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Community Affairs Legislation Committee
Therapeutic Goods Administration

Therapeutic Goods Administration

[ 20:49]

CHAIR: That brings to an end of questions on Access to pharmaceutical services. We will now move on to outcome 7, Health system capacity and quality.

Senator SIMMS: I have a question that relates to the deferral period that currently applies to men who have sex with men donating blood and tissue. Are you reviewing that at the moment? I understand the Australian Red Cross Blood Service and the Kirby Institute have recommended reducing the deferral period that applies from 12 months to six. Is that currently being reviewed?

Prof. Skerritt : It is not something currently under active review. We completed an extensive review a couple of years ago in collaboration with the Australian Red Cross Blood Service—at their request. We looked at a range of factors, including reports from the Kirby Institute and the expert panel review that the blood service commissioned. Our decision was about blood donation based purely on risk-benefit for the blood supply—benefit measured in terms of quantity of supply risk and any potential risk of blood that may be contaminated. I want to clarify one thing, however, because it has been misrepresented in the media. Our therapeutic goods regulation, the infectious disease order, actually establishes a deferral period for donation of blood from:

A donor whose sexual practices put them at increased risk of acquiring infectious diseases that can be transmitted by blood, cells or tissues.

It is not the TGA's role to specify particular groups in the population. It is actually the Red Cross Blood Service's role to determine donors who have an increased risk based on their sexual behaviour and therefore decide to defer them. However, after the decision was made not to change the deferral period we did say that we would be very happy to consider any new evidence. I discussed that with the CEO of the Red Cross Blood Service as recently as the end of October. There is no new evidence now, but she feels that, in a little while more, they will have some more substantial evidence and want to come back with further data.

Senator SIMMS: In terms of access to new evidence, have things like access to the new medication, PrEP, or rapid HIV testing within some state jurisdictions been taken into account in the deliberations of the TGA?

Prof. Skerritt : Firstly, as you are well aware, PrEP is not yet a registered medicine in Australia.

Senator SIMMS: Yes.

Prof. Skerritt : There are some clinical studies of PrEP underway in various states to get a good handle on the percentage reduction in transmission. There have been various numbers quoting between 90 per cent, which obviously would still leave 10 per cent out, and 94 per cent. One of the things the large trials in New South Wales and Victoria are trying to establish is whether we are closer to 100 or closer to 90.

Senator SIMMS: It has had good results overseas, hasn't it?

Prof. Skerritt : PrEP has had reasonably successful results overseas. One of the challenges with PrEP, which is a factor being considered in its evaluation, as it is for any drug, is the fact that this is a drug now being given to a group of healthy people as opposed to a drug being used for treatment of people who are infected with the HIV virus, and so your risk benefit changes when you give a drug to healthy people as opposed to people who are sick with the disease.

Senator SIMMS: Just while we are on the matter of PrEP, you might be aware that, in November of last year, the Senate passed a motion calling on the government to look at regulatory barriers for access to PrEP and rapid HIV tests and home self-tests. I am interested to know from the TGA, Professor Skerritt, about what investigations are happening in terms of availability of PrEP, but I am also keen to hear from the minister about what action the federal government has taken since the passage of the motion in the Senate last year.

Senator Nash: I am not aware. I will have to take that on notice for you. But I am very happy to do that for the minister. I will pass to the professor.

Senator SIMMS: Thank you. I appreciate that.

Prof. Skerritt : On 7 July 2014—18 months ago—the government made an announcement that they would change the regulatory requirements. Until that date, self-tests for HIV were not permitted in Australia. Since that date, they have been permitted, but, obviously, there has to be an application for a product, the product has to be reviewed and then approved. I cannot disclose whether or not we have received applications and how many. It is a convention that, for commercial reasons, we do not do that.

Senator SIMMS: That is fine.

Prof. Skerritt : I can comment, however, that there are three tests that are available for point-of-care testing. That is separate to self-testing; it is point-of-care testing. These have been used quite widely. In fact, New South Wales Health worked with the Mardi Gras organisers to organise a significant program of point-of-care testing with a healthcare professional there to help interpret the tests.

