French “anti-gift” rules strictly regulate the relationship between the life sciences industry and healthcare professionals (“HCP”) and the possibility for companies active in the health sector to offer benefits, in cash or in kind to healthcare professionals, medical students or associations representing them.  This includes a general prohibition against offering such benefits.

To strengthen the existing regulatory framework, France has taken several additional actions and significantly amended the anti-gift provisions, by an Ordinance dated 19 January 2017 (“2017 Ordinance”).  The new provisions, Articles L1453-3 and following of the French Public Health Code (Code de la Santé Publique or “CSP”), entered into force on 1 July 2018.  However, companies affected remain in a grey zone until the publication of implementing texts, that should be available in autumn 2019.

Law No 2019-774 sets out new rules, in particular, on training, hospital locations, video health consultations, and plans for the creation of a new data platform which will collect, organise and make available national healthcare data.  Among the new provisions, Law No 2019-774 further elaborated the anti-gift provisions of the Public Health Code.

First, Law No 2019-774 ratifies the 2017 Ordinance, so that text becomes law.  Ratification was needed to maintain the validity of the 2017 Ordinance for the future.

Second, article 77 of the law provide some changes to the anti-gift rules.

Article L1453-5 of the Public Health Code has been modified to clarify the scope of the anti-gift rules.  Under the 2017 Ordinance, the scope of the rules has been broadened and all pharmaceutical companies are now subject to the anti-gift rules regardless whether or not they have products on the market in France.  In addition, the law brings within the scope of the anti-gift rules products that are covered by the national health insurance system (‘social security’) even if the ANSM (the French authority for health products) does not regulate them.  Examples include clinical nutrition products.

As an exception to the general prohibition on the offer of benefits to HCPs, it is possible to offer benefits of negligible value.  The amount of these benefits of negligible value by category of benefit (i.e., meals included in normal working relationships, books, office supplies, items of medical utility, etc.) will be defined in an implementing text that should be published in the coming months.  In addition, Law No 2019-774 specifies that the maximum amount per benefit must be defined over a specified period of time (Article L1453-6, 4°).

Law No 2019-774 also expressly prevents professional ethics boards (conseils nationaux professionnels) from receiving any donations or grants in cash or in kind (Article L1453-7, 3°).

Finally, hospitality during scientific or professional meetings or promotional events cannot be offered to healthcare students and student associations anymore, in order to minimize or even eliminate any pressure on students and put an end to influential practices that are quite common in training places such as universities or health institutions (Article L1453-7, 4°).

Moreover, article 78 of the law also introduces a new definition under the sunshine rules.  Influencers are now expressly covered by the transparency requirements.  Article L1453-1, 7° states that companies marketing relevant products shall make available on a public website the existence of any agreement, and any benefits and fees granted to “persons who, in the media or on social networks, present one or more health products in such a way as to influence the public.”

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Photo of Grant Castle Grant Castle

Grant Castle is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation…

Grant Castle is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington’s Life Sciences Industry Group and is Head of Covington’s European Life Sciences Regulatory Practice.

Grant regularly advises on:

  • EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
  • Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
  • Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • Advertising and promotion of both pharmaceuticals and medical devices; and
  • Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 18 years. He is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “highly competent in understanding legal and technical biological issues.”