All plasma-based manufactured blood products are to be found from outside the UK for the foreseeable future, following Government advice that new variant CJD could be transmitted through blood.
The Committee on Safety of Medicines (CSM) issued this latest advice following its recent review of the sourcing of blood products.
It claimed that although there is currently no evidence that CJD can be transmitted by blood, there is a theoretical risk. It therefore suggested manufactured blood products should not be gained from UK plasma.
“Although it was accepted that some parts of the manufacturing process for blood products may separate prion proteins, the present state of the art means that these processes cannot be validated. Therefore the theoretical risk that CJD could be transmitted by blood products cannot be discounted,” said the CSM in its report.
As a result of the advice, the bodies which process plasma in the UK – the NHS’s Bio Products Laboratory and the Protein Fractionation Centre in Scotland – are to import plasma from outside the UK, with the US the most likely source.
CSM chairman, Professor Michael Rawlins, said the shift to imported plasma was likely to take several months. This is because suitable collection centres abroad will have to be identified and inspected by UK authorities, and the manufacturing centres cleaned before the new plasma can be used.
Rawlins stressed the advice did not affect the use of blood for transfusion, platelets and fresh frozen plasma.
“These products are produced from single donations and patients would not be exposed to the same large number of donors as when the manufactured products are used,” he said.
It is believed the decision could cost as much as £70m, as current stocks, worth £20m, will have to be scrapped. Unions claim additional blood filtration procedures will add a further £50m to the total bill.