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Legal and Constitutional Affairs Legislation Committee

RITTER, Professor Alison, Director, Drug Policy Modelling Program, National Drug and Alcohol Research Centre, University of New South Wales

CHAIR: I reopen the Senate Legal and Constitutional Affairs Legislation Committee's inquiry into the Regulator of Medicinal Cannabis Bill. I welcome Professor Ritter of the National Drug and Alcohol Research Centre from New South Wales. Thank you very much, Professor, for being with us and for your submission, which we have numbered as No. 19. As you would be aware, this is a committee of parliament, so parliamentary privilege applies. If there is any reason that you would like to give any of your evidence in camera, please let us know. If you want to amend, add to or in any way alter your submission, you can do that now. I now invite you to make an opening statement and then we will ask you some questions.

Prof. Ritter : Thank you very much for the opportunity. It is fantastic to see the federal government considering this fairly thorny issue.

CHAIR: Can I just correct you there? The federal parliament is considering the issue, which is different to the federal government. But we certainly hope that the federal government will consider the issue once this parliamentary committee reports.

Prof. Ritter : My sincere apologies for jumping the gun, in a sense.

CHAIR: We hope it is a prescient statement.

Prof. Ritter : Indeed. It is worth stating that the perspective that I come from is one of research. I do not have a particular view one way or the other and I am not advocating for a particular position in relation to medicinal cannabis. In our submission we have tried to encompass a whole variety of what we regard as critical issues. The first critical issue is the type of cannabis that is under consideration—whether it is pharmaceutical cannabis, medical grade herbal cannabis or the regular illicit cannabis. You have three options there that are clearly different. The second issue is the regulatory options and the features of the regulatory options, which I will talk about in a moment.

The third critical issue is, I think, the definition of medicinal cannabis. I note in the draft bill that there is not actually a definition of medicinal cannabis. There are definitions of all sorts of other things but not that. In our considerations we thought that one possibility would be to define medicinal cannabis very narrowly as a medical treatment prescribed by a doctor for known or diagnosed medical conditions for which efficacy research already exists. That is a very narrow definition which would then force you down a particular regulatory line. If you took a broader definition of medicinal cannabis it could be defined as a helpful intervention for people who were interested in it, and it would not necessarily require a defined diagnosis or a medical doctor's recommendation. That would take you down a different regulatory path, I think.

In terms of the regulatory options that we outlined in our table, there are two dimensions to the regulation of medicinal cannabis in Australia. The first dimension is how patients are authorised and the second dimension is how cannabis is supplied. We suggest that, under the way in which patients are authorised, you have three broad classes of options. You can introduce legal exemptions exempting from criminal prosecution for the possession and use of cannabis. You can have recommendations that are distinct from prescriptions. So prescriptions would be the highest level recommendations and this would be the middle level. So there would not need to be a doctor necessarily and a diagnosis. It could just be recommended as a treatment or an intervention. They are the three classes of patient authorisation.

CHAIR: Sorry to interrupt you, Professor. Cleverer people will follow clearly what you are saying, but could you just repeat that?

Prof. Ritter : Sure. There are, I think, three broad options for the way in which a patient becomes authorised to use cannabis. The first is to simply exempt people under the law from prosecution.

CHAIR: Everybody who might—

Prof. Ritter : Yes. These are not mutually exclusive. You could exempt people based on a doctor's recommendation or a recommendation from two fit people. You do not necessarily need to make this medical if you do not want to or you do not necessarily need to. Or you could have some kind of authorised health professional make a recommendation. That is quite different from a prescription which a medically trained doctor would make. So we draw a distinction between a recommendation and a prescription. If we look to the US, the medical marijuana laws in the US vary along this dimension of some states having recommendations and some states having prescriptions.

CHAIR: What sort of health professional who is not a doctor or a dentist or a—

Prof. Ritter : Generally they are medically trained in the US, but there is a whole range of medical disciplines in the US that are quite different from our general medical practitioners.

CHAIR: Are you suggesting a naturopath?

Prof. Ritter : A naturopath or someone with some kind of health training. Those kinds of approaches would conform to a very broad definition and to its attendant benefits—increased access—and its attendant risks, which is widespread use of cannabis. That is where you need to balance your definition and the policy goals that you are seeking.

