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One year of application of the “Anti-Gifts Law” in France

conformité réglementaire

One year of application of the “Anti-Gifts Law” in France

August 23, 2023

The decree of June 15, 2020, about benefits offered by those who manufacture or market health products or services, which came into force on October 1, 2020, is celebrating its first year of application. A review of this long-awaited decree.

First mentioned in the ordinance of January 19, 2017, relating to benefits offered by manufacturers or marketers of health products or services, then in the law of July 24, 2019 relating to the organization and transformation of the health system, the publication of the text was long postponed to a later date.

It was therefore in a state of uncertainty that health industries discovered the decree that specified the terms of application of the new framework for benefits. It was published in the official journal in June 2020, and set its full implementation date at 3 months.

This text, which overhauled the system initiated by the 1993 DMOS law and required adjustments for the professional associations and health industry, finally came into effect in the middle of a year marked by the covid-19, which was not a very opportune moment. One year after its entry into force, it is time for a first assessment.

This text clarifies many points: the definition of the actors targeted by the framework of advantages, the nature and conditions of the derogations as well as the prohibition of offering advantages. Similarly, this text clarifies the implementation of the authorization and declaration systems. In particular, it specifies the deadline requirements for the submission of agreements. The professional associations and the Regional Health Agencies (ARS) must now draw up a biennial report, addressed to the administration, in order to evaluate the operation of the system and to draw the consequences.

This decree specifies and details the new regime brought by the 2017 and 2019 texts. From this point of view, it appears to be indispensable and very useful. Nevertheless, several uncertainties remain and leave room for interpretation.

Some of the details of the schemes appear difficult to implement. The deadline set before sending an agreement, in declaration, is 8 working days. This is a short deadline. On the opposite, it is very long for the authorization system where the draft agreement must be sent at the latest 2 months before the beginning of the event. Authorization to combine activities, which is required for quasi-employed health professionals, is not always easy to obtain in practice from the health professional.

Materially, the implementation of the scheme is also complex. It is regrettable that there are two platforms for submitting agreements. This creates a lack of clarity for healthcare professionals and makes it difficult to apply complex texts on a daily basis. The existence of these two distinct platforms generates disparate operating rules, input methods and lists.

Finally, the authorities responsible for processing files are multiple, which leads to a lack of homogeneity in the analysis of files. This results in varying requests for additional information depending on the competent authority.

In short, a certain number of points require an official position from the authorities, which will then make it possible to stabilize the doctrine of the competent authorities (Professional Orders and ARS). These clarifications are therefore eagerly awaited by all stakeholders.

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