Sitting date: 11 November 2025

MEDICINES AMENDMENT BILL

Third Reading

Hon DAVID SEYMOUR (Minister for Regulation): I present a legislative statement on the Medicines Amendment Bill.

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

Hon DAVID SEYMOUR: I move, That the Medicines Amendment Bill be now read a third time.

Today, we bring the Medicines Amendment Bill to its third and final reading—a bill that is about improving access to medicines, trusting expertise, and delivering better health outcomes for New Zealanders. It is also about politicians listening to concerns about the community, formulating solutions, and staying the course until they are implemented so that people get better outcomes.

Throughout COVID-19, myself and others noted it was strange that Kiwis were waiting for medicines and devices that had been approved overseas and yet somehow we had to wait for Medsafe to check they were OK for us, too. It was crazy. We asked the question: has the rest of the world ever approved something, and New Zealand, at the end of the queue, said, "Oh, sorry, you guys got it wrong", and they all cancelled their approvals? Of course not. Kiwis should not come second to anyone in this world and we should not be waiting to access things that have been consented elsewhere. That is why we have introduced the rule of two: if a medicine is consented in two other developed country jurisdictions, then within 30 days, Medsafe will approve it here if there's an application from the manufacturer.

The bill also expands rights in a safe and sensible way. Nurse practitioners and now pharmacist prescribers will be able to prescribe unapproved medicines that are in their scope of practice just as doctors can. Especially when there's a supply shortage, this is important. Authorised prescribers will be able to prescribe funded alternatives without more hoops, and it means continuity of care for patients and a better use of our health workforce. Again, a clear problem in the community heard by the Government and a practical solution put in place. We've tidied up outdated rules around medicines classifications, committee-making membership requirements, fit for purpose, and moving detailed operational matters out of legislation and into procedures where they belong, because Good governance actually matters.

During the committee stage, we added two further changes that are a result of listening to people in the community and fixing things that matter to them. For too long, New Zealand clinicians have been going to trade shows where new medicines are promoted, in places like Fiji and Noosa—all that money going overseas, when, actually, we could be having these medical trade shows right here in New Zealand. Clinicians will be able to go and learn of the latest medical technologies in places like Queenstown and Auckland, that are part of the New Zealand economy, because we are removing an outdated restriction on advertising new medicines at trade shows—within strict limits that there has to be a genuine purpose to it.

We've also removed an outdated restriction on pharmacist prescribers having an interest in a pharmacy. You can understand what the intention of that might have been, but when we trust professionals to act ethically, we should also allow them to have a financial interest in a pharmacy where they may be prescribing.

This bill is ultimately about pragmatism, trusting professionals, speeding up access to medicines, and making sure our regulatory settings are agile and focused on the outcomes. I particularly want to acknowledge officials at the Ministry of Health and Medsafe; the Parliamentary Private Secretary for Health, Todd Stephenson; the select committee; and all the stakeholders who contributed their expertise. This has been a collaborative effort. I note that the rule of two was campaigned on by all three coalition parties and so far has had support from every party in this Parliament. It's a very good example of how politicians can actually hear people's concerns in the community, formulate a solution, stay the course, implement it confidently, and make New Zealand a better place to live, one step at a time. I'm very proud to be part of this bill and to commend it to the House. Thank you.

ASSISTANT SPEAKER (Teanau Tuiono): The question is that the motion be agreed to.

Hon Dr AYESHA VERRALL (Labour): Thank you, Mr Speaker. It's a pleasure to speak on the Medicines Amendment Bill. As the Minister has just outlined, this bill has achieved good support from across the House, and I'm pleased to say that Labour continues to support this bill. There are many things that we want to call out as positive aspects of this bill. One of the things that does reflect the Minister's statement that the bill was a collaborative process is the positive inclusion of changes made at the Health Committee.

The bill originally listed overseas regulators. It specified them by name in a schedule and, as submitters pointed out, that meant that, were there to be changes or were New Zealand to lose confidence in some of the processes of those regulators—and, let's be clear, they are very, very esteemed regulators internationally—we would need a change of the Act in order to no longer accept that organisation's approvals. The fact that, now, the bill takes an approach of specifying criteria that would allow the approval of particular overseas regulators is, we think, a positive development. It allows flexibility; it allows New Zealand control over its, shall we say, regulatory sovereignty should we ever have a reason to question those regulators in the future. That's not an unreasonable concern; some of those regulators have been the subject of political interference or suggested political interference overseas, so it's important that, should that ever reach a threshold that is concerning to us, we have the ability to take action there. We're grateful to the other members of the select committee and the Government for accommodating that change.

Another positive change was the inclusion of pharmacist prescribers among those that can prescribe unapproved medicines. It appears that unapproved medicine prescribing has grown in scope due to the challenges in supply chains for medicines, which have really escalated in recent years and following on from the pandemic. More and more, substitute medicines that are unapproved are being used, and, therefore, the very narrow ability for those to be prescribed is being shown up. These changes, which allow both nurse prescribers and pharmacist prescribers to prescribe unapproved medicines, are positive, and, of course, the number of protections that exist around the prescription of unapproved medicines remain, which is important.

I want to also note that our main objection to the bill as it is going, apparently, to be passed is the ability for ministerial appointments to the Medicines Classification Committee. It seems undesirable that what is, essentially, a technical committee should be the subject of ministerial appointments. We would have preferred to see the membership of that committee be appointed by the Director-General.

