Today, October 1st 2020, the updated anti-gift scheme in France enters into force.  The anti-gift rules impose obligations on pharmaceutical, medical device and cosmetics companies when interacting with healthcare professionals (“HCPs”) and healthcare organizations (“HCOs”) in France.  The updated framework was foreseen in the adoption of Ordinance 2017-49 of 19 January 2017 and Decree 2020-730 of 15 June 2020.  This blog summarizes the new French rules.

As a general principle, Article L.1453-5 of the French Code of Public Health (Code de la santé publique – CSP) prohibits companies manufacturing or marketing healthcare products or providing healthcare services from providing benefits to HCPs and HCOs.  The companies concerned by this obligation are those that manufacture products that are under the supervision of the French Medicines Agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé – ANSM), such as medicines, medical devices, cosmetic products, human tissues or cells, contact lenses, etc.

By way of derogation, only certain benefits can be offered subject to strict conditions and formalities (Article L. 1453-7 CSP):

  • Fees or payments in relation to research, consulting and, more generally, service agreements, provided that the fees are proportional to the service rendered.
  • Gifts, in cash or in kind, for research, research valuation or scientific assessment activities.
  • Prizes or competitions to reward scientific research.
  • Research grants.
  • Gifts to healthcare professional associations, except in case the main purpose is unrelated to the professional activity.
  • Hospitality provided during promotional, professional or scientific events, provided that the hospitality is reasonable, limited to the main professional and scientific objective of the event, and is not extended to persons other than recipients listed in Article L. 1453-4 CSP.
  • Funding to promote continuing medical education.

Granting any of the listed benefits is subject to the conclusion of an agreement between the company and the beneficiary, which must then be submitted to the relevant ethics board.  For benefits of low value, the agreement must only be declared to the relevant ethics board, whereas other benefits are subject to a prior authorization system supervised by the relevant ethics board.  The relevant ethics board depends on which physicians are involved.  Ethics boards are established per territoriality and there is one national ethics board (Conseil National de l’Ordre des Médecins – CNOM) in France.

The ministerial ruling from 7 August 2020 determines what constitutes benefits of “low value” to which the declaration procedure applies.  For instance, gifts and grants to HCPs intended exclusively to finance research and scientific assessment activities are subject to prior approval if they exceed a value of € 5,000.

When benefits are subject to prior authorization, the approval procedure will be initiated by the submission of the agreement to the relevant ethics board.  The ethics board will then take a decision within two months of receipt of the file.  In case of refusal, a new draft agreement may be submitted within 15 calendar days.  The ethics board will then have 15 days to take a new decision.  The rules also provide an urgency procedure, in which case the ethics board must take its decision within a time limit of three weeks.

The following benefits fall out of the scope of the anti-gift rules framework:

  • Fees linked to an employment contract or certain commercial agreements for the supply of goods or services;
  • Benefits related to the profession of the recipient and which are considered to be of “negligible value”, as determined by a second ministerial ruling from 7 August 2020 (for instance, office supplies worth up to € 20 are considered to be of negligible value);
  • Royalties and IP related payments.

Companies that violate these obligations may be subject to a criminal fine up to € 750,000.  This amount can be increased to 50% of the value of the benefits constituting the offence.  Ancillary sanctions may also apply, such as a ban on participating in public tenders, the suspension of business activities, or the closing of facilities.

The anti-gift rules apply in parallel to the transparency obligations under the “sunshine” rules concerning the disclosure of value transfers, but both systems have a slightly different scope of application and different reporting modalities.

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Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart…

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart holds a Ph.D. in EU and International Law and was a professor of EU law until 2013. During that time, he wrote the first-ever handbook with Cambridge University Press on “EU External Relations Law” (2014). He then transitioned to private practice, and frequently acted for the Belgian government before the EU Court of Justice (e.g. C-16/16P Belgium vs Commission). Bart joined Covington in 2016, leading some of our most consequential EU litigation proceedings (e.g. C-311/18 “Schrems II”) over the years.  Having handled nearly 50 cases before the EU Court, he’s uniquely qualified to support our corporate clients in our most high-stakes disputes. Recent examples include T-189/21 Aloe Vera of Europe v Commission (which we won, so the Commission decided to appeal); as well as T-201/21 Covington & Burling and Van Vooren v Commission (which we also won, and hence is also on appeal).

As a pioneer in biodiversity law, over the past 15 years Bart has built a unique, global practice on Access and Benefit-Sharing (ABS) laws under the Convention on Biological Diversity, the Nagoya Protocol, the Plant Treaty, the High Seas Treaty and the WHO Pandemic Agreement. ABS compliance is critical when sourcing biological materials for life sciences R&D and I work with many of the world’s innovative life sciences companies on the whole range of e.g. transactional, contractual, compliance, IP, (EU) regulatory and litigation work relating to ABS. As biodiversity has increasingly become identified as a major commercial and financial risk to companies, so has the practice expanded to e.g. biodiversity credit markets, biodiversity insurance, biodiversity claims and advertising, and so on. Since April 2025, Bart has been appointed as the industry representative to the Steering Committee of the UN Biodiversity Fund that seeks funding from the private sector for biodiversity conservation and restoration.

Bart also pioneered our global health practice. He has advised pharmaceutical clients on seasonal and pandemic influenza since 2016. Since then, this practice area expanded to cover all matters relating to infectious diseases, and as of 2020, emergency preparedness and response (eg. WHO prequalification, International Coordination Group negotiations, Emergency Use Listing, International Health Regulations Rev 2024). He has been the pharmaceutical industry’s lead lawyer advising on the WHO Pandemic Treaty negotiations, adopted on 14 May 2025. Currently, he continues to advise on the work of the Intergovernmental Working Group (“IGWG”) teasing out the technical details of the “Pathogen Access and Benefit-Sharing System” intended to create legally binding obligations on companies to commit vaccines, therapeutics and diagnostics in case of a new global health emergency.

In Chambers rankings, clients have kindly described Bart as “very knowledgeable, action-focused and service-focused lawyer”, adding that he “really tries to find a way of working through challenges”, am “customer-oriented” and provide “sound advice and reasonable options for our business with pros and cons.”

Finally, Bart has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation before the EU Court.

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