Mark Butler (Hindmarsh, Australian Labor Party, Deputy Manager of Opposition Business in the House of Representatives) Share this | Hansard source

I rise to speak on behalf of the opposition on the Narcotic Drugs Amendment (Medicinal Cannabis) Bill 2021. I indicate that Labor will be supporting this bill. So far as the bill goes it is worthy legislation, but I do make the point 'only so far as it goes'. There still remains much to be done in the emerging area of the therapeutic use of medicinal cannabis. Frankly the government doesn't appear to be doing much in that area, particularly in the area of improving access for patients across the country to safe, affordable and effective medicinal cannabis products. The government has been dragging its feet for years in this area, most notably when it continued to resist the opposition's calls in the other place for a Senate inquiry into barriers against patient access to those safe, effective and affordable medicinal cannabis products. I foreshadow that I will move a second reading amendment at the conclusion of my remarks to draw attention to those deficits in this bill.

As I indicated, though, we will be supporting this legislation. The legislation implements a number of recommendations from the McMillan review of the original legislation that was passed in this place in 2016. That review was delivered in 2019, the year before last. It was a review that had been built into the 2016 legislation, which for the first time put in place a legal framework in Australia for the use of medicinal cannabis. Essentially, this bill streamlines various processes for industry participants. The hope is that that will have some downstream impact on patients, and there's something to say for that, but the bill is relatively limited in terms of the impacts for patients we can glean in the foreseeable future.

The first thing of note that the bill does is to consolidate the existing structure of three separate industry licences into a single licence. Currently, there are three separate licences under the original 2016 medicinal cannabis legislation: one for cultivation, one for production and one for manufacture. One of the recommendations of the McMillan review was that those three licences be consolidated into a single licence. Obviously, I think it goes without saying even if you're not particularly familiar with this industry that, for those industry participants who are integrated vertically and who do cultivation, production and manufacture, having a single licensing system will be a substantial efficiency measure, and that should flow on to patients. We support that measure. As I said, it was a recommendation from the McMillan review.

The second and perhaps slightly less impactful but nonetheless important provision in this bill is to relocate the timing of formal assessments of supply chains to a later period in the development of a business. This is so that the assessment of a supply chain will be undertaken at a time when an application for an actual payment is made, rather than at the earlier licensing stage. This means that the assessment will happen when a business is more fully formed and therefore the assessment can be more meaningful. Again, that's a provision we support. It was a recommendation from the McMillan review.

The bill also creates a perpetual, but revokable, licence. Currently, industry participants are only able to obtain a fixed-term licence for five years. If you're a good industry participant, which we can expect the vast majority of participants to be, then you have to go through the rigmarole of renewing a licence. The bill puts in place a perpetual licence which, obviously, can be revoked if there are grounds to do so. This avoids the need for regular applications to essentially relicence reputable operations. All of that, as I said on behalf of the opposition, is worthy reform.

The bill also inserts what it describes as an object to the act to reflect the first recommendation, recommendation 1 of the McMillan review, which, thankfully, was focused on patients—it focused directly on the needs of patients. As far as it goes, there's nothing to argue against it, but the concern is that simply putting a change into the objects of the legislation which says that patient access is important runs the risk of being mere symbolism if it is not accompanied by substantive reform to deal with what I think every member in this House understands are really substantial barriers to access. I'll talk a bit more about those barriers to access later in my remarks.

The concern that this provision is mere symbolism and the concern that this legislation really just deals with some worthy but pretty modest streamlining of measures that were imposed by the original legislation upon industry participants is not just a view of the opposition. It's been a view expressed by a number of patient advocate groups through the McMillan review process and as this bill has been out for consultation. Mills Oakley, for example, said in its submission, 'In our view, the most significant disappointment in the bill is its lack of real measures to improve patient access to affordable and domestically sourced medicinal cannabis.' The well-known patient advocacy group United in Compassion was a little bit more forthright in its view, indicating: 'From a patient's perspective, it'—the framework from the 2016 act—'has been a catastrophic failure. The illicit market is booming. Patients are still being locked up because they cannot afford or achieve legal access.' I think I'm right in saying these are concerns that all members of this place, on both sides of the House, would be receiving from patients across the country and across a very diverse group of patient cohorts.

