Commission of the European Communities v Republic of Austria.
Date: 2001-11-27
19 As a preliminary point it should first be stated that, according to settled case-law, the application must be based on the same grounds and arguments as the reasoned opinion (see, in particular, Case 290/87 Commission v Netherlands [1989] ECR 3083, paragraph 8).
24 Thus, the register kept by the Federation is in no way an exhaustive catalogue of the medicinal products covered by the sickness insurance scheme but constitutes a working tool for the use of doctors enabling them to determine the medicinal products whose cost is borne by the social security system without prior authorisation.
25 More generally, the Austrian Government claims that in this action the Commission is seeking to interfere in the organisation of national systems of social security, which come within the sole competence of the Member States.
26 On the latter point 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 Austrian 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.
27 As to the argument that the register kept by the Federation under Paragraph 133(2) of the ASVG cannot be classified as a positive list under Article 6 of the directive, it should be stated that that provision precludes such argument.
28 Under the Austrian legislation, the cost of medicinal products included on the register is automatically borne by the scheme as a matter of principle, whereas the medicinal products not included in that register are not, unless authorised by the principal doctor or supervising doctor.
29 Yet it is clear from Article 6 of the directive that that provision is intended to apply where inclusion of a medicinal product on a list means that its cost will automatically be reimbursed or borne by the scheme. Thus, the fact that in a Member State there is a register and not a positive list and that the cost of medicinal products not included on the register may likewise be borne there by the scheme if the medicinal product prescribed by the doctor is necessary for the condition affecting the patient in no way detracts from the sole determining factor, namely the fact that inclusion of a medicinal product on the register normally means that its cost will automatically be borne by the scheme.
30 That interpretation is, moreover, corroborated by the purpose of the directive which, under 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 health insurance systems complies with the requirements of the directive.
31 On that point it should be stated that, as the Austrian Government acknowledged at the hearing, the register enables the competent authorities to reduce the expenditure of the Austrian social security system, inasmuch as the pharmaceutical companies are generally required to agree to lower prices in consideration for the inclusion on the register of one of their medicinal products since that inclusion means that the cost will automatically be borne by the scheme. Under those conditions inclusion of a medicinal product in that register thus constitutes a measure intended to control prices.
32 Accordingly, the register may be regarded as a positive list within the meaning of Article 6 of the directive, with the result that it is appropriate to ascertain whether that provision was correctly transposed into Austrian law.
The period of 180 days within which the Federation has to decide on applications for inclusion on the register of medicinal products
45 The requirement of judicial review reflects a general principle of Community law stemming from the constitutional traditions common to the Member States and enshrined in Articles 6 and 13 of the European Convention for the Protection of Human Rights and Fundamental Freedoms (Case 224/84 Johnston [1986] ECR 1651, paragraph 18; Case C-97/91 Oleificio Borelli v Commission [1992] ECR I-6313, paragraph 14, Case C-1/99 Kofisa Italia [2001] ECR I-207, paragraph 46, and Case C-226/99 Siples [2001] ECR I-277, paragraph 17).