Hidden defects in the authorisation procedure of placing drugs on the market

Economic Note / June 2006

The authorisation body for the introduction of drugs on the market of the French Agency for the medical safety of health products (AFSSAPS) announced in September 2005 the banning of Solutricine, Lysopaïne and 10 other products aiming at reinforcing immunity, because rare adverse effects of an allergic or a cutaneous nature would have appeared. The regulator poses as a guard to public health because beyond the vigilance which it exerts with respect to products already on the market, it requires pharmaceutical laboratories to perform a series of safety and effectiveness tests for every new product, before authorizing them to be put on the market. It could thus offer an essential protection against otherwise dangerous products to which patients would be exposed if such an obligation did not exist.

However, ensuring the safety and the effectiveness of the drugs is necessarily costly. From the point of view of patients, an arbitrage between these concerns and that of obtaining the products is always necessary. But the AFSSAPS tends to support an excess of precaution to the detriment of all those who are deprived of care on this basis. Moreover, it cannot respond to different requirements from a multitude of people. It is the bureaucratic and monopolistic character of decisions within the agency which is in question. Consequently, the introduction of competition into the drugs certification process should be considered vis-a-vis the prospect of a status quo.