Question reference: S5W-35514
- Asked by: David Torrance, MSP for Kirkcaldy, Scottish National Party
- Date lodged: 24 February 2021
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Current status: Initiated by the Scottish Government. Answered by Mairi Gougeon on 25 February 2021
Question
To ask the Scottish Government what action it is taking following the Medicines and Healthcare Products Regulatory Agency's (MHRA) review of the use of UK plasma for fractionation.
Answer
The Medicines and Healthcare products Regulatory Agency has advised Ministers that, following its detailed review in 2020, the Commission on Human Medicines has recommended that UK plasma can be used for production of immunoglobulin medicines as they are satisfied that the risk of transmission of variant CJD (vCJD) via immunoglobulins manufactured from UK plasma is now negligible. The MHRA is now the sole regulator for medicines and the agency responsible for the licensing of medicinal products in the UK.
For this reason, Ministers across the UK have agreed to lift the current ban on using UK plasma for fractionation, which was introduced in 1998 as a vCJD risk mitigation measure. All other existing vCJD risk mitigation measures will remain in place.
This means plasma from donations given in the UK will now be able to be used to produce medicinal immunoglobulin products to treat patients in Scotland and the rest of the UK. This should improve the security of supplies of these medicines in future.
The Scottish Government will now work closely with the Scottish National Blood Transfusion Service to review options for the collection and use of plasma from donors in Scotland in future.