Sitting date: 8 Apr 2025

MEDICINES AMENDMENT BILL

First Reading

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

ASSISTANT SPEAKER (Maureen Pugh): 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 first time. I nominate the Health Committee to consider the bill. At the appropriate time, I intend to move the bill be reported to the House four months and one day after it has received its first reading.

The purpose of the bill is to help more Kiwis to be able to access the medicines they need to live a fulfilling life. The bill contains two main parts: one is a verification pathway, and the second is a number of changes to prescribing rights. Both of these changes are designed to make it easier for New Zealanders to get timely access to medicines so that they can live longer, happier, healthier lives. Both of these initiatives remove red tape and regulation that stop people from doing beneficial things, but that red tape and regulation doesn't actually protect them from any harm.

To start with the bill's verification pathway, it will be an expedited alternative to the pathways currently available for pharmaceutical companies seeking consent to market their medicines in New Zealand. It will mean that, if a medicine has already been approved by two recognised overseas regulators, then Medsafe—the Government's agency for consenting medicines to be allowed to be marketed in New Zealand—will not need to carry out its usual full assessment.

I want to acknowledge that this idea is one that all three parties—the ACT Party, New Zealand First, and the National Party—all campaigned on in the lead-up to the election, and it is a commitment in the coalition agreements of all three parties. It comes from the fact that, in recent years, many global medicine regulators have adopted what are called "reliance models" for approving medicines, and these models rely, partially, on an approval and assessment report by another recognised regulatory authority overseas.

Now, Medsafe first adopted a reliance pathway 15 years ago and was one of—we're actually one of the first countries to do this. But, in New Zealand, our time frames for medicine approval are still slower than Australia's target. They are far too slow, in fact, for many New Zealanders to receive the medicines that they need. The new verification pathway will mean that any applicants that can demonstrate their products have approval from two recognised overseas regulators can have their products approved for marketing in New Zealand much, much quicker. At the moment, it can take 400 days for a new medicine that's allowed to be used elsewhere—and I'm talking 400 working days, so two years—to be allowed in New Zealand. Under this rule, if it's approved in two other countries, it'll be allowed in New Zealand after only 30 days.

I'd just make the point that I think this occurred to many of us during the time of COVID, when so many new treatments, new devices, were being created in order to battle COVID-19 and all its different variants. And oftentimes, things that were available and being used in other countries were not available here. Those of us who were in Opposition at the time would ask the Government, "Why is it good enough for Australians but not good enough for New Zealanders? Or good enough for Americans or Canadians but not good enough for New Zealanders?" And the answer was, "Oh, well, Medsafe has to approve it first." And we asked, "Why would we wait for Medsafe to prove that the rest of the world got it right?" Because Medsafe has never found something that's been approved overseas and not allowed it to be used here. The facts are—

Hon Dr Ayesha Verrall: Didn't we amend the Medicines Act over urgency when it came to the vaccines?

Hon DAVID SEYMOUR: We've got Ayesha Verrall heckling, saying, "Oh, we made amendments in the Medicines Act." Well, that's right, because even the previous Government found it so frustrating to have to do a separate approval when it was approved overseas, and of course, if the previous Government had fixed the problem, we wouldn't be here. In fact, if the previous Government had fixed more problems like this, they might be over here, but they're not; they're over there, because they were hopeless at fixing problems. But that's enough from Ayesha Verrall—she's had a go. She's had her chance.

Now, this verification pathway is actually part of the Government's wider work programme to streamline Medsafe's processes, find efficiencies, and speed up the public's access to medicines while maintaining appropriate safety measures and Medsafe's credibility as a trusted regulator, which I think is important. In this case, we have less red tape, more speed, and more access to medicines while maintaining the same level of safety, because we'll be asking ourselves: have any two of Australia, the United States, Japan, Switzerland, Great Britain, Canada, the European Union—you know, if any two of those jurisdictions have approved a medicine, the chances are that they didn't both get it wrong and it's safe to use here within 30 days, and I think that that's a wonderful improvement.

