Debate contribution: The draft Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024
Debate contribution by Mr Mike Nesbitt on .
- MLA
- Mr Mike Nesbitt
- Party at the time
- Ulster Unionist Party
- Date
- 7 April 2025
- Type
- Debate contribution (made as a minister)
- Business
- Executive Committee Business
- Heading
- The draft Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024
- Assembly identifier
- Official Report component 4891009
Read the official Assembly record
Text
I beg to move
Thank you, Mr Deputy Speaker. I am seeking the Assembly's approval for the making of the draft statutory instrument (SI), which will amend the Medicines for Human Use (Clinical Trials) Regulations 2004. The aim is to improve and strengthen the UK's clinical trials legislation, with the aim of helping to make the UK the best place to research and develop safe and innovative medicines following the UK's exit from the European Union. I am grateful to have been given the opportunity to debate the regulations today. They represent the most substantial reform of UK clinical trial regulations in over two decades. Clinical trials are vital for developing safe, effective medicines, especially for those with limited treatment options, such as the estimated three million people who are living with cancer in the United Kingdom and the 17·5 million people who are managing long-term conditions. To support innovation, our clinical trial regulations need to be flexible and proportionate. This legislation will do just that by delivering streamlined and efficient regulations, removing barriers to innovation and creating a patient-focused research environment. The reforms will support the development of new, life-changing treatments for those in need and strengthen the UK's position as a global leader in clinical trials. I now turn to why the change is necessary and, indeed, timely. The current legislation no longer aligns with the rapid advancements in medicine and technology. We have the opportunity to create a world-class regulatory environment for clinical trials and deliver a modernised framework that supports the safe development of innovative treatments. To that end, I will outline the key aspects of the reforms. The first is risk-proportionate regulation. Regulatory requirements will align with the risk level of a clinical trial. Low-risk trials will receive faster approval through automatic authorisation without compromising patient safety. The second is future-proofing. We have removed duplicative and granular legal requirements in favour of tailored guidance, ensuring flexibility for future innovations and moving beyond a one-size-fits-all approach. The third is international alignment. The UK will remain aligned to global standards, ensuring that trial data is recognised internationally and strengthening our position as a preferred site for multinational clinical trials. The fourth is the cementing of the UK as a destination for international trials. Streamlined processes will simplify applications and deliver globally competitive approval timelines. Finally, there will be increased transparency. We want to ensure that trusted information about clinical trials is publicly available. That will be for the benefit of all. New legal requirements will be introduced to register a clinical trial and publish a summary of results, including an easy to read summary for participants.
Those changes will build public trust in research by improving access to information about ongoing research, thus enabling informed decisions to be made.
The reforms will also bring benefits to Health and Social Care (HSC) and the wider National Health Service. Evidence shows that hospitals that undertake research have better patient outcomes and improved staff retention. Improved efficiency in conducting clinical trials will enhance research efforts and foster innovation, prevention, diagnosis and treatment across various conditions. Those conducting clinical trials will also benefit from a streamlined and risk-proportionate regulatory framework, thus reducing delays and administrative burdens. The reforms will stimulate growth in the UK's life sciences sector and position the UK as a global hub for clinical trials. I re-emphasise that participant safety remains paramount. While the legislation streamlines processes and removes some barriers to innovation, it prioritises robust oversight of clinical trials, ensuring that the safety of trial participants is never compromised. I am pleased to confirm that the Health Committee initially considered the policy intent of the SI at its meeting of 13 February of this year and again on 6 March, when it confirmed that it was content with clarification given by officials that the distinction drawn in the amending SI between the EU Commission directive 2003/94 in respect of Great Britain and the EU Commission delegated regulation 2017/1569 in respect of Northern Ireland would have no differential impact on clinical trials here. The Health Committee subsequently indicated at its meeting on 6 March that it was content that the draft SI be laid with the Northern Ireland Assembly Business Office to allow for today's debate. It is with the Committee's support, therefore, that I bring the SI before the wider Assembly and its Members. I commend the motion to the Assembly.
734 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 (0.75).
- No identity-based framing was identified (1.00).
- 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 | 0.02 | No |
| Controversy escalation | 0.02 | No |
| Legitimate policy scrutiny | 0.75 | 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 |
|---|---|
| No identity-related subject | 0.61 |
| Constitutional question, Brexit, the Windsor Framework and sovereignty | 0.38 |
| Disability (including neurodivergence and mental health), disabled people and disability or sickness benefits | 0.01 |
| Flags, emblems, symbols, names and memorials | 0.00 |
| Parades, bonfires and commemorations | 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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