The regulations and legislation are subject to change, so it’s important to keep up to date on the latest information.
It’s important to note that plant-based medicine containing cannabinoids has not been approved by the Therapeutic Goods Administration (TGA) as a registered medicine in Australia. At present, it can only be prescribed by doctors for patients who meet specific criteria outlined by the TGA Special Access Scheme. As part of this, doctors must apply for TGA approvals with each patient’s specific use of the medicine.
Australian trials and research from around the world is starting to suggest that plant-based medicine may have potential in helping symptoms presented by some patients. However, as with any medication, side effects can occur, and plant-based medication may also negatively interact with other medicines you take. That is why it is vital to discuss your situation with an experienced doctor who can assess your suitability, and talk you through the risks involved.
Plant-based medicine can be a number of things. If doctors prescribe cannabinoid-based plant medicine, it’s important that it is pharmaceutical-grade and regulated by Australia’s TGA. Cannabis plant species contain more than 100 different cannabinoids, with the primary ones being delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD).
These two cannabinoids act on the human body in different ways.
The TGA has not assessed cannabinoid medicine for safety, quality and effectiveness, and it is currently not an approved medicine in Australia. In research to date, the tolerability profile of such plant-based formulations has been found to be generally sound. However, like with any medication, there are side effects, which can vary. For cannabidiol these can include gastrointestinal discomfort, drowsiness and dry mouth. Side effects of THC in plant-based formulations can also vary but can include dry mouth, nausea, low blood pressure, feelings of anxiety and euphoria or intoxication.
Patients taking other medications also need to be aware of the risk of contraindications, which need to be discussed with a doctor. It’s also important to know that for many patients, plant-based medicine is not effective, so other treatment modalities to help manage your condition or symptoms need to be explored.
Plant-based medicine with cannabinoid compounds is federally legal in Australia on prescription if patients meet certain criteria and at a doctor’s discretion.
Patients wanting to assess their eligibility for legal plant-based treatment can go to their GP or a specialist doctor. The prescribing doctor will assess each individual case for medical suitability with supporting evidence and process the patient’s application via the Special Access Scheme (SAS) pathways.
Plant-based medicine can be prescribed via the Authorised Prescriber Scheme, where a doctor has the approval to prescribe a specific plant-based product to patients within their speciality. This pathway is infrequently utilised with most plant-based prescriptions processed through Special Access Scheme Category B (SAS-B).
Through the SAS-B pathway, medical practitioners process single applications for individual patients, based on their specific condition and the unregistered product that is intended to be prescribed.
As nearly all plant-based treatments containing cannabinoids are not registered as a medicine in Australia, this means the Australian Register of Therapeutic Goods (ARTG) has not evaluated products determining their safety and efficacy. As such, if the product a patient is prescribed is not listed on the ARTG there are no subsidies through the Pharmaceutical Benefits Scheme. State approvals and regulations with this medication range can still apply.
While plant-based medicine can be accessed for eligible patients under the TGA’s legal pathways, sources of such medicine not prescribed by a medical professional remain illegal.
All Australian states have legal pathways access to plant-based medicine for eligible patients through the amendment to the Narcotic Drugs Act in 2016. There are however various nuances to the laws regarding plant-based medicine dictating the applications needed at a state or territory level.
Plant-based medicine has not been approved by the TGA as a treatment in Australia. Under the Special Access Scheme, and under the close supervision of a healthcare professional, plant-based medicine may be considered as a therapy for some conditions and symptoms when other methods have been exhausted. More details can be found on the TGA website. It is important to note that the evidence based for the clinical utility of plant-based medicine is limited. To date, the reported benefits have been mixed and results show that the treatment is not effective for many patients.
Research is ongoing into providing clinical and scientific evidence behind the actions of plant-based medicine as a potential therapy for a range of symptoms. Overall, given that the results to date have been mixed or showed dose-dependent outcomes, further research is required.
We have a lot to learn about the actions of plant based medicines, and as yet, there is sparse clinical data of quality. There is some evidence to suggest that plant-based medicine may have a role to play in reducing certain symptoms, and also a role within palliative care settings.
There are many trials currently underway to explore the potential use of plant-based medicine and doctors can can enrol their patients in clinical studies if suitable.
The results of ongoing trials are required before any conclusions about plant-based medicine for any specific conditions can be made.
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