Judgment — ECLI:EU:C:2006:684
Date: 2006-10-26
Language of the case: German
Court formation: Fifth Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Concepts: Direct effect;General
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary of the Judgment 1. Approximation of laws – Pharmaceutical products – Directive 89/105 – Medicinal products for human use (Council Directive 89/105, Arts 1 and 6(1) and (2)) 2. Approximation of laws – Pharmaceutical products – Directive 89/105 – Medicinal products for human use (Council Directive 89/105, Art. 6(2)) 1. The purpose of Directive 89/105 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, according to Article 1 thereof, is to ensure that any national measure to control the prices of medicinal products for human use or to restrict the range of medicinal products covered by their national sickness insurance systems complies with the requirements of that directive. Those objectives would be compromised if a Member State were able to introduce a dual procedure for the establishment of a list of medicinal products qualifying for reimbursement by the national health insurance system, one pursuant to the obligations laid down by Article 6(1) of that directive, the other being exempt in part from those obligations and, in part, not complying with the objectives laid down by that directive. It follows that Directive 89/105 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. (see paras 25, 27, 36, operative part 1) 2. Article 6(2) of Directive 89/105 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 describes with precision and in unequivocal terms an obligation, namely that of stating reasons for refusing to enter a medicinal product on the list of products covered by the national health insurance system and informing the applicant of the remedies available, which is not qualified by any condition, or subject, in its implementation or effects, to the taking of a subsequent measure. Its wording thus appears to be unconditional and sufficiently precise so that it can be relied on by interested parties in their relations with a Member State. It follows that the said Article 6(2) must be interpreted as conferring 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 (see paras 42, 44, operative part 2)