Public health authorities may offer financial incentives to induce doctors to prescribe less expensive medicinal product

On 22 April 2010 the Court of Justice of the European Union ruled that national public health authorities of Member States may offer financial incentives to induce doctors to prescribe cheaper medicinal products.

On 22 April 2010 the Court of Justice of the European Union ruled that national public health authorities of Member States may offer financial incentives to induce doctors to prescribe cheaper medicinal products.

The Directive relating to medicinal products for human use (2001/83) prohibits - where medicinal products are being promoted to doctors or pharmacists - pecuniary advantages or benefits in kind being supplied, offered or promised to such persons.

The reference to the Court of Justice of the European Union (hereafter "the Court") was made in proceedings before the English High Court between the Association of the British Pharmaceutical Industry (corresponding to the Danish Association of the Pharmaceutical Industry (lif)), and the English Medicines and Healthcare Products Regulatory Agency (corresponding to the Danish Medi­cines Agency).

In order to reduce public expenditure on medicinal prod­ucts the national public health authorities in England and Wales introduced incentive schemes providing doctors with financial incentives to prescribe medicinal products that were cheaper than other medicinal products in the same therapeutic class to their patients. The English High Court asked the Court whether the prohibition on finan­cial incentives in the Directive precluded the incentive scheme system in England and Wales.

The incentive scheme induces the doctor to replace one specifically named medicinal product with another spe­cifically named cheaper medicinal product with a differ­ent active ingredient, but within the same pharmaceuti­cal class. The Court was not asked to rule on incentive schemes encouraging generic substitution between medicinal products with the same active ingredient, which were also part of the incentive scheme system.

The Court decided that as regards financial inducements to prescribe medicinal products the prohibition in the Directive does not apply to national public health au­thorities who are responsible for defining the priorities for action in relation to public health policy. This par­ticularly applies to the rationalisation of the public ex­penditure allocated to the policy, which the authority in question is responsible for. Pursuant to the Court 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 commercial promotion of medicinal products. The Court therefore ruled that it is permissible for au­thorities to determine, whether, in order to treat certain conditions, certain medicinal products are preferable to other medicinal products containing different active substances, but falling within the same therapeutic class.

The Court ruled that such schemes should be based on objective criteria, and should be transparent, so that there will be no discrimination between national medici­nal products and medicinal products from other Member States. National Public health authorities that adopt a financial incentive scheme are required to make such a scheme public and to make the evaluations establishing the therapeutic equivalence of the active substances belonging to the therapeutic class covered by the scheme available to health care professionals and to professionals in the pharmaceutical industry.

Choosing cheaper medicinal products with a different active substance may have adverse consequences for the patient. However, the Court has now approved incentive schemes aimed at increasing the use of cheaper medici­nal products and the judgment is silent as to whether the prescribing doctor is obliged to take the best interest of the patient into account with respect to choice of medi­cation.