You asked before whether the blood supply issues were related to the availability of point-of-care testing. Point-of-care testing is tremendous, because it increases the access for a wider population. It does, however, have one significant disadvantage over laboratory tests, and that is that it picks up antibodies to the virus. In the first three months, and it depends on the individual, you are virally infected but you do not have antibodies. A process known as seroconversion occurs. And so, in the first three months after an infection, you can still transmit that infection, but you can come up falsely as negative in one of these point-of-care tests. This is, again, one of the factors that has to be considered in looking at a range of factors, including blood donor withholding periods.

The other issue with PrEP, as the company has announced, is that it is under active consideration by us. We only received an application in the middle of last year for PrEP. The company could have put the application in a decade earlier, when similar approaches were made to regulators overseas, but they have made a series of commercial decisions related to the timing, and their Australian market strategy. We cannot force a company to put in an application for a medicine at any one time.

Senator SIMMS: I realise that, but do you have a deadline you are working towards on the availability of—

Prof. Skerritt : We originally had a deadline of March this year; however, we did not receive information back from a company in time to meet that deadline. Our deadline is now May this year. I am hopeful that the product will be considered. Normally we do not talk about applications, but the company has gone very public on this one, so I am not breaking any commercial confidentiality. They are happy for us to talk about it. So we are hoping it will be considered by our advisory committee at the very beginning of April and then a decision made soon after.

Senator SIMMS: I have two more questions on this. Again in relation to PrEP, there were media reports last year around overseas orders of PrEP being held up by Australian Border Force officials. It is my understanding that people can get access to PrEP in Australia but only on the advice of a doctor and that they pay slightly more for the availability of the medication if they order it overseas. Is that your understanding?

Prof. Skerritt : We have administered what is known as a personal implications scheme for many years. An individual with an Australian doctor's prescription can import up to a three-month supply of medicine for themselves. You would obviously need to check with the Australian Border Force on any issues that importers have had with them. There was some consultation with us because my understanding is that some people had consolidated shipments and so when they arrived at Sydney Airport it was not medicine for one individual. In order to save on shipping charges there might have been medicine for 12 people and therefore it looked like a commercial shipment rather than an individual one. But for the specific details of the hold-ups you would really need to refer to ABF.

Senator SIMMS: That is fine. Are you concerned about the health implications of a hold-up like that for people who might be relying on medication?

Prof. Skerritt : I cannot comment on Australian Border Force processes. Surely if they believe that something is being imported or may be being imported for commercial reasons they have a right to consult and check with others.

Senator SIMMS: But, theoretically, it could pose a risk to people if they are waiting for that medication and it is being held up, couldn't it?

Prof. Skerritt : Again, there is an individual issue here—whether people followed the TGA's processes in making quite clear that it was personal importation for one individual. I am not privy to any details on the shipments other than that there was evidence that there was consolidation and it was unclear whether it was therefore one individual importing material for themselves.

Senator SIMMS: I have one final question. Are you aware of any PrEP trials scheduled for South Australia? Is there any work being done in the state of South Australia in that regard or with provision of rapid testing? I do not think the state government have anything—

Prof. Skerritt : I am not aware of anything on PrEP. Colleagues may be. I mainly have heard about the large trials underway in New South Wales and Victoria and the smaller trials that have been announced by Minister Dick in Queensland. That is not to say that individual hospitals in other states are not organising their own trials.

Senator SIMMS: Sure. Could you take that question about South Australia on notice.

Prof. Skerritt : I will.

Senator SIMMS: Thank you.

Pr oceedings suspended from 21:03 to 21:16

Senator GALLAGHER: I have some questions for the TGA around codeine reclassification. Does the TGA conduct any postmarket monitoring of opioid analgesics and their use?

