Senator ROBERTS: Thank you, both of you, for being here, and involved in the inquiry. I found your submission excellent; it was very helpful and very eye-opening. As I see it, there are three issues: one is legalising medicinal cannabis; the second is legalising recreational use of cannabis; and the third is the quality of the bill itself. Perhaps a fourth one is the safety of product and the need for regulation. One Nation has strongly supported medicinal cannabis for decades, and we’ve worked to increase its availability and accessibility by reducing its price. The public is ready for medicinal cannabis; we’ve been convinced of that for quite some time. Will legalising recreational use scare people off legalising it for medicinal use?

Mr Barns: I’m not sure what the question was, Senator?

Senator ROBERTS: Will legalising the recreational use of cannabis scare the public off legalising medicinal cannabis? In other words, would it be better to—

Mr Barns: I’m not sure that’s right. The polling that I’ve seen indicates that certainly over 50 per cent of Australians support at least decriminalising the use of cannabis. That’s because, as I’ve said, around one in three Australians have used it, and it’s probably higher because there’s self-reporting, which means you get a lower number.

Senator ROBERTS: Some say that this bill seems sloppy and loose in its wording; what’s your view?

Mr Barns: I think it’s a good bill. Bills can always be improved, but I think that the framework of this bill is excellent. It provides for an effective regulator, and that’s what you need and that’s what you want. Very quickly, one of the issues in Canada—again, we can take this on notice—is that, as I understand it, the Trudeau government, because Canada has a much more federalised system, essentially handed over regulation to each of the provinces. That does explain some of the mixed data, but we can come back to you on that.

Senator ROBERTS: What problems do some of the details introduce for parliament?

Mr Barns: Having analysed the bill briefly, our major concern is to ensure that the policy behind the bill and the framework of the bill itself is there—and it is there. Of course,—I’m sure Senator Shoebridge would say the same—bills are subject to negotiation, and senators and parties will have different views on the bill. But in terms of an overall bill—I don’t want to get into it clause by clause, and one reason for that is that I don’t have it in front me, but I have read it—we certainly think the framework of the bill is sound, the bill’s direction is sound and the major provisions in the bill are sound.

Senator ROBERTS: I got the impression from your answer to the first question that you’re not necessarily convinced by all of the details.

Mr Barns: No, that’s not what I’m saying.

Senator ROBERTS: Okay, because you’ve mentioned that you’re very happy with the framework.

Mr Barns: We regard the bill as fundamentally sound. Of course, it can be tweaked; but, as a matter of law, we regard it to be fundamentally sound.

Senator ROBERTS: Are there any problems that it introduces for law enforcement officers?

Mr Barns: Again, anecdotally, I’ll tell you what police tell me, ‘What a waste of time; why am I doing this?’ They would rather spend their resources on aspects of the drug system other than cannabis, particularly when we know that lawyers use it, judges use it, police use it and military people use it—particularly on the medicinal side. It’s used so broadly in the community, particularly, as I say, for all medicinal purposes. The current system is not only farcical but also hypocritical.

Senator ROBERTS: Does it introduce any problems in detail for the judiciary?

Mr Barns: No, it doesn’t. I probably shouldn’t have said—and I withdraw my statement—that judges use it. I don’t know any judges that use it, so I’ll put that on the record. As I’ve said, I think the judiciary—

Senator ROBERTS: I didn’t mean judges in their—

Mr Barns: As for members of the judiciary that I’ve spoken to, and the magistracy, I’ve not met one who thinks that the current framework works.

Senator ROBERTS: I didn’t mean problems for judges who use it; I’m talking about problems for judges—

Mr Barns: No, I don’t know any judges who use it; as I said, I withdraw that.

Senator ROBERTS: Yes, just in making rules; that’s all.

Mr Barns: No. Again, I will repeat what I said. I think they’d be glad to get rid of this from their lists because it clogs up other cases and it means that you get courts having to deal with these petty matters day after day, maybe for an hour or so that could be freed up to deal, for example, with family violence or drink-driving matters.

Senator ROBERTS: What problems does it introduce for current users of medicinal cannabis and prospective users of medicinal cannabis, if any?

Mr Barns: I think anything that creates certainty for cannabis users—Shaun would say the same; in fact, he has said the same—would be welcomed by cannabis users. They’d no longer have to hide and feel a sense of unease, living in the community.

Senator ROBERTS: I’ll just put a small question for my last question in this bracket. As for the stigmatisation of cannabis, the use of hemp and cannabis in making paper, textiles, food and medicine goes back to the 1920s and 1930s, with big pharma, big newspapers and big synthetic textile manufacturers. The doctors almanac in the 1920s or 1930s—I can’t recall the year—actually had medicinal cannabis as the No. 1 treatment used in America. Has that stigmatisation been real, and is it still going on?

Mr Barns: You have to remember that the war on drugs started as an election ploy by Richard Nixon in 1968 to win over what he called the ‘quiet Americans’ or the ‘forgotten Americans’—the silent majority. That’s where it started. There was also his concern about soldiers coming back from Vietnam and using drugs. It had no medical efficacy attached to it. It was a political ruse and, of course, it was taken on and led to the destruction of communities and lives, particularly in Latin America. As I’ve said, the Economist, which, for many years, has supported legalisation, says that it’s an impossible war and you can never win it.

Senator ROBERTS: I also want to refer to your quote from Mick Palmer, a former Australian Federal Police commissioner, who began his policing career in the Northern Territory. He made a similar point to yours when he said:

As a young detective I found myself arresting decent young Australians who had never come to attention of police for any other crime. Weren’t ever likely to. Who were planning careers in a whole range of areas, including teaching and police …. Little tiny quantities were likely to kill these people’s careers. What sort of policy is that?

It is stupid policy. Could you elaborate on that, Dr Stevens.

Dr Stevens: Yes. I would definitely agree with Mick Palmer. We want to see a move away from policing of a drug that’s used by a percentage of the population quite safely. As we have said, the criminal justice system, as Mick Palmer says, is causing a problem for some of those people who get caught up in it. What we do know, too, is that it’s more likely to be people from lower socio-economic areas who get caught up. People who are in the high socio-economic areas seem not to get noticed by the police so often.

Senator ROBERTS: Your submission makes the point that a significant proportion of drug use is by people who are already feeling alienated or vulnerable, and that drives their habit. Then, when they get caught and they’re criminalised, they’re further isolated from society.

Dr Stevens: Yes.

Senator ROBERTS: That’s your basic argument, isn’t it, so you want to decriminalise?

Dr Stevens: Yes, it isolates people. It isolates them from their families as well, because kids keep this secret and then their parents find out when things go wrong, whereas if it weren’t illegal they could talk to their parents about it.

Senator ROBERTS: Are there also problems with the use of SSRs? Do people become dependent on them, and do they cause serious problems in the community?

Mr Bush: There is a problem with SSRs in the police force and the military community. In fact, there is an inquiry being undertaken at the moment.

CHAIR: We’ll have to get that on notice, I think, Senator Roberts.

Dr Stevens: We will take that on notice and Bill can give you some more details about that.

CHAIR: Yes. We are running short of time.

Dr Stevens: Okay.

