Breach of the “anti-gift” law
An investigation by the Directorate General for Fair Trading, Consumer Affairs and Fraud Control (“DGCCRF”) led to a €1,125 million fine on a pharmaceutical group for practices constituting a massive breach of the “anti-gift” law.
In 2021, the DGCCRF investigated compliance with the “anti-gift” system in the health products distribution sector and uncovered illegal practices in particular that certain pharmacists throughout France were unduly offered by a company, more than €55 million in gifts between 2015 and 2021. The system put in place by the pharmaceutical group in question consisted in the delivery of objects of value to pharmacists, in exchange for the waiver of commercial discounts that could be granted to their pharmacies, in order to build customer loyalty, to increase their margins, profits and market share at the detriment of their competitors, therefore breaching the so-called “anti-gift” law.
It should be underlined that accepting a prohibited advantage is as liable as the fact of granting an illegal advantage: the sanction incurred is one year imprisonment and a € 75,000 euro fine and can be accompanied by additional penalties such as a temporary or definitive ban on practicing or the confiscation of the proceeds of the offence (gifts received) for example. The investigation services of the DGCCRF will therefore continue the investigations with the pharmacists involved.
This case rendered by the Dijon judicial court constitutes a rare decision against a company commercialising healthcare products. Similar sanctions could be applied to all types of manufacturers, distributors of healthcare products, or healthcare service providers breaching the “anti-gift” law requirements that is the current focus of the DGCCRF.
Reminder of the “anti-gift” regime key requirements
The “anti-gift” system aims to preserve the independence of HCPs as only public health considerations should guide the prescription, delivery or use of health products. Therefore, as a principle, it is prohibited for any person providing health services, producing or marketing health products to offer or promise any benefit in kind or in cash, in any form, directly or indirectly, to HCPs, students aiming for such professions and associations representing them (“HCPs”).
By way of derogation, the “anti-gift” provisions strictly frame the conditions under which companies in the healthcare sector are allowed to provide advantages to HCPs. Indeed, any transfer of value authorised under the anti-gift regime is subject to the conclusion of an agreement between the beneficiary and the person providing the advantage, itself subject to formalities before the competent authorities (declaration or authorisation procedure depending on the amount at stake).
Implementing texts provide for maximum thresholds above which an agreement must be submitted for authorisation i.e. 200€ per hour for remuneration, up to a maximum of 800€ per half day or up to 2000€ for the whole agreement.
The same goes for additional fees or expenses such as travel or hosting costs that should also be included in the agreement and are also subject to thresholds (e.g. 150€ per hotel night or 15€ per coffee break).
If any of the thresholds or if the total amount of the agreement were to be exceeded, an authorisation procedure will have to be carried out.
Disclosure and transparency
In addition, it should be kept in mind that pursuant to the “Transparency” regime, all agreements concluded between the healthcare industry and healthcare actors must be disclosed, in particular information regarding the identity of the beneficiary, the subject matter of the agreement, the compensation/advantages provided, the total amount of the agreement, and date of signature.
The above-mentioned information will be made public by the competent authority on the public website https://www.transparence.sante.gouv.fr