A ban lasting more than 20 years on using UK plasma to manufacture albumin treatments has been lifted by the Medicines and Healthcare Products Regulatory Agency (MHRA), which described albumin as "a critically important medicine for the NHS".
The Agency said that human albumin treatments made from plasma proteins derived from donated human blood were "given to thousands of critically ill patients every year to replace blood loss from trauma such as severe burns or injuries, and [to] those suffering from conditions such as liver disease or sepsis".
It said that the Commission on Human Medicines (CHM) had confirmed that albumin could now safely be derived from UK plasma donors.
A ban on the use of UK human blood plasma for the manufacture of any plasma-derived medicinal product was introduced in 1999, in response to the emergence of variant Creutzfeldt–Jakob disease (vCJD). The disease had been linked with consumption of meat from cattle afflicted with bovine spongiform encephalopathy (BSE, commonly called 'mad cow disease'). Controversial modeller Neil Fergusson of Imperial College London had predicted that vCJD could lead to up to 50,000 deaths . In fact, the death toll was 178 .
British Blood Donors Banned Around the World
Over the subsequent two decades, anyone who had spent more than 3 months in the UK between 1980 and 1996 was prohibited from donating blood in the US, Australia , France, Canada, and various other countries. The NHS subsequently had to rely on imported plasma-derived products, primarily from the US.
In 2021 , the bar on using UK plasma to manufacture immunogoblins was lifted, and the latest MHRA announcement now removes the parallel prohibition for albumin products.
In a critical risk assessment in 2021, the MHRA noted that plasma was a starting component for the manufacture of a number of medicinal products and that, unlike transfusions of whole blood or blood components, plasma products involved "pooling blood donations from numerous donors to extract sufficient amounts of a particular component". This introduced the risk of a pathogen present in the blood of a single donor affecting the entire pool, it said, explaining the rationale for the ban.
Resulting supply limitations due to the need to import plasma in the UK had necessitated the NHS prioritising supply of plasma products to patients with the highest clinical need.
In its latest announcement, the MHRA said that following further review of the evidence, the CHM had recommended lifting the ban on treating patients with UK-derived albumin. Relevant organisations and manufacturers would still be required to abide by risk mitigation measures adopted for immunoglobulin manufacture, such as the use of leucodepletion (filtering the white blood cells from donated blood to reduce the risk of adverse reactions), high-risk donor deferral and the ability to trace donations.
No Transfusion-associated vCJD Transmission since 1999
The Agency noted that since the introduction of leucodepletion in 1999 there had been no reports of transfusion-transmission of vCJD. It said that a commercial process is underway to establish the capability to fractionate UK plasma to separate out the albumin and other components for NHS use.
The global plasma fractionation market is forecast to be worth US$ 60 billion by 2032 , as the world's population ages and becomes increasingly prone to uncommon ailments that can be treated by blood derivatives.
Commenting on the lifting of the ban, Gerry Gogarty, director of plasma for medicines at NHS Blood and Transplant, said: "This is another opportunity for the UK to reduce its reliance on imported plasma products, on which so many patients depend."
He added: "Our donors won't see any changes, but every precious blood or plasma donation can now save even more lives."
Dr Alison Cave, MHRA chief safety officer, said: "I am so pleased that we have been able to support the lifting of this ban by examining the safety evidence and that there is now the potential to produce life-saving treatments from plasma that has been donated in the UK."
