Transfer of value: amendments to the French “anti-gift” provisions by the draft Health Act

The “anti-gift” provisions were amended by an order of 19 January 2017 that officially entered into force on 1 July 2018.

In practice, the actual application of these provisions is subject to the publication of the corresponding implementing texts, which still remain awaited. This transitional situation gives rise to many uncertainties for companies active in the health sector.

The “anti-gift” provisions are about to be amended again in the framework of the upcoming Act relating to the organization and transformation of the health system (the “Health Act”), which is currently under discussion in Parliament.

The main changes to the "anti-gift" provisions arising from the draft Health Act are:

1. The inclusion of the following persons within the scope of the “anti-gift” rules:

• any person manufacturing or marketing health products in the field of competence of the French Medicines Agency ("ANSM"), regardless of whether they are funded under the social security scheme (this is already the case under the 2017 order);

and

• any person manufacturing or marketing health products funded under the social security scheme, regardless of whether they fall in the ANSM's field of competence.

The aim of this amendment is to include companies manufacturing or marketing certain products, such as nutrition products, which are reimbursed through social security but that are not in the field of competence of the ANSM, within the scope of the “anti-gift” provisions.

2. A complete prohibition on providing hospitality, such as in the framework of professional, scientific and promotional events, to students training to become HCPs and student associations.

3. Specification that the amount under which a transfer of value will be considered “negligible”, and therefore not considered an advantage under the “anti-gift” provisions, will be set for a given period of time (i.e. a sum not to be exceeded over said time period).

The next public discussion of the text will take place on 10 July 2019.