Therapeutic Products Act Repeal Bill

I present a legislative statement on the Therapeutic Products Act Repeal Bill.

ASSISTANT SPEAKER (Teanau Tuiono): That legislative statement is published under the authority of the House and can be found on the Parliament website.

Hon CASEY COSTELLO: I move, That the Therapeutic Products Act Repeal Bill be now read a second time.

Today, the Government is delivering on its commitment to New Zealanders to repeal the Therapeutic Products Act (TPA). Repealing the TPA is about more than delivering on an election commitment, however; repealing the TPA means that the Government can continue its important work to prioritise timely access to quality health services. Repealing the TPA will also allow for better legislation to foster innovation within our healthcare system.

The TPA was intended to modernise the current outdated regulatory framework for medicines, medical devices, and natural health products. However, industry practitioners and consumers told Parliament at the time, and then told us, that it didn’t get the balance right. The TPA fell short of delivering simpler, more flexible regulation. The Government believes that health policy must ensure access to the right treatments at the right time, without imposing undue burdens on consumers or stifling innovation.

The TPA would have introduced unnecessary cost and regulatory hurdles, particularly for low-risk products, and it failed to enhance healthcare equity or improve public access to critical medicines, devices, or natural health products.

I’d like to thank the members of the Health Committee for their diligence in reviewing the Therapeutic Product Act Repeal Bill. I’d like to extend my gratitude to the many submitters who wrote in to the committee during public hearings on the repeal bill. Industry leaders and health practitioners told us that the TPA risked obstructing the very innovations our health system needs. For instance, requiring New Zealand market authorisation for exported medical devices and natural health products, despite their compliance with international standards, would have discouraged exports. Fees and charges on natural health products would have made products less accessible here.

Repealing the TPA addresses these concerns, ensuring that New Zealand’s health policy is both practical and forward-thinking without sacrificing the quality or safety of care. Our approach to the health system emphasises the importance of reducing regulatory barriers, to encourage local innovation and to provide access to appropriate medicines and products.

The repeal of the Therapeutic Products Act will not leave medicines unregulated. The Medicines Act 1981 will continue to apply, and the existing regulator, Medsafe, plays a vital role in ensuring medicines meet our standards for safety and effectiveness. However, the Medicines Act 1981 is out of date and does need to be replaced. While the TPA was not the solution, new legislation is required to allow New Zealanders to benefit from advancements in medical technologies without unnecessary bureaucratic delays.

I’m pleased to announce the Government will repeal and replace the Medicines Act with a new Medical Products Bill. The bill will not only ensure timely access to medicines but also support our innovators, health practitioners, and patients. It will include provisions ensuring New Zealand’s health system is resilient and able to respond to future health emergencies.

A message that came through loud and clear in submissions on the repeal bill was that natural health products should not be regulated as medicines. I agree, and, on hearing public and industry concerns, in September this year, Cabinet also agreed that natural health products will be regulated under a stand-alone bill. This bill will be developed following engagement with the natural health products sector and the public. Work on a new natural health products bill will not commence until after engaging with stakeholders, and no decisions have been taken on the scope or approach to be adopted in the bill.

On that note, one of the things the dietary supplements industry has been saying for a long time is that it needs export exemptions to be able to compete internationally. We want to address this long-term issue for New Zealand companies and make improvements to support our exporters.

The Government plans a further change to the Therapeutic Products Act Repeal Bill in the committee stage, which will move Dietary Supplements Regulations 1985 from the long-repealed Food Act 1981 to the current Food Act 2014. This is a first step that will allow for exported products to apply for exemptions from New Zealand labelling and composition requirements so that they can better compete in international markets.

As a Government, we have an ambitious goal of doubling exports in the next 10 years. Repealing the TPA now will allow better legislation to be developed that supports exporters and recognises New Zealand as a trading nation. The Therapeutic Products Act Repeal Bill delivers on our promise to New Zealanders to get rid of a law that would have created unnecessary barriers to access and innovation. Repealing the TPA also sets the stage for us to put in place a better law that gets the balance right. I commend the bill to the House.

The question is that the motion be agreed to.

Well, it was interesting to hear the remarks the Associate Minister of Health just read. They bear a lot of resemblance to the remarks I read when I introduced the Therapeutic Products Bill—as it was in the last Parliament—to the House. In many ways, it’s apparent that the goals of the Government are the same as the goals of the last Government in pursuing medicines reform, so why are we repealing the Therapeutic Products Act?

Many of the arguments the Minister just outlined are good arguments for amendment of the Therapeutic Products Act. Many of the objectives she stated are already incorporated within the Act. For example, I notice in some discussion on the Health Committee about novel precision medicine technologies like Chimeric Antigen Receptor T-cells all able to be regulated within the Therapeutic Products Act.

The ability to deal with public health emergencies is a feature of the Therapeutic Products Act that is being repealed. The ability to properly regulate medical devices is also contained within that Act, and an approach to natural health products that need not mean that they are treated as equivalent to medicines—of course they are not. The Therapeutic Products Act was always about risk-proportionate regulation, which the Minister also mentioned.

It seems to me that this repeal is for political reasons, the management of stakeholders’ expectations around how they interact with the legislation. Fine—that happens in politics—but the problem is that now we’re back to 1981 and, if this repeal goes through, back to 1981 in terms of our medicines regulation, and that is wholly inadequate. What happens if there’s a situation in the intervening period? Well, I know because, in the last Parliament, we had to deal with COVID-19 and we had a public health emergency.

