[Medicinal Cannabis Scheme Consumers Session]

A few here to learn more about the details of the government's proposed referendum on the legalization of recreational cannabis, you might have to wait a little bit longer. These information sessions are about the medicinal cannabis scheme, which covers the medicinal cannabis products, which are available through prescription. So we're not here to talk about the referendum or the proposed legalization. New Zealanders will have a chance to vote on it at the 2020 general election.

I'd like out now like to introduce Chris James, who is the group manager of Medsafe, which is the New Zealand medicines and medical devices Safety Authority. That's a business unit was on the ministry which is responsible for the regulation of therapeutic products in New Zealand.

Hi everyone. Thanks for coming along. Appreciate you taking the time to come and hear what we've got to say and provide us with some information and just ask some questions , and very happy to answer them. Just a bit of intro, I'm some group manager of Medsafe, and we're responsible for implementing the medicinal cannabis scheme. I'm a pharmacist by background. Been at Medsafe for around 12 years now, and manager for about five.

So there's quite diverse views around medicinal cannabis, and there's quite diverse levels of understanding of what products are around and what products contain, and what may or may not be available, and so what I'm really came to do is give you some information about why we're here and what legislation is going through and what scheme we're putting in place, and getting information back so we can help make sure we're achieving our objectives.

So the key objective from the government is to improve access to affordable quality medicinal cannabis products. And this was one of the issues in a 100 day plan for the new government. It was high priority, and it was to put legislation in place that provided an exception in statutory defense, that was first for patients who are terminally ill to possess and use illicit cannabis. Also to deschedule CBD, which is cannabidiol, out of the Misuse of Drugs Act, which would make it merely a prescription medicine that wouldn't be subject to all the restrictions that non-CBD products like THC products have, and provides our ability to make regulations on the likes of quality standards for medicinal cannabis products. So what standards what standards should they meet and how can they better improve access to these products.

So when the legislation went through there is also a requirement to get the regulations in place within 12 months, and so that's I think the December. I wasn't aware until I started that Medsafe and started working in policy, how long it takes to get legislation through, which means 12 months is exceptionally fast. So it might not sound fast but it really is.

It's two to three times faster than any other country has done it. That's why we're looking to see what other countries are doing, what they've learned, what's worked well, what hasn't, and trying to get it put in place in to New Zealand. So the blue boxes in the screen near there, that's around the medicinal cannabis scheme, so while we seek regulations for quality standards and being out of seats quality standards, we have a medicinal cannabis scheme in place with an agency that looks at licensing. So fiercely licensing for cultivation, licensing for manufacture, and regulations around supply.

So a couple of things just to note-- just quickly-- around an international context and how we're working, we're not just isolated in New Zealand around what we can do. So there are a number of conventions, international conventions, New Zealand signed up two decades ago, and one of those is the Single Convention on Narcotic Drugs from 1961. And so that effectively establishes a framework, which requires New Zealand to monitor the cultivation and the use of products, such as cannabis.

And it also requires us to set up an agency to regulate cultivation in cannabis for medicinal and scientific purposes. Now the New Zealand context we're working on, we have the Misuse of Drugs Act. So cannabis is scheduled in the Misuse of Drugs Act. It proposes control of supply chain activities, including through a licensing regime to cultivation and manufacture and supply that's round for commercial purposes. So at the moment, we can issue licenses for cultivation and manufacture, but it's just for research and scientific research purposes.

So really the change here is moving from being able to get a license to cultivate manufacture just for research and studies, through to a license for commercial manufacture. So you can provide product. The Misuse of Drugs Act also included in there around the New Zealand context is that patient access to these products is through prescription medicines. And that is through prescription-- sorry-- and that is what's proposed. So other than cannabidiols or CBDs, also prescription medicine, even though it's not in the Misuse of Drugs Act, but there is talk about later on prescribing. What we can do to look at that in terms of reclassification and opening up access.

So there are two main areas here around the scheme, and its increasing supply of products and also improving access for patients. And so looking at more product being available through a sustainable industry. Commercial cultivation in New Zealand, also enabling export, manufacture of medicinal products and New Zealand, and being able to approve local and/or in use, have access to local and imported products to meet minimum standards for quality.

As far as improving patient access, we can provide reassurance around that products will have a quality be made to a quality standard. That helps with clinical decision making and also enables clinicians to prescribe when they're having conversations with their patients about what might work best and what won't, and the informed consent process. And to do that, you need to have information on both the products available, but also on general information around medicinal cannabis.

So this means the particular product that is being used, whether it's a formulation, what the concentration is, what the consistency is, how it's delivered. Is it capsules? Is it a spray? Is it a patch? Is it a tablet? And also general clinical information is we are having a feedback that sees health professionals aren't always that aware the moment of the evidence for medicinal cannabis products, and that research is increasing.

