Xenotransplantation and Risk : Regulating a Developing Biotechnology

Sara Fovargue explores the law's ability to protect people from the risk posed by xenotransplantation (cross-species transplantation). By exploring regulatory approaches to biotechnologies in the UK and elsewhere, she highlights how such biotechnologies challenge existing legal and ethical norms and how this influences their regulation.

Some developing biotechnologies challenge accepted legal and ethical norms because of the risks they pose. Xenotransplantation (cross-species transplantation) may prolong life but may also harm the xeno-recipient and the public due to its potential to transmit infectious diseases. These trans-boundary diseases emphasise the global nature of advances in health care and highlight the difficulties of identifying, monitoring and regulating such risks and thereby protecting individual and public health. Xenotransplantation raises questions about how uncertainty and risk are understood and accepted, and exposes tensions between private benefit and public health. Where public health is at risk, a precautionary approach informed by the harm principle supports prioritising the latter, but the issues raised by genetically engineered solid organ xenotransplants have not, as yet, been sufficiently discussed. This must occur prior to their clinical introduction because of the necessary changes to accepted norms which are needed to appropriately safeguard individual and public health.