Therapeutic Products Act Repeal Bill

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

DEPUTY SPEAKER: 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 first time. I nominate the Health Committee to consider the bill. At the appropriate time, I intend to move that the bill be reported to the House by 1 November 2024.

Today, the Government is keeping its promise to New Zealanders in repealing the Therapeutic Products Act 2023. At the moment, medicines and medical devices are regulated under legislation that is 43 years old, the Medicines Act 1981. This legislation is broadly agreed as being out of date and no longer meeting the needs of the public, industry, and practitioners.

The Therapeutic Products Act was intended to replace the Medicines Act with a more modern regulatory regime, but this Government disagrees with the approach proposed in the Therapeutic Products Act. We spoke out against this Act during the election and we promised to repeal it, and that is what we are doing. The Government considers the Therapeutic Products Act would have imposed unnecessary costs and paperwork on consumers, industry, and exporters, with minimal benefits for consumers.

Repealing the Therapeutic Products Act responds to the concerns of industry, it responds to the concerns of consumers, and it responds to the concerns of practitioners, who all collectively felt the Act would lead to over-regulation of low-risk products, impose unnecessary costs, and lead to products becoming more expensive or limit their availability or even remove availability. Repealing the Therapeutic Products Act shows that we are listening to the thousands of submitters who opposed the bill when Parliament considered it.

Of concern to many, the Therapeutic Products Act created a single regulatory regime for all health products, whether they were pharmaceutical medicines, devices, or natural health products. In repealing the Therapeutic Products Act, we are listening to the concerns of the submitters and listening to ordinary New Zealanders who considered that natural health products should be regulated in a separate, stand-alone bill.

I have spoken extensively to those in industry who had grave concerns about the Therapeutic Products Act and how it was going to be implemented. Those involved in the medical device industry were concerned we were going to follow the path of the EU, where red tape meant that people were not able to receive the devices they needed. Those in the natural health products industry were concerned that people would no longer be able to buy products that are currently on the shelves in New Zealand.

The Therapeutic Products Act would also have required natural health product exporters to obtain New Zealand market authorisation, even though they were meeting the standards of the importing country, and that is what really matters. This double regulation would have imposed red tape and cost instead of encouraging economic growth.

The Therapeutic Products Act was due to commence in 2026. Its provisions are not yet in effect and significant work and funding was still required to put in place the regulations necessary to support it. This means that repealing the Therapeutic Products Act now will not have any impact on industry or consumers. Industry will not have to change anything they are currently doing and consumers will continue to be able to access the same health products. Health practitioners will not be distracted from their important work by the need to familiarise themselves with a new bureaucratic regime at this time, and health officials will not have to spend further time working on implementing a regime we do not believe would have been effective.

This Government wants workable, practical policy that improves people’s lives. We need to ensure that the health policy is there for all New Zealanders to support better health outcomes. Once the Therapeutic Products Act is repealed, we can continue work on better regulation that will ensure New Zealanders have timely access to medicines that will back our innovators and exporters and which will allow our doctors and our other health practitioners to deliver quality healthcare every day. I commend the bill to the House. Thank you.

The question is that the motion be agreed to.

Madam Speaker, fire up your DeLorean. We’re going back to the future, back to the Medicines Act 1981, because what this Government proposes to do today is to repeal the Therapeutic Products Act.

The Therapeutic Products Act has been worked for, for 15 years, by officials in New Zealand across three different Governments, and what it sought to do was to modernise medical regulation in New Zealand. Let me name some of the treatments that have come into existence since the Medicines Act 1981: immunotherapy, mRNA vaccines, minimally invasive surgery, CAR T-cells, gene therapies, 3D printing, implantable devices—all of these modern technologies that some on that side of the House say they’re desperate to spend money getting but they are now abandoning a form of regulation for it.

Those products need to be appropriately regulated. Let me tell you why: because when you do not regulate them, people get hurt. I want to tell you about the people I have looked after with implantable devices that have had defects—that have started to rot their way out of their body—because they are not properly regulated. Think about the women who have been harmed by surgical mesh in this country, for which we do not have a system for going back and finding out where particular devices were used, and then going and telling those women that, actually, there’s a problem with the device. That is what the Therapeutic Products Act did, and that’s what this Government is repealing.

