A Brave New World? The 'French Sunshine Act' Imposes Online Disclosure Of Contracts With HCPs, As Well As Of Payments Of 'Advantages' To HCPs, Dating Back To 01 January 2012

Author:Mr Daniel Kadar
Profession:Reed Smith
 
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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...

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