Therapeutic Products Act Repeal Bill

Members, the House is in committee on the Therapeutic Products Act Repeal Bill. We come first to Part 1. Part 1 is the debate on clauses 3 to 6, “Repeal of the Therapeutic Products Act 2023 and related matters”. The question is that Part 1 stand part.

Thank you, Madam Chair. I want to start off by asking the Associate Minister of Health some of the broader questions, and I’m looking specifically in the context of clause 3 when we’re looking at the Therapeutic Products Act 2023.

Now, although this clause might seem quite simple, the ramifications of it on an Act with hundreds of pages and over 400 clauses is quite substantial, so this particular clause can’t be taken lightly. I guess my first question to the Minister is: what is the alternative? Why bring this bill to the House without a fully fleshed alternative already in the works? That is my first question. Thank you.

Thank you, Madam Chair. We have a series of questions, and it’s probably quite congruent with a bill like this that we perhaps make them a bit more sort of quick-fire questions and give the Associate Minister of Health the chance to answer in bulk.

I agree with the question that’s just been asked, and I suppose, on the back of that, I’d also like to know how does that abbreviated pathway address the complexities of regulating medical devices that currently lack suitable oversight such as surgical mesh, and pacemakers would be another good example of that.

We know that with the Therapeutic Products Act (TPA) that is being repealed, there’s been several mentions this afternoon about it coming into effect in September 2026, but, of course, before that was to happen—that was the runway, wasn’t it?—there was a huge amount of consultation and work in regards to that secondary legislation and those regulations. What is the Minister planning in that sphere to give us the requisite confidence, I suppose, if we’re just thinking about medical devices as an example? As a first question, how can she address those complexities?

Also, I’m wondering, can the Minister provide some sort of time line for the implementation, and explain how the delay that will inevitably happen? Again, we’ve heard comment that it doesn’t matter because the TPA wasn’t going to come into effect until 2026, but if you think you’re starting over again and you’re still not going to have to go through that secondary process, then that doesn’t make sense. Can the Minister provide a time line for what will be ultimately implementation, and explain how the delay could impact confidence in regard to that reform? Thank you.

Thank you, Madam Chair. Similar sort of question, but a different line, and that is around that sense of urgency—why the Associate Minister of Health believes that, when it comes to clause 3 of this part, it is important to do so despite the fact that there is an existing runway in place. That’s the first part.

In the second reading contributions, there were a number of comments about one example, and that’s surgical mesh. How does the Minister intend that, as colleagues have touched on, any new pathways that may exist—how will issues, like concerns around surgical mesh and others—I accept that there are other considerations there, but I just want to touch on that one for the time being. As a result of this legislation, as I understand it, there will then be a void in terms of any oversight over issues that relate to surgical mesh. How does the Minister intend that this part of the bill seeks to address or mitigate those concerns that certainly have been raised by constituents and others? I’m sure that some colleagues who may be watching from home will be interested in that as well.

I thank the members for their questions and the valid concerns about why—repeal versus amendment has been raised a few times. I think it’s important to recognise that across the House we recognise this is a big piece of work.

What I want to assure the members is that this is not throwing the baby out with the bathwater. We are very much aware that there is a lot of value in what has been done and that there’s a lot of knowledge and gain through that consultation process. The purpose of the repeal is so that we aren’t working towards a piece of work—that we are going to spend a lot of money, a lot of time, as has been mentioned, developing the secondary legislation. We really needed to clarify the position and that was the separation out of natural health products from the medicines and medical devices components. The pathway forward, as I said in my second reading speech, is the development of the medical products bill, and we have a lot of information and learnings.

One of the big discussion points we had was the concerns—and I think it came through with the select committee; there was a lot of concern—about the over-regulation, that we have significant issues like what has occurred with surgical mesh, and that we weren’t having a risk-proportionate approach in this regulatory framework that would allow us to differentiate high-risk products. That, I think, came through from the select committee responses about the over-regulation. The need to act at pace to repeal was so that we weren’t continuing with a piece of work.

I think the other thing is “Why not amend?” We broadly recognised across the House that we have talked a lot about the complexity of this legislation and the importance of getting it right. I don’t think you want to come to a piece of work that is as significant as this legislation and you have done a whole lot of amendments and repeals to the existing legislation before it’s come into place. I think it’s important that we recognise that this is about allowing us to reset the programme of work, and the repeal allows us to do that reset and keep moving forward.

