Susanne Sokoll-Seebacher.
Date: 2014-02-13
8. In those circumstances, the Unabhängiger Verwaltungssenat des Landes Oberösterreich, decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:
‘1. Do the rule of law considerations inherent in Article 16 of the Charter and/or the considerations of transparency inherent in Article 49 TFEU preclude a national provision such as point 3 of Paragraph 10(2) of the ApG at issue in the [main proceedings], pursuant to which the condition whether there is a need to establish a new public pharmacy is not specified at least in essence in the legislation itself but its elaboration is left in considerable respects to the national courts, since it cannot be excluded that a scheme of that kind affords a significant competitive advantage to interested parties from Austria, individually and as a whole, over nationals from other Member States?
2. If Question 1 is answered in the negative: Does Article 49 TFEU preclude a national provision such as point 3 of Paragraph 10(2) of the ApG, which in relation to the crucial condition whether a need is deemed to exist sets a rigid threshold of 5 500 people without allowing for any departure from that general rule, since de facto  under a scheme of that kind it does not appear possible to ensure (without more) the achievement in a consistent manner of the legislative objective pursued, in terms of paragraphs 98 to 101 of the [judgment in Joined Cases C‑570/07 and C‑571/07 Blanco Pérez and Chao Gómez  [2010] ECR I‑4629]?
3. If Question 2 is also answered in the negative: Do Article 49 TFEU and/or Article 47 of the Charter preclude a provision such as point 3 of Paragraph 10(2) of the ApG which has been interpreted, as result of the case-law of the highest national courts concerning the verification of the existence of a need, to include additional detailed criteria – such as whether an application has priority in time, the blocking effect of an existing application in relation to subsequent applications, the two-year lockout period following the rejection of an application, criteria for determining the number of ‘permanent inhabitants’ and ‘incoming users’ and for allocating the customer base in the event of an overlap between the four-kilometre radius surrounding each of two or more pharmacies, etc. – since, as a result, it is not possible to ensure that, as a general rule, the provision will be applied in a manner that is foreseeable and calculable and within a reasonable period and, hence, the legislative provision cannot be considered appropriate, in fact, to ensure the achievement in a consistent manner of the legislative objective pursued (see paragraphs 98 to 101 and 114 to 125 of the Court’s judgment in Blanco Pérez ) and/or the provision of an adequate pharmaceutical service must be regarded as de facto  not ensured and/or discrimination must be presumed as between applicants from Austria amongst themselves or between them and applicants from other Member States?’
Admissibility
10. In that regard, it should be recalled that, while national legislation such as that at issue in the main proceedings – which applies indiscriminately to Austrian nationals and to nationals of other Member States – is, generally, capable of falling within the scope of the provisions relating to the fundamental freedoms established by the FEU Treaty only to the extent that it applies to situations connected with trade between the Member States, it is far from inconceivable that nationals established in Member States other than the Republic of Austria have been or are interested in operating pharmacies in that Member State (see, to that effect, Joined Cases C‑159/12 to C‑161/12 Venturini and Others  [2013] ECR, paragraph 25 and the case-law cited).
12. Moreover, even in a purely internal situation such as that at issue in the main proceedings, where all the factors are confined to a single Member State, a response could nevertheless be useful for the referring court, in particular if its national law were to require it to grant to an Austrian national the same rights as those which a national of another Member State would derive from European Union law in the same situation ( Venturini and Others , paragraph 28 and case-law cited).
15. In that regard, it is the Court’s settled case-law that the need to provide an interpretation of European Union law which will be of use to the referring court requires that the referring court define the factual and legal context of its questions or, at the very least, that it explain the factual circumstances on which those questions are based (see, inter alia, Case C‑134/03 Viacom Outdoor  [2005] ECR I‑1167, paragraph 22; Joined Cases C‑453/03, C‑11/04, C‑12/04 and C‑194/04 ABNA and Others  [2005] ECR I‑10423, paragraph 45; and C‑284/12 Deutsche Lufthansa  [2013] ECR, paragraph 20).
16. The Court has also stressed that it is important for the referring court to set out the precise reasons why it was unsure as to the interpretation of European Union law and why it considered it necessary to refer questions to the Court for a preliminary ruling. The Court has thus ruled that it is essential that the referring court provide at the very least some explanation of the reasons for the choice of the provisions of European Union law which it requires to be interpreted and of the link it establishes between those provisions and the national legislation applicable to the dispute before it (see, inter alia, Case C‑318/00 Bacardi-Martini and Cellier des Dauphins  [2003] ECR I‑905, paragraph 43, and ABNA and Others , paragraph 46).
