Apothekerkammer des Saarlandes and Others (C-171/07) and Helga Neumann-Seiwert (C-172/07) v Saarland and Ministerium für Justiz, Gesundheit und Soziales.
Date: 2009-05-19
18. First, it is clear, both from the case-law of the Court and from Article 152(5) EC and recital 26 in the preamble to Directive 2005/36, that Community law does not detract from the power of the Member States to organise their social security systems and to adopt, in particular, provisions intended to govern the organisation of health services such as pharmacies. In exercising that power, however, the Member States must comply with Community law, in particular the provisions of the Treaty on the freedoms of movement, including freedom of establishment. Those provisions prohibit the Member States from introducing or maintaining unjustified restrictions on the exercise of those freedoms in the healthcare sector (see, to this effect, Case C-372/04 Watts  [2006] ECR I-4325, paragraphs 92 and 146, and Case C-169/07 Hartlauer  [2009] ECR I-0000, paragraph 29).
19. 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 must be allowed discretion (see, to this effect, Case C-322/01 Deutscher Apothekerverband  [2003] ECR I-14887, paragraph 103; Case C-141/07 Commission  v Germany  [2008] ECR I-0000, paragraph 51; and Hartlauer , paragraph 30).
22. According to settled case-law, Article 43 EC precludes any national measure which, even though it is applicable without discrimination on grounds of nationality, is liable to hinder or render less attractive the exercise by Community nationals of the freedom of establishment that is guaranteed by the Treaty (see, in particular, Case C-19/92 Kraus  [1993] ECR I-1663, paragraph 32, and Case C‑299/02 Commission  v Netherlands  [2004] ECR I‑9761, paragraph 15).
23. Legislation which makes the establishment in the host Member State of an economic operator from another Member State subject to the issue of a prior authorisation and allows self-employed activity to be pursued only by certain economic operators who satisfy predetermined requirements, compliance with which is a condition for the issue of that authorisation, constitutes a restriction within the meaning of Article 43 EC. Such legislation deters or even prevents economic operators from other Member States from pursuing their activities in the host Member State through a fixed place of business (see, to this effect, Hartlauer , paragraphs 34, 35 and 38).
25. Restrictions on freedom of establishment which are applicable without discrimination on grounds of nationality may be justified by overriding reasons in 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 (see Hartlauer , paragraph 44).
27. Second, the protection of public health is one of the overriding reasons in the general interest which can justify restrictions on the freedoms of movement guaranteed by the Treaty such as the freedom of establishment (see, inter alia, Hartlauer , paragraph 46).
28. More specifically, restrictions on those freedoms of movement may be justified by the objective of ensuring that the provision of medicinal products to the public is reliable and of good quality (see, to this effect, Deutscher Apothekerverband , paragraph 106, and Commission  v Germany , paragraph 47).
30. It is important that, where there is uncertainty as to the existence or extent of risks to human health, a Member State should be able to take protective measures without having to wait until the reality of those risks becomes fully apparent. Furthermore, a Member State may take the measures that reduce, as far as possible, a public-health risk (see, to this effect, Case C-170/04 Rosengren and Others  [2007] ECR I-4071, paragraph 49), including, more specifically, a risk to the reliability and quality of the provision of medicinal products to the public.
31. In this context, attention is to be drawn to the very particular nature of medicinal products, whose therapeutic effects distinguish them substantially from other goods (see, to this effect, Case C-369/88 Delattre  [1991] ECR I‑1487, paragraph 54).
32. Those therapeutic effects have the consequence that, if medicinal products are consumed unnecessarily or incorrectly, they may cause serious harm to health, without the patient being in a position to realise that when they are administered.
33. Overconsumption or incorrect use of medicinal products leads, moreover, to a waste of financial resources which is all the more damaging because the pharmaceutical sector generates considerable costs and must satisfy increasing needs, while the financial resources which may be made available for healthcare are not unlimited, whatever the mode of funding applied (see by analogy, with regard to hospital treatment, Case C‑385/99 Müller-Fauré and van Riet  [2003] ECR I‑4509, paragraph 80, and Watts , paragraph 109). There is a direct link between those financial resources and the profits of businesses operating in the pharmaceutical sector because in most Member States the prescription of medicinal products is borne financially by the health insurance bodies concerned.
34. In the light of those risks to public health and to the financial balance of social security systems, the Member States may make persons entrusted with the retail supply of medicinal products subject to strict requirements, including as regards the way in which the products are marketed and the pursuit of profit. In particular, the Member States may restrict the retail sale of medicinal products, in principle, to pharmacists alone, because of the safeguards which pharmacists must provide and the information which they must be in a position to furnish to consumers (see, to this effect, Delattre , paragraph 56).
35. In this connection, given the power accorded to the Member States to determine the level of protection of public health, it must be accepted that Member States may require that medicinal products be supplied by pharmacists enjoying genuine professional independence. They may also take measures which are capable of eliminating or reducing a risk that that independence will be prejudiced because such prejudice would be liable to affect the degree to which the provision of medicinal products to the public is reliable and of good quality.
36. In this context, three categories of potential pharmacy operators must be distinguished, namely natural persons having the status of pharmacist, persons operating in the pharmaceutical products sector as manufacturers or wholesalers, and persons neither having the status of pharmacist nor operating in that sector.
