The CJEU has just confirmed that the concerted provision of misleading information about product safety can constitute a restriction by object under Article 101(1) TFEU, when it is intended to reduce the competitive pressure resulting from an alternative medicinal product (Case C-179/16, F. Hoffmann-La Roche and Others v Autorità Garante della Concorrenza e del Mercato).

With the words of the Court, which concurred with the opinion of AG Saugmandsgaard Øe, “an arrangement put in place between two undertakings marketing two competing products, which concerns the dissemination, in a context of scientific uncertainty, to the EMA, healthcare professionals and the general public, of misleading information relating to adverse reactions resulting from the use of one of those products for the treatment of diseases not covered by the MA for that product, with a view to reducing the competitive pressure resulting from such use on the use of the other medicinal product, constitutes a restriction of competition by object”.

The finding of the CJEU echoes, in an Article 101 setting, the words of the Court in the Astra Zeneca decision (Case C‑457/10, Astra Zeneca and Others v European Commission), where the Court found it abusive under Article 102 TFUE to mislead public authorities about underlying facts or legal issues when attempting to obtain exclusive rights (in that case, SPCs). According to the Court in Astra Zeneca, this conduct, and in general a dominant company’s lack of transparency when seeking exclusive rights with public authorities, is not consistent with competition on the merits and the specific responsibility of dominant companies not to prejudice, by their conduct, effective and undistorted competition.

In Hoffmann-La Roche the Court goes one step further and extends the finding of unlawfulness to situations where the companies under investigation did not obtain exclusive rights, but simply issued misleading comments on the safety of the off-label use of a competing product, to discourage use of such competing product. As already highlighted (see e.g. here), similar considerations could apply in cases of unilateral conduct under Article 102 TFUE, so that the implications of this decision should be kept in mind by all market operators when commenting on product safety publicly or in their pharmacovigilance activity.

The decision also includes additional interesting findings on a variety of aspects (from product market definition in the pharma sector, to the definition of ancillary provisions in licensing agreements). We will cover them all very soon. Stay tuned.