I don’t know if, in this short time, I have the ability to go through the errors that were in the Associate Minister of Health the Hon Casey Costello’s speech, but here’s a few. The first was that the Minister said that there was a single form of regulation in the Therapeutic Products Act. Absolutely not true: medicines are regulated differently from devices, are regulated differently from natural health products, are regulated differently in some ways from rongoā. There is also a lack of clarity in the Minister’s remarks about how the bill was actually to be implemented. There is less clarity for industry now than when they had the opportunity to work through how regulations were to be brought into place, because now it’s apparent that the Government doesn’t have a plan at all.

We’re going back to there being no regulation. In fact, it’s less clear for industry. It seems to me that this Government can’t agree on how it’s going to take this forward, because if they could, they’d just bring an amendment. They’d bring an amendment, they’d change things about medical devices, perhaps, because I agree—I accept, though I do not agree, that members on the other side of the House might have a different view on regulation than we do. But if they had a view, they would make an amendment.

Instead, they’re removing all the options of regulation and, as the Minister confessed, they don’t want to spend the spend the cost of making the secondary regulation. So what happens as medical technology continues to advance? What happens when new products enter the market? Well, there’s no way—there’s no way—for medical devices, other than being listed on one website by the Ministry of Health. There are no other protections around them. There is no regulation. That’s what we found out during the pandemic—there was no regulation of rapid antigen tests.

I also want to remind new members of the House what happened during the COVID-19 pandemic. We did not have a way of enabling the vaccine roll-out because we have no way of having emergency authorisation options in the Medicines Act 1981, so we had to pass retrospective legislation in this House in order to be able to have the vaccine roll-out. So none of the lessons learnt from COVID-19 are incorporated into the Medicines Act 1981. That’s why when there was a monkeypox outbreak in Auckland, we also had to run that vaccine roll-out without publicising it because there was no opportunity to have public health emergencies responded to in this Act.

I have stood by too many New Zealanders’ bedsides when they have been hurt by products that are inadequately regulated. The Therapeutic Products Act sought to prevent some of this harm. This Government is taking New Zealand backwards.

Tēnā koe e te Pīka. E mihi atu ana ki a tātou i tēnei wā. He tū tautoko tēnei i taku hoa o te Āpetihana, a Ayesha Verrall, i tāna kauwhau i tēnei rangi.

[Thank you, Madam Speaker. I acknowledge all of us at this time. This is a position of support of my colleague of the Opposition Ayesha Verrall and her speech today.]

I stand on behalf of the Green Party to oppose this repeal. The Therapeutic Products Act is taking—well, actually, this Government is taking us back to the future. This legislation was needed and it was overdue. When I think about the links of consultation, engagement, that the team has undertaken since 2014 at the outset of the work towards building a new regulator, and then what I experienced out on the floor within hapū and iwi, I say moumou—that’s a waste. Ultimately, this bill repealing the Therapeutic Products Act is yet another piece of legislation where this Government is taking us back—just like Te Aka Whai Ora on the chopping block, just like smokefree laws on the chopping block. The work was well overdue. When we have legislation that sits back in 1981 for the Medicines Act, and then we also have our natural supplements regulations from 1985—way not fit for purpose, way out of date, and not enough regulation to control its flow into our communities.

Now, I want to talk about the engagement and the consultation that I saw and the robust nature by which officials from te Manatū Hauora - Ministry of Health and Te Aka Whai Ora led out in the consultation process. Within hapū and iwi, we engaged because we had concerns. We had the officials come to our marae—Parawhenua Marae in Tai Tokerau. There would have been probably about 100 whanaunga, and those 100 whanaunga were angry about the potential inclusion of rongoā Māori. What I want to share with you is that, actually, the officials did a great job in listening. The officials were awesome in the way that they heard the concerns from our people and they took the heat from te iwi Māori. But those that gathered also shared that there needed to be engagement, there needed to be shared understanding, and also standards and quality assurance in the rongoā Māori space, so it was a work in progress. So I mihi to Peeni Henare for his work in listening and being a listening guide for te iwi Māori in this space.