We're also going to be making changes to prescribing. This bill will help make medicine processes more efficient by expanding the ability for more types of prescribers to prescribe unapproved medicines for their patients where those are necessary for their care, and I want to acknowledge the role that the former Minister of Health Dr Shane Reti played in this change. Medicines that are unapproved in New Zealand are sometimes necessary for a patient's care as a last resort, and that particularly happens during a shortage, where the thing that's gone through the consenting process in New Zealand, even with the new faster process, may not be available because, often, there are shortages, especially in recent years with supply chain troubles. At the moment, only medical practitioners can prescribe what they call off label: give a different medicine—a substitute—while the usual medicine is unavailable. This bill expands that ability to nurse practitioners.

Nurse practitioners have advanced education in clinical training to practice, they can work autonomously, and they're often involved in innovative service provision. It's time to give them a bigger role. Especially in rural and other communities which have difficulties in accessing GP services, nurse practitioners are hugely important—not to mention in aged residential care. Now, nurse practitioners can currently prescribe a range of medicines for their patients, but enabling them to prescribe unapproved medicines within their scope of practice, I think that's appropriate for their patients—in the scope where these are appropriate for the patient's care, it means that the patients can access medicines faster and will not be required to seek a prescription from a medical practitioner.

Finally, in further changes to prescribing, the bill goes further and enables all authorised prescribers to prescribe unapproved but funded medicines in situations where there's a supply shortage. For example, in 2020, Pharmac funded an alternative oral contraceptive because there was a supply shortage, and with increasing supply chain issues, as I've mentioned, it's important that we have that flexibility. When there's a supply shortage of approved medicines, Pharmac can fund unapproved medicines as a temporary alternative, and yet not have to go through a consenting process all the while. It means that for patients that may not be able to get a prescription filled when they take it to a pharmacy, they can get another prescription from a GP because the only medicine available is that unapproved alternative.

The proposed changes will mean that pharmacists, prescribers, registered midwives, dentists, nurse practitioners, dieticians, and optometrists will be able to prescribe these medicines within their scope of practice, and this is going to save time for patients, doctors, pharmacists, and other health practitioners, and it will improve the continuity of care. All of our authorised prescribers are trained professionals, and this Government wants to make the best use of our health workforce.

As I was thinking about this bill coming to the House and the work that's gone into preparing it, I was thinking about the challenge that we face in healthcare. We have an ageing population, we have increasing amounts of medical technology, and we have enormous challenges affording the standards of healthcare that people want. I'm reminded of one of the greatest New Zealanders—that is, Sir Ernest Rutherford—who once said that we didn't have much money, so we had to think, and this is a small contribution to that culture.

We don't have much money, so we've got to think. If a medicine is already approved in two other countries, let's make it available to New Zealanders, because we ain't going to find anything that two other advanced countries that are already using the medicine haven't found. Other countries are already relying on each other; we should rely on them, too. If there's a medical shortage and there's a person who is qualified and capable, such as a nurse practitioner, of issuing a prescription of something off label, then let's let them do it, because if you don't have much money, you've got to think.

We're going to have to do a lot more of this in healthcare: remove red tape, enable people and empower them, and let them make a bigger difference. If we do all of that, then I think we can overcome the severe challenges that we face in healthcare in this country and across the developed world, and with that, I commend this bill to the House very much.

ASSISTANT SPEAKER (Maureen Pugh): The question is that the motion be agreed to.

Hon Dr AYESHA VERRALL (Labour): It's nice to hear that speech by David Seymour—a man who has many bad ideas, but I'm not convinced this is one of them. At the heart of the issue of medicines regulation lies the issue of patient safety, and it is important to recognise how important it is to New Zealanders that Medsafe and international regulatory organisations focus on that: ensuring the safety, quality, and efficacy of our medicines. Medsafe has a rigorous assessment process that protects public health by preventing the entry of unsafe and ineffective medicines to New Zealand.

I am not as rosy on the look of the history of medicines regulation as the Associate Minister of Health was. When I look at New Zealand's history and around the world, there certainly are examples where medicines regulators have not got it right. We should never forget that. The example that was important in the early part of my career was formoterol, asthma medication that caused children's death.

However, in New Zealand and around the world, there are regulatory bodies that do a good job of assessing the science, the data, and making sure that medicines that are available in markets are safe. Medsafe New Zealand has achieved that, but so have many others around the around the world. For that reason, Labour will support this legislation at its first reading so that these important issues can be considered at select committee.

