Sitting date: 21 October 2025

MEDICINES AMENDMENT BILL

Second Reading

Hon DAVID SEYMOUR (Associate Minister of Health): I present a legislative statement on the Medicines Amendment Bill.

ASSISTANT SPEAKER (Greg O'Connor): 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 second time.

During COVID-19, many New Zealanders were bemused that important treatments could not be allowed in New Zealand because they did not have Medsafe consent. Many people asked why it is even necessary for New Zealand to have an agency that consents things that are widely accepted in other countries. As a result of that, all three coalition parties campaigned on a concept, similar to what is in this bill, known as the rule of two. It simply says that if two other jurisdictions have consented a medication for an indication, then it can be used in New Zealand.

I want to thank Sam Uffindell, the chair of the Health Committee, and indeed the entire committee for the improvements that they have made to this bill, most notably changing the bill so that the range of countries which can be a consenting country can now be set in regulation rather than hardwired into primary legislation. This will go a long way to ensure that New Zealanders can have access to the best and latest medicines with minimal bureaucracy, and that is a very good example of this Government fixing what matters for New Zealanders.

There will also be changes to prescribing in two ways. One is that pharmacists and nurse practitioners will have their ability to prescribe medications expanded. That is particularly important in rural locations where nurse practitioners may be acting alone in remote areas and people need their prescriptions quickly.

Finally, there will also be changes for all prescribers so that in times of emergency, alternative funded but unapproved medicines can be prescribed in situations where there is a shortage of the approved medicine. This can be very important in times of—

Tākuta Ferris: Point of order, Mr Speaker. We're all told time and time again not to wear our party insignia in the House, and the Deputy Prime Minister comes in here time and time again with it on. Good on you for taking it off.

ASSISTANT SPEAKER (Greg O'Connor): Thank you for the reminder, and I'm sure the leader of the ACT Party will be very grateful for that reminder. So thank you for removing it. Continue.

Hon DAVID SEYMOUR: Yes. There are such things as magnanimity and grace, but they take time to earn in the House, and some members clearly have not spent that much time here just yet, but we have hope for them, just as we have hope for all people.

Allowing all prescribers to prescribe will mean that people can get access to medications at critical times. Finally, the Government has made a decision that it would like to introduce an Amendment Paper at the committee of the whole House stage, and that is very important for medical conferences. The whole point of a medical conference is that medicines which have not been approved or funded in New Zealand can be marketed and shown to clinicians who might well want to prescribe them in the future.

At the moment, many New Zealand medical practitioners end up taking time to go to places like Fiji or Australia to attend these conferences. We are going to introduce an amendment that will, effectively, legalise them here in New Zealand. That means that there will be an estimated $90 million in economic benefit over the next decade from being able to have these conferences here. This is something that has come through the Ministry for Regulation's red tape tip line and is a very good example of the Government listening and responding so that there can be more opportunities for New Zealanders to do well and to have greater opportunity to improve their lives through their own efforts.

That is all I need to say about this bill. It's very short. It's very positive. It will open up a lot of opportunity for New Zealanders around medication, and I hope that other parties will join in with magnanimity and grace to support something that can only be good for New Zealanders. Thank you, Mr Speaker.

ASSISTANT SPEAKER (Greg O'Connor): The question is that the motion be agreed to.

INGRID LEARY (Labour—Taieri): Thank you, Mr Speaker. Gosh, what a surprise. I didn't expect to be taking a call essentially in support of the bill as it's currently drafted and as amended and tweaked and considered—in great detail, actually—at the Health Committee to come here today and learn that, at the eleventh hour, there will be an amendment dropped at the committee of the whole House—without the ability for submitters to submit—that allows marketing and advertising of pharmaceuticals in New Zealand. Yes, it may be a great idea; however, it has come through the Ministry for Regulation, which, we know, is a creation from the ACT Party and is an interesting institution given that it's supposed to be about deregulating but is actually also being seen as a bit of an institution for fast tracking.

So I do have real concerns about that, and Labour will be looking very carefully at the detail of that amendment to see whether we agree with that or not. We wouldn't want to deprive the country of much-needed money and productivity. However, we don't also want to be like some foreign jurisdictions where we are seen as taking a silver bullet for every possible remedy, with relentless marketing on TV and with the big pharmaceuticals crowding out and basically medicalising other solutions for what could be lifestyle or other issues. I just want to put that on the record, because this is completely unexpected. We were given no warning, as far as I'm aware, and I think it does show, again, a bit of a lack of respect for due process by this Government.

Labour does support the bill as it's currently drafted. As I said, we looked at it in detail at the Health Committee, mainly because we do see that it's very difficult for a small market like New Zealand to be attractive to pharmaceuticals and particularly for those who are only going to be treating a small part of the population. It does beggar a question, really, as to whether at some point in the past we may have been better joining forces with our friends over the ditch to have a more combined market. It is very difficult to get the economies of scale that are needed, and so, for that reason, we think it's a good idea to rationalise how we look at the safety and availability of medicines. We asked a lot of questions about the system that is being introduced, and we are convinced that it is good to refer to the considerable work that is done by like-minded jurisdictions.

