Medicines Amendment Bill (No 2)

I move, That the Medicines Amendment Bill (No 2) be now read a third time.

I thank the House for their attention to this bill that will make a difference to more vulnerable parts of our population who seek the further assurance of an additional dose of an appropriate COVID vaccine. Our vaccination programme is dominated by the Pfizer vaccine—the brand name Comirnaty—but we have had two or three other vaccines as well, as part of our programme. AstraZeneca is probably the next most used, and there’s Novavax as well. So this bill simply allows the director-general, through an appropriate notice and on appropriate assurances, to approve a further dose being given, and the basis of that dose as well. This simply reflects the fact that there is international evidence that, for some parts of the population, the vaccine wans in efficacy. For those who are concerned about that, and where it’s medically appropriate, they can get an additional dose of that.

The alternative is to rely on the pharmaceutical company themselves to make an appropriate application to Pharmac. They haven’t done that. The alternative then would be for each individual person who wanted a further dose to go through their doctor, to go through the named patient regime for off-label use. This process obviates the need for that and makes it available on a broad basis for those defined in the notice and for whom the director-general is satisfied there is a therapeutic benefit and for whom it is safe to further administer that dose. It is a very simple process in that respect. But, as members have raised in the debate in the House, this House can look forward to—and I know they will in eager anticipation—a recasting of our legislation that governs pharmaceuticals and medicines and other products claimed to have a therapeutic benefit, with the forthcoming therapeutic products bill. I can assure the House that there has been considerable work done—with, I might say, a sense of alacrity—and they won’t have to wait too much longer. That bill is churning its way through.

💬 Todd Muller: What about sunscreen?

And I’m obliged to the member for Bay of Plenty for the work he has done on a therapeutic product, namely sunscreen. I think that member will find that his hard work, his labours, will be fully absorbed, no pun intended, into the therapeutic products bill, and his work will itself provide a therapeutic benefit to the therapeutic products bill. But this bill provides a very effective remedy to a problem, but, most importantly, allows people to get that additional dose, by way of further reassurance, to a virus that we all want to see the back of just as quickly as we can. On that note, I commend the bill to the House.

Thank you, Mr Speaker. This bill seeks to insert new section 34A into Part 2 of the Medicines Act. It operates primarily on section 20, or section 23, where provisional consent requires an application to Medsafe. What this bill, effectively, does is removes the prerequisite to have that consent from Medsafe.

We’ve talked about a number of things in the committee of the whole House. It’s interesting to consider the prospect of the therapeutic products bill maybe being the reason why this bill doesn’t require a sunset clause. It may well be introduced at the end of this year, but that could be a three- to six-month process to actually make its way through. So we’ll have to see if it’s actually going to provide any remedy here, and if the Government wanted to be cautious, they could have put a time frame on, themselves, in this bill—a sunset clause—to make sure that the therapeutic products bill was going to meet the ambitions that have been described in this House.

There were a couple of options. A section 25 option, where, on a prescription from a GP, one can purchase the vaccine, get it off-label—that’s actually what’s been happening to vulnerable communities at the moment. Not really tenable. One is the cost of access, two is GPs are already overwhelmed, and three is the burden of going through that off-label sort of process. It wouldn’t have really been able to roll it out in the way that we like a national vaccine programme to roll out. As you heard my colleague the Hon Michael Woodhouse comment, immediate modification orders are another option. The Government has put to us that the temporal nature of them doesn’t suit what we’re wanting to achieve here, and we tried to remediate that with some thinking in select committee.

It’s very clear that there is some urgency. All the experts have expressed concerns to us around maybe wave two, expressed concerns around the co-determinants of being in winter and the increased risk of spread, and certainly those who are knowledgeable in this space weighed up the benefits and the disadvantages. The disadvantage of not having the Pfizer data through Medsafe and through to the officials to follow normal processes versus the urgency of all these other things around COVID that would increase the risk particularly to the vulnerable, those immunocompromised and older people—weighing all of that up. What we’ve heard from the experts is that there are merits in progressing without approval from Medsafe and that there are more benefits relying substantively on the international evidence. We’ve listened. We’ve heard. We’ve expressed our concerns and some suggestions as to how this bill could be made better. But, at the end of the day, we’ve taken the advice of experts and the science and we will be supporting this bill in its final reading here today. Thank you.

Thank you, Mr Speaker. I don’t intend to take the House’s time this afternoon except to say that in the first reading, my contribution was around the hope that this would be a bipartisan or multipartisan approach of supporting this piece of legislation, and what we are experiencing in the House this afternoon is exactly that, because there are many tools in the tool kit when it comes to tackling the pandemic, and vaccination is a pretty crucial one around that. And what we have at the moment without this piece of legislation is a requirement for anyone who wishes to obtain a fourth dose, to make arrangements to go and see a GP to get a script in order to receive it. And what this particular bill does is it makes it easier; it makes it more accessible for whoever may wish to access the fourth dose. And, on that basis, I commend this bill to the House.

I rise on behalf of National as the member of Parliament for North Shore on the Medicines Amendment Bill (No 2) third reading.

I just wanted to make three key points, really. As has been articulated before, this is a reasonably simple bill which is, in effect, going to provide a remedy in terms of the problem that’s been articulated around access to this vaccination. The second element is in regard to, I think, highlighting the complexity in the regulatory burden and the complexity around the Medicines Act; I think that is something that is coming through via this process. I think the learnings that we have taken on board, as we’ve gone through the COVID response phase, also has highlighted some of the aspects around getting that balance between regulatory oversight and feedback from experts and the ability to move fast and be agile. I think that will no doubt be a key element in terms of any subsequent review that is undertaken in terms of the Government’s response to COVID in this country and, hopefully, a process that will be initiated as soon as practicable.

