[Medicinal Cannabis Scheme Industry Session]

First of all, I was just saying upfront, if you're here to learn more about the government's proposed referendum on the legalization of recreational cannabis, you may need to wait a little bit longer because this session isn't about recreational cannabis. This is about the medicinal cannabis scheme, which covers medicinal cannabis products which are only available on prescription. So it's through the medical model.

New Zealanders will choose whether or not to legalize or regulate medicinal cannabis as part of a referendum to be held as part of the 2020 election. So we're not going to talk about the referendum today.

So just on this slide, this is an industry-focused session. So we're going to talk about the background to the scheme, the context, and how we can improve access to medicinal cannabis products.

What will probably be of great interest to you all is the quality standards in the licensing scheme. So we're going to cover that and then talk about the prescribing requirements. So now, I will ask Chris to come and talk about the background to the scheme.

I'm going to talk about why we're here, medicinal-cannabis-wise, and how we got here, and what we're trying to achieve. And then Andrea will go through some of the more detailed stuff around quality standards in licensing.

Just as a bit of intro about me, so I'm group manager of Medsafe. Medsafe, for those who don't know, is the medicines/medical device regulator in New Zealand. Plus, we also regulate a number of other areas-- psychoactive substances. We license pharmacies. We do some work under the Misuse of Drugs Act. And we also regulate hemp. Well, it is part of the Misuse of Drugs Act. And we're also responsible for implementing the medicinal cannabis work.

So I'm a pharmacist by training. I worked for about 10 years in pediatrics and neonatology in hospitals in the UK and New Zealand, and then came back and joined Medsafe about 12 years ago. So came in as a pharmaceutical chemistry assessor, and then moved into clinical and risk communication and [? then ?] [? into ?] management. I've been group manager for around five years now.

Now, a number of you in the audience, we've met with. And we've found those interactions really helpful in this work and with medicinal cannabis. And a number of you, this will be new to you around what we're doing here.

So what we want you to get out of this, what we're trying to achieve-- what the proposals are, what the questions are, and the information that we're keen to get back from all of the groups, such as yourself-- keen to answer questions, to help with your submissions, and to help you understand what is in the consultation document and clarify any points that may be in there.

So I'll move on to-- really why we're here-- the background. And the wording in red is so we all remember what we're trying to achieve. So the government's objective here is to improve access to affordable, quality medicinal cannabis products for people in New Zealand.

Now, in doing that, this was part of a 100-day plan for the incoming government. And the government committed to introducing legislation to provide an exception in statutory offense for terminally ill people to possess and use illicit cannabis on compassionate grounds, and, in principle, to introduce a medicinal cannabis scheme. And that was to enable the cultivation, manufacture, and access to medicinal cannabis products made to a quality standard. The legislation was also designed to deschedule cannabidiol, or "CBD" as it's commonly referred to, so it would no longer be a controlled drug.

Now, there is a slightly confusing part of the legislation in New Zealand, in that we have the Misuse of Drugs Act that puts controls and restrictions on certain substances, such as cannabis, such as morphine, such as heroin-- various other products that are restricted. And that's what the Misuse of Drugs Act does. There is also the Medicines Act, which puts restrictions on medicines, what's scheduled as a medicine, how you can obtain them, can you get them from a prescription, can you get it through pharmacy, can you get them in the supermarket, who can prescribe, various controls in [? there. ?]

So with CBD, I'll just cover that off now. So with the legislation change, CBD came out of Misuse of Drugs Act. So it's no longer controlled from the Misuse of Drugs Act, but remains a prescription medicine. And that's something that we have seen some confusion around when that mode of change was made. I'll talk a bit about what we can look and what industry can do about CBD, and whether it should stay a prescription medicine or whether it should be more widely accessed in the future.

So the Misuse of Drugs Act amendment came into effect in December, 2018. It was enacted in December, 2018. What it did is people requiring palliation were eligible for the statutory [? event. ?]

And it allowed regulations to be made for all stages of cultivation and production and manufacture and [? sitting ?] quality standards. So it allows a license holder under the Misuse of Drugs Act the cannabis scheme to use locally sourced cannabis plants, fruits, and seeds, and requires regulations on the quality standards to be made. And these are to be made no later than the 18th of December this year.

And this is one of the reasons why we're having a four-week consultation period. This is very quick in terms of implementation to get regulations in place. It's around two to three times quicker than any other country has attempted to do. And that's why we are having to really squeeze this in, so we can make sure we get those regulations passed by the 18th of December.

