UKPGA-2026-8 — Rare Cancers Act 2026

preamble

Be it enacted by the King’s most Excellent Majesty, by and with the advice and consent of the Lords Spiritual and Temporal, and Commons, in this present Parliament assembled, and by the authority of the same, as follows:—

s. 1 — Review of law on marketing authorisations

s. 1(1)

The Secretary of State must—

s. 1(1)(a)

carry out a review of the law relating to marketing authorisations for orphan medicinal products that are for the diagnosis, prevention or treatment of cancer, and

s. 1(1)(b)

prepare and publish a report setting out the conclusions of the review.

s. 1(2)

In carrying out the review the Secretary of State must, in particular, consider regulatory approaches in other countries.

s. 1(3)

The report must be published before the end of the period of three years beginning with the day on which this Act is passed.

s. 1(4)

The Secretary of State must lay a copy of the report before Parliament.

s. 1(5)

In this section— “Human Medicines Regulations” means the Human Medicines Regulations 2012 (S.I. 2012/1916); “marketing authorisation” has the meaning given by section 9 of the Medicines and Medical Devices Act 2021; “medicinal product” has the meaning given by regulation 2 of the Human Medicines Regulations; “orphan medicinal product” means a medicinal product in relation to which the orphan criteria set out in regulation 50G(2) of the Human Medicines Regulations are met.

s. 2 — Secretary of State’s duties as to research

In section 1E of the National Health Service Act 2006 (Secretary of State’s duty to facilitate research etc)—

s. 2(a)

the existing text becomes subsection (1);

s. 2(b)

after that subsection insert—

s. 3 — Disclosure of information for research purposes

s. 3(1)

Section 261 of the Health and Social Care Act 2012 (power of NHS England to disclose information obtained in connection with information systems) is amended as follows.

s. 3(2)

In subsection (5), after paragraph (d) insert— .

s. 3(3)

After subsection (5) insert—

s. 3(4)

After subsection (6) insert—

s. 4 — Extent

s. 4(1)

Sections 2 and 3 extend to England and Wales only.

s. 4(2)

The remainder of this Act extends to England and Wales, Scotland and Northern Ireland.

s. 5 — Commencement

This Act comes into force at the end of the period of two months beginning with the day on which it is passed.

s. 6 — Short title

This Act may be cited as the Rare Cancers Act 2026.