Commission of the European Communities v République de Finlande.
Date: 2003-06-12
18.  By letter of 8 February 1999, the Finnish authorities stated, first, that they had not infringed the first subparagraph of Article 6 of the directive in so far as the decision fixing the medicinal products qualifying for higher-rate cover was taken by the Council of Ministers. Second, they stated that they had remedied the several shortcomings which occurred in practice with regard to the obligation to include in the negative decision the statement of reasons laid down in the second subparagraph of Article 2 of that directive.
29.  On the Finnish Government's argument alleging an interference in the organisation of the national social security schemes, it is sufficient to state that the action brought by the Commission in no way calls in question the method of financing or the structure of the social security system but seeks solely to secure observance by the Finnish legislation of the requirements laid down in Article 6 of the directive, which, moreover, relate neither to the functioning of the register and the inclusion on it of medicinal products nor to the possibility of having the cost of a medicinal product borne by the scheme (Case C-424/99   Commission   v   Austria   [2001] ECR I-9285, paragraph 26).
34.  It follows that the Council of Ministers' decision 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 the directive.
37.  In that regard, the purpose of the directive, 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 (Commission   v   Austria  , cited above, paragraph 30).
38.  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.
39.  Moreover, according to the sixth recital in the preamble to the directive, ensuring the effectiveness of the directive also requires that the persons concerned can verify that the official 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.
40.  However, those objectives would be compromised if, as the Finnish Government claims, a Member State were able to introduce a dual procedure for the establishment of a list of medicinal products qualifying for higher-rate reimbursement, one pursuant to the obligations laid down by the first subparagraph of Article 6 of the directive, the other being exempt in part from those obligations and, in part, not complying with the objectives laid down by that directive.
44.  It should be recalled in that regard that, in accordance with settled case-law, the letter of formal notice from the Commission to the Member State, and then the reasoned opinion issued by the Commission, delimit the subject-matter of the dispute, so that it cannot thereafter be extended. The opportunity for the State concerned to submit its observations, even if it chooses not to avail itself thereof, constitutes an essential guarantee intended by the EC Treaty, adherence to which is an essential formal requirement of the infringement procedure. Consequently, the reasoned opinion and the proceedings brought by the Commission must be based on the same complaints as those set out in the letter of formal notice initiating the pre-litigation procedure (Case C-365/97   Commission   v   Italy   [1998] ECR I-7773, paragraph 23).
45.  Thus, in so far as a judgment declaring that a Member State has failed to fulfil its obligations establishes the basis of liability which that State may incur as a result of its default and constitutes a condition precedent to the bringing of proceedings under Article 228 EC, the Member State must be afforded the opportunity, in the course of the pre-litigation procedure, to refute in their entirety the allegations made against it by the Commission (Commission   v   Italy  , cited above, paragraph 24).
46.  However, that requirement cannot be carried so far as to mean that in every case the statement of complaints in the letter of formal notice, the operative part of the reasoned opinion and the form of order sought in the application must be exactly the same, where the subject-matter of the proceedings has not been extended or altered (Commission   v   Italy  , cited above, paragraph 25).
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).