Therapeutic Products Bill

I present a legislative statement on the Therapeutic Products Bill.

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

Hon Dr AYESHA VERRALL: I move, That the Therapeutic Products Bill be now read a second time.

The Therapeutic Products Bill intends to replace the current Medicines Act 1981 and the Dietary Supplements Regulations 1985 made under the Food Act 2014 to provide for comprehensive and risk-proportionate regulation of therapeutic products. I will focus my remarks today on some of the changes made at select committee, but, I think before that, I will reiterate briefly the absolute importance of these reforms to our medicines regulation.

We need modern medicines regulation that will allow for 21st century treatments that are used in New Zealand today but are poorly served by our current legislation. We need legislation that is flexible for public health emergencies like the pandemic we have just experienced. We need legislation to regulate the use of medical devices that are currently inadequately regulated, and the example of the harm caused by surgical mesh is one area where these changes are needed. Another important imperative is to make sure we have flexible regulation to allow for innovative health products to be tested and used in New Zealand.

But, to focus on the work that that has been proceeded more recently, the bill was introduced on 30 November last year and referred to the Health Committee in December. The committee recently reported back on the bill, and I’d like to take this opportunity to thank committee members for their work over the last six months. I’d also like to thank everyone who made a submission, particularly those who shared their personal experiences. More than 16,500 submissions were received, and this shows how important these issues are to New Zealanders. Oral hearings were held in late March, and 210 organisations and 127 individual submitters were heard.

I recognise that many people who submitted on the bill were opposed to it or had concerns about how it would affect them, their whānau, or their businesses. Over 9,000 submissions focused on the inclusion of natural health products (NHPs) and called for their exclusion from the bill or that they be regulated in a risk-proportionate way. I also acknowledge that more than 700 submitters expressed concerns about the bill’s potential effect on rongoā Māori.

When the Health Committee reported back to the House recently, the Government announced that small-scale NHP manufacturers would be excluded from the legislation as well as rongoā. The Government intends to introduce a Supplementary Order Paper (SOP) to amend the bill during the committee of the whole House debate. A number of NHP producers operate out of their homes and produce only a small quantity of goods. These are often sold locally—for example, at farmers markets. I’m comfortable that the evidence available suggests these products don’t pose a significant risk to public health, so the SOP will introduce changes so that small-scale natural health products will be able to be exempted from a product authorisation or manufacturing licence from the new regulator where their products are made and supplied in person to customers in New Zealand.

There is still a need to regulate natural health products as they are not risk-free. It’s also important people have the information they need to make informed decisions about these products. Regulations can help ensure that products contain safe ingredients with information that is clear on the use and recommended dose, that quality manufacturing processes are in place to provide assurance that products are not contaminated, that health claims are substantiated, and that products made in New Zealand and exported overseas meet international standards.

Natural health products are categorised as a therapeutic product if they are intended to have a therapeutic purpose. They will, however, be regulated as a separate category to medicines and medical devices and reflect that they are generally lower-risk.

Contrary to reports on social media and feedback from submitters on the bill, you will still be able to buy natural health products and you will not need a prescription. Practitioners of natural medicine will still be able to deliver care to their clients. There is also no list of prohibited ingredients in the bill and no proposal to ban common herbs and spices used in cooking. If we did, my mother would never forgive me! The impact of the bill on any particular natural health product or ingredient will be determined by a secondary legislation following consultation with stakeholders and the public.

Turning now to rongoā, under the SOP, Māori will retain determination about what rongoā means to them and who is a rongoā practitioner. It’s important for the Crown to ensure mātauranga rongoā can access the export market if they choose and protect rongoā from those who might abuse it. The Government will establish an advisory committee of rongoā experts and Māori leaders to implement the new provision of the bill.

The committee recommended a number of amendments to the bill that the Government will support. Many submitters expressed concerns about the provisions of the importation of prescription medicines. People were concerned they would not be able to import life-saving medicines that are not available in New Zealand or not affordable. The Government is seeking, in this bill, to protect people from counterfeit or contaminated products. The committee has proposed amendments that achieve this sensible balance. People will be able to order and import prescription medicines for their own use, provided they have a prescription from a New Zealand health practitioner. To address concerns about cost, health practitioners will be explicitly able to consider affordability when prescribing an unauthorised medicine. I know this has been a major issue for a number of people and I welcome the proposed changes.

The committee has also proposed amendments to the advertising provisions in the bill. While it agreed with the need to regulate advertising of therapeutic products, especially products that have not been authorised for use in New Zealand, sensible amendments will clarify that patient fundraising, advocacy, and media activities are not intended to be prevented. Other amendments proposed by the committee will ensure advertising over social media platforms and the internet is appropriately regulated. I also want to provide reassurance that Government has never had any intention to restrict Givealittle pages around unfunded drugs. In addition, new defences have been added to the misrepresentation offence and the offence of unlawful advertising to protect research and media activities, advocacy, and satire.

Supporting and enabling innovation is also very important to me. We need a regulatory regime that enables innovation, supports exporters, and promotes trust and confidence in products made here in Aotearoa. This bill does exactly that. It supports new technologies coming to market, expediting when necessary, such as in a health emergency. It supports innovation more widely, creating pathways that are easily navigated and aligned with international standards. The amendments proposed by the Health Committee will ensure that a regime can respond to advances in health technologies such as software as a medical device or cell or gene therapies.

We have listened to New Zealand exporters, and I’m confident the bill will be implemented in a way that supports those businesses. The bill enables a risk-proportionate approval pathways for export-only products, and it’s my expectation that the new regulator will engage constructively with exporters.

In summary, the bill provides a risk-proportionate approach to regulation. Pre-market controls will provide assurances that products are made to the proper standards, while in-market and post-market controls will enable a timely response if safety issues arise. While the Medicines Act has served us well, by and large, it has not kept pace with international developments and there are gaps in the regulations of some therapeutic products such as medical devices and advanced cell and tissue therapies. Consumer safety is our top priority in this bill. The bill will provide New Zealanders with the assurances they would expect about the safety and quality of therapeutic products. In a time of significant change in the health sector, the bill will also provide flexibility for businesses like pharmacies and for the health workforce. The new regulator will cover a much broader scope of therapeutic products and activities. The new regime will become fully operational by 2026, following the development of secondary legislation and further consultation on that.

This is a historic and comprehensive bill. I would like to acknowledge my colleague Andrew Little, who, as previous health Minister, did the work to introduce this bill. The bill will provide reassurance to consumers about safety and will help deliver the Government’s vision of pae ora, healthy futures, for all New Zealanders. It is a fundamental and significant part of our new health system. I commend this bill to the House.

