European Commission v French Republic.
Date: 2010-12-16
18. It should be pointed out that, following the adoption of Order No 2010-49, some amendments were made to the regulations on biomedical analysis laboratories. Given 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-531/06 Commission  v Italy  [2009] ECR I-4103, paragraph 98, and Case C‑392/08 Commission  v Spain  [2010] ECR I‑0000, paragraph 26), those amendments are not taken into account in the present judgment.
The first complaint
Arguments of the parties
41. In exercising that power, however, the Member States must comply with EU law, in particular with the provisions of primary law relating to the freedoms of movement, including the freedom of establishment for the purposes of Article 43 EC. Those provisions prohibit the Member States from introducing or maintaining unjustified restrictions on the exercise of those freedoms in the healthcare sector (see, to that effect, Case C‑169/07 Hartlauer  [2009] ECR I‑1721, paragraph 29; Case C‑531/06 Commission  v Italy , paragraph 35; Apothekerkammer des Saarlandes and Others , paragraph 18; and Joined Cases C‑570/07 and C‑571/07 Blanco Pérez and Chao Gómez [2010] ECR I‑0000, paragraph 43).
42. That being so, for the purposes of 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 EC 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; Apothekerkammer des Saarlandes and Others , paragraph 19; and Blanco Pérez and Chao Gómez , paragraph 44).
44. According to settled case-law, Article 43 EC precludes any national measure which, albeit applicable without discrimination on grounds of nationality, is liable to hinder or render less attractive the exercise by citizens of the European Union of the freedom of establishment that is guaranteed by the Treaty (see, inter alia, Case C‑299/02 Commission  v Netherlands  [2004] ECR I‑9761, paragraph 15; Commission  v Greece , paragraph 27; and Case C‑531/06 Commission  v Italy , paragraph 43).
45. In that context, it should be noted that the concept of ‘restriction’ as used in Article 43 EC covers measures taken by a Member State which, although applicable without distinction, affect access to the market for undertakings from other Member States and thereby hinder trade within the European Union (see, to that effect, Case C‑442/02 CaixaBank France  [2004] ECR I‑8961, paragraph 12, and Case C‑518/06 Commission  v Italy  [2009] ECR I‑3491, paragraph 64).
50. According to well-established case-law, restrictions on freedom of establishment that 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 it ( Hartlauer , paragraph 44; Apothekerkammer des Saarlandes and Others , paragraph 25; and Blanco Pérez and Chao Gómez , paragraph 61).
52. In the first place, as the Court has recognised, the protection of public health is one of the reasons which can justify restrictions on the freedoms of movement guaranteed by the Treaty, such as the freedom of establishment (see to that effect, inter alia, Hartlauer , paragraph 46, and Case C-531/06 Commission  v Italy , paragraph 51).
53. In that context, it is apparent from case-law that the aim of maintaining the quality of medical services may be covered by one of the exceptions provided for in Article 46 EC, in so far as it contributes to the attainment of a high level of health protection (see, to that effect, Case C‑385/99 Müller-Fauré and Van Riet  [2003] ECR I‑4509, paragraph 67, and Case C‑496/01 Commission  v France  [2004] ECR I‑2351, paragraph 66).
55. In that regard, it is important to note 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 which reduce, as far as possible, a risk to public health (see, to that effect, Case C‑170/04 Rosengren and Others  [2007] ECR I-4071, paragraph 49; Case C‑531/06 Commission  v Italy , paragraph 54; and Blanco Pérez and Chao Gómez , paragraph 74).
60. First, the French Republic stated at the hearing – and the point was not disputed by the Commission – that, like biomedical analyses, a significant majority of medicinal products are sold in pharmacies on medical prescription. Second, in Case C‑531/06 Commission  v Italy  (paragraph 90) and Apothekerkammer des Saarlandes and Others  (paragraph 60), the Court held that medicinal products prescribed or used for therapeutic reasons may none the less prove seriously harmful to health if they are consumed unnecessarily or incorrectly. Thus, the existence of a prescription does not appear to prevent the risk for public health stemming from the incorrect or inappropriate dispensing of medicinal products.
66. Thus, given the power afforded to the Member States to determine the level of protection that they wish to give to public health, it must be accepted that Member States may require that biomedical analyses be carried out by biologists enjoying genuine professional independence. They may also take measures for eliminating or reducing a risk that that independence might be compromised, because that in turn would be liable to have an adverse effect on public health and the quality of medical services (see, to that effect, Case C-531/06 Commission  v Italy  paragraph 59 and Apothekerkammer des Saarlandes and Others , paragraph 35).
67. By definition, non-biologists have no training, experience or responsibility equivalent to that of biologists. Accordingly, they do not provide the same safeguards as those provided by biologists (see, to that effect, Case C-531/06 Commission  v Italy , paragraph 62, and Apothekerkammer des Saarlandes and Others , paragraph 38).
70. In that regard, it is apparent from the case-law of the Court that national legislation is appropriate for securing attainment of the objective pursued 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; Hartlauer , paragraph 55; and Case C‑531/06 Commission  v Italy , paragraph 66).
82. However, given the discretion which the Member States are allowed, as referred to in paragraph 42 above, a Member State may take the view that there is a risk that rules designed to ensure the professional independence of biologists would not be observed in practice, given that the interest of a non-biologist in making a profit would not be tempered in the same way as that of self-employed biologists and that, if biologists, as employees, were in a subordinate position with respect to a SELARL operating biomedical analysis laboratories in which non-biologists held the majority of shares, that could make it difficult for them to oppose instructions given by those non-biologists (see, to that effect, Case C-531/06 Commission  v Italy , paragraph 84, and Apothekerkammer des Saarlandes and Others , paragraph 54). As the French Republic points out, it cannot be excluded, inter alia, that such non-biologists would be tempted to refuse to carry out tests that were less profitable or more complicated to perform, or to cut down on the advice given with regard to patients at the pre-analysis and post-analysis stages, the existence of which is a feature of the organisation of medical biology in France.