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

Published online by Cambridge University Press:  20 January 2017

Anna-Miria Fuerst
Anna-Miria Fuerst*
Affiliation:
Bucerius Law School, Hamburg, Germany
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Abstract

Joined Cases C-471/07 and C-472/07 AGIM and Others [2010] ECR I-00000

  1. 1. 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. 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. 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).

Type
Case Notes
Information
European Journal of Risk Regulation , Volume 1 , Issue 3 , September 2010 , pp. 311 - 315
Copyright
Copyright © Cambridge University Press 2010

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References

** Editorial Hint: Art. 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 L – 40, of 11.2.1989, pp. 8–11.

1 Association générale de l'industrie du médicament (AGIM) ASBL, Bayer SA, Pfizer SA, Servier Benelux SA, Janssen Cilag SA, and Sanofi-Aventis Belgium SA. The last two companies took part in only one of the two proceedings.

2 See Case C-245/03, Merck, Sharp & Dome [2005], ECR I-637, at para. 27; Joined Cases C-352/07 to C-356/07, C-365/07 to C-367/07 and C-400/07, A. Menarini and Others [2009], ECR I-2495, at para. 36.

3 See Case C-317/05, Pohl-Boskamp [2006], ECR I-10611, at para. 29; A. Menarini and Others, supra note 2, at para. 27

4 See A. Menarini and Others, supra note 2, at para. 35.

5 See A. Menarini and Others, supra note 2, at para. 47.

6 See A. Menarini and Others, supra note 2, at para. 48.

7 In Case 152-84, Marshall [1986], ECR 723, at para. 46 the ECJ states that, wherever the provisions of a directive appear, as far as their subject-matter is concerned, to be unconditional and sufficiently precise, those provisions may be relied upon an individual against the State where that State fails to implement the directive in national law by the end of the period prescribed or where it fails to implement the directive correctly.

8 Case C-424/99, Commission v. Austria [2001], ECR I-9285; Case C-229/00, Commission v. Finland [2003], ECR I-5727; Merck, Sharp & Dome, supra note 2; Pohl-Boskamp, supra note 3; Case C-311/07, Commission v. Austria [2008], ECR I-113; A. Menarini and Others, supra note 2.

9 See the fifth recital of Directive 89/105.

10 See the sixth recital of Directive 89/105.

11 Commission v. Austria [2001], supra note 8; Commission v. Finland [2003], supra note 8; Commission v. Austria [2008], supra note 8.

12 See supra note 3.

13 For a thorough analysis of the legal changes required by the Pohl- Boskamp ruling in the German healthcare law see Gassner, Ulrich M., “Von der Intrasigenz zur Transparenz – Pohl-Boskamp und die Folgen”, 28 Pharmarecht (2006), pp. 545 et sqq. Google Scholar

14 A. Menarini and Others, supra note 2; for further reference see the case note by Baeyens, An and Goffin, Tom, “ECJ 2009/5 A. Menarini and Others”, 16 European Journal of Health Law (2009), pp. 381 et sqq. CrossRefGoogle Scholar

15 The ECJ has confirmed this line in Case C-62/09, Association of the British Pharmaceutical Industry [2010] ECR I-00000, at para. 36.

16 Treaty of Lisbon (Lissabon Vertrag), Judgment, 30 June 2009, BVerfGE 123, pp. 267 et sqq., at p. 359.

17 BVerfGE 123, pp. 267 et sqq., at p. 356 et sqq.

18 Case 238/82, Duphar and Others [1984] ECR 523, at para. 16; Case C-249/88, Commission v. Belgium [1991] ECR I-1275, at para. 31; Joined Cases C-159/91 and C-160/91, Poucet and Pistre [1993], ECR I-637, at para. 6; Case C-70/95, Sodemare and Others [1997], ECR I-3395, at para. 27; Case C-158/96, Kohll [1998], ECR I-1931, at para. 17; Merck, Sharp & Dohme, supra note 2, at para. 28; Case C-141/07, Commission v. Germany [2008], ECR I-6935, at para. 22; A. Menarini and Others, supra note 2, at para. 19; Association of the British Pharmaceutical Industry, supra note 15, at para. 36.

19 In contrast, to grant direct effect to those provisions of Directive 89/105 which only bestow procedural rights is permissible, see Pohl-Boskamp, supra note 3, at para. 42.