Reti Shane; Verrall AyeshaDr SHANE RETI (National): Thank you Madam Chair. Under Part 2 I would also like to address clause 16—I have a Supplementary Order Paper (SOP) in my name SOP 374 that starts to operate at clause 16. The concern we have here is that sunscreens are caught up in the regulations associated with the Therapeutic Products Bill. Part of the concern here is that unanimously across the House we all approved the Sunscreen (Product Safety Standard) Act 2022—a nod to Todd Muller here. We all agreed on this last year and we said there would be a transition period of one year through to September 8 which is coming up really soon actually yep. So what's happened is that manufacturers have done what is necessary for labelling and everything they needed to do to be compliant with the Act and yet this bill is going to repeal it no more than eight to 10 weeks away from it being fully enforceable—that would not seem to be right. What we do know is that there are other things that manufacturers have concerns about with sunscreens being removed from this bill. That includes the fact that it's taken quite a while to get joint approval with Australia and there are huge concerns that as this bill overtakes sunscreens if you like that joint standard with Australia and New Zealand may not stand up and there may not be the same interests that the manufacturers have and that this House agreed to when this bill overtakes it. So we have a proposal here on the Table SOP 374 in my name and what this does is it clearly amends the Therapeutic Products Bill. The Sunscreen (Product Safety Standard) Act 2022 came into force on 8 September 2022 with the transition period as I said through to 8 September 2023 and this was for the establishment of product safety standards created by the Act. Manufacturers have taken the steps necessary to be compliant with this legislation. The Therapeutic Products Bill would repeal the Sunscreen (Product Safety Standard) Act before the transition period is even expired causing further uncertainty and potentially wasted effort. Sunscreens are well regulated under the Sunscreen (Product Safety Standard) Act—everyone was reasonably happy with it; this House was unanimous—and the applicable standards. This SOP then seeks to retain the current regulations which are considered suitable by the Commerce Commission as the monitoring entity for the sunscreen Act.So you can see what's happened here: manufacturers have gone with what this House directed them. They've gone through this year-long transition period. They're only weeks away from it becoming fully enforceable—change labelling adopted standards; everything that we asked them to do—and now we're going to pull the rug out from under them no more than eight to 10 weeks away from it being fully enforceable and say Nah changed our minds actually. Therapeutic Products Bill is going to repeal the sunscreen Act"—which is what this will do; it will repeal the sunscreen Act—"and we're now going to bring it all under the Therapeutic Products Bill". The SOP in my name changes that; it removes that repeal and it places sunscreens back under the same standards applicable under the sunscreen Act. I would appreciate it if the Minister and her team could consider this with some seriousness; there was unanimous agreement across the House that this was good legislation. Manufacturers acted in good faith they did everything that was asked of them and now eight to 10 weeks away we're saying "Actually we're going to repeal that legislation and we're going to have a different framework for you to operate under." That would not seem to be the right thing to do when we were all in agreement on what our intention and our end-goal purpose was. So this SOP looks to reset that. It looks to give certainty back to manufacturers; back to the sector. It looks to give certainty that what this House agrees to in a unanimous way is something that we really intend and that we can deliver for New Zealanders. So I'd appreciate it if the Minister and her team could consider this.Under Part 2 with operating clauses starting around about clause 59 I would like to talk to exports and concerns that have been raised with us around the impact on exporters of the Therapeutic Products Bill. The concern that exporters have is that they will require some sort of export authorisation before they can export offshore even though there may never be an intention to actually supply that product to New Zealanders. They will become liable to legislation and regulations offshore: that is their customer market—why would we have any interest in that? We have no interest. We know there'll be good manufacturing practice in all good quality standards. I get that—we want our products offshore to be well representative of good-quality manufacturing in New Zealand absolutely. But it would seem somewhat ludicrous that for a product that is never going to be used in New Zealand—it will never be supplied here but it is part of our multibillion-dollar export industry—we will impose New Zealand regulations through this bill and expensive authorisation which manufacturers tell us could be in the hundreds of thousands—expensive authorisation for products that will never ever be in New Zealand. Why would we do that? That makes no sense whatsoever. It certainly makes no sense to manufacturers and exporters and they've told us as much. So what we've done here with the Supplementary Order Paper in my name SOP 375 is we've looked to redress this. What this SOP does is provide some remedy to the multibillion-dollar export industry and to those medicines that are manufactured in New Zealand for the export market. It removes the requirement for medicines and medical devices to have export authorisation—because this also actually applies to medical devices. They may never be supplied here in New Zealand: why would we require them to go through expensive authorisation when that will happen? Any requirements they need to have will happen in their target market. We shouldn't need to do that here. So this SOP allows a medicine or medical device to be exported provided it meets all other applicable export standards outside of what this bill may require. This doesn't make any sense. This would hurt our exporters. They have told us it would hurt them and so I think we should look to offer them some certainty offer them some remedy for what seems like common sense. The medicine or the medical device will never be used here in New Zealand. Why would we impose our regulations and they would face offshore regulations in their target market? So I'd appreciate if the Minister and her team could consider this as well.Hon Dr AYESHA VERRALL (Minister of Health): It's a pleasure to respond to colleagues' comments in turn: firstly Supplementary Order Paper (SOP) 373 relating to the "fit and proper" person test. It is important that the regulator has the opportunity to do due diligence on the individuals who are empowered under the Act to manufacture or undertake other controlled activities with drugs. The SOP undermines the ability of the regulator to undertake that due diligence. It is important that we note that those firms have the opportunity to disagree with a decision of the regulator and to seek an internal or external appeal. But I put it to members of this House that we would want to know if someone with influence over a person who was sponsor of a product for example had a criminal conviction for bad behaviour in this or another jurisdiction relating to medicines or drugs. On the matter of the special-case requirement—the colleague from ACT speaking to SOP 382—it is important that there are opportunities to use medicines off-label. It is an important source of flexibility to make sure that people get the care that they need. However there is an important role for being able to use clause 65 alongside other professional standards under the Health Practitioners Competence Assurance Act to make sure that prescribing is consistent with clinical guidelines for that disease or other criteria that might relate to informed consent. So for that reason we do not support that SOP.I recall the discussion about sunscreen in the House earlier in this parliamentary term and indeed that very good bill by colleague Todd Muller was supported by all parties. But the Government was always clear that the Therapeutic Products Bill would replace that sunscreen Act 2022. It's important to note that the Therapeutic Products Bill would come into force in 2026 so it would not be a case of the sunscreen Act being repealed so quickly after it's in force and most importantly it is possible for the existing standards such as those in the sunscreen Act to be taken up and incorporated as standards under the Therapeutic Products Bill. On the issue of export authorisations the Government shares the objective of promoting the export of innovative therapeutic products by New Zealand overseas through this bill. Export authorisation has a different purpose than product authorisation in the domestic context. Here it is for New Zealand to play its part in global traceability and post-market surveillance of therapeutic products. So it is serving a different purpose and in addition all the provisions in the bill are intended to be proportionate to the risk so this form of authorisation is likely to be very different from product authorisation for domestic use in New Zealand. The bill gives the Minister of Health the ability to recommend regulations relating to exports and it appears there is concern on both sides of the House to make sure the opportunity for strong export growth from this industry is maintained."