The apheresis working group was established in 2024 to provide independent advice to the Department on issues around apheresis capacity and the resilience of the United Kingdom’s stem cell supply. The group has submitted an internal, interim report to ministers for consideration and is currently working to gather additional data to strengthen the evidence base of this report, before proceeding to publication.

The apheresis working group was established in 2024 to provide independent advice to the Department on issues around apheresis capacity and the resilience of the United Kingdom’s stem cell supply. Membership includes the UK aligned stem cell registry, health professionals, and service providers. Stakeholder views have been captured through member organisations, including the Cell and Gene Therapy Catapult and blood cancer charities, and industry representatives have also been invited to present at meetings of the group.

There are no plans to consult external stakeholders prior to the publication of the group’s review of apheresis capacity. The group will look at options for formalising feedback following publication.

The Government is considering Sir Brian Langstaff’s recommendations, including recommendation 9 that relates to the use of alternatives to plasma-derived medicines. We will provide an update to Parliament on the progress we are making by the end of the year, as the Inquiry recommends.

In April 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) reviewed the latest scientific evidence available on the safety of donor plasma from the United Kingdom and was able to lift the ban on its use for immunoglobulin-based medicines; the ban had been in place since the mid-1990s due to concerns about over the potential spread of variant Creutzfeldt-Jakob (vCJD) disease. This was followed by a review of and lifting of the ban on albumins, also derived from UK donor plasma.

Both immunoglobulin and albumin are critical medicines for the National Health Service, with approximately 17,000 patients in England relying on immunoglobulins each year but these products are in short supply globally. Following the MHRA view that UK plasma is safe, the Department set up the Plasma for Medicines programme to increase our self-sufficiency and to protect vulnerable patients from the risk of global supply shocks. The first UK donor plasma was shipped for manufacture into medicines in August 2024 and these will be available to NHS patients from January 2025.