The rescheduling will be limited to oral, mucosal and sublingual CBD products, which means that vaping, topical creams and smokables will remain illegal.
Earlier today the Australian government announced that the Therapeutic Goods Administration (TGA) has elected to make registered low-dosage CBD products available for sale over-the-counter from Australian pharmacies, opening up a potential $200 million market.
The interim decision will see low strength CBD reclassified as a Schedule 3 drug—allowing the sale of products with a cannabinoid level of 2% or less—although consumers will still need to consult with their pharmacist to ensure that they are aware of any potential drug interactions.
Medicinal cannabis in Australia has traditionally been expensive and difficult to access with many turning to illegal channels to get their hands on it. Those in support of down-scheduling low-dose CBD see the need to improve patient access at the best possible price as well as reduce reliance on illegal, unregulated channels. Making low-dose CBD available over-the-counter in pharmacies will not only improve patient access to safe levels of CBD but it will also remove some of the administrative burden associated with medicinal cannabis. FreshLeaf Analytics Managing Director, Cassandra Hunt
Reports from FreshLeaf Analytics—which operates as a division of Southern Cannabis Holdings—have confirmed that TGA's decision featured no major changes from the initial proposal that was tabled back in April 2020 and may even open the door for Australian companies to apply for registration to other applicable products.
The rescheduling will be limited to CBD medicine that make use of oral, oral mucosal and sublingual delivery mechanisms—which means that vaping, topical creams and smokable products will remain illegal—while an additional requirement has also been added mandating that the products be packaged securely.
Unfortunately, in the same announcement the TGA also made an interim decision to reject a separate private scheduling application which—if approved by the government—would have made CBD a freely available unscheduled medicine.
According to the Addiction Specialist and medical advisory board member for CA Clinics, Dr Mark Hardy, the TGA's decision 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."
Under the new law consumers will be permitted to purchase 60mg of CBD per day—amounting to a 30 day supply of 1,800mg—with products expected to hit the shelves by late 2021, although the government's final decision is not expected until November 25th this year.
Conversely, there are some members for the medical community who have challenged the TGA's decision, saying that more clinical evidence is required before the drug can be made available to the general public.
However, the Managing Director of FreshLeaf Analytics, Cassandra Hunt, stated that "while this is undoubtedly an important issue that needs to be addressed by the industry, CBD at a low-dose has a good safety profile."
"We anticipate that up to 2.4 million Australians will choose to access CBD products through pharmacies. As such, we expect to see a reduction in the number of people accessing products through unregulated illegal channels."
"Many of these products fail to disclose contents or make claims on labels that aren't validated so safety and quality is a big issue. All over-the-counter CBD products will need to be registered with the TGA which means that Australians will be accessing products that are high quality and safe."
FreshLeaf also explained that the new regulations will lead to greater patient access and improved product quality, although its effect on medicine prices will likely be harder to detect.
As discussed in FreshLeaf's upcoming Q3 industry analysis—which is scheduled for publication on 17 September—the Australian cannabis market has already reached a new floor price of "RRP $0.06 per milligram of cannabinoid", putting it on par with the black market.
Furthermore, CBD products also have a lower retail price per milligram than formulations which contain THC.
"While we are seeing an increase in prescriber activity (SAS-B approvals are up to 60,000 from 25,000 in 2019) mainstream acceptance within the medical community will likely come as the evidence base for medicinal cannabis grows," Hunt said.
"There are concerns about efficacy of low-dose CBD and we expect indications will be limited to mild ailments that don't require large amounts other cannabinoids, such as THC, to be present in order to be effective."
"We certainly see this as a step in the right direction although the government is rightly being cautious. Calls to down-schedule CBD even further have so far been ruled out as pharmacist consultation allows government to maintain some level of control, helping ensure patients consume these products safely and with awareness of issues such as potential drug interactions."
Similarly, an advisory board member for Applied Cannabis Research, Dr Melissa Benson, noted that the announcement can be viewed as a win for the healthcare community, as it will promote greater safety for patients and further clinical research into the efficacy of low dosage CBD drugs, while also decreasing the usage of illegally-obtained products.
"We believe low dose CBD will become the largest market in Australia for cannabis products, quickly generating revenue in the hundreds of millions of dollars," Southern Cannabis Holdings Director Tim Drury said.
"There is a significant opportunity here for product companies to supply high quality, low cost medicine to pharmacies".
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