On the 25th February 2021 the Government issued a press release lifting the ban on the use of UK plasma for the manufacture of immunoglobulins.
An update from Immunodeficiency UK
Immunodeficiency UK is delighted that UK plasma, the liquid part of whole blood, will be available to make immunoglobulin (IgG) for primary and secondary immunodeficiency patients once more.
David McIntosh, Chair of the UK Plasma Action Alliance (UKPA), a consortium of stakeholders including Immunodeficiency UK, the professional bodies UK PIN, the Immunology and Allergy Nurses Group and the British Society for Immunology, has been lobbying for this change in Government policy over the last two years.
‘The United Kingdom Plasma Action, campaign has been a most satisfying testimony to what can be achieved when like-minded people work selflessly towards a common goal’ said David. It’s been a privilege to be involved. I can think of no better causes than patient safety and well-being and I’m confident that the UK Government’s new plasma policy will help to optimise both.’
This development will allow the UK to develop resilience against the worldwide pressures in plasma supply that have so adversely affected patients living with antibody deficiencies over the last few years. As soon as this plasma is ‘fractionated’ (pharmaceutically processed), there will be a direct benefit to patients in the security of the IgG supply.
Why did the UK stop manufacturing IgG from UK plasma?
The UK stopped fractionating plasma during the BSE/Variant Creutzfeldt‚ÄìJakob disease (vCJD) outbreak when a concern arose that blood products might possibly transmit prion disease. It was done as a precautionary measure, until the science became clearer. It has more recently been clearly established that there is no longer any significant risk of this kind associated with UK blood donors or the plasma that they donate.
How do we know that UK plasma is safe?
Plasma from UK donors was widely used, safely and efficaciously, in pharmaceutical manufacture for many years. This was discontinued during the UK vCJD epidemic which started in 1994/5 and peaked in the year 2000. This disease was subsequently shown to be contracted by eating contaminated meat products. It has never been known to be caused by any plasma product.
There have been very few cases of vCJD in the UK in the last ten years and none at all in the last five years. The most important point however is that after lengthy investigations it has been shown that even when the disease was prevalent in the UK, and even before the ban when UK donors’ plasma was still being used to make plasma derived medicines, there were never any cases of vCJD infection via any of those medicines. The ban on UK plasma was a purely precautionary move and has since proven to be no longer necessary. Over the last two decades, a number of detailed long-term studies have been conducted – all confirming zero transmission via plasma, including in a longitudinal study involving PID patients and a 25-year follow-up study on haemophilia patients receiving long term Factor VIII treatment.
Because of a theory that white cells might be the most likely reservoir of prion diseases in blood, all UK blood donations have been leucodepleted (filtered to remove white cells) since 1998. Since then there have been no recorded cases of vCJD infection via red cell transfusions or the administration of any other fresh blood components either.
During 2019 and 2020, with the weight of this safety evidence accumulating, the UK Government and its scientific advisers had already been investigating the advisability of allowing UK donors’ plasma to be used once again for pharmaceutical medicines manufacture. This very thorough scientific investigation was completed late in 2020, with a formal recommendation that reinstating UK donors’ plasma to pharmaceutical use was absolutely the safe and right thing to do.
How will this help patients?
One of the concerns for patients who are reliant on immunoglobulins to maintain health has been the availability over the last few years of the right quantity of the right product at the right time. When you are wholly reliant on donors in other countries to supply the plasma for IgG products, there is little resilience in the system, especially at times of global shortage. Market forces have created instability in supply, with patients having to switch products or have their dose adjusted to account for shortages in the last 5 years. Now, from the whole blood donations of generous UK donors, the recovered plasma will account for some 15% of the total UK need for IgG – more than enough to cover the annual increase in demand for new patients going on IgG and to help stabilise the supply for patients on existing IgG therapy. Beyond that, the UK Blood Transfusion Services are also now collecting plasma from convalescent donors in purpose-built collection centres. This has established a very welcome extra plasma collection capacity with the long-term potential to further enhance the availability of plasma for fractionation into IgG and other vital medicines.
How was this change brought about?
Over the last two years Immunodeficiency UK (PID UK) has been part of UKPA. The Alliance was formed in June 2019 by UKPA Chair David McIntosh. A blood donor himself and former Chairman and General Manager of the Scottish National Blood Transfusion Service, David has long experience in both blood services and protein fractionation. Under his leadership, the Alliance team has worked tirelessly over the last 18 months, consulting top experts in the field, preparing and presenting scientific evidence and following every avenue to lobby on behalf of patients, doctors, nurses and donors, to bring about this significant change in UK policy.
Immunodeficiency UK is extremely grateful to David and all stakeholders for all their hard work and dedication.
Views from patients
Margaret was diagnosed with eighteen years ago with CVID. ‘I have been having immunoglobulin therapy ever since, and there is a growing need for this treatment around the world. During this time, we have had to rely solely on imported plasma. There have been times in the past when plasma was in short supply and my hospital was unsure if, or when, new supplies would become available. It would be very reassuring to all PID patients to know that we could start using UK plasma again.’
Stacey, whose son, Xander, pictured left, has XLA says, ‘My son’s condition, XLA, means he cannot make the antibodies he needs to protect him against infection and we rely on the lifesaving medicine immunoglobulin to keep him well and healthy. Immunoglobulin is made from human plasma and up to now the UK has been 100% reliant on plasma supplies from overseas. Shortages of immunoglobulin are not uncommon and removing the ban on the use of UK plasma means the UK can start to become more self-sufficient in producing immunoglobulin products. This is a good thing for people like my son as it increases the security of supply of the treatment he relies upon to fight infection’.
Revised advice on the safety of UK plasma for fractionation to make immunoglobulins. Statement made on 25 February 2020.
Posted 3rd March 2021