

First, we are very clear that trained health professionals need to discuss the expressed wishes of the deceased person with the family. If members look at the figures that are presented in the Scottish Parliament information centre’s briefing, you will see the important difference that the involvement of a highly trained specialist nurse can make in terms of authorisation rates.

It is important to go back to the point that Mary Agnew made, which is that the professionals who do this at a very difficult time for families are highly trained; they are sensitive in the conversations that have and they have an ongoing relationship with the family.

We are also very clear that no practitioner should be put in the position of having to force a donation. Our understanding is that, in practice, that is the situation in Wales. Our position is that, if a family does not want a donation to go ahead, donation should not be forced.

That goes back to one of the issues that we have raised on the bill, which is the duty to inquire. It is absolutely true that the practitioners who are involved at such times, and the SNODs—specialist nurses in organ donation—have to have very difficult conversations with people who are facing bereavement or who have just been bereaved. It is important that we are absolutely clear what we expect of our practitioners.

It would certainly be helpful during the bill’s progress to understand better why the duty to inquire is being placed on individual practitioners rather than being placed at organisation level, because there will, potentially, be disagreements. SNODs are trained to deal with that, to manage the process and to help people to navigate through it. However, it is very important that, in statutory and legislative terms, we understand the duties that we are placing on our individual practitioners.

Keith Brown

I should say that we heard in earlier evidence nothing but praise for the people who are involved in the process, but we are faced with passing a law and difficult questions have to be asked.

I am getting the sense—I do not want to paraphrase unfairly—that the views of the donor are not paramount. Those views could, in the case of presumed consent where the person has not expressed a preference, be subordinated to those of the state in order to allow donation to go ahead, or to the views of the family. It is often down to chance which member of the family is consulted, for various reasons. If the family member is distressed—even though the deceased expressed, when in full control of their faculties, that they wanted to donate—that wish could be overturned by the family.

You have also expressed concern that health professionals should not be put in that position. It could be argued that that could not happen if it were made clear in the law that the views of the donor should be paramount.

I will make a last point. Dr Robertson said that the families might not give consent. That is exactly what has been described—that donation will not go ahead when the family feels strongly that it should not. That is not a definition of consent, I would have said. I am trying to make the point about the views of the donor, because the bill will become the law, if it is passed.

Rachel Cackett

To clarify our position, I will read the wording, because it makes a difference.

“Trained health professionals must discuss the expressed wishes of the deceased person with the person’s family, where contactable, before any donation proceeds. If a family does not want a donation to go ahead it will not be forced.”

We come back to my understanding of what the bill is trying to do, which is to say that a conversation is needed about the wishes of the deceased person. There is an important distinction between the wishes of the family and the wishes of the deceased person—an important break that our members felt it was important to put in the bill. When we are dealing with people who are in grief, it is important that the conversation can be had, and that it can be conducted sensitively by people who are properly trained to do that.

The Convener

SNODs demonstrated to the committee some time ago the process of asking questions, and the length of time and complexity that it can require. If a family has a discussion about the expressed wishes of the potential donor but then declines to answer the questions, does that amount to a veto? Is that a realistic proposition? Does it happen? Is there evidence that families, for good reasons or bad—because they cannot or because they choose not to—do not answer the questions that are asked?

Rachel Cackett

I do not sit here as a practitioner who does this every day. I am aware that the committee will hear from colleagues from NHS Blood and Transplant in the next session; I would prefer to leave it to them to answer on that practical detail.

Miles Briggs

I want to develop further the discussion around the rights of the family because, as Keith Brown was saying, they are an important aspect of what could be lost in the new bill. Around 100 donors a year in Scotland are lost due to families refusing to donate their loved one’s organs, including people who have actually recorded their wishes in the organ donor register. Should the bill reflect the current convention, which in effect gives families a right of veto?

Dr Robertson

Again, we need to look to Wales. Family consent rates are higher in Wales than they are in Scotland, which perhaps reflects the change in the legislation there and the fact that the public know more now about organ donation than they ever did in the past. One of the themes that came out of the committee’s earlier discussion was that education is key. If people understand what is involved and understand the benefits and the needs of the patients—who could be a friend of theirs, a member of their family or them in the future—they are much more likely to wish that they could help them by offering them a gift of life. Whenever I speak to anybody about organ donation and explain it in simple terms, generally they say, “Oh. I understand now. That makes much more sense.”

Education is key: educating the public; and educating health professionals about how the process might change. To some extent, educating the public is already being done—we have real-life stories coming out, so people see the benefits of organ donation much more. However, we still need to educate them some more and help them to have the conversations. That would get over much of the perceived problem.

11:00  



Rachel Cackett

I come back to the statement that our members have agreed and how we reflect that in legislation and in practice—that is what our members are asking for. The important point to come back to, and the one that we make repeatedly, is that we need investment in the infrastructure and the expertise to support discussions to go around this legislation. If the current bill is passed, we need trained professionals to be involved in the discussions—our members should not be put in the position of having to force something. I come back to the message about the expressed wishes of the deceased person and how we reflect that in the legislation—I guess that there are many ways to do that. Our understanding is that that is what happens in practice with the Welsh legislation.

Mary Agnew

I would agree with that. With public awareness—such that people are talking to their families about their wishes and these are not decisions that are taken in the heat of a crisis—a greater proportion of families would be much more comfortable and much more understanding of what is going on.

There is a significant shift with this legislation. I would not see it as giving a power of veto, and when we talk about not forcing health professionals, in practice we are probably talking about quite a small number of situations. However, the risk in saying that removal of organs will have to go ahead in some situations is that there is potentially an impact on trust in the medical and nursing profession, so that could be quite a damaging route. You would want to retain the ability to take the family’s views into account where they are very strongly held, while seeing the patient’s express wishes as what you ought to be following.

Miles Briggs

Given the conversations that we have had with people over a number of years in the Parliament, which has looked at different bills, to some extent people think that the law has already changed. Do any of you have specific concerns around deemed authorisation in the new bill increasing family uncertainty?

Rachel Cackett

I feel that we keep coming back to the same point, which is that it comes down to the education package that goes around this. If what you want is families to have an open conversation about what a person’s expressed wish is, whether, under this legislation, it has been to opt in, opt out or do neither, you want to discuss an active choice.

One of the issues that we raised in our written submission is the money that we see going into NHSBT and the specialist nursing community. That is really welcome and we absolutely support that going ahead, because that is the crucible—that is where the decision making goes ahead. However, our members told us that they thought that there was a much wider need for education—and I gave some figures at the start about how many of our members who responded were comfortable with these issues; so there is a bigger set of money that requires to go out. Those in NHSBT may not be the right people to go out and do this—it may be a Government issue—but we need to go out and work with the wider health community, because we want the conversation to be supported early, whether someone is in a school with a school nurse or in a general practitioner’s surgery with a practice nurse. You would not expect those members of staff to have the sort of expertise or to go into the sort of detail that you would want from your SNOD, but you would want them at least to be able to answer some basic questions and to do so in an informed way, to ensure that the public can make the right choice—however they then choose to express that.

Miles Briggs

One of the most interesting aspects of this is the issues that can arise when people have made their wishes known—especially the issue to do with eyes not being donated. I am struck by the fact that the bill might not get around that issue when it comes to families completing the questionnaire, so it is worth considering public information around the questionnaire in relation to individual organs. An individual in our group this morning said that, looking back, they would have donated the eyes. It is a sensitive area. I am sure that you have experience of that.

Dr Robertson

I just come back to your point that that, too, is about public information. We need to teach the public what benefit their eyes could have, in the event of their death, if they gave them for transplantation. We need to show how incredibly grateful my patients, and all patients who receive organs in a transplant, are, and how life changing—or life saving—those things can be. Then, many people, I think, would reflect on that initial reaction of, “Oh, I do not want to give my eyes,” and whether they really mean that; and, once they have heard what would happen in that situation, they might reflect on whether they might change their mind. Again, we come back to public information and public education.

The Convener

Given the way in which the bill is drafted at the moment, would there be any risk of legal or regulatory consequences for medical professionals who decided, for the reasons that we have discussed this morning, not to proceed because the family did not wish to do so even though the person in question’s express wish was to donate?

Mary Agnew

On regulatory consequences, our approach is about whether doctors have acted in good faith on the basis of the guidance that is available and in partnership with patients and, where appropriate, those close to them. When something comes to us, we have a duty to look at it and to consider whether we need to investigate fitness to practise, but we take the context into account. We expect the doctor to be able to justify their actions. I suppose the short answer is no, I do not see a problem.

In looking at what we and other organisations might need to do to support doctors to understand and apply this new law, we have raised some questions to get a little more clarity about what is envisaged in respect of the duty to inquire, in so far as it applies to the wider healthcare team as opposed to the specialist nurses involved. Ideally, we would want to see some sort of separation between the decisions that a doctor makes about a patient’s treatment and the set of decisions around possible organ and tissue donation—so the really sensitive conversations, which need careful and trained handling. We want to understand the sorts of circumstances in which the duty to inquire might apply to a doctor and what sort of training and support would be made available to them to handle those conversations. Those are some of the areas that we would be keen to see explored as the bill progresses.

Brian Whittle

As has already been mentioned, the bill is going to be law and, as I think Keith Brown said, if you want to create law in this matter, clarity is absolutely paramount. One of the things that strikes me is that, sitting alongside deemed authorisation, there will also be opt-in. There is a different connotation to opting in than there is to not opting out. Might that increase family uncertainty and have the potential to increase refusal rates?

Rachel Cackett

The college’s position is that we support an opt-out system with the conditions attached; exactly how that is framed requires a legislative answer. Clarity, though, is absolutely key. If you look through the conditions that our members said were really important to them, you will see that clarity keeps coming out—clarity about which organs are and are not included in deemed consent.

You will also see in our submission that we raise a number of times the issue about the bill, or the documents that accompany the bill, not always having clarity that makes it easy to understand exactly what the proposal is in every situation. Whatever system is chosen and if the bill goes ahead, the most important point is that people have to make an informed choice—whatever choice they make—and we have to be 100 per cent clear about what they are making a choice about. That would make practitioners’ and families’ lives a great deal simpler when they are trying to have the conversations at the point of real grief. If that is not clear, we do everyone a disservice.

We do not have a position on exactly how that is framed in the bill, but the important point is that, whatever choice is made, it has to be absolutely clear to us all what is being chosen.

Dr Robertson

The BMA position reflects that of the RCN, which is that clarity is key—along with communication. Clarity on what the change in legislation would mean for the public is key—the fact that if you opt out, your wishes will be registered. As the bill is written at the moment, written confirmation of an opt-out would be required. We feel that that will make it harder to opt out and is slightly contrary to making it as easy—if you do not wish to give your organs—to opt out as it is to opt in. Perhaps we might not require written confirmation of opt-out, much as we do not at present.

I can understand the concern about having opt-out or opt-in and, at the same time, deemed consent. That will have to be carefully managed. Certainly Wales left opt-in as an option because some people wanted to do that, and if people want to opt in actively, I do not think that we should stop them doing so, as long as everyone knows that if they do not opt in, we presume—unless they have opted out—that they wish their organs to be donated. I think people having the ability to opt in if they wish to do so is fine.

We know that at the moment about 50 per cent of the Scottish population have opted in but that if you ask people, nine in 10 will say that they would wish their organs to be donated. We are looking for that 40 per cent who have not opted in but who actually want their organs to be donated. Those are the people who we want to have that conversation with their families, because we know that they actually want their organs to be donated. Therefore, yes, I can understand the concern, but I think that we would leave the opt-in option too.

I am not sure whether that was clear.

The Convener

Yes, absolutely, I followed you.

Brian Whittle

The connotation of making the positive step to opt in is different from not opting out; that is the issue. I am looking at this from the perspective of the family who are in the horrible situation of having to have this conversation at one of the hardest times in their lives. From their perspective, if you can say, “Your loved one had opted in and consented to these organs being donated,” that is an easier start to the conversation. What I am getting at here is: should we create an environment in which everybody has the option to opt in or opt out? Should that be where we are heading?

Dr Robertson

I bring you back to the current situation. At present, everybody has the ability to opt in, positively, and it is very easy for them to do so, but people have busy lives and they just do not get around to it—and people think, “It is never going to happen to me.” Four out of 10 people in Scotland would wish their organs to be donated if you asked them but have not opted in. Their families may well know that they would wish to do that, but they just have not got around to officially registering their wish.

It is clear that some people wish to opt in. If you change the legislation and make it clear to them that they can opt in if they want or they can opt out if they want, but if they do neither, it is presumed that they wish their organs to be donated, I think that that is better than the system that we have now.

11:15  



Brian Whittle

I am one of the 40 per cent—the conversation that we have had here has prompted me to make that decision. There are several things in life that everybody goes through—getting your national insurance number when you turn 16 or getting your driving licence—all of which are points at which, potentially, we could put the option to everybody. We have to get this absolutely right, and that comes back to clarity.

My question is therefore this: would not creating the environment in which everybody has the option to make the decision be a more positive situation than just having presumed consent?

Dr Robertson

You have just made the argument for presumed consent by saying that you are one of the 40 per cent. The problem for many of us is that, as we age, we do not get sent a new driving licence; if we happen to stay living in the same area, we do not register with a new GP; and perhaps we do not use the library anymore because we buy our books online—so actually, the option does not pop up in front of us and we never get round to it.

Brian Whittle

Sorry, convener—

The Convener

Be very quick.

Brian Whittle

I think that we are all agreed that we want the outcome here to be more donations. My point is that the option has never been put in front of me. I am asking: should we, as part of this legislation, be creating an environment in which it is put in front of everyone?

Rachel Cackett

I guess that we come back to the point that the legislation is part of a whole panoply of actions that need to be taken to increase donation rates. So, yes, I think that receiving something in the post—something that hits me in the face and asks me the question and makes sure that I am having the discussion, so that my loved ones are informed about my wishes—is as important as you do. Also when we asked our members detailed questions around an opt-out, 71 per cent of them supported that as one tool to increase donation rates; the thing is that it is not the only tool that should be on the table.

Emma Harper

I remind everybody that I am a former liver transplant nurse. I have also been involved in retrieval and in kidney and pancreas transplants.

Simply put, deemed authorisation allows a conversation to begin, exactly as Brian Whittle described. I am interested in the information from the BMA about barriers to donation. It may be that people are not really familiar with donation or are a bit scared. If someone chooses to donate their solid organs, that is great. However, there are new procedures, such as face or hand transplants, and it can freak people out when we start talking about them. The submission from the BMA talks about the ability to exclude certain parts, and I am interested to know whether the BMA thinks that a good way to proceed would be to allow people to be explicit about which tissues or organs are potentially available.

Dr Robertson

It is difficult. Time moves on and medical advances are very rapid, so things change. This is another public information issue. The key thing is that we are trying to increase the number of organs that are available for patients, and we do not want situations in which people are not clear about what they are authorising. There needs to be a conversation in public about what we are actually talking about here. Are we talking about presumed consent to use any part of the body for transplantation, or are we talking about the common organs that we use for donation? Do we leave space for people to exclude certain parts of their body? If it means that people are better educated and can have their wishes respected when they die, I think our view would be that there should be a way for people to exclude organs.

Rachel Cackett

I come back to the point about clarity. One of the lines that the college has put against its support for an opt-out is that the scheme must be clear about what is included and what is not. We have also said that there should be limitations—that the opt-out should be limited to donations for transplantation and that everything else should require express authorisation. Our members have told us that that would be a helpful way to proceed if we are looking to increase donation rates.

Emma Harper

My supplementary question is about the duty to inquire. The bill sets out that donation cannot go ahead if a “reasonable person” would be convinced by the information that the potential donor’s latest view was that they were unwilling to donate. Does there need to be more detail on the standard of evidence required in order to override donation?

Rachel Cackett

We raised that issue in our written evidence. The duty to inquire falls on individual health professionals, and it is often nurses who negotiate the process with families. There are definitely two questions that need to be answered. First, is that duty rightly placed on individuals? Secondly, if the bill is to proceed in that way, can it be very clear so that our members know what it means for their practice? The last thing that we want is a bill that supports defensive practice because individual practitioners are concerned about the implications of what a statutory duty to inquire might result in.

Those two questions need to be answered. We certainly do not have the answers to them, but they are important questions as the bill goes forward. Practitioners operate with great sensitivity, and they need to know that they have the support of clarity around what we are asking them to do in these situations.

Dr Robertson

I echo what Rachel Cackett said. We think that the individual’s views about what happens to their organs are paramount. If somebody has changed their mind and there is evidence of that, it seems right not to proceed with donation. However, there needs to be clarity around what evidence is required. I think that that clarity is very important for the public, but it is also very important for the healthcare professionals involved at the time.

The Convener

Does that clarity need to be in the primary legislation? As a regulator, does Mary Agnew have a view?

Mary Agnew

I have no strong view about the best way to achieve that clarity in legislative terms. My hunch is that it probably does not need to be in the bill—it comes back to the question of the support that goes with the bill further down the line.

Rachel Cackett

I return to the point that the primary legislation contains an individual duty to inquire. We need first to investigate whether that is the most appropriate way of dealing with what I think is a reasonable request. Our position is that the conversation with the family needs to happen in case the individual has changed their mind since they formally opted in to the register. That discussion needs to happen. If there is a statutory duty in that regard, there must equally be something that makes the expectation in the statute absolutely clear. Whether that is done by regulation or through guidance or whatever, we need a failsafe system so that our practitioners are able to operate and the intent of the bill can then be realised.

Sandra White

One thing I have learned about the bill is that if I speak to my family or anyone outside the Parliament about organ donation, although they understand about opting in and opting out, they do not understand anything else. From the private talks that we have had with various witnesses, I know that it is very complicated and very emotional. I did not know anything about pre-death procedures, the 36-hour period and just how families are affected.

We have spoken about clarity and education, and the bill looks to clarify certain procedures when someone is not clinically dead. Those will be in the legislation if we have deemed consent. I have spoken to witnesses, not just today but previously, and there have been some concerns around PDPs. In particular, one issue that has been raised with the committee is whether there is a conflict of interest for doctors. Does that pose a danger? Does the bill make a significant change in terms of authorising PDPs? If PDPs are carried out under deemed authorisation, should there always be express consent? That is three questions all in one.

I was certainly surprised by just how involved people have to be with regard to deemed consent. As I said, I honestly did not realise that families can ask to witness the procedures if they wish to—in certain cases, the bodies were still warm. That was a real surprise to me.

What are the witnesses’ thoughts on the three questions that I posed? Do you want me to pose them again?

The Convener

The pre-death procedures are what we are talking about. Thank you, Sandra. Who would like to start? This is another sensitive area, but it is an important part of the bill.

Dr Robertson

The paramount responsibility of a medical professional or a nursing professional is the care of the patient in front of them, so we would not support anything that could put that patient at risk or in harm’s way. However, if a professional is in that situation and has a patient who wishes their organs to be used for donation, the PDPs are part of that organ donation happening.

Again, I go back to public information and teaching people what is involved so that nothing is hidden. It needs to be clear to people what they are putting their bodies through so that their organs can be used in the event of their death, when they do not need them anymore. We need to educate the public about what the procedures are and why they are done. We also need to ensure that everything that is done is done for the good of the patient in front of us, which includes continuing to respect their wishes after their death.

Mary Agnew

I very much agree with Dr Robertson. We are currently consulting on revised guidance on consent. Our general principle is that it is vital that patients have good, accurate information about the types of procedures that they may undergo. Through a public information and awareness campaign, we would see greater public awareness of the procedures—they would be seen as part of what is needed. Of course, there is a range: some things are minimally invasive, not particularly harmful and probably less controversial. However, this is an area in which there is limited public understanding of what might be involved. Bringing it into the conversation would be important.

Sandra White

Thank you. I certainly did not know anything about pre-death procedures, and I do not think anyone else does either. I do not know the reason for that.

You talk about clarity and education. Should people be informed in writing about what may happen when they opt in? Obviously, some organs cannot survive after 24 or 36 hours, so it is important that they are removed as quickly as possible. Should people be informed in writing about that, or should they just be told, “This is the procedure that you are going to go through”? Once someone opts in as a donor, should they be told, “As a donor, this is part and parcel of what will happen to you”?

Dr Robertson

I would have thought that public information is an important part of any legislative change. People should have access to written information if they wish to read it. However, the public should have access to that at any point in their lives and not just at the point of donation. The BMA supports a move to a situation in which organ donation is the norm. That is a long-term ambition, but public information about the processes around organ donation is part of that.

11:30  



Sandra White

I have a question about a legal issue for Mary Agnew, who mentioned the duty to inquire. The Law Society of Scotland picked up on aspects of pre-death procedures, and I wonder whether that area would raise any legal questions for you and your organisation in regard to people’s assumptions or whatever it may be.

Mary Agnew

It comes down to the point about clarity. One of the questions that we had at an earlier stage in the consultation was how the bill fits with the Adults with Incapacity (Scotland) Act 2000 and how it takes into account situations in which people may lack capacity. I am not sure what the legal ramifications are, but we would be keen to give as much clarity to practitioners as possible to make sure that they feel confident in acting ethically and within the law.

Emma Harper

For clarification, pre-death procedures are procedures such as putting in intravenous lines or giving medication that will improve organ perfusion. They are procedures that might be performed already, such as giving certain IV medication, but they are carried out once a decision has been made to donate. They might be simple things such as changing medication or increasing doses. Can you clarify what pre-death procedures are? It is not about doing stuff to people; it is about helping to support donation once the decision to donate has been made. Is that correct?

Dr Robertson

That is certainly how we see it. Again, that is part of the education that is needed. If someone wishes their organs to be used for transplantation in the event of their death, part of that wish is to try to ensure that those transplants will be of as much benefit as they can be to somebody else. The procedures will change over the years as medicine changes, but what is involved needs to be made very clear to the public so that people know. At present they perhaps do not.

Alex Cole-Hamilton

The committee had an informal evidence session this morning with recipients of organ donations. It was a very inspiring session. One of the things that came out of it was a discussion about the conversations that have to happen if we are to generate an uptick in the number of people who are on our organ donor lists. A gentleman who is an organ recipient suggested that the organ donor register could have a countersignatory box to show that a person’s next of kin was aware and had almost co-consented to the person’s registration. I understand that that might not be practical, but is there anything that we can put in the guidance for the bill to generate those conversations, for example by saying that the donor list that is being retained should show that a notification process has been adopted? Would that help to engender those conversations so that when people say, “Oh, he was an organ donor,” it is not a surprise to their next of kin?

Dr Robertson

Could you clarify what you mean by “notification process”?

Alex Cole-Hamilton

Perhaps the organ donor register could have a field or a box for new subscribers to tick so that an email would be sent to their next of kin. In that way, the next of kin would be notified that the person had signed up, even if they did not get around to talking about it. It would just be an automatic thing that would happen as part of that process.

Rachel Cackett

We need to think through how we have that conversation. It is important that those who are listed in the bill as the people who may end up making the decision, or having the discussion, about a person’s expressed intent understand what that expressed intent is. I think that conversation is important. I can only speak personally, but I would find it quite hard to receive an email saying that a loved one had just registered to donate organs, although I understand the point.

If the bill goes forward, we need to look at all the options that are out there to support those conversations to happen. It is interesting to think about how we use the resources that we have, which could include the opt-in, which it is being proposed at the moment to keep, to encourage a conversation. People will be dealing with a big enough shock at the point when they have to have this conversation, and the fewer shocks there are, the better. Anything around the bill that can support that is a really good thing.

Alex Cole-Hamilton

That is exactly why I asked the question. I think that it is incumbent on the committee not just to tease out the sections of the bill but to look at how we can improve the landscape for triggering those conversations.

Dr Robertson

I am concerned about the lack of conversation in that suggestion. Perhaps the email should come to the person who registers to say, “Remember to talk to your family. Remember to discuss it with them.” That would be a much more positive thing than just an email that tells people that a person has registered.

Alex Cole-Hamilton

The point is well made and taken in the spirit it is offered.

The second area that I would like to ask about is the lived experience of the recipients we met this morning. This goes for the families of donor patients as well. In particular, those who were on transplant waiting lists talked of the huge pressure on their mental health as a result of the rollercoaster that they described—the late night phone calls, being driven to hospital only to be turned around and told, “This is not the match we thought it was,” or, “The organs are not viable.” That creates a huge pressure and strain on relationships, but they do not have any specialist mental health care and counselling. Is that a gap in our society? Do we need to have provision for specialist teams that are dedicated to helping those on a transplant list, as well as supporting them after the fact and supporting the families of donor patients in the round?

Dr Robertson

Can I speak as a professional rather than on behalf of the BMA?

The Convener

Please do.

Dr Robertson

Having done a clinic on Monday at which all my patients were transplant recipients and then having looked after patients on dialysis waiting for a kidney in the afternoon, I think that there is a huge amount of pressure. That emotional rollercoaster that you describe of getting the phone call, being driven from Dumfries or Stranraer all the way to the transplant unit, and then waiting to find out whether this is the one that is going to be yours is huge. The pressure of having a failing organ—whether it is your kidneys, lungs, heart or liver—is huge on your mental health. At present in Scotland I think that too little resource is applied to this group of patients before, during and after transplant or, indeed, to the patients for whom transplant is not an option. Any increased investment and support that we can have for patients in those groups would be very gratefully accepted and is very needed.

Rachel Cackett

We have had many conversations around tables like this one about the pressures on mental health services in Scotland and we know that there are significant gaps. Although there have been announcements about addressing some of those gaps, we are really just catching up and clearly—as Dr Robertson has said from her experience—this is a patient group that has very particular needs.

The statement that the RCN put out on its position on deemed consent was very clear that the first condition that is attached to our support is that

“Sufficient resources are made available to define and support the additional infrastructure and capacity required to increase the rate of successful donations.”

We chose that wording very carefully. This is not just about increasing the rate of donation. It is about increasing the rate of successful donation, which requires us also to look at the wellbeing of the recipient population so that the people who are receiving donations are able to go on and make a success of that. We would be wrong if we did not take account of parity of esteem and consider both their physical and their mental health and wellbeing.

David Stewart (Highlands and Islands) (Lab)

I thank the witnesses for coming and for their evidence to date. Could the witnesses outline in their view the best practice on organ donation that exists in Spain, which is very much set up as one of the most successful countries in Europe?

The Convener

Who is an expert on Spanish transplantation?

David Stewart

It looks like I might have to answer my own question.

Rachel Cackett

I had a long conversation with a colleague, who you are going to be speaking to shortly, who knows a great deal more than I do about the detail of organ donation in Spain and how it compares with what is being proposed in Scotland. Rather than giving you an ill-informed response, I would defer to their contribution.

David Stewart

Perhaps I could help out and provide a few bits of information. It is always difficult, of course, to compare countries with different cultures and different systems, but SPICe provided some information to us today and, in very simple terms, the United Kingdom donation rate is half that of Spain, even if we adjust for the family refusal rates. One of the arguments is that Spain has a very strong system of transplant co-ordinators and donor detection programmes and has great provision of intensive care beds. Although I understand that the bill is focusing strongly on consent and different systems of consent, which I will put to one side, are we missing a trick here? Are there wider things that the committee should be introducing into the bill that would focus on some of those areas, which obviously Spain has shown to be extremely successful?

Dr Robertson

The little I know about Spain is that the infrastructure set-up in Spain supports as much transplantation as possible. There is no point in changing legislation if our infrastructure cannot support the increase in organ donation. So far, the Scottish Government and the transplant networks have done a huge amount to improve the rates of transplantation in Scotland. When you meet the transplant surgeons at the moment, you meet a bunch of very tired people. They are working very hard and I think that not to invest in the infrastructure so that it can deliver the aim of the bill would very much be a missed trick.

It may not be the job of this committee in this situation—I do not know how politics works—but it is very important that we have the infrastructure to deliver this. That includes having ICU beds. It includes having enough highly trained specialist nurses who can have these very sensitive conversations and make this work as easily as it can for families of potential donors and for recipients and their families, and it also includes having enough transplant surgeons so that the transplant can go ahead as speedily as possible, safely and well for everyone involved. There is no point in changing legislation if we do not have the system to support it.

David Stewart

The system of intensive care beds in Spain is crucially important. I think that that was Rachel Cackett’s point about successful donations. It may be that it is not for this legislation; it may be a wider issue for the Scottish Government to take forward in building up capacity in the Scottish health service. Am I correct in assuming that there is some best practice in Spain that you think could be successfully applied to Scotland?

Dr Robertson

I would expect that our transplant networks, our transplant surgeons and our specialist nurses and their networks would be able to advise as to what they think we need in Scotland in order to deliver an increase in transplant rates. I would defer to their better knowledge in the situation. We have a very highly trained, very highly motivated group of people who are very knowledgeable and I would ask them.

David Torrance

In Wales, deemed consent applies to people who are aged 18 and over. In Scotland, deemed authorisation will apply to individuals who are 16 and over. Do the witnesses agree with 16 being the age at which deemed authorisation will apply in Scotland?

Dr Robertson

The BMA is very supportive of 16 being the age. We think that there are some people from the age of 12 who are well enough informed to make decisions, but we consider 16 to be the right age for the bill.

Rachel Cackett

The position of the RCN is that this should be limited to adults and that consent for those who are not adults should remain as is. I guess that we come back to a pretty persistent question, which is whether the age should be 16 or 18, and this is not the first piece of legislation where we have had that debate. The college is not taking a position on what constitutes an adult in law for this legislation, but we are very clear that this is for adults, however that is defined in any of the four countries of the UK.

11:45  



The Convener

The GMC will have responsibility for regulating all four countries of the United Kingdom. How does the issue look from its point of view?

Mary Agnew

We have not taken a formal position on 16 being the age. It broadly fits with our wider guidance on 0 to 18-year-olds and the wider position under the legislation on mental capacity, for example. It will be interesting to see the full debate on that. We will obviously work with whatever the committee decides, but certainly my personal view is that, given the maturity of young people to think about these issues and consent to them, particularly in the context of a widespread public awareness campaign, there is a case for 16 being the age.

David Torrance

My reason for asking is that some of the witnesses last week were saying that there could be a difficulty with the transplant of an organ for which there was no suitable recipient in Scotland but which could go to a country where 18 was deemed to be the age of consent. Do you have any thoughts on that?

The Convener

Is there a cross-border issue?

Mary Agnew

There could be. I think that NHS Blood and Transplant will probably be better placed to talk you through some of those questions.

The Convener

I thank the witnesses for a very informative and stimulating session. We will suspend briefly to allow for a change of witnesses. Thank you very much.

11:46 Meeting suspended.  



11:51 On resuming—  



The Convener

Our second session of the morning on the Human Tissue (Authorisation) (Scotland) Bill is with expert witnesses. I am delighted to welcome to the committee Dr Stephen Cole, consultant in intensive care medicine at Ninewells hospital, who is representing the Scottish Intensive Care Society; Lesley Logan, whom we welcome again, who is the regional manager for Organ Donation Scotland with NHS Blood and Transplant; and Professor Marc Turner, medical director and designated individual on tissues and cells with the Scottish National Blood Transfusion Service.

I know that the witnesses will have followed some of our previous evidence. I would like to start with a general question on the fundamental principle of the bill, which is the introduction of deemed authorisation in place of the current system. Will that change achieve the objective of increasing the number of successful donations?

Lesley Logan (NHS Blood and Transplant)

I agree with previous witnesses, in that I do not think that a change in legislation will by itself make a difference. By starting a national conversation about organ donation and addressing educational concerns earlier, we will effect a culture change that in time—just as I hope the Welsh are beginning to feel—will make a difference. I think that the halo effect of introducing a change in legislation will make a difference.

We speak to one category of patient families, who are those that are uncertain of their loved one’s wishes and who, therefore, err on the side of caution and say no to donation. The deemed authorisation aspect might help in those cases.

Dr Stephen Cole (Scottish Intensive Care Society)

There is a mixed range of views on the bill in the intensive care community around Scotland. I think that there are some potential benefits from it, as Lesley Logan said. As a group, we are concerned that whereas at the moment we have the power of the wish, or the gift, that may be lost with the new legislation. We are also very concerned that this is a patient group, whom we heard about earlier, whose families are going through the worst days of their lives. They are coming to terms with the fact that someone they care about is dying; that everything that we have tried to do in intensive care to keep their family member alive has failed; and that death is the next step. That is not a normal set of circumstances for those families and we have concerns that anything that deems what may happen to them after death may end up coming between us and those families in terms of the level of trust that we currently have.

Professor Marc Turner (Scottish National Blood Transfusion Service)

I agree with Lesley Logan and with the witnesses on the previous panel. The key issues—at both Scottish Government level and for us as individual organisations—are our engagements with the public, and the support that we give to clinical colleagues in having those difficult conversations. Those are the key elements in building on deemed authorisation to a successful increase in organ and tissue donation rates.

The Convener

As I mentioned to the previous panel, one of the consequences of heightened awareness and greater debate is that the number of people who choose to opt out may also increase. Do you have any concerns about that, or is that more than offset by the increase in awareness of those who may wish to support organ donation?

Lesley Logan

I do not think that we have any concerns about that, but we know that people change their minds. Someone who has opted in may change their mind, but equally someone who has opted out may then change their mind. In the future, we could have the scenario in which someone has opted out but then a loved one has received the gift of a kidney transplant and they do not get round to opting back in. My service would plan to approach all families in which organ donation is possible to ascertain whether any change of expressed wish has happened.

Dr Cole

It is important for the committee to realise that we have come a long way on organ donation in the past 10 years. I have the end-of-life conversation with families on a weekly basis. In the past, it was not uncommon for people to have no idea about organ donation and what may or may not happen, whereas now it is very rare to speak to a family who are not aware and who do not have a view.

Your point is well made—people are more crystallised in their views and public awareness is far greater than it was a decade ago.

The Convener

That is an interesting observation, which relates to the Human Tissue (Scotland) Act 2006. I guess that the question is whether a further change in the law, in the bill that we are considering, will further increase that awareness. Do you have any views on that, Professor Turner?

Professor Turner

I have nothing to add to what my colleagues have said.

Keith Brown

I am sorry to return to a previous topic, but I was interested in a discussion that we had with the previous panel. I am not sure whether all of you were able to listen to that. Miles Briggs asked a pretty straightforward question about the practical reality of the current system; it was about the family veto, or family consent being required, and whether, once a wish has been expressed, it should not be overridden. I think that Miles Briggs’s question was whether that should be covered in the bill, given that everyone seems to agree on the need for clarity.

I had the impression that the previous witnesses did not really want to answer that, or did not answer that, maybe because they want to see the current practice rolled forward. I would be interested in hearing your views. It would be helpful to the committee to know the extent to which clarity should cover that point, not least because the individual—the donor—having expressed a wish must surely have some expectation that that wish will be observed subsequent to their death. Should there still be such a family veto? Should it be written into the bill?

Dr Cole

That is a really well-made point. At the moment, we would approach and communicate with the family. First and foremost, we would make sure that the family understood that there was nothing more that we could do for their relative in intensive care. Only when they have understood and accepted that point would we move on to any end-of-life conversations. That is done collaboratively by me, as an intensive care consultant, and the specialist nurse in organ donation.

12:00  



We listen to families’ views. Having dealt with this situation on a daily and weekly basis, I would find it difficult in my profession to override the wishes that are expressed by those patients’ relatives. The family might say, “Yes, he signed up to the organ donor register. That was an expression of a wish at a point in time. I now have more information, which says that that is actually not what he wanted.” As the intensive care consultant who is speaking to that family, I would listen to that. I do not think that we can push families into a situation in which donation is forced through against their wishes. I would find that situation very difficult.

Lesley Logan

To put this in context, there are only six times a year in Scotland that a family overrides someone’s decision. On probably half of those six occasions, it could be argued that they are not, in fact, overrides. Instead, someone has signed up to the organ donor register and has then told their family, “I’ve signed up to the register, but if that time comes I want you to make the final decision.”

The reality is that three times a year in Scotland we have a family who may have discord. There may be a mother and a father who cannot make a decision about a child. To be fair, we are trained to manage that situation. We have a conversation with the family about perhaps a limited donation of abdominal organs, because as we know people are very emotionally attached to the heart, for example, in a child. We are trained to have those conversations and, operationally, overrides are not a huge issue to us. They can be managed well by our asking a series of questions such as what conversation the individual had with their family, when they had it and what they said.

If a patient has an expressed wish, we are not approaching the family for their permission. Obviously I am paraphrasing, but we would say, “Johnny was on the organ donor register; he indicated his support for organ donation, so let’s work together to make that happen for him.” In the future, we might use wording such as, “Johnny didn’t opt out of organ donation, which indicates a support for it. Let’s work together to see whether we can make that happen for him.” We can have those conversations.

I think that overrides do not happen as frequently in Scotland as they perhaps do elsewhere in the UK. That is because we have 51 to 52 per cent on the organ donor register and very high public awareness. We find that families are raising the subject of organ donation with our intensive care colleagues.

Professor Turner

Clearly, this is a very difficult issue. In my view, from an ethical perspective one should give primacy to the views of the donor. Having said that, in reality, particularly for tissue donors, we need to ask the same broad range of donor selection questions as we would apply to a blood donation, for example. Those questions are very extensive in order to protect the quality and the safety of the tissue that will be transplanted into a recipient. Of course, the seminal difference is that for tissue donation the donor is no longer with us, so those questions have to be asked of the family. In reality, the family could have a de facto veto simply by refusing to answer the donor selection questions, in which case we could not proceed with the donation in any case.

Keith Brown

I assume that the answer from all three of you is no—it should not be written into the bill.

Lesley Logan

We have never had a family not want to answer the questions around lifestyle and healthcare choices.

The Convener

That is very interesting. It has never happened. Professor Turner, are you saying that it might happen if a family was reluctant to go ahead?

Professor Turner

At the moment, families can decline to give their authorisation. They can do that directly. In a scenario, for example, in which the donor appeared to have expressed their wish to donate but the family was very opposed—and if the law said that the clinician could override the family wishes—if the family simply did not answer the questions that we asked them, the donation could not proceed in any case for patient safety reasons.

The Convener

Is the general view that there should not be such a legal requirement? Your additional point is that, even if there was such a requirement, it would not necessarily be effective.

Professor Turner

I do not believe that a requirement for relatives to answer questions could be written into the law.

The Convener

Understood.

Miles Briggs

I want to develop that a bit further. First, the group we spoke to this morning were grateful for the understanding of the teams who had worked with them. It was good to hear about the positive experience that they had all had. I saw two individuals who had their medal with them—it was the first time that they had worn it. Those aspects are important, and we hope that they can be developed.

On the point that the bill might send out a confused message at a time when families are tired and their world is collapsing around them, could deemed authorisation increase family uncertainty with the result that refusal rates would stay the same? The information that we were given suggested that around 100 donors are lost in Scotland every year when families refuse to donate their loved one’s organs.

Lesley Logan

So far this year we have approached 158 families, and by the end of the year the figure will be close to 200. Authorisation rates this year are up, but you are correct in saying that a high number of families still say no. We are ever striving to provide information to make the process as simple and as streamlined and non-stressful for families as we can.

Dr Cole

The committee might find it helpful to know the totality of intensive care. In 2017, approximately 10,000 critically ill patients were admitted to intensive care units around Scotland; overwhelmingly, those were patients who would not have survived unless they were admitted. They required ventilation, inotropes to support the heart and so on. Approximately 1,400 of those patients—14 or 15 per cent—died in intensive care. That represents the totality of the potential pool of donors. As Lesley Logan said, we approached just over 150 of those patients’ families. The reason for that is that many patients die in intensive care in an uncontrolled way. Despite our best efforts to keep them alive, they continue to deteriorate and they die. For organ donation to be a consideration, there needs to be an element of control in the process.

Brian Whittle

It is nice to see Lesley Logan again after this morning’s private session. I am going to go back to the situation I was exploring earlier. I am doing that because, as has been said before, in creating this bill clarity is absolutely paramount. Simplicity in the bill, which deals with an extraordinarily complicated environment, is what will make the bill successful. I keep coming back to the tension between the making of a positive decision—“I will be on the register” or “I will not be on the register”—and deemed authorisation, which may not involve a decision having been made. When we have these conversations, inevitably I put myself in the situation. Do you not think that deemed authorisation almost creates a two-tier system for potential organ donation and puts the family in a dilemma?

Lesley Logan

When a person opts in, their wishes are known and it is very easy for a healthcare professional to start the conversation with their family. We can say, “Johnny was on the organ donor register. He has expressed a decision to donate his organs. I would really like us to work together to make that happen. We will give you more information.” When a person has opted out, equally, we need to have a conversation to ensure that they have not changed their mind. In 10 years’ time, we might say, “In 2017, Johnny opted out of the organ donor register, but we want to make sure that that remained his decision.” If he had changed his decision, that conversation would be helpful.

When a person’s wishes are unknown and deemed authorisation comes into play, a lot of families err on the side of caution and the default position is to say no to donation. However, unless a person opts out, it will be assumed that they are supportive of donation. Getting that clear message across to the public is key. The French have run some very simply worded campaigns—I can provide pictures of them—that have helped to get that message across to the French public.

As a healthcare professional who is involved in approaching families, I do not think it complicates matters for us. When people are registered, that makes the conversation easier, and when people might be deemed to have consented, that also allows us to be a little bit more culturally presumptive, because they have not made the decision to opt out. We are able to say, “Johnny has not opted out of the organ donor register; therefore, he has indicated his support.” The family may well object at that point, but deemed authorisation allows us to start the conversation with something tangible.

As you know from our previous conversations, we always check the organ donor register prior to going in to speak to a family. If necessary, we provide them with a copy of the organ donor register entry so that they can see it for themselves.

Brian Whittle

I am looking at this from my perspective, imagining that I was in that horrible situation. Before I got involved in this particular investigation, I thought that organ donation referred to the liver, heart and kidneys. After that, I was struggling a wee bit. Yes, we have lungs, but the list goes on, as we talked about earlier, and includes tissue, the face and hands. I suggest that it would be much better if that conversation was had with the donor or if the donor was able to tick the boxes that they needed to tick instead of that conversation being passed on to the relatives.

As I said, I am—disgracefully—one of the 40 per cent who has not yet signed up to the organ donor register, but if you put the form in front of me I would tick the box. Should we not be looking at ways in which we can make it easier for everybody to make that positive decision, in order to increase the number of people who say yes or who make the decision to say no? Should that not be put into legislation?

Lesley Logan

For some of the much rarer types of transplant—involving facial, composite tissue and limbs, for example—we would have to approach the family separately anyway, because it comes down to things like skin matching. There is a whole raft of other assessments that we need to make in those situations. The organs that are—for want of a better word—commonly transplanted—the ones that people sign on the register to donate—are the ones that people recognise. Therefore, those are the organs for which it should be possible to have deemed authorised donation.

We also have a uterine transplantation programme in London, and, internationally, you will hear in the press of other types of unusual transplants, particularly for individuals who have been at war. I do not have a problem. We spend up to three hours with a family, as you know, and some of the explanation really can come only through talking with a healthcare professional who knows what is likely to be considered in any individual situation. We do not want to burden families with a whole pile of information only to discover that they cannot donate X, Y and Z or A, B and C anyway. We try to tailor our conversations with them so that they know what we are thinking at an early stage.

Marc Turner is particularly interested in future proofing, so I will hand over to him.

12:15  



Professor Turner

I think we would all agree with the principle that it is better to ask the donor while he or she is still alive than to ask relatives after his or her death. We would probably all support the principle of trying to encourage people to have that conversation and to make an informed decision.

Even with those efforts, of course, one cannot force people to make a decision one way or another. Some people might never get around to it; some people might not want to make a decision because their own mortality is too unpleasant to think about. You say that you have not made a decision on organ donation. I have—I have opted in. However, there are many other things that come through my letterbox and in emails that I am too busy to deal with it. I think that I will deal with them at some other time but, of course, I never do.

For me it is not an either/or situation. I think that we absolutely should try to encourage people to make a decision one way or the other, but having deemed authorisation as well covers the gap, as it were, of other individuals as Lesley Logan has described.

Dr Cole

Your point is very well made. When we go in to have a conversation with a family, it is easier for us if their wishes—one way or the other—are known. The family are not then put into a position of trying to make a decision when they are exhausted and grieving and have not slept for two or three days.

At the same time, signing up to the organ donor register, as it currently happens, is an expression of a wish at a point in time; it is not informed consent. It is not the same as someone saying, “I’ll have a hip replacement and these are the things that will happen.” The patient often does not have the full picture or the information that they need to make an informed decision.

Throughout the UK, we have made the decision that that is the process that we will go through and that we will not have formal informed consent in signing up to the organ donor register. The new legislation, as proposed, may take away some of the difficulty in that, if someone has not opted out, they have not made a positive decision not to become an organ donor. Consent will be assumed, and we can start the conversation from there.

Lesley Logan

One of the real strengths of the 2006 act was that it afforded healthcare professionals the opportunity to work with families and provide information to the level to which the family wanted it. Some families say, “He was absolutely supportive of donation. He was on the organ donor register. Do whatever you need to do. I’ll answer your questions, but I don’t want to know anything.” However, some families want to discuss donation in minute detail, and the 2006 act allows us to provide that information.

That is one of the strengths of authorisation over consent, whereby the implication is that it is informed consent. I think it is really important to try to retain that, because that has allowed families under some circumstances to go home, and it allows us and our tissue service colleagues to take telephone authorisation from them. We work with the families to find the best solution for them.

The Convener

I assume that there is nothing in the bill, as it is drafted, that would take away that ability. Is that your interpretation?

Lesley Logan

Yes. I hope it is so.

Emma Harper

I would like to address issues around adults with incapacity, because we have not covered that area this morning. Your submissions describe how the provisions state that an adult who is incapable of understanding the nature and consequences of deemed consent is, therefore, not deemed to have consented. However, there are various issues around incapacity, such as whether it is a new issue or whether it has been prolonged or has developed over a period of time. Is there enough information in the bill to allow incapacity to be considered, so that people who do not have capacity are supported?

Dr Cole

I work with patients in intensive care who are critically ill, and 95 per cent of those patients lack capacity when they are in intensive care. It is a short-term lack of capacity rather than a more long-term lack of capacity.

As you will be aware, there are two sorts of deceased organ donation: those following circulatory death and those following brain stem death. Patients who suffer circulatory death remain patients until the point of their death, so the legislation that is pertinent to them is the Adults with Incapacity (Scotland) Act 2000. Patients who suffer brain stem death are considered dead at the completion of the first set of brain stem tests, and the legislation that pertains to them is the Human Tissue (Scotland) Act 2006, which is much more favourable in terms of the death procedures and the other things that you mentioned earlier.

In terms of the AWI for ICU patients, I think the bill as it is drafted is fine. Because it is not my area of expertise, I cannot comment on the chronically incapacitated patient who has long-term incapacity that predates their admission to intensive care.

The Convener

Does Lesley Logan have anything to add?

Lesley Logan

As you know, we adhere to a hierarchy within families or among nearest relatives whom we approach about organ donation, and we do come across relatives who are incapacitated for various reasons. Sometimes, it may be down to something as simple as the fact that they have consumed alcohol or drugs; sometimes it may be that they have a condition such as Down’s syndrome that limits their understanding of the process. Occasionally, families are so incapacitated by grief that they cannot even respond to us. In all those circumstances, we work very sensitively with our intensive care colleagues. If we are not comfortable that the family understands the process of authorisation, we make a decision not to consider that. When somebody is on the organ donor register, we already have authorisation to proceed and there is something around sharing knowledge. The situation does not arise very often, in truth, but if you are asking about taking authorisation from individuals who do not have capacity, that is a relevant concern.