CHAIR: What was the third one?

Prof. Ritter : The third one is prescription. That is aligning it with any other medical intervention available in Australia, which would follow the usual path.

CHAIR: By 'prescription' do you mean a script, a prescription?

Prof. Ritter : By 'prescription', that is what is implied. But it is really a doctor making a diagnosis and matching that diagnosis to the intervention, which in this case is cannabis.

CHAIR: I am sorry to labour this, but the first one, the option to exempt—

Prof. Ritter : Could go with either the recommendations or the prescription.

CHAIR: Okay. Keep going. I hope I did not interrupt you.

Prof. Ritter : No. It is all right because it is incredibly confusing, and all these things are not mutually exclusive, and we have tried to characterise them summarily, which may be a mistake. Then there are five supply options. The first is the illegal market. So there is no legitimate of supply of cannabis. The second is self-cultivation or own-cultivation, where the people who are in some way authorised from the above system are allowed to grow a certain amount themselves. The third is importation of the herbal product and medicinal grade herbal product as well. The fourth is domestic production through a licensed producer. The fifth option is a pharmaceutical. Again, each of these five options, broadly characterised, has attendant benefits and risks, and ultimately all of this, I think, depends on the health policy goals that are being sought.

CHAIR: Thank you very much for that. I was going to ask you to tell us a little bit about the National Drug and Alcohol Research Centre, but as I recall I did read that in your submission.

Prof. Ritter : There is probably a small blurb about that. We are the premier centre of research excellence in Australia and internationally, with 120 research staff located at the University of New South Wales.

CHAIR: Is that your own assessment or someone else's?

Prof. Ritter : No, that is an objective, independent assessment of our research rankings internationally. We are ranked third internationally for alcohol and drug research centres. Yale University is at the top. As you can see, we have just been through a review, so we have got the data. I head up the Drug Policy Modelling Program. What we aim to do is generate evidence for policy, at both federal and state levels in Australia and internationally, and translate and disseminate that research evidence in effective ways, and we also study how policy gets made.

CHAIR: Thank you for highlighting in your submission's introduction what the Prime Minister said about this, which is always useful.

Senator URQUHART: I have just got a question in relation to what you said about exempting people by law. How do you see that process working? Who has the authority to do that? Who is involved? How do you see a process like that occurring?

Prof. Ritter : You know there is already that program in New South Wales.

Senator URQUHART: Yes.

Prof. Ritter : There is a bill that was introduced. So this is a model, I suppose. I presume you are speaking with New South Wales Police. I understand there are about 20 people who are currently exempted under that bill. There have been people refused. There is a set of criteria that operate in that particular example. They must carry the card at all times, and there is a limit to the amount of cannabis they can hold and supply. I would have thought that would be a fairly typical regulatory framework—

Senator URQUHART: In the New South Wales model. It is already there; it is not re-inventing the wheel.

Prof. Ritter : No, that is right. It is being piloted for 12 months. I assume someone will summarise some data about the experiences.

Senator URQUHART: When you talked about the supply, you talked about self-cultivation and domestic production. I sort of understand the difference: someone is growing a certain amount for themselves, and with domestic production someone is growing a larger amount. Could you expand on what you mean by that?

Prof. Ritter : Indeed. The important difference is that, if you are growing it in your own home, you are unlikely to achieve a certain standard of plant, proportion of CBD et cetera; whereas if you are producing it commercially you can set requirements regarding potency, levels of THC and CBD and so on.

Senator URQUHART: It is about having control over quality.

Prof. Ritter : Yes.

Senator DI NATALE: I should probably put on the record that at one stage, through my public health training, I worked under the tutelage of Professor Ritter for a brief period of time. Thank you, it was a very useful summary of the options. It was nice and neatly laid out. I will go back a step. Is there any data available on the scale of the use of medicinal cannabis in the community? I imagine that it is complicated by the distinction between recreational and—

Prof. Ritter : In Australia?

Senator DI NATALE: Yes, recreational versus medicinal.

Prof. Ritter : It is such an obvious question, but, no, I am not aware of any data and I am not aware of any independent researchers who are objectively collecting that data.

Senator DI NATALE: It would be a fairly straightforward question to ask, wouldn't it?