Senator ROBERTS: Thank you both.

Senator ROBERTS: Thank you, Professor Williams, for attending. As I see it, there are three issues—I put this question to the first witnesses—and one is legalising medicinal cannabis; two is legalising recreational cannabis, possibly; and three is the quality of the bill. I think you can also add another topic—safety of the product and the need for regulation. One Nation has been supporting medicinal cannabis for decades. I’m intrigued by your comment that Canada—you’re very supportive of it—introduced it bit by bit so that they could assess the impacts of whatever they had introduced before moving to the next stage. Do you think legalising recreational use will scare people off it and maybe we should legalise medicinal cannabis first, wait for that to be bedded down and then consider—

Prof. Williams: We have legalised medical cannabis.

Senator ROBERTS: making it more accessible or more readily accessible to people? At the moment it’s effectively driven it onto the black market because it’s so expensive and difficult to get.

Prof. Williams: I can talk about the US experience. How medical cannabis—or marijuana, as they call it there—was rolled out was different in every state. It’s really interesting, as a researcher; I was in California at about the time that it was legalised, so I was very excited. I was working with colleagues at RAND, Rosa and Beau, who led all of the drug research there. Because I was in that area, I went to what was, I think, the first medical cannabis shop, but now it was legalised. They were still set up in that way; I think you needed a script to get in the door when it was a medical one. At another one that I went to in San Diego, even though cannabis was legal, you had to register. Because there were all of these constraints about getting in and getting access, you couldn’t see products from the street and that kind of stuff.

What research has shown is that it didn’t leak out to youth, and, for me as a researcher, I want responsible use of substances, because cannabis is, as you would all know, less dangerous, less harmful, than cigarettes or alcohol. Professor Nutt from the UK has well established that, but you still worry and you would want to restrict access to kids. The research all shows that it didn’t leak out into kids; there’s a lot of research, and its use by kids is really not increasing. The research out of the US suggests that there is some leakage into youth use in the US, but it’s not as large as 25- to 34-year-olds; in the US it’s 21. There is some leakage with legal cannabis, but not a whole lot, into youth, but there was none for medical cannabis. That was really good, from a statistical point of view, not from an individual experience point of view.

Senator ROBERTS: Would you be willing to take this on notice: give us a list of amendments that you would like to see regarding aspects of the bill that you’re not happy with?

Prof. Williams: You know that I’m not a lawyer, right?

Senator ROBERTS: That’s fine. We want a practical approach.

Prof. Williams: Okay. I’m not suggesting that I could be the architect of the world’s greatest bill. The other thing is that, with the Canadian bill, they’ve made amendments along the way. That’s the other thing that I noticed when I went to the US: I was at a conference and there were mayors and government officials there from, I think, Colorado and Washington state. Because they had no federal assistance, they were on the phone every week, having to make amendments. For example, butane was used to make concentrates, but they used grass clippings on the public lawns as mulch. That turned out to be toxic, and Agriculture couldn’t help because it’s a federal government body. They were having to trouble-shoot every week. Everyone has to be aware that it’s a new market, and we can take advantage of the research and the experience that have occurred in other countries and other jurisdictions, but it might not all translate precisely into the Australian jurisdiction. We have to be prepared to make amendments along the way. I don’t know whether that’s easy from a political point of view, but they’ve had to do it in Canada.

Senator ROBERTS: Let me check my understanding. You’ve said that, if a high tax is levied, it will drive out legal players and we won’t have much of an improvement.

Prof. Williams: Yes. Even in Canada, they’re saying that. I have seen a news article. The government is saying, ‘We made this much money,’ but all of the businesses there are saying, ‘We’re going broke,’ because of the high taxes and having to compete with the illicit market, which they observe in their day-to-day life.

Senator ROBERTS: One of the key themes that I took from your opening statement was that the cannabis market in this country, recreational and medicinal, is very large—

Prof. Williams: Yes.

Senator ROBERTS: and it’s largely illicit.

Prof. Williams: Yes.

Senator ROBERTS: If we introduce it sensibly, in well-managed stages, and levy a sensible tax, we will drive people away from the illicit market and into the regulated market; is that basically it?

Prof. Williams: I would say attract them into it. You’re not driving them, because there’s no stick. You’re attracting them into the legal market, yes.

Senator ROBERTS: Thank you. I appreciate your correction to my language.

Senator ROBERTS: Thank you, Chair. Thank you, Dr Bonning, for participating. In your submission you say:

In Australia, cannabis was present in 4.5 per cent of drug-induced deaths in 2021.

How many of those deaths were found by autopsy to have had cannabis as the primary cause of death?

Dr Bonning: I do not have that data at hand. We will take that on notice and get it for you.

Senator ROBERTS: Thank you, Again, your submission states:

A recent systematic review found an increase in acute cannabis poisoning post-legalisation in the US, Canada, and Thailand.

Those countries allowed unregulated supply into the market, didn’t they? These people could have been smoking cannabis laced with anything; isn’t that correct?

Dr Bonning: That’s correct, Senator.

Senator ROBERTS: In your data, can you tell me how many people have suffered hospitalisation or death from an approved cannabis product provided by a regulated and licensed supplier and being in the form of a vape, patch, topical, tincture, drops on the tongue or suppository?

Dr Bonning: We will take that question on notice and get the information for you via the TGA.

Senator ROBERTS: Thanks. Would you agree that the problem is, firstly, criminal gangs lacing unregulated supply with addictive drugs; and, secondly, amateurs growing, preparing, storing and using cannabis in unsafe ways?

Dr Bonning: Both of those issues are contributory to both the overdose and the mental health impacts of cannabis. They are not exclusively the problem, but they are certainly contributory, yes.

Senator ROBERTS: Do you see a role for medical practitioners and chemists in supervising supply at least in the foreseeable future to ensure safe use, as opposed to criminal supply and prohibition?

Dr Bonning: We would expect that the use of regulated cannabis products in limited medical situations, where there is evidence for use for medical reasons, could be, and potentially would need to be, in early circumstances, under the supervision of registered health practitioners.

Senator ROBERTS: Can you explain doctors’ current interest in cannabis use—medicinal cannabis, that is? What’s your involvement?

Dr Bonning: Personally, my involvement is very limited.

Senator ROBERTS: I am sorry; I meant doctors’ involvement in this. Where do doctors sit regarding the current use of medicinal cannabis?

Dr Bonning: There is growing evidence for specific conditions and the use of medicinal cannabis. This has been shown by the number of special access scheme authorisations for the use of medicinal cannabis. In addition, many general practitioners and subspecialist practitioners are now authorised to apply for cannabis-based products for their patients. That has been increasing steadily over the last five years. There is genuine interest in continuing research, and in the use of cannabis where there is clear medical and clinical evidence for the use of it. As with all things, if there is good evidence to support it, from a clinical perspective, doctors are happy to assess that evidence and use it for the benefit of their patients.

Senator ROBERTS: At the moment, doctors’ guilds, colleges and associations have it pretty well sewn up, don’t they? They have exclusive use.

Dr Bonning: Given that these are regulated products and that they require a prescription, yes, because, generally, with prescription-only medicines, the legal requirements are that a doctor provide that prescription.

