Reti ShaneDr SHANE RETI (National): Thank you Madam Chair. We're looking forward to contributing to the committee of the whole House here today because we have a range of provisions that we would like to put into the bill that we would suggest would improve its text. In fact there are seven issues that we want to focus on tonight and I'll make my way through them and then hopefully have the leeway to discuss them in further detail.First of all we have concerns that under the Therapeutic Products Bill natural health products which is a $1 billion-plus industry continue to be over-regulated and should not be managed with market authorisation but should be managed with market notification as originally proposed in legislation going as far back as 2016 rather than expensive authorisation which this bill continues to speak to.Secondly we have concerns that under the Therapeutic Products Bill exporters—which are a multibillion-dollar industry—are required to get authorisation if they are manufacturing products not for supply in New Zealand. Three we have concerns that under the Therapeutic Products Bill cosmetics such as toothpaste and shampoo may require authorisation where the existing Cosmetic Products Group Standard would seem to suffice.Four we have concerns that under the Therapeutic Products Bill sunscreens may require market authorisation and the Sunscreen (Product Safety Standard) Act 2022 will be repealed even before it comes into full force with the transition period ending 8 September.Five we have concerns that under the Therapeutic Products Bill prescription medicines will be advertised directly to consumers amidst unified prescriber and consumer.org resistance as one of only two OECD countries to allow this.Six we have concerns that under the Therapeutic Products Bill the fit and proper persons requirement is too stringent including offshore senior managers and those within seven years who have left the company to provide certification that they are still fit and proper persons.Finally we have concerns that under the Therapeutic Products Bill the transition time for medical devices is too short given that it includes things like laboratory consumables and pregnancy tests and the transition time needs to be increased. We'll make suggestions as to what an appropriate transition time might be.We want to start with the first concern that we have that natural health products continue to be overregulated in our view under this bill. Now there is a Supplementary Order Paper (SOP) that subsequent to the select committee deliberation is looking to change the authorisation process for natural health products. More specifically small manufacturers or those who manufacture directly to consumers would seem to be able to be excluded. This is a good thing; this was clearly an overreach. We have also concerns then for medium and large manufacturers. I have a number of medium manufacturers in my electorate who have said to me that if this bill proceeds in its current form they will go out of business.The overwhelming concern we have here is that natural health products are still enclosed in fundamentally a medicines framework. They are still being thought of as a medicine and they are a significant industry—a multibillion-dollar industry at least. We would propose that where there was last unanimous consensus in this House was with the Natural Health and Supplementary Products Bill 2016 and the Supplementary Order Paper that followed that was the last time this House agreed that the appropriate way to approve natural health products was through a market notification process rather than a market authorisation process.So we have two mechanisms that we want to propose to adjust this. The first is Supplementary Order Paper 384 in my name which talks about how we could basically change the market authorisation process: remove it and make it a market notification process and somewhat segment it in the bill and keep it to the side. Discussions with representatives of the industry have said that this would achieve most of the goals that they're looking for. They're not enthusiastic to go back and re-litigate and spend another four or five years through what's brought us here at least but they do feel that this part of natural health products should be segmented from the rest of the bill.So in collaboration with them and with their teams Supplementary Order Paper 384 creates a mechanism to do that. What it fundamentally says is that we believe that safety and quality and all the things that we want with natural health products can be achieved through default market notification without requiring what we believe is unmanageable unrealistic and unachievable market authorisation.So we have a proposal on the table here which we hope the Minister and the team will consider that puts natural health products in a safer place and encompasses more of the manufacturers and the industry that we want to offer quality assurance for but also a mechanism for them to go about their business in a safe way. We propose in my name SOP 384 as the mechanism to do that and we'd ask the Minister and her team to consider that. I hope to come back and talk to these other points in further detail.I would like to talk to a further issue that we have around how the legislation describes fit and proper persons". We have several concerns. We absolutely agree that there needs to be appropriate character certification for players who are entering this new market. But as the legislation is written we have a range of concerns.First of all the time frame for scrutiny of whether a person or an entity is of good character seems to be unbounded. It seems to be an endless open time frame and this would be out of keeping with other similar domestic legislation and similarly with international legislation. To have an unbounded time frame to assess suitable character is out of keeping.Secondly there's a part in the bill that talks about senior managers who have significant influence over an operation and a requirement for them to be of good character going back for what can be up to seven years' time. Now we've got a number of issues with that. First of all if we look at global corporates who are quite geographically removed from us here it is quite possible that a corporate offshore could be reached through this bill when they are quite removed from the field of operations here.CHAIRPERSON (Hon Jenny Salesa): If the member could come back to Part 1 please?Dr SHANE RETI: Oh OK. Thank you Madam Chair. This is an overview of what we can anticipate in Part 2 clause 60. Thank you."