CJEU holds that national public health authorities of Member States may lawfully offer incentives to doctors to prescribe certain medicines in preference to others

23 April 2010

Trevor Cook

In its judgment of 22 April 2010 the Court of Justice of the EU (CJEU, formerly the ECJ) rejected the recommendation of Advocate-General Jaaskinen, on 11 February 2010 in Case C-62/09, The Queen, on the Application of the ABPI v MHRA, and held that Article 94(1) of Directive 2001/83/EC as amended (the Community Code relating to medicinal products), did not render unlawful financial incentive schemes implemented by the national public health authorities of Member States, such as that in issue here, that provided an incentive to doctors to prescribe certain medicines in preference to others in the same therapeutic class.  Article 94(1) provides that ‘Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy’ The ABPI had argued that Article 94(1) applied not only to commercial operators but also to the activities of Member States in organising and delivering health services and medical care, and that the incentive scheme in issue (operated by the English National Health Service, and which encouraged the use of a different, but cheaper medicinal product within the same therapeutic class) constituted “promotion” within the meaning of the Article.  The Advocate General had agreed with the ABPI and considered that Article 4(3) of the same Directive, which recognised the right of Member States to set prices for medicinal products or to decide on their inclusion in the scope of national health insurance schemes, did not provide Member States with a generalised exemption from the application of Article 94(1).  The CJEU disagreed, limiting the application of the Article to commercial promotion, and moreover held that Article 168(7) of the Treaty on the Functioning of the EU (TFEU, formerly Article 152(7) TEC) preserved to Member States the right to organise their social security systems and in particular measures intended to govern the consumption of pharmaceutical products.  It did however observe that by virtue of Directive 89/105/EEC such schemes should be transparent, based on objective criteria and not discriminate between national medicinal products and these from other Member States.