Now, rongoā Māori is a whole system of hauora, led by mātauranga Māori. This isn’t wishy-washy stuff; this is indigenous health systems and it’s a taonga guaranteed through article 2 of Te Tiriti o Waitangi. The rongoā Māori practitioners have gathered and the experts met, and Peeni Henare listened. So I mihi to Peeni, because our people understood that we needed change in terms of therapeutics products, but also that rongoā Māori wanted to stand up through its own tikanga, its own standards, and work alongside as a complementary medicine to Western science. That’s that mahi tahi that we see as tangata whenua and tangata Tiriti working together.

Further, in February 2023, I had the honour of facilitating in the forum tent at Waitangi. I invite my colleagues of the Government to join us in the forum tent at Waitangi some time—it’ll put hair on your chest. Our people are fiery, and they want to share their whakaroa openly within the forum tent. Peeni Henare joined a panel alongside other Māori health experts to talk about the importance of hauora Māori, but also about therapeutics products, because it was so hot within the Māori community. This legislation actually moved and changed, because consultation was robust. The Government listened. The officials took the messages back into the ministry. They worked on the legislation to provide a dual pathway whereby we can still have robust regulation and then rongoā Māori could have that separation and the ability to self-regulation, aka rangatiratanga.

So I think that it’s a shame that we’ve gotten to this point, because did we really need to repeal? If there was a need to cut some corners or some red tape that the industry apparently is asking for, why do a full repeal? I think it’s a wasted opportunity after so much work has gone into it to build a robust machine that was and is and could have been something good for all New Zealand. Kia ora.

Thank you, Madam Speaker. It gives me great pleasure this afternoon to rise and speak to the Therapeutic Products Act Repeal Bill. It’s actually a great week for healthcare this week. On Monday, you might remember we had an amazing announcement for Pharmac, whereby 54 new medicines will be listed and 175,000 Kiwis are going to benefit from that. These are new technologies that are actually going to be made possible under the new regulatory regime that we’re going to be bringing in once we repeal this piece of rubbish.

I actually can’t believe—I was just listening to the last speaker Hūhana Lyndon—that I cannot find a single stakeholder that it is actually in support of the Therapeutic Products Act (TPA). Patients were upset. Industry was upset. Everyone was not happy with that Act, so what we’re doing today is making a pragmatic decision. We’re repealing something that actually isn’t actually even in force, and we’re putting in place proper regulations so we can get the latest and greatest medical technology to Kiwis faster and we can deal with natural health products in an appropriate way.

This is very, very exciting. We are moving forward into the future on this side of the House. We know that there’s great innovation and technology on the horizon, and we’re going to make sure New Zealand has the best system in the world to get that to Kiwis faster. Health conditions that we couldn’t even imagine could be treated and cured years ago are now on the brink of being tackled, and we’ve got to make sure we have the systems in place to do it. The TPA was not that piece of legislation; it was awful. ACT voted against it when it was passed through the House and we’re voting in support of its repeal today. We are going to be putting in place modern regulations to ensure that modern treatments get to Kiwis.

The natural health products sector have been very upset because, again, they were lumped into this and their actual concerns have not been listened to and weren’t taken on board. So despite there being 15 years of policy development, it was wasted because people were not listened to in the last few vital years when this was put together.

I am very excited that we’re actually going to be doing something on this side of the House to put in appropriate regulations. I look forward to working with Associate Ministers of Health the Hon Casey Costello and the Hon David Seymour on doing that, because I actually do know a little bit about this area, as has been well reported. My background in the medical technology industry will be a great asset. While I’m not financially invested in that sector any more, I am intellectually and emotionally invested in that sector and I’m going to make sure Kiwis get these amazing treatments that we need. So I’m very happy to stand here this afternoon in support of this bill, and I commend it to the House.

What a pleasure it is to listen to my friend Todd Stephenson over there—that was very good. Hey, look, this piece of legislation, at its first reading, fulfils a coalition agreement between National and New Zealand First. We’re repealing the Therapeutic Products Act. Later this year, we will get together and we will consider proposals for fit for purpose legislation. We will come up with new regulatory solutions for natural health products. I note that the current Therapeutic Products Act caused a lot of concern from that segment, and rightly so. Look, Labour’s approach didn’t work, it wasn’t popular, we are repealing it. I commend this bill to the House.

Carlos Cheung—the reason I say that is we’re on a first reading and we cannot pass on the Te Pāti Māori call.

