The General Medical Council (GMC) guidance for off-label prescribing could be tightened following concerns it could breach EU law.

The GMC is seeking legal advice on whether off-label prescribing should be restricted to cases in which no licensed alternative is available – current guidance also allows it where doctors judge that such a medicine would better serve a patient's needs than the licensed alternative.

The move follows concerns that the existing guidance might be in breach of an EU directive on the use of medicines.

GMC guidance on off-label prescribing could be in breach of EU law

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The issue was raised when the GMC asked for views on plans that would in fact have eased the regulation of unlicensed and off-label prescribing. But some stakeholders opposed the changes, and the GMC sought advice on the matter from legal experts, who suggested that the council should abandon its proposed changes for unlicensed medicines. They also unearthed complications that meant the GMC might in fact have to tighten up the current rules for off-label prescribing.

GMC guidance limits off-label and unlicensed prescribing to cases where "there is no appropriately licensed alternative", or where off-label prescribing would "better serve the patient's needs".

The council had proposed allowing doctors to prescribe unlicensed or off-label medicines if they judged that the drug was "as safe and as effective as an appropriately licensed alternative".

But while 70 per cent of people responding to a consultation on the matter supported easing the rules, the MHRA and the Association of the British Pharmaceutical Industry (ABPI) opposed the changes.

Following their concerns, the GMC sought legal advice that confirmed that unlicensed medicines could only be prescribed where there was a "special need" under EU law. The directive does not mention off-label products, meaning the situation for them is less clear.

The GMC has reverted to its existing guidance on prescribing unlicensed medicines for now and is seeking legal advice on off-label medicines.

Responding to the GMC's decision, Neal Patel from the RPS said: "In choosing an unlicensed product, prescribers will need to take particular care to ensure that, despite the unlicensed status, the treatment is still the treatment of choice and in the best interest of the patient."