MASRI, Mr George, Assistant Secretary, Regulatory Services and Drug Control Branch, Department of Health

PEGG, Dr Grant, Assistant Secretary, Pharmacovigilance and Special Access Branch, Department of Health

SKERRITT, Adjunct Professor John, Deputy Secretary, Department of Health

[17:05]

CHAIR: Welcome. Thank you very much for coming today and for being here throughout the proceedings. I remind witnesses that the Senate has resolved that an officer of a department of the Commonwealth or of a state shall not be asked to give opinions on matters of policy and shall be given a reasonable opportunity to refer questions asked of the officer to superior officers or to a minister. This resolution prohibits only questions asking for opinions on matters of policy and does not preclude questions asking for explanations of policies or factual questions about when and how policies were adopted.

I invite you to make an opening statement if you wish to, and then we'll ask you a lot of questions.

Dr Skerritt : Very briefly: people who appear as witnesses are entitled to voice opinions—other than those who are officers of the Commonwealth, of course. I think, however, it's incumbent on us to correct a few misunderstandings and facts that have been voiced during the day in terms of the opportunity to correct facts. I'm happy, once we check that the patient details have been de-identified—although they are largely de-identified by the time we get them. That's my scrawl on this example. This form is the special access B form, and the overwhelming number are, depending on whether you want to print it two-sided or whatever, one and a third pages. Generally there are no attachments.

We have heard today that there's a need for a patient declaration on informed consent. That's not part of this form or our requirement. The actual information—which is largely the doctor's address and the patient's details—about previous medicines tried and justification is eight, nine or maybe, if they're very wordy, 10 column-centimetres, or 100 words or so. This is one for chronic neuropathic pain. It's not, for example, one for paediatric epilepsy, where the evidence is extremely strong. The evidence about pain is still contested in many areas. This is one that was approved last week, for example.

Secondly, I want to clarify: it's not required that all other options have been exhausted. This is the Special Access Scheme for unapproved medicines. The law of the land is such that because these medicines are unapproved they haven't been evaluated for safety, quality and efficacy. Indeed, most medicinal cannabis products that are coming into Australia have not been assessed for safety, quality and efficacy by anyone. We do have requirements for quality, such as a TGO 93 declaration. Because of that, there is the requirement in law that they have to explain what they've tried, and it would generally not be seen as first line. We have heard today incorrectly that this scheme is only for if every other single medicine has been exhausted.

The other thing is that it has also been asserted that this whole scheme was created for medicinal cannabis, or it was shoehorned into the scheme. For medicinal cannabis, as people have talked about, there were about 30,000 or 25,000 special access B last year, but the total number of Special Access Scheme last year was 105,000, so it still only represents a minority of the total amount of the Special Access Scheme. This is a scheme that's been going for a long period of time and is used extensively for unapproved medicines. This form is available online and is cloned. If a medicine is out of stock, a new form does have to go in electronically and is looked at within 48 hours—generally much faster than that. They would need to replace these one or two boxes down here with the names of the replacement medicines. It's a cloned form, so it's retained on the site. In that sense, it's been streamlined. As I say, our service standard is that everyone is done within two working days.

Senator BILYK: Is that standard always met?

Dr Skerritt : To my knowledge. There are some times where there might be some public holiday you've never heard of in the Northern Territory or in Queensland inconsistent with Commonwealth public holidays. But it's two working days for both jurisdictions.

That leads me onto the other comment: why are the states required to be involved at all? State approvals do apply for S8 drugs, so it's not true to say that there is absolutely no control over a GP or anyone else trying to get a prescription for an opiate or a schedule 8 drug. There are state requirements in many states about the maximum dose that can be prescribed. I think in all states there are rules about the total duration; if you exceed eight weeks or two months, state authorities are required to be given. Then there's a check that the patient does not have a drug dependency. Those checks do apply for other drugs, whether they're opiates or other schedule 8 drugs, as well as schedule 8 THC.

One of the other things to clarify is around clinical trials. There are at least a dozen—perhaps as many as 20—commercial clinical trials of cannabis products underway in Australia. These are with the expectation that they will seek ARTG approval, which has always been the way because that's a pathway to the Pharmaceutical Benefits Scheme. We heard earlier that in March the drug for multiple sclerosis is coming up again to the Pharmaceutical Benefits Scheme. We cannot disclose the list of products before us. But, because the company has disclosed to the stock exchange, we can disclose that there's a cannabis based drug for epilepsy that's also been submitted to TGA for review.

The other thing we've perhaps heard some confusion about today is plant extracts. We've got eight or nine examples of where TGA has registered a medicine that is actually a mixture of plant extracts. There's nothing magic about using a drug that is an extract of a plant. It has to be standardised; it can't vary dose to dose. You always have the same ratios of things in that plant extract. We've already got one cannabis drug like that on the register—Sativex for multiple sclerosis—and for a range of other conditions there are about eight or nine other drugs. So there's nothing that stops that sort of thing, the same way that there's nothing that stops—as we heard some of the others say—use of either an accelerated approval based on an overseas regulator's review, the potential to apply for a provisional pathway where more evidence is gained while the product is on the market and those patients are monitored, or indeed other pathways, such as using a literature based submission.

Finally, there are different security requirements for THC and cannabidiol crops. Again, commercial confidentiality requirements mean I can't go into details because it may identify particular sites and locations, and policy is that we don't disclose names and addresses. For example, at a site that only applies to grow cannabidiol crops—these can be indoor or outdoor, but if it's outdoor it may have one layer of high fencing—they can incinerate or compost their crops on site. If it's high THC, they have to have additional security measures—it might be two layers of fencing; it might be security cameras; it might be 24-hour monitoring—and they actually have to account for all the crops that are unused and discarded. So there are already different requirements for CBD and THC crops.

There is an issue in international law about whether hemp crops, industrial hemp as we heard the previous speakers say, can use those crops, and I'm happy to go into that in more detail if senators wish. I would add that the Narcotic Drugs Amendment Act, when it was introduced and passed through the parliament in 2016, had a highly risk-averse posture. That's not an opinion expressed by a public servant, but the view, which has been endorsed by government, of the external review of our narcotic drugs act. So Professor McMillan, former Australian ombudsman, completed a review in July last year. The government has accepted all of the recommendations in principle and has already amended certain regulations under the existing act. It has also made a public commitment to introduce legislation into parliament, hopefully by midyear, to amend the act to take a lot of the unnecessary regulatory burden out of it and to adopt a more liberal posture, because it was highly risk-averse.

Finally, I do want to make one point clear. There has been a lot said today about the International Narcotics Control Board and this term 'scheduling' that they use. It is quite a different issue from what we in Australia call scheduling. There has been a lot of confusion and some misunderstanding about that, including from senators. So the United Nations Commission on Narcotic Drugs has this WHO recommendation to take cannabidiol out of the class of schedules, as they said, as drugs of dependence. There may well be implications for how hemp can be handled as a result of that, but I would remind senators that that has not yet gone—it has been deferred twice, for reasons outside our control, for discussion in the United Nations forum. It may be discussed this March—that's still to be confirmed—and, no, we do not know what the Australian government official position is on that. But that is about whether cannabidiol is or isn't a drug of dependence.

Now, in Australia, we actually took it out of the—we have schedules. Medicines are unscheduled, or schedule 2, 3, 4, 8 or 9. We took cannabidiol down to schedule 4, if it's sufficiently pure, because it wasn't a drug of dependence. In a way, we were actually ahead of WHO by a couple of years there. And while that may have implications for how hemp is handled that does not relate to whether scheduling, for example, low-dose cannabidiol products could be considered for over-the-counter use. That's something that could be considered at any time in response to an application. I'll leave it there, but I just wanted to clarify a few areas of misunderstanding.

