# C_2006326EN.01001701.xml

| 30.12.2006 | EN | Official Journal of the European Union | C 326/17 |
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30.12.2006

EN

Official Journal of the European Union

C 326/17

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Judgment of the Court (Fifth Chamber) of 26 October 2006 (reference for a preliminary ruling from the Sozialgericht Köln — Germany) — G. Pohl-Boskamp GmbH & Co. KG v Gemeinsamer Bundesausschuss

(Case C-317/05) (1)

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(Directive 89/105/EEC - Article 6(1) and (2) - Positive list - Obligation to state reasons and provide information concerning remedies)

(2006/C 326/33)

Language of the case: German

Referring court

Sozialgericht Köln

Parties to the main proceedings

Applicant: G. Pohl-Boskamp GmbH & Co. KG

Applicant:

Defendant: Gemeinsamer Bundesausschuss

Defendant:

Intervening parties: AOK-Bundesverband KdöR, IKK-Bundesverband, Bundesverband der Betriebskrankenkassen (BKK), Bundesverband der landwirtschaftlichen Krankenkassen, Verband der Angestellten-Krankenkassen eV, AEV-Arbeiter-Ersatzkassen-Verband eV, Bundesknappschaft, Seekrankenkasse, Bundesrepublik Deutschland

Intervening parties:

Re:

Reference for a preliminary ruling — Sozialgericht Köln — Interpretation of Article 6(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) — Concept of ‘positive list’ — National rules providing for the establishment of a list of medicinal products, normally available without a prescription and non-refundable, which may exceptionally be covered by the national health insurance system in cases where they represent standard treatment for certain serious ailments — Obligation to take a decision concerning inclusion on the list within a specified period, to set out reasons for refusal and to inform the applicant of the means of redress available to him

Operative part of the judgment

| 1. | 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 precluding rules of a Member State which, following the exclusion of non-prescription medicinal products from the range of benefits provided by the national health system, empower an authority under that system to adopt rules derogating from that exclusion in respect of certain medicines without making provision for a procedure under Article 6(1) and (2) of that directive. |
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1.

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 precluding rules of a Member State which, following the exclusion of non-prescription medicinal products from the range of benefits provided by the national health system, empower an authority under that system to adopt rules derogating from that exclusion in respect of certain medicines without making provision for a procedure under Article 6(1) and (2) of that directive.

| 2. | Article 6(2) of Directive 89/105 is to be interpreted as meaning that it confers on the manufacturers of medicinal products affected by a decision which allows the coverage by the health insurance system of certain medicinal products containing active ingredients referred to therein the right to a reasoned decision mentioning remedies, even though the rules of the Member State make no provision for any corresponding procedure or remedies. |
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2.

Article 6(2) of Directive 89/105 is to be interpreted as meaning that it confers on the manufacturers of medicinal products affected by a decision which allows the coverage by the health insurance system of certain medicinal products containing active ingredients referred to therein the right to a reasoned decision mentioning remedies, even though the rules of the Member State make no provision for any corresponding procedure or remedies.

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(1)  OJ C 281, 12.11.2005.

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