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Baroness Jay of Paddington: The assessment of suffering of a patient and the appropriate therapeutic action in response to that suffering is a matter for clinical judgment, within the context of the law. I refer the noble Lord to the reply I gave on 16 July at columns WA 112-113.
Baroness Jay of Paddington: We 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.
The 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.
Baroness Jay of Paddington: We have approved the report and accounts which has today been laid before both Houses of Parliament in accordance with the requirements of Section 5(2) and 5(3) of the Exchequer and Audit Departments Act 1921. Copies have also been placed in the Library.
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