Written question asked by Tom Clarke (Labour) on Thursday, 11 December 2014, in the House of Commons. It was due for an answer on Monday, 15 December 2014. It was answered by George Freeman (Conservative) on Thursday, 18 December 2014 on behalf of the Department of Health.

Drugs: Licensing

Question: To ask the Secretary of State for Health, with reference to the contribution by the Parliamentary Under-Secretary of State for Health of 7 November 2014, Official Report, column 1118, what the evidential basis is for the statement that the Off-patent Drugs Bill will impede the uptake of innovative medicines by making doctors feel that they should not use medicines except for their licensed indications.

Answer: Under current arrangements clinicians can prescribe for their patients the medicine which best meets their clinical needs, including medicines outside their licensed indications. The Bill proposes changes to these arrangements by introducing, for the first time, a duty to apply for a licence when a new indication for an off-patent drug becomes apparent. We are concerned this will carry a message that off-label prescribing is not allowed without a licence and thus end the current flexibility that allows clinicians to make their patients’ needs their first concern.

Secondary information