13.3.2010

Official Journal of the European Union

C 63/2

Judgment of the Court (Fourth Chamber) of 14 January 2010 (Reference for a preliminary ruling from the Conseil d'État — Belgium) — Association générale de l’industrie du médicament (AGIM) ASBL (C-471/07 and C-472/07), Bayer SA (C-471/07 and C-472/07), Pfizer SA (C-471/07 and C-472/07), Servier Benelux SA (C-471/07 and C-472/07), Janssen Cilag SA (C-471/07), Sanofi-Aventis Belgium, previously Sanofi-Synthelabo SA (C-472/07) v État belge

(Joined Cases C-471/07 and C-472/07) (1)

(Directive 89/105/EEC - Transparency of measures regulating the pricing of medicinal products for human use - Article 4(1) - Direct effect - Price freeze)

2010/C 63/03

Language of the case: French

Referring court

Parties to the main proceedings

Applicants: Association générale de l’industrie du médicament (AGIM) ASBL (C-471/07 and C-472/07), Bayer SA (C-471/07 and C-472/07), Pfizer SA (C-471/07 and C-472/07), Servier Benelux SA (C-471/07 and C-472/07), Janssen Cilag SA (C-471/07), Sanofi-Aventis Belgium, previously Sanofi-Synthelabo SA (C-472/07)

Defendant: État belge

In the presence of: Sanofi-Aventis Belgium SA (C-471/07)

Re:

Reference for a preliminary ruling — Conseil d’État (Belgium) — Interpretation of Article 4(1) of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ 1989 L 40, p. 8) — Price freeze in respect of medicinal products imposed by the competent authorities of a Member State — Scope of the obligation on the Member State to carry out a review, at least once a year, to ascertain whether the ‘macro-economic’ conditions justify that that freeze be continued — Review only as to whether healthcare expenditure is manageable, or need to take account of the macro-economic effects of the price freeze on the pharmaceutical industry?

Operative part of the judgment

1.Article 4(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 must be interpreted as meaning that it is for the Member States to determine, in compliance with the objective of transparency pursued by that directive and the requirements laid down by that provision, 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.

2.Article 4(1) of Directive 89/105 must be interpreted as not being, so far as its subject-matter is concerned, sufficiently precise for an individual to be able to rely on it before a national court against a Member State.

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.

(1) OJ C 22, 26.1.2008.