Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, pursuant to the contribution of the Parliamentary Under-Secretary of State for Business, Innovation and Skills in the debate on the Second Reading of the Off-patent Drugs Bill on 7 November 2014, Official Report, column 1124, what the evidential basis was of his statement that the resorting to legislation to demand regulatory measures carries the risk of some serious and unintended consequences.

The law currently allows medicines to be prescribed outside their licensed indications or without a licence provided that this best meets the individual clinical need of the patient concerned. The Off Patent Drugs Bill risks creating a presumption that a licence must be in place for every indication for which a medicine is to be used, removing the flexibility clinicians currently have to prescribe the medicine which best meets their patients clinical needs whatever it licensing status. This would create uncertainty for patients and clinicians and could disrupt important areas of care. For example, many medicines have historically not been licensed for use in children.

My Rt. hon Friend, the Secretary of State for Health, is responsible for the United Kingdom medicines licensing system and therefore for its operation and integrity. If he became a regular applicant for licences there would be a perceived conflict of interest between his role as an applicant competing in the medicines market and his role as an impartial overseer of the system. If he directed another body to make licence applications on his behalf we judge that this could incur similar risks.