I'll now turn to the main purpose of the bill. The bill has the intention of speeding up the approval of medicines in New Zealand, and, for that reason, it is a laudable aim. We note that the description of the aim according to the Government has changed over the course of the Government. Initially, it was described as a much more automatic approval process than is now reflected in the bill. Whereas approval overseas would have automatically led to approval as initially proposed, now, not only does the medicine need to be approved overseas in two jurisdictions, it also needs a local sponsor. What that means is that the incentives that apply to sponsors continue to apply under this bill. As we heard at select committee, those incentives are often what delays the approval of these medicines in New Zealand.

To give a little bit more context: drug companies will look at a market like New Zealand—we're clearly smaller than other markets—and they may not think it's worth their while to submit an application in New Zealand because they'd rather prioritise their resources for supporting that application into bigger markets. I suppose you can't really argue with that—it is the fact of being a small country—but that's one reason why we're slower to get new medicines approved in New Zealand. That won't be changed by this bill.

Another reason is that the pharmaceutical companies make a judgment about how much they'll sell. Of course, if you don't get Pharmac funding in New Zealand, that is the main determinant of the price of your drug to the consumer and the likelihood of it being widely used in New Zealand. The drug company doesn't know at the time of their application how likely they are to get Pharmac funding. That won't change with this bill. For those two reasons, there is reason to think that the incentives on what's referred to as "sponsors" in the Act, or pharmaceutical companies, are unchanged by this bill, and that's what makes me question how much this will, in practice, speed up the availability of medicines.

However, the bill also does not do much harm—actually, we're confident it does not do harm—therefore, the potential improvement is worth us voting for this on this occasion. Really, the proof of the pudding, I would argue, is in whether or not we see a speed-up in the approval of new medicines. We'll be very pleased if we do. That's why we're voting for the bill.

The final point I want to make is about the addition made to the bill at the committee of the whole House stage for the advertising of medicines at medical conferences. This was not included in the original bill, and, officially, the first I heard about this change was when the amendment got tabled. Unofficially, the first time I heard of this change was at a Business New Zealand event where one of the stakeholders who would be a beneficiary of this change approached me and outlined why they thought it was a positive change for the New Zealand scientific conference industry and encouraged me to support it. Good on that person who was up front and engaged with us over this change. It would have been nice to have heard that from the Government when the bill had garnered such cross-party support in every other respect.

It did make me wonder why that idea—the idea that the regulation of advertising at medical conferences should be changed—is being included at the last minute in this bill? Of course, that idea was kicked around when we debated the Therapeutic Products Bill in the last Parliament, and it did make me wonder if the Therapeutic Products Bill was in trouble. When we passed the Therapeutic Products Act, in the last Parliament, I had met an official who had been working on an update to the Medicines Act for over 20 years when I worked on that bill, and now it appears that, having repealed the Therapeutic Products Act and promised a new Medicines Act, David Seymour doesn't want to wait for that to make these changes in this Medicines Amendment Bill. We're told that there's another bill coming down the pipe that's going to take care of our outdated medicines regulation, but that bill must be in trouble, because why on earth would you put these changes about medical conferences into this bill at the last minute? Then I read in The Press the other day that Casey Costello is indicating that there will be new medicines regulation in by 2030. Well, colleagues, last time I checked, they're still writing science fiction about 2030. The Medicines Act is an Act from 1981. That is how outdated our medicines regulation is in New Zealand.

We support this bill and the modernisations and small changes to our medicines regulatory system that are in here, but our entire regulatory system is out of date. We saw that in the pandemic, when we had to debate, as a Parliament, retrospective changes to the Medicines Act to get an emergency approval for vaccines. We had no way of getting expedited approval, and, under the current Act, there is no proper way to deal with public health emergencies. There is no regulation of medical devices. There are a number of problems with our Medicines Act, and the fact that this bill has had this addition to it suggests to me that medicines regulation in New Zealand is in big trouble.

HŪHANA LYNDON (Green): Tēnā tātou katoa e te Whare. I stand on behalf of the Green Party to offer our tautoko towards this legislation also. I echo the sentiments of my colleague within the Labour Party around the small changes that are being made that look at patient care and the health and wellbeing of all New Zealanders. But of course, reformation of the entire system is required. I thank the former Minister of Health for reminding the House about the challenges of access to medications, to immunisations, vaccinations across the board, but particularly with COVID-19.

The rule of two fast-track is one fast-track that the Green Party do support. So it's good to be standing here to tautoko and also reflect on the select committee process that the Health Committee oversaw and the diversity of submissions received in the 185 rōpū, hauora, individuals, and whānau who provided submissions, both in writing and orally. There was strong support. But of course, you know, we've always got to keep an eye on health equity, on access, on timing—which this is addressing the timing issue.

Also, I want to talk about workforce and ensuring that our workforce is adequately trained, working at top of scope, but also fuelled in the system to deliver these medicines fast into the community. When we think of areas such as the far, Far North where we have a shortage of clinicians, and also those working in general practice, there continues to be these challenges in terms of workforce. But this legislation does open up the space for access for our nurse prescribers to work at top of scope and support an effective access for the community to medications. But of course, we need the trained clinicians in the community in the first place. So those are the questions we ask in terms of the way with which we can fuel not just this part of the system, but the entire system to ensure that we have the relevant workforce that is capable, that is trained, and has the supports and resources available to be able to deliver medications to the front line.

