UK Government lifts its ban on the use of UK donor plasma for PDMP manufacture

25 February 2021

In 1998, the UK Government imposed a ban on the use of UK plasma for PDMP manufacture as a precautionary measure against the risk of vCJD transmission by plasma products.

Following a comprehensive review of the scientific evidence by the UK Regulatory Authority (MHRA) accumulated for more than 20 years, the UK Government today (25th February, 2021) has announced its lifting of the ban and its intention to recommence plasma collection from UK donors for the manufacture of immunoglobulin products for the treatment of UK patients:

IPFA welcomes and celebrates this important development and warmly welcomes the return of the UK as a much needed contributor to the global plasma supply – as will UK patients, health care providers and donors.

It is understood that the lifting of the UK ban applies only to immunoglobulin products driven by a desire to increase security of supply of these products as international demand escalates and plasma supply reduces as a result of the SARS-Cov-2 pandemic. IPFA urges the UK authorities to widen its review to include other essential PDMPs for both UK patients and other patient communities throughout the world. International regulatory authorities beyond the UK have also adopted precautionary measures related to the risk of vCJD transmission, and in particular donor deferral policies and guidelines to exclude donation by those with a travel/residence history in the UK. IPFA similarly urges these regulatory authorities to review such policies to reflect the most recent data and risk assessment undertaken by the UK MHRA.

Meantime we eagerly await news of the operational plans being developed by the UK Blood Establishments and wish them every success in the development of their plasma collection programmes.