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Community Affairs References Committee
29/01/2020
Current barriers to patient access to medicinal cannabis in Australia

NICOLETTI, Dr Teresa, Partner, Mills Oakley; Director, Medical Cannabis Council; and Member, Australian Lawyers Alliance

[11:08]

CHAIR: Welcome. Thank you very much for coming. Do you have any comments to make on the capacity in which you appear?

Dr Nicoletti : I'm a partner at Mills Oakley and I'm representing the interests of my industry clients and patient clients as a partner of that law firm. I am also a director of the Medical Cannabis Council and am representing the interest of more than 120 members, which include industry patients, doctors, nurses, patients and patient advocates.

CHAIR: Thank you very much. I invite you to make a short opening statement. I know that you want to cover a range of issues.

Dr Nicoletti : I have shortened my opening statement because I'd like to devote the time to question time. Essentially, what I've tried to do is distil a lot of the information that is relevant to this inquiry in the Mills Oakley submission and the submission from the Medical Cannabis Council. I believe a lot of the information that I would have covered here today is in that submission. I endorse both of those submissions. I am very grateful for the opportunity to have made those submissions and to appear before the committee. I don't want to take any more time on opening statements. I'd like to just defer to you for questions.

CHAIR: Okay. Thank you. Your submissions are comprehensive.

Senator URQUHART: Thank you very much, Dr Nicoletti. I just want to go to the current regulatory framework to access medicinal cannabis. From what I understand, in your submission you talk about that being inadequate. Can you just go through the steps of why that is the case from your point of view.

Dr Nicoletti : The first subject I'd like to talk about is the access schemes. Doctors are required to apply for access under either the Special Access Scheme or the authorised prescriber scheme. The issue with those schemes is that they were never really intended for the suite of products called medicinal cannabis products. They comprise many different products containing very different compositions of cannabinoids, terpenes, flavonoids and other compounds. So it's not one product that you can try that may assist a patient. Feedback that we have received from both doctors and patients is that they are frustrated by the amount of time it takes to prepare an application to submit to the TGA. It requires them to provide a clinical justification for why they have chosen that particular therapy and also to explain to the TGA why conventional treatments haven't worked. Then the TGA evaluate that application and provide an approval. I appreciate that the TGA have done what they can in fast-tracking approvals. In their submission I believe they talk about the turnaround of around 30 hours. But that disregards the time and effort required by a doctor to actually prepare a submission in the first place.

With medicinal cannabis, if you submit an application for one product and that product is ineffective, which is quite often the case when you are trying to work out a treatment for a particular medical condition, you have to submit another application and explain why that treatment was ineffective—

Senator URQUHART: And do it all over again?

Dr Nicoletti : Yes. This can be as simple as starting with, say, a 20:1 CBD product and finding out that, instead, you need a 15:1 product or you need a higher dose or you need an oil instead of a capsule. Each of those are separate and distinct goods which require a separate application. In relation to how the scheme was originally introduced, it was intended to be more applicable to conventional medicines where you have a synthetic mechanism that has a known pharmacological action and a single molecule that has a well-defined safety net because it's profiled and tends to be approved overseas but may not be approved in Australia. The scheme works well for those types of drugs. I don't think it works well for medicinal cannabis.

How can that be addressed? You could create a modified scheme that would, in my view, allow a doctor to get an approval for medicinal cannabis. It would be like an authorisation that would allow that doctor to prescribe medicinal cannabis.

Senator URQUHART: And then vary that accordingly—

Dr Nicoletti : Correct.

Senator URQUHART: without going back all the time—

Dr Nicoletti : Yes, without having to go back for more applications. I note that in the Department of Health's submission they say that ultimately the decision about the treatment is the doctor's. So I do have to ask the question: why do we have to go through this onerous application process? Why can't the doctor—one who is properly educated, I must say—make the decision that they want to try cannabis in their patient and maybe submit a notification to the TGA saying, 'I am going to try this product in this patient'? If they decide to change, a notification form is a much easier thing to complete than having to put in a comprehensive submission with a clinical justification. That is the major issue that I have with the scheme right now.

There is also an issue around the inability to obtain reimbursement for medicinal cannabis. That's because it is an unapproved product. It is not a product which is registered on the Australian Register of Therapeutic Goods, which is a prerequisite before you can even apply for PBS listing. You can apply while an application is under evaluation, but you cannot get a product PBS listed if it is not a registered medicine. So either we would have to change the legislation to accommodate this type of product or we would have to look at other reimbursement schemes like Medicare funding or treating medicinal cannabis like it's a service, which includes subsidisation of a prescription, or looking at possibilities for private health insurance to accommodate these types of products.

