Medicines Amendment Bill (No 2)

I present a legislative statement on Medicines Amendment Bill—

💬 Hon Member: Keep going, bro.

ASSISTANT SPEAKER (Hon Jacqui Dean): No, no.

I move, That the Medicines Amendment—

ASSISTANT SPEAKER (Hon Jacqui Dean): No. Medicines Amendment Bill brackets.

Let me start that again. I present a legislative statement on the Medicines Amendment Bill (No 2).

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

I move, That the Medicines Amendment Bill be now read a first time—

ASSISTANT SPEAKER (Hon Jacqui Dean): Order!

No. 2. I move, That the Medicines Amendment Bill (No 2) be now read a first time. I nominate the Health Committee to consider the bill, and at the appropriate time I intend to move that the bill be reported to the House by 20 June 2022 and that the committee have authority to meet at any time while the House is sitting except during oral questions, during any evening on a day in which there’s been a sitting of the House, and on a Friday in a week in which there has been a sitting of the House and outside the Wellington area, despite Standing Order 193, 195, and 196.

The COVID-19 vaccination programme has been New Zealand’s greatest public health tool in the pandemic. It has enabled us to provide ongoing population protection against COVID-19 and to continue to adapt and to respond as the pandemic evolves.

As we know, immunity gained from COVID-19 vaccines developed so far does wane over time and can wane within a matter of months. This means the COVID-19 vaccination programme remains ongoing and has so far included two primary doses for most people as well as a third or “booster” dose; for some severely immunocompromised people, the programme has already provided four doses of a COVID-19 vaccine.

We’re now at the stage where further doses are required for our most at-risk groups, including those aged over 65 years. As we head into winter, the usual seasonal respiratory illnesses, alongside ongoing widespread COVID-19 infection, presents significant risk of severe outcomes for the most vulnerable. Winter will also bring increased pressure on a health system already stretched due to COVID-19.

As we continue to adapt our public health measures and response to the pandemic, we also have to adapt our vaccination programme to enable us to keep people protected and to be ready to roll out further doses to those who need them most.

The bill will allow us to do that by creating a new power that enables the Director-General of Health to authorise, by notice, the administration of a consented COVID-19 vaccine. The director-general can specify in the notice who may receive the vaccine, the recommended number and frequency of doses, the recommended manner of administration, and any other circumstances in which the vaccine may be administered. The director-general can only use this power in relation to COVID-19 vaccines that already have consent or provisional consent under section 20 or 23 of the Medicines Act. The director-general must be satisfied the authorisation is an appropriate measure to manage the risks associated with the outbreak or spread of COVID-19. They must also have regard to the likely therapeutic value of the COVID-19 vaccine and its risk to any person.

While the bill empowers the Director-General of Health to authorise the administration of an already consented COVID-19 vaccine, Ministers will be informed of the COVID-19 vaccination options based on the latest scientific and technical advice prior to the director-general’s decision.

The bill will provide a permanent and futureproofed solution to meet ongoing COVID-19 vaccine requirements, such as additional doses, changes to dose intervals, or targeting different population groups should the scientific evidence support this.

I anticipate that the new provision will initially be utilised by the director-general to enable fourth doses of the Pfizer COVID-19 vaccine to be rapidly rolled out to recommended at-risk groups without the need for a prescription in time for winter. This will, of course, be a decision for the director-general once the amendment comes into force.

Previous changes to the COVID-19 vaccine schedule have been enabled through immediate modification orders, or IMOs, under the Epidemic Preparedness Act. Earlier this year, as the highly transmissible Omicron variant reached our shores, the Government used an IMO to make provision for third or “booster” doses of the Pfizer COVID-19 vaccine to be administered at a reduced dose interval of three months instead of the approved six months; this was done in order to maximise protection at that time.

IMOs are temporary emergency powers that are automatically revoked when the epidemic notice expires or is revoked. It’s now necessary to enable enduring changes to the vaccine schedule and, at this stage of the pandemic, move towards a position where emergency powers are not required; therefore, this bill revokes the IMO and it is intended that the reduction of the third or “booster” dose interval will be authorised permanently via the new provision.

The COVID-19 pandemic has highlighted provisions in the Medicines Act that are not fit for purpose to enable a rapid, flexible, and equitable response in emergency situations. In particular, the Act does not facilitate the rapid roll-out of COVID-19 vaccines.

Looking ahead, it’s my expectation that the forthcoming therapeutic products bill will enable medicines, including vaccines, to be rolled out in a timely and flexible manner. In the meantime, this bill will help us to manage the ongoing public health risk of COVID-19. It does this by providing for the ongoing delivery of the third or “booster” doses at the reduced dose interval, providing fourth doses for our most at risk, and ensuring that we can easily roll out further doses should they be required in the future.

I’d like to acknowledge the huge effort of all those who’ve been involved in the COVID-19 vaccination programme so far, including community health providers and all the vaccinators across the motu. Their collective effort has meant New Zealand has one of the highest rates of COVID-19 vaccination in the world. This has prevented thousands of lives from being lost to COVID-19, allowed greater freedoms for all of us, and enabled us to open our borders to the world once again. We must keep up the good work of the COVID-19 vaccination programme to maintain that crucial population. On that basis, I commend this bill to the House.

Thank you very much, Madam Speaker. I want to start by saying thank you to the Government, particularly the office of the Hon Chris Hipkins and the office of the Hon Andrew Little for their constructive engagement over this tricky issue that the Parliament is now confronting. I think it’s a good thing that we are just debating the first reading tonight of this bill and sending it to a committee for ventilation of both the scientific but also the legal issues to do with the Medicines Amendment Bill (No 2), the purpose of which is to, essentially, make it easier to provide a fourth dose of the Pfizer vaccine to many New Zealanders.

There’s a couple of issues I want to canvass in my contribution. The first is in relation to the scientific background and the COVID-19 Vaccine Technical Advisory Group, or CV TAG, as they’ve become known in the vernacular amongst the panoply of advisory groups that assist the Government in relation to COVID, has recommended that people aged over 65, Māori and Pacific peoples aged over 50 years, people in aged residential care, and the severely immunocompromised should receive a fourth dose of the Pfizer vaccine, the Comirnaty Pfizer vaccine, before winter 2022, and many other countries have already moved to do that. We support the provision of the fourth dose to the groups that the Minister has outlined and that the regulatory impact statement for this bill provides for, and we support the provision of the money in Budget 2022—it’s quite a considerable sum of money—to provide that.

The issue then becomes how to go about doing that. Up until now, it’s all been pretty easy because Pfizer has made an application under the Medicines Act to the New Zealand Government, consent has been given, and we go forward from there. The conundrum that has arisen now is that Pfizer has not made any application for a fourth dose, and—I just might note in passing—that is pretty frustrating, to be honest. I understand Pfizer’s point of view is that they won’t make any application in any country. And, of course, other countries are going through the process of providing a fourth dose notwithstanding the fact that Pfizer hasn’t necessarily applied in those countries, because of course all those countries have their own legislative schema and their own legislative requirements, which differ from country to country.

In New Zealand, the law is Pfizer has to apply for approval, and they have chosen not to do so. But the New Zealand Government, advised by their experts—the CV TAG, the technical advisory group—has recommended that a whole group of people, about 834,000 give or take, possibly depending on if you use the Stats New Zealand database or the Health Survey User database, access the fourth dose via a GP on an individualised basis. And so the question for the Parliament is—because I think there’s broad consensus that the fourth dose should be made available—how to give effect to that.

Now, one of the issues that we’ve been canvassing in the discussions between the parties in advance of this legislation coming before the Parliament is whether or not what’s called an immediate modification order pursuant to the epidemic preparedness response Act should be essentially used to give effect to the fourth dose being widely available. And it’s been pointed out by people that the immediate modification order (IMO) process, as it’s known, has, for example, changed the time frames for the third dose from six down to four and then three months. The question is really: should that be able to be used for the provision of the fourth dose? For my part, I think that is an open legal question.

There is, I think, a strong argument that the IMO process could be used in order to give effect to the fourth dose, and, therefore, we are potentially legislating for no good reason, and that is one of the issues that I think should be explored at the select committee, which is: is the bill absolutely necessary? Because it’s a pretty unusual thing that we’re doing. We are, essentially, amending the Medicines Act, not under urgency—well, this bill has been taken under urgency, but we will not pass it under urgency. But it’s a pretty unusual thing to have a very truncated select committee process to amend a pretty significant piece of legislation in New Zealand—and a very short piece of legislation: five clauses only. And so a pretty unusual situation, but we do find ourselves in pretty unusual times.

So we will support this bill going to committee, but there’s two things we’re going to want to investigate at the committee. The first is the scientific rationale for the fourth dose. And I think that’s pretty widely understood. But I think it would be worth ventilating the scientific rationale for the fourth dose at the committee. I think that is meritorious, and I expect the Health Committee—where I expect the bill will go—will want to get into the scientific reasoning behind it and potentially get the technical advisory group in. And I see some colleagues who were formerly on the Health Committee with me—Sarah Pallett is giving me the thumbs up over there. She’s a very hard-working member of the committee. We’re very pleased in the Parliament, actually, that the Health Committee has real health sector expertise on it: Dr Shane Reti, obviously, from our side, but also Sarah Pallett and Tracey McLellan and Liz Craig—I think Liz Craig’s moved on from the chair. She’s nodding her head. That’s a shame because she has considerable medical expertise. But anyway, the Health Committee will get to the details of the science. But then my personal view—and colleagues on this side of the House may wish to explore it further; I know Michael Woodhouse may wish to do so—is that, for me, the real issue is the necessity of legislation to give effect to the fourth dose. Is it correct that we have to legislate in, essentially, a 10- or 11-day process to allow this to happen? From my view—and bear in mind that the Crown’s legal advice is privileged, so we haven’t had the benefit of the full legal advice—for my part, I think the summary of the advice that I’ve seen is equivocal. I think there is an argument that an IMO process could give effect to this and we wouldn’t have to be legislating through this quite unusual process.

So I’ll leave my remarks there, but we are in a very odd situation, and I do want to close by finishing where I started, which is to say thank you to the Government for the good engagement on this slightly unusual piece of legislation. We appreciate the opportunity. We’ve had some input into—well, some input; I wouldn’t want to take the point too far, but we’ve had some input. And I know Mr Woodhouse may wish to comment on some of the changes that have been made from the earlier drafts that we’ve seen, but we’ve had some input into it. And there is, I think, a genuine desire across the Parliament, I suspect, to get the legislation right or to get the fourth dose provisions right and to make sure that we don’t legislate in haste for something that’s not actually needed. You know, Parliament passes too much legislation anyway.

At some point, we will have to go back to the Medicines Act 1981 and have a rewrite. The Minister made brief reference to the therapeutic products Act that’s coming in. I’ve heard that before. At some point, we will have to—I see members smiling. That bill has been talked about as being passed for—

💬 Hon Michael Woodhouse: 10 years?

10? I think it’s even further.

💬 Hon Michael Woodhouse: Maybe longer.

It could be longer. I’m not making a political point here, because it didn’t make much progress under the last Government either, but it certainly hasn’t made much progress under the current Government. I think it goes all the way back to the Clark Government. But, anyway, I digress. At some point we’re going to have to have a good look at the Medicines Act, and I’m sure we will consider this in the context of it. But for the moment, let’s get the necessity right and let’s get the science right and go forward from there. And I’m sure the committee will get into that. Thank you, Madam Speaker.

Thank you, Madam Speaker. It’s a pleasure to rise and take a call in support of the Medicines Amendment Bill (No 2). Following on from the member who’s just resumed his seat, Chris Bishop, can I acknowledge his contribution and the bipartisan nature of those contributions that he’s made, and, hopefully, as we hear from other speakers, it might be a multipartisan approach for this particular piece of legislation.

There are many tools in the tool kit, as Minister Little has referred to, in terms of tackling the pandemic. Whether it’s around good hygiene practices, whether it’s around social distancing and the application of that, whether it’s around contact tracing, whether it’s around mask use, there is no doubt that the country’s vaccination programme is the greatest tool in the tool kit by far. The vaccination roll-out here in Aotearoa New Zealand has effectively delivered on two things. The first is that it has provided initial protection, but also ongoing protection for our communities. And secondly is that it’s been able to adapt and modify and respond to what are changing circumstances, and we’ve all seen that over the last 18 months, and then some.

We all know that winter is indeed upon us, and it’s evident in the education settings, in our classroom, with many people indoors, with influenza about to hit. So when we throw respiratory ailments in that mix as well, there is a seasonal risk for vulnerable members of our community. Those members who Minister Little has identified, whether they are those aged in the over-65 demographic or whether they have underlying respiratory or chronic illnesses, they particularly fit that bill.

So within the mix, it’s important that we have available to us an ability to be flexible and adaptable in a way that’s easy, consistent, and in line with legislative instruments. And the bill does exactly that. It allows the Director-General of Health to authorise the administration of a vaccine for COVID by consent based on a number of factors. In this sense, the bill is seeking to futureproof the way forward, in terms of the application and availability of the COVID vaccine, many of which—those circumstances—may not be known at the moment. What’s important to note is that the decisions that the Director-General of Health will be required to make must be based on scientific evidence. So this is not a matter of a whim, or of a particular day, but on the evidence, that of a scientific nature.

I want to just acknowledge that the bill will also allow for easy and equitable access to the fourth dose, which will make it widely available at many of our vaccination sites. Many of our Māori, Pacific, and other community providers in communities like my own in Palmerston North, in the Manawatū and Horowhenua, have done a great job and this will assist them. It will mean that people are not reliant on their ability to fund a visit to a GP or a medical practitioner to get a prescription in order to receive the fourth dose.

I just want to briefly respond to a suggestive comment that Mr Bishop had referred to in relation to the appropriateness of the IMO—or the immediate modification order—as perhaps being a more appropriate instrument. I guess I would just remind the member that this is not an emergency measure, so it should in the fullness of time come to the Parliament for the Parliament’s scrutiny and consideration. This bill would, effectively, replace the current method or mechanism or instrument that lies under the epidemic notice known as the IMO or the immediate modification orders. There is a suggestion from the High Court that that as an instrument should be used infrequently; it should be used or seen as a last resort. And so I encourage members to consider that alongside the tenor of what is a small and short bill, and delivers on the primary focus there.

Just in terms of my conclusion or concluding comments, I think it’s important to know that this is, as I understand it, being referred to the Health Committee. For Mr Bishop’s benefit, I am the chair of the Health Committee and I am ably supported by diligent and hard-working professionals from all around the House, so we look forward to receiving the bill and outlining our scrutiny role as part of that. In terms of the first reading, I am delighted to commend this bill to the House.

Thank you, Madam Speaker. This is a bill under urgency looking for unusual measures. In a bullet-pointed fashion initially, here’s what we understand with this bill and here is what we need to know.

First of all, there is some evidence from offshore that a fourth dose—a second booster—may be beneficial to those most vulnerable to COVID. This includes particularly the immunocompromised and older people. On 19 May—that’s three weeks ago—the US Centers for Disease Control and Prevention (CDC) made a recommendation in their document titled CDC Strengthens Recommendations and Expands Eligibility for COVID-19 Booster Shots. In this CDC document, they say: “In addition, today CDC is strengthening its recommendation that those 12 and older who are immunocompromised and those 50 and older should receive a second booster dose at least four months after their first.” This is CDC three weeks ago.

On 4 June, in what’s called an update, the Singapore Ministry of Health—and a number of jurisdictions referred to Singapore; in fact, initially Australia did—referred to the work; there’s a working group out of Singapore that’s exploring this. The Singapore Ministry of Health said this: “Local data to date shows protection against severe disease as sustained after the third mRNA booster. However, there can be waning of protection, particularly in the elderly and medically vulnerable. International studies show that vaccine efficiency against hospitalisation declines after the third dose mRNA booster. Persons aged 80 years and above, residents of aged care facilities, and medically vulnerable persons are at increased risk of severe disease and will be most affected by waning vaccine efficiency over time. These persons are therefore recommended to receive a second booster dose—that is, a fourth dose of receiving an mRNA vaccine—from about five months after receiving their first booster dose for personal protection against severe disease.”

We tend to follow the Australians somewhat, and on 25 May—so roughly two weeks ago—they put out a recommendation as well. This is what they said: “In this updated advice, an additional winter booster is now also recommended for other people at increased risk, to be given four months after the first booster dose. This applies to people aged 16 to 64 who have (a) a medical condition that increases the risk of severe COVID-19 illness, and (b) people with disability with significant or complex health needs or multiple comorbidities which increase risk of poor outcome from COVID-19.”

