Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the adequacy of the National Institute for Health and Care Excellence's preparedness for quickly assessing new medicines licensed through the Medicines and Healthcare products Regulatory Agency's international recognition framework that will be in place from 1 January 2024.

The new international recognition framework will allow the Medicines and Healthcare products Regulatory Agency (MHRA) to make the most of the expertise and decision-making of trusted regulatory partners to streamline assessments of specific products. As a result, cutting-edge medicines that have been approved in other countries will be licensed in the United Kingdom more quickly. The MHRA will continue to closely engage with key stakeholder groups in the development of their International Recognition Framework.

The National Institute for Health and Care Excellence (NICE) is committed to publishing guidance on new medicines close to the point of licensing wherever possible, and works closely with the MHRA to ensure that its appraisal timelines are aligned with the regulatory process. In 2022/23, NICE piloted a proportionate approach to health technology evaluation to drive rapid patient access to effective new medicines by optimising use of its appraisal capacity. NICE recommended five treatments through this proportionate approach, benefitting around 175,000 patients. For these topics, the appraisal process was completed 45% faster.

The Government is working with NICE and MHRA to consider the need for further changes to ensure that it is able to issue timely guidance.