Most medicinal cannabis products sold in Australia are unapproved therapeutic goods, even though they are prescribed by a healthcare practitioner.
Understanding the difference between an approved and unapproved therapeutic good can help you make informed decisions and have meaningful conversations with your healthcare practitioner, especially when considering treatments like medicinal cannabis.
An approved therapeutic good has been evaluated by the Therapeutic Goods Administration (TGA) to ensure it meets acceptable standards of quality, safety and effectiveness. It must be included on the Australian Register of Therapeutic Goods (ARTG) to be lawfully supplied in Australia.
In Australia, there are access pathways available that allow healthcare practitioners to lawfully prescribe unapproved products for certain clinical situations. An unapproved therapeutic good has not been assessed by the TGA for quality, safety or effectiveness and is not included on the ARTG.
While patients should be treated with an approved therapeutic good when possible, your healthcare practitioner may determine that an unapproved therapeutic good such as medicinal cannabis would better suit your individual situation. This should only occur after considering or trialling approved therapeutic goods, or where no appropriate approved option is available.
The decision to use an unapproved medicinal cannabis product should be one you make with your healthcare practitioner. When making the decision, your practitioner should:
- first discuss alternative approved treatment options
- explain what medicinal cannabis is, that it is unapproved by the TGA, and why it is being considered for you
- explain the expected benefits, known risks and side effects, possible interactions with other medicines you are currently taking, and any uncertainties or gaps in evidence
- explain the practical implications, including cost, how it is supplied (e.g. through an Australian pharmacy), and the requirement for monitoring during and following treatment
- explain that you can change your mind or stop treatment at any time
- allow you to ask questions and discuss any concerns
- obtain your verbal or written informed consent before applying to the TGA to access medicinal cannabis
- discuss how details about your therapy will be shared with other doctors involved in your healthcare.
Other important things to know:
- a prescription does not mean the product has been assessed and approved by the TGA
- your healthcare practitioner must use a TGA approved pathway to prescribe an unapproved medicinal cannabis product
- unapproved medicinal cannabis is not covered under the Pharmaceutical Benefits Scheme (PBS) and prices are set by private suppliers
- unapproved medicinal cannabis products supplied or manufactured in Australia must meet minimum quality standards set by the TGA
- you should only purchase products through an Australian registered pharmacy
- medicinal cannabis products may impact cognition and ability to participate in daily activities
- medicinal cannabis may impact your driving ability, so you should be aware of your state and territory laws
- be cautious of overseas websites that are selling unapproved therapeutic goods, including medicinal cannabis, as products may be counterfeit, contaminated, or contain undisclosed or illegal ingredients.
Reporting problems
If you have any concerns with your unapproved medicinal cannabis product, including any side effects, you should inform your healthcare practitioner as soon as possible. You or your healthcare practitioner can report issues to the TGA at report an adverse event or problem.
You can also make a report to the Australian Health Practitioner Regulation Agency (AHPRA) if you are concerned about a health practitioner - external site.