Miles Briggs

I want to raise a small point that was raised with us by the panel this morning. It relates to complex families, changing relationships and next of kin sometimes not being clear. What has been your experience of that? We heard this morning that, in some cases, decisions can be divided, especially between the partner and the parents of the individual.

Lesley Logan

We approach the nearest relative as opposed to the next of kin. Sometimes, there is a slight difference in who that is. Occasionally we approach a partner of more than six months when there is still a parent involved—when the individual is a teenager, for example.

Generally speaking, in the time that we spend with a family, we reach a consensus. We are reasonably skilled at doing that. In our experience, if there is family discord it is likely to be between two adults with a child who are, for whatever reason, separated. The father might say yes and the mother might say no. Again, our starting point is the individual’s decision, if they have made a decision.

In those circumstances, we give the parents time and space. It is our job to spend however long it takes helping the family to reach a decision. In trying to help everyone, we might go for a limited donation of abdominal organs but not cardiothoracic organs. That allows both parents to feel that they have had some input into and control over the situation. In some circumstances, when there is real strength of feeling, donation may not be possible. A newspaper headline saying, “They stole my son’s organs wheeling him down the corridor,” would be detrimental to the greater transplant programme and we would not want to be in that situation.

Dr Cole

I echo most of that. The most important thing in that conversation is families’ having time to come to an understanding about what should happen. The conversation is often easier if we have an understanding of the patient’s wishes. The more difficult situations arise when a patient did not sign the organ donor register when they were well, so the family does not understand their wishes. Generally, with time and with skilled communication, we can work through that.

Lesley Logan

I will give you a possible scenario. The father might arrive at the hospital first because he works locally, and he might accept death or dying much quicker than the mother, who is some distance away and arrives several hours later. People accept things at different rates, so we have to wait for people to catch up and move forward together. That is the key.

Miles Briggs

It was also raised with us that some families think that clinical research will automatically take place. I am thinking of the Scottish brain bank and things like that for dementia individuals, not necessarily about organ donation. Could that area be improved? I know that it is a separate issue.

Lesley Logan

We take authorisation and conduct the social history questionnaire that you have seen for other purposes as well—for research, training, education and audit. Marc Turner will talk about quality assurance as a welcome change in the bill. We do that so that families do not have to answer those questions twice for different sets of healthcare professionals.

When we hold our remembrance services, we acknowledge those individuals. Sometimes, patients go to theatre for organ recovery and the organs are not suitable for transplant but can be sent for research if we have permission for that. We write really nice letters to the families about their furthering medical education, and they are very pleased to receive those letters. They are also included in receiving the medal and so on.

Professor Turner

Organs and tissues are taken primarily for clinical reasons, but some that are taken are not suitable—perhaps because of microbiological contamination, for example. It is very important to us that we are able to use some of those tissues or organs for what we call process developments, because a lot of the tissues undergo quite complex manufacturing steps and require validation and quality control in exactly the same way as you would expect for a pharmaceutical. Therefore, we are very pleased to see quality assurance written into the bill, because we cannot transact our jobs properly under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 without applying quality assurance.

As Lesley Logan has said, although the principal consent is for clinical use, research use and evaluation are also written in, and people can assent to that or not. That is a very different scenario from asking to take tissues for research purposes only. In that scenario, independent ethics will be taken and there will be an independent consenting process. I would not want to conflate those two situations.

Sandra White

I want to explore again something that I asked the previous panel about, which is the pre-death procedures. Dr Cole, you talked about working in intensive care and mentioned that some people have concerns about the procedures that are carried out. I did not realise that if you opt in to organ donation such procedures are part and parcel of it—I have never seen any information about that. That was a new one to me and I think that people should probably be told about that. Do you share the concerns that we have heard from witnesses about pre-death procedures? How are they carried out just now? In the future, should they be carried out under deemed consent or always under express consent? Those are my three questions.

12:30  



Dr Cole

This could be quite a long answer; I will try to make it as short as I can. As you heard from the previous panel, there are a number of things that we do day in, day out for patients, some of which are quite invasive, for example putting central lines into a patient, reintubating a patient, giving drugs and strong medications to bring blood pressure up and so on, taking blood and that sort of thing. What generally happens at the moment is that, if a family agrees to organ donation, the worst thing that can possibly happen to that patient is that the organs are not able to be utilised, because the patient is not physiologically optimised in order to allow a successful organ donation retrieval to take place.

We have had a lot of discussions with colleagues in the Scottish Government about what is in the bill regarding interventions and pre-death procedures. “Pre-death procedures” is not a great term, but it is where we are. We have tried to stratify the procedures into two types: those that are routine, painless and have next to no chance of causing harm; and those that are less common, perhaps more invasive, and have a greater chance of potentially causing harm.

An example of the latter might be a bronchoscopy, where we put a telescope into the patient’s lungs and, under direct vision, we hoover out any secretions or contamination within the patient’s lungs. That is quite invasive and if you were awake it would be quite uncomfortable, but it is something that we do routinely to benefit patients who are on ventilation.

It is right and proper to stratify the procedures according to risk, as in patient risk. Remember that this population of people are patients, not donors. They remain patients until they die and then they become potential donors.

To avoid talking forever, I will say that the level that we have in the bill is about right. It is something that we have thought long and hard about.

Lesley Logan

Families who say yes to donation are pretty committed after that point. They want something good to come out of the tragedy and they want to save other people’s lives. We are very careful to explain to families what tests or pre-death procedures need doing to allow that to happen.

We already provide families with the information from any tests that are done: blood tests are taken to support the matching of organs with recipients; urine tests are taken to test for any infection or any obvious kidney damage; secretions from the chest are taken to check for infection. Any test that we would do, we already explain.

I would be concerned about having to ask families more questions in a tick-box manner, rather than having a conversation with them that went, “As I have explained, in order for donation to proceed, we need to do a number of tests. The tests will not harm your loved one at any time. They are not painful and we will be doing them to ensure things like the best matching of organs,” and so on. That is my thought on that.

Sandra White

I have one more question on this, and then I want to ask about the forms that are filled in, but that will be a short one.

The Law Society of Scotland has raised some concerns about medical ethics. Are you content that the bill covers you with regard to medical ethics in relation to pre-death procedures? I think that we should change the wording to something other than pre-death procedures.

Dr Cole

The Scottish Intensive Care Society has been closely involved with the detail of the bill. We feel reassured by how the bill is worded. As you alluded to earlier in the meeting, medical development takes place at a fantastic pace. Things that are not even thought about today may become commonplace next year. The bill tries not to be too descriptive about the list of tests, but to talk in generalities of the types of test. If we miss out test Y from the list in the bill and it becomes commonplace next year, we will end up in a situation where we have to go back and ask specifically about that.

An example of that is that in the past we specifically excluded the use of heparin in the potential donor, because we were concerned that there was a small possibility that heparin could cause harm by causing bleeds in the brain. Our surgical colleagues regret that that took place and feel that heparin is very important in optimising the potential organ for transplant. That is an example of what we were keen to try to avoid.

Sandra White

Are you quite content about that? The Law Society raised the point and you are quite content in that respect.

This is obviously not a small question because it has been raised many a time—I know that we have spoken to Lesley Logan about the bureaucracy around the 350 questions that people have to answer. We heard again this morning from the group that we spoke to that some of the questions are invasive and embarrassing—I will not go into the details of which questions they felt were embarrassing—particularly if they had their children around them. Is there any way of shortening the questions? Can we put something into the bill so that people do not need to answer those questions? It is a very emotional time for them and they are sometimes not ready to do that.

Lesley Logan

The questions are absolutely necessary because our job is to ensure that transplantation is safe, first and foremost, for the recipients. Marc Turner is better placed to talk about some of this than I am, but we know that some of the questions that we ask are specifically for tissue donation. It may be that in the future we are able to develop a subset of those questions so that, if we identify early on in the process that the patient will never become a tissue donor, we do not ask the questions. We do not want to not ask the questions and then find out that we have a potential tissue donor.

There is a way of doing that and I have provided to our Government colleagues, who will come to you in turn, some examples of questionnaires from Australia and the United States of America. My medical director, Professor Forsythe, has done something similar with some of the European questionnaires. You will see that they are pretty much all the same.

The authorisation form is a slightly different matter and we work hard to try to reduce the questions that we ask from that. We do that by asking the healthcare questions first, so that we know as professionals what we can exclude. For example, if we know that somebody has had a heart attack, we are not going to approach about heart donation, so we do not need to ask those questions. If we know that someone is a diabetic, we are not going to approach about pancreas donation. We will make those exclusions on the authorisation form to try to contract the process. The questions generally are very, very similar, if not almost identical, to those that are asked around blood donation.

Professor Turner

I agree with you that the questionnaire is a very extensive set of questions. Whether there are 350 questions, I am not sure. I will take your word for that. Some of them are nested questions, so you might ask a preliminary question such as, “Has your relative been overseas recently?” If they answer no, you move on from that and if they answer yes you go into more detailed questions.

The questions are more stringent for tissue donation than they are for organ donation because sometimes the risk benefit ratio is slightly different in those two scenarios. The questions are consistent with those that we ask of blood donors, although they are obviously phrased and framed in a slightly different way. They also tend to be consistent across both the UK and Europe. That is because of the regulatory framework that we work within. They are guided by, for example, the Human Tissue (Quality and Safety for Human Application) Regulations 2007, which are UK-wide, and are themselves a transposition of the European Union tissues and cells directive. The granularity around the questions is put in at a UK level by the UK blood services joint professional advisory committee.

Questions can also change. We have complex geographic exclusions because things such as malaria, West Nile virus and chikungunya fever change their distributions in the world, so that is a very complex set of questions. I come back to what Lesley Logan said: they are evidence based and they are there to try to secure the safety of the product that is ultimately going back to the patient. That is what is driving the complexity.

Dr Cole

I would make a plea that, with the new bill, we shorten the authorisation process as much as possible. It already takes a long time and is exhausting for relatives.

In the previous evidence session we heard questions about intensive care capacity. Intensive care is a very scarce resource within Scotland, and occupying a bed for an additional 12 or 15 hours may, in some circumstances, mean that somebody else who needs an intensive care bed is not able to access one locally.

The Convener

That is an important point.

Sandra White

The flip side of my question is whether there is anything in the bill that would make bureaucracy worse. Is there anything in the bill that would drag the process out even more?

Lesley Logan

My understanding of the changes to the duty to inquire is that we would not be expected to go to the ends of the earth and be phoning relatives in Australia or wherever. We generally always have the nearest relatives in the room, or close by, to consider whether anyone has additional knowledge. We also ask in the medical and social history questionnaire whether there is anyone else who we should be consulting about their decisions. I think that that is probably okay.

I would not like to think that the additional questions about pre-death procedures would lengthen that process because, as you saw from our armchair theatre this morning, the families want to get back to the bedside. That is absolutely where they rightly should be and we are mindful of that.

Alex Cole-Hamilton

I thank the panel again for their input. We were all very struck by the informal evidence session with Lesley Logan and her colleagues and I thank them again for that.

We talk about these being difficult decisions and difficult discussions to have with people who are enduring, as you said, the worst days of their lives. All the decisions that they have to make in that very short window of time place an immense degree of pressure on their mental health.

This morning, we also heard from people who are on the waiting list for transplants. They, too, experience a rollercoaster of waiting and false dawns when they get the phone call and jump in an ambulance, but are then turned around. It strikes me that we have no longitudinal mental health specialist support for either group of people, either the recipients in the long wait before they get an organ and in their convalescence afterwards, or for the family members who make the difficult decision to permit donation. Obviously, people do not necessarily need support until the very end, because in many cases they do not know that it is going to happen, but they need support around the decision and then in the weeks and months to follow. Is there a gap and is this bill an opportunity for us to close it?

Lesley Logan

There is a gap on both sides. I used to manage the transplant programme in Edinburgh and I know that the social workers and the recipient co-ordinators follow up patients who are called in for transplantation but are then stood down because the organs are not available. A discussion around the resource for that would be very timely, especially if we are hoping to increase the number of transplants.

A couple of years ago, I spent some time in Sydney with the Australian transplant and donation service. Earlier this year, I was with a donor in Scotland and we had waited some 24 hours for the son to come from Australia to be at his mother’s bedside. He agreed to donation, which proceeded, and I used my contacts in Australia to ensure that he was invited to a remembrance service there. The electronic conversation that I had with my equivalent in the Brisbane area was that she would also invite him to participate in what all Australian families are offered, which is up to two sessions with a psychologist or a bereavement counsellor to support them in their decision to agree to organ donation, in case there was anything that they wanted to pursue.

I knew that that existed, but I have never had a family have that offer. We direct them to organisations such as Cruse Bereavement Care. We do follow up our families: we write to them within two weeks of the donation to give them some information about the recipients. We also invite them to the annual service, as you know, and on an annual basis we can provide updates, but we do not do anything specifically for those individuals whose loved ones have donated and who might require on-going psychological support, unlike some other countries.

12:45  



The Convener

Stephen Cole, do you want to add anything to that?

Dr Cole

No, only to echo what Lesley Logan said.

David Stewart

What assessment have witnesses made of the Spanish system of organ transplantation?

Lesley Logan

I was in Munich last week at an international donation and transplantation meeting at which I was beefing up my knowledge about Spain. First, we need to be careful that we are compare apples with apples. The UK definition of a donor is someone who goes to theatre and has an organ removed for the purposes of transplantation. In Spain, the definition of a donor is somebody who goes to theatre for donation, so they are not the same thing.

In the Spanish system, families are re-approached up to six times to see whether they will say yes. We might feel that that is a little bit harassing. If the family says no, staff wait half an hour then go back in. If the answer is still no, they wait another half an hour and then go back. That is well understood in Spain’s intensive care, so their donation rates are high. The Roman Catholic Church supports organ donation, and people have extended families, so there are demographic, cultural and religious reasons why donation might be better supported there.

Stephen Cole has spoken, and may speak again, about intensive care bed numbers. What is really interesting—I do not think that anyone knows this yet—is that the latest surge in donation rates in Spain is because of a new initiative that they are calling intensive care for organ donation. Families of individuals in hospital wards who are not ventilated are being asked whether, following the individual’s catastrophic event—for example, a stroke—and their having entered a pathway of care in which they are likely to die, donation may be possible; if so, they are electively ventilated. That causes significant ethical concern.

In Spain, donation after circulatory death is different to the circulatory death donation that we pursue in the United Kingdom. They can retrieve organs in all their hospitals, whereas the UK model is that our retrieval teams are highly specialist doctors: seven abdominal teams and six cardiothoracic teams service the UK. The model of healthcare is also very different. All those things together contribute to the quite different numbers that you see.

Croatia is also a very high donating country but it has, I think, only nine organ-retrieving hospitals. It is much easier to manage nine hospitals and to move them all in the same direction. Scotland has 25 such hospitals and 14 regional health boards. There are big differences, but we watch all the time to see whether there is anything that we can consider.

David Stewart

That is very useful. All three of you will have heard my question to the previous panel. I have always been very wary of comparing countries, even within the EU. That said, very crudely—as you will have heard me say—the UK’s donation rate is half Spain’s rate, even assuming the same family refusal rate. That is quite striking. Notwithstanding cultural differences, is there best practice that we can pick up that might be included in the bill?

Lesley Logan

I should also have said that the organ discard rate in Spain is very high. Staff approach and get permission for donation from patients whom we in the UK might consider to be not suitable. The result is that organs are discarded and not transplanted. It is very important to us that, if we pursue donation, we are pursuing it for the expected outcome. We never remove organs unless we know that they have been placed and accepted by a transplant centre for a named patient. That is another difference.

Dr Cole

I heard your comments to the previous panel. As well as public awareness and education, I would like to highlight the fact that Scotland has fewer intensive care beds per thousand population than the rest of the UK, and many fewer than southern European countries and the United States. That is a cultural situation that we have developed within the UK and Scotland. Intensive care is a very scarce resource.

My other hat is for my role in the Scottish Intensive Care Society audit group, so I know about the numbers of patients who are admitted to hospitals. One of the ways through which we could effect change would be to invest more in intensive care capacity around the country. Donation would be a by-product of that, but it would also benefit the wider population in terms of lives saved and people returning to normal health.

Lesley Logan

Another thing that is worthy of note is that the further south in Europe you go, the higher the number of road traffic accidents that cause trauma. Only 3 per cent of our donors in Scotland come to us through road traffic accident trauma, because our roads are safe in comparison with those in southern Europe.

David Torrance

Do you agree that 16 should be the age for deemed authorisation?

Professor Turner

It is not for the SNBTS to take a position on that question. It is a question for the people of Scotland and for Parliament. Whatever age is decided is the right cut-off, we will respect that and apply the appropriate regulations.

The Convener

Thank you very much. There are no different views from other witnesses.

David Torrance

Could different ages for deemed authorisation across the UK cause legal problems for transplants?

Lesley Logan

I am not aware of any such problems, at the minute. In Scotland, we would still accept an organ from a child who died in Wales. Allocation of organs has not in the past been problematic in those circumstances.

Professor Turner

I might be able to answer the question by analogy. When we changed the regulations on blood donation around deferral of men who have had sex with men, England, Wales and Scotland changed to a 12-month, and now three-month, deferral. Northern Ireland did not change. It has continued with permanent deferral, at least for now. We obviously had to come to an understanding with Northern Ireland because sometimes, in times of shortage, we support healthcare there by providing blood, for example. It was agreed that Northern Ireland would receive blood from us, from either NHSBT or from SNBTS, that would obviously have been selected and screened according to our donor selection and testing criteria, and not theirs.

In the scenario that I think you are suggesting, where there might be a difference in age between, say, Scotland and England, both countries would have to accept the application of the criteria of the other jurisdiction.

The Convener

That is a relatively straightforward matter, in your view.

I thank our witnesses. It has been another very useful session.

12:54 Meeting continued in private until 13:36.  



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Third meeting transcript

The Convener (Lewis Macdonald)

Good morning, and welcome to the 30th meeting in 2018 of the Health and Sport Committee. I ask everyone in the room to ensure that mobile phones are switched off or set to silent. Although it is acceptable to use mobile devices for social media, please do not take photographs or record proceedings.

Agenda item 1 is the third of our evidence sessions on the Human Tissue (Authorisation) (Scotland) Bill, which proposes to introduce a system of deemed authorisation for organ donation. Today, we will focus on evidence from Wales reviewing the Human Transplantation (Wales) Act 2013, which came into force in 2015, in order to allow us to explore in greater detail that act and its impact on organ donation rates in Wales.

I welcome Richard Glendinning, who is now with Ipsos Mori and who was formerly director of social research and lead researcher on the evaluation of the Welsh act at Growth from Knowledge UK; Dr Frank Atherton, the chief medical officer and medical director of NHS Wales with the Welsh Government; and Dr Katja Empson, regional clinical lead for organ donation for south Wales, from Cardiff and Vale University Health Board. Thank you for attending—it is much appreciated by the committee. We are keen to learn the lessons of the Welsh experience and experience elsewhere.

I suspect that the central issue for the committee and the Scottish Government in considering a change in the law is whether that change would enable an increase in the rate of donation and the rate of transplantation. I ask the witnesses to start by offering an overview of the general perception from the evidence as to whether the act has met or is beginning to meet its fundamental purposes.

Dr Frank Atherton (Welsh Government)

Thank you for inviting us to talk about our experience in Wales. It has been our great pleasure to share our experience with Scotland and other countries. I emphasise that there has been a lot of interest in looking at our experiences to date.

Of course, it is still relatively early days in Wales, as it is only three years since full implementation of our act. We are still in a learning process but, generally, we believe that it has been a positive move. We can talk about the statistics and the figures on donation and consent rates—I am sure that we will get into some of that—but in general we feel that donation rates are going the right way. In Wales and the rest of the United Kingdom, too many people still die while they are waiting for organ donation. That is a tragedy in every individual case, and we want to work collectively on it.

My overarching point would be that the legislation has been a really important part of our process to improve organ donation rates in Wales, but it is not the whole story. We know that a range of things need to happen—we need to get the infrastructure for organ donation right, and we need to get the public engaged. I would say that the most important part of our journey has been to do with how we have used communication during the development of the Human Transplantation (Wales) Bill, during the pause between royal assent and full implementation of the Human Transplantation (Wales) Act 2013, and as we have proceeded with implementation. We believe that legislation is an extremely important part of changing cultural attitudes and working with and persuading the public, so that they believe that organ donation is the right thing to do.

Our success has been very positive. As I said, it is still early days, but we believe that we have a lot of useful experience to share. We believe that this is the right thing for Wales. There is very little public dissent in Wales. There was a lot of discussion and dialogue when the bill was proposed and, before that, when the white paper came out. The process that we went through was an important one, and so is the one that you are now going through in Scotland.

There has not been a lot of abreaction to the legislation. There are high levels of understanding and awareness of it and of the choices that people now have to make. There is a generally positive feeling that this has been the right way to go for Wales.

The Convener

I think that the initial evaluation of the impact of the 2013 act suggested that donor rates had not increased whereas family consent rates had, although there have been developments since then. Do you have a view on why one of the rates went up faster than the other? Is there any reason for the lag in the increase in donations?

Richard Glendinning

I do not think that there was any expectation that there would be an overnight change. The process whereby people’s knowledge and awareness of, and support for, the change grows is a gradual one. It is reasonable to expect that we will see change over time.

When we did the impact evaluation, one of the concerns was the fact that we had a relatively narrow window to look at the data—we had only seven quarters of data. In Wales, typically, there would be about 15 donors a quarter, so that was a very small sample to look at. We extended it as far as we could. There were a lot of positive signs on some of the softer measures to do with attitudes of the public and of national health service staff, but during the formal evaluation period that we reported on a year ago, there had been no significant change in donor levels. There was a very small rise over the 21 months before the implementation of the legislation and the 21 months afterwards.

In the past 12 months, there has been a marked increase, when there have been more than 80 cases. That is probably the highest figure that we have ever had in Wales. The evidence suggests that there needs to be a build-up of knowledge, awareness and support and that a rise in donor levels will come after a period of time.

Dr Katja Empson (Cardiff and Vale University Health Board)

Immediately after the implementation of the legislation, there was a lag period in which the specialist nurses acquired familiarity with the terms of the legislation. They understood the act, but it took some time for them to become familiar with it and confident about using the deemed consent terminology in the conversations that they had when they approached families. There was a significant shift in practice from what had previously been a family and relative-centred approach to one that was more to do with the presumptive facilitation of the deceased’s decision, and it took some time for the specialist nurses to acquire the skills that they needed for those conversations.

The Convener

That is interesting. Was there any change in the rate at which families were approached, or was it simply that there was a difference in the way in which the terminology was used?

Dr Empson

I do not think that there has been a significant increase in the rate, but there have been improvements in the recognition and referral of patients to the transplant teams. Outwith those teams, the ability of intensive care and emergency departments to identify potential donors and to refer those patients has improved, so there has been a degree of increase. However, the substantial change was around the specialist nurses’ familiarity with the use of the different terminology.

Emma Harper (South Scotland) (SNP)

Good morning, everybody. In Wales, 41 per cent of people have opted in, according to Dr Atherton’s submission. That means that 59 per cent of the Welsh population have still not registered whether they want to opt in or opt out, so you would deem their consent.

Has any analysis been done of the people who have not recorded any wishes to decide on the extent to which we will get those people to opt in or opt out?

Dr Atherton

You are right—41 per cent of people in Wales have chosen to opt in. That number has increased over time; it has been rising gradually, which we believe is positive. The number who opt out—people now have an opportunity to do that—is at about 6 per cent and seems to be stable, which is good news.

Younger people tend to be slightly more likely to opt in. Richard Glendinning might have some further numbers on that. However, we never expected to get to 100 per cent. It is really important that people understand their choices. We do an annual survey, so we know that 70 to 80 per cent of people now know what their choices are. Those people who have a view and who do not wish to donate have a clear understanding of their ability to opt out. It is reassuring for us that the figure for people opting out is staying stable at about 6 per cent.

Richard Glendinning

On the proportion of people who have made no decision one way or the other, it is interesting to see from the research that we have done across NHS staff and the general public in Wales that about three quarters or more of people support the idea that no decision implies consent. There is quite a lot of understanding out there about the implications of not making a formal decision.

As Frank Atherton said, 41 per cent of people have chosen to opt in; I think that that is the highest percentage in the UK. That figure has continued to rise, whereas there has not been much of a rise in those who have opted out. However, there is a general understanding across the public that not making a decision implies consent.

The Convener

It is the highest opt-in figure in the UK other than in Scotland, where we are at 51 per cent.

Richard Glendinning

It is good to know that.

Emma Harper

Dr Atherton mentioned that young people are more likely to opt in. Are you concerned that some groups might have been missed out and that a more targeted approach may be needed? I am also curious to know whether NHS staff have been assessed to find out whether they are opting in or opting out.

Richard Glendinning

There is definitely a higher level of opting in among NHS staff than among the general public. There is variation in the levels of positive opting in. I think that younger people are a bit less likely to opt in. Perhaps the issue is not very high on their radar, because of their age. We need to further communicate and push that point across to people.

Dr Empson

The public awareness campaign that was launched before the implementation of the 2013 act centred around the choices that people had. The three choices were to opt in, opt out or do nothing. The understanding was that, if people did nothing their consent would be deemed. The do-nothing option was very much presented as an option that people had and the expectation was that it would be seen as being on the same level as the opt-in option.

In the first year or two after implementation, there was a feeling that there was a two-tiered opt-in. If someone opted in on the register, that was seen as a stronger opt-in than deemed consent. Gradually, over time, the healthcare professionals who are working with the families of patients are seeing those two types of consent as being on the same level and they present them as such to the families who they are working with.

10:15  



Dr Atherton

I am sorry—younger people are less likely to opt in. I apologise if I gave a misrepresentation.

Emma Harper asked whether there are groups that we worry about, and that brings us to the question of ethnic minority groups. I do not have the figures to hand, but we recognise that people in black and minority ethnic groups are less likely to make those conscious decisions and are less likely to opt in as donors.

We have done specific work as the communications have evolved in the three years since implementation of the 2013 act; we recognised the need to do that. A lot of work was done before the bill was introduced to try to understand the views of religious leaders and ethnic minority groups, for example. However, we believe that we still need to do more work to target those groups.

Keith Brown (Clackmannanshire and Dunblane) (SNP)

I have a factual question, the answer to which may be evident from the evidence that has been given. In the Welsh system, if someone opts in and the family and the clinicians subsequently have a different view, can that be overturned?

Dr Atherton

It can be. That is a fact. We have always described the process in Wales as a soft opt-out process. Katja Empson may have more information about that, as she deals with it more regularly on a personal level. The policy was always that families would have the opportunity to make a final decision, bearing in mind the wishes of the deceased relative.

The good news in Wales is that, although there are occasions when families overrule the presumed consent or the opt-in consent that people have given before they became deceased, that proportion is going down.

To return to the communications issue, we recognised last year the need to provoke conversations in the family about the issues and the conscious decisions that people have made. When people opt in, we encourage them to have those conversations with the family so that the family are aware of their relative’s desire before anything untoward happens. We continue to use that messaging in Wales, and that is a key stream for the future.

Dr Empson

There will always be families that have to make the decision to override the decision that the deceased relative had made, and there are a number of reasons why people would make that choice. For the clinicians and specialist nurses involved, the sense now is that we are able to push families harder in what can be a very difficult time. Obviously, it is a very difficult time for the family but, because of the change in the legislation, perhaps we are empowered to have more presumptive conversations with families, to push and challenge them, and to try to ensure that they facilitate the decision that their loved one made in their life.

Ensuring that members of the public are educated to have conversations with their family so that their wishes are known is key. Much as they might choose to make known whether they want to be cremated or buried after they have died and in the same way that they make decisions about other aspects of what would happen to them after they have died, they should make their choices clear to their families.

It would be impossible to work with legislation that somehow enforced the pushing through of the decision to donate, irrespective of what the family’s position was in that situation; ultimately, the specialist nurses and clinicians who work with the family would not want to cause harm by pushing through donation if the family clearly felt that it could not support that. The family’s support is needed in order that donation can be proceeded with safely. There needs to be the ability to ask the family questions about the potential donor’s health and social aspects of their life, in order that the transplant can proceed safely. Trying to make that happen without the family being positive and on board with the process would be almost impossible.

Richard Glendinning

I want to support the point about the conversation, which is a key part of the process. It is less difficult for the specialist nurses to have the conversation in the knowledge that more people have been talking about the issue. The latest research shows that 55 per cent of people said that, at some point, they had had a conversation with family members about organ donation. That leaves a lot of people who have not had that conversation and some of those conversations will not necessarily be contemporary, so there is still a need to promote having that conversation because it makes the conversation that has to be had in due course less difficult.

The circumstances are challenging, for sure, but it becomes slightly more straightforward in the context that the conversation might have taken place within that family and that the wider family was aware of the individual’s wishes.

Keith Brown

I want to ask a quick question that should have a factual answer before I move to my substantive question. Would the reverse work if somebody had opted out? Can that decision be overturned by the family and clinicians?

Dr Empson

It can, in practice, if the family can provide evidence that the person had changed their decision. For example, the family might present evidence such as, “He decided that a few years ago when the legislation changed, but the other night we were talking to a family whose son was waiting for a kidney and he said quite clearly that, on balance, he would not have a problem with that.”

We ask families to provide evidence about the sort of conversation that they had to support that change in decision. That could happen. It is about the person’s last-known wish, and the decision that was recorded on the organ donor register might not be the last-known wish.

Keith Brown

My concern is about where the rights of the donor come in all this. It seems that they come behind those of a number of other groups when a person makes a decision to opt in, opt out or do nothing.

If a person’s decision, whether it is to opt in or opt out, which was taken when they were in full possession of the facts, can be overturned, why was it decided not to put that into the bill except in the circumstances that you just mentioned and when additional information can be offered? As far as I can tell—maybe it was in the communications strategy—it was not made plain to donors that their expressed view can be overturned. Is there a reason for not including the family veto in the bill?

Dr Atherton

We might need to go back to the Welsh act, but I believe that it was clear that we were talking about a soft opt-out process, which means that a decision can be overturned. You might need to look at what was in the bill, but my belief is that it was pretty clear.

The Convener

In Scotland, the convention is clear but it is not in the bill. The question is simply whether that is right and whether it is the Welsh model. We deduce that it is, but anything further that you might want to come back to us with on that would be welcome.

Alex Cole-Hamilton (Edinburgh Western) (LD)

Good morning, panel, and thank you for coming to see us. I would like to explore why families override such decisions. We had an illuminating meeting with specialist nurses who took us through a role play of the conversations that happen prior to or just after death, when a patient’s organs will be viable. They made it clear that, in Scotland, one of the barriers is the sheer number of questions that are asked of families at that time.

There might therefore be a bureaucratic impediment to a successful discussion with families at the time of death. They are experiencing one of the worst days of their lives and they might have to answer several hundred questions in some cases.

What happens in Wales? Is it as bureaucratic as Scotland? Have you found any workarounds or shortcuts?

Dr Empson

I am not sure that the process is bureaucratic, as such. A number of questions will be asked of families so that the donation can proceed in a safe manner. We need to ask quite deep questions of the family about their social history and the patient’s health to ensure that the transplant goes ahead safely. If the family was unable to support those questions it would be difficult to proceed with donation.

I do not think that they are presented in a bureaucratic way, because ultimately the specialist nurses are well trained and experienced and are able to manage families in that situation sensitively and compassionately. I would like to think that that conversation does not present itself as a tick-box exercise or a shopping list, but perhaps that is the way it might look if you were to simply review the forms that the specialist nurses use. The conversation would take place in a compassionate way.

Some families will look for more information from the specialist nurses about how the donation process goes. They might then be presented with further information by the specialist nurses about the processes pre-death or after death. Other families will want less information, because they simply do not want to know and are happy to let the process run its course.

The specialist nurses are able to share information as and when it is needed, but a series of questions need to be addressed and answered in order that donation can take place safely.

Alex Cole-Hamilton

I understand that, and I should say that the specialist nurses we met had a wonderful manner and turned those questions into a conversation about the life of the person who had just passed away, which I think was quite a cathartic experience—it certainly seemed that way in the role play that we experienced. Do either of your colleagues have a view on whether we could be doing things in a simpler manner?

Dr Atherton

I echo what Katja Empson said: the last thing that we need is to have layers of bureaucracy when people are going through very difficult circumstances, but safeguards need to be put in place and information needs to be gathered. What has just been described is the way to go about it. It is not about legislation, but policy and practice.

Richard Glendinning

I have nothing in particular to add, other than to say that specialist nurses continue to need support and guidance about best practice. That evolves over time—it is a continuous process of updating knowledge.

Alex Cole-Hamilton

I will ask a very short supplementary on that before I move on to a different area. What I am driving at is that, for me, one of the most jarring moments of that role play was when they started asking about intimate aspects of lifestyle and particular risky behaviour. It strikes me that families might not know about risky behaviour and that theirs is a subjective viewpoint. They might say, “I have absolutely every faith that they never engaged in that kind of practice,” but that is not a surety—there are no guarantees. Given that there will be strong clinical measures to test blood and tissue for evidence of contamination or disease, is it really necessary to ask such sensitive questions?

Dr Empson

It is set out in our code of practice that the expectation is that we will explore those themes with families. Our experience of that over the past few years suggests that it is necessary to ask those questions of families. I do not know the evidence behind that or what work has been done to try to prevent the need to ask those questions, but it is my understanding that they are an essential part of the process of safe donation and transplantation.

Alex Cole-Hamilton

Okay. That is absolutely fair enough.

What mental health support is offered to families in the initial 24 hours after the discussion about organ donation and in the weeks and months following a decision to donate?

Dr Empson

It is important to understand that the process of consenting to or authorising organ donation is a normal part of end-of-life care and that it does not require any particular special mental health or psychological support for the families. In many ways, the evidence suggests that families who have gone through the process of donation get an enormous benefit from it; it is a positive outcome for families at an otherwise very bleak time. I do not think that families require particular psychological support over and above what should be offered as part of standard end-of-life care and bereavement care for families who are going through the process of a loved one dying.

10:30  



Alex Cole-Hamilton

That is helpful. My final question is perhaps more pertinent. Last week, we had a powerful meeting with organ recipients. We were struck by what we heard about the absence of mental health support for people who are on transplant lists. The recipients described being on the list as a rollercoaster—they might be called several times in the middle of the night to tell them to be ready for a transplant, only to be stood down for whatever reason. That can be tremendously hard, particularly as the people who are involved are very ill. What support is offered to people in Wales who are on transplant lists?

Dr Empson

I cannot answer that, because I do not work on the recipient side—I am very much on the other side of the process. However, the psychological difficulties for patients who are in such circumstances are clear—they face chronic illness and uncertainty about their prognosis while waiting for an organ. When a patient receives an organ, the knowledge that it came from somebody who is deceased is also a psychological problem. I am sure that support is required, but I am not sure what we offer in Wales.

Dr Atherton

Likewise, I cannot answer at the moment, but I recognise the dilemma for the people whom Alex Cole-Hamilton mentioned. When we get back to Wales, we will check the situation with service providers. I do not believe that any specific mental health support is dedicated to such patients but, if it is, we will let the committee know.

Alex Cole-Hamilton

That would be helpful.

The Convener

We appreciate that.

Sandra White (Glasgow Kelvin) (SNP)

When I have listened to evidence and met families—Alex Cole-Hamilton mentioned that—the positive thing that has come through all the time is that people feel that a donation is a gift, which might not be the case for deemed consent. Do people in Wales think that a donation is a gift, rather than something that involves the state interfering?

Dr Empson

In the consultation period that led up to our legislation, there was much discussion about the concern that the legislative change would remove donors’ ability to make an altruistic gift at the point of death. However, the concern has not been borne out in implementation. There is no sense that people no longer see a donation as a gift; donor organs are still valued as a wonderful gift by the public and by people who are involved directly and closely with the process. Key to that is celebrating the donor’s life through the Order of St John UK awards and other softer activities outside legislative change that maintain positivity.

The Convener

When Keith Brown asked about family overrides, Dr Empson mentioned that, in some circumstances, a family might still take a different view even if somebody was deemed to have given consent or had positively opted in. Do the rates of family override differ for those categories, or are the numbers that are involved in both so small that they are statistically insignificant?

Dr Empson

I am sorry—I missed the first part of your question.

The Convener

Do the rates of family override differ between the group of people who positively opt in and the group of people who are deemed to have given consent?

Dr Empson

That is difficult to interpret from the raw data. In the period immediately after implementation, I am not sure that we were very good at recording where people were on that spectrum. It is not clear from the way in which we collected and recorded data whether deemed consent was being overridden because of a wish expressed verbally by the family, or whether there was a clear override of a known decision.

I do not think that we had that granularity of information immediately after the implementation phase. We are better at recording it now, because we have understood those different groups better and the information is better captured. In all groups, we have seen a reduction in both known expressed wish and deemed consent overrides. It is difficult to tease out the information and we are talking about very small numbers, so it is difficult to draw any true conclusions from it.

Miles Briggs (Lothian) (Con)

I want to ask a couple of questions about consent rates. The submission from Dr Atherton highlights that consent rates in Wales have increased and are now significantly higher than in England. What do members of the panel attribute that to? Has it been the national conversation that has taken place in Wales? Can that be maintained, now that the legislation has been passed and it is perhaps out of people’s minds?

Dr Atherton

I will start, and Richard Glendinning may wish to come in on some of the figures. Consent rates are increasing, which we have recognised as one of the positive markers of the programme. Your question was about what part the legislation plays in that, versus what part the communication plays. We have been trying to disentangle those elements, but they cannot be fully disentangled because they are interrelated. We believe, however, that on-going communication is required. We see that some of the things that we measure drop off when communication dips, so we recognise that we need both to continue with annual communication and to tailor that education towards specific issues. We talked earlier about having family conversations, for example. We think that donation rates are increasing and improving as a consequence of both the legislation and the communication processes.

Richard Glendinning

I echo Frank Atherton’s point that the percentage has gradually risen. It is at 41 per cent and it has been creeping up year by year over a period of time. The nature of the Welsh system and the widespread recognition that no decision implies consent may cap that figure. It is not necessarily going to surge ahead, but it may continue to rise because there is a gradual build-up of awareness and knowledge.

Miles Briggs

Thank you. On the age of consent, the bill that we are looking at proposes that deemed authorisation would apply to people aged over 16 in Scotland, while in Wales the age is 18. Why was the age of 18 chosen in Wales?

Dr Empson

I think that it was chosen because it is in line with the Mental Capacity Act 2005, but you might want to ask the lawyers. My understanding is that that age would keep our bill in line with other legislation in Wales.

Dr Atherton

It was to do with that and with our general definitions in a range of legislation about the point at which people are classified as adults and have sufficient mental capacity to make decisions of their own.

Miles Briggs

Given that the Scottish age of consent will be 16, if this bill passes, will there be any issues around NHS Wales accepting organs from a 16-year-old from Scotland, as far as you know?

Dr Empson

I cannot imagine that there would be. Much as you will do in Scotland, we receive organs from people who have had their consent deemed. It would not be an issue to deploy the legislation to receive organs from other nations.

Dr Atherton

Our approach has always been that any organs go into the general pool for UK-wide use. We would expect that to apply to Scotland, as it does to Wales.

David Torrance (Kirkcaldy) (SNP)

Some of the responses to the committee have highlighted the need for adequate efforts to inform the public about opting out. What avenues are available to people to opt out in Wales?

Dr Empson

People can opt out on the website. They can still opt out through the driving licence, but they are encouraged to opt out by the website that the NHS and the Welsh Government publicise and give links to whenever they send out public information.

Dr Atherton

In addition to the routes that Katja Empson has mentioned, we explored whether it would be possible to opt out through primary care records. However, that became quite problematic in Wales, and we did not go down that route. The reason for that was that, in primary care, there is often a delay between somebody making a decision in perhaps a paper-based system—our electronic systems are not quite as rapid as they should be—and getting that on to the register. It was seen that somebody could have elected to opt out but that that was not recorded within a small window and, if the person became deceased, what happened would be contrary to their wishes. We looked at that approach and discounted it, and we have tended to use the routes that Katja Empson has mentioned.

David Torrance

How did you manage to communicate with difficult-to-reach groups, such as the percentage of our population who have difficulty reading and writing and the deaf community?

Dr Empson

An adviser for ethnic minorities and for disability and disabled groups sat with the Wales transplantation advisory group. Specialist nurses—certainly in Cardiff—also did a number of outreach sessions for disability groups to try to raise awareness in them, and they also worked with faith leaders. The Welsh Government did work, and healthcare professionals such as specialist nurses did outreach work in communities.

Dr Atherton

That work to try to understand the needs of special groups and people with disabilities of whatever nature translated into the communications materials that we produced. They were produced in Braille, in a number of languages and in large font, for example. We tailored the information and communication to the needs of the community. That is very important.

Brian Whittle (South Scotland) (Con)

Good morning, panel. Thank you very much for coming to give evidence.

Wales has an opt-out system, and you have retained an opt-in system. If neither of those options is taken, there is deemed consent. Where does the public understanding of the potential decisions that can be made currently stand in Wales?

Dr Atherton

That is one of the issues that we regularly look at. We have seen the figures rise year on year. I do not have the latest figure in my head, but about 70 per cent to 80 per cent of people understand what their options are. The figure dipped slightly in one year, and we recognised the need to intensify our communications and remind people of their options. That is not something that we can do and forget; it is not a one-off thing. We have to continually drip-feed that information as part of our communications message. However, we think that we have very high and sustainable levels of public understanding of the three options.

Brian Whittle

I think that Dr Empson touched on this issue. If communication and marketing, for want of a better expression, are at a high level, every possible opportunity is given to those who wish to opt out and that decision is made as accessible as possible, why is the opt-in retained? If the communication is particularly good and a high level of understanding is delivered, why is the opt-in retained? Opting in and opting out are decisions, but deemed consent in those circumstances is potentially a non-decision and is easier to override. That is what we are trying to explore. Why is the opt-in retained?

Dr Empson

That is not something that I have given thought to. Perhaps that is partly historical. In the UK, we have always had the organ donor register, so there has always been the opportunity to opt in since transplants and donations became options.

10:45  



The opt-in also encourages people to consider the opportunity. We know that, statistically, when they are asked, most people say that they want to be donors, but fewer people take the action of registering. By maintaining the opt-in register, we allow people to say definitely and clearly, “In the event of my death, I want to donate my organs.” It will take some significant time and an awful lot of education for the public to see that on the same level as not registering—I am sorry, but I have lost my train of thought.

Given that we have always had that register and there has always been the opportunity for people to register their wish to be a donor, losing the facility for people to make that positive choice would go against the positivity around organ donation. If there was only an option to opt out, that would be a backward step for the public of Scotland.

Dr Atherton

There is something about aligning with the register. We have a UK register, and we need to be mindful that other countries have different policies and practices. We need to align with the register.

The other fundamental point that we touched on earlier was that having an opt-in—a conscious decision—is really important to help provoke conversations within families. Whether there is deemed consent or opt-in consent, we need to have those conversations to prevent the issue of families overriding decisions, which we talked about earlier. A conscious decision that is discussed in a family seems to us to be the best option, because it will provoke discussions and lead to higher organ donation rates.

Brian Whittle

Obviously, we are looking to increase donation as much as we possibly can. That is the outcome that we all want. What I am pushing at is whether we could give the maximum opportunity for people to opt out. There could be a conversation with the family to say, “Your loved one had the opportunity to opt out and their decision was to remain, so there is deemed consent.” Would that not be considered a positive decision?

Dr Empson

My concern about that approach is that you would allow people only to make a negative choice. In that situation, the education and publicity campaign that you would have to launch would have to be about making the choice not to donate and to register your wish not to be a donor. The negativity in such publicity might go against the popularity of organ donation, if you see what I mean. It could mean that people would just take away the message that they should register the fact that they do not want to be a donor. You might lose something in your messaging to the public.

The Convener

Richard, do you have anything to add to that from a communication perspective?

Richard Glendinning

No, not really.

The Convener

That is absolutely fine.

Emma Harper

I am interested in issues around deemed consent and people who might have incapacity or might not have the ability to understand what deemed authorisation means. The Scottish bill includes safeguards so that authorisation for donation cannot be deemed for certain categories of people with incapacity. It talks about people who have, over a significant period, lacked the capacity to understand deemed authorisation. Does the bill present enough information so that people who do not have capacity will not just be deemed to have provided consent when they have not had the ability to understand? What do you do about that in Wales?

Dr Empson

Our legislation protects that group of people. The code of practice puts it in the area for the specialist nurses to explore.

Of course, people who lack capacity can still donate through the same process that we had before the legislation, whereby their thoughts and feelings about donation could be explored with the family and we could go down the route of allowing them to become donors through their expressed wish. However, their consent would not be deemed in the same way as it would be for somebody who had capacity in their lifetime. The workaround for that is through the conversation that takes place with the specialist nurses at the time.

Emma Harper

The Scottish Independent Advocacy Alliance has said that the provisions in the Scottish bill need to be strengthened to support adults with incapacity. The bill talks about a “significant period” of incapacity. Does it need to be more prescriptive? A “significant period” could mean anything—a month, a week or six months. Should the bill be stronger on that?

Dr Empson

The situation is not clear; there is no specific time period in our legislation. There are potential advantages and disadvantages both ways. There could be a cut-off point at which somebody suddenly lacks capacity. In some ways, it is safer to allow the healthcare professionals who are involved to make that decision, based on their understanding of who that person was and for how long they had not had capacity.

It should be in the code of practice that it is the duty of healthcare professionals to explore whether the patient had capacity to deem consent and the length of time for which they had not had capacity. I cannot see an advantage to having a specific cut-off point, because there might be a patient who had lacked capacity for just a few days more than that, in which case it would not sit right. I think that it is best to leave it to the judgment of the healthcare professionals who are involved at the time.

Sandra White

I want to ask about pre-death procedures. The proposal from the Scottish Government is slightly different from the proposal that was put forward by the Welsh Government, because your legislation refers to part of the Human Tissue Act 2004. The Scottish proposal is that there should be more clarity and that there will be guidelines on procedures that can be carried out before death. Can you give us a bit more information about what happens as regards pre-death procedures in Wales, particularly under deemed consent?

Dr Empson

There are accepted practices and things that can be done to support a potential donor and facilitate their becoming a donor. Those are agreed at UK level through the work that was done by the UK donation ethics committee. I do not think that we approach families and ask them for specific consent for those procedures unless families are looking for information and want to understand it in greater detail. It is accepted practice by the healthcare professionals who are looking after the potential donor at the time. We understand that the family might not always wish to know the finer and more difficult details of the medical actions that are taken in relation to the donor.

Sandra White

That seems very different from what we have heard from families of donors. We heard from someone who had gone through the process; they were talked through it and were able, if they wished, to see some of the procedures.

You talked about people’s consent and their understanding. Your answer suggested that people do not understand the pre-death procedures that go ahead under the 2004 act, which allows a body to be kept alive to preserve its organs. Do you agree with those processes being undertaken in Wales under deemed consent?

Dr Empson

Families understand and are very much involved in the process, but we would not want to ask a family whether they agreed to a whole array of blood tests, to us starting this infusion and that treatment, and to us giving steroids and starting a particular type of treatment. Going through those specifics with a family would be unnecessary, but a family would be very much involved and would have the opportunity, for example, to observe things such as the certification of death by neurological criteria—to watch the brainstem death test taking place. We would support and encourage that if a family wanted to have that involvement, although not all families choose that. However, it is important that a family should not have to consent to every activity that might need to be undertaken with the potential donor.

