Over The Counter:
In December 2020, the Therapeutics Goods Administration (TGA) confirmed the down-scheduling of low dose CBD from a schedule 4 (S4) to a schedule 3 (S3) substance. That decision meant that as of February 1, 2021, it would be legal for companies to sell low dose CBD products over the counter in pharmacies Australia wide.
While low dose, Schedule 3 CBD oil is technically legal for over the counter sale in pharmacies, the TGA has set specific requirements for those products. The most important, and the most tricky requirement that these products must meet is that they must be listed on the Australian Register of Therapeutic Goods (the ARTG).
What’s the difference between low dose CBD oil over the counter and cannabis prescribed by a doctor?
There are a few important differences between over the counter, low dose CBD products you’ll eventually find at pharmacies, and CBD or cannabis prescribed by a doctor. The main differences are the ARTG listing, patient eligibility and conditions the cannabis will treat and product types and cannabinoid content.
The low dose CBD products that may be sold over the counter in the future will have to have successfully passed clinical trials and be proven to be safe and efficacious for a specific condition or indication.
Any GP in Australia can prescribe medical cannabis, with the exception of Tasmania where you need a specialist. There is no list of conditions for which a doctor can prescribe, so a doctor may apply for cannabis to treat any condition. To be eligible for cannabis, a patient (of any age) must have a chronic medical condition and must have tested other forms of treatment. Those treatments must have either had unbearable side effects or the patient must not have found relief from symptoms. Any doctor may prescribe any product for any chronic condition.
While it’s now legal to sell low dose CBD products in pharmacies, currently and for the next 18+ months, there are, and will be no products that meet the TGA’s requirements to be sold in pharmacies. It’s likely Australians won’t see CBD oil over the counter until 2023.
According to the Oceania Cannabis Report, produced by London-based advisory group Prohibition Partners, the Australian medical cannabis market is estimated to be worth up to $1.3 billion by 2028.
Although Mr Azzopardi, who leads Cannvalate’s Medical Cannabis Research Centre, did admit that political pressure could be a motivation for the TGA to expedite its usual approval timeframe – in which case, this could change forecasts.
“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.”
Product registration can be a lengthy process
Mr Azzopardi said the approach of the MCRC to register a Schedule 3 product involves preparing a comprehensive submission to the TGA detailing the proposed pathway and requesting validation.
However, there may be viability in a partial literature-based submission for some of the evidence required, which would enable an accelerated pathway.
The expectation from a regulatory body to register a product is that safety, quality and efficacy targets are met.
Rumours have since been circulating that CBD products are expected to be available over-the-counter straight away, or at least sometime in 2021.