Prof. Skerritt : We certainly do conduct postmarket monitoring of all sorts of medicines. People always think of TGA as a medicines approver, but that is only the beginning of a journey. We have done a number of studies on opiate analgesics. In fact, last year we conducted a safety review, and we published it on 1 October, on the use of codeine in children. A number of overseas regulators have taken action to forbid the use of codeine in kids under 12 or 18 who have had their tonsils or adenoids out, because of serious adverse events. There have also been reports overseas of breastfeeding mothers and even infants dying. Codeine is just a precursor to morphine. People think it is different, but it is not. It just turns into morphine in the body. And there is a group of people, including breastfeeding mothers, who break down codeine really quickly into morphine, so, the baby gets a big hit of morphine. Sadly—I think it was in Canada, some infants have died.

So, we conducted a safety review focused on children last year. I should add that quite often, again for objectivity, we use a medical expert organisation. I cannot name the organisation, because we are not expecting them to sign the contract until next week, but a review is planned over the next six to eight weeks on codeine efficacy and safety, especially at lower doses—in other words, whether OTC codeine is any more efficacious in pain relief than, say, a mixture of paracetamol and ibuprofen, or paracetamol alone, and also aspects of safety. That will feed into the further consideration of issues to do with appropriate scheduling of codeine.

Senator GALLAGHER: So, the history of this is that the TGA sought to reclassify codeine? That is right, isn't it?

Prof. Skerritt : The history of this is that there is a function known as medicine scheduling which determines whether medicines are available anywhere from the supermarket through to a locked safe, at schedule 8. And any individual or organisation can put an application for things to go up or down. So, an application was received. Unlike the medical marijuana one, where that has been initiated by the department, this one was on receipt of a submission—

Senator GALLAGHER: Which sought to reclassify—

Prof. Skerritt : which sought to reclassify it—

Senator GALLAGHER: to prescription only?

Prof. Skerritt : to prescription only. And the history of that is fairly well known. The advisory committee recommended so. There were many submissions based on that interim decision, so a further set of potential proposals were put out for consultation. The consultation closed on 29 January, and those proposals will be considered by a meeting of the advisory committee in March this year—next month.

Senator GALLAGHER: Is that fairly standard, how that is tracked? Or is that unusual because it was controversial?

Prof. Skerritt : Two things are unusual: the sheer number of submissions—

Senator GALLAGHER: Which sought to—

Prof. Skerritt : which commented on the scheduling proposal.

Senator GALLAGHER: In support of the reclassification? Or against?

Prof. Skerritt : The majority of the submissions were actually against. They were either from individuals or from business. The submissions are public, so yes; a number came from community pharmacy, but a number came from individuals. It is noteworthy that submissions, for example, from the AMA and the Royal Australian College of General Practitioners supported the upscheduling. The range of views was highly polarised.

Senator GALLAGHER: So, that was one of the reasons—the volume—

Prof. Skerritt : The volume, and also the broader set of issues around the decision and whether further work—one of the main themes in the submissions against it was saying, well, the submission made assertions about safety and efficacy, but we did not see systematic data. So a sensible thing there was to commission a major medical research organisation independent of TGA to do such a study, and that is what is just about to be launched.

Senator GALLAGHER: Before the reclassification application came to the TGA, the TGA had not—or does not—form its own view on this?

Prof. Skerritt : TGA can form its own view, or more broadly with colleagues in the department—and of course we are part of the department. For example, within the department we initiated a rescheduling of a number of the substances that had been abused in sport. But in this case this was on receipt of a submission to reclassify it.

Senator GALLAGHER: So, when you paused the reclassification for this other process, that was not the TGA changing its mind on the issues presented before it. It was about trying to understand various views.

Prof. Skerritt : It was realising that there was a range of views, but a consistent message was—

Senator GALLAGHER: Two views.

Prof. Skerritt : No, there was a gradation of views, and indeed from an early analysis of the submissions to the current views, there is a real spectrum. Some people are saying yep, do it with the tablets, but cough and cold medicines are low risk, so do not change them. Others, for example, are saying to cut it down to a three-day pack size, from the current larger pack size. So, we are seeing a spectrum of views; it is not just one or other.

