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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> AOK-Bundesverband & Ors (Competition) [2004] EUECJ C-264/01 (16 March 2004) URL: https://www.bailii.org/eu/cases/EUECJ/2004/C26401.html Cite as: Case C-264/01, [2004] EUECJ C-264/01, [2004] EUECJ C-264/1 |
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JUDGMENT OF THE COURT
16 March 2004
(1)
(Competition - Undertakings - Sickness funds - Agreements, decisions and concerted practices - Interpretation of Articles 81 EC, 82 EC and 86 EC - Decisions of groups of sickness funds determining maximum amounts paid in respect of medicinal products)
In Joined Cases C-264/01, C-306/01, C-354/01 and C-355/01, REFERENCES to the Court under Article 234 EC by the Oberlandesgericht Düsseldorf (Germany) and by the Bundesgerichtshof (Germany) for preliminary rulings in the proceedings pending before those courts between AOK Bundesverband, Bundesverband der Betriebskrankenkassen (BKK), Bundesverband der Innungskrankenkassen, Bundesverband der landwirtschaftlichen Krankenkassen, Verband der Angestelltenkrankenkassen eV, Verband der Arbeiter-Ersatzkassen, Bundesknappschaft, See-Krankenkasseand
Ichthyol-Gesellschaft Cordes, Hermani & Co. (C-264/01), Mundipharma GmbH (C-306/01), Gödecke GmbH (C-354/01), Intersan, Institut für pharmazeutische und klinische Forschung GmbH (C-355/01), on the interpretation of Articles 81 EC, 82 EC and 86 EC,THE COURT,
after considering the written observations submitted on behalf of:
- the AOK Bundesverband, the Bundesverband der Betriebskrankenkassen (BKK), the Bundesverband der Innungskrankenkassen, the Bundesverband der landwirtschaftlichen Krankenkassen, the Verband der Angestelltenkrankenkassen eV, the Verband der Arbeiter-Ersatzkassen, the Bundesknappschaft and the See-Krankenkasse, by C. Quack, Rechtsanwalt (C-264/01 and C-306/01), and A. von Winterfeld, Rechtsanwalt (C-354/01 and C-355/01), - Ichthyol-Gesellschaft Cordes, Hermani & Co. and Mundipharma GmbH, by U. Doepner, Rechtsanwalt, - Gödecke GmbH and Intersan, Institut für pharmazeutische und klinische Forschung GmbH, by U. Reese, Rechtsanwalt, - the Commission of the European Communities, by W. Wils and S. Rating, acting as Agents,having regard to the Report for the hearing,
after hearing the oral observations of the AOK Bundesverband, the Bundesverband der Betriebskrankenkassen (BKK), the Bundesverband der Innungskrankenkassen, the Bundesverband der landwirtschaftlichen Krankenkassen, the Verband der Angestelltenkrankenkassen eV, the Verband der Arbeiter-Ersatzkassen, the Bundesknappschaft and the See-Krankenkasse, represented by C. Quack (C-264/01 and C-306/01) and A. von Winterfeld (C-354/01 and C-355/01); Ichthyol-Gesellschaft Cordes, Hermani & Co. and Mundipharma GmbH, represented by U. Doepner; Gödecke GmbH and Intersan, Institut für pharmazeutische und klinische Forschung GmbH, represented by U. Reese; the German Government, represented by W.-D. Plessing, acting as Agent; and the Commission, represented by S. Rating, at the hearing on 14 January 2003,
after hearing the Opinion of the Advocate General at the sitting on 22 May 2003,
gives the following
Fixed maximum amounts and the statutory health insurance scheme
'(1) Is Article 81(1) EC to be interpreted as meaning that the leading associations of statutory sickness funds of a Member State are to be regarded as associations of undertakings or, where a leading association is also a direct provider of statutory sickness insurance, as undertakings within the meaning of Article 81(1) EC when they jointly determine the applicable level of uniform fixed amounts for medicinal products in the Member State, where such amounts constitute the highest price at which the statutory sickness funds, who are required to provide benefits in kind to insured persons, will purchase and pay for medicinal products and thereby limit their liability to insured persons? (2) If the answer to the first question is in the affirmative: (a) are determinations of fixed amounts as described in question 1 above to be regarded as agreements (or decisions) of the leading associations of statutory sickness funds which restrict competition, in particular within the meaning of Article 81(1)(a) EC, and are prohibited by Article 81(1) EC? (b) is question 2(a) to be answered in the affirmative at least where the object of the regulation concerning