Decree on French anti-gift regulation published

The long-awaited Decree issued for the application of Ordinance No 2017-49 of 19 January 2017 on benefits offered by persons manufacturing or marketing health products or services (see our previous post here), ratified by Act No 2019-774 of 24 July 2019 on the organisation and transformation of the health system. However, the value of an agreement stipulating the grant of an advantage that is subject to authorisation and the value below which benefits in kind or in cash are considered to be negligible have not yet been published.

The Decree specifies the terms and conditions relating to benefits offered by persons manufacturing or marketing health products or services. It determines the natural or legal persons concerned, the nature and conditions of the exemptions to prohibiting advantages offerings, and the arrangements for declaring and authorising exemptions. In addition, it ensures the consistency of the regulatory provisions of the Public Health Code with Ordinance No 2017-49.

Additionally, the Decree provides information on:

• Application. The Decree will come into force on 1 October 2020, after a transitional period of three and a half months. One point that remains unclear is whether or not the Decree applies.
• Declaration procedure. The signed agreement must be sent within the eight working days before the day on which the advantage is granted.
• Competence of the French Regional Health Authority (ARS) for legal persons and health professions other than those belonging to a professional order. The competent ARS is the one in whose jurisdiction the agreement was signed.
• Time limits for ruling on authorisation requests. The competent professional orders and the ARS must issue their decision within two months, except in the case of incomplete files, where the competent professional orders and the ARS have one month from the date of receipt of the file to indicate whether there are any missing documents (and the period of two months then runs from the receipt of the missing documents).
• Cases where an authorisation is refused. An amended agreement may be submitted within 15 days, and the competent authority will then have 15 further days to decide on the new agreement.

Orders allowing the application of the Decree are expected to be published shortly.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, July 2020 Issue (Thomson Reuters).