Senator GALLAGHER: In terms of the feedback you have had, you mentioned community pharmacy, and some of the doctors' peak organisations. Have you had feedback from other organisations, or do they largely fall into doctors versus pharmacists, or pharmacists versus doctors?

Prof. Skerritt : No, it is very broad. In fact, one of the parts of feedback that got the most wide media coverage in the past few weeks has been from rapper 360. Now, I am probably too old to realise who rapper 360 is, but he is a well-known rapper who is quite well known in music circles and who had an OTC codeine addiction, and he spoke at length on the ABC about that issue. So, all sorts of people have come out—those with addictions but also those who say, 'I have chronic pain, I have migraine, and other things don't seem to work.' So it is not just a pharmacist-versus-doctor thing.

Senator GALLAGHER: In terms of the research you have undertaken, the March date—correct me if I am wrong—is when you want to reach a decision.

Prof. Skerritt : No. I should add that the decision is made by a senior medical officer based on advice from the Advisory Committee for Medicine Scheduling, which consists of a mixture of state and territory representatives—because, as you may well remember, they actually give life to scheduling through state and territory legislative frameworks—and independent experts. That committee meets in mid to late March. They will then review the state of play, including further safety studies, and then a recommendation will be made and there will be an interim decision of a delegate.

Senator GALLAGHER: But you are not sure when that will be? It will be based on the outcome of the March committee meeting?

Prof. Skerritt : It will be based on the outcome of the March committee meeting. We would expect the decision to be made by about May. The other point that came through fairly strongly in the submissions from industry is that, because of stock in the supply chain, it is important to make sure there is an implementation period of at least 12 months. If there was a change in part or all of the way it is handled, it would not be changed until 2017 because of the need for relabelling a significant number of products.

Senator DI NATALE: I am very interested in the codeine issue—it is a fascinating space—but Senator Gallagher has pursued most of that. So I would like to go to the issue of medicinal cannabis. Could you talk me through the process for the review of the scheduling?

Prof. Skerritt : Sure.

Senator DI NATALE: In light of the announcement today, just so that we are clear—

Prof. Skerritt : The interface between this and scheduling?

Senator DI NATALE: Yes, the announcement from the government today about the framework for cultivation and manufacture. Cannabis is still scheduled as a schedule 9 drug—that is, it is illegal—and the bill to date does nothing to change the scheduling.

Prof. Skerritt : No.

Senator DI NATALE: It is still illegal for a doctor to prescribe it?

Prof. Skerritt : It depends on the state. The government is attempting to facilitate access to medicinal cannabis. One mechanism that was identified, as described by the minister today, was the fact that because overseas suppliers or availability of medicinal cannabis or purified substances is very limited—indeed, it has been a challenge with some of the clinical trials the states are running—there is a need for there to be local Australian production and manufacture. And that is what the bill that was introduced into the House today attempted to do. Obviously, there were a range of considerations in that. Scheduling is another piece of the puzzle. At the moment, with raw cannabis—cannabis leaf, botanical cannabis or however you want to describe it—being schedule 9, along with tetrahydrocannabinol—

Senator DI NATALE: Let's be clear for people who do not understand. Schedule 9 means the drug is illegal?

Prof. Skerritt : 'Illegal' is not quite the right word; it is access controlled. It basically means that there is not seem to be a therapeutic context for it and essentially the handling of it is forbidden in most situations.

Senator DI NATALE: So illicit drugs are schedule 9 drugs? If we are talking about heroin, that is a schedule 9 drug?

Prof. Skerritt : Drugs like that are generally schedule 9. However, cocaine, for example, which you sometimes get at the dentist, is actually schedule 8. Oxycodone and other opiates are schedule 8.

Senator DI NATALE: Yes, but we are talking about pharmaceutical opiates.

