Australia’s Cannabis Market: An Insider’s View

Australia has taken a strong approach with their medical cannabis program, enlisting the help of the government, doctors, and pharmacists to make the program efficient and reliable for patients. Paul Mavor, an Australian and UK licensed pharmacist and the CEO and Founder of Health House International, recently spoke to us about Australia’s medical cannabis program, the testing and regulations in place, and the future outlook for cannabis in his country.

How did you get involved in the cannabis industry in your country?
Paul Mavor: I first became interested after seeing some U.S. data on drug overdoses, mainly opiates and saw the horrendous toll compared to the zero deaths quoted from cannabis. I started researching mainly to prove it wrong but found not only was cannabis almost impossible to overdose on but had a number of medical benefits. One of the biggest uses is for chronic pain which is a massive problem both in Australia and globally.

Please explain the legal status of cannabis in Australia. How is Australia’s approach to cannabis legalization or regulation different from the United States?
Mavor: Cannabis was made federally legal in Australia in 2016. It is available with a doctor’s prescription via pharmacies and only for certain medical conditions where there is good clinical evidence. All prescriptions are approved by the government prior to access being granted for patients. Recreational cannabis remains illegal.

Are there any regulations in place in Australia such as those for ensuring quality, like what pesticides or heavy metals have to be tested for? Are there any other  regulations that are broader than quality control issues?
Mavor: All cannabis in Australia has to conform to a series of government standards called the Therapeutic Goods Order 93, which means they have to be of known purity and potency and free from mycotoxins, solvents, pesticides, fungus, and heavy metals.

What do you think is working best in Australia’s cannabis industry? What needs to be improved?
Mavor: It is great that it is federally legal and research is actually encouraged by the government. There are many projects underway on various medical conditions where there is insufficient evidence to prove that it works. 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.

Patient access is a problem that is slowly being addressed. When the government first legalized cannabis they made all prescribers submit any applications to various committees that contained a large number of members, some of them anti-cannabis. These committees were based on ones used to restrict doctors prescribing amphetamines and as a result have stifled the prescribing process and taken up to 2 months to approve any applications. This is slowly being switched to a one-page online form that is being processed under delegation within 48 hours.

There are also a number of educational programs being rolled out across Australia that are educating prescribers about the endocannabinoid system and some of the clinical evidence surrounding medical cannabis.

Do you think cannabis should be legalized for adult (recreational) use in Australia or is it better to restrict it to medical use?
Mavor: I think it is a foregone conclusion to 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. From a harm minimization point of view, I see that it can reduce harm and crime by allowing people access to tested legal products as well as offer an alternative to alcohol.

Based on your experiences in Australia, are there any guidelines or practices that you think other countries could benefit from following in their own cannabis industries? Likewise, did Australia look to any other countries when setting up their medical program?
Mavor: All cannabis is produced via good manufacturing practice (GMP), which sets the bar pretty high. We are adopting a strict medical model aimed at producing concentrates such as oils, capsules, sprays, and so on. 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 pharmaceuticals 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.

We are also gearing up to allow the export of cannabis, particularly to Asia who we are close to. 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.

How accessible is cannabis for medical patients in Australia? Are there specific qualifying conditions or registration requirements before getting a prescription?
Mavor: Access is a real problem. Patients have to find a prescribing doctor, they may need a sign off from a specialist, they need federal and state approval, and we are currently relying on imported medicines until our 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.

Currently there are six medical conditions that are being approved for patient use. These are:

• Chronic pain

• Drug resistant epilepsy

• Nausea in cancer related chemotherapy patients

• Palliative care

• Multiple sclerosis

• Post-traumatic stress disorder

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.

Is there a system in place to document adverse reactions in patients using cannabis? If so, how are those reactions shared with the broader community in Australia?
Mavor: The Australian government records adverse reactions for all medications. This can be accessed by the public. So far patients have only had access to GMP cannabis under medical supervision. In most cases, it has been really well tolerated. Part of the approval process for prescriptions requires extensive treatment monitoring.

How is the cannabis business in Australia structured? Is the government involved in any way other than regulating it? Are there any ownership restrictions in terms of different parts of the business, such as cultivation, processing, dispensing, and so on? Is the ownership concentrated in a few hands or spread out over many small business owners?
Mavor: At present there are 10-20 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. Companies need to get approval from the Australian Office of Drug Control (ODC) for one of three licenses: cultivation, manufacturing and research.

Conditions are strict and as at August 2018 only 42 licenses had been issued including:

• 19 Cultivation

• 10 manufacturing

• 13 Research

Can you tell us a little bit about the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney?
Mavor: The Lambert Initiative based in Sydney is one of the main research groups in Australia studying cannabis. They were well-funded when wealthy businessman Barry Lambert and his wife Joy gifted A$34 (about U.S. $24.5 million) to fund cannabinoid research. Their granddaughter, Katelyn, suffers from Dravets Syndrome and they were interested in the work the university was doing. They now have several teams doing extensive research in a number of areas including childhood epilepsy, neurological disorders, and cannabis and driving.

Are there any other cannabis research efforts taking place in Australia?
Mavor: Since Cannabis is federally legal in Australia there are a number of clinical trials taking place in a lot of different fields. The research is supported and sometimes funded by state and federal government. Some of it is funded privately and others by grant money.

Is there a stigma associated with cannabis in Australia? Are there any community- or professional-based education programs in place to teach people about cannabis?
Mavor: Most people (91%) support medical cannabis. Support for adult use or recreational like in the states is a lot lower. There are a lot of groups at the moment educating health professionals, many of them are cannabis companies but there is very little public education apart from what is in the media.

How do you think the cannabis industry in Australia will expand in the coming years?
Mavor: Australia is well placed to conduct research into medical cannabis. Over time I predict there will be a down scheduling of cannabis making access easier to patients. Eventually, in 10 to 15 years I predict like in Canada and certain U.S. states it will be available for adult use. Australia, because of its geographic location, is well placed to supply medical grade cannabis to Asia markets. There are a over a billion Indians and over a billion Chinese that have a long history of using medical cannabis dating back thousands of years. I predict that in coming years this will be a massive and emerging market.

Is there anything else you would like to add? 
Mavor: My wife Sharlene who is a medical scientist and I have been researching medical cannabis for a number of years and travelling to conferences around the world. We were lucky enough to attend the very first Cannabis Science Conference in Portland, Oregon in 2016. This was a real eye opener for us and showed us the importance of some of the science and testing behind this industry. It also gave us a really good idea on which way the cannabis industry-not only in Australia but globally-was heading and has been invaluable not only in knowledge but also networking of like-minded industry people, many of whom return year after year (like us). While the business side of this industry is important, I think some of the science behind cannabis will grow brands exponentially.

For more information on the Australian cannabis market, please see the "Cannabis Around the World" column in the January/February 2019 issue. 

About the Interviewee
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 US, Canada, Israel, and recently South America.  For more information, please visit: www.healthhouse.com.au