Prof. Ritter : Provided that you define 'medicinal cannabis use', because there would be many people who would argue that their consumption of cannabis makes them feel better. Wellbeing is an important health outcome.

Senator DI NATALE: Yes, provided that we put some boundaries around the definition.

Prof. Ritter : It would be a useful thing to do. Given the extent of support for medicinal cannabis, as demonstrated in the National Drug Strategy household survey—

Senator DI NATALE: Can you explain that?

Prof. Ritter : Sure. The National Drug Strategy household survey is a survey that is conducted every three years across Australia. About 20,000 people are surveyed. It is a deliberately selected, representative sample. They are asked two questions about medicinal cannabis. The first is whether they support a trial of medicinal cannabis, and 75 per cent of respondents support such a trial. They are also asked whether they believe a permanent change in the law should be made in Australia to support the availability of medicinal cannabis, and 69 per cent of people in 2013 indicated their support for a change in the law. So there is strong public support, and that has been consistent over the last 12 years of the survey. It hovers at around that level; it increases by one or two percentage points each time the survey is conducted.

Senator DI NATALE: Was that before the big debate took off?

Prof. Ritter : Completely before. These data were collected in October 2013.

Senator DI NATALE: It is probably too early to say, but would you expect the next survey to show an increase in support?

Prof. Ritter : Yes, I would without doubt.

Senator DI NATALE: We are talking about the great majority of the community that supports it. Let's look at the pharmaceutical model—which is really what we have at the moment.

Prof. Ritter : Yes. Well—

Senator DI NATALE: We have a regulatory body with the TGA that can assess any application from a sponsor, should it choose to.

Prof. Ritter : Yes.

Senator DI NATALE: And we do not have any products available in Australia at the moment.

Prof. Ritter : We have Sativex.

Senator DI NATALE: But we understand that that is not being made available. We are not sure why—for example, whether it is cost. It has been approved on the register. One of the issues that came up was whether the states have changed their individual schemes to fall in line with the national register. We certainly know it is not available for use in Australia at the moment. The company has not made it available.

CHAIR: From the evidence of one person.

Senator DI NATALE: The evidence that has been tendered. We intend to explore that further with the company.

Prof. Ritter : Sure.

Senator DI NATALE: Under that model, what we are left with at the moment is—and let us put the issue of Sativex aside—there are no cannabis products available yet in Australia.

Prof. Ritter : No, that is right. The advantage of the pharmaceutical model is that it clearly aligns medicinal cannabis with medicine and with the regulatory systems that we already have in place. You do not need to have creative laws or unusual circumstances where the same substance is being used for one purpose medicinally and for another purpose recreationally, for want of a better word. There is something to be said for the formal nature of our system. Our health system is not too bad—the TGA and PBAC and so on. There are many health conditions for which there are no registered medicines, and there are many patient groups who are angry that some medications are not available in Australia. I think last week Norman Swan's Health Report did a story about medicines that were available internationally and not in Australia.

The downside of that model is it limits access. It relies on a pharmaceutical company believing that there is profit to be made in this industry. A lot of people argue against the pharmaceutical model because of the so-called entourage effect, which in herbal cannabis is the combination of the various cannabinoids in the plant that are argued to produce the health benefits, the health outcomes, that are not seen with a pharmaceutical product like Sativex. I do not believe there is strong evidence to support that statement around the entourage effect or combined synergistic effects yet, but that is because it has not actually been tested.

Senator DI NATALE: That brings us to the next issue. Under the status quo, we are not seeing products coming to market for all sorts of reasons. Secondly, in relation to trying to get the research base more thoroughly developed, we heard earlier from researchers in this field who said it is a regulatory nightmare getting access to the product and so on. Have you got anything to add?

Prof. Ritter : I agree entirely. The problem is that it is cannabis, which has this long, social and political history about being an illegal drug that is dangerous, that is associated with pleasure. For goodness sake! That is awful! We cannot have any of that! It carries this enormous baggage. Here we are trying to design a scheme for people with medical conditions, when we are up against an object 'cannabis' that has all of this very difficult history associated with it.

Senator DI NATALE: It is unique in that sense.

Prof. Ritter : It is.

