Safety of UK Plasma for Fractionation to Make Immunoglobulins: Revised Advice

Helen Whately Excerpts

Thursday 25th February 2021 Written Statements

[The Minister for Care (Helen Whately)]

I would like to inform the House that the Government have decided to allow the use of UK sourced plasma for the manufacture of immunoglobulins.

In the wake of the bovine spongiform encephalopathy (BSE) epidemic in the 1990s, a number of extra precautionary safety measures were introduced to protect patients from exposure to blood products that may increase their risk of developing Creutzfeldt-Jakob disease (vCJD). This included the advice in 1998 of the then Committee on Safety of Medicines, that no UK plasma should be supplied for the manufacture of fractionated plasma-derived medicinal products. This has meant that over 250,000 litres of plasma are incinerated or not used for patient care each year.

Over the last 15 years, accrued scientific evidence has indicated that the risk of vCJD through the transfusion of UK plasma is much lower than initially thought; there have been no known transfusion transmissions of vCJD from any blood components since 1999. The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) evaluated the risk of transmission of vCJD and recommended that the current risk reduction measures be withdrawn.

In 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) undertook a comprehensive review of the safety of UK plasma to make immunoglobulins. The Commission on Human Medicines (CHM) considered the evidence and recommended that UK-sourced plasma can be used for the manufacture of immunoglobulins subject to several risk-mitigation measures.

The CHM’s recommendation is available online at:

https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/folder/109651850203

Upon receiving this expert advice, the Secretary of State for Health and Social Care has approved these recommendations, as have the Ministers in the devolved nations. This means that for the first time in over 20 years, UK plasma can again be fractionated to increase the availability of immunoglobulin medicines for the benefit of NHS patients in the UK.

This also means that convalescent plasma could potentially be fractionated and used, as part of a clinical trial, to produce hyperimmune globulin as a potential treatment for covid-19 patients.

The Secretary of State for Health and Social Care has directed NHS England and NHS Improvement, NHS Blood and Transplant (NHSBT) and the MHRA to begin preparations to appoint a fractionator(s) through a competitive process. The aim is to secure a domestic supply of immunoglobulins, starting with circa 250,000 litres of plasma that NHSBT is already collecting and not using for transfusion. We expect the first UK-sourced immunoglobulin product to be available for NHS patients in 2022.

The Secretary of State for Health and Social Care has also directed the MHRA to introduce a condition in new and existing authorisations granted to blood establishments, that plasma collected in the UK (including convalescent plasma) should be used for the benefit of UK patients, at least until domestic demand is met.

The Welsh and Scottish Governments and the Northern Ireland Executive have also directed their respective blood services to take forward work on this.

[HCWS797]