FRANCE Trends and Developments Contributed by: Liliana Eskenazi and Pauline Lecrenais, Fréget Glaser & Associés
The French competition authority (FCA) Durogesic decision also addressed this issue, but from a different angle, as the originator company had actually raised its concerns with the health authority. In this deci- sion, the FCA sanctioned Janssen-Cilag and Johnson & Johnson for abusing their dominant position, first by intervening in a “legally unfounded” manner with the health authority, and subsequently by disparag- ing generic products to healthcare professionals. As regards the first objection, the originator company allegedly presented to the health authority arguments that could prompt it to take a decision inconsistent with the legal framework to which it is subject – ie, to persuade it to refuse to grant generic status to prod- ucts competing with Durogesic, despite lacking the competence to do so (FCA, decision 17-D-25 of 20 December 2017). A closer look at the details of this case shows that it was Janssen-Cilag’s “head pharmacist” ( pharmacien responsable ) who contacted the health authority to raise public health concerns relating to fentanyl (the active substance in Durogesic, which is 100 times stronger than morphine), in particular in light of differ- ences in the pharmaceutical forms of the originator and generic products that could affect how the fen- tanyl is dispensed, and thus pose a risk to patients. The FCA did not dispute this scientific evidence and did not reproach the company for having presented to the health authority false or misleading information regarding competing products, but rather for putting forward arguments which it considered to be “with- out legal basis”. It thus concluded that the company “unduly interfered in the health authority’s decision making process” and had put forward “arguments likely to induce it to adopt a decision contrary to the legal framework binding upon it” (pt 435). The case is pending before the European Court of Human Rights, which is called upon to assess whether aspects of the sanction for this conduct are compatible with the freedom of expression protected by the Convention. Key competition law takeaways – in light of recent case law, originator companies should not criticise the safety, efficacity or bioequivalence of competing generic or biosimilar products that have complied with the regulatory process and obtained the necessary approvals.
If a company nevertheless considers that there is a genuine public health issue with one of these prod- ucts, it may raise this only with the competent health authorities, taking great care to: • use the appropriate procedures; • ensure that its intervention rests on a clear legal basis; • submit relevant, objective and scientifically robust evidence, preferably from independent sources; and • ensure that it never presents information in a biased or misleading manner, whether by selective- ly quoting certain passages, disclosing only some information, or otherwise giving a distorted overall picture. After Patent Expiry: Competition Law Continues to Constrain the Conduct of Originator Companies After patent expiry, an originator company may retain a dominant position for a significant period and must therefore ensure that all aspects of its conduct remain within the boundaries of competition on the merits. Competition concerns frequently arise in relation to the design of commercial strategy towards hospitals and the messages conveyed to healthcare profession- als. Pricing strategy at patent expiry must not hinder market entry Pharmaceutical companies are, in principle, free to determine the prices at which they supply hospitals. During the period of market exclusivity, they may set prices at their discretion, and once patent protection has ended and generic or biosimilar competitors enter, they are entitled to adjust their commercial strategy, including by lowering prices. However, where an originator company holds a domi- nant position, EU and French competition law impose specific constraints on how such price adjustments may be implemented. Key competition law takeaways – dominant pharma- ceutical companies cannot simply mirror competitors’ prices at patent expiry without further analysis. They must in particular avoid:
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