Australia’s system for medicinal cannabis is facing significant scrutiny as the country’s Therapeutic Goods Administration (TGA) reported over 979,000 prescription applications authorized in 2024. Originally intended for rare cases, the system has expanded to accommodate a wide range of conditions, leaving many doctors confused and patients underserved. The Australian Health Practitioner Regulation Agency (Ahpra) has announced plans to enhance oversight, but experts argue that comprehensive reform is essential for a system misaligned with its foundational goals.
Legalized in 2016, medicinal cannabis in Australia includes various forms such as oils, capsules, and dried flowers, with key components like THC (tetrahydrocannabinol) and CBD (cannabidiol). Initially, it was meant for patients with severe, treatment-resistant conditions, including those undergoing palliative care or suffering from chronic pain, epilepsy, and multiple sclerosis. However, the landscape has shifted, with prescriptions increasingly being issued for common issues like anxiety and sleep disorders.
The evidence supporting the efficacy of medicinal cannabis remains inconsistent. For instance, while some studies indicate that it may help reduce chronic pain—cited as the most common reason for prescriptions—many trials are small and lack comprehensive long-term data. Additionally, risks associated with THC include sedation and cognitive impairment, while CBD can interact adversely with other medications.
The TGA’s rigorous approval process typically ensures that only safe and effective medications reach the market. However, the majority of medicinal cannabis products lack the robust clinical research required for formal registration. As a result, many doctors find themselves in a challenging position, prescribing treatments without consistent information on their efficacy or safety.
Concerns have arisen about certain telehealth models prioritizing patient volume over quality care. Reports indicate that some practitioners have issued over 10,000 prescriptions within six months, raising alarms about the clinical integrity of these practices. The TGA oversees access pathways but lacks the resources to provide necessary clinical support, leaving many prescribers to navigate a complicated system on their own.
Access and affordability also pose significant barriers, particularly for individuals in rural and remote areas. Limited internet connectivity and fewer local healthcare options complicate access to medicinal cannabis. Financial constraints further exacerbate this issue, especially when ongoing consultations are required. For example, Sativex, one of the two TGA-approved medicinal cannabis products, is not subsidized by the Pharmaceutical Benefits Scheme, costing patients between A$700 and A$800 for a six to eight-week supply.
To address the shortcomings of Australia’s medicinal cannabis framework, experts recommend several critical reforms. First, there is an urgent need to collect robust real-world data on medicinal cannabis usage, conditions treated, and patient outcomes. This data could inform better clinical practices and policy decisions.
Second, establishing a national accreditation model for prescribers could ensure that medicinal cannabis is prescribed appropriately and based on evolving best practices. Such a model would require healthcare professionals to undergo specific training before they can prescribe these treatments.
Lastly, confronting access inequities is essential. Exploring government subsidies for TGA-approved products would ensure that patients do not have to choose between financial hardship and safe access to necessary medications.
Dr. Christine Hallinan, a Senior Research Fellow at the University of Melbourne and a member of an Expert Roundtable on medicinal cannabis, emphasizes the need for a more evidence-based regulatory framework. This roundtable, chaired by Ian Freckelton AO KC, aims to bring together experts to recommend improvements for the current system.
As Australia’s medicinal cannabis landscape continues to evolve, addressing these critical areas will be vital to ensuring equitable and effective care for all patients.