A key element of dealing with COVID-19 was a vaccination programme and we had no way of expediting the approval of the COVID-19 vaccine under the Medicines Act. My first ever piece of legislation I saw through Parliament as a Minister was the retrospective amendment of the Medicines Act under urgency for one vaccine. It illustrates how absolutely useless the Medicines Act is for dealing with public health emergencies.

Now, you might think COVID isn’t happening again, but, actually, we had another problem with the public health emergency in the Medicines Act later in the last term of Parliament, and that related to monkeypox. The monkeypox vaccine was not even able to be discussed publicly, really, under the Medicines Act, because of restrictions on advertising when, I think, section 25 of the Medicines Act is being used. The Medicines Act is a wholly unsuitable piece of legislation for the rapid approval of medicines like vaccines that are needed in public health emergencies. Yet the Government is taking us back to the future.

The other problem with the Medicines Act is that it contains no framework for the regulation of medical devices. The challenge with medical devices is there are some that can cause an awful lot of harm, and that has been happening, sadly, in New Zealand within the context of our inadequate regulation. The most distressing situation we’ve seen emerge publicly is the poor regulation of surgical mesh in New Zealand and the lack of framework that we had for preventing and dealing with that, and the response that has been ad hoc as a result.

The Therapeutic Products Act was intended to be able to make sure that those sorts of things don’t happen again—and it is not. There are chances of it happening again with medical devices. I am aware of certain implantable contraceptives that have had safety concerns raised about them as well, so we need a legislative framework to make sure that these devices are able to be safe. During this repeal, it is just another way in which the New Zealand public has to wait longer for this framework to be in place.

The Government may well have a different view on components of medicines regulation, and there might be some areas where the Government and the Opposition disagree, but there is an awful lot of good that is being undone through this repeal, and it risks harm continuing. I’ve outlined some of those harms as they relate to medical devices and vaccines. I just think that those are actually real risks, and I’ve outlined three risks that emerged just in the last term of Parliament. It seems to me that this repeal leaves us without a framework, parts of a framework that we would agree on in many areas, and I think that is ultimately to the detriment of New Zealanders—it imposes significant, significant risks to people.

The next area I want to touch on is some of the innovation that the Minister referenced that is already possible through the Therapeutic Products Act. That includes the changes to prescribing rights that enable wider classes of prescribers to be able to prescribe—but, of course, within well-defined scopes. This enables us to make medicines more accessible—still safely—and make sure that when we are challenged in many ways by health workforce shortages, New Zealanders are able to go to a more diverse range of prescribers in order to access their medicines. This is already in the Act, and yet we’re going backwards to get rid of that and then waiting for a period for the Government to come back with new proposals on all of it.

I do want to reject the idea that by including natural health products, medical devices, new technologies, and medicines in the same Act, they were all regulated in the same way—of course not. Of course the Act had separate criteria for all of them; of course they had separate processes. It may very well be that the Government disagrees on how those processes should be—fine—but why get rid of the Act altogether? It seems to me that it sends us backwards, and it means that there is just nothing in place except the old dunger of the Medicines Act 1981.

This is not responsible lawmaking. We could have been spending this time debating the things the Government wants to change about the Act. I am aware the ACT Party has proposals about an expedited pathway for approvals of medicines. That seems like something Parliament should discuss because it alters how our regulator makes decisions, and that’s an interesting proposal. Instead, we’re going back to the beginning.

Not only is it that the Medicines Act is from 1981 but, when I was Minister of Health, I worked with a team at the Ministry of Health who had been working on this issue—I think some for 20 years. We have known we’ve needed to replace the Medicines Act for 20 years, and we’re just undoing all of the work that’s been done—back to the drawing board, new sets of instructions, separating everything out, throwing out the baby with the bathwater.

It is so unfortunate that this is the position that we are in. Not only is it an example of making a show of ripping up legislation so that you can go back to stakeholders and say, “That bill you had concerns about? It’s all gone. We’ll start afresh.”, but those stakeholders, in many cases, have been consulted with for over a decade. This is a public policy failure that all parties have touched in some way, actually. It is just, I think, such a loss to New Zealanders, this piece of legislation that would have made significant advances and that large components of it everyone actually agrees on. My message to the Government is: you touched it last; you’ve broken it.

Members, the time has come for me to leave the Chair. The House will resume at 2 p.m.

Sitting suspended from 12.57 p.m. to 2 p.m.

Good afternoon, everyone. We’re on the second reading of the Therapeutic Products Act Repeal Bill.

E te Māngai, thank you. The Green Party is not supportive of this bill, which we have mentioned before and other speakers have mentioned before. The main issue that we take with this repeal is that it leaves a massive void. I think it’s concerning to hear the Associate Minister of Health fall back on a 40-plus-year-old piece of legislation to justify the repeal. It’s been really clear from patient safety advocates and, actually, even people who engage in the very same products, like natural remedies, that actually had a nuanced view on this bill, to see that we’re just going to go back to the previous status quo that wasn’t really serving people.

We have had patient safety advocates raise concerns around, for example, unregulated medical devices and the harm that those were causing in our community, some of those medical devices that Ayesha Verrall mentioned, like surgical mesh, having actually created a lot of issues for many people in our communities, and having other jurisdictions that have paused the use of surgical mesh to review its use should actually raise alarm bells here that we’re kind of just leaving a void, repealing a piece of legislation and not actually addressing what I think were genuine concerns that we could’ve worked through constructively.

I don’t want to pretend, as submitters noted, that this legislation was perfect. I mean, when we had the Therapeutic Products Bill at the time—it had not become the Act—being debated in the Chamber last term, we had concerns about the fact that a lot of the issues around things like rongoā, etc., were being left to regulations and that, actually, a lot of the success in relationship to regulatory bodies relied on those regulatory bodies being adequately resourced to ensure that, actually, they were set up to succeed. Actually, when I mean “to succeed”, I also mean to work collaboratively with communities directly impacted, with the entities that actually, for example, may sell some of those products that would’ve been regulated under the Therapeutic Products Act, and to give those different bodies and groups the guarantee that their feedback was going to be taken on board.

As others have noted, the Act that we’re repealing with this bill covered, actually, quite a range of products, and each of them requires their own processes, their own regulations, their own mechanisms to keep people safe. Again, like the Medicines Act of 1981, it’s just no longer fit for purpose.

I think, for me, what’s going to be really critical to give, particularly when I think of patients, the guarantee that their concerns will be listened to will be what else will come after this repeal. I just want to make sure we don’t leave a void. I think of many people who’ve been calling for, as a response to this bill, for example, a commissioner that deals with issues around patient safety. Many who’ve been calling for that argued that we probably needed that no matter what we were doing in this space, but now that the Therapeutic Products Act is being repealed, it’s needed more than ever. I think that should also be something that the Government should look at as we progress through the repeal of the Therapeutic Products Act.

I think the other area that I wanted to take note of is that the conversation around rongoā is something that should not end, because I think one of the challenges that we had last term when we started having questions about rongoā, around how we could make sure that the Therapeutic Products Act met our Tiriti obligations, is that, actually, the Crown—and, therefore, the Government—takes active steps to make sure that we create a way in which we enable it and not restrict it, but, at the same time, that we also don’t allow the potential harmful co-option of it by non-Māori in a space that actually could allow for that.

I think that’s a really difficult nuance to walk, and without active steps taken by the Government to protect rongoā, we could end up having almost the worst of both worlds, which is, like, we don’t have the kind of middle ground that we ended up in, which I think many of us were satisfied with, and I know that for at least Te Pāti Māori and the Greens at the time, that was one of the things that we needed to have resolved, I think, between the first and second reading, if I recall correctly. We do acknowledge the previous Minister, who worked really constructively on the ground to actually have changes made to the bill in time to have that addressed, but now if we’re just going to a full repeal of the Therapeutic Products Act, we now do leave a complete void in that space.

When I also think of the select committee process—and I was actually quite taken aback by the quite short nature of the report of the Health Committee, because while the bill in front of us may be really, really short, the impact and the nature of what we are doing is actually on a much larger scale. If I reflect on the select committee report—and submitters’ voices have been really critical—I do want to acknowledge that this is one of those bills where the range of contributions varied, and even if we put aside the fact that the majority of submitters did support a repeal, many of them actually acknowledge that the previous status quo would have not been good enough. I think that’s something that the Government should take on board, because, once again, the Medicines Act 1981 is not going to be the answer. We need a much more comprehensive regulatory system to ensure that, actually, we have a good regime for medicines, for medical devices, for natural health products as well.

I think I echo the comments from Ayesha Verrall that a much better answer would’ve been to take on board the pieces that could have been changed, to put amendments to this Act rather than do a full repeal. For a Government that talks a lot about wasteful spending, I think this is one of those areas, as others have noted. We have had public servants do a lot of work and spend a lot of hours, actually—over, in fact, decades, in some cases—to think of alternatives to the Medicines Act 1981. I think that’s work that cannot just go to waste now. If we have had, actually, public servants think of “What are the alternatives to the Medicines Act 1981 that we could have?” and then we just throw this in the bin, it’s in some ways not honouring the mahi that has been done and the resources that have been put to create alternatives to the Medicines Act 1981.

This is a field that does evolve quite rapidly and, therefore, I do think requires constant legislative attention. Therefore, I think, in a place where we are seeing, actually, a strangling of access to public resources for the purposes of research, for example—I worry that we’re going to end up with the worst of both worlds.

The other area that I’m really concerned with, particularly around the status quo, is that we’re going to be moving into a space where we’re going to have a lot of unregulated medical devices at a time where our healthcare workforce is particularly constrained. I think that also creates, particularly, a really dangerous situation for patients. We have a health workforce that is really, really—

Scott Willis: It’s stretched.

RICARDO MENÉNDEZ MARCH: —stretched—thank you, Scott—and a regulatory regime that is not sufficient. We could end up with more issues around patient safety on the ground happening that will be detrimental to our communities.

Look, I think this is quite a serious issue. Independent of where people want to put the blame on the state of our healthcare workforce, it is a reality that we do have people on the ground saying there is not enough protection for patient safety. The Therapeutic Products Act was a mechanism for that. It wasn’t perfect, but we can’t ignore the fact that right now we’re heading towards a place where several medical devices will continue being unregulated, a healthcare workforce that is not being supported to do their best, and patients being left out in a really, really dangerous position.

I don’t think members of the Government should treat those concerns lightly, because they have been raised by patients themselves. In fact, patient safety advocacy groups have—

Stuart Smith: Add some value.

RICARDO MENÉNDEZ MARCH: Look, I think it’s rich for the members who take 30-second calls to talk about adding value when, actually, often they do very little other than just say, “I commend this bill to the House.” In this case, I won’t be commending this bill to the House.

