The Medicines and Healthcare products Regulatory Agency (MHRA) has announced its approval for the use of UK-donated plasma in the manufacture of five high-priority medicinal products. This significant decision, made public on 9 July 2026, is expected to enhance the availability of life-saving treatments for thousands of critically ill patients across the UK each year and reduce the nation's reliance on imported plasma.
The move comes after a comprehensive safety review, which specifically assessed the potential risk of transmitting variant Creutzfeldt-Jakob disease (vCJD) through these products. Independent experts, utilising advanced modelling, concluded that the risk of vCJD transmission via these five plasma-derived medicinal products (PDMPs) is negligible. This finding paves the way for the domestic use of plasma in treatments such as Fibrinogen, Prothrombin Complex Concentrates (PCCs), C1 Esterase Inhibitor, Factor X, and Protein C.
A precautionary ban on using UK-sourced plasma for manufacturing these specific medicines had been in effect since 1999, prompting a reliance on imports amidst increasing global demand. This latest approval marks a further step in lifting these restrictions, following previous decisions in 2021 and 2023 that allowed UK plasma for immunoglobulin and human albumin products, respectively. The MHRA, an executive agency of the Department of Health and Social Care, stated that patient safety remains its top priority.
Plasma proteins, derived from donated human blood, are crucial for creating PDMPs. These medicines are typically administered to patients suffering from conditions such as bleeding disorders, neurological and autoimmune diseases, liver disease, or sepsis, helping to replace or restore vital plasma proteins. Dr Alison Cave, MHRA Chief Safety Officer, affirmed confidence in the negligible risk, ensuring these treatments become available to those in need.
Gerry Gogarty, Director of Blood and Plasma supply at NHS Blood and Transplant, welcomed the announcement, highlighting it as a significant step towards a more resilient UK supply of plasma medicines. The public is encouraged to continue donating blood and plasma regularly to meet the growing demand for PDMPs. While whole blood donations contribute plasma, direct plasma donations are currently possible at specialist centres in Twickenham, Reading, and Birmingham.