The question is that the motion be agreed to.

Thank you, Madam Speaker. The National Party will be opposing the Therapeutic Products Bill. We have many concerns, and I’ll list four them here in this reading. First of all, we’re concerned that the Therapeutic Products Bill remains a great overreach for natural health products; secondly, there are persistent issues with medical devices; thirdly, there are potentially significant effects on rare disorders; and, fourthly, it is an overreach in the cosmetic industry.

The Minister just said there were 16,500 submissions, and there were many against. Let’s be quite clear: most were against. There were 16,500 submissions—16,000 against. So let’s not trifle with the fact that there were some who had an alternative view—most had an alternative view.

Let’s start with natural health products. We remain of the view that this is a significant overreach, and I want to quote here from the lead representative of natural health products in New Zealand, “The Government has ignored the advice of the natural health products sector and is pushing ahead with an unworkable and bureaucratic product authorisation and assessment scheme that risks damaging the industry, resulting in less innovation, fewer jobs and reduced exports.” When we talk about the natural health products industry, let’s be clear that this is a $2.3 billion contribution to the New Zealand economy. This is not insignificant. They continue, “The new regulator will simply not be able to put 20,000 different natural health products through a bureaucratic authorisation and assessment scheme without significant delays and higher cost to industry. Consultation from the Government has been poor and we do not believe our concerns have been taken seriously.”

There are a number of things that the natural health products sector are asking for. Not only do they feel that the authorisation process is impractical, they’re requesting a notification scheme. They just simply believe it’s impossible for a regulator to market authorise 20,000 natural health products, and they also want to talk about the burden of cost in doing that. They also are concerned that claims that are accepted in other jurisdictions may not be able to be accepted here. They’re concerned with the means to export, the certification process for export, and they’re concerned with accountability and resourcing of the regulator.

There were three main changes from when the Health Committee deliberated through to today. I’ll talk to them now because it does affect natural health products. There were several changes that were made. The first was around rongoā, which was initially included and is now excluded. The second was around online importation. That has been clarified. I think there was a piece of work still to do with that. But natural health product small retailers, as the Minister said, that are direct to consumer have been somewhat cut out of this legislation, although a lot of secondary legislation will provide some clarity to that. So I think there’s still a lot of work and a lot of concern.

I met with some of with some of the medium-sized natural health product companies. There is one in Whangārei that is a manufacturer and has seven franchises, and they tell me they will have to close all franchises if they have to go through a manufacturing approval process and a market authorisation approval process for all of their products. So while some still somewhat-unknown work has been done around small manufacturers, the medium-sized manufacturers will still have a significant consequence.

I want to move on to medical devices. There has been some clarity around software in a medical device and software as a medical device. What is unclear are the provisions in the legislation that say that if there is a performance change, then you have to go back for re-certification. The concern I’ve got for the software industry is if you do code optimisation and improve performance in a software element, is that going to require re-certification? Because it would be a problem. That would stifle innovation and be a significant problem to our software industry. That needs a lot of clarity.

I want to talk to the group of medicines that are currently given free by companies. The example I’ll use is a rare disorder where the special-case requirement is never going to work because it’s too expensive. Even with a GP prescription, you’re never going to import it online; you’re never going to visit and bring it back in your luggage in view of the luggage regulation. This is always going to be too expensive. What we have with compassionate access schemes is we have companies who bring it in, and they give it to certain patients.

So it’s a free, gratuitous giving, as I say, under compassionate access schemes. The issue we’ve got here is that there appears to be no mechanism for prescribers to approach those companies, firstly. There are no provisions in the bill for providers looking to be part of a compassionate access scheme to approach companies and say, “We have someone with a rare disorder—can you help?” Secondly, if they do decide that they’re able to compassionately give these expensive medicines, they will require market authorisation. Why would you do that? You’re doing it for free. Why would you incur the burden of what may be $100,000 to $150,000 for something you are giving for free? Why would you do that? That makes no sense at all. There is a lot of work to be done with rare disorders.

There are other conditions as well. The situation where you have a clinical trial—again, it’s this free giving of medicines—and in a clinical trial you’ll have the medicine that’s under examination that’s qualified by the trial itself, but often you have a standard of care comparator: your placebo, if you like, which is something that’s already pervasive in the environment, already well understood. You give that for free to the clinical trial. Well, here’s the problem: same thing, there’s no ability for prescribers to approach the leads of the clinical trial or for the clinical trial to give those standard-of-care medicines free to participants. They’ll have to have market authorisation, at great cost.

Furthermore, after the clinical trial, if you did get a benefit from the standard-of-care medicine, again there’s no ability for the company to give that to you. The same thing applies for out of stock, and the classic example here at the moment is Estradot. Previously, you’d use a section 29: you’d approach a company, and the company, under section 29, would be able to provide that to you. Under this legislation, that is not available.

Off-label use, which particularly is for children with cancer, where a medicine that is used for one purpose is looking to be used for another purpose—again, section 29 would’ve done that. We see no provisions in this bill for off-label use, so we have significant reservations about that.

I want to talk about the cosmetics industry—$1.25 billion turnover in New Zealand, $400 million export dollars, 24 New Zealand - based manufacturers with Good Manufacturing Practices manufacturing. This is not a significant industry. Their concerns are that they are now caught up in the Therapeutic Products Bill—that anti-dandruff shampoo that might have selenium sulfide in it is now a medicine caught up in this bill, that anti-wrinkle cream with retinol is now a medicine caught up in this bill, toothpaste with fluoride is now a medicine caught up in this bill. None of this makes any sense. Currently, cosmetics are excluded under the Medicines Act and they’re regulated under the Cosmetic Products Group Standard. We think it should continue to be regulated under that standard. This is a terrible overreach to the cosmetics industry.

It’s also going to reach into sunscreens, and we can see that, because the Act is going to repeal the Sunscreen (Product Safety Standard) Act 2022, which was due to come into force in no more than three months’ time, about which all of this House, in September last year, said, “This is a great idea. We need to do that. Let’s have the same standards as we have with Australia.”—acknowledging Todd Muller; this was his member’s bill. Here’s what’s going to happen under this bill: it’s going to be repealed, but in the last eight months, sunscreen manufacturers in New Zealand have undergone the manufacturing, the labelling, all the requirements of that Act, and in three months’ time it’s going to be repealed. It was supposed to come into effect, but this bill will now repeal it—it’s done. The sunscreen Act, even before it could come into force, is done—not clear to us that we’ll still have the joint standard with Australia and New Zealand, whether it’s just going to be a Therapeutic Products Bill standard, but that would be a great tragedy for something that this House all agreed with to be repealed even before it can come into force.

