Dr. Denis Comet, President of AFCRO (the French Association of CROs), talks about the evolution of the clinical research environment in France and the new government actions aimed at speeding up the clinical trial process.   Didier Genot from France Biotech told us that France has lost competitiveness when it comes to clinical research and trials. More and more, companies are conducting their clinical trials in other countries such as Belgium and Spain. How would you say that the situation has evolved in recent years and what kind of market dynamics have you witnessed in the CRO field? AFCRO is indeed a partner of France Biotech. The latter being the association of biotech companies in France, their area of focus is naturally on Phases 1 and 2. In these phases, the time needed to get the authorization is very important and the situation in the past year was not the best in France. According to French law, the Ethics Committee is randomly selected, so as to break any potential link between the principal research investigator and the committee, itself. This results in having ethics committees that have to deal with dossiers in domains they have never worked in, due to the fact that each committee does not represent a comprehensive pool of experts. This is problematic especially in Biotech, Medtech and in the first two phases of trials, as the ongoing investment is considerable and you need to get approval as soon as possible to get to the next step of the research process. Luckily, in the first semester of 2019, the situation could change: a new law proposed to the National Assembly and a new software package will help assemble more qualified committees. For example, if a committee does not include an expert in the specific relevant field, you will not be qualified on the list of possible ethics committee. The random access will remain but it will be limited to qualified ethical committees that could have a good knowledge of the protocol. This is fundamental, as research is getting more and more specific.

France is back. We, the French, might be harsh critics, but for the first time, I see the Ministry of Solidarities and Health taking concrete and simple steps to improve the competitiveness of France in clinical research.