Senate debates

Wednesday, 17 June 2020


Export Control Legislation Amendment (Certification of Narcotic Exports) Bill 2020; Second Reading

9:41 am

Photo of Richard Di NataleRichard Di Natale (Victoria, Australian Greens) Share this | Hansard source

I rise in support of the Export Control Legislation Amendment (Certification of Narcotic Exports) Bill 2020. This bill removes barriers to Australian hemp and medicinal cannabis companies exporting their products to supply international markets. The Greens support this bill because we understand the many potential benefits of medicinal cannabis and we support a healthy Australian medicinal cannabis industry. But this bill also raises serious concerns about the domestic market. Since the Greens led the charge for the introduction of medicinal cannabis as far back as 2015, I've been highlighting the enormous barriers to patient access to medicinal cannabis in Australia. The TGA arrangements at present are failing to provide people with timely, cost-effective access. As a result of the problems within the current regulatory system, we undertook a detailed inquiry into the barriers and problems with regulation of medicinal cannabis in Australia. We did that earlier this year and the committee tabled its report in March. It's now essential that the government implement the recommendations of that report. At the end of my speech I'm going to be moving a second reading amendment to that effect.

It's really important to understand the history here. The government made medicinal cannabis legal in 2015 and set up the regulatory framework through The Therapeutic Goods Administration. At that time we advocated very strongly that a separate, independent standalone regulator be established to allow people to access medicinal cannabis. That's the approach taken by many jurisdictions right across the world, recognising the very unique issues associated with a drug that in many circumstances has been prohibited for consumption and understanding also that medicinal cannabis is not one drug but indeed many different drugs.

We decided to give the government the benefit of the doubt. It was a big change at the time. Up until 2015 it was illegal, full stop, for a doctor to prescribe a patient medicinal cannabis. But what we've seen now is that the system is failing people. In the five years that have now passed, what we've seen is people failing to get access to medicinal cannabis when they need it. The barriers are many and I'll go through some of them in a moment.

The Community Affairs inquiry into patient access to medicinal cannabis uncovered a range of issues which advocates in the industry have been highlighting for many, many years. At the moment, if a doctor wants to prescribe a patient medicinal cannabis, they require the use of the Special Access Scheme through the TGA. This is important to understand. The TGA regulates products for approval here in Australia, but where there's a pharmaceutical drug that's from another jurisdiction, that hasn't yet entered the Australian market and hasn't been approved for use in Australia, there is a special provision called the Special Access Scheme that allows doctors to seek permission to prescribe that product. That's a scheme that was designed to be used in exceptional circumstances for drugs that may be of benefit to a limited number of people. The scheme was never intended to be used at scale for something like medicinal cannabis. It's remarkable—you've got the regulator, the TGA, that is designed specifically to regulate for the approval of pharmaceutical products, and they've been chosen to regulate a drug which bypasses their normal approval processes and uses something called the Special Access Scheme. As I said, what that scheme does is to allow for the prescription of products not yet approved for sale here in Australia, but it requires doctors to jump through a number of hoops in order to be able to prescribe it. It requires doctors to complete a detailed form every time, per patient, per script.

There is another way in which you can avoid having to go through that approval process for every specific script for a patient. You can become what is known as an authorised prescriber, but, again, the number of authorised prescribers has been extremely limited, and not only is the process for becoming an authorised prescriber onerous but also the committee found that the required approvals are really hard to come by. There are very few people who have been designated as having authorised prescriber status.

I will just give a practical example. When I was in general practice, if a patient came in to see me I could write a script for an opiate. Opiates are drugs—codeine type drugs and other injectable preparations of opiates, like pethidine, for example. I can write a script for an opiate like codeine without requiring any approval from anywhere else. It's up to my discretion as a prescribing doctor as to whether I think the patient will benefit from an opiate. Now, we know from what is happening here in Australia—indeed, right around the world—that there is a crisis in overdose deaths from prescription opiates. In the US, tens of thousands of people are dying from prescription overdose deaths. I can do the same for benzodiazepine type drugs—I can write a script. And we know that, when it comes to the use of drugs like opiates and benzodiazepines, people do die when they are taken in large quantities. The potential for overdose is very real. I don't require any approval to be able to prescribe those drugs, and yet I have to jump through a range of hoops to prescribe a drug like medicinal cannabis, for which there has not been one documented case of overdose. When you talk about the relative safety of particular drugs, medicinal cannabis is safer than over-the-counter drugs like alcohol. We're trying to put a square peg into a round hole.

The issues don't stop there. Doctors are struggling to get the necessary training and information they need to appropriately prescribe these products. Look, when I was training, we didn't even know there was an endocannabinoid system—it was something that just wasn't understood in medicine. We know now that medicinal cannabis products work because we have our own endogenous system, our own endocannabinoid system—our own body produces variations of these drugs itself, and that's why these products are effective. We didn't know about that only a short time ago. So the amount of information that doctors have on cannabis type products is very limited. Indeed, the only training I got was that cannabis is a dangerous drug and you need to ensure that people stay away from it.

