Since October 1, 2020, healthcare companies have been required to implement the new French anti-gift legal framework, as substantially strengthened by the Ordinance No. 2017-49 dated January 19, 2017.

Its entry into force has finally been permitted after two years of uncertainties by the adoption of the long-awaited implementing regulations.

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 at least one regulated 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. The new anti-gift regulation now applies indistinctively, whether the health products are reimbursed or not, and is not limited to companies established in France. With respect to beneficiaries, the scope of associations prohibited from receiving benefits has been significantly expanded: in addition to associations responsible for defending the categorical interests of a health profession or group of health students, any association gathering healthcare professionals or students including if their purpose is unrelated to health are concerned by the prohibition.

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 (including for instance transportation and catering costs that must be paid by the employer), 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, provided that the benefit complies with the limits provided for by the regulation with respect to the concerned sold product if any;
• 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):

 

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

The exceptions to the prohibition principle

These restrictions are accompanied by a significant change in the procedure: after two decades of non-mandatory opinions, the professional orders are now empowered to prior approve benefits above certain threshold.

Benefits remaining below these thresholds 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:

Conclusion

Although it is not groundbreaking, stakeholders should pay special attention to this new framework as new control campaigns could be performed.

Moreover, the penalties the companies and beneficiaries are likely to face have also been increased by the Ordinance of 2017:

Companies may be sanctioned by a fine up to €750,000 (or 50% of the expenses incurred for the prohibited practice) as well as by additional penalties such as the closure of the establishment or the exclusion from public procurement;

Beneficiaries may be sanctioned by one year of imprisonment, a fine up to €75,000, and additional penalties such as the prohibition to practice their profession.