It's increasing a lot. There's been a lot of governments that put a lot of money in to looking at research for what the different cannabinoids do, in terms of how they work, but also how they interact with the body and how the body interacts with them. And what we need to be able to do is provide that information to both consumers and to health professionals so they can make informed choices. Because without that information, may very well be that health officials are reluctant to prescribe them because they feel like taking a risk with a product they don't know anything about.

So handover back to Andrea who talk a bit about quality standards and licensing, and then cover off the prescribing requirements.

So I'm going to talk a wee bit about the quality standards that will apply to products that are manufactured under the scheme. So why are quality standards important? If we want to improve access, then we don't want to be approving-- we don't want to be putting products on the market that would harm the patient. So if there are no requirements for quality, you might get poorly made products. So to protect the patient, people who use medicines expect that they will meet appropriate status of quality, regardless of the reason they are using the medicines.

So if you go to your supermarket and you buy panadol off the shelf, you would expect that it will do-- or help you-- in a way that it helped you before. There is a potential for patient harm of medicines that contain the right active ingredients and the right dosage, or they can find contain harmful substances like pesticides and heavy metals, which may harm you or if they're not stored under the right conditions.

So under the scheme of the medical cannabis scheme, we can set quality standards for cultivation. So processes, cultivation processes, manufacturing processes, for the finished products and for the active pharmaceutical ingredients, which go into those finished products. So we are seeking feedback from everyone around consumers, industry, and manufacturers, and medical professionals on what those quality standards should be.

So I want to spend a bit of time talking about the manufacturing quality standards because manufacturing quality standards are key part of the manufacturing process and also a part of the standard that a medicine is manufactured to. So when we started this journey, we had a lot of people that were saying that, why don't you do what the Canadians have done? So in Canada, they have this concept called, GPP, which is Good Production Practices, and I just want to find a bit of time telling you what we found on that journey, in terms of looking at what Canada have done.

So in New Zealand, we have the New Zealand approach for the manufacturing of medicines, it's called GMP. Good Manufacturing Practices that ensures that products are produced consistently, and in reliable, high quality. It's based on an internationally recognized system, and within Medsafe, we have the system set up, we have auditors who go out and audit, people who are manufacturing to GMP, so there is a system already in place.

When we started to look at Canada we were a wee bit puzzled because we looked at what they were planning to put in, which is called GPP, and so when we went down to the detail about well, what exactly is GPP? And so we put the two things side-by-side. And an actual fact, we found that in terms of the principles of each of those, they were much the same.

For example, you shall construct your premises so that you don't contaminate the product. But what we also found is that Canada has also a system for medicines in the same way that New Zealand does. So medicines in Canada manufactured under the Food and Drugs Act, and as similar to the New Zealand system, so they are required to be manufactured to GMP, and the medicines are subject to pre-market authorization, but Canada also have these products called non-prescription health products containing cannabis.

They basically see, for these products, they can be managed and processed following a standard, which they call, Good Production Practices. However, this doesn't apply to medicines, as we know them, the stuff that you can get off the shelf from the supermarket or at your pharmacy, or through prescription. It only applies to what we call the non-prescription classes of cannabis. The fresh and dried cannabis, and cannabis oil. And the way to access them is not through a prescription process, but through a medical document which is issued by your doctor.

So it's quite different. So it's basically on saying that Canada has a medicines process like we do, but they also have these non-prescription health products containing cannabis. So while it does apply at the moment the fresh and dried cannabis and cannabis oils, they are introducing regulations later on this year to also include edible and topical cannabis.

So really what is the difference? In GMP there is a code of practice of GMP, which sets out those principles that I just talked about, but also tells you what you need to do to comply. So if you are manufacturing a medicine, then you go to this code of GMP, and you want to be able to get your certificate of compliance, or certificate for GMP compliance, you will follow what's in the code.

That does also tell you-- that does also allow you to do things in a different way, but you have to justify how you are going to meet those principles. GPP has got those same principles, but while the guidance is developing, it's not there yet. So you have this principle. You shall construct your building in such a way that you don't contaminate your product, and that's it.

So it leaves you, at least a manufacturer, to try and decide what it means. So how do I construct my building so I reduce contamination? And on the other side of the spectrum, the regulator then has to look at what the manufacturer has done and then decide, does that meet those principles? So it's quite open to interpretation. It's quite a bit of work, I think, for both the manufacturer and the regulator, whereas, the GMP gives you that guidance.

The other key thing here is the validation programme is required under GMP. Why is this important? Because it means that quality is built into every step of the process, whereas, under GPP, there isn't that validation program required. Why it's important? Is consistency. So for example, if get a prescription, and you have your, say your box of your captures, and you expect that every single capsule in that bottle is going to be exactly the same, and deliver the same dose. Also, the fact that it's got a shelf life. So it might say that it's only good for three months or 12 months or it might have storage conditions on it.

