AQO 2611/22-27 Oral question to the Minister of Health

To ask the Minister of Health to outline any action he is taking to ensure patients in Northern Ireland are afforded the same access to clinical trials as patients in other parts of the UK.

Asked by Stewart Dickson MLA on 16 October 2025

  • Answered
  • Oral
  • Answered in the Chamber
Tabled
16 October 2025
Answer due by
3 November 2025
Answered
3 November 202518 days after tabling
Department
Department of Health
Priority question
No

Answer

Answered in the Assembly Chamber on 3 November 2025. Extract from the Official Report (Hansard), including any supplementary questions:

Mr Nesbitt

The Department of Health facilitates access for patients to clinical trials through the work of the Health and Social Care (HSC) research and development division in the Public Health Agency (PHA). The division oversees participation in UK-wide clinical governance and trial approval processes. In addition, it funds core research infrastructure, which, in turn, supports access to clinical trials. That includes the Northern Ireland Clinical Research Network, a cancer trials network, a clinical trials unit, a clinical research facility and research offices in each of the trusts. Approximately 80% of clinical trials taking place in Northern Ireland also have research sites in other UK nations. However, I recognise that many clinical trials open only in a small number of sites around the UK and seek to recruit only a limited number of patients who have very specific characteristics. Therefore, not all trials will open in Northern Ireland or, indeed, in any other part of the United Kingdom.

Mr Dickson

Thank you very much. Minister, how is your Department working with relevant stakeholders, such as universities, and the trusts to make Northern Ireland an attractive partner for UK-wide and international trials? Why has the Department brought about a great deal of confusion regarding EU rules, which, we were told, were blocking trials, with correspondence from you, Minister, last week saying that that was all wrong, there were no EU blockages and trials should be able to proceed? In reality, Minister, the blockage is in the Belfast Health and Social Care Trust.

Mr Nesbitt

To be fair to the Belfast Trust, the Department of Health and our arm's-length bodies (ALBs) rely, on such occasions, on the advice of a UK-wide body, which is the Medicines and Healthcare products Regulatory Agency (MHRA). It originally gave an opinion that we had to conform to specific EU regulations — the EU in vitro diagnostic regulatory conditions — and that therefore we could not proceed with the trial. It now appears that MHRA has reviewed its analysis, and we are good to go as long as we have the right governance structures locally through the Belfast Trust. That was unfortunate, because it has led to a delay, but I do not think that it has led to any patient safety concerns. At the Patrick Johnston facility on the Queen's site in Belfast City Hospital, I have seen in action the ball that goes down the throat to look for Barrett's oesophagus. It is magnificent. It is so quick, it is cost-effective and it delivers better outcomes, so it is a matter of regret that we have had that one-year delay. On how we tap into the rest of the UK, I was at the launch recently at the Ulster Hospital of the Northern Ireland commercial research delivery centre. That is a clinical trial centre. It is brand new, and it will link us in to a UK network. That is really good news, because we have clinicians who are incredibly passionate about clinical trials and Northern Ireland is of a size that is almost perfect for clinical trials. When we do them, we do them really well. I happen to think that we are missing a bit of a trick by not becoming global leaders or, certainly, UK-wide leaders in the field.

Mr Brooks

On the back of the Member's question, when will patients have access to those trials? For clarity, reiterating what the Member asked, can we be sure that the EU regulations will not be a barrier in future to patients accessing such trials?

Mr Nesbitt

I can be specific only about the clinical trials regarding that ball that goes down on a string for Barrett's oesophagus. The MHRA is now saying that the EU regulations do not apply, so we can go ahead. We cannot start it immediately, because we must make sure that we have the right governance arrangements in place in the Belfast Trust. I would like to think that they will now proceed at pace, because we should all be slightly embarrassed, although it was not our fault but that of the MHRA across the water. At that, it was a one-year delay that was unnecessary. Let us show the public that we will make up lost ground on that. On the application of other EU regulations for developments in health and social care, I can give the Member no assurance. He knows my view: we came out of Europe without thinking through the consequences, and, sadly, some of the consequences impact on health and social care delivery.

Mr Chambers

I was pleased to learn recently that good progress has been made on the cancer research strategy, and I think that publication is imminent. How important was it to give the research organisations and individuals locally that further time to feed into the draft plan and allow them to work in partnership with the Department?

Mr Nesbitt

I will respond to the Member in a couple of ways. There is no point in having what, we think, is a solid strategy if it does not have buy-in from stakeholders. As well as the need for buy-in, we have to be sure that, if we are going to have a strategy, we will be able to follow it up not just with an implementation plan but with one that is fully costed and deliverable. The Member will know that I pointed to the cancer strategy, rather than the cancer research strategy, and the mental health strategy as two gold-plated 10-year strategies that we cannot afford to implement in full. The feedback that we got some months ago was that some key stakeholders were not buying into the document as it was written up then, so it was important that we stepped back, re-engaged with them, listened to them and reacted positively. We have done that to the best of our ability, and I believe that all the key stakeholders are now relatively satisfied. They are not absolutely delighted: who would be? You cannot expect everybody to be delighted with a strategy. However, I believe that we have got to a place where we can have confidence that we are doing the right thing by the people whom we are trying to serve: the patients and service users for whom we are trying to deliver better outcomes.

Official sources