MELBOURNE, 16 October 2025 — Montu has called for Australia’s regulatory reform of medicinal cannabis to be grounded in clinical evidence and sector-wide education, noting that confusion around THC classification and product registration risks distorting an otherwise vital discussion about patient safety and quality.

Earlier this month, Montu was among the first organisations to lodge a comprehensive submission to the Therapeutic Goods Administration’s (TGA) review of medicinal cannabis regulation. The submission sets out a proportionate, education-led framework designed to improve safety, consistency and regulatory oversight across the system, while maintaining access for patients with legitimate therapeutic need.

Vice President of Corporate Affairs and Patient Advocacy Jodie Thomas said that while Montu and the Australian Medical Association (AMA) share a commitment to patient safety and higher regulatory standards, the discussion needs to be anchored in accurate science and practical pathways for reform.

“The goal we all share is a system that’s safe, transparent and clinically governed,” Thomas said.

 “To achieve that, we need to ensure the reforms are built on sound evidence – both in how products are categorised and how quality is regulated.”

Montu’s submission highlights that under current TGA settings, medicinal cannabis categories are determined by the proportion of CBD, not total THC content – a technical but important distinction often misunderstood in public debate.

“A Category 5 product is not necessarily a ‘high-THC’ product,” Thomas said.

 “The classification simply means the product contains less than two per cent CBD – it doesn’t speak to overall strength or dose. Without that context, it’s easy for well-intentioned discussions about safety to become distorted.”

Montu’s submission recommends standardised labelling that clearly sets out THC and CBD in milligrams per unit, to make prescribing safer and improve patient understanding. The submission also proposes development of a THC-CBD dose equivalence model, similar to the oral morphine equivalent system used in pain medicine, to help clinicians translate product strength across formulations.

“These are practical, evidence-based steps that improve safety and comprehension for everyone: patients, prescribers and pharmacists alike,” Thomas said.

Montu’s submission also proposes a “Declared Medicinal Cannabis Products” category on the Australian Register of Therapeutic Goods (ARTG), which would require GMP manufacturing, laboratory verification, and clear labelling – but without the extensive data burdens of full pharmaceutical registration.

“Full registration can be appropriate for certain novel medicines,” Thomas said.

 “But medicinal cannabis is fundamentally different. These products don’t fit the traditional pharmaceutical model – there’s no patent protection to offset the cost of clinical trials, and no commercial incentive for manufacturers to invest at that scale. 

“Mandating full registration for every formulation would stall research, restrict patient access, and penalise responsible operators who already comply with rigorous quality and safety standards.”

“A more proportionate solution is to strengthen existing safeguards — including real-world evidence collection, pharmacovigilance, and product traceability — which together provide a robust, data-driven understanding of safety and effectiveness without denying patients the care they need today.”

Instead, Montu advocates for a single national prescriber authorisation framework and a standardised education program aligned with Ahpra’s National Prescribing Competencies Framework, ensuring all clinicians meet consistent training standards before prescribing.

“This is an opportunity for genuine alignment between regulators, clinicians and the sector,” Thomas said.

 “With better data, better education, and a shared understanding of the evidence, we can build a system that protects patients, supports prescribers and strengthens public confidence.”

Montu’s submission – developed with input from the Expert Roundtable on Improving Quality of Care for Medicinal Cannabis Patients, chaired by Professor Ian Freckelton AO KC – presents a roadmap to modernise Australia’s medicinal cannabis regulation through proportionality, education and evidence.