Sandra White

Under deemed consent, there is an opt-out system, and people do not have to sign anything. Do you support pre-death procedures in that situation?

Dr Empson

Deemed consent would be the same as expressed consent from people who opt in. The problem is that, when people sign up to the organ donor register, they are uninformed about the process that will take place. Unless someone works in an intensive care or emergency department environment, they will be unfamiliar with the process by which somebody becomes a donor. Sharing that information in a publicity campaign would probably not be in the interests of the vast majority of the public, who will not want to understand the level of detail that is involved.

When a potential donor is going down the route of donation, appropriate information is shared sensitively and compassionately with families. Families are given the opportunity to observe and understand processes, but we would not want to put families through a tick-box process for every investigation, test or additional infusion that might be started.

Dr Atherton

When the Human Transplantation (Wales) Bill was discussed in the Assembly, the issue was looked at. The conclusion that we reached was that we would replicate section 43 of the 2004 act. I am obviously not a specialist in the matter, but I understand that the Scottish bill is slightly different. The issue will need to be looked at carefully. We chose to align the Welsh bill closely with the 2004 act.

Sandra White

The subject is difficult to broach, but it has been raised, and I have maintained an interest in how the process works in other areas. What we propose is slightly different and will involve a wee bit more information and guidelines.

The Convener

In his helpful submission, Frank Atherton compared the Welsh legislation with the Scottish bill and drew conclusions about the Welsh legislation’s effectiveness. Having answered members’ questions, do the witnesses wish to add anything that they feel that we should bear in mind for the next stage in the process?

Dr Atherton

I thank the committee for the opportunity to give evidence. All of us in the UK are on this journey, and it is good that it is shared. It is one of many experiences that we can learn about and share across countries. I wish the committee good luck with its deliberations.

The Convener

Keith Brown has made a late bid to ask a supplementary.

Keith Brown

I back what the convener said and thank the witnesses for their evidence, but I will raise one thing. Dr Atherton responded earlier to a question from Miles Briggs about 16-year-olds; I know that the point that was raised was probably not expected. The idea that a country that passed a law that says that people must be 18 to donate an organ would accept organs from 16-year-olds jars a little. It would be useful if Dr Atherton provided a basis for that when he writes to the committee.

Dr Atherton

I am happy to do that.

The Convener

I thank the witnesses for their comprehensive evidence. We look forward to hearing a little more from them on the basis of our conversations.

11:00 Meeting suspended.  



11:03 On resuming—  



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Fourth meeting transcript

The Convener (Lewis Macdonald)

Good morning, and welcome to the 31st meeting in 2018 of the Health and Sport Committee. We have received apologies from Alex Cole-Hamilton, and Brian Whittle will join us in the course of the meeting. I ask everyone in the room to ensure that their mobile phones are off or on silent. Please do not film or record proceedings, as we do that ourselves.

Agenda item 1 is the final evidence session on the Human Tissue (Authorisation) (Scotland) Bill, which proposes to introduce a system of deemed authorisation. Our first panel will focus on evidence relating to law and medical ethics. We will then take evidence from the Minister for Public Health, Sport and Wellbeing.

I welcome Dr Emily Postan, who is an early career fellow in bioethics and deputy director of the Mason institute for medicine, life sciences and the law at the University of Edinburgh; Professor Alison Britton, who is convener of the health and medical law sub-committee of the Law Society of Scotland; and Dr Calum MacKellar, who is director of research at the Scottish Council on Human Bioethics. Thank you very much for coming to the meeting.

Emma Harper (South Scotland) (SNP)

Good morning, panel. I declare an interest as a former liver transplant nurse who worked in Los Angeles. I am still a nurse who is able to practise.

I am interested in issues that relate to the rights of a deceased person. The committee has explored opinions about the role that a family should have in the decision to donate a deceased person’s organs. Much of the discussion that we have had has centred on whose wishes—the wishes of the patient or of the family—should have priority. I am interested in your thoughts on whether deceased people have rights and who owns the body of a deceased person.

The Convener

That is a big topic. Who would like to start?

Professor Alison Britton (Law Society of Scotland)

From a European and a European convention on human rights point of view, once a person has died, they probably do not have rights, but the question is probably more about respect for what they expressed in life, whether through the parameters of legislation or the opt-in system that we currently have. If a person registered their wishes to have all their organs or none whatever donated, they might not necessarily get that wish. There are reasons why it might not be possible to respect that wish. Their organs might not be compatible with transplant so that, even though they wished for and requested that and had written down and expressed that wish, it cannot be adhered to. There might be other reasons. Emma Harper raised the issue of the weight of the preferences, values and views of the family, for example.

If somebody refuses to give their permission for their organs to be taken, that is almost easier to deal with, because that is clear and fewer questions arise than when somebody has said that they wish to have their organs donated. That is one of many anomalies.

Dr Emily Postan (University of Edinburgh)

To complement that answer from an ethical perspective, a deceased person does not have interests, but the person that they were before they died certainly did, and respect for those interests is an essential concern alongside family interests.

Using the language of ownership is commonplace. We all fall into using that language, and it is used appropriately in many contexts but, because ownership implies thinking about property and remuneration, for example, it may be more helpful to think about self-determination. A key interest of the person before they were deceased is an interest in determining what will happen to their body, which need not be construed in ownership terms, but is still a powerful interest.

Dr Calum MacKellar (Scottish Council on Human Bioethics)

From a philosophical perspective, a deceased person no longer exists and therefore has no rights. I agree with my colleagues that there is still an element of respect for the memory of the person. That is why sometimes even statues of famous people in Edinburgh are protected to protect their memory.

Nobody owns a body. People have responsibilities to a body, but there is no ownership. In the past in the Soviet Union, before the iron curtain fell, the Government owned the bodies of deceased persons. In places such as Moscow, the bodies of tramps who had died in the street from the cold or whatever were used for transplantation. They were owned by the state, and the state could do whatever it liked with the bodies.

Emma Harper

Realistic medicine and anticipatory care planning are important. If we know the wishes of people ahead of their death, it is easier to make decisions about opting in or out on organs and tissue. When I worked in Los Angeles, I was aware of a case where a family disagreed about the final wishes of a man who was dying of AIDS-related dementia. His partner of 25 years had no say, because he was not the next of kin. The parents overrode the man’s decision that he wanted to donate his brain for research.

Are people’s wishes protected enough in the bill, if they have an anticipatory plan, or can the family overrule?

Dr Postan

As I understand it, there is no entitlement in the proposed legislation for the family to overrule. The only ground on which the family could challenge anything in an anticipatory care plan or on the register, whether an opt-in or an opt-out, or the deemed authorisation would be if they could bring persuasive evidence that that decision was contrary to the most contemporary competent wishes of the person concerned.

Everything hangs on what counts as the evidence that a reasonable person would be persuaded by and whether the transplant co-ordination professionals have the time to dedicate to understanding and investigating whether there are reasonable grounds. That is the only time that a family’s wish could ever alter the course from what the person wished.

Professor Britton

In addition, the realities of the situation have to be looked at. Taking a broad human rights perspective, the law has said in previous cases that the application of legislation on transplants is not theoretical or illusory. It is not about sitting round tables in buildings such as the Parliament writing legislation; it is about being at the coalface.

One of the biggest current anomalies is that although there is nothing in the current provision in Scotland to say that relatives’ wishes be taken cognisance of, that happens routinely. That is the reality and the effectiveness of how we behave. We are moving to a situation in which, in theory and perhaps illusorily, we are no longer going to take any cognisance of those wishes.

Even with the provision in the bill, there are some riders. For example, will a more unusual donation, such as of reproductive organs or limbs, be passed without comment? If the family member comes forward with evidence to say that that was not the wish of the deceased, how will that be evaluated? What will be the consistent approach?

The idea in law is that there has to be clarity. It is one thing to say that relatives no longer have any say, but will we apply that all the time? How are we going to apply it? It is not only about having the legislation; it is about the quality of the legislation and how it is interpreted.

Dr MacKellar

On 13 November, Professor Turner told the committee that clinicians will always ask the family, no matter what the law says. If the family refuse to co-operate, organ donation will not go ahead, to ensure medical safety for the organ recipient.

Sometimes, a person who has not registered their wishes on the organ donor register has told their relatives what they want. Normally, relatives respect those wishes. If my relatives wanted to override my wishes, I would be upset. However, about 30 per cent of people never tell anyone what they want and never register their wishes. The Scottish Parliament information centre briefing says that about 65 per cent of those people, who have told no one their last wishes, oppose the removal of their organs for transplantation.

Under the bill, in cases where nobody knows someone’s wishes, the nearest relatives of that person would have no legal right to oppose the removal of organs. Not many people have realised that that is a form of hard opt-out system. The bill would legalise a form of hard opt-out when nobody knows the wishes of the person who has died. That creates quite a lot of concern because, so far in the discussion, we have been told that what is proposed is a soft opt-out, yet in some cases a hard opt-out would apply. That should be made clear to the Scottish public, the media and everybody else.

David Stewart (Highlands and Islands) (Lab)

I am interested in Professor Britton’s submission, which refers to the European convention on human rights and cites the case of Elberte v Latvia in 2015. I am sure that my colleagues are familiar with that case, but a brief summary is that Mrs Elberte’s husband died in a car accident, and nothing in his passport indicated that he wanted to donate his organs, but Mrs Elberte found out later that organs and tissue were donated. She brought a successful case under article 8 of the ECHR.

Even if we pass the bill, we will still have to look at the wider issue of the ECHR. At least two recent test cases suggest that, when the deceased has expressed no wishes, some rights of living relatives will still apply. Is the outcome of the Elberte case consistent with the bill?

Professor Britton

One difference is that the legislation in Latvia contained the expectation that relatives or the next of kin would be consulted. As you said, the passport was looked at, and the authorities found no indication that a family member objected, but they took no active steps to check that—there was almost passive acceptance, if that makes sense.

Two years after the gentleman’s death, his wife found out that his organs had been taken, because the organisation that did that was being investigated under criminal procedures. She objected because the organisation had not taken positive steps to find out what she wanted.

Any interpretation based on the law on the subject needs three things. The whole idea is that there is a public agency, such as the national health service, that could invade an individual’s private right, which is captured under article 8. Mrs Elberte also successfully won under article 3, which is on inhumane treatment.

The law requires any invasion of those rights by a public authority to be three things—it must be proportionate, legitimate and in accordance with the law. In the case that you described, the issue was the last element—whether the activity was in accordance with the law. The court said that, although Mrs Elberte had not made an obvious objection, nobody had actively found out what she wanted. That is what she won on. She did not win on the fact that she was the next of kin; she won on the fact that she had not been consulted at that time, as was required within the legal provision. It was a personal right to her.

We have to be careful, because anything in law is always about terminology. If the bill proceeds, the rights of the family and the role of the family need to be very clear, because those are quite different things.

10:15  



Dr MacKellar

The Council of Europe, which is a lot bigger than the European Union, has an additional protocol on transplantation. Paragraph 102 of the explanatory report on that protocol states:

“It is the expressed views of the potential donor which are paramount”.

In 2005, I gave evidence on the topic of transplantation to the Health Committee, and I tried to explain that it may be possible to bring a case to the European Court of Human Rights because someone was not asked about what would happen to their organs. The response from one MSP was, “Well, they can’t do that, because they’re dead and they don’t exist.” However, we should follow the spirit of the law. Just because someone cannot bring a case to the European Court of Human Rights, that does not mean that what happened is okay. It can still be wrong from an ethical perspective, even though someone would never be able to bring a case to the European Court of Human Rights because they have died. For me, that is stronger—ethics is more important than just having or not having the possibility of bringing things to court.

Keith Brown (Clackmannanshire and Dunblane) (SNP)

On Dr MacKellar’s point about the Soviet Union having ownership of dead bodies, I think that the Soviet Union also had ownership of children under that law when it first came in.

I am interested in cases in which someone has expressed a definite preference either to opt in or to opt out and that is then overturned. Professor Britton’s evidence says:

“we are placing the rights of the relative far above the integrity of the deceased and the need of a possible recipient. The last autonomous wish of the donor is potentially being thwarted simply because he or she is in no position to object.”

If the potential donor, in full possession of their faculties, has taken a conscious decision to opt in or to opt out but that is reduced to a wish that should be respected rather than a right, whose rights then come into consideration? Professor Britton made the point that, if the families are to be the arbiters, surely that should be written into the law. Should the family have that right? At present, it seems that clinicians have the right to say that they feel a bit uncomfortable about the donor’s wishes and they will be guided by the discomfort that is felt by the family, even if that changes things. I suppose that I am trying to get an idea of the hierarchy of rights that applies.

Dr MacKellar

In 2007 in Singapore, where there was an opt-out system—I cannot remember whether it was a hard or soft opt-out system, but I think it was a hard one—there was a case in which the body of a young man was being taken away and the family were pleading with the clinicians not to do it because they wanted to be with the person for a few more hours. The mother was on her knees, crying and asking the clinicians not to take the body away. Eventually, nine police officers had to come. That was a scandal in Singapore, and the family were eventually compensated with five years of reduced healthcare costs—there is no national health service in Singapore.

It is a difficult issue. I feel that if the view on opting in or opting out is clear, that view should be respected by the family. It is a bit like a will. Some of us have a will, and that is respected in law. For me, the problem arises when nobody knows what the person’s wishes were. I believe that the family should certainly be able to have the last word in cases in which nobody knows the person’s wishes.

Professor Britton

The question takes us back to terminology again. We talk a lot about “deemed authorisation” or “presumed consent.” Consent, in particular, has a special meaning in law, and increasingly, as the years go on, it implies an understanding of the decision and that there has been an opportunity to weigh up the pros and cons. In recent case law, post-2000, it has been regarded as very personal to the individual—consent for me might be quite different from what it is for other people.

I do not think that it is possible for families to replicate that, so what we are then looking for from a family is permission, which is very different from consent, because the family might not understand fully the values that led the individual to make the decision that they made. We are not asking families to replicate the views of the individual; we are asking them to decide whether they are willing to give permission if the individual’s values, wishes and consent are not known.

Dr Postan

If it is genuinely the case that no one knows the deceased person’s wishes, it is misleading to say that the wishes of the family somehow give better access to those wishes and are the preferred option, because the position is in genuine equipoise: whatever the family decides could be contrary to the genuinely unknown wishes of the deceased person. Exactly as Professor Britton said, we then move to a whole different paradigm, which is about looking at the interests of the family and respecting their distress, or their wish to give a gift, by giving permission. We would be moving away entirely from the language of consent.

I add my voice to Professor Britton’s, because she made an excellent point. If, despite what is written in the legislation, it is hard for healthcare professionals to move away from a paradigm in which they have acquiesced to the wishes of the family more often than they have respected the wishes of the deceased person, there will be a problem for the success of the law. If it is hard to make that change, the law will say one thing but another thing will be happening, which will serve to undermine precisely the principle that Professor Britton was explaining, which is the importance to consent and authorisation of people having full information and a full understanding of the undertaking to which they are signing up when they opt in or opt out. If the law, as written, cannot function because it is too hard to change the culture, that strikes me as a real problem.

The Convener

There is no formal role for the family in the current legislation, but there was such a role before 2006. If we were to formalise the permission of the family or give the family some other formal legal role, would that reverse the change that was made 12 years ago?

Dr MacKellar

At the moment, the family authorises what happens. The family always has the final say as to whether the organs are used—

The Convener

But not in a formal sense.

Dr MacKellar

In the legal sense, yes, there is authorisation. The family always has the final say. At the moment, even if someone has registered their wish to donate organs and is on the register, family members can veto the donation, because it is the family that gives the authorisation.

It is an authorisation, not consent. We do not use the concept of presumed or deemed consent in medical ethics; we use the system of opting out or opting in. “Deemed consent” is a contradiction in terms in bioethics, because to consent is to make an active decision, as Professor Britton said. The decision is made for oneself; a person cannot consent on behalf of someone else, especially if they do not know what the individual’s wishes were.

Professor Britton

Let me qualify that in terms of my understanding of the current position on the role of the family. The anomaly, as I see it, is that there is no legal provision for the role of the family as the law currently stands, but there is a general recognition that specialist nurses will enter into dialogue with the family to gain their views and will not go against the views of the family. The role of the family is custom and practice rather than something that is provided for in statute.

The Convener

Would the provision of a statutory basis for the role of the family revert to the pre-2006 position?

Professor Britton

It would if that were done efficiently. However, I go back to what I said earlier—that the role cannot be arbitrary. If there is an exception on the particular organ that is to be removed and family members have a role, that might lead to the question whether there may be other such circumstances. That may then lead to a presumption that the role is arbitrary.

On the idea of having consistency and clarity in the provisions of the law, I will use the current position as an example, as that will be easier. Hypothetically, if there is no clarity in the law, the courts may often look to custom and practice. That takes us back to the effectiveness of the law and the reality of the situation. What happens is based not on ideology but on practicalities, and, without a doubt, the custom and practice at the moment is that the wishes and values of the families predominate.

Keith Brown

I am concerned about that last point and about the narrower point that somebody has expressed their wishes and been specific about opting in or out. I realise that, for practical reasons, it might not be possible to fulfil that wish and that other considerations apply when no wish has been expressed. I am not making a point about those situations. What is important is the need for clarity in the law about whose rights are being upheld. I feel that the process is, in essence, a charade with regard to the donor. It does not matter whether they consent or say that they want to opt in or out, because something else can subsequently supersede that wish. I have issues with that, but if that is the case, surely we should be explicit about it—we should say that the donor does not have that right.

I do not get the idea that authorisation does not clash with consent; the two are very much in conflict. Surely, we should be clear about what a donor might have thought, because that is important for the real-life situation of people opting in. They will not give consent if they think that, in any event, it means nothing because it can be overturned by somebody else. It is really important to be clear about whose rights and wishes are being followed—I do not wish to introduce a confusion, as the point is about clarity.

Some people think that the wishes of the family should take precedence, but four countries were identified where that is not the case—where what the donor wants takes precedence—so that is possible. Also, some of the donors’ families do not want to be involved in the decision, because they agonise over it. Is it not possible to have a straightforward situation in which the wishes of a donor who has expressed a wish to opt in or out are respected? They have made that decision as an adult in full possession of their faculties, so why should that wish not be followed?

Dr Postan

I understand that that is how the law is drafted at the moment. The concern is that there is a culture in which, or an expectation that, that does not happen in practice because that is not what has been done in the past.

For the bill to work, as it is written, support is needed to change the culture in the healthcare setting and to change social norms and public awareness, with publicity about the significant change that the bill, as drafted, will make. The change is that the wishes of the deceased person cannot be overturned by the wishes of their family; they can be overturned only if the family can bring to bear evidence that the person’s wishes had changed. That takes us back to the question of what guidance will be given to the transplant co-ordination team about what counts as good evidence of a changed wish.

In our written evidence, we say that the issue will be opaque, to some extent, because the team cannot look into people’s souls and tell whether a person is being absolutely straightforward. Perhaps the guidance could contain some indicative forms of evidential support, so that people are not in the dark when trying to work out what counts as someone knowing that their relative’s wishes had changed—and showing that—and when someone is trying to fulfil their own wishes by sleight of hand. As drafted, the bill would work as Mr Brown suggests, but there are many instances in which it might not.

10:30  



Dr MacKellar

I agree that, from an ethical perspective, it is wrong to go against a person’s last wishes. However, as we have heard from Professor Turner, from a practical perspective, the medical team would never go against the wishes of the nearest relatives. I have just checked the Human Tissue (Scotland) Act 2006 and, at the moment, the nearest relatives always have the last word in authorising—or not—what happens to the organs of the deceased. They can authorise their use for transplantation and give legal authorisation for the use of the organs for research, education and other purposes. That can happen even when the person has said nothing—the relatives can still authorise all those things.

I do not know how to get around the issue. If we wrote down in law that the wishes of the deceased should always take priority, in some—very rare—cases that would create incredibly distressing situations. I do not think that medical professionals would be prepared to deal with that problem, and they are the ones who would have to deal with it on the ground.

Professor Britton

As Dr Postan said, the legislation on its own will not be enough; it needs to be accompanied by cultural change and a change in people’s attitudes. Several studies have been made of legislation standing alone, and very few jurisdictions agree that that is sufficient. There must be buy-in, understanding and education. The Parliament would be fundamentally changing an active process of opting in to—arguably—a more passive process of opting in by doing nothing, whereby someone would have to actively opt out. Getting support for that would involve getting the support of families, which would be secured through education and people understanding that it would be a fundamental change in culture and approach.

Miles Briggs (Lothian) (Con)

I will pursue Professor Britton’s point about the rights and role of family members in the legislation. That is an important point, because the current position in law is very different from convention and practice. We know from the most recent data that the wishes of about 10 per cent of potential donors who had recorded their wishes on the organ donor register were overturned by family members. Would it be beneficial for any bill to reflect convention and practice to ensure that those whom we are tasking to work with families to achieve donation feel that they are protected and not exposed to potential legal or regulatory challenges?

Professor Britton

I will focus on the latter part of that question, considering the Elberte case and the idea of rights and roles. Mr Briggs raises the important point that none of this will work unless there is clear guidance for those who provide information and support for the families at the time. The specialist nurses already do the most challenging of jobs in the most sensitive circumstances—even before the introduction of what is proposed. Under the proposals, they will have to do the same job in the knowledge that there is now a legislative provision to acquiesce to the wishes of the deceased. That brings a greater challenge for them and makes it a more difficult role. Their training and the background and understanding that they bring will need to be much more acute.

Dr MacKellar

I have read the discussions that the committee has had over the previous weeks, and there is always a presumption that people have family members or at least friends of long standing. However, we live in a society in which some people—more and more people, unfortunately—do not even have a friend of long standing. I have a very good friend who is a Church of Scotland minister in north Leith. He sometimes has to ask the congregation if some of them will go to a person’s funeral, because otherwise the only people there would be the minister and the undertaker. We must think about cases in which people have no family and no friends of long standing. They may have a few friends who would come to their funeral but who are not really close friends, and nobody would know the deceased’s wishes. I do not feel that that has been taken into account in discussions and in some of the legislation.

Miles Briggs

We have met many families who have gone through the process, and they have always highlighted how good the nurses who have dealt with them have been. What is important, though, is that there have often been failures towards the end of the process, when, even though the family has signed up to the relative’s wish for their whole body—whatever is needed—to be used for transplantation and donation, the family has decided to veto the donation of the eyes, for example. I wonder whether, as Keith Brown has outlined, we could make the wishes of the individual paramount. Otherwise, families who had supported a family member’s wishes may decide that their personal wishes should apply to some aspects of the decision. Many nurses find it difficult to go back to families and ask them whether they will fulfil a family member’s wishes.

Professor Britton

That is why it is important to have clarity about exactly what the role of the specialist nurses will be. If there is no clarity from the outset, and if there is no consistent and non-arbitrary approach, the issues that you mention will arise—and, once again, they will become custom and practice. For example, it will become custom and practice to acquiesce in the decision not to remove the eyes, the heart or whatever is considered important at the time. As soon as we start to do that, we are in the realms of medical or ethical judgment and are moving away from the provisions that you have put before us today.

Dr Postan

There is also a risk of tension in how the bill’s intentions are drafted in the explanatory notes. For example, it is constantly emphasised that this is a soft opt-out system because of the importance that is given to the views of the family. However, the range of issues on which the family’s views will be sought—for example, the medical history of the person and any evidence of differing views—is fairly limited. If that tension between validating the family and limiting their input persists into practice, it could undermine the aims of the legislation and the family’s feeling that their views are being valued.

David Stewart

I will continue on the theme of the role of the family in deemed authorisation. Some of my points were covered earlier, at least in part. One point that has been raised is that, whatever the law might say, in practice medical professionals will take into account the wishes of the family. If we accept that that is a given—it is our culture and, in my view, it is a good thing—should that not be reflected in the law?

Dr MacKellar

I believe that it should be reflected in the law. I remember the Health Committee discussing those issues in 2005 and it was made very clear to the MSPs back then that the family will always be consulted because, for patient safety, information is needed about the deceased person. That reassured some MSPs, who, as a result, felt more comfortable about supporting the bill that is now the present legislation.

Professor Britton

It is a small point, but both of my colleagues have talked about the role of the family in providing evidence of underlying medical conditions. That could be problematic. As described by Dr MacKellar, family members may not have such specialist knowledge or may not be alive.

There are also matters of confidentiality to take into account; for example, a potential donor might have underlying conditions that the family have no knowledge of or are not aware of. Therefore, you will place quite a responsibility on them if you ask for information on a person’s medical background, because they might not have it. They might simply say, “They had no conditions,” when in fact that might not be the case.

David Stewart

Another question has just occurred to me. If surviving family members had power of attorney, would they, under Scots law, have any more clout in decisions that had to be made on possible organ transplantation with regard to their deceased relatives?

Professor Britton

Not really, unless certain issues had been raised about the person’s incapacity while they were alive. The rights of the now deceased are not transferable.

David Stewart

As you know, legislation has to be authorised as being compatible with the European convention on human rights but, if I have learned anything in this job, it is that not all lawyers agree with each other. Can the legislation be strengthened to make it more compatible in that respect, particularly in the light of the test case in 2015, which Professor Britton has already given information about?

Professor Britton

If you are trying to strengthen the law, you should bear it in mind that the law is enhanced at the price of the medical and ethical judgments that are highlighted in the examples that were given by one of your colleagues. Would you just go ahead and remove someone’s eyes? If the law was absolutely clear and compliant and there was no room for any questions to be raised or for arbitrariness, the eyes would be removed if those were the wishes of the individual. If you were to bring in ethical questions or moral judgment, you might compromise a hard and unequivocal take on the law.

Dr MacKellar

One pillar of medical ethics is informed consent, which is about providing the right information clearly and enabling people to make their own decisions. The more information you provide to the general public on the bill or the present legislation in a way that is clear and which ensures that nearly everyone knows what system is in place and what is involved, the less likely it will be that cases will go to the European Court of Human Rights or against the European convention on human rights. It is really important for that information to be provided because, for those who are still living, the process of consent is continual; it is not just a one-off that people will have forgotten about 30 years later. They have to be reminded again and again about having given it, and they also have to be able to withdraw it. All of that should be explained to the general public in Scotland clearly and continually, not just in a one-off fashion.

Professor Britton

That is a valid point that was experienced and discussed in Wales. One of the initial iterations of the Welsh legislation gave something like a six-month lead-in time for informing the public and providing support but, at the end of the day, that period was changed to two years.

Another important point is that, once that information is given and the education starts to feed through to people, you should not stop. You need to keep going, because the change in culture that means that you do not have to face those difficult legal, ethical and moral decisions will come when people are more familiar with the issues. There is always a knee-jerk reaction to anything new but, if people are educated, they will have a chance to understand the reasons for and benefits of the policy. However, that education has to be on-going.

Dr Postan

I absolutely agree with both witnesses. Education and ensuring that citizens understand what is going to happen are important if deemed authorisation is to have any traction at all with regard to our interest in self-determination over our bodies. If people do not have information about what will happen under deemed authorisation, we cannot even pretend that it has anything to do with respect for interest in self-determination.

Furthermore, there have been bad governance experiences in the United Kingdom—for example, with the care.data programme. Notwithstanding how lawful the use of patient data in research or other areas is, such perfectly lawful initiatives have failed to take off because, as a result of a lack of information, understanding and sympathy for the aims, they have not been given social licence and have not been deeply imbued enough in people’s understanding to make that shift in culture.

10:45  



David Stewart

I have a final question. Are there any obvious gaps in the proposed legislation that we are discussing? If we were starting from scratch, is there anything that you would change so that the legislation could be better? We all want the same thing—increased donation rates—but is there something in the bill that is getting in the way of that? Are we missing anything obvious that the committee could change in order to make the bill better?

The Convener

Feel free to think about that and come back to it, if you want.

Professor Britton

The only observation that I would make is that the legislation should be tied into the smaller detail of education, lead-in, change in culture and opportunities for all members of our society from all backgrounds, faiths and cultures. There might be slightly different perspectives in people’s cultures, so it is about taking cognisance that one size does not fit all and ensuring that there is a tie-in to the bill so that it reaches the widest possible audience.

Dr Postan

In our evidence, the Mason institute suggested the possibility—I do not believe that it is a current provision—of a statutory requirement for reporting to ministers on any research and monitoring on the uptake, effectiveness and impacts of the legislation. That would ensure that such reporting happens on a timetable that is rigid and frequent and that certain standards are met. Collecting and reporting on the evidence of effectiveness, and remaining alert to whether further nuancing and changes are needed, will be essential because, as we can see from the international evidence, it is not clear how authorisation systems work.

David Stewart

So it is about the assessment of the effectiveness of the legislation.

Dr Postan

Yes, but in qualitative as well as quantitative terms. It is about not just numbers of donors and donations but the nature of the discussions that are happening in healthcare settings.

David Stewart

That is a good point.

Dr MacKellar

You also have to ensure that your legislation is scandal-proof. At the moment, there is a lot of trust in the system, but you need only one scandal for all the trust to be undermined and for people to stop donating their organs. As I used to do as a member of a research ethics committee for the NHS, we must always consider whether there is a situation in which a scandal could take place and how we ensure that it does not so that trust in the system is not undermined. If there is one scandal, it is too late.

Brian Whittle (South Scotland) (Con)

Good morning, panel. I have a quick supplementary question. Professor Britton has discussed the need for continual education. We know that roughly 40 per cent of the population would give consent but have not yet done so. I was one of them until last week, but I did not find it that easy to find a way to sign up. With regard to a continuing education programme, would it not be simpler to ensure that it was easier for people to make a decision one way or the other? We would not need deemed consent if that was the case, because we would have an expressed wish. Would that not make the bill much clearer and make the nurses’ role easier?

Professor Britton

I am sorry, but I am not clear about that. What would you be expecting the individual to do in those circumstances?

Brian Whittle

I would expect them to make a decision. We could give everybody a much clearer opportunity to make a decision to opt in or out, which would negate the need for deemed consent.

Dr Postan

That would be a mandated-choice model.

Dr MacKellar

There was a proposal for that two years ago when Mrs McTaggart introduced a bill in the Scottish Parliament. There was an MSP—I cannot remember what party she was in or her name—who said in her speech in the hemicycle that we should bring in a mandated system where everybody has to make a decision. That would make things a lot easier. There would probably be more organs available and there would be a lot fewer ethical challenges and problems, because everyone would know what the position is.

There are places—Belgium, one canton in Switzerland and some states in Australia—where people are obliged to vote in elections. Would it be possible to have a mandated system in which everyone has to make a decision? Personally, I would not be opposed to that.

Dr Postan

These arguments have perhaps been rehearsed in front of the committee previously, but one of the problems is enforcing that mandated choice and another concerns the fact that all the problems that we have been discussing today around people changing their views or families believing—genuinely or otherwise—that they have contrary evidence about the person’s view persist in a system in which there is a mandated choice. With that system, you add an onerous layer of enforcement and penalty, but the dilemmas are still there.

Brian Whittle

To be clear, I was not suggesting that we force people to make a choice; I am suggesting that the opportunity to make a choice should be more readily available.

Sandra White (Glasgow Kelvin) (SNP)

On that point, we have been told that people are happy to see donation as a gift. A mandated choice might affect that.

I am interested in the ethics and the law behind the pre-death procedures. I am not an expert in that area and I was surprised by some of the evidence that we heard. People were suspicious that doctors would accelerate death in order to get someone’s organs, perhaps for experiments. People—even people who were in favour of donation—were suspicious when the issue became one of deemed consent.

I am interested not only in those issues but in how deemed consent affects the Hippocratic oath, and how that sits with the current medical law. Would it be seen as a conflict of interest in that regard? I know that we have an expert panel here today, so I am keen to hear your views.

Dr Postan

I will start on the issue of ethics, which might lead to the issue of law.

On whether deemed consent is contrary to the Hippocratic oath, it would not be—it certainly would not be if it were not contrary to the person’s best interests. It might not promote their best interests, but as long as it was not contrary to their best interests, it would not necessarily raise ethical concerns.

What I would say, with more force than that, is that the issue of what is in someone’s best interests is not solely determined in terms of medical treatment or even physiological interests; someone’s best interests also concern whether their wishes have been fulfilled and they can fulfil the life plans, projects and commitments that they value. If those involve donating their organs, an intervention that is non-painful and minimally inconveniencing—or however it is described in the policy memorandum—is by no means necessarily contrary to the best interests of the individual.

Sandra White

You are talking about a procedure that is done by someone’s consent and is not painful. However, what if the procedure under deemed consent was not to the patient’s benefit and was intrusive and potentially painful? That is the opposite of what you are saying, but that is what patients—

The Convener

Perhaps they are separate issues. I guess that the key question in relation to our current consideration is that, if we have deemed consent rather than explicit consent, does that affect the argument that you are making?

Dr Postan

If we understand deemed consent or deemed authorisation to be operating in a context in which people are informed, which means that it is in line with people’s wishes, a minimally invasive, non-painful procedure could be understood as being in their interests.

Professor Britton

Another ethical—and perhaps cultural—consideration, particularly for family and next of kin, is about whether, if there has been an expression of the intention to donate organs, those caring for a person might not go the extra mile to try to preserve life. That may be what Sandra White was alluding to in talking about the Hippocratic oath, but there would be no reason to believe that that would be the case, because the current position is that there is usually some time—although not always a great deal of time—to recognise a situation of potential donation, and at that point specialist nurses will start to have communication with those who are with the person who is the potential donor.

Those conversations already take place, but it highlights the need for greater clarification, because people are frightened. There are different definitions of death; there are ethical definitions and legal definitions, and the ones that the current proposals tend to focus on are very much focused on brain stem death, but what is not covered is the situation of somebody who may have a longer death—somebody who is terminally ill and may die in a longer time—so perhaps those definitions could be broadened out. Once again, it comes down to the skill of those who have that communication and to the cultural understanding that, at the end of the day, the person is going to die and the specialist nurses are trying to maximise the opportunity to donate those organs to someone else.

Dr MacKellar

As I said, the really important thing in medical ethics is informing people. If they are informed and know what is going to happen to them after they have died, that is acceptable. Problems arise when things happen to people and their families were unaware that that was going to happen to their bodies. That is why it is really important to support the provision of information. Of course, there is a lot of skill among specialist nurses, but they can do only so much. If people are not informed at all and it all comes as a surprise, the nearest relatives will be very upset, no matter what the specialist nurses say, so it is extremely important to inform people about what is going to happen.

There is a lot more work to be done in our society in the area of transplantation. Even in the SPICe briefing, we see how confused everybody is. On page 34, we read that there is a lot of confusion in the area, which causes me a lot of concern as an ethicist.

Sandra White

I take on board exactly what you are saying and I recognise that an awareness campaign must be carried out so that people understand. However, you mentioned that, if people have not filled in a donor card, the family have to be asked, and they can overrule their loved one’s wishes, whatever they may be. They would have to be asked about keeping the organs alive and the pre-death procedures. Even if there is deemed consent, you still have to ask the family. We are trying to pinpoint whether that goes against the Hippocratic oath or against the law or the ethics of doctors. Are you saying that, whether or not there is deemed consent, those procedures would not go against the law?

Professor Britton

What would normally happen at the moment in clinical practice is that there would be two medical teams—a medical team caring for that individual on the basis of whatever ill-health or condition they have, and a specialist transplant team. Those teams do not interact—they are separate. One is totally focused on the health and wellbeing of the individual patient, in so far as that can be achieved, and the other team deals with transplants.

Dr MacKellar

In medicine, there is always a bit of a balance to be struck. If the interventions are not very serious, such as taking blood samples or doing something that involves no pain, that would normally be acceptable. If the interventions actually reduce the life of the patient, that would certainly not be acceptable in any way. It is a bit of a grey area.

David Torrance (Kirkcaldy) (SNP)

Good morning, panel. Previous witnesses have raised concerns about the bill in relation to adults with incapacity. Is the bill clear enough about the level of capacity that will be sufficient for deemed authorisation to go ahead? Should the bill be clearer about the length of time that incapacity has existed?

11:00  



Dr MacKellar

I was talking to a psychiatrist who said that capacity is the holy grail and that everybody is different. It is very difficult to legislate in the area, because every case is different. Personally, I believe—as does the Scottish Council on Human Bioethics—that for adults with incapacity who cannot make decisions, it is appropriate for the persons in charge to make the decisions for them, although the adults with incapacity should be involved as much as they can be. It is a bit like the situation of children between the ages of 12 and 16, who should be involved as much as they can be in decisions about them. However, I think that the present legislation and the proposals in the bill are quite good in relation to how to address those situations for adults with incapacity.

Dr Postan

I have a question about whether the way in which capacity is spoken about is too “all or nothing”. There is a lot of emphasis on the persons having capacity for sufficient time during which deemed authorisation has been the law. I assumed that that was so that they appreciated that it was the context within which they functioned and that they would have had the opportunity, if they wished, to opt out. However, the understanding in both law and ethics is that capacity is context specific and question specific. It does not strike me that that comes through sufficiently in the bill or that there is the potential for people with fluctuating capacity to have help and support to work out whether they can make decisions about whether to opt in or opt out, or to change their mind about previous decisions. There should be nuancing of the fact that things can be more context specific and fluctuate more.

Professor Britton

I completely agree with that point. The current mental health legislation in relation to incapacity is very good because it takes cognisance of the person’s beliefs and values and of what they can contribute to the discussion of what they understand at the time. As Dr Postan said, the bill’s proposals should contextualise that a bit more.

David Torrance

Do the bill’s provisions fit with the Adults with Incapacity (Scotland) Act 2000 and would there be any benefit in linking them with the 2000 act in some way?

Professor Britton

It is probably not necessary to link them. I have at least tried to answer that already in saying that the 2000 act’s provisions give the opportunity for context for decision making. The act provides that the individual is encouraged to make a decision to the best of their ability and capacity at the time. There are therefore already good provisions that capture what we hope to be able to do in terms of respect for the individual and their contribution. For me, it is not about linking the bill to the 2000 act, but we should refer to the fact that the tests are there and ensure that the proposals that are before us take cognisance of those.

The Convener

I thank all our witnesses for their helpful evidence on a range of questions this morning.

I suspend the meeting briefly to allow a change of panels.

11:03 Meeting suspended.  



11:07 On resuming—  



The Convener

I welcome the Minister for Public Health, Sport and Wellbeing, Joe FitzPatrick.

The Minister for Public Health, Sport and Wellbeing (Joe FitzPatrick)

Thank you, convener, and good morning.

The Convener

Good morning, minister. Mr FitzPatrick is accompanied by Scottish Government officials Claire Tosh and Fern Morris, from the bill team, and Stephanie Virlogeux, from the legal directorate. I welcome you all. I believe that the minister will give us a short opening statement before we proceed with questions.

Joe FitzPatrick

Thank you, convener. I am grateful for the opportunity to speak to the committee about the Human Tissue (Authorisation) (Scotland) Bill. The primary aim of the bill is to introduce a soft opt-out system of organ and tissue donation from deceased donors. The bill will amend the existing Scottish legislation that supports donation—the Human Tissue (Scotland) Act 2006—by introducing a new, additional form of authorisation called deemed authorisation.

Deemed authorisation will apply to most adults from the age of 16 who have not otherwise explicitly opted in or opted out of donation. In practice, that will mean that where a person is not known to have any objection to donation, the assumption will be that the donation can proceed. The bill contains safeguards to ensure that donation will not proceed if that is not what the person would have wanted.

The bill is necessary in order to build further on the improvements that we have seen in this area. Despite the real benefits of transplantation and the advances that have been made over recent years, there are still over 500 people in Scotland on the transplant waiting list at any one time. There is an absolute limit on the number of people who could ever become donors—only around 1 per cent of people will die in circumstances in which organ donation is possible—but if there are steps that we can take to allow more of that 1 per cent to donate, I am keen that we do that.

Evidence suggests that there is not one answer to increasing organ and tissue donation, and that opt-out systems work better as part of a package of measures. A lot of work has been done over the past 10 years in Scotland to improve our infrastructure and systems, learning from countries such as Spain and responding to major reviews such as that of the organ donation task force. We have seen associated increases in donation and transplant numbers, but as support for and awareness of organ donation have grown in recent years, so has interest in a move to opt-out.

The member’s bill that was introduced in the previous session by Anne McTaggart began the conversation and, although the bill was not supported, both Parliament and the Government recognised that there was an appetite to move towards a different form of authorisation.

The bill is the product of a great deal of work over the past few years, following the previous committee discussions. We have worked with a lot of people including the NHS, professionals and people affected by donation and transplantation, to consider how best to introduce a system of opt-out in a way that contains appropriate safeguards and which will not compromise the already complex and lengthy donation pathway. I know that the committee has been interested in how long donation can take, and we are concerned not to lengthen that process.

We place particular importance on making the changes in a way that is transparent and open to the public. Organ donation enjoys and depends on a high degree of public support and we do not want to do anything to put that at risk. The bill therefore builds on the requirement in the 2006 act for Scottish ministers to support and raise awareness of donation by introducing a further requirement to raise awareness around the changes that the bill will introduce.

I know that the committee has had some discussion about the provisions relating to pre-death procedures—or ante-mortem interventions, as they are known to those who work in donation and transplantation. The area is complex, but I want to reassure the committee that those procedures are not new and are already an important part of the donation and transplantation pathway. The procedures help to ensure that donated organs are more likely to be transplanted successfully and that a donor’s wishes can be fulfilled. However, we recognise that clinical procedures have changed, and will continue to change, and we want to ensure that there is a clear framework in place that sets out how and when pre-death procedures can be used and what safeguards must be in place.

It is important that potential future donors understand that those procedures can form part of the donation process. The bill does that by ensuring that we are open about what is involved and by putting in place certain requirements around communication and awareness raising. As with provisions around opt-out, our approach is to be transparent and to maintain a high degree of trust in donation.

I am grateful for the expertise, dedication and experience of the NHS clinicians and professional organisations who have helped to shape the bill. In particular, I acknowledge the work of the Scottish donation and transplant group, which advises the Government on such matters. I pay tribute to every person who has donated in the past and to every family that has supported donation. It is through such selfless acts that lives are saved and improved. I hope that the bill will lead to further increases in donation and to further lives saved. I would offer any such progress as a tribute to all those who have donated in the past.

I am keen to hear from the committee and I know that we will have an on-going conversation as the bill progresses. I will give careful consideration to any proposals by the committee that will strengthen and improve the bill.

I am happy to take questions. I hope that my colleagues and I will be able to provide further clarity in what has been a very thorough stage 1 process.

The Convener

Thank you, minister. I welcome that commitment to pay attention to any proposals that are made as a result of the committee’s consideration of the issue.

This morning, we heard evidence that has reminded us of the debate around the 2006 act and you have just said that the purpose of the bill is to increase the level of donations. The Scottish Government’s review of evidence found that there is only weak evidence that simply changing from one authorisation system to another will make a difference to donation levels and that any change would need to be put in a wider context.

Can you give the committee confidence that the bill, in and of itself, will result in an increase in donations and transplantations?

Joe FitzPatrick

We are aware of the view that opt-out on its own would not result in a significant increase in donations. However, opt-out is part of a package of measures that we have been developing over several years. There is international evidence that opt-out, added to the other measures that we are taking, is what will make the difference.

The Convener

Given that those other measures have been in effect since 2006 and are on-going, what does the bill’s introduction of an opt-out system bring to the party? In other words, if awareness raising and engagement are proving effective under the current law, what additional benefit will the change to the law bring?

Joe FitzPatrick

There is no question but that the changes that we have made have made a difference. I will quickly go through some of the numbers. In the past 10 years or so, there has been an 89 per cent increase in donor numbers, which is a lot, and a 22 per cent decrease in the number of people who are on waiting lists. In 2008, the waiting list was 689 and, in 2017-18, the figure had gone down to 534. However, that still represents a lot of people who are waiting for a donation. The international evidence is that, if we do this correctly as part of a package of measures, it will lead to an increase in donations.

11:15  



The Convener

Some might argue that the numbers show that progress is being made and therefore the efforts should be dedicated to further progress along the same lines, such as by making it easier for people to express a wish or more likely that they will do so, and that that would make the difference.

Joe FitzPatrick

Those things are not contradictory—we can and should do both. The process of the bill going through Parliament and, assuming that it is passed, its enactment will increase awareness of donations in general and, I hope, the number of people who are on the register. The two things go hand in hand—there is no conflict.

Keith Brown

I thank the Minister for Public Health, Sport and Wellbeing for his evidence and congratulate him on doing the daily mile at Murrayfield on Saturday, which I have to say was more interesting than the match.

We heard earlier about public support and the need for the public to buy into the measures. Under the system that is proposed in the bill, if somebody decides to opt in or opt out, is it possible to say that their decision will be respected? There may be practical reasons why donation cannot happen because the organs might not be suitable, or evidence might be brought forward to show that the person had changed their mind. Notwithstanding that, and given that we are trying to get public support, will the express wishes of the individual be followed through?

Joe FitzPatrick

The bill is clear on that, and it follows on from the principle that was in the 2006 act that the right to authorisation is the donor’s right. The law on that is not changing. Clearly, there are discussions that have to happen with families, which might determine whether donation proceeds, but there is no family veto as such in most cases. That is consistent with the law as it stands in the 2006 act. That is not changing—it is a continuation of the law.

Keith Brown

That is my concern. As you rightly say, that is the current situation. A family override is not written into the current legislation, but I think that you are saying that there is a family override. My point is that, if there is a family override, when people are being subject to the education that we intend that they should have about their rights under the new legislation and when they are deciding what to do, they could easily say to themselves that there is no point, because their family—there is an interesting issue about what happens when there is no family—will be the ones who decide, along with the medical professionals. People might think that their decision is not relevant because it will be taken as an expressed wish rather than a right, and that might limit take-up or people’s involvement in the process.

Joe FitzPatrick

The current legislation and the proposed legislation are clear that the right to authorisation rests with the potential donor. Clearly, the decision to proceed with a donation is a clinical one, and that is a different aspect. The bill will add to the current provisions a duty to inquire and to try to find out what the last wishes of the donor were. When the family are asked, they will not be asked for their views; they will be asked about what they believe were the views of their deceased relative who is the potential donor. That is the family’s role in authorisation.

There is obviously a different role in the process relating to donation. There has to be a clinical decision to proceed with donation and it would be difficult for clinicians to make a decision to proceed with the donation if they had not managed to go through all the safety questions. They have to make that choice so, in practice, I do not think that there is anything that we could put in law that would change a family member’s ability to say, “I’m not going to co-operate.” That would put the clinicians in a very difficult position, because they have to make a choice about safety.

There are two big things that a clinician has to respect. One is the right of the donor, in terms of their donation wishes, but the safety of any recipient must also be considered. However, on the right to authorisation, the legislation as it stands in the 2006 act and as it would stand in the bill makes it very clear that that is a right of the person who would be donating.

Keith Brown

My very clear impression from previous evidence that we have heard is that that would still leave substantial doubt in the mind of somebody who is considering whether to opt in or opt out.

Leaving that aside, you made a point about the information that is required from the family being necessary in a decision to donate or for a transplantation to take place. A witness gave us an example earlier in today’s meeting of a person who has no family and nobody else to consult, and perhaps you or your officials can give us some information about what would happen in that circumstance. Is it possible that the tests that can be done would be sufficient to allow donation to take place, if you are unable to ask the dozens and dozens of questions that you would normally ask of the family or somebody else who is close to the potential donor? Could transplantation still take place?