I don't know the level of comfort of insurers at the moment even contemplating subsidising medicinal cannabis treatments, but one of the issues there is talking about indemnity. It's essentially an unapproved product, so what sort of indemnity issues arise both for the doctor and for the insurer considering the subsidisation. Ultimately, though, I think those issues can be addressed through patients completing indemnity forms and also signing informed consent forms, which puts it more into the control of the doctor and the patient. My view is—and this is more on a personal level than a professional level—that the relationship between doctor and patient is paramount. A doctor, particularly a general practitioner who has known a patient for a long time, will know what's in the best interests of their patients, and I do not believe that a GP will administer a medicinal cannabis product to a patient if they don't believe it's in their best interests.

Senator URQUHART: Okay. Can you talk to me about the key issues in relation to state and territory regulations, and the problems that they cause?

Dr Nicoletti : I think it is less so than it was 12 to 18 months ago.

Senator URQUHART: Why is that? What's changed?

Dr Nicoletti : The streamlining has had a major positive effect on removing a lot of that state layer of regulation. We still do hear some stories about state intervention, but not to the level of intervention that there was 12 to 18 months ago. I applaud the government for taking the steps needed to remove that state layer of regulation.

I do believe that any future iterations of the scheme need to ensure that there is no intervention by the states. I believe that at the moment Tasmania has not taken up the streamlined process. Patients in Tasmania are, therefore, affected. There's also this expectation that you can only be prescribed a product by a doctor in the same state you reside in, and so that is putting Tasmanian patients at a disadvantage.

Senator Bilyk interjecting

Dr Nicoletti : Yes. There are other barriers there.

Senator BILYK: Apparently our GPs are less asked than GPs in the rest of Australia. That's how I read that, but that's my sarcasm coming out. Sorry, Dr Nicoletti.

Dr Nicoletti : That's all right.

Senator URQUHART: All right; I'm happy to leave it there at the moment and give someone else a go.

Senator DI NATALE: Firstly, let me congratulate you on your very thorough submission, Dr Nicoletti; it's excellent.

Dr Nicoletti : Thank you, Senator.

Senator DI NATALE: And given you're an expert on the regulation of therapeutic products, I want to explore that bit more. Also, thank you for clarifying that when we talk about 'medicinal cannabis' we're talking about a range of different products, in the same way as when we say 'antibiotics' we don't mean one thing, we mean lots of different things. Let me ask you a question about that for people who might not know. As you say, most medicinal cannabis products—there's only one as far as I know—aren't registered on the Register of Therapeutic Goods. So they're unregistered drugs, and that's why we need to go through this convoluted Special Access Scheme, which is designed for drugs that aren't approved in Australia. What is the barrier to these substances actually becoming approved as therapeutic products? Why aren't they registered?

Dr Nicoletti : At the moment all medicinal cannabis products, except cannabidiol, in greater than 98 per cent purity are schedule 8 medicines. CBD in greater than 98 per cent purity is schedule 4. By definition they're all prescription medicines; they can only be provided under a doctor's prescription. And in order to be registered in the ARTG you are required to submit a comprehensive dossier of quality, safety and efficacy data that complies with the requirements for a prescription medicine. And I would say that for probably all companies that are currently supplying medicinal cannabis products the cost prohibition on generating the data required to support a registration is too prohibitive. We're talking about tens of millions of dollars in investment.

Senator DI NATALE: Let's unpack that a bit more, because there's a lot of technical language in that. Schedule 8 is usually about drugs that might have psychoactive properties, drugs of dependence—

Dr Nicoletti : Controlled drugs—yes.

Senator DI NATALE: and so on. Because a lot of medicinal cannabis products have THC in them, they're basically classified as schedule 8 drugs.

Dr Nicoletti : Correct.

Senator DI NATALE: To have a schedule 8 drug listed and approved you need to provide a very comprehensive evidence base, and what you're saying is that usually that's the domain of big pharmaceutical companies—

Dr Nicoletti : Correct.

Senator DI NATALE: and that many of the companies involved in medicinal cannabis just don't have the ability to generate that data.

Dr Nicoletti : Correct.

Senator DI NATALE: Schedule 4—the more garden-variety drugs, if we can call them that—don't have the potential for addiction. You're saying the drugs with very low THC or less than two per cent are under schedule 4, but schedule 4 still has prescription drugs.