We also are happy that the medicines that are introduced will still need a sponsoring pharmaceutical company. That does provide a level of accountability that, we feel, will avoid New Zealand becoming a dumping-ground for inferior batches of drugs or drugs that could potentially be harmful. I'm thinking, here, when we're talking about safety, that these are important issues, because we're a generation that has seen the harms caused by drugs like thalidomide. They are in the minority, but the impacts can be devastating. So this is one of those areas of lawmaking where we really need to weigh up the benefits and the risks, and make sure that we are not being unduly difficult and disallowing potentially life-saving drugs for people in New Zealand who need them, while also making sure that we don't put members of the public at harm. It has struck a pretty good balance, we think.

The question we have, really, is whether this is going to be the magic bullet that the Government likes to think. There are a number of other issues in the health system that we think are really worthy of a great deal of attention, including funding the system properly, including workforce planning, tertiary planning and how that works with workforce, what our immigration settings are, and how we make sure we have the right numbers counted. We've got the Government saying, you know, "We need eight full-time nurses on the front line in ED departments in Dunedin Hospital." We've got the nurses saying, "We need 16." That kind of focus, I think, would see some really big impact. This is going to be more niche. Nevertheless, medicines, we do accept and agree, are the new frontier for intervention, and can make a remarkable difference to the lives of the people who get them. Time will tell whether this bill will be everything that the Government has said it will be.

I think the other area that we do have a little bit of concern about, though, is around the technical panel that the Minister will be able to appoint, because we don't want to see the politicisation of the health system and because we are all too aware of the heavy lobbying presence of pharmaceutical companies globally. They have huge market share, they invest a lot of money, and then they definitely reap the profit, and they use that to be able to lobby. We want to mitigate that influence coming into our democratic institutions. What we normally see with the appointment of these advisory committees is people who are appointed for their technical expertise, who can make evidence-based decisions and can justify them on evidence, and who the public can trust to have their best interests at heart. When we are now looking at the Medicines Classification Committee being a ministerial appointment, we don't think that is correct. It should be appointed by the director-general. Some people could argue the toss and say that, in reality, that's kind of what happens anyway, but I think that the way the law is currently drafted in this bill just leaves that too open for our liking.

The other thing we would say is that extending the exemption to prescribing unapproved medicines to nurse practitioners and the change to include prescribing pharmacists seems reasonable. Particularly, I think, we do want to see people work up to the top of scope of practice. We are already seeing changes that, I know from a mental-health perspective, I think are great, around nurse practitioners and the medication for ADHD and the difference that will make for those who are not normally able to access GPs or the health system or even psychiatrists and the specialist level of care who end up often in our courts and then in our prisons. So working to top of scope is a good idea, and I think, for pharmacists, we've also seen conglomerate pharmacy groups that, in some ways, have disempowered a little bit the active role that the community pharmacist can have in terms of being able to provide good advice—good health advice—make good decisions, and also approve where appropriate. So we think those are reasonable changes; they are pragmatic. But again, it's important to review them and to make sure that we are not unnecessarily putting people at risk. Labour would like to see the devil in the detail when the regulations and the executive orders come out about how those types of safety issues are going to be handled.

That's probably all I've got to say on this. We do welcome the Medicines Amendment Bill. People can be assured that we have given it a great deal of scrutiny at select committee, and I feel really grateful that we have somebody like my colleague Hon Dr Ayesha Verrall there who can ask these clinical expertise-type questions. Unfortunately, today we have now seen a massive change in terms of the bill that will be dropped at the committee stage. I don't understand why this was not foreshadowed. I don't understand why it has to be introduced now as a fast-track rather than earlier in the piece so that submitters could express their opinions. I certainly feel there are a lot of New Zealanders who would not want to see New Zealand emulate some of the jurisdictions such as the US, where watching dinner TV, every ad that comes on seems to be about some magic pill that is going to save your life or make you live to an old age. That's not the New Zealand we want, and I think people should be very cautious.

We will be asking lots of questions and probably doing quite a lot of research into the official documents to find out why this late amendment is going to come in so late in the piece. That's for the committee stage, and I'll just forewarn you, Mr Speaker, that we would seek your indulgence in that committee stage to really traverse those questions given that they would not have been to a select committee. So with those comments, I commend the bill to the House.

HŪHANA LYNDON (Green): Tēnā koe, Mr Speaker. On behalf of the Green Party, I rise to also tautoko this legislation, and I acknowledge our colleagues on the Health Committee, who sat and heard from a range of submitters. I think nearly 200 submitters came before the select committee in writing and orally, and there were about 30-odd in terms of oral submissions. The voice of support was very strong but there were also cautions within what was shared.