Joe FitzPatrick

I will ask Claire Tosh to answer that. I heard what was said earlier and, to answer your other question, I think that the point that you were trying to make emphasises the need for us to have a strong publicity campaign to encourage people not just to get on the donor register but to ensure that they have that conversation with their family beforehand. It will make conversations with clinicians much easier if the family conversation has taken place before any unexpected circumstances arise.

Claire Tosh (Scottish Government)

In the bill as introduced, there is a duty to inquire, and it would be quite difficult to fulfil that duty to inquire if there was nobody to seek those inquiries from. The bill puts a duty on clinicians to find out what a person’s wishes were, and if somebody did not have a family or anyone else clinicians would not be able to find out that information. As mentioned earlier, there is also a question about a person’s medical history, which would need to be gone into, and it is unlikely that that could happen.

In developing the bill, we spoke to people about some of those issues, not just around big publicity campaigns but also how to reach different groups. We have spoken to some faith groups about how to reach people, and that will be part of implementation as well. We are trying to ensure that the publicity is as widespread as possible, so that it could be assumed that, where a person has not registered a decision to opt in or opt out, their families should be aware that there may be deemed consent. There is also the additional duty to inquire, which would be difficult to fulfil if somebody did not have any family.

Keith Brown

I am pursuing a narrow point that is not about consent. If a person has nobody that clinicians can speak to about their medical history, is it possible, based on the tests that can be done, for transplantation still to happen?

Joe FitzPatrick

It would be for the clinician to decide whether they were comfortable with that.

Claire Tosh

It would be a matter for the clinicians and for NHS Blood and Transplant. However, our broad understanding is that it would be quite difficult for them to proceed in those circumstances.

The Convener

The point that Keith Brown explored about authorisation came up in the earlier evidence this morning, as you probably heard. The suggestion was made that, ultimately, under the 2006 act, despite the sense that it puts the donor at the centre, final authorisation may in fact still lie with the family. The NHS Blood and Transplant leaflet that is currently in circulation states:

“When a person dies, and organ donation is a possibility, we rely on their family to agree to donation going ahead.”

Rather than giving a detailed answer now, I wonder whether your officials could reduce to a flow chart—or some similar form—an indication of how the wishes of family members are taken into account under the 2006 act and how, if at all, that would change under the bill.

Joe FitzPatrick

I have asked for that flow chart.

The Convener

Excellent—I am glad that we think in the same way on those matters. That is very helpful.

Miles Briggs

I want to ask about the Welsh system. Last week, the committee heard evidence from officials from Wales. What did you learn from the Human Transplantation (Wales) Act 2013 and the progress that the Welsh have made in some areas? Is there anything that we in Scotland could learn from them? Specifically, although it is not contained in the bill, concerns have been raised about the infrastructure in Scotland and the potential to do something about that. Do you have any comments on that?

Joe FitzPatrick

In drafting our bill, we spent a lot of time learning lessons from how the Welsh act has been implemented in practice and the impacts that it has had. Positive figures are coming out of Wales, particularly when it comes to increasing rates of consents, as they call them in Wales—in Scotland, we call them authorisations. Wales now has the highest level of consents in the United Kingdom. We have certainly looked at the experience in Wales.

The financial memorandum covers a number of areas where there will be significant investment in donation pathways. Does anybody else want to add anything?

Fern Morris (Scottish Government)

The Welsh undertook an evaluation, and we looked at some matters that came out of that—for example, clarity about the role of the family. To begin with, there was uncertainty about the family’s role. Therefore, as the minister set out, the expectation in the bill is clear—it is the individual who decides whether authorisation or consent is in place. The family’s role is to give evidence on that. Another matter that came out of the evaluation was the need for on-going awareness raising, so that awareness is maintained over time.

Miles Briggs

I have been taken with the cultural change that we will need and how we can achieve that on a positive note. Sometimes, Government advertising does not achieve the outcomes that we hope it will and the money that we spend on public information does not necessarily drive the change that we want to see. What work have you done on future publicity if the Parliament passes the bill, so that we can generate a national conversation and ensure that, outside of the bubble, people understand the issue and want to engage with it?

Joe FitzPatrick

The Government would not necessarily be the main organisation fronting the education—it is more likely that NHSBT and the Scottish National Blood Transfusion Service would do that. We need to work with all our partners to make sure that the messages reach the widest possible range of people. We have agreed to work with religious groups to make sure that, where there are particular issues, people understand what the legislation means.

Claire Tosh

There is the duty on ministers regarding information and awareness; that is led by the Scottish Government and it follows the general marketing principles. The minister said that there will be work under way to develop the right messages about what the changes are and on how to reach different groups of people. We can learn from Wales about that, but we should also take into account the marketing work that the Scottish Government has already undertaken. There has already been consideration on how to take that work forward. The prospective costs of the work have been included in the financial memorandum. The schools pack has been developed and it could be further developed in the future.

Miles Briggs

We have discussed the age difference and the fact that 16 and 17-year-olds in Scotland will be included. You mentioned discussion about the schools pack. To ensure that the information is age specific, that is welcome, but what work have you done on the potential for the parents of 16 and 17-year-olds living at home to be part of that discussion?

11:30  



Joe FitzPatrick

As I said earlier, it is always best if such decisions are made after discussion with families. That is good practice and something that we should be encouraging. In Scotland, the age of legal capacity is 16, and that is the age at which the 2006 act says that a young adult is able to make the decision. We are not making a change to that; we are keeping the age at 16, as it is just now. That is appropriate. We want to ensure that young people understand the legislation before their 16th birthday. That is why we will be sending packs to schools. There is also a proposal for a direct mailing to all young people as they approach their 16th birthday so that they can make a decision.

Once someone has made their decision, we would still encourage them to register on the organ donor register and to let their family know what their decision is. That would make it a lot easier for families if they ever found themselves in those unfortunate circumstances.

Brian Whittle

Good morning and welcome, minister. I will start with a straightforward question. I have heard from the specialist nurses that their conversation is made easier and the number of family overrides is reduced if people have already given consent and opted into the programme. The bill proposes three different options: opt-in, opt-out and deemed consent. Would it not be better to maximise the number of opt-ins and remove the ambiguity of deemed consent?

Joe FitzPatrick

Having deemed consent will make conversations easier, because the starting point of those conversations is about what the family thinks the person thinks about donation, so rather than thinking about their own views on donation, the family is thinking about the person they have just lost or are expecting to lose.

I am clear that there is a two-track approach. We will have the new system, but we will continue to try to encourage people to register and, most importantly, have those conversations with their families. It is more important that someone who is registered has that conversation with their family than it is that they are registered—having the conversation is the most important thing for everyone. The bill does not prevent us from encouraging people to sign up to the organ donor register and tick the box.

Brian Whittle

The part that I am struggling with is that, for deemed consent to be effective, we must ensure that everyone has an easy opportunity to opt out. That is the only way in which deemed consent can be effective. We know that 40 per cent of people who have not opted in would opt in. As I have said many times during the discussion on the bill, I was one of the 40 per cent. I managed to opt in last week, but that was only because I changed address and wrote away to change my driving licence—that is one of the ways in which people register.

If we agree that, to strengthen deemed consent and make it work well, we have to ensure that people have really good and on-going opportunities to opt out, can we not agree that by using education and publicity we can increase people’s opportunity to opt in, which is a much stronger statement than deemed consent?

Joe FitzPatrick

You are evidence that the passage of the bill has encouraged people to start thinking about such things and to make decisions on them, which is good. Welcome to the organ donor register club.

As part of the process, we want to make it easier for people to record their preference and their decision on organ donation and that goes either way—-they might want to express whether, should they find themselves in circumstances in which their organs could be used for donation, they want their organs to be used or not to be used. We want to encourage people to make that decision and record it on the register, but it is equally important for people to ensure that their families are aware of their decision, either way.

David Stewart

Good morning, minister. I welcome you and your officials.

What assessment have you made of the Spanish system of organ donation?

Joe FitzPatrick

Spain has very high levels of donation. In drafting the bill, the Government has looked at all countries that have an opt-out system. It looks as though the opt-out system in Spain is part of the reason why there is such a high level of donation, but there have been other cultural changes that explain why the level is so high there. We have looked at all the international examples.

David Stewart

Thank you, minister. The officials should feel free to contribute as well.

You will know that we have had considerable evidence on the bill, including an article that appeared in The BMJ in 2010 that argued that the evidence suggests that the consent system in Spain is not the real factor in the increase in donation rates there. It argued that the really effective thing has been to have transplant co-ordinators, donor detection programmes and the greater provision of intensive care beds. Just for completeness, to compare Spain with the UK—obviously, we operate within the UK system—even if we reduced family refusal rates here from 40 per cent to 15 per cent, the donation rate would still be only half that in Spain. Clearly, the best practice is in Spain. Of course, other evidence has said that we cannot compare apples and oranges. I appreciate that there is also the cultural issue and in particular the role of the Catholic church, which has supported the measures, which is obviously welcome.

If we place the consent system to one side, there is an argument about the opportunity cost. Instead of looking primarily at consent, you could invest the money that is set out in the financial memorandum in increasing the number of intensive care beds, which are important in the Spanish example.

Joe FitzPatrick

Clearly, we need to look at other examples. The financial memorandum makes significant provision for extra resources for staff for registration, training and development and recruitment. A large amount of extra resource is set out in the financial memorandum. Even if we increased donation to the levels that we hope for, it is unlikely that that would lead to the number of transplant units exceeding the forecast in the current strategy—“Commissioning Transplantation to 2020”—which runs until 2020. There is no expectation that the levels would go above that in that short period. There will still be capacity in the system.

David Stewart

I was struck by your opening comment that you are willing to listen and to consider amendments to the bill. I think that I speak for my colleagues when I say that this is not a partisan issue—all members want more organ donation, and we want to do it right. As someone said, what is right is what works. Although I accept that there might be some different cultural issues in Spain, it is top of the league among the European examples. Will you have a look at the issue of intensive care beds? I realise that the situation cannot be turned round overnight, but that seems to be a much more relevant factor than the consent issues.

Joe FitzPatrick

Obviously, we need to look at all the circumstances around donation. However, I do not think that that direction of travel would be dealt with in the bill, because it is not relevant to the bill—it is more of an organisational factor. However, I hear your points and we will feed those in and consider your suggestion.

David Stewart

To ask my question another way, have you looked at cost alternatives to the financial memorandum? In other words, have you considered whether you could do something better with the funding that you have allocated to the bill?

Joe FitzPatrick

The financial memorandum is about how we fund what we are trying to do with the bill. I do not know whether Claire Tosh wants to add anything.

Claire Tosh

The financial memorandum and the business regulatory impact assessment were prepared with input from NHSBT, the SNBTS and other partners. The financial memorandum takes account of the on-going work on the package of measures that is currently in place, including the high-profile awareness raising. However, as we go forward with the bill, the intention is to work with those partners to see what measures could be put in place, if necessary, to further support the implementation. As the minister said, with regard to the work with the National Services Division on the taking organ transplantation to 2020 strategy, there will be a further commissioning strategy as a result of the work on transplantation costs that is under way. There are therefore opportunities beyond the bill.

David Stewart

I am sorry if I am stressing this point too much. I believe that the consent system has a place; all that I am saying is that it appears from the Spanish example that we might be missing a trick by not looking at their best practice, given that their donation rate is double ours. Even adjusting for cultural differences, the Spanish example shows the importance of having intensive care beds, transplant co-ordinators and donor detection programmes. I ask you to have another look at the Spanish example. Provisions for such good practice might not appear in the bill, but I believe that learning from the Spanish example would make a big difference.

Joe FitzPatrick

We are introducing the bill because we want to increase the number of donors and transplantations to help the 500 people who are waiting for a transplant at any one time—that is our ultimate aim. We have never said that the bill on its own will get us to where we want to be, so I am happy to look again at the specifics to which Mr Stewart referred.

Fern Morris

I think that it was Lesley Logan of NHSBT who highlighted some of the differences in Spain, such as higher discard rates and organs being retrieved without recipients being identified, which is very different from the system that we have in the UK.

The Convener

If the objective is to increase the number of transplants, which is clearly a shared objective, we heard from Dr Robertson of the British Medical Association, who described transplant surgeons as

“a bunch of very tired people ... working very hard”.—[Official Report, Health and Sport Committee, 13 November 2018; c 23.]

How confident is the Government that the transplant infrastructure that we have can cope if the Government is successful in significantly increasing the number of donations?

Joe FitzPatrick

As I said, we would not expect the bill in the short term to lead to a number of transplants that is above the 2020 target, which is what the current infrastructure supports. If it looks as if the bill is going to be more successful than expected, we will have to look at the future strategy beyond 2020.

The Convener

Thank you. Can you say a little about opting in? We understand from the bill and its accompanying documents that that remains a focus of Government effort. How significant is that as part of the overall picture that you have painted this morning?

Joe FitzPatrick

People recording their views on opting in or opting out is very important. If we can encourage people to do that, it will make the conversations with families easier. It is important that they record their decision and then have that conversation, because the conversation is so important.

The Convener

So when you are increasing awareness of the bill, that will include awareness of opting in—the existing register—as well as that of how to opt out.

Joe FitzPatrick

We will obviously engage with stakeholders to ensure that our messaging works and that people understand what the bill does and what their options are.

David Torrance

Why do options for registering opting out not match those that are available for registering opting in, such as when applying for a driving licence or a passport?

Claire Tosh

Perhaps I can take that one. On opting out, the organ donor register is operated by NHSBT on a UK-wide basis and there is also the organ donation Scotland website. I think that the specific opt-out box was placed on that website after the introduction of the Welsh legislation. Publicity could also direct people there for the opportunity to opt out.

Joe FitzPatrick

So it is already there on the register. Brian Whittle may be able to tell us about that, because he registered just last week.

11:45  



Brian Whittle

It is very easy to do.

Fern Morris

I think that the specific issue that you are alluding to is with the Driver and Vehicle Licensing Agency. At the moment, you can only opt in via the DVLA and those other routes, and there is a delay in those registrations being processed in the central NHSBT ODR so that is why there is no option to opt out through those routes.

David Torrance

You touched earlier on working with religious groups. Can you expand on how you will communicate with minority groups and hard-to-reach groups, including people who do not speak English and adults who have difficulty reading and writing?

Joe FitzPatrick

That is a very important question. We want to ensure the widest possible understanding, so there has already been engagement with religious groups and other stakeholder groups. A lot of work has been done so that we understand what we need to do.

Claire Tosh

More work will be undertaken to understand what is needed. The plan is to have public information to target different groups. There is also updated training for peer educators, who are currently important in on-going work that is being done under the Scottish donation transplant group on raising awareness about organ donation among south Asian communities.

We are also considering presenting information in different ways. We understand that there is a need for that from focus groups of people with learning difficulties about providing information and enabling people to make choices.

There will be consideration of how best to communicate, and there is, obviously, the bill’s duty on ministers to raise awareness and to promote information about donation.

Emma Harper

I am interested in aspects of the medical questionnaire. We have heard evidence about the questionnaire and learned that up to 350 questions could be asked of a family or the next of kin in order to obtain a medical history to enable clinicians to make informed decisions about whether organs or tissue can be donated and transplanted.

I am sure that you are aware of yesterday’s news about Pauline Hunt, who is 49, from Kilmarnock in my South Scotland region. She received a donated kidney and has now developed cancer. This might be an opportunity to talk about the process of assessment of donors and of organs and tissues for transplant, to assure people that the current process is robust and safe and that it supports optimal practice. What review is intended, or is taking place, following yesterday’s news? Is there room for a review of the current process or of the medical questionnaire?

Joe FitzPatrick

First of all, let us separate those two questions. The case that you mentioned is absolutely tragic, and my sympathy goes out to Pauline Hunt and her family. I cannot imagine what she is going through. It is clearly important that, if there are lessons to be learned from that case, they are learned and are understood across the whole donation and transplantation system. That has to happen, and the Cabinet Secretary for Health and Sport has said that she wants to ensure that lessons are learned. As I said, it is a tragic case and I genuinely sympathise with Pauline Hunt and her family.

I know that the committee’s concern is that there seem to be an awful lot of medical and social history questions. In some cases, there are a lot of questions, but the process is about safety, so that is the amount of questions that clinicians say they need to ask. There are about 40 questions that have other questions underneath them, so if you add them all together you get a much bigger number. We have shared with the committee information on how questioning is done elsewhere: similar numbers of questions are asked in other places. Our specialist nurses ask the questions in a very sensitive way—they are trained to do that. We need to take the lead from clinicians to ensure that we get the balance right in assessing safety in the donation process.

Emma Harper

The questionnaire is not the only approach to determine whether organs or tissues—we keep talking about solid organs, but it can be tissues, too—can be donated. We can use case notes, we can connect with general practitioners and we can use other information to ensure that organs are used optimally.

Joe FitzPatrick

Yes. All that information comes together so that we do what we can in the relatively short time that is available in which to determine whether a donation can proceed, in order to make the process as safe and sensitive as possible.

Sandra White

I will continue on the theme of pre-death procedures, which I raised in the previous evidence session. I thank the minister for his opening remarks—especially his points about this being a very sensitive area and about more information being given to people.

You will be aware of the concerns that folk have raised about the procedure, including concerns from people who are very supportive of organ donation. I, and others, lack knowledge about what happens, so I welcome your comments about an awareness campaign.

I have two specific questions. Could PDPs be carried out under deemed authorisation before any conversation about donation has taken place with the family? My second question relates to the opposite position. What are your thoughts on requiring expressed consent for PDPs from the patient or the family?

Joe FitzPatrick

The answer to the first question is no: there is a duty to inquire in the bill. Whether the procedures are type A or type B, that duty will exist.

Could you repeat your second question?

Sandra White

The second question relates to the opposite of deemed consent. What are your thoughts on requiring expressed consent for PDPs from the patient or the family? Would that be the best way forward?

Joe FitzPatrick

For some of the procedures—

Sandra White

The family or the patient would be spoken to.

Joe FitzPatrick

Yes. There is a range of procedures. Procedures might involve a urine test or a test of a blood sample, for example. Through the bill, we are trying to bring transparency to a process that has been being carried out throughout the UK since before the 2000s. It is important that we have a framework that can adapt to changes. That is why it is appropriate to have the two lists that will come to Parliament in regulations. It is important that people understand the processes.

Sandra White

That was the point that I wanted to make. Again, I thank you for your opening remarks about an awareness campaign. At previous meetings I have asked why people are not aware of the tests. The answer that I received was that, if such tests are to be done, the family will be spoken to: the family is informed, but the people who are donating an organ will not necessarily be informed. In the awareness campaign, will you let people know that, when they opt in and donate their organs, they might be subjected to certain procedures—or whatever language is used? Is that the type of awareness that you are talking about?

Joe FitzPatrick

That will be a new duty on ministers. The existing legislation places a duty on ministers to inform people about the organ donation register; the bill creates a duty to ensure that we raise awareness about the opt-out system and pre-death procedures. More transparency is good, because we can build trust in the system if more people understand it.

Sandra White

There will be no secrecy. That is great.

The Convener

We discussed earlier the circumstances in which there are no family members to whom questions could be put. It seems from what was discussed that that could, in terms of organ donation, be a show-stopper, in the sense that people would be unable to access vital medical and social information.

Emma Harper was right to draw our attention to the fact that the bill covers tissue as well as organs. When there is no family to consult and no access to medical and social records, is there still the possibility that tissue could be used for research or other purposes, when that question would need to be addressed before the donor had died?

Joe FitzPatrick

Deemed authorisation refers to the main categories of donation. One of the officials will talk about the specifics.

Fern Morris

There is a higher threshold for tissue donation because in most cases it is life enhancing rather than live saving, so a lower level of risk than for an organ would be accepted. The medical team would seek assurances and more information about the safety of the tissue before a transplant could take place.

The Convener

You are saying that they would require more information, so it would be more difficult when there were no immediate family members who were able to answer any questions.

Fern Morris

Yes.

The Convener

That is very helpful.

Joe FitzPatrick

The other point about the main categories of donation is that deemed authorisation would not apply to unusual categories of transplantation, such as face transplantation.

The Convener

Would deemed authorisation not apply because there is a greater level of risk?

Joe FitzPatrick

No—it would not apply because such procedures are not what people generally understand by “donation”.

Claire Tosh

Similar to the Welsh model, there will be excepted categories that will be set out clearly in regulations for Parliament to consider, after consultation about organs or tissue that might not be expected to be the subject of deemed authorisation. That is a slightly different question about what deemed authorisation would or would not apply to. That is what is understood by “excepted categories”.

The Convener

So, that is acknowledged in the bill, but would be set out in regulations to be laid before Parliament.

Claire Tosh

Yes.

Emma Harper

Is there an argument for calling pre-death procedures, “pre-donation procedures”? We are talking about cardiac or neurological death, but there are now issues around anticipatory care planning, when the person knows that they are going to die, and might choose to donate a kidney or even both kidneys. It might be better to use the term “pre-donation procedures” instead of including the word “death”, with all its finality.

Joe FitzPatrick

It is difficult. If we are to be transparent, we should stick to the most accurate language. The medical term “ante-mortem interventions” might be preferred, but I am not sure whether that will be understood. If we want to ensure trust in the system, we need to be careful not to use language that is unclear.

The Convener

I suspect that we may come back to that subject. David Torrance will ask the final question.

David Torrance

Does the minister agree that the provisions on incapacity need to be strengthened in the bill, and that it would be better if the bill were linked to the Adults with Incapacity (Scotland) Act 2000?

Joe FitzPatrick

We need to understand people’s ability to understand the legislation. People need to be able to understand “deemed authorisation” for a period: we specifically make the point that there needs to be a period of time to allow people to make a judgment. That is clear in the bill.

Stephanie Virlogeux (Scottish Government)

The definition of an adult who, over a period of time, has been incapable of understanding “deemed authorisation”, has intentionally been left flexible. That is to take account of the different circumstances of individual potential donors before their death. A more rigid definition could lead to unintended consequences and difficulties in fulfilling the wishes of people who want to become donors.

The Convener

I thank the minister and his officials for attending the committee, and I look forward to our further engagement on the bill as it progresses.

Joe FitzPatrick

Thank you, convener.

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6 November 2018

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13 November 2018

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20 November 2018

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27 November 2018

Committee Findings

What is secondary legislation?

Secondary legislation is sometimes called 'subordinate' or 'delegated' legislation. It can be used to:

  • bring a section or sections of a law that’s already been passed, into force
  • give details of how a law will be applied
  • make changes to the law without a new Act having to be passed

An Act is a Bill that’s been approved by Parliament and given Royal Assent (formally approved).

Debate on the Bill

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Stage 1 debate transcript

The Deputy Presiding Officer (Christine Grahame)

The next item of business is a debate on motion S5M-16001, in the name of Joe FitzPatrick, on the Human Tissue (Authorisation) (Scotland) Bill at stage 1.

14:58  



The Minister for Public Health, Sport and Wellbeing (Joe FitzPatrick)

I am pleased to open the debate on the Human Tissue (Authorisation) (Scotland) Bill. Before discussing specific elements of the bill, I will talk about the bigger picture, which it is always important to remind ourselves of when talking about organ and tissue donation and transplantation.

The transplantation of donated organs and tissue is one of the most incredible developments in modern healthcare. It reflects the best of humanity, as people respond to acute need with incredible generosity, and it is a testament to the wonders of the national health service, to the skills of our nurses, clinicians and surgeons and to the organised efforts of everyone who works to make these life-changing gifts possible.

Scotland has seen tremendous progress over the past decade. Following our work to build and strengthen the system, and as a result of the incredible generosity of donors and families, the number of donors has significantly increased, as has the number of organ and tissue transplants. Those transplants have saved and improved lives. They have allowed people to live fuller lives, to be less dependent on hospital visits and healthcare, to get back to work and to contribute to society.

For the transplant recipient, the gift that they receive represents an opportunity to start life anew. However, not everyone receives the organs or tissue that they need. Although many lives have been saved and improved over the past decade as a result of the hard work that has been done to build the necessary infrastructure, too many people are still waiting for the organ transplant that could save their lives. More than 500 people in Scotland are waiting for an organ transplant at any one time. Those people want to live their lives to the full; they want to work, contribute and support their families. It is my job—it is our job—to make sure that we are doing all that we can to get as many of those people as possible the transplant that they need.

There will always be an absolute limit on the number of people who can become donors. Only about 1 per cent of people die in circumstances in which donation is possible, but if there are steps that we can take to allow more of that 1 per cent to donate, I hope that members will agree that it is important that we do so.

The primary purpose of the Human Tissue (Authorisation) (Scotland) Bill is to introduce a soft opt-out system of organ and tissue donation for deceased donors. The bill would amend the existing Scottish legislation that supports donation—the Human Tissue (Scotland) Act 2006—by introducing a new additional form of authorisation called “deemed authorisation”. In practice that means that, if a person was not known to have any objection to donation, donation may proceed.

Deemed authorisation would apply to most adults from the age of 16 who have not otherwise explicitly opted in or opted out of donation. However, the bill contains safeguards to ensure that donation will not proceed if that is not what the person would have wanted. The bill also provides safeguards for those adults who lack the capacity to understand deemed authorisation and for adults who are resident in Scotland for fewer than 12 months—neither will be subject to deemed authorisation.

Evidence suggests that there is no one answer to increasing organ and tissue donation; there is no magic bullet. However, there is evidence that opt-out systems can make a difference as part of a package of measures. Scotland has already made many improvements. With our partners in the national health service, work has progressed over the past 10 years to improve the infrastructure and systems that support donation. That includes learning from other countries such as Spain, and responding to major reviews such as “Organs for Transplants: A report from the Organ Donation Taskforce” from 2008.

David Stewart (Highlands and Islands) (Lab)

The minister rightly identifies Spain—it is top of the league table for organ donation. He will know that its success has been because of the high level of intensive care beds rather than to do with issues of consent. Will the minister respond to that point?

Joe FitzPatrick

We should learn lessons from across the world about how we can adapt our system, but we have to recognise that there are differences in systems and we need to be mindful of differences in culture and approaches. I am pleased that the Health and Sport Committee in its review of evidence agrees and specifically makes that point regarding the differences between the Spanish and United Kingdom systems.

Improvements have also been realised through “A donation and transplantation plan for Scotland 2013-2020: More donors, more transplants, more lives saved”. That includes the appointment of a Scottish regional manager for specialist nurses for organ donation and the publication of an education pack for secondary schools, which has contributed to the highest awareness among young people.

Work continues. For example, we have recently confirmed to NHS Blood and Transplant that we will provide funding to support new technology to improve the outcomes for patients receiving liver transplants and increase the proportion of livers that are suitable for transplantation.

A duty on ministers in the Human Tissue (Scotland) Act 2006 to promote donation through regular publicity and awareness raising has resulted in Scotland having 52 per cent of its population on the NHS organ donor register, which is the highest proportion of any of the UK countries.

As support for and awareness of organ donation have grown in recent years, so has interest in a move to opt out. Anne McTaggart’s member’s bill—the Transplantation (Authorisation of Removal of Organs etc) (Scotland) Bill—which was introduced in the previous session, was significant in that regard. Although the approach in that bill was not supported by the Parliament or Government, both recognised the appetite to move towards a different form of authorisation. The Human Tissue (Authorisation) (Scotland) Bill is the product of that appetite, and of the great deal of work that we have undertaken over the past few years following those discussions.

We have worked with a lot of people, including NHS professionals and people affected by donation and transplantation, to consider how best to introduce a system of opt-out in a way that will contain appropriate safeguards and in a way that will not compromise the already complex and lengthy donation pathway.

We place particular importance on making these changes in a way that is transparent and open to the public. Organ and tissue donation enjoys and depends on a high degree of public support, and we do not want to do anything that puts that support at risk.

The bill sets out a framework for pre-death procedures—that is, medical procedures that may be carried out for the purposes of transplantation. The medical procedures that we are talking about here include, for example, blood tests or the collection of urine samples to help ensure that donated organs are more likely to be transplanted successfully, and that a donor’s wishes can be fulfilled.

The bill also sets out that the authorisation for some procedures can be deemed in certain circumstances. I am pleased that the committee accepts the proposals in the bill, but I recognise that this is a complex area. I want to reassure members that that sort of clinical practice is not new, and it is already an important part of the donation and transplantation pathway. We recognise that clinical procedures will continue to change. We want to ensure that there is in place a clear framework that will set out how and when pre-death procedures can be used, and what safeguards must be in place to ensure that future developments in clinical practice can be introduced where appropriate. We agree with the committee that the use of such procedures should be kept under review.

The bill provides that the procedures and proposed changes to them will require consultation to be carried out with the appropriate clinical bodies and will also require scrutiny on the part of the Parliament. As with provisions around opt-out, our approach is to be transparent and to maintain a high degree of trust in donation.

The bill includes a new duty to inquire. In practice, that will ensure that the NHS understands the wishes of the donor before further steps are taken. The aim of the bill is to ensure that the interests and the views of the donor are safeguarded at all times, but also that there is a clear and effective mechanism in place for relatives and other entitled people to provide information to exercise their rights.

To meet those aims while reflecting current good practice, the bill includes a duty to make inquiries in respect of authorisation given by the donor or whether an opt-out decision is in place. For example, the specialist nurse for organ donation or the tissue donor co-ordinator will undertake a check of the information that is held on the organ donor register. Inquiries will also be made of the nearest relative or other person to find out the most recent views of the donor, or whether the donor falls within an excepted category.

To be clear, as with the law as it currently stands, families do not have a right to overrule the wishes of a loved one. However, they have an important role to play in relation to providing information on whether the donor had expressed any wish, or whether they had changed their mind.

Mike Rumbles (North East Scotland) (LD)

The bill would change the law as it stands. At the moment, the legislation says that the relative can provide knowledge of the intended wishes of the donor, but the bill says that the relative has to provide evidence to a health worker that would convince a reasonable person. That is quite a different level of bar that the relative has to jump over.

Joe FitzPatrick

The standard of evidence in respect of the donor’s view was given a great deal of consideration during the development of the bill. The view of those working in the system was that requiring written evidence was impractical, as it is almost never provided. That is why, although the consultation referred to written evidence, the bill does not. The discussions take place with families and things are rarely written down. I think that we have got the appropriate level of evidence that is required.

Maurice Corry (West Scotland) (Con)

We talk about families being consulted, but has consideration been given to powers of attorney and deputies of the court of protection?

Joe FitzPatrick

The aim is to ensure that we are identifying the views of the potential donor. In many cases, that will require consultation with the family, but in other cases, it will require consultation with someone else. That is part of the process as it stands just now. The specialist nurses ensure that they are speaking to the most appropriate person to identify the wishes of the donor. That is our aim, and it is a crucial part of the legislation.

Good public awareness will be crucial to achieving the aim of increasing support for donation. The bill builds on the provisions in the 2006 act for ministers to support and raise awareness of donation by introducing a requirement to raise awareness of the new authorisation processes that it introduces. We need to ensure that members of the public are aware of the opt-out system, are able to exercise their choice to opt out of donation, and are encouraged to tell their families.

In addition to the duties in the 2006 act and those in the bill, the Scottish Government is committed to a high-profile awareness-raising campaign during the 12-month lead-up to the introduction of the opt-out system. Awareness activity will be designed to reach a wide range of people, including hard-to-reach groups, minority groups and people with specific needs. We recognise the importance of raising awareness among young people as they approach the age of 16, so that they are aware of the implications for them. We are exploring ways of achieving that.

A great deal of work has gone into developing the bill over the past 18 months. I am grateful for the expertise, dedication and experience of the NHS clinicians, professional organisations and individuals who helped to shape the bill. I particularly acknowledge the Scottish donation and transplant group, which advises Government on these matters.

Our long-term aim is to increase donation and transplantation rates. I hope that this bill will contribute to that. I welcome the committee’s support for the general principles of the bill and I thank committee members for their thorough and constructive consideration at stage 1.

I move,

That the Parliament agrees to the general principles of the Human Tissue (Authorisation) (Scotland) Bill.

The Deputy Presiding Officer

I call Lewis Macdonald, convener of the Health and Sport Committee.

15:11  



Lewis Macdonald (North East Scotland) (Lab)

Lung transplant recipient Gillian Hollis gave the Health and Sport Committee a neat summary of the general principles of the Human Tissue (Authorisation) (Scotland) Bill:

“Tell us if you want to donate, tell us if you don’t want to donate, and if you don’t tell us anything we’ll presume you have authorised donation.”

She was one of several people with direct personal experience from whom we heard, formally or informally, and who helped to shape the committee’s report at stage 1 of the bill. I thank everyone who assisted with our scrutiny by responding to our call for views or our survey or by giving oral evidence, and I particularly thank those who, like Gillian Hollis, gave evidence from their own experience, including people who have benefited from donated organs, patients who are still waiting for a transplant and relatives who have authorised the donation of an organ from a deceased family member.

I also thank the clerks to the committee and the Parliament’s external engagement and media teams.

As is the case with the current law on organ donation, the Human Tissue (Scotland) Act 2006, the bill’s fundamental purpose is to enable an increase in rates of organ donation to save lives.

The evidence that we heard at stage 1 was that donation rates have benefited from the changes to law and practice that followed the 2006 act, but have not yet ended the tragedy of people dying while on the waiting list for an organ transplant. Despite all the good work that has been done since 2006, more than 500 people are waiting for a transplant at any one time and there are not enough organ donations to enable them all to survive.

The 2006 act boosted donor rates in Scotland to the highest in the UK, as the minister said, although we are now being challenged by Wales, since the passing of the Human Transplantation (Wales) Act 2013.

In Scotland, about half the population has opted in. However, that is not enough. We know from survey work that 90 per cent of Scots say that they would like their organs to be available for transplantation after death. That means that up to 2 million people in Scotland would like to be organ donors but have not registered their wishes.

The bill deems those who have expressed no view on the matter to be potential donors, thereby bringing the share of the population who can donate closer to the proportion of the population who want to do so. Of course, as Joe FitzPatrick said in his speech, in practice, transplantation is appropriate in only 1 per cent of deaths.

People need to be able to make an informed choice about opting in or out, and they must understand the implications of deemed authorisation. The language around organ donation can be confusing, so we also need a robust and continual engagement strategy, to explain what it all means.

The committee was keen to learn from the experience of other countries. The legislation passed in Wales in 2013 introduced a system of deemed authorisation similar to that proposed here. Evaluation of the impact of the Welsh act confirmed that the new law did not at first lead to a major increase in donor rates but that that has begun to happen in the past year or so. The evidence is that increasing donation follows increasing awareness, not simply a change in the law alone.

Likewise, as we have heard, the evidence from Spain did not prove a direct link between an opt-out system of deemed authorisation and an increase in transplantation rates. As David Stewart pointed out, high numbers of intensive care beds have been at least as important to the high organ donation rates in Spain, as has the high number of hospitals able to retrieve organs.

When we asked the minister to review the issue of intensive care beds, he indicated that the 2020 strategic forecast did not anticipate an increase in donation rates above existing capacity as a result of the bill. We therefore recommended a review of infrastructure across the country for organ donation, and I very much welcome the minister’s commitment today to discuss with stakeholders whether further improvements can be made.

The committee’s online survey on the bill attracted 747 responses. The most widely-held concerns related to the rights of the individual who has not expressed a view but whose body could, some felt, be treated as if in some way it belonged to the state. While recognising the ethical and legal issues raised, the committee accepted the minister’s view that, in the final analysis,

“the right to authorisation rests with the ... donor”—[Official Report, Health and Sport Committee, 27 November 2018; c 24.]

and, by the same token, so does the right to withhold consent.

The idea that deemed authorisation could undermine the sense of a gift from donor to recipient was also highlighted in our survey. Patients awaiting transplant, on the other hand, were insistent that any organ would be welcome as a gift, whether it was enabled by registration as a donor or by deemed authorisation. It would be useful for the Scottish Government to revisit that after a period to see whether there is any change in public attitudes and any impact on donor rates. Mr FitzPatrick has indicated that that is his intention. We also want a review after a similar period—perhaps five years—of medical procedures prior to death to help successful transplantation. The minister mentioned that, too. It is critical to ensure that such procedures are being conducted with the necessary sensitivity.

The committee had a valuable session with specialist nurses in organ donation—SNODs—who showed us how they work with the families of potential donors. It became clear that families have a dual role in providing the essential medical and social history of the prospective donor, and in enabling donation to go ahead. We were struck by the many and sometimes difficult questions that SNODs have to ask at what is already a distressing time. Those questions are standardised across the UK in order to maximise the opportunities for donations and transplants between jurisdictions. We suggested that this would be a good time to review those questions, to ensure that every question continues to be of clinical importance. We welcome the minister’s commitment to take that forward.

The law already says that the wishes of the donor are paramount, not the views of family members, but, as we heard from Dr Stephen Cole, consultant in intensive care medicine at Ninewells hospital, doctors

“would find it difficult ... to override the wishes ... expressed by ... patients’ relatives.”—[Official Report, Health and Sport Committee, 13 November 2018; c 27.]

We accept that, in practical terms, it would not be possible for the medical profession to proceed with donation against the wishes of the family. The role of SNODs in working with families is therefore critical.

We heard from patients on the transplant waiting list who told us about the emotional and financial distress caused by waiting for an organ to become available. Even when an organ is found, 40 per cent of transplants do not proceed for a variety of reasons, which is tough for those on waiting lists, whose hopes can be dashed time and again.

Specialist post-transplant support is provided to recipients of blood stem cell or bone marrow donations, and we see no reason for any difference in approach. We welcome the Government’s assurance that psychological support across all those services is under review, including for people affected by organ donation. Having had that assurance from the minister, we look forward to the findings of that review later this year.

For the bill to achieve its aim of increasing donation rates, a high-profile public information campaign is required, running for at least 12 months before commencement of the new rules. We are pleased that the Government has accepted our recommendation that it reviews the engagement strategy in Wales and undertakes outreach sessions with ethnic minority groups. We also welcome its commitment to build on the existing collaboration between the Scottish Fire and Rescue Service and the Anthony Nolan charity, which work together to promote awareness of stem cell donation in secondary schools and colleges.

The committee supports the general principles of the bill, but we stress that the bill alone will not achieve the desired effect. Scotland, like Wales, must use the change in the law as a vehicle for promoting greater awareness of the benefits and requirements of organ donation. Ministers must therefore ensure that the necessary infrastructure is in place in good time to support the increased number of transplants that we all want to see in Scotland in the 2020s.

15:20  



Miles Briggs (Lothian) (Con)

When I attended university in Aberdeen, all the students in the granite city became aware of and concerned about our fellow student Millie Forbes. Millie needed a vital bone marrow or stem cell transplant, and significant work to find a donor had led to no suitable match.

As I was a young man who had just escaped rural Perthshire for the city life of Aberdeen, registering for any donation list was the last thing on my mind. However, it was the need to do something and wanting to help that made so many of the student population in Aberdeen sign up en masse to the Anthony Nolan register and donate blood stem cells in the hope of providing the match that Millie needed.

Millie sadly lost her fight aged just 21, surrounded by members of her family at the ANCHOR unit at Aberdeen royal infirmary in 2004, eight months after she had successfully undergone a stem cell transplant operation—her only real hope of survival against acute myeloid leukaemia. Millie was a real inspiration, and it is remarkable to see, 15 years after she lost her life to leukaemia, how Millie’s campaign has brought fresh hope and has saved the lives of others with leukaemia across Britain since then.

That experience made me think about these issues and decide, during my time at university, to sign up to the Anthony Nolan register and the organ donation register. Sadly, for many of our fellow Scots, taking that step or even having a conversation about it with loved ones is just not happening, which is why so many people’s wishes on organ donation are simply not registered or not known by family members. The situation clearly needs to be improved. In Wales, the most recent figures since it changed its organ donation legislation show that, from November 2018, the rate of family consent is now at its highest-ever level of 80 per cent compared with 63 per cent in Scotland, 66 per cent in England and 66.7 per cent in Northern Ireland.

I thank all the organisations and groups that have provided briefings ahead of the debate, and I thank them for their contribution to the work of the Health and Sport Committee. I also put on record my thanks to the committee team for their work during the inquiry, and I recognise the work that was done by Mark Griffin in introducing his member’s bill on the issue.

In the time that I have, I will touch on some of the important aspects of the bill that we need to get right as it progresses through Parliament. The wishes of the donor’s family have already been mentioned, and we need to make sure that those are at the heart of the bill. Throughout our inquiry, it was clear that the role of the donor’s family is fundamental to the success of any donation and will be central to the success of the bill.

Keith Brown (Clackmannanshire and Dunblane) (SNP)

Is it the member’s view that the wishes of the donor’s family should supersede those of the donor?

Miles Briggs

The committee found that issue difficult, specifically in the context of what happens if someone is not known to have expressed a wish. The family already have the opportunity not to go ahead with the questionnaire, and the questionnaire is staying as part of the bill. So, in theory, that will still be the case if they are not willing to go ahead with the donation questionnaire. I know that the SNOD team has always found that issue difficult.

During our inquiry, when Keith Brown was still a member of the Health and Sport Committee, the work that we did with the specialist nurse in organ donation team was very important. Listening to examples of the conversations that the team facilitates with families at the most distressing time any of us can imagine showed how incredibly professional they are and demonstrated our national health service at its best. The professionalism of the SNOD team is critical as they provide sensitive assistance and support to the families of potential donors, and the openness and transparency of those conversations is vital to the process. I pay tribute to their work in supporting families at times of unimaginable distress while highlighting the benefits of organ donation and keeping them informed after the process.

It was clear that organ donors’ families have always been and will always be at the heart of facilitating donor selection through the questionnaire process and in implementing donors’ wishes. As Lewis Macdonald has highlighted, that was demonstrated by the conversations that the committee had with families, and I thank those who generously gave their time to the work of the committee. I am sure that I speak for all members when I say that we learned much from them.

The decisions of families who had decided not to go ahead with donation were understandable, though. I hope that we have been able to make improvements for the future regarding the factors that they outlined as having influenced their decision making at the time and in the organ donation system and such families’ experience of it. Refusal by families accounts for 50 per cent of non-donations. In countries that have adopted opt-out systems, that figure has reduced to an average of around 25 per cent. Clearly, much work remains to be done to improve family consent rates, but I believe that the work that the committee has done on the bill can help to do that.

I do not have time to highlight the amazing work of the Family Donor Network and other organisations such as Transplant Sport, which runs the British transplant games, but I thank them. As has been mentioned, infrastructure is another issue that has been raised with the committee, and I believe that we need to see a significant commitment from ministers on it. As David Stewart outlined, intensive care beds are a key area that the committee highlighted. It is clear that, if the bill is to achieve the outcome of increasing organ donation, we will need to see progress on improving the infrastructure for transplantation. I welcome the minister’s response to the committee, but it is important that we have further clarity on what will be done to address capacity issues in order to support the aims of the bill in the future, especially on staffing and intensive care beds.

The useful briefing that the Royal College of Physicians of Edinburgh provided ahead of the debate makes some key recommendations and points that will be important for us to examine as we progress to stage 2.

I hope that the bill will help us to achieve a celebration of organ donation. We need to change the culture in Scotland to recognise organ donation publicly and to celebrate it more. We must see the life-saving and life-changing difference that donors and their families make—in the majority of cases for total strangers. Giving the gift of life is incredible. The committee’s report recommends that a communication programme be established. If the bill passes stage 1, we must ensure that such a public information campaign is one of the best and most innovative that the Scottish Government has undertaken.

Scottish Conservatives welcome the introduction of the Human Tissue (Authorisation) (Scotland) Bill and today’s debate as the Parliament moves forward on this important issue. We believe that all options should be considered in order to increase organ donation. Therefore, if the bill passes stage 1, we will engage in the legislative process before the final vote at stage 3.

The SNP Government must ensure that comprehensive information and the infrastructure that we will need are in place so that, in the future, donors and families will be fully informed and it will be possible for organs that are donated to be transplanted successfully.

Every day, someone in the UK dies while waiting for an organ transplant. I believe that, here, we have the opportunity to change that.

The Deputy Presiding Officer

I call Monica Lennon to open the debate on behalf of Labour.

15:28  



Monica Lennon (Central Scotland) (Lab)

I am pleased to speak in the debate on the Human Tissue (Authorisation) (Scotland) Bill at stage 1. Like other members, I thank the Health and Sport Committee for its diligent work and its report, which was ably summarised by the committee’s convener, Lewis Macdonald, a few minutes ago. I am also grateful to the British Heart Foundation, the Royal College of Physicians of Edinburgh, the Royal College of Nursing Scotland, Anthony Nolan and Kidney Care UK for the briefings that they provided ahead of the debate.

Scottish Labour supports the general principles of the bill, including its overarching aim of increasing the organ and tissue donation rate and, consequently, the number of transplants that can be carried out. We have long supported a soft opt-out system. I thank my colleague Mark Griffin for influencing the agenda on the subject through his member’s bill of 2016 and Anne McTaggart for her work prior to that on her member’s bill of 2015. I look forward to hearing from Mr Griffin and other colleagues this afternoon.

At any one time, 500 people are on the organ transplant list in Scotland, and, each year, up to 60 people die while they are on that list, so there is certainly a need to increase the number of donated organs. That is why I am pleased that there is public support for a soft opt-out system, as was demonstrated in the Scottish Government’s consultation and the committee’s survey.

That said, we are all alive to some of the concerns that have been raised about the move to a soft opt-out system. Some people expressed a worry that people will have organs removed against their wishes, so it is important to highlight that people will still be able to opt in and opt out of the system, as we have always been able to do. For people who have not declared, consent will be presumed, but there will be safeguards in place. For example, the next of kin will be able to provide information if donation was against their family member’s wishes.

Mike Rumbles

As I said to the minister, that is the law as it stands, under the Human Tissue (Scotland) Act 2006, which refers to “knowledge” of the deceased person’s intent. However, section 7 of the bill says that the family must provide

“evidence to a health worker that would convince a reasonable person”.

That requirement to provide evidence is quite different and is a step change in legal terms.

Monica Lennon

I have been reassured by the committee’s scrutiny and by the Government that there are appropriate and robust safeguards. I will come on to talk about the public education aspect, which is important.

Fundamentally, it is crucial that we get these things right, because people who are on the transplant waiting list urgently need help. Organ transplants save lives and can make a transformational change to people’s quality of life. For example, Kidney Care UK describes dialysis as distressing, extremely painful and hugely disruptive to daily life, with five-hour dialysis sessions three times a week, which is challenging for people in rural areas, as I am sure Mike Rumbles knows. A kidney transplant can give a person their life back.

The committee heard that the wait for a transplant can be a lonely experience and can take a huge toll on people’s mental health. There can be an anxious wait for a suitable organ to be found and disappointment when delays and complications arise, which can happen even on the day of surgery. A return to the transplant waiting list can be a source of disappointment and anxiety. I recognise the committee’s recommendation that, where possible, we need to improve the experience of people on the waiting list by, for example, having specialists provide support.

It is crucial that the bill be backed by clear and consistent messaging throughout Scotland so that people understand the system, and in order to spark conversations about organ donation. The British Medical Association has said that, although half of the population have opted in to organ donation, its experience is that, when asked, nine out of 10 people say that they would donate their organs. Deemed consent will help to close that gap.

I hope that we can all agree that a person who is desperately waiting for an organ transplant, which could be the difference between life and death, should not miss out simply because many of us never got round to opting in to be an organ donor. The committee’s convener touched briefly on the work of Anthony Nolan with the Scottish Fire and Rescue Service, which is an excellent partnership that works with young people in our schools. Since 2009, 13,000 people in Scotland have registered on the stem cell donor register, which has potentially saved 42 lives. That is fantastic work, and I hope that the Government can help those organisations to build on it.