I was listening to the other side of the House just now talking about engagement and talking about the problems of people. Let’s talk about the truth. The truth is that in 2023, the Health Committee reviewed more than 16,500 submissions, and over 95 percent opposed the Therapeutic Products Act. I think this is better law, I commend this bill to the House.

Well, well, well, we’ve heard it all now from big pharma; we’ve heard it all now from the people who don’t understand this bill whatsoever. We’ve heard it through the election campaign, where they told and promised the New Zealand public, “We’re going to change the way Pharmac do things. We’re going to change the Therapeutic Products Act.” Then, they got here and went, “Oh my gosh! That’s actually a bit harder than we thought it was.” Actually, they’ve got to come to this House and explain, through the process of democracy, how they’re going to do that. We haven’t seen that today. What we’ve heard is a repeal with no answers.

Mr Stephenson just gave us a glimpse into what the ACT Party are going to do: they’re going to ram regulations and laws through in this House, probably under urgency, not listening to the people. That’s why we’re here today—that’s why we’re here today. I can tell Mr Stephenson, in the 135 meetings I had up and down the country, he wasn’t at one of them. He absolutely wasn’t at one of them. I went to maraes, convention centres, offices, and health centres, and that man wasn’t there. So he can stand up all he wants; his view on this reminds me of his view on the arts: it’s non-existent.

When this bill is interrogated as it moves forward, we want to see from this Government what’s going to replace it, because all we’re seeing is repeal and that’s about it. Nothing else. We’ll probably be here in urgency, which I know that side of the House hates, which is why I’m going to take my full five minutes today. Buckle in whānau! Buckle in! We’re going all the way.

What we know with respect to rongoā Māori and the natural health products is it’s very clear that it’s important to listen to the people. When I went around the country to make sure that we heard the voices of the people, we managed to find a way forward in order to support that sector—so much so that ACC now allows rongoā Māori to service those whānau who need to access rongoā Māori, who choose to access rongoā Māori.

I’ve got a bit of rongoā Māori for the other side of the House: if you grab the patete leaf, you boil it till it makes a pulp, you rub it on your ears, and it will help your hearing. That’s what the other side of the House needs to do. Under the old Therapeutic Products Act, we made sure that that was still possible. We not only protected rongoā Māori; we allowed it a future to continue to help service the health needs of this country. So we will be looking towards what this Government is going to put in place to replace this.

The other thing is we want to make sure, as Mr Stephenson said, we listen to the people. If we are back here in urgency, pushing through the next piece of legislation on the therapeutic products, they’re going to hear all about it. For far too many times over the past eight months, they have sidestepped democracy in this country in the hope that they can help their friends in big pharma. I’m going to put it out on the record because that’s what’s happening. We heard it very clearly from Mr Stephenson.

Now, what I want to know, as I look across at the three-headed taniwha which is the coalition Government: this time, is it the tail wagging the dog, or is it the head wagging the rest of the tail? Because what I heard from ACT today is a clear insult to the public of New Zealand who shared their views on this particular legislation. They did so for over 15 years. Now, ACT come in here and all of a sudden Mr Stephenson—who’s probably five foot one at a stretch—now thinks he’s six foot 10. That doesn’t happen that way. We’re going to be here to push the ACT Party, who got a small percentage of the party vote, who are now trying to wag the tail of the dog.

This is going to be a fascinating debate because, as we talk about rongoā Māori, as we talk about natural health products, as we talk about the instruments of health that my colleague Dr Ayesha Verrall talked about today, everyone in this family of MPs here will know somebody who’s had to use those particular facilities. They’ll know somebody who has had a bit to do with the rongoā Māori. In fact, I suspect that as we debate this bill, many of them will have a come to Jesus moment. They’ll stand there in a moment of clarity and they’ll say to themselves, “By crikey! Are we doing the right thing? Maybe we should go back to how it was. Maybe the 15 years of work by experts on this know better than the people who are here in this House.” I’m going to put that on the record here.

Of course we oppose this amendment bill—of course we oppose it. I look forward, as this Government introduces more regulations, to holding their feet to the fire on this matter. But that’s OK, because I’ve got another rongoā for when your foot burns.

Thank you, Madam Speaker. It is with great honour that I rise to speak in support of the Therapeutic Products Act Repeal Bill in this first reading.

Glen Bennett: Say it like you mean it.

