Order of the Court (Seventh Chamber) of 9 November 2009 – Roche and Federfarma v Agencia italiana del Farmaco (AIFA) and Ministero della Salute

(Joined Cases C-450/07 and C-451/07)

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 – Price freeze – Price reduction

Approximation of laws – Medicinal products – Directive 89/105 – Medicinal products for human use (Council Directive 89/105, Arts 1(1) and 4(1) and (2) (see para. 10, operative part 1-5)

Re:

Reference for a preliminary ruling – Tribunale Amministrativo Regionale del Lazio – Interpretation of Article 4(1) and (2) 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 imposed on medicinal products – Procedures to be followed in the case of a price reduction.

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 is to be interpreted as meaning that, provided the requirements laid down by that provision are met, the competent authorities of a Member State may adopt general measures reducing the prices of all, or of certain categories of, medicinal products, even if the adoption of those measures is not preceded by a freeze on those prices.

2. Article 4(1) of Directive 89/105 is to be interpreted as meaning that, provided the requirements laid down by that provision are met, the adoption of measures reducing the prices of all, or of certain categories of, medicinal products is possible more than once a year and for several years.

3. Article 4(1) of Directive 89/105 is to be interpreted as meaning that it does not preclude measures controlling the prices of all, or of certain categories of, medicinal products from being adopted on the basis of predicted expenditure, provided that the requirements laid down by that provision are met and that the predictions are based on objective and verifiable data.

4. Article 4(1) of Directive 89/105 is to 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 the macro‑economic conditions referred to in that provision is to be conducted and that those criteria may consist in pharmaceutical expenditure alone, in health expenditure overall or even in other types of expenditure.

5. Article 4(2) of Directive 89/105 is to be interpreted as meaning that:

– the Member States must, in all cases, provide for the possibility for an undertaking, which is concerned by a measure freezing or reducing the prices of all, or of certain categories of, medicinal products, of applying for a derogation from the price imposed pursuant to such measure;

– they are to ensure that a reasoned decision on any such application is adopted, and

– the genuine participation of the undertaking concerned consists, first, in the submission of an adequate statement of the particular reasons justifying its application for derogation and, second, in the provision of detailed additional information if the information supporting the application is inadequate.