Misuse of Drugs (Medicinal Cannabis) Amendment Bill

Thank you, Mr Chair. There is a supreme irony in this new clause, in respect of the licensing regime. The famous 59 words—at least, in the bill as it was introduced and considered by the Health Committee—used the term “licensing”. We have debated and removed what was their clause 7, and our new clause 8A doesn’t—as far as I can tell—even make reference to licensing. What this is now called is “Regulations setting minimum quality standards”. The description of which regulations should be put in place refers only and solely to the product. There’s a little more detail there which kind of makes a bit of a mockery of the Minister of Health’s comments about adherence to regulatory rigidity, which he accused our Supplementary Order Paper of having. Indeed, he himself is now doing what I think should be done, which is guide officials at least in getting from the start line to a regime, but that’s not a comprehensive guidance. It talks about the ability to make a regulation. They may prescribe quality standards; the process by which the product is cultivated, manufactured, produced, supported, or supplied; it may be made generally to something which is an imported product or class of products; and so on.

Here’s what it doesn’t do, and here’s what the whole framework no longer does, even in an oblique way: it doesn’t refer to any sort of standard for the people and the place and the restrictions that could go not on the product but on the whole process. So, in my ignorance of the Medicines Act or any other prevailing legislation that may have that in it and therefore cover those things as standard practice for the development of a medicine—because I can’t think there would be much to be gained by a fit and proper person test for the manufacture of aspirin—I don’t imagine the manufacture of aspirin within a kilometre of a school is of particular note, and, therefore, I doubt whether the Medicines Act actually speaks to that.

So where the Minister has been so insistent that we free the officials up and not rigidly constrain them in their practice of developing the regime, we have taken away any sort of fetters, except on the quality of the product. But the product itself is cannabis, and it, appropriately, should have some expectations placed on it for the people and the place and the co-location with other things that I now am a bit lost about because the Minister and the Government are not prepared to take Dr Reti’s good advice on this and have those things included. That’s fine, that’s their prerogative, but they do need to explain to the public of New Zealand and to this House why it’s not important to them whether or not a cannabis factory can be beside the local school. I can be pretty sure that if we do pass a piece of legislation that has those conditions placed on it, then it’s almost certain that the public is going to be concerned about that.

What about planning rules? Is it going to be necessary for local council planning rules to introduce a new set of criteria for, for example, resource consenting manufacturing of this type? Does this constitute a farming activity? Who knows? I don’t and I won’t after this bill is passed, and neither will the officials, because they’re focused only on the quality of the product. It seems entirely incongruous that we do that to the extent of things like traffic laws, Resource Management Act laws, Medicines Act laws, and fit and proper person guidelines. I’m even more confused than ever.

Thank you, Mr Chair. This particular clause sort of gets to one of our two main issues that we have with this bill. We’ve already talked about our concerns with smoked loose-leaf and how that’s going to migrate from the terminal exception and statutory defence into the full-blown medicinal cannabis scheme. We have significant concerns around that. But, really, our biggest fall-over issue was this blank scope—this empty, vacuous void of nothing—around what a medicinal cannabis scheme will look like. And here is the Government’s solution to that: setting regulations for minimum quality standards—those regulations still to be determined.

NGOs, industry, everyone in the sector are all looking for more guidance than a blank cheque that regulations and unnamed officials will write on, as Matt Doocey described—a blank cheque—to define the minimum quality standards for a medicinal cannabis scheme. All we see here that starts to talk to it that’s different from its original version are a few words—“cultivation”, “manufacturing”—but nothing around processing; I don’t know if the Minister knows that it’s actually a step in the manufacturing process. It is unclear whether that’s part of manufacturing, where boxing and labelling comes in. I mean, these are some of the details that you’d reasonably expect to be described in a medicinal cannabis scheme, and which we do describe. Again, this is a huge disappointment to industry. They’re wanting more than just what you’ve asked of us—“Sign this off; we’ll figure it out in a few years.”