Now, the blue parts of the scheme up here of the slide talk about the medicinal cannabis scheme. And this is around the expectation-- so the agency will be operational very soon after the 18th of December date. So in law, when you have regulations passed, you have a number of things, such as a 28-day rule. And also, obviously, there's a Christmas period and closed down.

And there's information to be put in place that can't be finalized until the regulations are confirmed. And it's things like, what are the actual forms that need to be put in place? What guidance is there? And so we expect the agency to be operational very soon after the 18th of December.

So just a bit of international context for you on what we're working on to establish the scheme. There isn't a national context here. There are a number of international agreements that New Zealand has signed up to, that they aim to restrict production, manufacture, export, import, imposition of narcotic drugs, including cannabis. And that's exclusively for medical and scientific purposes.

And the most relevant one here that we're looking at is the single convention of narcotic drugs in 1961. And that establishes a framework to prevent abuse and diversion of controlled drugs, but also to facilitate the availability for medical and scientific purposes. So under that convention, New Zealand has an obligation to carefully control and supervise and report on the various stages of cultivation and production.

Now, it also means that New Zealand is required to establish an agency. And the agency is here to regulate the cultivation and manufacture in supply.

Now, a number of countries have done this in different ways. And they all interpret it in different ways. We've looked at all of these countries.

Germany has recently put in place a state-run scheme. We're looking at what Canada has done over the number of years since they've provided access to medicinal cannabis products. And also, there's obviously the US, where they have both the federal laws but also the state laws, which can sometimes contradict. But what we're looking at is putting in a pragmatic solution that allows us to align with our conventions that the New Zealand government signed up to, while also we're expecting to enable improved access for patients.

Some New Zealand context on this. We talked about the Misuse of Drugs Act, which was very old-- 1975. This is what we administer. And this legislation already allows the import, export, and manufacture of medicinal cannabis products, but do not allow the lawful cultivation of cannabis plants for medicinal purposes. So we are proposing to control the medicinal cannabis supply chain through licensing activities and having licenses for cultivation, manufacture, and supply.

As these are prescription medicines-- so all medicinal cannabis products will be prescription medicines at this stage-- patient access will be through a prescription from a medical professional. I have a little bit more on that later, after Andrea has talked about the manufacturing standards and licenses.

So the agency being put in place-- effectively, we're already able to license under Misuse of Drugs Act for research and scientific research purposes. And we're already licensing for hemp production, for instance. So this is just another stage in the path for us, obviously, to enable medicinal cannabis products to be produced and manufactured for commercial reasons.

So the scheme has two main parts, really. Obviously, we're looking to improve access for patients with products being made to a quality standard. We're also looking at increasing the supply of products, having a sustainable industry in New Zealand, for commercial cultivation, and for manufacture made to minimum standards, enabling, also, ongoing import of products to encourage competition and to improve affordability-- and also improving access for patients by ensuring medical practitioners have confidence in what they are prescribing.

So this is where we get the classic balance of quality standards versus cost, but also versus confidence from those health care professionals that will be prescribing for patients. The minimum standards-- obviously, they provide assurance of quality.

We're also looking for providing information for health care professionals. These, in most cases, won't be like traditional medicines, where if you have a medicine approved in the Medicines Act, you have a full medicine data sheet with all clinical data and all information for a prescriber who can talk through with a patient on risks and benefits for that patient. And that includes not just how you use it, but also possible side effects, any possible interactions.

Now, with medicinal cannabis products, this information is not routinely available. But there is a huge amount of research that is happening now and is starting to come through. And so one of the key challenges for this scheme is to make sure health care professionals and consumers have the information they need to make choices-- know how to use these products, know how to dose titrate, know how they may interact with medicines that the patient's already on, how do you monitor them. And that's one of the key parts of the scheme, because if we don't provide that information for health care professionals, they're unlikely to prescribe them.

So that's the intro. I'll hand over to Andrea now who can go through some of the detail around quality standards and licensing. And then I'll come back and talk to you about some of the prescribing requirements. Thanks.

So I'm first of all going to cover the quality standards, which cover cultivation, manufacture, and finished products. So why are the quality standards important? At the moment, we are having products coming into New Zealand which don't have those quality standards.

