To ask Her Majesty's Government what assessment they have made of whether the ability of NHS doctors to provide the most clinically appropriate treatment to patients is being constrained by rules imposed by the General Medical Council, which are interpreted by doctors to limit them to using drugs within the scope of EU marketing authorisations and therefore may prevent doctors from exercising their clinical judgment to provide off-label and unlicensed medicines to NHS patients when it is clinically appropriate to do so.
Answered on
21 December 2017
Clinicians can prescribe any treatment, including an unlicensed product or a product not licensed for a particular indication, which they consider to be the best available to meet the individual clinical needs of their patient, subject to their primary care organisation agreeing to fund the treatment.
Decisions about prescribing rest with the general practitioner or other prescriber who has clinical responsibility for that particular aspect of a patient’s care. Prescribing is informed by a range of factors, including any national or local prescribing guidelines but, ultimately, the decision on what to prescribe is made by the prescriber themselves, using their own clinical judgement.
The General Medical Council publishes advice to doctors on the standards expected of them through Good Medical Practice (GMP). This guidance includes good practice in prescribing and managing medicines and devices. On the subject of unlicensed medicines, the GMP states:
‘You should usually prescribe licensed medicines in accordance with the terms of their licence. However, you may prescribe unlicensed medicines where, on the basis of an assessment of the individual patient, you conclude, for medical reasons, that it is necessary to do so to meet the specific needs of the patient.’
All doctors must be familiar with and follow GMP and the explanatory guidance. Serious or persistent failure to follow this guidance could lead to fitness to practise procedures.