The demise of UKXIRA and the regulation of solid-organ xenotransplantation in the UK
- Institute of Law and Ethics in Medicine, University of Glasgow, The Stair Building, Glasgow G12 8QQ, UK; s.a.m.mclean@law.gla.ac.uk
- Correspondence to: Sheila McLean Institute of Law and Ethics in Medicine, University of Glasgow, The Stair Building, Glasgow, G12 8QQ, UK; s.a.m.mclean{at}law.gla.ac.uk
- Received 14 February 2007
- Accepted 14 February 2007
- CGS, clinical governance committee
- GTAC, Gene Therapy Advisory Committee
- LREC, local research ethics committee
- UXIRA, United Kingdom Xenotransplantation Interim Regulatory Authority
The new regulations on xenotransplantation pay insufficient attention to the broad ethical (and legal) problems raised by this technique and that the abandonment of a national body with overall regulatory authority in this area is a mistake.
Following reports from the Nuffield Council on Bioethics1 and, most importantly, the Advisory Group on the Ethics of Xenotransplantation2 (the Kennedy report), the UK Xenotransplantation Interim Regulatory Authority (UKXIRA) was established in 1997. The existence of a national body to govern xenotransplantation was deemed to be of critical importance by the Kennedy report (and by the government of the time) given the practical and ethical issues associated with xenotransplantation. Indeed, the Kennedy report recommended that ultimately UKXIRA should be placed on a statutory footing.2 The remit of UKXIRA was to advise the Secretary of State on particular applications, gather information on issues such as safety, and assess whether the preconditions identified by the Kennedy report had been met.3
In December 2006, UKXIRA was quietly disbanded, and the Department of Health issued a statement of guidance, the terms of which now govern xenotransplantation in the UK. This document superseded procedures that had been in place since 1998, which had placed the overall regulation of applications to conduct xenotransplantation in the hands of UKXIRA and, ultimately, the Secretary of State.4 The revised guidance defines xenotransplantation as being: “… any procedure that involves the transplantation, implantation, or infusion into a human recipient of either live tissues or organs retrieved from animals, or, human body fluids, cells, tissue or organs that have undergone ex vivo contact with live non-human animal cells, tissues or organs.”5 (emphasis added). Given the range and nature of the procedures covered by the guidance, it is surprising, not to say a little worrying, that it is so …
