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Legal and Constitutional Affairs Legislation Committee - 31/03/2015 - Regulator of Medicinal Cannabis Bill 2014

MOSTYN, Mr Benjamin Thomas, Member, Australian Drug Law Reform Initiative

WODAK, Dr Alexander David, AM, Member, Executive Committee, Australian Drug Law Reform Initiative


CHAIR: Welcome, gentlemen. Thanks very much for your submission, which we have numbered 36, and for taking the time to help us today with our inquiry. If you want to make any amendments or alterations to your submission, you can do that. I think you understand that this is a proceeding of parliament and parliamentary privilege applies. If there is any reason you want to say anything in camera, let us know. I invite either or both of you to make a short opening statement and then we will ask you a couple of questions.

Dr Wodak : I am a physician who has worked in the alcohol and drug area since 1980. From 1982 until I retired in 2012 I was the director of the alcohol and drug service at St Vincent's Hospital Sydney. I now work full time on drug law reform on a voluntary basis. For over 20 years I chaired the medical committee into the 1966 New South Wales poisons act, which considers applications from New South Wales medical practitioners wishing to prescribe drugs of addiction for persons considered to be addicts—they are words from the act. My experience on this committee I believe is very relevant to consideration of the lawful use of medicinal cannabis as the committee regulated the clinical use of powerful drugs of dependence for the population of New South Wales in often very challenging circumstances.

The objectives I believe that are relevant for medicinal cannabis use in Australia are: firstly, effectiveness; secondly, safety; thirdly, cost effectiveness; and, fourthly, maintaining the integrity of Australia's pharmaceutical regulatory system—that is, the TGA. In the current state of knowledge, medicinal cannabis does not appear to be curative for any condition; however, in my view there is sufficient evidence of sufficient quality to conclude that medicinal cannabis usefully reduces distressing symptoms in a number of conditions when conventional medicines have proved ineffective and/or were accompanied by unacceptable side effects. Though conventional medicines are often more effective, they are ineffective often enough for medicinal cannabis to be a useful backup. This is the view of many experts and highly regarded scientific organisations; however, some experts have different views. Hippocrates said that doctors should 'cure sometimes, treat often and comfort always'. My presentation is about the need to 'comfort always'.

The principles that I believe should be taken into account when formulating how and when lawful provision should be implemented are as follows. First, a national approach I believe is preferable to individual approaches from six states and two territories. Second, regulated cannabis is preferable to unregulated cannabis; however, currently an unknown but presumably large number of persons, some for probably legitimate reasons, are using unregulated cannabis they have cultivated themselves or procured from the black market. Third, in general when introducing an intervention not previously part of the official healthcare system it is better to start incrementally and slowly expand as evaluation warrants. By extension, it is easier to liberalise a too restrictive approach than restrict a too liberal approach. The appropriate balance requires careful consideration as the more restrictive the approach adopted the larger the proportion of patients who will utilise unregulated supplies.

Fourth, any system for administering medicinal cannabis should be sufficiently flexible as to allow for changes over time as knowledge increases. Fifth, ill people whose use medicinal cannabis and/or their carers and their doctors should not have to worry about possible legal repercussions provided they stay within unambiguous legal boundaries covering cultivation, purchase, possession and use. Sixth, the system established for medicinal cannabis should identify approved medical conditions and may also identify required diagnostic criteria and criteria indicating sufficient severity. Seventh, in some exceptional cases there should also be a scope for approving medicinal cannabis on the grounds of compassion. Eighth, decisions about medicinal cannabis for individual patients should be made by independent experts and not by ministers, Department of Health officials or members of parliament. Ninth, lawful cultivation by patients and/or the carers should be an option, but not the only option, as some will be unable to cultivate cannabis. Tenth, most patients requiring medicinal cannabis are likely to have limited funds after some years of poor health, so affordability is an important consideration. Eleventh, the least-worst way of ingestion at present is inhalation of cannabis vapour. Nabiximols—otherwise known as Sativex—the next best option, is currently approved in Australia for only one condition. In reality, it is unavailable and expensive. The older pharmaceutical preparations Nabilone and Marinol, now obsolete, were too poorly and erratically absorbed to succeed commercially. Administration by inhalation of smoke may sometimes have to be tolerated. Thank you.

Mr Mostyn : I am a founding member of the Australian Drug Law Reform Initiative at the University of New South Wales. We have been set up by academics in the law department there to try to provide input into drug law reform debate from a legal-academic perspective and also from a criminology perspective, with a focus on the criminal justice system.

CHAIR: So you are a lawyer?

