Case C-179/16: Judgment of the Court (Grand Chamber) of 23 January 2018 (request for a preliminary ruling from the Consiglio di Stato) — F. Hoffmann-La Roche Ltd and Others v Autorità Garante della Concorrenza e del Mercato (Reference for a preliminary ruling — Competition — Article 101 TFEU — Agreements, decisions and concerted practices — Medicinal products — Directive 2001/83/EC — Regulation (EC) No 726/2004 — Allegations of risks associated with the use of a medicinal product for a treatment not covered by its marketing authorisation (off-label) — Definition of relevant market — Ancillary restriction — Restriction of competition by object — Exemption)
Date: 2018-01-23
Institutions: Court of Justice
Subjects: cartel, consumer information, labelling, market approval, medicinal product, restriction on competition








C_2018104EN.01000301.xml










19.3.2018   


EN


Official Journal of the European Union


C 104/3





Judgment of the Court (Grand Chamber) of 23 January 2018 (request for a preliminary ruling from the Consiglio di Stato) — F. Hoffmann-La Roche Ltd and Others v Autorità Garante della Concorrenza e del Mercato
(Case C-179/16) (1)

((Reference for a preliminary ruling - Competition - Article 101 TFEU - Agreements, decisions and concerted practices - Medicinal products - Directive 2001/83/EC - Regulation (EC) No 726/2004 - Allegations of risks associated with the use of a medicinal product for a treatment not covered by its marketing authorisation (off-label) - Definition of relevant market - Ancillary restriction - Restriction of competition by object - Exemption))
(2018/C 104/03)
Language of the case: Italian

Referring court

Consiglio di Stato

Parties to the main proceedings


Applicants: F. Hoffmann-La Roche Ltd, Roche SpA, Novartis AG, Novartis Farma SpA

Defendant: Autorità Garante della Concorrenza e del Mercato

Interveners in support of the defendant: Associazione Italiana delle Unità Dedicate Autonome Private di Day Surgery e dei Centri di Chirurgia Ambulatoriale (Aiudapds), Società Oftalmologica Italiana (SOI) — Associazione Medici Oculisti Italiani (AMOI), Regione Emilia-Romagna, Altroconsumo, Regione Lombardia, Coordinamento delle associazioni per la tutela dell’ambiente e dei diritti degli utenti e consumatori (Codacons), Agenzia Italiana del Farmaco (AIFA)

Operative part of the judgment







1.


Article 101 TFEU must be interpreted as meaning that, for the purposes of the application of that article, a national competition authority may include in the relevant market, in addition to the medicinal products authorised for the treatment of the diseases concerned, another medicinal product whose marketing authorisation does not cover that treatment but which is used for that purpose and is thus actually substitutable with the former. In order to determine whether such a relationship of substitutability exists, the competition authority must, in so far as conformity of the product at issue with the applicable provisions governing the manufacture or the marketing of that product has been examined by the competent authorities or courts, take account of the outcome of that examination by assessing any effects it may have on the structure of supply and demand.










2.


Article 101(1) TFEU must be interpreted as meaning that an arrangement put in place between the parties to a licensing agreement regarding the exploitation of a medicinal product which, in order to reduce competitive pressure on the use of that product for the treatment of given diseases, is designed to restrict the conduct of third parties promoting the use of another medicinal product for the treatment of those diseases, does not fall outside the application of that provision on the ground that the arrangement is ancillary to that agreement.










3.


Article 101(1) TFEU must be interpreted as meaning that an arrangement put in place between two undertakings marketing two competing products, which concerns the dissemination, in a context of scientific uncertainty, to the European Medicines Agency, healthcare professionals and the general public of misleading information relating to adverse reactions resulting from the use of one of those medicinal products for the treatment of diseases not covered by the marketing authorisation of that product, with a view to reducing the competitive pressure resulting from such use on the use of the other product, constitutes a restriction of competition ‘by object’ for the purposes of that provision.










4.


Article 101 TFEU must be interpreted as meaning that such an arrangement cannot be exempt under Article 101(3) TFEU.






(1)  OJ C 222, 20.6.2016.