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Organs (SaBTO) evaluated the risk of transmission of vCJD and recommended that the current risk reduction measures be withdrawn.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: