F. Hoffmann-La Roche Ltd and Others v Autorità Garante della Concorrenza e del Mercato.
Date: 2018-01-23
39


It is a matter of settled case-law that the Court may, of its own motion, on a proposal from the Advocate General, or at the request of the parties, order the reopening of the oral procedure under Article 83 of its Rules of Procedure, if it considers that it lacks sufficient information or that the case must be decided on the basis of an argument which has not been debated between the parties (judgment of 15 September 2011, Accor, C‑310/09, EU:C:2011:581, paragraph 19 and the case-law cited). By contrast, neither the Statute of the Court of Justice of the European Union nor its Rules of Procedure make provision for the parties to submit observations in response to the Advocate General’s Opinion (judgment of 16 December 2010, Stichting Natuur en Milieu and Others, C‑266/09, EU:C:2010:779, paragraph 28 and the case-law cited).
44


In that regard, it must be borne in mind that, in the context of the cooperation between the Court and the national courts provided for in Article 267 TFEU, it is solely for the national court before which a dispute has been brought, and which must assume responsibility for the subsequent judicial decision, to determine in the light of the particular circumstances of the case both the need for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits to the Court. Consequently, where the questions submitted concern the interpretation of EU law, the Court is, in principle, bound to give a ruling (judgment of 6 September 2016, Petruhhin, C‑182/15, EU:C:2016:630, paragraph 19 and the case-law cited).
45


It follows that questions on the interpretation of EU law referred by a national court in the factual and legislative context which that court is responsible for defining and the accuracy of which is not a matter for this Court to determine, enjoy a presumption of relevance. The Court may refuse to rule on a question referred by a national court only where it is quite obvious that the interpretation of EU law that is sought bears no relation to the actual facts of the main action or its purpose, where the problem is hypothetical, or where the Court does not have before it the factual or legal material necessary to give a useful answer to the questions submitted to it (judgment of 26 July 2017, Persidera, C‑112/16, EU:C:2017:597, paragraph 24 and the case-law cited).
49


In order to answer those questions, it should be borne in mind that the sole purpose of the definition of the relevant market, in the context of the application of Article 101(1) TFEU, is to determine whether the agreement in question is capable of affecting trade between Member States and has the object or effect of preventing, restricting or distorting competition within the internal market (judgment of 11 July 2013, Gosselin Group v Commission, C‑429/11 P, not published, EU:C:2013:463, paragraph 75 and the case-law cited).
50


The relevant product market comprises all those products and/or services which are regarded as interchangeable or substitutable by the consumer, by reason of their characteristics, their prices and their intended use (see judgment of 28 February 2013, Ordem dos Técnicos Oficiais de Contas, C‑1/12, EU:C:2013:127, paragraph 77).
51


The concept of the relevant market implies that there can be effective competition between the products or services which form part of it and this presupposes that there is a sufficient degree of interchangeability between all the products or services forming part of the same market in so far as a specific use of such products or services is concerned (judgment of 13 February 1979, Hoffmann-La Roche v Commission, 85/76, EU:C:1979:36, paragraph 28). Interchangeability or substitutability is not assessed solely in relation to the objective characteristics of the products and services at issue. The competitive conditions and the structure of supply and demand on the market must also be taken into consideration (see, in respect of Article 102 TFEU, judgment of 9 November 1983, Nederlandsche Banden-Industrie-Michelin v Commission, 322/81, EU:C:1983:313, paragraph 37).
53


Under Article 6 of Directive 2001/83, no medicinal product may be placed on the market of a Member State unless an MA has been issued by the competent authorities of that Member State in accordance with that directive or an authorisation has been granted in accordance with Regulation No 726/2004.
57


On that point, the Court has held that it is apparent from all the conditions set out in that provision, read in the light of the fundamental objectives of that directive, and in particular the objective of seeking to safeguard public health, that the exception provided for in that provision can only concern situations in which the doctor considers that the state of health of his individual patients requires that a medicinal product be administered for which there is no authorised equivalent on the national market or which is unavailable on that market (judgments of 29 March 2012, Commission v Poland, C‑185/10, EU:C:2012:181, paragraph 36, and of 16 July 2015, Abcur, C‑544/13 and C‑545/13, EU:C:2015:481, paragraph 56).
58