But the reason why they are important is to protect the patient. If there are no requirements for quality, we get some things. We get potential for harm if they don't, for example, contain the right active ingredients in the right dosage or they contain harmful substances, like pesticides, heavy metals, or microbiological contamination. If they're not manufactured, transported, or stored under the right conditions, then that could affect the quality of the product.

So it is very important. And it's one of the key components of the scheme, is to introduce making these products to a minimum quality.

So as I said earlier, the quality standards can be set for a process like cultivation or manufacture. And they can also be set for products.

So let's start with cultivation. I know that there are a number of people in this room that have already engaged with us to put in the applications for license for cultivation for research or medical purposes.

So let's start with cultivation. We're seeking feedback on three options. The first one is that the cultivator must meet the manufacturer's quality requirements. So the manufacturer sets these quality requirements for the cultivation process or the starting material. This would be a good thing in the case that a manufacturer knows what they are going to do with the product.

In some cases, if they are going to process it in a minimal way and just compress it and maybe use it for vaping, then it's quite appropriate to set high standards of quality to make sure there is no pesticide contamination or mold on the product. In other cases, they may be taking that starting material and processing it further, in which case some of those things can be managed throughout the manufacturing process.

So in this option, the manufacturer decides and has a contract with their cultivator. Or if he or she grows the cultivation themselves, then they will set what standards they require of that.

The second option is for the regulator to set a cultivation process standard. And a number of things have been discussed over the years with industry, things like Good Agricultural Practice or the New Zealand equivalent of agricultural practice, like Growsafe.

And then there are all these international documents like the WHO Good Agricultural Practice Standard. Those are ones that could be set here. And then the regulator would audit this cultivator's agricultural practices against the cultivation process standard. There will, of course, be cost involved in all of this.

The third option is to set a product quality standard for the starting material, which are set by the regulator, which would be similar to our product quality standards and would specify the limits and amounts of ingredients that the starting material may contain or not contain, such as pesticides or heavy metals. And the cultivator would then test each batch of starting material to ensure it meets the quality standard and provide evidence of compliance. So again, this involves the regulator auditing the cultivator.

So I guess that what we're seeking through consultation is what industry think about either of those three options. So this is a key thing for you to put in your submission.

The other area of intense interest to people is the quality standards for manufacture. So what I want to talk about in this session, because a lot of people have asked us-- not only industry, but consumers as well, because it does affect access-- what about the Canadian approach? Which is what we call "GPP," Good Production Practices. And this is also versus the New Zealand approach to the manufacture of medicines, which is GMP.

So I do want to spend a bit of time. Because we have gone and looked at GPP as an option, I just want to spend a bit of time explaining what the differences are so that you can understand that. Because it's not is as simple as just having a set of rules which are lot less stringent and easier to comply with and all of that. It has flow on effects. And the GPP system in Canada is quite different from what we are trying to do here.

So first of all, there is the New Zealand approach to the code for the manufacture of medicines. So this is known as the New Zealand Code of Good Manufacturing Practice, GMP. So I'm going to use "GMP" from now on, because it's a bit of a mouthful.

So GMP ensures that products are produced consistently and are of reliable, high quality. It's based on an internationally recognized system and Medsafe has all those systems and processes set up for people to be audited and to get a certificate of GMP.

Now, the Canadian approach is something that we looked at in great detail. And we started off by saying, well, what is the difference between GMP and GPP? And on the face of it, when we laid the two systems side by side, we sort of figured out that there was very little difference in the high level principles. So both GMP and GPP set out those high level principles.

What GMP does as a code is set out some guidance on how you can comply with those principles. So the way a code functions is that it would set out this guidance. But if you want to do something differently, then you have to demonstrate how that what you're doing differently meets the requirements of GMP-- meets the principles, in other words.

So it does provide flexibility for you to do things and innovate and do things in another way. But essentially, if you comply with the code, then you are seen to be complying with the principles of GMP.

GPP, on the other hand, also sets out those same principles. But while the [? guidance ?] is developing on that, it just sets out the principles and says, OK, Mr. Manufacturer or Mrs. Manufacturer, you tell us how you're going to comply with these principles. So it's very much open to interpretation.

When we went to look at the Canadian system, we found out that prescription medicines like the New Zealand system are required to be manufactured to GMP and there is a premarket authorization process and a whole system set up for medicines, which is almost-- we hadn't gone into the great detail of whether it's exactly the same. But that's like the New Zealand system for the manufacture of medicines.