If you can find a doctor who's willing to undertake the paperwork and feels comfortable in prescribing, you're going to find red tape in accessing medication thanks to the overlapping regulation not just at a federal level through the TGA process but also at a state level. I'm sure we'll have a contribution later on where we hear about the huge problems in Tasmania specifically, where that state has decided to make it harder than any other state for someone to access medicinal cannabis.

If you manage to go through the tangle of federal and state restrictions, patients are then going to be hit by the enormous cost associated with accessing these products because they're not subsidised—again, unlike other medications. So patients who need these treatments, who will benefit from them and who want to do the right thing continue to use the black market because they can get these products cheaply. Unfortunately they don't know what they're getting, it's an unregulated market and often what people think they're getting is not what they're purchasing, but they are being forced to break the law.

Our inquiry included contributions from senators on all sides and made unanimous recommendations on how to urgently fix this failing system. These recommendations need to be the government's highest priority in this area. While we support our local industry accessing export markets, surely we should be looking after Australian patients first. Our committee has recommended that immediate changes be made to both the Special Access Scheme and the Authorised Prescriber Scheme to allow a smoother, simpler, more straightforward process for doctors. We recommend that investment be made by the government and by the colleges to ensure that appropriate doctor education is available so that people learn about the endocannabinoid system and the benefits of medicinal cannabis rather than the stigma that's currently associated with the use of these products. Crucially we recommend that the government investigate a compassionate subsidy scheme for medicinal cannabis so that patients are not faced with huge price tags just for accessing their medication. Right now, when people are given a script, they can be forced to pay hundreds and hundreds of dollars each month simply to get access to a medication that would be of tremendous benefit to them and their families.

Through the committee we made a number of other recommendations, and I commend the report to all senators, but the key one is that the government moves forward to reform the system—that we establish an independent, stand-alone expert regulator for medicinal cannabis and move away from the TGA system, which is good for what it needs to do, but we are trying to put a square peg into a round hole. The report said very clearly that the government should reform the system if barriers to patient access persisted 12 months after tabling the report. Personally, I would've liked to have seen a stronger recommendation—immediate reform of the system—but, working across the divide with both Liberal and Labor senators, we accepted that the government be given 12 months to address the inadequacies of the regulation associated with medicinal cannabis.

We know that an independent regulator which understands many of the complexities associated with medicinal cannabis would allow for far greater patient access. That's experienced in many jurisdictions overseas. The irony of the current system is that, although the TGA is the pharmaceuticals regulator—it regulates the introduction of pharmaceutical products in Australia—most medicinal cannabis bypasses the normal regulatory framework within the TGA through the Special Access Scheme. So it circumvents the processes that are established within the TGA to regulate medicines. We have decided to use a regulator to regulate medicinal cannabis only to have it bypass their normal regulatory processes. It makes no sense, it's not sustainable and Australians deserve much better.

Of course, all these improvements to patient access would improve the viability of the Australian medicinal cannabis industry. This is a young market. It's just starting out and it wants to supply a domestic market, but the barriers are so high that despite knowing how many Australians are likely to benefit from these treatments there are only a trickle of prescriptions coming through. Yes, there has been incremental improvement over recent months, but it's coming off an extraordinarily low baseline and is still not enough to meet the extraordinary demand there is for medicinal cannabis progress. It's been estimated that millions of Australians would benefit from the use of medicinal cannabis or at least a trial of those products. At the moment, all we have is a few thousand Australians being able to access those products.

We know that our domestic market isn't enough to sustain a medicinal cannabis industry, and that's why the export market is important. As I've said, we do support that, but let's sort out our system here in Australia so that Australians can benefit from medicinal cannabis products. I have said on many occasions that this isn't a wonder drug. It doesn't have the benefits that some advocates purport, but it does have many, many potential benefits. You only need to talk to people who've experienced a remarkable improvement in their quality of life to know that this is a drug that Australians should be able to get access to.

The key issue for both industry and patient access domestically is the descheduling of CBD, one of the components of medicinal cannabis—and again it's important to understand here that THC is the drug with the psychoactive effect; CBD products don't have any psychoactive effects—and there's now a move to deschedule CBD-only products so that they can be accessed like other complementary medicines. Since the inquiry, the TGA has begun a progress to down-schedule small-quantity-CBD products, from schedule 4 to schedule 3, so they can be available over the counter at pharmacies, rather than requiring a prescription. It's a good start, but the issue remains that even schedule-3 CBD—which, as I said, has no capacity to create a so-called high; we know it's safe, we know it's well understood—would still require registration on the Australian Register of Therapeutic Drugs, requiring all the years of huge investment in clinical trials. Clinical trials are important, but they shouldn't be a barrier.

So we support the bill, but it's time we got on with fixing the situation at home so that Australians can access medicinal cannabis products here. I therefore move the following second reading amendment:

At the end of the motion, add:

", but the Senate calls on the Government to urgently implement the recommendations contained in the report of the Community Affairs References Committee on its inquiry into current barriers to patient access to medicinal cannabis".


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