So Singapore, Australia, CDC, and we know Israel has for a while had the fourth dose or the second booster—all of them making this recommendation in the past two or three weeks. Now, here’s the process that every other COVID vaccine to date has gone through. The company, the pharmaceutical company—Pfizer, in this instance—does phase one, phase two, and phase three studies. When they reach a satisfactory phase three, then they’ve met the threshold for a vaccine generally being acceptable for public distribution. What happens then is they pass the data to Medsafe. Medsafe analyses it, and then the third step is Medsafe makes a recommendation.

What is happening here is Pfizer has not sent any data, and therefore made approval to Medsafe—that is, there is no Medsafe recommendation. Pfizer tells us, however, that they’ll have the data in a month or two; in fact, in a meeting we had with the ministry on Friday, they suggested maybe even by the end of the month.

What we know is that immunocompromised people are already getting the fourth dose, the booster, through what’s called a “section 25 off-label authorisation”, whereby a GP can write a prescription for off-label—have that discussion with the patient, they’ve got their medical records in front of them. It’s a high-level consenting process and people are already getting the fourth booster here in New Zealand.

Of course, what the regulatory impact statement also tells us is that under an immediate modification order we could also potentially distribute the fourth dose. The Government’s technical advisory committee is recommending New Zealanders therefore follow Singapore, the US, and Australia—to name but a few—and have a fourth vaccine. So what they’re doing here is they’re balancing off the need to protect the vulnerable—on evidence provided not by Pfizer to Medsafe in a Pfizer recommendation at this point, but on evidence from other organisations and other studies outside the Pfizer multi-cohort study they started in January—and the evidence there does seem to be suggesting that there’s benefits to a fourth dose.

We all need more information. We need to hear more from Medsafe. We need to hear from the technical advisory committee and any legal advice that’s being provided to support this bill. That is the benefit of what will be a truncated select committee process, that we can now go through that due diligence.

There’s a number of questions that we’ll be wanting to ask. What reassurances can the Government give for the vaccine without the Pfizer data? So I’ve mentioned international studies offshore. What reassurances does the Government have that non-Pfizer data provides efficacy and/or the side effect profiles we might want to know about? How many people will be protected over the month or two before Pfizer does have that data? So let’s say it’s six weeks, then. Are we sure that the benefits to the vulnerable outweigh waiting for that six weeks and having that data moving through Medsafe? I think it’s a good question to ask how many people might be protected.

Is the legislation that we’re talking about here tonight confirming COVID vaccines in perpetuity without the normal checks and balances that we’d normally have through Medsafe with Medsafe data, or is it just for this vaccine? So we need to know if it’s a for ever—certainly in the immediate future—that we’re signing off here.

Is the fourth vaccine that we’re talking about here going to be mandated? Are there any ACC implications when vaccines are not approved by Medsafe, but are given out for general distribution in this fashion? What legal opinions have been received, for example, from Crown Law?

I think these are all questions that we’d like to explore in the select committee and hopefully bring back to this House an informed view that we can all agree on. Thank you, Madam Speaker.

Thank you, Madam Speaker. I’ve listened with great interest to the words of my colleagues, and I’d just like to share some information and thoughts from my perspective. What we do know is that a two-dose primary course and a booster provides very good and lasting protection for most people, but the latest advice we’re hearing is that an additional booster is important for the most vulnerable. Vaccination with booster doses now that the prevalent variant is Omicron don’t seem to be quite as good as we would like at preventing infection and transmission, but they’re extremely good at preventing serious illness, hospitalisation, and death.

Now, my father is a really good example of a vulnerable person in the United Kingdom who was able to receive that fourth dose, in what they called the spring booster programme for the over-75s. At 86, with lungs that were damaged by tuberculosis infection—unfortunately, he wasn’t able to be vaccinated against TB due to the war—and asthmatic, you can imagine how I felt when, although he had successfully managed to avoid contracting COVID for two years, he became ill. Having had that fourth dose, my father—and bearing in mind this is anecdata; this not part of a study—did become unwell but not seriously unwell and didn’t require hospitalisation, which was a source of great relief to me. This is what we’re hoping will be borne out by larger studies, larger than the one that’s recently taken place in the UK, recently published in The Lancet, that has shown that my father’s experience is pretty similar.

As COVID changes, we have to change too, and this bill allows us to keep people protected by, as we’ve heard, enabling the Director-General of Health to authorise by notice the administration of a consented—consented—COVID-19 vaccine. I would just encourage those in Canterbury. We have two doses at 98.9 percent, which is awesome, but only 75.8 percent have had those boosters. I’d strongly encourage them to get that done. Thank you, Madam Speaker.

Thank you, Madam Speaker. It’s my pleasure to also take a call on the Medicines Amendment Bill (No 2) as well. And the Greens—we will be supporting this piece of legislation.

I have been listening with interest with the contributions from members from around the House, and I would echo the sentiment around trusting the Health Committee—it’s well known that it’s got many health professionals on that select committee. I’ve only been able to sub on there a couple of times. But I also appreciate that with this truncated process and the questions that members have been posing tonight, they will be able to get to the crux of some of those questions—and possibly some of those questions they may already have the answers to. I look at this from the public perspective as well as that when you have those answers, when we kick them around amongst trusted health professionals and amongst science and ask those really specific scientific questions, that gives reassurance to the public. It’s that reassurance and that communication which is also a really vital cog in our response to COVID-19. So I look forward to following the select committee’s process in that regard.

The purpose of this bill is to allow a second COVID-19 booster to be rolled out from mid-June for people who are high risk from COVID-19. The majority of people will become eligible in July for the second booster, but some will be eligible in mid-June as the booster programmes started in late November. Therefore, there has been a push for this to go through urgency—and I totally get that because of the quickly evolving nature of the COVID pandemic and the need to actually do that. But also—as I was saying previously—it’s good to actually get that detail so that the public has that information and it kind of alleviates some of the anxiety out there.

