Updates on the new French health law and it's impact on clinical trials.

Presenters included Jean-Pierre Isal, Consultant, UK; Jean-Marc Husson, Prof, Eur Acad of Pharm Med, France; Astra Zeneca. The system has been changed from the Notification System, established in 1988 to a formal Clinical Trial Authorization, 2004-5.

Participants discussed the changes that have taken place on the protection of study subjects due to the Directive implementation. Patient associations and consumers of the health systems have access to pertinent parts of protocols. There has been a reinforcement of pharmacovigilance and risk management, and interventional studies and non interventional studies have been defined. The role of the clinical trial authorization committee has changed and it appears that these committees are overwhelmed with paper work. In addition, most of the committee members are voluntary, and they are in need of training and education in the scientific part of a protocol. The committees have more responsibilities now and activities to cover. The sponsor is now the essential partner of the committee, whereas before, the investigator and the sponsor worked together. Dialogue and feedback between the sponsors and the committee are a necessary requirement.

It was pointed out in the audience discussion that there also remain contradictions with regard to non commercial trials. There still remains a conflict of interest with this directive. It was suggested that national health should pay for the drugs in these trials, they should not be donated by pharmaceutical companies. Some attendees spoke about the differences with non commercial trials, these trials are put in a position where they do not have to follow regulations.

Although there is only one valid authorization within the EU, authorities in each country are reading them differently, and interpretation and questions in each country may vary or be very different. This makes it difficult for sponsors to run trials for one drug in different countries.

Many of the session participants felt that the objective for harmonization is not yet there. It was suggested that it may take as long as ten years to establish an FDA of the European Union.