We heard in the select committee the way with which the access to faster medicines, will support better health outcomes for all New Zealanders. The view of those particularly—and I think of our hauora Māori—is how do we take a Te Tiriti based approach, looking at health equity for those most impacted on the system and ensure that voice is heard across the kaupapa? I think about the way with which appointments can be made to committees and I'm thinking about, also, the Medicines Classification Committee having recognition of an ao Māori voice—a clinical expert and leader can offer that lens.

We do have concerns, of course, around the Amendment Paper that was tabled without notice really. It's a missed opportunity that the Minister brought it into the committee of the whole, because we could have interrogated and provided community and the health sector the opportunity to have a voice on the amendment that the Minister put forward at a very, very late stage. While I wasn't present for the debate of the committee of the whole, we have to be really careful about the way with which non approved medications can be advertised and promoted, and what is a conference too. So those are some concerns that we have. But again, going back to the foundation of the Medicines Act in general, this is a good start, but there requires more.

I want to talk particularly again about rural communities and the way with which those—who are in rural and urban settings—who serve those who are most impacted and have the lack of access. Te Hau Awhiowhio o Otangarei Trust came before us and spoke to the way with which they have to work in a collaborative approach. This is a low socio-economic community in Whangārei. The clinicians, as well as those that are allied health, are trying to usher whānau into the health system so that they can access medication and treatment.

They were absolutely supportive of this legislation, but they did also bring in the consideration around how do we bring everyone up in the health system as kaimahi to work at top of scope, because that's part of the challenge; is the way with which we can provide access to timely, quality health services no matter where you live—no matter where you live. Whether you're in Kaitāia, whether you're in Bluff, whether you're in Ōtauthi, Taranaki, or the East Coast, or for me in Tai Tokerau; those are the challenges. While we do provide this fast-track process to bring medications into the country, it is about form following function, and are we readying the system sufficiently so that both our health providers, Te Whatu Ora Health New Zealand, and those on the front line in pharmacy, dental, everyone has the ability to be able to exercise at top of scope what they need to do to provide the medicines?

Also, when we're talking about Pharmac, you know, we've seen the increase in funding. That's really awesome, because we know that there are a broad range of medications that are available internationally that have yet to land here in Aotearoa. I'm hoping that this will be one of the levers to increase access. I reflect on a fundraiser that a particular whānau member has, a loved sister, cousin, and niece; 10 years fighting a frontal lobe tumour. They are currently fundraising $70,000 for another year of treatment for a medication to help treat this issue she's had for 10 years. She's been everywhere, man, in terms of trying to get a range of treatment options. But this medication, of which I cannot pronounce the name—vorasidenib; something like that—is available in Australia for free. It's available in Australia for free, but she can't move to Australia. She has commitments here and she has whānau.

What I am pointing out to members of the House, is that this is an opportunity for us to open our eyes and our hearts in the way with which funding is distributed into the health system, because there are those that are impacted, like this whanaunga who's reached out to me. She's just like, you know, "Can this new thing that's come through—", because people are googling, people are watching Parliament TV more now than ever. So when this amendment legislation came through, it's then that I got a message saying, "There's a whānau member. There's an issue. How can we get these types of medications into the country?" I said, "Oh, that's something new to me. Aroha mai. But let's scope that." This is not something that is foreign to many of us. We have many whānau who have been impacted.

So what do we do? In terms of the levers that are available, we have got this fast track that provides the way with which access can open the door for more medications into New Zealand. We have now seen an increase in budget for medications through Pharmac into the system. But ultimately, it is about the entire system, the health system in the fullest and also providing our workforce with the necessary skills, tools, and ability to be able to deliver these medications into community so that they can help prevent, but also treat.

So, again, prevention is better of course than getting it further down the track and you're only treating it. If we can pull it back in taking a population-based approach, we could start looking to identify and work with those communities most impacted, those who have the biggest challenges to support and care. I always go back to the far, Far North, Te Hiku o Te Ika, and consider the way with which they have a serious lack of access to primary care with some 3,000 whānau members who cannot access a GP. I hope that levers such as this legislation will provide a mechanism for our doctors to be able to offer the medications available. But how do we find the workforce to do the mahi, ultimately? Tēnā tātou.

SAM UFFINDELL (National—Tauranga): It's a pleasure to be able to rise on behalf of a Government that is improving the healthcare system in New Zealand, and the Medicines Amendment Bill helps to further that. The Minister has already spoken about the rule of two, which is going to bring more medicines more quickly into New Zealand—this is a very good thing—and about the extended rights to nurse practitioners and pharmacist prescribers, which is going to increase access, which is much needed. I want to say thank you to the members of the Health Committee for their collaborative and pragmatic approach to this bill and for the positive inclusions that were made in the committee. This is a fantastic bill, another step on the way to improving healthcare outcomes for New Zealanders. I commend the bill to the House.

JENNY MARCROFT (NZ First): Thank you, Mr Speaker. It is a privilege to stand on behalf of New Zealand First in support of the Medicines Amendment Bill. This bill is the tonic that the country needs to ensure that we get rid of that bureaucratic sluggishness, which has basically held-up medicines at our door. This bill, as has been mentioned by other members, is a fast track to medicines. Actually, I'd like to go further and say this is the smart track to getting medicines out the door to New Zealanders. We should be at the front of the queue when it comes to accessing world-class medicines; whether they're safe, life-changing, life-extending medicines, New Zealanders should be at the front of the queue.

The Rule of Two enables this pathway to be expedited, to get these medicines that have been approved by two other regulators, that we agree are the regulators that we can trust. Then those medicines can be prescribed in New Zealand rather than undergoing that full local evaluation. We've expanded, also through this bill, the prescribing rights to nurse practitioners, and, through the select committee, we included pharmacist prescribers as well.

