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46 <strong>EDI</strong> European Law ECJ: Economic Incentives to Promote the Description of Low-Cost Medicinal Products are Legal In its decision dated 22 April 2010 (C-62/09), the European Court of Justice in Luxemburg (ECJ) has ruled that a scheme by national public health authorities offering financial incentives to medical practices to prescribe low-cost medicinal products is compatible with European law. The background of the case: In England and Wales, the National Health Service (NHS) is responsible for providing a comprehensive health service, including the procurement of medical drugs. If healthcare professionals issue prescriptions to be funded by the NHS, they must comply with its rules. To reduce the costs of medicinal products, the NHS has introduced financial incentive schemes to induce physicians to prescribe for their patients specific named medicinal products, thereby establishing a positive list of lowcost medicinal products (statins, in the case at hand). Physicians were to give preference to medicinal products in the same therapeutic class, but not necessarily containing the same active substances. The rules did not exclude the possibility that another medicinal product in the same therapeutic class might be better suited to the treatment of a particular patient, so that switching the prescribed medication to another based on a different active substance in some cases might have adverse consequences for the patient. The NHS established therapeutic equivalence of medicinal products in the same therapeutic class in accordance with, inter alia, the guidelines of the National Institute for Health and Clinical Excellence. Financial incentives Under the scheme, financial inducements are calculated according to how certain targets are met. One target is to increase the proportion of prescriptions for a specific named medicinal product from the positive list. Another target is to increase the number of patients whose established medicinal product has been changed in favour of a specific named medicinal product from the list. The Association of the British Pharmaceutical Industry (ABPI), representing 70 pharmaceutical companies operating in the United Kingdom, objected to these financial incentives, voicing its concerns to the British Ministry of Health and requiring an investigation, especially in the light of Directive 2001/83/EC on a community code relating to medicinal products for human use. The Directive states, inter alia, that persons qualified to prescribe medicinal products must be able to carry out these functions objectively without being influenced by direct or indirect financial inducements. Where medicinal products are being promoted, no premiums or other advantages in money or in kind may be given, offered or promised to persons qualified to prescribe or supply them, unless they are inexpensive and relevant to the practice of medicine or pharmacy, as Article 94 (1) of Directive 2001/83/EC states. Safeguarding of public health an essential aim The British Ministry of Health considered the NHS incentive schemes to be legal, as in its opinion the prohibition of incentives in Directive 2001/83/EC did not apply to national public health authorities but only to commercial organizations, whereupon the ABPI brought an action before the High Court of Justice (England and Wales). This court referred the case to the ECJ for an interpretive ruling of Directive 2001/83/EC, asking whether a public body forming part of a national public health service is precluded by Article 94 (1) from offering financial incentives to medical practices for prescribing a specific named medicine. During the ECJ proceedings, the European Commission submitted, in support of the ABPI, that the provision also applied to national authorities, precluding the NHS from offering financial inducements for the prescription of specific named medicinal prod - ucts. The United Kingdom held an opposing view,
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