Abstract
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.
Résumé
Le débat sur l’acceptabilité des essais cliniques pour les xénotransplantations a essentiellement porté sur les analyses: 1) des bienfaits médicaux dont pourraient bénéficier les patients nécessitant une thérapie de remplacement d’organes; 2) des risques d’introduction d’une ou de plusieurs nouvelles maladies infectieuses au sein de la population; et 3) des capacités qu’ont les mesures de sécurité publique de minimiser ce risque. Tout le monde reconnaît aujourd’hui que si nous devons aller de l’avant avec la xénobiotech-nologie, il faut tout d’abord mettre en place des mesures suffisantes pour protéger la sécurité publique. En dépit du consensus croissant pour reconnaître qu’il est indispensable de disposer de mesures de protection scientifiques, rares sont les auteurs qui doutent que les cadres juridiques actuels et nouveaux ne puissent pas faire appliquer pareilles mesures de protection. Il importe donc d’intégrer au débat une analyse juridique des préoccupations relatives à la santé du public si l’on veut s’assurer de suivre un processus de prise de décisions qui soit complet et fasse preuve de responsabilité.
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