Parliament has enacted the Rare Cancers Act 2026 following Royal Assent on 5 March 2026. The Act creates a statutory review of how orphan oncology medicines are authorised, strengthens the Secretary of State’s research duties, and provides a defined route for NHS England to disclose information to support clinical trial recruitment. (hansard.parliament.uk)
Commencement is two months after Royal Assent, bringing the Act into force on 5 May 2026. The amendments to the National Health Service Act 2006 and the Health and Social Care Act 2012 extend to England and Wales, while the review of orphan cancer authorisations applies UK‑wide. (researchbriefings.files.parliament.uk)
The Act requires the Secretary of State to review the law on marketing authorisations for orphan medicinal products used in the diagnosis, prevention or treatment of cancer. The review must consider approaches in other countries, and a report of conclusions must be published and laid before Parliament within three years of 5 March 2026. (bills.parliament.uk)
Key definitions are placed on a statutory footing. A “rare cancer” is one affecting not more than 1 in 2,000 people in the United Kingdom. “Orphan medicinal product” follows the criteria in regulation 50G(2) of the Human Medicines Regulations 2012, while “marketing authorisation” has the meaning given in section 9 of the Medicines and Medical Devices Act 2021. (researchbriefings.files.parliament.uk)
The Secretary of State’s research duty in section 1E of the NHS Act 2006 is expanded to include research into rare cancers. In discharging that duty, the Secretary of State must ensure appropriate arrangements exist to identify and contact potential participants for clinical trials and must appoint a National Specialty Lead for Rare Cancers with a remit to advise on study design and to facilitate collaboration. (researchbriefings.files.parliament.uk)
Section 261 of the Health and Social Care Act 2012 is amended to allow NHS England to disclose information for the purpose of facilitating relevant clinical trials, by enabling potential participants to be identified and contacted. The provision covers trials conducted in or outside the UK and is limited to research and development of orphan medicinal products for rare cancers as defined in the Act. (researchbriefings.files.parliament.uk)
Safeguards are explicit. The new disclosure power does not authorise processing that would contravene data protection law, and the terms “data protection legislation” and “processing” are to be read as in section 3 of the Data Protection Act 2018. Compliance with UK GDPR and the 2018 Act therefore remains a pre‑condition for any data flow under the Act. (researchbriefings.files.parliament.uk)
Operational delivery is expected to build on existing national services. The explanatory material indicates government intends a bespoke contact registry for rare cancers and notes that ‘Be Part of Research’ could be developed to support this function; separately, DHSC has signalled that the NHS App will enable participation in clinical trials as part of the National Cancer Plan. (researchbriefings.files.parliament.uk)
Analysis: For clinicians, the immediate effect from May is a clearer route for NHS England or approved research teams to identify and approach potentially eligible patients for studies involving orphan oncology products, within standard confidentiality and information‑governance controls. Providers should ensure diagnostic coding and pathology reporting reliably capture the markers commonly used in trial eligibility criteria.
Analysis: For research sponsors and universities, a trial must fall within the Act’s definition of “relevant clinical trials” to rely on the disclosure power. Protocols, consent materials and data‑protection impact assessments will need to set out the legal bases for contact, the handling of enquiries, and the interface with NHS England’s processes. Patient organisations may wish to prepare explanatory materials so individuals understand how and why they may be contacted about rare cancer studies.