European Court of Justice Decisions on the Pricing and Reimbursement of Medicine

Directive 89/105, on the transparency of medicines pricing and reimbursement rules (hereinafter the “Directive”) was first interpreted in 2001 and 2002, when the European Court of Justice (hereinafter the “ECJ”) rendered two decisions regarding the implementation of the Directive in Austria and in Finland. The two initial rulings –European Commission of the European Communities v. Austria (C-424/99) andEuropean Commission v. Republic of Finland (C-229/00) – were issued by the ECJ following complaints of the European Commission for failure to implement the Directive.

Among others, the ECJ applied the requirement for national authorities to use objective criteria and not to discriminate regarding the inclusion of medicines in the positive list covered by Article 6.1. of the Directive. The ECJ also decided (in case C-229/00) that an appeal procedure before an “administrative authority” made of “experts belonging to the[administration] itself” did not meet the requirement of “remedies” contained in Article 6.2. of the Directive.

The two recent decisions of the ECJ inMerk, Sharp & Dohme BV v. Etat Belge (C-245/03) and inGlaxosmithkline SA v. Etat Belge (C-296/03) were issued in the context of requests for a preliminary ruling made by the Belgian State Council (the highest administrative court) in disputes between the Belgian State and two pharmaceutical manufacturers. Both cases refer to applications for the registration of medicines on a positive list of products covered by the health insurance system (under Article 6 of the Directive). In both instances, the procedures appear to have gone significantly beyond the 90 days period provided by the Directive, involved negative decisions with regard to the inclusion of the medicines concerned in the positive list and the subsequent annulment of these negative administrative decisions by national courts.

Overall, the ECJ reached three main conclusions from reviewing the two cases. Firstly, and this point is common to both cases, the time limit of 90 days (which may extended by a further 90 days under certain conditions) provided in Article 6.1. of Directive for the competent national authorities to reach a decision is a mandatory deadline.

The second conclusion reached by the ECJ (in case C-245/03) is that the consequence of exceeding the time limits of Article 6.1. of the Directive are not the automatic inclusion of the medicine concerned on the positive list. The ECJ indicates that this particular issue is not covered by the Directive and must be settled by national law while observing the principle of equivalence and not affecting Community rights.

The third conclusion reached by the ECJ with regard to the Directive (in case C-296/03) is that the procedure for a new decision of the national administrative authorities (coming after the annulment of an initial decision in the context of Article 6.1. of the Directive) is not covered by the Directive itself but must be taken within the same time limit.