Another change was that all prescribers, in times of emergency—where there is a shortage with some supply chain in terms of the medicines that have been approved—will be able to prescribe funded but also unapproved medicines. This is practical and pragmatic, and it is that smart track for medicines approval and getting those medicines to the patients.

I'd like to thank all the submitters that contributed to the development of this bill through the select committee stage, and, in particular, noting Dr Malcolm Mulholland from Patient Voice Aotearoa and the advocacy and the work he has done to get the voice of our patients right into this Chamber. That voice has been loud and strong. We've made changes today. I think we should all be proud in this House today that we can support this legislation.

I'd just like to turn to the "good book", the good book called the coalition agreement between New Zealand First and National, and I'd like to read very briefly from the scriptures, which state: "From this coalition agreement, we will require Medsafe to approve new pharmaceuticals within 30 days of them being approved by at least two overseas regulatory agencies recognised by New Zealand". For that reason, I support this bill. I commend it to the House.

RICARDO MENÉNDEZ MARCH (Musterer—Green): Thank you, Mr Speaker. As canvassed by my colleague Hūhana Lyndon, we are supporting the Medicines Amendment Bill. I just wanted to take a moment, before I go into some other aspects of the bill, to just recap reflections of the committee of the whole House stage that we had. I think there's a bit of an irony here with the other piece of legislation we've seen that aims to create better frameworks for high-quality legislation and make sure that we are having robust processes. Yet, while we support this bill, it was concerning to see a last-minute amendment being added which would add—this is the new addition of clause 12A—the exemption for advertising medicines at medical conferences. I think good process would have meant that this change would have been introduced at the select committee stage so that it would have been adequately canvassed. It was a shame that we did not have the opportunity to have the select committee adequately evaluate the merits of the amendment that was introduced by the Minister during the committee of the whole House stage.

An example of this is when we tried to examine some of the commentary by the Minister at the time, in relationship to, for example, the amount of revenue and the changes being made that this amendment would bring to the country. The Minister, at that time, during the debate, for example, made some—I would characterise them as kind of flippant—remarks and just raced figures off the top of his head around the revenue that these medical conferences would bring. I think it makes it hard for us to have a robust committee of the whole House stage when we have these sorts of amendments being introduced at the very last minute and no analysis to go alongside them except the Minister's opinions on the matter.

It also does not do service to an adequate democratic process when members of the Opposition are not able to adequately engage with these amendments, because we're engaging with them at the last stage that we're able to and without adequate analysis to do so. So I think that while this bill has a lot of merits, I'm still none the less concerned that the Government did not follow, I think, best practice when it comes to making sure that the bill was fit for purpose at its introduction and during the select committee stage. We didn't support the amendment at the time, but we still think that the bill has merits.

As others have canvassed, access to medicines in this country—to the most modern and most, sort of, recent medicines available—is a barrier. What we can lean on are other countries' robust processes in order to acquire more medicines to alleviate the issues that we are facing in relationship to access to medicines. This is why we are welcoming this bill, and we welcome the provisions that allow us to lean on peer-reviewed research from overseas. My colleague Lawrence Xu-Nan, at the committee of the whole House—and I know that he's got a pharmacology degree—helped evaluate some of the robustness in which we'll have in this bill, in relationship to making sure that we have those peer-reviewed studies being done before we are able to evaluate whether overseas jurisdictions have done due diligence.

There were some questions in relationship as to whether we're genuinely tapping into the wide range of jurisdictions that are out there, particularly because the provisions in this bill require that these entities produce those reports in English. I did welcome the Minister's engagement on the issue at the committee of the whole House stage, where he did note that some jurisdictions that may not use English as an official language none the less take steps to produce that material in English. But none the less, I think, moving forward, in terms of creating legislation that allows us to genuinely tap into as broad a range of medicines as is available, and where robust processes have been followed, there's a missed opportunity to move away from the Anglosphere when it comes to access to medicines.

I think in order for this bill to be genuinely successful, we have to turn our eyes to supporting some of the bodies that help distribute those medicines to our communities, for example, our pharmacies. We know our pharmacists are under humongous pressures. They are often the first line of defence when it comes to public health, and they're often engaging with sectors of our communities that would have been underserved by other parts of the health system. As we broaden the range of medicines that our pharmacists can deliver to our communities, I hope that the Government turns its eyes to adequately resourcing our pharmacies and our pharmacists so that they're well looked after and they're community-led, as opposed to risking those bodies being run by corporates. Thank you.

Dr HAMISH CAMPBELL (National—Ilam): It is a great pleasure to rise and speak in favour of the Medicines Amendment Bill in the third reading. This Government has been focused on increasing our access to pharmaceutical interventions. When we look at the money we've added to Pharmac, we can see we've added an extra $604 million for those really important cancer medications and other life-saving medications. This is a step that makes very good sense so that we can speed up access to cutting-edge medicines that actually will extend people's lives and make people's lives better.

We're also making sure we're expanding the ability for various health professionals to be able to prescribe medications. This, once again, is all about getting timely healthcare, which is what this Government is very focused on. Therefore, I commend this bill to the House.

Dr TRACEY McLELLAN (Labour): Thank you, Mr Speaker. That was a very big claim from a very short contribution, which is probably summing up this bill quite nicely—it claims a lot, and doesn't necessarily do everything that's written on the till.

