Australia: Turning over the leaf: TGA to review CBD scheduling

In brief - TGA to consider making CBD available over-the-counter in Australia following public consultation

Potential for exponential growth of the market for CBD products in Australia

Australia's Therapeutic Goods Administration (TGA) has recently announced that it will meet to consider rescheduling cannabidiol (CBD) as a Schedule 3 substance in June 2020. CBD is currently a Schedule 4 substance and therefore only available with a prescription.

The amended scheduling, if approved, will mean that cannabis products in which CBD comprises 98% or more of the total cannabinoid content will be available over-the-counter without a prescription in pharmacies across Australia for therapeutic use. It is proposed that CBD products will come with a recommended daily dose of 60 mg or less, in packs containing not more than 30 days' supply and be available only to adults over the age of 18.

The TGA notes the following in support of the proposed rescheduling:

• A safety review conducted by the TGA established that low doses of CBD may have possible clinical utility in the management of some conditions without medical practitioner oversight. A copy of the TGA's report can be accessed here: Review on the safety of low dose cannabidiol,
• CBD has an acceptable safety and tolerability profile at the proposed 60 mg/day dose and the proposed dose is within the range of dosages seen in overseas' CBD products available for retail sale, and
• Current access controls on CBD in Australia are notably more restrictive than comparable regulators, noting CBD is available as an over-the-counter product in the UK and some U.S. states.

As of 1 April 2020, only six medicines were registered with the TGA containing CBD as an active ingredient, all categorised as export only medicines. Given the significant M&A and capital markets activity across the Australian and international cannabis industries in the last three years, we anticipate seeing several applications to register new medicines with the TGA soon after a successful rescheduling of CBD.

As Australian entities have already made significant R&D investments to develop CBD products for the overseas market, we do not expect to see much lag time between rescheduling and new products and brands hitting the Australian market, as has been the case in other jurisdictions.

The TGA is accepting public submissions in relation to the proposed rescheduling of CBD up to 22 May 2020. Details on how to respond can be found here.

DEA's descheduling of Epidiolex may be a model for future CBD regulation in Australia

Australia's public consultation is occurring against the backdrop of the U.S. Drug Enforcement Administration's (DEA) recent step to remove GW Pharmaceuticals' flagship CBD-based drug to treat epilepsy, Epidiolex, from the list of federally controlled substances.

Under U.S. federal law, controlled substances are generally understood as drugs with a high potential for abuse or addiction, such as Vicodin and Xanax. Only physicians who are registered with the DEA can prescribe controlled substances and they are often tasked with stringent reporting standards to prevent overprescribing. On the other hand, non-controlled prescription drugs (e.g., blood pressure or cholesterol medications) do not require physicians to register with the DEA and have far fewer reporting requirements.

In our view, Epidiolex's descheduling represents a sensible relaxation of the restrictions affecting the sale and use of CBD and a significant step towards improved patient access. We would like to see a similar position reached in Australia at the conclusion of the TGA process set out above.

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