Debate contribution: Rare Cancers Bill: Legislative Consent Motion

Debate contribution by Mr Mike Nesbitt on 30 June 2025.

MLA

Mr Mike Nesbitt

Party at the time

Ulster Unionist Party

Date

30 June 2025

Type

Debate contribution (made as a minister)

Business

Executive Committee Business

Heading

Rare Cancers Bill: Legislative Consent Motion

Assembly identifier

Official Report component 5043620

Read the official Assembly record

Text

I beg to move

Thank you very much, Mr Deputy Speaker. I very much welcome the opportunity to debate the motion. It seeks Assembly endorsement in principle to the extension to Northern Ireland of clause 1 of the Rare Cancers Bill. The Bill was introduced in the House of Commons on 16 October last by Dr Scott Arthur of the Labour Party. It is a private Member's Bill, the aim of which is to:

"Make provision to incentivise research and investment into the treatment of rare types of cancer; and for connected purposes."

If passed, the Bill will introduce three measures, all of which are intended to encourage more research. They are, first, the placing of a duty on the Secretary of State for Health and Social Care in England to promote and facilitate research into rare cancers. That will include the appointment of a national specialty lead for rare cancers in the National Institute of Health and Care Research (NIHR). The second measure is to improve patient recruitment into clinical trials for rare cancers through greater data sharing. The third measure is to place a requirement on the Government to review UK-wide law on marketing authorisations or product licences for:

"orphan medicinal products for the diagnosis, prevention or treatment of cancer".

Rare cancers themselves are types of cancer that affect relatively small numbers. The definition of a rare cancer can vary. The Rare Cancers Bill, however, defines a rare cancer as a type of cancer:

"that affects not more than 1 in 2000 people in the United Kingdom."

In addition, there are also many different types of rare cancers. They include blood cancers, cancers affecting the female reproductive organs or the digestive system, head and neck cancers, and cancers that affect soft tissues, which are known as sarcomas. Orphan drugs are medications that are used to treat rare conditions. They are known as "orphan" because pharmaceutical companies may be unwilling to invest in research and development into new treatments for diseases that affect only a very small number of people. With smaller patient populations, there is an increased logistical challenge in bringing patients together to undertake clinical trials, which are necessary in order to bring a product to market. Even if companies succeed in running a clinical trial, and a drug proves to be an effective treatment, manufacturers then face the challenge of selling a drug developed at great expense to such a small market. Ultimately, those companies exist to return a profit for their shareholders, and, given a choice between investment and potential treatment for a rare cancer or a more common one, too often it is rare cancer patients who lose out. To help encourage more research and development, Governments around the world offer incentives for the development of orphan medicines, such as the provision of a period of market exclusivity, during which a competitor's medicines of a similar nature cannot enter the market. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) can grant a period of up to 10 years' market exclusivity where the criteria for orphan designation has been met. Clause 1 of the Rare Cancers Bill, as introduced, places a duty on the Secretary of State for Health and Social Care in England to carry out a review of the UK law related to marketing authorisations for:

"orphan medicinal products that are for the diagnosis, prevention or treatment of cancer",

as set out in the Human Medicines Regulations 2012. The review will aim to examine how the current law can be reformed to better incentivise pharmaceutical companies to invest in clinical trials for rare cancers. Such a review will also need to compare regulatory approaches in other countries with the UK's approach, which will be done by assessing international regulatory approaches to orphan medicinal products, with a view to assessing whether the regulations in the UK are considered effective at encouraging research and development into treatments for rare cancers. The clause also requires that the conclusions of such a review must then be prepared and published in a report and that the report has to be:

"published before the end of the period of three years beginning with the day on which this Act is passed",

should the Bill become law.

In addition, it is important to emphasise at this point that any proposed amendments to the Human Medicines Regulations 2012 as a consequence of any review that may be conducted by the Secretary of State for Health and Social Care would remain, as provided for under the Medicines and Medical Devices Act 2021, subject to joint consultation and progression on a joint UK-wide basis, with any amending legislation being subject to the draft affirmative procedure in both Houses of Parliament and in the Northern Ireland Assembly.

With regard to stakeholder views, I understand that cancer charities that focus on rare cancers have expressed their full support for the Bill and have encouraged people to write to their MPs to ask that they support it in Parliament. Those charities include Brain Tumour Research and Pancreatic Cancer UK. Although I seek legislative consent only for clause 1, which deals with the review and report on orphan medicines, I assure Members that I am committed to working with counterparts across the rest of the United Kingdom to support and encourage research into rare cancers and that my Department, along with the Public Health Agency, has the necessary infrastructure in place to ensure that there will continue to be equitable access to research relating to rare cancer trials for patients living in Northern Ireland. That is achieved through the identification of studies through Northern Ireland Cancer Trials Network's participation in UK and all-island research networks, with relevant details being provided to relevant clinicians in Northern Ireland cancer centres. The Northern Ireland Cancer Trials Network provides support to any clinician wishing to open a trial site in Northern Ireland. Patients are also advised of the opportunity to sign up to be part of research, which allows them to search for and be notified about relevant trials for their condition. The Rare Cancers Bill passed its Second Reading in the House of Commons on 14 March, with early July provisionally earmarked for Committee Stage consideration of the Bill in the Commons. At their meeting on 29 May 2025, the Executive agreed to progress the legislative consent procedure in the Northern Ireland Assembly for clause 1 of the Rare Cancers Bill in respect of:

"orphan medicinal products that are for the diagnosis, prevention or treatment of cancer."

A legislative consent memorandum was subsequently laid with the Business Office on 3 June. I am pleased to inform Members that the Health Committee also considered the Rare Cancers Bill at its meeting on 12 June. At that meeting, the Committee confirmed its support for the legislative consent memorandum that had been laid in the Business Office with the intention of progressing with the motion in the Assembly today. Indeed, the Health Committee has reported its support for the motion in its written report. It is, therefore, with the Health Committee's support that I have brought the motion before the Assembly. I ask Members to support the motion.

1,198 words. Text as published by the Northern Ireland Assembly.

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