In the aftermath of the turmoil prompted by public allegations
against one of France's top cabinet ministers of having had
undisclosed ties to pharmaceutical companies in a previous public
function, the French Ministry of Health published decree no.
2013-414 on May 21 imposing transparency obligations on companies
manufacturing, marketing, or providing services in relation to
health and cosmetic products (hereinafter "Companies").
It is still unclear whether the decree will be applied to
French-based Companies only or to Companies based in other
countries as well.
The decree requires disclosure of agreements entered into and of
benefits provided by Companies with or to, in particular but not
limited to, health care professionals. The decree applies to the
vast range of health products under the oversight of the French
Agence nationale de sécurité du médicament et
des produits de santé, or ANSM. This includes 17 categories
of products including, among others, pharmaceuticals, medical
devices, blood products, and in vitro medical diagnosis
Pursuant to this decree, the Companies are required to disclose
the existence of agreements entered into with natural persons,
associations, institutions, foundations, companies, and
organizations and the variety of bodies referred to in article L.
1453-1 of the Public Health Code (i.e., a wide array of
stakeholders in the health care sector, including the media) as
well as benefits provided to such natural or legal persons.
Benefits encompass any in-kind or monetary benefits, whether
provided directly or indirectly. For most products, including
pharmaceuticals and medical devices, Companies have to disclose
information on any and all agreements; for other products,
including cosmetics, only certain agreements have to be disclosed,
in particular those that relate to the evaluation of performance
and safety of such products.
For these agreements, Companies must disclose the name of the
parties involved, the date of execution of the agreement, the
purpose of the agreement, and the program of the professional or
scientific meeting or convention involved, if applicable.
For benefits provided, the decree requires Companies to disclose
the identity of the beneficiary and of the Company involved, the
value amount (including applicable taxes), and the date and nature
of each benefit provided to the beneficiary for each six-month
period. In addition, Companies are required to identify the period
during which such benefits have been provided.
The obligation applies to benefits—in cash or in
kind—representing or exceeding a value of €10 (inclusive
The above information is made public, in French and free of
charge, on a dedicated web site and submitted to the authority in
charge of the web site (the ministerial order laying down the
details of the creation and management of the web site has not yet
The information must be forwarded to the authority responsible for
the web site by Companies within 15 days from the execution of an
agreement and no later than August 1 for benefits provided during
the first half of the calendar year and no later than February 1
for benefits provided during the second half of the year. The
authority makes the information public prior to each October 1 and
April 1, respectively. Data shall remain available for five years
from its online publication. Where an agreement is entered into for
a period exceeding this five-year period, data in relation thereof
is made available beyond such term.
It is important to note that the decree has a retroactive effect.
The above provisions apply to information relating to agreements
entered into in 2012, which was required to be forwarded to the
National Councils of the Order of the health professions concerned
(Conseil National de l'Ordre de la profession de santé
concernée) by June 1 and must be published by councils and
companies concerned by October 1.
Until the entry into force of the ministerial order referred to
above, information must be made available:
On the web site of the National Council of the Order of the
member of the health profession concerned, and
On the web site of health products manufacturers and
distributors or on a site shared for this purpose.
Failure to comply with these new obligations may carry
significant criminal penalties, with fines of up to €225,000
(for a company) and the prohibition to manufacture, condition,
import, and market the relevant health products for a maximum of
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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