Senator ROBERTS: Following Senator Scarr’s questions, I have a similar question but with a different angle to it. In your submission’s conclusion you say:

The AMA does not support the Legalising Cannabis Bill 2023. The AMA is concerned that if cannabis were legalised for recreational purposes, it may increase health and social-related harms. This in turn may increase demand on an already overstretched healthcare system.

Isn’t it true that the healthcare system, certainly in Queensland, and I suspect in other states, is over-stretched because of two things? First of all, the COVID mandates have led to a lot of doctors and nurses leaving the system. Secondly, I refer to the high number of excess deaths due to the COVID injections—not only deaths but increased diseases of all kinds due to the lack of good manufacturing processes in the COVID vaccines. They are things that the AMA supported.

Dr Bonning: Senator, I do not have the data that you would need regarding those questions. I can say that we have continually supported WHO, Australian government and other evidence-generating organisations around the safety and efficacy of COVID vaccines, and that those COVID vaccines were responsible for protecting many millions of lives here in Australia and around the world. In addition, while there have been some people who left the healthcare system due to COVID mandates, those numbers have been relatively small. I would say that the more likely cause of our stretched hospital system is a need for increased investment, developing our healthcare workforce over the long term, and recognising that there are ongoing increases in chronic disease as Australians not only live longer but also live with longer periods of ill-health.

CHAIR: Senator Roberts, I have to hand the call over to Senator Polley.

Senator ROBERTS: Thank you both for appearing. I loved your commitment and your enthusiasm. They are very powerful statements; I’m looking forward to getting copies of them. I am going to ask several questions. They need only brief answers, but if you want longer, that’s fine. From your submission, the way for a safe and regulated product is through a system of government regulation, correct?

Ms Lai: Yes.

Ms Sietaram: Yes.

Senator ROBERTS: A regulation would allow for better education and harm reduction, which is the problem with the free-growing system—nobody has the role of educating, do they?

Ms Lai: Yes, that’s currently correct.

Ms Sietaram: Correct.

Senator ROBERTS: I am not sure how strain registration will reduce harm, unless the intention is not to register some of these new extreme strains with THC over 25 per cent, even 30 per cent. You’ve heard of that. What are your thoughts, please, on some of these new strains going into general use?

Ms Sietaram: It boils down to education. Without body shaming, there are people who have a higher BMI. They have a higher metabolism and they need a higher type of strain. People in palliative care might need a higher type of strain. It’s very much about matching the individual needs to the vast variety of strains that are out there. I do think it should be in the legal market, but there should be regulation in place about who can access it, when they can access it and why.

Ms Lai: The number of cultivators that exist and will exist in the future is unknown. That’s because we keep making genetic advances in this field, and that is really exciting. The law should not prohibit cultivators from providing end consumers with access to particular strains based on levels of THC—one of 120 active compounds that are within cannabis. It doesn’t make any sense, and it kind of reflects upon Australia’s current lack of understanding around this very powerful plant. There are many strains in particular that have incredibly low levels of THC and high levels of CBD, for instance, which we know is non-intoxicating. Should that be regulated in the same way as a really high THC concentrated plant that is sedative in nature? In my opinion, it all needs regulating but it needs expertise from the legacy community and medicinal practitioners to make sure that we understand the plant fully.

Senator ROBERTS: We need to be practical. A down regulation would allow easier and cheaper access to medicinal cannabis. Do we need to change how medicinal cannabis is done in Australia?

Ms Sietaram: Yes, please.

Ms Lai: Yes.

Senator ROBERTS: Do you think this bill will increase jobs or will it simply move them out of the shadows?

Ms Lai: Of course it will increase jobs, and it will encourage a lot of valuable labour that is currently being kept in the dark due to stigma. People are unable to share their wealth of knowledge with the general public, and it’s a grave shame. It would possibly affect jobs in virtually all sectors, such as tourism, hospitality.

Senator ROBERTS: How so?

Ms Lai: Well, I am from Western Australia. If we look to the wine region that we have there, which is highly sought after as a place to visit not only for leisure but also for wine connoisseurs, we know that is one of the most successful tourism regions we have in Australia. The wine is excellent there because of the growing conditions of that area. There’s no reason why that can’t extend to cannabis plants. That craft industry that would boom up around cultivation of beautiful, Australian, sun-grown, high-quality cultivators would put us on the map globally.

Senator ROBERTS: I was at Margaret River recently with my wife. We tasted some olive oil. So you’re saying we could even get a tasting of CBD?

Ms Lai: Correct. Cannabis can be infused into olive oil. It can be used topically, and our regions could be really well-known for extremely high-quality and unique products.

Senator ROBERTS: Ms Sietaram, Amsterdam has been done well, you say?

Ms Sietaram: Yes.

Senator ROBERTS: You’re very proud of it. If you put them side by side, how does this bill stand up relative to Amsterdam? What more is needed?

Ms Sietaram: I think that, because of all the data that is out there, Australia can be at the forefront of proper regulation. What does happen—we have seen this in Thailand and in some ways in the Netherlands—is that there is a regulatory vacuum. That vacuum needs to be filled. We have the opportunity to really think: how are we going to legalise that? Put the rules in place, have the data in place and have it science backed. This hurts my little Dutch heart, but I think that we can do it better than the Netherlands, because we can use their 30 years of data, we can use the 10 years of data from the US and we can use the six months of data from Thailand and really figure out how to do this properly.

Senator ROBERTS: Would it be asking too much for you to answer a question on notice in writing with respect to what amendments you would like to see to the bill?

Ms Sietaram: Yes, I can do that.

Senator ROBERTS: And why?

Ms Sietaram: Yes.

Senator ROBERTS: Ms Sietaram, on page 4 of your submission, which is page 48 of the briefing pack, you have a list of two significant economic benefits being increased: tax revenue and job creation. Wouldn’t a third one be lower health cost to the nation?

Ms Sietaram: Yes, I agree with that.

Senator ROBERTS: Would that be significant?

Ms Sietaram: My personal opinion is that it would be significant, but I don’t have an Excel spreadsheet to prove that.

Senator ROBERTS: You have done a lot of research and you have read a lot of papers.

Ms Sietaram: Yes, I have. We do see it. I heard earlier the AMA talking about the strain it would have on mental health services. I disagree with that 100 per cent. I go back to my farmer’s market stallholder. This is a man who is in his late 60s who has worked at farmers’ markets his whole life. His back is broken. He has to go on Endone. He couldn’t play with his grandkids because he didn’t feel good. Now we’ve put him on alternative medication and he is a new human being. Not only does it reduce the strain on the medical environment but also it helps Australians. We cannot stand there and say, ‘We prefer people to be on opioids.’ We cannot say that.

Senator ROBERTS: Just to follow up on that one, I have no doubts about medicinal cannabis being highly beneficial. We need to bring it in quickly. So many Australians—I am looking across everyday Australians—can see that, but they are not yet ready to accept recreational use. Is it a mistake to try to bring in both at once? Why not get medicinal cannabis in first and then tackle the issue of recreational cannabis?