22. That reference to European Union law must be understood as meaning that Article 16 of the Charter refers, inter alia, to Article 49 TFEU, which guarantees the fundamental freedom of establishment.
24. Second, it should be borne in mind that, according to the settled case‑law of the Court, Article 49 TFEU must be interpreted as not precluding, in principle, a Member State from adopting a system of prior authorisation for the establishment of new healthcare providers, such as pharmacies, where this proves indispensable for filling in possible gaps in access to public health services and for avoiding the duplication of structures, so as to ensure the provision of public health care which is adapted to the needs of the population, which covers the entire territory and which takes account of geographically isolated or otherwise disadvantaged regions (see, to that effect, Blanco Pérez and Chao Gómez , paragraphs 70 and 71 and the case-law cited).
25. The Court has thus held that national legislation setting out certain criteria to which the issue of licences to open new pharmacies is subject is generally appropriate for attaining the objective of ensuring that the provision of medicinal products to the public is reliable and of good quality (see, to that effect, Blanco Pérez and Chao Gómez , paragraph 94; see orders of 17 December 2010 in Case C‑217/09 Polisseni , paragraph 25 and of 29 September 2011 in Case C‑315/08 Grisoli,  paragraph 31).
26. The Court has also held that it must be taken into account that the health and life of humans rank foremost among the assets and interests protected by the Treaty and that it is for Member States to determine the level of protection which they wish to afford to public health and the way in which that level has to be achieved. Since that level of protection may vary from one Member State to the other, Member States must be allowed a measure of discretion ( Blanco Pérez and Chao Gómez , paragraph 44 and the case-law cited).
27. More specifically, it follows from the Court’s settled case-law that a prior administrative authorisation scheme cannot render legitimate discretionary conduct on the part of the national authorities which is liable to negate the effectiveness of provisions of European Union law, in particular those relating to a fundamental freedom such as the freedom of establishment. Therefore, if a prior administrative authorisation scheme is to be justified even though it derogates from a fundamental freedom, it must be based on objective, non-discriminatory criteria known in advance, in such a way as adequately to circumscribe the exercise of the national authorities’ discretion (C‑169/07 Hartlauer  [2009] ECR I‑1721 paragraph 64 and the case-law cited).
39. Third, it should be noted that, according to the Court’s settled case-law, national legislation is appropriate for securing attainment of the objective sought only if it genuinely reflects a concern to attain that objective in a consistent and systematic manner (see, to that effect, Hartlauer , paragraph 55; Joined Cases C-171/07 and C-172/07 Apothekerkammer des Saarlandes and Others  [2009] ECR I-4171, paragraph 42; Blanco Pérez and Chao Gómez , paragraph 94; and Case C-539/11 Ottica New Line di Accardi Vincenzo  [2013] ECR, paragraph 47).
40. In that regard, it is ultimately for the referring court, which has sole jurisdiction to assess the facts and interpret the national legislation, to determine whether and to what extent such legislation satisfies those conditions. However, the Court, which is called on to provide answers of use to the referring court, may provide guidance based on the documents relating to the main proceedings and on the written and oral observations which have been submitted to it, in order to enable the referring court to give judgment ( Ottica New Line di Accardi Vincenzo paragraphs 48 and 49 and the case-law cited).
41. To that end, it should be recalled that the uniform application, over the entire territory concerned, of conditions relating to the demographic density and the minimum distance between pharmacies, laid down by national legislation governing the opening of a new pharmacy, might well be unsuccessful, in certain circumstances, in ensuring adequate access to pharmaceutical services in areas which have certain special demographic features (see, to that effect, Blanco Pérez and Chao Gómez , paragraph 96).
42. More specifically, as regards the conditions relating to demographic density, the Court considered that the uniform application of those conditions, without any possibility of derogation, would lead, in certain rural areas where the population is generally dispersed and less numerous, to certain inhabitants concerned finding themselves beyond reasonable distance of a pharmacy and thus possibly being denied adequate access to pharmaceutical services (see, to that effect, Blanco Pérez and Chao Gómez , paragraph 97).