This bill also provides for a long-term solution for the provision of the third booster dose in a three-month dose interval and also provides for any future doses of COVID-19 vaccines to be administered if scientific evidence demonstrates this is recommended—and I know that will be tested at the select committee. The bill meets these objectives by creating a new provision that enables the Director-General of Health to authorise, by notice, the administration of a consented COVID-19 vaccine otherwise done in accordance with the approved data sheet for that vaccine. The director-general must be satisfied that doing so is an appropriate measure to manage the risks associated with the COVID-19 outbreak or spread, in having regard to the likely therapeutic value of the proposed administration of the COVID-19 vaccine and the risk—if there’s any—that any proposed administration of the vaccine may injuriously affect the health of any person.

One of the things I think we learnt—and I hope that we all learnt—is that we need to have equitable access to vaccination. And the Green Party wants everyone to feel safe and supported to get vaccinated in a way that is accessible to them—that’s really important. We are being particularly focused on ensuring that the vaccine provided is fully accessible and promoted to Māori communities, recognising current uptake is below that for non-Māori—you measure that right across and we can see those numbers.

But what we did learn, I think—and I hope that we all learnt that—was that this includes partnering with community providers and Māori collectives. And I would add Pasifika collectives as well to ensure vaccination is fully available throughout Aotearoa. Because what we see is, when we walk with our communities and—we look at it from a scientific perspective but we’ve also got to look at it from the community’s perspective as well. Trying to translate what that means scientifically for them on the ground is also really, really important. And we saw the huge uptakes with Pasifika communities in South Auckland and, of course, around the country as well, and our Māori health providers as well—that they have the ability to actually make those connections. So it’s important that we support community providers in determining their own approach to vaccine incentives. Actually, that’s a lesson that should apply to all of our communities as well because they’re the best placed people to understand what incentivises and what incentives are appropriate for building trust.

So on that, clear communication wins the day. That needs to be factored into everything that we do with the COVID-19 response. We will be supporting this bill. Thank you.

Thank you very much, Madam Speaker. I rise on behalf of the ACT Party in support of this legislation to its first reading. We believe the Medicines Amendment Bill (No 2) should be examined by a select committee, and I want to go through some of the reasoning in why that is, but first I just note the previous member, Teanau Tuiono, said he had great faith in the Health Committee to scrutinise legislation on behalf of the people of New Zealand, scrutinise the Government’s response on behalf of the people of New Zealand. This is the committee, dominated by Labour members, that has repeatedly refused to get officials before it in order to examine New Zealand’s COVID-19 response. This is the committee that has actually gained infamy for the behaviour of a previous chair in not allowing Opposition members to ask questions on behalf of the public. And bear in mind that the Health Committee was performing that task in the absence of a COVID-19 epidemic response committee, which the Government has repeatedly refused to have re-formed, despite, or perhaps because of, the success that it had in scrutinising the Government’s COVID response back in 2020. I think that has to be said when you hear someone say that they’ve got great faith in the Health Committee, because it’s actually been a sore spot for our democracy and for New Zealanders wanting representation to be effective throughout the COVID-19 saga.

What this bill will do is give the Director-General of Health the ability to approve COVID-19 - related vaccinations to be applied without a GP prescription, without going through the normal Medsafe process. I want to unpack a few of the concerns that people may well have about that. The first concern that I think people might have—and I haven’t heard the Minister of Health, or any Government representative, or the regulatory impact statement—prepared hurriedly, I suspect, by the Treasury or the Ministry of Health—explain why it is that the people who manufacture the Comirnaty vaccine, being Pfizer, have not been prepared to make an application for it to be used in New Zealand.

We’re told that there are 834,000 people, vulnerable for a variety of reasons, who would use it. Now, I would have thought that the prospect of selling 834,000 doses at, what is it—we may never know, but let’s make it $30 a pop—would have actually motivated Pfizer to submit the data and have it approved. But it seems, for some reason that hasn’t been given to us by the Government advancing this bill, that Pfizer are not approaching countries with a rationale for a fourth dose to be allowed under their regulatory systems. I think that’s a question that the Government is going to have to provide answers to. Why is it that the Government is keener to get these doses approved than the manufacturer? That is a wrinkle that I don’t think has been properly explained.

A second question that people will ask is: could this somehow lead to a fourth dose not just being available but mandatory? Unfortunately, I think people that ask that question actually have a reason to be sceptical of the Government. This is a Government where the Prime Minister promised that people would suffer no penalty whatsoever if they didn’t want to have the original doses of the Pfizer vaccine. Now, I think that was a really foolish promise for the Prime Minister to make, because, actually, all choices in life have consequences. That is cause and effect thinking. It would be naïve to think that you could make a choice and it wouldn’t, at the very least, lead to the judgment of your peers and friends, or, perhaps, other people saying that they were setting conditions for their private property that included a requirement to be vaccinated, and perhaps that property owner might be your employer.

So it was never a promise that the Prime Minister was in a position to keep, but she made it, I would say foolishly, and perhaps the worst thing about that is that she eroded people’s trust in the institutions of New Zealand. This Government came in promising wellbeing Budgets off the back of a Living Standards Framework, and the promise was that we’d think about more than just one thing. We wouldn’t just think about GDP; we’d think about social and human and environmental capitals, and the wellbeings of New Zealanders in every aspect. Then COVID came along and it was back to focusing on just one thing, and when it comes to our social capital, I think it’s been eroded by the distrust fomented by some of the Government’s behaviour around the COVID-19 epidemic response.

So I think people will ask, “Well, you know, we trusted you last time; you changed. Is this somehow a precursor to a fourth dose not only being available but required?” I actually don’t think those fears are well founded. I think it’s clear that this legislation does not do anything of the sort. But the Government has got itself in a sticky position where it needs to provide that reassurance.

