G. Pohl-Boskamp GmbH & Co. KG v Gemeinsamer Bundesausschuss.
Date: 2006-10-26
22. The Court has already ruled that a decision like that adopted by the Gemeinsamer Bundesausschuss, even if it covers only the acceptance for coverage of a series of active ingredients, constitutes a bundle of individual decisions on the inclusion of certain medicinal products in one of the social security schemes, so as to bring it within the provisions of Article 6 of Directive 89/105 (see, to that effect, Case C-229/00 Commission  v Finland  [2003] ECR I-5727, paragraph 34).
25. According to settled case-law, the purpose of Directive 89/105, according to Article 1 thereof, is to ensure that any national measure to control the prices of medicinal products for human use or to restrict the range of medicinal products covered by their national sickness insurance systems complies with the requirements of that directive (see, to that effect, Case C-424/99 Commission  v Austria  [2001] ECR I-9285, paragraph 30, and Commission  v Finland , paragraph 37).
26. The Court also pointed out that the decisions pursuant to which certain medicinal products qualify for higher-rate cover constitute a means of determining the extent of the range of medicinal products covered by the sickness insurance scheme and likely to be used in the treatment of such or such an illness. Moreover, according to the sixth recital in the preamble to Directive 89/105, ensuring the effectiveness of the directive also requires that the persons concerned can verify that the entry of medicinal products on the list corresponds to objective criteria and that there is no discrimination between national medicinal products and those from other Member States (see, to that effect, Commission  v Finland , paragraphs 38 and 39).
27. According to that case-law, those objectives would be compromised if a Member State were able to introduce a dual procedure for the establishment of a list of medicinal products qualifying for reimbursement, one pursuant to the obligations laid down by Article 6(1) of Directive 89/105, namely, for Germany, that set out by the Bundesinstitut für Arzneimittel und Medizinprodukte, the other being exempt in part from those obligations and, in part, not complying with the objectives laid down by that directive, namely that established by the Gemeinsamer Bundesausschuss (see, to that effect, Commission  v Finland , paragraph 40).
29. In that regard, it is sufficient to state that, even if possible detriment to intra-Community trade was taken into consideration during the drawing up of Directive 89/105, its main purpose, according to its fifth recital, is to ensure transparency of pricing, including the manner in which it operates in individual cases and the criteria on which it is based, and to provide public access to pricing arrangements for all those involved in the market in medicinal products in the Member States. A barrier to intra-Community trade does not constitute a requirement for the application of that directive.
40. As regards the issue of the direct application of Article 6 of Directive 89/105, it is clear from the settled case-law of the Court that, whenever the provisions of a directive appear, so far as their subject-matter is concerned, to be unconditional and sufficiently precise, they may be relied upon before the national courts by individuals against the State where the latter has failed to implement the directive in domestic law by the end of the period prescribed or where it has failed to implement the directive correctly (see, inter alia, Joined Cases C-397/01 to C-403/01 Pfeiffer and Others  [2004] ECR I-8835, paragraph 103).
41. A Community provision is unconditional where it sets forth an obligation which is not qualified by any condition, or subject, in its implementation or effects, to the taking of any measure either by the Community institutions or by the Member States. Moreover, a provision is sufficiently precise to be relied on by an individual and applied by a national court where it sets out an obligation in unequivocal terms (see Joined Cases C-246/94 to C-249/94 Cooperativa Agricola Zootecnica S. Antonio and Others  [1996] ECR I-4373, paragraphs 18 and 19).