Rare Cancers Act 2026 in Scotland
2026 c. 8 · Enacted 5 March 2026 · Extends to United Kingdom
An Act to make provision to incentivise research and investment into the treatment of rare types of cancer; and for connected purposes.
[5th March 2026]
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:—
Contents
1Review of law on marketing authorisationsI1
The Secretary of State must—
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
prepare and publish a report setting out the conclusions of the review.
In carrying out the review the Secretary of State must, in particular, consider regulatory approaches in other countries.
The report must be published before the end of the period of three years beginning with the day on which this Act is passed.
The Secretary of State must lay a copy of the report before Parliament.
In this section—
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“Human Medicines Regulations” means the Human Medicines Regulations 2012 (S.I. 2012/1916);
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“marketing authorisation” has the meaning given by section 9 of the Medicines and Medical Devices Act 2021;
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“medicinal product” has the meaning given by regulation 2 of the Human Medicines Regulations;
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“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.
4ExtentI1
Sections 2 and 3 extend to England and Wales only.
The remainder of this Act extends to England and Wales, Scotland and Northern Ireland.
5CommencementI1
This Act comes into force at the end of the period of two months beginning with the day on which it is passed.
6Short titleI1
This Act may be cited as the Rare Cancers Act 2026.