§ Lord Lucasasked Her Majesty's Government:
Whether they are aware of any experimental results that show that, when cattle infected with BSE are used in the preparation of substances used in making human vaccines and injectible medicines, no 14WA infectious material reaches the final product; and, if not, whether they propose to sponsor any such research. [HL2368]
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath)Research into the pathogenicity and epidemiology of Bovine Spongiform Encephalopathy has been extensive. Last year this Government spent over £26 million on research on Transmissible Spongiform Encephalopathy. There has been no specific research to detect these agents in medicines. However, when bovine materials are used in the manufacture of some human vaccines and some injectable medicines, manufacturers are required to comply with the European Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products. This requires careful sourcing of the bovine materials such as from countries where there have been no reported cases of BSE, the nature of the animal tissue used in the manufacture, and the production process and its control.
For injectable products that do not include bovine material as an ingredient in the finished product, purification processes designed to remove the material are used. The manufacturers of such products are required to provide validation of those processes to the Medicines Control Agency. For products that include bovine material in the finished product, compliance with the guidance minimises any risk of the presence of BSE infected material at any stage of the manufacturing process.