Plans by the General Medical Council (GMC) to allow doctors, for the first time, to prescribe cheaper off-label alternatives to licensed medicines will increase the risk to public safety, the Association of the British Pharmaceutical Industry (ABPI) has warned.

The GMC's proposal to change its current guidance to permit the prescribing of an off-label or unlicensed medicine - even where a licensed product is available, if the prescriber is satisfied on the basis of authoritative clinical guidance that it is as safe and effective as an appropriately licensed alternative - represents "a watering-down" of the protection currently offered to patients, says the ABPI.

"Clinical guidelines are no substitute for a formal risk-benefit evaluation by the competent regulatory body after full, scientific scrutiny of the evidence. The proposes changes appear to directly undermine the medicines regulatory process that exists to protect the public," the industry group warns, in its response to the GMC's consultation on its proposed new guidance, entitled Good practice in prescribing and managing medicines in devices.

Most respondents to a scoping exercise undertaken to determine the key issues to be covered by the proposed new guidance (which is intended to replace the Council's existing guidance, published in 2008) had agreed that doctors should be able to prescribe off-label or unlicensed medicines under these conditions, says the GMC. 

"Examples of what many regarded as acceptable or good practice include amitriptyline as a first-line treatment for neuropathic pain (National Institute for Health and Clinical Excellence [NICE] clinical guideline 96) and sertraline, if drug treatment is chosen, for generalised anxiety disorder and panic (NICE clinical guideline 113). In both cases there are licensed alternatives, but they are not considered by NICE to be as cost-effective," says the Council, in its consultation document.

But the ABPI calls on the GMC to maintain its existing guidance, which emphasises that while doctors should make "good use of the resources available," this does not extend to prescribing a medicine outside the terms of its license, unless the doctor is satisfied that it would better serve the patient's needs than a licensed alternative.

"The existing guidance does not imply that cost can be an acceptable consideration in choosing an unlicensed medicine when there is a licensed alternative that meets the same clinical need," the ABPI adds.

The industry group notes its concerns that current financial pressures on the NHS could impact on the interpretation of the proposed guidance, warning that it would be "unfortunate,"for example, if GMC guidance was used by NHS commissioners "to exert pressure on doctors to put financial consideration ahead of the best interests of patients." It also points out that any attempt by a Primary Care Trust (PCT) to influence clinicians and patients to use an unlicensed medicine or an approved product off-label on cost grounds where there is a licensed and NICE-approved alternative is contrary to law.

The ABPI is also worried at the consultation document's suggestion that patients need not be given information relevant to giving their consent to treatment with off-label or unlicensed medicines, and at thepossible threat to the development of new medicines, arising from a "compromised regulatory framework" and apotential disincentive for companies to submit products for approval which includes commitments to continuing post-authorisation safety reviews.