So they already have an approach for prescription medicines. But in addition, Canada then decided that they would put in the system of GPP for what they called "non-prescription health products containing cannabis." Now the key difference here is that it only applies to the non-prescription classes of cannabis, like fresh and dried cannabis and cannabis oils. And later on this year, they will be adding to that list edibles and topical creams.

So there's the difference. There's a reason why they call it "good production practices" as opposed to "manufacturing practices," just to highlight what the difference is, and also because they are minimally processed. So these products are only allowed to contain cannabis, and with a little bit of allowance for carrier oils and the cannabis oils. So essentially, they are not prescription medicines as we know them. And I think that is a key difference.

The other difference, which I won't go into, or Chris won't be going into later on with the prescriptions, is that access to these non-prescription health products containing cannabis is through going to see your doctor and getting a medical document.

So the system in Canada, it's not the same as a prescription because there isn't that oversight. But the Canadians spent a lot, lot of time looking at the access model, and basically saying that you can get a medical document from your doctor that will enable you to either grow your own, get someone to grow it for you, or get it from the producer.

So that is something that we haven't looked at in terms of these non-prescription health products containing cannabis. We are looking here about prescription medicines and making that available through the prescription process.

So when we were challenged by our medicinal cannabis advisory group to say, well, what actually is the difference? And so we went into great detail.

As I mentioned, the GMP process gives you a code which provides you with detailed compliance on how to comply. The GPP system is less detail. It just sets out a set of principles and said, tell me how you are going to achieve these outcomes. That in itself is probably a lot more work, because then industry will then have to interpret those principles and come up with a way of meeting them.

From a regulator point of view, we are then going to have to go into detail on what the manufacturer is proposing to do and then assess whether or not we think those will meet the principles. So there's quite a bit of interpretive work on both sides and, I would imagine, quite a bit of toing and froing.

However, if I was industry, what I'd be going is to say, what's GMP? What are the GMP requirements? And that would be my starting point. But then that's entirely up to industry.

There are two other key differences which are part of GMP which are not part of GPP. One is a validation program which is inherent in every step of the production process for GMP. Why is that important? Because it ensures that the product that you have come out the other end is consistent within a batch.

So the same bottle of pills, for example, that came out of a batch, every pill, every dose is the same. And it's the same as one that was manufactured a month ago or six months into the future. It provides that consistency.

And that's really important as far as medical professionals are concerned. Because if they are going to prescribe it, then they want to know that whatever they're prescribing is going to be the same every time.

The other issue is stability testing required. And with the medicinal cannabis products, there isn't a lot of information that has been done about how stable the products are-- whether or not what you buy today is still going to have the same active ingredients six months down the track, how long will it be stable for.

And this is the approach taken in most other jurisdictions. Canada, at the moment, is the only one that requires GPP. So they don't have the validation program, and they don't have stability testing.

And Canada, while their GPP requires batch testing, that only says that the dose that you are testing meets the requirements of the finished product. It doesn't say whether all the other doses in that pack meet those requirements or whether it's the same as the one you manufactured one month ago or six months into the future.

So these are the key differences between GMP and GPP. And I am highlighting these because that's what may be important when we get them to the prescribing. What do prescribers want?

So here are the two options. And then there are probably others. And if you have alternative options, then please feel free to tell us through the submission process.

So adopting the New Zealand approach to the manufacture of medicines, which is basically saying, requiring GMP for all products, or adopt the New Zealand approach and, like Canada, allow for some forms of products to be manufactured to GPP, as in Canada. This was something that we would look at. But in Canada, be aware that it only applies to fresh and dried and oils.

As I said, the advisory group challenged us to set out, what exactly are the differences, and beyond actually what the manufacturer has to do? What are the setup costs? How much does it cost to set up a GMP facility versus a GPP facility? And how long will it take an under/either option will it take to get products to the market? And then, what impact does it have on finished product cost?

And on setting up a regulatory regime, these are the challenges that we are going to have to balance about whether the regulatory requirements will result in two higher cost products or setting the regulatory requirements at a level that gives us that assurance of quality. So the ideal situation is for us to see it reasonable standards of quality and that will result in lower cost products.

So the setup cost, there are some suggestions that we could start with GPP and move to GMP. So we have been talking to some of the Canadian industry and the Canadian regulators and say, how about this? Could we start with GPP and move towards GMP?

