José Manuel Blanco Pérez and María del Pilar Chao Gómez v Consejería de Salud y Servicios Sanitarios (C-570/07) and Principado de Asturias (C-571/07).
Date: 2010-06-01
3. Recital 26 in the preamble to Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ 2005 L 255, p. 22), the terms of which are essentially the same as those of the second recital in the preamble to Council Directive 85/432/EEC of 16 September 1985 concerning the coordination of provisions laid down by Law, Regulation or Administrative Action in respect of certain activities in the field of pharmacy (OJ 1985 L 253, p. 34), states:
‘This Directive does not coordinate all the conditions for access to activities in the field of pharmacy and the pursuit of these activities. In particular, the geographical distribution of pharmacies and the monopoly for dispensing medicines should remain a matter for the Member States. This Directive leaves unchanged the legislative, regulatory and administrative provisions of the Member States forbidding companies from pursuing certain pharmacists’ activities or subjecting the pursuit of such activities to certain conditions.’
35. In that regard, it should be borne in mind that 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 (see, to that effect, Case C‑379/98 PreussenElektra  [2001] ECR I‑2099, paragraph 38, and Case C‑169/07 Hartlauer  [2009] ECR I-1721, paragraph 24).
36. It follows that questions concerning EU law enjoy a presumption of relevance. Thus, 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 is unrelated 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 (see, to that effect, Joined Cases C-94/04 and C-202/04 Cipolla and Others [2006] ECR I‑11421, paragraph 25, and Joined Cases C-222/05 to C‑225/05 van der Weerd and Others  [2007] ECR I-4233, paragraph 22).
39. Admittedly, it is common ground that Mr Blanco Pérez and Ms Chao Gómez are of Spanish nationality and that all aspects of the main proceedings are confined within one Member State. However, as is apparent from the case-law, the Court’s answer may be useful to the referring court even in such circumstances, in particular if its national law were to require it to grant a Spanish national the same rights as those which a national of another Member State would derive from EU law in the same situation (see, inter alia, Case C‑451/03 Servizi Ausiliari Dottori Commercialisti  [2006] ECR I‑2941, paragraph 29, and Cipolla and Others , paragraph 30).
40. Furthermore, while national legislation such as that at issue in the main proceedings – which applies to Spanish nationals and to nationals of other Member States alike – is, generally, capable of falling within the scope of the provisions relating to the fundamental freedoms established by the 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 Kingdom of Spain have been or are interested in operating pharmacies in the Autonomous Community of Asturias (see, to that effect, Case C-384/08 Attanasio Group [2010] ECR I-0000, paragraphs 23 and 24 and the case-law cited).
43. It should first be noted that, pursuant to Article 168(7) TFEU, as clarified by the case-law of the Court and by recital 26 in the preamble to Directive 2005/36, EU law does not detract from the power of the Member States to organise their social security systems and to adopt, in particular, provisions to govern the organisation of health services such as pharmacies. In exercising that power, however, Member States must comply with EU law and, in particular, with the Treaty provisions on the fundamental freedoms, since those provisions prohibit Member States from introducing or maintaining unjustified restrictions on the exercise of those freedoms in the healthcare sector (see, to that effect, Hartlauer , paragraph 29; Case C-531/06 Commission  v Italy  [2009] ECR I-0000, paragraph 35; and Joined Cases C-171/07 and C-172/07 Apothekerkammer des Saarlandes and Others  [2009] ECR I-0000, paragraph 18).
44. That being so, when assessing whether that obligation has been complied with, account must be taken of the fact that the health and life of humans rank foremost among the assets and interests protected by the Treaty and that it is for the Member States to determine the level of protection which they wish to afford to public health and the way in which that level is to be achieved. Since the level may vary from one Member State to another, Member States should be allowed a measure of discretion (see, to that effect, Case C-141/07 Commission  v Germany  [2008] ECR I-6935, paragraph 51, and Apothekerkammer des Saarlandes and Others , paragraph 19).
45. Secondly, neither Directive 2005/36 nor any other measure implementing the fundamental freedoms lays down rules, concerning access to activities in the pharmacy field, which seek to set the conditions for opening new pharmacies in Member States.