Thank you, Mr Speaker. I rise to take a short—but I will take a call on this bill because it is important, the Therapeutic Products Act Repeal Bill. I want to thank the very diligent Health Committee, chaired by Mr Sam Uffindell, for their work on this and from other members across the House, including my good colleague Cameron Luxton.

The report is short, but I think it’s very succinct in what it says—224 submissions—but the key bit is that the majority supported the repeal of the Therapeutic Products Act (TPA) and acknowledged that something needed to be updated, but they didn’t consider that the Therapeutic Products Act was the right Act to repeal it. They also noted that excessive compliance costs, regulatory burdens, and the costs that would, in turn, be passed—these costs will be passed on to consumers and the health system at large. I can also tell you there will be significant delays in getting new technologies to New Zealanders if we had gone ahead with the Therapeutic Products Act.

I just want to clear up a couple of things. With the repeal of the TPA, we won’t be unregulated. Medical devices and medicines will still continue to be regulated; it will just be under the old regime. It’s also worth noting that the Therapeutic Products Act wasn’t going to come into effect until 1 September 2026—2026. This wasn’t in effect. There was plenty of time before it was going to be in effect, and it’s also plenty of time for us to modernise New Zealand’s regulatory settings. That will take the form—and I think some speakers already talked about that—of things like at 30-day approval for medicines, which is part of our coalition agreement. I look forward to that.

I also just want to reflect that taking 20 years to update the regulations and the laws in this area is part of the problem. It shouldn’t take that long. This is a very fast-moving area, and we actually need to do things much, much faster while still ensuring safety. I think that we can do that on this side of the House with what we’re going to put in place.

Then, finally, I just want to reflect on the Amendment Paper that the Minister has put on the table. This will be welcomed news to the natural product exporter sector. I’ve engaged with them extensively. Again, on this side of the House, we want to double exports out of New Zealand, and, at the moment, we have these absurd regulations where New Zealand - made, say, vitamins and other natural health products have to meet New Zealand standards, not the standards of the country they’re being exported to. Again, we look forward to, hopefully, being able to deliver some relief in that area. I commend this bill to the House.

The Therapeutic Products Act Repeal Bill is a simple bill. It’s a repeal bill. The Therapeutic Products Act hasn’t even commenced yet. The vast majority of the submissions were in favour of the repeal bill, and the Government is working to build an enduring piece of legislation. I commend this bill to the House.

Five-minute call—Francisco Hernandez.

Thank you, Mr Speaker. Thank you for allowing me to take a call on this bill. I don’t have a health-related portfolio as one of my portfolios for the Green Party, so my speech will be more low-energy than, perhaps, members on the opposite benches are used to—more low-energy.

I think it is correct that some members opposite have stated that this bill repeals an Act that hasn’t even come into effect yet, but I think it’s still important to discuss what the bill would have potentially done, and also the gap that it leaves behind. I think the Therapeutics Products Act took 15 years of development across three different Governments. I take the points of my comrades in ACT on my left here: it shouldn’t take decades to create these regulations, but it does create a framework to modernise medical regulation in New Zealand.

I think it’s particularly important to actually acknowledge that now there is a huge number of medical treatments, advances, and devices that are available on the market. The Therapeutic Products Bill had the potential to create a regulatory framework around that, because we do need—and I think this is one of the, I guess, great philosophical differences that separate the parties on the left and the parties on the right; I think it’s the role of regulation in society. I think it would be fair to say—and I think my colleagues opposite won’t object to my characterising it this way—in general, parties of the right believe in less regulation, and I think it would be fair to say that parties on the left—

Dan Bidois: Liberty and freedom!

FRANCISCO HERNANDEZ: Yes—our libertarian friends and comrades across the House, yes. For the left, we generally do see the need for regulation. That’s one of the big philosophical differences. [Interruption] Well, I mean, I think it’s an exaggeration to call the repeal of the Therapeutics Products Act “Big Brother”, but anyway.

Look, the main concern that we have is that the repeal of this legislation—I acknowledge that the Minister and Government speakers have said that there will be a plan, but they haven’t presented it as part of this proposal; this merely replaces it. We would like to see what actually does replace it. Also, the question is: who is going to be doing the work of coming up with the alternative proposals? It just seems like there’s a huge amount of effort and energy that went into doing this.

I shared the reflections that were made by my colleagues in Labour and by my colleague Riccardo Menéndez March that it was imperfect legislation, and I think the submissions that were received during the select committee stage—you know, we acknowledge that it was imperfect legislation. Surely it would be easier to do a review, or get rid of the key parts of it, rather than scrapping it and starting it again from scratch, because it just seems like we’re creating a huge amount of effort to do this.

Look, who’s going to be doing this work? I think this morning there was a report on RNZ that said there were further cuts to Health New Zealand. Are we going to be pulling front-line health workers to be doing the work to replace this bill? Is the Ministry for Regulation going to be doing the work on this? I mean, who is going to be leading the actual work to replace this bill? If it does end up being the Ministry for Regulation that ends up creating the alternative legislation that replaces this—I mean, we’ve already shown that the Ministry for Regulation has the highest average and mean salaries out of the wider Public Service. Is it actually going to be replaced by people with the relevant health expertise from the Ministry of Health to the people at the Ministry for Regulation—is it going to end up costing more money?

I think I’ve laid out the concerns that we’ve got with this repeal, in that we’re kind of just repealing things without a plan for replacing it, and we absolutely do need to make sure that we’re protecting New Zealanders. Thank you.

