Entry into force of reinforced anti-gift rules in France

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Today, October 1, 2020, the updated anti-donation system in France comes into force. The anti-gift rules impose obligations on pharmaceutical, medical device and cosmetic companies when they interact with healthcare professionals (“HCP”) and healthcare organizations (“HCO”) in France. The updated framework was provided for in the adoption of Ordinance 2017-49 of January 19, 2017 and Decree 2020-730 of June 15, 2020. This blog summarizes the new French rules.In general principle, article L.1453-5 of the public health code (Public health code – CSP) prohibits companies manufacturing or marketing health products or providing health services from providing benefits to health professionals and HCOs. The companies concerned by this obligation are those which manufacture products under the control of the French Medicines Agency (National Agency for Medicines and Health Products Safety – ANSM), such as drugs, medical devices, cosmetic products, human tissues or cells, contact lenses, etc.

By way of derogation, only certain services can be offered under strict conditions and formalities (article L. 1453-7 CSP):

  • Fees or payments related to research, advice and, more generally, service contracts, provided that the fees are proportional to the service rendered.
  • Donations, in cash or in kind, for research, research evaluation or scientific evaluation activities.
  • Prize or competition to reward scientific research.
  • Research grant.
  • Gifts to associations of health professionals, except in cases where the main objective is not related to professional activity.
  • Hospitality provided during promotional, professional or scientific events, provided that the reception is reasonable, limited to the main professional and scientific objective of the event, and does not extend to persons other than the recipients mentioned in the Article L. 1453-4 CSP.
  • Funding to promote continuing medical education.

The granting of one of the listed benefits is subject to the conclusion of an agreement between the company and the beneficiary, which must then be submitted to the competent ethics committee. For low-value services, the agreement must only be declared to the competent ethics committee, while other benefits are subject to a prior authorization system supervised by the competent ethics committee. The competent ethics committee depends on the doctors concerned. Ethics committees are established by territoriality and there is a national ethics committee (National Council of the Order of Physicians – CNOM) in France.

The ministerial decision of August 7, 2020 determines what constitutes “low value” services to which the declaration procedure applies. For example, donations and subsidies to health professionals intended exclusively to finance research and scientific evaluation activities are subject to prior approval if they exceed a value of € 5,000.

When the services are subject to prior authorization, the approval procedure will be initiated by the submission of the agreement to the competent ethics committee. The ethics committee will then make a decision within two months of receiving the file. In the event of refusal, a new draft agreement can be submitted within 15 calendar days. The ethics committee will then have 15 days to make a new decision. The regulations also provide for an emergency procedure, in which case the ethics committee must take its decision within three weeks.

The following benefits are outside the scope of the anti-gift rules:

  • Costs related to an employment contract or certain commercial agreements for the supply of goods or services;
  • Benefits linked to the beneficiary’s profession and considered to be of “negligible value”, as determined by a second ministerial decree of 7 August 2020 (for example, office supplies with a maximum value of € 20 are considered to be of negligible value );
  • Intellectual property royalties and payments.

Companies that violate these obligations may be liable to a criminal fine of up to € 750,000. This amount may be increased to 50% of the value of the services constituting the infringement. Ancillary sanctions may also apply, such as prohibition from participating in public tenders, suspension of business activities or closure of facilities.

The anti-donation rules apply alongside the transparency obligations of the “sun” rules regarding the disclosure of transfers of value, but the two systems have a slightly different scope and different reporting procedures.

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