CHAIR: Thank you.

Senator URQUHART: Thank you for your clarification of some of those points. I just want to go to a couple of areas in your submission. You say, on page 13, that over 18,000 patients have accessed the medicinal cannabis legally. That's obviously very welcome, but do you acknowledge that there is still an unmet demand?

Dr Skerritt : It's not the role of a regulator to assess demand for a product. We don't go out and say, 'Hmm, there's a new drug for breast cancer and there are 5,000, 10,000 or 520,000 patients.' We believe that demand is determined by the patient-doctor discussion. So we don't have a position on what demand is for any particular drug.

Senator URQUHART: So you haven't analysed or modelled the extent of that demand or how many people are actually missing out?

Dr Skerritt : No. Well, the phrase 'missing out' is subjective, but we don't have an idea of the number of patients who would like—again, it comes down to do you say, 'Is this the number of patients who'd like to have access to medicinal cannabis, or the number of doctors who'd like to prescribe it?' At the end of the day, our role is to enable products to be available. In the case of unapproved medicines, our role is additional controls to check what they're prescribing is appropriate. In about five per cent of cases, we return the SAS B application because we have questions about it.

Senator URQUHART: The Lambert initiative estimated that only three per cent of people using medicinal cannabis in Australia are able to do so legally, which means that up to 600,000 people are missing out on legal access. Do you have any comments on those estimates?

Dr Skerritt : No. We have no way of knowing how those figures were obtained.

Senator URQUHART: Do you contest those numbers?

Dr Skerritt : We have no way of knowing whether they're correct or incorrect.

Senator URQUHART: Putting aside that number then, what are the key barriers to accessing legal medicinal cannabis as of today?

Dr Skerritt : I think the main issues have been raised throughout the submissions and throughout the testimonies today. Clearly, when a medicine—and it doesn't matter whether it's cannabis or a cancer medicine or even a range of other medicines—is not PBS reimbursed, it means that, for those who are of challenging means, the cost is a significant factor. The cost of medicinal cannabis does vary tremendously. Some of the low-dose THC products are as little as $5 to $6 a day. That's still a lot if you're on a pension, but if you're in a good job, like all of us here, that's affordable. The challenge is for the children, especially the larger children, who are on the cannabidiol medicines for epilepsy, because the amount of cannabidiol used for each child—the actual quantity, the size of pill—is quite large. The cost, as we've heard today, can run into the thousands of dollars a month.

Senator URQUHART: So would cost be the key barrier that you see?

Dr Skerritt : The various ones—cost, doctor education. But, at the end of the day, there's a link between education and evidence. The evidence varies in strength depending on the condition or indication. There would be few doctors, for example, who specialise in epilepsy who would not be satisfied with the quality of the data supporting the use of medicinal cannabis products as an adjunct in certain genetic epilepsies in children; the evidence is quite strong. It's quite contested in other areas like pain, for example.

Senator URQUHART: Can you talk me through what the government is doing to address those issues such as cost and doctor education. What role is the government undertaking in those areas?

Dr Skerritt : The policy of the government is to encourage more and more of these products to be TGA registered and for the companies then to seek reimbursement through the Pharmaceutical Benefits Scheme. It does appear that we've developed two broad commercial models. Some companies are clearly not expressing interest in producing registered pharmaceutical medicines. Others, as indicated by the 12 to 20 commercial clinical trials—and I say 12 to 20 because some of the them are partnerships with academia—clearly have a priority of getting products on the TGA register and then, hopefully, on the Pharmaceutical Benefits Scheme.

Senator URQUHART: So is that simply what the role of government is at this stage?

Dr Skerritt : State and territory governments have also been quite active in funding a range of compassionate access schemes. There are a range of schemes, and we're happy to provide our summary of those on notice. While they vary in the number of patients that they can target, many of them have indeed targeted the patients of greatest need, such as kids with serious epilepsies.

Senator URQUHART: It would be useful if you could provide the state and territory stuff on notice. Just to go to the states, in your submission, on page 21, you've got the documentation that shows that there are no authorised prescribers in South Australia, Tasmania, the ACT and the Northern Territory. Is that still the case? I think that was as of 2019.

Dr Skerritt : Yes. There are two issues. Firstly, the term 'authorised prescriber' has often been used incorrectly in the media. Remember there are two broad approaches to accessing an unapproved medicine. The first is the Special Access Scheme, where you do it patient by patient. The second is broad authorisation. We had expected that the majority of medicinal cannabis would come through a large number of authorised prescribers when the scheme came out, but we can't say to a doctor, 'You must become an authorised prescriber.' We have some doctors who may have prescribed—I don't know, Grant?—50, 100 or more SAS applications, and they say to us: 'Well, I can clone them now. It's easy. It's just a couple of keystrokes. I couldn't be bothered becoming an authorised prescriber.'

Senator URQUHART: In Tasmania, where Senators Askew and Bilyk and I are from, we've got a state government who hasn't signed up to that streamlining process that they need to go through. Why have they not done that and what assistance has the Australian government given those states to do that?

Dr Skerritt : COAG health ministers did discuss this. Minister Hunt strongly urged other health ministers to come on board with the scheme. Tasmania made their sovereign choice not to take part in the scheme.

Senator URQUHART: Can you tell me why they made that choice? What was their rationale?

Dr Skerritt : I wasn't in the room for those discussions. They believe that the system of, on the one hand, strictly limiting the number of patients but, on the other hand, funding every single one of the 17 or so patients was the best. That was the view of the Tasmanian government.

Senator BILYK: Where did that number of 17 come from?

Dr Skerritt : We believe that there have been 17 patients who have been supported in Tasmania only.

Senator BILYK: Seventeen patients, not 17 applications?

Dr Skerritt : Seventeen patients. I think the number of applications is higher. That figure is in the public domain.

Senator BILYK: And that's through specialists?

Dr Skerritt : In Tasmania, they're the only state that remains with the absolute requirement for specialists.

Dr Pegg : That's right.

Dr Skerritt : Thanks, Grant. Just checking.

Dr Pegg : Can I add something there? We also engaged heavily with Tasmania in the development of the streamlined online system.

Senator URQUHART: Okay. Tell me about that. Why aren't we doing it?

Dr Pegg : As you can imagine, it was quite a complex process engaging with every state and territory with their various requirements and building that into an IT system. Tasmania was part of that conversation but indicated they didn't want to be part of it and didn't really clearly articulate that to us. As John has indicated, that was mooted at COAG. The other thing I would mention is that if the Commonwealth were to receive an application from a patient in Tasmania we would assess it on its merits and approve it if it met the criteria. However—

Senator URQUHART: But it just makes the hurdles—

Dr Pegg : It would be moot because the state requirements are basically an agreement.

Senator URQUHART: So the impact on those patients in, say, Tasmania, even though they could go through that process, is an impact that they wouldn't really need to have if they lived in, say, Victoria or somewhere?

Dr Pegg : Correct.

Senator BILYK: So it's a postcode situation at the minute, isn't it?

Dr Pegg : The system as it stands, if a doctor in Tasmania is to make an application through—

Senator ASKEW: Can I clarify your comment earlier. Was it about the computer system? Was the expense of that the issue?

Dr Pegg : No, it was in the development of that, because each state and territory has different requirements. We had to build in, for want of a better word, a smart form in the back end of the system to, once a prescriber selected which state they were in, walk them through the requirements. That's why there was close consultation with the states and territories.