I look back to members of the Wellington Community Justice Project, who are a group of student volunteers at Victoria University, and they shared that whilst overseas regulators have been historically reliable, it doesn't mean that it's always that way. While the bill allows the Minister to make rules for verification through secondary legislation and they can be refined and reflected to best practice at an international level, they felt that there still needs to be something within the text of the bill itself to ensure that the regulatory authorities themselves are regularly assessed and uphold standards of international best practice. That's really helpful in terms of the way in which we look at a system in its entirety, acknowledging that the Minister will be a part—one of those important cogs—of the approvals, ultimately, and that the legislation also opens up the space for us to have two overseas-recognised regulators putting forward medications.

Reflecting also on submissions, Te Hau Āwhiowhio ō Otangarei Trust from Whangārei spoke to the select committee. They, as clinicians, celebrated the way in which there could be an expansion in terms of prescribing, knowing that we have shortages in the workforce and we have such a talented range of kaimahi within the health system who could join in this space with that relevant clinical supervision and the right provisions in place for their clinical safety, but they could also become prescribers. In Ōtāngarei, for those that don't know, this community has high levels of deprivation. It's an urban community in Whangārei, and they have big waiting lists, like many do in the primary care system. But the nurses and the manager came online and shared that they really welcomed the opportunity, at a community grassroots level, to increase the way in which they can provide access to timely quality medications for their communities that they serve.

I think that that really reflects the intent, knowing that it is a bit of fast-track medicine legislation and we don't know what the amendments will be, and that's a pity, because we could have had that interrogation by submitters if it had been received earlier. The opportunity for us to sit as a select committee, ask the relevant pātai, or questions, and then for submitters—because the submitters were diverse. We had industry, we had health sector, we had leadership from the health sector, and we had our students who had put forward voice, and so there was a missed opportunity there for us to interrogate what are proposed amendments.

We know that we want to get faster access to medicines, and it's absolutely welcomed, but there also needs to be consideration around the wider pūnaha hauora, or the wider health system, in terms of both medication and the medicines but also access to those skilled clinicians that are needed in the community but also in secondary and tertiary care. Thinking about those issues, it is a question for the Government and the Ministers to consider: how do we fuel and how do we resource the health system to be as effective as possible? While we're gearing up access to medicines and we're recalibrating the way in which we can get medicines into New Zealand, how does the system overall prepare for that, and then will that see the ripple effect in communities like Ōtāngarei, or in Hokianga Health and Hokianga Rāwene—at the hospital there—or at Te Hiku Hauora in Kaitāia? Will they see benefit in knowing that they're always under clinical pressure to the demands of community?

There's a significant lack in primary care right now, for instance, in the far Far North. In Kaitāia, there are some 3,000 whānau in Kaitāia that don't have access to a GP right now. It is like we are here in one part of a system and we're gearing it up for action, and then we've got these other areas within te pūnaha hauora—our health system—that need solid support and resourcing, and then, of course, we need to find the relevant workforce to go to rural populations and provide support.

I think that in terms of what the Green Party supports, we absolutely honour the way in which voice came through in the select committee and the way that we, as a select committee, worked together in our questioning and the robustness of the dialogue, considering also the way in which we can, as the Health Committee now, just challenge ourselves as members of that Health Committee. When it comes time for the committee of the whole House and the amendments that are to come in, we can take a look at it with our own critical eye, knowing that we have had hands on the steering wheel to date. They will be new amendments that we're not aware of, and we all could take the opportunity to have a good look at them and to look at the pros and cons that might be there. But also, knowing that we have that general support around the House for this legislation, how can we ensure that whatever amendments come through don't undermine that collective support that we have across the House—which is great. It's great to be working together and seeing this legislation come through.

On behalf of the Green Party, we absolutely know that this is an important step in terms of supporting increased ways in which our whānau, our hapū, and our community can access increased medications within whatever sphere of illness that they suffer, but the wider questions still remain and are outstanding in terms of what are the remedies, what are the solutions, and what resource is there to support the strengthened workforce, who will need to take on board this legislation and become those prescribers. Is the training, the supports, and the clinical supervision there? Is the workforce ready to deliver it, are we gearing them up, and do we need to look at the commencement date?

These are the types of levers that are available to help ready the system to start receiving these opportunities coming up, and then, further, the health system in general. We cannot turn a blind eye to the pressure points that exist within a strained health system in terms of workplace safety, patient-staff ratios, and pay and equity—and, as we start supporting more kaimahi to be prescribers, can we afford that, because it's awesome for them clinically, but can the system afford that? We see that strikes are coming up on 23 October, so clearly there are some issues within the health system. But, by and large, we are here and we tautoko, in general, for now. As we get into the committee of the whole House, we'll see what those amendments look like, and we'll put the relevant interrogation and robust consideration into that space.

But I thank the Minister and all of those who have provided submissions into the process. You voice was heard. Your voice clearly articulated both considerations and some concerns, but through the process we have come out the other side, and the Green Party supports this. Kia ora.