Medicinal cannabis is a very fast-developing therapeutic product not just here in Australia but across the world—a product derived from the cannabis plant, which has some 80 to 100 different cannabinoids, only two of which are used for medicinal or therapeutic purposes as opposed to recreation. The first is formally called delta-9-tetrahydrocannabinol and is better known as THC. This is the cannabinoid in the cannabis plant that gives you the high, has the psychoactive and is generally the reason for people using this plant recreationally. But it also has medicinal or therapeutic uses and applications. The more predominant cannabinoid from the plant for medicinal purposes is technically called cannabidiol, or CBD. That is the one that most patients will be seeking to access through the framework that was created in 2016.

As I think all members of this place know and as we've had reinforced through the course of this pandemic, our outstanding medicines approvals authority, the Therapeutic Goods Administration, has responsibility for assessing and then approving therapeutic goods and registering those goods on the ARTG, the Australian Register of Therapeutic Goods. There is currently only one medicinal cannabis product that is actually registered on the ARTG and has been approved by the TGA, and that is Sativex, which is only approved for very limited use, particularly to deal with spasticity associated with multiple sclerosis. Other than that, there is no approved medicinal cannabis product under the TGA's regime, in spite of medicinal cannabis now being very widely used for a range of different purposes through the community.

The Australian Institute of Health and Welfare—funded, obviously, by the Commonwealth—conducts a regular National Drug Strategy Household Survey. It reported last year that as many as 600,000 Australians use cannabis for medicinal purposes—not recreational purposes but medicinal purposes. The institute further reported that less than four per cent of those 600,000 Australians are obtaining their medicinal cannabis product through legal pathways. That is a major concern. More than 96 per cent of the hundreds of thousands of Australians using medicinal cannabis are obtaining those products other than through the legal pathways established by this legislation, by the originating 2016 legislation and by the general TGA framework.

The only ways in which, at the moment, an Australian can obtain a medicinal cannabis product through the legal pathways are under two separate schemes operated by the TGA: the Special Access Scheme, which I'll come back to, and the authorised prescriber scheme. The authorised prescriber scheme, or the AP scheme, can involve the TGA approving a particular individual prescriber or medical practitioner and granting that practitioner authority to prescribe medicinal cannabis products for a class of person—not just an individual patient but a class of person. The usual example given is a paediatric neurologist who can prescribe medicinal cannabis products for children with very severe epilepsy, for example. This is not a part of the TGA's scheme that is commonly used, but it is open to some areas of medical practice.

The more common method is the Special Access Scheme. The Special Access Scheme, under the TGA framework, is there for what's described generally as exceptional clinical circumstances. This is where a medical practitioner takes a decision that there is no alternative therapeutic good available to their individual patient and so makes the clinical decision to give that patient a product that is not on the ARTG—one that has not been approved by the TGA for general prescription. This is a relatively cumbersome process in that a medical practitioner has to submit an individual application to the TGA for every individual patient. There's a reasonably quick turnaround here, but every doctor has to submit an individual application to the TGA for every single patient—whether that's a parent with an epileptic child, a terminally ill patient in excruciating pain or a patient with a condition for which there is emerging evidence that medicinal cannabis products can do good, and there are a range of those conditions, as most members of this House know.

At the end of 2019, there were some 18,000 patients in Australia who had received medicinal cannabis products through the Special Access Scheme. That sounds like a lot, but out of the 600,000 Australians that are using these products it's not many really. The TGA has its approval processes down to a much quicker turnaround. Those numbers have been climbing. I read a piece in the Australian Prescriber journal over the last couple of days which indicated that by the middle of last year there were about 4,500 approvals being granted by the TGA every month for the Special Access Scheme provision of medicinal cannabis products by a single medical practitioner to a single patient.

This does come with substantial cost to the patients. Not only are these products not on the ARTG; ipso facto they are obviously not on the PBS. The patients are paying for these products out of their own pocket. In that same study I described, in the Australian Prescriber, it was indicated that the average cost is somewhere between $5 and $15 per day for patients accessing medicinal cannabis products through the Special Access Scheme. That is an average. If you have conditions, such as epilepsy, that require relatively high doses of CBD, or medicinal cannabis, in your therapeutic good, then you are paying substantially more than $15 per day, day in, day out. This is a very substantial impost on families and patients across the country. The TGA, to their credit, have for some time been considering alternative ways of granting access to these products, through some sort of legal framework. Through the course of last year they had a consultation process underway around what is described as down-scheduling. That would mean that medicinal cannabis products would be available not just through schedule 4 of the TGA scheme, which requires an individual prescription by an authorised medical practitioner, but also through schedule 3, which is generally known as OTC, or over-the-counter, products at a pharmacy. They're generally behind the counter. You'll know them. They're not on the shelves at the front of the pharmacy, which is schedule 2. They're 'pharmacist only', so they're generally behind the counter. As with things like pseudoephedrine and ventolin, they generally involve a discussion between the customer and the pharmacist about the product.

