The Queen, on the application of Association of the British Pharmaceutical Industry v Medicines and Healthcare Products Regulatory Agency.
Date: 2010-04-22
30. In the case of advertising of medicinal products, the Court has already held that, even where it is carried out by an independent third party outside any commercial or industrial activity, such advertising is liable to harm public health, the safeguarding of which is the essential aim of Directive 2001/83, and that, consequently, dissemination by a third party of information about a medicinal product, including its therapeutic or prophylactic properties, may be regarded as advertising within the meaning of Article 86(1) of that directive, even though the third party in question is acting on his own initiative and completely independently, de jure  and de facto , of the manufacturer and the seller of such a medicinal product (Case C‑421/07 Damgaard  [2009] ECR I‑0000, paragraphs 22 and 29).
34. In addition, while, in the case which gave rise to the judgment in Damgaard , the dissemination by an independent third party of information about a medicinal product was liable to harm public health, the safeguarding of which is the essential aim of Directive 2001/83, such a risk cannot be demonstrated in the case of financial inducements made by the public health authorities. The very nature of the task of those authorities is to supervise public health, for which they assume political responsibility and they are thus in charge of evaluating the therapeutic value of the medicinal products which they authorise to be marketed.
36. In accordance with Article 168(7) TFEU, European Union law does not detract from the power of the Member States to organise their social security systems and to adopt, in particular, measures intended to govern the consumption of pharmaceutical products in order to promote the financial stability of their health‑care insurance schemes (Joined Cases C-352/07 to C-356/07, C-365/07 to C-367/07 and C-400/07 A. Menarini Industrie Farmaceutiche Riunite and Others  [2009] ECR I‑0000, paragraph 19 and the case‑law cited).
37. However, it should be noted that, in order to ensure the effectiveness 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), 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 (see, to that effect, Case C‑229/00 Commission  v Finland  [2003] ECR I‑5727, paragraph 39, and A. Menarini Industrie Farmaceutiche Riunite and Others , paragraph 28).
38. 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 (Case C‑245/03 Merck, Sharp & Dohme  [2005] ECR I‑637, paragraph 27), 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.
39. Finally, it must be noted that such practices entailing public financial incentives for the prescription of medicinal products containing certain active substances cannot compromise the objectivity with which, as noted in recital 50 in the preamble to Directive 2001/83, a doctor must act when issuing a prescription for a given patient.
40. First, a prescribing doctor is required, from the point of view of professional conduct, not to prescribe a given medicinal product if it is not fitting for the therapeutic treatment of his patient, despite the existence of public financial inducements for its prescription.