Recent Developments in Pharmaceutical and Bioethics Law

Law n° 2004-806 dated 9 August 2004 relating to health care policy implements the EU Clinical Trials Directive 2001/20/EC of 4 April 2001 on medicinal products for humans and reforms the French law n° 88-1138 "Huriet-Sérusclat" of 20 December 1988 on the protection of clinical trial subjects.

The amending law modifies the existing provisions of the French Public Heath Code in the following areas:

Specific clinical trial subjects are now strictly protected including are minors and incapacitated adults who are either covered by a legal protection measure or unable to give their informed legal consent. They can only participate in clinical trials if clinical trials presenting the same level of efficiency cannot be carried out on other clinical subjects and subject to the following conditions: