What representations has the Welsh Government made to the UK Government concerning the Rare Cancers Act 2026 statutory duty to undertake an orphan drugs review?
Prior to the Bill receiving Royal Assent in March 2026, Welsh Government officials held discussions with Department of Health counterparts regarding its potential implications. These discussions supported coordination and alignment across the UK in relation to the objectives set out in the Rare Cancers Bill - now the Rare Cancer Act 2026.
The Rare Cancers Act 2026 places a statutory duty on the UK Secretary of State to undertake a review of the law relating to marketing authorisations for orphan medicinal products that are for the diagnosis, prevention or treatment of cancer.
Powers regarding the grant of marketing authorisations for medicinal products are reserved by the UK Government and medicines licensing is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA).
Welsh Government officials meet regularly with the MHRA to discuss a range of issues, including progress on the review being undertaken by the MHRA in response to the requirements of the Rare Cancers Act.