Senator URQUHART: I want to clarify—obviously these dates are when your submission was written—that there have been 12 SAS category B approvals in Tasmania, but you talked about 17, so I'm not sure what the difference there is, and five in the Northern Territory.

Dr Skerritt : It may be an issue of timing. Last I heard it was 17 in Tasmania. I remember it well. It was finalised on Boxing Day.

Senator URQUHART: Okay. So there are hardly going to be five since Boxing Day.

Dr Skerritt : There could have been five more. They might come through in clusters. I think the main point is that the number is disproportionately small compared with other east coast states.

Senator BILYK: Part of that might be that they have to actually go to a specialist, mightn't it?

Dr Skerritt : Yes.

Senator BILYK: And what if they can't afford it?

Dr Skerritt : These are requirements—believe it or not, we still have states, senators. The states do have their legal rights to be able to do this. We often get correspondence to say the Commonwealth should override the Tasmanians and this, that and the other. As much as it may be tempting, this business is perfectly within the legal pharmaceutical framework for the individual states and territories.

Senator URQUHART: Just in terms of that, then, is the Commonwealth working with the Tasmanian government to address that? Are both jurisdictions committed to fixing the problem in Tasmania?

Dr Skerritt : It depends on whether you identify it as a problem. I know that Minister Hunt—

Senator URQUHART: I'm sure the patients do.

Dr Skerritt : Yes. Minister Hunt has committed to raise it with Tasmania at every opportunity he has. There is another meeting of health ministers, I think, late in February. I would be surprised if he didn't raise it. Again, it is Tasmania's sovereign right to manage their scheme as they wish.

Senator BILYK: Sorry, Senator Urquhart, I need to clarify this: you said 12 as of Boxing Day—is that correct?

Dr Skerritt : We can clarify that on notice. We will clarify it with the chief pharmacist.

Senator BILYK: I'm a bit confused about whether it's 12 or 17.

Dr Skerritt : If I can take that on notice, we'll clarify it with the Chief Pharmacist of Tasmania.

Senator BILYK: I'm wondering whether the extra five are the Northern Territory ones.

Dr Skerritt : We can never give up-to-date numbers on medicinal cannabis when you have, nationally, 3½ thousand new ones every month. Every day we're always a couple of hundred out if we're reporting to senators and ministers.

Senator BILYK: Maybe you can take that on notice.

CHAIR: If you can clarify that. The point is that it's an exceedingly low number.

Dr Skerritt : It is.

Senator URQUHART: That's probably because of the process.

CHAIR: Exactly.

Senator URQUHART: Can you confirm that there are no clinical trials of medicinal cannabis in Tasmania or the Northern Territory?

Dr Skerritt : I would have to take that on notice. Most of them are in the other mainland states and territories. Most of the money for this is from companies in Victoria, New South Wales, Queensland and Western Australia, as well as the state governments, such as New South Wales, who have also funded clinical trials.

Senator URQUHART: In the table you've got on page 23, Tasmania and Northern Territory don't show at all. I'm trying to clarify that.

Dr Pegg : That would indicate that that is correct. To clarify, the data we hold with respect to clinical trials is a notification scheme. The trial sponsor notifies the TGA prior to commencement of the trial once all other various approvals are in place. They will nominate where their trial sites are. An extract of that is how we populated the table.

Senator URQUHART: So we can assume by that that there are none. What impact does that have for patients in Tasmania and the Northern Territory that there are no clinical trials?

Dr Skerritt : If they were to take part in a clinical trial they would have to travel interstate.

Senator URQUHART: So there's no opportunity for them to do that?

Dr Skerritt : Not in their home state. That's really the decision of either the public sector researchers or the private sector companies as to where they form partnerships to hold those roles.

Senator URQUHART: Would you agree then that there is significant variation between jurisdictions in access to medicinal cannabis, given that that's clearly—

Dr Skerritt : I think the facts show that there is a difference between jurisdictions in the number of SAS, Special Access Scheme. Again, we are responsive to that. We accept what we receive and also clinical trial notifications.

Senator URQUHART: It certainly undermines the concept of a national scheme, doesn't it, when you haven't got states and territories that are participating?

Dr Skerritt : It reflects two things. It reflects differences in the willingness of doctors to prescribe—for example, if you look at it demographically, there are differences that don't correlate with population, even for mainland states, and then you also look at where research groups and industry choose to form partnerships to establish clinical trials. If you took a particular group of cancer medicines, there would be some states and territories that would not have trial sites. This is a common problem. We often hear that if you've got cancer you have to be in Sydney and Melbourne to be in the clinical trials. The government has brought in a measure to encourage clinical trials—I'm now talking more broadly on clinical trials—in rural and remote areas, but it has been an ongoing challenge globally as far as access to clinical trials once you're outside major cities.

Senator URQUHART: Are you saying Hobart's not a major city?

CHAIR: Don't go there!

Dr Skerritt : I better not go there, Senator. In fact, if it's any comfort, I really like Hobart. I was in Hobart—

Senator URQUHART: It doesn't matter whether you like it or not; the fact is you can't get the treatment.

Dr Skerritt : Senator, I was in Hobart on Monday, two days ago. It really just determines where for the companies, the research and the hospital institutions.

Senator URQUHART: In your submission it tells us that the National Health and Medical Research Council has invested $3.4 million in medicinal cannabis research over the last decade and that another $3 million will shortly be available through the Medical Research Future Fund. Of course that's welcome, but would you agree that they're relatively small amounts?

Dr Skerritt : We don't have any influence on the relative quantum of funds for the NHMRC.

Senator URQUHART: What would be a normal amount for a trial of research?

Dr Skerritt : The trials vary hugely according to their size, whether they're observational trials or whether they're randomised. Research funding for a clinical trial can be a couple of hundred thousand up to many millions of dollars. I think it's fair to say that there's a reasonably dynamic group of clinical trials being done with industry funding and also with state and territory funding, as well as with funding from these sources. We actually have a link to the clinical trials that are current—not ones going back 10 years, but ones that were in the last few years, and many are still going—on the TGA website. They go into the dozens. You can see that the number of notifications, if you add them all up, also goes up to probably over 100.

Senator URQUHART: Would you agree that additional research would help build the evidence for medicinal cannabis and possibly strengthen ultimate TGA and PBS applications?

Dr Skerritt : Certainly—

Senator URQUHART: We've heard today that that's what's needed.

Dr Skerritt : but I'd also like to clarify that, especially in TGA registration—and, indeed, PBS—looking at the efficacy base we are not country specific. We look at evidence from all over the world. Many of our new medicines are reviewed and approved where most of the patients involved in the clinical trials have been based overseas. It's really looking at the quality of the data, not that they have been within our borders.

Senator URQUHART: Your submission acknowledges resourcing and processing challenges for the Office of Drug Control. Has the government made additional resources available to the ODC? We heard earlier that it's very underfunded and under-resourced, so has the government made any additional resources available?

Dr Skerritt : I'll pass over to my colleague Mr Masri, but, as we heard before, the original staffing of the Office of Drug Control was premised on a Deloitte's study that suggested that there were going to be only a handful of applications. Therefore, it wasn't a scalable funding model. If the TGA gets twice as many new medicine applications, the TGA gets twice as much funding. The model for the Office of Drug Control has the money going into consolidated revenue and then, with a bit of a lag time, we have to apply for that funding based on the volumes we expect. Everyone was caught out. The volumes were much higher.

Senator URQUHART: So, having been caught out, has the government made additional resources available?

Mr Masri : There are a couple of factors to take into account. The government did provide to the ODC, in the context of the medicinal cannabis scheme, additional funds in the December 2018 MYEFO decision.

