At the start of November, news broke that the Australian government would be reassessing their approach to Medicinal Cannabis. The news was met with thunderous approval from the overwhelming majority of Australians, who’s eyes lit up bright green at the thought of gaining an oft-coveted ‘Green Card’ from their GP to combat their ‘chronic restlessness’, just like in the movies.
However, now that the fanfare from the initial announcement has faded, what’s actually different? Much of the language surrounding the change to legislation was diluted with legal and medicinal jargon. So, in the interest of full-disclosure, we spoke to Associate Professor Nick Lintzeris from Sydney University, a known point of authority in the fields of drug and alcohol research, as well as addiction medicine.
This topic is a labyrinthian minefield that we will continue to navigate as the story develops.
To put it simply the changes in Australian legislation, implemented on November 1st, enable “a legal framework for the direction in which the government has decided medicinal cannabis will be implemented.” Now, let’s break down what that means.
In most other parts in the world, medicinal marijuana has developed outside of a ‘normal’ medicinal regulatory framework.
“In the U.S, Canada, Israel and Holland, they’re all either countries or states that have a capacity for treatment with medicinal cannabis. So they’ve put in, sort of, alternative approaches to the way medicines are regulated. In Australia, the governments have decided that’s not the approach they’re going to follow. What they’re saying is if cannabis is medical, then it should be licensed and regulated like any other medicine. So that’s the framework that the Australian governments have proposed to put in place.”
This means medicinal cannabis-based products can now be considered a viable option for treatment without the previous fear of legal persecution for obtaining a controlled substance. Medicinal marijuana will now be considered a “Schedule 8 substance”, meaning the law and medicinal communities are now “treating it as though it’s an opiate-based medicine.”
So, legally, medicinal marijuana is now available. But that doesn’t mean you will be able to get it at this stage.
Technically speaking, all medicinal marijuana and any medicine based on a cannabinoid are unlicensed in Australia, and remain so. In order for a medicine to be licensed, a long, litigious and difficult road must be taken whereby “a range of regulatory things need to happen” to meet the standards of the regulatory body in Australia, the Therapeutic Goods Administration (TGA).
“Generally a drug company needs to have a medicinal product, that meets what we call good manufactory practice that ensures a high quality product that’s going to be consistent time after time, and free from any contaminants. Then you have to demonstrate that it’s safe and is effect for a particular indication. You don’t licence medicine for general use, you licence it for a particular condition. Then, if it meets TGA’s approval, it gets licensed.”
There’s still a fair way to go before any marijuana-based medicine will be licensed and regulated in Australia. Until then, “What we have is this capacity to use unlicensed medicines.” Nick labels all of this “standard procedure – this happens all the time”, as people successfully apply through the TGA to gain access to treatments unlicensed in Australia.
“This framework was normally set up for treating patience with, say, a cancer that hasn’t responded to normal medicine. Maybe there’s an investigational drug that some research lab is showing good findings with, there is a mechanism that Australian doctors can access this medicine through the TGA.”
However, despite the fact that there’s a whole range of conditions people want to use medicinal marijuana for that there are currently no other medicines licensed, “for example, paediatric epilepsy, or palliative care”, only one cannabinoid-based medicine has successfully undergone this process. That being Sativex, which was proven to be successful in the treatment of Multiple Sclerosis.
A big part of this was due to the fact that up until now, medicinal cannabis was considered illegal.
“We had a system that made it illegal for anyone to have these drugs – Doctors, farmers, patients. So as of the 1st November, all that changed is that if a patient has gone through and got all the proper approvals from the TGA to use an unlicensed medicinal cannabis product, it is no longer now considered a prohibited drug.”
While there may now technically be a legal pathway to access the previously prohibited substance, it’s a long way off before a patient can simply walk into their GP’s office and request a prescription, having seen that medicinal marijuana is now legal.
“Technically, they are correct [it is legal], but if the doctor assessed the patient and said ‘Ok, I think medicinal cannabis could be useful for you’ the regulatory red tape, the process to get approval and to get the medicine to the patient, we’ve calculated it’ll probably take somewhere between 6-18 months to get all the boxes ticked. That’s assuming the doctor knew what they were doing.”
Australia’s previous approach to medicinal cannabis meant that there were no guidelines, no training programs and no promoting of cannabinoid-based medicine. Therefore, chances are your GP won’t know what they’re doing.
“Largely, there’s no education system. No training programs or guidelines available. Because these medicines aren’t licensed in Australia, they can’t be promoted here. The TGA can’t say ‘here’s three companies that you can go and approach to get your medicinal cannabis from’. Really, most doctors have never been trained and have no guidelines to follow.”
“Assuming they knew the local pain specialist,” and keeping in mind that both doctor and patient need to adhere to federal and state laws, “The specialist would then have to identify which medicinal cannabis product, and where might they import it from. Then start applying for approval.”
That wasn’t the only change that happened on November 1st. What Nick calls “totally coincidental – there was no alignment in these processes,” it was also announced that companies can now apply to get a license to begin cultivating cannabis for medicinal, or therapeutic reasons.
“We actually never needed that to happen in Australia. As with most medicine, we actually import them form overseas. We can actually import medicinal cannabis from a handful of countries. So why do we need a local industry? It will almost certainly reduce the red tape down the track, it’ll be good for the farmers, but it was never a necessary step, but it’s a good thing overall.”
So, in summary – is medicinal marijuana now legal? Yes. Can a patient just walk in, be assessed and get a script? No. “We still have a long way to go” adds Nick.
This includes gaining the approval of the medicinal colleges. While many GPs appear to be in favour of medicinal cannabis (or at least eager to learn more), the professional colleges, “the college of pain medicine for example”, remain cautious and have held off on voicing their support until further, and stronger evidence is presented.
For good reason, too. Both the colleges and the lawmakers don’t want the creation of “Pot Docs” like you may see Stateside. Described by Nick as doctors “who may have no experience in treating pain or epilepsy – they don’t know anything about those conditions but they’re prepared to prescribe medicinal cannabis.”
The changes have only been in place for a matter of days now, so it’s next to impossible to gauge any outcome or results. Nick does firmly believe that “With time, we expect we’ll reduce the timeframe it takes to get approvals, some training programs and guidelines.” There’s a lot of work that needs to be done to get these programs up and running. But, technically it’s not illegal. Where as up until a few days ago, it was almost illegal. Not quite, but almost.”
To conclude, the recent changes to legislation are “promising” for those who require medicinal cannabis, but ultimately “nothing to get excited about. “There’s one patient in Australia that’s using a medicinal cannabinoid product that isn’t licensed. That’s the number w’re working with at the moment, one”.
…How many are we going to end up with? 5,000? 50,000? 500,000? We don’t know.”