Official Report: Minutes of Evidence

The Chairperson (Mr McGuigan): I welcome from the Department of Health Karen Simpson, head of the medicines legislation unit, and Sean Curley, principal pharmaceutical officer. From the Public Health Agency (PHA), I welcome Rhonda Campbell, assistant director of Health and Social Care (HSC) research and development. You are all welcome. If you will make some brief opening remarks, that would be great.

Ms Karen Simpson (Department of Health): Thank you for the opportunity to brief the Committee today on the Rare Cancers Bill and the Department's plans to progress with a legislative consent motion (LCM), insofar as provisions contained in clause 1 of the Bill as introduced deal with the transferred matter of the regulation of medicines.

As you and Committee members will be aware, Chair, the Rare Cancers Bill was introduced in the House of Commons in Westminster on 16 October 2024 by Dr Scott Arthur of the Labour Party. The aim of the Bill is:

If passed, the Bill will introduce three measures that are intended to encourage more research. They are, first, placing a duty on the Secretary of State for Health and Social Care in England to promote and facilitate research into rare cancers, which will include the appointment of a national speciality lead for rare cancers; secondly, improving patient recruitment into clinical trials for rare cancers through greater data sharing; and, thirdly, requiring the Government to review UK-wide law on marketing authorisations — product licences — for orphan medicinal products that diagnose, prevent or treat cancer.

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

There are many types of rare cancer, including blood cancers, cancers affecting the female reproductive organs or digestive system, head and neck cancers and cancers that affect soft tissues, which are known as sarcomas.

Orphan drugs are medicines that are used to treat rare conditions. They are known as "orphan" because pharmaceutical companies may be unwilling to invest in research and development for new treatments for diseases that affect only very small numbers of people. To help encourage more research and development, Governments offer incentives for the development of orphan medicines.

Clause 1(1)(a) of the Rare Cancers Bill places a duty on the Secretary of State for Health and Social Care to:

as set out in the Human Medicines Regulations 2012 —

Such a review must also consider regulatory approaches in other countries and compare the UK's approach by assessing international regulatory approaches for 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 conclusions of such a review must then be prepared and published in a report, and that report has to be published before the end of the period of three years, beginning on the day on which the Bill 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 a review that may be conducted by the Secretary of State for Health and Social Care will remain, as provided for under the powers of the Medicines and Medical Devices Act 2021, to be consulted on and made jointly on a UK-wide basis and be subject to the draft affirmative procedure in both Houses of Parliament and in the Northern Ireland Assembly.

On stakeholder views, cancer charities that focus on rare cancers have expressed support for the Bill and encouraged people to write to their MP to express their support for it in Parliament. Those include Brain Tumour Research and Pancreatic Cancer UK.

Although we are primarily concerned about the progression of a legislative consent motion for clause 1 of the Rare Cancers Bill as it relates to orphan medicines, the Committee can be assured that the Department, along with the Public Health Agency, has the necessary infrastructure in place to ensure that there is equitable access to research on rare cancer trials for patients living in Northern Ireland. That is achieved through the identification of studies through the participation of the Northern Ireland Cancer Trials Network (NICTN) in UK and all-island research networks, details of which are then provided to relevant clinicians in Northern Ireland cancer centres. The Northern Ireland Cancer Trials Network provides support to any clinician who wishes 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.

I can advise that the Rare Cancers Bill passed its Second Reading in the House of Commons on 14 March 2025, with early July now likely for Committee Stage consideration of the Bill in the House of Commons.

At the Executive meeting that was held on 29 May, the Executive agreed to the progress of the legislative consent procedure in the Northern Ireland Assembly for clause 1 of the Rare Cancers Bill as it relates to orphan medicinal products for the diagnosis, prevention or treatment of cancer. The legislative consent memorandum was subsequently laid in the Business Office on 3 June and an Assembly debate has now been provisionally scheduled for 30 June 2025.

We are happy to take questions.

The Chairperson (Mr McGuigan): Thank you very much. In his correspondence with the Committee, the Minister highlights the lack of secondary use of data in regulations present in the Bill. Over time, I have engaged with cancer charities, and I met the Cancer Registry. It and others have raised concerns about the wider use of secondary data in cancer research. Can you tell us about the impact of that in the Bill and, specifically, beyond it? Why are the regulations currently not in place? Is there any intention to progress them or a timeline for doing so?

Ms Simpson: The regulations sit outside the Bill —

The Chairperson (Mr McGuigan): They do.

Ms Simpson: — but I am aware that there is to be an amending Bill to be taken forward on the Health and Social Care (Control of Data Processing) Act (Northern Ireland) 2016, which will then specify the regulations. The secondary-use regulations will then be developed after that. As to the timeline, I know that the Minister has prioritised the amending Bill for this Assembly mandate. It was hoped that it would be introduced before the summer recess. I checked again today, however, and I am not sure whether that will happen. It will depend on timelines, but I imagine that that amending Bill will be introduced in early September to make amendments to the 2016 Act.

The Chairperson (Mr McGuigan): That would be good, because it is an important issue.

Ms Simpson: It is an issue for research. We recognise what you say about data and secondary use, so we want to prioritise that.

Mr Donnelly: Staffing, reporting and data infrastructure obligations will be placed on the Department of Health here. Will there be any additional funding from Westminster for that?

Ms Simpson: The review report will be taken forward by the Department of Health and Social Care (DHSC). We will receive the outworkings of it, but there will be no cost to us. It will be a report. If there are any amendments to be made to the Human Medicines Regulations 2012, my team will take them forward and come to the Committee with them. I think that the cost, from looking at the assessment, was £140,000 for DHSC, but there are no costs for the Department of Health.

Mr Donnelly: Thank you.

The Chairperson (Mr McGuigan): No other members have questions. Thank you very much.

Ms Simpson: You are welcome.