[The French National Medicines Assessment Committee, innovation and therapeutic progress]

In France the role of the French National Medicines Assessment Committee, which is a part of the French National Authority for Health (HAS), is to evaluate the expected performance of new drugs in comparison with that of existing drug or non-drug treatments. This process includes evaluation of degree of innovation generally based on whether the drug can be considered as possibly, likely or certain to represent a factor of progress. However innovation and progress are not always synonymous. Progress is defined in terms of improvement in efficacy or tolerance determined by estimating the impact of the new product in comparison with existing modalities on the health of a subgroup of patients that can be readily defined, identified and studied. In general the committee considers any originality as positive since a new chemical or pharmacological class or a new mechanism of action may allow treatment of patients that did not respond to or tolerate existing products. However, when confronted with a concept without clear clinical benefits, the committee must distinguish between true and false innovation so that deliberation focuses more on recognition and quantification of progress than on systematic evaluation of innovation.