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Document 62009CB0198
Case C-198/09: Order of the Court of 9 November 2009 (reference for a preliminary ruling from the Tribunale Amministrativo Regionale del Lazio (Italy)) — IFB Stroder Srl v Agenzia Italiana del Farmaco (AIFA) (Article 104(3), first subparagraph, of the Rules of Procedure — Directive 89/105/EEC — Transparency of measures governing the pricing of medicinal products for human use — Article 4 — Price freeze — Price reduction)
Case C-198/09: Order of the Court of 9 November 2009 (reference for a preliminary ruling from the Tribunale Amministrativo Regionale del Lazio (Italy)) — IFB Stroder Srl v Agenzia Italiana del Farmaco (AIFA) (Article 104(3), first subparagraph, of the Rules of Procedure — Directive 89/105/EEC — Transparency of measures governing the pricing of medicinal products for human use — Article 4 — Price freeze — Price reduction)
Case C-198/09: Order of the Court of 9 November 2009 (reference for a preliminary ruling from the Tribunale Amministrativo Regionale del Lazio (Italy)) — IFB Stroder Srl v Agenzia Italiana del Farmaco (AIFA) (Article 104(3), first subparagraph, of the Rules of Procedure — Directive 89/105/EEC — Transparency of measures governing the pricing of medicinal products for human use — Article 4 — Price freeze — Price reduction)
SL C 51, 27.2.2010, p. 16–17
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
27.2.2010 |
EN |
Official Journal of the European Union |
C 51/16 |
Order of the Court of 9 November 2009 (reference for a preliminary ruling from the Tribunale Amministrativo Regionale del Lazio (Italy)) — IFB Stroder Srl v Agenzia Italiana del Farmaco (AIFA)
(Case C-198/09) (1)
(Article 104(3), first subparagraph, of the Rules of Procedure - Directive 89/105/EEC - Transparency of measures governing the pricing of medicinal products for human use - Article 4 - Price freeze - Price reduction)
2010/C 51/26
Language of the case: Italian
Referring court
Tribunale Amministrativo Regionale del Lazio (Italy)
Parties to the main proceedings
Applicant: IFB Stroder Srl
Defendant: Agenzia Italiana del Farmaco (AIFA)
Re:
Reference for a preliminary ruling — Tribunale Amministrativo Regionale del Lazio — Interpretation of Article 4(1) and (2) of Directive 89/105/EC 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 (OJ 1989 L 40, p. 8) — Price freeze imposed on medicinal products — Procedures to follow in the case of a price reduction
Operative part
1. |
Article 4(1) of 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 is to be interpreted as meaning that, provided the requirements laid down in 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 of those prices. |
2. |
Article 4(1) of Directive 89/105 must be interpreted as meaning that, provided the requirements laid down in 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 in 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 accordance with the objective of transparency pursued by that directive and the requirements laid down in that provision, the criteria on the basis of which the review relating to macro-economic conditions, as provided for 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 must be interpreted as meaning that:
|