The peak professional body for doctors in Australia — the Australian Medical Association (AMA) — has published its submission for the Therapeutic Goods Administration’s (TGA’s) review into unapproved medicinal cannabis products.
The TGA’s public consultation was launched in August amid growing concerns surrounding access to unapproved medicinal cannabis products available in Australia — particularly those with high levels of the intoxicating cannabinoid tetrahydrocannabinol (THC). Submissions closed on October 7.
Among the parties to lodge a submission was the AMA. In a note accompanying the submission, the AMA says:
“The AMA has consistently advocated for a robust, evidence-based regulatory framework that ensures patient safety, clinical integrity, and responsible prescribing and dispensing practices. The rapid expansion of medicinal cannabis prescribing — particularly through vertically controlled, direct-to-consumer telehealth models — has exposed significant gaps in the current regulatory framework.”
Among the AMA’s recommendations is an immediate high-THC concentration product freeze and prescribing volume thresholds, which it says will promote patient safety while the regulatory arrangements for medicinal cannabis products are reviewed.
In its submission, the AMA also repeatedly expressed concerns about concentrated high-THC liquids intended for inhalation, or devices enabling rapid pulmonary absorption, which is says pose disproportionate risks compared to orally titrated products such as oils.
There’s a lot to unpack in the AMA’s 11-page submission; among it, the organisation says:
- Current labelling requirements for unapproved medicinal cannabis products is inadequate, and makes recommendations.
- All products used beyond exceptional access should be registered on the Australian Register of Therapeutic Goods (ARTG) within fixed timeframes.
- Packaging should be child-resistant and include calibrated dosing aids.
- Unregulated compounded products with unclear cannabinoid ratios should be prohibited.
- Graduated controls should be implemented; e.g., more stringent frameworks at higher THC bands.
- The AMA supports restricting access to THC-containing medicinal products for pregnant or breastfeeding women.
- Enhanced screening and risk mitigation for patients with a history of mental health conditions, addiction, significant cardiovascular disease, or those in safety-critical occupations is recommended.
The AMA does not support a blanket prevention of access to unapproved medical cannabis products as it believes the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways must remain available for exceptional clinical need.
The TGA says it will consider submissions to help inform options for future changes to a regulatory framework, and further consultation with stakeholders will be undertaken for any proposed reforms.
