The Regulation of Xenotransplantation in the United Kingdom After UKXIRA: Legal and Ethical Issues
| Published date | 01 December 2007 |
| Date | 01 December 2007 |
| DOI | http://doi.org/10.1111/j.1467-6478.2007.00400.x |
JOURNAL OF LAW AND SOCIETY
VOLUME 34, NUMBER 4, DECEMBER 2007
ISSN: 0263-323X, pp. 441±64
The Regulation of Xenotransplantation in the United
Kingdom After UKXIRA: Legal and Ethical Issues
Laura Williamson,* Marie Fox,** and Sheila McLean*
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 significantrisks 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 biotechno-
logical developments in the United Kingdom.
Advances in biotechnology pose significant ethico-legal challenges for the
delivery of healthcare and the conduct of research that precedes the
development of innovative medicinal products and therapies. Similarly, they
present complex issues for traditional regulatory structures in the field of
health and health-related research, often posing the question of how private
benefit may appropriately be reconciled with collective risk.
1
In recent years,
441
ß2007 The Author. Journal Compilation ß2007 Cardiff University Law School. Published by Blackwell Publishing Ltd,
9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA
* School of Law, The Stair Building, 5±9 The Square, University of Glasgow,
Glasgow, G12 8QQ, Scotland
** School of Law, Keele University, Staffordshire ST5 5BG, England
l.williamson@law.gla.ac.uk m.fox@law.keele.ac.uk s.mclean@law.gla.ac.uk
1 I. Welsh and R. Evans, `Xenotransplantation, risk, regulation and surveillance:
social and technological dimensions of change' (1999) 18 New Genetics and Society
regulatory initiatives and reforms have tackled some of these challenges,
2
demonstrating how the regulatory landscape of contemporary health care law
must shift and evolve in response to the emergence of new technologies and
the novel problems associated with them. Such reforms encounter particular
difficulties when traditional boundaries or relationships ± for example,
between different individuals, between humans and animals, and between
humans and their environment ± are altered or eroded. While such
difficulties are not necessarily barriers to biotechnological progress, they
require close examination given their potential impact on how we live as
individuals and on the type of society we inhabit. In this article we will use
the example of animal-to-human transplantation as a means of identifying
and analysing obstacles to the regulation of novel biotechnologies. This case
study is particularly pertinent given recent changes in how xenotechnologies
are regulated in the United Kingdom. We argue that it illustrates the ill-
considered and ad hoc nature of many regulatory reforms, notwithstanding
the important social consequences they have.
XENOTRANSPLANTATION UNDER UKXIRA
Xenotransplantation ± the transfer of living tissue between species ± came to
be afforded attention in the United Kingdom, and internationally, because of
its potential benefits for individual and public health.
3
Animal-to-human
transplantation has long been lauded as a potential solution to the shortage of
442
197±217; E.R. Gold and W.A. Adams, `Reconciling Private Benefit and Public Risk
in Biotechnology: Xenotransplantation as a Case study in Consent' (2002) 10 Health
Law J. 31±75, at 32.
2Thus, the Human Reproductive Cloning Act 2001 was a response to new methods of
human cloning; the Human Tissue Act 2004 established (in s. 13) a new Human
Tissue Authority to oversee research involving human materials; in 1999 a non
statutory body ± the Human Genetics Commission (HGC) ± was entrusted with
analysing current and potential developments in human genetics and advising
Ministers on their likely impact on human health and healthcare, and their social,
ethical, legal, and economic implications; in 2006 a Government White Paper
introduced proposals which would radically overhaul existing laws regulating
reproductive technologies and embryology ± Department of Health, Review of the
Human Fertilisation and Embryology Act: Proposals for revised legisl ation
(including establishment of the Regulatory Authority for Tissue and Embryos)
(2006; Cm. 6989).
3 Nuffield Council on Bioethics, Animal-to-Human Transplants: The Ethics of
Xenotransplantation (1996); Advisory Group on the Ethics of Xenotransplantation,
Animal Tissue into Humans (1996) (The Kennedy Report); World Health
Organzation (WHO), Report of the WHO Consultation on Xenotransplantation,
Geneva, Switzerland 28±30 October 1997 (1998); WHO, Xenotransplantation:
Guidance on Infectious Disease Prevention and Management (1998); OECD/WHO,
Consultation on Xenotransplantation: Summary Report (2001).
ß2007 The Author. Journal Compilation ß2007 Cardiff University Law School
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