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Why Australia Treats Medical Cannabis With Extreme Care

October 10, 2016
Two orange pill bottles laying down next to one another. One is filled with marijuana flower buds and the other is filled with white prescription pills. Studio shot on a white background.
In Canada, licensed dispensers dispatch neat little packets of cannabis to medicinal users all over the country for as little as $5 a gram. The packets wouldn’t look out of place in a supermarket.

In Australia, the Therapeutic Goods Administration (TGA) has a very different plan for patients accessing cannabis. The TGA is the Department of Health agency charged with regulation of therapeutic goods, from medicines to sunscreens. Until recently, the Australian government has taken a restrictive approach to creating legal access to medicinal cannabis.

But on Aug. 31, in the face of mounting demand for clinical trials and patient access, the TGA down-scheduled cannabis from Schedule 9 (Prohibited Substance) to Schedule 8 (Controlled Drug). The administration recognizes only “limited high level evidence” for the efficacy of many cannabis products, although GW Pharma’s cannabis extract nabiximols—trade name Sativex—was registered with the TGA in September 2013. 

There are concerns about potential abuse and about smoking as a delivery method.

Nabiximols, a mouth spray containing CBD and THC, is used to treat symptoms of multiple sclerosis, and is one of the only cannabinoid drugs registered with the TGA. Manufactured in the UK and imported to Australia, it isn’t cheap. When Novartis Pharmaceuticals Australia applied to have nabiximols listed under the Australian Pharmaceutical Benefits Scheme in 2013, it estimated the annual cost to the PBS to be between AU$10 million and AU$30 million. (In 2011, GW Pharma signed a deal with Novartis giving Novartis exclusive commercialization rights to Sativex in Australia, Asia, the Middle East, and Africa.)

This is likely the kind of medicine the TGA has in mind when dealing with cannabis—pharmaceutical sprays or tablets provided on a strict, prescription-only basis. Front and center in its communications with the public is the Single Convention on Narcotic Drugs 1961, an international convention which requires its signatories not to allow the accumulation of drugs like cannabis in excess of domestic requirements.

But Canada is also a signatory to the convention, as are the UK and US. So what’s with the laborious, laboratory-heavy approach Down Under? The TGA cites accuracy of dosage as a concern. There may be other, unstated concerns as well—about potential abuse of cannabis or the problems with smoking as a delivery method.

The Australian Medical Association also takes a conservative view. The AMA states that cannabis should be subject to the same scrutiny and testing as any other medicine. That’s all well and good, but last year, across the Atlantic, the Journal of the American Medical Association conducted a systematic review of benefits and adverse effects of cannabis used medicinally, and found moderate-level evidence to support the use of cannabinoids for the treatment of chronic pain and spasticity.


Australia Fights for Medical Cannabis: Will Full Legalization Soon Follow?

The long road to patient access in Australia has led to serious frustration among patients who believe they would benefit from medicinal cannabis.

In practice, Australia’s slow and steady approach will likely lead to development of medicinal cannabis of a world-leading quality and efficacy. Patients accessing medicinal cannabis in Australia will have the assurance of the TGA backing the product, and their doctors will need a very clear understanding of the prescription and dosage.

These upsides are little benefit for those who need access now, however. The burdensome regulatory framework and incredibly stringent manufacturing standards are likely to make any Australian-manufactured products very expensive.

While patients deserve access to high-quality, accurately dosed medicine, the TGA and the federal government should continue to review and develop their approach to the promising medical uses of cannabis. Hopefully the numerous clinical trials being conducted around the country will provide a clearer and more comprehensive picture of cannabis’ efficacy and risks, backed by homegrown research.


    Good story Joe, some accurate bits, there but some key missing issues. Australia federally and in states bills have recently redefined “medical Cannabis” from a plant or extract of a full spectrum plant, to a suite of products that include no THC. This is further defined in a new bill in the state of Queensland where non specific synthetics are now also medical cannabis. This was specifically legislated to use synthetic opioids like Fentanyl that killed the singer Prince recently and is not clear what are the new “synthetics” in the new bill. Also another recent bill (Feb 2016) passed 33-6 in the state of Victoria to increase the penalties of trafficking for the drug ICE. VIewed as a good thing, it was only discovered late, that obscure references in the ice bill, referring to ICE and other drugs of dependence to be really be 100% about cannabis, users, patients, caregivers, and growers. Lawyer advocates called it the worst legislature ever seen in Australia. To further illustrate this the new Government division in the Department of Health, called the Office of Drug Control (ODC), working with states also redefined otherwise legal licensed growers of hemp, now redefining hemp as being below 3% THC to being below 1% THC, resulting in hemp growers having to cull crops, or pay thousands in new licensing fees. However with Cannabis with THC being 110% illegal the government is quick to point out, that the new definition of hemp (below 1% THC) does not apply to pharmaceuticals being less than 1% THC as also being hemp not Cannabis per their own definitions. In response to this BIll Turner head of the ODC said, don’t confuse the potency of hemp with the potency of Cannabis. Hemp is specific medical Cannabis can be anything if used as medicine. WIth the media being government controlled, and the Prime Minister (the richest in history) and married to a chair-woman of a biotech pharmaceutical company, it is an uphill battle to get any medical Cannabis products that include THC, let alone natural cannabis products. All this and more on the all the new bills is here ( and

  • Chuck Farley

    “The illegality of cannabis is outrageous, an impediment to full utilization of a drug which helps produce the serenity and insight, sensitivity and fellowship so desperately needed in this increasingly mad and dangerous world.” — Carl Sagan

  • Henri Dowd

    There’s a huge high demand multi-billion dollar market for raw cannabis as a much healthier option to alcohol. The government should already know this. Why have laws that support a black market ? Cannabis is categorized as a herb. Herbs like sage, rosemary, thyme and basil cost between $10 and $30 per pound. Big Pharma and the black market are ruled by greed and are both supported by policies which make it too expensive ($500 to $1,000 per month) for the majority to afford. All Patients demand economic justice.

  • James Bodie

    “accurate dosage” is not possible. The plant is extremely complex (that is what helps make it so valuable) and individuals are just that – individual, with different bodily systems, including the endocannabinoid system. People who use cannabis can only arrive at the right dose by titrating it – starting low and increasing the daily amount until they begin to feel positive effects. That is why all persons who believe they will benefit from the plant must be allowed to grow it (they choose the strain) and if they wish, make the products (raw weed, dried weed, edibles, oil, etc.) that suit them best.

  • Darren Young

    People will just start growing their own and risk criminal convictions, well I’m sure they already do.So nothing will change except a growing tide of justification for doing this will see a dramatic increase in Law abiding people being convicted and labeled criminals by the courts of Australia for using a natural plant Medicine for free . One group of people who would be pleased by the Governments approach to medical cannabis are the Bike gangs and other criminal organizations that supply the illegal market or are they one in the same? who’s making all the money out of medical cannabis?