There has been a lot of concerns about the surgical mesh issue, and I recognise and I give absolute total respect to those brave women who fought so hard to have this issue recognised and concerned. The controls and systems that were in place around surgical mesh, the pause on the use of surgical mesh, and the ongoing development of guidelines are continuing. There is nothing about this repeal that will change those controls and protections that are in place currently. The assurance is that we have a complete recognition of the importance to not undo anything on any of those safeguards that are currently in place.

I think the programme of work from now in, in terms of the time line—I’d love to give you a fixed time line at this point, but the repeal is the first stage. The intention is that now we will be developing the replacement legislation, but also working on the secondary legislation at the same time. I think you heard a lot in the process—there was a lot of concern that there was primary legislation without secondary legislation in place and there were a lot of unknowns. We want to make sure that there’s some balance in this process as we develop, as we move forward.

I think the recognition across the House and the expertise is that we all know how important this is to get it right. We all know how important it is, this programme of work, but we also had to recognise that the legislation, as it was, was creating a much bigger regulator and need because we had incorporated natural health products into that development of a solution. It was about how we differentiate that. I hope that’s answered some of those questions.

Thank you, Madam Chair. I thank you, the Associate Minister of Health, for your explanation, which has helped me shape up my question and partially—partially—answered it or given me some guidance, because I wanted to reflect on my colleague Lawrence Xu-Nan’s question earlier. I understand the Minister wants to sweep things clean back to 1981 and then start again. I’m really wanting a little bit more detail about what that legislation might look like, because surely there has been some thought put into it.

What I’m really interested in is what proposals, in more detail, does the Minister have for delivering a modern regulatory regime? I’m not seeking the general approach—I’d like to hear some detail because—[Interruption]

CHAIRPERSON (Barbara Kuriger): Can we just have quiet to my right-hand side, please? I’m listening very carefully and I can hear some of the points are being made. I think the questions around the pathway to the Minister are fair, but there’s no expectation that the Minister should be able to explain—it’s a repeal process. There’s no onus on the Minister to explain the next piece of legislation that’s coming—just to clarify that.

SCOTT WILLIS: I do understand that this is a repeal, but what we are hoping for—and what we had expected to see—was that there had been some thought into not just breaking but also making. What we’ve seen from this Government is a case of vandalism over the past year, breaking and repealing legislation. This may not have been the most perfect legislation, but we haven’t seen anything positive. Creation is a difficult thing, and this is what we’ve got.

We’ve heard from members opposite that this bill took a long time, an accusation that it was very slow in the process—15 years. The irony here is that it is being slowed down—a modern regulatory regime is being slowed down—even further by a repeal. That’s the irony of what we’re facing here. The Government is accusing the previous Government of taking a long time and now is doing even worse. Why not spend some time to do it right? I’m really seeking some greater clarity from the Minister. Thank you.

Well, thank you, Madam Chair. I listened to that explanation from the Associate Minister of Health the Hon Casey Costello and I do have further questions around this.

The option they have chosen is to repeal. We hear that the Government recognises the need to have something to replace this. We are being told that there has been some thinking that has been done around that, that maybe a lot of the work that has gone into it may not be wasted and that some of it can inform that work that they’re doing, but when I was listening to that contribution—given that this wasn’t going to come into effect until 2026—I don’t understand why we are having to rush through this repeal under urgency just before Christmas. If the Government had plenty of time before it actually came into effect, it could have done that through the work that the Minister said was being done and come back with amendments to this legislation, and not in fact just have a repeal and start with a clean slate, and so on.

I want the Minister to explain why it is so necessary to rush this through urgency when it wasn’t going to come into effect until 2026 and you know that further work has to be done and the Government knows that it could have addressed those issues with amendments. The question is: why is this being rushed through now?

I thank the member Willow-Jean Prime for her questions, and I note, as a former associate health Minister, she will appreciate the complexity of developing this legislation and that it wasn’t that we had a piece of legislation that was going to appear in 2026 and we had time to work on it. As we’ve heard, there was a huge amount of secondary legislation to develop, there were the IT systems and information systems that needed to be developed to deliver the product. Therefore, if we had continued work on that piece of legislation, then we would have been committing a whole lot of resource that wouldn’t necessarily be done. It’s important to get some really clear frameworks around what needed to be done.

I think, in terms of the member from the Green Party who was questioning about the future state or what it looks like, we need to get back to the point that there is a lot of work to be done on that future state, but this is about repealing this existing legislation. I think that one of the things the select committee heard and recognised was that there were a lot of issues to be dealt with; there wasn’t a huge amount of support for the legislation as it was. Rather than floundering around for an extended period of time with uncertainty, it was really important to demonstrate to the sector a clear path forward: that we weren’t going to be continuing with this piece of legislation; we were going to carve out natural health products.

