The TGA told Hack the decision to make low-dose CBD oil available over the counter wasn’t based on how well it works, just that it isn’t harmful.
“The scheduling decision was made on the basis of the safety profile of CBD at this dose,” a TGA spokesperson said.
Cassandra from Fresh Leaf Analytics admits evidence of how well these products work is hard to come by but agrees they’re not harmful.
Medical Association “surprised” by down-scheduling
She says this will make life much easier for people who want to use this drug.
However, while the laws have been changed so you can buy CBD oil over-the-counter, there are currently no products approved for sale.
Cassandra Hunt, the managing director of cannabis industry consultancy, Fresh Leaf Analytics, told Hack the change is significant.
She also says that for the first time, as the cost of medical cannabis production comes down, legal products are reaching price parity with the illegal market.
Compared with other medicines, the response of each individual to CBD varies enormously among individuals, Mr Sclavos said. That meant that pharmacists will have a “bigger say” in adjusting the dose.
Clinical research has shown it can help reduce anxiety, insomnia, post-traumatic stress disorder and pain, said Dr Ben Jansen, the director and founder of Cannabis Doctors Australia.
The Australian Medical Association opposed the proposal to sell cannabidiol over the counter. A spokesperson said it had not changed its position.
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A worker on the first farm licenced in NSW to produce medicinal cannabis prunes a plant. Credit: Janie Barrett
Dr Jansen said his practice specialising in medicinal cannabis was passionate about CBD because it was life-changing for about a quarter of patients.
Manufacturers are working at a “lightning” rate to get products approved for sale in pharmacies, the former president of the Pharmacy Guild of Australia, Kos Sclavos, said.
Cannabidiol is an active ingredient in cannabis that doesn’t make a user high. A review by the World Health Organisation found it didn’t lead to drug abuse or dependence.
“We’re currently supporting four companies for registering one or more Schedule 3 CBD products and we look forward to unmasking the new regulations as each stage is crossed,” he said.
“Registering a CBD product on the TGA register is not automatic and requires strong clinical data including phase I, II and III clinical trials. Once the data has been collected and the dossier is submitted to the TGA, there is a TGA evaluation timeline of approximately six months.”
Rumours have since been circulating that CBD products are expected to be available over-the-counter straight away, or at least sometime in 2021.
Product registration can be a lengthy process
According to the Medical Cannabis Research Collaboration (MCRC), Cannvalate’s research division, a major misconception is that products are available to buy right now – but in reality, consumers could be waiting a year or more.
“You could expect to find CBD available in your pharmacies in 2022,” Mr Azzopardi said.
While this is expected to have a positive impact on many patients’ lives, there are myths circulating about this development that require clarification.
However, meeting the TGA’s criteria for Schedule 3 over-the-counter status will “not be easy”, according to Cannvalate chief growth officer Julian Azzopardi.