Australians might be looking at a cleared path to cannabis medications as soon as next year.
The Australian government made an interim decision earlier this month (Sept. 9) to bring low-dose CBD medication over-the-counter.
Right now, accessing treatments Down Under means meandering through pathways to get a doctor’s prescription and approvals from the government’s Therapeutic Goods Administration (TGA), the Aussie version of the FDA. However, this government announcement means that CBD could be labelled down from a Schedule 4 to a Schedule 3 drug with implementation proposed on June 1, 2021.
So just how big is the market for low-dose CBD medication? FreshLeaf Analytics, Australia’s leading industry data source, wrote in its Q3 Patient, Product and Pricing Analysis that 20% of patients are taking low-dose CBD. There’s also the potential for the over-the-counter CBD market in Australia to grow rapidly and exceed A$200 million of revenue.
FreshLeaf Managing Director Cassandra Hunt said, “This will be the biggest thing to happen in the industry since Federal legalisation of medicinal cannabis in Australia in 2016. We expect it will result in more Australians benefiting from the healing properties of cannabis and will reduce the number of people seeking products through unregulated illicit channels.”
It’s not all smooth sailing though. Dr Mark Hardy of Australia’s first and largest medicinal cannabis network, CA Clinics said, “This is a welcome move but it’s important to note that the effects of low-dose CBD may be negligible for many patients. Patients seeking treatment for chronic conditions that may benefit from medicinal cannabis may require higher dosages or other cannabinoids such as THC and should therefore consult their GP before taking these products, even in small amounts.”
And there are other factors that might still stand in the way of this initiative bringing over-the-counter medicinal cannabis within closer reach of consumers.
While the new regulations would theoretically allow the sale of pure and securely packaged CBD to adults, with each packet containing 1,800mg of product (30 day supply of the recommended 60mg daily dose), Hunt said that “‘The next challenge will be getting products in the market as quickly and cost effectively as possible’.
Registering a product for a Schedule 3 label means producing clinical data providing evidence for efficacy that may be difficult to do for 60mg doses.
FreshLeaf’s Q3 report wrote, “This raises substantial questions around the ability of any company to successfully register its products, even if the regulatory pathway exists.”
FreshLeaf has declared that it is working closely with the TGA to define these requirements.
Product types have also been limited to oral, oral mucosal and sublingual formulations, dismissing other common delivery types such as vapes and topical creams.
The good news for Aussie patients is that, even if there are hurdles to over-the-counter low-dose CBD, FreshLeaf’s Q3 report states that general legal market prices are now 25 percent of what they were at the industry’s dawn in early 2016. This has been the largest drop in its history and “a clear example of market forces, not regulation, being successful in driving prices down.”
The number of legal medicinal cannabis products available in Australia has also seen a 50 percent rise to 150 in the last year. FreshLeaf expects to see it spike to 300 products at the end of 2021…. good news for patients and choice, tough if you’re a doctor trying to choose which one is the most appropriate for your patient!
A final decision for the over-the-counter move is expected to be made by the Australian government on November 25.