Mr Mostyn : Yes. I am an alumni of the UNSW law school.

Senator DI NATALE: Thank you for providing evidence today. As you are aware, I think Professor Ritter summarised the three possible options; this is perhaps a middle road. Why do we need to change anything? We have got a regulator that can assess the quality of current pharmaceutical grade medicinal cannabis products—why do we need to change that?

Dr Wodak : In my view, the evidence is clear that it is a useful medication. At this stage of our knowledge it is probably only a second line medication; in other words, the standard medicines should be used first, but they fail often enough, leaving patients in considerable distress. That happens often enough to, I think, justify the use of medicinal cannabis for those patients. We are often talking about very distressing symptoms in terminal conditions or serious medical conditions that are limiting the quality and quantity of life.

Senator DI NATALE: Why can't the TGA do this job?

Dr Wodak : Sorry?

Senator DI NATALE: Why can't the TGA fulfil the role of assessing new products as they are put forward by a pharmaceutical company and make them available to patients?

Dr Wodak : In many respects it is so different from the usual agents the TGA handles that I think they would struggle to manage that. I say that respectfully, not disrespectfully. My hope is that, in setting up an office of medicinal cannabis, we may only need it for 10 or 15 years. The second reason is that not only is it so different from conventional medicines but also the evidence is rapidly changing. And one of the reasons for that is that there have been major obstacles to doing research on medicinal cannabis in most parts of the world. These were not trivial obstacles, they were very serious obstacles, and those obstacles are starting to come down now. In the United States cannabis is still on schedule 1, which means it is as dangerous as heroin and more dangerous than cocaine, which is on schedule 2. That gives you an idea of how serious the obstacles are. But getting funding, getting approval from an ethics committee and, most importantly of all, getting supplies of lawful medicinal cannabis in Australia, the United States and many other countries at the moment is virtually impossible.

Senator DI NATALE: For research purposes?

Dr Wodak : For research purposes, yes—it is virtually impossible. That is now starting to change—a good thing—and that means that there is going to be a flood of information coming out over the next couple of decades.

Senator URQUHART: Dr Wodak, I just want to take up one point: you said that you thought that we only needed it for 10 or 15 years. Can you just elaborate on that, and say why?

Dr Wodak : I think that setting up an office of medicinal cannabis, which a number of other countries have done with great benefit—and I think the Netherlands and Israel and Canada are examples of that—would help us introduce the drug. There are a lot of people in the community and in the professions who would welcome that, but there are some people who are very nervous about that, and I think we should try to allay their fears, and say that this is going to be done seriously and properly. I think an office of medicinal cannabis would do that. It is a very difficult area, as your committee no doubt agrees, and I think that having a dedicated office that does this and does not do other things would allow them to focus and concentrate and sort out some of the thorny issues. With due respect to the committee, I think that whatever law you come up with in 2016 or 2017 is going to be changed many times within 10 years time, and so an office of medicinal cannabis would help us through a period where things are fairly uncertain.

CHAIR: Are you suggesting that, once you get the system in place, the TGA might then be able to do it, after the process had been established by this new authority? I do not want to put words in your mouth, but is that what you are getting at?

Dr Wodak : That is correct. I think that, in 10 or 15 years—that is my hope—things would not be in the turmoil in which they are now and a lot of things would have become a lot more certain. For example, there is a lot of speculation, with good reason, about the relative roles of the different components of cannabis: the THC type chemicals and the cannabidiols—the more sedating chemicals—and what ratios might be good or not good for different conditions. In 10 or 15 years, that will be a lot clearer than it is today, and we will know whether that is real or whether it was just idle speculation.

CHAIR: In my limited understanding, the TGA would not be able to authorise or regulate where you grew it, how you grew it or what sort of strain of plants you used, whereas a specialised agency might. But you are suggesting that, after 10 or 15 years, that would all be put in place and that process would be pretty standard and the TGA could just do their thing.

Dr Wodak : I believe so, and I think the nervousness that some people in the community have about this—and there are some people who are nervous about it—would dissipate over time, and people would see that this is not some horrible new monster that we are allowing in but that it is a useful drug for some people but it is not a panacea either—it is not going to end unemployment or anything else! It is a useful drug for some conditions. That is my view and it is ADLRI's view. It is not a magical drug that cures everything.

CHAIR: From a government point of view, the thought of having a new agency that had a restricted life has some benefit as well!

Senator DI NATALE: I thought you were going to say that a new drug that cured unemployment would be useful!

CHAIR: Well, that one too!

