Commission of the European Communities v Federal Republic of Germany.
Date: 2008-09-11
22. It is certainly clear, both from the case-law of the Court and from Article 152(5) EC, 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 consumption of pharmaceutical products in order to promote the financial stability of their health-care insurance schemes and the organisation and delivery of health services and medical care (Case 238/82 Duphar and Others  [1984] ECR 523, paragraph 16, and Case C‑372/04 Watts  [2006] ECR I‑4325, paragraphs 92 and 146).
23. However, in exercising that power, the Member States must comply with Community law, in particular the provisions of the Treaty on the free movement of goods (see Case C‑120/95 Decker  [1998] ECR I‑1831, paragraphs 23 to 25). Those provisions prohibit the Member States from introducing or maintaining unjustified restrictions on the exercise of that freedom in the healthcare sector (see, in relation to the freedom to provide services, Watts , paragraph 92).
24. Accordingly, this action brought by the Commission, as part of the performance of its tasks, which, under Article 211 EC, include ensuring that the provisions of the Treaty are applied, is restricted to determining whether the Member States have acted in compliance with the rules of that Treaty relating to the free movement of goods.
25. It should be noted that, as Community law stands at present, since there has been no harmonisation at Community level of the rules on the provision of medicinal products to hospitals, the Member States continue to be empowered to lay down rules on that subject, subject to compliance with the provisions of the Treaty, in particular the provisions on the free movement of goods (see, to that effect, Case C‑369/88 Delattre  [1991] ECR I‑1487, paragraph 48).
27. The free movement of goods is a fundamental principle of the Treaty which is expressed in the prohibition, set out in Article 28 EC, on quantitative restrictions on imports between Member States and all measures having equivalent effect (Case C‑170/04 Rosengren and Others  [2007] ECR I‑4071, paragraph 31).
28. According to settled case-law, the prohibition of measures having equivalent effect to quantitative restrictions which is set out in Article 28 EC covers all legislation of the Member States that is capable of hindering, directly or indirectly, actually or potentially, intra-Community trade (see, in particular, Case 8/74 Dassonville  [1974] ECR 837, paragraph 5; Deutscher Apothekerverband , paragraph 66; Rosengren and Others , paragraph 32; Case C‑297/05 Commission  v Netherlands  [2007] ECR I‑7467, paragraph 53; and Case C‑143/06 Ludwigs-Apotheke  [2007] ECR I‑9623, paragraph 26).
29. The Court of Justice has none the less made clear that national provisions restricting or prohibiting certain selling arrangements which, first, apply to all relevant traders operating within the national territory and, second, affect in the same manner, in law and in fact, the marketing of domestic products and those from other Member States are not liable to hinder, directly or indirectly, actually or potentially, trade between Member States within the meaning of the Dassonville  line of case‑law (see, to that effect, Keck and Mithouard , paragraph 16).
30. In the present case, it must be recalled that Paragraph 14 of the ApoG lays down the requirements which external pharmacies must meet if they are to be eligible to supply medicinal products to hospitals in Germany.
31. However, the contested provisions do not concern the characteristics of the medicinal products, but concern solely the arrangements permitting their sale (see, to that effect, Case C‑244/06 Dynamic Medien  [2008] ECR I‑0000, paragraph 31). Consequently, they must be regarded as concerning selling arrangements within the meaning of Keck and Mithouard , which is moreover not disputed by the parties to these proceedings.
32. As is made clear in Keck and Mithouard , however, such a selling arrangement can fall outside the prohibition laid down in Article 28 EC only if it satisfies the two conditions stated in paragraph 29 above.
38. Those provisions cannot cease to be restrictive merely because in one part of the territory of the Member State concerned, namely that part that is distant from the hospital concerned, those provisions affect in the same way the marketing of medicinal products by pharmacies established in Germany and by pharmacies established in other Member States (see, to that effect, Case C‑254/98 TK-Heimdienst  [2000] ECR I‑151, paragraph 28).
39. Nor can it be maintained that the marketing of medicinal products from other Member States is no more affected than the marketing of medicinal products from regions of Germany which are remote from the hospital to be supplied. For a national measure to be characterised as discriminatory or protective within the meaning of the rules on the free movement of goods, it is not necessary for it to have the effect of favouring national products as a whole or of placing only imported products at a disadvantage and not national products (Joined Cases C‑1/90 and C‑176/90 Aragonesa de Publicidad Exterior and Publivía  [1991] ECR I‑4151, paragraph 24, and TK-Heimdienst , paragraph 27).