Dr Nicoletti : Yes. But the point I'll make is that any CBD-rich products that have low THC but don't fit into 98 per cent purity are actually schedule 8 drugs, so they're also controlled drugs. At the very least, I think the scheme needs to look at how we are regulating these products. One of the major barriers to facilitating the scheme is the scheduling of these products, and that is a decision made by the secretary. Even if we produced legislation that addressed regulatory issues per se, you would still need to deal with the scheduling status of these substances.

Senator DI NATALE: Yes. Effectively, we've got this dilemma, if you like. We've got a range of drugs—some of which we've got very good evidence on but for some it is anecdotal—although we're now getting a lot of pressure from members of the community who have experienced a significant benefit from some of these drugs, which they've been able to access either illicitly or through the Special Access Scheme, but the Special Access Scheme treats this drug very differently to other potentially much more dangerous drugs.

The example I'll give is that, as a GP, I could prescribe somebody an opiate, like Panadeine Forte or Endone, which, if taken in large quantities, would kill them because opiates in overdose have the potential to be fatal. But, as a GP, I can't prescribe a medicinal cannabis product in the same way, despite the fact that it has almost no overdose potential. So we've got a scheme that is unable to deal with medicinal cannabis, because of some of the inherent problems with the companies that are putting forward these applications, and we've got doctors who are hamstrung, in terms of the way they can prescribe it.

I'll come back to the question I asked earlier witnesses. These are inherent in the system we're trying to administer. Given those barriers and given that they're unlikely to change anytime soon, is the only way to ensure that a doctor's able to prescribe this drug—which is safer than many of the other drugs they can prescribe already—to create an independent regulatory pathway for medicinal cannabis rather than try to tinker with an existing system that, by design, is unable to cope with the regulation of medicinal cannabis in the same way as other drugs?

Dr Nicoletti : Quite honestly, I think changes could be made to the present scheme, but the question I ask is: why would you try and adapt a scheme that has, for the last 30 or 40 years, been focused on conventional medicines and try and adapt that scheme to fit what is a very different group of medicines? I don’t understand why there should be any resistance to a separate regulator to deal with this type of product.

Senator DI NATALE: So your view is that we could make changes to the existing system but that might be difficult, given that it's not designed to deal with the issues around medicinal cannabis. I don't want to put words in your mouth. But it would just be easier to have an independent regulator for medicinal cannabis in the same way as many other countries have.

Dr Nicoletti : I think so. I hesitate because I think of all the issues that would need to be taken into account, such as scheduling, such as cost, such as the regulatory 'approval' process. If I had my way, I would just sit down and set up a separate scheme and say, 'Okay, these are the things we need to do and this is how we will address them.'

Senator DI NATALE: In terms of the state issues, you've addressed those. Do you think there are any states that stand out in terms of the problems that exist there? Do you think the Tasmanian example is a good one?

Dr Nicoletti : Tasmania. If you'd asked me 18 months ago, I wouldn't have shut up, quite honestly, but a lot of the issues that were prominent 18 months ago have been addressed. But I have to say: there are a lot of people that did a lot of very strong advocacy 18 months ago to effect those changes. It was quite a frustrating scheme to work with back then. There are still frustrations, but the removal of the state layer has appeased some of those frustrations.

Senator DI NATALE: This might be a question more relevant to the industry groups—and we'll be hearing from those later—but do you think these barriers are an obstacle to us being able to develop a medicinal cannabis industry here in Australia?

Dr Nicoletti : I can answer that. I represent a number of industry players. One of my clients has spent $35 million investing in the capital needed to establish what I call 'the Fort Knox facility' so that they can cultivate, produce and manufacture medicinal cannabis for supply. The fact that we only have two companies at the moment, since legalisation in 2016, that are actually supplying the domestic market will give you some sense that the barriers to being able to cultivate, produce, manufacture and supply are quite onerous, as well.

Senator DI NATALE: So we're really talking about a separate set of barriers now; we're talking about the production of the drug rather than access to the drug.

Dr Nicoletti : Yes.

Senator DI NATALE: What are some of the of those barriers you see with regard to, as you said, the Fort Knox facility?

Dr Nicoletti : The cost of setting up secure facilities for medicinal cannabis and whether they are even necessary for CBD products that are non-psychoactive.

Senator DI NATALE: If you're growing a strain that has almost no THC—so it doesn't get you high, just to put that in generic terms—you still need to have those security arrangements?

Dr Nicoletti : Yes. I can give you an example. A company that has a hemp licence can grow industrial hemp, broadacre. I have a client that did exactly this. If you grow that hemp strain as an industrial crop then you can grow it broadacre. You may need some security fencing, but it's just two- or three-metre-high fencing to comply with local requirements. If that same crop is used for medicinal purposes, you can spend $10 million to $20 million constructing a secure facility that regulates that product as a medicinal cannabis product. And that is a real-life scenario; it's not something that I'm just putting out there.

