§ Mr. BakerTo ask the Secretary of State for Health what criteria will be applied to determine whether the disease transmission risks associated with xenotransplantation are of a magnitude to rule out the commencement of clinical trials. [31686]
§ Mr. BoatengThe rapid rate of progress in the scientific knowledge surrounding xenotransplantation is such that any set criteria used to determine disease transmission risks would quickly become outdated. Nevertheless, the safety of the individuals concerned and of the public in general must be foremost in the consideration of any proposal to undertake a xenotransplantation procedure. Our position remains that clinical trials in xenotransplantation involving humans will be allowed to take place only when we are fully satisfied that the risks associated with such procedures are acceptable, taking account of all the available evidence at the time.
We are advised by the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA) on these issues and on the acceptability of applications to undertake clinical trials in xenotransplantation involving humans. Any application will be assessed on its own merits and will be expected to include a full assessment of the microbiological risk of the proposed procedure. The UKXIRA will be assisted in its deliberations by independent assessors who will offer expert advice in all the relevant fields. The Advisory Committee on Dangerous Pathogens has agreed to set up 398W a subgroup to look at the risks of various types of xenotransplant and will be a further source of advice to the UKXIRA.