§ Lord Kennetasked Her Majesty's Government:
Whether cows now being genetically engineered to produce human blood components are free of BSE, and how this freedom from BSE has been established.
§ Baroness Jay of PaddingtonWe are not aware of any trials of this sort, intended to produce human blood components, being undertaken in the United Kingdom, although there have been reports of such trials in the United States of America.
If in the future it should be proposed to market a product in the United Kingdom based on the kind of technology mentioned, marketing authorisation would be required. The applicant would need to demonstrate that manufacture of the product complied with European guidelines for the minimisation of the risk of transmission of transmissible spongiform encephalopathies, from the committee on proprietary medical products.
160WAThe safety of blood and blood products is kept under regular review by the expert advisory committee on the microbiological safety of blood and tissues for transplantation, which advises the United Kingdom health departments. Earlier this year a United Kingdom xenotransplantation interim regulatory authority was set up to advise the United Kingdom health departments. Its terms of reference include the safety, efficacy and any other pre-conditions for xenotransplantation, from animals for human use.