Debate contribution: The draft Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024
Debate contribution by Mr Danny Donnelly on .
- MLA
- Mr Danny Donnelly
- Party at the time
- Alliance Party
- Date
- 7 April 2025
- Type
- Debate contribution
- Business
- Executive Committee Business
- Heading
- The draft Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024
- Assembly identifier
- Official Report component 4891022
Read the official Assembly record
Text
I welcome the opportunity to speak on the motion. Like other members of the Health Committee, I was briefed previously on the matter. The regulations form a critical part of a framework that governs how medicines are authorised, manufactured, distributed and made available to patients in Northern Ireland. While the regulations are technical in nature, their implications are far-reaching, affecting not just clinicians but manufacturers, patients, carers and everyone who relies on timely access to safe and effective treatment. As the Minister outlined, there are advantages to patients, the health service and wider society. As a healthcare professional, I understand the essential role that clinical trials play not only in driving innovation but in giving real patients in our communities early access to potentially life-changing treatments. In recent years, the UK has seen a sharp decline in trial activity. Between 2017 and 2021, the number of industry-led clinical trials dropped by 41%. Over that same period, patient recruitment fell by 44%. Those are not abstract figures. They represent lost opportunities, patients who waited longer for new treatments, researchers who were bogged down in bureaucracy and a system that, frankly, needs to move faster to meet modern challenges. This legislation aims to do just that. It introduces a more proportionate and streamlined process, particularly for low-risk trials, without compromising on what matters most: patient safety and ethical standards. To put it in context, the median time to start a clinical trial in the UK is 186 days. In Germany, it is 92 days, and in France, it is 141 days. We are simply not competitive, and, in a post-Brexit landscape where collaboration is crucial, we cannot afford to fall behind. The amendments will help us cut out unnecessary delays, support our researchers and accelerate innovation. I highlight the importance of maintaining open channels of cooperation between the MHRA, the Department of Health in Northern Ireland and our local health bodies. In the post-Brexit context, Northern Ireland finds itself in a unique regulatory position due to the Windsor framework, with elements of EU medicines law continuing to apply here. While that dual alignment can present challenges, it can also offer opportunities, particularly in ensuring continued access to EU- and UK-authorised products. However, that will work only if we have clarity, consistency and a genuine commitment to ensure that Northern Ireland is not left behind in availability or innovation. Northern Ireland has the talent and the infrastructure to lead in this space. Our life and health sciences sector contributes £1·9 billion to our local economy, with over 250 companies exporting to more than 145 countries. Queen's University, Ulster University and our health trusts have played key roles in international research, but, to grow that, we need a regulatory environment that enables ambition. The changes will help to make Northern Ireland an attractive, reliable place to conduct world-class trials, with benefits not just for our economy but for patients across the region. Let us not forget that clinical trials are not about future treatments; they are part of our healthcare system today. Industry research contributes £7·4 billion to the UK economy and supports more than 65,000 jobs. Patients in trials often receive earlier access to new medicines, and trials can ease pressure on the health service by offering alternative pathways for care and treatment. The amendment represents progress: a clear and necessary modernisation of how we regulate clinical trials that will make it faster and easier to run safe, effective and ethical studies. It puts transparency and public trust at the heart of clinical research, and it gives Northern Ireland the tools to be a leader in health sciences, discovery and patient care. I support the regulations, and I urge all Members to do the same.
622 words. Text as published by the Northern Ireland Assembly.
Assessment
Jev’s structured answers met the documented threshold for “not flagged”.
- Overall probability that the activity is being used to promote, exploit or escalate an identity-based controversy: 0.02 (flagging needs at least 0.70; at or below 0.30 is not flagged).
- None of the five culture-war criteria was met (each was below 0.60).
- Assessed as legitimate policy scrutiny (0.87).
- No identity-based framing was identified (1.00).
- Subject area: Constitutional question, Brexit, the Windsor Framework and sovereignty.
- The overall probability was at or below the not-flagging threshold.
This is an AI-generated assessment of the text, made against published criteria. It is not a finding of fact about the MLA or their intentions. The Assembly record itself is the fact.
Jev’s structured answers
| Question | Probability | Met? |
|---|---|---|
| Identity framing | 0.02 | No |
| Sectarian or communal antagonism | 0.01 | No |
| Cultural grievance politics | 0.01 | No |
| Dog-whistle messaging | 0.01 | No |
| Controversy escalation | 0.02 | No |
| Legitimate policy scrutiny | 0.87 | Yes |
| Overall judgement | 0.02 | At or below not-flagging threshold |
| Option | Probability |
|---|---|
| No identity-based framing (chosen) | 1.00 |
| Reports or questions it | 0.00 |
| Criticises or condemns it | 0.00 |
| Adopts it | 0.00 |
| Subject | Probability |
|---|---|
| Constitutional question, Brexit, the Windsor Framework and sovereignty | 0.76 |
| No identity-related subject | 0.24 |
| Flags, emblems, symbols, names and memorials | 0.00 |
| Parades, bonfires and commemorations | 0.00 |
| Irish language, Ulster-Scots and language policy | 0.00 |
Assessed 21 October 2026 at 12:20 UTC by jev-1.13.0 (requested as typesafe/jev) under rubric 2026.10-r9, methodology 1.9.
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