Ms Sietaram: I personally don’t like the term ‘recreational cannabis’. I believe it is about wellness—sleeping better, relaxing after a hard day and dealing with pain. Instead of drinking a glass of wine, having an edible is a healthier solution. I would consider it to be wellness. I think that, in the end, they will merge together. The way they will merge together is by education. A book which I highly recommend is Steve DeAngelo’s The Cannabis Manifesto, which he wrote many years ago. He has been one of the biggest cannabis advocates since the seventies. He says that it’s the intent that matters. There is misuse and there is wellness, and it’s only in the state of the mind. What happens is that if someone comes in and says, ‘I want to use this because I want to feel better,’ et cetera, they use it in the right way.

We see this in the Netherlands. The problems in the Netherlands with cannabis don’t come from the people who live there; they come from the tourists, because they come with an intent of misuse. ‘I’m from France. I want to party in Amsterdam and’—respectfully—’I’m going to get wasted.’ The societal change will make such a difference. Instead of looking at it as recreational, it becomes a wellness thing. The only way we can solve that is by providing proper education to people.

Senator ROBERTS: What is the author’s name?

Ms Sietaram: Steve DeAngelo. I can send you a copy, if you want.

CHAIR: We are running a little bit behind time. I will keep my questions really brief. You’ve both spoken about the need for regulation and to have rules in place. The bill itself is pretty light on what those rules would be and what the regulation is. It creates some offences and talks about the types of activity that would be regulated, but it doesn’t actually say what that regulation would be. What are some of the types of regulation that could be introduced to manage the market, keep it safe, particularly protect young people and ensure that we don’t bring the illegal market into a legal one?

Ms Lai: An obvious one is to learn from the way that we regulate alcohol, especially in public spaces, and especially with the aim of protecting youth. I don’t see why we can’t lend that to cannabis and create a responsible service of cannabis. Licence holders would need to ensure that their staff and anyone that interacts with the general public in providing cannabis to them is trained in a way that is providing education.

CHAIR: Liquor licences.

Ms Lai: Yes; and really specific guidance on how to consume cannabis. That’s a really obvious one.

Ms Sietaram: I agree with that. It is about education; putting in regulation about age verification; putting in regulation that the products aren’t marketed to appeal to children. There is the vape example. Let’s not use bubble gum flavours; let’s not use cutesy products; and let’s make sure that it’s not attractive to children. I think that’s really important. I think the education is important. In America, they call them ‘budtenders’. They’re almost like a sommelier, where you go in and say, ‘This is what I need,’ and they will give you the product that will work for you. It is about making sure that the patrons of these cannabis cafes and online shops have that education and that we have some formalisation of that. ‘You cannot work here unless you’ve done this course.’

CHAIR: You were talking about the fact that people need to be—prescribed is really what you were talking about, essentially; that there needs to be the right type or dose for the right person. How would you do that, if not by medical prescription?

Ms Lai: It’s really easy. You ask the customer what it is that they are trying to achieve. That might simply be coming to a place of homeostasis, which you can do with cannabis in a non-intoxicating way or through psychoactive measures. You ask the customer what they need and, with your training, you offer the appropriate cannabis product.

Ms Sietaram: I think that’s absolutely correct. I am a little bit of a geek, so I’ve been playing with this algorithm. Basically, I’ve taken all of the information that’s out there on strains and scientific research, and started to match that. It is about having an algorithm that builds on that, so that people can say, ‘This is what I want to achieve.’ Having the experience of a budtender or a patron of a coffee shop can definitely help with that. But having data behind it will make it into a playbook and it will secure more regulation for consistency.

CHAIR: That’s all we have time for. If you have taken some questions on notice, we will let you know a date by which we need to get them back. The committee will now suspend for lunch.

Senator ROBERTS: Thank you all for participating today. My questions will initially be to Dalgarno. In your submission, you say, ‘this submission will show how proponents of increased promotion and permission models for illicit drugs must persistently deny evidence-based science’. By illicit drugs, do you mean medicinal cannabis?

Mr Varcoe: Are you talking about the pharmaceutically and clinically trialled, double placebo, accounted for medicines that are on the pharmaceutical register? I’m not referring to those—

Senator ROBERTS: My question is: by illicit drugs, do you mean medicinal cannabis?

Mr Varcoe: Illicit substances are, again, drugs that are still registered on the market as being and scheduled as being illegals, whatever the scheduling is in a particular jurisdiction. When it comes to pharmaceutical grade cannabis, double blind, placebo accounted for and clinically trialled medicines are not illicit; they are prescribable drugs. Simply by putting the title ‘medicinal’ in front of cannabis doesn’t make it medicine. It doesn’t make it medicine. In no jurisdiction—pharmaceutical grade has been clinically trialled—

CHAIR: I think we might still be able to hear you—

Mr Varcoe: I’m sorry—

CHAIR: You can keep answering—or if you have another question, Senator Roberts—

Mr Varcoe: I’m sorry, I thought we were cut off. I apologise. I can name—I can’t name all of them, but the ones that are pharmaceutically available—certainly Sativex has been on the market in Australia for a long time. It’s a therapy related to cancer treatment and, obviously, nausea issues. Of course, Epidiolex is the newest one. It was created by GW Pharmaceuticals, who did a great due diligence to create a fourth line, by the way—fourth line treatment for Dravet syndrome epilepsy with a 25 per cent efficacy rate. But they did the due process on that to have it marketed. But, outside of those three or four pharmaceutically trialled medicines, just creating a cannabis plant and then putting the word ‘medicinal’ in front of it doesn’t make it medicine.

Senator ROBERTS: So the thousands of scientifically peer reviewed papers, Mr Varcoe, that show benefit from using cannabis in a medical setting don’t exist—not one benefit from cannabis?

Mr Varcoe: No, I’m not arguing that there are some benefits, but there are also side effects. That’s one of the reasons why you have double blind, placebo accounted for clinical trials—to ensure that the product does do what it says going to do with a minimum amount of side effects. We are seeing that a lot of those perceived benefits also have massive side effects—genotoxicity, neurotoxicity and other factors—that are not being considered. But the ones that have been properly done, like GW Pharmaceuticals did, now owned by Jazz Pharmaceuticals—13 years to create that.

Senator ROBERTS: Your submission lists 19 known harms from medical cannabis, supported by a document called ‘Cannabis and hemp scientific review’, which is a paper by Drug Free Australia. The document you cite is not referenced. I see you have lots of opinion pieces on your website that follow your 19 talking points here. Can you provide a direct link for the scientific proof for each of the 19 assertions, please? On notice is fine.

Mr Varcoe: Yes, we can do that.

Mr Toumbourou: Just on my own position, I’d just say clearly that I totally support therapeutic trials of drugs. I’m in support of cannabis being trialled if it’s for a medical purpose where there’s going to be therapeutic doses tested. That is I think what we’re saying here. That is supported. The problem is that a lot of the way that the legalisation model has worked in the US is to claim medicinal benefits forms of cannabis that have never been through those trials. There is concern that those doses are actually doing harm. They’re not of therapeutic benefit. Cannabis, of course, is a very powerful drug. Used for therapy I’m sure there would be titrations of it for which would be for a medicinal purpose. But they’ve got to be carefully tested. So this is the point. But if what you’re looking for is evidence about some of the models that have been used and promoted to legalise medicinal cannabis use, which have been the forerunners of the non-medical or recreational legalisation, then we can provide some of those papers, including papers that show that there have been increased birth defects and cancers in association with the bringing in of legalisation, which in the early phases was for these so-called medicinal variants. But, in fact, what we’re arguing here is they never went through therapeutic testing. Thank you.