We didn’t need intense detail. Yes, we did do the work and can produce that. We could have got by with a framework that roughly described licensing, fit and proper persons, location, and manufacturing as a whole, taking into account cultivation, processing, and manufacturing, and then other parts that are not in this bill—something around dispensing distribution. We could have maybe got alongside with that, but the Minister and the Government have refused to move off “Leave it with us—we know best.” For a sensitive topic like cannabis, for a really important issue which commences cannabis reform in this country, nothing—“Leave it with us.” That is a huge disappointment to me; it’s a huge disappointment to the sector.

We’ve offered, and we’ve brought to this table already—we continue to offer—some detail and some thinking around how to manage this. We offer detail and thinking around fit and proper persons: what a licence holder might have to have as minimum eligibility qualifications. We don’t think that’s unreasonable; it’s consistent with international best practice. We also have some eligibility criteria around what an employee might have, and we also think that to be reasonable as well.

We give much greater detail around the minimum quality standards, particularly for pharmaceutical production. We’re considered “near pharmaceutical”, but our discussions with industry suggested that that was probably not the way to go, particularly since a large part of industry is looking to export. Just by the way, there’s probably not enough critical mass in the medicinal cannabis environment in New Zealand for an industry to be sustainable. Most will need to export. Therefore, most will need to be GMP-compliant, and every day we wait for these unnamed officials to spend two years to come up with what they think is best, absent from parliamentary oversight, absent from significant public scrutiny, although we are hearing of some advisory panels. I understand that the proposed Minister’s advisory committee is so far late that it’s sort of not believable, so we’ll see how real that becomes.

But, certainly, those sorts of standards that we believe our export industry will require—and I would also add that every day we wait, we lose market share to Australia, who earlier this year said, “We want to be the cannabis producers of the Southern Hemisphere.” Well, good luck—another two years before we get substantive descriptions around how our own producers can do anything. We bring to the table, through our work and through our Supplementary Order Papers, knowledge and a background and a consensus and an international review of parts of these things that we want to help the Government with. We still wanted to. We’ve been told no.

So we challenge the Minister in a very sort of urgent way to maybe discuss when we might see some of the quality standards. Might we see something in January next year, in the next quarter? Oh, wait, there’s a time line that was put out here: in 2020, there might be some standards where we might be able to start cultivating. Well, that schedule is already six months late, so can the Minister describe: is he on schedule with his published time line, or are we already behind, and how far behind? I think it would be useful, as we address the weakness and the lack of detail around the minimum quality standards, if the Minister could at least address that issue.

Thank you, Mr Chair. I just want to address a couple of points raised by Dr Reti and the Hon Michael Woodhouse. Dr Reti raised concerns about unnamed officials—he likes to repeat this phrase—consulting on this regime. These are experts. We’ve canvassed this in many of the clauses so far through the debate. But we would expect that the consultation with industry and with users and with wider stakeholder groups would be thorough, and that is one of the big differences between what he’s proposing, which is a templated thing that Parliament signs off that the politicians make a call on, versus actually getting this right for our exporters and those who have an interest in the regime and are consulting fully and thoroughly to make sure there are no unintended consequences. We’ve canvassed some of those in previous clauses—potential unintended consequences of Mr Reti’s proposed regime.

Both Dr Reti and the Hon Michael Woodhouse raised concerns about stuff that is not in the bill. Michael Woodhouse said that the part doesn’t refer to licensing, and in fact under new section 37A(1)(b) in clause 8A, it does refer explicitly to a licence granted under the Act. But his general point was that a full licensing regime is not set out here. That’s because it’s not needed—it’s under section 37 of the Misuse of Drugs Act. He asked for clarification on that. That legislation is already laid out in the existing legislation; we don’t need to duplicate it here. Likewise, Dr Reti raised things around labelling regimes, licensing, dispensing—well, all of that is covered in the Medicines Act, Dr Reti. So these things are already, at law, described for medicinal products. There is no need to duplicate that in this legislation.

E Te Māngai, tēnā koe. I want to address a few of the points that have been raised, predominantly by my colleagues across the Chamber in Opposition. But I firstly just want to speak to the crux of what we are debating in this clause, that being clause 8A, and celebrate the fact that in this clause we have managed to get two substantive amendments to the legislation—two of three substantive amendments to the legislation—they being the inclusion of local native strains of cannabis in Aotearoa New Zealand but also the amendment which will guarantee that we have these regulations made public and functioning within a year.

