France is known for its strict regulatory provisions when it comes to medications. No exception will be made regarding the regulation of relationships between the pharmaceutical industry and healthcare professionals, known as the Anti-Gift Law.
What is the French Anti-Gift Law?
The Anti-Gift Law is a set of regulations to better regulate relationships between the healthcare industry, in particular, and healthcare professionals. This framework is distinct from the framework of transparency of link, which aims to disclose benefits provided and agreements entered into in order to inform the general public and prevent conflicts of interest.
The Anti-Gift Law applies to all healthcare products, whether reimbursable or not, and its scope includes, in particular, healthcare professionals, students, and their associations. The goal is to ensure that healthcare professionals are guided solely by medical considerations when choosing a healthcare product or service and to prevent conflicts of interest.
More specifically, the general principle is as follows:
• Healthcare providers, as well as companies that manufacture or market healthcare products, are prohibited from offering direct or indirect benefits, whether in kind or in cash; and
• Healthcare professionals, associations of healthcare professionals, and civil servants/public officials covered by the regulations are prohibited from receiving such benefits.
It should be noted that these prohibitions are subject to criminal penalties and that there is joint liability between companies that grant improper benefits and the recipients of those benefits.
The Anti-Gift Law then provides for exceptions to this prohibition and requires that all authorized interactions (remuneration, coverage of hospitality expenses in connection with professional, scientific, or promotional events, participation in research activities, provision of services, sponsorships, and donations) be subject to prior review by the competent authorities, which are the medical professional associations where they exist or the Regional Health Agencies. However, a condition for the implementation of these exceptions is the establishment of an agreement, which must then be submitted to the competent authorities.
These exemptions should not be confused with items excluded from the definition of a prohibited benefit, such as benefits in cash or in kind that are related to the recipient’s professional activities and are of negligible value (e.g., impromptu meals, samples, books).
It should be noted that any benefit valued at more than 10 euros must also be disclosed on https://www.transparence.sante.gouv.fr/ as part of the transparency of link requirements.
here are two possible submission procedures:
submission for declaration or for authorization, depending on whether the threshold values published by administrative order have been reached.
If the benefits granted are below the thresholds, a declaration must be filed 8 days before the benefit is granted, either on the IDAHE2 platform for doctors or the EPS platform for other healthcare professionals and associations; the latter cannot be implemented before this deadline.
If the benefits granted exceed the thresholds, a request for authorization must be submitted at least two months before implementation. At the end of these two months, the competent authority will issue a binding decision.
ATESSIA is here to help you comply with this regulation!
Article written by Emilie BADET, Legal Consultant specialized in Health Law