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:
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.
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).
While consumers are technically able to get CBD now without a prescription across Australia, it may be 10-12 months(3,4) or more before they're available over-the-counter. The usual process of conducting clinical research to register a product for over-the-counter medical use can take several years. A regulatory body must come to the conclusion that CBD products are safe, high-quality, and effective.
One concern shared by manufacturers, pharmacists, and patients relates to the maximum recommended dosage of 150mg/day allowed by the ACMS scheduling guidelines and efficacy. For instance, in order to determine efficacy, a CBD pain medication must lower a patient's pain intensity by at least 33% (4). A daily dose of 150mg may not be strong enough to effectively treat patients suffering from chronic pain and other more severe disorders or diseases, potentially leading regulatory bodies to determine CBD is an ineffective treatment. Plus, since the 150mg concentration was only just confirmed by the TGA in December, most manufacturers are only now beginning their clinical trial programs.
Currently, the best way to get CBD in Australia is through your GP, healthcare specialist, or nurse practitioner, each of whom can write prescriptions for a wide range of applications. Medicinal vapes and topical creams containing CBD will not be available over-the-counter as they have not been approved as Schedule 3 drugs. Doctors will still need to write prescriptions for patients who need these specific products.
The last barrier for consumer access to CBD may be a lack of training on the part of pharmacists (5). Most pharmacists in Australia are not ready to answer questions related to timelines for availability or to convey accurate information to help patients manage their expectations regarding CBD. But as public awareness increases, politicians and regulatory boards will face pressures to reevaluate current policies and perspectives concerning medical cannabis as a whole. As attitudes toward these medicines change, we may soon see a bright future for the medical cannabis industry across Australia.
As we move into 2021, "CBD is now available†coverage on the news and social media will spread far and wide, and more pharmacists will be questioned about the product. For now, the best course of action is to explain to patients that Schedule 4 CBD is currently available, and that they can ring their doctors for a prescription. That way, they can still take advantage of potential treatments from CBD rather than waiting around for Schedule 3 purchases.
Many advocates for CBD's legalization in Australia believe the TGA's final decision is a net positive and a welcome outcome for patients who can benefit from its myriad uses. The decision should encourage registration applications from a wide range of CBD manufacturers, improving accessibility and reducing costs for medicinal cannabis products across the country.
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