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 devices.
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 of taxes).
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 been published).
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 five years.