Medicines Amendment Bill (No 2)

I call on Dr Shane Reti.

Point of order, Madam Chairperson. My apologies; I was waiting for instructions but I’ve just missed it. So I seek leave for all provisions to be taken as one debate.

Leave is sought for that purpose. Is there any objections? There are no objections. The question is that clauses 1 to 5 stand part.

Thank you, Madam Chair. I just have a few questions which we actually note in our report. Just to record and double check with the Minister, can I just reply to my colleague David Seymour, his very good question—I interpret it the same as what David does. Pretty sure I talked about that the assay can’t change, so it can’t be a different strain added into what we currently have, that it has to stay this dose and frequency or it comes back. That’s my interpretation as well, because we did ask questions about the flu vaccine and different strains and how that got a different set of legislative requirements.

The questions we want to ask the Minister, and it has been touched on in second reading, is he certain that there need be no requirements—and my colleague Simon Watts raised points of this type as well—no provisions, or it is not necessary to have provisions to review this Act at some point in the future? Let’s remember it hasn’t had a New Zealand Bill of Rights Act (BORA) vet, it hasn’t had a regulatory impact statement (RIS), it hasn’t had an impact analysis, and even though the therapeutic products bill is promised, it is some point in the future and doesn’t really address these questions that we’d have with any other normal legislative process. So I’m just looking for some reassurance from him or reasons as to why not or that maybe it could be considered.

The second question I’d ask—and it’s been raised by my colleague the Hon Michael Woodhouse—is around the sunset clause. It was raised by submitters; again, it’s being held for—as we understand it—the therapeutic products bill, which has been on the order sheet, I believe, over several Governments. So it might be a bit wishful to say this is a temporary measure, and if that temporary becomes a lot longer—and we know that with COVID vaccines there’s been issues with temporality in front of the courts anyway.

So I think we want to have this sort of tidied up so, two questions to the Minister. One, a consideration of review, RIS, BORA, and efficacy. Then second, the provision of a sunset clause.

Thank you, and I thank the member for his questions. In case it hadn’t already become apparent to the member, he will know that I’m a Minister that gets things done. So having picked up the therapeutic products bill that was started under the previous Labour Government and made absolutely no progress under the previous Government, I have picked it up, and I can assure the member that that bill will be introduced before the end of this year. In fact, there’s a fair amount of work going into it, and we thought very carefully about the amendment to the Medicines Act for this purpose and its relationship to the therapeutic products bill. So I can assure the member that we will have a therapeutic products bill in this House, and that will be an opportunity to look at the full regime and to draw on any lesson we’ve learnt from this particular provision. That’s the reason we didn’t consider that there needed to be a sunset clause because the days of the Medicines Act 1981 are going to draw to a close. We will have a modern therapeutic products piece of legislation before too long.

Thank you, Mr Chair. I just wanted to ask the Minister about how he interprets the legislation before us. It says that if the Minister has given consent or provisional consent to a COVID-19 vaccine and a data sheet is approved for the vaccine under the regulations, the director-general (DG) can authorise a different way of administering it. In other words, that would mean that a vaccine that’s already being used for COVID—and I assume that would include several, and I wonder if he could tell us which ones—the way it’s administered, the doses, the frequency, perhaps even how it’s injected, could be changed. Could he just confirm that is really what this is about. It’s not about new vaccines; it’s about the administration of those that have been consented, and, if so, which ones will it apply to that are currently consented COVID-19 vaccines?

The reason I ask that, as a secondary part, is I know there are people—and I have constituents in the Epsom electorate—who are interested in whether this will allow the director-general, if they were to choose, to allow the administration of Comirnaty to younger New Zealanders. Because the Food and Drug Administration and the Centers for Disease Control and Prevention in the United States have just said that you can now give a Comirnaty—three doses over, I think, 11 weeks—to a six-month- to five-year-old child. Currently, that’s not allowed in New Zealand but there’s certainly a lot of parents who would like that to be an option. So I think it would be really helpful for the Minister to tell us if that will be possible, theoretically. If not, then I think we should discuss, perhaps, how the legislation could even be amended to allow it in this committee.

The third question, I guess, is: what is his position as the Minister of Health? Will he use his influence? Will he consider, perhaps, writing to the director-general and asking that the director-general should make it available for six-month- to five-year-olds and—assuming that I’ve interpreted the law correctly, it would allow for six-month- to five-year-olds to have a Pfizer vaccine—will he then encourage that to happen rapidly? Because, as I said in my second reading speech—and I’ll just give the Minister a bit more time as he’s consulting his officials—I think this whole episode, while we support the legislation and think it’s a good idea and it should go through as quickly as possible, has exposed some weaknesses, I guess, in our legislation, our regulatory regime for medical products and medications; perhaps, actually, a weakness in our regulatory regime for all sorts of products, which I believe, and ACT believes, are very duplicative, whether it’s plasterboard or whatever.

So I hope the Minister can answer those three questions. Does this mean any currently consented COVID vaccine and, if so, which ones would this law apply to right now? Second of all, could that mean that we could allow it to be applied to six-month- to five-year-olds, as has just been allowed in the US and, if so, will he encourage the DG to do that?