The Minister was right to point out that the verification pathway is the focus of this bill, but also already exists to some extent the ability to use data from overseas medicines regulators—that's section 23 of the current Medicines Act 1981. This bill introduces a new pathway based on recognition of full authorisations from two trusted overseas regulators. It could represent an improvement by reducing the duplication of regulatory effort and potentially speeding up the availability of medicines in New Zealand.

Of course, we commit to taking the time in select committee to checking that there are adequate safeguards and particularly mechanisms for Medsafe responding promptly if safety concerns arise overseas. It's important that detailed requirements and conditions attached to medicines approved by this pathway are clearly set out in secondary legislation and regularly reviewed. I'm thrilled by the Minister's enthusiasm for alternative prescribers, including nurse practitioners, but many others. It is a shame that the Therapeutic Products Act is not there to give effect to those, but never mind—we'll move on to the next point.

Why are we doing this? The stated benefits of this ares that—and they're well outlined in the regulatory impact statement (RIS), I think it's paragraphs 14 and 16—the proposed changes emerged in the context of discussion around improving access to medicines. That is a very helpful discussion our country has had. The intent behind the verification pathway is to facilitate faster public access to medicines. However, as the RIS notes, the actual impact on medicines availability and access may be limited because, in practice, after Medsafe approval, Pharmac funding is often required for this to be available at scale in our communities. And, of course, this bill doesn't address that. So while it may speed up part of the process and reduce costs for pharmaceutical companies, it may not have a big impact on patients. I guess we won't know until we see how it goes.

It's critical that the Government clearly articulates the expected and tangible benefits of these changes, including which patient groups will be benefited. We look forward to having those conversations. One area where we do have concerns is the change of a technical advisory group into one where the appointees are appointed by the Minister of Health. That is an area where we will be focusing our scrutiny in select committee because that appears to create some possibility of conflicts of interest as well.

ASSISTANT SPEAKER (Maureen Pugh): The member's time has expired.

HŪHANA LYNDON (Green): Tēnā koe, Madam Speaker. On behalf of the Green Party, I rise to speak on this piece of legislation that, strangely, we support as well. We have many things that we have concerns about, but, for this, we do agree that access to medicines is important. When I think about the challenges for Māori in access to vaccinations during COVID and the fact that inequalities did exist and the inequities were there, because we couldn't access the relevant medications. These types of changes will help all of us to benefit as Aotearoa New Zealand.

I want to labour the point of support around how we can look at a multidisciplinary approach to the administration of medicines, and having nurse practitioners be able to work at top of scope for the delivery of medicines into community is important. With this legislation, we are looking forward to what the select committee process will bring, as we will be encouraging iwi Māori, Māori providers, and the various stakeholders to bring their voice into the select committee and inform the way which we will move forward as the Health Committee, cautious, as always, in terms of the way that we will look to analyse submissions as they come forward, because we are taking a safety approach in making sure that we do have the relevant safeguards in place.

Patient access to medicines is important, but so is looking at the wider health system. We do have current barriers and challenges in the way that we need to take a population-based approach across the entire system. And so while we are looking at medicines in this part of the system, let's look at the entire system and the very deep challenges that we have within Health New Zealand and within primary care and in the way which we deliver secondary care as well.

Now, medicines are only one part of that. Accessing medicines in a timely way is important, but if we can pull the ambulance back from the edge or the bottom of the cliff, then we can actually look to improve the lives of all New Zealanders across Aotearoa. Kia ora to my colleague Francisco. I want to recognise the workforce that is coming from overseas to support us in this time of crisis. Our Filipino nurses and those who are clinicians that come from overseas, because those skills that we have from overseas are kaimahi that come to Aotearoa to support us—whether it's in hospitals, primary care, or in aged care as well.

Now, when we think about this legislation and safeguards, the Minister does have a lot of power in this space, and our forming of committees just through ministerial appointment also needs to be looked at through the select committee process. But the flexibility to be able to prescribe and to find medicines that have already been approved into other jurisdictions does provide some comfort and safety for us at the stage of the process.

We do look forward to hearing from across the board in terms of community and patient voice—those who have been impacted on both the access issues and concerns as families and those who have sought care, but also those who are the prescribers. Can we find, across the workforce, their voice to come forward into the select committee process? Because we want to have regulations that safeguard patient care and also safeguard the workforce and those who are the prescribers to ensure that there are relevant protections in place but also open up access to a broad range of medicines that, maybe, we have not had access to here in Aotearoa New Zealand.

