Reti ShaneDr SHANE RETI (National): Thank you Madam Speaker. The National Party will be opposing the Therapeutic Products Bill. We have many concerns and I'll list four them here in this reading. First of all we're concerned that the Therapeutic Products Bill remains a great overreach for natural health products; secondly there are persistent issues with medical devices; thirdly there are potentially significant effects on rare disorders; and fourthly it is an overreach in the cosmetic industry.The Minister just said there were 16500 submissions and there were many against. Let's be quite clear: most were against. There were 16500 submissions—16000 against. So let's not trifle with the fact that there were some who had an alternative view—most had an alternative view.Let's start with natural health products. We remain of the view that this is a significant overreach and I want to quote here from the lead representative of natural health products in New Zealand The Government has ignored the advice of the natural health products sector and is pushing ahead with an unworkable and bureaucratic product authorisation and assessment scheme that risks damaging the industry resulting in less innovation fewer jobs and reduced exports." When we talk about the natural health products industry let's be clear that this is a $2.3 billion contribution to the New Zealand economy. This is not insignificant. They continue "The new regulator will simply not be able to put 20000 different natural health products through a bureaucratic authorisation and assessment scheme without significant delays and higher cost to industry. Consultation from the Government has been poor and we do not believe our concerns have been taken seriously."There are a number of things that the natural health products sector are asking for. Not only do they feel that the authorisation process is impractical they're requesting a notification scheme. They just simply believe it's impossible for a regulator to market authorise 20000 natural health products and they also want to talk about the burden of cost in doing that. They also are concerned that claims that are accepted in other jurisdictions may not be able to be accepted here. They're concerned with the means to export the certification process for export and they're concerned with accountability and resourcing of the regulator.There were three main changes from when the Health Committee deliberated through to today. I'll talk to them now because it does affect natural health products. There were several changes that were made. The first was around rongoā which was initially included and is now excluded. The second was around online importation. That has been clarified. I think there was a piece of work still to do with that. But natural health product small retailers as the Minister said that are direct to consumer have been somewhat cut out of this legislation although a lot of secondary legislation will provide some clarity to that. So I think there's still a lot of work and a lot of concern. I met with some of with some of the medium-sized natural health product companies. There is one in Whangārei that is a manufacturer and has seven franchises and they tell me they will have to close all franchises if they have to go through a manufacturing approval process and a market authorisation approval process for all of their products. So while some still somewhat-unknown work has been done around small manufacturers the medium-sized manufacturers will still have a significant consequence. I want to move on to medical devices. There has been some clarity around software in a medical device and software as a medical device. What is unclear are the provisions in the legislation that say that if there is a performance change then you have to go back for re-certification. The concern I've got for the software industry is if you do code optimisation and improve performance in a software element is that going to require re-certification? Because it would be a problem. That would stifle innovation and be a significant problem to our software industry. That needs a lot of clarity.I want to talk to the group of medicines that are currently given free by companies. The example I'll use is a rare disorder where the special-case requirement is never going to work because it's too expensive. Even with a GP prescription you're never going to import it online; you're never going to visit and bring it back in your luggage in view of the luggage regulation. This is always going to be too expensive. What we have with compassionate access schemes is we have companies who bring it in and they give it to certain patients. So it's a free gratuitous giving as I say under compassionate access schemes. The issue we've got here is that there appears to be no mechanism for prescribers to approach those companies firstly. There are no provisions in the bill for providers looking to be part of a compassionate access scheme to approach companies and say "We have someone with a rare disorder—can you help?" Secondly if they do decide that they're able to compassionately give these expensive medicines they will require market authorisation. Why would you do that? You're doing it for free. Why would you incur the burden of what may be $100000 to $150000 for something you are giving for free? Why would you do that? That makes no sense at all. There is a lot of work to be done with rare disorders.There are other conditions as well. The situation where you have a clinical trial—again it's this free giving of medicines—and in a clinical trial you'll have the medicine that's under examination that's qualified by the trial itself but often you have a standard of care comparator: your placebo if you like which is something that's already pervasive in the environment already well understood. You give that for free to the clinical trial. Well here's the problem: same thing there's no ability for prescribers to approach the leads of the clinical trial or for the clinical trial to give those standard-of-care medicines free to participants. They'll have to have market authorisation at great cost.Furthermore after the clinical trial if you did get a benefit from the standard-of-care medicine again there's no ability for the company to give that to you. The same thing applies for out of stock and the classic example here at the moment is Estradot. Previously you'd use a section 29: you'd approach a company and the company under section 29 would be able to provide that to you. Under this legislation that is not available.Off-label use which particularly is for children with cancer where a medicine that is used for one purpose is looking to be used for another purpose—again section 29 would've done that. We see no provisions in this bill for off-label use so we have significant reservations about that.I want to talk about the cosmetics industry—$1.25 billion turnover in New Zealand $400 million export dollars 24 New Zealand - based manufacturers with Good Manufacturing Practices manufacturing. This is not a significant industry. Their concerns are that they are now caught up in the Therapeutic Products Bill—that anti-dandruff shampoo that might have selenium sulfide in it is now a medicine caught up in this bill that anti-wrinkle cream with retinol is now a medicine caught up in this bill toothpaste with fluoride is now a medicine caught up in this bill. None of this makes any sense. Currently cosmetics are excluded under the Medicines Act and they're regulated under the Cosmetic Products Group Standard. We think it should continue to be regulated under that standard. This is a terrible overreach to the cosmetics industry.It's also going to reach into sunscreens and we can see that because the Act is going to repeal the Sunscreen (Product Safety Standard) Act 2022 which was due to come into force in no more than three months' time about which all of this House in September last year said "This is a great idea. We need to do that. Let's have the same standards as we have with Australia."—acknowledging Todd Muller; this was his member's bill. Here's what's going to happen under this bill: it's going to be repealed but in the last eight months sunscreen manufacturers in New Zealand have undergone the manufacturing the labelling all the requirements of that Act and in three months' time it's going to be repealed. It was supposed to come into effect but this bill will now repeal it—it's done. The sunscreen Act even before it could come into force is done—not clear to us that we'll still have the joint standard with Australia and New Zealand whether it's just going to be a Therapeutic Products Bill standard but that would be a great tragedy for something that this House all agreed with to be repealed even before it can come into force.The last thing I want to talk to is the complete disrespect this Government has had for the select committee process. When we deliberated there were three working group reports still to come back two on rongoā and one on the impact on small business of the natural health product changes in this bill. We were not privy to those deliberations and it was very awkward for Government officials when asked "What progress has the working group made?" to dance and not be able to provide an adequate opinion. The purpose of the select committee was to provide scrutiny public accountability to all the information available. We did not have all that information and five days later the Minister announces Supplementary Order Papers (SOPs) that take that information into account. They couldn't wait five days? There was such urgency to ram this through they couldn't wait five days and let the select committee have the same information that the Minister has had to progress these SOPs in the next stage. That is disrespectful.It is not the first time this Government has been disrespectful of the Health Committee. If you recall the pae ora legislation: completely new chair completely new select committee. I feel sorry for the disrespected members sitting on the other side of the House. I believe they worked diligently but this Government and their Minister disrespected them.This process has been poor. We agree with the natural health products industry: there has not been enough consultation. We will oppose this bill."