On 23January 2018 the Court of Justice of the European Union (CJEU) rendered its judgment in the case Hoffman – La Roche and Novartis (C-179/16). The CJEU ruled that an arrangement between two companies that concerns the dissemination of misleading information regarding the adverse reactions resulting from the use of one of their medicines constitutes a restriction of competition 'by object' for the purpose of article 101 paragraph 1 TFEU.
La Roche was granted a marketing authorisation (MA) for Avastin, a medicine for the treatment of certain tumorous diseases. Two years later, Novartis was granted a MA for Lucentis, a medicine for the treatment of eye diseases. Before Lucentis was placed on the market, a practice developed whereby medical practitioners prescribed Avastin off-label for the treatment of eye diseases. This practice continued after Lucentis was placed on the market due to the low price of Avastin. According to the Italian Competition Authority (AGCM), La Roche and Novartis had entered into an agreement to disseminate misleading information which could give rise to public concerns regarding the safety of the use of Avastin in ophtalmology. This information caused a shift in demand towards the more expensive medicine Lucentis, which led to a cost increase for the national health services.
The case was referred to the CJEU with the question, inter alia, whether dissemination of misleading information relating to the adverse reactions resulting from the use of one of their medicines constitutes a restriction of competition' by object', for the purpose of article 101 paragraph 1 TFEU.
The CJEU pointed out that MA holders must inform EMA of new risk information that is scientifically proven and when it is likely to influence the assesment of the medicine's risks and benefits. Since this information obligation only lies with the holder of the MA, the CJEU held that the two companies colluded to disseminate information about the medicine that is marketed by only one of them. According to the CJEU it is evident that the agreement pursues objectives which exceed the objectives of the information obligation of the holder of the MA. Therefore, the arrangement must be regarded as to restrict competition by object if the referring judge finds that information is misleading. According to the CJEU the information is misleading if it is intended (i) to confuse the EMA and Commission, and (ii) to give rise to public concerns regarding the safety of the off-label use of Avastin.