Senator DI NATALE: The drugs you were talking about earlier, which we do not have access to in Australia, cannot be grown in your own backyard. We have this unique circumstance where people are able to produce this stuff—an unknown quantity. Going to the other extreme that you have mentioned is the third option, which is that effectively people can grow their own. There is exemption from prosecution. Of course, the downside there is the quality issues. Building the research base becomes difficult in those circumstances as well, because we do not know what we are actually testing.

Prof. Ritter : That is right.

Senator DI NATALE: This bill has the intent of walking that middle path, which looks at cannabis as a herbal product but recognises that we need to get some quality control, we have to facilitate international research, we have to make it very clear that recreational use is a very separate issue and that we are trying to keep those things separate. Do you think this bill does those things? If it does not, what could we do to improve it? Could you also make any general comments.

Prof. Ritter : In general, yes, absolutely, I think this bill does that. It will entirely come down to the decision-making of the regulator, how that body is constituted and the people on it and I think clarity about intent. If there is clarity that the goal is to walk that middle ground, a bill such as this is actually the ideal instrument to achieve that. The other advantage, from my reading of this draft bill, is that it has the capacity to be flexible and the regulator can then change over time. One of the problems with public policy is that decisions get made and then there is no ability to then change those decisions once one starts to see either very positive consequences or unintended negative consequences. It seems to me that there is the opportunity for enormous flexibility. If you look at the United States experience, many of the states have changed and resharpened some of their regulatory approaches over time. You really want to have that ability, and I think the bill gives that.

Senator DI NATALE: The criticism we have had from some quarters—but not overwhelmingly—is that there is too much discretion. The intent was to allow discretion. As you say, we need flexibility. I am not sure how good we are as legislators at working through that very fine detail, and the intent was to leave it to the regulator, composed of expertise in a whole range of areas that are relevant. Do you think there is a danger in allowing too much discretion or do you think, on balance, it is the only approach that will work for something like this?

Prof. Ritter : That is a very difficult question. Again, it comes down to the goals. If there is an agreement that the goals are to have a broad definition of medicinal cannabis then this bill is very good. If, however, there is an intent to have a very small group of people able to access medical grade herbal cannabis, for example, then probably the bill is too broad if that is the goal. So it comes back to what the intent is.

This morning I checked the most recent literature from the United States, comparing states with and without medical marijuana laws, as they call them there. Really, there is not good evidence that freely available medical marijuana increases use. There is research evident that it decreases traffic fatalities.

Senator DI NATALE: How would that work?

Prof. Ritter : Through decreased alcohol consumption.

Senator DI NATALE: Interesting.

Prof. Ritter : So people consume less alcohol when they consume more cannabis. That is the mechanism that is argued in the paper. In fact, they do an analysis of alcohol consumption in medical marijuana states and non-medical marijuana states and they found a significant difference of lowered alcohol consumption in those states with medical marijuana laws. They also found a significant reduction in rates of fatal opioid overdose in states with medical marijuana laws compared to states that do not have medical marijuana laws. The opioid overdose fatality finding is to do with using cannabis as a pain relief medication rather than using pharmaceutical opioids and analgesics. I have become fairly convinced that this evidence is solid. It is accumulating almost on a monthly basis with papers published in peer-reviewed academic journals. These are not technical reports published by advocates but by very good scientists. In sum, I think the risks are quite small of some of the unintended negative consequences that some people think are associated with the wider availability of medicinal cannabis.

Senator DI NATALE: It is probably fair to point out that there is a big variation within the US around the application of those laws. In some states, it appears to me, that it is really de facto legalisation; whereas in other states it is much more like what we are proposing, which is a more medical model. Would you agree with that?

Prof. Ritter : Indeed. In fact, there have been two papers just published that distinguish the features within each state and try and tease out the impact of those. To summarise, the states that have lots of dispensaries—read California—have increased rates of treatment admission for cannabis related disorders and an increase in use amongst some populations, whereas the states that have strict patient registration requirements and not freely available dispensaries have significantly lower use, lower treatment admissions. So, yes, the features of the regulatory model matter enormously.

Senator DI NATALE: Thank you. I have probably got a few more, but I have taken up enough time.

Senator SINGH: Professor, in your submission you talk about establishing boundaries around medicinal use of cannabis. You specifically talk about the definition issue. For this committee and the bill before us, how can we ensure that we have this definition? Obviously there is the narrow version of that. I know you touch on that, so how can we ensure we do get the definition right when we obviously are only talking about the medicinal use of cannabis?