If you manufacture something under GMP, you'd know that everything in the bottle is the same dose, but you also know that if you had that same prescription a month ago or three months into the future, then that's going to deliver you the same dose as well. So under GPP, not having that delegate validation program as a requirement, means that there's batch testing is required of each batch that comes off the production line. All that tells you as the particular poll that you picked to test meets the requirements. It doesn't tell you that everything in that same bottle as consistently the same dose. It doesn't tell you that it's the same as the one you bought a month ago or three months ago.

So that's why it's important when we get to talk about whether or not doctors can prescribe, and for medicinal cannabis products we are suggesting that the prescribing from a doctor, that they do monitor how the patient is going with us. And then in a traditional medical model, they will adjust the dose to suit what's happening with the patient. So consistency is important, and also under GPP, there isn't that requirement for stability testing, either.

So GMP, as I said before, is internationally recognized. It's a requirement, and the EU, Australia, and Japan, Canada is the only one that has introduced this GPP requirement. Just talking about what finished dose forms will be allowed under the scheme. Products of smoking will not be allowed under the scheme, but products for vaping are.

Modified released dose for medicines and medicines that are required to be sterile, in other words, they are higher risk, are only be allowed if they are approved, or professionally approved, by the ministry. So under the scheme, and Chris will talk on this later, we have approved products, provisionally approved products, and unapproved products, and we're basically saying, for these high risk dose forms, they will only be allowed if they have been gone through a proper assessment.

Food containing medicine medicinal cannabis is not allowed under the Food Act because it's prescription medicine. Cannabis-based dietary supplements, natural health products, and nutraceuticals must also meet the requirements of the scheme. They are prescription medicines, so they are not allowed on food, but they must meet the requirements of the scheme. There isn't a regulatory scheme at the moment for natural health products, but until something else comes along, cannabis-based products will fall under the requirements of the scheme.

And I'll hand now back to Chris to talk about the prescribing requirements.

This bit really covers some of the access and how you can actually access these products. So before we do that, just a little bit of an explanation because we talk about approvals and provisionally approved or not approved. After I'd done the definitions, we'll go through what we're not changing, and then what we are proposing to change. And in terms of prescribing and access, this is a key area-- I think-- for consumer groups to get your feedback on if you think there are still barriers in the way, as far as prescribing, and whether this is the right way to go or whether it's a different way to get these products, in terms of prescribing.

At the end of the day, these are prescription medicines, so they will follow a medical model of needing a prescription. So approvals. Just really to cover this off, so when we talk about approval and provisional approval, approval to distribute the medicine is really something from the Medicines Act. So it's weird we approve medicine to be able to be sold in New Zealand.

And what this involves is data provided by the applicant that demonstrates that the product's safe and that it works and that it's manufactured to high quality. And this evidence is assessed by the ministry, and then if it meets effectively internationally group criteria, then we have an approval. And provisional approval isn't approval in the Medicines Act, but it's basically like an early approval. And so what it means is you can make this an improved medicine on, for instance, an earlier clinical trial data.

So this has been used in the past to both put conditions on medicine, so some medicines have risks and you want to put conditions on them to say, this medicine should only be prescribed by a certain specialist or this medicine can only be prescribed if the patient is under a blood cell monitoring system. This is for a medicine that may have real benefits, but also has risks. You can do that through a provisional approval.

We've also used provisional approval for antiretrovirals in the past. So decades ago, we see when the HIV issue became apparent, we had antiretrovirals. The clinical data that was available for them was quite early, and so there was clinical need clearly, and so they were given a provisional approval while more clinical data came through. And as more and more research comes through for medicinal cannabis products, there is simply a question about how products are eligible for a provisional approval based on early clinical trial data, so that's why we explain it.

Unapproved products really are just the safety, the efficacy, is and the work, and the quality has not been / so you don't necessarily know what's in them, and there is no evidence from clinical studies about whether they work or not. So before we start on proposals, let's look at what we're not changing. So cannabidiol CBD products we're not looking to change. Obviously, they've come out of the Misuse of Drugs Act so that prescription medicines only.

And this means that approved CBD products can be prescribed by a medical practitioner or a nurse practitioner. Now unapproved CBD products can also be prescribed, but the way the medicines act is worded, and this is 1981, so it's quite a long time ago, only medical practitioners can prescribe them. And this is for unapproved CBD products, now we've just consulted a couple of months ago on throwing out the Medicines Act and bringing in the Therapeutic Products Bill, which will change a lot of that. That's a huge project, and to be honest, it's a couple of years away. So just to tell you where we are said at the moment.

