Read the full submission here

Montu strongly supports the TGA’s initiative to review and reform Australia’s regulatory framework for medicinal cannabis. The current reliance on the SAS-B and AP pathways - originally intended for exceptional access to unapproved medicines - has become unsustainable as these mechanisms have evolved into primary routes of supply. This shift has introduced inefficiencies, hindered evidence generation, and created inconsistencies in prescriber authorisation and product oversight.Drawing upon the expert consensus of the Roundtable chaired by Professor Ian Freckelton AO KC, Montu proposes a coherent, evidence-informed regulatory model that aligns with contemporary clinical practice while maintaining high standards of safety and patient care.The core elements of this proposed reform include:

1. Use of Real-World Evidence (RWE) – Leveraging secure extraction of de-identified electronic medical record data, linked where appropriate to PBS/MBS datasets, to inform ongoing safety and effectiveness monitoring without imposing excessive administrative burden on clinicians

2. Unified Prescriber Authorisation Framework – Replacing SAS-B and AP with a single, nationally consistent process integrating training, registration, and jurisdictional requirements

3. Appropriate Regulatory Oversight of Products – Creating a “Declared Medicinal Cannabis Products” category on the ARTG to ensure GMP compliance, clear labelling, and pharmacovigilance without requiring full registration dossiers for every product

4. Nationally Consistent Education Standards – Developing a comprehensive medicinal cannabis curriculum embedded into undergraduate, postgraduate, and continuing professional development (CPD) frameworks, aligned with the National Prescribing Competencies Framework

5. Standardised THC-CBD Dose Equivalence Model – Exploring the viability of a labelling and dosing framework analogous to oral morphine equivalents in opioid prescribing, enabling safer and more consistent clinical practice

6. Evidence-Proportional Approach to Psychosis Risk – Ensuring that policy decisions distinguish between recreational cannabis use and clinically supervised medicinal use, with targeted safeguards rather than blanket restrictions on THC

These reforms will better align regulatory oversight with the realities of clinical practice, address public health concerns proportionately, and maintain patient access to clinically indicated therapies. By integrating robust data collection, targeted education, and product oversight, the TGA can create a regulatory environment that is safe, sustainable, and supportive of high-quality patient care.