Prof. Ritter : I think this is absolutely the critical issue, and I think it is really difficult. I think it depends on the extent to which you want to maximise access. If your goal is maximising access to medicinal cannabis, then you define it as a helpful intervention for those people that want and need it. If your goal is to make it available in a very small and confined way, then the definition is for diagnosable conditions with known efficacy. That is basically our current pharmaceutical system, so it needs to be moved back from that, but I would suggest, depending on what your goal is, that you might not want the broadest possible definition to do with people's wellbeing. I do not have a personal view; I am sorry.

Senator SINGH: I guess that is for us to consider.

Senator DI NATALE: Yes. It is something to consider.

Senator SINGH: But you are saying the current definition for other pharmaceutical drugs is the narrow—

Prof. Ritter : It is prescribed by a doctor for a known diagnosis, a known condition, for which efficacy research exists. There are clauses that enable doctors to prescribe off label, and special access schemes. There are various things that sit to the side, but basically it is a known diagnosis with efficacy research that shows that this treatment works for that condition.

CHAIR: Your research centre accepts that THC does have a long-term psychotic effect on users?

Prof. Ritter : There are harms associated with THC, yes, indeed—not for every user and it depends on a whole variety of other factors, but, yes, indeed, along with alcohol and tobacco and most medicines, to be frank.

CHAIR: It seems, from the evidence that we have been given, as I understand it, that the cannabidiol part of cannabis is the good part and ameliorates any bad parts of the THC. You would accept that there is caution about over-easy access to marijuana or cannabis?

Prof. Ritter : Sure. I think that is the real challenge with designing a regulatory scheme for medicinal cannabis. I think it is important that Australia has available medicinal cannabis, but it is also very important that that is done in such a way as to minimise the risks of diversion of the cannabis into the black market and what I call in our submission 'net widening', which means increasing the numbers of people. There are other issues as well, such as people who use cannabis recreationally pretending to be patients in order to gain access to medicinal cannabis. There are reports of this in the US. That is probably not a good policy outcome. Yes.

CHAIR: We have had some evidence about some of the American states, and I think California was mentioned as having some regulation, but it is so loose and open that they may as well not have bothered.

Prof. Ritter : That is right.

CHAIR: That is your understanding as well?

Prof. Ritter : The evidence about California is that there have been more unintended negative consequences associated with the way in which they have provided medicinal cannabis. You only need to visit Venice Beach and Santa Monica, which I have done. It does not feel like a supportive environment that enhances people's wellbeing; it feels like an open drug market.

Senator DI NATALE: I am more than happy to perhaps just tease out a few issues, if we have time.

CHAIR: We have five minutes.

Senator DI NATALE: Okay, terrific. In terms of the various options, do you have a view about authorised prescriber status? Do you think it should be limited? I am just going to pick your brains now. Do you think it should be limited to doctors, or should it be broader than that? And I think there is probably another step: should it be just some doctors? That is the other possibility. So you have three options really.

Prof. Ritter : Yes. I think—

CHAIR: What do you mean by 'some doctors'?

Senator DI NATALE: For some drugs we only allow particular specialists to prescribe—for example, dexamphetamine for ADHD or ADD.

Prof. Ritter : Methadone.

Senator DI NATALE: To prescribe methadone as a drug treatment, you have to be an approved methadone prescriber. There are different ways of achieving that status, but it might just be a weekend course for somebody to learn a bit more about medicinal cannabis, or it might be that you just say every doctor can prescribe it. So there are different ways. Or, as we suggested, we might allow some allied health staff—I do not know—such as physiotherapists, occupational therapists et cetera. Do you have a view about who should be authorised to prescribe medicinal cannabis?

Prof. Ritter : I think it would be fine not to confine it to medical practitioners but to keep it to broader health professionals, but I do think training or some form of accreditation actually is very important, particularly considering Senator Macdonald's comment about risk of psychosis and also understanding working with some people who may actually be drug seeking. That is quite a skilful exercise on the part of the practitioner. So I think some level of training and support, honestly, would be beneficial, but not necessarily just medical prescribers.

Senator DI NATALE: That is helpful. What about a patient register?