Prof. Skerritt : Yes, the pharmaceutical opiates are schedule 8. So generally the forbidden products, for want of a better word, are up in schedule 9. The way schedule 9 is handled varies between states, so that is why I am not giving a very specific answer. It could create legal problems for doctors prescribing it and/or if it had been at schedule 9 it could create legal problems—and it still is only a proposal—even in the shipping of it. So let's say we bring in a system for cultivating, manufacturing and transporting medical marijuana. The truck driver could be committing an offence in some states if the thing in the back of his truck was schedule 9. So the rescheduling proposal—and, unlike most of them, this one was actually initiated by the department—

Senator DI NATALE: I seem to recall that, when we asked you about this last time, you were telling us that the usual process for scheduling was that an external body applied.

Prof. Skerritt : That is still factually correct. For medicine scheduling, it is usually an external body. It can be anyone.

Senator DI NATALE: Yes. I would like to go back to the transcript.

Prof. Skerritt : We have one interesting individual who would like to schedule alcohol as schedule 9. So it can be anyone. There is a process known as delegate initiated scheduling. The only exception where it is usual for us to be the delegate initiated scheduler for medicines is for routine new prescription drugs, which go to schedule 4 or schedule 8 depending on their prescription. But for changes it is usually based on a submission from an external individual or body.

Senator DI NATALE: Talk me through the process. Basically the department is the delegate. They apply to have a change from schedule 9 to schedule 8, which, as I think you described earlier, is pharmaceutical drugs that are locked in a safe.

Prof. Skerritt : It also includes oxycodone, medicinal cocaine and so forth—drugs that are a high risk of dependency and so forth.

Senator DI NATALE: So what is the process? The delegate applies to change the scheduling. Talk me through what happens next.

Prof. Skerritt : This is one of the few regulatory processes that are spelt out hook, line and sinker in our acts and regulations in different parts. Essentially the delegate puts forward a proposal. This proposal was put forward after discussions with the states and territories—and I do not want that to be read as they fully endorsed it as written, because they will have the opportunity to comment. A scheduling proposal goes up. It is open for public consultation for several weeks. Later this month, that consultation on the proposal will close. If it is anything like recent ones, I am sure we will have a very large number of views and they will probably be all over the place again.

Senator DI NATALE: Have you got a sense of where things are at right now with the public submissions?

Prof. Skerritt : No, we have not been keeping track of them. Generally, we wait until public submissions are closed so that there is no risk of bias or anything. There has been a reasonable amount of publicity about it. Anyway, we will wait and see. Then the submissions are analysed and shared, together with the proposal, with the Advisory Committee for Medicine Scheduling. That committee, as I said, meets in the middle of March. They will provide advice back to us, again using their experts and their state and territory representatives. And then an interim decision is made. This rather arcane process is specified in regulations; it is not something we make up. There is then the chance for anyone who had put in a submission originally to come back and have further comment on the proposed interim decision. That is then considered and then a final decision is made.

The schedule is published three times a year. Despite all these steps, it would still be possible for a final decision to be implemented from 1 June this year. It should not hold up, for example, Victoria's plans to provide Victorian grown medicinal marijuana.

Senator DI NATALE: So in practice if the scheduling change occurs and it becomes a schedule 8 drug, and is cultivated and manufactured here in Australia, there is the possibility then for it to be made available under prescription by a doctor.

Prof. Skerritt : The availability under prescription from a doctor is there. As I said, it is even there now. We have actually provided cannabinoids through the Special Access Scheme.

Senator DI NATALE: That is just special access, though.

Prof. Skerritt : But that is still prescription by a doctor. One thing I would want to put on the record is that these access pathways—the Authorised Prescriber and Special Access schemes—do provide access of medicines to a large number of patients. I have the statistics here, which I would like to provide. In calendar year 2015, there were 653 authorised prescribers for a range of different types of medicine and a very large number of Special Access Scheme medicines supplied. If we worked on the basis that each authorised prescriber prescribed 20 patients—and that is an assumption—that would be 75,000 patients in Australia who have received access through these pathways just for medicines.

Senator DI NATALE: But you are talking about a whole lot of different medicines; we are not talking about one medicine.

