Report on the remodelling of risks in tissue- and cell-therapies

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. In the last few years cell-based therapies, and especially transplanted pancreatic islets, have taken the lead in the development of xenotransplantation. In the shift of scientific and regulatory interest from organs to cells rights and risks are also necessarily going to be reshaped. As individual risks are imagined to be reduced and dispersed, individual rights are also being resized and minimized, while collective rights are re-enunciated as detailed lists of safe behaviors. The precautionary principle, if has not disappeared as a term from policy agendas as the main legitimizing discourse on safety, is going to be replaced with other, more defined and operationalized concepts, like traceability – keeping track of all elements involved, from subjects to processes to products – and smart legislation. In this process of regulatory normalization, XT has come to resemble ordinary forms of risk, associated with well-known and well-characterized hazards, and has stopped to be perceived as an unknown. Also, all risks from cell-therapies are considered as specific to each product, be it either human or nonhuman-cell based. Despite the tendency toward a more international and standardized approach to cell-therapies, some relevant differences exist between the United States and European Union regulatory strategies, still reflecting different ways to think about risks; and the normative landscape is becoming even more complicated after New Zealand, Canada, and Australia are framing, or reframing, their own perspective.