The importance of public awareness and frank conversations is brought into sharp focus when we consider that family refusal results in the loss of around 100 donors in Scotland per year. Changing that situation could make a huge difference to people on the transplant waiting list. It might not be an easy conversation, and it might feel morbid to discuss it, but it is important that we overcome the stigma and make our wishes known to our loved ones. I was moved by the stories from families for whom organ donation has been a positive experience, even helping them to come to terms with their loss.

Just recently, I was walking our dog in Chatelherault country park, in Hamilton, where there is a bench that is a tribute to Lanarkshire organ donors. I have passed it a number of times, but I knew that the debate was coming up, so I looked more closely. It is very poignant. As we would expect, there are flowers and little plaques, and it simply says that it is

“to remember those who gave the gift of a life time”.

I was pleased to hear about the measures that are currently in place for the families of the deceased through which they get a certificate. That must be hugely important and meaningful, as it is an extraordinary gift.

Evidence suggests that an additional benefit of good public awareness is that it will help to drive up donation rates. Although the soft opt-out system is important, the BMA and others have highlighted that a change in legislation is not a panacea and must be accompanied by investment in the infrastructure to support delivery, which other members have touched on in respect of intensive care capacity.

Scottish Labour supports the general principles of the bill and looks forward to working with others on amendments. Organ donation is one of the greatest gifts that a person can give, and it is life-changing to receive. It is important that the bill maintains the special way in which organ donation is viewed and that surrounding measures are implemented to ensure its success.

The Deputy Presiding Officer

Thank you. I remind members that, if you intervene, your request-to-speak button will be switched off, so you must check that you have switched it back on again. It is how the wonderful technology in the Parliament works.

15:35  



Alison Johnstone (Lothian) (Green)

I, too, would like to thank the Health and Sport Committee and all those who were involved in getting the bill to stage 1, including the expert groups and witnesses who gave their time. I also note the contributions of Anne McTaggart and Mark Griffin to the on-going debate.

Right now, about 4,300 people in Scotland are living with a donated organ. Thousands of people have a second chance at life because someone made the active choice to register as a potential donor. We are all aware of the heartfelt letters that organ recipients have sent to the families of donors to give them a sense of what the donation meant to them.

When it comes to getting people to register to be a donor, Scotland is doing well. As we have heard, around 50 per cent of Scots are registered, compared to 38 per cent of people across the UK. As a result, the number of successful donations has increased significantly over the past decade, with waiting lists having reduced by more than 100 in that period.

However, as we know, that is still not enough. In Scotland, 500 or so people are on the waiting list for an organ transplant and, sadly, 40 to 60 people will pass away while they are waiting. Despite having that high proportion of people who are registered, Scotland’s level of donations is the lowest in the UK. That is why, among other measures, it is vital to increase the total number of potential donors. Clearly, there is scope to do that, as there is a persistent gap between the number of people who state in surveys that they would wish to donate organs and the number who go on to join the organ donation register.

The question before us is whether an opt-out system, such as that which is proposed in the bill, is likely to increase the number of organs that are available for donation. As we have heard, and as the policy memorandum to the bill rightly notes, the evidence is mixed. Therefore, we need to be clear—and it seems that, across the chamber, we are clear—that an opt-out system is not an instant solution on its own.

Some countries have experienced increased donation rates after adoption of such systems, and in some there have been decreases. However, the evidence that was presented to the Health and Sport Committee and which is in many of the briefings that members have received suggests that an opt-out deemed authorisation system, as part of a broader strategy to increase donations, may well have a positive impact. Figures that were released by the Welsh Government show that there was a significant increase in the number of families consenting to donation after the new system was established. The figure in Wales stands at 80 per cent, compared with 63 per cent in Scotland.

NHS Blood and Transplant’s audit of potential donors in 2016-17 showed that 177 families across the UK said no to donation because they were not sure whether their relative would have agreed to it. Based on last year’s average number of 2.6 transplants per deceased donor, those decisions could instead have led to around 460 life-saving or life-transforming transplants. If, as the bill intends, the Scottish Government is able to reduce the high number of refusals by families in Scotland, it will have a very positive impact. However, the ideal is clearly still to have as many people actively opting in as possible. The rate of family consent is always highest when the person who has died opted in, and that is when the intent of the person is the clearest. That is one of the many reasons why section 2 of the bill is particularly important. It places a duty on the Scottish ministers to

“promote ... awareness about how transplantation may be authorised”.

It would therefore be useful if, in his closing speech, the minister could give some more detail on how that awareness will be raised.

Deemed authorisation depends significantly on people being well informed about their options, so awareness raising must continue over time. As we have heard, anyone who is resident in Scotland for more than 12 months will be subject to deemed authorisation. The logical conclusion of that is that we must have a continual, year-on-year campaign of awareness raising. NHS Blood and Transplant surveys show that more than 80 per cent of people support organ donation but only around 49 per cent have ever talked about it. We need to have a wider and more effective national conversation about organ donation. I would be interested to hear from the minister how he thinks that can best be achieved.

Before closing, I want to focus on the role of specialist nurses for organ donation. The whole system really hinges on the incredible work that the specialist nurses do. They lead the discussion about the patient’s decision on donation with the family. Where a decision to donate is established, they ensure that the relevant medical tests are carried out and they discuss the patient’s medical history with the family. However, the new system will potentially change their role significantly. For example, it is likely that the new duty to inquire that the bill establishes will, in practice, lie with the specialist nurses. There will be retraining needs related to that.

The evaluation of the Welsh system has drawn attention to the pressure to make the policy work that some specialist nurses feel. Some nurses were concerned that they might be blamed if consent and donation rates did not improve. We can learn from that, and I am sure that that is something that we will seek to avoid. It is also important that the guidance for specialist nurses and other professionals is clear, particularly in relation to some of the challenging situations that they might face, such as when the family objects, even though relatives have no formal entitlement to refuse a donation.

As part of a broader strategy to increase donation rates, the bill is welcome. Clearly, this is a sensitive issue, and the bill’s provisions will need to be implemented with care, with appropriate safeguards and with respect being paid to the difficult situations faced by families who have lost a loved one. However, if there is a chance that it will lead to more people getting the gift of life, it should be welcomed. Greens support the general principles of the bill and will vote accordingly at decision time.

15:41  



Alex Cole-Hamilton (Edinburgh Western) (LD)

I am delighted to stand here today and offer my full-throated support for the Human Tissue (Authorisation) (Scotland) Bill. When I was out losing elections as an aspirant Liberal Democrat candidate, I was often asked at hustings and party meetings, as I am sure other members were, “If you make it to Parliament, what will be your member’s bill?” It was a hypothetical question, but I always gave the same answer, and it was the bill that we are discussing today. I always supported legislation to introduce a soft opt-out system and presumed consent for organ donation, and I will tell members why.

When I was 14 years old, I met a guy called Anders Gibson. He was 12 at the time. He and I soon became friends, and I was told by adults around Anders that I had to be prepared for the fact that he might not see 20, because he had cystic fibrosis. However, happily enough, he rode the wave of medical advancement and benefited from new treatments that emerged in his late teens. He went on to become a fierce campaigner on cystic fibrosis issues, an ardent footballer and a brilliant stand-up comic. Very sadly, we lost Anders in 2014, when he was in his mid-30s. I speak in his memory today and I am grateful for his impact on my life and the lives of everybody with cystic fibrosis in this country.

It is for that reason that I entirely understand the personal motivation that led to Anne McTaggart and Mark Griffin introducing members’ bills on the subject, and I thank them for their work. They have paved the way for change in this country that might not have happened were it not for their efforts, and rightly so, because we are pushing at an open door here.

As we have heard, we have a high rate of registration with the organ donation register and some 70 per cent of our fellow countrypeople support change in this regard, but there is always a disconnect—it has been alluded to by several speakers in the debate—between those who do not mind the idea of having their organs give life to others in the event of their passing and those who actually sign up to the register. The human cost of that disconnect is that, in Scotland, on any given day, 500 people are waiting for an organ, some of whom may wait in vain and pay the ultimate price.

The bill might not create a huge uplift in the number of organs that are made available, but it is a vital step and one that we need to take. It is important to recognise that, if we introduce a soft opt-out system, it will not mean that everybody’s organs will automatically be donated in the event of their death. People will need to die in specific conditions for that to happen. Nevertheless, it will give hope to those 500 people where none existed previously.

We do not need to wait for people to die in order for others to benefit from organ donation. In mid-March, I will be hosting a photo call after First Minister’s question time for Give a Kidney, which is a UK organisation of philanthropic organ donors that does not get enough publicity. I urge all members to learn about it because it is truly heaven sent.

The process around the bill has been enjoyable, touching and inspiring. I want to pay tribute to the outstanding work of the specialist transplant nurses: they are a credit to their profession. I had no idea about the pre-death procedures that take place in advance of a transplant. They are onerous; hundreds of questions have to be asked of families at the most vulnerable point in their journey through grief. Often prior to somebody’s actual death, families have to take time away from the patient’s bedside to answer those questions. The transplant nurses ask them in a way that makes it a cathartic experience. The families get to unpack their relative’s life: their likes and their dislikes, and who they were as a person. It was really touching to see how the nurses make a bureaucratic exercise intensely cathartic for the families around them.

However, it is vital that that process should not become a barrier. Although I understand the duty to inquire, I support the suggestion from my friend and colleague Mike Rumbles that we need an amendment regarding the requirement for families to provide evidence that would “convince a reasonable person” about the deceased’s views. Nevertheless, retaining opt-in is important—we need to engender those conversations, to continue to make organ donation feel like giving a gift and to provide an element of the process through which people can proactively make that statement. People who receive organs absolutely regard it as a gift.

One of the most touching moments in the consideration of the bill was a breakfast session with half a dozen recipients of organ donations, who were inspiring people who talked of their gratitude and exhibited such good will towards their donors. They particularly felt the impact of that gift on their lives.

It is so important to recognise that each of those people have been through a roller-coaster of emotions on that journey, and we need to do more for them in the periphery around the bill. Anders, whom I mentioned at the start of my speech, had four abortive attempts at going to Newcastle to get a lung transplant. Waiting by the phone, being turned around to start the whole process again and feeling guilt about waiting for somebody to die had a profound effect on his mental health. At the moment, we do nothing to help people who are on the transplant register, and I hope that the minister will address that in his remarks and agree to meet me to discuss how we can do more.

To get down to brass tacks, I absolutely support the principles of the bill. It will give hope to those 500 people and do more to make sure that people like Anders will have a fighting chance at survival.

The Deputy Presiding Officer

We move to the open debate.

15:48  



Emma Harper (South Scotland) (SNP)

I am pleased to speak in today’s stage 1 debate on the Human Tissue (Authorisation) (Scotland) Bill as deputy convener of the Health and Sport Committee. The committee took a large volume of evidence, and I thank the clerks for their hard work and diligence. I also thank all those who provided evidence to the committee, including healthcare professionals—among them Lesley Logan and her team—who provided us with insight and medical expertise so that we could be better informed about the process of organ and tissue retrieval and donation, as well as the transplant process.

Like Monica Lennon, I also thank the organisations who provided briefings ahead of this stage 1 debate, including Anthony Nolan, which supports education with the Scottish Fire and Rescue Service and which has previously worked with my colleague Bill Kidd MSP.

As a former member of trauma and liver transplant teams in Los Angeles, I was especially grateful to hear from people who were waiting for an organ. The personal voices of recipients and people waiting for organs and tissues are vital in informing the debate, because around 500 people in Scotland are waiting for a transplant at any given time.

The primary aim of the Human Tissue (Authorisation) (Scotland) Bill is to increase the organ and tissue donation rate. Organ transplantation is a complicated process. It normally requires two teams of healthcare professionals—and two surgeries—to engage in and co-ordinate the process of obtaining the organ and transplanting it into the recipient. I have participated in the retrieval of organs, as well as the transplantation of solid organs into a recipient patient. On one occasion, I even went up three floors in the elevator carrying a heart in a sterile, ice-filled bowl from one surgical team to the waiting transplant team. It was an awesome—in the true sense of the word—experience to see the gift of an organ being transplanted into a recipient.

The biggest challenge that I have faced while working on the bill has been in relation to deemed authorisation or presumed consent. One of the key arguments in favour of deemed authorisation is the fact that many people in Scotland support donation but have not yet recorded their wishes on the organ donor register. In evidence, Dr Sue Robertson, who is the deputy chair of the British Medical Association Scotland, told the committee that about 50 per cent of the Scottish population have already opted in, so they are already registered to be donors. The committee also heard that 68 per cent of people in Scotland support being organ and tissue donors, but that not all of them have got round to registering.

It is worth highlighting that, when we talk about organ donation, we are referring to the heart, lungs, liver, pancreas, kidneys and even the small bowel; that is before we even start on tissue availability. I believe that we must encourage people to make an informed choice on donation. We need to encourage families, friends and colleagues to have conversations about donation. It is easier to have a conversation about donation when family members meet to engage in a chat than it is at the stressful and traumatic time when a family member is in the intensive care unit. When the patient has registered their wish to donate, it puts the specialist organ transplantation nurses, who have to have those difficult conversations with the relatives of the patient, in a better position. Therefore, I encourage people to register their wishes.

For me, having such conversations, along with education, is key. During the stage 1 process, I discovered from surveying my family and my staff team that all my family and my staff are on the organ donor register. I was quite chuffed to hear that, because no coercion was needed. My dad, who is 77, proudly pulled out his organ donor card to show me his evidence. He would be absolutely happy to give the gift of his heart, liver, lungs, kidneys, pancreas or even his eyes if they could save the life of someone or support their vision. If, in some terrible, tragic or traumatic circumstances, someone’s life depended on the gift of any of those organs, he would be grateful to have the opportunity to make that gift.

Donors could be called superheroes because they have the power to save many lives with the use of their heart, their liver, their lungs, their two kidneys or their pancreas. We can all be superheroes. I am on the donor register, and I would be interested to know how many other superheroes we have in the chamber today.

I was a bit disconcerted by the conversation that I had with my nephews, one of whom is 14 and one of whom is 16. Neither of them has had a conversation about organ donation with any educator. The briefing from the Royal College of Physicians of Edinburgh says that it is particularly important that we provide education in tandem with the measures in the bill. One of my big asks is we engage with education on donation that is provided by schools and with ethnic minority communities. That engagement must be sustained as the bill progresses so that we can save lives in Scotland. We must make sure that people are able to opt in and to opt out, and that there is deemed authorisation. In that way, we will save lives.

15:54  



Maurice Corry (West Scotland) (Con)

It is my pleasure to speak in the debate on the bill today. The subject is certainly a challenging one for all of us. ln the midst of grief over the loss of a loved one, organ donation is one of the most positive and life-changing actions that we can take. Playing a part in giving someone a second chance at life is a privilege. With that in mind, any legislation that alters how the process works needs to be carefully considered, and it must fully inform those whom it affects.

We have seen a rise in the number of organ donations in Scotland over the past 10 years. We can only imagine what organ donations mean for those living with kidney failure or a congenital heart defect and their families. It gives them a renewed outlook on what is possible. However, we have heard that although the number of organ donations in Scotland may be increasing, there are still many living in need of a transplant. The necessity of having more organ donors on the register is clear: over the past year, 27 people in the UK died while awaiting a heart transplant.

That is the area where the proposed legislation seeks to bring about change. By creating three options—opt in, opt out or deemed authorisation—the bill aims to encourage an all-important increase in organ donations in Scotland. I thank John Mason for his email, with his Christian angle on the matter. I found it very helpful and thought provoking as I spent a little time in church today before I came to the debate.

Deemed authorisation—in essence, presumed consent—has been successfully adopted in a number of countries. Indeed, of the top 10 countries in the world for organ donation rates, nine have adopted a similar presumed consent model. In the right circumstances, it can work.

Many people support organ donation but never get round to signing themselves up actively as donors, despite the best of intentions. Often, public support does not translate into actual donations. Deemed authorisation would help to tackle that problem. For many people, it produces the outcome that they may have intended and supported, but which they have not acted on.

The option of deemed authorisation or presumed consent also means that there is a higher chance of medical suitability. With a larger pool of potential donors, the likelihood of identifying a match is greater. We all want to see a rise in organ donations, and in principle the objective of the bill is right and well meant. It has the potential to be effective in leading to more successful donations.

I am pleased to see that there will be safeguards surrounding the change. For example, it is perfectly right that those under 16 or who are incapable of understanding the implications of deemed authorisation will not be automatically opted into organ donation upon their death. Those who have been a resident in Scotland for under a year will also be excluded from that pathway. The measures go some way towards ensuring that the bill is not a blanket change in legislation with no thought for potentially sensitive cases. Having a soft opt-in system solves the issues in cases in which the wishes of a deceased person were not made known before their death. In such situations, it maximises the use of potential donors.

However, although having three options—opt in, opt out and deemed authorisation—might be the right way forward, changing the law alone will not work. The bill should not be implemented without proper investment in organ donation awareness. There must be active engagement alongside the change in legislation.

First and foremost, I hope that there will be engagement with the families of the deceased, including—as I said to the minister—the executors of the deceased’s estate, those with power of attorney and the Office of the Public Guardian.

The way in which families are approached and handled by organ donor professionals in the hours after the death of a loved one is important. A sensitive donor liaison team can make all the difference to a family’s experience. With generally exemplary training, those teams can help to guide families’ decisions—yet Scotland has the lowest family authorisation rate in the whole of the UK. For that reason, the proposed changes will not work unless families are consulted as part of the process. If loved ones are fully informed about what the changes mean, the transition to deemed authorisation will be much smoother. I hope that the bill will be considerate about and mindful of upholding the rights of the deceased as well as the rights of families. The Scottish Government needs to take into proper consideration the ethical concerns that can spring up from that balance.

Secondly, there must be engagement with the wider public, which can surely be done only if there is a strong emphasis on communication and awareness. We cannot take for granted the importance of having a public discussion on changes with such a subject. Without such discussion, how can we expect to see a noticeable rise in organ donations?

We have seen the benefits of the partnered visits conducted by the Scottish Fire and Rescue Service and Anthony Nolan to Scottish secondary schools. Through such visits, teenagers have been equipped to understand what organ donation really means and how they can sign up. Awareness campaigns can be the spark that encourages families to talk about their wishes. Like Emma Harper, I discussed the subject last night with my daughters and son and asked them for their views—they clearly supported the opt-in, opt-out approach. I am glad to say that half of them had donor cards—which I had not realised—and one of them was on the Anthony Nolan register, which I commend.

Organ donation awareness and communication need to be embedded at the root of our communities. In that way, people can understand how they can choose to express their wishes and the implications that their choice could have for their family. The reason why my children had made their choice was because they had been told about the process at their secondary school, so the approach is working in the Argyll and Bute Council area.

Co-ordinating those efforts to make the handling of the process as efficient as possible but with the utmost consideration is in everyone’s interests. Even so, I agree with Mike Rumbles, as I also have concerns about the written proof of the deceased’s wishes being necessary to support the family’s wishes at such a difficult time. However, I am advised that the required questionnaire is the safety mechanism that will be in place.

I welcome today’s debate. We all want to see a rise in donation rates in Scotland, but for that to be possible, all sides must be listened to and taken into consideration. If legislating for a soft opt-out option is the way forward, the Scottish Government must ensure that that is done sensitively and with an effective and supportive infrastructure.

The Deputy Presiding Officer (Linda Fabiani)

You must close, Mr Corry.

Maurice Corry

The proposed legislation cannot stand alone; it needs to be connected to increased awareness, communication and co-ordination.

16:01  



Sandra White (Glasgow Kelvin) (SNP)

I thank all the organisations, individuals and professionals who took part in the evidence sessions, the meetings and surveys that have proved to be so invaluable to our report. I also thank Mark Griffin and former MSP Anne McTaggart, who introduced a member’s bill in the previous parliamentary session. Although the Health and Sport Committee at that time could not support the general principles of the bill, I believe that it has led to the much more comprehensive bill that we are looking at today at stage 1.

I will be perfectly honest: having supported the previous bill, I thought that I had learned a great deal about transplantation and organ donation, but I was very wrong. Having heard the evidence on the bill, I realise that the Human Tissue (Authorisation) (Scotland) Bill is much more complicated and comprehensive than I had thought. The subjects of the evidence included mandated choice, the rights of the individual, the gift element, the authorisation process, the rights of the family and their consent, post-transplant care and mental health. It is a huge and very comprehensive list.

I felt while hearing evidence to the committee that I was learning all the time. An area that I had known nothing about, and to which I paid special attention, was pre-death procedures. I had never heard of them, so I will concentrate on them. During evidence taking, I was intrigued by the procedures, so I asked questions about them. The committee convener, Lewis Macdonald, mentioned the 2006 act and highlighted many points.

I think that I will take my glasses off, as I do not seem to need them today.

The bill creates two procedures—type A and type B—

“with further details ... contained in regulations. It is anticipated that type A procedures would be more routine”.

The minister mentioned in his opening remarks that those are blood and urine tests. Those tests

“would be allowed to proceed under deemed authorisation or when the person has opted-in.”

It is anticipated that type B procedures will be

“less routine including the administration of medication or more invasive tests. Regulations could also specify what requirements would apply to type B procedures and how they could be authorised. Deemed authorisation would not automatically apply to type B procedures.”

The bill’s policy memorandum states:

“In all cases where pre-death procedures may be undertaken, a decision will have been taken that the person is likely to die imminently and that, if the person is receiving life sustaining treatment, this will be withdrawn.”

That is very complicated but very necessary. I found it intriguing that those things were going forward.

The stage 1 report says:

“During our informal meeting with families who have authorised donation, we asked their opinion on pre-death procedures. They expressed their discomfort of any invasive tests on relatives but accepted the notion of blood tests and other routine tests.”

The subject is very sensitive and very important.

We questioned various experts, including Dr Empson, who confirmed that, although health professionals would not go through specifics with families for every blood test that was taken, families would be involved in respect of tests that help to certify death by neurological criteria—for example, to observe the brain-stem-death test taking place. As Dr Empson explained:

“When a potential donor is going down the route of donation, appropriate information is shared sensitively and compassionately with families.”—[Official Report, Health and Sport Committee, 20 November 2018; c 18.]

That might answer some questions that have already been asked.

A lady who gave evidence had gained understanding through seeing the process. That was very brave of her, but she felt that her relative had not suffered and so agreed to donation of organs. As I said, the issue is very complicated.

There are other pre-death procedures issues to do with the law and doctors. The Law Society of Scotland highlighted such issues.

“Doctors should be concerned with prolonging the life of the patient, rather than viewing them as a source of organs”,

although that quotation is not from the Law Society’s evidence. The Law Society also mentioned the Hippocratic oath, in which the first consideration is the health and wellbeing of the patient.

I thank the minister, as well. When he gave evidence to the committee, he reiterated the need for transparency to maintain a high degree of trust in donation. I know that the minister has accepted the committee’s recommendation on the steps to inform families on pre-death procedures and the proposal to review procedures in five years. That is really important, because medical science moves on, so the approach might not be appropriate by then.

I am very supportive of the bill, and I thank everyone who gave evidence. It is a comprehensive bill, and I certainly learned a lot during its passage.

16:07  



Mark Griffin (Central Scotland) (Lab)

The Human Tissue (Authorisation) (Scotland) Bill is an important piece of legislation, and the Government has my support for introducing it. I lodged a proposal for a member’s bill to introduce the same system that the Government intends to introduce, and was grateful to the Health and Sport Committee for giving me permission to take that forward without consultation because of the extensive work that had already been done. I said at my appearance at committee that I would take forward my proposal only in the event of the Government’s deciding not to. Therefore, I very much welcome the bill.

In the committee and in previous debates, I have spoken about my personal experience of the current organ donation system. I want now to talk about the huge impact that increasing the number of organs that are available for transplant could have on the lives of people who are on the transplant waiting list and their families.

Almost 12 years ago, a man received the phone call that he had been waiting for for more than 10 years. He was told that a transplant heart was available and that he should come into hospital to prepare for his operation. He had taken ill 10 years previously, and had struggled with the diagnosed heart condition ever since. His health gradually deteriorated all the time, there were regular hospital admissions, and he lost the ability to work in his job as a welder or to take part in any physical activity at all.

That man and his family made the trip to the hospital and said their goodbyes that day, full of hope that the operation would lead to a much better quality of life. Unfortunately, that was not the case. After the operation, he was placed in intensive care as expected, but the hoped-for recovery just did not happen. That was not as a result of failure in the care that he received from the NHS consultants who carried out the operation, or from the intensive care nurses who sat vigilantly by his bedside 24/7 during the recovery period. The reason why he did not recover was that his liver, kidneys and other organs failed as a result of having had to work harder in the previous 10 years to compensate for the heart condition, and they just were not strong enough to cope with the operation.

A matter of days after the surgery, the man died at the age of just 47—he was a young man, given life expectancy in this country. He left behind a wife and a family of four children—two boys and two girls. His oldest child was 22 and the youngest was 13 when they lost their dad. Today, he would have been 59. He has missed the university graduations and weddings of his children, significant birthdays, anniversaries and the births of all his grandchildren. So many family milestones have been missed and are still to be missed.

It would be naive to expect everyone to survive a major operation such as a heart transplant, but it is common sense that, for the person to be given the best chance of survival, they have the operation as soon as possible after they have been placed on the transplant waiting list. That is where the bill becomes significant. If we can follow the lead of other countries around the world and implement a system of presumed consent, alongside a high-profile publicity campaign, we can boost the number of organs that are available for transplant, so that people will get access to operations sooner, and we can help to save lives. Even just one more organ donor from one tragic incident means many more saved lives.

I pay tribute to the Evening Times, the British Heart Foundation and Anne McTaggart for the fantastic work that they have all done in working towards an opt-out system. I also acknowledge the early adopters and drivers of the policy among Government party members, including Kenny Gibson, whose hard work in pushing for the change has been notable.

During the various campaigns, research has repeatedly shown—as others have said today—that although 90 per cent of people are in favour of organ donation, only just over half the population are on the organ donor register. If people are willing to receive a donated organ, they should be similarly willing to donate.

The only thing that prevented me from registering as a donor years ago was my unwillingness, as a young man, to confront my mortality. That is a silly reason when we think about it, and we could overcome such things by having a system of presumed consent.

Some members will know whom I was speaking about earlier, and most others will probably have guessed that the reason why I have spoken so personally about organ donation is that the man whom I described was my dad, who was lost to me, my mum and my brother and sisters at such a young age. That is why I feel so strongly about the subject, why I support the bill, why I am speaking today and why I whole-heartedly support the Government in its ambition to introduce a system of presumed consent.

16:12  



Mike Rumbles (North East Scotland) (LD)

I have been on the organ donor register for the past 20 years. When we passed the Human Tissue (Scotland) Act 2006, I was on the then Health Committee. In the stage 3 debate on the Human Tissue (Scotland) Bill, I said:

“The bill ... is perhaps one of the best bills that the Scottish Parliament will ever pass. It is good news for the families who are waiting for a transplant for their loved ones. I hope that, at decision time, the bill will be passed unanimously.”—[Official Report, 2 February 2006; c 22985.]

The bill was passed almost unanimously, with the exception of the votes of four Scottish Socialist Party members. I noted in that debate that we had achieved more than 25 per cent of people in Scotland on the organ donor register. Now, 13 years later, we have more than 50 per cent of Scotland’s population on the register.

The 2006 act has been a success. I understand that the Scottish Government now wishes to go further, so we have a bill before us that will change the system from opt in to opt out in order to achieve even more successful organ donations.

The Health and Sport Committee’s report says:

“The overarching aim of the Bill is to increase the organ and tissue donation rate”.

I could not agree more with that aim, and I will concentrate on that, because I do not believe that section 7 of the bill will achieve it.

The Minister for Public Health, Sport and Wellbeing said at the Health and Sport Committee:

“The current legislation and the proposed legislation are clear that the right to authorisation rests with the potential donor.”—[Official Report, Health and Sport Committee, 27 November 2018; c 24.]

Unfortunately, that is not what section 7 says. It says that the deemed authorisation in section 7 does not apply if a person provides evidence to a health worker

“that would convince a reasonable person that”

the adult was unwilling for the transplant to take place. Why have those words been used instead of the wording in the current legislation, which states that

“the nearest relative may not give authorisation ... if the relative has actual knowledge that the adult was unwilling for any part of the adult’s body ... to be used for transplantation”?

There is a real difference between those two approaches. In the bill, the evidential bar for the family of the deceased to confirm the wishes of the deceased is being raised unnecessarily. The family of the deceased will have to provide “evidence ... that would convince” about the wishes of the deceased. What sort of evidence does the new wording in the bill require in that regard? The bill is silent on that.

I acknowledge that the public health minister has said that the bill does not change the fact that the right to donation rests with the potential donor. However, that right has to be a real right. Again, I focus on the problems that the family would have in meeting the new evidential test about the wishes of the deceased, particularly if those wishes had been expressed to them only orally.

In summing up the stage 3 debate on the Human Tissue (Scotland) Bill, the then Deputy Minister for Health and Community Care, Lewis Macdonald, said:

“Our new system of authorisation, which is founded on honouring people’s wishes, will mean that the person’s own wishes are paramount.”—[Official Report, 2 February 2006; c 22989.]

I could not agree more. I continue to believe—as, I hope, does Lewis Macdonald—that, if we are to get the uptake in organ donations that we need, we have to get the wording in section 7 of the Human Tissue (Authorisation) (Scotland) Bill right.

Keith Brown

Is the member saying that the rights of the donor—someone who is in full possession of their faculties, who has decided to donate—should be superseded, whatever evidential bar is set, by the family? I think that that is what he said.

Mike Rumbles

They certainly should not be superseded by the family—absolutely not. With the 2006 act, we said that we had to have a system in which the rights of the individual donor are paramount. That is the important thing.

The reason why I am so exercised about the words in section 7 is that, if those words remain in the bill, I am fearful that the legislation could end up being counterproductive to achieving an increase in organ donations, which is what all of us in the chamber want.

In 2006, all the members of the Health Committee were concerned about the issues that had arisen at Alder Hey children’s hospital, the Bristol royal infirmary and other hospitals, which had resulted in a loss of public trust; I know that the then Deputy Minister for Health and Community Care would acknowledge that. Indeed, we need only look at more recent incidents, such as the baby ashes scandal, to see that public trust is precious and that we must not put it at risk.

I make it clear that I want to vote for the bill at decision time. I am pleased to see that, in paragraph 35 of its report, the Health and Sport Committee agrees with me that,

“if the nearest relative, next of kin, or a longstanding friend is in possession of information regarding the deceased wishes on donation, this information could be taken into account”.

That is marvellous. However, the problem is that that is not what section 7 of the bill says. It replaces the wording about “knowledge” of the wishes of the deceased with a requirement to provide “evidence ... that would convince” a health worker of those wishes. Why has that unnecessary change been made?

If the minister confirms in summing up a willingness to return at stage 2 to the language that is used in section 7 of the Human Tissue (Scotland) Act 2006, I will happily vote for the Human Tissue (Authorisation) (Scotland) Bill. If the new words about “evidence ... that would convince” remain in the bill, rather than the current words in the 2006 act about “knowledge”, that would strike out one of the fundamental principles of the bill.

I am with the Health and Sport Committee on this. In paragraph 10 of its report, the committee says:

“Deemed authorisation would apply when someone dies without making their decision on donation known, with their consent to donation being presumed unless their next of kin provided information to confirm this was against their wishes.”

That is what the committee has said, and that is what I support.

The Deputy Presiding Officer

You must close, please.

Mike Rumbles

Knowledge is knowledge and evidence is evidence—there is a clear difference. I urge the minister to commit to using the word “knowledge” and not “evidence” in the bill. I want to vote for the bill, but before I can do that at decision time I need to hear a commitment from the minister that he will look at changing the wording in section 7.

16:19  



Kenneth Gibson (Cunninghame North) (SNP)

Although this is a stage 1 debate, it is actually the culmination of decades of concerted campaigning by patients, medical professionals, third sector organisations, newspapers such as the Glasgow Evening Times, and, of course, many of my colleagues in the chamber today. Indeed, on 1 November 2012, I led a members’ business debate on this issue. I am, therefore, delighted to contribute to this afternoon’s debate and to support unequivocally the principles of the bill.

I recognise the excellent work that has been done by the Health and Sport Committee, and I thank the British Heart Foundation in particular for the excellent briefing that it circulated to members ahead of this afternoon’s debate, which provided illuminating data on organ donation in Scotland. More important, I acknowledge the organisation’s dogged and proactive support for soft opt-out over many years.

We should also, of course, acknowledge the sterling work of Anne McTaggart in the previous session of Parliament and, in this session of Parliament, the work that has been done by Mark Griffin, who gave a moving speech a few minutes ago.

As we know, there has been a significant shift in attitudes towards organ donation in Scotland over the years, and it is incredibly heartening that more than half—50.4 per cent—of the Scottish population are already registered to donate their organs or tissue after death, which is far higher than the UK average of 38 per cent. That shift has yielded positive results, with a 22 per cent drop in people waiting for transplants between 2008 and 2018. However, sadly, I am sure that many of us know someone who waited too long for an organ, or who is still waiting today. Indeed, we heard about such cases in the chamber earlier this afternoon.

At the end of 2018, 577 people in Scotland were waiting. Any reduction in that number, no matter how small, will be life saving. Having campaigned on this issue for many years, I was delighted when the commitment to introduce a soft opt-out system was included in the SNP Government’s 2017-18 programme for government. Indeed, we could have passed a member’s bill to legislate on the issue in the previous session of Parliament. I voted for it, but the majority of colleagues deemed that it was not robust enough to prevent unintended negative consequences.

The Scottish Government has fully consulted people working in donation and transplantation to ensure that the proposed system will work not only on paper but in practice. The consultation shows that there is not only expert clinical backing for the bill, but that there is widespread public support for the principle of organ donation; that support needs to be translated into donor numbers, as there is a gap between the number of people who state that they would wish to donate organs and the number who join the organ donation register.

By creating a soft opt-out system, we can more easily capture the estimated 80 to 90 per cent of Scots who support organ donation. Unfortunately, family authorisation for organ donation in Scotland, at only 57 per cent, is the lowest in the UK. As Dr Sue Robertson, the deputy chair of the British Medical Association Scotland, said:

“if you ask people, nine in 10 will say that they would wish their organs to be donated. We are looking for that 40 per cent who have not opted in but who actually want their organs to be donated. Those are the people who we want to have that conversation with their families, because we know that they actually want their organs to be donated.”—[Official Report, Health and Sport Committee, 13 November 2018; c 14.]

On that point, I heard what Alison Johnstone said earlier about specialist nurses, and I think that what she said was important.

Of course, the bill would introduce a soft opt-out system, meaning that it incorporates safeguards and conditions that might include seeking authorisation from a person’s nearest relative in cases involving certain groups of people or certain circumstances. This is not about the wishes of family overriding the wishes of donors and, as the Minister for Public Health, Sport and Wellbeing, Joe FitzPatrick, has clarified, when the family are asked about donation,

“they will not be asked for their views; they will be asked about what they believe were the views of their deceased relative who is the potential donor.”—[Official Report, Health and Sport Committee, 27 November 2018; c 24.]

There is strong evidence to suggest that a soft opt-out system can improve levels of family authorisation, with those who live in countries with opt-out legislation being between 27 and 56 per cent more likely to authorise donation of their relatives’ organs. Indeed, that has been the case in Wales, where consent rates have risen by almost half, from 49 per cent in 2014-15 to the current level of 72 per cent.

Of course, medical suitability is key, because only 1 per cent of people die in circumstances that leave their organs suitable for medical use. Unfortunately, we cannot legislate for medical suitability of organs, so we must concentrate our efforts on areas in which we can make real change, such as increasing the number of potential donors and maximising family consent. In doing so, we will increase the pool from which medically suitable donors can be found and increase the likelihood of patients being matched with suitable donors and getting off waiting lists.

David Stewart

The member is correct about the 1 per cent figure. However, does he share my view that, if we increased the number of medical care beds, that would allow the medical circumstance in which more organs would be available for transplantation?

Kenneth Gibson

Yes, I agree. I listened with care to what Mr Stewart said earlier. The bill is not a magic bullet, and other issues must be taken into account. As has been shown in Spain, for example, increasing intensive care beds makes a big difference.

As many members said, it is vital that the bill is accompanied by a co-ordinated campaign to raise public awareness and a concerted effort to make all sections of our diverse Scottish society aware of their rights. That is a key feature of the Health and Sport Committee’s report on the bill. The committee recommends a high-profile public information campaign, including outreach sessions with minority groups and awareness raising with children, through appropriate methods. Lewis Macdonald covered that in detail. I agree whole-heartedly with that recommendation and encourage the Scottish Government to take it forward.

The bill is simply the latest step towards driving a long-term change in attitudes towards organ and tissue donation in Scotland. It is an important step, which I wish that we could have taken many years ago.

The Deputy Presiding Officer

Please close.

Kenneth Gibson

In supporting the bill, we will be voting to increase the pool of viable organ donations and to improve and indeed save the lives of people in Scotland who are waiting on an organ. We are not stripping away individual choice; we are empowering the majority of people who support organ donation but might not have had the time or knowledge to formally register.

The Deputy Presiding Officer

Please close.

Kenneth Gibson

In death, our bodies would normally give the world little, but in donation, our bodies can give life and happiness to others for many years.

The Deputy Presiding Officer

Okay. I will have to cut the final two speeches in the open debate to five and a half minutes.

16:26  



Tom Mason (North East Scotland) (Con)

The issue before us is of unmistakeable importance. Organ donation is a life-saving procedure for thousands of people every year.

More than 500 people in Scotland are waiting for a transplant, so we need to find ways to increase the pool of available donors and speed up the process of donation for more people.

With that in mind, I support the general principles of the bill and the incorporation of deemed authorisation into the current system. I think that the majority of people in Scotland will welcome proposals to create a soft opt-out system, as is confirmed by consultations by the Scottish Government, the Royal College of Nursing and the British Heart Foundation.

A fundamental reason for introducing the bill is to put in place a system that will increase the pool of donors and thus the chances of someone on the transplant list getting a suitable organ in a shorter period. In the Health and Sport Committee’s discussions on the matter, concerns were raised about the bill’s ability to deliver on that aim. However, people were by no means unanimous in taking that view. The bill should be given the chance to progress, with such concerns addressed by the introduction of measures to ensure that it achieves its stated goal.

I also hope that, at the bill’s subsequent stages, issues to do with the information that is available to the wider public about the organ donation programme will be addressed.

The Royal College of Nursing has asked for a public awareness campaign for at least a year before any change comes into effect, and the Royal College of Physicians asks for a parallel process of public education about organ donation and the infrastructure that is available to support families.

That is particularly important, given that 80 per cent of Scots support organ donation but only 52 per cent have signed up to the organ donor register. Getting people to support donation is an important first step, but it is vital to capitalise on their support and ensure that they put themselves forward and expand the number of potential donors.

The Law Society of Scotland noted that it would be extremely difficult if donations were to proceed against the wishes of the family. However, allowing families an effective veto over the previously expressed wishes of the potential donor would be contrary to the fundamental aim of the bill. At stage 2, the committee will have to consider how to balance those competing issues, to ensure that the legislation has legitimacy in the eyes of families and the wider public.

We must never lose sight of the human side of this issue and why it is so important. In 2014, one of my constituents was taken into hospital with an extreme nosebleed. He was diagnosed with high blood pressure. By the end of the year, he had been diagnosed with total renal failure. Fortunately, he was suitable for peritoneal dialysis, which involved liquid transfer treatment up to four times a day and the requirement to have about two litres of chemical fluid attached to his stomach all the time.

That is not easy to say, and that relentless regime was not easy to cope with, day after day, with no end in sight. The only escape was a kidney transplant. In October 2015, my constituent learned that a prospective organ was available, only to find out that it was not suitable.

In 2016, there was the prospect of another kidney, but that was not a successful match either. Deep clinical depression threatened, mitigated only by the dedication of my constituent’s family members. At last, at the end of 2016, a successful match was obtained, which allowed his life to get back to normal. So far, this kidney transplant has been successful, but there are signs that a viral infection is slowly destroying the kidney. Once again, donors will need to be found. For my constituent and the countless others in a similar situation, we are obliged to do all that we can to maintain a good supply of organ donors.

In 2017-18, more than 400 people across the UK died while waiting for a transplant. We have the clinical skills and expertise that are necessary; we just need to expand the pool of potential donors so that organs can be made available sooner. The public would, I think, support such a move, so let us move forward. Urgency is important, but so is getting the legislation right. It is with that in mind that I look forward to the bill receiving further consideration in committee and returning to the chamber for stage 3 in due course.

The Deputy Presiding Officer

Thank you for giving me some time back, Mr Mason. As the last of the open debate speeches, Mr Brown, you can have six minutes.

16:31  



Keith Brown (Clackmannanshire and Dunblane) (SNP)

I was about to ask whether I was allowed to donate half a minute of my time to other members, but I am grateful for getting it back.

The debate has been very good and almost entirely consensual. I am grateful to the members of the Health and Sport Committee. I was on the committee for a short time and I know that they went about their business extremely diligently, through quite a number of lengthy evidence sessions. Like other members, I was very impressed by the specialist nurses, particularly when they did a role play of family members going through the medical and social history questionnaire. Obviously, that is at a very difficult time for families, but the questions were asked professionally, thoughtfully and with kindness.

I thank donors’ families, whose evidence was about what were obviously very difficult circumstances. Even in that evidence session, there was some concern. One family member talked about the questionnaire and said that she would rather not have been part of that process. I cannot remember whether she said that she would rather that there was an opt-out, so that she would not be put in that situation, or whether the rights of the donors were evident and accepted, but she would have liked to have the process taken out of her hands.

The process is exhausting and extremely intrusive, and happens at a very difficult time. As one member said, relatives are sometimes questioned while the donor is still alive. I wonder whether there could be further scrutiny of the process. Would it be possible, for example, to ask the potential donor some of the questions, at an earlier stage? It is difficult for a son, daughter or mother to be asked about the sexual history of their relative. Could more medical tests be done on the person concerned, at that point or earlier? If we can find a way to reduce the intrusiveness of the questionnaire, that would help to increase donor figures.

There were other concerns. Some witnesses who were registered donors told the committee that if there was to be a soft opt-out, they would come off the register. They felt strongly about what they saw as a diminution of their rights if the state could go in and take organs from their body without them having taken any action to prevent it. That concern is out there and it worries me somewhat.

However, my main concern is the relatives’ discounting of the wishes of the donor, who is the central person in all this. We heard that that happens time and again. We heard of instances in which people did not want to donate and did donate. We heard of many instances in which people wanted to donate, but the family vetoed it. The family veto exists, whatever some members have said. We heard time and again about family refusals—I think that another member said that there have been about 100 cases in which somebody in full possession of their senses and who knew what they were doing took a legally competent decision to donate, but their wishes were frustrated by someone, for their own reasons, which might be understandable. That person might not even have been a close family member. That should be a real concern to us all. We can imagine somebody who might benefit from, say, the donation of a heart, and somebody who has, in all conscience, taken the decision to donate their heart, and possibly other organs, and then that wish is frustrated by family members, and the person waiting on the heart does not get it. Kenny Gibson said that every one of these cases is crucial, and if we can increase donation by one it would be a tremendous achievement.

It is also true to say that we heard a lot of evidence about the feelings and wishes of the medical staff. The convener is quite right that it was said that medical staff cannot be expected to proceed with a donation when the families are expressly against it, or words to that effect—I do not want to put words in the convener’s mouth.

I do not agree with that position. There are jurisdictions where the right of the donor to donate is what is respected. If the family members understand that well in advance—and I support all the work that has been suggested to make sure that there is a campaign so that people are much more aware of this—there should not be a family veto. The donor’s right should be respected. Of course relatives, especially in that horrible set of circumstances, will have strong feelings, but it is my view that the person who is at least at that stage in possession of the organs should have the ultimate right over them. I would be grateful if the committee could look at a number of things—I have highlighted some of them—including evidence from some of the jurisdictions where they follow that path.

There is also an issue about the age at which people can decide about donation. I think that the bill proposes that people can decide from the age of 16. That would include 16 and 17-year-olds, a situation that has no counterpart in England and Wales. That might throw up some issues in terms of donation. Organs can go across boundaries within the UK and we have not heard much about that.

Those are some of my concerns. The Health and Sport Committee has done a tremendous job and I hope that the committee and the Government will listen to those concerns as the bill progresses. At this stage, I agree that the intentions of the bill are good: it tries to achieve what we all want, which is more viable organs going to more people who need them. For that reason, as things stand and at this stage, I am willing to support the general principles of the bill.

16:36  



David Stewart (Highlands and Islands) (Lab)

This has been an excellent debate, with well-informed and thoughtful contributions from across the chamber.

As we have heard from, I think, all members, this is crucial legislation. How do we raise the level of organ donations in Scotland to match the needs of those desperately awaiting transplantation? As we have heard, tragically, 426 patients died in the UK last year while on the transplant list or within one year of removal from it.

We have heard that Scotland has the highest percentage of people on the organ donor register in the UK but the lowest actual rate of organ donation per million people. The key issue is the gap between those who wish to donate organs and the number who go on to join the organ donor register. Around 80 per cent of people support donation but only 52 per cent have signed up to the register. In simplistic terms, the purpose of the bill is to bridge the divide—to encourage those who support organ donation but have not registered to have their wishes respected.

My friend Gary is in his mid-50s and lives in Glenrothes in Fife. Nearly two years ago, he was given the gift of life by a crucially needed heart transplant. Prior to that, he was on the transplant list for 12 months and had a pacemaker. He had been slowly deteriorating, and without the transplant he would have died. When I spoke to Gary at the weekend, he said that he could not praise enough the dedicated support of the medical and nursing staff at the Golden Jubilee national hospital. He said to me, “It was a matter of life or death.”

We know that international evidence and best practice are crucial elements of the principles underpinning the bill. We know from background research by the British Heart Foundation that people living in countries with a soft opt-out are 17 to 29 per cent more willing to donate their organs.

In general terms, a soft opt-out means that unless the deceased expressed a wish in life not to be an organ donor, consent will be assumed. As we heard from a number of speakers, of the top 10 countries in terms of donors per million, nine have an opt-out system. That brings us to Spain, on which I made a couple of interventions earlier. Spain leads the world league table for organ donations, and we took evidence at the Health and Sport Committee on why Spain is successful. There are three main reasons: it has comprehensive networks of transplant co-ordinators, a donor detection programme and greater provision of intensive care beds. Even if the UK family refusal rate was reduced to a level that was similar to that in Spain—from 40 per cent to 15 per cent—the UK donation rate would still be only half of that which Spain enjoys. Could the minister comment on that in his closing speech?

We should bear it in mind that, as this is not a zero-sum game, we must also concentrate on increasing the number of intensive care beds to allow for the increased numbers of organ donation patients who will require such care.

Although Labour will support the bill, it considers that some issues will be worth further discussion, such as the position of adults with incapacity, on which we heard from Keith Brown, and the variable age of children’s capacity to consent—it is 16 in Scotland and 18 in Wales—which was referred to by many members.

There are issues regarding the rights and obligations that affect decision making on organ donation. As we have heard—this is putting matters in simple terms—the three routes to a decision are opt-in, opt-out and deemed authorisation, which is a passive form of decision. However, as the minister will know, the Law Society of Scotland and others have raised legal questions about those routes, which he might wish to consider.

