Therapeutic Products Bill

Members, the House is in committee on the Therapeutic Products Bill. We come first to Part 1. This is the debate on clauses 3 to 13 and Schedule 1—Preliminary provisions.

I seek leave for all provisions to be taken as one question.

Leave is sought for that purpose. Is there any objection? There is objection to that. The question is that Part 1 stand part.

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Products Bill, sunscreens may require market authorisation and the Sunscreen (Product Safety Standard) Act 2022 will be repealed even before it comes into full force, with the transition period ending 8 September.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.

Thank you, Madam Chair. The ACT Party is also very concerned about this bill, with a lot of the overreach—and especially concerned around the safety, quality, and efficiency. And once again, most of us don’t have too many problems with Part 1; we’ve got Supplementary Order Papers (SOPs) in further parts. But overall, we’ve been talking to a lot of the people in the industry, and they’re just concerned about these overreaches—again, those within the cosmetic trade, our toothpastes, as well as the natural health products. Again, we’re very concerned that there’s overreach and there’s regulation systems that this bill is going to bring to New Zealand.

We all believe in making sure that these things are safe for people to use, but when you have to put a whole lot of regulation—and where are we going to get all these regulators from? This is where we’re a bit concerned, around the administration of this regulatory system. It is a huge concern, definitely, because these products are important in everyday lives for everybody, and whoever is going to be part of this regulatory authorisation is—you know, where is this expertise coming from, and what sides of these expertise have we got? Now, this is our biggest concern.

And again, the likes of Dr Shane Reti, the ACT Party—under Brooke van Velden—have put many SOPs in the following parts, and we look forward to discussing this, because we, again, think there is a lot of overreach that’s been going on in this bill, and also so many changes. Thank you.

Thank you, Madam Chair. It’s a pleasure to be able to see this bill, the Therapeutic Products Bill, through to its committee stage. It’s right to reflect on the work that’s gone on across both sides of the House on this bill since 2003.

I want to address the concern in relation to the notification of authorisations of natural health products (NHPs), which I believe is being addressed as part of Part 1. This is Supplementary Order Paper (SOP) 376 in the name of Dr Reti. The SOP seeks to develop a notification instead of an authorisation for declaration of online natural health products. That’s a concern and an interest of the industry here that the Government has heard as well.

Overall, one of the principles we’ll come back to probably several times this evening about this piece of legislation is the desire to have risk-proportionate legislation. We’ve had many debates on these issues around natural health products previously in this House, and, of course, it’s well-established that there are harms from natural health products, but these harms are different from those of medicines, and this bill seeks to regulate them in a risk-proportionate way.

So in turning to SOP 376—

Dr Shane Reti: 384.

Hon Dr AYESHA VERRALL: Sorry, 384, which is very similar to 376 in that it seeks a notification scheme for natural health products. I just draw the committee’s attention to clauses 122 through to 124 that already provide for an approval pathway that is functionally equivalent to a notification scheme. The bill’s provisions also allow the regulator to exercise necessary regulatory powers and decision making. The SOP removes this, putting in doubt the regulator’s ability to respond to unforeseen circumstances—for example, IT failures.

In addition, the proposed SOP may unintentionally restrict the ability of the regulator to assess and improve custom health benefit claims. This is the only way by which a sponsor can be approved to use a health benefit claim that is not on the preapproved list of the health benefit claims specifically for that product. That is something the industry has sought to have in the bill.

So for that reason, the Government does not support SOP 384, because the provision for a notification scheme is already there. Rather than providing clarity to the industry, the proposed amendments risk creating uncertainty over natural health claims.

Thank you, Madam Chair. Thank you for that clarification, but we still have concerns. Information and statements around the mechanism for market authorisation for natural health products (NHPs) would appear to be not only unclear but in some cases contradictory. Furthermore, there are concerns with the capacity of the regulator to assess the potentially huge number of NHP authorisations. The process for NHPs should be a market notification process where the regulator is satisfied that an NHP product conforms to the relevant criteria. Currently, under clause 124 of the bill, an NHP would meet the criteria if the regulator is satisfied on reasonable grounds that a number of criteria apply. This includes that “there is reasonable and adequate evidence to demonstrate the safety and quality of the NHP”. Reasonable grounds should not be a condition, because the product will be declared to meet the requirements in regulations and rules.

So, fundamentally, we have quite a number of concerns for the large number—the hundreds, probably thousands—of NHPs that will require market authorisation, even with the exclusion of the Supplementary Order Paper (SOP) that the Minister has put on the Table. We just can’t see how there will be a regulator who could possibly undertake the compliance for those authorisations, both in a snapshot inventory on day one, or any transition period leading up to it, or certainly monitor it in perpetuity. This is why, through SOP 384, relevant to Part 1, we’re seeking to make a change.

The question is that Dr Shane Reti’s amendments to Part 1 set out on Supplementary Order Paper 384 be agreed to.