Thank you, Mr Chair, and thank you to the member. He is right: this is simply about the administration of vaccines. The bill makes it clear that it does not allow for the approval of new vaccines. So it’ll be existing vaccines approved by Medsafe and Pharmac—so Comirnaty but also the other ones that we have, the AstraZeneca—

💬 Dr Shane Reti: Novavax.

Novavax. Thank you, Dr Reti. So it won’t allow the director-general to issue a notice in relation to any vaccine for COVID-19 other than those that have already been approved.

In relation to whether it could be administered to age groups not so far the subject of an application by Pfizer, I’d just draw the member’s attention to clause 4 of the bill. It does require the director-general, in issuing the notice, to have access to data to justify the notice that the director-general might give and having regard to the likely therapeutic value of the administration of the vaccine and any risk and that it’s an appropriate measure. So the director-general has to be satisfied of that. In reality, that data is going to be most likely obtained from the pharmaceutical companies, so the director-general would be reliant on that. So unless there is some other source of data—

💬 David Seymour: Such as the FDA committee?

Well, decisions about the use of particular pharmaceuticals is typically reliant on data provided by the pharmaceutical company applying for the application to distribute and sell in the country. So I expect the director-general would be reliant on that as opposed to third-party sources of it. In your third question—would I prevail upon the director-general to make representations about how it should be administered—no, I do not have a clinical background. I do not regard myself as having clinical expertise. I’m reliant on advice from the director-general. I might ask the director-general from time to time what is an appropriate regime for New Zealand, but I am reliant on the director-general and the other experts that the director-general calls upon before any such decision would be made.

Just very quickly in response to the last comment: I recognise that the Minister of Health is a trained lawyer and not a medical expert. I certainly wouldn’t ask him to approve a vaccine. But he’s also an elected representative of New Zealand. And if you believe that New Zealanders wanted the Director-General of Health to consider it, then he might think about passing on that message in the spirit of being an elected representative; not to force the decision but to actually draw it to the director-general’s attention, I think, would be a helpful thing to do in a representative democracy.

But can I just—you know, one more follow-up to that previous question, which really was that the Minister’s drawn our attention to clause 4, that says that “Before issuing a notice … the Director-General must—(a) have regard to the likely therapeutic value of the proposed administration of [a vaccine and the risk]; and (b) be satisfied that the proposed administration … is an appropriate measure to manage the risks associated with the outbreak or spread of COVID-19.” I thought it strange that the Minister, despite having said, “Look, I don’t have the expertise here.”, was quite adamant that if the director-general was going to make a decision, then he could certainly use datasheets from Pfizer, but he couldn’t consider the fairly fulsome proceedings of the Food and Drug Administration (FDA) which has been published in the US in the last week. Surely he’s not saying this statute as we’re currently proposing it would prevent the director-general from having a look at the proceedings of the FDA and the decisions of the Centers for Disease Control and Prevention in the last few days and referring to those, and, if so, do we need to consider whether this legislation is overly prescriptive? I don’t think the legislation supports the comments the Minister’s made, but, if he could clarify, I think that would be very helpful.

Finally, we know that vaccination and some of the Government’s policies in response to COVID-19 have led to enormous resentment and distrust and erosion of social capital—and we saw the irrational extremes of that on the front lawn of our Parliament. I know that in response to this legislation, which ACT supports and which is fairly straightforward, there will be people who will ask, “Is the possibility of a fourth dose a precursor to the requirement under certain circumstances for people to have a fourth dose?” And I think it would just be helpful for the Minister to state whether he’s had any advice about that or any communications or consideration of a fourth dose being required in any context, particularly in relation to the health system where he has ministerial responsibility once it’s allowed? I think it would be helpful for New Zealand for the Minister to get up and make a very candid statement about where he lands on that particular issue. So there are two questions there. I’d really like to hear the Minister’s answers.

I thank the member again. In relation to my earlier comments, I said that I’d expect the director-general to be reliant on information provided directly by a pharmaceutical company, as opposed to third-party sources. The information that the Food and Drug Administration considers typically comes directly from pharmaceutical companies, and I therefore think that it is likely, if not probable, that were the director-general to be of a mind to, the director-general could consider data that had been considered and accepted by the Food and Drug Administration in the US, providing that the director-general was satisfied that the information had come from a reliable and credible source. If it comes from a pharmaceutical company, it is the same source that our Pharmac and Medsafe use, so I think it would most likely meet that standard. So I hope that answers that question for the member.

Secondly, I accept the member’s point about the erosion of social capital that we have suffered as a consequence of the dynamics that have built up around the COVID response. I can say to the member that the very reason we’re taking this approach is that it is not this Government’s intention at all, and the Government will not be mandating a fourth dose. This is on a voluntary basis because of the available evidence that there is waning immunity for some parts of the population—the more vulnerable parts of the population. Therefore, if those parts of the population wish to avail themselves of a fourth dose without having to go through the named-patient process, which is very cumbersome, then they will be able to do so, but we will not be making a fourth dose mandatory for anybody.

