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Meg is the Group Editorial Director for Cannabis Patient Care and Cannabis Science and Technology magazines at MJH Life Sciences.
Here we take a closer look at Australia’s medical cannabis program, the laws surrounding it, and speak to Australian pharmacist Paul Mavor.
As cannabis legalization ramps up in the United States, it’s important to look at other countries to see how they are handling the new age of cannabis legalization and discover what we can learn from them. Australia has taken a strong approach with its medical cannabis program, enlisting the help of the government, doctors, and pharmacists to make the program efficient and reliable for patients. In this article, we take a closer look at Australia’s medical cannabis program, the laws surrounding it, and speak to Australian pharmacist Paul Mavor, who imported the first legal commercial shipment of medical cannabis into Australia under the new regulations.
The United States is in a unique situation: As of January 2019, 23 states have legalized medical cannabis and 10 states as well as the District of Columbia (Washington, D.C.) have legalized adult use in addition to medical cannabis. However, cannabis is still illegal on the federal level, which means there is no oversight by government agencies for quality assurance and quality control testing or regulations.
Because each state governs its own testing and quality control issues independently, it’s worthwhile to take notice of what other countries are doing-without the federal restrictions imposed in the United States. In this new column series, we will interview people involved in the cannabis industry in various countries to get a better understanding of how cannabis programs are managed around the world. Here in the first installment, we focus on Australia and discuss the laws, testing, and overall reach of the medical cannabis program they have in place. Let’s discover what we can learn from our friends around the world.
Australia is composed of six states: Queensland, New South Wales, Victoria, Tasmania, South Australia, and Western Australia. There are also several territories, two of which were granted a limited right of self-government by the federal government (called the Commonwealth)-the Northern Territory (NT) and the Australian Capital Territory (ACT). The responsibility for regulating medicines and poisons is shared between the Commonwealth and the states and territories. The Commonwealth controls what drugs may be used for therapeutic purposes and the individual state or territory regulates patient access to those drugs (1).
Similar to the United States, many of the states in Australia introduced their own cannabis legislation prior to passage of a Commonwealth law, which is discussed in more detail below. The legislation pushing for legalized medical cannabis in Australia at the Commonwealth level included several amendments to the federal Narcotics Drugs Act 1967 that decriminalized the use and supply of medicinal cannabis (2). In 2017, the Therapeutic Goods Administration rescheduled certain medicinal cannabis products to schedule 8 of the Poisons Standard, which made the prescription of medicinal cannabis legal in Australia. The Therapeutic Goods Administration published guidance documents for health professionals and consumers to provide advice and further explanation about the evidence for use of medicinal cannabis products. A series of systematic reviews by the National Drug and Alcohol Research Centre informed the evidence-based guidance documents which assess the evidence for use of medicinal cannabis in the following conditions (3):
Victoria was the first state to introduce legislation to legalize medical cannabis in 2016, in a law referred to as the Access to Medicinal Cannabis Act 2016. That legislation went into effect in early 2017, making it legal for medical cannabis to be used by children with severe, treatment-resistant epilepsy (2). Since then, the Commonwealth implemented its own laws and Victoria is now following those federal guidelines. The Access to Medicinal Cannabis Act 2016 is no longer necessary under the Commonwealth law, but patients that were granted compassionate access under the program will continue to receive funding provided for under that law through June 2020 (4).
Queensland instituted the Public Health (Medicinal Cannabis) Act 2016 in March 2017. This law allowed medical cannabis by prescription from specialists for use by patients with a range of conditions including MS, epilepsy, cancer, and HIV/AIDS (2).
New South Wales
South Wales introduced legislation for use by adults with end-of-life illnesses that went into effect in July 2016 (Poisons and Therapeutic Goods Amendment Regulation 2016).
In November 2016, South Australia legalized prescriptions from doctors under certain conditions. The South Australian Controlled Substances Act 1984 regulates the prescribing and supply of medicines in South Australia and applies to medicinal cannabis products as follows (3): “A section 18A authority to prescribe a medicinal cannabis product that is a Schedule 8 controlled drug (drug of dependence) is required:
Western Australia also legalized medicinal cannabis prescriptions from doctors under certain conditions in November 2016 (2).
The Controlled Access Scheme began in 2017 in Tasmania, which allowed patients to access unregistered medicinal cannabis (2). No legislative changes were required. The scheme reportedly allows relevant medical specialists to be authorized to prescribe medical cannabis (unregistered cannabinoid products) in limited circumstances where conventional treatment has been unsuccessful (5).
The Northern Territory follows the laws of the Commonwealth through the Therapeutic Goods Administration. Access is restricted to patients with certain medical conditions (2).