Senator URQUHART: How much was that?

Mr Masri : It amounted to a bit over $5 million. It was a significant increase on what was the projected volume of work and the staffing requirement. What we're conducting presently—and we'll be shortly engaging with industry as part of our responsibility to consult around fees and charges—is an assessment of the work effort involved. In considering the work effort involved and, therefore, the resources we require, there are a few challenges. There is projecting further licence applications, the nature of the industry and the regulatory activity that we'll be focusing on. We're still getting 10 or 12 applications a month—we're close to 300 applications for licences. Then you have the permits and the compliance sort of work. We're factoring in that our regulatory focus will be moving from licence applications to permits, permit renewals, variations and, importantly, inspections and compliance.

Starting tomorrow in Melbourne and going to Brisbane on Friday and Sydney on Monday, we're about to provide some options as a starting point to talk about the fees and charges that we're likely to ask the government to agree to. We've got obligations, in relation to fees and charges, to be consistent with the Commonwealth government's framework on fees and charges. Effectively there are some options that we're looking at to ensure that we have a more agile and appropriate set of fees and charges that will actually reflect the effort involved in our regulatory function. We've had some quite constructive discussions with the Department of Finance charging area just to ensure that we're consistent. We're engaging with them around our obligations under the charging framework. We're confident that through this process we will get a better revenue source through a more appropriate fees and charges framework and that will give us then the right level of resourcing.

The other important thing is that, as Professor Skerritt mentioned, even though we don't have a special account, unlike the TGA, there are opportunities to review and adjust what we will get by way of revenue from industry to match our resource requirements. We have the benefit, I guess, of three-years-plus regulation. We've also got to factor in that there will be amendments to the legislation that will streamline some activity. We are factoring in some of that streamlining. We're factoring in business process improvements, we're removing duplication and we're making some internal improvements. I'm reasonably confident that we'll have a pretty good basis for the appropriate level of resourcing.

Senator URQUHART: I have a quick follow-on question. There was $5 million in the MYEFO of 2018. Is that what you said?

Mr Masri : Yes, December—

Senator URQUHART: Were there any additional FTE staff? And was it additional money or was it offset within the department?

Mr Masri : It was additional money. One of the important principles of a charging framework is that the revenue we get from industry should be what we get by way of revenue to fund the regulatory function. That's the basic principle. We're anticipating the revenue we get from fees and charges. That was part of our submission—that the volume of licence applications and permits means that we get more revenue. One of the challenges has been that we were limited by the ASL cap—also within the department. We've had to resource a lot of the new staffing by way of contractors. That is a challenge. Contractors are very much part of the team—we train them and we support them—but there's a greater level of throughput because there are other opportunities for contractors.

Senator DI NATALE: I want to go to the numbers again. We're talking about 18,000 patients in total. Did I hear that number correctly? Just a ballpark—

Dr Skerritt : There are about 19½ thousand patients now. As has been said before, we do not trace through to the script being filled and dispensed. We have heard that there are cases where patients get sticker shock and don't fill the script. Increasingly, the clinicians we talk to have a discussion with patients about the likely cost of the product. It's a very different discussion—a doctor having a discussion with a patient about neuropathic pain and using a low-dose THC product compared to a discussion about a child with epilepsy, where you will need a very high amount of CBD.

Senator DI NATALE: Basically, just that so I'm clear, these are 18,000 unique patients—

Dr Skerritt : We believe there are over 19,000 unique patients.

Senator DI NATALE: Over 19,000—sorry. A total of 25,000 was bandied around. Some of those will be repeat scripts. Is that why—

Dr Skerritt : Some of those are repeat scripts—yes. There were 25,000 SAS Bs last year, roughly.

Senator DI NATALE: But 19,000 individuals, and of those a proportion will not have had their script filled because of cost. We don't know how many, and it's not your role to—

Dr Skerritt : It's not our role, although, increasingly, in communications with clinicians, clinical groups—they didn't say it today, but one of the things they say to our members is that, for any non-PBS medicine, and it's been the same when I've been prescribed a non-PBS medicine, the doctor says it's going to cost $150 a month.

Senator DI NATALE: It depends on which doctor you see. We heard from the pharmacists. The pharmacists said to us that there are a number of patients who go there and say, 'Sorry, we're not paying for it.' That's the unknown, as far as we can tell. Did I hear correctly that you said there are 100,000 Special Access Scheme scripts—

Dr Skerritt : There are over 100,000 Special Access Scheme applications and notifications a year. Medicinal cannabis is only a proportion.

Senator DI NATALE: Maybe one-fifth of that.

Dr Skerritt : Maybe a bit more.

Senator DI NATALE: Okay. A quarter, if there are 25,000 scripts—

Dr Skerritt : Last calendar year—

Senator DI NATALE: So it's a quarter. Do any other drugs represent as big a proportion?

Dr Skerritt : No, but remember that medicinal cannabis products, as we've heard today, are not one product. They're also a cluster—

Senator DI NATALE: I get that, but we're talking about medicinal cannabis products. What's the next biggest unregistered drug through the Special Access Scheme?

Dr Pegg : We'd have to take that on notice.

Senator DI NATALE: Would one drug come close to representing a quarter of the Special—

Dr Pegg : No.

Senator DI NATALE: I would imagine you're talking about lots and lots of very different drugs and that maybe, at most, 1,000 or 2,000 might be represented by one drug.

Dr Skerritt : There are some that number a couple of thousand. Why we're a bit hesitant is that it varies dramatically by year. Often there will be a big burst of Special Access Scheme requests and then, with a bit of encouragement, a company will register it and it will disappear from the Special Access Scheme. We're happy to take, say, SAS B requests—

Senator DI NATALE: Yes, but it's a safe assumption to say medicinal cannabis is, by far and away, as a drug category—

Dr Skerritt : Well, we'll have a cluster. But there are quite a few antibiotics, for example, that are no longer registered in Australia, so there'd be a large number of them too.

Senator DI NATALE: What's the purpose of the Special Access Scheme?

Dr Skerritt : Well, the overall scheme is these products are unapproved, so they haven't been through TGA assessment for quality, safety and efficacy. Generally, the other Special Access Scheme drugs, such as those on Special Access Scheme C, have a long history. They might have been in the German and French markets for 20 years and the Australian market's too small.

Senator DI NATALE: I'm going to come to that in a moment.

Dr Skerritt : With medicinal cannabis, we actually don't have that. With those particular products we don't have that history of use anywhere in the world , regarding evidence of quality, safety and efficacy in the long run, so there are additional unknowns with medicinal cannabis compared even with many of the other drugs on the Special Access Scheme.

Senator DI NATALE: Do you feel that the fact that more patients are getting access is a good thing now through the Special Access Scheme?

Dr Skerritt : You've asked me for an opinion, Senator. We respond to demand. If 200,000 applied next year, 200,000 apply; if five applied next year, five apply.

Senator DI NATALE: Your job, though, is to test for safety and efficacy, isn't it?

Dr Skerritt : Our job, eventually, is to encourage—

Senator DI NATALE: That's the job of the regulator, isn't it?

Dr Skerritt : as many products as possible to go through the application process to be assessed against safety, quality and efficacy. So we're absolutely delighted, although we'll assess it on its merits, that there are other drugs now—cannabis based drugs—that are coming into TGA for—

Senator DI NATALE: Well, there's one.

Dr Skerritt : There's one that I've mentioned.

Senator DI NATALE: And it costs thousands of dollars. My point is: you're a regulator whose purpose is to assess safety and efficacy.

Dr Skerritt : And quality.