Prof. Skerritt : It is, but it is still a very significant number of patients.

Senator DI NATALE: But they are all getting totally different medicine. I do not understand how that relates to this specific example.

Prof. Skerritt : What I am saying is that the reason for looking at access—particularly through authorised prescriber—is that the states and territories have also indicated to us that various states want mechanisms for looking at prescribing through to groups of patients and so forth. They may establish specialist committees.

Senator DI NATALE: My next question is: who makes the decision? There is a range of possibilities. One is that it is available through a prescription from a doctor or a GP—and that could be any GP. It could be treated like codeine; at the moment, any GP can prescribe an opiate. Or it may be treated like methadone, I suppose, where you would have to have some sort of accreditation program run by the college that means you can only prescribe it if you have been through that accreditation program. Or it could be limited to specialists, so that you are only accrediting particular specialists. How is that decision made?

Prof. Skerritt : This is a framework that still has to be built up. The framework that will be in place—assuming the bill passes both Houses and assent is made—will enable local cultivation and manufacturing.

Senator DI NATALE: Sure; that is the cultivation bit.

Prof. Skerritt : That is through the office of drug control, which is separate from the Therapeutic Goods Administration. Under the Therapeutic Goods Administration we administer the Authorised Prescriber and the Special Access schemes. As for the states and territories, that is a discussion that will happen over the next while—and I might turn to my two colleagues who have actually been working directly with the states and territories on that. The states and territories want to have an involvement in determining groups of patients and groups of medical practitioners—

Senator DI NATALE: I understand that, but I am interested in the process of how that is decided. It would seem to me to be silly to have one state that allows GPs to prescribe it and another state that says, 'We're only going to restrict prescribing rights to a small group of people. I am interested in what that architecture looks like and who decides it.

Dr Studdert : I think the practical realities of the Special Access Scheme and/or the Authorised Prescribers Scheme is that they provide a lot of flexibility depending on the particular formulation of cannabis that a prescriber might be looking to provide and/or on the patient and their condition. So there is no set view as to what that would be in practice. That will depend a lot on particular conditions, patient groups and doctors—whether they are GPs or specialists—that may want to use a product.

Senator DI NATALE: So why are we assuming it needs to be dealt with through the Special Access Scheme?

Dr Studdert : Because, other than a few products, they are not on the Australian Register of Therapeutic Goods. To supply a product that is not on the Australian Register of Therapeutic Goods there are the three pathways: the Clinical Trial Notification Scheme, the Special Access Scheme and the Authorised Prescribers Scheme.

Senator DI NATALE: Is it conceivable that under that scheme you could have a scheme where GPs prescribe it in the same way as they prescribe other medications—for example, codeine, opiates?

Dr Studdert : Again, it would depend on the product and the patient that they are working with, or patient group that they are working with, and what the conditions is. That is a delegate decision. In most cases, it is a decision made by a delegate in the TGA and the variables that they would have to consider would be those.

Senator DI NATALE: Let us unpack that a bit, because it is confusing to a lot of people, including me. When you say it is a delegate's decision, someone in the TGA says, 'Here is a list of conditions for which we will allow product X to be prescribed,' is that how it works?

Dr Studdert : Over time that might develop. At this time, I think, it is fair to say there is not a list of conditions—

Senator DI NATALE: I understand that is—

Dr Studdert : that we have had any experience with providing approvals for—

Senator DI NATALE: Right, so let us work through how this is going to roll out.

Dr Studdert : It would be a case of a prescriber putting a case to the delegate that says, 'I want to prescribe this product—whatever the particular formulation is—for this patient and whatever their condition is.' They would provide some justification for that application. In the case of an authorised prescriber, they would be saying, 'I want to work with a particular group of patients—children with severe epilepsy that have not responded to other medicines—and I believe this product has some justification for use in this case, and there is a supply that I have identified.' So based on the evidence and variables that they are describing that decision would be made. Obviously, over time there would be a growing familiarity with a range of conditions, a range of particular medicines, especially as we see production develop in Australia and that familiarity would grow on both the part of doctors and delegates in TGA.

