Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, pursuant to the contribution of 6 November 2015 by the Minister for Community and Social Care, Official Report, column 1307, what the evidential basis is for his statement that the provisions of the Off-patent Drugs Bill would be potentially harmful.

The current legal framework allows a clinician to prescribe drugs outside their licensed indication where that will best meet the clinical needs of their patient. This clinical freedom is crucial in delivering appropriate healthcare to groups of patients for whom medicines have not historically been licensed, e.g. children. It is also helpful in enabling prescribers to quickly pick up and apply new evidence that will help patients with particular clinical needs. The Off-Patent Drugs Bill would introduce a legal duty to apply for a licence for off-patent drugs where evidence of effectiveness for a new indication becomes available. This will create an expectation that only licensed uses of drugs are acceptable and therefore that off-label use is not appropriate. This would cause unnecessary delays in patients getting the medicines they need by slowing the rapid uptake of new evidence in clinical practice. This is why we believe the proposed legislation could potentially be harmful.