Case C‑179/16

F. Hoffmann-La Roche Ltd and Others

v

Autorità Garante della Concorrenza e del Mercato

(Request for a preliminary ruling from the Consiglio di Stato)

(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)

Summary — Judgment of the Court (Grand Chamber), 23 January 2018

1.        Agreements, decisions and concerted practices — Relevant market — Delimitation — Subject matter — Determination of the effect on trade between Member States — Criteria for assessment — Substitutability of the products or services on the supply side or the demand side — Medicinal products — Substitutability of products manufactured or sold illegally

(Art. 101(1) TFEU; European Parliament and Council Directive 2001/83, Art. 6)

2.        Agreements, decisions and concerted practices — Relevant market — Delimitation — Criteria — Substitutability of the products or services on the supply side or the demand side — Medicinal products — Taking into account medicinal products authorised for the treatment of a given disease and those used for that purpose despite the lack of reference to such a disease in the marketing authorisation — Conditions

(Art. 101 TFEU)

3.        Agreements, decisions and concerted practices — Adverse effect on competition — Ancillary restriction — Concept/Meaning/Definition — Restriction necessary for the implementation of a main operation — Objective and proportionate nature — Restriction rendering the main operation more difficult or less profitable — Concept excluded — Separate nature of the indispensability of a restriction that may be exempted

(Arts 101(1) and (3) TFEU)

4.        Agreements, decisions and concerted practices — Adverse effect on competition — Ancillary restriction — Concept — Restriction necessary for the implementation of a main operation — Restrictions in an agreement relating to the exploitation of a medicinal product seeking to limit the use of another medical product for the same treatment — Excluded

(Art. 101(1) TFEU)

5.        Agreements, decisions and concerted practices — Adverse effect on competition — Criteria for assessment — Analysis of conditions of competition on the market — Medicinal products — Taking into account the impact of EU rules

(Art. 101(1) TFEU)

6.        Agreements, decisions and concerted practices — Agreements between undertakings — Adverse effect on competition — Bilateral agreement between undertakings marketing competing medical products covering the dissemination of misleading information on the adverse reactions of one of those medical products for the treatment of a disease which is not covered by its marketing authorisation in order to reduce the competitive pressure resulting from such use — Anti-competitive objective — Exemption excluded

(Arts 101(1) and (3) TFEU)

1.      See the text of the decision.

(see paras 49-53)

2.      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.

(see para. 67, operative part 1)

3.      See the text of the decision.

(see paras 69-71)

4.      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.

(see para. 75, operative part 2)

5.      See the text of the decision.

(see paras 78-80)

6.      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.

Article 101 TFEU must be interpreted as meaning that such an arrangement cannot be exempt under Article 101(3) TFEU. The applicability of the exemption provided for in Article 101(3) TFEU is subject to the four cumulative requirements laid down in that provision. Those requirements are, first, that the arrangement concerned must contribute to improving the production or distribution of the goods or services in question, or to promoting technical or economic progress; secondly, that consumers must be allowed a fair share of the resulting benefit; thirdly, that it must not impose on the participating undertakings restrictions that are not indispensable; and, fourthly, that it must not afford them the possibility of eliminating competition in respect of a substantial part of the products or services in question. In the present case, however, suffice it to note that the dissemination of misleading information in respect of a medicinal product cannot be regarded as ‘indispensable’ within the meaning of the third requirement for the purpose of being exempt under Article 101(3) TFEU.

(see paras 95, 97, 98, 101, operative part 3, 4)