Opinion of the Advocate General — ECLI:EU:C:2010:75
Date: 2010-02-11
Language of the case: English
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: United Kingdom

Summary of the Judgment Approximation of laws – Medicinal products for human use – Directive 2001/83 – Advertising (European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 94(1)) Article 94(1) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, must be interpreted as not precluding financial incentive schemes implemented by the national public health authorities in order to reduce their public-health expenditure and designed to encourage, for the purpose of treating certain conditions, the prescription by doctors of specific named medicinal products containing an active substance different from the active substance of the medicinal product that was previously prescribed or that might have been prescribed but for such an incentive scheme. In general terms, the health policy defined by a Member State and the public expenditure devoted to it do not pursue any profit-making or commercial aim. Since a financial incentive scheme forms part of such a policy, it cannot be regarded as falling within the commercial promotion of medicinal products. However, in order to ensure the effectiveness 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, professionals in the pharmaceutical industry, whether or not the prescription of their medicinal products is subject to financial inducements, must also be able to verify that the financial incentive scheme implemented by the public authorities is based on objective criteria and that there is no discrimination between national medicinal products and those from other Member States. Consequently, even though Directive 89/105 has as an underlying principle the idea of minimum interference in the organisation by Member States of their domestic social security policies, national public health authorities which adopt a financial incentive scheme for the prescription of specific named medicinal products are required in particular to make such a scheme public and to make available to health-care professionals and professionals in the pharmaceutical industry the evaluations establishing the therapeutic equivalence of the active substances available belonging to the therapeutic class covered by that scheme. (see paras 33, 37-38, 42, operative part)