The new system could help thousands of chronically ill patients access innovative new treatments, Dr Nicoletti explained.

Currently, many of these patients are forced underground to access their treatment, putting their health at risk and exposing them to criminal charges.

The new act is a first step to creating a national scheme where patients could access cannabis medication legally and safely.

Yet Australia is still a long way from creating a fully functioning framework and a host of challenges remain. All this and more coming up on this episode of The Lawyers Weekly Show.

Podcast transcript

Intro: Welcome to the Lawyers Weekly Podcast, for an in depth look at the issues facing the legal profession. This is your host, Stefanie Garber.

Stefanie: Hello and welcome to the Lawyers Weekly Podcast. I'm your host, Stefanie Garber, the acting editor of Lawyers Weekly. In today's episode we're looking at legalizing medical cannabis in Australia. A new law last month made the cultivation and production of cannabis for medical purposes legal across the country, but what does this actually mean and how will the system work? I'm joined today by Dr. Teresa Nicoletti, a partner at Piper Alderman whose made the regulation of therapeutic goods something of her specialty. Welcome Teresa.

Dr. Teresa: Thank you Stefanie.

Stefanie: Teresa, last month the federal government passed an act establishing a licensing and permits scheme for the cultivation of cannabis for medical or scientific purposes. Can you give us an overview of what the impact of this law is likely to be?

Dr. Teresa: Sure. What the scheme proposes to do is create a licensing and permit scheme for the cultivation and production of cannabis for medicinal purposes. What it proposes to do is to grant licenses to either growers of cannabis or manufacturers of cannabis who will process the cultivated cannabis into products for medicinal end use. There will be strict restrictions on the scheme, but for the first time what we have is an enabling mechanism which will allow a farm to pharmacy concept and will give patients some access to medicinal cannabis.

Stefanie: For end users in states where possessing marijuana is still illegal, how does this work? Do they need a permit?

Dr. Teresa: Anyone that grows medicinal cannabis for commercial purposes will need a license and a permit to do that. Anyone that then manufactures that for medicinal end use will also need a license and permit to do that. Right now there are a number of restrictions in every state for the possession and supply of medicinal cannabis. You can possess it generally for research or scientific purposes, but not for commercial purposes. There will need to be changes made in all states which will include a change to the scheduling of cannabis. Right now most cannabis products or derivatives are in schedule nine which makes it illegal to possess, but with the change in the legislation there's also a proposed change to the scheduling scheme to place medicinal cannabis products in schedule eight and that will allow wider access to it for cultivation and production purposes and will allow supply with a prescription to patients who need it.

Stefanie: It's fair to say that a lot of people are familiar with the recreational uses of marijuana, some with more first-hand experience than others but I think the medical application isn't understood as widely. Can you talk a little bit about why the government has taken the step to create a medical marijuana scheme?

Dr. Teresa: Cannabis is one of those interesting products that contains a whole host of compounds which have shown some therapeutic benefit. There are two main known cannabinoids in Cannabis. One's called tetrahydrocannabinol and another is called cannabidiol and they're both have shown quite important therapeutic properties in cancer pain, in neurological conditions such as Multiple Sclerosis and there has been a push towards allowing patients who need access to cannabis for a genuine medicinal need to relax the legislation so that they can have access to it and that has been part of my advocacy work. I'm not a proponent for recreational use, I'm a proponent for genuine medicinal use and this is what this legislation is all about.

Stefanie: For the advocates of medicinal uses, what are the challenges that you've faced or what are the roadblocks that we're seeing in terms of having a scheme rolled out across Australia?

Dr. Teresa: The passing of this legislation is a start in the right direction. There's no doubt about it, but what people don't realize is that once you pass legislation, the next step is to create an enabling framework to administer the legislation. Right now we don't have a structured regulatory framework which can facilitate access. There's a lot of unanswered questions now and the government is, I'm sure working behind the scenes to put a framework in place, but for example, we're not certain at the moment who is the gate keeper of the licenses and permits. Will it be the therapeutic goods administration or will it be a separate body within the department of health who will administer those licenses. What sort of restrictions will be placed on cultivation and permits and who will be allowed to get a license or permit.

For example, there is a fit and proper person test as part of the legislation and it's quite a strict test which will look at whether you can be granted a license at all. They'll look at your history, including whether you've got any criminal record, they will look at your premises and whether they're sufficiently secure, they will look at what sort of production capabilities you've got. There's a whole checklist of issues that need to be addressed. To be able to administer the scheme properly, you have to have a set of rules or guidelines that underpin the legislation. I don't want listeners to think that now that we've had the legislation passed, tomorrow we're going to be able to cultivate and manufacture. There's still a long way to go and how long will that take? Well, I don't know the answer to that, but there's certainly steps being taken.

For example, last week there was a meeting of the scheduling committee to look at the placement of medicinal cannabis derivatives in schedule eight, so that's another step forward. In time we'll start to see draft rules and guidelines coming out for consultation, so there's still a long way to go.

Stefanie: You've obviously been involved in advocacy work on this issue. Why do you think it's so important? What's the need to bring in a scheme like this across the country?