I wanted to address the point made by Dr Shane Reti with regard to best practice, and just, once again, drive home that whilst I recognise and actually quite deeply respect the huge amount of research that he’s done in travelling overseas, we’re both aware, as most people who are engaged in this dialogue across the committee are, that there are a number of different ways that we can go about producing this regulatory scheme, as there are a huge breadth of different experiences in different jurisdictions. That best practice, I think, is to a certain extent subjective. It depends what the outcomes are that we’re looking for, and I think that if we were, for example, to measure it against the key performance indicator of perhaps who’s able to access it and who it works well for—the efficacy of the system—and whether we manage to make a dent or a reduction in the black or illegal market, all of those different things are variables to take into account when we are considering the notion of best practice.

To that point, I wanted to address the concerns that have been raised time and again with regard to the delegation for the creation of these powers to the Ministry of Health. We’ve heard that we’re supposedly throwing them away to faceless officials. I’m not sure who the National Party thought were making laws or legislation when they were in power. But it is indeed, you know, the people who are behind the scenes who are producing the research and the evidence which informs the decisions that we end up making as lawmakers. This is incredibly important, because there is going to be an expert body that is going to come together and consult with the public and with stakeholders in the production of the regulations that we end up putting forward by the end of next year.

That is an important point, because I mean we’ve actually already been through quite thorough consultation in the creation of this legislation—that being the select committee process, which many members from different parties in this House were involved in. But I also wanted to drive home the point that I made earlier, which was raised in debates by Dr Shane Reti, around the tighter regulatory framework which he proposed in his Supplementary Order Paper (SOP). To that point, he raised the types of persons who may be involved or engaged in the industry as it develops, and I just, again, wanted to drive home the concerns about inequity and about Te Tiriti o Waitangi when we are looking at excluding people who have already served their time for being convicted under, for example, the Misuse of Drugs Act, but also those people who are looking at turning over a new leaf and looking to those different jurisdictions that Dr Shane Reti refers to. The types of people in those more conservative jurisdictions who are presently benefiting and profiting from a medicinal cannabis industry are quite different from the demographics who’ve been targeted and penalised under the war on drugs.

I also wanted to refer explicitly to one of the stakeholders who’s already been raised in this debate—that being Manu Caddie of Hikurangi Enterprises, who I referenced earlier, stating that I’d had spoken to him this morning. He mentioned that he thinks that what is being proposed in the Government legislation is actually far superior than what was proposed in the SOP, and that is because of those concerns around inequity but also the potential stifling proposed in the SOP around community-based organisations getting a foothold in this market and it not being something that can be captured by the likes of “Big Pharma”. So, finally, I just wanted to say that we’re really happy—stoked, if I may say—with the inclusion of native strains, which is something that the Greens advocated for strongly on the basis of what has been raised actually by stakeholders, and also with the narrowing of the time line and the clarity provided to the industry and to patients within 12 months.

Thank you, Mr Chair—just to address some of those points and the Minister’s response. First of all, notably, while we’re talking time lines around minimum quality standards, I note that the Minister refused to address the question I put to him around if the time line which he published—which is currently in the public domain—is kept to or if it’s already got slippage.

Secondly, I think the question that the member Chlöe Swarbrick, who’s just taken her seat, puts out—the issue that they addressed around encouraging local manufacturing by allowing domestic strains—has some merits, and I think we would support that. We want to be supportive of our local manufacturing community. The issue and the problem, and what needs more detail, is this: every strain of cannabis in New Zealand at the moment came here illegally. The only way you could get a strain into New Zealand was to breach our biosecurity border and bring it in illegally. So what other countries have done when they’ve confronted this is they’ve said, “Look, we want to support our domestic industry because if people have to bring strains from offshore, they’ll pay a levy.” We know that levy can be 10 percent or more—very expensive—and, automatically, the goal you’re trying to achieve, which is affordability and accessibility, starts to decrease.

