The French National Medical Council has published its annual report for the year 2021, in which a section is devoted to the “anti-gift” scheme.
As a reminder, the “anti-gift” scheme prohibits persons producing or marketing health products for health purposes or providing health services from offering or promising benefits to health professionals or similar, to students and to associations of such persons. However, this scheme provides for exemptions to this prohibition principle[1], subject to compliance with the declaration or authorization procedure applicable according to thresholds set by decree (see our article of August 14, 2020)[2].
This scheme went into effect on October 1, 2020 (see our article of October 1, 2020). The French National Medical Council ‘s 2021 annual report provides figures on the first full year of application of this scheme.
What should we remember?
At least once a month, the French National Medical Council’s Commission on Physician-Manufacturer Relations meets to make decisions and recommendations on draft agreements and agreements concluded between physicians and manufacturers, after studying the benefits proposed or granted by manufacturers.
For the year 2021, the Commission received 9,136 applications for authorization and 49,155 prior declaration files.
With regard to authorizations
Of the 15,836 decisions[3] rendered by the Commission, 13,698 authorizations were granted and 2,138 requests for authorization were denied.
With regard to the declarations
Of the 49,155 reporting files received by the Commission, 4,005 were the subject of recommendations[4].
It should be remembered that the Commission’s recommendations may, for example, concern the definition of benefits, their amounts and the content of the agreement (non exhaustive list).
The recommendations are not binding on manufacturers. That said, they may be taken into account by the control services in the event of an investigation or litigation related to the granting of an advantage[5].
[1] For the record, the following benefits can be offered:
- Remuneration, compensation and expenses for research, research promotion, scientific evaluation, consulting, service provision or commercial promotion activities;
- Donations and gifts intended exclusively to finance research activities, the promotion of research or scientific evaluation;
- Donations and gifts to associations of health professionals or similar or students;
- Hospitality offered during events of an exclusively professional or scientific nature, or during events promoting health products or services;
- The financing or participation in the financing of professional training or continuous professional development.
[2] The order of August 7, 2020 sets the amounts above which an agreement is subject to authorization.
[3] 15,836 represents the total number of decisions rendered by the Commission, while 9,136 represents the number of applications for authorization that were received by the Commission and that include one or more draft agreements.
[4] These files included one or more draft agreements.
[5] Certain authorities, such as the DGCCRF, are empowered to investigate and qualify (subject to the sovereign appreciation of the courts) violations of the scheme.
GD Avocats advises manufacturers on issues related to the “anti-gift” scheme and assists them in their litigation. Contact us by e-mail : contact@gd-associes.com