I think the other thing, the third thing, that they’re going to have to do, other than reassuring people that it’s OK to be approving something the manufacturer doesn’t seem that interested in approving and that’s not going to become required, is they’re going to have to be transparent and open about the benefits so that people can make an individual choice under this framework, which I’m sure will inevitably lead to a fourth dose being permitted in New Zealand. There’s no doubt that the evolution of the COVID-19 virus—or, perhaps more properly, viruses—from one variant to the next has changed the underlying epidemiology, and therefore what is desirable policy.

Omicron, being the latest, and currently the dominant, variant, clearly has greater immune escape properties for people who have had natural infections and for people who have been immunised against COVID-19. It is also far less virulent and milder. In the UK, its infection fatality rate is now comparable to the flu. There was a time when people who made that comparison with earlier variants of COVID—they didn’t know what they were talking about and you couldn’t be taken seriously. But that infection fatality rate is now comparable to the flu, at least in studies of the UK population.

Now the question is to what extent is vaccination a factor or necessary. That’s a decision that people need to weigh up. I personally probably will get a fourth dose. I don’t see why I wouldn’t give myself extra reassurance against having a nasty bout of COVID, and a lot of people I know have been having that. But the Government is going to have to be, as it’s promised, open and transparent about informing people.

Finally, I think the Government is going to have to explain why at various points in the roll-out of the vaccine it has been highly convenient for the Prime Minister to stand up and say, “We are going to make the vaccine available but we’re waiting for Medsafe approval.” The ACT Party’s made the point that this is nuts. How many times in New Zealand’s history has Medsafe rejected the approval of a pharmaceutical, and the rest of the world, who’ve probably been using it for 20 years, because, sadly, that’s the way it is, have said, “Oh my god! New Zealand said it’s not safe. We’ll stop.”? It just doesn’t happen.

The question has to be asked why it is that New Zealand insists on doing its own product regulation—and I’d add to that, we might have a bit less shortage of Gib board if we didn’t insist on that. I was going to joke maybe we should start inspecting cars—because, you know, BMW are quite good at making cars, but maybe New Zealand’s Government should have someone inspecting that—but I don’t want to joke, because the Green Party might hear and make it a policy. But we actually have to ask ourselves why we have such a rigmarole, and whether we shouldn’t adopt ACT’s policy of saying that if a pharmaceutical is approved by Australia, the UK, the EU, or the US, then maybe New Zealanders should be able to access it as well. We could save a lot of time and a lot of money along the way.

Nevertheless, we still have that restriction in place, and because we don’t think it’s a particularly good restriction, we’re happy to support, at least for now, a bill that will allow people to bypass nonsensical restrictions, but we will be listening very carefully to the answers to those three questions I posed. Thank you, Madam Speaker.

Thank you, Madam Speaker, for the chance just to say a few brief words in support of the Medicines Amendment Bill (No 2). I think it’s very clear, as my colleague Tangi Utikere said earlier, that the vaccination programme itself has probably been our best tool in the tool kit during this pandemic. It’s certainly given us a chance to provide ongoing population protection, and as we’ve done, we’ve been able to adapt our response as the pandemic inevitably evolves.

So the two-dose initial primary course and the booster, as my colleague Sarah Pallett mentioned, has been really efficacious. It’s been a really good and lasting protection for most people, but the latest advice is that an additional booster is going to be really important for our most vulnerable, for the people who need it the most, particularly as we move into this winter peak.

And this bill allows us to do that. It allows us to adapt our public health measures by enabling the Director-General of Health to authorise, by notice, the administration of consented COVID-19 vaccines to be used without, and to be administered without, a prescription. So in that sense, it’s, essentially, making a permanent and a bit more of a futureproofed solution to meet those ongoing vaccine requirements. Some of those requirements include, as we’re talking about now, additional doses but, also, changes to the dose intervals, perhaps, or targeting different population groups, should that be required, but always and only should the scientific evidence support doing so.

So we know that the second boost dose is effective, we know that the second boost dose has no additional safety concerns, according to trials that have been conducted to date, and we also know that Medsafe actively monitors vaccine safety in conjunction with various other partners around the world. So given the need and given the risk to our most vulnerable, I have no hesitation to commend this bill to the House.

I call Simon Watts—five minutes.

Thank you very much, Madam Speaker. I rise on behalf of the National Party and as the member of Parliament for North Shore in support of the Medicines Amendment Bill (No 2). It’s been noted by prior speakers on this side, including Chris Bishop and Dr Reti, National are supporting this bill because it is important for this bill to progress to a select committee process, where a number of questions can be asked in terms of the concerns that have been raised across this House, before this decision is decided upon.

As has been noted before, National do support the principle that a fourth dose, or a booster dose, should be available to Kiwis in New Zealand, and particularly those 800,000 or so individuals who are elderly and immunocompromised. The reality, though, as has been canvassed by Dr Reti, is that the evidence position on this is still evolving and it is important that we do make an informed decision in regards to the availability of this. The select committee process provides a mechanism in which to achieve that. It is also important to note that, actually, Kiwis today can access the fourth dose through a process through their GP, but it is not readily available to everyone and that’s why this process is required.

I guess the challenge, really, in terms of what needs to be achieved from the select committee process, is to provide substantiation that, actually, this bill is the necessary mechanism in order to achieve the outcome of providing availability of that fourth dose to Kiwis. Are there other processes or mechanisms existing or otherwise that could be used in order to achieve this outcome, instead of this bill? What is the latest position in regards to the scientific rationale and evidence, taking into account where this is on the global stage as well, in terms of the appropriateness of provision of this dose to Kiwis and the right target audiences for that?

