Debate contribution: Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024
Debate contribution by Mr Mike Nesbitt on .
- MLA
- Mr Mike Nesbitt
- Party at the time
- Ulster Unionist Party
- Date
- 13 January 2025
- Type
- Debate contribution (made as a minister)
- Business
- Executive Committee Business
- Heading
- Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024
- Assembly identifier
- Official Report component 4738032
Read the official Assembly record
Text
Madam Principal Deputy Speaker, thank you. I will be finished before 2.00 pm. I thank the Chair of the Committee and the others who have spoken for their broader support for what we are achieving. I want to address two specifics. I will take them in reverse order. Mr Carroll mentioned a constituent of his. I have not seen his communication yet, but, as a more general point, as there are no medicines currently being manufactured under modular manufacturing or point of care, I do not see how there is any impact on the patient whom he has referenced and their care. His point goes beyond what we are discussing today. I am more than happy to look at the potential removal of a medicine, which, if I heard him correctly, is being carried out on the grounds of expense. Mrs Dodds talked about alignment with the European Union. It is my understanding that this legislation achieves the same aim for decentralised manufacture as that of the European Union's proposal in its future pharmaceutical reforms, which is to ensure that current standards of safety, quality and efficacy are maintained while, at the same time, delivering the framework that enables innovative manufacturing across multiple decentralised sites. I emphasise, again, that it is UK-wide legislation. While the Windsor framework resolves concerns around the long-term risk to Northern Ireland medicine supply expressed by the pharmaceutical industry through the disapplication of the EU falsified medicines directive and a move to UK-wide licensing of medicines, it is true that other aspects of EU law relating to the manufacture of medicines continue to apply here in Northern Ireland. That includes directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Therefore, we will, of course, keep a close eye on developments from within the EU. I firmly believe that the introduction of these legislative changes to enable the introduction of a new tailored regulatory framework to support point-of-care and modular manufacturing is a very, very positive step. Instead of placing additional burdens on the health service, some patients will be able to be treated with novel medicines manufactured in their home, aligning with the concept of moving care from hospitals to communities — the shift left that you often hear me discuss. We could see a greater number of hospitals being able to use new medicines, safe in the knowledge that they comply with a regulatory framework that is appropriate to innovative manufacturing methods, and which maintains patient safety. In short, the regulations support wider access to life-saving, innovative medicines. They make an enabling change that caters for new ways of manufacture and supply and has the flexibility for future technological developments. They are a vital step forward in making sure that regulation not only supports but actively encourages innovation.
475 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 (0.93).
- 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 | 0.02 | No |
| Cultural grievance politics | 0.01 | No |
| Dog-whistle messaging | 0.02 | No |
| Controversy escalation | 0.02 | No |
| Legitimate policy scrutiny | 0.93 | 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 | 0.55 |
| No identity-related subject | 0.45 |
| 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 11:42 UTC by jev-1.13.0 (requested as typesafe/jev) under rubric 2026.10-r9, methodology 1.9.
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