The TGA is re-examining the clinical evidence for medical cannabis – including over-the-counter CBD

The TGA is re-examining the clinical evidence for medical cannabis – including over-the-counter CBD

This is the third article in our series about the Department of Health’s submission to the Senate Inquiry into medical cannabis patient access. You can read the Department’s submission here.

In December 2017 the TGA, in collaboration with several universities, produced clinical guidance documents for the use of medical cannabis. These quickly became a trusted source for doctors who were considering medical cannabis for their patients. But clinical research into cannabis therapies is bourgeoning and there are already many new clinical trials, meta-analyses and case reports that need to be included. So it’s encouraging to see the DoH is on top of this, and are aiming to update the guidance documents by June 2020. Coincidentally that’s around the time the DoH has indicated that major legislative changes recommended by the McMillan Review into to the Narcotic Drugs Act will be implemented.

The big news: over-the-counter CBD?

This little nugget was hidden away in the DoH submissions and didn’t feature in the executive summary. It’s possible the DoH didn’t think it was important enough to put front-and-centre. But given how well this submission was written, and the detailed research that clearly went into it, it’s possible the DoH knew how important this issue was and chose to play it down. Regardless, it’s a couple of short sentences worth quoting in full:

“The TGA is currently undertaking a safety review of CBD at lower doses, although there are only limited published studies. Based on the outcome of these studies, it is possible that relaxation of the scheduling status of low dose CBD (e.g. to over the counter) could be considered during 2020.”

It’s important to emphasise all of the carefully couched qualifying words here. The DoH isn’t saying they intend to down-schedule CBD for over-the-counter sale. It is ‘possible’ that such a relaxation ‘could’ be ‘considered’ in 2020. However, if the only thing making the TGA hesitate about allowing low-dose (15-100mg/day by their definition) CBD products to be made available OTC is safety, it doesn’t seem like they’ll have much of a problem. The efficacy of low-dose CBD is dubious. And there haven’t been many safety studies using low dose CBD. But it’s a pretty benign drug and is already widely available online and in retail outlets across North America and Europe.

At the Senate hearings, John Skerritt from the Department of Health advised that the TGA expects to complete their safety literature review by March 2020. If their findings are positive, the next step will be a public consultation and people will be invited to submit comments. Then it will go to a panel of expert representatives from the States and Territories to determine what actions to take. So it’s possible that a decision could be made on this before the end of the year, and if that decision is positive, the SUSMP could be amended in 2021, which will be the final step.

However, it’s not certain that such a change would immediately result on products being made available. Low-dose CBD would still be Scheduled, and require companies to submit applications for their product to be registered on the ARTG. The requirements for registering a Schedule 3 product are less onerous, but still similar, to those required for registering a Schedule 4 product. And no S4 products have been registered in Australia so far.

Regardless, should this down-scheduling change occur, it would be a watershed moment in Australia’s medical cannabis framework. For those who want to try CBD but can’t afford or don’t want to bother getting a prescription, it would be a great alternative. And for industry it could be a massive windfall. Will this happen in 2020? Only time will tell.

FreshLeaf Analytics, a division of Southern Cannabis Holdings, is the leading supplier of data about the medicinal cannabis industry in Australia. We have access to medicinal cannabis product, pricing and clinical data sets from some of Australia’s leading healthcare companies and organizations including healthcare clinics, pharmacies, product suppliers and the TGA. The FreshLeaf Analytics team provides custom research, analysis and consulting services in the Medicinal Cannabis market in Australia. The FreshLeaf Analytics team can be contacted on +61 2 8203 8741 or info@freshleafanalytics.com.au 

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