Title: Life at all costs: European precautionary policies on xenotransplantation

Authors: Jan Reinert Karlsen, Roger Strand, Jan Helge Solbakk

Addresses: Department of General Practice and Community Medicine, Section for Medical Ethics, P.O. Box 1130 Blindern, N-0318 Oslo, Norway. ' Centre for the Study of Sciences and the Humanities, University of Bergen, P.O. Box 7805 N-5020 Bergen, Norway. ' Section for Medical Ethics, Faculty of Medicine, University of Oslo, Pb. 1130 Blindern, N-0318 Oslo, Norway

Abstract: Xenotransplantation is becoming an independent political and regulatory issue. Most national regulations and international recommendations prescribe a precautionary approach, including strict monitoring and surveillance of patients. This is due to the risk of xenosis, a disease induced by non-human biological material. The paper shows how the precautionary approach violates fundamental principles of medical ethics, and might violate human rights and European values. Accordingly, the important question is whether to allow xenotransplantation at all, given the risk of xenosis. Indeed, if the precautionary approach recommended by the Council of Europe is implemented, the concept of |inclusive governance| becomes at best unclear and at worst contradictory and unviable. Can there be an inclusive governance process that democratically leads to an ethical state of exception becoming routine?

Keywords: medical ethics; human rights; informed consent; precautionary principle; xenotransplantation; precaution; patient monitoring; patient surveillance; xenosis; risk management; human rights; European values; inclusive governance; risk assessment.

DOI: 10.1504/IJRAM.2009.024128

International Journal of Risk Assessment and Management, 2009 Vol.12 No.1, pp.35 - 47

Published online: 26 Mar 2009 *

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