Dr HAMISH CAMPBELL (National—Ilam): Excellent. Thank you, Mr Speaker. It's with great pleasure I rise to support the Medicines Amendment Bill, and it's great to hear the other parties in the House so far are supporting this bill as well. This bill is about making it easier for New Zealanders to access medicines they need in a timely manner, because we know that some of these medicines can be the difference between life and death.

We've also heard one of the main amendments of this bill, from the Medicines Act 1981, is going to make a new pathway in which we can get medicines approved here in New Zealand. It does seem a little bit strange that when there's been other countries of the same ilk who have approved medicines that we would have to have a long, drawn-out procedure before they could be used here in New Zealand. This is about having new pathway to speed that up.

It's also about increasing the ability of some of some of our healthcare professionals to be able to prescribe what we call Section 29 medicines. And this is very important because we know, as COVID showed, sometimes there's breaks in the supply chain. We need to have alternatives on hand because as I say, this is about the lives of New Zealanders and the quality of life of all New Zealanders. Therefore, I commend this bill to the House.

JENNY MARCROFT (NZ First): Thank you, Mr Speaker. It's a pleasure to rise on behalf of New Zealand First in support of the Medicines Amendment Bill in its second reading. What a great Health Committee we have. We had a great process of taking a look at this bill. We worked collaboratively and I think we have produced some good amendments which the entire committee unanimously agreed to. We heard 185 submissions and oral evidence from 32 submitters.

The point of this bill is to help more New Zealanders to be able to access the medicines that they need. It will allow the medicines to be approved for distribution in New Zealand when they've been approved by two other overseas jurisdictions. This makes sense. This will reduce the time it takes to get the medicines approved. It's called the rule of two. It's great to see that the coalition Government—we came into this coalition with the same concerns around the processes around Pharmac. This bill goes some way to amend some of that.

There will also be a couple of other additions into this bill where we will ensure that those prescribing, whether they're nurse practitioners, or, as we included, pharmacist prescribers, will be able to work at top of scope. Because they have really good clinical skill levels—very high clinical skill levels—enabling them to prescribe medicines under section 29 will ensure that if there is that break in the supply chain, as others have mentioned, these prescribers will be able to get these medicines out to patients.

We did also do a little amendment around replacing calendar days with working days. It was a tiny technical amendment which actually would have slowed down the process for progressing these medicines through the approval process.

This is a very good bill. I acknowledge the committee and all of those from Medsafe who worked on this with us so we could understand the entire process. The committee, as I mentioned, recommends all the amendments unanimously. I commend this bill to the House.

ASSISTANT SPEAKER (Greg O'Connor): Five-minute split call—Tākuta Ferris.

TĀKUTA FERRIS (Te Pāti Māori—Te Tai Tonga):

[Authorised reo Māori text to be inserted by the Hansard Office.]

[Authorised translation to be inserted by the Hansard Office.]

RICARDO MENÉNDEZ MARCH (Green): Thank you, Mr Speaker. The Green Party is supporting the second reading of the Medicines Amendment Bill. My colleague Hūhana Lyndon already outlined some of the reasons why we feel more confident in our support. As it would have been noted, initially, we had some concerns around the pharmaceutical industry's influence over the overseas regulators and that there need to be adequate protections. Also, we wanted a more streamlined approach and to get some certainty and/or guarantees that it would not compromise medicine safety, and that the interests of Māori and medicine are appropriately protected.

I want to commend the Health Committee for the work they did to also put in place some changes to the bill. One thing I did want to note around the list of recognised overseas regulators is particularly around the fact that yes, we did have a framework—that's now been created and it's been tightened—and the new section 22AA, inserted by clause 7. One thing that I did want to point out is the requirement that the person or body "conducts their business and releases reports in English." I think that needs to be further looked at by the Minister and the Government because I think, to me, this does narrow the range of regulators that the Government could be tapping into. Right now, it's the Anglosphere as well as countries that may conduct a business in English, but I also want to acknowledge that, ultimately, there may be countries that may be putting quite a bit of resourcing into the medicine space that may not choose to conduct their business in English. Ultimately, the Government could be choosing to resource adequate translation and interpretation services within the public sector to make sure that we can tap into those spheres and resources when they do exist.

Another part of this bill is around the prescription of unapproved medicines by pharmacist prescribers. I think this has potential to broaden the scope of the workforce that is able to do this. I note that, particularly, unapproved medicines are prescribed in a more common way due to global shortages, but, at the end of the day, if we're going to be broadening who's able to do these prescriptions, the workforce needs to be adequately supported as well.

