Parker DavidHon DAVID PARKER (Attorney-General): I rise to take a call on the second reading of the Medicines Amendment Bill. Can I thank the Opposition parties for their support for the bill. I also want to make a few comments about this. Can I endorse some of the comments that have been made in respect of the careful way in which Justice Ellis went about her work. I thank her for that. I think this is a good example of the different branches of Government showing respect for each other in respect of what are important issues.The member Chris Bishop is correct that the judgment whilst it makes no finding that the decision was illegal because there has not yet been a substantive hearing of that point suggests that the Government looks at the issue because as Chris Bishop has said and Minister Verrall has also acknowledged there is a doubt as to whether the plain words of the existing Medicines Act which only allows provisional approvals for a limited number of patients are sufficient to cover the breadth of vaccination that is intended in respect of the COVID roll-out. The court suggested that we look at this despite the fact that the Medicines Act has been in place for decades and similar broadly used vaccines have been given provisional approvals previously perhaps also with a question mark over at least some of them. I found the analysis of Justice Ellis interesting in her comment that the evidence on the affidavit evidence in front of her in respect of the application for injunction showed that often provisional approvals don't specify the number of patients who are going to be treated by a proposed new therapy not always vaccines. But in a lot of those cases it's self-evident because the class of people who would benefit from a medicine that's been introduced for a small class of people is obviously for a small class of people or a smaller class of people.The legislation that we have before us today effectively changes the provisional regime to remove the limited number of patients" part of the rules relating to a provisional approval. It does that not just in respect of the COVID vaccine but in respect of the other medicines that are listed in Schedule 1AA which include the annual influenza jab that is widely used and has been approved under this methodology for many many years under successive Governments. A number of medicines have been granted provisional consents over the years under both National and Labour Governments and it's clear that the provisional approval or consent power clearly has value for New Zealand. And again the reasons for that are discussed in the judgment including the fact that under a provisional consent further information can be required to be provided by the provider of the medicine as a condition of the provisional consent in a way which is not as clear in respect of final consents and therefore it is often desirable that a provisional consent be granted on those terms because it can't be granted on those terms for a final consent. That obviously is something that probably she looked at more broadly and already the Minister of Health has made it clear that there will be a new Therapeutic Products Bill introduced to replace the Medicines Act which will look at that more holistically. In the meantime we're left with a provision in the drafting of the Medicines Act which the judge described as "inapt"—that was her word. We've taken the advice essentially that was given by the court that we look at this urgently and as a House we are. In respect of the question that the member asked in respect of legal advice I'm not going to give him legal advice or waive legal advice but I can confirm in the House which would have consequences for me were it incorrect that Ministers were not provided with that advice as to the issue that the member seems to think that we were alert to earlier; we weren't. This first came to the attention of the Government upon the filing of the court proceedings not before. The member might be correct to ask whether it should have been but I can confirm that that wasn't brought to the attention of Ministers earlier. The other point I would make is that the court's decision yesterday confirmed that Medsafe did a robust and comprehensive evaluation of the safety and efficacy of the Pfizer COVID-19 vaccine and that Medsafe's decision is consistent with decisions that have been made in other countries including Australia. I would also note that this is working out very well with this vaccine in other parts of the world where many millions of doses have already been administered.The court said that Medsafe's processes for analysing the COVID-19 vaccine went above and beyond what is normally required. I was pleased to see that recorded. The court commented that "it is difficult to see how the assessment process could … have been more thorough." and that New Zealanders can have confidence. I believe that all New Zealanders—on the basis of those comments and because of the confidence that we have and the care that has been taken by New Zealand's medical authorities—can have confidence in Medsafe's decision to approve the COVID-19 vaccine. So the COVID-19 immunisation programme will continue to be rolled out here as it is in other parts of the world and I of course for one—and I'm sure I'm joined by other members in this House—am so pleased about that because it's such an essential part of enabling New Zealand's recovery from the COVID-19 pandemic and keeping our people safe. So in closing I would just again note that this is a very simple bill. In effect it takes the words out—"limited number of patients"—from the provisional approval criteria. It does that prospectively but also retrospectively in respect of the decisions and in respect of the provisional consents that are validated set out in Part 1 of new Schedule 1AA and listed in clause 1(1)(a) to (f). And as I say it includes the H5N1 influenza vaccine. I endorse this bill to the House."