Reclassifying CBD as Medicine
In December of last year, Australia’s Therapeutic Goods Administration (TGA) announced it was down-scheduling low-dose cannabidiol (CBD) from Schedule 4 (Prescription Only Medicine) to Schedule 3 (Pharmacist Only Medicine)(1). This means that soon, Australians will be able to purchase CBD products over-the-counter from their pharmacists without a doctor’s prescription.
However, rumours have spread that CBD products will be available over-the-counter immediately, if not in the first few months of 2021. As we will soon see, these rumours are largely misleading. While CBD has been down-scheduled by the TGA, it will be some time before products are widely available due to a complicated set of hurdles each product must cross.
The TGA’s decision to down-schedule CBD reflects additional safety information, public requests, and new advice from the Joint Committee of the Advisory Committee on Medicine Scheduling (ACMS). The ACMS requirements include the following:
CBD must have a maximum recommended daily dosage of 150mg in a 30-day supply
CBD products must be kept behind pharmacy counters
All CBD projects are subject to rigorous clinical trials
CBD products must not be advertised to the public
Only oral and sublingual forms of CBD
The decision to increase the maximum daily dosage from 60mg per day to 150mg per day is seen as a success to manufacturers, since it provides a pathway to progress medical registrations with the Australian Register of Therapeutic Goods (ARTG). Any medicine not included on the ARTG is considered ‘unapproved’ as they have not been evaluated for quality, safety, and effectiveness. But by recognizing CBD as a wellness and health supplement, the ACMS is paving the way for its legal future.
As we move forward into next year and beyond, it’s critical we understand more about CBD – it’s function as a successful medication, it’s availability to the Australian public, and what its over-the-counter status means for doctors, pharmacists, and patients alike.
Consumer Demand for CBD
As awareness has increased globally regarding the health benefits of CBD-infused products, so too has the number of people willing to buy and try these products. In Australia, as news has reached the public that CBD will be available over-the-counter, many would-be patients are ready to jump at the opportunity to make a purchase and decide for themselves.
Unfortunately, as we have mentioned, no CBD products in Australia currently meet the standards of the TGA or the ARTG. Regardless, consumer demand will continue to increase, and once these products are approved and ready for retail, the market may grow rapidly.
The global market size for CBD products was valued at $10.6 billion in 2019 with an estimated annual growth rate of 24.6% (2). According to the Oceania Cannabis Report produced by Prohibition Partners, Australia’s medical cannabis market will be worth $1.3 billion by 2028 (3).