Therapeutic Products Bill

Members, we come now to Part 9, the debate on clauses 330 to 362 and Schedule 3, “Regulator”. The question is that Part 9 stand part.

Thank you, Madam Chair. I’d like to stand on behalf, again, of Supplementary Order Paper (SOP) 378 in Brooke van Velden’s name. Again, this is around information sharing—this, again, is companies as well as individuals that have worked very hard to create information and products—products that we send overseas. It’s about regulating how the information is going to be shared, and, once again, many of these people have a bit of concern. And what we just want to do is we just want to tighten this up a little bit better to make sure that this information—people’s intellectual property (IP)—is not going to be shared to other companies or other individuals. Like as we said in an earlier SOP that we did as well, again, it was around information sharing and making sure that it is held and contained and it’s not going to leak out. Also, the bill—because we jump around from one thing to the next—can be very confusing for a lot of these businesses out there to know where all this actually stands, especially around IP and information. We’ve got two different sections within this bill, and all we want to do is make sure that it is very, very tight.

We’ve got replacement clauses here that are actually necessary to make sure that these powers are not accidentally abused with people’s information and that they sneak out and that that register is actually well and truly tight and that we don’t accidentally send information out to other companies that are competitors to those that are giving their IP to the regulators so that their products can be regulated. And, again, a lot of this comes around the concern about the compliances and making sure that these people are going to be guaranteed that this information doesn’t leak out. And that’s a huge concern for many companies that we have spoken to and also quite a few individuals who have created their own. It’s necessary to make sure that this information—because of this bill with this information sharing with the regulator—does not sneak out, especially around people’s property rights, IPs, that they have spent time and they’ve spent the money to create. And it’s necessary that we make sure that they’re all tight, especially around the powers here.

Thank you, Madam Chair. I think my colleague Toni Severin has done a wonderful job explaining this Supplementary Order Paper 378, in my name. But I also wanted the opportunity to speak to it.

Look, New Zealand is a very small market. We’re a very tiny little nation on the edge of the world for a lot of big players, especially large pharmaceutical companies, and I think it’s really important that this regulator gets things right. And it doesn’t appear that that’s the case, as drafted, because we’ve had people who are involved in medicines and pharmaceuticals say to us, “We’re a little bit concerned about this law and we’re concerned because we spend a lot of money, a lot of time, a lot of resources in developing new and innovative medicines and new technologies. That means we have a lot of data and information that we have that’s privileged information, because we have spent so much time investing in our own products.”

Now, under this law, they’ve said, “We’re a little unsure that that data would actually still belong to us”—that it would still be safe, it would still be secure—as intellectual property. So they’ve asked for an amendment to this law to ensure that if they are a big player internationally and they take the chance of coming to New Zealand, going through the rigmarole of becoming regulated under this new regulator, in fact it’s not going to open them up to having damage to their intellectual property in New Zealand and internationally. Now, you can understand why that’s of huge importance, because if you have spent so much time and energy and resource and capital into investing in new innovative medicine, you want to know that you can actually hold on to that product—that is your product—and not because the process that you’ve gone through with a small regulator on the other side of the world has opened you up to other people having access to your data and privileged information. You might, all of a sudden, see competition where your intellectual property is no longer valid.

I think this law does need to be tightened to make sure that people have the faith that they can invest, they can develop new technology, new medicine, and they know that it will be safe and secure—it is their intellectual property, and they do have access to their own data. I think it’s also important for New Zealanders. That’s what’s missing here. If we want Kiwis to feel like they have a shot at having access to new, innovative medicines and they have a shot at having better health outcomes, they need new, innovative technology. They need new medicines. If companies around the world don’t have faith that this regulator will protect their intellectual property then they won’t seek to have their products regulated in New Zealand. And that means all New Zealanders are worse off.

So I hope the Minister will see sense and tighten up this regulator to make sure that international companies, people who import and export, can have faith that the New Zealand regulator will not disrupt their intellectual property.

