The Court of Justice of the European Union has resolved the preliminary question raised by the Consiglio di Stato (the Italian Council of State) and, in accordance with the conclusions of the Advocate General, it concludes that the dissemination of misleading information about a medicinal product could be considered as a breach by object of article 101.1 of the Treaty on the Functioning of the European Union.
On 23 January 2018, the Court of Justice of the European Union (“CJEU“) made a ruling on the preliminary questions raised by the Consiglio di Stato in relation with the sanctions imposed on Roche and Novartis by the Italian Antitrust Authority (“AGCM“), for carrying out practices aimed at disseminating misleading information about a medicinal product to condition its demand in favour of another product that is ten times more expensive (C-179/16). With regard to the background of this matter, please see our previous publication on the Advocate General’s opinion on this proceeding.
In the ruling, the Court considers that an agreement between two companies that market two competing medicinal products to disseminate misleading information about the adverse effects of the use of one of those medicinal products with the clear aim of shifting demand in favour of the other product, constitutes a restriction of competition “by object” in accordance with article 101.1 of the Treaty on the Functioning of the European Union (“TFEU“).
The CJEU arrived at this conclusion after conducting an interesting analysis of two main issues, the relevant market of both medicinal products (note that Avastin was not authorised for the treatment of eye disease) and the nature of the misleading information disclosed, in light of EU regulations on medicinal products.
In Competition Law, the market definition should include all those products that consumers consider as interchangeable or substitutable with each other. In this case, the market would contain all those products that are used for the same therapeutic purpose. Given that Avastin and Lucentis were owners of valid marketing authorisations at the time of the infraction, the prescribed off-label use of Avastin under medical supervision, led to both medicinal products falling under the same market definition.
With regard to the nature of the misleading information disclosed, and from a regulatory point of view, the CJEU understands that its objective was not related to the fulfilment of pharmacovigilance obligations, but that it was intended to try to create an artificial distinction between Avastin and Lucentis, thereby manipulating the perception of the EMA and the competent authorities in Italy regarding Avastin.
On this point, the CJEU has conducted an interesting analysis of the legal context in which the behavior is defined, making reference to the European regulations on medicinal products in accordance to which the information intended for the public and the competent authorities must be presented objectively and without misunderstandings by the owner of the marketing authorization.
In addition, the CJEU considers that the disclosure of such misleading information may cause doctors not to prescribe the use of Avastin for the treatment of eye problems. Therefore, an agreement between competitors with this objective in mind can be considered as behaviour that is harmful to competition by object, the consequence of which is that it will not be necessary to test the effects of such agreement on the market.
In consideration of the foregoing, it can be said that this ruling is significant since it is the first time that the concept of a restriction by object has been applied to an agreement that (if the premises established by the CJEU are confirmed by the national courts) is aimed at disseminating allegedly misleading information about the safety of a medicinal product.
It is now just a matter of waiting for the ruling of the Consiglio di Stato on the national lawsuit, to validate if the interpretation of the CJEU is accepted and the sanction imposed by the AGCM on Roche and Novartis is confirmed.
By: J. Nicolás Otegui Nieto and Gemma Sammuel.