The regulatory landscape in France regarding the relationship between the life sciences industry and health-care practitioners (HCPs) continues to undergo significant changes.
Transparency requirements are regulated in France by two main sets of regulation: Law No. 93-121 of 27 January 1993 (the “French Anti-Gift Law or French DMOS Law) regulates the provision of gifts, discounts and other incentives to HCPs by life sciences companies, while Law No. 2011-2012 of 29 December 2011 (the French Sunshine Act) imposes on companies disclosure obligations relating to benefits granted to and agreements concluded with HCPs.
While the French Sunshine Act has been frequently amended to reflect subsequent changes brought by implementing decrees, orders, and circulars, the Anti-Gift Law has been less subject to change, at least until now.
Reshaping of Anti-Gift provisions
Changes to the Anti-Gift Law are contemplated in the near future pursuant to the recent adoption of Ordinance No. 2017-49 on 19 January 2017, which aims at extending the scope of the Anti-Gift Law and at changing the procedure related to the prior submission to the national or departmental board of the relevant HCP professional body.
Upcoming clarification on the disclosure of remuneration paid to HCPs
In addition to the Anti-Gift Law, life sciences companies are required to disclose certain information on a public Stateportal. In recent years there have been changes concerning the content of the disclosure and this has presented a challenge for life sciences companies trying to meet their disclosure obligations.