Australia’s medicinal cannabis system is under increasing scrutiny as the number of prescriptions continues to rise, with at least 979,000 applications approved in 2024 alone. The Therapeutic Goods Administration (TGA), which oversees these prescriptions, has seen a shift in its specialised access pathways, originally intended for occasional use of unapproved drugs, now functioning as a mainstream avenue for treatment. This transition has led to a system that is proving confusing for doctors, inequitable for patients, and challenging to regulate.
Despite recent announcements from the Australian Health Practitioner Regulation Agency (Ahpra) to enhance oversight of prescribing practices, critics argue that these measures do not adequately address the urgent need for comprehensive reform within the system.
Current State of Medicinal Cannabis Use
Legalised in Australia since 2016, medicinal cannabis includes various forms such as oils, capsules, and dried flowers, with key components like THC (tetrahydrocannabinol) and CBD (cannabidiol). Initially aimed at patients suffering from severe, treatment-resistant conditions, such as chronic pain, multiple sclerosis, and intractable epilepsy, the scope of prescriptions has expanded considerably.
Today, many prescriptions are issued for more common ailments like anxiety and sleep disorders, raising concerns about the appropriateness of these treatments. According to a TGA review, while there is some evidence that medicinal cannabis may help certain patients with chronic pain, the data is inconsistent. Many studies lack sufficient sample sizes and do not adequately assess long-term effects. Moreover, products containing THC can lead to side effects, including sedation and cognitive impairment.
Challenges in Access and Regulation
The current regulatory framework has become problematic. Most medicinal cannabis products lack the rigorous testing and evidence required for registration with the TGA, resulting in a market where physicians are often prescribing without reliable data. This situation is compounded by the rise of telehealth services, which have led to high-volume prescribing but may prioritise quantity over quality in patient care.
Notably, reports indicate that some practitioners have issued over 17,000 prescriptions within a six-month period, raising alarms about the adequacy of patient consultations. The system currently lacks sufficient clinical oversight, leaving many doctors to navigate a complex landscape with minimal support.
Accessibility also poses significant challenges, particularly for individuals in rural or remote areas, who may struggle with limited resources for follow-up care. Financial barriers further complicate matters, as the costs of medicinal cannabis products can be prohibitive. For instance, one of the few TGA-approved products, Sativex, can cost patients between A$700 and A$800 for a six to eight-week supply, and is not subsidised under the Pharmaceutical Benefits Scheme.
Urgent Reforms Needed
To address the shortcomings of the current system, several reforms are urgently needed. First, the establishment of a comprehensive data collection framework is essential. Gathering robust, real-world data on how medicinal cannabis is prescribed, the conditions treated, and patient outcomes will provide valuable insights into its clinical efficacy and safety.
Second, a national prescriber accreditation model should be developed in collaboration with healthcare professionals and regulatory bodies. This model would ensure that doctors receive adequate training on prescribing medicinal cannabis, similar to the requirements for immunisation accreditation for vaccines.
Finally, addressing the inequities in access to medicinal cannabis is crucial. Government subsidies for TGA-approved products could help alleviate the financial burden on patients, ensuring that safe access to medicinal cannabis is not a privilege reserved for those who can afford it.
Dr. Christine Hallinan, a Senior Research Fellow at the University of Melbourne, has conducted extensive research on medicinal cannabis and its regulation. Her work, supported by the National Health and Medical Research Council (NHMRC), highlights the pressing need for a more evidence-based and structured approach to medicinal cannabis use in Australia.
As the landscape of medicinal cannabis continues to evolve, it is imperative for stakeholders to prioritise reforms that enhance patient care, improve accessibility, and ensure that safety and efficacy remain at the forefront of treatment practices.
