The 2017 New Legal Framework Finally Ready to Go Live on October 1, 2020

The French anti-gift legal framework was substantially amended by the Ordinance No. 2017-49 dated January 19, 2017. However, these new rules were subject to the adoption of an implementing decree. Their implementation, which was initially planned for July 1, 2018, has been delayed to October 1, 2020.

The adoption of the long-awaited decree on June 15, 2020 and of two ministerial orders on August 7, 2020, put an end to two years of uncertainty faced by the pharmaceutical industry. This also marks a significant paradigm shift with the implementation of this new set of much stricter rules.

Principal of prohibition of proposing/offering benefits

In order to raise the standards and trust of the patients vis-à-vis the pharmaceutical sector, the anti-gift legal framework introduced by the 2017 ordinance notably broadened the scope of healthcare companies and professionals subject to the anti-gift prohibition. Any person manufacturing or marketing healthcare products or providing healthcare services (e.g. healthcare institutions, medical biology laboratories) is now prevented from proposing or offering benefits, in cash or in kind, either directly or indirectly, to healthcare professionals, students, associations and public officers.

While “benefits” are not defined by the regulation, it is at least specified that the following should not be deemed benefits, provided that they do not exceed the permitted thresholds:

• The remuneration, compensation and expenses provided for in an employment contract or a contract of practice, provided that the purpose of this agreement is the direct and exclusive exercise of the professional’s practice;
• Benefits from the exploitation or assignment of intellectual property rights relating to a health product;
• Commercial benefits offered in accordance with an agreement whose purpose is the purchase of goods and services by the industry;
• Benefits in cash or in kind, at market value, including all taxes, that may not exceed the following amounts (standard amounts regardless of the professional’s practice):

Click here to see the benefits table

In addition, several exceptions to the prohibition of benefits remain.

The exceptions to the prohibition principle

The other main change brought by the new rules consists of the necessity to obtain a prior authorization to offer some benefits to professionals, students or associations.

Benefits remaining below the thresholds that have been set forth by the recently published orders remain subject to prior notification, without the need to get a formal approval.

The new legal framework of exceptions to the anti-gift principle can now be summarized as follows: click here to see the table.

Conclusion

The entry into force of the anti-gift legal framework and its pre-approval regime will certainly shake up the habits of pharmaceutical companies which will need to update their internal procedures to comply with the new rules. The forthcoming case law on refusal of agreements will also have to be carefully analyzed.

However, despite the new clarifications, several questions remain, such as, for instance, the fate of the agreements referred to the competent authorities for opinion before October 1, 2020 (and therefore subject to the current anti-gift system) but providing for benefits to be paid after the entry into force of the new legal framework, or the definition of the emergency.