French legal framework relating to human tissues and cells

Abstract

Thousands of patients receive human tissue grafts every year. Developments in cell and tissue engineering have also increased considerably the number of available products of human origin. France has very strict regulations, in part stimulated by problems of public health and ethics that have emerged in recent years and also in part as a result of a report by the ‘Inspection Générale des Affaires Sociale’ on the removal and grafting of human tissues in May 1993. These have resulted in two laws on bio-ethics being passed, in July 1994, that are the basis of current legislation and represent the first steps in differentiating between organs and tissues or cells. Henceforth, the French legal framework covering tissues and cells of human origin has been increased to include a large number of legislative texts and regulations. The fundamental ethical principles that are consent, free donation, anonymity, no publicity and respect for public health have become a major ethical imperative that applies to all products originating from the human body including tissue and cells. In addition, specific provisions have been made covering: removal (conditions for removal and system for authorisation); conservation, transformation, distribution, packaging, import and export of tissues and cells; and tissue and cell grafts. Finally, penal and administrative sanctions have been foreseen where there is non-compliance with these regulations.