The last thing I want to talk to is the complete disrespect this Government has had for the select committee process. When we deliberated, there were three working group reports still to come back, two on rongoā and one on the impact on small business of the natural health product changes in this bill. We were not privy to those deliberations, and it was very awkward for Government officials, when asked “What progress has the working group made?”, to dance and not be able to provide an adequate opinion. The purpose of the select committee was to provide scrutiny, public accountability to all the information available. We did not have all that information, and five days later, the Minister announces Supplementary Order Papers (SOPs) that take that information into account. They couldn’t wait five days? There was such urgency to ram this through they couldn’t wait five days and let the select committee have the same information that the Minister has had to progress these SOPs in the next stage. That is disrespectful.

It is not the first time this Government has been disrespectful of the Health Committee. If you recall the Pae Ora legislation: completely new chair, completely new select committee. I feel sorry for the disrespected members sitting on the other side of the House. I believe they worked diligently, but this Government and their Minister disrespected them.

This process has been poor. We agree with the natural health products industry: there has not been enough consultation. We will oppose this bill.

Kia orana, Madam Speaker. It’s a pleasure to rise and take a call on the Therapeutic Products Bill. I had the opportunity at first reading to make a contribution, and at that time I noted that this was a bill that would replace the Medicines Act 1981 and a set of regulations, the Medicines Regulations 1985—but also that we shouldn’t just replace them because of historical data, but rather because they needed to. I want to acknowledge the work that the Health Committee has undertaken in looking at this bill. It’s a committee that I’m very familiar with: I was chair of the committee when the bill was received by the Health Committee and extended the period for submissions as part of that, so I acknowledge the chair, Dr McLellan, and her colleagues for working through this bill.

Much has been said already of the over 16,000 submissions that were received and that were considered by the select committee. As part of that process of scrutiny and turning a bill into something that is more user-friendly, the select committee has returned something to the House that seeks to do exactly that—particularly listening to the concerns around the personal importation of prescription medication and making some changes there. The need to ensure that the protection from counterfeit or contaminated products still is an underlying feature of that.

Regulations around social media platforms, and the advertising that might follow in relation to therapeutic products is another example, and then of course noting that it was not an intention of the Government to place any restrictions around things like Givealittle pages and the like. We’ve heard from the Minister, in her contribution, that there is an intention to progress a Supplementary Order Paper that will address a number of issues through the committee of the whole House, and I’m sure the House will look forward to that. I commend this bill to the House.

Thank you very much, Madam Speaker. I wasn’t expecting to rise so quickly. I thought the chair of the Health Committee would have had a lot more to say about the select committee process, but I could imagine why he would want to sit down as quickly as possible, because, in fact, what the Minister of Health has done today is throw the Government Health Committee members under the bus. They spent hours of Health Committee time debating this bill and passing amendments, but the first thing the Minister did was to come out and say that the amendments were wrong. So now she’s going to introduce Supplementary Order Papers (SOPs) to the House to pass to correct her own caucus members’ faults in the amendments. If I was a Government backbencher today, I would refuse to get up and speak on this bill purely because the Minister has thrown them under the bus.

How embarrassing that your Minister would come out within days of the amendments to this bill being passed to say that they got it wrong, and this bill is nothing but another example of the coalition of chaos. It’s another back-down bill. Could you imagine that days after the commentary comes back to the House, the Minister is already desperately putting up SOPs in defence and waving the white flag because the Government knows they have got this wrong? We saw it last week with the three waters bill—I mean, imagine bringing in a bill that amends two other bills already before the House. Now, we’re at the second reading, where the purpose of a second reading is to debate what happened in the select committee, and the Minister is already pointing to the committee of the whole House what SOPs she will put up because she knows that Labour has got this bill wrong.

I want to acknowledge Dr Shane Reti for clearly articulating the issues in this bill, and, in fact, we didn’t need to be here because it clearly came out in the submission process. There was already a bill in place under the last National Government that this Government could have adopted, and that would have done a far better job. So it really concerns me that here we are, after 16,500 submissions—16,000 of those were opposed to the bill—and hours of select committee time taken up at the cost of tens of thousands of dollars, the Government MPs think they’re doing right by their Minister by passing the amendments and passing the bill into the second reading, and the first thing she does is wave the white flag and say, “Look, we’ve got this wrong and we’ll have to introduce SOPs.”

Now, look at the overreach in this bill about natural health products. You heard from my learned colleague Dr Shane Reti about the value of natural health products to our economy: $2.3 billion—$2.3 billion to our local economy. Remember a time when the Prime Minister used to talk about returning to bread and butter issues for New Zealand because of the cost of living crisis that we’re encountering, and yet this Government—ideological, “Wellington knows best”, “Labour knows best”—is prepared to put a $2.3 billion industry at risk. It makes hundreds of millions of dollars in export earnings, it employs hundreds of hard-working Kiwis around the country, and because of the regulatory overreach that they are trying to bring in today, it will put that at risk at a time of a cost of living crisis, when we need to address and make sure our economy is doing well. In an export-led economy, which is New Zealand, this is what Labour is up to today. So much for bread and butter! It always defaults back to ideology.

We’ve heard from the submitters, especially Natural Health Products, the peak body in the natural health space. It has talked about the regulatory overreach as being delayed and bureaucratic. How many times have we heard that term every time this Government touches something? Look at the response to mental health: delayed and bureaucratic. Look at the response around the local government reform of water: delayed and bureaucratic. The Resource Management Act (RMA)—oh yes, the RMA. What a shambles—the coalition of chaos. So here we are, we’ve got another bill that’s an overreach and is delayed and bureaucratic.

Now, I want to turn my contribution today to one very brave New Zealander, Theresa Zame. Now, Theresa Zame, to me, epitomises the belief that one person can make a difference, and, boy, has Theresa Zame made a difference. Theresa’s story is that she has stage four lung cancer. She wasn’t able to access medicines in New Zealand, so she used a compassionate import scheme to access Tagrix from Bangladesh on a script from New Zealand. That cost her $1,000 a month. The equivalent in New Zealand would have been $10,000 because she didn’t qualify for publicly funded medicines, which she couldn’t afford, and, in Theresa’s own words, Tagrix has made a “huge impact” on her health and given months back to her life expectation.