So what other countries have done is they’ve introduced an amnesty which said, “OK, we acknowledge that all our domestic strains came here illegally. We accept that, but we also accept that there may be some strains that are suitable for commercial manufacture.” I’m understanding and I’m hearing that there may be four or five commercial strains suitable and able to be ramped up for commercial manufacture. So what other jurisdictions have done is said “OK, accepting that, we want to support the local environment. We want to help avoid overseas fees if we can. What we’ll do is we’ll have an amnesty period.”, which is actually quite short—sometimes a period of two weeks, I think I’ve seen overseas. It’s an amnesty period where if you are growing a domestic strain illegally, over that amnesty period you can register your strain. Now, it’s deliberately short so that people don’t cross the border knowing that eventually you’ll be able to use domestic strains, and this is part of my concern here now that this has been flagged. And I get the principle and support the principle, but there’s more detail to make it really good.

The detail that’s missing here is: is there an amnesty period? How long will it be for? And I think that leads to greater discussions relevant to this clause, around biosecurity and probably a bit further down that path—that’s where I need to go here. But, really, the main point I’m getting at is several things. First of all, being supportive of our local environment, our local manufacturers—supportive that there may be some domestic strains here illegally that are suitable for commercial production—and therefore supportive of the intent of this clause, but is there an amnesty period and, if so, how long will that be? Does the Minister take into account—has he considered—our biosecurity risk, having flagged that we will allow domestic strains? Has he communicated with our biosecurity, border, and other officials that we will be permitting domestically acquired medicinal cannabis seeds—that we’ll be authorising them in some way? What is his plan for that is my question.

I will respond to the key point that Dr Reti has raised: amnesty on strains. I’ll be guided by expert advice and international best practice on that, or I’d expect that the oversight body would be.

I do also want to acknowledge the member Chlöe Swarbrick and the Green Party of Aotearoa New Zealand for their push to have the inclusion of these local native strains. This is a coalition Government that’s working well together, and there are many great things that have come to this bill as a result of the other parties contributing. I just want to acknowledge that in this committee of the whole House.

I also want to say that we will be making the regulations public and available within a year, as the member Chlöe Swarbrick said, and, again, I thank the Green Party for that contribution.

Thank you, Mr Chair, for the opportunity to take a call on new section 37A, which is proposed to be inserted by clause 8A. I’d just like to challenge the assertion made by the member Chlöe Swarbrick, who said something along the lines of “Who was it who wrote all the legislation and passed all the legislation in the last Government?” Well, it was the National Government. It was the Ministers. It was the members of Parliament, who are responsible for the legislation. We are the ones in this House. We debate the legislation. It is Parliament’s job as legislators to debate legislation and to understand its impact, and to be able to have that discussion and debate, because, at the end of the day, we are responsible for the passing of it, and we can’t just pass the buck on to officials and pass the buck on to other people. Yes, they may assist in the process and may be able to provide advice on the process, but we are ultimately the decision makers, as Parliament, when it comes to regulation and when it comes to legislation, and that is why it is so important that as parliamentarians, we pass legislation which provides clear direction as to what the intent of Parliament is in a particular bill or on a particular topic.

That is why the National Party has serious questions about this clause, which inserts new section 37A, which has broad powers to be given to the Minister. The Governor-General may, by Order in Council made on the recommendation of the Minister, make regulations to prescribe the minimum quality standard that must be set by a product or class of products that contain a controlled drug that can be cultivated, manufactured, produced, imported, or supplied under a licence. The Minister got up before and said, “Well, we’ve already got section 37, so we don’t need to include in this section some additional aspects of what Shane Jones”—sorry—“Shane Reti has been advocating in his SOP.” Dr Shane Reti actually beat the other guy, and justifiably so. He is far superior in his knowledge and his expertise in a wide array of fields, including this one here.

So I’d like to ask the question about whether section 37 will provide adequate ability for the Minister to recommend regulations which focus on the location of where licences can be placed and whether exclusion zones around residential zones will be able to be put in place under the regulations, because what I read here is that this is about products and classes of products; it doesn’t deal with issues relating to where those licences can be, where the people who have a licence to cultivate, manufacture, produce, or import can actually locate their premises. All of those issues around whether there should be an exclusion zone—can those regulations be put in place under this new section 37A that the Minister has here on the Table in his Supplementary Order Paper? And also whether the Minister will be able to put in place regulations which actually deal with fit and proper persons and what type of regulations that might include.