First, is deemed authorisation consistent with the Supreme Court’s ruling on informed consent in the case of Montgomery v Lanarkshire Health Board? Secondly—this issue is perhaps more important and I am sure that the minister will already have information from his advisers on it—is the bill consistent with the European convention on human rights, and specifically the case of Elberte v Latvia of 2015? For members who are not familiar with that case, tragically, Mrs Elberte’s husband died in a car crash, leaving no record of his wishes on organ donation. However, his tissues were used, and the court later ruled that that was a violation of article 8 of the ECHR. As the minister will know, the bill will have to be deemed consistent with the ECHR before it can gain the Presiding Officer’s approval. What assessment has there been of whether, in practice, medical professionals will take into account the wishes of a donor’s family, irrespective of the provisions of the bill? Should the law cover that? Will transplant units have the capacity to cope with the increase in donations that I mentioned earlier?

I am conscious of the time, so I will conclude by saying that Labour supports the general principles of the bill. However, we have also highlighted areas in which its provisions could be strengthened. I agree with Andrew Tickell of Glasgow Caledonian University, who said, in response to the Scottish Government’s consultation, that

“failure to put the rights of family members and duties of doctors on a statutory footing appears even more problematic”.

Therefore, I strongly suggest that the Scottish Government looks again at the question marks around the bill’s compliance with article 8 of the European convention on human rights.

Notwithstanding that, the bill is a vital piece of legislation that will improve Scotland’s position in the international league table of organ donation and might mean the difference between life and death for the many Scots who are—like my friend Gary once was—desperately in need of life-saving organ donations. As Kahlil Gibran once said:

“You give but little when you give of your possessions. It is when you give of yourself that you truly give.”

16:42  



Brian Whittle (South Scotland) (Con)

I am pleased to have the opportunity to close the debate on behalf of the Conservatives.

As has been mentioned, the debate has been very consensual, which is hardly surprising. It has shown that we all want to increase organ and tissue donation rates. However, a number of questions have been raised.

As has been ably demonstrated by the contributions of members from across the chamber, the bill has instigated much thought and deliberation. Given its aim, which I have just mentioned, members might imagine that it will be commended by most of us, and that its passage will be straightforward and smooth. Consequently, Scottish Conservatives will support it at stage 1. However, in doing so, we must recognise the level of investigation and evidence taking that the Health and Sport Committee has undertaken and the discussion that that initiated among its members. Some issues were revealed then and have been revealed again in today’s debate.

I think that my fellow committee members would agree that in some cases, the evidence that was taken was as comprehensive as it was uncomfortable to hear. Many members, including Miles Briggs, Alison Johnstone and Alex Cole-Hamilton, have mentioned the specialist nurses and their demonstration of how they do their incredible work, in which they acted out an intervention by means of role play. None of us failed to be moved by what we heard in that session. We learned that up to 300 questions can be asked of family members in those incredibly difficult circumstances when they have just lost a loved one.

The minister highlighted that one reason why it is so important to increase organ donation is that only about 1 per cent of people meet their end in a way that means that donation is possible. Maurice Corry reminded us that people who are on an organ waiting list die while waiting for donation, so the bill is incredibly important.

Throughout the Health and Sport Committee’s consideration of the bill, Keith Brown was exercised by the rights of organ donors. He consistently raised that issue and he has done so again today. On the face of it, I agree with Mr Brown that if someone decides to donate their organs, their wishes should be paramount. However, as Miles Briggs highlighted, the wishes of the family will be taken into account and healthcare professionals will not go against those wishes. Because the family has to fill in a questionnaire before organs can be donated, if they do not want to take part in the questionnaire, that will in essence supersede the wishes of the individual. That is a conundrum. I recognise Keith Brown’s campaign to highlight the rights of the deceased, and we will continue to discuss how to get round that issue. One thing that we can do is to encourage discussion among family members long before we get to the stage of donation, so that the donor’s wishes are understood completely by the family.

Dave Stewart raised the situation in Spain and the comparison between it and Scotland. We have to be careful with that, because we are not comparing apples with apples. As he rightly said, Spain has a different system from ours, with intensive care beds in every hospital and therefore a capacity that we currently do not have. In conjunction with the bill, it is important that we consider the capacity in Scotland and how many more donors we can take. There is an idea that presumed consent is a magic bullet, but it will not necessarily increase organ donation in the way that we would like.

I have been exercised quite a lot by the fact that there is a significant difference between actual consent—a stated opt-in—and deemed consent. My view is that we should ensure that the opportunities for people to take the stated position are made widely available. Ensuring awareness of the bill is crucial. It was not until I became a member of the Health and Sport Committee that I was made aware that I was one of the 40 per cent who would donate organs but who have not consented, and it was only because I happened to move house and had to change my driving licence that I got the opportunity to sign up. It is a very simple process that takes seconds. We need to be cognisant of that and ensure that the opportunity is as available as possible.

I want to mention Mark Griffin’s and Anne McTaggart’s personal contribution to the cause. They have both been influential in bringing the debate to the stage that we are now at.

I believe that the bill in itself will not necessarily lead to an increase in organ donation. However, the scrutiny of the bill by the Health and Sport Committee and the subsequent awareness raising will create an environment in which individuals can speak about the issue and consider their situation. It is the Scottish Conservatives’ view that, along with the bill, it is essential that we have a continuing awareness-raising campaign that encourages a clear decision by the 40 per cent of the population who are yet to make their views clear.

It is said that 50 per cent of marketing works, but we are just not sure which 50 per cent. If we raise awareness and encourage people to have such conversations and take a position, and if that ultimately leads to an increase in organ donation, which could save many lives, the bill will have been worth it.

The Deputy Presiding Officer

I call Joe FitzPatrick. Nine minutes or so, minister, will take us up to decision time.

16:49  



Joe FitzPatrick

I thank members for an interesting debate on a complex and sensitive subject. There are differing views on how we get there, but I think that everyone in the chamber is of the view that we want to increase donations. The evidence suggests that there is no one solution to increasing organ and tissue donation, but I am sure that we all agree that it is important that we do what we can—and that we take the initiative to do so.

It is hoped that, over the long term, deemed authorisation will continue to change the culture around support for organ and tissue donation. I thank the Delegated Powers and Law Reform Committee, the Finance and Constitution Committee and, in particular, the Health and Sport Committee for their work in informing the Parliament’s consideration of the bill. I also add my thanks to those of other members to the many organisations that have provided briefings, which we have all found helpful.

I will use my time to pick up on as many of the issues that members raised during the debate as time permits, and I will follow up on others in writing if I do not quite get there. I thank members who raised personal experiences today, which I think is always particularly helpful. Miles Briggs talked about Millie, Mark Griffin made a very moving speech about his father and Emma Harper talked about her experience as a nurse. All those experiences are important in understanding what the bill means to so many people.

Lewis Macdonald talked about the on-going process of culture change and awareness raising around organ and tissue donation, which is important in encouraging more people to support donation. Many members have said that an opt-out system alone is not the answer to making the change; it has to be part of a package of measures—measures that we already have—in order to make a real impact.

Maurice Corry, Emma Harper and Brian Whittle talked about an important point that I think will make a big difference, which is about people making a decision but also discussing that decision with their family. I know that the progress of the bill has taken longer than some members would have liked, but I hope that the process has got more people talking about donation, and talking about it to their families, which will make the donation process easier.

Before I touch on some of the points that I need to respond to, I recognise the important point that Alex Cole-Hamilton made about living donors. I echo the praise that he and Keith Brown, and possibly others, gave to our specialist nurses, who, along with others in the donation and transplantation community, do a fantastic job.

A number of members—Miles Briggs, Alison Johnstone and Keith Brown in particular—talked about the role of families. Families will remain critical to the process in communicating the views of the potential donor and in providing information about them to ensure the safety of organs and tissue for transplantation. Families will also continue to perform an authorisation role in certain circumstances. Any potential donor’s family members would be fully involved in the process.

David Stewart

I reinforce that I support the bill, as the minister knows, but I think that there are issues around article 8 of the European convention on human rights and, in case he has forgotten, I stress again the relevance of the case of Elberte v Latvia in the European Court of Human Rights. I am sure that the minister has his lawyers working on that test case.

Joe FitzPatrick

I need to make progress, but the member raises one of the points that I was going to cover. We are content that the bill is compliant with article 8. There was a specific issue in the Elberte v Latvia case, the outcome of which turned on its own particular facts and circumstances. The issue was the quality of the Latvian organ donation legislation, which gave family members a right to object to donation but provided no mechanism for that right to be given effect to. The case involved a very different set of processes. If we have learned anything from the case, it is that we need to make it clear that the bill is about the rights and the views of the person who would be making the donation. It is an important point and we should learn lessons from other countries, but I am confident that the bill team has learned those lessons.

Keith Brown spent some time talking about his concern that there is, in effect, a family veto in some cases. I make it clear again that authorisation is for the person who makes the donation, but we need to remember that losing a loved one is always a very difficult time for families. The current system deals with the issues sensitively, and that will continue under the new system. The principle behind the proposed system, as with the current system, is to give effect to the donation decision that the person made in life, but we also need to be mindful that donation happens at a distressing time for the family, so it is right that clinicians are able to respond to that.

Sandra White talked about pre-death procedures, and we discussed with the committee whether there is a better term. However, it is important that our transplant system be transparent, and the term “pre-death procedures” describes what those procedures are about. The inclusion of those provisions in the bill means that it not only sets out a framework for carrying out the procedures that will be able to respond to change but brings transparency to the donation process by letting people know what they are agreeing to. We have made it clear that, if there are changes to the process, we will come back to the Parliament for them to be approved under the affirmative procedure.

A large number of members, including Lewis Macdonald, Alison Johnstone, Emma Harper, Kenneth Gibson and, I am sure, others, talked about the need for awareness raising, as did the committee. The Government is clear that that is an important part of taking the matter forward. Indeed, it is essential if a soft opt-out system is to work. As was set out in the consultation, the intention is to have a high-profile awareness-raising campaign over at least 12 months before the introduction of the new system and regular campaigns after implementation in order to maintain awareness. That is a crucial part of the safeguards that will underpin the system, which are aimed at ensuring that people will not become donors if that is not what they want, and that they will become donors if that is what they want. We will work with a range of groups, including disability groups and faith groups, to research, develop and test clear and accessible information, which will always be available in a range of languages.

Alex Cole-Hamilton talked about support for families, which is a very important subject. NHS National Services Scotland is reviewing the provision of psychological support across all our nationally commissioned specialist services, including organ transplantation, to ensure that appropriate provision is in place, and the Scottish Government understands that the review will be completed later this year.

Alex Cole-Hamilton

Will the minister take an intervention?

Joe FitzPatrick

I apologise, but I have to make progress in order to respect other members who took part in the debate.

Miles Briggs and David Stewart talked about infrastructure. The 2008 UK organ donation task force report considered the introduction of an opt-out system but prioritised improvements in infrastructure as it was considered that they would have the greatest impact on donation at that time. Throughout the task force’s work and the subsequent Scottish plan, we have seen significant developments around donation and transplantation infrastructure over the decade. However, I recognise—as I recognised in my response to the committee—that there is an on-going commitment to supporting measures, including infrastructure, to increase donation.

I move on to a point that was raised by Mr Rumbles in particular, and I think by Maurice Corry, too. We are satisfied that the wording in the bill is not overly burdensome, but I am happy to discuss that further with Mr Rumbles to make sure that I fully understand his point. I hope that, with officials, I will be able to allay his concerns. I offer a serious discussion to make sure that we all understand what the bill is trying to do. The approach in the bill is broadly similar to that in the legislation in Wales, and we are not aware of the issues that Mr Rumbles is concerned about arising there. As we have heard, our specialist nurses are highly skilled in having conversations with families and the provisions largely mirror the current practice around conversations exploring a loved one’s views with family members. As that is taken forward, guidance will be produced by NHSBT and the Scottish National Blood Transfusion Service, but I am keen to have that discussion with Mr Rumbles.

I acknowledge and thank the Scottish donation and transplant group, which advises the Scottish Government on donation transplantation matters, for its assistance in the development of the bill. I again pay tribute to everyone who has contributed to the debate today, everyone who has donated in the past and every family that has supported those donations. Through such selfless acts, lives are saved and improved. I hope that the bill will lead to further increases in donation to save more lives, and I offer any such progress as a tribute to all those who have donated in the past.

Members have raised several issues during the debate. I will respond in writing to members whose issues I have not managed to cover. If members want to discuss particular issues to ensure that the most robust bill goes through stage 2 and into stage 3, I will be happy to have those discussions. I thank all colleagues for taking part in what I think is a very important debate.

Financial resolution

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Financial resolution transcript

The Presiding Officer

The next item of business is consideration of S5M-15594, on the financial resolution for the Human Tissue (Authorisation) (Scotland) Bill.

Motion moved,

That the Parliament, for the purposes of any Act of the Scottish Parliament resulting from the Human Tissue (Authorisation) (Scotland) Bill, agrees to any expenditure of a kind referred to in Rule 9.12.3(b) of the Parliament’s Standing Orders arising in consequence of the Act.—[Derek Mackay]

Vote at Stage 1

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Vote at Stage 1 transcript 

The Presiding Officer

The first question is, that motion S5M-16001, in the name of Joe FitzPatrick, on the Human Tissue (Authorisation) (Scotland) Bill, be agreed to. Are we agreed?

Members: No.

The Presiding Officer

There will be a division.

For

Yousaf, Humza (Glasgow Pollok) (SNP)
Wightman, Andy (Lothian) (Green)
Whittle, Brian (South Scotland) (Con)
White, Sandra (Glasgow Kelvin) (SNP)
Wheelhouse, Paul (South Scotland) (SNP)
Wells, Annie (Glasgow) (Con)
Watt, Maureen (Aberdeen South and North Kincardine) (SNP)
Torrance, David (Kirkcaldy) (SNP)
Tomkins, Adam (Glasgow) (Con)
Todd, Maree (Highlands and Islands) (SNP)
Sturgeon, Nicola (Glasgow Southside) (SNP)
Stewart, Kevin (Aberdeen Central) (SNP)
Stewart, David (Highlands and Islands) (Lab)
Stewart, Alexander (Mid Scotland and Fife) (Con)
Stevenson, Stewart (Banffshire and Buchan Coast) (SNP)
Somerville, Shirley-Anne (Dunfermline) (SNP)
Smyth, Colin (South Scotland) (Lab)
Smith, Liz (Mid Scotland and Fife) (Con)
Simpson, Graham (Central Scotland) (Con)
Scott, John (Ayr) (Con)
Sarwar, Anas (Glasgow) (Lab)
Russell, Michael (Argyll and Bute) (SNP)
Ruskell, Mark (Mid Scotland and Fife) (Green)
Ross, Gail (Caithness, Sutherland and Ross) (SNP)
Robison, Shona (Dundee City East) (SNP)
Rennie, Willie (North East Fife) (LD)
Paterson, Gil (Clydebank and Milngavie) (SNP)
Neil, Alex (Airdrie and Shotts) (SNP)
Mountain, Edward (Highlands and Islands) (Con)
Mitchell, Margaret (Central Scotland) (Con)
McMillan, Stuart (Greenock and Inverclyde) (SNP)
McKelvie, Christina (Hamilton, Larkhall and Stonehouse) (SNP)
McKee, Ivan (Glasgow Provan) (SNP)
McDonald, Mark (Aberdeen Donside) (Ind)
McArthur, Liam (Orkney Islands) (LD)
McAlpine, Joan (South Scotland) (SNP)
Matheson, Michael (Falkirk West) (SNP)
Mason, Tom (North East Scotland) (Con)
Mason, John (Glasgow Shettleston) (SNP)
Martin, Gillian (Aberdeenshire East) (SNP)
Macpherson, Ben (Edinburgh Northern and Leith) (SNP)
Mackay, Rona (Strathkelvin and Bearsden) (SNP)
Mackay, Derek (Renfrewshire North and West) (SNP)
MacGregor, Fulton (Coatbridge and Chryston) (SNP)
Macdonald, Lewis (North East Scotland) (Lab)
MacDonald, Gordon (Edinburgh Pentlands) (SNP)
MacDonald, Angus (Falkirk East) (SNP)
Lyle, Richard (Uddingston and Bellshill) (SNP)
Lockhart, Dean (Mid Scotland and Fife) (Con)
Lochhead, Richard (Moray) (SNP)
Leonard, Richard (Central Scotland) (Lab)
Lennon, Monica (Central Scotland) (Lab)
Lamont, Johann (Glasgow) (Lab)
Kidd, Bill (Glasgow Anniesland) (SNP)
Kerr, Liam (North East Scotland) (Con)
Kelly, James (Glasgow) (Lab)
Johnstone, Alison (Lothian) (Green)
Johnson, Daniel (Edinburgh Southern) (Lab)
Hepburn, Jamie (Cumbernauld and Kilsyth) (SNP)
Harvie, Patrick (Glasgow) (Green)
Harris, Alison (Central Scotland) (Con)
Harper, Emma (South Scotland) (SNP)
Hamilton, Rachael (Ettrick, Roxburgh and Berwickshire) (Con)
Halcro Johnston, Jamie (Highlands and Islands) (Con)
Griffin, Mark (Central Scotland) (Lab)
Greer, Ross (West Scotland) (Green)
Gray, Iain (East Lothian) (Lab)
Grant, Rhoda (Highlands and Islands) (Lab)
Gougeon, Mairi (Angus North and Mearns) (SNP)
Golden, Maurice (West Scotland) (Con)
Gilruth, Jenny (Mid Fife and Glenrothes) (SNP)
Gibson, Kenneth (Cunninghame North) (SNP)
Freeman, Jeane (Carrick, Cumnock and Doon Valley) (SNP)
Fraser, Murdo (Mid Scotland and Fife) (Con)
FitzPatrick, Joe (Dundee City West) (SNP)
Finnie, John (Highlands and Islands) (Green)
Findlay, Neil (Lothian) (Lab)
Fee, Mary (West Scotland) (Lab)
Fabiani, Linda (East Kilbride) (SNP)
Ewing, Fergus (Inverness and Nairn) (SNP)
Ewing, Annabelle (Cowdenbeath) (SNP)
Dugdale, Kezia (Lothian) (Lab)
Doris, Bob (Glasgow Maryhill and Springburn) (SNP)
Dey, Graeme (Angus South) (SNP)
Denham, Ash (Edinburgh Eastern) (SNP)
Cunningham, Roseanna (Perthshire South and Kinross-shire) (SNP)
Crawford, Bruce (Stirling) (SNP)
Corry, Maurice (West Scotland) (Con)
Constance, Angela (Almond Valley) (SNP)
Cole-Hamilton, Alex (Edinburgh Western) (LD)
Coffey, Willie (Kilmarnock and Irvine Valley) (SNP)
Chapman, Peter (North East Scotland) (Con)
Carson, Finlay (Galloway and West Dumfries) (Con)
Carlaw, Jackson (Eastwood) (Con)
Campbell, Aileen (Clydesdale) (SNP)
Cameron, Donald (Highlands and Islands) (Con)
Burnett, Alexander (Aberdeenshire West) (Con)
Brown, Keith (Clackmannanshire and Dunblane) (SNP)
Briggs, Miles (Lothian) (Con)
Bowman, Bill (North East Scotland) (Con)
Ballantyne, Michelle (South Scotland) (Con)
Baker, Claire (Mid Scotland and Fife) (Lab)
Baillie, Jackie (Dumbarton) (Lab)
Arthur, Tom (Renfrewshire South) (SNP)
Allan, Alasdair (Na h-Eileanan an Iar) (SNP)
Adamson, Clare (Motherwell and Wishaw) (SNP)
Adam, George (Paisley) (SNP)

Against

Rumbles, Mike (North East Scotland) (LD)

Abstentions

Grahame, Christine (Midlothian South, Tweeddale and Lauderdale) (SNP)
Beattie, Colin (Midlothian North and Musselburgh) (SNP)

The Presiding Officer

The result of the division is: For 107, Against 1, Abstentions 2.

Motion agreed to,

That the Parliament agrees to the general principles of the Human Tissue (Authorisation) (Scotland) Bill.

The Presiding Officer

The final question is, that motion S5M-15594, in the name of Derek Mackay, on the financial resolution for the Human Tissue (Authorisation) (Scotland) Bill, be agreed to.

Motion agreed to,

That the Parliament, for the purposes of any Act of the Scottish Parliament resulting from the Human Tissue (Authorisation) (Scotland) Bill, agrees to any expenditure of a kind referred to in Rule 9.12.3(b) of the Parliament’s Standing Orders arising in consequence of the Act.

The Presiding Officer

That concludes decision time. We will take a few moments before the next item of business to allow members and ministers to change seats.

MSPs agreed that this Bill could continue

Stage 2 - Changes to detail 

MSPs can propose changes to the Bill. The changes are considered and then voted on by the committee. 

Changes to the Bill

MSPs can propose changes to a Bill  these are called 'amendments'. The changes are considered then voted on by the lead committee.

The lists of proposed changes are known as a 'marshalled list'. There's a separate list for each week that the committee is looking at proposed changes.

The 'groupings' document groups amendments together based on their subject matter. It shows the order in which the amendments will be debated by the committee and in the Chamber. This is to avoid repetition in the debates.

How is it decided whether the changes go into the Bill?

When MSPs want to make a change to a Bill, they propose an 'amendment'. This sets out the changes they want to make to a specific part of the Bill.

The group of MSPs that is examining the Bill (lead committee) votes on whether it thinks each amendment should be accepted or not.

Depending on the number of amendments, this can be done during one or more meetings.

First meeting on changes

Documents with the changes considered at this meeting:

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First meeting on changes transcript

The Convener

Item 3 is stage 2 consideration of the Human Tissue (Authorisation) (Scotland) Bill. I welcome the Minister for Public Health, Sport and Wellbeing, Joe FitzPatrick.

The Minister for Public Health, Sport and Wellbeing (Joe FitzPatrick)

Good morning.

The Convener

Good morning.

The minister is accompanied by Sharon Grant of the Scottish Government bill team; Jackie Pantony and Claire Montgomery from the Scottish Government legal directorate; and Max McGill from the parliamentary counsel office. I understand that members of the team will come and go according to the particular items that we are discussing. I also welcome Jeremy Balfour, who has lodged amendments to the bill. I believe that Gordon Lindhurst will join us later this morning to speak to amendments that he has lodged.

I will briefly explain the procedure, as this is our first consideration of the bill at stage 2.

There will be one debate on each group of amendments. I will call the member who lodged the first amendment in the group to speak to and move that amendment and to speak to all the other amendments in the group. I will then call any other members who have lodged amendments in the group. Other members may, of course, catch my eye and indicate their intention to speak to the group of amendments. If the minister has not already spoken to the group of amendments, I will invite him to contribute to the debate before I ask the member who moved the amendment to wind up. The debate on the group will be concluded by my inviting the member who moved the first amendment in the group to wind up.

Following the debate on each group, I will ask whether the member who moved the first amendment in the group wishes to press it to a vote or to withdraw it. If they wish to press it, I will put the question on the amendment.

If a member wishes to withdraw their amendment after it has been moved, they must seek the agreement of other members to do so. Any member present may object and therefore require a vote on the amendment.

If a member does not move their amendment, any other member may move it. Failing that, I will move on to the next amendment on the marshalled list.

Voting is by members of the committee only, and voting on any division is by a show of hands. If there are divisions, members should indicate their intention clearly and for long enough that their vote can be recorded.

We move directly to consideration of the bill at stage 2. If we are successful in completing stage 2 today, it would clearly be a good thing. If we are not successful in completing stage 2 today, the bill will be reprinted first thing tomorrow morning and further amendments can be lodged. However, let us press on.

Section 1 agreed to.

Section 2—Information and awareness about authorisation of transplantation and about pre-death procedures

The Convener

The first group of amendments to the bill covers information and awareness. Amendment 4, in the name of Jeremy Balfour, is grouped with amendments 56, 57, 7, 8 and 63.

Members should note that amendments 7 and 8 are direct alternatives to each other. That means that both can be decided on and, if both were agreed to, the last one that was agreed to would apply. Clearly, that is a matter for members to consider when they come to it.

Jeremy Balfour (Lothian) (Con)

Thank you, convener, and good morning to the committee and the minister. I start by saying that this is a very helpful bill, which I think has all-party support. The amendments that I will put forward this morning seek to strengthen the bill and make it work better.

The key amendment that I am putting forward is amendment 4, which relates to the issue of informed consent. I hope that a positive of the bill will be that it will kick-start a debate in Scotland on organ donation, so that families and individuals will be able to have better conversations, meaning that, when someone is dead, the family is better informed.

The evidence from Wales has been positive. Before the bill that became the Human Transplantation (Wales) Act 2013 was introduced, public awareness in Wales was fairly low. Since then, it has greatly increased, which is very positive. I am aware that the Scottish Government has committed to putting in a lot of resource when this bill becomes an act, so that there will be advertising and suchlike, including on the television. However, the question is how we keep the conversation going over the next five to 10 years. There is a danger that there will be a high take-up initially, when people understand that it is going on, but that it becomes less well known as other issues come on to our agenda and things move on.

If we are to have informed consent, it has to be genuinely informed. People who are 16 or older now will be part of the awareness campaign. However, people who are behind that group in years may not be aware of what is going on. Amendment 4 would simply commit the Scottish Government to ensuring that there is some kind of communication with people in Scotland every two years. I do not suggest that it has to be an individual letter to each person. It could work well if the communication went out with other communication, such as council tax letters or other forms, on a two-yearly basis, so that people would be aware.

The advantage of that would be that it would allow the debate to continue over the next four, five or 10 years. It would also mean that those who are turning 16 would be aware of it. It will be a number of years before those who are eight, 10 or 11 years old at the moment reach that time—will they be informed about the decisions that they are being asked to make?

I would be interested to know the views of the Scottish Government and the committee on the matter. A key part of the bill relates to informed consent, and we need to ensure that there is informed consent not only now but in the future.

As the convener said, amendments 7 and 8 are direct alternatives, which would give either a two-year or a three-year option. The amendments relate to people who come not from the United Kingdom but from Europe or other parts of the world. At the moment, there is a period of one year before a person from a different jurisdiction enters the system. Again, my concern relates to informed consent. If someone pitches up from Australia, will the issue come on to their radar within the first 12 months of their being in Scotland? I am not convinced that it will.

I accept that the Welsh have gone for a 12-month period, and I think that the legislation for England includes the same period, but we do not need to follow suit. We need to be comfortable in ourselves that there is deemed authorisation that comes from individuals giving informed consent. I suggest that a slightly longer period than one year is required for an individual to know what is going on and to be able to have the appropriate conversations with his or her relatives in other parts of the world.

I move amendment 4.

The Convener

I have lodged two amendments in the group, following discussions, particularly with the Law Society of Scotland, on the most appropriate format for addressing the issues, including those that Jeremy Balfour has raised.

Amendment 56 would ensure that the duty to promote information and awareness is continuous and that ministers should promote awareness at least on an annual basis. Amendment 63 would amend the bill to provide for a two-year information and awareness period before the commencement of the provisions in the bill. The amendments are linked, but they need not be agreed to together. They are intended to achieve the same objective: to allow for an adequate level of information and awareness in advance of the bill’s implementation.

David Stewart (Highlands and Islands) (Lab)

I thank the minister for meeting me to discuss the generalities of the amendments. Like Jeremy Balfour, the Labour Party and I are very supportive of the bill’s general principles, but there are opportunities to strengthen the bill through amendments.

Amendment 57 would add to section 3, which concerns the maintenance of the register. At stage 1, it was clear to the committee that the success of the bill in achieving an increase in the number of organ donations would rest on individuals making clear that their wishes were explicit. Therefore, amendment 57 seeks to make the process easier and more commonplace. It would place an obligation on the Scottish ministers and the maintainers of the register to consider and “promote regular opportunities” for individuals to make clear their intentions regarding the donation of their organs or to alter their stated wishes in that regard.

Proposed new section 2E(2) of the Human Tissue (Scotland) Act 2006 would require the Scottish ministers to consider how such opportunities could be made available through the existing interactions that individuals have with the national health service and other health services. Such interactions could include, but would not be exclusive to, the times when an individual registers with a general practitioner or attends clinical appointments. When individuals are asked to confirm their details by the NHS, the information should include confirmation of their wishes regarding organ donation.

Although I am sympathetic to the intention behind amendment 4 and the need to inform the public of changes that the bill will make, I believe the amendment to be too resource intensive. I am also concerned that the link to the electoral register would allow people who are not registered to fall through the gaps. There would be possible practical problems relating to people who do not wish their address to be used for purposes other than voter registration. I consider amendment 56 to be a better alternative, which satisfies the intention behind amendment 4 but which could be delivered more efficiently and does not limit the potential audience who might be reached.

Alex Cole-Hamilton (Edinburgh Western) (LD)

I welcome Jeremy Balfour to the committee and thank him for moving amendment 4. Although I support the intent of amendment 4, I agree with David Stewart that it would be resource intensive and would potentially miss out key vulnerable people in our society. Also, I think that it would be counterproductive to attach something as positive as information about organ donation to a council tax demand or similar. The amendment in the convener’s name, and annual publicity or media buy-in from the Scottish Government, might lend an air of celebration to what is and should be a very positive development in public policy.

I will not support the amendments in the name of Jeremy Balfour, but I will support the amendments from the convener and David Stewart.

10:15  



Emma Harper (South Scotland) (SNP)

Good morning, everyone. I thank Jeremy Balfour for lodging his amendments.

As I am a former liver transplant nurse who has also taken part in kidney and pancreas transplants, my input might be different from that of other members. I absolutely support the idea that we need to raise awareness about informed consent, presumed consent and opting in and out, and I am keen to ensure that we raise awareness with schools and encourage conversations to occur within families.

I agree with Alex Cole-Hamilton and David Stewart that it would be resource intensive to implement the process suggested by amendment 4. However, I would be interested to hear from the minister how we would monitor engagement, uptake and whether people were adding their names to the organ donation register. In Spain, they do not even have an organ donation register, because it has become the norm for people to donate their organs and tissue.

I am keen to support the Government’s amendments on this issue.

Miles Briggs (Lothian) (Con)

Good morning. I welcome my colleague Jeremy Balfour.

I suppose that my question is more for the minister, because it relates to the guidance that will be attached to the bill. Where is the direction of travel for public information on the bill? I completely accept the aim of amendment 4, but a letter may be limiting. What will the public information campaign be, as we move towards far more digitalisation of health information?

Sandra White (Glasgow Kelvin) (SNP)

I thank Jeremy Balfour for his amendment, but I agree with David Stewart and Alex Cole-Hamilton about the convener’s amendment. Once a year is better than once every two years.

I have some concerns about amendments 7 and 8, in the name of Jeremy Balfour. Changing the period before consent can be given from 12 months to two or three years would be concerning for people involved in organ transplants.

I wonder whether amendment 57, in the name of David Stewart, would cause extra work. I presume that people can say whether they wish their name to be on the register or taken off it, and there might be a bit of duplication there. Perhaps the minister can clarify that point, and Jeremy Balfour can clarify my points on amendments 7 and 8.

Joe FitzPatrick

Agreement to amendment 56 would mean that, as part of their duties in respect of transplantation and donation, the Scottish ministers should have a campaign of awareness raising and information at least once every calendar year.

Amendment 57 would set a duty on the Scottish ministers to promote regular opportunities for persons to make, or to review, their decision to donate or not to donate, and to consider how such opportunities can be provided when a person is receiving healthcare services. Under the Human Tissue (Scotland) Act 2006, Scottish ministers have a duty to promote information and awareness about donation for transplantation. Proposed new section 1(d) of the 2006 act—as set out in section 2 of the bill—will add to that by requiring Scottish ministers to promote information and awareness about how authorisation for transplantation may be given, including deemed authorisation. Awareness raising that is carried out in accordance with the duty will make it clear to people what their choices are, and what the implications of the new system will be.

One of the strengths of the Human Tissue (Scotland) Act 2006 has been the duty on Scottish ministers to promote awareness and information about donation. As a result of the importance that has been placed on that by successive Administrations, and of the evidence-based approach to awareness raising, efforts to fulfil the duty have resulted in high public awareness of donation, which is demonstrated by year-on-year increases in people recording their decisions on the organ donation register.

The duty is fulfilled in a range of ways—from specific initiatives being targeted at various groups of the population, to high-profile media campaigns. Awareness raising is on-going and includes promotion at public sporting or entertainment events, and information being provided in general practitioner surgeries, pharmacies and other public places, which is similar to what David Stewart calls for in amendment 57. In addition, information is given through various media activities, including on social media, that happen regularly throughout the year. We will build on that as we raise awareness about the opt-out system.

As well as broad awareness raising, it is crucial that we undertake work to reach specific groups. We are committed to working with different groups including disability and faith groups, and to research, develop and test clear and accessible information, which will be available in a range of languages. I know that the committee has made a number of helpful suggestions in that regard.

We are also committed to learning from Wales about its engagement strategy—in particular, regarding reaching minority groups. Officials are also in regular dialogue with English counterparts about developments there. We will continue to work with Kidney Research UK, which will provide updated training for peer educators in order to raise awareness of donation among south Asian communities.

Specific work will target young people—I think that that point was made by Jeremy Balfour. We will update the secondary schools education pack; as we did previously, we will work with Education Scotland to do that. We are also looking to identify ways to inform young people of the law shortly before they reach their 16th birthday, and to continue to keep them informed on an on-going basis. The bill’s financial memorandum takes that into account.

Our intention, which is backed up by the new duty in section 2, is that regular awareness raising about the opt-out system will be a priority, so opportunities will continue to be taken to promote information and understanding of the opt-out system and the choices under it. That will be supported by monitoring of changes in public attitudes—which was mentioned by Emma Harper—and awareness, as part of the planned evaluation of the opt-out system, which means that we can be responsive, if there is a need to adopt that approach.

I support the principles of amendment 56 to have an awareness and information campaign at least once every calendar year, so I am happy to recommend that it be agreed to. However, given the crossover between the provisions in the bill and the amendment, I think that it would be preferable to refine the text at stage 3. I will be happy to work with Lewis Macdonald before stage 3 in order to achieve that.

I thank David Stewart for lodging amendment 57. I hope that I have been able to provide reassurance about our continuing commitment to use every opportunity to raise awareness—in particular, about the new system. I consider that the duties in the bill and on-going practice already meet the intentions of the amendment, so I ask him not to move amendment 57.

In light of the fact that I hope to have discussions with the convener in relation to amendment 56, I will also be happy to meet David Stewart, to ensure that any refinement of the text takes into account his points and anything that is missed by the committee not passing amendment 57.

Amendment 4 would require Scottish ministers to send information at least once in every two-year period to persons who are registered on the electoral roll. In light of the intended awareness raising and the general approach that I have outlined, although I appreciate the aim of the amendment, I consider it to be too limiting. Even if the law allowed access to the electoral register for that purpose—I understand that it does not—the information would not reach people who had decided not to include their details on the electoral roll, as has been mentioned.

In addition, the proposal in amendment 4 would have a high cost—estimated, at current rates, at about £2.5 million every two years—and would have the effect of reducing the ability of the Scottish ministers to raise awareness in other ways. The awareness-raising work that we undertake is based on evidence of what works best. I do not want inadvertently to limit us by being required to use specific awareness-raising methods that might not be the most effective ones. I reassure Mr Balfour that, as well as the awareness-raising methods that I outlined, there will be a direct mailing to all households within a 12-month period, which will mean that even those who are not on the electoral roll will have access to the information. That is accounted for in the financial memorandum. On that basis, I ask Jeremy Balfour to consider seeking to withdraw amendment 4.

Amendments 7 and 8 are direct alternatives that would increase to two or three years the time that a person need ordinarily be resident in Scotland before deemed authorisation for transplantation would apply. I appreciate that Mr Balfour is concerned that people who are newly resident in Scotland might be subject to deemed authorisation when they are not aware of the system. When developing the bill, a key consideration was the need for the protection of certain groups of people who might not be aware of or understand “deemed authorisation”. The “ordinarily resident” requirement is part of those protections, and the required duration of 12 months is in line with the legislation in Wales and England, as Mr Balfour said.

Establishment of what length of time spent living in Scotland is sufficient before deemed authorisation will apply requires that a balance be struck. Mr Balfour’s amendments 7 and 8 seek to lengthen the period to either two or three years. The proposal in the Transplantation (Authorisation of Removal of Organs etc) (Scotland) Bill, which was introduced by Anne McTaggart in the previous parliamentary session, was six months. The Health and Sport Committee at that time considered that to be an insufficient period and recommended that it be increased to 12 months. I appreciate and accept that there are differing views on what is appropriate, but I am not persuaded that the duration should be increased from 12 months. A 12-month residency requirement has been in place in Wales since 2015 and we are not aware that difficulties have arisen from the approach there.

Additionally, the bill contains safeguards that aim to ensure that donation does not proceed when that would be against the potential donor’s wishes. The safeguards include awareness-raising duties to ensure that there is public awareness of the implications of the new system, and of the duty to inquire, which applies in all cases and seeks to ensure that the views of the potential donor will establish whether donation is authorised. I hope that the information on awareness raising that I have already outlined provides assurance on that point.

For people who are newly resident, we are looking at what has been undertaken in Wales, which uses various channels for awareness raising, including new GP registrations, universities, estate agents and major employers. Such activity would supplement the broader on-going awareness-raising campaign.

I hope that that provides reassurance that the system will include sufficient safeguards alongside the awareness-raising work and that, therefore, the requirement for residency of a duration of 12 months should be retained. On that basis, I ask Mr Balfour not to move amendments 7 and 8. If they are moved, I urge members to resist them.

Finally, amendment 63 would prevent the opt-out system from being implemented before a two-year awareness-raising period has passed, which would begin from royal assent. We have always been clear that there needs to be a high-profile public information campaign over at least 12 months before commencement of the system, so I was pleased that the committee welcomed that commitment in its stage 1 report. The approach was also proposed in the Scottish Government’s consultation, and attracted significant support.

I understand that there is in the Welsh legislation a similar requirement to what is proposed in amendment 63. However, there has been more exposure of the opt-out system since then. There have been many conversations in Scotland over the past few years about the introduction of opt-out, including in this Parliament. Most recently, an awareness-raising campaign, which will run for 12 months, was embarked on in England.

I reassure members that, although we have committed to an awareness-raising campaign of at least 12 months before the introduction of the opt-out, that is not limiting. I am grateful to Lewis Macdonald for taking the time to discuss his amendment 63 with me, and I am happy to give the assurance that, in addition to the 12-month campaign, we intend to provide information about the move to the new system in a variety of ways, which will start as soon as the bill receives royal assent.

As I said, I am pleased that the committee welcomes the Government commitment to having a high-profile awareness-raising campaign. I am satisfied that the awareness-raising duties in the bill, along with the commitments that the Scottish Government has made, including to raise awareness over a period of at least 12 months, support the bill’s aims and will ensure that people are aware of the new system and their choices within it.

Although I agree that awareness raising is needed, I hope that members will agree with me that the balance is right, given the additional assurances that I have given today, so I ask Lewis Macdonald not to move amendment 63. If he moves it, I ask that members reject it.

10:30  



The Convener

Thank you, minister. I ask Jeremy Balfour to wind up and to press or seek to withdraw his amendment 4.

Jeremy Balfour

I thank members for the helpful debate that we have had. The comments by the minister were particularly helpful. I offer a slight caveat to the minister’s view: I am not sure that the public are as aware as he suggested, so that needs work.

Agreement to amendment 65 would achieve more than I sought to do, so I am willing to seek to withdraw amendment 4, and I ask the committee to support amendment 56 and to make the commitment it contains. I will not move either amendment 7 or amendment 8. However, I ask the minister to find out what particular information is given, when they visit a GP, to people who arrive in the country from abroad. Most people will probably register with a GP within a year of arrival, so it would be of some comfort if they could be given an appropriate letter or information when they do.

I also ask the minister to reflect, before we get to stage 3, on whether a letter could go to every 16-year-old, as part of a pack that they get when they leave school. That would not add any extra cost and might start the debate within school, as well as beyond it.

With your permission, convener, I seek to withdraw amendment 4, and will not move amendments 7 and 8.

The Convener

We will come back to amendments 7 and 8 in due course.

Amendment 4, by agreement, withdrawn.

Amendment 56 moved—[Lewis Macdonald]—and agreed to.

Section 2, as amended, agreed to.

Section 3—Establishment and maintenance of register

The Convener

The next group is on excepted body parts. Amendment 5, in the name of Jeremy Balfour, is grouped with amendment 6, amendments 9 to 17 and amendments 19 to 23.

I call Jeremy Balfour to move amendment 5 and speak to all the amendments in the group.

Jeremy Balfour

Amendment 5 would ensure that tissue is not used to create reproductive cells in research. It highlights the fact that while everyone believes that the bill is talking about organ transfers, which we are obviously all very keen to see, there is also the matter of tissue and how it could be used. I am open to the minister’s comments on the matter, but my understanding is that currently the bill would allow different body tissue to be taken and used for research into reproductive cells, artificial sperm or eggs, or the creation of human embryos. That goes beyond what most people understand the bill to contain, and there is an ethical difference between working on those types of tissue and a kidney or heart transplant, for example. What is the minister’s understanding of the intention of the bill? Do the Government, and this committee, believe that, ethically, that is the direction that we want to move in?

The other amendments in the group all deal with the difference between non-exempt body parts and exempt body parts. My understanding is that such terminology is not found in any of the other acts in Wales or the rest of the world. Again, I hope for a correction of that distinction. There should be no difference between excepted and non-excepted body parts.

As far as I am concerned, we should be encouraging people to use all parts of their body for transplantation. Again, I want to understand where the Government is coming from by drawing up these two different lists. As I understand it, that is not what happens in Wales, and I am interested to know why the Government thinks that it should happen in Scotland.

I move amendment 5.

Emma Harper

I am interested in this, because from discussions that we have had, it seems that the issue is transplantation of not just solid organs but tissue. It is quite common for tissue such as tendons and heart valves to be transplanted, but there are people who can freak out when face transplants and so on are mentioned. That sort of thing does not really happen in this country, but research and development of that kind continue to happen, and I am aware that other types of organ transplants are being trialled such as uterus transplants in Wales. For me, there are issues around pancreas transplants and obtaining islet cells.

We must give people time to engage with and come to an understanding of what is meant by organ and tissue. Most folk understand about common transplants of solid organs such as hearts, lungs, livers and kidneys, but the distinction that is being made here is, I think, warranted to ensure that we do not restrict the transplantation of other tissue and that we do not end up with people not opting in because they are afraid of what meaning of tissue might be applied to them or their families.

The Convener

As no one else wishes to contribute, I invite the minister to respond to this group of amendments.

Joe FitzPatrick

The amendments would remove a protection from the bill. The bill as introduced includes an exemption to ensure that deemed authorisation does not apply to excepted body parts and includes provision for regulations to be made to specify what is included in the excepted body parts category. Those regulations will be subject to affirmative procedure as well as to consultation.

The intention, as outlined in the Scottish Government’s consultation, is for deemed authorisation to apply only to those organs and tissues that are commonly transplanted. They are, in other words, the organs and tissues that most people might commonly understand as being able to be donated and include the kidney, heart, lungs and liver. The intention is for body parts aside from those commonly transplanted ones—in other words, the excepted body parts—to be listed in regulations and, as a result, to be exempt from deemed authorisation. That approach has been taken elsewhere; indeed, there are regulations as part of the Welsh legislation that set out that list. As well as that exemption, deemed authorisation will apply only to transplantation, not to research—again, that comes back to a point that Mr Balfour made—and no body parts can be used for research purposes without explicit authorisation.

Amendments 9 and 10 seek to remove the category of excepted body parts and instead set out protections only for parts of the body that contain “reproductive cells” or which are

“to be used for reproductive purposes”.

The effect would be that those parts of the body that it is intended would be excepted could be removed and transplanted under deemed authorisation.

I point out to Mr Balfour that I am very much a supporter of organ donation and, indeed, have opted in to make it clear that I am content for all of my body parts to be used after my death, if I die in such circumstances that they can be used. However, the bill does not assume that that would be covered by deemed authorisation, if the organ in question is not one of those accepted as commonly transplanted. There is a slight difference in that respect, and I think that it highlights how the organ donor register remains important in this legislation.

As I have said, there is a list in Wales, and it includes body parts such as the face and hands. I do not think that it is commonly understood by the public that such parts of the body would be donated and transplanted, and it is appropriate that we provide safeguards to make the limitations of deemed authorisation clear to the public.

I understand Mr Balfour’s concerns with regard to reproductive cells and body parts to which deemed authorisation for transplantation does not apply. As I have said, the Government’s intention is to ensure that only material that the public commonly understand to be routinely donated should be part of deemed authorisation, and I do not think that the material that the amendments relate to would fall within that. The list in Wales includes the types of material that the amendments relate to, such as the ovaries, uterus, penis and testicles. Subject to consultation and the Parliament’s view, it is expected that the list of excepted body parts here will be very similar.

I suggest that the excepted body parts regulations are the vehicle to limit the parameters of what can be donated under deemed authorisation. On that basis, I urge Jeremy Balfour to withdraw amendment 5 and not to move the other amendments in the group.

Mr Balfour asked how reproductive cells will be covered under the bill. The procurement, storage and use of gametes, or reproductive cells, are dealt with under the Human Fertilisation and Embryology Act 1990 and require a Human Fertilisation and Embryology Authority licence. That is completely separate from the 2006 act and the bill.

The Convener

I ask Jeremy Balfour to wind up and say whether he wishes to press or to seek to withdraw amendment 5.

Jeremy Balfour

I have nothing to add, convener. I seek to withdraw amendment 5.

Amendment 5, by agreement, withdrawn.

The Convener

The next group relates to the establishment and maintenance of the register. Amendment 24, in the name of the minister, is grouped with amendments 25 to 33.

Joe FitzPatrick

I have lodged amendments 24 to 33 following further consideration of how the provisions of section 3 on disclosure of information by the register organisation will work in practice. The amendments aim to reflect more accurately whom information needs to be shared with; to clarify that the information that is disclosed must be about a particular potential donor; and to refine the purposes for which information can be shared.

Proposed new section 2C(1)(a) of the 2006 act, as will be inserted by amendment 25, will restrict the powers of the register organisation to disclose information within Scotland to those carrying out functions under part 1 of the 2006 act. New section 2C(1)(b), which is also set out in amendment 25, provides a power for the register organisation to disclose information to persons outwith Scotland who are carrying out functions related to the removal and use of parts of the body for transplantation. The power to disclose information outwith Scotland reflects the collaborative arrangements with which donation and transplantation services operate. New section 2C(1)(a) will allow information to be shared within Scotland by the register organisation with those listed under section 2C(2) for particular purposes but no longer directly with relatives of donors.

In practice, there is a need for the register organisation to disclose information only to specific persons who are engaged in functions related to the removal and use of a part of the body for transplantation. Therefore, amendment 27 reflects that by replacing the existing reference to health boards and so on with a reference to those persons.

Amendment 26 makes it clear that the register organisation’s power to disclose information includes the power to disclose that there is no recorded information on the register. Within Scotland, that will support those undertaking the duty to inquire and will, for example, allow specialist nurses to have conversations with the family about the views of the donor.

