GMC postpones plans for unlicensed drug prescribing

30th May 2012

The UK General Medical Council (GMC) has postponed plans, which were put out for consultation last year, which would allow doctors to prescribe cheaper off-label or unlicensed alternatives to licensed medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Association of the British Pharmaceutical Industry (ABPI) opposed the proposals. Legal advice, on the European Union (EU) directive on medicinal products for human use, confirmed that unlicensed medicines could be prescribed only where there was a special need, and that this could not be taken to encompass unlicensed medicines for patients with rare conditions if there were a licensed alternative or circumstances in which commissioning bodies did not support the funding of a licensed alternative. As a result, the GMC has agreed to revert to their existing guidance on prescribing unlicensed medicines, although they are still exploring the issue as the EU directive does not specifically address prescribing drugs outside the terms of their licence.

click here to view