Legal summary

June 2023

Janssen-Cilag SAS v. France (communicated case) - 47086/22

Article 10

Article 10-1

Freedom to impart information

Pharmaceutical company sanctioned for anti-competitive practices after cautioning the authorities and health-care professionals against the use of a generic drug: communicated

In 2007 the European Commission recognised certain medicinal products developed by Ratiopharm as generic equivalents of certain originator medicinal products marketed by the applicant company and instructed the member States concerned to grant them marketing authorisations (hereinafter “MAs”). The relevant panel of the French Agency for Health Product Safety (AFSSAPS) subsequently issued two opinions in favour of issuing the relevant MAs.

The applicant company then sent two letters to the AFSSAPS arguing that granting generic status to Ratiopharm’s products did not strike it as “appropriate” or “conducive to the proper use of these drugs” since they were not, in its view, “exactly similar” to its own. The company further shared its concerns as to the potential consequences of substituting any of these products for its own products during ongoing treatment. It reasserted its position in an interview with the director of that agency.

In 2008 the AFSSAPS issued MAs for the Ratiopharm products and registered them in the register of generic groups, subject to a caveat. The applicant company then launched, for about eight months, promotional campaigns for its product and conducted several communication campaigns to dissuade health professionals from using the generic product.

Following a referral by Ratiopharm, the French Competition Authority imposed a fine on the applicant company for abuse of dominant position, the amount of which was set on appeal at 21 million euros. The Court of Appeal held in particular that the appellant had first unduly interfered in the national procedure for reviewing MA applications in order to persuade the national authority to refuse to grant the competing products generic status in spite of their having obtained that status at the European level and then, once those authorisations had been granted, had disseminated disparaging messages concerning these Ratiopharm products among health-care professionals. The appellant had thus acted, the Court of Appeal concluded, in pursuit of an anti-competitive aim thus committing a single, continuous and multi-act infringement.

In June 2022 the Court of Cassation dismissed the application lodged by the applicant company, in substance finding:

(i) that the course of conduct at issue had not been part of a debate in the public interest concerning the health consequences of a new medication’s entering the market, but part of a strategy to delay the market development of competing products, the implementation of which alone, in the specific contextual circumstances, was capable of producing the impugned anti-competitive effect;

(ii) that the sanction had not infringed the principle of free scientific research and had not disproportionately or unjustifiably interfered with the applicant company’s freedom of expression when weighed against the need to uphold public policy in matters of competition.

The applicant company viewed the sanction as unjustifiably interfering with its freedom of expression and submitted that it had approached the AFSSAPS solely out of public-health concerns, thus contributing to a debate in the public interest.

Communicated under Article 10 of the Convention.

© Council of Europe/European Court of Human Rights This summary by the Registry does not bind the Court.

To access legal summaries in English or French click here . For non-official translations into other languages click here .