I thank the members for those contributions. Of course, these issues around protection of intellectual property of companies that develop and manufacture medicines and medical devices is not new, and in the case of medicines, the existing regulator already deals with them on a day-to-day basis. In formulating the bill, the Government has taken account of that need for confidentiality, and we believe there are already strong and robust protections for confidentiality around intellectual property in the bill. We are also confident that it aligns with our international obligations in this area.

Thank you very much, Madam Chair. Just a brief one from me, if I may, within Part 9, which I think we’re sitting in at the moment, just about the procedural aspects of reviews that are able to be made under this part. So clause 361, for example, allows an appeal to a District Court if an applicant for review wants to seek another look, for want of a better phrase, against the regulator’s original decision. I think it’s actually quite helpful that the following clause, 362, sets out that a person still has the right to go to another court or tribunal, for example—and this is just, now, my own thinking, but I think it would be a reasonable thing to point out that at a High Court, for example, someone could go and seek a review of an executive decision. So that’s all good and helpful so far, and it actually points out—again in, I think, actually helpful clarity—that if that takes place, then a review under this part would be put on hold.

So my question is simply: if a complaint to the Health and Disability Commissioner is made, I would say that’s outside the meaning of the phrase “proceedings in any court or tribunal.”, but roughly speaking it might be—you know, in general terms, it could cover the same subject area. I think I know what the answer is, or certainly from my point of view it seems to me that someone should still have the right of review under this Act, as it will be, even while they’ve made a complaint to the Health and Disability Commissioner. The Minister in the chair, Ayesha Verrall, may or may not have thought that far ahead—comfortable if not—but if she or her officials are able to give any clarity on that now, then that might save some argy-bargy later, to use a technical legal term.

Kia ora koutou. Firstly, I want to thank the Minister and all of the officials who have worked on this bill. As a member of the Health Committee, I’m very conscious of the huge amount of effort that has gone through the drafting of this and multiple changes that were made through that select committee process, and then this significant Supplementary Order Paper that the Minister has brought to us to consider.

The only reason I am voting against it is because of the provisions related to rongoā. When I was a Green MP and I spoke in the first reading, we supported it, hoping that through that process the provisions for rongoā would be improved, and specifically to respond to the call from Māori across the country—the resolution that was made at Waitangi that rongoā should be excluded. We’ve had further conversation through the first reading that would necessitate a definition being added, which has been.

My concern remains that instead of just excluding the impact of the different parts of the bill, it goes further and establishes an advisory committee. So this is here in Part 9. We’re just wondering about and want to get some feedback from you and clarity about the powers of the advisory committee, because it appears that instead of resting the power to do with rongoā, identifying rongoā practitioners in the community and that mātauranga Māori in Te Ao Māori, this rongoā advisory committee will then advise Government how it will protect this whole field.

So some questions that I have are around how this advisory committee will work. We see under subsection (2) of clause 347 that the regulator is required to notify the advisory committee and take into account any advice. So we see that we have our rongoā practitioners in the community, and they have associations, organisations that they affiliate to, collectives that exist around the country. Government has this particular role, the regulator has a role, and this advisory committee seems to be the liaison between them, as opposed to those organisations themselves. So it appears that if the regulator has reasonable grounds, it can actually ignore that advice, and decide, actually, not to even notify this advisory committee of issues that might impact on rongoā practitioners.

It seems to us, with the absence of a Tiriti o Waitangi clause in this bill, as we did in the revolutionary Pae Ora legislation, that there’s no requirement in here for the regulator to give effect to Te Tiriti when it’s dealing with issues to do with rongoā, and the Government has taken on a role to protect rongoā itself, as opposed to perhaps funding, resourcing the groups in the community whose role, I believe, is to actually protect and guard the mātauranga Māori that is rongoā. Yeah, so I’ll start there and ask for some clarity around that. Kia ora.

Madam Chair, thank you. I’ll deal with Mr Penk’s question first. The bill doesn’t limit the ability to go to the Health and Disability Commissioner for that set of concerns where, within the scope of the Health and Disability Commissioner, the consumer has received a health service.