Senator ROBERTS: I’d like to see those papers—I look forward to them. Are you aware that the TGA recently approved for use—in recent years, it approved for use, with no testing in this country, mRNA vaccines. They relied on the FDA in America. The FDA in America had already said previously that they did not test the mRNA vaccines. They relied upon Pfizer’s testing. Pfizer admitted later that they had not completed their testing. Is that the kind of regime that we should take a lot of respect in?

Mr Toumbourou: Again, we’re in favour of therapeutic testing. We believe that’s the way forward. We’re not in favour of a vote for whether or not a drug is going to be harmless. It seems to us that the model we’re proposing is one that would continue to have rigorous therapeutic testing for any claims that a drug has benefits.

Senator ROBERTS: Okay. In your submission you say, ‘the regulating and this new industry will require a level of bureaucratic monitoring that will, as we are seeing in other jurisdictions, take more and more financial and human resources to oversee’. How does the totality of that cost compare to the totality of the cost of prohibition, policing, courts, prisons and the opportunity cost of low-level convictions for possession that may cost that person a career and the tax revenue that goes with that loss of career?

Mr Varcoe: Again, in the addendum document that was submitted with the submission also covers that quite thoroughly. A number of papers and reviews in there make it clear the assumptions made about people being incarcerated for simply blazing a spliff are fallacious. The costing—we’re mostly a diversion mechanism in this country. Incarceration models and the enforcement around that are a problem. As I’ve stated in the submission too, one metric is policing the possession. Once you remove that metric—as previously said by my colleague here, it doesn’t remove the other potential criminal metrics that can come into play. Bureaucracy in California—it’s in one of our papers in our submission there as well; in that single large document. It also talks about the grey market, how under-resourced it is and trying to bureaucratically manage the new market and all that’s going on, and the failings of that—and, of course, the failings and the corruption in the testing regimes. Groups that have been used to test legal products have also come into the fore in recent data coming out. So, again, we’ve got a real problem here with—again, we talk about talking points and just throw out the incarceration change. That’s just a talking point that has got to have evidence to it and we’ve seen the evidence—

Senator ROBERTS: Mr Varcoe, I asked you about the cost.

Mr Varcoe: We’re looking at what’s going on at the moment and the cost savings, in the law enforcement alone, will soon be swallowed up, as we’ve seen in other jurisdictions, like Colorado, with other forms of policing and with other forms of bureaucracy. So your net fiscal outcome is going to be, if not zero then negative.

Senator ROBERTS: Prescription opioids, Remdesivir, known now as ‘Run—death is near’ and statins are examples of pharmaceutical products over many years with a history of fatal outcomes that exceed cannabis notifications using DANE data. I note that Dalgarno does not campaign against those, yet you’re opposing the TGA decision to legalise the use, under limited circumstances, of psychedelic drugs. Can I ask where is the line? What TGA approved drugs are okay and what are not? What is your logic? Could cannabis ever be okay with you for any purpose?

Mr Varcoe: That looks like a straw man question to me. Our concern is that we have an unpredictable, highly promised substance that has not delivered. In 50 years of promise, it has not delivered what it could deliver, although we have, as I said, a number of therapeutic capacity based cannabis products on the market. We’re certainly opposed to any pharmaceutical drug that causes harms and any illicit drug that causes harms—of course we are, and we do that. But we’re wanting to mobilise and commercialise this particular market and pretend that’s not going to be a problem. That’s the concern that we have about cannabis. It’s also the substance that was most easily stepped into that place, as was indicated in our opening statement, back in 1993 by the head of—that’s the agenda. So we’re concerned that we want to foist another psychotropic toxin onto the marketplace for families and communities to contend with and pretend that we can manage the harms of that. That’s a concern that we have. We certainly want to see good, evidence-based, clinically trialled use of cannabis for certain issues, as we have with Epidiolex. That’s a wonderful product. But again, this is the issue. We’re not pretending that other drugs are not a problem. We’re saying we don’t want to add another problem to the problem.

Senator ROBERTS: I just need to clarify that we’d like a single large document, not documents in a pack, when Mr Varcoe provides that evidence.

CHAIR: Senator Roberts, if the witness is taking a question notice, they will provide that information.

Mr Varcoe: The evidence is there.

CHAIR: Thank you very much. If you have taken any questions on notice, we’ll give you a date by which we would like to get those back from you.

Senator ROBERTS: Thank you all for participating today. My questions will initially be to Dalgarno. In your submission, you say, ‘this submission will show how proponents of increased promotion and permission models for illicit drugs must persistently deny evidence-based science’. By illicit drugs, do you mean medicinal cannabis?

Mr Varcoe: Are you talking about the pharmaceutically and clinically trialled, double placebo, accounted for medicines that are on the pharmaceutical register? I’m not referring to those—

Senator ROBERTS: My question is: by illicit drugs, do you mean medicinal cannabis?

Mr Varcoe: Illicit substances are, again, drugs that are still registered on the market as being and scheduled as being illegals, whatever the scheduling is in a particular jurisdiction. When it comes to pharmaceutical grade cannabis, double blind, placebo accounted for and clinically trialled medicines are not illicit; they are prescribable drugs. Simply by putting the title ‘medicinal’ in front of cannabis doesn’t make it medicine. It doesn’t make it medicine. In no jurisdiction—pharmaceutical grade has been clinically trialled—

CHAIR: I think we might still be able to hear you—

Mr Varcoe: I’m sorry—

CHAIR: You can keep answering—or if you have another question, Senator Roberts—

Mr Varcoe: I’m sorry, I thought we were cut off. I apologise. I can name—I can’t name all of them, but the ones that are pharmaceutically available—certainly Sativex has been on the market in Australia for a long time. It’s a therapy related to cancer treatment and, obviously, nausea issues. Of course, Epidiolex is the newest one. It was created by GW Pharmaceuticals, who did a great due diligence to create a fourth line, by the way—fourth line treatment for Dravet syndrome epilepsy with a 25 per cent efficacy rate. But they did the due process on that to have it marketed. But, outside of those three or four pharmaceutically trialled medicines, just creating a cannabis plant and then putting the word ‘medicinal’ in front of it doesn’t make it medicine.

Senator ROBERTS: So the thousands of scientifically peer reviewed papers, Mr Varcoe, that show benefit from using cannabis in a medical setting don’t exist—not one benefit from cannabis?

Mr Varcoe: No, I’m not arguing that there are some benefits, but there are also side effects. That’s one of the reasons why you have double blind, placebo accounted for clinical trials—to ensure that the product does do what it says going to do with a minimum amount of side effects. We are seeing that a lot of those perceived benefits also have massive side effects—genotoxicity, neurotoxicity and other factors—that are not being considered. But the ones that have been properly done, like GW Pharmaceuticals did, now owned by Jazz Pharmaceuticals—13 years to create that.

