Parliament has enacted the Rare Cancers Act 2026 following Royal Assent on 5 March 2026. The legislation is designed to incentivise research and investment in treatments for rare cancers by mandating a review of the authorisation regime for orphan oncology medicines, strengthening the statutory research duty in the National Health Service Act 2006, and creating a targeted NHS England power to disclose information for clinical trial recruitment with clear data protection safeguards.
Section 1 requires the Secretary of State to review the law on marketing authorisations for orphan medicinal products used for the diagnosis, prevention or treatment of cancer. The review must consider regulatory approaches in other countries, and its conclusions must be published and laid before Parliament within three years of Royal Assent, by 5 March 2029. The Act cross‑refers to section 9 of the Medicines and Medical Devices Act 2021 for “marketing authorisation”, to regulation 2 of the Human Medicines Regulations 2012 for “medicinal product”, and to regulation 50G(2) of those Regulations for the “orphan” criteria.
Through amendments to section 1E of the National Health Service Act 2006, the Secretary of State’s general duty to facilitate or promote research expressly covers cancers that, in the Secretary of State’s opinion, are rare. In discharging that duty the Secretary of State must ensure appropriate arrangements exist to identify and contact potential participants in clinical trials and must ensure the appointment of a National Specialty Lead for Rare Cancers with responsibilities to advise on research design and planning and to facilitate collaboration.
The Act introduces a statutory threshold for “rare cancer” in these contexts as a cancer affecting not more than 1 in 2,000 people in the United Kingdom. This establishes a clear prevalence measure for scoping eligible studies and for configuring recruitment processes under the amended section 1E of the 2006 Act.
Section 3 amends section 261 of the Health and Social Care Act 2012 to add a new permitted purpose for disclosure of information obtained in connection with NHS England’s information systems. Disclosure is now authorised where it facilitates the carrying out of relevant clinical trials by enabling potential participants to be identified and contacted. New subsection 261(5A) defines “relevant clinical trials” as those connected to the research and development of orphan medicinal products for cancers that, in NHS England’s opinion, are rare, and confirms that this includes trials conducted outside the United Kingdom.
New subsections 261(6A) and (6B) make clear that the information‑processing power does not authorise any processing that would contravene the data protection legislation. The definitions of “data protection legislation” and “processing” adopt those in section 3 of the Data Protection Act 2018. The statutory gateway therefore operates alongside existing requirements, meaning controllers remain bound by purpose limitation, data minimisation and security obligations when using the power.
The Act uses two institutional opinions to anchor scope: for research facilitation under section 1E of the 2006 Act, the Secretary of State determines whether a cancer is rare; for the data‑sharing gateway under section 261 of the 2012 Act, NHS England does so. Each provision applies the same prevalence threshold of not more than 1 in 2,000 people across the United Kingdom.
Extent provisions specify that the amendments to the National Health Service Act 2006 and to the Health and Social Care Act 2012 apply in England and Wales. The remainder of the Rare Cancers Act 2026, including the Secretary of State’s review duty, extends to England and Wales, Scotland and Northern Ireland.
Commencement is fixed by the Act as the end of the period of two months beginning with 5 March 2026. The operative provisions therefore take effect on 5 May 2026, at which point NHS England may rely on the new disclosure gateway and the strengthened research duty and appointment requirement on the Secretary of State take legal effect.
For NHS England and research system partners, the legislation drives configuration of information systems and recruitment processes so that potential participants can be lawfully identified and contacted for qualifying trials. Controllers can expect to update transparency materials and data protection impact assessments where relevant, and to record the basis on which a cancer is assessed as rare in line with the statutory threshold.
For sponsors and clinical research networks, the establishment of a National Specialty Lead for Rare Cancers provides a defined source of advice on study design and a point of coordination among interested parties. The time‑bound review of marketing authorisations mandated by section 1 places the wider regulatory framework for orphan oncology products under formal scrutiny, with conclusions due by 5 March 2029.