In addition, the EU rules on pharmaceutical matters govern the conditions under which a medicinal product such as Avastin may be repackaged so as to allow its intravitreal injection. Thus, according to Article 40 of Directive 2001/83, the manufacture of a medicinal product is subject to authorisation, except for repackaging carried out for retail supply by healthcare professionals (judgment of 28 June 2012, Caronna, C‑7/11, EU:C:2012:396, paragraph 35). The repackaging of Avastin with a view to its use in ophthalmology therefore requires an authorisation, as a rule, unless it is carried out solely for the purposes of retail supply, by pharmacists in dispensing pharmacies or by persons legally authorised in the Member States (judgment of 11 April 2013, Novartis Pharma, C‑535/11, EU:C:2013:226, paragraph 52).
59


It follows that the EU rules on pharmaceutical products prohibit neither the off-label prescription of a medicinal product nor its repackaging for such use but do require that they comply with the conditions laid down in those rules.
69


In that regard, it is apparent from the case-law of the Court that if a given operation or activity is not covered by the prohibition laid down in Article 101(1) TFEU, owing to its neutrality or positive effects in terms of competition, a restriction of the commercial autonomy of one or more of the participants in that operation or activity is not covered by that prohibition either if that restriction is objectively necessary to the implementation of that operation or that activity and is proportionate to the objectives of one or the other (see judgment of 11 September 2014, MasterCard and Others v Commission, C‑382/12 P, EU:C:2014:2201, paragraph 89 and the case-law cited).
70


Where it is not possible to dissociate such a restriction from the main operation or activity without jeopardising its existence and aims, it is necessary to examine the compatibility of that restriction with Article 101 TFEU in conjunction with the compatibility of the main operation or activity to which it is ancillary, even though, taken in isolation, such a restriction may appear on the face of it to be covered by the prohibition rule in Article 101(1) TFEU (judgment of 11 September 2014, MasterCard and Others v Commission, C‑382/12 P, EU:C:2014:2201, paragraph 90).
71


Where it is a matter of determining whether a restriction can escape the prohibition laid down in Article 101(1) TFEU because it is ancillary to a main operation that is not anticompetitive in nature, it is necessary to inquire whether that operation would be impossible to carry out in the absence of the restriction in question. The fact that that operation is simply more difficult to implement or even less profitable without the restriction concerned cannot be deemed to give that restriction the objective necessity required in order for it to be classified as ancillary. Such an interpretation would effectively extend that concept to restrictions which are not strictly indispensable to the implementation of the main operation. Such an outcome would undermine the effectiveness of the prohibition laid down in Article 101(1) TFEU (judgment of 11 September 2014, MasterCard and Others v Commission, C‑382/12 P, EU:C:2014:2201, paragraph 91).
78


In that regard, it is important to recall that the concept of restriction of competition ‘by object’ must be interpreted strictly and can be applied only to certain types of coordination between undertakings which reveal a degree of harm to competition that is sufficient for it to be held that there is no need to examine their effects. Indeed, certain forms of coordination between undertakings can be regarded, by their very nature, as being harmful to the proper functioning of normal competition (see, inter alia, judgments of 20 November 2008, Beef Industry Development Society and Barry Brothers, C‑209/07, EU:C:2008:643, paragraph 17, and of 27 April 2017, FSL and Others v Commission, C‑469/15 P, EU:C:2017:308, paragraph 103).
79


In order to determine whether an arrangement can be considered to be a restriction of competition by object, regard must be had to the content of its provisions, its objectives and the economic and legal context of which it forms a part (see, to that effect, judgments of 8 November 1983, IAZ International Belgium and Others v Commission, 96/82 to 102/82, 104/82, 105/82, 108/82 and 110/82, EU:C:1983:310, paragraph 25, and of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 53).
80


When determining that context, it is necessary to take into account the nature of the goods or services affected, as well as the real conditions of the functioning and the structure of the market or markets in question (judgment of 23 November 2006, Asnef-Equifax and Administración del Estado, C‑238/05, EU:C:2006:734, paragraph 49 and the case-law cited). Where the question arises as to whether there is a cartel agreement in the pharmaceuticals sector, account must be taken of the impact of EU rules on pharmaceutical products (see, by analogy, judgment of 16 September 2008, Lélos kai Sia and Others, C‑468/06 to C‑478/06, EU:C:2008:504, paragraph 58).