Medlab Clinical CEO Dr Sean Hall says the TGA’s interim decision to down schedule CBD means some business plans will need to change, but the whole industry stands to benefit.
The TGA’s interim decision to down schedule CBD to a schedule 3 drug means that medicinal cannabis-based products will be available over the counter, without a prescription, from July 2021. It is a structural shift in the way medicinal cannabis is accessed in this country, and while currently limited to the oral delivery of 60mg per day of CBD-only products, it could be a sign of things to come.
While the industry at large has met the down-scheduling decision with enthusiasm, many Australian companies are not yet on the drug approval pathway and will need to play catch-up to remain competitive under this new regime, where gaining regulatory approval will eventually become the norm.
Until now there has been two schools of thought on cannabis. One is that it will follow various US states and/or Canada and become more a retail item, widely available and with little to no medical/pharmacy oversight. The other view is that science and medical investigation need to lead the way, with the goal of developing a registered medicinal cannabis product that has measurable medical claims.
In the Australian market, we’ve been sitting in the middle. Cannabis has been available under the Special Access Scheme (SAS), and although only available under prescription, these products have not had to undergo the rigours of testing and validation required for a drug approval. The downgrade of CBD to schedule 3 signals that the goalposts may soon shift and that seeking drug approval could be a blanket requirement.
To date, most ASX-listed pot stocks have not elected to choose a drug approval pathway via the TGA or other regulatory bodies. Instead most companies have built their sales – and investment proposition – on importing or growing product, to sell under the Special Access Scheme.
The down-scheduling of CBD puts that strategy at risk.
This is because the purpose of the SAS is to allow access to unapproved medicines for approved patients when all other options have failed. This means that once a cannabis product is approved for an indication, one can’t request a SAS approval for a similar product for a similar claim. For example, if a 60mg daily CBD product is approved for usage to help treat anxiety, it becomes very difficult for any other medicinal cannabis product – regardless of the dose or ingredient – to be prescribed or approved for the treatment of anxiety under SAS.