Dr HAMISH CAMPBELL: Yes. Now, the National Party opposed this bill when it went through. We do agree that there needs to be modernisation of the regulation on therapeutic products. Unfortunately, this legislation is not it. It just offers a tangle of red tape and increases crippling compliance costs on many in our society.

The things is, when this went through Health Committee last term, there were a number of areas we opposed it on, and I’ll just mention two. One of them is including software into this. This is some innovative stuff that we can really use right now. We don’t need to regulate it. We do need to make sure that we are being innovative, cutting edge. The other one is, of course, the regulations that if we’re going to export some of our natural health products—and New Zealand does have a lot of these manufacturers—they were going to have to be held to a standard that is greater than the importing country. Once again, it’s a sign of red tape going nuts. Therefore, I commend this bill to the House.

Madam Speaker, thank you so much. Gosh, National don’t want a bar of this bill, do they? In fact, that’s all they could put up. They’ve barely taken a call, they’ve focused on two specific things that were the only things that they had a problem with, they got one of them factually incorrect, and they got the other one completely the wrong way round. So that was very, very interesting.

Look, this is a clear and unequivocal demonstration of a Government that just simply doesn’t have a plan, and they are quite literally taking us back in time and taking us backwards. As my colleague the Hon Dr Ayesha Verrall has said, they’re taking us back to 1981. Robert Muldoon was Prime Minister, the first ATM was installed just down the road in Wellington, and Brendon McCullum was born—and we know that he grew up and scored lots of test runs and has since retired. That’s how long ago it was—the Medicines Act 1981. It’s a medicines Act that doesn’t cover huge numbers of the products that are now routinely used in our health system, in a modern healthcare system.

Now, in comparison, the Therapeutic Products Act, as we’ve said, was the fruition of a huge amount of work over a series of Governments over 15 years. It was modern, it was comprehensive, and, most importantly—something that hasn’t been mentioned, and it certainly wasn’t mentioned by Associate Minister of Health Costello—the fact is that it was risk proportionate. It was a risk-proportionate regulatory regime for therapeutic products—and, no, for the people that have said that the natural health product industry was against that, because, actually, half of them weren’t. Half of them were the ones that were right behind this because they wanted to be able to export. They needed to be able to make healthcare claims and medicinal claims, and to be able to do that, it required legislation. So you are going to be leaving those people out to dry—

DEPUTY SPEAKER: Not “you”.

Dr TRACEY McLELLAN: Not you, Madam Speaker—obviously, not you. I know you wouldn’t do that.

The Therapeutic Products Act, as we’ve said, was just needed. It really kind of blows my mind that if this Government had any plan—and let’s remember, I don’t necessarily think that this is the National Government. I remember sitting with Dr Shane Reti all through this process, listening to all of those thousands of submissions—which many of you haven’t heard, and most of you don’t know anything about—and he only had a couple of small problems with it. So this is actually New Zealand First and ACT. As Peeni Henare said—tail wagging the dog. If they had a plan, they would have had an idea of what the two pieces of legislation that they needed to introduce to cover the repeal were, and they don’t, because they haven’t done the work.

So, bearing all of that in mind, you’ve got to admit that—you know, why wouldn’t you just do some amendments? Why wouldn’t New Zealand First advocate during those coalition negotiations that they wanted to amend the Therapeutic Products Act? I believe it’s because they were operating under misconceptions about what it was. We had a submitter come to the select committee who raised an apple and said, “This is a therapeutic product.”, and it was like: “No, that’s an apple. That’s regulated under the Food Safety Act. It may be healthy, but it’s not a medicine.” So this Therapeutic Products Act was weaponised from the very beginning by some groups that used it as a means to organise people for their own purposes, and this is the outcome of it. We have a Minister and a party that has fed into that, and it is now causing this huge amount of disruption and it will leave us with a massive gap in our regulatory framework.

We don’t support this bill. It’s a rubbish bill. It’s a pretty bad way to finish off the very exciting urgency period that we’ve just stumbled our way through, and, hopefully, the National Party will see fit to make some sort of other comment on it. Thank you.

It’s an honour to be the last speaker in this first reading of the Therapeutic Products Act Repeal Bill. Other speakers in the House have said pretty much everything that I might have said, so I just will finally say, Mānawatia a Matariki.

Motion agreed to.

Bill referred to the Health Committee.

Instruction to Health Committee