43. Since the contested provisions are liable to hinder intra-Community trade, they must be considered as a measure having equivalent effect to a quantitative restriction on imports within the meaning of Article 28 EC, without it being necessary to prove that they have had an appreciable effect on such trade (see Case C‑166/03 Commission  v France  [2004] ECR I‑6535, paragraph 15).
46. It must be recalled that the health and life of humans rank foremost among the assets or interests protected by Article 30 EC and it is for the Member States, within the limits imposed by the Treaty, to decide on the degree of protection which they wish to afford to public health and on the way in which that degree of protection is to be achieved ( Deutscher Apothekerverband , paragraph 103; Case C‑262/02 Commission  v France  [2004] ECR I‑6569, paragraph 24; Rosengren and Others , paragraph 39; and Ludwigs-Apotheke , paragraph 27).
47. It is common ground that the contested provisions, which, according to the Federal Republic of Germany, have the objective of ensuring that the supply to hospitals of medicinal products by an external pharmacy is reliable and of good quality, reflect concerns for public health which are within the ambit of Article 30 EC and that, consequently, they are, in principle, capable of justifying a restriction on the free movement of goods.
48. However, legislation which is such as to restrict a fundamental freedom guaranteed by the Treaty, such as the free movement of goods, can be justified only if it is appropriate for securing the attainment of the objective pursued and does not go beyond what is necessary in order to attain it (Case C‑14/02 ATRAL  [2003] ECR I‑4431, paragraph 64; Case C‑254/05 Commission  v Belgium  [2007] ECR I‑4269, paragraph 33; judgment of the Court (Third Chamber) of 13 March 2008 in Case C‑227/06 Commission  v Belgium , not published in the ECR, paragraph 61; and Case C‑265/06 Commission  v Portugal  [2008] ECR I‑0000, paragraph 37).
50. Secondly, as regards the assessment of whether those provisions are necessary, it must be recalled at the outset that it follows from the case-law of the Court that since Article 30 EC is an exception, to be strictly interpreted, to the rule of free movement of goods within the Community, it is for the national authorities to demonstrate that those provisions are necessary in order to achieve the declared objective, and that this objective could not be achieved by less extensive prohibitions or restrictions of lesser extent or having less effect on intra‑Community trade (see, to that effect, Case C‑17/93 van der Veldt  [1994] ECR I‑3537, paragraph 15; Case C‑189/95 Franzén  [1997] ECR I‑5909, paragraphs 75 and 76; Case C‑434/04 Ahokainen and Leppik  [2006] ECR I‑9171, paragraph 31, and Rosengren and Others , paragraph 50).
51. In accordance with settled case-law of the Court, set out in paragraph 46 of this judgment, when assessing whether the principle of proportionality has been observed in the field of public health, account must be taken of the fact that a Member State has the power to determine the degree of protection which it wishes to afford to public health and the way in which that degree of protection is to be achieved. Since that degree of protection may vary from one Member State to the other, Member States must be allowed discretion (see, to that effect, Case C‑41/02 Commission  v Netherlands  [2004] ECR I‑11375, paragraphs 46 and 51) and, consequently, the fact that one Member State imposes less strict rules than another Member State does not mean that the latter’s rules are disproportionate (Case C‑262/02 Commission  v France , paragraph 37, and Case C‑443/02 Schreiber  [2004] ECR I‑7275, paragraph 48).
60. While objectives of a purely economic nature cannot justify a restriction on the fundamental principle of free movement of goods, none the less, as regards interests of an economic nature concerning the maintenance of a balanced medical and hospital service open to all, the Court has accepted that such an objective may also fall within one of the derogations, on grounds of public health, in so far as it contributes to the attainment of a high level of health protection (see by analogy, in particular, Case C‑158/96 Kohll  [1998] ECR I‑1931, paragraph 50, and Case C‑444/05 Stamatelaki  [2007] ECR I‑3185, paragraph 31).
61. It must be possible to plan the number of hospitals, their geographical distribution, their organisation and the facilities with which they are provided, and even the nature of the medical services which they are able to offer, in a way which, first, meets, as a general rule, the objective of guaranteeing in the territory of the Member State concerned sufficient and permanent access to a balanced range of high-quality hospital treatment and, secondly, assists in ensuring the desired control of costs and prevention, as far as possible, of any wastage of financial, technical and human resources (see Case C‑157/99 Smits and Peerbooms  [2001] ECR I‑5473, paragraphs 76 to 80; Case C‑385/99 Müller-Fauré and van Riet  [2003] ECR I‑4509, paragraphs 77 to 80; and Watts , paragraphs 108 and 109).