Novartis Pharma GmbH v Apozyt GmbH.
Date: 2013-04-11
30. In that regard, it should be recalled, first, 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 where the case must be decided on the basis of an argument which has not been debated between the parties (see order in Case C‑17/98 Emesa Sugar  [2000] ECR I‑665, paragraph 18; judgments in Case C‑210/03 Swedish Match  [2004] ECR I‑11893, paragraph 25, and Case C‑138/05 Stichting Zuid-Hollandse Milieufederatie  [2006] ECR I‑8339, paragraph 23).
31. Second, under the second paragraph of Article 252 TFEU, it is the duty of the Advocate General, acting with complete impartiality and independence, to make, in open court, reasoned submissions on cases which, in accordance with the Statute of the Court of Justice of the European Union, require the Advocate General’s involvement. In carrying out that task, the Advocate General may, where appropriate, analyse a request for a preliminary ruling by placing it within a context which is broader than that strictly defined by the referring court or by the parties to the main proceedings. Since the Court is not bound either by the Advocate General’s Opinion or by the reasoning on which it is based, it is not absolutely necessary to reopen the oral procedure, under Article 83 of the Rules of Procedure, each time the Advocate General raises a point of law which was not the subject of debate between the parties (Case C‑361/06 Feinchemie Schwebda and Bayer CropScience  [2008] ECR I‑3865, paragraph 34).
42. In such circumstances, provided that the referring court does in fact find that the processes in question do not result in any modification of the medicinal product and that they are carried out solely on the basis of individual prescriptions making provision for them, there is no ground for considering that the activity thus carried out can be equated with a new placing on the market of a medicinal product included in point 1 of the Annex to Regulation No 726/2004; accordingly, the company concerned is, in that respect, not subject to the obligation to hold a marketing authorisation granted by the Community pursuant to Article 3(1) of the regulation.
43. It is true that in its judgment in Case C‑433/00 Aventis [2002] ECR I‑7761 the Court held that where a medicinal product had been the subject of two separate central marketing authorisations, one for packs of five items and the other for packs of 10 items, the European Union rules precluded that product from being marketed in a package consisting of two packs of five items which had been joined together and relabeled, commonly known as ‘bundling’. However, the circumstances of the present case can be distinguished from those at issue in Aventis , which concerned repackaging for the purposes of parallel trading, and the Court observes in particular, concurring with the Portuguese Government, that the activity carried out by a company such as Apozyt occurs after the medicinal products at issue in the main proceedings have been placed on the market. In particular, 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 modification of those products, is in reality analogous to actions which, in the absence of Apozyt’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.
46. It should be borne in mind in that regard that Article 5(1) of Directive 2001/83 is a specific derogating provision, which must be interpreted strictly, applicable in exceptional cases where it is appropriate to meet special medical needs, in circumstances in which a doctor, following an actual examination of his patients and on the basis of purely therapeutic considerations, prescribes a medicinal product which does not have a valid marketing authorisation in the European Union and for which there is no authorised equivalent on the national market or which is unavailable on that market (see, to that effect, Case C‑185/10 Commission  v Poland  [2012] ECR I‑0000, paragraphs 35, 36 and 48). The Court pointed out in particular, in paragraph 37 of that judgment, that Article 5(1) cannot be relied on where medicinal products having the same active substances, the same dosage and the same form as those which the doctor providing treatment considers that he must prescribe to treat his patients are already authorised and available on the national market.
49. Concerning the last point, it should, however, be recalled that a prescribing doctor is required, from the point of view of professional conduct, not to prescribe a given medicinal product if it is not appropriate for the therapeutic treatment of his patient, including from the point of view of how it is administered (see Case C‑62/09 Association of the British Pharmaceutical Industry  [2010] ECR I‑3603, paragraph 40).
51. With regard to the requirements applying to an activity such as that carried out by Apozyt, the referring court mentions Article 40 of Directive 2001/83. In that regard, it is indeed the case that, under the first subparagraph of Article 40(2) of the directive, authorisation, as referred to in that provision, is required for that activity in so far as it concerns the repackaging of medicinal products which have a marketing authorisation.
52. However, as Ireland and the Commission submit, under the second subparagraph of Article 40(2) of Directive 2001/83 such authorisation is not required for, inter alia, dividing up and changes in packaging where those processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorised in the Member States to carry out such processes.