The Australian drugs regulator is weighing whether to allow cannabidiol-only (CBD) products to be sold over the counter in pharmacies, bringing it into line with other countries where medical marijuana is legal.

The Therapeutic Drug Administration (TGA) is asking for submissions by May 22 on whether to create a new Schedule 3, or pharmacists only medicine, category for CBD products.

CBD is one of the two main ingredients in cannabis products, the other being THC. There are an unknown number of minor active ingredients in marijuana.

A change would massively widen the market for cannabis-based drugs, medications and hemp-based CBD supplements in Australia.

The US legalised CBD-only products in late 2018 when it legalised hemp, a plant which has been selectively grown until it contains very small amounts of THC.

The market there has been the basis for the huge growth of Ecofibre (ASX:EOF), and the downfall of Elixinol Global (ASX:EXL) which wasn’t prepared for the wave of competition hemp legalisation created.

Locally, companies like Bod Australia (ASX:BDA) would have a route to market for its skin care products, while companies peddling hemp-based products that contain large amounts of CBD will be brought in from the grey and black markets.

The move could also undermine companies currently developing cannabis-based drugs and putting them through the expensive clinical trial regulatory process, as Australians, frustrated with the difficult processes put in place by government to access medical marijuana, turn to what is available rather than what might be most useful.


A new America

The new category would be for products with doses up to 60mg/day, and break CBD-only out of the current Schedule 4 or prescription-only category which is the current catch-all for medical cannabis.

“A safety review conducted by the TGA has established that low doses of CBD may have possible clinical utility when used via the oral route in the management of some conditions that do not require medical practitioner oversight,” the regulator said in its call for submissions.

The TGA’s review follows the Senate committee inquiry at the start of the year into the difficulties Australians were having in accessing medical marijuana.

The standout comments from the dozens of submissions to the committee were that products were too expensive and unaffordable for most people, quality was inconsistent, and the Special Access Scheme route to obtaining medicines was difficult to navigate and made sourcing medical cannabis challenging.

The TGA review found that CBD didn’t have much impact on the body’s CBD1 and CBD2 receptors, which are flicked on by THC and provide the psychoactive effects associated with the drug.

The new schedule would open access to over-18s who take pharmacist advice to protect against “CBD’s high potential for drug-drug interactions when used concomitantly with many other commonly prescribed drugs that are metabolised via CYP pathways”.

The TGA plans to make an interim decision in June which will be followed by another round of public consultation before a final decision is made.