53. It is settled case-law that any national measure which, albeit applicable without discrimination on grounds of nationality, is liable to hinder or render less attractive the exercise by EU nationals of the freedom of establishment guaranteed by the Treaty constitutes a restriction within the meaning of Article 49 TFEU (see, to that effect, Case C-299/02 Commissio n  v Netherlands  [2004] ECR I‑9761, paragraph 15, and Case C-140/03 Commission  v Greece  [2005] ECR I-3177, paragraph 27).
54. A national rule which makes the establishment of an undertaking from another Member State conditional upon the issue of prior authorisation falls within that category, since it is capable of hindering the exercise by that undertaking of freedom of establishment by preventing it from freely pursuing its activities through a fixed place of business. First, the undertaking may have to bear the additional administrative and financial costs which any such grant of authorisation entails. Secondly, the system of prior authorisation acts as a bar to self-employed activity for economic operators who do not satisfy predetermined requirements, compliance with which is a condition for the issue of that authorisation (see, to that effect, Hartlauer , paragraphs 34 and 35).
55. Moreover, national legislation constitutes a restriction where it makes the pursuit of an activity subject to a condition which is linked to the economic or social needs for that activity, since it tends to limit the number of service providers (see, to that effect, Hartlauer , paragraph 36).
61. It is settled case-law that restrictions on freedom of establishment which are applicable without discrimination on grounds of nationality may be justified by overriding reasons relating to the general interest, provided that the restrictions are appropriate for securing attainment of the objective pursued and do not go beyond what is necessary for attaining that objective ( Hartlauer , paragraph 44, and Apothekerkammer des Saarlandes and Others , paragraph 25).
63. In the second place, it is apparent from Article 52(1) TFEU that the protection of public health can justify restrictions on the fundamental freedoms guaranteed by the Treaty, such as the freedom of establishment (see, inter alia, Hartlauer , paragraph 46, and Apothekerkammer des Saarlandes and Others , paragraph 27).
64. More specifically, restrictions on the freedom of establishment may be justified by the objective of ensuring that the provision of medicinal products to the public is reliable and of good quality ( Commission  v Italy , paragraph 52, and Apothekerkammer des Saarlandes and Others , paragraph 28).
65. The importance of that objective is confirmed by Article 168(1) TFEU and Article 35 of the Charter of Fundamental Rights of the European Union, under which, inter alia, a high level of protection for human health is to be ensured in the definition and implementation of all policies and activities of the European Union.
68. In that connection, it should first be noted that, in view of the discretion referred to in paragraph 44 above, the fact that one Member State imposes more stringent rules than another in relation to the protection of public health does not mean that those rules are incompatible with the Treaty provisions on the fundamental freedoms (see, to that effect, Case C‑110/05 Commission  v Italy  [2009] ECR I‑519, paragraph 65 and the case-law cited).
70. Secondly, it should be borne in mind that, according to the case‑law of the Court, public health establishments and infrastructures may be subject to planning. That may include prior authorisation for the establishment of new service providers, 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, by analogy, Case C‑157/99 Smits and Peerbooms  [2001] ECR I‑5473, paragraphs 76 to 80; Case C‑372/04 Watts [2006] ECR I‑4325, paragraphs 108 to 110; and Hartlauer , paragraphs 51 and 52).
71. That finding is fully transposable to the provision of public health services in the field of pharmacy.
72. Thirdly, it should be observed that there are certain densely populated areas which might be perceived by many pharmacists as very profitable, and consequently more attractive, such as those in urban areas. By contrast, other parts of the national territory might be considered to be less attractive, such as rural, geographically isolated or otherwise disadvantaged areas.
73. In those circumstances, it is not inconceivable that, if this field were wholly unregulated, pharmacists would become concentrated in the areas considered to be attractive, so that certain other less attractive areas would suffer from a shortfall in the number of pharmacists needed to ensure a pharmaceutical service which is reliable and of good quality.
74. Fourthly, it should be borne in mind that, where there is uncertainty as to the existence or extent of risks for public health, a Member State can take protective measures without having to wait until the reality of those risks becomes fully apparent ( Apothekerkammer des Saarlandes and Others , paragraph 30).
