An investigation by the DGCCRF in 2021 led to the penalization of 6.6 million euros for illegal practices by the URGO group, which unduly offered certain pharmacists more than 55 million euros in gifts.

Although heavy sanctions have already been pronounced against companies in the medical device sector and, more particularly, in the dental sector [1], they have now reached an unprecedented level.

This case is a reminder of the criminal nature of anti-gifting violations.

Criminal conviction of the Urgo Group for violation of the anti-gift law

Within the framework of its control and policing powers, provided for in articles L. 1453-3 to L. 1454-10 of the Public Health Code ("PHC"), the DGCCRF has uncovered illegal practices by Laboratoires URGO Healthcare and Laboratoires URGO.

These were commercial practices based on the granting of benefits in kind to pharmacists in exchange for the purchase of the laboratory's products and the renunciation of the contractual discounts on the purchase price of these products. To this end, pharmacists received personal rewards in the form of gifts whose value corresponded to the amount of the commercial discount.

Following the searches ordered by the Dijon Public Prosecutor's Office and the police custody hearings of a manager of the pharmaceutical group, a procedure of appearance on prior recognition of guilt ("CRPC") was approved by the President of the Dijon Judicial Court on January 27, 2023. This procedure resulted in the confiscation of more than 5.4 million euros via a criminal seizure, and the imposition of two fines totaling 1.125 million euros.

The DGCCRF reminds us in its press release of January 27, 2023 [2] that the investigation is continuing with the pharmacists involved.

It should be remembered on this point that, like offering an illegal advantage, receiving such advantages is punishable by a penalty provided for in Article L. 1454-7 of the PHC, which may be accompanied by up to one year's imprisonment and a fine of 75,000 euros, as well as additional penalties such as temporary or permanent disqualification from practicing or confiscation of the proceeds of the offence.

The "anti-gift" device in practice

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Law n° 93-121 of January 27, 1993 on various social measures ("DMOS") initiated the "anti-gift" system as a system for supervising benefits with the aim of moralizing relations between industrialists and healthcare professionals and preventing conflicts of interest. Ordinance No. 2017-49 of January 19, 2017 on benefits offered by persons manufacturing or marketing health products or services, and its implementing regulations, reformed this system as of October^1, 2020.

The system as it applies today imposes a double prohibition:

• The prohibition for health actors, including health professionals, students and associations grouping them, to receive benefits in cash or in kind, in any form whatsoever, directly or indirectly offered or provided by persons providing health services, producing or marketing health products ("companies");

• The prohibition for these companies to offer or promise cash or in-kind benefits, in any form, directly or indirectly, to these health actors.

Exceptions to this principle of double prohibition have been strictly defined by the legislator, in particular (i) the obligation to set up agreements, the content of which is set by regulation, and (ii) the terms and conditions of control of these agreements through the introduction of a dual declaration and authorizationsystemon the applicable IDAHE2 and EPS platforms. The granting of certain benefits and the contracting of certain agreements whose amounts exceed the thresholds set by decree is now subject to the prior authorization of the relevant professional bodies (CNOP, CNOM, etc.).

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Beware of the penal co-responsibility of companies and health actors in case of non-compliance with these provisions. This case illustrates the announcement made by the DGCCRF to ensure strict compliance with these regulations.

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[1] Court of Cassation, Crim. 4 April 2018 n°17-82.446

[2] DGCCRF, Press Release, January 27, 2023

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