Pharmacies across the country—those that are more community-led—are facing a more perilous position due to the creeping corporatisation of the pharmacies. Part of the public having trust that this new system will work in practice is also knowing and being confident that our workforce is grounded in knowing the community and being able to adequately prescribe in a way that also meets the specific population needs. I think this is where the Government needs to also do additional work to better support our pharmacists, and our pharmacies more broadly as well. We know that the way in which the contracts work is very out of date and also that pharmacies are the almost the front line and the first point of contact for many population groups that are not able to access other forms of primary care. So, for example, pharmacies are often the point of contact for people who have been recently incarcerated, who may have gang-affiliated connections, people who the system has left behind but who nonetheless deserve access to healthcare.

With these broadening provisions for the prescription of unapproved medicines, what will be key is ensuring that the workforce is supported so that these decisions are made in an informed way. So, we also hold concerns about the current state of our healthcare system because I think, sometimes, bills and the intent of bills are not often matched with the resourcing and realities on the ground. In order for this bill to be successful, I think we will need to make sure that our public service and people at the front lines, pharmacies, and GP clinics are given the support that they need. This is, I think, a future area of work that the Government needs to continue embarking with so that the public has the confidence so that when there are, for example, global shortages of approved medicines, that those prescriptions are made in a way that genuinely meets the need of our communities.

But on the whole, we welcome the Government taking steps to give people greater access to medicines, to make sure that we tap into global knowledge where we can, but that we also create greater protections to make sure that when we are making these decisions, the pharmaceutical industry isn't having undue influence on how we choose to do them. Kia ora.

Dr CARLOS CHEUNG (National—Mt Roskill): I rise to support the Medicines Amendment Bill, which makes meaningful improvements to our health system. It will allow medicine already approved in recognised overseas jurisdictions to be approved in New Zealand within 30 working days. It also enables the wider prescribing of unapproved medicines in specific cases, while ensuring all the prescribers stay within their professional scope over their approved list.

These changes will improve access, reduce delay, and support timely and high-quality care. For communities like Mt Roskill, this means faster treatment and better health outcomes. I commend this bill to the House.

ASSISTANT SPEAKER (Greg O'Connor): Just before the next speaker, Dr Cheung, I just encourage you to not read your whole presentation, particularly when it's that short. Thank you.

Dr TRACEY McLELLAN (Labour): Thank you, Mr Speaker, and thank you. I also will make a relatively lengthy contribution to the Medicines Amendment Bill, which Labour will be supporting, but, obviously, we do have some concerns so we'll be cautiously supporting—and that late amendment does give rise to some extra considerations, which my colleague Ingrid Leary said will be well and truly interrogated at the committee of the whole House stage, given that it hasn't had any scrutiny to date.

The bill, as has been said, creates a new consent by verification pathway for Medsafe to approve medicines faster, and that sounds like it's a really good idea. We do agree that, certainly on the surface, that does sound like a really good idea. People should have access to medicines quickly and efficiently, and anything we can do to improve the process under which the current system works is good news. If a medicine has full approval from the two approved overseas regulators, which we've heard today being termed as—I can't now actually remember what the term was, but it was something to do with the number two, which I thought was a little bit ironic and—

Jenny Marcroft: Rule of two.

Dr TRACEY McLELLAN: The rule of two—rule of two. Thank you, Jenny Marcroft, for availing me of that information. So the two approved overseas regulators, then, therefore, its sponsor, which would be the pharmaceutical company, can apply for a streamlined approval to be able to market it here. The bill also extends the prescribing rights for unapproved medicines, which I think is really important, to nurse practitioners and prescribing pharmacists.

I would like to take the opportunity to give a wee bit of a shoutout to nurse practitioners and nurse prescribers, who I think do an amazing job. Before plying my wares in this House, I worked for the New Zealand Nurses Organisation and represented some fabulous nurse practitioners and nurse prescribers, which is a relatively newish concept within the scope of what nursing offers in New Zealand. It is something that we should continue to support: the ability of our fabulous nurses to do more and more in our healthcare system.

The updates and processes for recognising approved overseas regulators now needs to be based—and this bill purports to do that—on clear criteria instead of naming them directly in the legislation, which we think sounds sensible. Listening to my colleague Ingrid Leary earlier on making her contribution, she provided a little bit more detail about that, and we're happy to agree with that.

Now, it also changes how members of the Medicines Classification Committee are going to be appointed. My understanding—having looked through this bill and having listened to some of the kōrero at the select committee process—is that that's now going to be a ministerial appointment, not by the Director-General of Health. That is something that we do take issue with, and I'm going to elaborate on that a little bit more.

If we look at the main issues, I think the main issues in this bill that do warrant some clarification—there's probably six main points. Labour does support the bill, but we support it with some caution. We support faster access to safe, effective medicines, and we are relatively reassured that the patient's safety remains central, as proposed in this bill. But we do want to say that it's not automatic, the approval process, and so it's not quite what the coalition agreement promised.

Hon David Seymour: Oh, 30 days!

Dr TRACEY McLELLAN: But, nevertheless, we understand the complexities around thinking what you might do before you get to Government and then having to work constructively to do so. But—

Hon David Seymour: How did the member learn about that?

