Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what provision the National Cancer Plan will make for orphan drug pathways for patients with rare cancers requiring personalised treatment plans; and how those pathways will differ from existing commissioning arrangements.

On 4 February 2026, NHS England and the Department published a National Cancer Plan for England. The National Cancer Plan is part of our work to build a National Health Service that is fit for the future and will make England a world-leader for cancer survival.

The orphan drug designation is assessed by the Medicines and Healthcare products Regulatory Agency and is granted at the same time as the marketing authorisation. It provides a period of market exclusivity during which similar competitor medicines cannot enter the United Kingdom market. The orphan drug regulations are designed to support the development of medicines to treat rare diseases including rare cancers.

All new licensed medicines, including orphan medicines, are evaluated by the National Institute for Health and Care Excellence (NICE), which makes recommendations for the NHS on whether they represent a clinically and cost-effective use of NHS resources. NICE aims wherever possible to issue recommendations on new medicines close to the time of licensing, and the NHS in England is legally required to fund medicines recommended by NICE. NICE has a strong track record in recommending orphan medicines for use on the NHS and many thousands of patients with rare diseases have benefitted from access to new medicines as a result.

The Rare Cancers Bill, currently going through the House of Lords, places a duty on the Government to publish a review of the law related to marketing authorisation for rare cancer drugs, for instance orphan drugs for cancer, comparing the UK’s approach to other approaches internationally. Through the National Cancer Plan the Government has committed to full implement of the Rare Cancers Bill to streamline trial pathways and review regulatory barriers that prevent access to promising new treatments.