By ALLISON HORE
The Therapeutic Goods Association (TGA) has announced it intends to make CBD products available over the counter as early as next year. This comes as our neighbours across the Tasman debate a referendum to legalise marijuana for recreational purposes.
CBD (or cannabidiol) is a non-intoxicating component of the hemp plant, currently listed as a Schedule 4 “prescription-only medicine”. Some research suggests the substance can be useful in treating conditions such as epilepsy, anxiety, pain and insomnia while carrying few, if any, risks of major side effects or addiction.
For a cannabis product to be deemed legal in Australia, the CBD component of the oil must be more than 98 percent concentration. This means only 2 percent of the product can contain other cannabinoids such as tetrahydrocannabinol (THC), the substance that gives users a high.
Currently, CBD is only available with a prescription, and that prescription must be approved by the TGA through their Special Access Scheme. In 2019, the TGA granted 25,182 applications from doctors to prescribe the drug. It is estimated that more than 600,000 patients have been prescribed CBD since its legalisation.
By down scheduling the substance to a Schedule 3 poison, rather than a Schedule 4 one, the TGA is set to make CBD available for medical use without a prescription.
Australia slow of the mark
Despite more doctors getting behind the treatment, it can be difficult for patients to get a prescription. According to a survey by Melbourne-based medicinal cannabis company Montu, only 5 percent of GPs are prescribing medicinal cannabis despite more than 3 quarters of Australians supporting it.
Research from the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney suggests Australia is lagging behind other Western countries when it comes to embracing CBD products. In North America, the UK and most of Europe, CBD products are readily available online and over the counter in health food stores and pharmacies.
But the tides are turning. The TGA has flagged making CBD based medication available over the counter, without prescription, as early as 2021. Lambert Initiative researcher Professor Iain McGregor said he supports moves which will make CBD more accessible.
“CBD use without a prescription is an unprecedented global phenomenon. We are entering a period that is a huge exercise in self-medication,” he said.
Sharon Bentley, Managing Director of Medical Cannabis Australia, told City Hub while she thinks the interim decision is “a step in the right direction” it’s “not as great as it appears”.
“The TGA has proposed a maximum daily dosage of 60mg per day,” she said.
“The problem with this is there is currently little to no evidence to suggest that CBD at a low dose of 60mg per day is effective for the most common disorders, such as anxiety, insomnia and pain.”
Analysis by the Lambert Initiative agrees a dose of 60mg “may not be high enough to benefit patients”. They suggest benefits of CBD products are usually seen at doses of between 300mg and 1500mg a day.
Health community pushback
Not everyone supports the move. In a submission to the TGA, the Australian Medical Association suggested that there wasn’t enough evidence to support making CBD more widely available. They said making an untested product more readily available may dissuade people from using other, less controversial, medicines.
“There is a risk of normalising the concept that cannabis is a good therapeutic product without established evidence to support it, and potentially dissuades use of products with a genuine evidence-based for benefit,” the AMA said.
Even the TGA’s committee is mixed on the decision. The committee which was led by Associate Professor Suzanne Nielsen of the Monash Addiction Research Centre, in Melbourne, noted adverse reactions linked with CBD including drowsiness, diarrhoea and liver dysfunction.
The Federal government recently announced $3 million worth of additional funding into clinical trials involving CBD’s medical applications. But Ms. Bentley said she anticipates “we will see very few products make it to market”.
“Expensive clinical evidence is required before any new products will be allowed to be sold and it may be difficult to obtain sufficient evidence of effectiveness at 60mg per day,” she said.
“We believe there is a risk that if products are ineffective, they could have a damaging effect on consumer confidence.”
For this reason, she said, patients may not get access to the amount of products they might be anticipating from the TGA’s rescheduling.
New Zealand weed referendum
Across the pond, New Zealand is also looking at making big changes to their laws regarding cannabis products.
Alongside their federal election on October 17, kiwis will be asked to vote in two referendums. The first asking whether assisted dying should be legalised for the terminally ill. The second, whether they support legislation to make recreational cannabis legal.
Under the proposed legislation, to be voted on in the referendum, growing your own cannabis or buying up to 14 grams of dried cannabis per day from a licensed dealer will be legalised. If the “yes” vote on the referendum succeeds the proposed legislation would be brought to parliament. The legal age for the purchase and consumption of recreational marijuana would be 20 years old.
The close relationship between Australia and New Zealand means the result of the referendum may have serious implications in Australia.
In the end of January use of marijuana for recreational purposes was decriminalised in the ACT, but in the rest of the country it remains criminal. Despite that, in a 2019 survey by the Australian Institute of Health and Welfare, 36 percent of all Australians reported having used cannabis in their lifetime, and 11.6 percent had used it within the past year.
Roy Morgan polling revealed in 2019, 42 percent of Australians supported cannabis legalisation.
Gino Vumbaca, the president of Harm Reduction Australia told the Sydney Morning Herald that he will be watching the referendum closely.
“It will have an impact here because of the close ties between the two countries. If they move down a pathway that we think is fairly sensible, it will raise the need to review what we are doing here,” he said.
“At the very least we hope it sparks some discussion about what we are actually doing with our drug laws. New Zealand may also end up attracting more Australian tourists too.”
As for the TGA’s decision regarding CBD, they are taking public comment about amending the Poisons Standard until October 13. The final decision on whether it will be made available over the counter will be made in November.