Dr TRACEY McLELLAN: Just noting the point, Mr Seymour, just noting the point.

The key limitations remain. It still requires a sponsor application. Companies need to see a commercial reason to apply in the first place, and the biggest barrier to that is going to be and will remain Pharmac funding, not necessarily Medsafe approval times. So unless Pharmac can fund the medicine, companies simply aren't going to bother making those applications and applying in the first place. Therefore, the outcome from that is that patients still won't benefit from those medications. So in itself the bill—again, happy to support it, but—it certainly won't fix access on its own.

The third point worth mentioning is that it applies only to new medicines. It doesn't include changes to existing drugs, new indications, formulations, or administration routes, and these actually make up a large share of the Medsafe applications. So the practical, real-life implication might not necessarily be as big as it sounds on the tin.

The fourth point I wanted to make was about changes to approved overseas regulators. We are pleased with the select committee process with regards to this and the improvements that were made. The regulators will now be approved by criteria that won't necessarily have to be locked into legislation, and that allows the flexibility that I think is required in that circumstance. It also allows for the flexibility, if political interference—something that could affect trust in regulators.

The fifth point is the prescribing changes. I think it absolutely is a reasonable extension to reflect what is, as I intimated earlier, a more and more modern practice when we look at who can prescribe and how those prescriptions are made. It's particularly helpful amid any kind of global medicines shortages. We have had plenty of examples in this country, over the last short while, where, for one reason or another, there have been particular shortages or particular blockages in either the medicines that we hold or in the way that we've been able to disseminate them to the public. So I think that that's good. But it should be reviewed regularly, and I think that that is just wise. Most people would agree that when we're talking about something as critical as the safety of medicines, we would like to ensure that that is reviewed regularly to ensure that the safety continues and therefore the effectiveness is in place.

The last point, as I alluded to, was the committee appointment change. We are opposed to this aspect and I think it is worth being very explicit about that. The Medicines Classification Committee, we think, should remain absolutely independent. I think that's important not just from a practical point of view or a procedural point of view but also from the perspective of public trust and the absolute public buy-in that needs to happen to maintain the integrity of a robust system. Technical appointments, we think, most definitely belong with the Director-General of Health and certainly not the Minister.

The bill, as we say, is about ensuring safe, timely access to medicines, which is something that I think everybody in this House agrees that every family and every person deserves in this country. Certainly, Labour agrees with that. It is our focus and it remains our focus: making it cheaper and easier for everybody in this country to see a doctor or a nurse, a professional that is close to the home. Speaking of which, we know that, certainly under this Government's watch, it's become harder than ever to see a doctor or a nurse or a specialist. I can't help but reflect on the fact that National's focus on cutting corners, on shifting control to Ministers rather than making the system work for patients, has been a step in the wrong direction. We know that families are paying more, they're waiting longer, and they're getting less. While this Government may tinker around the edges—and certainly this is one aspect of tinkering that we do support—it's not part of the bigger picture and it's something that doesn't go nearly far enough of what needs to happen in this country.

So we support this bill because it improves efficiency, but I want to reiterate the point that faster paperwork doesn't mean faster access if Pharmac isn't properly funded. We believe that Kiwis deserve quick, safe, effective, and affordable treatments and medicines that work as well.

CARL BATES (National—Whanganui): It's unfortunate that on something that has wide support of the House, the member who just resumed her seat, Tracey McLellan, couldn't but help herself to take the opportunity to spread misinformation about what this Government is doing in the health sector. I find it is my obligation to remind the House that this Government is putting more money into health than ever before—ever before. Despite the amount of money we have to spend on interest because of the previous Government's mismanagement of the economy, we have put more money into health than ever before.

My constituents of the mighty, wonderful Whanganui electorate, like the previous speaker said, are pleased to see another pathway for the speedy approval of medicines here in New Zealand, and I thought that it would be valuable to end the pre - dinner break contribution to this bill by noting what those countries are that are recognised as part of the fast-track 30 - working day approval for medications, the "working day" part being added as part of the Health Committee process. Those are the European Union, Australia, Canada, the United States of America, the United Kingdom, Singapore, and Switzerland. If a country has a medicine approved by two of those countries, then clearly it is appropriate for approval here. I commend the bill to the House.

ASSISTANT SPEAKER (Greg O'Connor): The time has come for me to leave the Chair for the dinner break. The House will resume at 7.30.

Sitting suspended from 5.56 p.m. to 7.30 p.m.

DEPUTY SPEAKER: The House is resumed. When the House rose for the dinner break, we were discussing the Medicines Amendment Bill. We're up to call No. 10 and it's a split call for Labour—Helen White.

HELEN WHITE (Labour—Mt Albert): Thank you, Madam Speaker. I want to start my call by talking about the things that are really good about this bill and that we very much support. I think the swift approval process makes a lot of sense, and it looks like the Health Committee did some very good work making sure that there are a great deal of standards around that situation, and I like the amendment with regard to nurse practitioners and prescribers.