I rise to support the Therapeutic Products Act Repeal Bill. It does exactly what the title says. Therefore, I commend it to the House.

Thank you, Mr Speaker. Thank you for the opportunity to spend a good 10 minutes, I should assume, talking about the repeal of the Therapeutic Products Act (TPA). I must express some consternation and some surprise that members opposite are not so enthusiastic about this. It’s almost like they’ve got no plan or they don’t have anything in particular to say, because they don’t know what the plan is to talk about. It’s all very well to repeal things. It’s all very well to say that you’re going to scrap things and stop things and not do things, but it’s a whole other kettle of fish when you’ve actually got to say what you’re going to do instead. Perhaps that’s the reason for the brevity from the other side.

Repealing this Act has been cited by the Minister as a means by which the Government can do something else. Of course, we don’t know what that other thing will be. We’re led to believe—we’re absolutely led to believe—that the Government is going to be developing some better law that is going to get the balance right. They’re all catchphrases we’ve heard before, across a variety of bills and a variety of rhetoric, but the devil will be in the detail, won’t it? If ever there was detail, it certainly is in the Therapeutic Products Act. It is in the Medicines Act. It is in all of the legislation that currently governs what is a really important part of our life. I can’t wait to see what the Government is going to come up with.

We’ve heard several submitters mention the fact that this is a piece of work that really has been worked on over a number of years. I remember being on the Health Committee last term. It occupied a large amount of our time; it was a big piece of work under consideration. There was a huge amount of to and fro. There were many amendments. There were some things that, even in first draft, we thought, “Oh, that’s not going to work the way it was intended”, and changes were made and loads of contributions were taken into account. It’s not a simple thing to do, but it will be interesting to see where this Government lands, particularly because I don’t think it would be unfair to say that the impetus for repealing this bill seems to be that New Zealand First, in particular, formed a bit of a pact with some people, a small minority of people, who were quite exercised and quite wrong in a lot of expression of some of their concerns.

We know that, during that process leading up to the election, these were issues that were ripe for weaponisation. These were issues that were seen as good organising structures by which to stir up a little bit of controversy and to stir up a little bit of much-needed support. It will be interesting to see, again, what this Government is able to come up with. I’ve got a prediction: I think that they will, obviously, repeal the Therapeutic Products Act, they will work on an alternative, the alternative, as we know, will be split across a couple of different bills, and where we’ll end up landing will be pretty much where we would have been all along. Again, 15 years of considered work by experts is unlikely to completely, radically change where we need to go, particularly because, when we think about what the rationale is behind those regulations and what the rationale is behind the legislation itself, it is to protect people.

We’ve heard from the Hon Dr Ayesha Verrall that the Medicines Act is particularly useless for dealing with the inevitabilities of public health emergencies—the sorts of things that will happen and that will require rapid approval processes. We know that, without the TPA, there is no real framework that we should feel assured about and confident about when we are talking about medical devices. Things have moved on dramatically since 1981. There are medical devices that we talk about today in this context, that we talk about as incredibly normal—not popular; that’s the wrong word, but incredibly normal—and incredibly commonplace that weren’t even thought about in 1981. The impetus for needing and requiring a good piece of legislation is really, really important, and it’s not something to take lightly.

Medicines and natural products are, I think, something that’s also worth delineating—those two concepts—because, again, they were in the TPA, and I understand that the Government therefore has a preference, which is their prerogative, to parcel out medicines from natural health products. I can understand why they would want to do that. We went through that first process, where, sometimes, people perceive them to be synonymous, and, therefore, they overlook the fact that the risk-proportionate elements within the TPA were there in stark, stark reference to the way that both of those products should be treated. Again, it’ll be interesting to see how the Government acts with that in mind, remembering, of course, that the natural health product industry isn’t a single body. It’s not a homogeneous set of people who all think the same way about regulation and all have a very clear idea of what needs to happen.

There are, in fact, at least two quite different concerns at play. We have our exporters who produce top quality, world-leading products, and they want to be able to make therapeutic claims where therapeutic claims exist. Without the TPA, they weren’t allowed to do that, which restricted their ability on the export market. Then we have the other side of the natural health product industry, where they shouldn’t make therapeutic claims where therapeutic claims don’t exist.

Actually, consumers and people purchasing products deserve safety. There needs to be some prevention—for instance, I think one of the examples in the original process was caffeine enemas for curing cancer. We know that’s not real. There is plenty of evidence to show that that’s not real. Sometimes, consumers can be beguiled by therapeutic claims, and if, as a Parliament, we don’t have provision for those protections, it’s not only not preventing people from being sucked in and parting with their money for products that don’t have sufficient efficacy but there can be real health harms and real harms to people, not only by taking something that’s not what they should be taking, because it may interfere with existing medication regimes, but by then preventing them from seeking traditional and efficacious proper medical solutions.

It is a complicated area that we are embarking on, and I do sincerely wish the Government all the best of luck. As has been said earlier, they are literally throwing the baby out with the bathwater. I hope common sense prevails behind the scenes and behind the need to have that external bravado to those fringe groups that deals have been made with, and that behind the scenes the Government and the officials are able to impress upon their Government the need to actually look at the body of evidence that exists and not start all over again, because—

Sam Uffindell: Point of order. Thank you, Mr Speaker. I think we had a comment there from the member saying something to the effect that this legislation was done as part of making deals with side groups. That’s, effectively, an allegation that part of the arrangement for this bill is that there has been some deal-making process in the background between one of the members of this Government and those groups that the member was referring to. I think that such a comment there was out of order, and I’d ask for you to consider that.

