---

Xenotransplantation Arrangements

I am announcing today changes to the arrangements for approval of xenotransplantation procedures. Xenotransplantation is the use of live cells, tissues and organs from animal sources for transplants into humans. It can be viewed as a partial solution to the ongoing shortage of human organs and tissues for transplantation. It can also raise concerns—for the safety of the individual and the wider public, for the efficacy of the procedures, and for the welfare of the animals involved. To date there have been no xenotransplant procedures in the UK, and very few, if any, are anticipated over the next few years. The Department has reviewed the interim xenotransplantation regulatory arrangements put in place by Ministers in 1997. At that time, the UK xenotransplantation Interim Regulatory Authority (UKXIRA) was established to develop a regulatory framework for xenotransplantation, and to advise Ministers on specific proposals for xenotransplant procedures. UKXIRA was a pioneer in the early debates around xenotransplantation. Its approach has been reflected in a number of international recommendations and developments. In particular, EU legislation on medicinal products (Commission Directive 2003/63/EU) and the Clinical Trails Regulations (2004) make specific provision for xenotransplantation proposals. With these statutory arrangements now in place, UKXIRA has completed its work and it will cease to exist from today, 12 December 2006. Guidance clarifying the new arrangements has been placed in the Library and is available on the Department's website at http://www.dh.gov.uk/PolicyAndGuidance/OrganisationPolicy/SecondaryCare/Transplantation/fs/en.