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
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.
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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