Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the review of orphan medicines regulation required by the Rare Cancers Act 2026 will consider the full pathway from regulatory authorisation to NHS patient access, including evidence generation, health technology assessment and uptake of treatments for rare cancers.

The review required by the Rare Cancers Act 2026 will focus on the regulatory framework for orphan medicines used in the diagnosis, prevention and treatment of rare cancers. It will consider international regulatory approaches and assess whether the United Kingdom's regulatory framework is effective in encouraging research and development of treatments for rare cancers. We will set out further details in the usual way in due course.