Senator DI NATALE: And quality. Yet every time we have this discussion through estimates you're very keen to tell us about the numbers of patients who have been prescribed medicinal cannabis through the Special Access Scheme, which is effectively a scheme that bypasses your role to assess safety and efficacy.

Dr Skerritt : Regulators globally have similar schemes.

Senator DI NATALE: That's not my point.

Dr Skerritt : But, Senator, if I could explain the policy intent—I think that's the role of an official. Regulators globally have similar schemes to the Special Access Scheme. They recognise that there may be medicines or groups of medicines that, because the market is small, the market is new or for other reasons, are not on the market either yet or at any one time—we've talked about the old French and German antibiotics, for example—and yet patients still have requirements for them, and the regulator has a role, and it varies by country, depending on their legislation. We have a role, therefore, in checking that these products are of appropriate quality, because they have to meet the TGO 93. We have a role to check under SAS B that the indications are appropriate. And, while 95 per cent go through, it's not 100 per cent that go through—

Senator DI NATALE: But these are drugs not assessed for efficacy, safety and quality in the way that you assess other drugs that are approved.

Dr Skerritt : They're not assessed as for registered medicines.

Senator DI NATALE: And yet we've got a big and growing number of products through a pathway that bypasses your central function, which is to assess products for safety, quality and efficacy. And every time we have this conversation that number keeps growing and growing, and, based on the trajectory we are on, we are looking at significant multiples of what we've got at the moment with people on a category of drugs that won't have been assessed for the functions that you exist to assess for.

Dr Skerritt : They're assessed for quality. Our ambition is that—

Senator DI NATALE: Sorry, let's be clear about this: they're assessed for quality.

Dr Skerritt : They're assessed for quality in terms of the requirement to meet Therapeutic Goods Order 93.

Senator DI NATALE: What does that mean? Let's be clear about this compared to what it means to get on the register.

Dr Skerritt : Therapeutic Goods Order 93 is a quality order. It's a legal instrument that goes into the content of THC and CBD having to be as declared. It goes into heavy metals. It goes into fungal and bacterial contamination, because there have been deaths—for example, in California—due to fungal contamination.

Senator DI NATALE: How do you assess those things?

Dr Skerritt : It is on declaration, but—

Senator DI NATALE: Do you test? Do you do any testing—

Dr Skerritt : We do.

Senator DI NATALE: or is it based on—

Dr Skerritt : It's on both. There's declaration, but we do do testing.

Senator DI NATALE: What proportion are tested?

Dr Skerritt : I'd have to take that on notice.

Senator DI NATALE: Less than one per cent?

Dr Skerritt : It's more than that. We don't test every batch, but we do check if there are problems or issues reported to us.

Senator DI NATALE: But not for safety, which is one of the things that has come up time and time again.

Dr Skerritt : No, our check for safety is when we receive the thing I waved around at the beginning.

Senator DI NATALE: That's a separate matter. I want to be clear: this is a very technical area, and it's very easy to confuse people.

Dr Skerritt : I'm the regulator talking to you about safety. We check for safety. For example, we had a toddler who was prescribed a specific medicinal cannabis product as a sleeping aid. We questioned the safety of that in a young toddler, and we've acted on that.

Senator DI NATALE: On a drug that hasn't been assessed for safety?

Dr Skerritt : On a medicinal cannabis product.

Senator DI NATALE: But it has not been assessed for safety. That's my central argument.

Dr Skerritt : That's why our ambition is that as many of these products as possible end up on the Australian Register of Therapeutic Goods.

Senator DI NATALE: But it's not happening. The opposite is happening. We are seeing an increasing number of people being prescribed a drug through a scheme that exists to bypass an assessment of safety, quality and efficacy based on your acts.

Dr Skerritt : I think you have to be patient. These clinical trials have only just started over the last couple of years.

Senator DI NATALE: I've been at this for five years; I've been very patient. I've been speaking to people whose kids are having fits. I've spoken to people who are puking their guts out because they can't access a simple, straightforward drug that they should be able to access legally. So don't tell me to be patient. I'm very patient, but I'm running out of patience.

Dr Skerritt : But the initial clinical trials—for example, ones supported by New South Wales or by Queensland—started less than three years ago. You know the time it takes from commencement of clinical trials through to the reporting.

Senator DI NATALE: We've just heard that in Canada that the market is 18 years old.

Dr Skerritt : Yes, it's 18 years old. Our uptake of medicinal cannabis is actually faster than it was in the first few years of the Canadian scheme, as we say in our submission.

Senator DI NATALE: Your uptake is through a scheme that bypasses what you do. Do you understand my point?

Dr Skerritt : This is a scheme for medicines that are not registered.

Senator DI NATALE: That's right.

Dr Skerritt : Is the alternative that we do not have a scheme at all?

Senator DI NATALE: They're not registered for safety, quality and efficacy. This comes up every time we meet through Senate estimates. You've got the numbers there. We've had an extra 3,000 people through the scheme. We've just heard again that we're up to 19,000 people—only 17 in Tasmania. It's terrible. People are accessing a drug via a pathway that bypasses what you exist to do. Doesn't that say to you that there's something wrong with the scheme?

Dr Skerritt : I do not agree with your assertion that it bypasses in full. Our role—why we have an SAS B—is to look at signals for safety about particular patients. That's where we go back to the clinician and say: 'We think your dose is 10 times too high. You shouldn't be giving this to a toddler.'

Senator DI NATALE: But the drug itself hasn't been assessed for safety. You're making an assessment of safety on a drug that hasn't been assessed for safety.

Dr Skerritt : As we've heard throughout today, there is a reasonable amount known about the clinical safety of THC and CBD. That's different from assessment of a finished product. But we have clinical literature on the safety or otherwise of low, medium and high doses of THC, CBD and otherwise. This is why we can feel that there would be limited adverse events for a low dose of CBD, for example, going into almost any patient and why we might have some signals and concerns raised of a high dose of THC being given to a toddler. I think I've moved into a different universe if we're now asserting that there's not anything known about the safety of THC or CBD. However, these products have not been through as finished products, and that is the ambition. That is why the schemes exist, and, quite often once there are a large number of drugs that come through the Special Access Scheme, the next step is that they apply for TGA registration.

Senator DI NATALE: You've said that you couldn't talk about specific drugs. How many drugs are currently before you with an application for registration?

Dr Skerritt : I can talk about the GW Pharmaceuticals product—because they've announced it to the stock exchange—Epidiolex.

Senator DI NATALE: You can't talk in general terms about the number of drugs—

Dr Skerritt : I can't confirm or deny numbers, and that's the same for any pharmaceutical application. That's government policy.

Senator DI NATALE: So we can't have a sense of this—we're talking about categories; we're not talking about individual drugs.

Dr Skerritt : We can't disclose categories.

Senator DI NATALE: All right. Let's go to a few other issues. Again, you come at this from the perspective of a regulator. I come at it from the perspective of someone who has worked as a GP and who has spoken to patients. You gave the argument of opiates and that there are state requirements for the prescription of opiates. I'm not sure what argument you were trying to make there.

Dr Skerritt : I rebutted the assertion that you'd made because I thought it was an incorrect assertion that there were 'no controls' for GP prescriptions over opiates.

Senator DI NATALE: No, I didn't—maybe I was paraphrasing. But the point is that I can write a script, provided that it conforms with the appropriate dosages. A specialist in Tasmania is not going to step in and monitor my script for an opiate and say I can't prescribe it. Isn't that the case?

Dr Skerritt : It is if your duration is limited to under eight weeks in most states, if your dose is limited in most states, and if your patient does not have a history of drug dependence. That is why all states have a record of S8 prescribing and rules around schedule 8 prescribing. For example, in some states you have to do it in handwriting.

