The regulation of xenotransplantation in the United Kingdom after UKXIRA: Legal and ethical issues

Xenotransplantation - the transfer of living tissue between species - has long been heralded as a potential solution to the severe organ shortage crisis experienced by the United Kingdom and other 'developed' nations. However, the significant risks which accompany this biotechnology led the United Kingdom to adopt a cautious approach to its regulation, with the establishment of a non-departmental public body - UKXIRA - to oversee the development of this technology on a national basis. In December 2006 UKXIRA was quietly disbanded and replaced with revised guidance, which entrusts the regulation of xenotransplantation largely to research ethics committees. In this article we seek to problematize this new regulatory framework, arguing that specialist expertise and national oversight are necessary components of an adequate regulatory framework for a biotechnology which poses new orders of risk, challenges the adequacy of traditional understandings of autonomy and consent, and raises significant animal welfare concerns. We argue for a more considered and holistic approach, based on adequate consultation, to regulating biotechnological developments in the United Kingdom.