Australian Capital Territory
The Australian Capital Territory legalized medicinal cannabis for people who fall under category 6 illnesses within certain criteria as of 2017 (2). This law seems to be in accordance with the Commonwealth.
Now that we know the status of medicinal cannabis in Australia, we can discover how people access it there and what kind of testing or regulations are in place by speaking to someone with firsthand knowledge of the Australian market.
Paul Mavor is a registered pharmacist in Australia and the UK as well as the CEO and Founder of Health House International. He became interested in the cannabis industry after seeing some U.S. data on drug overdoses, mainly the horrendous death toll from opiates, which contrasts with the statistic of the zero deaths that have been attributed to cannabis. “I started researching mainly to prove that statistic wrong, but found not only was cannabis almost impossible to overdose on but had a number of medical benefits,” said Mavor. “One of the biggest uses is for chronic pain which is a massive problem both in Australia and globally.”
Mavor’s wife Sharlene is a medical scientist and shares his passion for researching medical cannabis and travelling to cannabis conferences around the world. One of those, the first Cannabis Science Conference in Portland, Oregon in 2016, was a real eye opener, because it showed them the importance of the science and testing behind the industry. “While the business side of the industry is important, I think some of the science behind cannabis will grow brands exponentially,” Mavor said.
Testing, Quality Control, and Exporting
With that science in mind, we asked Mavor how Australia handles its cannabis testing and quality control. He explained that all cannabis in Australia has to conform to a series of government standards called the Therapeutic Goods Order 93 (or TGO93), which means they have to be of known purity and potency and free from mycotoxins, solvents, pesticides, fungus, and heavy metals.
Mavor also explained that all cannabis in Australia is produced via good manufacturing practices (GMPs), which sets the bar pretty high. He described some of the products that will be offered in Australia under the GMP guidelines, noting that there is only one Australian product to market at this stage because the industry is still in its infancy. “We are adopting a strict medical model aimed at producing concentrates such as oils, capsules, sprays, and so on,” he said. “I see these as being a far better delivery method than smoked cannabis because it delivers better (lower) more constant levels. In this way, it is no different from any other pharmaceutical sold as medicine. I think this is smart and predict most of the world will end up adopting pharmacy-based cannabis distribution, at least for medical use.”
Australia is also gearing up to allow the export of cannabis, particularly to Asia, Mavor stated. “This will hopefully allow the industry to grow and provide jobs. Canada has already done this, but there are a couple of major cannabis producing countries like the U.S. and Israel who are yet to allow export,” he said.
The Good and The Bad
As with most legislative and distribution frameworks for cannabis, there are aspects of the Australian system that work well and others that could use improvement. In Australia-unlike in the United States-cannabis research has been actually encouraged by the government since cannabis became federally legal-a major positive in terms of advancing the use for medical applications. “There are many projects underway on various medical conditions where there is insufficient evidence to prove that it works,” Mavor said, adding that a number of clinical trials are taking place for different medical applications. “The research is supported and sometimes funded by state and federal government, while other research is funded privately or by grant money,” he said.
For example, the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney is one of the main research groups in Australia studying cannabis. According to Mavor, the group became well-funded when a wealthy businessman, Barry Lambert and his wife Joy, donated A$34 million (equivalent to about US $24.5 million) to fund cannabinoid research. “Their granddaughter, Katelyn, suffers from Dravets Syndrome and they were interested in the research the University of Sydney was doing,” said Mavor. “The Lambert Initiative now has several teams doing extensive research in a number of areas including childhood epilepsy, neurological disorders, and cannabis and driving.”
In addition, there are a number of clinical trials being carried out in Australia in areas such as drug resistant epilepsy, palliative care, and sleep studies as well as several other trials that are in development (6). Mavor also mentioned that preclinical work has been published by Professor Marco Falasca of Curtin University in Western Australia on rat models using a combination of cannabis and chemotherapy for pancreatic cancer. Falasca’s study has shown the life expectancy has increased four-fold and they are just moving on to human trials now (7,8). “Considering most of these patients have a very low survival rate and treatments have not changed in 50 years, this has the potential to be a substantial breakthrough,” Mavor added.
Mavor said there are also a number of educational programs being rolled out across Australia that are teaching prescribers about the endocannabinoid system and some of the clinical evidence surrounding medical cannabis.
Mavor also praised the pharmacy distribution method, particularly in comparison to the dispensary system in the U.S. “In my opinion, having a pharmacy distribution method is really good because pharmacists can not only counsel and monitor patients, but they are also qualified to assist with any potential interactions,” he said.
In addition, the government is closely monitoring the medical cannabis prescriptions for any adverse reactions, which they do for all medications. “So far, patients have only had access to GMP cannabis under medical supervision. In most cases it has been really well tolerated,” said Mavor. “Part of the approval process for prescriptions requires extensive treatment monitoring.”
