Woodhouse MichaelHon MICHAEL WOODHOUSE (National): 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 800000 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 834000 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."