It is acknowledged that National—and I do, again, reflect on Chris Bishop and Dr Reti, who have been able to have input into this process to date, to ensure that we are able to have a conversation this evening around this. I think it is important just to reflect the last speaker, Dr Tracey McLellan—that this legislation doesn’t mandate this fourth dose for individuals. I think that is important, as that will be a question by a number of Kiwis out there.

National are happy to support this bill on the basis that necessary questions will be asked at the select committee process, in order to substantiate that this is the right decision.

I’m the wrong sort of doctor to speak on this bill, so it’s lucky that I’ve had my friend Sarah Pallett next door to talk me through this, because I think this is what we’re doing here, and it does answer some of the questions coming from across the room. These are not medicines that haven’t been approved; they’re approved medicines with a new use.

Normally, they have to have a prescription from a doctor every time you get an off-list use of an approved medicine for a different purpose. This bill streamlines that so that the Director-General of Health, who’s no slouch when it comes to these matters, can make the decision to make this medicine, which is normally required on prescription, available across our vulnerable people—85,000 or so of them—in an equitable manner. I commend it to the House.

It’s a pleasure to speak on the Medicines Amendment Bill (No 2) today in the House. It was really good to hear from the other side some very cordial words, for the most part. I just want to say, first of all, that our vaccination programme has been one of the most leading in the world and has been applauded across the world, apart from by the Opposition on the other side. But the vaccination programme still continues, and, as Dr Reti said, there is emerging evidence that shows that having a fourth dose can make all the difference, especially to our vulnerable population. Studies in Israel and the UK have shown this, which is why Israel and Germany, as well as the UK, have looked into now having the fourth dose rolled out, which is what this bill is all about.

What we’re doing here is just making sure that the Director-General of Health is authorised permanently to be able to make such decisions in terms of additional doses, changing the doses interval, as well as what the target population should be. For the fourth dose, this time there’ll be 850,000 people who will be affected, and that’s a large population, especially in the winter, when we see a lot of people getting respiratory illness from other viruses, which increases hospital admissions. So having that alongside having COVID-19, which is still in high numbers in New Zealand, just means that we need an extra layer of protection, and having a fourth dose can make all the difference.

I do want to say, however, that recently the World Health Organization released its data and said that, since March 2020, we have now the lowest number of COVID-19-related deaths around the world, and a large part of that is obviously related to the vaccinations which scientists have been able to research, invent, and actually roll out. This fourth dose will make a huge difference in that. So I would like to recommend this bill to the select committee. Thank you.

Thank you, Madam Speaker. I think I heard Dr Henderson say that she was the wrong kind of doctor to be speaking on this bill. I’m not so sure that’s the case, because as well as the medical questions, there are a few legal questions as well to be answered in respect of whether we are doing the right thing or in the right way.

As has been mentioned before, this has had a fairly hasty passage to the House, but a relatively long preamble. The first conversations between the Minister and the National Party spokesperson for COVID took place about six weeks ago, so it was clear to the Government that they intended to do this. It came to our attention a week ago today, where it was the Government’s intention, with other parties’ support, to sort of let this one go through to the keeper pretty quickly on a morning this week, and that did not find favour with us.

So I join Mr Bishop in giving credit to the Government for actually engaging in a very meaningful way. I had two meetings with Minister Hipkins’ advisers. There was another, broader meeting where National MPs were able to join with officials, and as a consequence there have been a couple of minor changes to the bill as it has been introduced today, and a change in the process. So I want to acknowledge that. I’m not sure that that would have happened had we not raised these concerns quite so emphatically, but to point that out might be a bit trite. You’ve got to give the Government credit for actually responding in the way that they did. It is a short—a very short—report-back period, but I think it’s sufficient to answer some of the quite important questions that we have.

Now, as the Minister moving the motion pointed out, it’s already possible for somebody to get a fourth dose. It’s known as an off-label prescription, and the Government is concerned about the equity issues with that for the more than 800,000 people that they would like to have this dose. They want them to be able to have the fourth dose in the manner, at the place, and by the person who gave them the previous three—it could be a pharmacist, it could be a district health nurse, it could be on the marae, it could be in the workplace—without having to go through a booking to the GP, probably paying a fee, and then going to the pharmacy and getting a prescription. So that’s all understood. The two questions I have were: is this the right thing to do, and is this the right way to do it?

Now, we’ve talked about it, and Dr Reti and Dr Sharma went through some details about that. I’m not quite as enthusiastic as they are. They are medical practitioners. Dr Sharma said that it would make a huge difference, and he cited the World Health Organization (WHO), which took data right back to 2020. Actually, as recently as two weeks ago, the WHO were quite equivocal about whether a fourth COVID vaccine dose was beneficial: “The WHO notes that data on fourth booster doses and beyond only exists for mRNA vaccines; and even then it is still sparse for this vaccine type. … Taken together, these studies [that they reviewed] show some short-term benefit of an additional booster dose [for] those over 60”, and data to support an additional dose for healthy younger populations is even more limited. So we don’t know how much of a difference it’ll make.

We’ve heard of the several countries that are doing this—because there are about 190 countries that aren’t—and the reality is that Pfizer have not made an application for a fourth dose. Why? I think it’s because they’re not convinced, either, that it’s necessary or beneficial.

Now, I hate to sound like the accountant in the room, but the regulatory impact statement makes no reference to cost benefit. Let’s not beat around the bush: this is going to cost the taxpayer another $50 million or more, and I think they have a reasonable expectation that that’s necessary and that that would be money well-spent. We don’t have that data, and we’re not going to have it by the time the winter is ending, much less when we’re going to start administering this. So the most important thing, I think, is whether it’s going to be safe, and I don’t think there’s any reason to believe that a fourth dose will be more harmful than the very incredibly infinitesimally rare complications that we’ve seen with previous doses.