Under this bill originally, that would have been stopped, and not only would that have been stopped but Theresa would have been criminalised.

Sarah Pallett: That’s why we changed it.

MATT DOOCEY: Now, the Government member Sarah Pallett calls out, “That’s why we changed it.” No, you changed it because Theresa Zame brought a petition with 6,500 signatures. She led a hīkoi with Malcolm Mulholland from Patient Voice Aotearoa that turned up on this forecourt to protest against your bill. National was there, the Greens were there, ACT was there, and Te Paati Māori was there. Was Labour there? No, they weren’t there because they knew they were wrong, and here they are now gloating: “Oh, it’s because of us those changes were made.” If it was because of you, that would have not been in the bill in the first place, so don’t you take that one.

That was Theresa Zame, a brave mother. She calls herself just a lady from “Gizzy”. I say that she’s strong and she’s bold, and she led that campaign. One person can make a difference, and Theresa Zame made that difference. The reason that bill arrives back today with the ability for people like Theresa Zame to now go on and continue to get lifesaving drugs is because they put up the fight, and good on them.

This is another reason that this bill comes back into the House as a back-down bill, because they have got it wrong. They didn’t listen at the start. They were forced to listen when dying people—

Sarah Pallett: Rubbish—rubbish.

MATT DOOCEY: —turned up on the forecourt—“Rubbish.”, Sarah Pallett says, the MP from Ilam. Malcolm Mulholland, one of the most respected patient voice advocates in New Zealand, said that under this bill, people would die, and he is right. That’s why this Government was forced into a back-down, and already the Minister, days after it comes out of the Health Committee, throws MPs like Sarah Pallett under the bus and says, “The bill is not right. We’re going to have to make further changes in SOPs.” This is unheard of. This is a shambles. The wheels are falling off this Government.

But all of us—120 of us in the House—should never forget that we make decisions that impact people individually in their lives, and that’s what we’re doing today. Thank you, Madam Speaker.

Thank you, Madam Speaker. That was a very impassioned speech from the previous member there. What he absolutely fails to recognise through that contribution is the fact that exactly what has happened is exactly what select committees are for. The Opposition, when they were in Government, also took the liberty of introducing bills into this House. It goes through a select committee process and changes are made, and through those changes you have, of course, people coming to the steps of Parliament, waving their flags and saying “we disagree with that”. We have people enter this process through the select committees, they submit, and these days they can submit in from their bedroom in the far reaches of Aotearoa just to have their points heard.

That’s exactly what the Health Committee have gone and done. I want to say thank you to our Minister for actually acknowledging those people that came through, that wanted changes to happen, and she’s gone and introduced the pathway forward—the way that we’re going to help their concerns be accommodated and in the future movement of this bill. She’s talked about a Supplementary Order Paper (SOP) that’s going to be introduced into the House specifically around rongoā Māori.

I’ve heard for the last few months quite a lot of opposition from our Māori communities around the place of rongoā Māori in here, and I want to say thank you to the committee for hearing those concerns. I want to say thank you to the Minister for looking to introduce an SOP in this respect, an SOP that will allow Māori to determine what rongoā means, and exactly who is a rongoā practitioner. It’s important that the Government make sure that rongoā practitioners can also export if they choose to as well. These are all really important changes. It shows that the Government is listening. It shows that our Minister is listening. It shows that our select committee is doing exactly what select committees are supposed to do. They’re actually supposed to inform the legislation to make it the best piece of legislation that we can put through. This is for the benefit of New Zealanders.

Thank you to the Minister for listening to that concern, specifically around rongoā Māori. I want to note the submissions of Rereata Makiha, of Waikato-Tainui, those organisations that came forward and said this needs to change. It is going to change. I commend it to the House.

Thank you, Madam Speaker. I’m actually flabbergasted—because this is such an important bill—that our colleagues across the House are taking such a short call.

Now, if you were sitting in the Health Committee that I was and listened to all the people that had given their stories about how this bill is going to affect their lives—and we had over 16,000, as we said, submissions and we listened to, I think, close to 300 or 200 and something in that time, and it was a huge range of submitters. Now, ACT is actually going to oppose this. The reason why we’re going to oppose it is that this bill that is 256 pages still has more questions than answers. Now, how can we help New Zealanders to have better medicines and better treatment when medical companies can’t even understand how this going to affect New Zealanders?

Now, also, we’re going to be creating regulatory reform secondary legislation, and we need regulators to be able to assist with our medicines and natural health products. Now, what red tape and what cost is that going to put on these companies that create and bring in these products, and where are these regulators coming from? We already have a staffing problem. Again, are they going to be qualified? Are they actually going to understand what they are going to be regulating? Now, this is why I said this lovely bill has still got far too many questions than answers.

Now, we’re all for the Medicines Act 1981 and for the 1985 regulations for the dietary foods to be updated, because they are outdated. Anyone who has worked in medicine knows that these things need to be updated. But how do we do it? You needed to listen to the concerns.

Even in the pages pack, when you read from our doctors and natural health medicines people who have written about it, like one stakeholder—Patient Voice Aotearoa—about the Therapeutic Products Bill. Now, he states in an article that happened on 22 June 2023, after this was reported back, that New Zealand patients access 2.3 million medicine packages under this section—this is section 29 of the Medicines Act—it’s an unknown. This is a concern because this is a huge section, which is people with cancer and rare disorders that get particular medicines imported for them that isn’t already on our sheet. Now, this is a huge concern.

I know we managed to get some changes, but there are still so many unanswered questions. There are still too many questions. You talk to the medical councils, you talk to a lot of people—like the burden that may cause companies to simply fly out of the New Zealand market because of reducing the medicines, because of the unanswered questions that we have in this bill. They say, “Wait till the next piece comes out. Wait till the secondary legislation comes out, we will have more answers.” But all that we see is that it’s just going to hold up our medicines. We believe that if a medicine has been approved in the US, Australia, and it’s been over there for many years, been working well, we should be looking at approving them here—

Sarah Pallett: We are.

TONI SEVERIN: —fast—but we’re not doing it fast enough. This is the problem: we’re holding up medicines here in New Zealand.

Then in the medical text thing, the concerns—a series of concerns about regular overreach and lack of alignment with international best practices. Now, that was sent to us just two days ago. These are the people who understand what’s going on in this bill. These are the people that are supplying our doctors and nurses and hospitals with the technology that we need. They are still saying, just two days ago, that they still have serious concerns of overreach and burdens. What else is going to be happening, slowed down to give good practices?