Senator DI NATALE: Perhaps we could go to a few pointier issues. As you are aware, the intent of this bill is to walk a middle path between allowing people to grow their own product, where we are not sure what they are using and of course the relationship with the recreational market becomes more difficult to manage, and, on the other hand, the current status quo where people just are not getting access to the drug in the way that they need to and research is not able to proceed because of all the issues you mentioned. So we are trying to walk this middle path. As to the very specific questions around who should be allowed to prescribe—some doctors; all doctors; other health professionals—do you have a view on that?

Dr Wodak : All doctors—and I do not think they need special authorisation. Really, this is not all that complicated. A lot of fuss is made about the life-threatening side effects of cannabis. Undoubtedly, it has some side effects, but the side effects are relatively modest. They are not life threatening, but some of them are important. When you look at the side effects of medicinal cannabis and compare these to the unrelieved symptoms of the person's condition or the side effects from the standard medicines, the side effects of medicinal cannabis are much less. We are not dealing with a terribly dangerous drug.

Senator DI NATALE: What about beyond doctors? Do you think there is a role for other health professionals?

Dr Wodak : All doctors, because a lot of these conditions are very common.

Senator DI NATALE: Yes. But, if we are talking about allied health professionals, do you think there might be a role for physiotherapists, occupational therapists, nutritionists to also be able to prescribe?

Dr Wodak : I would not start with that initially, because of the nervousness in the community. This is where I would prefer to start, incrementally, and in 10 or 15 years I would certainly be open to extending it further, if that was warranted.

Senator DI NATALE: People have made various suggestions about forms. You have mentioned: vaporiser and inhalation. Do you think the raw plant should be made available as well as oral preparations, tinctures, oils et cetera?

Dr Wodak : Today, the raw product inhaled as vapour is the least worst way of somebody taking this as a medicine for several reasons—and these reasons are quite important. One reason is that, because of the speed of absorption, it allows the patient to titrate the right dose. If that process is very delayed between taking the drug and feeling the effects, it is much more likely to undershoot and therefore not relieve the symptoms, or overshoot and get unwanted intoxication. Many patients, and I am sure most elderly patients—and most patients will be elderly—do not want to be intoxicated. Younger patients may be different. Inhalation of vapour is number one, and that requires botanical leaf cannabis. This is supplied in the Netherlands and grown under stringent conditions. It goes through a process to make sure that the botanical and fungal contamination is kept below certain limits, so we are dealing with a quality product.

Senator DI NATALE: And you know the ratios of CBD and THC?

Dr Wodak : All of that. The plant is controlled. That, for me, is the optimal. That is not going to meet all needs—for example, if we are talking about paediatric populations, children, that is not suitable, and we would have to have some form of liquid preparation. Liquid preparations are more difficult. There is much less research on them, much less known about them and we have a real question mark about predictability and speed of absorption. We would need to have a liquid which is rapidly absorbed so that parents can titrate the dose.

CHAIR: Sorry, Dr Wodak, I might have misunderstood you or did not understand, but I thought you said smoking was the least worst way of doing it.

Dr Wodak : The least worst form of someone administering this to themselves, in my view, is inhaling the vapour.

Senator DI NATALE: Could you explain how that works.

Dr Wodak : That is different from smoking. Smoking involves combustion. It involves burning the leaves and inhaling the smoke. All doctors, myself included, find that unacceptable in a medical context. We may have to tolerate that at times when a patient has six weeks to live et cetera. Inhalation of vapour is like inhaling steam, which is the vapour that comes from water.

CHAIR: I must have misheard you, because I thought you had said 'smoking'.

Senator DI NATALE: I think perhaps in your introductory statement you might have mentioned smoke at some point.

Dr Wodak : I did.

Senator DI NATALE: I was not sure of the reference there either.

Dr Wodak : What I said about that is:

Administration by inhalation of smoke may sometimes have to be tolerated.

So it is grudging tolerance, not enthusiastic tolerance.

CHAIR: Anyhow, you have cleared that up: vapour is the best.

Dr Wodak : Vapour is the best, and there are now devices the size of a fountain pen that are relatively cheap—$25 or $50—that come from the e-cigarette technology that people can carry around in a handbag or a pocket and, when they have got distressing symptoms, they can rapidly inhale the vapour.

Senator DI NATALE: I think that is consistent with the evidence we heard earlier about some of those regulatory options. You mentioned a patient register, and there are obviously privacy concerns there. What is the rationale for a register?