Dr. Teresa: For me it's been all about access to medicines and a proven benefit for these types of drugs. Can I tell you how I first got interested in it?

Stefanie: Yeah, please.

Dr. Teresa: I read a study of cannabidiol in mice and they had grown these mice with Alzheimer's. They had a control group that they didn't administer anything to and the active group they gave cannabidiol to. The cannabidiol group, over the course of the study had their Alzheimer's reversed.

Stefanie: That's incredible, reversed?

Dr. Teresa: Yes. They showed complete memory response and recognition in the study. Now that is only in animal study, but my mother has Alzheimer's and it really sparked my interest in it. I started to do my own research and then I started to become an advocate for change. You might have seen also in the media a lot of individuals, young children with epilepsy whose parents have been desperate to find a treatment that actually works and in some cases their epilepsy is life-threatening. Some of these children have derived benefit as well from cannabidiol where it's reduced their seizures dramatically with cannabidiol. Now clearly, there is some therapeutic benefit. We don't even know how far cannabidiol has neuroprotective properties and there are a range of neurodegenerative disorders that it might assist and so part of my advocacy has been to push or more research, for more science, for more access to these drugs. If you've got a cancer patient that's in the terminal stages of their disease and all they've got is to try and get some quality of life of how many days they've got left., why can't they have access to medicinal cannabis for that purpose?

Stefanie: Absolutely. The stakes are incredibly high in this debate. There has been some discussion about whether medical cannabis scheme is the first-step towards legalization across the board or decriminalization. Do you have a view on this? Do you think this is likely to be the next issue on the agenda?

Dr. Teresa: Personally I don't and without wanting to be too controversial, I'm not in favour of that. I'm certainly in favour ... Those individuals that want to use it for recreational purposes, there is a concern about the psychotropic effects of cannabis and so an individual that's using it for recreational purposes, are they going to be responsible enough in its use? That's a question that I'm not intending to answer, but I'm just putting it out there. Medicinal purposes is a totally different ball game though. I don't think there should unfettered access for medicinal purposes because we have a world class regulatory scheme that works well and that's part of what this legislation has tried to do, is try to put in place some controls that will give access and still have some fettering of that scheme as well.

Stefanie: From what you're saying, it seems that implementing a scheme isn't going to be an easy process. What timelines are we looking at?

Dr. Teresa: I think the public should be aware that things don't happen overnight. To be honest, I have been one of the frustrated ones that felt at times that I've been bashing my head against a brick wall through communications with federal and state governments and the slow progress of change. Stepping back from that, we will have a scheme and in maybe a couple of years time there will be cultivators out there who are growing high grade medicinal cannabis, there will be a pocket of producers who will be taking the harvest from the cultivars and manufacturing it into finished products, and patients will have some access to high quality medicinal cannabis products for end use.

I could see this being implemented within the next couple of years. I don't see it happening within the next six months because those that grow will need to have pilot production to see which cultivars grow the best and which conditions are the best. It all takes time and I think we do need this scheme to operate for sometime before there can be a relaxing on the restrictions, and the relaxing on the restrictions will depend on ensuring that this existing scheme operates without too many hurdles.

Stefanie: This new federal act is the first step on a fairly long road towards medical cannabis being more widely in use?

Dr. Teresa: Yes, I think so. I think the scheme can widen, but I do think we need to just get this scheme up and running under the current legislation, make sure the scheme operates smoothly and efficiently, and then look at what other areas we can expand on.

Stefanie: Teresa, to flip the question on its head, what's the danger of not having a scheme like this in place in Australia?

Dr. Teresa: Stefanie, there are some significant concerns about not having a legalized scheme. One of my biggest concerns has been the knowledge that there are websites setting up that will market what they purport to be cannabidiol products, but they’re untested, they're of questionable quality, safety, and efficacy, and a number of patients or carers of patients in desperation are ordering these products online. We had become aware of this about eighteen months ago, so wherever we see those illicit websites popping up, we notify the regulator. It has been a slow process to address this because these websites are obviously making some profits out of vulnerable patients. They're selling their products, the patients are obtaining them unlawfully for the benefit of themselves or the people they care for.

I do think that legalizing the scheme will allow proper access to products which have tested quality, safety, and efficacy and it will minimize the risk of harm to unwitting users who order these products online. In some cases if you look at the products, they've got photographs of them online. They look like black tar, they contain a lot of plant matter in them, so you can just see from looking at them that they have questionable quality and so we want to eliminate illicit sources of medicinal cannabis. We want to provide a legal scheme where we can at least provide patients and their carers with some surety of quality, safety, and efficacy.

Stefanie: Sure. It's about protecting the people who could benefit the most from this type of medication.

Dr. Teresa: Yeah, I think so and not putting them in a situation where they need to break the law in desperation. I do feel for them, but unfortunately the reality is they are breaching the law by doing that and they could end up being prosecuted if that is discovered.

Stefanie: Absolutely. It seems like a legalized scheme would prevent people being put in this position where they have to choose between their medical care and breaking the law. Today we've been discussing the legalization of medical cannabis in Australia. Teresa, thanks again for coming in. To all our listeners, thanks for listening.

Dr. Teresa: Thank you Stefanie. It's been my pleasure.