We’re in a cost of living crisis. It’s already bad enough for many of our patients to get hands on medicines, let alone having to add more regulation and red tape.

Yes, in select committee, we did talk about rongoā, we kept asking questions, “When are we going to hear back?” We said, “Oh, wait for the Crown to come back to us.” So now we’ve finally heard that it’s going to be a Supplementary Order Paper (SOP). Well, that’s fine, but it would have been nice for us to have had the same information as the Government, because I feel that the majority of us in the select committee would have been very happy for that SOP to be actually added in the bill; at least we would have had the say during that process.

Now, the thing is that we here in ACT go, “The new regulator, is it following these questions that must be asked: what is the problem this bill seeks to solve and will this bill solve the problems?” Well, we don’t think it’s going to solve those problems; we think that all it’s going to do is make it even harder.

And then what are the costs of this scheme proposed and do the potential benefits outweigh them? Well, we don’t know. We get told “Wait till the second legislation, then we’ll know.” But already, how many regulators will we need? There are three parts to this therapeutics bill. It’s medicines. It’s medical devices. It also brings in dental. It brings in surgery. So even those who are waiting for transplants, it’s all encapsulated in this bill. And then we have the natural health medicines. So it’s three huge industries within our medical profession being dragged into one and we still have more questions than answers.

Now, who will bear the costs and will they be fairly shared? Now, that is the biggest question for the majority within the industries that help us. That’s not just natural health medicine but that was also the medical companies that come in and do trials. It was also the medicines that get brought in, as Dr Shane Reti said, for free—companies that bring it in for free and pass those medicines on, especially within special cases that are rare or cancers that are very rare. So we just see that all this bill is going to do is tie up our medicines.

And, also, like software, everything changes so rapidly. So how fast can these regulators keep up with changes?

So we say: let’s go back to the drawing board. We even heard from the medical profession that submitted on the original bill, which was before my time, and they said that it was better than this bill. It had its problems, but it was better. So why did they have to draft a whole new bill? Why couldn’t we take what was good in the previous bill and improve it? Why keep reinventing the wheel and making things tougher on New Zealanders? We have just been flabbergasted. We had the Government yelling at us that it’s all—

Hon Member: What a load of hoo-ha.

TONI SEVERIN: —exactly, but it’s not. We’re talking for patients. Those who work in the medical field know that more regulations and more red tape is just going to hold up bringing new medicines and bringing new technologies to New Zealand.

We even had the Dental Association during one of the submissions say that under the bill, everybody who had to have a new filling would have to be registered, because it’s an individual piece. So is that being changed? Or if someone had to have something slightly modified for themselves, that would have to be registered.

There’s still, as I said, a 256-page bill and there are still more questions in it than answers and it is not fair on New Zealand. We’ve just gone through one huge health reform and now we’re trying to throw this on top of it. How about we get all the ducks in a row and make sure we’re looking after everybody, especially the patients of New Zealand; they are the ones who are going to be let down. Businesses of New Zealand that export overseas, they are going to be let down. We’re all for changes, because things change quickly, but let’s stop putting more burden on New Zealand citizens and raising costs by putting more red tape and bureaucracy on our bills. This is what this bill does. We have to form a regulator, and who are they going to be; what expertise? Those are the questions that we would like to be answered. How many are going to have to be employed? We oppose this bill.

So if we take a step back and think about what is it that we are all trying to achieve and what this bill is trying to achieve, I think the intent of what we’re trying to get behind is to have things like acceptable safety quality and efficacy or performance of medical devices and active pharmaceutical ingredients across a lifetime and acceptable safety and quality of natural health products across the life cycle—I think these are goals that we can all rally behind.

I want to acknowledge everyone who contributed in the select committee process and who has campaigned on the ground to put the lived experiences in front of politicians, the challenges that they have faced, but also to propose constructive changes to the legislation so that these goals are met. Because I think it’s critical that we do have a regulatory framework of medical products and devices, and it is fair to say that the feedback about small players not wanting to get unnecessarily caught up in the regulations is incredibly fair. We also want to make sure that patients are not disadvantaged by these regulations. To just make a sweeping statement that any form of regulation is inherently harmful is just simply not true.

We have examples of where there are necessary and actually urgent regulations that we need to put in for devices that have proven time and time again to be incredibly harmful. Surgical mesh is a massive example of this, of why this bill actually will help enable finally having a regulatory framework—and the Green Party feels we can move towards banning the use of surgical mesh—and that is one that has proved to be incredibly difficult to regulate. We haven’t made significant progress, despite years of campaigning by many people who have shown the harms that such a device can create. So with this bill, I do hope that we can move towards finally banning things like surgical mesh.

But there are still outstanding concerns, and while I welcome the Minister’s move to introduce Supplementary Order Papers (SOPs), particularly to address the concerns around—well, the SOPs that would then set processes to then address concerns on a case by case basis, we really welcome that. And actually part of that has only been, in my view, addressed thanks to the grassroots campaigning by so many. What we want to see as part of this SOP is that the body that will then deal with complaints around the use of rongoā is fully made up of Māori. That is the feedback of the Greens that we want to send to the Minister—that that this body actually reflects the people who should be empowered to then deal with these concerns and who have the knowledge to deal with these concerns.

Then the other one is around enabling secondary legislation to exempt small-scale natural health products from the regime. I think, with this one, while there is always a tension about how prescriptive we want to be in primary legislation and the risk that that could create in terms of futureproofing things, there’s also the reality around the fact that the Ministry of Health is not currently adequately resourced to actually be able to field the nuances that are required to make the secondary legislation work. And it’s interesting hearing the previous speaker from the ACT Party, Toni Severin, who talked about the staffing concerns in the Ministry of Health, because to me it’s one of those great examples of where often the right talks about the so-called bloated Public Service, but this is a great example of actually the importance that the Public Service plays in keeping us all safe. And, actually, I do think we should be having those conversations about how can we adequately resource the Public Service to make sure that the secondary legislation works as intended.

We have seen in the medicinal cannabis space that the risks from not properly resourcing the ministry to make good decisions based on community feedback creates problems. And the reality here is that when we create frameworks, there are imbalances in power between the big corporates and the small players in the market. I think we all talked about the concerns that we have around small players getting unnecessarily caught up by the secondary legislation. One way to address this is to adequately resource the Ministry of Health so that it can do its job, and ensuring that the feedback and the voices of the small players and of patients are adequately taken into account and are not lost in what can often be really heavy-handed lobbying from big, big players. So that is one of the key things that we will want to continue exploring and holding the Government to account.