Senator ASKEW: I've got a quick question about the current legislation around the use of medicinal cannabis and cannabis in general: are you aware of many clients or patients that have been charged or have had legislation used against them with regard to use?

Dr Nicoletti : Criminally charged?

Senator ASKEW: Yes, 'criminal' is the word I was looking for.

Dr Nicoletti : Yes. I'm not sure if Mr Barns is here. He would be the better person to talk about the criminal law aspects.

Senator ASKEW: I don't think he is on the line.

CHAIR: No. We'll make sure we follow that up.

Senator ASKEW: What legislation changes do you see as necessary to relax the access to medicinal cannabis? Would that relaxing of legislation see an increase in the use of recreational cannabis and that sort of thing?

Dr Nicoletti : No. Our scheme doesn't allow recreational cannabis at the moment, and the legislation prohibits it. I think the relaxation to the scheme would be the actual patient access schemes—looking at those and how to operate those. On the industrial side, one of the major barriers is the gross under-resourcing of the Office of Drug Control. They're just overburdened with applications and are incapable of managing those applications in a timely manner. We're looking at licences taking two years to grant. In one case that I'm aware of it was more than two years. That really needs to be addressed so that the domestic industry can get up and running. Once the domestic industry gets up and running, leaving aside reimbursement issues, there will be increased supply, and natural market competition will set in and start to at least push the price down.

Senator ASKEW: That makes sense. My final question relates to the one from Senator Di Natale. You were talking about the growth, and there was your example of the industrial-hemp side of things—the ability to grow in broadacre. How does that relate comparatively to opiate plantings?

Dr Nicoletti : These are non-psychotropic drugs. As I understand it, the opioid drugs that are being grown need to be transformed first, before they have the illicit effect. I think that if you actually chewed the opiate plant it would probably kill you from toxicity. The therapeutic value comes once it's actually produced. There are different issues at play here. The hemp plant itself is non-psychotropic. If you take that and chew it, you're not going to get high.

CHAIR: Senator Bilyk has a short clarification, and Senator Di Natale has a question to put on notice.

Senator BILYK: I just want to clarify this. Is an authorised prescriber someone who has gone through an ethics committee at the college or whatever?

Dr Nicoletti : Yes.

Senator BILYK: Can a general practitioner be a prescriber if the state legislation allows it?

Dr Nicoletti : A general practitioner can apply to be an authorised prescriber if they get endorsement from a specialist college—the Royal Australian College of GPs, for example.

Senator BILYK: So, if you want to prescribe a category B drug, you would need to be an authorised prescriber?

Dr Nicoletti : No. You can apply through the Special Access Scheme.

Senator BILYK: Okay. Through—

Dr Nicoletti : Category B.

Senator BILYK: Who makes that determination?

Dr Nicoletti : The TGA.

Senator BILYK: Thank you. So there are basically two different ways you can become a prescriber?

Dr Nicoletti : Correct.

Senator BILYK: Thanks.

CHAIR: Senator Di Natale, do you want to put your question on notice, unless there will be a short answer?

Senator DI NATALE: It might be short. You raised issues around driving and medicinal cannabis. Could you summarise those?

Dr Nicoletti : Yes. The issue that we have at the moment—I will talk to New South Wales because I reside in New South Wales and that's the area I've looked at—is that, interestingly, in our Road Transport Act are provisions that make it a strict-liability offence to have a substance detected in your blood, and one of the substances in the Road Transport Act is tetrahydrocannabinol—that is, THC. Even if you have a medical prescription for medicinal cannabis, if you're at a roadside and you have a drug test and THC is detected, it's an immediate offence. The first offence costs $2,200, I think, and every repeated offence costs $3,300, or even more if you have repeat offences. So the legislation has not actually kept in step with the changes that have happened. There is, for example, a carve-out in the same legislation for morphine. It is an offence to have morphine detected in your system, but, if you can demonstrate to a court's satisfaction that you have a medical prescription for morphine, that is a defence to prosecution. The driving laws in every state need to be amended as well. Patients who have a prescription may not want to fill it, because they have a job in which they have to drive every day and they would be at risk of prosecution for doing something which they took steps to do lawfully.

Senator DI NATALE: Thank you.

CHAIR: Thank you very much for your time today. It was very productive and very useful.

Dr Nicoletti : Thank you.