Judgment of the Court (Eighth Chamber) of 17 July 2008 – Commission v Austria
(Case C‑311/07)
Failure of a Member State to fulfil obligations – Directive 89/105/EEC – Inclusion of medicinal products for human use in national health insurance systems – Article 6(1) – List of medicinal products covered by the national health insurance system establishing three separate categories with different conditions for reimbursement – Time-limit for adopting a decision on an application for inclusion of a medicinal product in the categories of that list offering the most favourable reimbursement conditions
1. Actions for failure to fulfil obligations – Examination of the merits by the Court – Situation to be taken into consideration – Situation on expiry of the period laid down in the reasoned opinion (Art. 226 EC) (see para. 26)
2. Approximation of laws – Medicinal products – Directive 89/105 – Medicinal products for human use – Application for inclusion of a medicinal product in the list of medicinal products covered by the national health insurance system (Council Directive 89/105, Art. 6(1), first para.) (see paras 33-39)
Re:
Failure of a Member State to fulfil obligations – Infringement of Article 6(1) of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ 1989 L 40, p. 8) – National legislation on social security establishing a list of medicinal products covered by the health insurance system comprising three categories of medicinal products with different conditions for reimbursement – Failure to have set a time-limit as required by Article 6(1) of Directive 89/105/EEC for decisions relating to the inclusion of medicinal products in the most favourable categories.
Operative part
The Court:
1.
Declares that, by failing to lay down a time-limit, in accordance with Article 6(1) of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems, for the adoption of decisions relating to applications for inclusion of medicinal products in the yellow or green categories of the medicinal products reimbursement code provided for by the general Law on social insurance (Allgemeines Sozialversicherungsgesetz), as amended by the Law of 2003 amending social insurance (Sozialversicherungs-Änderungsgesetz 2003), the Republic of Austria has failed to fulfil its obligations under that provision;
2.
Orders the Republic of Austria to pay the costs.
Full & Egal Universal Law Academy