Following an extensive safety review, the Medicines and
Healthcare products Regulatory Agency (MHRA) has approved the use
of UKdonor plasma for
five highpriority medicines,
helping to strengthen supplies of life-saving
treatments used by thousands of critically ill
patients each year.
The decision, announced today (9 July 2026), follows an
assessment of the potential risk of
variant CreutzfeldtJakob disease (vCJD). Independent
experts concluded that the risk of transmission through these
products is negligible.
Plasma proteins from donated human blood can be used to make
medicines known as plasma-derived medicinal products
(PDMPs). They are typically given to critically ill
patients to replace or restore vital plasma proteins
and help treat or prevent serious diseases, bleeding, infections,
and other conditions where the body's natural plasma components
are missing, deficient, or not functioning properly in the
body. This includes patients with conditions such
as bleeding disorders, neurological and autoimmune
diseases, liver disease or sepsis.
A precautionary ban on the use of UK-sourced plasma
for manufacturing these medicines has been in place since
1999, requiring reliance on imported plasma at a time of growing
global demand. Restrictions have been lifted
for immunoglobulin and human
albumin products in 2021 and 2023 respectively. This
latest decision extends the use of UK
plasma for these essential treatments.
The review drew on advanced modelling to assess
the risk of patients receiving the proposed five PDMPs
being infected with vCJD.
Allowing the use of plasma from UK blood donors for
the manufacture of Fibrinogen, Prothrombin Complex
Concentrates (PCCs), C1 Esterase Inhibitor, Factor X
and Protein C, will aid supply and reduce reliance
on imports from other countries.
The public are encouraged to donate blood and plasma regularly,
given the growing demand for PDMPs and potential supply
constraints. Plasma can currently be donated directly at three
specialist centres in Twickenham, Reading and
Birmingham. However it is also taken from every whole
blood donation collected across the country.
Dr Alison Cave, MHRA Chief Safety Officer,
said:
Patient safety is our top priority and we will always
take precautionary measures where there is any possibility
of risk to public health. 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, says:
This announcement is another significant step which highlights
the trust and confidence in UK plasma and our ability to create a
more resilient UK supply of plasma medicines.
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.
To register or book an appointment to donate blood or
plasma, visit the NHSBT
website or download the NHS Give Blood app.