So at the third reading of the Medicines Amendment Bill, it's worth, I think, reminding ourselves what this legislation actually does—and it does do some good things; it certainly doesn't do any harm—and what it doesn't do. So the bill has been presented by the Government as a step forward to access to medicines in New Zealand. In reality, it's a relatively modest set of technical changes, some of which may help streamline regulatory processes—we have no problem with that; that's a good move—but few of which are going to make any particular tangible differences in terms of people's access to medicines, and particularly for New Zealanders struggling to access medicines and the healthcare that they need. There are many other problems afoot, and the Government is choosing not to tackle those.

At the heart of this bill lies Medsafe—as we've heard from previous other contributors—New Zealand's medicines regulator and agency, obviously, that performs an essential public service to New Zealanders. We know that Medsafe's work is critical, it's really critical. It's an agency that people fundamentally rely upon to make sure that the medications that they receive are safe, and that they have access to the medications that they fundamentally do need.

We also rely on standards set by respected international regulators. We've heard much said—well, we've heard it mentioned; not exactly much said because the contributions from the Government have been very short and very brief. But we've heard the rule of two mentioned, and that seems to be a little bit of a catch phrase that has been relied upon quite heavily. But those international benchmarks should fundamentally complement Medsafe's work, and not replace it in any way, shape, or form. So as Parliament continues to consider these changes, we've got to be very clear—and we are clear on this side of the House—that nothing in this or any future legislation should diminish Medsafe's independence or its ability to make those incredibly important, careful, evidence-based decisions.

So with respect to the verification pathway, Mr Chair—Mr Speaker, I should say—the bill introduces a new verification pathway allowing approval for medicines that have already been authorised by trusted overseas regulators. That sounds sensible, and on paper, that absolutely makes sense. If a medicine has been fully approved by a regulatory body, a comparable regulator, it absolutely could save time and reduce duplication, to recognise the approval process here. But the key, I suppose, is in how that is done. Safeguards must be in place so that Medsafe can swiftly act if issues arise from those overseas regulators. It must retain the power to halt or even revoke approvals if new evidence comes to light that points to some sort of safety concern. It's also important that the operational details—you know, the documentation, the conditions, the oversight mechanisms—are clear and that they're regularly reviewed. Without that clarity, we risk that shortcuts could undermine the trust that people have in the system, which obviously is incredibly important. So while Labour sees potential in this pathway, and we do support this bill, we do so with caution. Efficiency, ultimately, must never come at the expense of safety, or at the expense of independence.

So that brings me to thinking about the difference between intent and impact—so intent versus impact. The stated goal of this bill is to improve access to medicines. That's something that absolutely everybody in this House could get behind, and everybody in this House, no doubt, supports. But the question is whether this particular bill meaningfully achieves that. The Government has promised faster access, but there is little evidence in this particular pathway that it will deliver real change. My colleague the Hon Dr Ayesha Verrall outlined some of those specific concerns earlier.

When we consider patients waiting on life-saving treatments, it's important that this bill is meaty enough to actually make those changes, and not just the sound bites that the Government are offering at the moment. Otherwise, it risks being more symbolic, really, than any kind of proper fix, any kind of structural fix.

So if the Government truly wants to improve access, it should be (a) transparent about who stands to benefit, how much sooner treatments will be available—specifically, we should have been able to hear details potentially about that today—and what accountability will be in place if those improvements don't actually materialise. We haven't heard information about that, and it's important because New Zealanders, quite frankly, are tired of announcements that don't come with delivery. But as my colleague the Hon Dr Ayesha Verrall said earlier, in effect it doesn't do any harm, hence the fact that we will be supporting this bill.

Now, another area that deserves some close attention is the proposed change to the way that members of the Medicines Classification Committee are going to be appointed. Labour is concerned that shifting more power over appointments to the Minister risks politicising this process, opening the door to what could potentially be undue influence from industry.

That brings us, I suppose, to the broader question about priorities. That's a broader question that is raised on this side of the House frequently because it needs to be. At a time when New Zealanders are struggling with the cost of living, they're struggling with a health system that is absolutely under immense pressure, the Government has chosen, as core business, to focus on this bill, which while perfectly acceptable, while it does no harm, probably isn't anything more than a technical fix, but, nevertheless, this is a priority. It's tidying up a regulatory process, and its tidying up, in regulatory terms, offers little to the average family, who are still trying to struggle to fill a prescription or to actually see a GP. And remembering this is the same Government that scrapped free prescriptions, a decision that immediately made it harder for low-income families and vulnerable New Zealanders to access the medicines that they need. So whilst, again, we'll support this bill, it's potentially largely symbolic. I don't think it's the fix that it's claimed to be on the other side of the House during these short contributions. But it's a little bit ironic that it crows about access to medications on one hand—by a Government that has directly made that access more difficult on the other.

So while we're here debating procedural tweaks and international alignments that all sound very good, thousands of people are now thinking twice about actually collecting their prescriptions because of the cost. That's the real access issue. If we're going to talk access issues to medications, that is the real access issue—not at all something that's even touched on with this bill. So it's another example of the Government, I think, focusing much more on appearances than outcomes. After all, they did talk a big talk, and when it comes to delivery, these are the types of things they're offering up.

Now, in the remainder of my time, I'd like to repeat something that was mentioned earlier in relation to the Medicines Act 1981—which is older than some of the medicines that it continues to regulate; it absolutely belongs in a different era. If the Government truly was interested in making this sector better, and this sphere of operations safer, that's the Act that they'd be working on. But we haven't heard much about that. It does raise our interest, on this side of the House, as to exactly what's going on with the update of the Medicines Act 1981. As I said, it was written in an era before modest biotechnology, it doesn't reflect today's complex international supply chains, it doesn't reflect new forms of therapy, and there's absolutely gaps around things as basic—as absolutely basic—as medical devices.