Now, we don't have anything concrete on that, but we have a lot of anecdotal evidence and people in industry. We've talked to some industry in Canada that have said that's not necessarily cheaper or as difficult. So the requirements are different. It's in the setup cost. So starting with one, and it's not an option to gradually step and move to the next one. That's a different set of requirements.

It's difficult to compare the costs of GMP versus GPP because we haven't come across anyone who has done both. So you can't say, well, actually we manufactured this product under GMP, and this is the product cost; or we manufactured this same product [? under ?] GPP, and it was a lot less or more. So I just want to reiterate that Canada has a medicines regime, which is similar to our New Zealand regime-- manufacture to GMP and premarket assessments of products.

So the other thing that we were looking at is, how long does it take to get products to market? In Australia, they took 2 and 1/2 years from implementation to having the first products come out. And I think they are only a few manufacturers that are producing those products.

We think we can do better. And we need your help to do this. So this is really what this is about, is saying, could we get products on the market in less than 2 and 1/2 years at a high quality and low cost? That's the challenge.

Just moving onto the product quality standards, the question that we have asked in the consultation is, should these product quality standards as set out in the appendix to the consultation document-- should that apply to starting material, active pharmaceutical ingredients, or finished dose form products?

We've proposed that there be a quality standard set for the API that they must meet the product specifications listed in that monograph. Part of GMP says that it's important that you have quality active pharmaceutical ingredients, because then you will be able to manufacture your products to that specified quality.

And that Product Quality Standard Monograph that said alternative tests, methods, or limits can be used, but they must be scientific-justified. The monograph lists the product specifications for the product, what you must meet, the kinds and amounts of ingredients that are allowed or not allowed, and defines the test, methods, specifications, and limits, which are required to meet to verify that your product meets those specifications.

For the finished product, we are proposing that the products must meet the product specifications listed in the New Zealand Product Quality Standards Monograph and the products must also meet the dose form requirements and requirements for stability, shelf life, packaging and labeling, and quality of the non-active ingredients.

We're proposing that certificates of analysis will provide evidence that the product meets the quality standard. And those certificates of analysis will have to be presented to the regulator before these products can be supplied into the market. But there'll be more on that later [? in ?] the distribution.

Now, the finished does forms under the scheme, we're not proposing to allow smoking. So we're proposing that some of the higher risk dose forms, like the modified-release dose forms and medicines required to be sterile are only allowed if it's been approved or provisionally approved by the Ministry. So they still come under the scheme, but there needs a higher level of risk assessment [? on top ?] [? of ?] these.

Food containing medicinal cannabis is not allowed under the Food Act. And cannabis-based dietary supplements, natural health products, and nutraceuticals, because there is no regulation of that and because cannabis as a prescription medicine, [? or ?] CBD products are prescription medicine, then they must meet the requirements of the scheme. So they are all covered under the scheme.

So there are some general requirements that are required for all of the licenses. So we'll be wanting details of the applicant and then details of the premises, including geographical location. Because the licenses will be issued to specific locations, we are, [? at ?] [? this, ?] proposing that we would require applicants, directors, partners in a partnership, and responsible persons to be vetted under this legislation.

And licenses can be issued, as I said, before for a specific location. So we are not proposing to put restrictions on locations with regard to, for example, proximity to a school. So that won't be outlined in the legislation, but just be aware that it is at the discretion of the minister or his delegate to decide on these applications.

So if there are particular issues associated with an application-- for example, an applicant might try and set up or apply to set up activities next to a school-- we would be aware of that. And we would look at that. And there might be requirements to engage with your neighbors.

But at the end of the day, while we're not sort of putting hard and fast rules on what is allowed and not allowed, that's at the discretion of the minister or his delegate. So these things can be decided on a case-by-case basis. And if there are concerns about the location or its proximity to sensitive areas, then this can also be considered on a case-by-case basis. So we're setting general requirements out here.

We will also be requiring detailed security plans, because under the international obligations, we have an obligation to ensure that the cannabis is not diverted to illicit purposes. So the security plans will cover physical security, operational and procedural security, and personnel security, which is around making sure that you have systems and processes in place to employ suitable staff.

We aren't proposing to put such vetting restrictions on people you employ. That is your responsibility as an employer to make sure that the people that you employ are suitable. How you do that is up to you.

So I'm moving on to licenses to cultivate cannabis. What they will be issued for a year. It's a new industry. We're seeking feedback on this. And we've also looked at the Canadian approach and proposed that there be small scale and large scale. But it's a nominal amount which is based on Canada's operations and making that distinction. And we'd like some feedback on whether that's set at the right level.