Senator ROBERTS: Your submission lists 19 known harms from medical cannabis, supported by a document called ‘Cannabis and hemp scientific review’, which is a paper by Drug Free Australia. The document you cite is not referenced. I see you have lots of opinion pieces on your website that follow your 19 talking points here. Can you provide a direct link for the scientific proof for each of the 19 assertions, please? On notice is fine.

Mr Varcoe: Yes, we can do that.

Mr Toumbourou: Just on my own position, I’d just say clearly that I totally support therapeutic trials of drugs. I’m in support of cannabis being trialled if it’s for a medical purpose where there’s going to be therapeutic doses tested. That is I think what we’re saying here. That is supported. The problem is that a lot of the way that the legalisation model has worked in the US is to claim medicinal benefits forms of cannabis that have never been through those trials. There is concern that those doses are actually doing harm. They’re not of therapeutic benefit. Cannabis, of course, is a very powerful drug. Used for therapy I’m sure there would be titrations of it for which would be for a medicinal purpose. But they’ve got to be carefully tested. So this is the point. But if what you’re looking for is evidence about some of the models that have been used and promoted to legalise medicinal cannabis use, which have been the forerunners of the non-medical or recreational legalisation, then we can provide some of those papers, including papers that show that there have been increased birth defects and cancers in association with the bringing in of legalisation, which in the early phases was for these so-called medicinal variants. But, in fact, what we’re arguing here is they never went through therapeutic testing. Thank you.

Senator ROBERTS: I’d like to see those papers—I look forward to them. Are you aware that the TGA recently approved for use—in recent years, it approved for use, with no testing in this country, mRNA vaccines. They relied on the FDA in America. The FDA in America had already said previously that they did not test the mRNA vaccines. They relied upon Pfizer’s testing. Pfizer admitted later that they had not completed their testing. Is that the kind of regime that we should take a lot of respect in?

Mr Toumbourou: Again, we’re in favour of therapeutic testing. We believe that’s the way forward. We’re not in favour of a vote for whether or not a drug is going to be harmless. It seems to us that the model we’re proposing is one that would continue to have rigorous therapeutic testing for any claims that a drug has benefits.

Senator ROBERTS: Okay. In your submission you say, ‘the regulating and this new industry will require a level of bureaucratic monitoring that will, as we are seeing in other jurisdictions, take more and more financial and human resources to oversee’. How does the totality of that cost compare to the totality of the cost of prohibition, policing, courts, prisons and the opportunity cost of low-level convictions for possession that may cost that person a career and the tax revenue that goes with that loss of career?

Mr Varcoe: Again, in the addendum document that was submitted with the submission also covers that quite thoroughly. A number of papers and reviews in there make it clear the assumptions made about people being incarcerated for simply blazing a spliff are fallacious. The costing—we’re mostly a diversion mechanism in this country. Incarceration models and the enforcement around that are a problem. As I’ve stated in the submission too, one metric is policing the possession. Once you remove that metric—as previously said by my colleague here, it doesn’t remove the other potential criminal metrics that can come into play. Bureaucracy in California—it’s in one of our papers in our submission there as well; in that single large document. It also talks about the grey market, how under-resourced it is and trying to bureaucratically manage the new market and all that’s going on, and the failings of that—and, of course, the failings and the corruption in the testing regimes. Groups that have been used to test legal products have also come into the fore in recent data coming out. So, again, we’ve got a real problem here with—again, we talk about talking points and just throw out the incarceration change. That’s just a talking point that has got to have evidence to it and we’ve seen the evidence—

Senator ROBERTS: Mr Varcoe, I asked you about the cost.

Mr Varcoe: We’re looking at what’s going on at the moment and the cost savings, in the law enforcement alone, will soon be swallowed up, as we’ve seen in other jurisdictions, like Colorado, with other forms of policing and with other forms of bureaucracy. So your net fiscal outcome is going to be, if not zero then negative.

Senator ROBERTS: Prescription opioids, Remdesivir, known now as ‘Run—death is near’ and statins are examples of pharmaceutical products over many years with a history of fatal outcomes that exceed cannabis notifications using DANE data. I note that Dalgarno does not campaign against those, yet you’re opposing the TGA decision to legalise the use, under limited circumstances, of psychedelic drugs. Can I ask where is the line? What TGA approved drugs are okay and what are not? What is your logic? Could cannabis ever be okay with you for any purpose?

Mr Varcoe: That looks like a straw man question to me. Our concern is that we have an unpredictable, highly promised substance that has not delivered. In 50 years of promise, it has not delivered what it could deliver, although we have, as I said, a number of therapeutic capacity based cannabis products on the market. We’re certainly opposed to any pharmaceutical drug that causes harms and any illicit drug that causes harms—of course we are, and we do that. But we’re wanting to mobilise and commercialise this particular market and pretend that’s not going to be a problem. That’s the concern that we have about cannabis. It’s also the substance that was most easily stepped into that place, as was indicated in our opening statement, back in 1993 by the head of—that’s the agenda. So we’re concerned that we want to foist another psychotropic toxin onto the marketplace for families and communities to contend with and pretend that we can manage the harms of that. That’s a concern that we have. We certainly want to see good, evidence-based, clinically trialled use of cannabis for certain issues, as we have with Epidiolex. That’s a wonderful product. But again, this is the issue. We’re not pretending that other drugs are not a problem. We’re saying we don’t want to add another problem to the problem.

Senator ROBERTS: I just need to clarify that we’d like a single large document, not documents in a pack, when Mr Varcoe provides that evidence.

CHAIR: Senator Roberts, if the witness is taking a question notice, they will provide that information.

Mr Varcoe: The evidence is there.

CHAIR: Thank you very much. If you have taken any questions on notice, we’ll give you a date by which we would like to get those back from you.

Senator ROBERTS: In your submission, you said:

… only 3% or less of the burden of schizophrenia, anxiety disorders, road traffic injuries and depressive disorders in Australia are attributable to cannabis use.

The data on these health outcomes is not normally based on longitudinal studies with patients being provided with cannabis known to be grown and processed to good manufacturing process standards. In other words, these results are more reflective of the effects of illegal cannabis, whatever that substance they took actually was, rather than regulated, safe cannabis. Could we have your thoughts on that, please, Professor Lee?

Prof. Lee: Yes, I would say that’s an accurate assessment. One of the benefits of legalising and regulating cannabis is that currently these studies are based on people accessing whatever cannabis they access, without any understanding of the dose. It could be very potent or moderately potent or not potent at all. One of the benefits of regulating is that people can access a known dose of the drug of cannabis when they choose to use it. It is actually likely or at least possible that, with a regulated dose, that figure would actually come down because the doses may be smaller than people are currently accessing. We actually don’t know.

Senator ROBERTS: Thank you. Your submission says there are no barriers preventing the sale of cannabis to minors, because, without regulation, illegal supply abounds and can be directed to children. Do you think growing six plants at home will reduce the incidence of kids getting hold of cannabis?

