In 2024, Australia’s Therapeutic Goods Administration (TGA) approved at least 979,000 applications for medicinal cannabis prescriptions through its specialised access pathways. Initially designed for occasional use of unapproved medications, these pathways have evolved into a mainstream system. As the volume of prescriptions rises, the current framework is proving to be confusing for healthcare providers, inequitable for patients, and difficult to regulate.
The Australian Health Practitioner Regulation Agency (Ahpra) has recently announced plans to enhance oversight of prescribing practices. Despite these efforts, many experts argue that the need for comprehensive reform is more pressing than ever.
Understanding Medicinal Cannabis in Australia
Legalised in 2016, medicinal cannabis encompasses various forms, including oils, capsules, dried flowers, and gummies. Key components include THC (tetrahydrocannabinol) and CBD (cannabidiol). THC is known for its psychoactive effects, while CBD is generally considered non-intoxicating.
The TGA intended for medicinal cannabis to serve patients with severe, treatment-resistant conditions, such as multiple sclerosis, intractable epilepsy, and chronic pain not responding to standard treatments. Recommendations emphasised that medicinal cannabis should not be a first-line treatment and should follow a cautious dosage approach. However, the prescribing landscape has expanded significantly, with many prescriptions now issued for more common ailments like chronic pain and anxiety.
The Evidence Behind Prescriptions
The clinical evidence supporting the efficacy of medicinal cannabis remains inconsistent. Chronic pain, the most prevalent reason for prescriptions, illustrates this uncertainty. A recent review by the TGA indicated that only a subset of patients might experience moderate pain relief. Many studies lack robust data, and the long-term effects of medicinal cannabis remain inadequately understood.
Moreover, the risks associated with these products cannot be overlooked. THC has been linked to side effects such as sedation and cognitive impairment, while CBD, although typically better tolerated, can interact negatively with other medications.
Despite the rigorous clinical testing that approved medicines undergo, most medicinal cannabis products lack the necessary data to validate their safety and efficacy. Only two products currently possess TGA approval. This disparity leaves many healthcare providers prescribing without clear guidance on effectiveness and appropriate dosage.
Access and Affordability Challenges
Patients, particularly those in rural and remote areas, face significant barriers in accessing medicinal cannabis. Limited digital access and fewer opportunities for follow-up consultations with general practitioners hinder informed decision-making regarding treatment options. Cost presents an additional obstacle, with some patients unable to afford the full price of cannabis products.
For example, Sativex, one of the two approved products, costs between A$700 and A$800 for a 6–8 week supply and is not subsidised by the Pharmaceutical Benefits Scheme. This places a heavy financial burden on patients, particularly those who require multiple consultations to obtain prescriptions.
Pathways for Reform
To address the pressing issues within Australia’s medicinal cannabis system, a multifaceted approach is necessary. The following reforms are critical:
1. **Capture Real-World Data**: Establishing robust, real-world data collection is essential to understand how medicinal cannabis is prescribed, the conditions treated, and patient outcomes. This information is vital for improving clinical and policy decisions regarding medicinal cannabis use.
2. **Develop a National Accreditation Model**: A national prescriber accreditation model for medicinal cannabis should be established in collaboration with healthcare professionals and regulators. This model would ensure that prescribing practices are evidence-based and aligned with evolving standards of care.
3. **Address Access Inequities**: The government should explore subsidies for TGA-approved medicinal cannabis products, ensuring that all patients have equitable access to safe treatments without facing financial hardship.
Dr. Christine Hallinan, a Senior Research Fellow at the University of Melbourne, has conducted research on the pharmacovigilance of medicinal cannabis and advocates for a more evidence-based regulatory framework. Her involvement in the Australian Centre for Cannabinoid Clinical and Research Excellence highlights the need for coordinated efforts among experts to improve the current system.
As Australia’s medicinal cannabis landscape continues to evolve, it is crucial that reforms address these systemic issues to provide safe, effective, and equitable care for all patients.
