On June 17, 2020, an important decree related to “anti-benefits” was published in France, including the ministerial orders implementing this decree. The new rules contain changes in the regulatory framework for interactions between the industry and healthcare professionals (HCPs). A summary of the decree can be found below and a link to the full decree can be found here.
One of the important changes relates to the types of companies concerned. The new rules apply to any entity, both French and foreign, manufacturing or marketing healthcare products or providing health services. The definition of healthcare products includes all products having a health-related purpose, for human health, with some limited exceptions. This is a notable change as, until now, the scope was limited to companies manufacturing or marketing products/services that are reimbursed by the French national health insurance.
In addition, the range of stakeholders concerned by the prohibition is extended. The regulations apply to various types of HCPs, such as persons working in regulated professions in the health sector, osteopaths, chiropractors and psychotherapists, as well as students and persons following trainings in the medical sector. Furthermore, the rules apply to associations of HCPs or students, including associations which interfere in their training and civil servants and public officials who participate in public health or social security policies or who have administrative police powers in health-related matters. This scope is, however, narrower than the stakeholders covered by the Sunshine Act regulations.
"Benefit" is not explicitly defined in the rules; however, we know that it should be understood very widely, covering transfers of value in kind or in cash.
The following benefits can be granted to the stakeholders, under certain conditions: (1) remuneration, compensation and payment for research activities, research promotion, scientific evaluation, advice, provision of services or trade promotion, (2) hospitality offered, directly or indirectly, during professional, scientific or promotional events, (3) educational grants (e.g., in the context of continued medical education) and research grants and (4) grants made to associations composed of HCPs and/or HCP students, provided that the purpose of the association is related to their professional activity.
Not subject to the anti-benefits regulations are: (1) remuneration for an employee who is an HCP (2) benefits resulting from the exploitation or assignment of IP rights (e.g., royalties), (3) advantages granted within the framework of commercial agreements (e.g., discounts) and (4) benefits of negligible value which are related to the stakeholder's activity. The new rules set out a variety of thresholds below which the benefit will be considered to be of negligible value. The publication of the ministerial orders setting out the new thresholds is coming soon.
The new rules specifically list the required content for agreements that need to be entered into before granting any benefit. A ministerial order will further stipulate the scope of some of these requirements.
Declaration and an authorization process
Furthermore, there is an introduction of a declaration and an authorization process involving French health authorities or professional bodies, depending on the amounts involved. This differs from the current rules which require only a prior opinion to be sought from professional bodies. If the transfer of value is below the thresholds, the agreement must be notified to the competent authority eight working days before the day the benefit is granted. Companies should carry out the notification and authorization procedure through an online application system.
An exception is made for clinical study agreements. These are not subject to the declaration procedure but must be transmitted for information to professional bodies under a separate procedure.
Finally, tougher criminal sanctions will be incurred in case of non-compliance with the new rules (e.g., two years of imprisonment for persons having offered or procured illegal benefits and/or a fine of up to EUR 750,000 for companies.)