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
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
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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