By Stewart Eisenhart, Emergo Group
Two versions of a draft law amending regulations of pharmaceutical and medical technology products in France have been adopted by the French National Assembly and Senate.
The modernization law sets up a collective redress system for litigation similar to class action lawsuits available in the US, and will necessitate reorganization of the French Health Products Safety Agency (AFSSAPS) as well as promotion and advertising of medical devices, according to Eucomed.
Under the law, medical device and pharmaceutical firms would be required to make public all benefits and perks they provide to health care providers, hospitals, patient groups and media. The French Ministry of Health has argued that the threshold for reporting by firms should be €1, but the actual threshold amount will not be determined until finalization of the law.
The National Assembly and Senate must now hammer out a final version of the law; if no compromise can be reached, the National Assembly’s version of the law will stand. Final adoption of the law is expected by the end of 2011.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.