Prof. Lee: That’s a good question, and it’s hard to know the answer to that. If I make an analogy with alcohol, many people, including me, have a bunch of bottles of alcohol on my shelf. My now 18-year-old, when he was younger, was not allowed to access those and he didn’t. That’s part of parenting, I think. There is potentially an increased risk, but it is certainly up to parents, as it would be for alcohol, tobacco, sweets and lollies, to ensure that those products are out of reach of children. That needs to be part of the regulations as well.

Senator ROBERTS: Thank you. You draw a connection between the increase in harm in Canada following legalisation and a commercial model. Can you quickly explain your thoughts on that and why this legislation will avoid that happening if at all?

Prof. Lee: Some of the criticisms of legalisation have come from looking at the US model. Predictably, the US have gone for a completely free market model of cannabis sales. So, in the same way that we have that model for alcohol, for example, for me, that comes with some unnecessary risks, because we know that there are very strong commercial drivers, particularly of alcohol, and there’s no reason to think that there wouldn’t be strong commercial drivers of cannabis sales as well. There’s an enormous number of models of regulation, but my personal view is to start conservative and then move up. I don’t think that the fully commercialised model is a model that is suitable for Australia.

Senator ROBERTS: Let me just ask one question just out of speculation. I haven’t prepared this one. There’s been an enormous decrease in trust in health institutions, health agencies and the medical profession as a result of the COVID and the government’s lies to us over the last four years. People are seeking independence. That’s very clear. They want to make their own decisions on medication. I’m not an expert on medicinal cannabis, but, as I understand it, medicinal cannabis and around 150 or 180 natural compounds in Aboriginal medicine have minimal side effects and are very safe to use. Do these give people that independence?

Prof. Lee: All of those medicines still need to be prescribed and managed by a medical practitioner. If someone has a medical condition that cannabinoids would be helpful in treating then I am 100 per cent in support of people being able to access that with the support of their doctor. But I guess what we’re talking about here is more recreational use, not medicating. I think it’s risky for people to self-medicate if they have a health problem without the supervision of a doctor. But certainly regulating and having a known dose and known potency does allow people who are recreational users as well to have some autonomy over their use.

Senator ROBERTS: Your submission credits the bill with regulating product quality, strength and safety, but those areas to be made in regulation. At the moment, all this bill does is provide the framework, albeit a very useful framework, for unknown regulations to come later. Would you like to see more information on those regulations now? I know that, as a senator, I want to see more information on what I’m voting for.

Prof. Lee: In general, I think the more information that we have about things, the better decisions we can make. But also I think the actual model of legalisation and the ins and outs of it are quite complex. They may take some time to get agreement on, to get in place and to get right. So I’m super keen to see at least a framework set up that will move us towards regulation rather than prohibition.

Senator ROBERTS: Thank you.

CHAIR: Thank you, Professor Lee. If you’ve taken anything on notice, we’ll get some dates for you to return that information to us. The committee will suspend for a short break.

Senator ROBERTS: Thank you for participating, Professor Keyzer. I want to commend you for your clear, concise and very powerful opening statement. Pauline Hanson, who’s the leader of our party, has been pursuing this for decades and we’re hearing some marvellous evidence today. First of all, I just want to do a quick recap to make sure I understand your position before asking you a question—again, following Senator Scarr—about international matters. Really, by criminalising it, we’ve now got a justice system that is perpetrating injustices through no fault of their own. We’ve also got, in 2020, 70,000 arrests for cannabis use, huge opportunity costs, police and other professionals could be engaged on other duties within our community and be far more productive. You said we should be managing people with drug disorders in the health system, which would give us better health and them better health. Is that a fair summary so far?

Prof. Keyzer: Yes, absolutely. I guess I’d add to that, if I may, that a legal, regulated tax market would provide additional revenue that could be hypothecated to harm minimisation measures in the health system.

Senator ROBERTS: Thank you. One of the questions I have is from the Department of Home Affairs submission. On page 3—I don’t know if you have it near you, but I’ll just read it for you; it’s fairly straightforward—it says: The policy agency for the control of drugs is the Department of Health and Aged Care. This includes ensuring compliance with the following conventions that Australia is a signatory to the:

Single Convention on Narcotic Drugs 1961, as amended by the 1972 Protocol;

Convention on Psychotropic Substances of 1971; and the

United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychoactive Substances 1988.’

As far as I’m concerned, we should get out of the UN. Even if we stay in the UN, we should just take no notice of these or at least revoke our signatures.

CHAIR: Let’s stick to this inquiry. We can have another one on that if you like.

Senator ROBERTS: Given that, what’s your advice there? Apparently, according to Department of Home Affairs, there are several other laws within this country that Commonwealth has enacted that are associated with these. What’s your advice regarding UN conventions and obligations and also Commonwealth biosecurity laws and other laws? We’ve got about half a dozen listed here by the Department of Home Affairs.

Prof. Keyzer: Thank you for your question. My response would be in two parts. Firstly, as a principle of constitutional law, the Commonwealth parliament can decide how far and to what extent it implements international treaty obligations into domestic law. There’s a decision of the High Court in 1996, reported at volume 187 of the Commonwealth Law Reports, page 416, in which a five-judge majority of the High Court of Australia, led by Sir Gerard Brennan, held that it is a matter for the Commonwealth parliament to decide what parts of a treaty it will implement into domestic law. The debate about the operation of the single convention, whether in Australia or any other country, and declining to give effect to that convention by creating a legal market for regulated cannabis has been had in Canada about 10 years ago. I commend any person who’s interested in the topic to read the debates that were had in parliament and the research that was done around that issue at that time. In other words, Canada is sufficiently similar to us that their considerations around the issues that you raised are very instructive. The second observation I’d make is a little bit of a discursive—just like I think you did just a moment ago, Senator Roberts. I find it interesting that the Australian Department of Home Affairs would insist on the implementation of those treaties into domestic law when there’s so much evidence of the Australian government’s unwillingness to comply with the International Covenant on Civil and Political Rights in its treatment of immigration detainees. That’s not just me saying that. That’s the United Nations Human Rights Committee.

Senator ROBERTS: Thank you very much. What about the other laws that this proposed bill, if passed, would violate—import regulations; biosecurity—

Prof. Keyzer: I think what you’d need to have happen there is—obviously, there needs to be an advice from the Commonwealth Solicitor-General, drawing the attention of the people in his office to the implications of the legislation for the various instruments that have been identified by the Department of Home Affairs so that one can feel confident that the legislation would survive a High Court challenge. I’ve read the bill. I can’t see any significant or major problems. I also am, unfortunately, unable to predict what the High Court would decide, although I’ve certainly tried and had some success on some occasions. No Australian constitutional lawyer in Australia, including the Solicitor-General, would give an unequivocal advice about a matter such as this. But certainly the bill seems to be consistent with the Constitution, according to my reading of it.

Senator ROBERTS: Thank you. The next question is to do with comparison with alcohol. This is going to be very subjective for you, but that’s what I’m interested in. You know a hell of a lot about this topic, so I value your advice. People say there are two camps. They say, ‘Well, a recreational use of cannabis is not as dangerous, harmful, damaging or addictive as alcohol’. Then the other camp says, ‘We’ve already got alcohol making a mess of our society. Why add another one?’ What are your thoughts on those two arguments, please? How dangerous is cannabis recreational use compared to alcohol? Is it lesser? Then take it from there.