Dr Wodak : I see advantages and disadvantages. The advantage is that I think it would allay the fears of many patients and carers that they may inadvertently get drawn into the legal vortex and suffer adverse legal repercussions. A register would alleviate those concerns. It would be great for research. That is a plus. But there are cost concerns and privacy concerns, and I do not know that it is really all that necessary. On balance, although I can see the attractions, I would not favour a register, provided that we could have a higher degree of certainty that the patients and their carers and their doctors do not face any legal risks. Ben might want to comment on that.

Mr Mostyn : We were talking before that one possible system that has been considered by New South Wales parliament is just the issuance of a card, and I have some examples that have been used for syringes in New South Wales, if the committee is interested. The card makes it clear that the people have a lawful prescription and, therefore, they should not be subject to the criminal sanctions of Drug Misuse and Trafficking Act in New South Wales.

Senator SINGH: I am interested in this law enforcement side because you raise it in your submission as a concern about the bill, notably because the bill is silent to some degree on that issue. It does go to the heart of people's privacy and personal freedoms versus law enforcement doing their job and so forth. The concern that I have with your concern is this issue with a register or even a card if the card is not on the person at the time of a law enforcement officer intervening in someone's privacy or freedoms or if the registry is not kept up to date, which is often the case with governments' registries and the like. So, other than the card and the register, is there any other kind of solution to this issue of people's personal freedoms and privacy? Obviously, they would, at some point, have a script and, like with any medication, you have it labelled with the name of the person that it is prescribed to. Would that be sufficient to deal with law enforcement? I am interested in what other ways you have explored to address this issue because we do want to have, through this inquiry process, a bill that takes on the concerns and the issues that have been raised. If this is one of those issues, then we are interested in your solutions, other than, obviously, those that you have already outlined in your submission.

Mr Mostyn : We agree that it is a significant issue. I suppose the other side of the coin is that it could place police in a difficult position because they are the ones who need to enforce the regular cannabis laws whilst not overstepping the boundaries in any Commonwealth system. Unfortunately—and we discussed this in our group—we can point to the problem, but we do not necessarily have the solution.

I think you are very right in noting that government databases are not perfect. In New South Wales they have certainly had problems with bail databases which are not being kept up to date, so police have been arresting people for breach of bail because their computer system in their car was telling them that these people still had bail conditions when in fact they did not have bail conditions. The problem can be that, if there is a database, police will understandably rely on the database, and if it is not absolutely correct it can lead to problems.

That is where the idea of the card came up. It is old technology, but as far as we can see it is probably the simplest and easiest way. It is far from foolproof, because elderly, sick people may not have a card on them for various reasons, but hopefully the vast majority of people would just get in the habit so that, if you are going to get your medicinal cannabis or you are going to be carrying it with you in public, you should have the card on you.

Senator SINGH: Couldn't it be just like a letter from your doctor? When you go overseas, you often get a letter from your doctor to say, 'X is travelling with this medication,' so that it is not seen as strange that this person has so much of a particular kind of medication. Could it be something like that—like a letter from a doctor?

Mr Mostyn : I think that, the more paperwork you have to justify your possession, it would be great, but I am not sure how a letter from a doctor is any better than a card, in the sense that once again it requires people to carry it. A card that fits in your wallet or purse is probably the most convenient.

In our written submissions, I think we suggested possibly a voluntary database. That can alleviate some privacy concerns. If people want to put their name on the database, if they are happy to share that information with the local police, that could be a secondary protection that people may want to choose to opt in with.

CHAIR: Mr Mostyn, you have had a look at the draft bill, the suggested bill. Do you have any lawyer's comments on it at all? I am getting a bit of free legal advice here! We probably could not afford your fee in other circumstances!

Mr Mostyn : I am sure you get much better legal advice down in Canberra! Overall, we are very supportive of the bill. To go back to the original question, 'Why is this bill necessary?' there are two reasons from our perspective why this bill is necessary. First is the Therapeutic Goods Act, as the bill makes very clear. We have the perverse situation in New South Wales at the moment where every party has expressed support for medical marijuana; there seems to be very strong support in the community, where 75 or 80 per cent of people do not want to see people who use medical marijuana facing prosecution; and unfortunately the New South Wales parliament just seems to not have the authority or the jurisdiction to do anything about it. Any attempt that they make to try medical marijuana will have to be a very laissez-faire trial—

CHAIR: A very what?

Mr Mostyn : laissez-faire—because it will have to try and completely avoid the Therapeutic Goods Act. They will have to be doing something completely outside that therapeutic framework. The second reason this proposed act is necessary is that, as the law stands in New South Wales, people can face up to two years in prison for marijuana possession, and the community seems to very strongly now feel that people who want to use medical marijuana should not be facing two years in prison. The only way that that seems to be able to happen in the current system is for the Commonwealth parliament to pass a bill like this. So the preliminary view is that the bill seems to be a very good attempt at addressing this problem of strong support in the community for medical marijuana but the state governments not being allowed to do anything about it.

