Novartis Farma SpA v Agenzia Italiana del Farmaco (AIFA) and Others.
Date: 2018-11-21
43


In that regard, it must be borne in mind that, in the context of the cooperation between the Court and the national courts established in Article 267 TFEU, it is solely for the national court, before which the 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).
44


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 for a preliminary ruling 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).
48


It should be noted that, in accordance with Article 168(7) TFEU, EU law does not detract from the power of the Member States to organise their social security systems and to adopt, in particular, measures intended to govern the consumption of pharmaceutical products in order to promote the financial stability of their healthcare insurance schemes (judgment of 22 April 2010, Association of the British Pharmaceutical Industry, C‑62/09, EU:C:2010:219, paragraph 36).
50


However, although EU law, in particular Directive 89/105, does not detract from the powers of the Member States in this area, the fact remains that, in exercising those powers the Member States must comply with EU law (judgment of 2 April 2009, A. Menarini Industrie Farmaceutiche Riunite and Others, C‑352/07 to C‑356/07, C‑365/07 to C‑367/07 and C‑400/07, EU:C:2009:217, paragraphs 19 and 20).
51


In addition, 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 (judgment of 23 January 2018, F. Hoffmann-La Roche and Others, C‑179/16, EU:C:2018:25, paragraph 59).
55


For the purposes of answering that question, it must be borne in mind that the scope of Directive 2001/83 is defined according to what falls within it in Article 2(1) thereof, which provides that the directive is to apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process. Article 3(1) and (2) of the directive sets out certain exceptions to its scope in respect of medicinal products prepared in a pharmacy, either in accordance with a medical prescription for an individual patient, or in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question. It follows therefrom that, in order to fall within the scope of Directive 2001/83, the medicinal product in question must, firstly, satisfy the conditions laid down in Article 2(1) of that directive and, secondly, must not fall within one of the exceptions expressly provided for in Article 3 of that directive (judgment of 16 July 2015, Abcur, C‑544/13 and C‑545/13, EU:C:2015:481, paragraphs 38 and 39).
68


Those conditions include the requirement of holding an MA and manufacturing authorisation, both authorisations being stated in Articles 6 and 40 of Directive 2001/83 respectively. In order to provide the referring court with a helpful answer to allow it to resolve the dispute before it, the Court considers that it is also necessary to give an interpretation of Article 40 of that directive even if that article is not specifically mentioned in the request for a preliminary ruling before it (judgment of 11 April 2013, Berger, C‑636/11, EU:C:2013:227, paragraph 31).
69


As regards placing a medicinal product on the market, the first subparagraph of Article 6(1) of Directive 2001/83 provides that 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 unless an authorisation has been issued in accordance with the centralised procedure provided for in Regulation No 726/2004 for medicinal products referred to in the annex to that regulation (judgments of 23 January 2018, F. Hoffmann-La Roche and Others, C‑179/16, EU:C:2018:25, paragraph 53, and of 29 March 2012, Commission v Poland, C‑185/10, EU:C:2012:181, paragraph 26).
70


The principle of a mandatory MA also applies, according to the second subparagraph of that article, when a medicinal product has been granted an initial [MA] in accordance with the first subparagraph, in so far as, in that case, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions are also to be granted an authorisation in accordance with the first subparagraph or be included in the initial [MA].
71


In accordance with that principle, the Court thus held that where a medicinal product was the subject of two separate central marketing authorisations, one for packs of five items and the other for packs of 10 items, EU pharmaceutical rules precluded that product from being marketed in a package consisting of two packs of five items which had been joined together and relabelled, unless an MA was issued in that regard, on the ground that the detailed and specific requirements regarding the packaging of medicinal products subject to a central MA were intended to prevent consumers from being misled and thereby to protect public health (judgment of 19 September 2002, Aventis, C‑433/00, EU:C:2002:510, paragraph 25).
72


In a case similar to that at issue in the main proceedings, the Court held that the repackaging of Avastin for off-label use in the treatment of eye diseases did not require a new MA, provided that that process does not result in any modification of the medicinal product and that it is carried out solely on the basis of individual prescriptions making provision for that process (judgment of 11 April 2013, Novartis Pharma, C‑535/11, EU:C:2013:226, paragraph 42).
74


The Court thus stated that the drawing off of liquid medicinal products from the original vials, and the transfer into ready-to-use syringes of the portions so drawn off, without any modifications of those products, is in reality analogous to actions which, in the absence of another undertaking’s activities, could otherwise be, or have been, carried out, under their responsibility, by doctors prescribing the treatment or by pharmacies themselves in their dispensaries, or else in hospitals (judgment of 11 April 2013, Novartis Pharma, C‑535/11, EU:C:2013:226, paragraphs 42 and 43).
76


As regards the manufacturing of a medicinal product, while, under Article 40(1) of Directive 2001/83, the manufacture of medicinal products is subject in general to the requirement of holding an authorisation, the second subparagraph of Article 40(2) of the directive provides that the manufacturing authorisation is not required for processes such as the preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply of medicinal products, by pharmacists in dispensing pharmacies or by persons legally authorised in the Member States to carry out such processes. It follows that, where those manufacturing processes are not carried out for such purposes, pharmacists are not exempt from the requirement to hold manufacturing authorisation (judgments of 28 June 2012, Caronna, C‑7/11, EU:C:2012:396, paragraph 35, and of 11 April 2013, Novartis Pharma, C‑535/11, EU:C:2013:226, paragraphs 51 and 52).