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ABPI slams GMC unlicensed medicines proposal

Manufacturers have hit out at proposals from doctors to use medicines off-label when licensed alternatives exist, warning it would put patients at risk.

Although unlicensed medicines were sometimes "in the best interests" of patients, use must be strictly limited to avoid patients "being exposed to avoidable risk", manufacturer body the Association of the British Pharmaceutical Industry (ABPI) said in response to a General Medical Council (GMC) consultation.

The news follows recommendations by the GMC that doctors could use unlicensed medicines "on the basis of authoritative clinical guidance, that it is safe and effective as an appropriately licensed alternative".

However, the ABPI slammed the proposals as a "watering down of protection currently offered to patients", which would disrupt clinical policy and reduce patient involvement in decision making. Research and development of new medicines and innovation would also be put at risk by the proposals, the ABPI added.

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