Amendments 28 and 29 have the effect that those who are listed in section 2C(2) can disclose information that they receive from the register organisation to another person carrying out transplantation functions under part 1 of the 2006 act as well as to relatives of the donor. In practice, that will, for example, allow a specialist nurse for organ donation to share information with a retrieval surgeon that an authorisation for donation is in place so that, among other things, the retrieval surgeon can be satisfied that the requirements in section 11 of the 2006 act are fulfilled before retrieval takes place.

Amendments 30 to 33 are consequential.

I move amendment 24.

Amendment 24 agreed to.

Amendments 25 to 33 moved—[Joe FitzPatrick]—and agreed to.

Amendment 57 moved—[David Stewart].

The Convener

The question is, that amendment 57 be agreed to. Are we agreed?

Members: No.

The Convener

There will be a division.

For

Whittle, Brian (South Scotland) (Con)
Stewart, David (Highlands and Islands) (Lab)
Macdonald, Lewis (North East Scotland) (Lab)
Cole-Hamilton, Alex (Edinburgh Western) (LD)
Briggs, Miles (Lothian) (Con)

Against

White, Sandra (Glasgow Kelvin) (SNP)
Torrance, David (Kirkcaldy) (SNP)
Harper, Emma (South Scotland) (SNP)
Adam, George (Paisley) (SNP)

The Convener

The result of the division is: For 5, Against 4, Abstentions 0.

Amendment 57 agreed to.

Section 3, as amended, agreed to.

Section 4 agreed to.

Section 5—Express authorisation by adult

10:45  



The Convener

The next group is on how authorisation, declaration or withdrawal is to be made. Amendment 34, in the name of the minister, is grouped with amendments 36, 40 and 42.

Joe FitzPatrick

I will speak to all the amendments in the group. They seek to enable a person to verbally withdraw a decision that they have given to the register organisation. At present, in Scotland, a person can withdraw their donation decision only in writing. When contacting the organ donor register helpline to withdraw a donation decision, individuals in Scotland are advised that it can be done only in writing, either by changing their decision online on the organ donor register, or by writing to the organ donor register requesting the change.

Amendments 34, 36, 40 and 42 will provide flexibility as to how a person can withdraw a previously recorded decision from the register and bring Scotland into line with practice in the rest of the United Kingdom. NHS Blood and Transplant has welcomed the fact that the amendments will mean that callers from Scotland to the organ donor register helpline will not require to be directed away from the call centre to withdraw decisions online or separately in writing. As a matter of good practice, any withdrawal of a recorded decision is followed up by the organ donor register in writing, as confirmation.

I move amendment 34.

The Convener

Thank you. I invite other members to comment.

Miles Briggs

I seek clarity about how a verbal withdrawal will be logged or recorded. Can the minister provide more information on the procedure for someone to verbally withdraw consent?

The Convener

The minister may respond now, or once we have heard from other members, if any of them wish to comment.

Sandra White

I have a small comment on an issue that I raised during the debate on amendment 57, which I thought duplicated this. It is important that people have the opportunity to say whether they wish to continue and amendment 34 fills that gap, so I support it.

The Convener

I concur that it will be a useful improvement to the bill. I am interested to hear the minister’s comments as he winds up.

Joe FitzPatrick

To respond to Mr Briggs’s point, the change will bring us in line with practice in the rest of the UK. I understand that the procedure there is for a person to telephone the ODR, which then verifies their ID and follows up the call in writing. The ODR holds the register for the whole of the UK, but currently it has the two different systems—one for the rest of the UK and one for people from Scotland, who are diverted away to do things differently. The amendments will mean that there will be one system for the whole of the UK.

The Convener

Have there been issues with the different methods in use under the current legislation, or is the change a precaution against a possible issue arising in the future?

Joe FitzPatrick

I am told that NHS Blood and Transplant will be very pleased if the amendment is agreed to. Currently, if someone from Scotland telephones to say that they have decided to change their registered view to opt in or out, they are turned away, and members of the public are often not happy when they are told that they cannot do what everybody else can.

Amendment 34 agreed to.

The Convener

The next group is on the standard of evidence. Amendment 35, in the name of the minister, is grouped with amendments 37, 58, 59, 38, 60, 61, 39, 41 and 43.

Joe FitzPatrick

I note Mr Rumbles’s interest in the standard of evidence. When we met to discuss the amendments that he intended to lodge on that point, we found that we shared the aim of ensuring that authorisation for transplantation is not deemed when it would be against the potential donor’s wishes. Safeguards that are included in the bill aim to achieve that.

The Government agreed to look further at whether we could amend the test that is in the bill, in order to address Mr Rumbles’s concerns. Amendment 38 will amend the test; I am pleased that we have reached agreement and I am grateful that, on that basis, Mr Rumbles will not lodge amendments.

Amendment 38 relates to the test to displace deemed authorisation for transplantation. The amendment will ensure that a person must provide evidence to a health worker that would

“lead a reasonable person to conclude”

that the potential donor would have been unwilling to donate. That evidence will be about the potential donor’s most recent view. The revised test will also apply in establishing whether a potential donor would have been unwilling to donate in the circumstances—perhaps because, in the particular circumstances of death, donation would be incompatible with their faith.

The formulation that evidence would

“lead a reasonable person to conclude”

will apply instead of the existing threshold in the bill, which requires evidence that

“would convince a reasonable person”.

When we met, Mr Rumbles expressed concern about the word “convince”, and I am glad to address his concern. The change to the word “conclude” rather than “convince” is also in line with the wording in legislation in England and Wales.

As a consequence of amendment 38, amendments 35, 41, 37 and 43 will replicate the test that evidence would

“lead a reasonable person to conclude”

when an adult or a child who is aged 12 or over has expressed authority for or opted out of donation. That will change the test for the evidence that is required to show that a potential donor had changed their previous decision or to show that, in the circumstances, they would have changed their mind if they were capable of doing so. The test will be replicated in those contexts to reflect the intention that deemed authorisation should have equal status with other decisions and to avoid operational confusion from the application of different tests in different scenarios.

I reassure the committee that, as with the previous test, the new test is designed to enable in all circumstances evidence about a potential donor’s views to be provided and to enable their views to determine whether donation is authorised. The test is robust enough to ensure that donation will proceed only when it would not have been against a potential donor’s wishes, and the test has been designed with the kind of decisions that take place with families by the bedside in mind.

Operationally, evidence will most frequently come from a family telling a specialist nurse for organ donation or tissue donor co-ordinator about conversations that they had had about donation and the views that their loved one had expressed. However, the test is flexible enough to enable any evidence to be provided.

In addition to the test to establish views on donation, a revised test will apply to establishing incapacity. Amendment 39 will amend the

“example of when an adult is to be considered ‘incapable of understanding the nature and consequences of deemed authorisation’”

in proposed new section 6D(4) of the 2006 act. Under new section 6D(2)(b), deemed authorisation will not apply when someone is considered to be so incapable. In practice, a specialist nurse or tissue donor co-ordinator will seek to establish whether a potential donor had the capacity to understand deemed authorisation. Staff who have been caring for a patient are likely to be aware of whether they lacked capacity, but a potential donor’s family member could also provide evidence of incapacity.

Although evidence is not required to establish incapacity, the example in the bill will make it clear that, when evidence is presented, it should

“lead a reasonable person to conclude”

that the potential donor was incapable of understanding the nature and consequences of authorisation.

A great deal of consideration has been given to the tests that are set out in the bill to ensure both that information can be submitted to respect a potential donor’s wishes and that there are sufficient safeguards for those who are incapable of understanding the nature and consequences of deemed authorisation. I confirm that NHSBT and the Scottish National Blood Transfusion Service were consulted and are content with the bill’s approach to those issues and with the associated amendments. I accordingly ask members to support them.

I turn to amendments 58 to 61, which I am unable to support because they undermine the very principle of an opt-out system. Authorisation for donation for transplantation is able to be deemed in the context of the Scottish ministers’ duties to raise awareness about the new system. If an adult is made aware of how the system operates, and such operation is by means of deemed authorisation, we consider it reasonable to assume that they are willing to donate unless they opt out. We recognise that that assumption may be displaced in ways other than by opt-out declaration. If a person’s most recent view is that they are unwilling to donate, that should also be given effect. That is the reason for the safeguards in the bill, which ensure that evidence about an adult’s latest views can be submitted.

Importantly, the bill provides that evidence of an adult’s unwillingness to donate can be submitted by a wide range of people, to ensure that relevant information is not excluded from consideration. However, amendment 59 restricts the provision of evidence to the adult’s nearest relative, which reduces the likelihood that relevant information will be produced. Taken together, the amendments would mean that deemed authorisation would apply only if a person’s nearest relative provides evidence that that person is willing to donate. It destroys the basis on which deemed authorisation operates, because there is no assumption of willingness; instead, willingness must be demonstrated by the nearest relative.

Crucially, amendments 58 to 61 could risk the progress that we have seen happen under the 2006 act. Currently, under section 7 of the 2006 act, which would be repealed by the bill, if an adult has not authorised donation, their nearest relative may authorise it upon their death, unless that relative has actual knowledge that the adult was unwilling to donate, which is the opposite test to what the amendments propose. Part of the reason for introducing an opt-out system is that we know that many more people support donation than register their willingness to donate. That is why we want to move to a system of deemed authorisation, which makes donation the default position.

The Scottish Government hopes that the provisions relating to deemed authorisation, together with raising awareness of the new system, will contribute towards the on-going improvements that we have seen in donation rates. However, amendments 58 to 61 would damage that progress and undermine the efforts of those who are working in the system to increase donation. I therefore urge members to resist them.

I move amendment 35.

The Convener

I welcome Gordon Lindhurst to the meeting and invite him to speak to amendment 58 and other amendments in the group.

Gordon Lindhurst (Lothian) (Con)

I have heard what the minister has had to say on amendments 58 to 61. Nevertheless, I would like to set out the reasoning behind them.

Amendments 58 to 61 relate to the formulation of the consent principle. Rather than that principle being expressed in a negative way—or, indeed, as a double negative, as it is set out in the bill—the amendments seek to express it in a positive way. That is in keeping with modern best practice, as is set out in the European convention on human rights and biomedicine, which is numbered 164 in the European treaty series; and its additional protocol concerning transplantation of organs and tissues of human origin, which is numbered 186. The simplest way to illustrate the point is to consider one of the most up-to-date European regulations: the general data protection regulation, which requires conscious affirmative consent to be given in relation to personal data, rather than the previously allowed passive consent.

As amendment 58 is a probing amendment, it has been drafted in relation to only one section. If it were to be agreed to, further amendments would be lodged at stage 3 in relation to the wording that is intended to be amended where appropriate in the rest of the bill.

Mike Rumbles (North East Scotland) (LD)

This set of amendments from the minister is all about the potential donor’s wishes and the safeguards that are in the bill to ensure that they are carried out.

I was pleased to withdraw on Friday the amendments that I had lodged, because we reached agreement with the minister on this point. We both want to do the right thing.

My background is that I have been on the organ donor register for the past 20 years. A campaign on the issue was the first that I was involved in after being elected to the Scottish Parliament. I was on a previous Health Committee that spent many months taking the Human Tissue (Scotland) Act 2006 through—the convener was the minister at the time.

11:00  



I support this bill, except for the phrase

“convince a reasonable person”,

which is a particular standard of law that is used in many bills. I think that the legal team may have put the phrase in the bill. Amendment 38 is key, with the minister’s other amendments setting the rest of the bill as a result of amendment 38.

I voted against the bill at stage 1 because I was worried that the word “convince” was unintentionally putting in a barrier to the success of the bill—when I met the minister, it was clear that it was unintentional—and that there might be a problem further down the line.

The minister’s amendment uses the phrase,

“lead a reasonable person to conclude”,

and I am pleased that the minister listened to and accepted the arguments. We all want to achieve the right thing with the bill. I hope that the committee will unanimously support the minister’s amendments in the group.

The Convener

A reasonable person would conclude that Mr Rumbles supports the amendments. [Laughter.] As no other members wish to comment on the amendments in this group, I ask the minister to wind up.

Joe FitzPatrick

The principle behind the bill is to respect the primacy of the views of the potential donor. Safeguards are in the bill to ensure that it is the donor’s view that establishes whether donation is authorised.

Against the backdrop of the move to a soft opt-out system and the awareness raising that will take place, it is entirely appropriate to set the default in favour of donation when an adult has not opted out. The safeguards in place are a check to make sure that donation would not go ahead against the donor’s wishes. That is the appropriate balance, and the Government’s amendments have sought to address concerns about that. I urge members to support amendments 35, 37 to 39, 41 and 43 and to resist amendments 58 to 61.

Amendment 35 agreed to.

Section 5, as amended, agreed to.

Section 6—Opt-out declaration by adult

Amendments 36 and 37 moved—[Joe FitzPatrick]—and agreed to.

Amendment 6 not moved.

Section 6, as amended, agreed to.

Section 7—Deemed authorisation for transplantation as respects adult

Amendments 7 to 11 not moved.

The Convener

I call Gordon Lindhurst’s amendment 58, which has already been debated with amendment 35. Do you wish to move your amendments?

Gordon Lindhurst

I am not sure that the minister has responded to my point, but I will not move the amendments.

Amendments 58 and 59 not moved.

Amendment 38 moved—[Joe FitzPatrick]—and agreed to.

Amendments 60 and 61 not moved.

Amendment 39 moved—[Joe FitzPatrick]—and agreed to.

Amendment 12 not moved.

Section 7, as amended, agreed to.

Sections 8 and 9 agreed to.

Section 10—Excepted body parts: authorisation for transplantation by nearest relative

Amendment 13 not moved.

Section 10 agreed to.

Section 11 agreed to.

Section 12—Authorisation by child 12 years of age or over

Amendments 40 and 41 moved—[Joe FitzPatrick]—and agreed to.

Section 12, as amended, agreed to.

Section 13—Opt-out declaration by child 12 years of age or over

Amendments 42 and 43 moved—[Joe FitzPatrick]—and agreed to.

Section 13, as amended, agreed to.

Sections 14 to 20 agreed to.

Section 21—Removal of part of body of deceased person: further requirements

The Convener

We move to the next group. Amendment 44, in the name of the minister, is grouped with amendments 45 to 49.

Joe FitzPatrick

I lodged amendments 44 to 49 following an approach from the Scottish National Blood Transfusion Service, which is responsible for tissue retrieval. SNBTS is seeking the opportunity to amend section 21, which amends section 11 of the Human Tissue (Scotland) Act 2006 and concerns the requirements that must be satisfied before retrieval takes place.

The amendments in the group are intended to amend sections 11(1) to 11(4) of the 2006 act, to clarify the role of the registered medical practitioner in cases in which another person has been authorised to retrieve tissue. The amendments will allow SNBTS to operate more effectively and to be responsive to practice development.

Section 11(1) of the 2006 act provides that removal of a body part for transplantation must be undertaken by a “registered medical practitioner” or someone who is

“authorised to do so in accordance with regulations”.

Regulations can provide that a registered medical practitioner may authorise removal by a non-practitioner; current regulations provide that a registered medical practitioner may authorise any person, provided that they are satisfied that the person who will undertake retrieval is sufficiently qualified and trained to perform the operation competently.

Amendments 44 and 45 and 47 to 49 will amend section 11 to make it clear that the body parts of a deceased person may be removed by a person who is authorised to do so under a general authorisation made in accordance with regulations, and to enable the regulations to make provision for general authorisations for a “description of person”.

Amendment 44 will also remove section 11(3)(b) from the 2006 act, which implies that authorisation must be given in individual cases, to ensure that only the person who proposes to remove the body parts is required to be satisfied that the requirements of section 11(4) are met.

Amendment 46 will amend section 11(4)(a) of the 2006 act so that where the person who proposes to remove a body part from a donor is a registered medical practitioner, that person may examine the donor’s body to confirm that the donor is deceased or satisfy themselves that another registered medical practitioner has examined the donor’s body to confirm that the donor is deceased.

Amendment 46 will also add new paragraph (ab) to section 11(4) of the 2006 act so that where the person who proposes to remove a body part from a donor is not a registered medical practitioner, that person must satisfy themselves that a registered medical practitioner has examined the donor’s body to confirm that the donor is deceased.

I ask the committee to agree to amendments 44 to 49, which will allow the SNBTS to continue to respond effectively to increases in tissue retrieval.

I move amendment 44.

Sandra White

I fully support the minister, but I would like clarification on amendment 46. It says:

“if the person is not a registered medical practitioner, that a registered medical practitioner, by personal examination of the body, is satisfied that life is extinct”.

The person in question does not have to be a registered medical practitioner. I presume that the body would be examined first, and there would be paper authorisation from a registered medical practitioner. I would like a wee bit of clarification on amendment 46.

Joe FitzPatrick

The point that I made was that the person who is removing the organ needs to be satisfied that a registered medical practitioner has examined the donor’s body to confirm that the donor is deceased. That could happen in the hospital, for example. It is about confirming that that will be done and ensuring that the bill works in practice.

Sandra White

That satisfies me. Thank you for the clarification.

Amendment 44 agreed to.

Amendments 45 and 46 moved—[Joe FitzPatrick]—and agreed to.

Amendment 14 not moved.

Amendments 47 and 48 moved—[Joe FitzPatrick]—and agreed to.

Amendment 15 not moved.

Amendment 49 moved—[Joe FitzPatrick]—and agreed to.

Amendment 16 not moved.

Section 21, as amended, agreed to.

Section 22—Pre-death procedures relating to transplantation

The Convener

The next group of amendments is on pre-death procedures relating to transplantation. Amendment 50, in the name of the minister, is grouped with amendments 51 and 18.

Joe FitzPatrick

Amendments 50 and 51 will make minor amendments to the provisions in the bill relating to pre-death procedures. They are aimed at ensuring that the provisions will work effectively when they are applied in practice.

The provisions in the bill that support the carrying out of pre-death procedures are robust and provide a clear legal framework by specifying the circumstances in which they may be carried out and in which they may be authorised. Transparency is important to that, and amendment 50 will enable the procedures that may be specified as “Type A” to be described more accurately by making it clear that they may also be described by reference to how they are carried out. The ability to specify the procedures in regulations will also ensure that the statutory framework is responsive to changes in practice and particularly to developments in medical practice and care. The minor change that amendment 50 will introduce to the enabling power will further enhance that.

11:15  



Amendment 51 also seeks to make it clearer how the system is intended to work in practice. As the committee is aware, pre-death procedures are not new; those that are currently carried out include taking blood and X-rays, and it is not intended that, for example, a radiographer who is asked to take an X-ray will have to be involved in the authorisation process or to carry out the duty to inquire. Amendment 51 makes that clear, while also retaining the important safeguards in the bill, including that the procedures cannot be carried out if it is known that the person is unwilling for that to happen. I hope that members share my aim to ensure that the bill works in practice, and I invite them to support the amendments.

On amendment 18, I understand Mr Balfour’s concerns about pre-death procedures not bringing about the premature death of a potential donor. As I have said, the provisions in the bill that support the carrying out of pre-death procedures are robust and include significant safeguards with regard to how and when they can be carried out. Importantly, they should not be carried out if they are

“likely to cause more than minimal discomfort”

or harm

“to the person”,

and I believe that not shortening someone’s life expectancy would be captured in that requirement not to harm people.

Equally important is that the bill also explicitly provides that procedures can be carried out only if, in the view of those responsible for the patient’s care, “the person” in question

“is likely to die imminently”

and, where “life-sustaining treatment” is being administered, a decision has been taken to withdraw that treatment. That provision takes account of the very specific context in which such procedures are carried out; they happen in a very narrow window at the end of a patient’s life, when they are being cared for by medical professionals with family involvement in discussions about care and end-of-life procedures.

As I am satisfied that the bill includes significant safeguards, I am not persuaded of the need for amendment 18. I hope that I have provided sufficient reassurance and therefore invite Jeremy Balfour not to move amendment 18.

I move amendment 50.

Jeremy Balfour

First, I want to say that I support amendments 50 and 51 in the name of the minister.

Amendment 18 will put down in law what we all hope should happen, but it will also give individuals who decide to opt in an absolute guarantee that they will be treated no differently from those who have not opted in. That will happen anyway, but the amendment sets it out as a legal requirement. I do not think that it will take anything away from what the minister has proposed in amendments 50 and 51 or, I hope, make any difference in practice to what medical teams do. In the past, a concern was expressed about people being treated slightly differently according to whether or not they were on the donor list, and amendment 18 will simply clarify that that will not be the case. It is a safeguard that will assure people about putting themselves on to the list, which is, after all, what we want them to do.

Emma Harper

Having worked on both the donation and recipient sides of transplantation, I can say that the situation in question is really difficult. In my professional working life, I have never seen anyone wish to hurry someone’s death so that we could get them to an organ donation site or operating theatre. I therefore think that, given current healthcare practice across Scotland, amendment 18, though well intended, is not required.

Sandra White

I thank the minister for lodging his amendments, given that I have been raising this particular matter from the beginning of our scrutiny. As a layperson, I did not know a lot about pre-death procedures. After meeting people whose loved ones had passed away and hearing about what happened and the information that they received, I was comforted, but I still wanted to raise the issue. I therefore thank the minister for the proposal with regard to type A procedures and for ensuring that there will be transparency for the families involved. My concern was always about people not knowing a lot about what was happening.

I understand why Jeremy Balfour has lodged amendment 18. It is probably just a probing amendment that might well not be moved—although I cannot speak for Jeremy in that respect—but I have to say that I am very pleased with amendments 50 and 51.

Joe FitzPatrick

As I said earlier, the bill sets out provisions for pre-death procedures that are robust, transparent and responsive to change, with the important aim that they work in practice. Amendments 50 and 51 are minor changes that add more to that. I invite the committee to support them.

Safeguards are important, and the provisions in the bill for pre-death procedures have been carefully developed to ensure that they recognise the particular circumstances in which they are carried out. People will be under the care of health professionals who work within an ethical framework and for whom patient care is a priority.

The bill provides that procedures may be carried out only if necessary and only if they are not likely to cause any harm. I am satisfied that that addresses Jeremy Balfour’s concerns; I therefore urge the committee to reject amendment 18.

Amendment 50 agreed to.

Amendment 51 moved—[Joe FitzPatrick]—and agreed to.

Amendment 17 not moved.

Amendment 18 moved—[Jeremy Balfour].

The Convener

The question is, that amendment 18 be agreed to. Are we agreed?

Members: No.

The Convener

It seems clear that there are no votes in favour of amendment 18. However, to be absolutely clear, we had better have a vote. There will be a division.

Against

Whittle, Brian (South Scotland) (Con)
White, Sandra (Glasgow Kelvin) (SNP)
Torrance, David (Kirkcaldy) (SNP)
Stewart, David (Highlands and Islands) (Lab)
Macdonald, Lewis (North East Scotland) (Lab)
Harper, Emma (South Scotland) (SNP)
Cole-Hamilton, Alex (Edinburgh Western) (LD)
Briggs, Miles (Lothian) (Con)
Adam, George (Paisley) (SNP)

The Convener

The result of the division is: For 0, Against 9, Abstentions 0.

Amendment 18 disagreed to.

Section 22, as amended, agreed to.

Section 23—Duty to inquire

The Convener

The next group relates to the meaning of the term “health worker”. Amendment 52, in the name of Joe FitzPatrick, is grouped with amendments 53 and 54.

Joe FitzPatrick

Amendments 52 to 54 seek to change the definition of “health worker” in the bill. Following the bill’s introduction, and after speaking to key people who deliver donation and transplantation services, we have reviewed how the current definition of “health worker” in the bill will work in practice and are of the view that these amendments are necessary.

For it to work properly in practice, there needs to be more flexibility in the definition of “health worker” in the bill. The definition should apply consistently to those who might be involved in the authorisation process and those who might carry out inquiries into the wishes of potential donors, which is likely to be the same person. The definition is also relevant to pre-death procedures, as other people who work in healthcare—who are not registered medical practitioners or registered nurses—might be involved. For example, radiographers who carry out X-rays would not be covered by the current definition.

Our view is that the amendment achieves the appropriate level of flexibility by enabling “health workers” to include not only clinicians or nurses, but others who are suitably qualified. We also think that it is precise enough to maintain appropriate restrictions as to who can fulfil the health worker role in the different contexts in which it applies. The additional power for ministers to issue directions means that it also includes adequate safeguards to maintain the integrity of the process.

As we all know, practice and procedures develop all the time. We are mindful that the system has to work in practice, and our view is that the amendments are responsive enough to allow for further developments in procedures and practice. I therefore ask members to support amendments 52 to 54.

I move amendment 52.

Amendment 52 agreed to.

Section 23, as amended, agreed to.

Sections 24 and 25 agreed to.

Section 26—Interpretation

Amendment 53 moved—[Joe FitzPatrick]—and agreed to.

The Convener

Before we proceed, I suspend the meeting to give Jeremy Balfour a moment to return. I understand that he will be back with us any second.

11:25 Meeting suspended.  



11:26 On resuming—  



Amendment 19 not moved.

Amendment 54 moved—[Joe FitzPatrick]—and agreed to.

Section 26, as amended, agreed to.

Section 27—Minor and consequential modifications

Amendments 20 to 23 not moved.

Section 27 agreed to.

After section 27

The Convener

Amendment 62, in my name, is in a group on its own.

Again, the amendment follows discussions and reflects the experience elsewhere. It would insert a new section—headed “Review and report on operation of Act”—which would place an obligation on ministers to research and report on the impact of the provisions in order to determine the efficacy of the legislation. It imposes a duty to undertake a review and report back to Parliament.

A similar exercise was carried out in Wales, where the evaluation was published in December 2017. However, that was done so close to the legislation in Wales coming into effect that the evidence of the benefits did not appear in the evaluation. Committee members will recall that we heard that in the 12 months following the publication of that evaluation, evidence began to come through of an increase in donations. Amendment 62 is designed to ensure that there is an adequate period before a review takes place and calls for that to happen five years from when the bill is given royal assent.

I move amendment 62.

Alex Cole-Hamilton

I seek clarification, convener. Although I am generally in favour of reviewing the impact of legislation, I am concerned that doing so might open the door for the bill, if enacted, to be repealed or its provisions overturned. The bill is much needed, and I want to check the motivations behind your amendment and ask for assurances that you do not imagine that that would happen.

The Convener

I am happy to do that, and will have the opportunity to do so in a moment.

Emma Harper

I agree that, if we want to increase the number of people who donate, we should be able to review whether the legislation is working, including in relation to how many people opt out.

Joe FitzPatrick

I support amendment 62. I am content that it is not a so-called sunset clause and, on that basis, I am happy to recommend that it be accepted. However, I think that it would be preferable for the start of the period to begin not on the date of royal assent but on the date of the opt-out system’s introduction. I suggest that change on the basis of the experience of the Welsh Government’s evaluation, which concluded that two years of data were not enough to give an indication of the early impact of system. Five years after the system’s introduction feels like the right length of time. I would be happy to work with the convener before stage 3 to achieve that.

11:30  



The Convener

I thank the minister for that suggestion, which is much appreciated. I am likewise happy to work with him, as we will in relation to amendment 56, which we discussed earlier. I hope that Alex Cole-Hamilton will agree with the minister that there is no intention—or route—for amendment 62 to become a sunset clause. The intention is simply to ensure that there is a review.

Alex Cole-Hamilton

With that clarification, I am happy to support the amendment.

Amendment 62 agreed to.

Section 28—Commencement

The Convener

Amendment 55, in the name of the minister, is in a group on its own.

Joe FitzPatrick

Amendment 55 seeks to remove references to certain sections of the bill from section 28, so that those sections are not commenced on the day after royal assent.

Following the bill’s introduction and our engagement with stakeholders, including NHSBT and SNBTS, we have reviewed the approach in the bill. We consider that amendment 55 is necessary to ensure that there is sufficient time for guidance to be produced and training to be provided, so that the pre-death procedures and timing of authorisation provisions can be implemented successfully, and those working in the system are able to adhere to the new legislative framework. Further, following the introduction of the bill, sequencing issues were also identified that make amendment 55 necessary.

Before the pre-death procedures regime can be fully implemented, the regulations specifying the procedures need to be in place. Commencing the provisions for the regime before that process is complete would be unworkable. If we did that, the regime would be in place but the procedures would not be specified and so could not be carried out. In addition, the duty to raise awareness of pre-death procedures cannot be met if the procedures are not yet specified.

It is the Scottish Government’s intention instead to commence those provisions and the remaining provisions in the bill by commencement regulations. As set out in the public consultation and the bill’s accompanying documents, the intention is to carry out awareness raising over a period of at least 12 months following the introduction of the opt-out system. As I have said, a period of at least 12 months for awareness raising is appropriate, given the increased debate about opt-out, and people’s exposure to the issue, across the UK since such a regime was introduced in Wales in 2015. More recently, the start of the 12-month awareness-raising period in England will inevitably have some reach in Scotland.

I move amendment 55.

Amendment 55 agreed to.

Amendment 63 not moved.

Section 28, as amended, agreed to.

Section 29—Short title

The Convener

Amendment 64, in my name, is in a group on its own.

The amendment reflects discussion with the Law Society on the short title. Clearly, the bill amends the Human Tissue (Scotland) Act 2006 and therefore the short title should start with “Human Tissue”, as it does. There is currently no reference in the short title to transplantation. Given that, in newspaper and other public comment, it is the short title that is referred to, I suggest that amendment 64 would improve clarity and allow the use of the bill’s title itself as a means of raising awareness of its content.

I move amendment 64.

Joe FitzPatrick

I am grateful to the convener for his attention to the detail of the bill, but I will resist amendment 64, which seeks to amend the short title.

We take care in selecting bill titles to ensure that they meet the Presiding Officer’s recommendation that they should accurately and neutrally reflect what the bill does. We considered adding a reference to transplantation to the short title during the development of the legislation. However, such a reference was not added because it was felt that it would potentially mislead readers, who might then think that the bill was about transplantation only. The short title reflects the fact that the bill is also about authorisation of donation for other purposes, not only transplantation. That is further reflected in the long title, which sets out that the bill is about authorisation

“for transplantation and other purposes”.

It seems to me that transplantation is given sufficient prominence in the long title.

The bill makes significant changes to authorisation for transplantation by introducing deemed authorisation for that purpose, but it also ensures that authorisation for other important uses—such as research, education, training, audit and quality assurance—will require express authorisation from a potential donor or by their nearest relative. The current short title acknowledges that point.

Therefore, although I understand why Mr Macdonald has raised the issue, I ask him to consider not pressing amendment 64.

The Convener

In the light of the minister’s comments, I am minded not to press amendment 64. Of course, members will be able to revisit the issue at stage 3.

Amendment 64, by agreement, withdrawn.

Section 29 agreed to.

Long title agreed to.

The Convener

That completes stage 2 consideration of the bill. I thank the minister and his team, as well as members and non-members of the committee, for their attendance. The bill will now be reprinted, as amended at stage 2. Members will be informed when a date has been selected by which amendments can be lodged for stage 3.

11:36 Meeting continued in private until 11:53.  



Additional related information from the Scottish Government on the Bill

Stage 3 - Final changes and vote

MSPs can propose further changes to the Bill and then vote on each of these. Finally, they vote on whether the Bill should become law.

Debate on the proposed changes

MSPs get the chance to present their proposed changes to the Chamber. They vote on whether each change should be added to the Bill.

Documents with the changes considered in the Chamber:

Video Thumbnail Preview PNG

Debate on the proposed changes transcript 

The Presiding Officer (Ken Macintosh)

The next item of business is stage 3 of the Human Tissue (Authorisation) (Scotland) Bill. In dealing with the bill, members should have with them the bill, as amended at stage 2, the marshalled list and the groupings of amendments.

Should there be a vote this afternoon, the division bell will sound and proceedings will be suspended for five minutes for the first division of the afternoon. The period of voting for the first division will be 30 seconds. Thereafter, there will be one minute for the first division after a debate.

Members who wish to speak in the debate on any group of amendments should press their request-to-speak buttons as soon as possible after I call the group.

Section 2—Information and awareness about authorisation of transplantation and about pre-death procedures

The Presiding Officer

Amendment 1, in the name of the minister, is grouped with amendment 2.

The Minister for Public Health, Sport and Wellbeing (Joe FitzPatrick)

I thank Lewis Macdonald and David Stewart for lodging stage 2 amendments that related to the duties of the Scottish ministers to provide information and raise awareness about authorisation for transplantation. Amendment 1 draws together the overall intentions of the amendments that Mr Macdonald and Mr Stewart lodged at stage 2 by setting out how ministers are to carry out their new duty under the new section 1(1)(d) of the Human Tissue (Scotland) Act 2006. That provision places a duty on the Scottish ministers to promote information and awareness of how transplantation may be authorised, including, in particular, how authorisation for transplantation may be deemed to be given.

The effect of amendment 1 will be that the duty must be carried out at least once in every calendar year. It will also mean that, when the duty is exercised, the Scottish ministers must have regard to the need to provide information to the public about how authorisation of transplantation might be deemed to be given and how to give an express authorisation or to make an opt-out declaration. The amendment makes it clear that the Scottish ministers must have regard to the need to provide that information in healthcare settings, which could include providing information in general practitioner surgeries or in hospital waiting areas, in line with the intention of Mr Stewart’s stage 2 amendment.

Amendment 2 is consequential on amendment 1, and I ask members to support amendments 1 and 2.

I move amendment 1.

Lewis Macdonald (North East Scotland) (Lab)

I welcome the minister’s amendment 1, which fulfils his commitment to refine the text of amendments that were agreed to by the Health and Sport Committee at stage 2. I also welcome his willingness to seek agreement on the area. As he said, amendment 2 is consequential on amendment 1.

My amendment at stage 2 was to commit ministers to an annual campaign to raise awareness of both deemed and express authorisation and opting out. David Stewart’s amendment was to commit the national health service to communicating with patients about authorisation and opting out. I am glad that the minister has engaged with Mr Stewart and myself on those matters and that his two amendments deliver on the commitment that he gave at stage 2. I therefore look forward to supporting both of the amendments in the group.

Amendment 1 agreed to.

Section 3—Establishment and maintenance of register

Amendment 2 moved—[Joe FitzPatrick]—and agreed to.

After section 11

The Presiding Officer

Amendment 3, in the name of Lewis Macdonald, is grouped with amendment 4.

Lewis Macdonald

The purpose of amendment 3 is to require ministers to review and report on the new system of authorisation five years after it comes into force, which includes conducting a review of the Government’s actions to raise awareness of the changes under the bill in general. The Health and Sport Committee unanimously agreed that approach in supporting an amendment in my name at stage 2. Amendment 3 refines the approach, and amendment 4 is consequential.

I am grateful to the minister for working with me on the amendments, which I believe deliver the shared purpose of the Government and the Health and Sport Committee. Amendment 3 provides that ministers must review both the new arrangements for deemed authorisation and their own actions to promote information and awareness about the revised system of organ donation. The report must say whether the objectives of the bill have been met and whether family members have had the support that they need. That will allow ministers and the Parliament to make a judgment, five years after implementation, about whether the bill that is before us today has made the difference that we hope it will, and, if it has not, about what more needs to be done.

I move amendment 3.

Joe FitzPatrick

I support amendments 3 and 4, which were lodged by Lewis Macdonald. I thank him for working with the Scottish Government to ensure that the proposals align with the overall aim of the bill.

Amendment 3 agreed to.

Section 27A—Review and report on operation of Act

Amendment 4 moved—[Lewis Macdonald]—and agreed to.

The Presiding Officer

Members will be delighted to hear that that concludes the consideration of amendments.

As members will be aware, at this point in the proceedings I am required under the standing orders to decide whether, in my view, any provision of the bill relates to a protected subject matter—that is, whether it modifies the electoral system and franchise for Scottish parliamentary elections. In my view, it does no such thing; therefore, the bill does not require a supermajority at stage 3.

Final debate on the Bill

Once they've debated the changes, the MSPs discuss the final version of the Bill.

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Final debate on the Bill

The Presiding Officer (Ken Macintosh)

The next item of business is a debate on motion S5M-17615, in the name of Joe FitzPatrick, on the Human Tissue (Authorisation) (Scotland) Bill at stage 3. I invite all members who wish to speak in the debate to press their request-to-speak buttons as soon as possible.

15:58  



The Minister for Public Health, Sport and Wellbeing (Joe FitzPatrick)

I welcome the opportunity to open the stage 3 debate on the Human Tissue (Authorisation) (Scotland) Bill. I am proud to have led the bill through the Parliament, but I start by recognising the work of my predecessors in relation to both the bill and wider improvements in the transplantation landscape. Since the early days of the Parliament, there has been much discussion about the pros and cons of moving to an opt-out system. I put on record my thanks to the bill team and other officials who have got us to the stage of having a bill that I am clear will be a positive addition to the work that has delivered so much progress over the past decade.

I also thank the Health and Sport Committee for its consideration of and sensitive approach to scrutiny of the bill. That approach reflects the committee’s understanding of the circumstances in which organ and tissue donation must take place as a result of the incredible generosity of donors and their families.

I also thank other members for having taken the time to discuss their concerns with me, particularly Mike Rumbles, Jeremy Balfour and Gordon Lindhurst, who lodged amendments at stage 2 that facilitated further refinement, discussion and clarification of the operation of the bill.

There is no one answer to increasing organ and tissue donation, which is why we must continue to build on the measures that have been put in place over the past 13 years, to which this bill contributes.

The primary aim of the bill is to introduce an opt-out system of organ and tissue donation for deceased donors. The bill amends the Human Tissue (Scotland) Act 2006, the existing Scottish legislation that supports donation, by introducing a new additional form of authorisation called “deemed authorisation”. In practice, deemed authorisation means that, when a person who is aged 16 or over is not known to have any objection to donation, donation may proceed. However, the bill contains safeguards for people who do not have the capacity to understand deemed authorisation or who have resided in Scotland for less than 12 months and may not be aware of the system, who will not be subject to deemed authorisation.

Key to the success of donation are donor families and the way in which they are approached. The bill ensures that the donor’s interests and views are safeguarded at all times by including a clear and effective mechanism for that. There is a duty on health workers to make inquiries of families and others who are entitled to provide information that reflects the most recent views of the donor. The committee was given a demonstration by the specialist nurses for organ donation on how the approach is made to families and the sensitive and supportive way in which families are guided through the process at such a difficult time. That approach is a real strength of the current system, and it will continue under the new system.

There is a high awareness of donation in Scotland, and the importance of information and awareness was the subject of a lot of discussion in the committee and during the stage 1 debate. I welcome the strengthening of the duty to promote information and awareness in the bill by amendments that were developed in collaboration with Lewis Macdonald and David Stewart.

I reiterate to members our intention and commitment to fulfil that duty. We are committed to an awareness-raising campaign of at least 12 months during the lead-up to the introduction of the opt-out system. We will take time in that period to work with communications experts and representative groups to ensure that information is accessible to different groups in the population, including hard-to-reach groups, minority groups and those with specific needs. In addition to the multimedia activity that is planned, there will be a direct mailing to all households in Scotland in the lead-up to the system’s introduction to explain the change in the law, including, among other things, information about how a person can opt into or out of donation.

The secondary school education pack, which is highly regarded as good practice, will be updated and disseminated, and we are also exploring how information can be provided to young people when they reach 16 years of age, so that they are aware of the opt-out system and can make an informed choice about their donation decision.

We will continue to work with Kidney Research UK to train its volunteer peer educators, who are a valuable resource in raising awareness of donation and transplantation among ethnic minority groups. In that respect, I am delighted that Kidney Research UK has invited officials to speak about the opt-out system at its conference with imams in July, to raise awareness of donation and transplantation.

The bill makes an important contribution to the development of donation and transplantation, and I thank the experts in the national health service who have guided us through the sensitive and complex issues in the process. They have worked with us to develop a legal framework for authorisation of donations that respects those issues.

As we move towards the introduction of the opt-out system, we will work with the NHS to ensure that NHS systems are developed and that the people who work in donation and transplantation have the necessary guidance and training that will be needed to deliver a new system safely and successfully.

The work to increase donation and transplantation will not stop with the passing of the bill. Less than 1 per cent of the population die in circumstances in which donation is possible, so it is important that we continue to find different ways to make progress.

I want to be clear about what progress means to the lives of those who are awaiting a transplant. Members might not know Gordon Hutchinson by name, but they might recognise him from his scar. Gordon has featured as part of the donation campaign in Scotland for the past six years. Since his transplant as a child, he has gone on to live a full life. He has married and has recently become the proud father of a baby girl. In relation to his transplant, Gordon has said:

“The life I lived before the heart transplant compared to my life now is night and day ... An organ donor saved my life.”

For the many people who are awaiting a life-changing transplantation operation, I move,

That the Parliament agrees that the Human Tissue (Authorisation) (Scotland) Bill be passed.

16:05  



Miles Briggs (Lothian) (Con)

For many families and campaigners across Scotland, today is an incredibly important day. Every day in the United Kingdom, three people die waiting for a new organ. As has been outlined, more than 500 people in Scotland are waiting for a transplant that could save their lives. Across the UK, Scotland has the highest proportion of people on the organ donor register, but it has the lowest rate of family consent and the lowest rate of organ donation.

Giving the gift of life is an extraordinarily special thing for someone to do following the death of a family member. Like the minister, I pay tribute to those who have already taken the decision to join the organ donor register; I also pay tribute to their families for the work that they need to undertake to ensure that the person’s wishes are met. Making it easier for an individual to express their personal wishes and starting a national conversation on organ donation are at the heart of what we are trying to achieve today.

I pay tribute, too, to those who have worked on the issue in this parliamentary session and in previous sessions, including Anne McTaggart and Mark Griffin.

I thank those who gave evidence to and met the Health and Sport Committee during our inquiries. I think that I speak for all members of the committee when I say that their personal experiences have stayed with us and helped to take forward and shape the committee’s suggestions on how the bill could be strengthened and improved. As the minister outlined, key to the success of any organ donation programme is learning from the experiences of a donor’s family and friends, because that can help to improve decisions and the experiences of others during the hardest time that anyone can imagine.

The experience in Wales was raised repeatedly during the Parliament’s scrutiny of the bill. It is clear that significant and positive progress has been made in Wales, and learning from what has happened there could help us to improve our system in Scotland. In Wales, family consent rates have increased from less than 49 per cent to 70 per cent following the introduction of an opt-out system in 2015. That is welcome progress, and I hope that the same progress will be realised soon in Scotland.

I know that members still believe that the specific issue of the provision of intensive care beds across the country—particularly in the Highlands and the south of Scotland—needs to be addressed further. Scotland has the lowest number of intensive care beds anywhere in the United Kingdom. That was highlighted by the Royal College of Physicians of Edinburgh at stage 2, and my Health and Sport Committee colleague David Stewart raised the issue, too. As the bill progressed, we both thought about lodging amendments to tackle the problem, but I do not think that doing so in this bill would have been useful or appropriate.

However, there needs to be further discussion, and the Scottish Government needs to clarify its commitments and further proposals, as the issue will ultimately affect the potential success of the bill. I welcome the minister’s constructive approach to working with the committee, but I would like to see further details and an assessment of future staffing and provision of intensive care beds, along with a commitment to keep the issue under review as the bill’s provisions are implemented.

People whom I meet who have received a donation send the clear message that the collaborative approach between the organ donation teams and families has literally had a life-saving impact. Like the minister, I thank them for their work. One donor can save up to nine lives and can transform even more by donating tissues. Thanks to the generosity of donors and their families, and the work of the NHS, great progress on organ donation has been made over the past few years. I hope that the minister will ensure that he provides an innovative and positive public information campaign, which will capture the positive spirit of what it is to be a donor and the points that families have expressed during the committee’s work.

We need to work to continue to make progress, increase donor numbers and save the lives of more people in Scotland and the UK. I believe that the bill can and will deliver on its two main aims: further increasing the number of donors; and honouring the decision that a donor has taken during their life.

From speaking to people who have received an organ and their families, I know how incredibly thankful they are to the individual donors and their families. What it means to someone whose son or daughter has been saved by a total stranger genuinely cannot be put into words sometimes. I hope that the passing of the bill will help to take forward a positive national conversation for donors.

I will conclude with the words of Steve Donaldson from Largs in North Ayrshire, who is 57 years old. He had a heart transplant in 2010 after suffering severe heart failure. He waited for nine months on the organ donor transplant list before a suitable donor was found. The briefing that the British Heart Foundation provided for this debate states that he said:

“My message to everyone is please sign the organ donation register and have that conversation with your family about your wishes. It really can make all the difference.”

As a Parliament, we are currently debating and passing many pieces of legislation—although maybe not as efficiently as we are today. However, none can be as important and have such a life-changing impact as the Human Tissue (Authorisation) (Scotland) Bill. We should all rightly be proud of passing it.

16:11  



David Stewart (Highlands and Islands) (Lab)

This is, of course, crucial legislation. How do we raise the level of organ donation in Scotland to match the needs of those who are desperately awaiting transplantation? The principles of the bill have been broadly accepted across the political divide, notwithstanding the lodging of a number of amendments that were designed to improve and, indeed, develop it. I acknowledge the help of the minister and his officials with my amendment, which is now in Joe FitzPatrick’s name—I stress that no copyright fee is required.

Scottish Labour has long been supportive of a soft opt-out for organ donation, and we are glad that Scotland is finally moving to adopt such a system. Credit should be given to individuals across the political divide who have consistently campaigned for that change. In particular, we owe our thanks to Scottish Labour’s Anne McTaggart for her proposed member’s bill in the previous session of Parliament. Although it was unsuccessful, it significantly moved the debate forward. I also acknowledge the fantastic contribution of Mark Griffin, who has a big family relationship with the issue.

Wales has led the way on the issue. Although it is still relatively early to assess the impact of the legisation there, there are positive signs of increased levels of family consent and donations. We must learn from the experience of implementation in Wales, including, as the minister said, about the importance of resourcing the public awareness and information campaigns. Scottish Labour’s successful amendments at stage 2 have strengthened the awareness-raising elements of the bill by requiring annual campaigns. We have also secured a five-year assessment of the changes so that there will be clear learning on the effectiveness of implementation and improvements in organ transplantation.

However, the bill is not the only change that is needed to increase transplantation rates in Scotland. The Scottish Government must ensure that there is sufficient investment in Scotland’s infrastructure to support an increase in organ donations. As we have heard from previous speakers, including the minister, in 2018, 426 patients in the UK died while they were on the transplant list or within one year of removal. As Miles Briggs said, Scotland has the highest percentage of people on the organ donation register in the UK but the lowest actual organ donation rate per million of population. The level of family authorisation is also low in Scotland.

The key issue is the gap between those who wish to donate organs and the number who actually go on to join the organ donation register: 80 per cent of people in Scotland support donation, but only 52 per cent have signed up to the donation register. In simplistic terms, the bill’s purpose is to bridge that divide and encourage those who support organ donation but who have not registered on the ODR to have their wishes recorded and respected.

Let me tell you about my friend Gary. He is in his mid-50s and lives in Glenrothes, in Fife. Nearly two years ago, he was given the gift of life by a crucial heart transplant. Prior to that, he was on the transplant list for 12 months and had a pacemaker. He slowly deteriorated and, without the transplant, he would have died. Gary cannot praise enough the dedicated support of the nursing staff at the Golden Jubilee hospital. He told me that

“it was a matter of life or death.”

We must look at international evidence and best practice, which are crucial. We know, from background research by the British Heart Foundation, that people who live in countries with a soft opt-out system are more willing to donate their organs. In general terms, a soft opt-out means that, unless the deceased expressed a wish in life not to be an organ donor, consent is assumed.