75. Thus, a Member State might see a risk that some parts of its territory will be left with too few pharmacies and that, as a consequence, the provision of medicinal products might well not be reliable and of good quality.
76. Accordingly, the Member State may, in view of that risk, adopt legislation under which only one pharmacy may be set up in relation to a certain number of inhabitants (see paragraph 57 above).
77. The effect of laying down such a condition may be to channel the setting-up of pharmacies towards parts of the national territory where access to pharmaceutical services is lacking since, by preventing pharmacists from setting up in areas where there is already a sufficient number of pharmacies, it encourages them to do so in areas where there are too few.
78. It follows that that condition is likely to result in an even distribution of pharmacies throughout the national territory; in that way to ensure that the population as a whole has adequate access to pharmaceutical services; and, as a consequence, to improve the reliability and the quality of the provision of medicinal products to the public.
81. By its very nature, that condition enables such a concentration to be avoided and is thus likely to lead to a more even distribution of pharmacies within a given geographical area.
82. As a result, the ‘minimum distance’ condition also leads members of the public to be more confident that they have a pharmacy nearby and, in consequence, that they have quick and easy access to adequate pharmaceutical services.
90. First of all, it should be observed that the freedom of establishment of economic operators must be weighed against the imperative requirements of the protection of public health, and the seriousness of the objectives pursued in that domain may justify restrictions which have adverse consequences, and even substantial adverse consequences, for certain operators (see, to that effect, Case C-183/95 Affish  [1997] ECR I-4315, paragraphs 42 and 43).
94. While it is apparent from the above that legislation such as that at issue in the cases before the referring court is generally appropriate to attaining the objective of ensuring that the provision of medicinal products to the public is reliable and of good quality, it is also essential that the way in which that legislation pursues that objective is not inconsistent. According to the case-law of the Court, the various rules – and the national legislation as a whole – are appropriate for ensuring attainment of the objective relied upon only if they genuinely reflect a concern to attain that objective in a consistent and systematic manner (see, to that effect, Hartlauer , paragraph 55, and Apothekerkammer des Saarlandes and Others , paragraph 42).
96. On that point, it should be noted that the two conditions laid down in Decree 72/2001 – applicable throughout the territory concerned – are supposed to ensure the reliable and satisfactory provision of medicinal products to the public on the basis of standards, applied across the board, which necessarily take into account ordinary demographic factors, regarded as average. It follows that the uniform application of conditions conceived on that basis might well be unsuccessful in ensuring adequate access to pharmaceutical services in areas which have certain special demographic features.
97. That may be the case, first, in certain rural areas where the population is generally dispersed and less numerous. The effect of that special feature may be that, were the condition of the minimum number of 2 800 inhabitants to be uniformly applied, certain inhabitants concerned would find themselves beyond reasonable reach of a pharmacy and would thus be denied adequate access to pharmaceutical services.
117. In those circumstances, it remains to be considered whether Article 49 TFEU precludes the criteria provided for in points 6 and 7(c) of that annex, given that Article 49 TFEU requires, in particular, that the criteria applicable in the context of an administrative authorisation scheme not be discriminatory (see Hartlauer , paragraph 64).
118. In this connection, it should be borne in mind that the principle of non-discrimination prohibits not only direct or overt discrimination on grounds of nationality but also all covert forms of discrimination which, by the application of other distinguishing criteria, lead to the same result (see Case C‑212/99 Commission  v Italy  [2001] ECR I‑4923, paragraph 24, and Case C‑224/00 Commission  v Italy  [2002] ECR I‑2965, paragraph 15).
119. Thus, unless objectively justified and proportionate to its aim, a provision of national law must be regarded as indirectly discriminatory if it is intrinsically liable to affect the nationals of other Member States more than the nationals of the State whose legislation is at issue and if there is a consequent risk that it will place the former at a particular disadvantage (Case C-212/05 Hartmann  [2007] ECR I‑6303, paragraph 30).
122. Thus, by dint of those two criteria, the selection process favours pharmacists who have pursued their activities on part of the national territory. Obviously, such a criterion can be more easily met by national pharmacists, who more often pursue their economic activities on the national territory, than by pharmacists who are nationals of other Member States, who more frequently pursue those activities in another Member State (see, by analogy, Hartmann , paragraph 31).