Like one of our other speakers, I've worked as a lawyer for people who have been doing those jobs and it's a great career pathway. They are extremely skilled, they are well trained—they have four years of training, they have 300 clinical hours—and they are good people to extend that part of the Act to.

I am concerned to hear about a new amendment. If the Minister has what sounds like a substantial amendment ready, I'd like to see it. I would have liked to stand up and take this call knowing the full effect of it because it sounds like it's about medical conferences in New Zealand, and that's a very different purpose from the rest of the Act. It will be something that we will need to scrutinise. I'd love to see that amendment. I don't know if it's good or bad.

The concerns in this area for New Zealanders are very real. I recently read a book that many people in this House have probably read, which was called Empire of Pain and it was about the opioid crisis in the US. It didn't actually mention New Zealand in it. It wasn't that it didn't touch us, but we had very different rules around the way that medicines are advertised, etc., and it has absolutely caused a world of pain in the US to have had the rules they had.

People have such a right to care about rules in this area. We had a select committee process and if this amendment was something that was seen as beneficial and was on the boil, it would have been really good for the people who made submissions to be able to contribute their knowledge in this process. I picked up an article that was about the lessons to be learnt from that crisis. That was by a New Zealand doctor and so I simply don't know whether I'm dealing with something that might open New Zealanders up in a way and make them vulnerable or not. It's best practice that it goes through a select committee process, for a good reason. There are experts in this field, international lessons to be learnt, and we have a very powerful pharmaceutical industry across the world. We have the example of what happened with the Sackler family enterprise in that book. If anybody is interested, I think it's an amazing read. And they weren't alone.

These kinds of loopholes in the law have caused huge tragedies and the ways that we structure our laws can make a huge difference, and so it's really important. I don't mean to suggest that there is an issue here, because I simply don't know. I would like to see that amendment as soon as possible. I will be looking at it carefully, and I know that my colleagues will, but that's not really the point. The point is, it's the people who are the experts in the area, and it is also the people who might be the victims of anything that we get wrong in this House.

I love our select committee system and I tell young children that I visit that it is the most incredible thing about New Zealand and the parliamentary system that they can make a submission, that people will listen to them, and, actually, if we get it wrong, we can change things before it's too late through that system. It is a participatory democracy. So I would like to see that—the sooner the better. Other than that, I commend this bill to the House. Thank you.

NANCY LU (National): The purpose of this bill—the Medicines Amendment Bill, in its second reading—is to speed up the approval of, and access to, medicines for patients in need in New Zealand. Therefore, it is good for patients in need; it is good for the families of the patients. We are a Government that puts patients first; therefore, I commend the bill to the House.

VANUSHI WALTERS (Labour): Thank you, Madam Speaker, for the opportunity to speak on the Medicines Amendment Bill. I wasn't a member of the committee, but there were a few times when I subbed on and the committee were considering matters of secondary legislation powers in various bills. I do think that that is an interesting matter to consider, when you're thinking about medicines and how they are regulated, because there is a huge amount of public interest in terms of getting it right and making sure they are accessible.

I did go back and read some of the submissions in relation to this bill, and it felt, to me, like there were three categories of issues that submitters were really focused on. The first was the approval times for medicines to get approved by Medsafe. The second was the issue of actually attracting those big providers—those big companies—to New Zealand, given what Pharmac does and doesn't fund and the timing in terms of it being inside New Zealand and being able to be funded. And then there were some submitters who spoke to broader issues in this space as well, in terms of access to medicines, which I do think are relevant, because, largely, the suggestion was that while this will fix some of the issues, it's not going to address all the issues that are relevant in terms of New Zealanders being able to access medicines.

Before I speak to the content of the bill that we have in front of us now, I just wanted to echo the comments made by Helen White in relation to the Government's indication that we'll see an amendment at the committee of the whole House. Much like Miss White, I am disappointed that that hasn't been brought to the committee at an earlier stage, because, as I've said, I think this is an area of huge public interest, and I suspect that there would have been submissions in terms of what is and isn't permissible at those medical conferences. I do think it's a shame, but I would just urge the Government to ensure that members of the committee have access to that as soon as possible.

The committee of the whole House is, of course, only effective when we've truly been able to engage with the materials well. And certainly, as long as there's a sufficient gap between this second reading and the committee of the whole House, there's an opportunity to speak to the Hon Dr Ayesha Verrall and ensure that as many conversations as is possible can be had with relevant stakeholders before the committee stage happens.

The first thing I always tend to look at, in terms of legislation that comes to the House, is the gap that it's trying to fill, to determine what the scope of the gap is and whether the legislation has done that. This bill's regulatory impact statement sites research comparing the registration of medicines across 20 OECD countries, which, in shocking news, between 2011 and 2020, New Zealand ranked last for the approval of modern medicines. And so it is about looking at that quite shocking, in many ways, gap, in terms of New Zealand being able to be relatively similar to countries that we would consider us ourselves similar to.

