Therapeutic Products Bill

Members, we come now to Part 4, and this is the debate on clauses 117 to 150—market authorisations for medicines, medical devices, and NHPs. The question is that Part 4 stand part.

Thank you, Madam Chair. We want to address the issue of natural health products (NHPs) again through Part 4, starting with clause 122, as we continue to be of the view that natural health products are over-regulated and are an overreach in this bill. Despite the post - select committee Supplementary Order Paper (SOP) 368, we continue to believe that this bill is an overreach for the natural health products market.

Supplementary Order Paper 376 that we’re proposing amends the Therapeutic Products Bill, and we do it in quite an elegant way. What we say is that, OK, continue with the market authorisation process—that’s fine. Do whatever you’re doing there, even though we’ve got concerns that there are thousands of natural health products that are going to require authorisation. Even removing the small manufacturers, we don’t believe that there’s going to be enough administration, or if it will, it’ll be exceedingly cumbersome to actually regulate those. Go through that process, but here’s the operative clause we’re wanting to insert: Clause 123(2), “For the purpose of subsection (1), the Regulator must accept the applicant’s declaration referred to in section 124 as sufficient evidence of the matters declared unless there is evidence to the contrary.”

Now, under the bill, natural health products require market authorisation—certainly, our moderate and medium sized manufacturers. Information and statements around the self-identifying method of market authorisation would seem to be unclear and sometimes contradictory. There are concerns, as I’ve mentioned, with the capacity of the regulator to moderate a large number of NHP authorisations. This SOP, effectively, develops functional notification instead of legislative authorisation by maintaining the market authorisation framework for NHPs, but it has the authorised criteria, the sponsor criteria, and the applicant’s declaration all accepted by default.

In this respect, the legislation would function more like the near-unanimous cross-party support for a previous natural health and supplementary products bill. It’s an elegant way to achieve what we’re wanting to achieve—to move towards market notification of natural health products, rather than cumbersome bureaucratic market authorisation—and the way we do that is we say, “OK, go through the market authorisation process, but, again, the operative clause is here: “the Regulator must accept the applicant’s declaration referred to in section 124 as sufficient evidence of the matters declared unless there is evidence to the contrary.”

So it is a market notification process by default. It sits within the market authorisation framework that this bill is proposing. Certainly, our discussions with the industry were that this would make a significant difference. They have the grave concerns for their industry that they have had right from the beginning. That hasn’t been substantively allayed. There has been some shift around small manufacturers—and that was appreciated by a number, actually—but there are still many who will be caught up in this legislation who remain of the view that it is an overreach.

We are offering here a midway point that utilises the framework that the Government is proposing, albeit we still have concerns about the bureaucracy around market authorisation. But if that is where the Government is committed to going, then accept that documentation by default, unless, as we say, there is evidence to the contrary. That would reasonably achieve what the industry is looking for, which is a more “market notification by default” sort of process, rather than a cumbersome, bureaucratic, and expensive market authorisation process.

So we’ve put this forward as a middle ground that utilises existing frameworks, which we have concerns about—but if the Government is committed to going down that path, there it is—but provide an option and an ability to achieve what industry is looking for in changing the focus with just a few words: “sufficient evidence of the matters declared”, “must accept the applicant’s declaration”. That’s the word—“must” accept the applicant’s declaration—and we think that that will make a difference. Industry think that that will make a difference, and we’d ask the Minister and her team to reconsider this, please.

Kia ora. I’d like to echo the words of my colleague who just resumed his seat, Dr Shane Reti. One of the major concerns we heard from submitters, from natural product producers, especially small producers across the country, was about compliance costs and the range of requirements of this bill, and that that level of compliance is absolutely disproportionate to the overall level of risk that they pose. Again, echoing words my colleagues have used earlier in this committee, the framework for medical devices and medicines is not appropriate to be used for natural health products.

The other concerns that people who came to us raised were about those expected compliance costs being a barrier to entry into the market. I think, as climate change is continuing, more people are thinking that it might be better to start growing their own food. I come from the Tairāwhiti. Where some seed falls in the ground, that is going to grow. People think, “Well, I could make some money out of—and maybe an income, a life out of—what our whenua produces.”—and just a shout-out to all of those producers now in that situation after our severe weather events that have actually impacted on that as well.

Coming back to this, we know that overregulation will disadvantage small businesses, who are unable to maintain those maintenance costs while staying competitive with our larger, multinational companies that have products available online and from across the world. We just wondered, when you’re discussing in this reply back to us, about how these amendments will ease their minds. Kia ora.

Many concerns shared by the Government expressed in the House. Let me reassure the previous speaker, Dr Elizabeth Kerekere, that foods that are governed by food standards under the Food Act are excluded from the Therapeutic Products Bill. And, on the matter of regulation of natural health products (NHPs), I think everyone accepts in this debate that natural health products have some activity, some risk, but not no risk, and the overall approach to this bill is a risk-proportionate approach to regulation. That will be borne out in how authorisations are done.

