On the Review of Macro-Economic Conditions in the Case of a Price Freeze for Medicinal Products

Abstract

Joined Cases C-471/07 and C-472/07 AGIM and Others [2010] ECR I-000001.The Member States determine, in compliance with the objective of transparency pursued by Council Directive 89/105/EEC and the requirements laid down by Article 4(1) of that Directive, the criteria on the basis of which the review of macro-economic conditions which is referred to in that provision is to be carried out, provided that those criteria are based on objective and verifiable factors (author's headnote).2.Article 4(1) of Directive 89/105, so far as its subject matter is concerned, is not sufficiently precise to have direct effect for the purposes of the national legal systems of the Member States (author's headnote).3.Article 4(1) of Directive 89/105 must be interpreted as meaning that a Member State may, 18 months after the end of a general price freeze in respect of refundable medicinal products which lasted eight years, adopt a new measure freezing the prices of medicinal products without carrying out the review of macro-economic conditions which is provided for in that provision (official headnote).