French Sunshine Act Implemented…Awaiting Guidance
As pharmaceutical and device manufacturers and others are scrambling to finalize interpretations and implementation of the U.S. Physician Payment Sunshine Act, the French government added to the activity by releasing similar transparency regulations. On May 22, 2013, the French Ministry of Health published Decree No. 2013-414, implementing the French Sunshine law, which was enacted on December 29, 2011 and is known as the Bertrand law, after the French Minister of Health, Xavier Bertrand. The compliance date was set for June 1, 2013, and reporting is retroactive to January 1, 2012, giving companies a mere 10 days to interpret the regulations and compile and report data. It is expected that a Circular (i.e., guidance document) interpreting the Decree will be released soon.
The French Sunshine law requires reporting by companies that produce, market, or provide services associated with products listed in a particular section of the French Code of Public Health, including companies that make drugs, devices, blood and tissue products, contact lenses, cosmetics, and tattoos. These companies need to report information regarding (1) contracts entered into with French health care providers (HCPs), excluding commercial sales agreements for goods and services; and (2) benefits with a value over 10 Euros (including tax) provided, in cash or in kind, to French HCPs. HCPs include providers whose practice is regulated by the French Code of Public Health and students who are going to become such providers, as well as health care institutions, health foundations, and certain other health-related entities (full list).
For each contract covered by the Sunshine law, reports must include, among other information, the names and addresses of the parties, the HCP’s medical specialty and registration number, the date of the contract, the purpose of the contract (described in such a way as to protect trade secrets), and, if the contract is for an event, the program of the event. For each benefit provided to a HCP, reports must include, among other information, the value of the benefit (rounded up to the nearest Euro) and the date and nature of the benefit provided.
Information about contracts must be reported within 15 days of execution of the contract. Generally, benefits provided to HCPs must be reported twice each year: on August 1 for benefits provided from January 1 to June 30, and on February 1 of the following year for benefits provided July 1 to December 31. However, the first publication of information under the Decree retroactively covers contracts entered into and benefits provided from January 1, 2012 through June 30, 2013. By June 1, 2013, companies were to have reported information regarding contracts and benefits from 2012. Thereafter, the regular reporting requirements begin (i.e., by August 1, contracts and benefits from the first half of 2013 must be reported). Companies that fail to comply with the reporting obligations are subject to fines and other sanctions.
A public website where the reported information will be posted is under development. In the meantime, information will be published on the website of the applicable national professional body (e.g., CNOM, Conseil National de l’Ordre des Médecins, for physicians) and must be posted on each reporting company’s website or on a common website shared by several companies (a link to which must be provided on the company’s website). Benefits provided and contracts entered into from January 1 through June 30 must be posted on the website by October 1, and benefits provided and contracts entered into from July 1 to December 31 must be posted by April 1 of the following year. Information must be reported in French. Companies’ websites must provide for security measures to ensure information integrity, and companies must comply with applicable data protection regulations with respect to HCPs’ identifying information.
Just as with the US Sunshine Act, there are significant questions and open issues, which stakeholders hope will be addressed in the yet-to-be-released Circular, including:
Confirming that the requirements apply only to companies that operate in France;
Clarifying the scope of companies that must comply, in particular clarifying the definition of companies that “provide services associated with” covered products;
Clarifying the definition of “benefits;”
Providing guidance regarding reporting format to help ensure uniformity in reporting information; and
As previously reported here, whether there will be any relief on the extremely short timeframe for compliance and retroactive reporting requirements.