On June 12, 2013, the French Ministry of Health published Circulaire No. DGS/PF2/2013/224 relative to Article 2 of the Law No. 2011-2012 of December 29, 2011, on the Strengthening of Health Protection for Medicinal and Health Products, also known as the “Loi Bertrand” or the “French Sunshine Act,” adopted following the Mediator case.
As a reminder, Article 2 of the FSA amended Article L. 4113-6 French Code of Public Health (CSP), which generally prohibits any transfer of value from certain companies to certain actors of the health care sector. Article 2 of the French Sunshine Act also inserted Article L. 1453-1 CSP, which provides that health products companies must make available to the public the existence of any contract entered into with French health care providers (HCPs) and certain entities of the health sector, and any benefits whose amount is equal to or higher than 10 Euros (all taxes included) provided, in cash or in kind, to French HCPs.
Circulaire No. DGS/PF2/2013/224 outlines the rules for the application of Articles L. 1453-1 and L. 4113-6 CSP. It became effective June 13, 2013.
Article L. 4113-6 CSP (Prohibition of Benefits)
- The Circulaire restates that the French Sunshine Act extended the general prohibition of benefits to health care students and associations of health care professionals or students.
- The Circulaire details the concept of “association of health care professionals.” The concept includes associations representing or defending the interests of a category of professionals. The concept therefore depends on the purpose of the association.
- The Circulaire states that a transfer of value to an association that in turn makes a transfer of value to a health care professional is an indirect transfer of value to a health care professional.
Article L. 1453-1 CSP (Transparency Obligation)
- The Circulaire establishes a list of companies that must comply with transparency obligation: on one hand are companies that manufacture or commercialize 19 categories of health products that are under the French Medicines Agency’s supervision (full list); on the other hand are companies that "provide services associated with" covered products (examples). The French Sunshine Act has then a broader scope than the U.S. Sunshine Act, which only applies to manufacturers of drugs and devices covered by federally funded health programs.
- The Circulaire establishes a list of nine categories of concerned health care professionals (HCPs). The list notably includes health care providers whose practice is regulated by CSP; students who are going to become such providers; and health care institutions, health foundations, and certain other health-related entities (full list). Yet again, the French Sunshine Act applies to a broader range of practitioners and entities than the U.S. Sunshine Act, which applies only to payments to physicians and teaching hospitals. Such a scope does not include nurse practitioners, physician assistants, or other allied health professionals.
- The Circulaire clarifies the definition of “benefits,” which is not legally defined by the French Sunshine Act. The Circulaire confirms that fees paid to HCPs or institutions for their services, like benefits given in relation to purchase agreements, should not be disclosed. It also confirms that direct and indirect benefits or agreements should be disclosed.