Labour will support this bill's passage, mainly because it does no harm. It could have been better, but it's not—that's OK. We remain deeply concerned about the Government's overall direction in general, but particularly in health. And we implore the Government to start thinking about the fact that New Zealanders need policies that make a real difference—we hope for better, but we aim for less.

Dr CARLOS CHEUNG (National—Mt Roskill): This bill is another critical step by this Government to ensure New Zealanders have access to timely and quality healthcare. This Medicines Amendment Bill increases patient access to medicine by introducing a streamlined ratification pathway for medicine approval, the rule of two, allowing safe and effective treatment to reach patients more quickly. It's also updating prescribing settings to enable suitable qualified health professionals to prescribe an approved medicine in appropriate circumstances. This reform modernises our regulatory system and aligns with international best practice.

This Government continues to work to improve patient wellbeing and healthcare outcomes. This Government's focus is all about patients—their safety, their access, and their care. I commend this bill to the House.

TANGI UTIKERE (Labour—Palmerston North): Kia orana, Mr Speaker. It's a pleasure to take a call on the Medicines Amendment Bill, and, as colleagues from my party have indicated, we will be supporting this bill this morning. I do want to acknowledge the Health Committee, which has obviously progressed this bill which appears to have multi-party support across the Parliament, and I think it's fair to appreciate that because this is a bill that will deliver some modest technical changes that I'm sure will make some difference.

I think the jury is still out as to the full extent of the difference that it will make, because we hear from the Government that this bill is about improving access to healthcare, improving access to medicines. What would actually make a difference, I think, is a Government that introduced a bill that delivered things that led to things like three free GP visits a year. That would certainly send a strong signal around improved access to health. What would actually make a difference is a Government that would instead spend its time ensuring that free prescriptions were still made available to the community. That would have a direct impact on access to healthcare, in particular, to medicines as well. But, instead, they decide to strip all that stuff away and make it more difficult, and they have done something quite different.

Joseph Mooney: Health targets. We're investing.

TANGI UTIKERE: It's interesting that members opposite love to chip in whenever we get up, and we intend to take our full calls because the public of New Zealand deserve to hear what members of this House actually think about this legislation. It's unusual that we're sitting here on a Wednesday morning, but the Government believed that this is so important that it needs to set aside the time of select committees. I look forward to the next Government member taking a full call. [Interruption] There's no need to chip in with your interjections. You've got an opportunity to stand up and tell us exactly what it is that you want to say. So we look forward to that for the future.

This is a particular bill that relies on things like international best practice. It relies on the way in which other jurisdictions are approaching things. It relies on the fact that some specified practitioners, as identified in the bill, will have an increased level of support and ability to be able to provide medication to members of the community.

I was listening to colleagues, and I listened to my colleague from the Green Party talk about the role that pharmacists actually play in our community, and he is absolutely right. Any member of this House who talks with a community pharmacist will know that they are often the first port of call. They are the ones that don't just dispense the medication but often are in circumstances where they are required to dispense some advice—for example, when someone is choosing between one medicine or another because they can't afford it. The fact is that when they front up—and this Government have stripped away free prescriptions now so people have to pay for their medicine—pharmacists are tasked with giving advice on what medication might be better for them, given that element of choice.

What this bill does is it provides additional powers and responsibilities to specified practitioners, including pharmacists, nurse practitioners, and others as well, in addition to medical practitioners. Now, my colleague Dr McLellan talked about the fact that we cannot afford as a country, as a community, to set aside the safeguards that are in place to protect communities when it comes to medication. We expect that when someone goes and gets their medicine it's able to actually hit a particular threshold. We rely on this bill in terms of the international reciprocal approaches that may exist in terms of standards that actually do fit the bill and do cut the mustard. So whilst we are supportive of what are technical changes to this bill, it is important that the underlying intention of providing safeguards is actually not compromised, and that is something that the Labour Party do express some concern around, in particular when we're talking about the ministerial appointments to the committee that would be making recommendations that would inform the decision-making process.

We cannot afford for that to become a political exercise. Yes, we accept that Ministers of the Crown, through holding the warrant, are empowered to make those appointments. But what we don't want to see, what we cannot see, is the nature of those appointments becoming political; effectively, jobs for the boys. Instead, what is really important is that those who sit on that particular committee, who are making these decisions, have the technical skill, the medical capacity, to be able to make decisions that are right.

Dr VANESSA WEENINK (National—Banks Peninsula): Thank you, Mr Speaker. It's a pleasure to rise to speak in this third reading of the Medicines Amendment Bill. Some very sensible changes are made within this bill, and it has real-world implications for people working in the clinical coalface every day. Because of the way our supply chains are often interrupted, some medicines have to be sought that are alternative sources. That means that they are, effectively, unapproved medications and come under what's called section 29. Previously to this, only a registered medical professional could sign a prescription for those, even if another prescribing authority could prescribe the same medication, because it comes from a different factory, it's, essentially, not allowed to be prescribed any more. It creates a huge amount of confusion and extra bother for people. So this change will have real-world improvements for people on the ground, along with the other sensible changes. Therefore, I comment the bill to the House.