With respect to rongoā, the Government has heard very clearly from Māori the concern about regulating rongoā, and you’ll note in the earlier parts of the bill, there is a statement that the bill seeks not to regulate rongoā. However, there are some challenges there, and the main one posed by that approach is the ability for natural health products to carve out rongoā as a way to escape regulation even when they’re not rongoā. So the regulator is not tasked with proactively going out and identifying what is rongoā and what isn’t and what is OK—not at all. It is more likely to be used in a situation where in order to not be subject to the natural health products regulation, a producer says, “Oh, well, my product is actually rongoā so it doesn’t need to be regulated.” In that case, it will be very helpful for the regulator to say it is or isn’t rongoā and that’s the purpose of that. The committee does make sure that the voice of Māori will always be heard in these decisions.

I wish to turn to page 186 of the Therapeutic Products Bill, all the way through to 188, talking about costs. Now, we know that this new regulator is going to impose a lot of costs on to companies and individuals who will now be wanting to regulate their products. It seems like there’s quite a lot in here, and I know that a lot of New Zealanders are also quite concerned about the cost of living; the cost of everything seems to be going up.

When I’ve been out talking to industry leaders across the board who’d be captured by the Therapeutic Products Bill, they’ve suggested this goes all the way from your medical devices like your hips and your knees through to software, new technology, all the way down to your shampoo and your hand soaps. Every single little thing that you can think of, even if it might be a toothpaste, could be regulated under this bill. Now, my concern is that this regulator will impose these costs, which will then have a flow on effect of increasing the cost to consumers in New Zealand for very basic products that they never thought could be actually captured by the Therapeutic Products Bill, but might be. But I also note that there are quite a few formulas about how the fees and levies will be set, and there are principles for cost of recovery, but it also says that “The Minister must not recommend … regulations be made imposing a fee or levy unless satisfied on reasonable grounds that” it’s in accordance with all of these other parts of the bill, and that “the fee or levy is otherwise appropriate and proportionate.”

I’m just seeking from the Minister a guarantee that people will know—people on the ground, New Zealanders who are actually struggling—that this bill is not going to impose such a huge burden on them or such a huge cost that it will actually flow on to basic goods that they need in the rest of their lives; things like toothpaste, shampoo, hand soaps. Can the Minister actually guarantee New Zealanders that this regulator won’t impose such high costs that they will actually feel that effect in their daily life?

I am thrilled to see that that member shares my concerns about the cost of medicines in New Zealand, and perhaps I’ve found a new-found friend in support for this wiping of the co-pays of medicines for the public in New Zealand, which is an excellent matter to address the cost of living. Yes, we canvassed in the parts of the debate that ran last night, these issues around risk proportionality of regulation as an important way of keeping the costs and burdens of regulation down, where they are not appropriate, and, indeed, we canvassed the ways in which products such as cosmetics could be excluded, where appropriate, but not as an entire class because there are some areas where regulation of them is necessary, where they have a therapeutic purpose.

We also talked about the different classes and how there could be different approval processes depending on their risk. Indeed, a number of formulas are used, and criteria for determining the appropriate levy, and a fundamental concept in this bill is the idea that the burden of regulation is in proportion to the cost. So I can assure that member that there are protections in that place.

I’m very happy to hear that from the Minister. I just wondered, when you touched on the fact that you’d talked already about cosmetics and that there are some that you don’t believe should have a high cost imposed on them versus others, whether you can give any form of example about which types of cosmetics you deem appropriate enough to be exempt and which ones you don’t.

Indeed I did, during that section of the debate on the relevant part.