So will the Minister be able to recommend to the Governor-General regulations which say that people who have a criminal history won’t be able to be part of the cultivation, manufacture, production, or importation of medicinal cannabis? Will the Minister be able to put in place regulations to that effect? Clearly, in this bill we don’t get any indication as to who should or shouldn’t be able to have a licence. There is nothing in here which determines whether someone should or shouldn’t be able to have a licence to produce medicinal cannabis products. So no doubt the officials who will be working on these regulations will potentially be doing something, and the Minister might be interested in that.

So I guess that’s another question: is the Minister interested in regulations which will deal with whether someone is a fit and proper person, and, if so, what will be the extent of that? Under what section will that be provided under the current Misuse of Drugs Act to allow him to be able to do that, and what subsection of that section will give him the power to be able to do that? So those are two questions: one is about the fit and proper person and the second is around locality.

Just let me address those points; they have been addressed before. Section 37 is where that material is, as the member says. He can read the Act in detail himself if he wants to find the subsection. I can assure him it’s in there, because I’ve seen it.

The Order in Council is a mechanism under regulation to ensure that we have the right people who are able to have a licence, as he indicates. Again, that means that there’s Cabinet oversight of this decision making and answerability in this House, so that’s an argument in favour of the approach we’ve taken. I note that and thank the member.

I appreciate that the Minister has touched on this point, which I raised earlier, around the regulation-making powers, but all he points to is section 37. Now, under section 37, there is a range of subsections—his officials are there behind him—and I’d like to know under what subsection of section 37 will the Minister be able to put in place regulations which deal with locality of premises and of fit and proper persons. I hope that the Minister now has that information and will supply that to the House.

I want to continue the conversation about section 37 because the Minister has—and rightly so—put the replies to my initial questions about why this bill doesn’t contain much more detail about this licensing regime. It’s all going to be down to two things—it’s all going to be down to the officials, and there’s already sufficient guidance in section 37 of the Misuse of Drugs Act—and yet there are no provisions on the things that Mr Brown has raised. But if there are, what he is suggesting—because, effectively, the officials came and told us that the reason we need to add to the Misuse of Drugs Act for the provision of cannabis-based medicines is that there isn’t a minimum quality standard for such a product to be manufactured. I don’t actually agree with that. I think the Misuse of Drugs Act is clear that the regulations can be made to do a number of things, and in section 37(1)(a) or (b)—I can’t remember now; I’ve just lost it—there is an ability, albeit a slightly vague one, for quality standards to be established.

Indeed, one would like to think that that was the case for any controlled drugs that were going to be turned into prescription medicines. Of course, we’re not breaking that new ground, if you like, because we already do this with opioid-based products where the opioids on the black market are illegal and they’re class A drugs, which raises the obvious question: what on earth are we doing here? We’ve got a terminal exemption that the police told us they don’t need because they’re not prosecuting terminally ill people, and we’ve got now a regulation setting quality standards that we don’t need because the Minister himself told us it’s already in section 37 of the Misuse of Drugs Act. And even if it were needed, why, Minister, does it in clause 8A, new section 37A, have the word “may” littered through it? It says, “Without limiting section 37, the Governor-General may, by Order in Council … make regulations”. It “may” contain regulations to prescribe minimum quality standards: “(3) Regulations made under this section may—(a) apply generally to a product or class of products;”.

There’s no compulsion here at all, which means we’ve spent months debating an unnecessary and, I would suggest, virtue-signalling piece of legislation. Why? Because this Government wanted to look good in its first 100 days. The officials told us, and now we have it conceded to by the Minister—although I don’t think he intended to—that there is no basis for changing the law. We have the Misuse of Drugs Act, we have the Medicines Act, we have the commensurate regulations, and we have a benevolent New Zealand Police service that is not arresting and locking up terminally ill patients who have a joint. What a waste of time.

I move, That the question be now put.