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Drug switching schemes ‘illegal’

By Lilian Anekwe

GP prescribing incentive schemes to support drug switching have been ruled illegal in a shock European court judgment.

The European Court of Justice said drug switching schemes contravened a European directive governing the advertising or promotion of medicines, following a legal challenge from the pharmaceutical industry.

The judgment, officially an ‘opinion', is still subject to appeal, but if ratified by the UK's High Court could see drug switching schemes banned in the next three to six months.

The European court said the schemes were illegal as they ‘have the deliberate intention of promoting within the NHS certain medicinal products at the expense of others'.

In 2006, the Association of the British Pharmaceutical Industry (ABPI) brought a High Court action against the MHRA, which was then referred to the European Court.

The ABPI argued paying GPs for use of specified drugs was prohibited under Article 94(1) of European Directive 2001/83 (see box).

In response, the MHRA argued PCTs were exempt from the law as it related only to incentive schemes of a commercial nature.

But the European opinion ruled in favour of the ABPI, with advocate-general Nilo Jaaskinen concluding the schemes meant GPs were ‘positively discouraged' from prescribing one named drug in favour of another ‘even if their overall objective is to save budgetary resources'.

A recent Pulse survey of 900 GPs found them split over drug switching schemes, with 46% said they were an appropriate way of achieving NHS savings, although 81% backed generics targets more generally.

GP prescribing experts attacked the judgment. Dr David Russell, a GP in Darlington and PCT prescribing lead, said the ruling was ‘farcical'.

‘All of us can see these schemes are in the best interest of the NHS and the betterment of patient care. I hope if this farcical ruling comes into force there are ways round it because it would be terrible if these schemes were made illegal.'

Dr Andrew Green, a member of the GPC's clinical and prescribing subcommittee and a GP in Hull, said: ‘It's in all our interests that prescribing should be both clinically and cost-effective. Drug switching is a very time-consuming and expensive thing to do and prescribing incentive schemes recognise this work that GPs do and enable them to do it properly.'

But another subcommittee member Dr Peter Fellows, a GP in Lydney, Gloucestershire, and a former adviser to the ABPI, said: ‘The pharmaceutical industry is coming under enormous pressure. Companies trying to remain in this country and do research and development are being chased away by the Government. Doctors should not be rewarded for distorting prescribing decisions.'

Statins are often included in the prescriptions incentive schemes that are now under threat The legal judgment on drug switching

The European Court of Justice has given the UK High Court its opinion that Article 94(1) of Directive 2001/83/EC of the European Parliament ‘precludes a public body forming part of a national public health service, in order to seek to reduce its overall expenditure on medicines, from implementing a scheme which offers financial incentives to medical practices (which may in turn provide a benefit to the prescribing doctor) to prescribe a named medicine supported by the incentive that is either:
• a different medicine to that previously prescribed by the doctor to the patient, or
• a different medicine to that which otherwise might have been prescribed to the patient but for the incentive scheme
– where such a different medicine is from the same therapeutic class of medicines used for treatment of the patient's particular condition'.

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