Tangi Utikere: Speaking to the point of order, I listened very carefully to Dr McLellan’s comments and the inference was around deals, not an implication that the Government had—[Interruption]

ASSISTANT SPEAKER (Greg O’Connor): In silence.

Tangi Utikere: —an implication that there was some wrongdoing. It’s certainly in order for a member to indicate that deals may be done in any form. Where it sort of heads down the wrong path is when there’s an implication that there is a deal for something in return. That is not what Dr McLellan has alluded to in her contribution.

ASSISTANT SPEAKER (Greg O’Connor): Thank you. Those in the House last night will have heard a point of order on one word in particular, around “pressure”. As I said last night, it’s in the context of what happened. Also, if you go to 55/5 of the Speakers’ Rulings, it also talks about differentiating between what happens in the House and what happens outside, and particularly before the election. If the implication is that something was decided as a policy before the election, then that is actually permitted. It’s when it’s an influence that takes place within the House once the party is here. My understanding is that it was part of a policy coming into the election, so that would be the implication there. The member can carry on.

Dr TRACEY McLELLAN: Thank you, Mr Speaker, and certainly that was my intention: to highlight the fact that the Government parties did campaign on repealing the Therapeutic Products Act, and they campaigned on repealing the Therapeutic Products Act because they, as they’re entitled to, are able to listen to certain parts of their constituencies who have particular policies in mind that they wish their representatives to champion. That is exactly what this Government is now doing. As I said, in the context of my comments, I now wish them luck.

I now wish them all the very best, and I mean that sincerely, for actually taking a wider view, not just the very narrow view that they may have been exposed to before the election, when they devised their policy, but now they’ve got the opportunity to actually look under the hood, take advantage of all of the resource and all of the official resource that they’re now entitled to as members of the Government, and are able to furnish us with a new piece of legislation, in the not too distant future, that can allay our concerns about the void that is now going to be left by virtue of the repeal of the Therapeutic Products Act. We do not commend this bill to the House.

When almost every single health professional tells us that the Therapeutic Products Act is not fit for purpose, repealing the Act is the right thing to do. I commend this bill to the House.

Thank you, Mr Speaker. Gee, I don’t know where to start with my five-minute contribution. There is so much to cover. It’ll be the full five minutes, for your pleasure.

I might just start by pointing out that this is one of the thinnest departmental disclosure statements I have picked up. It is one of the briefest. If I just point out: “Were any regulatory impact statements provided to inform the policy decisions that led to this [repeal] bill?” No. “Has there been any external consultation on the policy to be given effect [to] by this bill, or on a draft of this bill?” No. Right then, so this is all just what everybody campaigned on and brought to the House and agreed in their coalition agreements, and what we have is the Government, once again, just simply cutting and repealing.

That seems to be all that they really know how to do, because I have not heard, from the eight-second contributions on the other side, what the actual plan is. I mean, it’s just so easy to talk to yourselves, agree amongst yourselves, not get any advice, not do any consultation, and then all agree it’s a wonderful idea to repeal this because it is politically popular, but did anybody take a minute to consider that the political decision you are making is putting at risk patient safety?

Todd Stephenson: No—

Hon WILLOW-JEAN PRIME: No, that’s right—no, you didn’t. That’s right.

Hon Member: That’s not what—

Hon WILLOW-JEAN PRIME: Right. Sorry, that’s not what—what says? Oh, you didn’t make a contribution? I couldn’t possibly understand what your reasoning is, because everybody only speaks for eight to 10 seconds on the other side.

This bill is taking us backwards—so far back, about 40 years back. The other side of the House doesn’t believe that there is any need or reason to modernise the law. You are repealing something that takes us back to the Medicines Act 1981. Where is your plan? No plan.

Andy Foster: Come on, stop mischaracterising it.

Hon WILLOW-JEAN PRIME: Oh, well, please tell us what it is if I’m wrong, because nobody has made a contribution to elaborate on that. By repealing this Act, the Government has not brought forward an alternative.

I want to just highlight one issue that this repeal impacts, and I encourage you all to not just simply say “Yes”. Why did you not want to have advice on this? Why did you not want to do wider consultation on this? If you had done that, you would have learnt that, for example, “Patient safety advocate [is] horrified at [the] government’s plans to drop Therapeutic Products Act”.

I am a former Associate Minister of Health, and I was responsible for righting the harm that has been done—wait for it—by surgical mesh. Anybody thought about that? Anybody know the history of that? Everybody comfortable with the fact that your repeal, without a plan, will expose more people to harm. You OK with that?

ASSISTANT SPEAKER (Greg O’Connor): Just less first person.

Hon WILLOW-JEAN PRIME: That’s right; not you, Mr Speaker—them. Is that side of the House OK knowing that the Government has no plan in place after this repeal to address the very serious issues of harm that has been caused by mesh not being regulated?

Hon Casey Costello: Those controls are still in place.

Hon WILLOW-JEAN PRIME: They weren’t sufficient, and that’s why the advocates have been pushing for this and support this. Fifteen years of work has gone into it and you—sorry, the Government—are just throwing it out the door with no plan to replace it. You are leaving people exposed to harm. I do not commend this bill to the House, Mr Speaker.

Thank you, Mr Speaker. I commend the bill to the House.