Those decisions needed to be made to make some clear direction, both for the officials developing the legislation and for all of the external expertise that we will need to bring in to make sure this legislation is truly fit for purpose and delivering exactly what all members across the House want, which is a robust and futureproofed delivery of medicines and medical products to New Zealanders.

I move, That debate on this question now close.

Dr Lawrence Xu-Nan’s been on his feet for a little bit, or trying to, so I’m going to let him have a question. The Minister’s been very forthcoming in answering the whys around this Part 1, so please make it very succinct.

Thank you, Madam Chair. I would have other members know that I always reference the clause number, and I’m always on the correct part.

CHAIRPERSON (Barbara Kuriger): That’s why I took your call!

Dr LAWRENCE XU-NAN: Thank you so much, Madam Chair. I think the reason we’re asking a few questions around clause 3 is because there is no information, there is no departmental report whatsoever on this, and it is very clear in the departmental disclosure statement that no work has been done around identifying the issues around this particular repeal. I want to just ask a follow-on question to how the Minister responded to clause 3 before. I want to move on to clauses 5 and 6, but also, in particular, to the Minister’s Amendment Paper, which hasn’t gone through select committee, and this is Amendment Paper 239.

On clause 3, one of the things that the Minister said is that we are looking at a reset. I appreciate what the Minister is saying in terms of what will happen, but I want to check with the Minister again, in lieu of a departmental report or any sort of regulatory impact statement or supplementary analysis: what about the work that’s been done already? Does the Minister know how much work has been done in terms of secondary legislation or consultation before we repeal this bill? Again, there’s no information on this. This just provides some certainties to some of the submitters, who also reflected on the time, money, and effort already spent on the process of introducing the Therapeutic Products Act.

Also, if the Minister wouldn’t mind clarifying: if there was work that was being done on this, has the work stopped since the Minister came in to become the Associate Minister of Health, or has that work stopped when this bill went through first reading or has been introduced to the House? Again, that is significant, I think, for the public to realise whether that has been something that has stopped so people didn’t waste their time working on consultation, etc., over the last year—last 14 months, to be exact.

In terms of clauses 5 and 6—again, still on Part 1—we are looking at amendments to the Food Act. I want to just check the Minister’s clarity in terms of her Amendment Paper 239 and the new addition of section 420(3), inserted by clause 6, and new clauses 6A and 6B—particularly, I’m interested in clause 6B and the fact that we’re looking at dietary requirements, with supplements not being a part of this, or being excluded from some of these. I just wanted to ask, in light of some of the reasoned examples I mentioned, particularly with the Ministry for Primary Industries’ investigation into AG1 and other natural health product issues, whether she will have confidence that this isn’t going to put people at harm, because it’s now being excluded from some of the food standards that we have. Thank you.

I thank the member Lawrence Xu-Nan for his questions and his concerns about the future state and recognise that there is important information, but I think for the purpose of this discussion, we need to be focusing on the repeal bill. In terms of when work stopped, if you bear in mind the legislation was passed about three months before the election, work stopped as soon as that commitment to repeal was put in place. We were able to work and develop concepts and theories around the future state, but beyond that detail, it’s sort of beyond what we’re discussing here in the bill.

I think I’d like to just highlight first, before I go into the amendment—it was just to talk about how we’ve had a lot of discussion about going back to the medicines legislation and we talk about the 1981 legislation. We have to recognise that, since 1981, there has been quite a significant amount of amendments and there will continue to be amendments as we work through this process to ensure—we touched on the nurse practitioners, and so work is continuing around how we create more efficiencies within the existing legislation. We’re not sitting dormant, not doing anything about how we can gain efficiencies and improve health systems in the meantime.

I think it’s worth noting that we’re not talking about going back to anything; we are continuing with the legislation that we’re currently operating under. We’re not reverting; we’re not changing. I think, when you talk about the departmental statements and the impacts, there is no impact, because we’re not avoiding anything. They weren’t in place; therefore, there is no impact, because the existing framework continues and will continue through this process. We’re not changing anything significantly. Impact has to be considered on that basis.

I will take some time just to talk about the amendment because I can appreciate that, walking into it relatively fresh, it’s just a bit of an anomaly around the legislation. The Amendment Paper lays the groundwork for improvements to the regulation of dietary supplements. The effect of the Amendment Paper will be to move the Dietary Supplements Regulations 1985 from the repealed Food Act 1981 and, instead, deem them as being made under the modern Food Act 2014. While this may sound like a merely procedural change, it will bring some immediate benefits to dietary supplement exporters.

