Debate contribution: The draft Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024
Debate contribution by Mr Timothy Gaston on .
- MLA
- Mr Timothy Gaston
- Party at the time
- Traditional Unionist Voice
- 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 4891024
Read the official Assembly record
Text
I have great reservations about the regulations. I say that because, having read the summary of consultation responses, I believe that profoundly serious issues about the regulations have been raised. Question 22 of the consultation asked:
"Do you agree with the proposal to remove the requirement to include listings of serious adverse events and serious adverse reactions in annual safety reports and instead include an appropriate discussion of signals/risks associated with the use of the medicinal product as well as proposed mitigation actions?"
There were 1,214 responses, of which 380 — 31·3% — agreed; 660, which equates to 54·4%, disagreed; and 173 had no opinion. The main concern of individuals and organisations was that the removal of the listings would reduce transparency and introduce a deviation from international standards. Question 17 of the consultation asked:
"Do you agree that legislation should enable flexibility on consent provisions where the trial is considered to have lower risk?"
While the majority of the 1,181 responses agreed, a significant minority of 379 or just over 32% did not. I noted that many raised concerns that, with flexible consent provisions, participants might be unaware of what is being investigated and of the available options. That runs contrary to some of the comments that Mr McGuigan made on behalf of the Health Committee. There were many requests for clear guidance and definitions to ensure clarity about what would be required and the different consent options available. Some contended that the guidance should be developed with suitable patient and public involvement to provide flexibility while continuing to provide assurance on safety. Since COVID, many people have rightly started to question what they are told by the Health Department and by those throughout government. In Northern Ireland, we had an Executive led by a First Minister who operated under the mantra of "Do as I say, not as I do". We operated under a lockdown philosophy that has left a generation scarred by a mental health pandemic. Yes, medicines play a vital role in the health of our society, but government should never again step over the line and try to force a medicine on people through coercive tactics. I trust that we have learned many lessons from how we dealt with the COVID pandemic. I would be obliged if the Minister could address in his summing-up the matters that I have raised on the consultation.
, Mr Deputy Speaker.
402 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: 0.10 (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 (0.91).
- No identity-based framing was identified (0.97).
- 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 | 0.04 | No |
| Sectarian or communal antagonism | 0.05 | No |
| Cultural grievance politics | 0.02 | No |
| Dog-whistle messaging | 0.10 | No |
| Controversy escalation | 0.16 | No |
| Legitimate policy scrutiny | 0.91 | Yes |
| Overall judgement | 0.10 | At or below not-flagging threshold |
| Option | Probability |
|---|---|
| No identity-based framing (chosen) | 0.97 |
| Reports or questions it | 0.00 |
| Criticises or condemns it | 0.00 |
| Adopts it | 0.03 |
| Subject | Probability |
|---|---|
| No identity-related subject | 0.81 |
| Disability (including neurodivergence and mental health), disabled people and disability or sickness benefits | 0.16 |
| Gender, sexuality, abortion and related social issues | 0.02 |
| Another identity-related subject | 0.01 |
| Flags, emblems, symbols, names and memorials | 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.
Disagree with this assessment?
Classifications can be challenged. A person reads every challenge, and any change is recorded publicly above with its reason.