The Cannabis Council of Australia says the medical association and the Pharmacy Guild of Australia have gone too far in pushing for a ban on high-THC products.
A group backed by medicinal cannabis industry players is attempting to shut down proposals from the AMA and Pharmacy Guild of Australia to immediately suspend all Category 5 products containing THC concentrations above 98%.
The Cannabis Council of Australia represents organisations like Montu, which boasts a portfolio including Alternaleaf telehealth clinic, Leafio distribution, uMeds fulfilment and Saged clinical education, not to mention Montu-branded cannabis products.
Non-Montu members of the council include various pharmaceutical products wholesalers, pharmacies, dispensaries and distributors.
In direct response the letter sent to Health Minister Mark Butler earlier in the week by the AMA and the guild urging action on the medicinal cannabis industry, the CCA has released a statement of its own.
“Both the Council and the AMA have identified gaps in oversight, but prohibition is not the solution,” CCA CEO Lisa Penlington said.
Ms Penlington took particular issue with the AMA and guild’s call for immediate suspension of products containing THC concentrations in excess of 98%.
The AMA and guild not only made this recommendation together as part of the letter to Mr Butler, but also included it in their respective submissions to the TGA’s review of the safety and regulatory oversight of unapproved medicinal cannabis products.
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The guild submission cites emerging evidence that high-potency cannabis use is linked to increased rates of psychotic episodes and hospitalisations and said that Category 5 unapproved medicinal cannabis products (up to 98% THC content) have the highest potential to cause harm, including risks of addiction, misuse and abuse.
“There is also little robust evidence, if any, to support the use of high-THC medicinal cannabis,” the guild said.
In its submission, the AMA specifically recommended stronger scheduling for ultra-high THC products pending further evidence.
Ms Penlington said it was “critical that rhetoric around Category 5 does not become misinformation”.
“The TGA’s categorisation of medicinal cannabis products is based on their CBD content – as a percentage of total cannabinoids,” she said.
“Category 5 products have less than 2% CBD, the remaining 98% of the cannabinoid content may or may not include THC.
“And this categorisation is in no way indicative of the concentration of the cannabinoids within any particular product. Thus, Category 5 does not relate to the outright potency of THC content.”
In its own submission, the CCA specified that it did not support a THC potency cap.
“Patients with severe symptoms or higher THC tolerance may require higher THC potency medicines,” it said.
Like the AMA and guild, it noted that evidence was “incomplete” for higher-potency medicinal cannabis THC products.
Instead of a suspension, though, the CCA recommended a risk-tiered approach whereby prescribers need additional credentials in order to prescribe higher-THC products.
The submission also stated that the council does not regard “any medicinal cannabis dosage form or administration route as posing an ‘unacceptable risk’ in absolute terms”, adding that risk is a “routine feature of modern medicine” that can be mitigated through things like informed consent and clear labelling.
