Xenotransplantation and public health: identifying the legal issues.

The debate over the acceptability of clinical trials for xenotransplantation has focussed primarily on analyses of: 1) the medical benefits that might accrue to individual patients in need of organ replacement therapy; 2) the risk of introducing new infectious disease(s) into the population; and 3) the ability of public safety measures to minimize that risk. It is now generally accepted that if we are to proceed with xenobiotechnology, sufficient public safety measures must first be adopted. Despite the growing consensus as to the indispensability of scientific safeguards, few authors have questioned the ability of current or novel legal frameworks to sustain and enforce such safeguards. A legal analysis of the public health concerns must be incorporated into the debate if we are to ensure a thorough and responsible decision-making process.