Following the lift and shift of the Dietary Supplements Regulations, exporters will be able to apply for exemptions from New Zealand labelling and composition requirements. This will enable them to better compete in international markets. At the moment, our exporters are competing with other countries’ products at a disadvantage. Other countries can make and label their products according to the laws of the importing countries. Our manufacturers must follow New Zealand rules, even if they are incompatible with overseas laws. Industry has long advocated for exemptions for exported products. We have a chance to help exporters today, and that is the reason we’re bringing it through today, because this is an opportunity to, as you’ve mentioned, do something sooner.

While the Therapeutic Products Act (TPA) would have included provisions for exported dietary supplements, it would have also imposed overly complex regulations for these products. Making this change by amendment to the TPA Repeal Bill shows that the Government is continuing to listen to industry and is delivering on its commitment to double exports within 10 years. The lift and shift of the Dietary Supplements Regulations is only the first in a series of reforms to the export of dietary supplements, and in the longer term, other natural products, and we’re working on those solutions moving forward.

Madam Chair?

CHAIRPERSON (Barbara Kuriger): I understand the member’s just put an Amendment Paper.

TANGI UTIKERE: I have, but not relevant to Part 1; it’s to the commencement. I’ll talk to that.

CHAIRPERSON (Barbara Kuriger): Yes, thank you.

TANGI UTIKERE: Thank you, Madam Chair. I want to speak to clause 3. This is very important because there are still a number of questions that I understand members on this side of the committee have, and it’s important for us to work through those. The reason for that is that what clause 3 does is it repeals, basically, all the work that is currently in place at the moment, being undertaken, under the existing Act that this particular bill seeks to repeal. I know it’s one sentence, clause 3, but the implications of this—this is really where it all comes down to it—is going to, basically, can all of the work that has been put in place.

I’ve got questions around Māori approaches to rongoā. I’ve got other questions around other forms of device. I’ve got challenges around natural health. They are all things that currently are in play as a result of the legislation that is in place right here, right now. What this bill is seeking to do is to not just put it on hold; it’s, basically, seeking to can it entirely. My questions for the Minister are around what mitigation can she give for the various things that I wish to touch on to, I guess, mitigate the concerns that we may or may not have about whether we think clause 3 should be enacted or not.

This is about whether the bill is going to be repealed or not. The first one I want to touch on—and I accept that surgical mesh has been referred to—really is around the significant risks that are associated with many of these medical devices outside of surgical mesh, and what immediate measures the Minister intends to put in place. What I heard from the Minister, I think, was that there is a piece of work that will be ongoing. She cannot give a definitive time frame for that suite of works that’s going to be undertaken or given. What I think she, hopefully, is able to provide the committee with is some mitigation that these concerns that are in place, right here, right now—and that’s the reason why the principal Act has been put into place to sort of, I guess, ameliorate some of those concerns.

What is the Minister seeking to do to ensure that the risks associated with unregulated medical devices—not regulated ones, because that’s subject to a whole new process or framework—that those that might want to engage, if they’re able to, with that type of device would right here, right now understand that there was a framework in place that would provide some certainty for them? If this bill is repealed, that certainty goes, so what is the Minister’s response to address the concerns for those out there that might have concerns in this space? What are this Minister’s plans to, I guess, allay some of those concerns?

The other is around the regulatory approach to these devices. Where do we sit compared with other global or international best practices? Is the Minister concerned that, by repealing this legislation, we would be better or we would be worse or there is no difference in terms of how we might be seen in a global sense, our international reputation, which is very important to this Parliament—indeed, I don’t speak for the Government, but it could be for them—how these changes or this proposed change would place us compared with other parts of the world?

I thank the member for his question and recognise that the repeal doesn’t change anything around medical products and devices that currently exist at the moment.

The legislation, as we’ve said, wasn’t in place, so there were no additional controls that were in place. The repeal doesn’t change the state of things, and, in fact, from the feedback we’ve received, and, I think, from the select committee, the risk of over-regulating and not having risk-proportionate legislation would actually have made things harder for medical products, particularly in an advancing technology environment where we need to be able to be nimble and recognise and approve products quicker. There is no impact, on that basis.

In terms of international relationships, as I understand, I think at the moment, and I think it would have been recognised as this legislation was developed, that in terms of New Zealand’s approach around medical devices, we were a bit of an outlier in terms of the other countries’ approaches to controls around medical devices and medical products, which is why we’re pushing forward with this legislation.

I move, That debate on this question now close.

The question is that the Minister’s amendments to Part 1 set out on Amendment Paper 239 be agreed to.