Thank you, Mr Chair. Mr Seymour’s questions around the breadth of the bill was one of my questions, and the Minister has answered that satisfactorily. This is not just about Pfizer; it’s about all of the vaccines that have been approved so far, although I note that Pfizer was the only one mentioned in the regulatory impact statement, which is rather unusual and probably reflects a degree of influence of, and breadth of the use of, that vaccine.

What I then heard, I think, David Seymour ask was about the potential for vaccines to be administered to children between the ages of six months and five years. I may have misheard the Minister’s answer but it seemed to me that he was saying to the committee that when this bill is passed, that could happen under a consent granted by the Minister under section 34A(1)(a), which seems quite surprising and a bit concerning to me because what I thought we were doing was extending the number of doses to people in an age range, and with certain conditions, like being immunosuppressed, who have already had the dose. Now, at six months to five years they haven’t had the dose yet, and it surprises me—if I heard right, and I think we need to have that clarified—that this Act could then enable the director-general to authorise the administration of Pfizer vaccines, for example, for that age group when (a) Pfizer hasn’t applied for it and (b) they haven’t previously had that. And I think that takes us into a realm that I wasn’t expecting. So some clarity on that—if I misunderstood—would be helpful.

The second question I have is around the immediate modification orders (IMOs) and the rather extraordinary comment in the regulatory impact statement that basically said that Ministers didn’t think that an IMO was an option. I think we need to flesh that out, because I have previously heard the previous Minister for COVID-19 Response giving the country a bit of an expectation that we were going to be in orange for the foreseeable, and certainly past the winter period that we are concerned about right now.

Two things: what was the nature of the discussion between Ministers that had formed the regulatory impact statement, and what is his level of confidence? Has he had an exchange of views with either the previous or the current Minister for COVID-19 Response about the likelihood that the epidemic notice, which, actually, expired last week, was renewed? I didn’t see any press release on that. I think it was due to expire on 17 June, which was four days ago. If it didn’t, that may answer my question. Was it extended and, if so, why wouldn’t an IMO have been appropriate? And, in fact, if it wasn’t extended, why not? Why are we still in orange if the epidemic notice wasn’t extended?

The third question relates to the question of page 3 of the regulatory impact statement, which is around the benefits. Firstly, there’s been no financial data on this at all. How much is it going to cost and how much is it going to benefit? There’s a pretty standard equation in a regulatory impact statement. We know there are more than 800,000 doses expected to be administered once the bill passes. What is the cost of that administration for both vaccine and the fees to the people who will be administering them? And then at the bottom of page 3 it talks about the benefit, which is basically a reduction in the risk of infection and severity of the illnesses—approximately two to four times less likely for those aged between 60 and 100 years, and a 78 percent lower mortality rate from COVID than those who only received a third dose. I wonder what the research was. How much is that in quantity of the reduction in harm? That’s usually pretty easily able to be measured by QALYS, or quality-adjusted life years, or some other kind of metric. And did any analysis take into account the fact that many of those people would not only have had three doses but would’ve also had COVID and therefore by dint of that would’ve had a boosted natural immunity, which may have the same effect as a fourth dose? That, for me, I think, actually underscores why the World Health Organization were pretty equivocal about the benefits of the fourth dose.

But my question really is: what analysis, if any, was done? I don’t want to bring it down to dollars and cents—this is actually about benefits as well as the cost. But what analysis, at all, was done or was this just done on a whim and emotion?

I’ll attempt to respond to the member’s questions. On the extent of the director-general’s approval—and the member, I think, wrapped it up in what discussions or what advice did Ministers have about the background to this. What we were invited to consider was, first of all, the growing international evidence that there is waning immunity—particularly for vulnerable populations—when it comes to COVID vaccines, and, therefore, for those vulnerable populations, should we be considering further assurance, if you like, through more doses of the vaccine to afford greater protection. We considered the advice we received and we took the view that it was appropriate to make a fourth dose available to those populations. We weren’t prepared to mandate it, but we thought it should be an option that is available for those who wish to do it. So that is the background to it and what we have approved.

On the reading of the bill, it is possible that the director-general, in giving a notification under these provisions, could provide for vaccination to be available to those currently not covered by approvals of Pharmac or Medsafe, but in order to do so, the director-general has to have access to relevant data and has to be sure about the safety and therapeutic benefit of doing so. That’s what clause 4 largely takes us to.

So I don’t think people should be particularly worried that there is now some sort of recipe to expand the use of vaccines to parts of the population who do not currently have access to it. The focus right now is on those vulnerable parts of the population who are looking for further assurance through an additional dose.

The member raised a question about the epidemic notice, and it goes right outside the scope of the bill. So, apart from saying that, in all things that the Government does, we act lawfully and we will continue to do so.

The final question the member raised was about cost. What I can say is that this Government has procured enough of the vaccines, including the Pfizer vaccine Comirnaty, to administer additional doses. There will be no additional cost to the Government in doing so. We have enough doses installed.

Clauses 1 to 5 agreed to.

Bill to be reported without amendment.

House resumed.

Madam Speaker, the committee has considered the Medicines Amendment Bill (No 2) and reports it without amendment. I move, That the report be adopted.

Motion agreed to.

Report adopted.

Third Reading