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.