Date lodged: 21 July 2017
To ask the Scottish Government, in light of the reported findings of the Medicines and Healthcare products Regulatory Agency (MHRA) following a routine inspection of Bio Products Laboratory premises, what action it is taking regarding any impact on patient safety in Scotland.
Answered by: Shona Robison 15 August 2017
At present, in terms of supply, the MHRA do not envisage any disruption. In Scotland a three month contingency stock of plasma products is held by the Scottish National Blood Transfusion Service. The national oversight provided by the National Plasma Product Expert Advisory Group and this three month contingency stock would allow for smooth transition to alternative products in a controlled manner, which would not expose patients to any risk, should a supply issue occur.
The Scottish Government have been working with the MHRA to establish any potential impact in Scotland on both patient safety and supply. The MHRA have confirmed that in light of all of the information currently available, their assessment is that no patients have been harmed and none put at any additional risk of harm.