Report on regulatory models for xenotransplant

Xenotransplantation (XT), the transplant of tissues or organs from animals to humans, has been seen as a promise to solve the problem of shortage of human organs. However, XT has the potential to introduce new infections (so-called xenozoonosis or xenogeneic infections) into humans. The tension between the potential benefits to individuals and the potential risks to the population through the transmission of infectious agents from patients to the general public remains problematic. In this challenging context, moving from preclinical to clinical trials, different regulatory frameworks have been established as an attempt to normalize XT, namely to create well-defined, secure normative environments to minimise the potential risks of infections while respecting fundamental rights in democratic societies. The analysis of these different legal approaches show how science and law are mixed in the production of different regulations. Scientific and legal statements are mutually adjusted to each other to support the legitimacy of XT. Specific scientific assumptions are adopted if and when they match desirable legal outcomes, while scientific needs are used to justify legal constraints. In the US system individual rights and individual autonomy represent the unsurpassable tenets of the liberal society. In the European context the existence of a political entity such as Europe and the sovereignty of Member States are the dialectic poles for the legal framework. In Canada and Australia the tensions between the exploration of new forms of democracy and a more traditional vision of expertise and decision-making are at stake.