Judgment — ECLI:EU:C:2003:334
Date: 2003-06-12
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Concepts: General;Protection of personal data
Procedure: Action for failure to fulfil obligations - successful;Action for failure to fulfil obligations - unfounded
Origin: Finland

summary statement of reasons for the second complaint in the letter of formal notice and the reasoned opinion in which reference is made to a defective practice in respect of the statement of reasons for decisions refusing to accept the price of medicinal products, it is, however, alleged against the Republic of Finland in the operative part of the reasoned opinion that they did not adopt the laws, regulations and administrative provisions necessary to comply with the directive. 48. It follows that the second complaint is admissible. 49. As for the merits, the Commission, on the basis of a few examples of the Finnish system in practice, claims that the statement of reasons for negative decisions does not comply with the provisions of the directive, which require a more detailed statement of reasons than that laid down by Finnish law. 50. In that regard, as the Finnish Government rightly pointed out, first, it is apparent from Articles 23 and 24 of Law No 598/1982 that any administrative decision must contain a statement clearly setting out the rights and obligations of the party concerned and all the factors taken into account and the legislative provisions upon which the decision is based (see, in that regard, paragraphs 8 and 9 hereof). 51. Second, the examples of a failure to state reasons put forward by the Commission do not reveal a practice which infringes the provisions of the directive. 52. Indeed, it is apparent from the data supplied by the Finnish Government, which have not been challenged by the Commission, that whilst, in 1999, 3 266 decisions were taken by the Commission for Medicine Prices, only 133 contained an inadequate statement of reasons. 53. However, generalised failure on the part of the administrative authorities to comply with the directive cannot be inferred from a few defective cases in practice. 54. Accordingly, it cannot but be held that the Commission has not shown how the Finnish practice or legislation was contrary to the provisions of the directive. 55. It is settled case-law that in proceedings under Article 226 EC for failure to fulfil an obligation, it is incumbent upon the Commission to prove the allegation that the obligation has not been fulfilled and to place before the Court the information needed to enable it to determine whether the obligation has not been fulfilled (see, in particular, Case C-159/94 Commission v France [1997] ECR I-5815, paragraph 102 and Case C-263/99 Commission v Italy [2001] ECR I-4195, paragraph 27). 56. In those circumstances, it must be held that the second complaint is unfounded. 57. It follows from all the foregoing that, by not adopting the laws, regulations and administrative provisions necessary to comply with the directive as regards the decisions establishing the categories of medicinal products subject to a higher rate of health insurance cover, the Republic of Finland has failed to fulfil its obligations under the first and second subparagraphs of Article 6 of that directive. Costs 58. Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party's pleadings. However, under Article 69(3) of those Rules, the Court may order that the costs be shared or that the parties bear their own costs where each party fails on one or more heads. In this case, since the parties have each been partially unsuccessful, each must be ordered to bear its own costs. On those grounds, THE COURT (Sixth Chamber) hereby: 1. Declares that, by not adopting the laws, regulations and administrative provisions necessary to comply with Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems as regards the decisions establishing the categories of medicinal products subject to a higher rate of health insurance cover, the Republic of Finland has failed to fulfil its obligations under the first and second subparagraphs of Article 6 of that directive; 2. Dismisses the remainder of the action; 3. Orders each party to bear its own costs. Puissochet Gulmann Skouris Macken Cunha Rodrigues Delivered in open court in Luxembourg on 12 June 2003. R. Grass J.-P. Puissochet Registrar President of the Sixth Chamber 1: Language of the case: Finnish.