An Opinion from the European Court of Justice (ECJ) has supported the Association of the British Pharmaceutical Industry (ABPI) in its claims that prescribing incentive schemes operated by Primary Care Trusts (PCTs) in the UK are in fact banned under European law.

The Opinion, given late last week by Advocate General Nilo Jaaskinen, relates to the action brought in the High Court by the ABPI against the Medicines and Healthcare products Regulatory Agency (MHRA). The industry group’s case challenges PCTs’ establishment of such schemes - which reward doctors financially for prescribing specific named medicines - and suggests that they are in fact prohibited under Article 94(1) of European Directive 2001/83, which covers the provision of human-use medicines, including their advertising and promotion.

On July 3 2006, after the ABPI wrote to the MHRA expressing concern about the incentive schemes being implemented by PCTs, the MHRA had replied that, in its opinion, Article 94 covered incentive schemes “of a commercial nature” only. The ABPI disputed this interpretation and sought a review of the legality of the MHRA’s position in the High Court, which in turn asked the ECJ for an interpretation of Article 94 before it could give judgement.

In his Opinion on the matter, AG Jaaskinen last week concluded that prescribing incentive schemes do “have the deliberate and direct intention of promoting within the National Health Service (NHS) certain medicinal products at the expense of others,” and that they therefore amount to promotion, which is prohibited under Article 94(1) of Directive 2001/83.

The AG also commented on the arguments presented by the UK government to the ECJ on the ABPI’s motives for bringing the case. The UK had claimed that the industry group was “not concerned…with preserving the independence of doctors or with patient safety, but wishes instead to maximise the prescription, and therefore the sale, of branded medicinal products manufactured and marketed by its members.”

However, AG Jaaskinen responded that, in his view, “the self-regarding nature of ABPI’s motives is legally irrelevant. As a line of business the pharmaceutical industry is lawful, socially useful and even encouraged by the EU legislature. It is also inherent in the economic order of the EU, which aims for an open market with free competition, that private economic operators pursue lucrative purposes. This logic also applies to the pharmaceutical industry.”

Moreover, he added: “even if some form of financial incentive schemes designed to reduce medicinal costs seems to exist in other member states, the UK appears to be the only member state that has prescribing incentive schemes involving the substitution of specifically named medicines.”

Commenting on the Opinion to Pharma Times this morning, an ABPI spokesperson said: "We welcome the views of the Advocate General who, on this crucial area of patient interest, has concluded that prescribing incentive schemes are prevented under the Directive. We will now await the final judgement of the court."