The anti-gift law: where do we stand?

The anti-gift law is a law of January 27, 1993 aimed at guaranteeing the independence and transparency of health professionals, by ensuring that they are only concerned with medical reasons in their prescriptions. This was materialized by the prohibition, for these professionals, of receiving benefits in kind or in cash (Article L.365-1 of the Public Health Code).

This is an age-old concern, already present in the Hippocratic Oath: "I will give my care to the needy and to anyone who asks me. I will not be influenced by the thirst for gain or the pursuit of glory."

This 1993 law was strengthened and implemented by various laws, such as the law of December 29, 2011; ordinances, such as that of January 19, 2017, which was subsequently ratified by the law of July 24, 2019; decrees and orders.

The decree of June 15, 2020, decree n°2020-730 relating to benefits offered by persons manufacturing or marketing health products or services, therefore mainly pharmaceutical laboratories, allowed the entry into force of a new system. This decree is accompanied by orders. All came into force on this October 1st. This decree is intended to strengthen the "anti-gift" system, by specifying several points, particularly with regard to agreements, declarations or authorizations.

This decree determines in its Article 1, codified in Article R.1453-13 of the Public Health Code, the persons providing health services, who, as such, cannot be offered or promised advantages, in cash or in kind, directly or indirectly, under Article L.1453-5 of the Public Health Code. These persons are mainly doctors, persons practicing a regulated health profession, future doctors, etc.

The decree then sets out derogations from the principle of prohibition of offering advantages. These derogations are codified in Articles R.1453-14 et seq. of the Public Health Code. However, these derogations must meet a certain number of conditions, listed in Article R.1453-14 of the Public Health Code. Indeed, the offer of an advantage must, according to Article L.1453-8, follow an agreement concluded between the beneficiary and the health provider, producer or distributor. It is this agreement that is subject to various conditions, relating to the identity of the parties, the precise purpose of the agreement, the possibility of identifying indirect and final beneficiaries who are not signatories to the agreement, information on the advantages, etc. These derogations must be declared according to the formalities of Articles R.1453-15 and R.1453-16 of the Public Health Code, to the supervisory authorities (Article R.1453-15 of the Public Health Code). One of the decrees of August 7, 2020 sets the amounts from which an agreement, provided for in Article L.1453-8 of the Public Health Code, stipulating the granting of advantages is subject to authorization.

The decree then sets out derogations subject to authorization. According to Article R.1453-17, paragraph 1, of the Public Health Code, this concerns benefits exceeding the amount of the thresholds set in Article L. 1453-11. This authorization request is subject to formalities, provided for in Article R.1453-18 of the Public Health Code.

Furthermore, a decree of August 7, 2020 sets the amounts below which benefits are considered negligible in value, according to Article L.1453-6, 4° of the Public Health Code: these are benefits, in kind or in cash, that are limited in amount and frequency. According to Article L.1453-6, these benefits do not constitute "benefits" within the meaning of the other provisions, and thus are not subject to any formalities.

Thus, there are three types of exceptions set by the decree and the orders: those whose amount is considered negligible; those subject to authorization; and those whose amounts fall between the two, which are then only subject to declaration.

Business law