We have expressed concerns a little bit about part 4, 'Monitoring and investigation powers'. The explanatory memorandum does acknowledge that there are concerns about these powers. Once again, while we are good at pointing out the problem, we may not be so good at coming up with a solution. It is our preliminary viewpoint that it is concerning to create another federal agency with powers of entry and seizure that will explicitly be set up to target patients. It would seem that that part and those monitoring and investigative powers may not be necessary in the sense that either people who are licensed suppliers will be supplying it in accordance with their licence or they will not be, or they may overstep the powers of the licence. It would appear that, once they overstep the powers of the licence, they would quite clearly then come within the jurisdiction of the local police because they would be supplying cannabis without lawful authority. So it may be simpler and preferable to just leave any of that unlawful supply to the current systems in place.

Senator DI NATALE: I think that is valid. I do not think the intent of the bill is to effectively create new powers within the new authority, to invest those sorts of powers within the new authority, but I think that feedback is absolutely valid, and we will need to go back and have a look at how that is worded.

CHAIR: Mr Mostyn, I must confess that I will be reading tonight the Queensland Bar Association submission. I am just wondering if you have read it and whether their submission addresses a couple of those issues that you did. Perhaps you have not read it, so do not let me embarrass you.

Mr Mostyn : We have had a quick look at it. My understanding is that the Queensland bar has suggested that medicinal use by a registered user should be a complete defence to prosecution. We would wholeheartedly support that. Getting back to earlier questions, there is a significant issue about how you create a complete defence. Primarily, the problem can be that people who have marijuana in their possession obviously are at risk of arrest by police, so to create a complete defence is very difficult because, even though the people may get arrested, may get taken to the station and may call a friend and get the proof of prescription to come down to the station, that has already been a significant impost on their life. A couple of hours in police detention is not a good experience for anyone if it can be avoided. So how to make a complete defence? Once again, I would suggest that carrying a card or some sort of clear prescription that makes it clear that the marijuana is medicinal is going to be the best way to do that.

The Queensland bar, I understand, argue that the bill would be compliant with international conventions, and we agree. As far as we can see, the international conventions do not seem to prohibit medical use of these drugs. Indeed, the international convention the Single Convention on Narcotic Drugs of 1961 makes it very clear that drugs do have strong medical benefits and that those conventions are not intending to prevent that.

CHAIR: Do they mention that same point that you did about giving the regulator powers of the police—

Mr Mostyn : I am not sure, sorry.

Dr Wodak : Can I just cut in there and say that I am certainly no lawyer, let alone an international lawyer, but I am certain that the 1961 and the 1971 international drug treaties explicitly make it clear that the prohibition of recreational drugs is not intended to restrict the medicinal or the medical and scientific use of those drugs. That is something that is emphasised again and again.

CHAIR: I think we had some evidence to that effect yesterday, if I remember correctly, but, as I understood that evidence, it needed an overarching Commonwealth framework to allow the states then to introduce laws which are within the states' jurisdiction rather than the Commonwealth's jurisdiction in relation to this aspect.

Dr Wodak : If I could just add to that, I think that, as much as we can when we are thinking about the medicinal use of cannabis—as we do with morphine, ketamine, cocaine, amphetamines and other drugs that are also used recreationally and used medically—we should separate the medicinal use and the recreational use when we are thinking about whether to use it. When we are thinking about how to use medicinal cannabis, we will have to think about the fact that a lot of people are using recreational cannabis, because, as I said in my introduction, the more restrictive we are in approaching medicinal cannabis, the more the people who want to use it and will use it anyway will be using an unregulated product, which I certainly do not favour and I imagine the committee does not favour. On the other hand, the less restrictive we are in approaching this area, the more people will be using a regulated product, which I think we would all favour. The 'whether' question and the 'how' question are different in terms of whether we should be ignoring the recreational use of the drug. In the 'whether' question, we should ignore that; in the 'how' question, we cannot ignore it, in my view.

CHAIR: As there are no further questions, thank you very much for your time today and for the help you have given to the committee in what you have presented. We very much appreciate that.

Dr Wodak : I am happy to send in my notes if that would help the committee.

CHAIR: Yes, please, if you would. The secretariat will take them from you, and we will table those as part of the proceedings, if the committee is happy with that.

Proceedings suspended from 15:02 to 15:38