Nature-based Medications Australia

The regulations and legislation are subject to change, so it’s important to keep up to date on the latest information.

Nature-based medicine Australia: legality and uses

It’s important to note that if the nature-based medicine contains cannabinoids, it 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.

However, as with any medication, side effects can occur, and nature-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.

What is nature-based medicine?

Nature-based medicine can be a number of things. If doctors prescribe natural medicines, it’s important that it is pharmaceutical-grade and regulated by Australia’s TGA.

Is nature-based medicine safe for use?

The TGA has not assessed nature-based 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 nature-based formulations has been found to be generally sound. However, like with any medication, there are side effects, which can vary and can include gastrointestinal discomfort, drowsiness and dry mouth.

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, nature-based medicine is not effective, so other treatment modalities to help manage your condition or symptoms need to be explored.

Is nature-based medicine legal in Australia?

Nature-based medicine 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 nature-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.

Nature-based medicine can be prescribed via the Authorised Prescriber Scheme

Nature-based medicine can be prescribed via the Authorised Prescriber Scheme, where a doctor has the approval to prescribe a specific nature-based product to patients. This pathway is infrequently utilised, with most natural-medicine 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 nature-based treatments 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.

Legal nature-based medicine in Australia

While nature-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.

What states have nature-based medicine?

All Australian states have legal pathways access to nature-based medicine for eligible patients through the amendment to the Narcotic Drugs Act in 2016. There are however various nuances to the laws regarding nature-based medicine dictating the applications needed at a state or territory level.

What medical reasons could nature-based medicine be used for?

Nature-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, nature-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 nature-based medicine is limited. To date, the reported benefits have been mixed and results show that the treatment is not effective for many patients.

Nature-based medicine trials in Australia

Research is ongoing into providing clinical and scientific evidence behind the actions of nature-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.

What does nature-based medicine do?

We have a lot to learn about the actions of nature-based medicines, and as yet, there is sparse clinical data of quality. There is some evidence to suggest that nature-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 nature-based medicine and doctors can can enroll their patients in clinical studies if suitable.

The results of ongoing trials are required before any conclusions about nature-based medicine for any specific conditions can be made.