HL Deb 27 May 1993 vol 546 c37WA
Lord Kennett

asked Her Majesty's Government:

Which body is responsible for licensing the use of animal genes or viruses in human beings, and of other xenotransplants for therapeutic or research purposes; and whether the liability of those performing these transfers or licensing them is limited in time.

Baroness Cumberlege

If animal genes or viruses are produced commercially for use in human subjects, they will be licensable as medicinal products under the Medicines Act (1968) and under the relevant EC Directives, in particular 87/22/EEC. If any research involves a clinical trial an application needs to be submitted to the Medicines Control Agency and the physician or the applicant takes responsibility for the trial.

In addition, approval for work with genetically modified organisms is the responsibility of the Health and Safety Executive and the Department of the Environment in relation to "contained use" and "deliberate release" respectively.

Further consideration is being given to a range of issues raised by xenotransplantation, which is at an early stage of development.