However, there are some limitations to the program. Patient access, for example, is a problem that is slowly being addressed. When the government first legalized cannabis, Mavor said that all prescribers had to submit any application to various committees that contained a large number of members, some of whom were anti-cannabis. “These committees were based on ones used to restrict doctors from prescribing amphetamines and, as a result, they have stifled the prescribing process and taken up to two months to approve any applications,” he said. “This is slowly being switched to a one-page online form that is being processed under delegation within 48 hours.”
Other aspects that make patient access difficult include finding a prescribing doctor, which may require sign off from a specialist, in addition to obtaining federal and state approval. Furthermore, Mavor said Australia is currently relying on imported medicines until their own domestic production gets up to speed. “Lots of barriers exist, but we are starting to see some light at the end of the tunnel with patient numbers increasing,” he said.
Currently, there are 10 additional medical conditions that are being approved by the Australian federal government for treating doctors to prescribe for patient use. These are:
Mavor said that other conditions aren’t disallowed, they just need a gold standard clinical trial to provide enough evidence to justify their use. “I predict in the next couple of years that a number of more conditions will be added to this list as results of research is published worldwide,” he said. Currently, the government are allowing uses where medical cannabis is treating the symptoms of diseases when patients have tried other therapies unsuccessfully for more than three months.
The Business Model
Australia’s business model for medical cannabis does not allow for vertical integration. Companies need to get approval from the Australian Office of Drug Control (ODC) for one of three licenses: cultivation, manufacturing, and research. According to Mavor, as of August 2018 only 42 licenses had been issued: 19 for cultivation, 10 for manufacturing, and 13 for research.
At present there are about 20 Australian cannabis companies listed on the stock exchange with a market cap of around A$1 billion dollars (U.S. $700 million) and approximately 100 companies that are not listed.
Adult or Recreational Use
Cannabis is still illegal for adult or recreational use in Australia, and that does not seem likely to change soon. “Most people (91%) support medical cannabis,” Mavor said. “Support for adult use or recreational is a lot lower.”
However, Mavor thinks it is a foregone conclusion that adult use legalization will happen in 10 to 15 years. “Most jurisdictions around the world that have legalized for adult use have run a successful medical program for a number of years and then have down-scheduled cannabis to allow it for recreational purposes,” he said. “From a harm minimization point of view, I see that it can reduce harm and crime by allowing people access to tested legal product as well as offer an alternative to alcohol.”
Mavor also mentioned the recent referendum scheduled in neighboring New Zealand in 2020, which he believes could potentially accelerate the argument in Australia if it’s successful (9).
What Does the Future Hold for Australia?
Mavor believes that Australia is well positioned to conduct more research into medical cannabis. He also foresees a down scheduling of cannabis, making access easier for patients for a wider range of medical conditions.
Mavor also thinks Australia is primed to be a major cannabis exporter of medical-grade cannabis, given the country’s geographical proximity to Asian markets. “There are more than one billion Indians and Chinese that have a long history of using medical cannabis dating back thousands of years,” he said. “I predict that in coming years this will be a massive and emerging cannabis market.”
As Australia’s medicinal cannabis program enters its third year, it offers a lot of positive lessons for state-level regulators in the United States. For example, the pharmacy delivery method ensures that patients have access to a healthcare professional every step of the way. The GMP regulations that apply to all cannabis in Australia are also important for ensuring product quality. How is the cannabis in your state tested and what is required? Do you know? Without federal oversight, there are many questions of quality control left unanswered in the United States. As consumers, it is our right to demand quality products that are free of harmful contaminants; product quality is even more important in medical products. We should treat cannabis like medicine and test it that way.
To read the full interview with Paul Mavor, please visit: www.cannabissciencetech.com/cannabis-voices/australias-cannabis-market-insiders-view.
Paul Mavor is a registered Australian and UK pharmacist. His company Health House was granted the first medicinal cannabis import license in Australia and he is currently distributing medicinal cannabis products to eligible patients. Over the last 30 years he has owned several retail pharmacies and worked both in Australia and the UK. In the last 3 years, he has focused on researching medicinal cannabis and has been to conferences, grow and manufacturing facilities, and spoken to patients and prescribers in the U.S., Canada, Israel, and recently South America. For more information, visit www.healthhouse.com.au
This article was originally published by Cannabis Science and Technology in the January/February 2019 print issue. The original story can be found here: https://www.cannabissciencetech.com/view/australias-cannabis-market-what-can-us-learn
M. L'Heureux, Cannabis Science and Technology 2(1), 32-39 (2019).