Unapproved products, so non-CBD products or unapproved products that have THC and don't meet that definition, they do not meet the quality standards, we're also not proposing to change how they're prescribe, so there'll be a specialist became prescribed, but you need to come to the ministry with an application each time. And the reason for that is because they don't meet a quarterly standard, we need to get some sense of what these products contain, so patients can have reassurance, for instance, things like contamination and consistency and instability.

So looking at the new proposals around access. So approved product like, at the moment, use an example of such as Sativex, which is an approved medicine. Contains THC and CBD, you may have seen it in the media. For on-label use and what we mean by that is for using it and what it's approved for. So it's approved for spasticity in multiple sclerosis. If it's prescribed for that, then we're proposing that it be prescribed by a medical practitioner, remove any recommendation, remove any requirement to get a specialist to recommend it.

However off-label use, for instance, if you said it's for anything else or any other approved product for anything else, then it can be prescribed by a medical practitioner, with a recommendation from a specialist. Now what normally happens now is you also have to apply the Ministry of Health. We're planning on getting rid of it. For unapproved products that meet the quality standards, which Andrea has been talking about, they can be prescribed by specialists, and we will also remove the Ministry of Health approval.

So if it meets the quality standard, then you don't need to come through the Ministry of Health. And also adding a provision that medical or any medical practitioner can also prescribe with a specialist recommendation. So that's the that's the proposal at the moment. I'm really keen to get feedback, as I've mentioned about, that we've had people coming back to us about, well, if we can't get to see a specialist, that's a barrier. That costs, it takes time, is this really required? And we've heard in earlier sessions, there are a lot of medicines that don't require specialist to be recommended before you get access to it. Is that right?

So I think this group would be very helpful in providing information about should do you think you should be able to go to any GPP, any nurse practitioner, any pharmacist prescriber, or some have said to us, look, this should be specialist only. Some say it should be only be specialist cannabis centers. So really, it's quite a wide range and we're really keen to get feedback from industry, from consumers, from healthcare professionals about what they think with us says to improve access.

I've talked about the products and talked about that they're no longer controlled in Misuse of Drugs Act. The prescribing for these now really follows any medicine, which is what I've just talked about. CBD products can be prescribed on the Medicines Act and can be, by any medical practitioner, if they're approved CBD products. If they're unapproved, then a medical practitioner can prescribe them also, it's like any medicine is approved or unapproved.

One thing that we've got here is that CBD as a prescription medicine. And we've had questions about, well, should access be widened? So you can buy it from a pharmacy or buy it from a supermarket, there are many countries around the world that have supplements that have CBD in them. And they're in the states, in Europe, although the FDA is currently looking at a safety review on CBD, but we'll have a look at it, but there is the ability under the Medicines Act to look at widening access, and that is we understand industry is actually putting together an application for that at the moment which will go up to a bunch of experts who look at, can you safely extend access?

So for instance, if you're in a supermarket, is this product, and in terms of the safety profile, mean that a patient can diagnose themselves and they can go and select it themselves or should they-- before they buy this product-- talk to a healthcare professional? Should there be a pharmacist, or should you have to go and talk to a prescriber? And we expected that to come through, depends on how quickly that application comes through, and then the expert group makes a recommendation, and the minister then decides whether that should happen or not. So that's a way of looking at access to CBD products.

So just to go through what happens next. So we've got a four week consultation period, which will go until the 7th of August. We tend to try to consult for longer when we're coming out for legislation change, but the frame is so tight that, if we consult for another two weeks, for instance, we may lose that December timeline, and we must hit that December 18 timeline for getting regulations in place.

And obviously that then enables a scheme that will improve access to products. We're holding information sessions in Auckland, Wellington, and Christchurch, and that's including industry, excluding Maori industry, medical professionals, and consumer groups. And what we're really trying to do out of this is get their diverse views, but there are diverse views between groups as well.

Obviously, industry will have a view, health professionals have a view, consumers have a view, we want to hear from all of those groups, and that's going to help put together the information we need to make policy decisions on where we're going to sit. So in terms of quality standards, in terms of education, in terms of prescribing, and access. We have an expert advisory group advising us. They have helped us put together the consultation document that includes consumer representatives, health professional representatives, and industry representation.

Will be meeting at the end of September to look at all the feedback and look at what proposals are in place, and then going to cabinet to get approval for draft regulations in October, and then approval of the regulations in December. Now it sounds like a wee way off, but trust me, it's not. So there's a lot there's a lot to go through to get that done. So thanks very much for your attention, and please make sure you make a submission online.

This consultation document is on the Ministry of Health website. If you're looking for it, you can just put medicinal cannabis into the search tool in the top right-hand corner, it comes up with all your information. So please do. We really keen to hear.