Well, thank you, Mr Speaker. Isn’t it interesting that Vanessa Weenink, the member who has just resumed her speech—her seat, had nothing to say about it. Actually, she probably resumed her speech, as well. That was it—started and resumed all in one breath. This is a terrible piece of legislation.

Carl Bates: That’s why we’re getting rid of it.

TANGI UTIKERE: No, no, no—not the one that’s in place. The one that, actually, you guys have put up here—that’s the terrible one that’s on the cards today.

This was something that was in its tentative stages, actually, with the Health Committee when I was a member on it in the last Parliament, before Dr McLellan took over as chair of the committee. The existing piece of legislation indicates that there is already stuff in the Act that is provided for—yes, there’s a runway, and we’ll talk about that in a moment—but the reality is this: the Government could have simply taken time to work through these issues.

Why is it that we are here under urgency wishing to rush through the repeal of an Act that actually doesn’t come into play until late 2026? Why is it that the clocks still say that it’s Tuesday here in this place, at a time when this Government want to ram a piece of legislation through all its remaining stages in order to tick a few boxes? Really, it’s quite simple: it’s because they have to, as a collective, prove to their backers that this is a signal that they’re doing what has been asked of them.

That’s all it’s about—nothing about the aspects of the existing piece of legislation that actually would make a difference, and my colleague the Hon Willow-Jean Prime has touched on just one. That’s surgical mesh, and, actually, that reminds me about the number of constituents that have spoken to me—and I’m sure members in the House and members opposite will have had constituents or others that have spoken to them over their time in Parliament—about the impacts that this has had on not just them but their whānau and the way in which they go about their lives. Not a single member of the Government has taken a call to address how this piece of legislation will provide certainty of protection for those for whom that is a real issue. Not a single call has been made.

We question why it is that we’re in urgency and we’re having to rush through this piece of legislation when the protection that exists for women who have that as a real issue, and something that is extremely time-sensitive, as well—

Dr Hamish Campbell: We’re not rushing it through; it’s been to select committee.

TANGI UTIKERE: What’s that, Dr Campbell?

Dr Hamish Campbell: It’s been through the select committee process.

TANGI UTIKERE: Yeah, OK. Why didn’t you talk about that? You’re the deputy chair of that committee and you’ve said, basically, nothing, except that you commend this bill to the House. The second reading is the chance where this House—

ASSISTANT SPEAKER (Greg O’Connor): Through the Chair, please.

TANGI UTIKERE: The second reading is the chance where, generally, members who are part of that committee can explain why it is that they’ve landed at this position. What I find rather disappointing is that the chair and the deputy chair of the Health Committee have taken calls, but they have not delved into the specifics around that. While Dr Campbell might say, “It’s in the report.”, well, point out where—where in the report does it indicate that this continues to protect women when it comes to issues around surgical mesh? It does not.

We would hope that when we get to the committee stage, there will be plenty of questions. I commend the Government on its former bill in terms of the committee stage, when we did actually hear from members opposite about some of the issues. I hope that they will take the opportunity to share some of the concerns, and also some of the opportunities that they have addressed as part of that, because, otherwise, members of the public who are listening and those who are watching are none the wiser as to why it is that this Government doesn’t want to maintain protections for those individuals in our community for whom surgical mesh is a real issue. That’s disappointing.

This is a bill that is going to really turn back the clock—it really is. I mean, we’re talking about returning to a piece of legislation that’s from 1981. So much has changed since 1981. When we think of the aspects of innovation and technology, and all of those sorts of things, and when we align that alongside medicine, medical devices, and opportunities, so much has changed. We can all reflect on members of our own families for whom innovation and technology in the medical space has meant the difference between life and death. This is a bill that seeks to, basically, discredit or remove not just protections but a lot of the thinking in this space around innovation and technology.

Now, we need to keep up in terms of our pace with technological change. This bill, in terms of it being a repeal bill, is doing absolutely nothing in that particular space. It is a piece of work in itself, but what it seeks to remove is all of the years of work that Governments of various different colours have been working on over the last 15 years to get to this point.

I have had an opportunity to look at the select committee report. It didn’t take very long because it’s actually very brief, let alone the fact that they had, I think, over 200 submitters—yeah, 224 submissions—but not many of them have actually been covered. There’s one bit of information there that has been raised in the report, and I do want to just touch on it because I do think it’s going to have an implication on a particular subset or sector of our community for whom this will make a real difference. It’s on page 4 of the report, and it talks about the fact that at the moment, there is a section of the Medicines Act, which is section 29, that does actually allow doctors—specifically doctors—to request the supply of medicine that hasn’t been approved by Medsafe. Now, the submitters on this process indicated that, actually, there is another group of medical professionals for whom this would make a lot of sense, and that’s nurse practitioners.

Now, when we’re having real issues in this country—and this is a Government that, clearly, wants to make it worse, because they’re not interested in having front-line support when it comes to health services in Aotearoa New Zealand—this opportunity for nurse practitioners to be able to have that right to be empowered under legislation or regulation to support communities for whom it’s really difficult to gain access to medical support or assistance and for them to be able to have that provision is going to be a game-changer. When I think about rural communities and when I think of other communities who rely on the support of health professionals and, in particular, nurse practitioners, this change is, basically, gutting that opportunity within the time frame through to late 2026. Why? Because the existing piece of legislation that is currently on the books would have allowed those prescription powers to, basically, be extended to include nurse practitioners.

