UK lifts ban on use of domestic blood plasma donations in treatments
The UK government said Thursday it will lift a decades-old ban on British donations of blood plasma for use in the manufacture of medicines, in a move that could help treat thousands of critically-ill patients.
The medicines, known as immunoglobulins, are manufactured from blood plasma donated by the public and used to treat several serious diseases and conditions, including antibody deficiencies and severely reduced immune systems.
They are also being used in trials to treat the coronavirus.
The ban on UK-sourced plasma was introduced in 1998 in response to concerns over the spread of a human variant of BSE — known as “mad cow’s disease” — called Creutzfeldt Jakob Disease.
The change follows a comprehensive review last year by the Medicines and Healthcare products Regulatory Agency (MHRA) of the evidence on the safety of UK blood plasma for the manufacture of immunoglobulins.
“Following expert advice, I am pleased we are now able to lift this ban to help thousands of NHS patients access these potentially life-saving treatments as quickly as possible,” Health Minister James Bethell said.
“The move will also help England become self-sufficient and we will not have to rely only on imports from other countries, ensuring every NHS patient can always access the treatments they need,” he added in a statement.
The Scottish government, which has responsibility for health policy in Scotland, said simultaneously it would also lift the ban there.
Britain has relied on imports of blood plasma from other countries, primarily the United States, to manufacture treatments.
Amid growing global demand for immunoglobulins, supplies have been stretched in recent years, with a “significant drop” in donations from the US, the health ministry noted.
Convalescent plasma is currently being trialled in Britain to treat Covid-19 and, if results prove positive, could see immunoglobulins from donated plasma rolled out more widely to coronavirus patients.
“I am very pleased that after our thorough review of the evidence, there is now the potential to produce life-saving treatments from plasma donated in the UK for the benefit of NHS patients,” MHRA Chief Executive June Raine said.
“Patient safety is at the forefront of all the work we do, and as with any medicine available in the UK, the MHRA ensures that robust safety standards have been met before treatments made from plasma can be given to the public.”