Of the top 10 countries for donors per million of population, nine have an opt-out system. That brings us to Spain, which I mentioned at stage 1 and which leads the world league table for organ donations. The Health and Sport Committee took evidence on why Spain is so successful, which I know the minister has a big interest in. The three main reasons are that Spain has a comprehensive network of transplant co-ordinators, it has a donor detection programme and it provides more intensive care beds. In winding up, will the minister comment on that? Given that this is not a zero-sum game, we must concentrate on increasing the number of intensive care beds as well as changing the consent system.

I will be brief, as I am conscious of the time.

In the stage 1 debate, I spoke about two issues that the Law Society of Scotland raised, so the minister has had warning of them. The Law Society asked whether deemed authorisation is consistent with the ruling in Montgomery v Lanarkshire Health Board, which was a Supreme Court case about informed consent. It also asked whether the bill is consistent with the European convention on human rights, as dealt with in the case of Elberte v Latvia in 2015, when article 8 was found to have been breached. The five-year review will allow considered reflection on those points. What assessment has been made that medical professionals will, in practice, take into account the family’s wishes?

The bill is a vital piece of legislation that will be a matter of life and death for many Scots, such as my friend Gary, who desperately need a life-saving organ donation. As Gibran said,

“You give little when you give of your possessions. It is when you give of yourself that you truly give.”

The Presiding Officer

I call Alison Johnstone to close—I mean to open—for the Scottish Green Party.

16:17  



Alison Johnstone (Lothian) (Green)

I, too, thank all those who have campaigned for many years to change the law. I thank the Royal College of Nursing, the British Medical Association, the British Heart Foundation and the Law Society of Scotland for their briefings, and I express my gratitude to Mark Griffin for his lengthy campaigning and to Anne McTaggart for her work to introduce a bill in 2015. Although that bill did not win support in Parliament, it was a key impetus for change.

The policy memorandum reminds us that

“Organ and tissue donation and transplantation is an incredible development in modern healthcare which continues to save and significantly improve lives.”

The Greens strongly support the intent of this important bill. The policy memorandum also reminds us that

“Organ and tissue donation and transplantation is dependent on the generosity, commitment and skill of a number of ... people.”

I thank them all.

As we have heard again today, Scotland does well on donor registration, with 52 per cent of people in Scotland having signed up to the organ donor register. That is the highest percentage in the UK, but a gap persists—David Stewart spoke strongly about it—between that figure and the approximately 80 per cent of people who support organ donation. The results of a new poll that the British Heart Foundation released today revealed that seven in 10 people in Scotland back the proposed changes to organ donation law. It is clear that the will to donate exists, and I hope that the bill will help to tackle the disparity between people’s intentions and the number of donations.

Scotland’s family authorisation rate for organ donation is the lowest in the UK, which results in the loss of about 100 potential donors a year. Evidence from elsewhere in the UK suggests that the bill can go some way towards rectifying that. In Wales, the family approval rate for organ donation has increased from 49 to 72 per cent since the opt-out system was introduced, so I am optimistic that a similar pattern will emerge in Scotland and that the number of family consents will rise, which will lead to an increase in donations.

Nevertheless, during the stage 1 debate, I and others highlighted that an opt-out system on its own is not an instant solution, but must be part of a broader strategy to increase donations. Therefore, I am pleased that a duty will be placed on the Scottish ministers to provide information annually to the public about how to opt in or out of the system. Ultimately, it is preferable to maximise the number of people opting in, as that will remove any ambiguity about the patient’s wishes and, I hope, allay family members’ concerns about going against their wishes.

Healthcare professionals must be given comprehensive guidance about the changes to organ donation that are proposed in the bill. The Royal College of Nursing has revealed that only 25 per cent of its members feel that they can speak with confidence about organ donation with patients and their families, so much work is still to be done to raise awareness among healthcare professionals.

The RCN has called for an education programme for all healthcare professionals and sufficient resources for the education and training of the wider nursing workforce, to support a shift in the culture of conversations on donations. It is really important that we empower our healthcare professionals to speak confidently to patients about organ donation and to address any concerns or fears that the change in legislation might cause.

I thank the BMA for sharing a number of personal stories about organ donation. I will focus on the words of Gill Hollis:

“The lung transplant I received in 2004 took me from being close to death to living again ... My transplant was the most amazing gift, and I have nothing but gratitude for my donor family and the medical team.”

I hope that the bill will lead to more stories like Gill’s and enable more people to give the gift of life.

16:21  



Alex Cole-Hamilton (Edinburgh Western) (LD)

The keeper of organisational memory and parliamentary history, Mike Rumbles, remarked to me just a few moments ago that he thinks the timing of these stage 3 proceedings is a record, given the swift way in which we have dispatched all the amendments. The brevity of the proceedings speaks to the consensus that has been built around the bill. However, as Alison Johnstone said, that has not happened in isolation. I, too, reflect on the contributions of Anne McTaggart in the previous parliamentary session and Mark Griffin, who, it is fair to say, held the feet of the Health and Sport Committee and the Government to the fire in the early days of this session to ensure that we got to this day. I thank him very much for getting us to this point and, indeed, the Government for making good on its commitment to do so.

This is an emotional and joyful day for me. As I said during the stage 1 proceedings, as an aspiring political candidate—which, I am sure, all members were once—I was often asked at hustings what my member’s bill would be if I made it to the Scottish Parliament. This is that bill, because I have a lifetime of understanding the need for organ donation and, indeed, because of the paucity of organ donation that has until this day existed in this country. My good friend Anders Gibson suffered from cystic fibrosis, and I grew up with him with the expectation that his life would be cut short. It is to my great sadness that Anders did not live to see this day. Ultimately, when his lung transplant came, it was too late and it did not take properly. I speak in his memory today, and I know that he is looking down on us with great pleasure at what this Parliament is about to do.

Organ donation is vital. There is not enough of it, so I was keen to host a reception and a photo call earlier this year for Give a Kidney, which is a UK philanthropic kidney donation organisation. There are people who give healthy kidneys to complete strangers altruistically—completely out of the will to be philanthropic and to give life to others who might have to suffer protracted periods on dialysis or even limitations to their life. I salute that organisation.

It was in the foothills of our preparation for the legislation that I learned the full extent of what goes into the organ donation process. I am sure that I speak for all committee members when I talk about our experience of meeting the specialist organ donation nurses, who are angels heaven sent and a credit to our national health service. It was a great privilege to meet them. They talked about the onerous bureaucracy of the process, and committee members found it quite shocking to be told how many intimate questions were asked of a soon-to-be-deceased relative in the final hours, literally at their loved one’s bedside. They talked about turning that process into the telling of a life story and about finding mirth and merriment in what for everyone concerned would be their darkest hours.

We also met transplant recipients, which is when the idea of organ donation as a gift really struck home and I understood the sheer magnitude of the present that someone can give in the last hours of their life to someone who is unknown to them, who can go on to live a happy and fulfilling existence because of the organs that they receive. We learned about the rollercoaster of emotions that goes with that. Anders experienced that, too. He had a couple of false starts that involved being driven to Newcastle and returning after the transplant fell through. I hope that the minister will address that point in his closing remarks and talk about the mental health support that we can give to people who are on transplant waiting lists.

We must recognise that what we are doing involves only one aspect of this area and that encouraging people to have conversations about organ donation is also important.

I will finish with a quote from Simon Gillespie, the chief executive of the British Heart Foundation. He said:

“There is a desperate shortage of organ donors. Introducing an opt-out system will better reflect the views of the general public and give hope to those currently waiting for a transplant they so desperately need.”

We support the bill.

The Deputy Presiding Officer (Linda Fabiani)

We now move to the open debate. I ask for speeches of four minutes.

16:26  



Emma Harper (South Scotland) (SNP)

I am pleased to be able to speak in support of the Human Tissue (Authorisation) (Scotland) Bill this afternoon. From the outset, I emphasise that, at any one time, 500 people in Scotland are waiting for a transplant, which shows the need for Parliament to take action and support the bill.

As deputy convener of the Health and Sport Committee, I have had the opportunity to participate in much of the scrutiny of the bill at stage 2, and I thank everyone who provided briefings during the bill’s progress through Parliament, including Anne McTaggart, Mark Griffin, who is in the chamber today, the BMA and the other professional organisations.

As I was a nurse and liver transplant team member in Los Angeles, California, I was especially grateful to hear from the people who were either waiting on an organ or those who had received one. I have heard many pre-transplant stories from patients who were about to be recipients of organs. The personal voices of the recipients and people waiting for organs were vital in helping to inform committee members, and I thank all who came to speak to us.

It is useful to again stress that the bill’s principal aim, which I am pleased that the Parliament overwhelmingly supported at stage 1, is to bring about a long-term culture change to encourage people to support organ and tissue donation by registering on the organ donation register and by moving to a soft opt-out system.

Just over half of Scotland’s population have registered to donate their organs or tissue after death, which reflects their incredible generosity and the progress that has been made in highlighting the need for organ donors, which is absolutely welcome. However, if we are to achieve the aim of reducing the number of people dying as a result of the unavailability of organs, we need more people to register.

Most organ and tissue donations can occur only in tragic circumstances, and only 1 per cent of people die in situations in which they could be an organ donor. Given the clear need for more organs to save lives, the bill will therefore introduce deemed authorisation for deceased donation where an adult has not clearly opted in or out. That means that when someone dies and has not made their wishes on donation known, their consent to donation would be assumed and conversations regarding the commencement of donation processes could occur.

The committee received evidence and submissions from some people who were concerned that the deemed consent element of the bill meant that people’s organs might be donated even though they had not opted out only because, for example, they had never got around to it. I address that argument by assuring people that the bill includes safeguards to ensure that the donation wishes of the deceased are followed. The bill also provides a legal framework for pre-death procedures that facilitate successful donation for transplantation, so that people are educated and encouraged to make their wishes known. The section of the bill that addresses opt-out declarations by an adult can be found on page 16.

The committee received submissions and took oral evidence from people who were concerned about a lack of public awareness of the change in legislation. That was initially a concern for me, too, so I am pleased that the Scottish Government has committed to continuing high-profile awareness-raising activity every year and to promoting a continued national conversation. The Scottish Government’s campaign, “We need everybody”, which was launched in July 2016, has been a success and has led to an increase in the number of people who join the organ donor register.

I am probably the only person in this chamber who has held a kidney, a pancreas, a liver and a heart in my hands, for the organ to be placed into another person. I encourage everyone to consider registering to be a tissue and organ donor and to offer that gift to save someone’s life. I urge all members to vote in favour of the bill.

16:30  



Lewis Macdonald (North East Scotland) (Lab)

The bill gives us a fresh opportunity to maximise organ donation and help some of the hundreds of people who are waiting for organ transplants that could save their lives. Instead of presuming that people do not want to donate their organs after death unless they have opted in, we will presume that people want to donate unless they have opted out.

That change is made within the framework of the law as it stands. The bill amends the Human Tissue (Scotland) Act 2006—it is evolution, not revolution, which I welcome; in this case, not least because I took the current law through the Parliament and I believed then that it laid the foundations for whatever evolution in the law might be needed in the future.

Before 2006, people did not authorise transplantation of their organs after death; they consented to transplantation. The difference between “consent” and “authorisation” is not just the difference between two words. Providing for authorisation makes the law far clearer than it was, in requiring that people’s wishes on these matters be followed.

The 2006 act called for a concerted effort to tell people how authorisation works and to explain the difference that organ donation can make. Successive Governments have delivered on that. As a result, Scotland achieved the highest rates of authorisation in the UK over several years—the level is now half the adult population, although, as members said, that is not the whole story.

The 2006 act was designed to enable the further development of the transplantation infrastructure in Scotland. As members said, the Health and Sport Committee heard impressive evidence from specialist nurses in organ donation about how the system works.

Despite all that progress and our high rate of opting in, Scotland has the highest rate of bereaved relatives saying no to organ donation. Health professionals are understandably reluctant to challenge a family’s right to do that at what is already a very sad and stressful time. The law should not seek to reduce the family’s right to be heard, nor should it compromise the duty of care that doctors and nurses owe to the bereaved at the time of death.

Instead, the bill seeks to widen the pool of people from whom organ donation might come. We are following the lead that Wales took in 2015, and a similar change will happen in England in 2020. Rates of donation in Wales have now overtaken rates in Scotland. The coming into force, in 2015, of the Human Transplantation (Wales) Act 2013 was the trigger for increased public awareness. It took some time for that to result in increasing rates of organ donation, but that is now happening, and the time is right to follow Wales’s lead.

As other members have done, I thank my colleague Mark Griffin and my former colleague Anne McTaggart for their efforts to introduce the principle of opting out, in place of opting in. The Scottish Government has now enabled that principle within the framework of the existing law, and with broad cross-party support, as has been evident today.

Our passing this bill can help to increase rates of donation and save lives, but changing the law will not in itself be enough. Amendments that we agreed to today mandate ministers to use the bill to raise awareness and encourage people to authorise donation, even though deemed authorisation will be in place, and to strengthen the transplantation infrastructure in Scotland.

We also agreed that ministers should review the legislation, including the way in which the new approach has been communicated, in five years’ time.

We should renew the promise that the Parliament made in 2006. We will give the measures every support, to achieve the change that we want to see, but if the Parliament needs to return to this topic in the future, it should not hesitate to do so.

16:34  



Kenneth Gibson (Cunninghame North) (SNP)

It is a pleasure to speak in the debate knowing that at decision time the Parliament will, I believe, vote for a bill that MSPs past and present, third sector organisations such as the British Heart Foundation, healthcare professionals and, indeed, patients themselves have long been calling for.

The Human Tissue (Authorisation) (Scotland) Bill, like Anne McTaggart’s member’s bill—the Transplantation (Authorisation of Removal of Organs etc) (Scotland) Bill that was introduced in the previous session—is intended to increase the availability of organs and tissue for transplantation and therefore reduce the number of people who are waiting for a transplant. At stage 1, members shared moving stories of loved ones or constituents who waited too long for an organ and the grave consequences that that can have. Indeed, almost 600 people in Scotland are waiting for a potentially life-saving organ. If the bill can achieve any reduction in that number, all of us can and should get behind it.

The bill contains three key provisions: as well as giving people the ability to opt in by explicitly stating their authorisation for donation and to opt out by explicitly removing authorisation, it provides for deemed authorisation, which will be the default option if someone has not recorded their wishes.

The development of that soft opt-out system will enable us to more easily capture the estimated 80 to 90 per cent of Scots who support organ donation, while closing the gap between the number of people who state that they would wish to donate and the number who actually sign up to the organ donor register. Given that an overwhelming majority of people would wish their organs to be donated, it can be surmised that many of the 48 per cent of Scots who are not registered donors have simply not got round to opting in. The bill will help to capture those folk, who have the potential to save lives by donating their organs and tissue.

Of course, individual choice must be protected. That is why the bill introduces a soft opt-out that incorporates safeguards and conditions that might include seeking authorisation from a person’s nearest relative in cases involving certain groups of people or specific circumstances. Deemed authorisation will not apply to under-16s, people who have been resident in Scotland for less than 12 months and those without capacity. It will not be a case of asking the family for their views or overriding the wishes of donors; the family will be asked what they believe were the views of their deceased relative.

Unfortunately, at just 57 per cent in 2017-18, Scotland has the lowest level of family authorisation in the UK. I am glad, therefore, that the Scottish Government has taken an evidence-based approach to resolving the situation. There is strong evidence to suggest that such legislation will improve levels of family authorisation by encouraging frank conversations between relatives about their wishes. Indeed, people who live in countries with opt-out systems are between 27 and 56 per cent more likely to authorise donation of their relatives’ organs. That has absolutely been the case in Wales, where consent rates have risen from 49 per cent in 2014-15 to 72 per cent, and I hope to see a similar uplift in Scotland.

I am grateful to the Health and Sport Committee for its excellent work in scrutinising the bill and strengthening it at stage 2. I am particularly grateful for the amendment to place a duty on the Scottish ministers to promote an annual awareness-raising and information campaign that will give people regular opportunities to make or review their decision about whether to donate. The amendments that were agreed to earlier this afternoon will also help. We know about the power that such awareness raising can have—the duty on the Scottish ministers to promote awareness of donation in the Human Tissue (Scotland) Act 2006 resulted in year-on-year increases in the number of people recording their decisions on the organ donation register. The Human Tissue (Authorisation) (Scotland) Bill will have an even greater impact.

I am certain that deemed authorisation will drive a long-term increase in support for organ and tissue donation. Perhaps it is even the case that the bill’s progress through Parliament has inspired more people to discuss donation with loved ones, which can only be a good thing.

Of course, the ability to transplant is always reliant on the medical viability of organs, which the bill cannot legislate for. At stage 1, the minister highlighted other work that the Government is undertaking to increase the number of viable organs, such as providing funding for new technology to improve the outcomes of patients who receive liver transplants and to increase the proportion that are suitable for transplantation. That work is to be commended and should be built on.

I pay tribute to everyone who has donated and every family that has supported and facilitated those donations; in doing so, they have saved and improved lives. That is truly a gift, and it is one that the bill will help to bestow on untold numbers of lives in the future.

16:38  



Mike Rumbles (North East Scotland) (LD)

I am convinced that if we pass the bill at decision time, there will be a greater chance of saving lives, so why was I the only MSP to vote against the bill at stage 1? Let me explain.

I have been on the organ donation register for the past 20 years. It is heartening to see that a majority of Scots are now on the register, too. That has come about through many measures, not least of which is the Human Tissue (Scotland) Act 2006, which Lewis Macdonald mentioned, in which we focused on the wishes of the deceased rather than on the wishes of his or her nearest relative. When I first saw the bill after publication, I was perturbed that the safeguards in it were not sufficient in respect of the wishes of the potential donor. By that I mean that it seemed to me that there was a danger that the wishes of the potential donor might, in some cases, be ignored.

There was one phrase in the bill which I thought could undermine the success of the legislation. The bill originally said in section 7 that deemed authorisation would not apply if

“a person provides evidence to a health worker that would convince a reasonable person that ... the adult was unwilling”

for transplantation to take place. The evidential bar for the family of the deceased to confirm the wishes of the deceased was being raised unnecessarily. The legislation in England and in Wales does not do that; in my view, there was no need for our legislation to raise the evidential bar in that way. I was concerned that if that was not changed at stage 2, and if in even one case the nearest relative of the donor could not provide evidence that would “convince”, and a donation went ahead against what the relatives believed were the wishes of the deceased, the legislation could be undermined.

I am very pleased that Joe FitzPatrick, the Minister for Public Health, Sport and Wellbeing, took on board my point and lodged Government amendments to alter the bill which have had the same effect as my amendments would have had, so I was happy to withdraw them. The bill now states that if

“a person provides evidence to a health worker that would lead a reasonable person to conclude that ... the adult’s most recent view was that”

he or she was unwilling for donation to take place, that would be acted upon.

Keith Brown (Clackmannanshire and Dunblane) (SNP)

Will the member give way?

Mike Rumbles

I only have 40 seconds left.

With that safeguard now in place, I will be more than happy to support the bill at decision time.

Joe FitzPatrick was willing to take my concerns on board and to change the wording of the bill. With only my vote against it at stage 1, he was not under any real pressure to change the bill, but he took the time and made the effort to get this right. Presiding Officer, I want to put on the record my thanks to Joe FitzPatrick, and I want to thank you for providing me with the opportunity to do so in the debate.

16:42  



Christine Grahame (Midlothian South, Tweeddale and Lauderdale) (SNP)

I say to Mike Rumbles that I abstained at stage 1. I support organ donation and carry a donor card. I encourage others to go on the register, and much in the bill is commendable.

However, three words do not appear in the bill—“donation” and “presumed consent”. These have been displaced by “transplantation” and “deemed authorisation” respectively. I ask myself why.

I suggest that the terms are used to assuage any concerns that members might have, because “donation” requires the owner of something to transfer it voluntarily to someone else: it is a gift. A person cannot make a gift if they are dead and have not registered as a donor. “Presumed consent” is a prime example of an oxymoron: consent cannot be presumed, but must be indicated in some form or other, no matter how minute it is: the blink of an eye in response to, “One blink for yes, two blinks for no,” would do.

In my view, that is why “organ donation” and “presumed consent” have been rebadged as “transplantation” and “deemed authorisation”. The greater deceit is to say that “deemed authorisation” is somehow different from “presumed consent”, although Emma Harper transposed the two—and she is quite right. My consenting to someone hitting me with a brick will have the same result as my authorising them to do it: I will still have been hit by a brick. Consent and authorisation are one and the same. Neither authorisation nor consent can be “presumed” or “deemed” in the vital absence of an indication either way. In my view, it is wrong for the state to do so on behalf of a silent deceased person.

Although I fully support the intention of the bill, I regret that I cannot support it as it is worded. I understand that it is well intended, and I want people to have access to organs, but I cannot support the bill as it stands. Accordingly, I will not support it at decision time.

16:44  



David Stewart

This has been an excellent debate with well-informed and thoughtful contributions from across the chamber. I believe that the key point that has been echoed by several members is that the bill is crucial legislation because we need to raise the level of organ donation in Scotland to match the number of people who are desperately awaiting transplants.

Miles Briggs, who is currently absent from the chamber, paid tribute to people who are on the organ donation register and their families. He is right that we need to start a national conversation. He was also right to thank all those who gave evidence to the Health and Sport Committee. I believe that it is important that we analyse the experience in Wales, albeit that the system there is still relatively new. I summarise his point on that by saying that he said that where Wales walks, we follow. He was also correct that we should look at provision of intensive care beds.

Alison Johnstone made the important point that organ transplantation is a vital development of scientific healthcare. As she said, there is a will to donate in Scotland, as has been clearly evidenced in polling. I agree that the number of family consents will rise, and that it is important to have the wider strategy of annually analysing opt-ins and opt-outs.

Alex Cole-Hamilton made the genuine point that, before he was elected, his wish for a member’s bill would have been to have one on organ donation. He also made the vital point that the gift of giving has always been there, and we should always remember that. I agree with him that it is important to praise organ donation nurses, some of whom members of the Health and Sport Committee met. We should never forget the need to tell donors’ life stories.

Emma Harper, who is a former nurse, obviously has tremendous experience in the area. She talked about the safeguards in the bill, the pre-death procedures and the need to raise awareness. I am glad that the minister introduced an amendment on that. I congratulate the Government on the work that it has done through the “We need everybody” campaign.

Lewis Macdonald talked about the opportunity to launch the organ donation campaign afresh. Of course, we should never compromise families’ rights, but we need to widen the pool of organ donation. He said that awareness raising needs to be highlighted, as has been done through amendments to the bill, and he pointed out that the amended legislation will be reviewed.

The stakes are high, so we need the legislation to be a success. More than one in 10 people on the waiting list will die before they get the transplant that they need. As BMA Scotland has suggested, the bill will change the culture and philosophy in society, so that donation becomes the norm. We need to aim for societal change so that organ donation becomes accepted and is part of the fabric of our national life. The greatest gift that a person can ever give is the gift of life itself.

16:47  



Brian Whittle (South Scotland) (Con)

I am delighted to close the stage 3 debate on behalf of the Conservative Party. Given the topic, the debate has been consensual. As has been said, the bill’s swift passage is testament to the work that was done previously by Anne McTaggart and Mark Griffin, who is in the chamber today.

Many members, including the minister, have highlighted the incredible work that specialist nurses do in dealing with bereaved families in their time of grief. That also became clear during the Health and Sport Committee’s investigation. I know that my fellow committee members were moved by the demonstration of a conversation between nurses and a deceased person’s next of kin. As Alex Cole-Hamilton alluded to, we were all surprised by the number of questions that are asked. It is certainly a lot of questions to tackle at a time of grief, but the delicate and empathetic way in which the nurses deal with organ donation with bereaved families is testament to their skill and dedication. I know that we all want to give them our thanks.

During the passage of the bill through its committee stages, although not many people spoke against it, there was much discussion and debate about the nuances and the potential implications. Far be it from me normally to praise Keith Brown in any way, but I think that I might do so now, to see whether I can ruin his reputation. I was taken by how he consistently pressed for the rights of the donor and said that their wishes should be paramount. However, there is a need for next of kin to answer the complex questions about the deceased prior to donation, and there will always be the final veto for the family. Mike Rumbles spoke about that issue, too. I am not sure that there is any way round it, but Keith Brown certainly got committee members to think about the issue in depth. No healthcare professional will go against the wishes of a family, irrespective of the donor’s wishes, either expressed or presumed.

As has been said, nine out of the 10 top countries in terms of transplant have a form of opt-out system. However, implementation of an opt-out system will not of itself necessarily increase the number of donors. David Stewart, among others, mentioned Spain, where every hospital has capacity for and expertise in organ transplant. What plans does the Scottish Government have to ensure that increased organ donation here will be matched by an increase in capacity? In these days of multiple shortages in staff across many disciplines in the NHS, is the Scottish Government confident that it can recruit the requisite specialist nurses in our hospitals and ensure that they are equipped with the necessary acute specialist facilities? I join David Stewart in asking the minister to address that in his closing remarks.

I have also spoken about my reservation that having the bill deal with both presumed and expressed consent could lead to confusion. Scotland has the highest level of card-carrying donors in the UK, but it also has the highest level of families overruling donors’ wishes. As Alison Johnstone, David Stewart and Miles Briggs highlighted, 40 per cent of the population would donate, but have not yet expressed their consent. Until recently, I was one of them. Only when I had to change the address on my driving licence online was I prompted to express my consent, which took little more than a minute. I advocate there being more opportunities for people to express their consent because, to my mind, that is a much more powerful declaration of intent than any presumption.

However, the bill offers the opportunity to bring the topic to the nation’s attention. This morning, I caught part of a BBC Radio Scotland discussion on it, so mentioning the proposed change in the law does work. That in itself must be a good thing. As Kenny Gibson said, instigation of a conversation in families about how their thoughts and wishes might be expressed has to be positive.

In supporting the bill, the Scottish Conservatives ask the Scottish Government to run a consistent marketing campaign alongside implementation, in order to ensure maximum understanding of the idea of expressed consent. Finally, we also ask that an audit of the current number of intensive care beds and specialist staff be undertaken, and that a plan be put in place for the increase in donors that might result from the legislation.

Donation of organs is an incredible legacy to leave. The passing of the Human Tissue (Authorisation) (Scotland) Bill will mean the culmination of many years of work by campaigners. Let us hope that, if it is passed, it will have the impact that we all believe it can have.

The Deputy Presiding Officer

I call Joe FitzPatrick to wind up the debate. You have six minutes, minister.

15:52  



Joe FitzPatrick

I thank members for what has been a good debate on a very complex and sensitive subject. I especially thank members from across the chamber for reading out the names and statements of people who have benefited from organ transplant. It is so important that we hear such stories, and I hope to have time to talk about some that I have heard and the people whom I have met.

Of course, organ donation can be a very personal issue. Although there are differences in our views on moving to an opt-out system, I am sure that we would all agree that it is important that we do all that we can to support initiatives that aim to increase donation. Moving to such a system, which the bill provides for, will add to the initiatives that have been driving improvements over the past decade, leading to the progress that I spoke of earlier. I hope that that change will contribute further to on-going positive developments. Those are underpinned by a commitment from the Scottish Government to support and promote donation, but they have been driven forward by those who work in the system. I put on record my thanks and admiration for their dedication.

In overseeing progress, the Scottish donation and transplant group has played a key role in ensuring that opportunities to improve donation and transplantation are maximised. The group has also provided valuable insight on the bill to ensure that it provides for a system that will work in practice. I am grateful for that input and know that the group will continue to play an important role as the new system is implemented and monitored.

Miles Briggs, David Stewart and Brian Whittle asked about infrastructure and capacity. The Scottish Government has an on-going commitment to ensure that the infrastructure supports donation, that performance is continuously monitored and that potential improvements are considered via the Scottish donation and transplant group. The group oversees the delivery of the current plan for donation and transplantation for Scotland, which runs from 2013 to 2020. As part of the plan to increase organ and tissue donation and transplantation in Scotland from 2020 onwards, we will discuss with stakeholders whether further initiatives should be progressed to improve infrastructure for organ and tissue donation in the future, which is an important issue.

David Stewart raised the issue of human rights legislation. I assure members that we have worked with people who work in organ donation and transplantation to ensure that we have a system that will work in practice and which clearly takes account of a person’s rights, particularly under the European convention on human rights. Mr Stewart mentioned the Montgomery case. The bill is in line with that decision, although that case was more concerned with medical treatment, whereas the bill is about authorisation of donation.

David Stewart

Will the minister take an intervention?

Joe FitzPatrick

I want to cover another point that David Stewart raised. He asked specifically about the Latvian case of Elberte. The outcome of that case turned on its particular facts and circumstances, with the issue being the quality of Latvian organ donation legislation. That legislation gave family members a right to object to donation, but provided no mechanism for the right to be given effect in practice. The judgment does not suggest that a right to be consulted is a necessary feature of an opt-out system; it simply illustrates that if a right is provided for, it must be capable of being exercised. That was where the Latvian law fell short.

David Stewart

Will the minister take an intervention now?

Joe FitzPatrick

Very briefly; I have lots of other points to cover.

David Stewart

I am grateful. In raising the 2015 case of Elberte v Latvia, my point was that a breach of article 8 of the European convention on human rights was proved. If we have a five-year review, it will be the courts that decide whether there is a breach. Does the minister agree that, in the long term, that is the best way to human rights-proof the bill?

The Deputy Presiding Officer

Could members quieten down, please?

Joe FitzPatrick

David Stewart is absolutely right. From looking at the case law, particularly the Elberte case, we are content that the bill is solid in that area, but he is right that the five-year review allows that further examination.

Alison Johnstone asked about the very important issues of staff training, education and awareness. Training for people involved in the donation and transplantation process will be a crucial part of the successful implementation of the new system.

Alex Cole-Hamilton asked about psychological support for patients and donor families—a point that he has raised before. NHS National Services Scotland is responsible for commissioning all psychological support in the pre-transplant and immediate post-transplant phase, and it is currently reviewing the provision of psychological support across all nationally commissioned specialist services, including organ transplantation, to ensure that appropriate provision is in place. We understand that the review will be completed later this year.

Mr Cole-Hamilton also mentioned support for families. We recognise the selfless decisions that donor families have made. Specialist nurses direct families to bereavement services, where appropriate. However, it is important to note that, for many donor families, donation is seen as a positive outcome from a tragic situation. It is a legacy for their loved ones and can be a valuable part of their bereavement journey.

Kenneth Gibson mentioned a range of other work that is improving donation, and he was absolutely right to do so. I have made it clear that the opt-out will deliver the increases in donation that we all want to see only if it is part of a package of measures. He also talked about the frank conversations that people should have with their loved ones. Having those discussions about donation will make it so much easier for families to make the decision comfortably and to have those conversations with the specialist nurses, should someone die in tragic circumstances that mean that their organs could save a life. A message from today’s debate is that I encourage everyone to have those conversations and speak to their family about their wishes.

Christine Grahame talked about consent versus authorisation. Lewis Macdonald answered that point when he talked about how the wording in the bill relates back to 2006.

I go back to why we are doing this. This morning, I was at the Royal infirmary of Edinburgh, where I saw at first hand the difference that donation can make when I met two organ recipients, Jamie and Clare. They spoke of the life-changing gift that they had received and the difference that it had made to their lives.

Of her transplant, Clare said:

“Waking up, I was like a different person. It is impossible to explain. Even though there have been some ups and downs with my recovery, my life is better than I could have expected.”

Jamie was equally grateful. He said:

“It’s an amazing gift; it’s the gift of life. I will never be able to meet the person who did this for me and I am not sure I’d know what to say to them if I did. It’s so completely changed my life.”

We need to remember that that is why we are doing this. I am so proud to commend the bill to members in the chamber today. Like the 2006 act, it will provide the basis for further progress.

Final vote on the Bill

After the final discussion of the Bill, MSPs vote on whether they think it should become law.

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Final vote on the Bill transcript

The Presiding Officer (Ken Macintosh)

The first question is, that motion S5M-17566, in the name of Kevin Stewart, on the Fuel Poverty (Targets, Definition and Strategy) (Scotland) Bill, be agreed to. As the question is on passing a bill, there will be a division.

For

Yousaf, Humza (Glasgow Pollok) (SNP)
Wightman, Andy (Lothian) (Green)
Whittle, Brian (South Scotland) (Con)
White, Sandra (Glasgow Kelvin) (SNP)
Wheelhouse, Paul (South Scotland) (SNP)
Watt, Maureen (Aberdeen South and North Kincardine) (SNP)
Torrance, David (Kirkcaldy) (SNP)
Tomkins, Adam (Glasgow) (Con)
Todd, Maree (Highlands and Islands) (SNP)
Stewart, Kevin (Aberdeen Central) (SNP)
Stewart, David (Highlands and Islands) (Lab)
Stewart, Alexander (Mid Scotland and Fife) (Con)
Stevenson, Stewart (Banffshire and Buchan Coast) (SNP)
Somerville, Shirley-Anne (Dunfermline) (SNP)
Smyth, Colin (South Scotland) (Lab)
Smith, Liz (Mid Scotland and Fife) (Con)
Smith, Elaine (Central Scotland) (Lab)
Simpson, Graham (Central Scotland) (Con)
Scott, Tavish (Shetland Islands) (LD)
Scott, John (Ayr) (Con)
Sarwar, Anas (Glasgow) (Lab)
Ruskell, Mark (Mid Scotland and Fife) (Green)
Rumbles, Mike (North East Scotland) (LD)
Rowley, Alex (Mid Scotland and Fife) (Lab)
Ross, Gail (Caithness, Sutherland and Ross) (SNP)
Robison, Shona (Dundee City East) (SNP)
Rennie, Willie (North East Fife) (LD)
Paterson, Gil (Clydebank and Milngavie) (SNP)
Neil, Alex (Airdrie and Shotts) (SNP)
Mundell, Oliver (Dumfriesshire) (Con)
Mountain, Edward (Highlands and Islands) (Con)
Mitchell, Margaret (Central Scotland) (Con)
McNeill, Pauline (Glasgow) (Lab)
McMillan, Stuart (Greenock and Inverclyde) (SNP)
McKelvie, Christina (Hamilton, Larkhall and Stonehouse) (SNP)
McKee, Ivan (Glasgow Provan) (SNP)
McDonald, Mark (Aberdeen Donside) (Ind)
McArthur, Liam (Orkney Islands) (LD)
McAlpine, Joan (South Scotland) (SNP)
Matheson, Michael (Falkirk West) (SNP)
Mason, Tom (North East Scotland) (Con)
Mason, John (Glasgow Shettleston) (SNP)
Martin, Gillian (Aberdeenshire East) (SNP)
Maguire, Ruth (Cunninghame South) (SNP)
Macpherson, Ben (Edinburgh Northern and Leith) (SNP)
Mackay, Rona (Strathkelvin and Bearsden) (SNP)
Mackay, Derek (Renfrewshire North and West) (SNP)
MacGregor, Fulton (Coatbridge and Chryston) (SNP)
Macdonald, Lewis (North East Scotland) (Lab)
MacDonald, Gordon (Edinburgh Pentlands) (SNP)
MacDonald, Angus (Falkirk East) (SNP)
Lyle, Richard (Uddingston and Bellshill) (SNP)
Lockhart, Dean (Mid Scotland and Fife) (Con)
Lochhead, Richard (Moray) (SNP)
Lindhurst, Gordon (Lothian) (Con)
Leonard, Richard (Central Scotland) (Lab)
Lennon, Monica (Central Scotland) (Lab)
Lamont, Johann (Glasgow) (Lab)
Kidd, Bill (Glasgow Anniesland) (SNP)
Kerr, Liam (North East Scotland) (Con)
Kelly, James (Glasgow) (Lab)
Johnstone, Alison (Lothian) (Green)
Johnson, Daniel (Edinburgh Southern) (Lab)
Hyslop, Fiona (Linlithgow) (SNP)
Hepburn, Jamie (Cumbernauld and Kilsyth) (SNP)
Haughey, Clare (Rutherglen) (SNP)
Harvie, Patrick (Glasgow) (Green)
Harris, Alison (Central Scotland) (Con)
Harper, Emma (South Scotland) (SNP)
Hamilton, Rachael (Ettrick, Roxburgh and Berwickshire) (Con)
Halcro Johnston, Jamie (Highlands and Islands) (Con)
Griffin, Mark (Central Scotland) (Lab)
Greer, Ross (West Scotland) (Green)
Greene, Jamie (West Scotland) (Con)
Gray, Iain (East Lothian) (Lab)
Grant, Rhoda (Highlands and Islands) (Lab)
Grahame, Christine (Midlothian South, Tweeddale and Lauderdale) (SNP)
Gougeon, Mairi (Angus North and Mearns) (SNP)
Golden, Maurice (West Scotland) (Con)
Gilruth, Jenny (Mid Fife and Glenrothes) (SNP)
Gibson, Kenneth (Cunninghame North) (SNP)
Freeman, Jeane (Carrick, Cumnock and Doon Valley) (SNP)
Fraser, Murdo (Mid Scotland and Fife) (Con)
Forbes, Kate (Skye, Lochaber and Badenoch) (SNP)
FitzPatrick, Joe (Dundee City West) (SNP)
Finnie, John (Highlands and Islands) (Green)
Findlay, Neil (Lothian) (Lab)
Fee, Mary (West Scotland) (Lab)
Fabiani, Linda (East Kilbride) (SNP)
Ewing, Fergus (Inverness and Nairn) (SNP)
Ewing, Annabelle (Cowdenbeath) (SNP)
Dugdale, Kezia (Lothian) (Lab)
Dornan, James (Glasgow Cathcart) (SNP)
Doris, Bob (Glasgow Maryhill and Springburn) (SNP)
Dey, Graeme (Angus South) (SNP)
Denham, Ash (Edinburgh Eastern) (SNP)
Davidson, Ruth (Edinburgh Central) (Con)
Crawford, Bruce (Stirling) (SNP)
Corry, Maurice (West Scotland) (Con)
Constance, Angela (Almond Valley) (SNP)
Cole-Hamilton, Alex (Edinburgh Western) (LD)
Coffey, Willie (Kilmarnock and Irvine Valley) (SNP)
Chapman, Peter (North East Scotland) (Con)
Carson, Finlay (Galloway and West Dumfries) (Con)
Carlaw, Jackson (Eastwood) (Con)
Campbell, Aileen (Clydesdale) (SNP)
Burnett, Alexander (Aberdeenshire West) (Con)
Brown, Keith (Clackmannanshire and Dunblane) (SNP)
Briggs, Miles (Lothian) (Con)
Bowman, Bill (North East Scotland) (Con)
Bibby, Neil (West Scotland) (Lab)
Beattie, Colin (Midlothian North and Musselburgh) (SNP)
Beamish, Claudia (South Scotland) (Lab)
Ballantyne, Michelle (South Scotland) (Con)
Balfour, Jeremy (Lothian) (Con)
Baker, Claire (Mid Scotland and Fife) (Lab)
Baillie, Jackie (Dumbarton) (Lab)
Arthur, Tom (Renfrewshire South) (SNP)
Allan, Alasdair (Na h-Eileanan an Iar) (SNP)
Adamson, Clare (Motherwell and Wishaw) (SNP)
Adam, George (Paisley) (SNP)

The Presiding Officer

The result of the division is: For 121, Against 0, Abstentions 0.

That is agreed to, and the Fuel Poverty (Targets, Definition and Strategy) (Scotland) Bill is passed. [Applause.]

Motion agreed to,

That the Parliament agrees that the Fuel Poverty (Targets, Definition and Strategy) (Scotland) Bill be passed.

The Presiding Officer

The next question is, that motion S5M-17615, in the name of Joe FitzPatrick, on the Human Tissue Authorisation (Scotland) Bill, be agreed to.

For

Yousaf, Humza (Glasgow Pollok) (SNP)
Wightman, Andy (Lothian) (Green)
Whittle, Brian (South Scotland) (Con)
White, Sandra (Glasgow Kelvin) (SNP)
Wheelhouse, Paul (South Scotland) (SNP)
Watt, Maureen (Aberdeen South and North Kincardine) (SNP)
Torrance, David (Kirkcaldy) (SNP)
Tomkins, Adam (Glasgow) (Con)
Todd, Maree (Highlands and Islands) (SNP)
Stewart, Kevin (Aberdeen Central) (SNP)
Stewart, David (Highlands and Islands) (Lab)
Stewart, Alexander (Mid Scotland and Fife) (Con)
Stevenson, Stewart (Banffshire and Buchan Coast) (SNP)
Somerville, Shirley-Anne (Dunfermline) (SNP)
Smyth, Colin (South Scotland) (Lab)
Smith, Liz (Mid Scotland and Fife) (Con)
Smith, Elaine (Central Scotland) (Lab)
Simpson, Graham (Central Scotland) (Con)
Scott, Tavish (Shetland Islands) (LD)
Scott, John (Ayr) (Con)
Sarwar, Anas (Glasgow) (Lab)
Ruskell, Mark (Mid Scotland and Fife) (Green)
Rumbles, Mike (North East Scotland) (LD)
Rowley, Alex (Mid Scotland and Fife) (Lab)
Ross, Gail (Caithness, Sutherland and Ross) (SNP)
Robison, Shona (Dundee City East) (SNP)
Rennie, Willie (North East Fife) (LD)
Paterson, Gil (Clydebank and Milngavie) (SNP)
Neil, Alex (Airdrie and Shotts) (SNP)
Mountain, Edward (Highlands and Islands) (Con)
Mitchell, Margaret (Central Scotland) (Con)
McNeill, Pauline (Glasgow) (Lab)
McMillan, Stuart (Greenock and Inverclyde) (SNP)
McKelvie, Christina (Hamilton, Larkhall and Stonehouse) (SNP)
McKee, Ivan (Glasgow Provan) (SNP)
McDonald, Mark (Aberdeen Donside) (Ind)
McArthur, Liam (Orkney Islands) (LD)
McAlpine, Joan (South Scotland) (SNP)
Matheson, Michael (Falkirk West) (SNP)
Mason, Tom (North East Scotland) (Con)
Mason, John (Glasgow Shettleston) (SNP)
Martin, Gillian (Aberdeenshire East) (SNP)
Maguire, Ruth (Cunninghame South) (SNP)
Macpherson, Ben (Edinburgh Northern and Leith) (SNP)
Mackay, Rona (Strathkelvin and Bearsden) (SNP)
Mackay, Derek (Renfrewshire North and West) (SNP)
MacGregor, Fulton (Coatbridge and Chryston) (SNP)
Macdonald, Lewis (North East Scotland) (Lab)
MacDonald, Gordon (Edinburgh Pentlands) (SNP)
MacDonald, Angus (Falkirk East) (SNP)
Lyle, Richard (Uddingston and Bellshill) (SNP)
Lockhart, Dean (Mid Scotland and Fife) (Con)
Lochhead, Richard (Moray) (SNP)
Leonard, Richard (Central Scotland) (Lab)
Lennon, Monica (Central Scotland) (Lab)
Lamont, Johann (Glasgow) (Lab)
Kidd, Bill (Glasgow Anniesland) (SNP)
Kerr, Liam (North East Scotland) (Con)
Kelly, James (Glasgow) (Lab)
Johnstone, Alison (Lothian) (Green)
Johnson, Daniel (Edinburgh Southern) (Lab)
Hyslop, Fiona (Linlithgow) (SNP)
Hepburn, Jamie (Cumbernauld and Kilsyth) (SNP)
Haughey, Clare (Rutherglen) (SNP)
Harvie, Patrick (Glasgow) (Green)
Harper, Emma (South Scotland) (SNP)
Hamilton, Rachael (Ettrick, Roxburgh and Berwickshire) (Con)
Halcro Johnston, Jamie (Highlands and Islands) (Con)
Griffin, Mark (Central Scotland) (Lab)
Greer, Ross (West Scotland) (Green)
Greene, Jamie (West Scotland) (Con)
Gray, Iain (East Lothian) (Lab)
Grant, Rhoda (Highlands and Islands) (Lab)
Gougeon, Mairi (Angus North and Mearns) (SNP)
Golden, Maurice (West Scotland) (Con)
Gilruth, Jenny (Mid Fife and Glenrothes) (SNP)
Gibson, Kenneth (Cunninghame North) (SNP)
Freeman, Jeane (Carrick, Cumnock and Doon Valley) (SNP)
Fraser, Murdo (Mid Scotland and Fife) (Con)
Forbes, Kate (Skye, Lochaber and Badenoch) (SNP)
FitzPatrick, Joe (Dundee City West) (SNP)
Finnie, John (Highlands and Islands) (Green)
Findlay, Neil (Lothian) (Lab)
Fee, Mary (West Scotland) (Lab)
Fabiani, Linda (East Kilbride) (SNP)
Ewing, Fergus (Inverness and Nairn) (SNP)
Ewing, Annabelle (Cowdenbeath) (SNP)
Dugdale, Kezia (Lothian) (Lab)
Dornan, James (Glasgow Cathcart) (SNP)
Doris, Bob (Glasgow Maryhill and Springburn) (SNP)
Dey, Graeme (Angus South) (SNP)
Denham, Ash (Edinburgh Eastern) (SNP)
Davidson, Ruth (Edinburgh Central) (Con)
Crawford, Bruce (Stirling) (SNP)
Corry, Maurice (West Scotland) (Con)
Constance, Angela (Almond Valley) (SNP)
Cole-Hamilton, Alex (Edinburgh Western) (LD)
Coffey, Willie (Kilmarnock and Irvine Valley) (SNP)
Chapman, Peter (North East Scotland) (Con)
Carson, Finlay (Galloway and West Dumfries) (Con)
Carlaw, Jackson (Eastwood) (Con)
Campbell, Aileen (Clydesdale) (SNP)
Burnett, Alexander (Aberdeenshire West) (Con)
Brown, Keith (Clackmannanshire and Dunblane) (SNP)
Briggs, Miles (Lothian) (Con)
Bowman, Bill (North East Scotland) (Con)
Bibby, Neil (West Scotland) (Lab)
Beattie, Colin (Midlothian North and Musselburgh) (SNP)
Beamish, Claudia (South Scotland) (Lab)
Balfour, Jeremy (Lothian) (Con)
Baker, Claire (Mid Scotland and Fife) (Lab)
Baillie, Jackie (Dumbarton) (Lab)
Arthur, Tom (Renfrewshire South) (SNP)
Allan, Alasdair (Na h-Eileanan an Iar) (SNP)
Adamson, Clare (Motherwell and Wishaw) (SNP)
Adam, George (Paisley) (SNP)

Against

Mundell, Oliver (Dumfriesshire) (Con)
Lindhurst, Gordon (Lothian) (Con)
Grahame, Christine (Midlothian South, Tweeddale and Lauderdale) (SNP)

Abstentions

Harris, Alison (Central Scotland) (Con)
Ballantyne, Michelle (South Scotland) (Con)

The Presiding Officer

The result of the vote is: For 116, Against 3, Abstentions 2.

That is agreed to, and the Human Tissue (Authorisation) (Scotland) Bill is passed. [Applause.]

Motion agreed to,

That the Parliament agrees that the Human Tissue (Authorisation) (Scotland) Bill be passed.

The Presiding Officer

The final question is, that motion S5M-17529, in the name of Bill Kidd, on standing order rule changes, be agreed to.

Motion agreed to,

That the Parliament notes the Standards, Procedures and Public Appointments Committee’s 12th Report 2019 (Session 5), Standing Order Rule Changes (SP Paper 532), and agrees that the changes to Standing Orders set out in Annexe A of the report be made with effect from 3 September 2019.

This Bill was passed on and became law on 18 July 2019. 
Find the Act on legislation.gov.uk