Senator DI NATALE: Sure, there are a number of requirements around prescribing the drug. My point is that as a GP I can prescribe it. I don't need to get special permission from you—

Dr Skerritt : It's because these drugs have been assessed by the TGA for safety, quality and efficacy.

Senator DI NATALE: Okay. Let's get to that then. What is the potential for overdose with any medicinal cannabis product compared with opiates such as Endone, Panadeine Forte and a range of others?

Dr Skerritt : Opiates have a much greater propensity for overdose; however, medicinal cannabis products are not without adverse events.

Senator DI NATALE: No, I'm talking about the potential for a fatal overdose.

Dr Skerritt : For fatal overdoses, it's much higher for opioids.

Senator DI NATALE: It's much higher.

Dr Skerritt : They're big killers.

Senator DI NATALE: How many people are you aware of who've died from a potential overdose of a medicinal cannabis product?

Dr Skerritt : I'm not aware of anyone who has directly, in a toxicological sense, died from an overdose of a medicinal cannabis product.

Senator DI NATALE: How many people in the US died last year from overdosing from opiates?

Dr Skerritt : I'd have to take the exact figure on notice.

Senator DI NATALE: I'll give you a ballpark. I think it's about 50,000 to 60,000 people.

Dr Skerritt : It depends whether you include fentanyl or—

Senator DI NATALE: Opiates—drugs which I can prescribe without any controls.

Dr Skerritt : Senator, my highest priority as the head of the TGA is to reduce Australian overdose deaths from opioids. To me that is my No. 1 priority.

Senator DI NATALE: I'll tell you what: have a look at some of the evidence that is emerging from the States, where medicinal cannabis is being prescribed, and you'll see a significant substitution effect and a reduction in overdose mortality from opiates.

Dr Skerritt : The evidence on that is sadly contested. The studies show, if you look at a state level where there have been strong medicinal cannabis schemes, that there are fewer deaths due to prescription opioids. But those states also tend to have good methadone and Suboxone programs, so they have good addiction-management programs as well. I'm not a drug policy researcher, but the cause-and-effect issue is still being debated. If we, for even one patient, could get someone off opioids and onto a suitable medicinal cannabis product, that would be a good thing. But I think it is still an area among drug policy people that is hotly debated—whether there is a direct substitution of people at the population level off opioids and onto medicinal cannabis—because of these confounding factors.

Senator DI NATALE: You might on notice want to review the evidence on this specific issue.

Dr Skerritt : I'm happy to provide you with references to half-a-dozen papers on that subject.

CHAIR: That would be appreciated.

Senator DI NATALE: Great. Excellent. The other issue that I think you raised was the issue of the scheduling of drugs. I think there might be a bit of confusion here. My understanding of the evidence provided from a number of witnesses was that, in relation to the Single Convention on Narcotic Drugs and the vote that's happening on CBD—and we don't know when that's going to happen—if in fact CBD is removed then the impact, while not direct, would be that it would provide more evidence for a change to the scheduling around CBD from schedule 4. I think that's the argument that's been made—

Dr Skerritt : I don't agree.

Senator DI NATALE: It provides another reason to change the scheduling of CBD here in Australia.

Dr Skerritt : Not if you look at the law of the land. Scheduling is determined by a thing known as a scheduling policy framework. A schedule 8 drug is something with a propensity for abuse, diversion and control. A schedule 4 drug, which cannabidiol is already, is not associated with a propensity for abuse. In the rescheduling of cannabidiol from schedule 8 to schedule 4—in a way, that's already happened.

Senator DI NATALE: I understand that, but the point I'm making is that it's another statement made by the international community that we don't think this drug is a harmful drug.

Dr Skerritt : I agree with your assertion there. Where I think we can flavour things is that several speakers asked—and we, indeed, raised it in our submission—whether it is appropriate for low-dose cannabidiol products to have to be a prescription, pharmaceutical or not. We're currently doing a literature review, and it is possible that that question will go out to public consultation.

Senator DI NATALE: Okay, that's encouraging.

Dr Skerritt : Should low-dose cannabidiol be available, for example, through pharmacies rather than on a doctor's prescription? But we're a couple of months away from that, and it would be an extensive public consultation because, as was highlighted earlier, there will be hundreds and hundreds of submissions with a wide diversity of views.

Senator DI NATALE: Yes. That's a shift, as far as I can tell.

Dr Skerritt : Well, the whole thing has shifted. It wasn't so many years ago that all these products were in the prohibited schedule, schedule 9. It's happening with cannabis, but it's almost the history of every single medicine over the last 50 years. If you take ibuprofen, it's very common. You can buy it at the 7-Eleven. That started off as a prescription medicine in Australia, and then, as we got familiar with its safety—it's comparatively low risk, although it does have some side effects—it moved down to being pharmacist only, and then they said, 'No, you don't need the pharmacist.' So this is a common pattern.

Senator DI NATALE: It's an encouraging pattern.

Dr Skerritt : Medicines move down from prescription only to over the counter. I can't predict what will happen and what the decision will be, but I wouldn't be surprised, as we've put in our formal submission, if there were a public discussion, with formal public consultation, submissions published, transparency and going to an advisory committee of experts and state and territory reps for their view.

CHAIR: What do you expect the time line for that to be?

Dr Skerritt : We, of our own volition, are doing a study that will be completed in March. We're happy to make the results of that study available. We will then ask the committee and get their advice, and I expect that they will say, 'Let's put it out to public consultation.' So it won't be until that study is complete and we have the discussion with the committee, but it would be during the course of calendar year 2020.

Senator DI NATALE: There was another thing that you said about GPs continuing to use the approval process for the Special Access Scheme rather than becoming authorised prescribers. I think the words you said were that they 'couldn't be bothered'. I want to understand what's involved to become an authorised prescriber. Am I correct in saying that you have to have either approval from a medical college or ethics approval?

Dr Skerritt : That's the approach. Again, my colleague Dr Pegg can explain a bit more. It was a little bit misconstrued earlier, that there was then a second round of approvals by TGA. Our role is more to check that the submission is complete. But the fundamental thing is approval by either the college or the ethics committee.

Dr Pegg : That's right. From the TGA end, it's essentially a regulatory check. The one example, perhaps, where there's a bit of nuance is in the cannabis clinic space, because the intent of the scheme is for patients under your direct care, and that model is potentially like a referral model, where a GP might refer. So sometimes it's not about a no or a rejection; it's more about tweaking some of those conditions.

Senator DI NATALE: Are most cannabis clinic doctors authorised prescribers?

Dr Pegg : There's a mixture. But we find that, as there's increasing familiarity with the SAS online system, what we're told by the prescribers who use it is that they prefer it, because the cloning function is something that they can—

Senator DI NATALE: Sure, but it's still a burden. You can argue about how much of a burden it is, but often for GPs a minute extra per patient is significant. But, if you can make your life easier, why wouldn't you, as a one-off, become an authorised prescriber? Your view was that they couldn't be bothered. I'm trying to understand. That doesn't make sense to me, given that you have to go through an ethics approval process or have a college approve it. I understand the College of General Practitioners and the College of Physicians won't approve it. So then you need an ethics approval. What's involved in an ethics approval for authorised prescriber status?

Dr Skerritt : As you know, many GPs—not all—especially if they're specialists or fellows of RACGP, have affiliations with particular hospitals and even universities.

Senator DI NATALE: Most don't.

Dr Skerritt : Many don't.

Senator DI NATALE: Most.