Responding to Supplementary Order Paper (SOP) 376, we canvassed some of the issues we discussed in relation to the related SOP tabled in Part 1. Just to repeat: those clauses 122 to 124 already provide what is being sought by this SOP, which is a notification scheme, but also allowing flexibility where necessary. These clauses provide the platform for an automated self-assessment declaration pathway for most natural health products. But rather than providing clarity to industry, the proposed amendments risk creating uncertainty over the criteria that might apply to NHPs.

Finally, removing clause 123(3) will limit the ability of the regulator to assess and approve custom health claims. These claims are what industry will want to be able to make in order to speak to the potential benefits of their products. So, for that reason, we won’t be supporting the SOP.

I’d like to speak on the Supplementary Order Paper (SOP) 380 in the name of Brooke van Velden around clause 120(2A) in this that we’re wanting to look at. We’ve just got concerns around, as the explanatory note of the SOP says, “The circumstances which justify a product being made available in New Zealand through provisional authorisation may include a public health emergency or other time critical matter, it is essential for the avoidance of doubt that the Act clearly states the Regulator may rely on evidence from trusted overseas entities or expert organisations when determining a product’s safety, quality, and efficacy. Any uncertainty in this regard presents a risk of delay or a trigger for debate concerning what evidence a decision may be based on, and delay and debate may be counter-productive given the circumstances. So this is a concern that was brought to us again from a lot of our medical companies that have come to see us—just not also in natural health stuff as well. We’re just a bit concerned around this, and about a risk of delay especially.

I know that, yes, things happened through COVID, but this is just to make things a little bit more clear and a little bit more precise because there is a little bit of doubt around some of these clauses in here. I know we jump around with a lot of the clauses, too. We’re just trying to make things a little bit more tidy so that people can understand these bills a little bit more clearly because they are very complicated—especially this page—because, as you know, we’re going from one Part to the next. So I’d like to speak on behalf of SOP 380 in the name of Brooke van Velden. Thank you.

Thank you, Madam Chair. I am also very concerned around issues relating to the use of authorisation of medicines for response to a public health emergency, because one of the first piece of pieces of legislation I passed in this House was the retrospective amendment to the Medicines Act under urgency in order to do the COVID vaccine roll-out, and that is not the ideal situation we want to be in.

We want to be able to respond to public health emergencies in a timely way, and that may mean that different processes for authorisation may need to be used in that setting. It may mean that we’ll rely more—there is the option to use information from overseas authorities already, as well, in this bill. The proposed Supplementary Order Paper (SOP) 380, unnecessarily duplicates clause 346, which says that the regulator may rely on decisions of designated entities in evaluating a therapeutic product. In fact, that is a codification of current existing practice; half of the approvals that Medsafe currently make, they make using information from overseas regulators as important parts of their decision.

So that reason, while we agree with the intent of the SOP, it is already reflected in the bill and we will not be voting for it.

I would like to speak on Supplementary Order Paper (SOP) 385, on behalf of Brooke van Velden. This one is around clauses 148, 149, and 150. It’s all to do with commercially valuable assets owned by pharmaceutical companies, and confidential information, including tech data and trade secrets and intellectual property (IP). Now, quite a few of our companies have come to see us and they’re concerned about their IP and how safe from disclosure the active ingredient information or use will be. Because, again, a lot of people—not just companies but also people—have created natural health medicines or medicines in general. You know, they’ve put a lot of time, effort, and money into making these medicines, and a lot of them have already gone through a lot of regulatory stuff, like the Food Act and all that. And I know that they’re all behind. But, the thing is, we want a guarantee that if we give this information to the regulator, it is going to be kept safe and it is not going to leak out. That’s the biggest thing that these people have asked us. You know, we have created this stuff in good faith; we are selling it. If someone else is able to get some of their information around the products and then are able to compete against them, it puts it into an unfair advantage.

So we just would like to make sure that protection period in clause 148 and also 149, the protection with the ingredients, and then also the limited circumstances in which protected active ingredient information may be disclosed and used—so we just want to reiterate and make sure that these loopholes are tidied. Again, you know, intellectual property is a huge thing for a lot of people, and especially when they’ve put a lot of time, effort, and work into creating products, and we need to make sure that we’re not going to disadvantage them by giving this out accidentally to a competitor or something. So we would hope that the Government would recognise that there could be possible problems with this and make sure that no loopholes are there. So this is why we support this SOP 385.

The bill contains protections on data and confidentiality already, and care has been taken to make sure that they are in line with our international obligations, with respect to these matters. It is important that we protect the data that is used as part of the development of innovative medicines. There is a risk with the Supplementary Order Paper, as it’s drafted, to undermine the ability of the regulator to discharge its obligations.

The question is that the Minister’s amendments to Part 4 set out on Supplementary Order Paper 368 be agreed to.