fixed amounts is, inter alia, to exploit all reserves of medicinal product manufacturers in terms of economy as regards sale price, and the application of the regulation concerning fixed amounts in the Member State so far has had the effect that, of the finished medicinal product packages offered on the market that fall within the regulation concerning fixed amounts, approximately 93% do not now exceed the amount fixed for them? (3) If the answer to either or both of the questions in question 2 above is in the affirmative: Can a system of fixed amounts as described in questions 1 and 2 be exempted from Article 81(1) EC under Article 86(2) EC, first sentence, even though when they determine fixed amounts the leading associations of statutory sickness funds represent the biggest purchasers on the medicinal product market, who when taken together dominate the market, and it would be possible, as a solution to the problem of trying to reduce costs in the health sector, to grant power to determine such fixed amounts to an institution other than a participant in the medicinal product market, in particular to the Federal Government or a Federal Minister? (4) If the answer to question 3 is also in the affirmative: (a) what conditions must be set forth and proved by the leading associations of statutory sickness funds so that they may be exempted under Article 86(2) EC, first sentence, in relation to determinations of fixed amounts or (b) is the grant of an exemption under Article 86(2) EC, first sentence, precluded in any case by Article 86(2) EC, second sentence, owing to the effects the system of fixed amounts has on trade?' Cases C-354/01 and C-355/01
'(1) Are Articles 81 and 82 EC to be interpreted as precluding national rules under which national leading associations of statutory sickness insurance determine binding maximum amounts for all statutory sickness funds and compensatory sickness funds up to which the funds bear the costs of medicines, where the legislature defines the criteria by which the maximum amounts are to be calculated, providing in particular that the fixed amounts must ensure comprehensive and quality-assured treatment of insured persons as well as an adequate range of therapeutic alternatives, and the determination is subject to comprehensive review by the courts, which may be initiated by both insured persons and affected medicinal product manufacturers? (2) If question 1 is answered in the affirmative: Does Article 86(2) EC exempt such a determination from Articles 81 and 82 EC where the purpose of the determination is to safeguard, in the manner provided for in Paragraph 35 of SGB V, a sickness insurance scheme whose existence was endangered by a significant increase in costs? (3) If question 1 is answered in the affirmative and question 2 in the negative: Are leading associations such as the defendants liable to claims under Community law for damages and an injunction even where in determining maximum amounts they follow a statutory direction, notwithstanding that national law does not impose any penalty for refusal to assist in the making of such a determination?'
(1) Are groups of sickness funds, such as the fund associations in question in the main proceedings, to be regarded as undertakings or associations of undertakings within the meaning of Article 81 EC when they determine fixed maximum amounts corresponding to the upper limit of the price of medicinal products whose cost is borne by sickness funds? (2) If the first question is answered in the affirmative, do those groups infringe Article 81 EC when they adopt decisions intended to determine the amounts? (3) If the second question is answered in the affirmative, does the derogation provided for in Article 86(2) EC apply to those decisions? (4) If the Treaty competition rules are infringed, is there a right against such groups to an injunction remedying the situation and to compensation for the loss suffered?
Observations of the parties
Findings of the Court
On those grounds,
THE COURT,
in answer to the questions referred to it by the Oberlandesgericht Düsseldorf by orders of 18 May 2001 and 11 July 2001 and the Bundesgerichtshof by orders of 3 July 2001, hereby rules:
Skouris |
Jann |
Timmermans |
Gulmann |
Cunha Rodrigues |
Rosas |
Puissochet |
Schintgen |
Macken |
Colneric |
von Bahr |
|
R. Grass |
V. Skouris |
Registrar |
President |
1 - Language of the case: German.