In particular, the rules have been broadened and pharmaceutical companies are now subject to the anti-gift rules regardless of whether or not their products are covered by the health insurance system. All products included in the Public Health Code list, even if the French National Agency for Medicines and Health Products Safety does not regulate them, fall within the scope of regulation. In addition, and as stated by Leem, the French pharmaceutical industry association, some amendments are immediately applicable, such as the prohibition on offering hospitality to students and student associations during scientific or professional meetings or promotional events, to avoid any pressure on students and to stop influential practices. However, as pharmaceutical companies are still waiting for the implementing texts, they are currently operating in a grey zone. The future anti-gift rules are expected to become applicable in autumn 2019.
In addition, the transparency requirements have also been broadened by the New Health Law, by the inclusion of a new category of person to be covered by the requirements: influencers, who are persons who, in the media or on social networks, present one or more health products in such a way as to influence the public, are now also regulated persons.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, September 2019 Issue (Thomson Reuters).
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.
- France has passed new laws regarding pharma events: As of October 1, 2020, all french pharma external events will have to adapt to the last DMOS updates. The changes are made on the following points: CNOM” stands for Conseil National de l’Ordre des Médecins (French National Medical Council). he OM ( (Already active since August) – Previously: Pharmaceutical events were to be reported to the CNOM for advisory purposes only. – Following the evolution of DMOS law: Organizers of pharmaceutical events will have to declare all their events for validation. Events will be split into two regimes triggering different processes. o Regime 1 The declaration will remain consultative for events respecting the DMOS ceilings and not representing a total cost of more than 1500 euros HT per participant. o Plan 2 The declaration will lead to a request for validation by the CNOM, which may cancel/refuse the event up to 1 month before its start. This plan concerns all events representing a total cost of more than 1500 euros HT per participant or less but not respecting the ceilings (discussed below in this email). CEILINGS (active change as of October 1)