Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what his policy is on compassionate use programmes that allow the use of an unauthorised medicine.

In the United Kingdom, there are currently arrangements in place for unlicensed medicines to be provided that are either manufactured in the UK or imported into the UK under a notification scheme. The national provisions are set out in the Human Medicines Regulations 2012 (Statutory Instrument 2012/1916). Sponsor companies may set up compassionate use programmes under the direction of a prescribing physician for specific patients.

Where an unmet need has been identified, the Early Access to Medicines Scheme run by the Medicines and Healthcare products Regulatory Agency also provides opportunity for supply of medicines awaiting a licence. These are to be prescribed under the responsibility of the treating physician, supported by a published scientific opinion that has been considered by the Commission on Human Medicines.