Dr Skerritt : So that is a challenge for them, and that's why we had hoped the colleges would. Those colleges you mentioned have taken the view that they don't have the resources and they don't really have a research ethics role. We can't force them to do it, so sadly they are not doing it at the moment.

Senator DI NATALE: Isn't it possible to create a separate approach?

Dr Skerritt : The act could be changed to do that.

Senator DI NATALE: The example is that to become a methadone prescriber you've got to attend an accredited course.

Dr Skerritt : You would have to require a change to, I think, section 19 of the Therapeutic Goods Act.

Senator DI NATALE: Is a legislative change required?

Dr Skerritt : It's a legislative change, yes. To go back to why doctors are finding this easy: let's say you're a GP who specialises in pain; all this down here—the product that you've got familiar with for neuropathic pain—is all filled in. This is probably coming cut and paste out of the clinical notes from the discussion you've had with your patient. They can just cut and paste it across. That's why a lot of them are finding it pretty easy. So whether it's the scheme for the future or whether there is a need—it's not our decision; it's a decision of parliament, of course—to change the act to have a different form of authorised prescriber scheme is really up to the parliament.

Senator DI NATALE: And you don't have an opinion on what that—

Dr Skerritt : I'm an official; I don't have an opinion, Senator.

CHAIR: Have you provided advice to government on that?

Dr Skerritt : I don't know if I'd describe it as advice to government. I think there was corro where someone said, 'Can we alter the authorised prescriber scheme?' and I think we did say, 'It would require an act change.' So, as part of the corro response, we did. It wasn't a formal 'Here is a ministerial briefing on everything you wanted to know' but I do believe that in draft corro—and, of course, the final corro is under the hand of the minister's advisers and all that—we did explain that it would require a change to the act if the authorised prescriber scheme were changed. I just want it correct on the record.

Senator DI NATALE: I'm thinking again of the possible ways through both the education problem and the authorised prescriber problem. Would it be possible to administer a scheme where, to become an authorised prescriber, you've got to satisfy an accredited two-day program? That way you'd have dealt with the education component.

Dr Skerritt : Again, anything is possible if the parliament is minded to amend the act.

Senator DI NATALE: You don't see any obstacles in anything like that?

Dr Skerritt : Only one called parliament.

Senator DI NATALE: Okay. That's a small one. There was the issue we heard about from the Lambert crew, which was around getting access to data from the TGA. They'd found it was very difficult to get access to data. Particularly, they would have benefited from real-time information.

Dr Skerritt : The government announced in MYEFO that a small amount of money is now being made available—I think it was $3½ million this year and $6.6 next year—to partly cover a range of functions for which TGA wasn't funded. One of the challenges with TGA's fully-industry-cost-recovered model is that there are a number of functions, and they go into the tens of millions of dollars, for which we can't really directly charge people. We don't want to charge doctors or patients under the Special Access Scheme. We've heard enough about the financial impost. So that has been one of those things that we've had to absorb. For all the work to date, until very recently—everything we did on the Special Access Scheme, and I've got a list of about 10 other things that I can rattle off—we've had to squirrel away funds. We haven't had the resources, frankly, to provide as much disaggregated information as some groups would like. That's why, essentially, they've had to go through the formal process of requesting it under freedom of information.

We now do have a little bit of government support to cover off some of the costs of the Special Access Scheme, and some of the things, like medicine shortages, we heard about today, and things like orphan drugs—and I could go on. The government will continue to look at our cost-recovery model over the years to come, but the challenge was simply one of resources. It's nice to put up a whole lot of analyses of every scheme we do—you've asked about what other antibiotics and other things we do—but all that requires staff time and is a little bit discretionary, rather than the key focus of getting these things reviewed and out to doctors and patients. That's why they had to ask for that data under freedom of information.

Senator DI NATALE: Far be it from me to provide advice, but, given the amount of interest in this issue within the community, obviously the more information that's publicly available the more informed some of these decisions will be.

Dr Skerritt : I think now there's a small amount, and I've got to make sure I don't commit Dr Pegg and his team to a massive amount of work, but I think, now there's a little bit more funding, we can do a bit more. For example, another thing is that we realise it's two years since those clinical guidance documents came out. There has been not a flood but a trickle of some new studies, reports, out on clinical effects in different conditions. We'll use some of that funding to support an update of reporting on those studies, and we'll put all that up on our website.

Senator DI NATALE: A final question, which relates to resourcing but is a question for the Office of Drug Control. We heard time and time again through all the submissions—this is not a criticism of you personally—that you just don't have all the people and financial support to do what you need to do, to do the job. I get that's a question as much for the government as much as for you. What's going to change?

Mr Masri : A couple of things: I guess you've got to look at this in the context of the new scheme that started three years ago, but the nature of—

Senator DI NATALE: In some people's opinion, three years doesn't make something new.

Mr Masri : Yes, but the regulatory scheme had applicants who weren't familiar, I guess, with the requirements under the act and the regulations. On applications that were made, we could have made decisions early on in the piece to refuse applications, but the approach was taken to work with industry to ensure that the right information has come into play.

A couple of factors that will determine our resourcing and our capacity to deal with backlogs and to ensure that the industry is well regulated go to some of the issues that were in the McMillan report that go to the restrictive and prescriptive nature of the legislation being a big factor in our capacity to streamline some of the processes. In parallel to the review, we undertook some internal assessment of our organisational structure, our business processes, looking at the risk appetite and also looking at where we needed to focus our regulatory attention. All those factors need to be taken into account when you're looking at resources. I'm pretty confident, as I said earlier, that the process we're going through, and we'll be looking to government around the budget process, will give us the right level of resourcing. So we've got to match our fees and charges that we're seeking from industry to the resources that we need to undertake our regulatory function.

Dr Skerritt : I'd just add that a really important step will be amendments to the Narcotic Drugs Act. Our bid has A status, which, as you know, has a reasonably high priority for introduction, maybe not in the autumn sittings but mid-year. It aims to take a lot of the unnecessary, risk-averse stuff that the parliament put in the initial amendments to the Narcotic Drugs Act—20/20 hindsight is a great thing. We heard from the industry players who were speaking before us about the complexity of having three licences—one for research, one for manufacture, one for cultivation. It was a good idea at the time, and they all supported it at the time—

Senator DI NATALE: No, it wasn't. No, it was a bad idea. We told you at the time it was a bad idea.

Dr Skerritt : One of the central things that are being consulted on at the moment is to say: 'Let's have a bit of flexibility. Let's just have one type of licence that can cover a range of different activities.' That will give the burgeoning industry in Australia a lot more flexibility and take out a lot of the 'Sorry, guys, you've got to now submit a whole new licence application because you're moving from research into cultivation'. Apart from the additional resources and the internal business processes, we're counting the days until, hopefully, the act is amended to take out some of this thing that we don't believe is really adding value. But when you have an act of parliament that says the secretary, or the decision-maker, 'must do dot, dot, dot', we have to do it, even if it's not a value-adding step.

Mr Masri : Also, in this legislation it's not only 'the secretary must have regard to', but the applicant must provide all this information. It is very prescriptive. We've removed some of those in the regulations that have come into force from 1 January—

Senator DI NATALE: I thought this government hated red tape.

Mr Masri : The amendments to the act will go further, I think, into reducing the mandatory requirements and information that we need to consider—applications that go into the hundreds and thousands of pages.

Dr Skerritt : To be fair to this government, or any government, a lot of the risk aversion was actually from state and territory law enforcement officials. To be fair, while we're all sitting around talking about medicinal cannabis all day, we must remember that the illicit cannabis market is still a major source of diversion of funds by criminal elements, and they had a lot of data about that.

