GPs are generally cautious about their use of medicines, but there is no getting round prescribing off-label from time to time. One in 10 of the drugs GPs prescribe to children is outside its licensed indication, the standard migraine drug amitriptyline doesn't have a licence for that purpose and prescribing of SSRIs off-label is recommended by NICE.
Sticking to licensed indications can be expensive, too – ranibizumab, licensed for age-related macular degeneration, costs £5,180 a year per patient, whereas bevacizumab, licensed for cancer treatment but with a similar molecular structure, costs just £420 a year.
So the GMC's attempt to change its guidance on off-label prescribing, to allow it whenever there was evidence a drug was as safe and effective as the licensed alternative, sounded like common sense from an organisation not always known for it. Current GMC guidance only allows a drug to be prescribed off-label where demonstrably better for the patient than the alternative.
The proposed change would have legitimised GPs' current prescribing behaviour, resolved the ridiculous situation where GPs could be in breach of GMC rules for following NICE guidance, and opened up a new avenue for reducing costs without harming patient care. At least, that was the view of most of those responding to the GMC consultation – 70% of whom supported the change. But it was not the view of the MHRA, with its remit for patient safety, and was most emphatically not the view of the Association of the British Pharmaceutical Industry.
We reveal this week that the GMC, in the face of opposition from two key constituencies and advice suggesting its plan could have been illegal under EU law, has pulled the plug on the change. What is more, it is taking advice on whether its existing guidance could also be in breach of EU law, which might preclude any off-label prescribing where a licensed alternative exists. The GMC reserves the right to ‘revise our guidance, when we have resolved the legal questions'.
The idea that standard GP prescribing practice could be overturned at a stroke because of the objection of the pharmaceutical industry and the ambiguities of EU law is extremely worrying. But in neither case would it be unprecedented. The Department of Health is already consulting at length with the pharmaceutical industry over how to bring new drugs online more quickly, with CCGs to be held to account for their speed at implementing NICE appraisals. And the EU too has been allowed huge sway over NHS policy, preventing EU doctors from being tested by the GMC, and at one point threatening the legality of prescribing incentive schemes.
The GMC had a clear view that relaxing rules on off-label prescribing would make them more practical for GPs and cheaper for the NHS – but no less safe for patients.
If it believes that, it must not simply accept its legal advice and bow to the EU – it must lobby the Government hard to clarify legislation and clear a route forward. And it must be confident that when it raises the issue with ministers, it gets at least as much of an ear as the pharmaceutical industry.