A decision was taken by the TGA, after a draft decision and then a further consultation process in December last year, to down-schedule registered CBD products only—not THC products, which have a psychoactive element, but the CBD-only products, which would only be allowed to be, at a maximum, one per cent THC. The decision also indicated that only adults would be able to access a product through this schedule, schedule 3, and only up to 150 milligrams a day. That was an increase on the initial draft decision that limited it to 60 milligrams a day. They lifted it to 150 milligrams a day. A range of patient advocacy groups have indicated that that is a subtherapeutic dose. For many, many conditions 150 milligrams a day simply won't do the job. I make no criticism of the TGA for this. They work in a framework that requires them to assess the safety of a product and they have taken the view that that is the level at which they can be confident there are no safety concerns. All I do is make the observation that that simply doesn't do the job for many thousands of patients across the country. So that's the first point I'd make. It's potentially a subtherapeutic dose for many, many patients.

The other point I'd make is that, even though this decision has now been made and is in operation, there are actually no products on the register that activate the decision. There actually are no approved products that would be able to be sold by a pharmacist to a patient in accordance with this decision. So, until there is, this is very much an abstract decision of no particular impact for patients across Australia.

To get a product approved and put onto the ARTG and then to activate that ability to get it over the counter under schedule 3, subject to that dose limit of 150 milligrams a day, a company is going to have to put a product to the TGA for assessment. That will, under the existing framework, for very good reason, require substantial evidence of the efficacy and safety of that product. That potentially takes years of evidence gathering and clinical trials and many, many dollars, sometimes running to tens of millions of dollars, by the proponent company. So it is difficult to see products being approved by the TGA any time soon that will actually make that down-scheduling decision by the TGA something of real moment or of practical application for patients. I make the point that the TGA has been trying to make some changes that will accommodate the needs of patients, but it hasn't really been able to do anything that I think will have a real-world impact for those many hundreds of thousands of Australians who are using these products every day.

I acknowledge that the AMA has been critical of the down-scheduling decision, even though it won't have any practical implications for patients right now. I acknowledge the AMA takes the view that it's not optimal that patients will go directly to pharmacists for these therapeutic goods, if they ever come onto the market, instead of going to their doctor. The AMA is concerned that patients with potentially very serious conditions—because people with a range of very serious neurological conditions or painful conditions access MC products—might not end up going to their doctor and might instead go to the pharmacist. I think those concerns from the AMA and, to a lesser extent, perhaps, the College of GPs are concerns that need to be a prominent part of this debate as we move forward.

But I do make the point that these processes and the lack of affordable, safe, approved products available as part of the existing legal framework of the TGA and this legislation are all leading to the vast bulk of Australians using medicinal cannabis products to access them outside the legal framework. As I said, according to the AIHW, more than 95 per cent of the 600,000 Australians using these products are accessing them outside the legal framework. We've all heard these stories in our electorates. We've heard stories of veterans seeking medicinal cannabis products to help deal with PTSD. I'm sure all of us have heard stories of parents seeking to access medicinal cannabis products to help children with epilepsy in particular but other conditions as well. We've all heard stories of patients with excruciating and chronic pain caused by a range of conditions, some of them terminal, seeking to access medicinal cannabis products and far too often getting into trouble with the law because of the lack of a dependable supply of safe, affordable and effective products.

Now, I don't pretend this is easy. This is a relatively new product not just in Australia but across a range of jurisdictions across the world. There is still only an emerging base of clinical evidence. I don't pretend you can fix this overnight, but I do make the criticism, on behalf of the opposition, that the government seems too flat-footed on this issue. Other jurisdictions are ahead of where we are in trying to deal with these admittedly very tricky issues. As Olivia Newton-John said last year:

"Why not make it easier for people to get, particularly those suffering with pain? Why not make their lives a bit easier?"

In summing up, I move:

That all words after "That" be omitted with a view to substituting the following words:

"whilst not declining to give the bill a second reading, the House urges the Government to implement reforms to significantly improve patient access to medicinal cannabis".

See this speech in context