French anti-gift and transparency rules
Definition : French anti-gift and transparency rules
The Public Health Code regulates relations between undertakings that manufacture or market health products and healthcare professionals through two complementary mechanisms. The first, derived from the 1993 anti-gift law and recast by a 2017 ordinance, prohibits in principle the offering or promising of benefits to these professionals. The second, derived from the Act of 29 December 2011 on strengthening the safety of medicinal and health products, requires links of interest to be published on a public database.
The prohibition of benefits and its exemptions
The prohibition covers benefits in cash or in kind, direct or indirect, granted to healthcare professionals, to students preparing for those professions and to the associations that represent them. It is subject to exemptions for the remuneration of research or expert activities, hospitality offered at professional or scientific events, and the funding of training, provided that an agreement is concluded and the amounts remain reasonable. Depending on their amount, these agreements are subject to declaration to, or prior authorisation by, the professional order or the competent authority, through an online platform.
Transparency of links of interest
Undertakings must disclose, on the Transparence Santé database, the existence of agreements concluded with healthcare professionals and other health sector actors, benefits granted above a regulatory threshold and remuneration paid. This obligation is distinct from the previous one, since a duly authorised benefit must nevertheless be published. Breaches are criminal offences for the undertaking and, as regards the prohibition of benefits, for the professional who accepts them.
Impact on research and intellectual property agreements
Expert, consultancy or research and development agreements concluded with practitioners fall within this regime and must provide for remuneration proportionate to the work performed. Where a hospital practitioner contributes to an invention, the allocation of rights depends on the practitioner’s status and public employer, under the rules applicable to employee inventions and to inventions by public servants, and the agreement must then be coordinated with the intellectual property clause and with the institution’s consent.
Key points
Any financial relationship between a health products undertaking and a healthcare professional must be assessed from the twin perspectives of the prohibition of benefits and transparency. A written agreement, proportionate remuneration and the required declaration or prior authorisation are the basic reflexes. Before signing an expert or collaboration agreement with a practitioner, the applicable declaration route and the allocation of rights in the results should be checked.
This glossary entry is general in scope and does not constitute legal advice.
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