However, there is also the secondary issue which came up in multiple submissions about medicines not being funded by Pharmac, and external providers not seeing that as a viable opportunity. So while this certainly does address one of the issues, it doesn't address the second leg of the issues, and so there's, actually, a big question mark about whether this will go the whole way in resolving the issue of ensuring that there is access to medicines.

Many who've spoken about the bill earlier this evening have spoken about the two-limb test, or the test of two. I also forget the precise—

Todd Stephenson: The rule of two.

VANUSHI WALTERS: The rule of two. We'll get it eventually, won't we? The rule of two. And I do think looking at the select committee's report, and their work on this section in particular, it was useful to see how they shifted from that list of specific countries to, actually, a broader power so that a determination could be made on a set of factors, as opposed to just looking at those countries themselves.

There was one submitter who pointed to the fact that part of the rationale for that being a sensible way to go is that we can't always guarantee that in other countries their authorisation agency will be politically independent; it could be motivated by lobbyists in very, very different ways, and they gave some, I thought, quite useful specific examples of that as well.

The secondary legislation point—so that is the piece that creates secondary legislation—it's in clause 7, new section 22A, which gives the Minister the power to gazette and then recognise on the basis of those new criteria. But again, I would like to say—and I know I probably said this many times—that I do think it's a very careful line to walk, in terms of understanding where we should set those secondary powers. And calling my time on the Regulations Review Committee last term, there was a reflection on the trend towards creating broader powers in secondary legislation. But, as a House, we should always be remembering that the accountability mechanisms have remained the same.

We have the Regulations Review Committee—absolutely—but that has limited capacity, and it certainly does rely on issues coming to it at times, in terms of people challenging whether the power is—

Arena Williams: Hey, don't talk mean about that committee.

VANUSHI WALTERS: I hear the enthusiastic contributions from the current chair of the committee, Arena Williams. It is a very important role, that function of the committee, in terms of deciding not to be explicit and giving these broader powers is useful, but we also must be mindful that that is exercised in the way that it should be.

I've spoken to one of the changes made by the select committee to the bill during the process. I also mentioned that there were other submitters who spoke about broader issues. The Law Association's submission was one of those, and the Law Association said that "The Bill may get medicines into the country faster. That's a good thing. Yet, it means very little if patients in most need of them cannot access a pharmacist in the first instance". They went on to say, "The cost savings of addressing issues at their root are also significant. If the hospitalisation rates of those who could not afford a prescription, representing an unmet need, were reduced to the levels of those with no unmet needs". And they say that "there could be 27,000 fewer hospitalisations over a three-year period. With the cost of staying overnight in a hospital being estimated at $1.200,".

The point here is that an important piece of the access to a medication's story is people actually going to their pharmacy to get it. The cost of getting that medication is often a barrier for people, and they propose that there should be free prescriptions. This is, of course, something that the Labour Government introduced and that, in July this year, was removed. That is a factor that is going to still be front of mind for a lot of people who are choosing whether they do make the choice to spend that money getting their prescription, or whether they go another week. And if they go another week, we risk them presenting in the hospital. That's just something to be mindful of. This isn't the whole story of access to medicine.

Earlier this evening, Ingrid Leary spoke to one of our objections, which is the appointments process, and she spoke to the fact that our view is that, given the independence required but also the technical requirements—and so technical expertise of the individuals—that, perhaps, the director should be making these appointments, as opposed to the Minister. At the moment, in our Crown Entities Act, it is quite specific about how appointments can be made, but I'd just like to draw the House's attention to a review that the UK did, in 2016, where they overhauled the way they make appointments.

They have a new code of practice that was introduced in 2016, with updates in 2024, with a real understanding that for the public to trust these institutions, they need to know that they're independent, and they need to trust not only the individuals who are in those roles but the way in which they were appointed. So there's an opportunity to learn from the UK, look at our appointment system, and see whether, in regard to roles such as these, we should now be looking to a more independent model. With that, I commend this bill to the House.

Dr VANESSA WEENINK (National—Banks Peninsula): Thank you, Madam Speaker. It is a pleasure to be able to speak on this very sensible bill, which is the Medicines Amendment Bill, and I do commend the Associate Minister of Health and the Health Committee for their diligent work in this.

A couple of things that really excite me about this: firstly, the expansion of nurse practitioners to be able to prescribe unapproved medicines where that's appropriate to their scope of practice. That was very painful, I'd have to say, as a GP, to have to prescribe medicines just because they were unavailable—that made it a section 29. It meant that otherwise approved medications, just because they came from a different manufacturer, were no longer able to be supplied, so it was very, very tedious. I commend the bill to the House.

Motion agreed to.

Bill read a second time.

Home Page | Parliament | Previous Story | Next Story

Copyright (c) Scoop Media