The European Union Court of Justice (ECJ) has rejected UK drugmakers’ claims that prescribing incentive schemes operated by Primary Care Trusts (PCTs) are illegal under EU law.
ECJ judges in Luxembourg ruled yesterday that such 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.
This decision comes as a shock, because in February an Opinion from ECJ Advocate General Nilo Jaaskinen had upheld the industry’s position. He had concluded that, as prescribing incentive schemes have the “deliberate and direct intention” of promoting “certain medicinal products at the expense of others,” they amount to promotion and are therefore prohibited under Article 94(1) of European Directive 2001/83.
However, the judges ruled yesterday that while the Directive bans any “pecuniary advantages or benefits in kind” from being offered where medicines are being promoted to doctors or pharmacists, this prohibition “concerns primarily the promotional activities carried out by the pharmaceutical industry and seeks to prevent promotional practices which may induce doctors to act in accordance with their economic interests when prescribing medicinal products.”
The ban does not apply to national public health authorities, said the judges. As the health policies of EU member states and public spending on such policies do not pursue any profit-making or commercial aim, and prescribing incentive schemes form part of such a policy, they “cannot be regarded as seeking the promotion of commercial promotion of medicinal products,” they ruled.
Moreover, no danger to public health can be established through the use of such schemes, as the therapeutic value of the “favoured” products is constantly reviewed by the public authorities, said the judges.
However, they added that health systems must “make available to professionals in the pharmaceutical industry information showing that the scheme at issue is based on objective criteria and that there is no discrimination between national medicinal products and those from other member states.”
Also, the schemes must be made public, and the evaluations used to establish therapeutic equivalence should be made available to the industry, the judges said.
The ruling concerns a case currently proceeding in the High Court in London, brought by the Association of the British Pharmaceutical Industry (ABPI) against the Medicines and Healthcare Products Regulatory Agency (MHRA), The ABPI had expressed its concern to the MHRA about the incentive schemes being operated by PCTs, but in July 2006 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 judgment.
An informed source suggested to Pharma Times that a decision from the High Court could now be expected possibly within the next two to three weeks.
Yesterday the ABPI said it was “disappointed” that the ECJ had not followed AG Jaaskinen’s Opinion, and that the Association would now consider the implications of this judgment in relation to its case in the High Court.
“The ABPI believes it is important that patients can have total confidence that when their doctor is making prescribing decisions those decisions are, and are seen to be, completely independent of personal financial considerations. The ECJ interpretation of the legislation risks this being put in doubt,” said a spokesman for the industry group.
The European Generic medicines Association (EG) welcomed the ECJ’s decision that national public health authorities “have the legal right to provide incentives to physicians to encourage cost-effective prescribing,” and the judges’ restatement that “there are clearly no patient health concerns in such incentive schemes.”
“It is in the interests of all European patients and healthcare systems that prescription decisions should take account of the affordability and cost-effectiveness of different medicines,” the group stated.