We are also proposing a difference between if you want to grow high THC or low THC crops, and also requiring crops to be separated. So if you have an industrial hemp license and you want to grow cannabis for industrial hemp purposes, then you can do that. If you then want to also grow medicinal cannabis, you need a medicinal cannabis license, but you need that to keep the two crops separate.

The purpose of the cultivation is, you need to provide us with details on the purpose of the cultivation and the details of the cultivation activity. So a few are growing to supply to a manufacturer, or you are going to carry out research-- the details of the cultivation activity, for example, the cultivars and cannabinoid profile, the area, or the number of plants under cultivation. So we are required to report that annually to our international organization.

The amendment in December also made a provision to bring illicit New Zealand seed into legitimate supply chain. So this is basically saying that at the time that you apply or after you have your license, you can declare an amount of seed that you got from a New Zealand source and to bring that into the legitimate supply chain.

However, that isn't the intention of this scheme to allow there to be an ongoing illicit source. So we think that it is worthwhile bringing that New Zealand seed and New Zealand cultivars into the supply chain, but if somebody wants to get into the business of supplying you, then they will need a license to do so.

So that would be through a declaration process. And we're seeking feedback on how many times you can declare, how much you can declare-- all of those sorts of things.

We have been asked about the transition from cultivation for research and the cultivation for commercial purposes. So there are a number of companies that maybe have applied or are seeking to apply for research into breeding cultivars.

And if they did come up with a super cannabis plant, then we're not going to say, sorry, you have to destroy that. The whole purpose of breeding is to find a preferred cultivar with your preferred characteristics. And you will be allowed to transition an amount into the new system.

However, that doesn't allow you to start stockpiling all your plants now so that once the regulations come into place, you can just plant them out and get a head start. It is to allow you to carry through your breeding research into the commercial area, but not in terms of stock.

A number of people have sort of asked whether or not we can just automatically transfer a research license into a new commercial license. At the moment, we're saying unlikely, because the research licenses are given on the understanding that you've only got a small number of plants and you want to be able to get that research.

And we have said that at the end of that research, you will need to destroy all your plants. Because the purpose is not allowing you to breed all these plants in anticipation of what might come out of the research. But as I said, we will allow for the transition of a limited number of plants to maintain your cultivar.

We don't know what the regulations are going to come out. So that new application for commercial cultivation will need to be assessed against these new requirements.

So a license to manufacturer medicinal cannabis products-- I talked before about the standard GMP versus GPP. The licensed manufacturer will include packaging as a manufacturing activity. But if we land on GMP as a manufacturing standard, then the license to manufacture will be issued under the Medicines Act. If we land on GPP for some forms of cannabis, then that license to manufacture will be issued under the Misuse of Drugs Act.

CBD products-- because, as Chris mentioned, they are prescription medicines but not controlled drugs-- the license to manufacture CBD products will be issued under the Medicines Act. So the Medicines Act-- the supply license is a license to sell medicines by wholesale under the Medicines Act. So again, for CBD products, we are proposing that they must meet the requirements of a finished product quality standard.

So when we talk about the supply chain, the Medicines Act proposals-- we already have a pathway for consent or provisional consent for those medicinal cannabis products. Those pathways can still be used. So you can still apply for your products to be fully consented or provisionally consented under the act. And then just more on what all that means in the next section.

So for CBD products, there will be a requirement for the finished product to meet the quality standard as a minimum. Once that has been verified, then the product can be added to a license to sell your medicines by wholesale. And that will allow that product to enter into the supply chain.

As I mentioned before, approved and provisionally approved medicinal cannabis products will be also able to be applied for. For these products, you will also need a license to deal under the Misuse of Drugs Act because they are also controlled drugs.

The majority of products that will be entering the supply chain will be unapproved, simply because, as Chris mentioned, there won't be-- at least in the short-term-- that clinical data, clinical trials that will talk about safety and efficacy.

So the license to supply unapproved medicinal cannabis products under the Misuse of Drugs Act-- so the non-CBD products-- in other words, the ones that have THC in them-- you need to provide evidence, again, that the product meets the requirements of the finished product quality standard. And once verified, the product will be added to the license to supply.

So, again, your license to supply under the Misuse of Drugs Act or your license to sell medicines by wholesale will allow your products to enter the supply chain. But that needs to be verified that it meets the product quality standards.