Prof. Ritter : The real concerns about patient registers are to do with issues to do with privacy, stigma and so on. I have not got a model in my head of a patient register that has worked well that has not suffered from those consequences. If there were a way of managing the privacy and the stigma issues, sure, but I have yet to see that operationalised.

Senator DI NATALE: In terms of what sorts of products are available, there is the raw plant product, which we know comes from largely the flower heads and so on, concentrated, but we can get proportions of cannabidiol and THC. We can get the proportions to match the particular conditions that we might be trying to treat. That can be smoked. It could be vaporised. Then there are oils and tinctures and so on. Do you have a view about what products should be made available?

Prof. Ritter : I think what products are made available depends on the interaction between the patient and the practitioner and what is most appropriately tailored for that particular individual's need.

Senator DI NATALE: But do you think all of those options I mentioned should be available if they are suitable for the patient, or should it be restricted just to—

Prof. Ritter : Within the context of medical grade herbal cannabis, so my own view is that own cultivation does not provide the level of quality or standards that one would hope for.

Senator DI NATALE: So we are talking medical grade cultivation. We are talking—

Prof. Ritter : And pharmaceuticals.

Senator DI NATALE: licensing of growers so that they meet particular standards—

Prof. Ritter : Yes.

Senator DI NATALE: so that we can get some quality control; we know exactly what is being prescribed and so on.

Prof. Ritter : Yes.

Senator DI NATALE: In your view, do you think it would be appropriate to have the raw plant product? I imagine smoking would be of concern to you, but there are vaporisers now that are available. Do you have a view about whether that is—

Prof. Ritter : I think the method or the route of administration is really dependent on the healthcare interaction that occurs, so I would not preclude any options.

Senator DI NATALE: I suppose if somebody has a terminal cancer, for example, and decides they want to smoke it—

Prof. Ritter : Indeed.

Senator DI NATALE: because they feel they get best relief then you would not talk them out of that. That is what you are suggesting.

Prof. Ritter : That is right, and it is all about the interaction between the practitioner and the patient, which is why I think authorisation and training are actually very important, rather than just a simple exemption, because it should be an ongoing relationship between the practitioner and the patient.

Senator DI NATALE: I will finish here because I think we are running out of time. The intent of the bill—and I accept your comments about being very clear about the boundaries—is to develop a model such as the one we have just discussed. The other option is to not do anything and allow the TGA to continue doing what it does, and I suppose the status quo continues. Do you see a need for this?

Prof. Ritter : I certainly have spoken with and can see people who are desperately keen to receive medicinal cannabis in ways other than they are currently receiving it. And I think that if there is a way of avoiding subjecting people to criminal activity then that is a worthwhile endeavour. As to the prevalence of the disorders or diagnoses for which it is suitable and the proportion of the population who would benefit, for me that is a research question that I have not seen the data for.

Senator DI NATALE: Okay.

CHAIR: You mentioned that you are not in favour of self-grown. On the assumption that it was legal to do it for certain people and you got a strain, a seed, of a plant that was certified as being the right percentages for your disease, is that—

Prof. Ritter : That is a very good point, Senator. Yes.

CHAIR: In that event, you would say that it is possible?

Prof. Ritter : Yes. I think the principle that I am trying to maintain is the therapeutic benefit, quality and quality control and not producing any harm, so yes.

CHAIR: You may not have this information, but what I am suggesting is: is there a way that people, were it legal and they were authorised and they were the right type of person, could buy a seed that would allow you to get the right result without having to bother with commercial production?

Prof. Ritter : I would assume that that is possible, but technically I do not know. No doubt there will be other witnesses who will be able to answer that question for you.

CHAIR: I am just wondering. I do not know enough about how the poppies are grown, but I assume that somewhere—although that is commercially grown, isn't it; it is not self-grown.

Prof. Ritter : Yes, that is commercially grown.

CHAIR: You do not go and stick in a poppy field.

Senator DI NATALE: Starting a home-grown poppy—

CHAIR: Well, I do, but not for drugs; only for Anzac Day.

Prof. Ritter : Only red ones!

CHAIR: Only red ones. Professor, thank you very much for your help today. We very much appreciate your time.

Prof. Ritter : Thank you very much. Best wishes with it.

CHAIR: Thank you.