Prof. Keyzer: Thank you for your question and for also acknowledging that, to answer it, I’m straying a little bit into the edges of my expertise. Certainly you can buy and consume a lot of alcohol and you can get very drunk, but a lot of people don’t. A lot of people will buy alcohol, they’ll consume it in moderation and they’re able to lead happy and successful lives even though they don’t mind having a glass of wine at the end of the day. Australia is a country where it is known that per capita we drink large amounts of alcohol compared to other countries around the world. Professor Lee and the other medical experts are better placed to talk about alcohol-related harm and that sort of thing. I think it’s fair to make an observation that there is a double standard here and that there are many adult users of marijuana who would say that they can consume in moderation and it hasn’t affected their health adversely or, if it has affected their health adversely, they have it under control. Ultimately, it’s a matter for government to decide whether to allow people to exercise their own good judgement. Again, everything I’ve been saying today—I’ll just reiterate what I said at the start—is about the adult use of marijuana. I note Professor Toumbourou’s expertise in adolescent use of alcohol and adolescent use of marijuana, but his research is not concerned with the adult use of marijuana. We’re talking about adult use here. The question whether an adult should have the opportunity to decide whether they want to have a smoke or a drink has historically been something for an adult to decide. There are plenty of other jurisdictions that are doing this, as we know. This is a matter of politics, and it’s a matter for people like you.

Senator ROBERTS: Thank you very much.

Senator ROBERTS: Thank you. Is it true that, unless a product has a sponsor, there’s nobody to put an application through the TGA? You don’t do public interest applications such as cannabis—is that correct? It needs a sponsor?

Prof. Langham: That’s correct. We require a sponsor to present a product to us for consideration of safety, quality and efficacy in order for it to be registered.

Senator ROBERTS: Thank you. So cannabis can never be scheduled for medication on the PBS because there’s nobody to sponsor the application because there’s no patent to make that a profitable proposition. Is that correct?

Prof. Langham: That’s not correct. Scheduling is an entirely different consideration. The requirements around scheduling have to do with the particular toxicity, the potential for abuse, the potential for diversion and the potential for addiction. They are the particular properties of particularly THC-containing compounds that have been placed on as schedule 8. Schedule 4 are those that be prescribed and must be on the ARTG for schedule 4.

Senator ROBERTS: Could you use the reports of lack of harm for the products available under the pathway scheme? We’ve now had several years—is it six years?—of the pathway scheme. I asked in Senate estimates and was told that the department was not recording harm from cannabis prescribed under the pathway scheme. Is that still correct?

Prof. Langham: It’s correct in a way. When we are dealing with unregistered drugs, such as cannabis and other unregistered medicines that we provide access to, there is no requirement or no opportunity to act on adverse events. So we don’t legally require sponsors to report under the act.

Senator ROBERTS: Okay, thank you. So you’ve now added the word ‘legally’. Document discovery around that answer produced a document that listed harm from the pathways prescriptions for cannabis. Do you record harm resulting from cannabis prescriptions under the pathway scheme—yes or no? I heard there’s no legal requirement, but I want to know if you’re recording it anyway.

Mr Henderson: As Professor Langham noted, we don’t legally require the adverse events to be recorded, but I do have some numbers here. Since 2016 to 30 January 2024, we have received 614 adverse events in relation to medicinal cannabis products. The most commonly reported adverse events are nausea, diarrhoea, dizziness, sleepiness and headache. So, although they’re not legally required to report to us, we do record and keep record of those adverse events.

Senator ROBERTS: Thank you. Couldn’t you use the six years of prescribing data to authorise cannabis by THC CBD terpene flavonoid profile for schedule 4 based on the pattern of safe use over the last six years—if you wanted to, that is?

Prof. Langham: The data requirements, the dossier requirements and the evidence requirements for substances such as medicinal cannabis to lead to registration—I might add that there are two medicinal cannabis compounds that have been registered. The dossier requirements are extensive in that there’s a requirement to prove efficacy through a series of randomised control trials and also through safety in terms of laboratory production and quality as well. That’s, I guess, the source of evidence. The data that you’re suggesting would really not be sufficient to support registration of a medicinal cannabis drug, if that’s your question.

Senator ROBERTS: I’ll come back to that in a minute. How can the TGA approve an untested experimental gene therapy based treatment, the mRNA vaccines, yet put off for years a safe treatment that millions of Australians are using? Millions of Australians are using medicinal cannabis. I was told by Professor Skerritt personally in Senate estimates that the TGA in Australia did no testing of the experimental gene therapy based treatments—mRNA vaccines. They relied upon the FDA in America. The FDA in America had already previously advised publicly that they had done no testing and they relied on Pfizer. Pfizer later confessed to not finishing its trials and having serious questions about those trials. Yet the mRNA was approved. We’re getting millions of Australians on medicinal cannabis seeking it for the right reasons, by word of mouth. And, as Senator Scarr has been taking up consistently, the price is very high because it’s not available readily. What’s going on?

Prof. Langham: Senator Roberts, apologies—I do need to correct you. The mRNA vaccines are not gene therapies. That’s No. 1.

Senator ROBERTS: So gene therapy based treatment—

Prof. Langham: I’m sorry, can you let me finish please? The mRNA vaccines are not gene therapies. Secondly, the clinical trials that were undertaken to prove their efficacy were not done in Australia, no. But that’s not to say we don’t register other drugs where the clinical trials are not done in Australia. They were extensive, they were robust and all of the processes, from production through to clinical trials and outcomes, were evaluated and assessed as robust, safe and efficacious by both the FDA and the TGA prior to their registration.

Senator ROBERTS: So the FDA publicly—

CHAIR: Senator Roberts, we might be veering into territory which is not relevant to this inquiry. Can you direct your question—I know you’re asking about the comparison, but can we keep on the relevance of this inquiry. I’ll have some questions at the end.

Senator ROBERTS: Out of respect for the chair, I will do that. I’d like to see the list of tests that were done by the FDA itself—not what they relied upon but the testing that the FDA had done on the experimental mRNA vaccines, please. Could you take that on notice?

Prof. Langham: Senator Roberts, I would be happy to send through to you the other information that was provided through Senate estimates process that we’ve already done. I’ll undertake to do that for you. I might add also that a lot of the information we’re talking about is already publicly available.

Senator ROBERTS: Thank you. Germany proposed a bill for sensible cannabis regulation. After trying to get consensus from regulatory authorities, they gave up and now propose decriminalisation. Do you concede that the risk in defending the status quo is that you force a wider deregulation, as Senator Shoebridge is doing here?

CHAIR: You might be asking those officials for an opinion. It might be best to ask about what the Commonwealth policy is or isn’t, if that can assist you in any way. But officials aren’t able to give you an opinion on an issue.

Senator ROBERTS: Okay. Are you aware that Germany proposed a bill for sensible cannabis regulation and, after trying to get consensus from regulatory authorities, they gave up and now propose decriminalisation? Are you aware of that?

Mr Engel: I’m not sure if other agencies have a view, but I’m not aware of that specific case in Germany.

Senator ROBERTS: Thank you.