On behalf of iwi Māori, we think that we are heavy users in the system of health, whether it's Health NZ services and whether it is out in community healthcare spaces and primary care. And so, of course, we need access to timely medicines that this legislation can bring forth. So, on behalf of the Green Party, we do stand in support and look forward to seeing what we can bring out in the Health Committee process. Kia ora.

SAM UFFINDELL (National—Tauranga): Thank you, Madam Speaker. I rise in support of this bill. This is a good, pragmatic bill that creates a new verification pathway, a faster option for getting approvals here in New Zealand. We've got two overseas trusted regulators who have approved it. Medsafe will not need to do a full assessment. The decision must be made within 30 days. It meets the promise in the coalition agreements. It'll help New Zealanders get faster access to medicines while keeping safety in place. I commend this bill to the House.

SPEAKER: I call the Hon Jenny Marcroft.

JENNY MARCROFT (NZ First): Thank you for the promotion as well. Thank you, Madam Speaker.

ASSISTANT SPEAKER (Maureen Pugh): Under-Secretary.

JENNY MARCROFT: I appreciate that. The Medicines Amendment Bill: I stand on behalf of New Zealand First in support of this piece of legislation, and I am very privileged to do so as well. The purpose of this bill is to increase patients' access to medicine. It does this by reducing some of the barriers to access currently that we see in the Medicines Act 1981. We have commitments with our coalition agreements, and it is a pleasure that all this side of the House is in agreement that this is a really vital piece of legislation to make that pathway to wellness so much easier for so many patients in New Zealand. We campaigned for the last two elections on tidying up the processes in Pharmac to make sure that there's increased funding but also that the pathway of procuring medicines and having them approved in this country is much quicker.

This verification pathway that comes through this bill: the streamlined approach under which the medicines can be approved for distribution in New Zealand if they've been approved by two recognised overseas jurisdictions. New Zealand First recognises health as a critical and essential investment that reflects how New Zealand values its people. We see this as an investment in our people as opposed to a cost on society. So this bill will actually enable that increase in access to medicines for New Zealanders through that streamlined verification pathway for medicines.

Why do we need this? We've had so many stories we've heard over the last number of years of people having to go overseas to get their medicines because they just weren't able to access them here in New Zealand, whether it's go to Australia or Malaysia or various countries around the world; people who have not been able to get well, who may have passed away because the whole process of getting access to modern medicines has not been available for them. This legislation will ensure that health and wellness is at the forefront in being able to access these medicines.

Introducing a verification pathway for medicines approval in New Zealand is the purpose of this bill; updating prescribing settings as well to enable wider prescribing, enabling those in the health force workforce to actually work at top of scope. I think that's a very important change that this bill will make as well. Studies have shown that for every dollar spent on modern drugs, $3 to $19 is saved in the health system via things like reduced hospitalisation, so this is very sensible legislation.

I'd just like to conclude my contribution with a quote from Malcolm Mulholland, who many in this House will know. He's advocated for patient voice in terms of getting access to medicines, and this is what he has said: "There can be no greater legacy in politics than improving the health of our citizens." On that note, I'd like to commend this bill to the House.

ASSISTANT SPEAKER (Maureen Pugh): I call the Hon—no, not the honourable—Dr Hamish Campbell.

Hon Member: Everyone's got a promotion tonight!

ASSISTANT SPEAKER (Maureen Pugh): I know; everyone's honourable.

Dr HAMISH CAMPBELL (National—Ilam): Thank you for the promotion. It is a great honour to stand and speak in support of the Medicines Amendment Bill in this first reading. It's great that we actually have agreement across the House on this piece of legislation, because I think this is just common sense.

It creates a new verification pathway for medicines in in New Zealand. We've already traversed that a number of times in the House, but what are we going to find different that these other major countries haven't found? We're often using the same data that the pharmaceutical companies have submitted to the overseas regulators. They're resubmitting it here. It's unlikely that we're going to find any difference. Also it's great to be able to make sure we can empower our healthcare workers to be able to deliver medicines that everyday Kiwis need, so therefore I am happy to commend this bill to the House.

ASSISTANT SPEAKER (Maureen Pugh): This debate is interrupted and is set down for resumption next sitting day. The House stands adjourned until 2 p.m. tomorrow.

Debate interrupted.

The House adjourned at 9.59 p.m.

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