37. It is undeniable that an operator having the status of pharmacist pursues, like other persons, the objective of making a profit. However, as a pharmacist by profession, he is presumed to operate the pharmacy not with a purely economic objective, but also from a professional viewpoint. His private interest connected with the making of a profit is thus tempered by his training, by his professional experience and by the responsibility which he owes, given that any breach of the rules of law or professional conduct undermines not only the value of his investment but also his own professional existence.
38. Unlike pharmacists, non-pharmacists by definition lack training, experience and responsibility equivalent to those of pharmacists. Accordingly, they do not provide the same safeguards as pharmacists.
39. A Member State may therefore take the view, in the exercise of its discretion referred to in paragraph 19 of the present judgment, that, unlike the case of a pharmacy operated by a pharmacist, the operation of a pharmacy by a non-pharmacist may represent a risk to public health, in particular to the reliability and quality of the supply of medicinal products at retail level, because the pursuit of profit in the course of such operation does not involve moderating factors such as those, noted in paragraph 37 of the present judgment, which characterise the activity of pharmacists (see by analogy, with regard to the provision of social welfare services, Case C-70/95 Sodemare and Others  [1997] ECR I‑3395, paragraph 32).
40. It is therefore permissible for a Member State inter alia to assess, in the exercise of that discretion, whether such a risk exists in the case of manufacturers and wholesalers of pharmaceutical products on the ground that they might compromise the independence of employed pharmacists by encouraging them to promote the medicinal products which they produce or market themselves. Likewise, a Member State may determine whether operators lacking the status of pharmacist are liable to compromise the independence of employed pharmacists by encouraging them to sell off medicinal products which it is no longer profitable to keep in stock or whether those operators are liable to make reductions in operating costs which may affect the manner in which medicinal products are supplied at retail level.
42. As to those submissions, it is apparent from the Court’s case-law that national legislation is appropriate for securing attainment of the objective relied upon only if it genuinely reflects a concern to attain that objective in a consistent and systematic manner (see Joined Cases C-338/04, C-359/04 and C-360/04 Placanica and Others [2007] ECR I-1891, paragraphs 53 and 58; Case C-500/06 Corporación Dermoestética  [2008] ECR I-0000, paragraphs 39 and 40; and Hartlauer , paragraph 55).
45. However, this exception proves justified having regard to protection of the legitimate property rights and interests of the members of the deceased pharmacist’s family. It must be found that the Member States may take the view that the interests of a pharmacist’s heirs are not such as to jeopardise the requirements and guarantees flowing from their respective legal systems which operators who have the status of pharmacist must meet. In this context, account is to be taken especially of the fact that throughout the transitional period a qualified pharmacist must be responsible for operating the inherited pharmacy. Therefore, the heirs cannot, in this specific context, be equated with other operators who do not have the status of pharmacist.
46. It should also be noted that the effects of this exception are only temporary since the heirs must transfer the rights to operate the pharmacy to a pharmacist within 12 months.
47. This exception is thus designed to enable the heirs to assign the pharmacy to a pharmacist within a period which does not prove unreasonable and it may thus be regarded as not presenting a risk to the reliability and quality of the provision of medicinal products to the public.
48. Next, nor can such a risk result from the fact that hospitals may operate internal pharmacies. The latter are intended to provide medicinal products not to persons outside those hospitals but to the hospitals in which they are established. Thus, hospitals which operate such pharmacies are not, in principle, capable of affecting the general level of reliability and quality in the provision of medicinal products to the public as a whole. Furthermore, having regard to the fact that those hospitals provide medical care, there are no grounds for assuming that they would have an interest in making a profit to the detriment of the patients for whom the medicinal products of the pharmacies which they house are intended.
49. Finally, although the national legislation allows pharmacists to operate up to three branches of a single pharmacy, such a possibility is subject to a number of conditions which are intended to safeguard public health requirements. First of all, the pharmacist concerned is himself responsible for the branches’ operation and he therefore determines their general commercial policy. Those branches are thus also presumed to be operated from a professional viewpoint, the private interest connected with the making of a profit being tempered to the same extent as in the case of the operation of pharmacies which are not branches. Next, those branches must be located within a specified geographical radius in order to ensure a sufficient presence in the branches of the pharmacist operating them and actual supervision by him. Last, the pharmacist operating the branches must designate, for each branch, a responsible pharmacist, who must ensure that legal obligations are complied with and that the management of the branch concerned conforms to the general commercial policy determined by the pharmacist operating the branches.
50. Since the operation of the branches is subject to those conditions, the legislation at issue in the main actions cannot be regarded as inconsistent.
54. However, having regard to the discretion which the Member States are allowed, as referred to in paragraph 19 of the present judgment, a Member State may take the view that there is a risk that legislative rules designed to ensure the professional independence of pharmacists would not be observed in practice, given that the interest of a non-pharmacist in making a profit would not be tempered in a manner equivalent to that of self-employed pharmacists and that the fact that pharmacists, when employees, work under an operator could make it difficult for them to oppose instructions given by him.
60. Given the particular nature of medicinal products and of the medicinal-product market, and as Community law currently stands, the Court’s findings in Commission  v Greece  cannot be transposed to the field of the retail supply of medicinal products. Unlike optical products, medicinal products prescribed or used for therapeutic reasons may none the less prove seriously harmful to health if they are consumed unnecessarily or incorrectly, without the consumer being in a position to realise that when they are administered. Furthermore, a medically unjustified sale of medicinal products leads to a waste of public financial resources which is not comparable to that resulting from unjustified sales of optical products.