Prescribing medicinals

UK pharmaceutical firms have been defeated in their attempt to put an end to British government incentives to doctors to supply patients with cheaper but equivalent medicines. The European Court of Justice rejected a complaint by the Association of the British Pharmaceutical Industry (ABPI), ruling that such National Health Service schemes were not an illegal inducement under EU law.

In order to reduce public expenditure, the public health authorities in England and Wales introduced schemes providing doctors with financial incentives to prescribe cheap generic drugs rather than their more expensive patented counterparts. Doctors were encouraged, first, to change the treatment of their patients as regards existing prescriptions and, second, to favour a treatment based on a certain active substance rather than another when prescribing medicinal products for a given condition for the first time. The incentive schemes at issue in this case primarily concerned the prescription of statins, which are cholesterol-reducing substances.

In July 2006, the ABPI expressed its concerns about these incentive schemes but the Medicines and Healthcare Products Regulatory Agency on the other hand claimed that, in its view, the 2001 European directive relating to medicinal products banned only promotion or incentive schemes of a commercial nature. Following this, the ABPI sought a review from the High Court, which in turn asked the European Court of Justice for an interpretation of the directive on the matter.

In February this year, the Advocate General for the European Court of Justice issued its opinion suggesting that prescription incentive schemes are illegal under European law. He concluded that such schemes have the deliberate and direct intention of promoting within the NHS certain medicinal products at the expense of others, and that this therefore represents promotion of the products, which is banned under the said directive.

Although the Advocate General's opinion is generally followed by the European Court of Justice, in this case the court chose to differ.

The court found that the directive was concerned primarily with the promotional activities carried out by the pharmaceutical industry and sought to prevent promotional practices that could push doctors to act more in line with their wallet than a patient's interests. It held that the prohibition did not apply to national public health authorities which do not pursue any profit-making or commercial aim, and concluded that the schemes cannot be regarded as seeking the commercial promotion of medicinal products.

The Luxembourg court further ruled that schemes which reward doctors for prescribing cheap generic versions of higher-priced patented drugs are compatible with EU law and do not prejudice prescribers' objectivity. The ban laid down in the directive does not apply to national public health authorities because health policies of EU member states and public spending on such policies do not pursue any profit-making or commercial aim.

Hence, prescribing incentive schemes forming part of such a policy cannot be regarded as seeking the commercial pro-motion of medicinal products.

The court, however, maintained that for such schemes to be acceptable, EU health systems applying such schemes must make available to professionals in the pharmaceutical industry inform-ation showing that the schemes at issue are based on objective criteria, and that there is no discrimination between national medicinal products and those from other member states.

Furthermore, the schemes must be made public, and the evaluations used to establish therapeutic equivalence should also be made available to the industry.

Dr Grech is an associate with Guido de Marco & Associates and heads its European law division.