Senator DI NATALE: Let us bring it to the real world. I am a GP and somebody comes to see me who has end-stage cancer and has intractable nausea and nothing else seems to have worked. I then have to apply through the special access scheme for approval to prescribe—

Prof. Skerritt : To that patient—

Senator DI NATALE: to that patient. There are a couple of things. What is the process for doing that? How do I do that?

Dr Studdert : I might refer to my colleague Bill Turner, who has some experience with administering the scheme.

Mr Turner : The process for applying to use an unregistered good for therapeutic use is there is a form on the TGA website which a physician downloads, fills in with details—for privacy reasons we only get the initials of a patient. We get the product that the physician wishes to prescribe, the condition for which they wish to prescribe and the clinical justification. We are moving into a space where, in a lot of cases, in the physician's judgement registered options have not worked or there are no sufficient registered options. They would detail those sorts of things. That is then sent to a medical officer within the TGA who assesses that. In theory, each one is done case by case and makes a decision whether to approve the supply of that unregistered good for that patient.

Senator DI NATALE: It sounds very cumbersome and it sounds—you are looking quizzically at me so—

Mr Turner : I will make the point that we are talking here about an unregistered good. When a good becomes registered for supply, so it is on the ARTG, it is more generally available and doctors do not have to go through that sort of process to be able to prescribe it. If, say, the clinical trials that are currently being undertaken in the various states provide sufficient evidence to support the registration of a product then that product would become more available for general marketing.

Senator DI NATALE: We know that is several years away at best—

Dr Studdert : I think what Dr Skerritt said before was—

Senator DI NATALE: Three to five years one would imagine.

Dr Studdert : Obviously, when we have to step it through like that it does sound a bit cumbersome but in practice it is used a lot every day in the TGA for a range of medicines.

Prof. Skerritt : If I could give a statistic. We successfully process 220 of these applications every single working day of the year.

Senator DI NATALE: Is there the possibility for this to be done online with an immediate response?

Prof. Skerritt : It is funny that you should say that. One of the recommendations—and this is in the public domain of the Expert Review of Medicines and Medical Devices Regulation's recommendations—said, 'Even though you guys are able to do over 200 a day of these things, can we even further streamline it by doing it all online? And can you perhaps consider, as you get greater familiarity with drug X for symptoms Y, to make the approval much faster and simpler?'

That is a recommendation for government. It is a fairly common sense one, but it will be for government to decide. That was something that was picked up in the review that could be streamlined even further. And who knows, if it were streamlined further we could move from 200 a day to 1,000 a day. I do not know.

Senator DI NATALE: Given that the demand for this is significant, as one would imagine, that will clearly test the capacity of your systems.

Just to finish, because I know we are pressed for time: the difficulty, obviously, is the range of options within the broad label of 'medicinal' cannabis in terms of THC to CBD ratios and so on. Will the request be simply 'medicinal cannabis', or will you expect that they will need to specify particular strains? How is that going to work?

Prof. Skerritt : I think guidance will have to be developed. Once we know where we sit with the bill and with scheduling, guidance will need to be developed which will explain the level of information required, and what is reasonable but also descriptive. If people just wrote 'marijuana', it could be cannabidiol or it could be THC. It could be anything.

Senator DI NATALE: Okay. I look forward to progress. Thank you.

Mr Bowles : Given the hour, can I get a bit of an indication about who we might want to get to, because I have about 50 or 60 people starting to block up everywhere here?

CHAIR: I have word that outcomes 8 and 9 have some questions that can be put on notice, and other things. I am told that those here for outcomes 8 and 9 no longer need to be here, but we are going to push on with the rest at this stage.

Mr Bowles : Thank you. Is there anything else in this program other than NICNAS? So nothing on e-health?

Senator GALLAGHER: I have some, but I will put them on notice.

CHAIR: So the rest of this outcome can also go.