Variant Creutzfeldt-Jakob Disease (vCJD) Risk Reduction Measures: Revised Advice

Monday 9th September 2019 Written Statements

[The Minister for Care (Caroline Dinenage)]

I would like to inform the House that the Government, along with the Scottish Government and the Welsh Government, will be updating some specific variant Creutzfeldt-Jakob disease (vCJD) precautionary measures in England, Scotland and Wales.

In 2004, the Government were advised to establish precautionary vCJD risk reduction measures in the UK, acknowledging the unknown risks of vCJD to recipients of UK plasma and platelets. A number of measures were introduced, such as the introduction of leucodepletion of all blood components and the deferral of previously transfused donors. These specific risk reduction measures are highly effective and will remain in place to maintain the safety of the UK blood supply.

An additional risk reduction measure adopted involved the treatment of patients born on or after 1 January 1996 with imported plasma and/or apheresis platelets. This was to reduce the risk of exposure to components that were thought to have potentially increased their risk of developing vCJD.

Over the last 15 years, accrued scientific evidence has indicated that the risk of vCJD through the transfusion of UK plasma or platelets is much lower than initially thought; there have been no known transfusion transmissions of vCJD from any blood components since the leucodepletion process was introduced. In March 2019, the independent advisory committee for the safety of blood, tissues and organs (SaBTO) reviewed the scientific evidence and operational practices, engaged with stakeholders, and recommended that some specific risk reduction measures, requiring the use of imported plasma and apheresis platelets for individuals born on or after 1 January 1996 and/or with TTP, be withdrawn.

SaBTO’s final advice has been published on the gov.uk website, providing a comprehensive analysis of the risk attributed with updating these vCJD risk reduction measures. This advice is available online at: https://www. gov.uk/government/collections/sabto-reports-and-guidance-documents.

Upon receiving this expert advice, the Minister for Care has approved the use of domestic plasma and pooled platelets for patients born on or after 1 January 1996 or with TTP. Other risk reduction measures will remain in place, including leucodepletion, deferral of previously transfused donors and a ban on the manufacture of plasma derived medicinal products from plasma sourced in the UK.

NHS Blood and Transplant already sources 94% of plasma from UK donors and increasing domestic plasma use will provide further benefits relating to equitable provision of blood components, reduced operational complexity for hospitals and increased accessibility at the point of use. Clinicians who wish to prescribe and source commercial imported plasma products for patients, based on patient need and clinical preference, will continue to be able to do so in accordance with local and national guidelines.

The Minister for Care has now directed NHS Blood and Transplant (BT) to begin increasing domestic plasma acquisition in England through a managed, incremental transition. The Scottish Government and the Welsh Government have also asked their respective blood services to begin implementing SaBTO’s recommendation. In Northern Ireland, any decision on SaBTO’s recommendation to update vCJD risk reduction measures will be deferred until a Minister is in post.

[HCWS1821]