Reti ShaneDr SHANE RETI (National): Thank you Madam Speaker. It's a pleasure to speak to this bill. I want to thank the select committee and officials who met in a truncated process and I also want to thank our team and shadow Leader of the House who made persuasive arguments for us to have a truncated process so at least we could have some feedback on this bill.The select committee met with oral submitters and received written submissions. To each oral submitter we asked several questions: are they comfortable proceeding without waiting for the Pfizer data which we were told would be available in a month or so or in the coming months quote unquote is what Pfizer says. Every oral submitter said to us Yes". We then asked: do they believe progressing without the Pfizer data on the basis of the international evidence provides more benefits than waiting for that data? Again every submitter said yes.Of the written submissions I want to just recall for a moment the very valuable submission from Te Rōpū Whakakaupapa Urutā whose data through the COVID pandemic has been very useful. Their response to the committee was "At our meeting last night we discussed the purpose of the amendment and agreed that the proposed amendment is sensible. It is pleasing to note this determination to improve access to COVID-19 vaccines for Māori and other New Zealanders. We are supportive of the amendment and are of the view that it will ease access to further COVID-19 vaccinations when and if required." Te Rōpū Whakakaupapa Urutā—that is their submission.We asked several questions of officials. We asked them: "Is this bill in any way mandating the fourth dose?" The answer we got was "No". "Is this bill only related to the current assay?"—that is if the Pfizer vaccine changes in any way is that being permissioned by this bill? We were told that this bill is specific to the current Pfizer assay; any changes would need new legislation.The Royal New Zealand College of GPs presented and raised a really interesting question because conceptually this is an off-label - type process under section 23 and they raised the question that with most off-label medicines there's a much more involved and engaged informed consent process that is required. They had concerns that for the number of vaccines that might be being looked at that informed consent process for off-label could be cumbersome. Officials replied that the consenting process for the COVID vaccine is now mature and the college should be reassured that the burden of any new consent will not fall on them—that is the standing consenting mechanisms should suffice for what is required for this slight variation of off-label.We were reassured by the submissions that we heard. If we just remind ourselves what we're doing here treatments provided under section 23 go through a Medsafe approval process. Due to the timing and the urgency this particular booster—the second booster the fourth dose—is unable to go through that same process. There's currently six preparations approved under section 23 provisional consent: two types of contraceptives two pandemic flu vaccines the Pfizer COVID-19 vaccine and an electrolyte solution used in hospitals. So there is some use of provisional consent section 23—a little bit of section 20 as well—already out in the environment.Of the submissions that we heard that addressed the bill we were reassured that some of the issues that we have grappled with they were comfortable with and many of them are much greater experts than we are in this domain. More particularly we were reassured by their assay of the international evidence—which in the absence of the Pfizer application to Medsafe which they wrote to us saying it would be in the coming months—that suggests that there are more benefits to proceeding now rather than waiting for that application to Medsafe. So here in the second reading it has an assessment of what the select committee did. National will be continuing to support this bill in the committee of the whole House. There will be a few points that we'll just raise for discussion but here in the second reading we are supporting this bill. Thank you Madam Speaker."