§ Miss Emma NicholsonTo ask the Secretary of State for Health what steps his Department has taken since 1985 to screen all products such as growth hormones for contamination by serious disease.
§ Mr. DorrellThe Medicines Control Agency, which is responsible for the grant of licences under the Medicines Act 1968, requires that applicants for licences supply scientific information to support the application. The agency has issued guidance on the selection of human and animal-derived materials used in the manufacture of medicinal products. Manufacturers are expected to apply appropriate criteria for selecting the sources of such material including screening tests so that contaminated material may be excluded. The agency evaluates data submitted in support of applications with advice, when required, from expert advisory committees set up under the Medicines Act.
§ Miss Emma NicholsonTo ask the Secretary of State for Health if he will make a statement regarding the nature and extent of screening of blood products by the blood transfusion service for contamination by highly infectious diseases.
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§ Mr. DorrellIn the interests of maintaining the safety of the blood supply, all potential donors are advised not to donate blood or plasma if they consider that they are in one of the high-risk groups for infectious diseases. Additional specific groups are also excluded—such as recipients of human growth hormone, although there is no evidence that Creutzfeldt-Jakob disease infection is transmitted by blood or blood products.
In addition, all blood and plasma donations collected by the National Blood Transfusion Service are routinely tested for HIV 1 and HIV 2, hepatitis B and syphilis. These arrangements are kept under review in the light of any new developments. The Blood Transfusion Service is currently evaluating tests for the hepatitis C antibody and it is expected that routine tests for hepatitis C will be introduced from September 1991.
All factor VIII and IX produced from screened and tested donations are heat treated to inactivate HIV and other viruses. Blood itself cannot be heat treated.