The other thing that remains unresolved so far is the direct-to-consumer advertising for pharmaceutical medicines. The Green Party’s position is that we should just ban it. The feedback is overwhelming and it is heartening to see other MPs having make public comments about this as well. This is also a way of evening the field and ensuring that we put the safety of our communities as paramount as part of any framework that covers natural health products and medicines.

There are also issues that we have and unresolved questions that were raised actually by Shane Reti around the use of cosmetics. Particularly for us, it’s the use of sunscreens and how these products will get caught up in the new legislation—whether in this case we could be risking creating unnecessary barriers, but then also acknowledging that if we’re going to create a comprehensive framework for all of these kinds of products, we have to be careful of just making sort of discrete carve-outs—avoid making discrete carve-outs unless absolutely necessary. So that’s something that we will continue exploring in the next phases of the bill. We also take the constructive comments from the National Party around the use of software products. That is a really valid concern that I think we still need to unpack in the later stages of the bill.

Finally, I want to acknowledge the members of the Health Committee, who did put an incredible amount of hours into listening to the feedback of said matters. Other speakers have talked about how this bill has generated a huge amount of public discourse. I think, in some ways, while I know the National Party was talking about the Labour Party flip-flopping, what I want to frame it as is actually Government responding to overwhelming feedback. Some of it remains unresolved, but what it shows is the power of the grassroots. It shows the power that the public actually has in guiding the direction of Government legislation. This is how the Green Party has worked on several pieces of legislation historically where I think we forget that actually people have the power to pressure Government into moving into the right direction.

There is so much more that needs to be addressed and I think the public will continue to hold our feet to the fire when it comes to making sure that the secondary legislation works as the Government intends it to work, and the Green Party will continue putting scrutiny and accountability—to make sure that we don’t create a framework that disadvantages patients and small players.

Thank you, Madam Speaker. I’ll just begin my contribution by commending the Minister on her work in this important area. Therapeutic products are not risk free and they do require regulation, so it is important that we’re bringing this legislation to the House. Much has been said about the Health Committee and their work on this bill, so I do want to commend them and their chair for really robust work on the number of submissions.

But there is another select committee that has been working on this bill as well, and that is, of course, the Regulations Review Committee, and I just want to acknowledge my Regulations Review Committee colleagues in the room, and also Toni Severin, who referred to regulation a fair amount in her speech. The Regulations Review Committee really does contribute to the robust and rigorous debate of bills in the House, and we specifically look at regulation-making powers. As we’ve heard today, it is very important that constraints are put around regulation-making powers and that secondary legislation is deemed secondary, or where it should be, so that it can be brought back to the House if necessary.

So I just wanted to touch very briefly on some of the recommendations that the Regulations Review Committee communicated to the Health Committee as they were going through this process. We spoke about exemptions and the need to specify criteria around them, the clarity of various terms, the importance of ministerial involvement and emergency arrangement notices, and we also discussed where the regulator could rightfully set conditions without going through the normal rules process and where they shouldn’t. We discussed and made recommendations around the setting of fees and levies, in particular the period that those fees and levies could be attached to. And we also discussed whether regulator notices should be classified as secondary legislation, which the House will know is extremely important because where it is classified as secondary legislation, it can then be brought back to the House and indeed determined to be disallowable by the House if need be. And, of course, secondary legislation can also be found to be ultra vires if it’s going outside the terms of primary legislation.

So I mentioned all this just to ensure those who are watching that there is a really robust process that these bills, and this bill in particular, have gone through, and would really invite members of the public to look to the Regulations Review Committee and the role we play in ensuring we bring robust, risk-sure legislation through to the House. I commend this bill to the House.

I understand this is a split call. I call Nicola Grigg—five minutes.

Yes, Madam Speaker, I rise just to take that short call on the Therapeutic Products Bill, and, like my colleagues, I too oppose this bill. The National Party did support this bill at the first reading, and I suppose, you know, we still have a belief in the process of democracy, and we wanted to see it referred to the select committee to go through that thorough, rigorous assessment, and, more importantly, to invite the public of New Zealand to have its say. I think the public of New Zealand has been pretty adamant in its opposition to this bill. Other people have quoted the numbers, and I thought it was extraordinary: 16,586 submissions, with 16,057 in opposition. I think that is a very loud, clear message to the Government that it has not got this thing right. That’s 97 percent of submissions in opposition to it.

Yet again, and my colleague Matt Doocey referred to it, this select committee process has just been a farce, and we’ve seen it multiple times with multiple pieces of legislation that have come before this House where the public has been very strident in its views and it has just been ignored. We’ve seen so many times when the Labour Party’s majority on a select committee has just rammed bills through with absolutely no consideration to what the people of New Zealand are saying.

Look, it’s not just members of the public. I understand there’s been submissions from peak bodies, from organisations like Malcolm Mulholland’s Patient Voice Aotearoa, from Natural Health Products New Zealand, and from the New Zealand Chiropractors’ Association. I did giggle when I saw this, and I can’t quite believe we’re on the same side of the ledger here, but even Jane Kelsey is on the same side as the National Party. So, you know, I think that does speak volumes as to how far away from the right side of history the Government is on this.

But I think, more importantly, there’s some really fundamental principles at stake here. And look, I don’t sit on that select committee, but I am an electorate MP, and I have heard loud and clear from the people of Selwyn that they hate this thing. They absolutely hate it. And it is mostly because they’re so angry and so appalled at the idea of having freedom of choice taken away from them.

The National Party understands the principles and the needs for regulation around safety and all that kind of thing; we do. But this is an extraordinary overreach from the Government. And it really does come down to an issue of natural justice. It is not fair. We don’t believe that the proposed regulator is either going to have the time, resource, or indeed the inclination to make sure timely factory approval or market authorisation is given, particularly to the cottage industries that have emerged, especially in and around the natural health products area. And again, I have these cottage industries around Selwyn all the time, particularly in deer velvet and mānuka honey production, and often these are young couples, often these are farming people, they are looking for a substitute income, they are looking to—you know, they deeply believe in their product and in the efficacy of their product and what it can do to enable the health of other New Zealanders. And they want to be able to share those products and take them to market. But under this proposal, this regulator is going to make it so hard for them to be able to do that and even harder for them to be able to have, you know, a viable business, so to speak.

