Written question asked by Baroness Finlay of Llandaff (Crossbench) on Wednesday, 13 April 2016, in the House of Lords. It was due for an answer on Wednesday, 27 April 2016. It was answered by Lord Prior of Brampton (Conservative) on Tuesday, 26 April 2016 on behalf of the Department of Health.

NHS: Drugs

Question: To ask Her Majesty’s Government whether the database created by the Access to Medical Treatments (Innovation) Act 2016 is intended to supersede the Medicines and Healthcare products Regulatory Agency’s hierarchy for the use of unlicensed medicines.

Answer: The database will not supersede the Medicines and Healthcare products Regulatory Agency’s (MHRA) guidance on the hierarchy for the use of unlicensed medicines, which is set out in the MHRA’s ‘Guidance Note 14’. The Access to Medical Treatments (Innovation) Act 2016 seeks to facilitate access to innovative medical treatments including the off-label use of medicines and the use of unlicensed medicines, such as in schemes like the Early Access to Medicines Scheme (EAMS). The Act provides for the establishment of a database of innovative medical treatments, which doctors can access to search for innovative treatments in schemes like the EAMS, including unlicensed or off-label medicines for which there is evidence that a patient might benefit. Where appropriate they can also search for clinical trials that are underway and discuss their findings with their patients to establish if they would benefit from being part of a clinical trial. There will be a full consultation on the database in due course.

Secondary information

Type: Written question
Reference: HL7600
Session: 2015-16
Attachment: MHRA Guidance Note 14
Subjects: Databases Licensing Drugs NHS Medicines and Healthcare products Regulatory Agency
Legislation: Access to Medical Treatments (Innovation) Act 2016
Link: View this Written question on www.parliament.uk