Abcur AB v Apoteket Farmaci AB and Apoteket AB.
Date: 2015-07-16
33. As a preliminary point, it should be noted that, in the context of the procedure established by Article 267 TFEU providing for cooperation between national courts and the Court of Justice, it is for the latter to provide the national court with an answer which will be of use to it and enable it to determine the case before it. To that end, the Court may have to reformulate the questions referred to it. Moreover, the Court has a duty to interpret all provisions of EU law which national courts require in order to decide the actions pending before them, even if those provisions are not expressly indicated in the questions referred to the Court of Justice by those courts (judgments in eco cosmetics and Raiffeisenbank St. Georgen , C‑119/13 and C‑120/13, EU:C:2014:2144, paragraph 32, and Subdelegación del Gobierno en Guipuzkoa — Extranjeria , C‑38/14, EU:C:2015:260, paragraph 25).
34. To that end, the Court may extract from all the information provided by the national court, in particular from the grounds of the decision to make the reference, the legislation and the principles of EU law that require interpretation in view of the subject-matter of the dispute in the main proceedings (see, to that effect, judgments in eco cosmetics and Raiffeisenbank St. Georgen , C‑119/13 and C‑120/13, EU:C:2014:2144, paragraph 33, and Aykul , C‑260/13, EU:C:2015:257, paragraph 43 and the case-law cited).
38. It follows from the wording of those provisions that Article 2(1) of Directive 2001/83 makes a positive determination of the scope of that directive, by providing that it 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, while Article 3, points 1 and 2, of that directive provides for certain exceptions to its scope.
39. It follows therefrom that, in order to fall within the scope of Directive 2001/83, the product in question, firstly, must 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 (see, to that effect, judgment in Octapharma France , C‑512/12, EU:C:2014:149, paragraph 38).
40. That restriction of the scope of Directive 2001/83 is clear, furthermore, from recital 6 in the preamble to Regulation No 1394/2007, which recalls that the regulation of medicinal products which are prepared industrially or manufactured by a method involving an industrial process is ‘in accordance with the general scope of the [EU] pharmaceutical legislation laid down in Title II of Directive 2001/83’ (see also, to that effect, judgments in Hecht-Pharma , C‑140/07, EU:C:2009:5, paragraphs 21 and 22, and Octapharma France , C‑512/12, EU:C:2014:149, paragraphs 29 and 30).
45. According to the Court’s settled case-law, the need for a uniform application of EU law and the principle of equality require the terms of a provision of EU law which makes no express reference to the law of the Member States for the purpose of determining its meaning and scope normally to be given an independent and uniform interpretation throughout the European Union; that interpretation must take into account not only its wording but also its context and the objectives pursued by the rules of which it is part (see, to that effect, judgments in Ekro , 327/82, EU:C:1984:11, paragraph 11, and A , C‑523/07, EU:C:2009:225, paragraph 34 and the case-law cited).
47. With regard to the objectives pursued by the rules on medicinal products for human use, both recital 2 in the preamble to Directive 2001/83 and recital 4 in the preamble to Directive 2004/27 recall that the primary purpose of any rules concerning the production and distribution of proprietary medicinal products must be to safeguard public health (see also judgments in Antroposana and Others , C‑84/06, EU:C:2007:535, paragraph 36, and Commission  v Poland , C‑185/10, EU:C:2012:181, paragraph 27).
50. Having regard to the objective of protection of public health pursued by the EU rules on medicinal products for human use and thus recalled, the terms ‘prepared industrially’ and ‘manufactured by a method involving an industrial process’ cannot be interpreted narrowly. Those terms must therefore include, at the very least, any preparation or manufacture involving an industrial process. Such a process is characterised in general by a succession of operations, which may, in particular, be mechanical or chemical, in order to obtain a significant quantity of a standardised product.
54. In order to interpret those provisions, it must be taken into account that, generally, provisions which are in the nature of exceptions to a principle must, according to settled case-law, be interpreted strictly (see in particular, to that effect, Erotic Center , C‑3/09, EU:C:2010:149, paragraph 15, and Commission  v Poland , C‑185/10, EU:C:2012:181, paragraph 31 and the case-law cited).
56. Moreover, by virtue of Article 5(1) of Directive 2001/83, a Member State may, to fulfil special needs, exclude from the provisions of that directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under his direct personal responsibility. In that regard, the court has held that it is apparent from the conditions as a whole 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 (see, to that effect, judgment in Commission  v Poland , C‑185/10, EU:C:2012:181, paragraphs 29 and 36).
57. It follows therefrom, as the Advocate General noted in point 55 of his Opinion, that 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, there cannot in fact be a question of ‘special needs’, within the meaning of Article 5(1) of Directive 2001/83, necessitating a derogation from the requirement for an MA (see, to that effect, judgments in Commission  v Poland , C‑185/10, EU:C:2012:181, paragraph 37, and Novartis Pharma , C‑535/11, EU:C:2013:226, paragraph 46).
66. With regard to Article 3, point 2, of Directive 2001/83, the view must be taken, as has been noted in paragraph 58 of this judgment concerning the exception provided for in Article 3, point 1, of that directive, that the implementation of the exception for which it provides is also subject to the fulfilment of a set of conditions concerning the medicinal products in question. They must be prepared ‘in a pharmacy’, ‘in accordance with the prescriptions of a pharmacopoeia’ and ‘intended to be supplied directly to the patients served by the pharmacy in question’. Those conditions are also cumulative so that the exception provided for in that provision cannot be applied if one of them is not satisfied.
73. It is clear from Article 3(1) of Directive 2005/29 that that directive applies to unfair business-to-consumer commercial practices, as laid down in Article 5, before, during and after a commercial transaction in relation to a product. Article 2(d) of that directive defines such practices as ‘any act, omission, course of conduct or representation, commercial communication including advertising and marketing, by a trader, directly connected with the promotion, sale or supply of a product to consumers’.
74. As the Court has already held, Directive 2005/29 is characterised by a particularly wide scope ratione materiae  which extends to any commercial practice directly connected with the promotion, sale or supply of a product to consumers (judgment in Mediaprint Zeitungs- und Zeitschriftenverlag , C‑540/08, EU:C:2010:660, paragraph 21).
76. Directive 2001/83 forms part of the EU provisions relating to health, recital 2 in the preamble to that directive recalling that safeguarding public health must be the essential aim of any rules governing the production, distribution and use of medicinal products.
79. Finally, it must be pointed out that Article 3(4) of Directive 2005/29 provides that, in the case of conflict between the provisions of that directive and other EU rules regulating specific aspects of unfair commercial practices, the latter are to prevail and apply to those specific aspects. That directive accordingly applies only in so far as there are no specific EU law provisions regulating specific aspects of unfair commercial practices, such as information requirements and rules on the way the information is presented to the consumer.
80. Since Directive 2001/83 contains specific rules on the advertising of medicinal products, it constitutes a special rule as compared with the general rules concerning protection of consumers against unfair commercial practices by undertakings towards them, such as those provided for in Directive 2005/29 (see, by analogy, judgment in Gintec , C‑374/05, EU:C:2007:654, paragraph 31).