It’s always helpful if the Minister could actually articulate that, because not everybody, all the time, is actually watching Parliament TV, so it’s actually nice to have those things clarified. But, if I may, I’m also interested in knowing a little bit more about the set up of this rongoā Māori advisory committee. So the committee, it says, consists of members appointed under section 367 and “the joint Ministers must appoint the number of persons that they think is appropriate to be members of the rongoā advisory committee.” Can the Minister give any sort of guidance as to how big they think this committee could be? You know, we see bureaucracy, we see so much waste throughout all of Government, and things can grow and grow and grow and we see the number of bureaucrats even hired under this Government just grow and grow and grow. Is this deemed to be a committee that should only have one or two or three members? Or is this a committee that will actually end up being, you know, 20, 30, 40 people, and it just becomes a large committee where nothing actually gets done and people just sit around all the time? You know, is this actually going to be useful? Has the Minister considered what an appropriate number would be to actually get things done?

In the response to the questions by Dr Kerekere, I have already outlined the function of the committee. I have outlined the limited set of circumstances in which we believe it would be used, which I think is probably the major influence on the costs of regulation in the committee, and I do wonder why the member draws particular attention in this instance to “people sitting around all the time” when it is a committee for the purposes of advancing Māori interests.

I’m happy to answer that. It’s because, under this Government, we’ve seen a number of cases of very poorly thought-out pieces of legislation. We’ve seen a number of advisory boards being created, we’ve seen a number of working groups which have created reports that go absolutely nowhere, so that’s where the concern comes from. This Government likes to just pass things over to other people but actually fails to get things done. So, of course, there is a concern about added layers of bureaucracy. There’s a concern about people just sitting around and not actually achieving what is set out in legislation—not actually achieving anything that helps with policy development. We know that this Government puts in place lots of working groups that never actually saw the light of day. The reports were made. Nothing happened to them. So we are cynical. We are cynical about more advisory boards being created by this Government.

I just wanted to say that I am less concerned about the fact that if that group is formed it will be made up of committed individuals who will do actual work, so long as the process is sound, the selection is sound, and it’s rooted in finding who community would best want to represent them in that space. I did wonder, though—and I want to express the concern that has been expressed to us from across the country that we’ve seen through this process where the Government did not heed its own agencies, Te Aka Whai Ora and Te Puni Kōkiri, who explicitly stated that rongoā should be excluded from the bill and that there should be strong Tiriti o Waitangi provisions in the bill.

And so our concern is more that the people in that group may not actually get listened to when it comes their time to voice that opinion, because we know advisory groups are there—and I have been on Government advisory groups before, long before I came into this role. And it goes—the advice is given but somebody else makes the decision. And if one of the major concerns is making sure that people are not appropriating rongoā for financial gain—because that’s a significant concern; I can see how people would try to do it, but, also, there are certain constraints around that. Rongoā is a way of being; it’s an entire practice. It’s not about using particular individual ingredients for a particular lotion or treatment; it’s a whole philosophy that’s rooted in mātauranga Māori. So it should be very, very simple to see that somebody is trying to make false claim, so I’m fine that that is the place that it goes to.

But, I guess, I wonder, in the scale of advisory committees across the whole of Government, can we assure our rongoā practitioners across the country that what gets said in there will actually be heard, will actually be acted on?

The Government has heard the concern from Māori about the regulation of rongoā. A number of hui were held around the country to understand the depth of that concern. There has been a tremendous effort made, I believe, in the Supplementary Order Paper that the Government has presented to make sure that that concern is addressed, but it does create other unintended consequences, which is why this committee is needed. It’s mostly about the ability of natural health products that are not rongoā to escape regulation. So that is our purpose in setting up the committee. The member will note the process was put in place around how decisions about appointments to the committee are to be made. Te Aka Whai Ora is also capable of providing advice on these issues.

Thanks for your patience, members. Dr Shane Reti’s amendment to clause 332 of Supplementary Order Paper 368 set out on Supplementary Order Paper 384 is out of order, as being inconsistent with a previous decision of the committee.

The question is that the Minister’s amendments to Part 9 set out on Supplementary Order Paper 368 be agreed to.

The question is that Brooke van Velden’s amendments set out on Supplementary Order Paper 378 be agreed to.