I don’t know, Mr Assistant Speaker O’Connor, about your fine electorate, but I know that, in mine, nurse practitioners are doing some really good work, whether it’s around diabetes prevention, whether it’s in the asthma space and respiration, and then a whole lot more. Why is this Government on the one hand wanting to, basically, slash funding in health and support for front-line workers and, at the very same time, removing the various tools in the tool kit that will support the practitioners for whom this will make a real difference? The flow-on effect of that is through to the households that would benefit from that. It is very disappointing that that’s a particular view that those members have formed.

Of course, if we step back and look at that, it’s not just the legislation that would say that, yes, all nurse practitioners would be able to do that; what the existing legislation empowers is the Nursing Council to provide approval for it, alongside the Minister of Health. It’s not just saying that there are no guidelines here or—people might call it hurdles—no hoops to go through; this is saying that there is a regulatory and legislative process that would support and empower our communities to be able to receive that support in their time of need, if that is what they needed to do.

We haven’t heard much from the Government around this, and what I would really like to hear is how this change is going to make it safer for our communities. How is having a piece of legislation or a law drafted and enacted in 1981—I’m not saying that all laws that are historical need to be redrafted and re-enacted, but what I am saying is that, when it comes to medicine and healthcare, innovation, and technology and when we have those changes that are taking place, Governments need to be agile and responsive to those, otherwise our communities miss out. This is a short-sighted attempt to, basically, cut that opportunity off at the knees.

The Government has a runway through to late 2026. The only reason that we are progressing this under urgency this afternoon is because they simply need to tick a couple of boxes for those who have asked for this, rather than look at the bigger picture. We will continue to oppose this in light of the silence from the Government.

Thank you, Mr Speaker. This is pretty simple. It’s a bad piece of legislation. We’re getting rid of it, and then we’re going to replace it. I commend this bill to the House.

Lawrence Xu-Nan, I take it that you are applying for Te Pāti Māori’s five-minute call.

Dr Lawrence Xu-Nan: Yes, I am, in accordance with parliamentary practices.

ASSISTANT SPEAKER (Greg O’Connor): Very quick off the mark.

Thank you, Mr Speaker. I rise on behalf of Te Pāti Kākāriki to also take a five-minute call to express that we do not support this legislation, and there are a number of reasons why. I think, first of all, there are two main concerns with this particular legislation more broadly. Number one is: why? I think, when we are looking at putting legislation through the House, there is an intended purpose and a clear trajectory forward on what we are expecting to be the next step and whether we’re expecting it to be a benefit to Aotearoa and to the people, as opposed to a tit for tat.

Some of the things that I would like to explore more during the committee stage and some of the things I have seen from the very brief report from select committee is around the fact that people do not have the level of certainty to what it means if this is repealed. I guess my question is: why are we repealing a bill as opposed to bringing something fully fleshed out? The Government parties keep on mentioning that it doesn’t come into effect until 2026, which I understand, in which case it actually does give the Government parties some time to put out a fully formed bill, as opposed to repealing something that isn’t in effect yet and completely leaving a vacuum to what is to come.

Now, the second part of this is more concerning in terms of the fact that we do see the Minister in charge. It would be good to get some of that advice from the Minister when we get to the committee of the whole House stage—that we’re seeing a lot of work being done but not a lot of work being done on the main ministerial portfolio, which is seniors, which is a growing concern.

In this particular bill, I think this is one of the reasons that we’re seeing this tit for tat in Parliament, where we are repealing each other’s bills over time. One of the comments that submitters have made is the wasted time and energy that it cost people, and it cost everyone, because some of the consultations and some of the changes and some of the money have already been spent in line with the Therapeutic Products Act (TPA), despite the fact that it doesn’t come into effect until later.

To give a broader context in terms of the original TPA, I think other speakers have mentioned a lot in terms of the various elements when it comes to the natural health products (NHPs), when it comes to medical devices such as surgical mesh, when it comes to other forms of medicine and pharmaceutical active compounds, but I think one of the things that is clear when we’re looking at the original purpose and intent of the TPA is the fact that it wants to do what’s best for the people of Aotearoa, in terms of having that genuine engagement and consultation with the public in the process of putting together secondary legislation to be ready for that 2026 launch date. It is about collaborating and co-creating with the people of Aotearoa, rather than putting something forward and just deciding “You know what? This is what we’re going to do; we don’t care what people think.” and expecting other people to be brought along as a part of this.

There are other things that I think are also kind of important in this. I think many have mentioned, and I would like to home in on some particular legislation that was repealed under the TPA—or is updated in the TPA, but now has been repealed and put everyone into a limbo situation—and that is the Dietary Supplements Regulations 1985. Now, people have mentioned that that is 40 years ago, and we have seen that NHPs have come a long way since 1985. There’s also a lot of research that’s being done. I want to also draw attention to the House of the most recent. In fact, over the last few days, some of the concerns by the US Food and Drug Administration is around the company AG1, and in terms of some of the investigation discovery that has been done around liver harm issues and also an increased level of hepatic enzyme functions that we’re seeing with NHPs. In fact, this is something that the Ministry for Primary Industries is currently investigating, and I think this is a really important point to mention in the context of when we are repealing this bill.

Again, there are a number of questions that we would like to ask and get clarification on from the Minister. Particularly the other thing to mention is the completely lacklustre departmental disclosure report. There is no regulatory impacts or interest, nothing. We’re just repealing it with no additional information. We’re really keen to discuss that at the committee stage. Thank you.

I declare the House in committee for consideration of the Therapeutic Products Act Repeal Bill.

In Committee

Part 1 Repeal of Therapeutic Products Act 2023 and related matters