The Roche group produces two medicinal products: Avastin which, according to its marketing authorization (MA), is prescribed for the treatment of tumorous pathologies, and Lucentis, which is intended for the treatment of eye diseases and whose commercialization is entrusted to the Novartis group through a license agreement. In practice, Avastin, whose price is lower than that of Lucentis, is also used without an MA for the treatment of eye diseases.

The Italian Competition Authority imposed two fines worth approx. €90 million each to Roche and Novartis for concluding an agreement that was contrary to Article 101 of the Treaty of the Functioning of the European Union (TFEU) which aimed to obtain an artificial differentiation between the Avastin and Lucentis medicines. The agreement would have consisted, in a context of scientific uncertainty, in regarding the security of Avastin’s ophthalmic use. Following the rejection of the two pharmaceutical laboratories’ appeals against this decision, the latter brought the matter before the highest Italian administrative jurisdiction that referred five preliminary questions to the Court of Justice of the European Union.

Two of these questions concern the possibility of considering that these two medicines belong to the same market while, according to the parties, Avastin was sold without an MA and under conditions that did not comply with the pharmaceutical regulations. The Court of Justice answered that one medicine used without an MA can belong to the same market as a medicine with an MA if the prescribing doctors consider them interchangeable, as long as the products are produced and sold legitimately. In this case, the Court considered that the state of uncertainty regarding the lawfulness of the repackaging and prescription conditions of Avastin for the treatment of ocular pathologies did not prevent the Italian authority from considering that it belonged to the same market as Lucentis.

The question was also raised as to whether the competition restrictions for which the companies were criticized could escape the application of Article 101 paragraph 1 of the TFUE since they were ancillary to the license agreement concluded between Roche and Norvatis and strictly necessary to its performance. The Court considers that such provisions concerned the behavior of third parties to this agreement (prescribing doctors) and therefore could not be considered ancillary to said agreement. The two laboratories indeed agreed to raise, in a context of scientific uncertainty, concerns regarding the security of a medicine used for treatments not covered by its MA in order to reduce competitive pressure on the medicine with this indication in its MA. In this regard, the Court considers that this represents a restriction of competition ‘by object’ and believes that the degree of harm of such practice makes the analysis of its effects superfluous.

Lastly, the Court excludes the benefit of individual exemption as the restriction in issue cannot be qualified as essential.

Following the recent conviction of Janssen Cilag in France in December 2017 for having constrained the development of a generic medicine by interventions with health authorities and through a smear campaign directed at doctors, laboratories are once again reminded that all approaches aimed at limiting the use of products by raising unjustified concerns among users on the risks they present are serious restrictions of competition.