VANUSHI WALTERS (Labour): Thank you, Mr Speaker. It's a pleasure to join with my colleagues in support of this bill. I commend the select committee for its work; I didn't have the pleasure of sitting on the committee, but I have reviewed some of the submissions that went to the select committee, and they tend to fit into one of three categories in terms of the points that submitters were making. Some were around the time taken for approvals; some were around attracting suppliers to New Zealand—so the actual funding gap, and what fund is Pharmac committed to funding; and then there was a third broad set around access to not just medicine but healthcare.

I do think that that's relevant to this bill, and I do think that that's relevant to the intent of this bill, which is to address a healthcare issue. The Government really must recognise that all these issues, in terms of access, do sit side by side for people in their real lives. It does cost too much for them to access their prescriptions, they simply will not go and make use of that opportunity to resolve an issue at its earliest stage. If we are finding it takes up to $70 or $90 to visit your doctor, then, again, people will simply just not engage with the system whatsoever. [Interruption] I hear members commenting opposite about the cost—those are the prices in some parts of West Auckland, so those are issues for real people when it's time to access medical facilities.

The other issue is delay, when you find people who need to access specialist services having to often wait for months and months before they see a specialist, but even for the simplest of things. I've spoken to people who have had delays just getting their children vaccinated at their local GP because of the lack of nursing staff in their medical facilities. So delayed access is an important issue as well, and the Government needs to look at the cost of prescriptions. The cost of prescriptions is something you could also remove. It is part of the reason why people do not go and access those medicines at an early stage. Those submitters were making very, very valid points.

In terms of the genesis of the bill—and we do support the bill. I think that the need for the support is really there in the data. The regulatory impact statement refers to some research that was done over 20 OECD countries between 2011 and 2020 where New Zealand ranked last for the approval of modern medicines—last out of 20 countries, which is really shocking. There was a core list of 403 medicines included in that analysis and New Zealand had only publicly funded 24 of those medicines—that's 6 percent—by 2018, which is really shocking. On the 2020 study, it took New Zealand, on average, 659 days to publicly fund modern medicines, which was compared to an average of 273 days for other OECD countries, which is really, really shocking.

That research was then extended into 2025 and the data remained really bad in terms of New Zealand's comparators. New Zealanders, at 2025, are missing out on access to 142 modern medicines that are publicly funded in Australia, and 81 percent of those medicines are considered core by international standards; 38 are oncology medicines, including therapies for blood cancer. So this is really significant in terms of some of the data that demonstrates that change is needed.

Change is needed, and this will go some way to addressing that, but I think we also have to recognise that it doesn't go all the way in terms of addressing what the problem is. A number of submitters raised the issue of the gap between approvals and what Pharmac will actually fund as being a core issue that we need to address before we believe we've solved this problem. Many companies, it was argued by some submitters, wouldn't be interested in entering the New Zealand market because they don't think it's worth the effort to submit, simply because the funding isn't there overall. That problem absolutely must be addressed. Again, we do support this bill, but the view from many submitters is that it doesn't go far enough.

I wanted to briefly speak to the issue of the secondary legislation provisions that are in the bill, which the committee did make some changes to. This is new section 22AA, the recognised regulatory authority, and this is where the Minister may, by notice in the Gazette, declare a person or body to be a recognised regulatory authority if the Minister is satisfied across a number of criteria. The important thing, in my view, is that the power also gives revocation powers to the Minister, so the Minister may revoke a declaration if they're satisfied that the recognised regulatory authority no longer meets one of the criteria.

This was important in reflection of what some of the submitters to select committee reflect on, which is that while a certain list of countries can be useful in terms of predicting where we might go and who our comparators are, that's not always the case. We had members of the Wellington Community Justice Project, for example, who are made up of Victoria University law students, who argued that while a country may historically be relevant and reliable, it doesn't remain the case that they would always be so, so it's important that we have flexible powers of regulation to allow determinations to change those standards should they be required.

There were also some submitters who, again, said that the bill didn't go far enough. The Law Society was certainly one of those, and I do tend to think that we need to review those submissions in terms of understanding whether further statutory changes are needed to ensure that international players are able to pitch in to the market and have a reasonable hope that they will be considered for Pharmac in terms of funding as well, and that is absolutely a barrier.

Other members have spoken about our objection, in this side of the House, to a part of the bill. Our main objection is that the appointment to the Medicines Classification Committee should not be a ministerial appointment, and that's really because of the technical nature of this role. It shouldn't be a political appointment, and therefore our view is that that is one change that could really reassure the public that the people who are appointed are being appointed because of their technical skills. Interestingly, on this point, the UK, in 2016, looked at its processes of appointment. They were looking particularly at judges, but they did do an examination of what is an appropriate appointment and to what extent you should assure that there's independence in the appointment process. They updated their transparency and appointment guidelines—well, in 2016 they were first created; they then updated them in 2024.

I'm of the view we should be doing precisely the same thing. We should have very clear guidance on how appointments should be made and the criteria that Ministers should be following, including potentially having a system where if you have potential appointees that are vetted through a department, the Minister may only appoint from those who are deemed capable and qualified—that the Minister can not appoint from anyone who is outside that "A list", if you like, of individuals who've been individually and independently vetted. Right now, New Zealand doesn't have that system and Ministers can overlook the recommendations of a department. I think what that has meant for us is that we are subject to political appointments, but also, for me, is a lack of public trust in terms of some of our appointments.

Again, we wish that the Government had considered this. They haven't. However, we are supportive of the bill overall and I commend it to the House.

