UK-sourced plasma approved for medicine manufacture 27 years after BSE crisis prompted ban

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PLASMA sourced from UK blood donations has been approved for use in manufacture of five medicines, 27 years after the “mad cow disease” outbreak prompted its ban.

It follows an assessment made last month by the UK Medicines and Healthcare products Regulatory Agency (MHRA) concerning the risk of contracting variant Creutzfeldt-Jakob disease (vCJD) - the human form of BSE, widely known as mad cow disease - from blood transfusions. Its expert panel found the risk to be negligible. 

The move means that five “high priority” medicines can now be manufactured domestically to treat patients with blood conditions. The MHRA noted that the five medicines - Fibrinogen, Prothrombin complex concentrates, C1 Esterase Inhibitor, Factor X and Protein C - face increasing demand at a time of “global decrease in the number of blood donations”. 

The ban on UK-sourced plasma in medicines came after the country’s mad cow disease epidemic in the 1980s and 90s sparked widespread fear of vCJD, when the variant of CJD first emerged. vCJD is a fatal condition leading to brain damage; it has caused 178 deaths since it was first identified in 1995. In 2000, an inquiry into mad cow disease criticised public authorities at the time for being slow to acknowledge the link between BSE and vCJD. 

While most cases of vCJD have been caused by eating contaminated beef, it can also be transmitted through blood transfusion. The 1999 ban was accompanied by a £30m ($40.8m) programme phasing out UK-sourced plasma from medicines. 

Previous modelling predicted that a second outbreak of vCJD could affect tens of patients each year in the 2020s, but in reality there have been no cases since 2012. There have also only been five recorded vCJD deaths associated with blood transfusions since 1995. 

Alison Cave, the MHRA’s chief safety officer, said: “Having thoroughly reviewed the evidence, we are now confident that the risk of using plasma from UK donors is negligible, ensuring these potentially life-saving products will become available to those who need them.”

Gerry Gogarty, director of blood and plasma supply at NHS Blood and Transplant, said: “These life-changing treatments are only possible thanks to our incredible blood and plasma donors. As the UK’s ambition to increase plasma medicines production grows, we need more regular donors to ensure these vital treatments are available to every patient who depends on them.

“We urge people to come forward and help us continue to grow and boost our supplies.”  

Very British scandals

The BSE inquiry was not the only public inquiry to examine the vCJD outbreak. The disease’s link to blood transfusions was examined in the inquiry into the UK’s infected blood scandal, published in 2024, triggered by around 6,000 haemophilia and other bleeding disorder patients who had been treated with contaminated blood, mostly in the 1970s and 80s.

That inquiry heard evidence from one patient who contracted vCJD in 1997 as a result of a blood transfusion during surgery. The risk of having contracted vCJD was established in 2000, but the patient was not informed of this risk until four years later. The inquiry reported that he should have been informed much sooner.