For approved or provisionally approved products, they don't require a separate assessment against the finished product quality standard because the finished product quality [? standard ?] will be the minimum requirement. And there is a separate assessment under these other schemes.

A license to import or export for non-CBD products, because they are controlled drugs, need an import and export license under the Misuse of Drugs Act. We are proposing to require that imported and exported medicinal cannabis products must meet the New Zealand quality standards as a minimum and that it comprises the manufacturing quality standard and the product quality standard.

So a number of industry players are interested in the export of medicinal cannabis products. It makes sense, because of economies of scale. And ultimately, that will provide cheaper products that are available in New Zealand if there are those economies of scale in allowing export.

So we are proposing to allow export of unapproved products that meet the quality standards and standardized, packaged, and labeled raw cannabis that meets the quality standards. Being aware that if you apply for an export license here, you also need to have an import license to verify that they will take the product from the importing country.

Like other countries, we are proposing to not allow the export of unprocessed or bulk raw cannabis. So we'd be interested in your views on that.

Fees and charges. Our fees and charges section may be a bit difficult to follow. So we're following the treasury guidelines, which is basically full cost recovery of the direct cost-- things like some of the compliance activities and policy development. And the costs of those aren't really included. So this is sort of based on the hours and the effort that it has taken to approve your application. So that includes the assessments and the audits.

The proposed fees are calculated for two fees models for licenses to manufacture. So the first set of fees is if we just had the GMP model of manufacture. And so all the licenses will be issued under the Medicines Act for manufacture. And that is the first [? set. ?]

If the second option is taken where some products are allowed under GPP and some under GMP, then the second model [INAUDIBLE] [? is ?] the number of licenses that will be applied for for manufacturing will be half GMP and half GPP.

So the fees sit under the Medicines Act. They're not changing at this time. But some of you will be aware that we are developing new legislation-- the Therapeutic Products Bill-- which will eventually replace the Medicines Act. And the Medicines Act fees may be reviewed as part of that. They're just some years away.

So, Chris, have you had enough of a rest? And now we can hand you back to talk about the prescribing requirements.

OK. So I just want to take you through the access parts and prescribing requirements. A little bit of information about what "approved," "provisionally approved," an "unapproved" means, because that's really medicine terminology. And I just want you to be aware of what that is. Go through what we're proposing that doesn't change, and then some proposals for change.

Obviously, this is why we're coming out for consultation. So we are very keen to get your thoughts on what we're proposing to change and what we're proposing not to change.

So just some information to start with around approvals. So effectively, you have an approval which in the legislation and Medicines Act is called "consent." We tend to use "approval" because no one really knows what "consent" means.

But effectively, you get approval to distribute a medicine. And this is where there's evidence supporting the efficacy, safety, and the quality of the products. And this evidence is assessed by Medsafe and the Ministry. And then a consent is given by the minister in the Medicines Act, or a delegate. So that's the approval.

A provisional approval is a clause in the legislation that allows us to give an early approval or a provision or an approval with conditions to distribute a medicine on a restricted basis. And it's based on clinical need and potentially on a limited number of patients.

Now, we use this in a number of ways in the Medicines Act to do things like put conditions on medicines. So there's a medicine used in mental health, for instance, that is very effective, but also can have serious side effects as far as effects it can have on your blood cells. So we use a provisional consent pathway to say, this can be approved, but you must have a white blood cell monitoring system in place.

This provisional consent has also been used in the past for early access to antiretrovirals. So decades ago when the clinical data was quite limited and was developing, the clinical need meant that these products needed to be approved. And so they were. And what it meant was, you can give an approval while the clinical studies were continuing.

And then there's unapproved products, where the safety and efficacy and quality has not been assessed by the Ministry. So happy to answer questions if there's any further clarification needed. But that's really the key parts to it.

So firstly, on what we're not looking at changing. So CBD products-- no change, other than, obviously, them coming out of the Misuse of Drugs Act. [? They're ?] [? around ?] access.

So there's a definition. CBD products-- medicinal cannabis products that contain less than 2% of the cannabinoid THC or other controlled drugs or psychoactive substances. So we have had some feedback on that definition. I'm keen to get feedback on that definition, as well, through your consultation process. And please send that through.

So no changes proposed for approved or provisionally approved CBD products that can be prescribed by a medical practitioner or a nurse practitioner, for instance. Unapproved CBD products could only be prescribed by a medical practitioner.

