Drug price setting and regulation in France

In France, drug prices have historically been regulated but approaches to setting and regulating prices have been evolving in recent years. In 2003, the prices of new outpatient drugs, which had hitherto been entirely regulated, were semi-liberalised, with drug companies setting prices in line with those in neighbouring countries; and in parallel with this in 2004, the prices of expensive drugs and/or drugs qualifying for reassignment must now also be set in line with European prices. In addition to this, price/volume regulation has recently been introduced. This document describes the price setting rules applicable to each drug category and discusses different measures for regulating drug price, particu-larly the conventional policies implemented under successive framework agreements. The regulatory path for medicines and the different actors involved are presented in an Appendix.