In probably one the longest-awaited decrees in recent French regulation, the French Ministry of Health published on 22 May 2013, the application decree to the French Sunshine Act (dated 29 December 2011) implementing the specific ways and means that health care companies must disclose agreements with health care practitioners ("HCPs"), a term that includes medical students, as well as so-called "advantages" paid to HCPs. Under French Public Health Law, the term "advantage" encompasses any form of payment or hospitality, including payment of a contractual fee.
The Decree sets forth the threshold for disclosure at 10 euros (VAT included), but also seems to make a distinction between contractual remunerations and any other form of payment to HCPs. For agreements with HCPs, whereby the health care company enters into a consultancy/research agreement or into a contract to finance the HCP to participate in medical congresses/trainings, the Decree does not seem to require the health care company to disclose the amount it is paying.
However, for other payments – including hospitality and meals – every amount at or above 10 euros, rounded up to the nearest euro, must be disclosed.
The industry has shown surprise that the Decree requires disclosure of the amount of an invitation for lunch, but does not require disclosure of a contractual remuneration. It is foreseeable that the French Ministry of Health, given this interpretation, may shortly take position on that point.
A particularly severe measure is that this disclosure obligation applies to every payment and contract issued from 01 January 2012 onward. This seems to mean that health care companies look back into 18 months of activity to comply.
Disclosure is to be made to a unique website that has yet to be implemented. Nonetheless, the decree foresees an eventual transition to this unique website. For now, the French National Medical Association is to receive the relevant data, and the disclosures will also mandatorily have to be posted on the health care company's website, or a joint website where different health care companies are involved.
Even though it took 18 months for the successive governments to get the application decree published and the unique portal is still not set up, the regulator seems to have concluded that health care companies should be able to comply within ... a week. The Decree sets forth that the complete set of information be available to the French National Medical Association by 01 June 2013.
However, as this date is not realistic and different Health Care Industry associations have raised its impracticability, a second date, 01 October 2013, has been recommended for the publication of these disclosures on the National Medical Association and companies' websites.
Going forward, disclosure of "advantages" to HCPs will have to be made on a semestrial basis, while the disclosure of contracts with HCPs will have to be made, at the latest, two weeks after the signature of the contract.
As mentioned in one of our previous blogs, and still remains true, the cosmetics industry, which is subject to these new disclosure requirements, is concerned by this disclosure obligation even though in a slightly reduced scope.
Last but not least, the Decree recognizes that the disclosure obligation implicates the processing and publishing of HCP personal data, and health care companies have expressed concern about posting this information on their websites. For those reasons, the Decree mandates that the disclosures must be done through appropriate notification to the French Data Protection Authority, the CNIL, and by providing each HCP with adequate information about their access, modification and removal rights.
No doubt that implementation of this regulation will raise a lot of questions and will require further clarification.
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