And this is because the Medicines Act has that terminology in it. The Medicines Act is 1981. As Andrea said, we have just consulted on getting that legislation updated. But there is probably a couple of years away. So that's the key difference there between approved CBD products and unapproved CBD products.

Now, talking about CBD, they are prescription medicines that are scheduled in the Medicines Act now. They have to be prescribed. The way to change that access in the Medicines Act is to look at a classification change. And that's something that I imagine industry would be very interested in. And what we do is look at an application, for instance, on the safety and access balance for a product, for a substance such as CBD, and then get some expert advice on that.

So I guess the key way to describe it is, is this product sufficiently safe that a patient can go in and self-diagnose and self-select? Or should they really be having a conversation with a health care professional?

Is that a pharmacist, so that you can have it in a pharmacy and sell in a pharmacy? Is it a pharmacist where you have to have a consultation, where you have to go and talk to the pharmacist before you get it from the pharmacy? Or should you be going to see a medical practitioner or a nurse practitioner and get a prescription? Or a pharmacist practitioner, prescriber, as well.

So there is a way that CBD can be looked at, as far as access goes. We know that it has wider access in other countries. We've talked to industry representatives about that process and how you can have a look at where the CBD should be widened in terms of access.

Unapproved medicinal cannabis products, that's the other part of the prescribing change we looked at. We're not looking at changes where unapproved products that do not meet the quality standards. This is for unapproved medicinal cannabis products they aren't CBD products. We're looking at no changes there where a specialist can continue to prescribe those with Ministry approval.

And what typically happens is information comes to the Ministry about the quality of the product and some clinical information, and our chief medical officer has a look at the clinical information. We look at the quality information and help provide some advice back to the prescriber about that product to help them make the decisions for the patients. So it's really for informed consent, but also so prescribers know what they are prescribing if it's an unapproved product.

Now, onto the new proposals. There's approved products-- so non-CBD products are approved products, such as we currently have the moment, is [INAUDIBLE].

But that may grow in the future.

Now, on-label use-- and what I mean by "on-label" and "off-label" is [INAUDIBLE] is approved for treatment of spasticity in multiple sclerosis. And that's through clinical trial data that they've sent through. And [? an ?] approval was [? administered. ?] That's what's termed as "on-label." Use of [INAUDIBLE] for anything else is called "off-label." So it can be prescribed, but that's the difference between the two.

So the proposal was for on-label use that these products can be prescribed by medical practitioners. And currently they have to be recommended by a specialist. We propose removing that.

For off-label use, they can also be prescribed by medical practitioners. They will need endorsement by a specialist or recommendation by a specialist, but [? we'll ?] remove any requirement to have to send these through the Ministry of Health. So at the moment, any prescribing of [INAUDIBLE] for off-label use, for instance, has to come through the Ministry of Health. We'd propose removing that.

Now, for unapproved products that meet the quality standards, we're proposing that they be prescribed by specialists and also remove the requirement for Ministry approval. Also, adding a provision for medical practitioners to prescribe with specialists' recommendation.

So what we're looking at here is a balance between access and looking at barriers to access for patients with who should be prescribing these and what sort of specialty do you need. This is obviously a key question that we have for-- well, for all groups. Obviously, health professionals are going to provide us with quite a lot of feedback, as well. We're really interested in what industry thinks about this, too.

Should all of these products just be open and be able to be prescribed by any medical practitioner or authorized prescriber? Should you require specialists? Should you not? What sort of specialists? We're really keen to get feedback on this, as well as, obviously, the rest of it.

Now, the consultation period, just to close off, running for four weeks from the 7th of August. We typically try to run these for a bit longer, but I've talked to you about why we've had to condense this down to four weeks.

We're running information sessions obviously here in Auckland. We're also running sessions in Wellington and Christchurch. We're talking to industry groups. We're talking to medical professionals and consumer groups so we can get everyone's views. Obviously, as probably no surprise, there are quite diverse views on these products around access and around quality.

Our expert advisory group, the Medicinal Cannabis Advisory Group, will be meeting early September to look at reviewing the regulatory proposals-- so looking at all the consultation information, looking at the key themes, seeing which proposals would go forward, and which proposals should change. And that's why your submissions are really important here.

We're then looking at [? cabinet ?] approval for draft regulations in October, and then approval of the regulations in December. Thanks very much for your attention.