I think the third point I want to recognise, and the Minister Andrew Little has clarified this very clearly in the House today, is that there will be no mandating of a fourth dose of vaccination. The Minister said that in his remarks today, and I think that was a point that was raised in the first and second readings, in terms of clarity on that. So for those out there who have that question, it provides that aspect.

I think the conversation more broadly around that, that only 42 percent of our health workforce are currently vaccinated for the flu—that is a key contributor in terms of hospital admissions or presentation admissions at the moment—is obviously a significant issue. When I was part of the health system before this role, we had numbers in the region of 70 to 75 percent that were getting vaccinated for flu and influenza at that point, and so 52 percent is quite a considerable decrease versus where we have been previously. So, obviously, that’s part of this broader conversation.

We’ve covered elements, lastly, around the sunset clause, and the Minister’s provided some confirmation around the therapeutic products bill, and, no doubt, that shines a little bit of light for the member of Parliament for Bay of Plenty in terms of his contribution in regards to that very bright and positive bill. So, with no further ado, I will commend this bill to the House.

Thank you, Mr Speaker. The COVID-19 pandemic—the tricky sort of pandemic—has highlighted several things, but among them it’s highlighted that provisions in the Medicines Act were not designed to be particularly sort of rapid, certainly not very flexible, and not designed to be particularly equitable in terms of our response that we find ourselves in in emergency situations. Specifically, the Act doesn’t facilitate a very timely or a very efficient roll-out of already consented vaccines and the types of things that we use to manage evolving public health risk.

As has been mentioned in a previous stage of this bill, the changes that we’ve made prior to this to the vaccine schedule—such as reducing the dose interval for that third dose—have been enabled through immediate modification orders under the Epidemic Preparedness Act, but it’s certainly our belief on this side of the House that it’s now necessary to enable enduring mechanisms that don’t specifically rely on the use of emergency powers. And, on that basis, I commend this bill to the House.

Thank you, Mr Speaker. It feels like an age since we were last here reading the second reading of this bill, approximately about an hour and a half.

The Greens will be supporting this bill. It would insert a section 34A into Part 2 of the Medicines Act, which relates to “medicines and medical devices”. This will allow COVID-19 boosters to be rolled out for those who are of high risk for COVID-19. I appreciate the conversations that we’ve had around the House this afternoon around ensuring that we are mindful of the information that we get from people. So making sure of the source that we get that information from and having experts come in and give us that advice is really important.

I attempted a plumbing analogy, which fell flat with a few members around the House as well, but it just reminds me that I should try to think carefully before clogging the drains with any metaphors. It is also great to see the bipartisan support for this bill, as well; often that’s just a pipe dream. It would be good to see that across the House.

But also there were a number of questions that were raised around the committee stage and different points that members have raised, which I think is really important that when experts and advisers come to us that we have that time to actually go through it and ask those questions that our constituents and interested parties would ask those experts as well. But it’s important that we don’t get any Tom, Dick, and Harry with a YouTube account showing up to the select committee; that we get those people that have the background expertise in that, and we put those questions to them as well.

So the select committee process was short. I do understand the motivation for why it was truncated, but it was also incredibly important to get those perspectives on paper, as with the contributions made by members around the House as well.

I guess the thing for me that lands most that I am learning and continue to learn, and I hope others around the House are learning that as well, is that when we get leaders from our communities—from impacted communities—that empowers appropriate decision-making, because people are more likely to take on board those messages when you have leaders from those communities. I was reflecting in my second reading speech around some of the lessons learnt around the Delta outbreak: how when Māori and Pasifika leaders, particularly health leaders, say certain things that the Government should actually be engaging with those and prioritising those voices—particularly our immunocompromised and disabled whānau.

And also being mindful, I guess, for many of us who are both parents or grandparents, uncles and aunties, about the winter of infections along with COVID coming in from our schools and the importance of having a school plan in place to help to support our school communities, because they’re asking for that. I hope that’s on the agenda for the Government. The Greens will be supporting this bill.

Thank you, Mr Speaker. I rise on behalf of ACT in support of the third reading of this Medicines Amendment Bill (No 2). I think it’s been an interesting process, particularly an interesting discussion at the committee of the whole House stage, and, in particular, the question of whether or not this legislation will not only allow a fourth dose but also allow those parents of six-month-old to five-year-old New Zealanders, with the agreement of the Director-General of Health, to be able to immunise their young ones against COVID-19, as young American children are now able to thanks to developments from the Food and Drug Administration and Centers for Disease Control and Prevention over the past week.

As we’ve traversed, it’s also instructive that New Zealand’s regulatory systems are at a stage where we have to do these kind of truncated, half-arsed—that’s a parliamentary term, Mr Speaker!—legislative manoeuvres in order to—I’m sure it is in Rangitīkei, Mr Speaker!—get through an impasse where people can’t get access to a vaccination because of the regulatory situation. I think that’s possibly the beginning of a much more sophisticated and very necessary debate about the duplication of our regulatory systems. These are the regulations that are passed in other countries.

But, in the meantime, this is absolutely the right thing to do. It is absolutely a choice. It was absolutely reassuring to hear from the Minister that the Government has not considered and will not make it in any way compulsory for anyone, for any condition, for any reason, to have a fourth dose. But what it will do is allow people who might not have the time or capacity to get to their GP who do want a fourth dose to have one, and possibly for more younger New Zealanders whose parents want it to be able to get that protection for them as well. I think that’s a very positive development for our country, and the ACT Party stands in favour of this legislation. Thank you, Mr Speaker.

Motion agreed to.

Bill read a third time.