So the second question is: is this the right way to do it? Now, the Government in its regulatory impact statement said this about the choice between an immediate modification order (IMO) and changing the legislation. It said, “Consideration was given to replacing the current IMO with one that also allows for the delivery of a fourth dose, but Ministers decided that this was not an option due to its temporary nature and vulnerability of being tied to the temporary Epidemic Notice.”, and that raises some fascinating questions. “Ministers decided that this was not an option”—of course it’s an option. It’s an option they’ve used in the past, it’s an option that’s part of the epidemic response Act, and it’s an option that they can use in the future. They’ve just ruled it out.

Then, we say, “Oh well, OK. It’s being tied to the temporary epidemic notice.” This is a temporary epidemic—it will pass. Now, the current epidemic notice ends on 17 June. I’ll lay wagers that it will be extended for another three months and almost certainly another three months after that, so on 17 December, we’ll still have an epidemic response notice in place. The IMO is a perfectly legitimate vehicle for being able to get on with this. We would have been able to do that straight away if it wasn’t somehow for the Minister’s cold feet on this.

The regulatory impact statement also says this about doing it under legislation: “Treating a fourth dose as other than a ‘new medicine’ undermines the scheme and purposes of the Medicines Act and the consent process in the Act”, but that’s exactly what this bill will do when it is passed. There is a specific clause which says that a COVID-19 vaccine is not a new medicine for the purposes of section 20 by reason only of blah-blah. So they’re saying that they don’t want to treat it like this, but that’s exactly what the bill does.

Now, kudos to officials for making a change to the bill that I thought was confusing, at new section 34A(1)(a) in clause 4, where it had initially had said that this section applies and the Minister can authorise an off-label administration if the Minister gives consent. Now, one would have thought that that means that the Minister is giving consent to an application, but, as we’ve heard, Pfizer don’t have to make an application. So the bill has been changed—and I think that’s an improvement—to say that “(1) This section applies if—(a) the Minister has given consent”. It’s a past tense situation. So that’s only partially easing my concerns.

The other concern I have is that on my reading of the bill, when passed into law, Pfizer will never have to apply for another vaccine approval for COVID again. The Minister and the Director-General of Health will have the power under the consent already granted to continue to authorise future doses and future doses.

Now, my questions are—and the select committee really need to drill into this—what happens if the dose changes in its configuration? As the virus changes, the vaccine may need to change. If the vaccine changes, another consent should be sought. My reading of this amendment to the Medicines Act is that that won’t be necessary, and if—and I must stress that I don’t think there is any material chance that this will happen—a fourth dose was harmful, who is liable? Well, not Pfizer, because Pfizer have made it very clear that they didn’t apply for consent for a fourth dose. They weren’t sure of the benefits, and I’m quite sure they don’t think there’s any real risk, but what if there is? What if there is harm—who is responsible? It won’t be Pfizer.

Now, I think that in the Government’s attempts to say that, well, they don’t want to be vulnerably tied to a temporary epidemic notice, they’re actually putting something in place into perpetuity while the COVID epidemic is in place that could let drug companies off the hook, and I think the select committee really needs to dive more deeply into the questions of liability and into whether the bill is even necessary. I’m not convinced.

I think an IMO, or an immediate modification order, is still the right vehicle, the right tool, to be able to do what the Government wants to do, which we support, which is to protect the 834,000 elderly and immunocompromised—and front-line health workers, I think, might be included in that. I don’t believe it’s their intention to mandate it, and that would certainly bring strong opposition from not just members of this side of the House but right across the country.

So there are a number of really important questions. I think the Health Committee is very good. I’ve been on it a couple of times. I wish those members well in their deliberations, but they’re going to need to see the whites of the eyes of the officials and of the people who are researching and the technical advisory group—or the TAG, I think it’s called—to make sure that this is the right thing to do in the right way, because I am not yet convinced.

Tēnā koe, Madam Speaker. Thank you for the opportunity to contribute to this debate, a debate which I have been privileged to be a part of. It is always great to be in the House on nights where members are deeply engaged in not only the policy detail but the legal and procedural questions, and I thank the members on the other side of the House for that close engagement, including the Hon Michael Woodhouse.

But we find ourselves in a situation where our COVID-19 vaccination programme is ongoing. It is one of the many tools in the tool kit for which this Government has committed to combatting the worst effects of COVID-19. We’re now at stage where a second booster is required for those people who are most vulnerable.

These aren’t people in an abstract idea; these 85,000 people include people like my dad. He’s in his late 80s or early 90s; he lives in South Auckland, which is a community that forms a buffer around the Auckland Airport; and he lives with his young grandchildren who go to kindy every day in a South Auckland kindy. He has underlying conditions. He’s also someone who has a mistrust of the medical system and not a regular GP. He is exactly the kind of person who would not have access to a prescription Pfizer vaccine when he needed it, but through taking action in this House tonight, we can make sure that people like him have access to the medicines they need to remain well and to lessen the burden on our public health system and hospitals like Middlemore, which have gotten through so well in this pandemic and have defied all expectations and managed their resources really well to serve the community.

I think the Hon Michael Woodhouse’s point around the right way to do it is a good one, but when we look at the ability of the Government to legislate in this way, where there are checks and balances in place, where the director-general must be satisfied that the authorisation is an appropriate measure to manage the risk associated with an outbreak and the spread of COVID-19 within a community but also to individual people and therapeutic value to them must be considered, I think that, overall, this is the best way to undertake this measure, and so that’s why I commend this bill to the House.

Motion agreed to.

Bill read a first time.

The question is, That the Medicines Amendment Bill (No 2) be considered by the Health Committee.

Motion agreed to.

Bill referred to the Health Committee.

Instruction to Health Committee