On 17 December 2015, the French National Assembly adopted a law on modernisation of the French health system (the “Public Health Law”). Key provisions will bring changes to how the pharmaceutical and medical device industries interact with HCPs, by introducing changes to the existing French anti-benefits and sunshine regulations (Articles 178 and 180 of the Public Health Law). The impact of the new law and the regulations to follow might be felt even by companies that do not sell products or services in France.
The Public Health Law is accessible here (in French).
Additional reporting under sunshine regulations
The French sunshine regulations require industry to make public the existence of certain agreements with, and benefits provided to, various stakeholders in the healthcare industry. Based on a 24 February 2015 decision of the French Administrative Supreme Court, there had been debate between the authorities and industry about what needed to be disclosed and how, but the new law resolves the disagreement.
- Companies will now have to disclose fees above a certain threshold (to be established by the government) paid under agreements with HCPs and with other stakeholders.
- Industry will also need to report the purpose of the agreements in a more detailed manner, and not by generic descriptions.The specifics will be established by an implementing decree.
- The “direct” and the “final” beneficiary of the agreements will have to be reported.
Further, the re-indexing of the information disclosed by internet search engines is made possible, which will make the reported information more readily accessible to the public.
Because the Public Health Law does not expressly state that the reporting requirements are to be retroactive, they can be presumed to be imposed only on a going-forward basis.
Importantly, the new regulations have been challenged before the French Constitutional Court. The legal concerns at issue include:
- Disclosing the precise purpose of the agreements could lead to disclosing confidential business information;
- Disclosure of detailed personal data and the amount of the fees paid, combined with re-indexation of the information, could violate the right to privacy and business secrecy. Particularly considering the global competition in this industry, such disclosure could also harm commercial strategy (notably in highly strategic projects such as in R&D) and the exchange of such information could lead to anticompetitive practices;
- What/who is a “final” beneficiary of an agreement needs to be carefully considered, as the term could be broadly construed.