We heard a very defensive speech from the Minister, I think, who really is doubling down on this piece of legislation that New Zealanders just abhor and oppose. Again, to have this House informed of the process that really has gone on, which, you know, the Government members of the select committee worked in conjunction with the Opposition members on and came up with a proposal that, you know, the Minister is now overriding and is apparently going to introduce Supplementary Order Papers—we are yet to see whether or not they do transpire in the committee of the whole House. But it is just, yet again, an issue of fairness; it’s yet again an issue of a Government that said it was going to be the most honest, transparent, open Government in the history of the world. And we just keep seeing, time and time and time again, legislation that New Zealanders oppose, that we Opposition parties oppose, and it just keeps being rammed through without any thought for the consequence to the sentiment of New Zealanders and to, indeed, our views on democracy. So with that, I do oppose this bill, and we will continue to do so.

E te Māngai o te Whare, tēnā koe. On behalf of my colleague Debbie Ngarewa-Packer, it is a pleasure to speak to the second reading of the Therapeutic Products Bill on behalf of Te Paati Māori. She has put on the record, in the first reading and through the Health Committee, that if Māori rights, under Te Tiriti, were being acknowledged and reflected in this process, then engagement with the tangata whenua would have occurred before the bill was introduced to Parliament. And this would be reflected by Treaty-based protections in the bill. Instead, we have the dire situation in which our people have had to fight tooth and nail for the protection of Rongoā and Rongoā practitioners when this should never have had to be a fight. Rongoā Māori is a Treaty-protected taonga. The Government has acknowledged that this bill was the result of a 10-year work programme, and yet they totally failed to work with tangata whenua on Rongoā regulations until after the bill’s introduction. This is completely unacceptable.

The opposition of tangata whenua to the Crown regulating Rongoā has been unmistakeable, it has been loud, and it has been clear. Submission after submission to the select committee communicated this. Rongoa practitioners around the country have been generous in their time and commitment to ensuring this bill is changed. I note the submission of Tohe Ashby, heamana mō Ngā Rongoā o Ngāpuhi Nui Tonu, who laid out the whakapapa of the rights and protections which must be upheld: from He Whakaputanga, to Te Tiriti, to the Wai 262 claim, and the kōrero and findings of the Te Paparahi o Te Raki inquiry. I also acknowledge the hīkoi that arrived to the steps of Parliament in recent weeks, voicing opposition by our people. But, despite all that, the bill before the House still includes Rongoā.

We acknowledge the announcement of the Minister of Health that it is now proposed that in most cases Government will not regulate Rongoā in the new regulatory system and that they will introduce a Supplementary Order Paper (SOP) to make this change at the committee of the whole House stage. We appreciate her statement, on his behalf, that we are serious about protecting Rongoā and Rongoā practitioners.

Proposed changes to the bill will also ensure Rongoā activities and services operating from marae continue as usual. On that basis, we will be conditionally supporting the bill at second reading.

However, we do question why these changes weren’t made during the select committee process—an opportunity for parties to work together and make the necessary amendments before the bill was brought back to the House. We will be keeping a close eye on the provision of the SOP that has been signalled by the Minister. We will scrutinise that in detail to ensure that it sufficiently protects Rongoā and the rights and interests of tangata whenua. We hope that the Minister will work with Rongoā experts, and parties across the House, to ensure that he gets the wording right. The Crown has no right to bring Rongoā into Pākehā law, putting Rongoā practitioners at risk of civil and criminal penalties. Tēnā koe, Mr Speaker.

It’s my pleasure to take a call on the second reading of the Therapeutic Products Bill, which, as has already been mentioned in previous contributions, plans to exempt many small-scale natural health product manufacturers and rongoā practitioners from regulation under the bill as has been announced by the Minister of Health. This is due to feedback received by the Health Committee from submitters. There was a wide range of feedback, and these changes were an acknowledgment that the bill as originally drafted went a little bit too far. Particular concerns were raised around the regulatory regime for natural health products as they weren’t proportionate to the risk that was presented. And the last thing we want to do is put on additional costs that may drive those small producers out of business.

We all know those small producers in our communities. There are many in the electorate that I live in, for example, in the Waimakariri, where they’ve set up many of their local farmers markets in Kaiapoi, Rangiora, Ōhoka, and out at Oxford. They have a whole lot of herbs and spices and things like that that won’t fall under this bill. So that’s fantastic.

The bill is intended to support product safety. We took a common-sense approach, and I think we’ve struck the right balance with this regulation being proportionate to the risk. So we’ve taken a common-sense approach to this bill, and it’s striking the right balance, and, as a result, I commend it to the House.

Well, there’s a familiar ring about this bill—it reminds me of the Therapeutics Products and Medicines Bill 2006, which was the last time that this Government, a Labour Government, wanted to ram through big pharma regulation to impose it on our small businesses in New Zealand. Small businesses have actually set up a very successful exporting market, not only in cosmetics—and as we heard from Dr Shane Reti, $400 million worth of exports of cosmetics from New Zealand—but also on our therapeutics goods providers. We’ve heard from Te Paati Māori about the effect on traditional Māori health, and to have the Minister come and tell us today “Don’t worry, it’ll all get fixed some time”—when she does another Supplementary Order Paper—that’s simply not good enough. There was no need for this bill to come to Parliament in the first place, and when we have a situation where the New Zealand National Party, the Greens, Te Paati Māori, and the ACT Party are all on the same side, the Labour Party should be rethinking what they’re doing.

I thought it was a very defensive Minister this morning trying to justify this piece of legislation; very defensive, and the Minister told the House that there had been some people who had been against the bill. We then heard from our colleague, Nicola Grigg, the MP for Selwyn, that actually it was over 16,000 submissions against the bill, and it seems as though there were a few who were for it—and I wonder who they were; they’re not the people who either produce, sell, or consume the therapeutic natural products that people want to be able to consume.

If I look at the innovation side in health—I am obviously involved in quite a lot of that around the technology, innovation, and science areas, and I know that software is now being used in health to provide a better service for New Zealanders, and it’s the sort of work that is currently being exported. We can, at the moment, do that sort of work in New Zealand: trial it; do it—but no, this Government wants to put a whole big set of regulations onto it, and so much of this innovation comes from the smaller people—the people who are the PhD students at the universities, the people in our Crown research institutes, and the people who are actually thinking about solutions. This bill makes it harder for them to be able to get the evidence that they need to be able to then export their innovation to places like the United States, for instance—and instead, this is actually about protecting vested interests. The Minister and the Labour Party have stood up and said “Look, it’s really all about protecting New Zealanders”. Well, when someone’s got 16,000 New Zealanders who submit against being protected in that way, well, maybe they don’t want that sort of protection. And the fact is, it’s not about protecting New Zealanders: that may be the intent of the start of the bill, but it’s become this enormous great overreach.