Senator DI NATALE: Sure, but they don't have to comply with any of these regulations, which is why they can make it very, very cheap and why people aren't paying $1,000 a week to get their medicine.

Dr Skerritt : They have an advantage, yes.

Senator DI NATALE: No, this is actually an important point. This idea that we're so concerned about diversion, the reality is that we've got people accessing the illicit market because they can't get access to product that's affordable and that's accessible. All of the red tape, the lack of investments and the other problems that we've heard about are all what are really driving people to the illicit market. We could reduce people accessing the illicit market if we had a model that worked better, because most people want to know what they're getting; they want to have the assurance that it's appropriate quality, that it's not contaminated, and they'll pay more for that.

Dr Skerritt : When you say 'lack of investment' I'd remind senators that there is almost $2 billion worth of ASX and private capital in the medicinal cannabis market in Australia.

Senator DI NATALE: I was referring directly to the investment in the Office of Drug Control.

Dr Skerritt : I see. You're not talking about the industry?

Senator DI NATALE: No. The industry are waiting to go. It's not the industry that's the problem here; it's the barriers and obstacles that have been put in its way.

Mr Masri : You've still got to get the balance right in the regulatory framework.

Senator DI NATALE: I agree.

Mr Masri : In the international context, the Australian regulatory framework is well regarded. I think the benefits for industry, especially in the export market, would also be recognised.

Dr Skerritt : I'd remind senators that even if not a single additional licence was granted licence holders with permits, as per our submission, are already authorised to produce over 35,000 kilograms of medicinal cannabis. Again, we can't tell you what companies are making, but we did estimate that about 10 per cent of medicinal cannabis is already Australian made. I believe that by the end of 2020 that might be getting higher; it might be half, I don't know. But the permits that have been granted authorise 35,000 kilograms, which is an awful lot of medicinal cannabis in Australia.

Senator ASKEW: Can you clarify how many providers there are in that?

Dr Skerritt : The current number of permit holders is—

Mr Masri : There are licence holders and permit holders. At present the number of licences granted, as of last week, that are still in operation is 99, so just short of 100. And the permits that are in operation and are granted are 39. So there is a lag time between the granting of a licence and then production. They might build the facility and so on before they start applying for permits. And amongst that there are a whole lot of applications for variations and so on that add further complexity and further time and further effort.

Senator ASKEW: I just want to get a clarification on a comment that was made earlier this afternoon regarding the need to provide the name and address details for anybody who is actually receiving or having a script done for medicinal cannabis. We were told at the time to ask you, so I'm asking you.

Dr Pegg : Yes, so the application that we receive is de-identified. The details we have of the patient are initials and date of birth, and that's it. That's what's on the approval letter that's issued to the doctor from the Commonwealth. It's that approval letter that needs to be shown to the sponsor, who's the supplier of the product, to enable the supply of that product.

Senator ASKEW: So the actual supplier doesn't receive the details of the person who—

Dr Pegg : Just that de-identified information.

Dr Skerritt : That's from us. We don't even get the names of patients; we just get their initials. What we have been told by some of these medicinal cannabis clinics is that, because they want to build up their own database on efficacy, which we can't under our—the Special Access Scheme is not a clinical trials framework. Some of these clinics say, 'We'll give you 100 bucks off a bottle if we can get feedback from you and your doctor as to how the product has gone.' And that's where full information—they've signed an informed consent between them and the cannabis clinic for it. It's nothing to do with us, and I don't believe it's illegal or anything.

CHAIR: Certainly in my understanding it's separate to what was raised this afternoon where it sounded like it was a requirement.

Dr Skerritt : Certainly not.

Dr Pegg : I wonder if they're potentially also supplying the state and territory approval to enable supply because the state and territory approval, depending on the jurisdiction, may have extra details of the patient. Under the Therapeutic Goods Act that's not required to enact supply; it's the Commonwealth approval.

CHAIR: We need to clarify it.

Dr Skerritt : The states and territories will sometimes need the full name of the patient because, remember, they do check whether the patient has a drug dependency for any schedule 8 drug. We at the TGA don't for our approval.

CHAIR: That's an area that we're going to need to pursue.

Senator URQUHART: I have one final question, which Senator Bilyk wanted me to ask. Have there been any clinical trials of the use of benzodiazepine for the treatment of PTSD?

Dr Skerritt : We can certainly look on the registry of clinical trials and take it on notice.

Senator URQUHART: It would be great if you could.

Dr Skerritt : We would just do an open search on the Australian New Zealand Clinical Trials Registry.

Senator URQUHART: And maybe just a little bit of information if there has been—

Dr Skerritt : This isn't cannabis—

Senator URQUHART: No, it's something different—

Dr Skerritt : this is benzodiazepine for PTSD.

Senator URQUHART: but it came up earlier in the day.

Dr Skerritt : One of our clinicians could quickly check that.

Senator URQUHART: And, if there has been, what the outcomes of those were.

Dr Skerritt : If it is completed, yes.

Senator URQUHART: That would be great, thank you.

CHAIR: We couldn't actually have that form at this moment because it has details—

Dr Skerritt : I've written all over it.

CHAIR: Are you able to provide us with a clean copy?

Dr Skerritt : We'd be delighted to. We can provide you with a de-identified real-world example. This isn't the shortest form; it's a typical form. It does get wearing to hear about 100 pages when you know it's this much. We'll also provide you with a blank form. We can provide you with both.

CHAIR: I've chaired many Senate hearings.

Dr Skerritt : You have.

CHAIR: Many times I've heard doctors talk about the excessive time it takes to fill out forms and things like that, so it didn't surprise me at all when I heard that there was concern about filling out the form. Have you any feedback from people who are using the form about how long it is taking them to do?

Dr Pegg : We haven't studied how long it takes, but I must admit that the feedback we get from prescribers who use the portal is almost universally positive.

CHAIR: When a drug is out of stock and they have to go back—and that was one of the complaints we heard fairly loudly today—does the clinician then need to redo the form? Do they need to go back to the patient? Does the patient need to come back in?

Dr Pegg : I suppose it depends on what discussion has been had with the patient. If the risk profile is perceived by the prescriber as changed, according to the product being different, then they might need to have a discussion. This issue probably is broader than medicinal cannabis. With products supplied under the SAS there is no oversight by the TGA of actual supply, so it's possible that when our approval is received you might go to get the product and it's not there.

CHAIR: Yes, you said that earlier. I understand that that can happen. The process has to be that they come back. There is extra time for the doctor, but does the patient have to come back in for that? Is there another check-up required?

Dr Skerritt : It would vary.

Dr Pegg : There is no requirement from the TGA's point of view that that occur, but I'm thinking in the clinical paradigm that, if I'm a doctor and I hadn't discussed it with my patient—

CHAIR: You might need to. So that's also a barrier for people being able to access this.

Dr Skerritt : This is a common problem. Medicine shortage is one of the biggest threats we have to public health in Australia writ large. They have to go back and substitute another medicine. Because these are on the Special Access Scheme we lack the same powers we have for mandatory reporting of shortages. The Therapeutic Goods Act changed so that as at 1 January last year, 2019, it was mandatory for companies to report shortages only of the registered TGA approved ones, so we don't have good visibility of shortages of these products. It's another reason why we want more of these to be on the register.

CHAIR: We've reached the end of questions today. We've been going a long time today, so I'll call it quits for today if everyone is happy. Thank you very much for your time today. I thank all of our witnesses for their time today and for bearing with us with the sheer volume of what we've heard today. I also thank them for their submissions. I'd also like to thank the secretariat and, very importantly, broadcasting. Thank you very much.

Committee adjourned at 18:25