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The trade body representing the drug industry is taking the UK government to court over its attempt to encourage doctors to switch patients to cheaper generic medicines.
The Association of the British Pharmaceutical Industry (ABPI) has won permission to challenge the legality of the Department of Health's drive to persuade doctors to prescribe generic statins in place of the more costly branded versions.
The government is determined to cut the £7bn (€5bn; $3.5bn) a year the NHS pays for branded drugs. With nearly two million Britons taking statins to help lower their cholesterol, the Department of Health estimates that at least £84m a year could be saved if doctors prescribed generic statins.
But a spokesman for the association said that although it supports the government's desire to get the best value for money, it has “serious concerns” about the methods adopted to persuade doctors to switch their patients to the cheaper drugs. It questioned the legality of offering doctors money as an incentive and cast doubt on the adequacy of safeguards for patients.
The Department of Health's guidance to primary care trusts last month stated that any change to a patient's treatment regime “should be based on good quality evidence or guidance” and that payments under an incentive scheme “should go into practice funds and not to individuals.”
It added, “It is good practice to specify appropriate use of the money—for example, for the benefit of patients of the practice.”
The association said that its first concern was the lack of central guidance “to ensure that such switches were not being made without proper regard to the welfare of individual patients.”
The second was that “additional payments to doctors were being made as a direct financial inducement to prescribe certain medicines in substitution for other named medicines, which the ABPI considers is illegal under European law.”
The association said that the guidance “contains many provisions to safeguard the patient but fails to go far enough. For example, guidance should require patients to give informed consent to a switch rather than leave them to object if they wish to do so.
“Nor does the guidance address the legal issue of payments to induce doctors to switch their prescribing from one specific medicine to another, named medicine.
“As it is essential this is clarified, the ABPI has, with regret, started a judicial review to clarify the legality of this procedure.” But the association was “available for further discussions at any time in order to avoid the need for the case to go before the courts.”
A spokesman for the Department of Health maintained that financial incentives had a place in the strategies employed by primary care trusts to get the best treatment for their patients, and that it was up to trusts to decide the best use of their resources.
“We will rigorously defend this legal challenge from the ABPI. The NHS could potentially save £84m if it switched to low cost generic statins. These generic drugs are safe, of good quality and just as effective, and are used to treat many millions of patients worldwide.
“We are talking here about achieving best value for money for the taxpayer and are backed by authoritative guidance from the National Institute for Health and Clinical Excellence. Cost effective prescribing releases resources for more patients to receive treatment.”
The Department of Health's guidance, Strategies to Achieve Cost-effective Prescribing, is at www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_076350.