In a previous edition of our newsletter we wrote about the French draft law on the modernisation of the drug and health products system (projet de loi "relatif à la modernisation du système des produits de santé”). The law, developed as a response to the scandal in which the pharmaceutical product Mediator was involved, was presented to the French Council of Ministers on 1 August 2011 and will affect the pharmaceutical and medical technology industry.

Following the adoption in September by the French National Assembly (the lower house of the French Parliament), the French Senate (the upper house) agreed on 27 October to a tightened version of the draft law on the modernisation of the drug and health products system, introducing a collective redress system or ‘group of victims’ litigation mechanism, similar to class actions in the US. It will impact governance and reorganisation of the French Health Products Safety Agency (AFSSAPS), pre-market approval, control and post-market evaluation of drugs, and promotion and advertising of medical devices.

Part of the law dedicated to transparency and conflict of interests between healthcare professionals (“Title I”) will look familiar to companies based in the US and is often billed as the “French Sunshine Act”. Such act makes it obligatory, among other things, to make public all direct and indirect benefits drugs and medical device companies provide to healthcare professionals, patient associations, hospitals, students, scientific societies and specialised media. Even though the questions about its implementation are to be specified by an “implementation decree”, the French Ministry of Health indicated, during the debates in the Parliament, that the threshold for reporting by companies on their relationships with healthcare professionals should be €1. The exact threshold will be determined in the upcoming regulation.

Next, the two Houses will try to reach an agreement on the final text. Should they be unable to do so, the National Assembly has the prevailing voice. The French government intends to adopt this law by the end of the year.

Eucomed, together with its US counterpart AdvaMed and the French medical technology industry association SNITEM, is closely monitoring the situation and will try to ensure that the proposed system remains balanced.

For more information, please contact Aline.lauteberg@eucomed.org