Commission of the European Communities v Italian Republic.
Date: 2009-05-19
23. So far as concerns the first plea of inadmissibility, it is for the Commission, in performing the task conferred upon it by Article 211 EC, to ensure that the provisions of the Treaty are applied and verify whether the Member States have acted in accordance with those provisions. If the Commission considers that a Member State has infringed provisions of the Treaty, it is for it to determine whether it is expedient to take action against that State and what provisions the State has infringed, and to choose the time at which it will initiate infringement proceedings; the considerations which determine its choice of time cannot affect the admissibility of its action (see Case C-35/96 Commission  v Italy  [1998] ECR I-3851, paragraph 27, and Case C-33/04 Commission  v Luxembourg  [2005] ECR I-10629, paragraph 66).
35. 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 and the free movement of capital. 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).
36. 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).
38. Third, the regime applicable to persons entrusted with the retail supply of medicinal products varies from one Member State to another. Whereas, in certain Member States, only self-employed pharmacists can own and operate pharmacies, other Member States accept that persons not having the status of self-employed pharmacist may own a pharmacy while entrusting its management to employed pharmacists.
40. It is to be recalled that, if the legislation under examination concerns a stake which gives its holder definite influence over the decisions of the company concerned and allows him to determine its activities, it is the provisions relating to freedom of establishment which are applicable (Case C-251/98 Baars  [2000] ECR I-2787, paragraphs 21 and 22, and Case C-436/00 X and Y  [2002] ECR I-10829, paragraphs 37 and 66 to 68). However, if that legislation is not intended to apply only to stakes which enable the holder to have a definite influence on a company’s decisions and to determine the company’s activities, it should be examined in relation to both Article 43 EC and Article 56 EC (see, to this effect, Case C‑446/04 Test Claimants in the FII Group Litigation  [2006] ECR I‑11753, paragraphs 36 and 38, and Case C-157/05 Holböck  [2007] ECR I‑4051, paragraphs 23 and 25).
43. As regards Article 43 EC, according to settled case-law that provision 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).
44. 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).
46. As to Article 56 EC, national measures must be regarded as restrictions within the meaning of Article 56(1) EC if they are liable to prevent or limit the acquisition of stakes in the undertakings concerned or to deter investors from other Member States from investing in their capital (see Case C-112/05 Commission  v Germany  [2007] ECR I‑8995, paragraph 19, and Joined Cases C-463/04 and C-464/04 Federconsumatori and Others  [2007] ECR I‑10419, paragraph 21).
49. Restrictions on freedom of establishment and on the free movement of capital 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 Case C-370/05 Festersen  [2007] ECR I-1129, paragraph 26, and Hartlauer , paragraph 44).
51. 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) and the free movement of capital.
52. 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 Case C-141/07 Commission  v Germany , paragraph 47).
54. 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.
55. 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).
57. 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.
58. 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).
59. 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.
62. 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.
63. A Member State may therefore take the view, in the exercise of its discretion referred to in paragraph 36 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 61 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).
66. 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).
73. Finally, although Article 7(9) and (10) of Law No 362/1991 grants certain heirs a period of 10 years to assign the pharmacy, a period which might prove unreasonable, it must be stated that, in the light of its particularly restricted field of application, limited to the case where the successor is the spouse or the heir in the direct line up to the second degree of the deceased pharmacist, and of the fact that this successor must enrol as a student at a pharmacy faculty within a period of one year from the date of acquisition of the pharmacy, this provision cannot be sufficient to conclude that the national legislation concerned is inconsistent.
84. However, having regard to the discretion which the Member States are allowed, as referred to in paragraph 36 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.
90. 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.
98. As regards, first of all, the Italian Republic’s argument deriving from the adoption of the Bersani Decree, it is well established case-law that the question whether a Member State has failed to fulfil its obligations must be determined by reference to the situation prevailing in the Member State at the end of the period laid down in the reasoned opinion and that the Court cannot take account of any subsequent changes (see, inter alia, Case C-103/00 Commission  v Greece  [2002] ECR I-1147, paragraph 23, and Case C-152/05 Commission  v Germany  [2008] ECR I‑39, paragraph 15).