(Case C‑353/08)

First subparagraph of Article 104(3) of the Rules of Procedure – Directive 89/105/EEC – Transparency of measures regulating the prices of medicinal products for human use – Article 4(1) – Price freeze – Price reductions

Approximation of laws – Medicinal products – Directive 89/105 – Medicinal products for human use (Council Directive 89/105, Arts 1(1) and 4(1)) (see para 8, operative part 1-4)

Re:

Reference for a preliminary ruling – Tribunale Amministrativo Regionale del Lazio – Interpretation of Article 4(1) and (2) of Council Directive 89/15/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) – Medicinal products covered by a price freeze – Procedures to be followed in the event of any decrease in prices.

Operative part:

1.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 must be interpreted as meaning that, provided that the requirements laid down in that provision are respected, the competent authorities of a Member State may adopt general measures consisting of the reduction in the prices of all medicinal products or certain categories of medicinal products, even if the adoption of those measures is not preceded by a freezing of those prices.

2.Article 4(1) of Directive 89/105 must be interpreted as meaning that, provided that the requirements laid down in that provision are respected, the adoption of measures to reduce the prices of all medicinal products or certain categories of medicinal products is possible several times per year and for many years.

3.Article 4(1) of Directive 89/105 must be interpreted as not precluding the adoption of measures seeking to control the prices of all medicinal products or certain categories of medicinal products on the basis of expenditure predictions, provided that the requirements laid down in that provision are respected and that those predictions are based on objective and verifiable information.

4.Article 4(1) of Directive 89/105 must be interpreted as meaning that it is the task of the Member States to determine, in compliance with the objective of transparency pursued by that directive and the requirements laid down in that provision, the criteria in accordance with which the macroeconomic conditions laid down in that provision are to be verified, and that that criteria may consist of pharmaceutical expenditure alone, of total health expenditure or other types of expenditure.