I come back again: when you’ve got the Green Party, Te Paati Māori, the ACT Party, and the New Zealand National Party all against this legislation, it’s time for this Government to have yet another rethink, as they were forced to do in 2006. I was, at that stage, the health spokesperson for the National Party, so I’m very aware of what happened. The people who were most upset that that bill didn’t get passed were the big pharmaceuticals and the Australian Government, because they wanted to have our regulation exactly the same. And why is that? Because it is vested interest. The bill was then being driven through by Hon Annette King, who is currently the Government’s appointee to the High Commission in Australia—it is no reason for us to repeat the problems of the past. And even then, in those days, there was not the software development that is currently being undertaken. I have seen software literally changing people’s lives in healthcare: whether it’s in access to medical treatment, or whether it’s actually providing—through the use of software and artificial intelligence and data—the ability for New Zealanders who could not otherwise access it to get specialist assessment. This is amazing work that is going on, and a lot of it is coming out of Auckland in particular, and the reason is because of the drive that is there around medical technology. In fact, there is, at the moment in Newmarket, a whole new sector being set up around medical health and medical tech. We have enormous potential in this country to be a massive exporter of high-worth science that actually helps to change the world for the better, and that innovation is coming, again, from the little people; the small people—not the great big multinationals.

This bill is not needed. To hear from Dr Shane Reti about how fluoride in toothpaste will now be regulated—tell me: how many instances of overuse of fluoride in toothpastes have we had? Sunscreens are now going to be called medicines. We’ve got retinol used by some of us in our skincare, and I must say very successfully, I think—people tell me! I’m so modest, you know I am. Retinol is suddenly going to be a medicine. This is ridiculous: New Zealanders can’t even get appointments with GPs, and, suddenly, it’s going to be a medicine. New Zealanders can’t even get treatment in emergency departments, and, suddenly, it’s going to be a medicine. The whole thing is bonkers. This Government needs to actually think about—in their last few months of being in Government—the harm that they’re doing to a fledgling industry and our therapeutics producers and those who consume them because that Government thinks that they want to protect us.

Perhaps we could take some personal responsibility; I know it is a vile concept for the other side, but just occasionally, I think of some of these businesses that I’ve visited. The Ārepa people, for instance, they produce a blackcurrant drink with other things in them—it is all scientifically proven that it does actually affect people in a good way around brain health. These are the sorts of things—and they are exporting. What’s going to happen to them? I mean, I don’t know what’s going to happen to them under this, but the fact is, is that they shouldn’t be having to worry about that. It is absolutely nonsense, overreach; typical behaviour from a Government that thinks that 16,000 New Zealanders could be just ignored.

I was surprised that the former chair of the Health Committee did not want to take a longer call on this. In fact, I’ve noticed that the people who don’t want to talk about it are in fact the Labour Party. Yet, I see other parties here happy to talk about it. Why? Because this is, yet again, another anti-innovation, big multinational industry - friendly piece of legislation and, again, Government thinking it knows best. Actually, as I say, when you look at the philosophical divides in Parliament, the fact that all this side that is not Labour is against it should tell you everything. And it’s actually quite patronising to hear the Minister stand up this morning and say that the Māori therapeutics “that’ll all be fine; don’t worry about that, that’ll be fine”. Yeah, well, what about everyone else? What about those who bring in supplements from overseas or those who bring in, for instance, their own medicines that they can’t get here because they’re not on the regulated list of Pharmac; those people who have rare diseases that pharmaceuticals actually want to ask them if they can let them trial their products. What about them? Well, we’re being told that they can’t get that.

Dr Shane Reti, who is a very mild-mannered and measured person, an extremely intelligent, hard-working and experienced not only medical practitioner, but in many other ways, researcher—when he says that this is a really dopey bill, he’s right; it’s a really dopey bill. We’re trying to fix something that the Government thinks is going to come. It’s almost 20 years since they last tried to do it, and it’s in the next 20 years that we should see anything like it. It’s absolutely ridiculous; we stand against this bill.

Thank you, Mr Speaker. It’s with pleasure that I rise to speak to the Therapeutic Products Bill at the second reading. I would like to commend the Health Committee who have worked through what is, as you can see, a substantial piece of work that has been many years in the making. As we’ve heard there have been many, many submissions to the select committee in this process. Variable submissions, as you will often see when you have a great deal of submissions—as we’ve seen with other pieces of legislation passed through—with very significant and real concerns raised by experts and also by people who were affected, who were very specific, and I’m going to explore those and see how we have addressed those in the amendments in a moment.

Unfortunately, though, it’s also true to say that the committee was bombarded with many submissions—in addition to many submissions that were valid and came from an expert point of view—that I would describe as being weaponised by misinformation and disinformation. That’s not to say that there were not serious concerns, and that amendments didn’t have to be made. We should know by now in the House that the purpose of the select committee is to ensure that the best possible legislation is presented at the second reading, and that when we actually move any piece of legislation through the House, the concerns that are raised at select committee have been addressed, because that’s literally the purpose of a select committee. It’s a little frustrating for me to hear that process being misrepresented in the House.

I want to explore a couple of really serious concerns that were raised by submitters and by constituents, to me. One was the importation of medicines for personal use—a very serious issue. Clause 105 in the bill, as it was brought to us in its first stage, was indeed going to restrict access. So that has been amended to remove the prohibition on importing prescription medicines as part of the delivery conditions, providing that if it’s a prescription medicine, it would need to be prescribed by a New Zealand health practitioner prescriber for that medicine, and for the intention of being used by a patient in New Zealand. Which I think will reassure many people who expressed very serious concerns on lifesaving medication that they may not be able to import. That is covered, thank goodness, by the hard work of the committee.

The Government members were also committed from the very beginning to ensure that rongoā Māori was not going to be captured by this legislation, and we will see a Supplementary Order Paper (SOP) being presented to ensure that Māori will determine what rongoā is, and who is a rongoā practitioner, and protect it from those who might abuse it. But to protect rongoā is incredibly important, and we recognised that from the get-go, as indeed we did, the need to exempt small-scale natural health product manufacturers who will not need, under the SOP to be introduced, to get a product authorisation or manufacturing licence from the new regulator. For that reason, I have confidence in this bill and the Supplementary Order Papers to come, and I commend it to the House.

The question is, That the amendments recommended by the Health Committee by majority be agreed to.