Everything you need to know about medical cannabis

Medical cannabis products are now available for doctors to prescribe in Australia, although they are currently considered ‘unregistered medicines’, requiring the Therapeutic Goods Administration (TGA) in the Department of Health to approve prescription requests.

The TGA has approved applications for the use of medical cannabis products including, but not limited to, chemotherapy-induced nausea and vomiting, refractory paediatric epilepsy, palliative care indications, cancer pain, neuropathic pain, spasticity from neurological conditions, anorexia and wasting associated with chronic illness (such as cancer).

“Doctors in Australia can now prescribe medical cannabis to their patients, although rules are different in each state and territory. New Zealand has a slightly more restrictive framework than Australia but that is currently being reformed. It is not yet legal in any other Asia-Pacific nations,” says cannabis industry expert Mr Rhys Cohen.

He is also the Senior Project Officer at the Lambert Initiative for Cannabinoid Therapeutics at The University of Sydney, who were behind a recent study which showed many doctors feel they don’t have enough knowledge in this area and most rate their level of knowledge of medical cannabis as poor.

This is despite 61.5 per cent of GPs having had at least one query regarding medical cannabis in the previous three months and 7.5 per cent having more than five queries. More than half of the GPs in the study agreed with the statement that medicinal cannabis should be available on prescription for certain indications.

“The numbers tell the story,” Cohen adds. “In Australia since 2016 we’ve had about 1500 people get access to these unregistered medicinal cannabis products. In Canada the number is 300,000 people and rising.”

Many people with serious medical conditions are asking their GP or medical specialist about medical cannabis, although it is important to know not all health specialists will consider or be able to prescribe it.

You will need to fit specific requirements to be allowed access.

Medical professionals first need to show there is a good reason they are recommending this product over a registered medicine.

It is up to the Federal Health Department to OK whether or not a doctor or specialist can prescribe a medical cannabis product.

Doctors also need to show they recognise the potential side effects. And there’s a patchwork quilt of additional regulations at the State/Territory level.

One of the biggest issues in this area is the fact that medicinal cannabis products have not yet gone through the normal pharmaceutical drug development processes (including large-scale clinical trials) and are therefore ‘unregistered medicines’. While clinical trials are now underway in at least two Australian States – with the Victorian and NSW governments partnering with medical cannabis producer Tilray Inc to evaluate its use in paediatric epilepsy treatments and to prevent nausea and vomiting in chemotherapy patients – the fact that medicinal cannabis products currently remain unregistered medicines makes them difficult for doctors to prescribe. But even these unregistered medicines must comply with strict quality and safety standards.

But even these unregistered medicines must comply with strict Australian quality and safety standards.

“In contrast, in California for example, you can grow your own medical cannabis in your house if you want. You can get a license to grow a bunch of plants in a field somewhere with no real safety or quality control and then sell it wholesale to a store, which can sell it to someone who’s got permission from a doctor to purchase it,” adds Cohen.

“The historical prohibition of cannabis both in Australia and around the world is the main reason why there’s been relatively little proper research on its therapeutic potential. It’s the absence of evidence that’s the issue. And then there’s the price,” says Cohen.

“It is very expensive and there are no rebates at all on private insurance or Medicare. To cover a legal medical cannabis prescription for a young person with paediatric epilepsy for a year, for example, you’d be looking at between $40,000 and $60,000. For an adult with chronic pain it will cost about $20,000 a year in Australia. The government has no policy around price and no plans to address the price issue. But we hope that local Australian producers will drive down prices eventually as almost all medical cannabis is being imported at the moment.”

Some Australian companies have permission to grow cannabis but not surprisingly, there are very strict restrictions on advertising and a lot of red tape.

There was a breakthrough in April 2018 when all Australian States and Territories agreed to a new streamlined approval process managed by the TGA. As of October 2018, except for the ACT and Tasmania, doctors now only need to submit a single online application which can get approved within 48 hours.

Meanwhile, Australian companies applying for licenses to make medical cannabis products are waiting more than six months for the government to even start looking at their applications.

“If the government isn’t going to subsidise these medicines, they need to add a lot of staff to speed up the license processing time for local companies to cultivate and manufacture medical cannabis,” adds Cohen.

It’s a catch 22. With a clear need for cheaper yet quality product, industry insiders are considering the need for a legal amnesty for those people who are compelled to use illicit cannabis for serious medical conditions out of desperation.

The NSW government have addressed this issue somewhat with the Medicinal Cannabis Compassionate Use Scheme. “If you have a terminal illness and live in NSW, for example, you can put yourself on a registry where the police are advised to not prosecute you if you are in possession of illicit cannabis. This scheme continues to run despite the ‘legalisation’ of medical cannabis because the NSW government knows almost no-one can access or afford legal medical cannabis,” says Cohen.

There are 14 countries world-wide where medical marijuana is legal.

Australia
In 2016 Australia introduced legislation to allow medical marijuana to be available via prescription, yet a doctor must be an ‘authorised prescriber’ or make an application on behalf of their patient via the Therapeutic Goods Administration (TGA) ‘special access scheme’.

Uruguay
Uruguay became the first country to legalise marijuana across the board in 2017.

USA
Washington, DC, and nine states have legalised marijuana for adults over the age of 21 for recreational use. While medical marijuana is legal in another 30 states.

Canada
Canada legalised the adult use of recreational cannabis with the Cannabis Act on October 17, 2018, for adults 18 years or older (depending on their province or territory) to possess up to 30 grams of legal cannabis in public and grow up to four plants per residence for personal use, including medical issues.

England, Wales, Scotland & Northern Ireland
Doctors in Northern Ireland have been given permission from the Department of Health to prescribe cannabis products from November 1, 2018, and medical cannabis oil will be available on prescription in England, Wales and Scotland.

New Zealand
Terminal patients with less than a year to live are able to have a legal defence to possess and use cannabis and may be able to consume legally. Although a ‘green fairy’ helping to secure a supply would still be at risk of prosecution. The Ministry of Health guidelines say doctors can approve specific treatment with cannabis products, yet the costs are prohibitive for the average person as there are no subsidies. A referendum is expected to occur in 2019 or 2020.