TODD STEPHENSON (ACT): Thank you, Mr Speaker. We actually live in one of the most exciting times in human history. Science has delivered to us innovations, including medical innovations, that were completely unimaginable only a few decades ago. We now understand the human genome, or we can at least sequence it; I don't know whether we completely understand it. What this amazing scientific revolution has led to in the area of medicines is that we now have new ways of treating diseases.

Yesterday, I was privileged enough actually to host an event around skin cancer, and that was put on by the Skin Cancer College Australasia. It was focused around prevention and detection, which is extremely important, but unfortunately, skin cancers can often develop into very aggressive diseases. I remember, about 15 years ago, when I was working in the medicines industry, I actually helped launch what was called the first BRAF inhibitor, which is a medicine that can actually shut down a cancer from growing. How that works is it actually attacks a particular pathway that causes the cancer to grow. That's the kind of amazing medical technology that we're faced with today, and since then, there have been lots and lots of advances: we've got CRISPR technology, we've got CAR T therapy, we've got immunotherapies. What this bill does is mean that we're actually allowing New Zealanders to get these technologies much, much faster.

We want to ensure that New Zealanders get access to all of the medical treatments that are available in other countries as quickly as possible, and I do want to commend everyone in the House for coming in behind this bill and saying, "Actually, Kiwis' health and treatments matter as much as other countries'." This pathway of allowing us to recognise two other highly competent international regulators who have approved a treatment and then expedite it into the New Zealand market is a great step forward. This was asked for by patient communities and groups; it was campaigned on by ACT, and I've got to acknowledge our other coalition partners as well; and it has been supported by members across the House. This is a way of actually making sure we get these exciting technologies and medical treatments to people quicker.

Now, there has been some talk about funding, and, look, I totally acknowledge there is more to do, but this is a very important step in making sure our regulatory processes are fit for purpose and deliver treatments in a timely manner. The Government has an entire other programme of ensuring that Pharmac is fit for purpose. We obviously have increased funding to Pharmac, and we look forward to making the case for more funding to Pharmac. I am very pleased to commend this to the House. This will make a difference to New Zealand patients and really make sure we can get new medical technologies and new treatments into New Zealand faster.

Dr LAWRENCE XU-NAN (Green): I rise on behalf of the Green Party of Aotearoa to also speak on the Medicines Amendment Bill in its third reading. Like previous speakers Hūhana Lyndon and Ricardo Menéndez March, we do support this bill. But having partook in the committee stage, there are a few things that I want to address specifically from the committee stage. A part of our time was spent discussing, particularly Part 1, clause 6, subclause (2), with regards to some of the clarifications around the idea of peer reviewing but also around susceptibility to undue pressure from industry and also political pressure. I think, in those cases, the Minister has expressed, which is very helpful, that when it comes to things like peer review etc., those regional authorities, or local authorities, do, in fact, do some of that ahead of time. The reassurance that we were given is that these peer reviews, particularly, will be in line or up to the same standards, if not better, than what we have here in Aotearoa. When we're looking at the susceptibility to industrial and political pressure, we're hoping, as the Minister expressed, that we're not going to be seeing some of those aspects.

We do still have concerns around new section 22C, when it comes to the Minister's consent by verification, although the Minister did raise the idea that the ministerial consent by verification "does not require independent assessment by the Director-General to contextualise the benefit-risk profile of the medicine due to local disease epidemiology". I think the Minister said that we are looking at a diverse culture and diverse society. When we're looking at multiple authorities around the world that do approve these sorts of medicines already, we should be reassured that those kinds of data can be extrapolated or used here in the Aotearoa New Zealand. I think, in particular, part of the concern with that is, in terms of the pharmacological properties, that we're still not entirely sure if sufficient work has been done on local disease epidemiology and how that relates to, particularly, Māori populations and Pasifika populations, as other regulatory authorities overseas may not have access to some of those data, bar a few particular regions. I think that particular challenge of that element is still something that should be teased out and should be considered when we are reviewing this bill or how this bill is put into practice.

Now, a big part of this bill is also around expanding the prescribing rights by allowing nurse practitioners to prescribe medicine under section 29 of the Medicine Act. I think this is also a really pertinent and crucial moment to thank our nurses in Aotearoa for the work that they are doing and for the challenges that they are currently facing right now in the current political environment.

Finally, I think it's also really important to address, as my colleague Ricardo Menéndez March mentioned, the surprising, and we have seen a lot of that, amendment bill that was dropped by the Minister during the committee stage without any prior select committee process and without any prior consultation with the House. In general, we've seen a number of those kinds of amendments taking place, over the last few weeks, but, in this particular case, the new addition of clause 12A, in terms of the advertisement of medicine, was something that this bill shouldn't really be addressing. If we're looking at the core essence of this bill, it is to expedite the approval of medicines and make medicines more accessible for the people of Aotearoa. We fail to see how the advertisement of medicine would support or enhance that particular purpose of the bill. I think, more concerningly, we don't want it to turn into a situation, like we are seeing in the US, where the advertisement is a way of pushing medicine to people who don't really need in the first place. That's something that is of a little bit of concern. But, overall, the Green Party does support this bill.

A party vote was called for on the question, That the Medicines Amendment Bill be now read a third time.

Ayes 121

New Zealand National 49; New Zealand Labour 34; Green Party of Aotearoa New Zealand 15; ACT New Zealand 11; New Zealand First 8; Te Pāti Māori 4.

Noes 2

Ferris; Kapa-Kingi.

Motion agreed to.

Bill read a third time.

(continued on Wednesday, 12 November 2025)

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