An overview of medicinal cannabis products available in Australia
There are many different medicinal products available in Australia that differ in active ingredients, concentrations, format, quality and regulatory control.
Registered cannabis medicines
There are currently only two medicinal cannabis products registered on the Australian Register of Therapeutic Goods (ARTG) registry:
Epidyolex (cannabidiol), which is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome for patients 2 years of age and older.
Sativex Oromucosal Spray (nabiximols), which is indicated as treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
Unregistered medicinal cannabis products
Most medicinal cannabis products are unapproved products in Australia as they do not appear on the ARTG. Unappproved medicines need to be accessed through "special access" pathways with approval from the Therapeutics Goods Australia (TGA). Find out more about how to access medicinal cannabis in Australia.
It is the responsibility of the prescriber to specify which product they wish to access. The TGA provides a list of unapproved medicinal cannabis products that can assist prescribers with selecting the appropriate product.
Types of medical cannabis products available
While the cannabis plant contains hundreds of bioactive molecules, there are two main active constituents that are being used for medicinal purposes; delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
The term "medicinal cannabis" encompasses any form of cannabis that is used for therapeutic purposes, and therefore comes in many forms. Medicinal cannabis should be thought of as a class of medication, rather than a single form of medication. There are many medicinal cannabis products available in Australia that differ in chemical constituents, strength, formulation, and quality.
Medicinal cannabis products can be:
Derived from the plant, e.g. a cannabis plant extract
Made synthetically in a lab
There are three main forms of medicinal cannabis products:
Isolate: isolated cannabinoids, only THC or only CBD
Full-spectrum: products containing a range of the constituents of the cannabis plant is different concentrations. These are typically high in THC or CBD and have lower levels of the other lesser-known minor phytocannabinoids. These products tend to have THC.
Broad-spectrum: products containing a range of cannabinoids and other cannabis constituents, but with no THC present.
Medicinal cannabis can come in many different forms, including:
Oil (most common)
Scheduling of medicinal cannabis products
All medicines in Australia are classified under a national system called the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), more commonly called the 'Poisons Standard'.
The Poisons Standard dictates the level of regulatory control that is applied and how easily people can access these substances.
Each drug mentioned in the Poisons Standard is placed in a certain category called a 'schedule' based on the potential risks and harm associated with its use.
Medicinal cannabis products are classified as either Schedule 8 (controlled drugs), Schedule 4 (prescription-only or Schedule 3 (pharmacist-only) drugs.
Low dose CBD: Products with CBD as at least 98% of the total cannabinoid content (with less than 1% THC), a maximum daily dose of 150 mg CBD and registered on the ARTG are classified as Schedule 3 (pharmacist-only) medicines.
CBD only: Products that contain CBD only (at least 98% of total cannabinoid content) are Schedule 4 (prescription-only) medicines.
All other medicinal cannabis: All other medicinal cannabis products are classified as Schedule 8 (controlled drugs).
What to look for when selecting a medicinal cannabis product
As most medicinal cannabis products are unregistered medicines, they can vary in quality. When selecting a medicinal cannabis product, ask the manufacturer for a certificate of analysis to verify the cannabinoid content and the absence of impurities like heavy metals and pesticides.
Does the patient need to drive?
It is currently illegal for patients taking cannabis medicines that contain THC to drive. Read more here: Cannabis and driving.
Product types: understanding the difference
Medicinal cannabis products can involve either plant-derived cannabinoids (so-called phytocannabinoids) or synthetically produced cannabinoids.
Plant-derived products are raw cannabis plant materials that have been produced in a strict GMP-compliant environment from cloned plants and allow for predictable cannabinoid content. This plant material would be vaporised or smoked by the user. Medicinal cannabis products in 'flos' or 'bud' form are only prescribed to be vaporised via a TGA approved and registered medical device.
Plant-derived products can also come in the form of liquids (oils or tinctures), which are made by extracting cannabinoids from plant material by exposing it to solvents such ethanol or supercritical carbon dioxide. The liquid is typically swallowed or put under the tongue using a dropper. Other sublingual methods of ingestion such as a wafer or lozenge are also under development. Other extracts are made into gels for topical application onto the skin.
Finally, concentrated plant extracts are sometimes put into capsules that are swallowed much like any other medicine.
Plant-derived products vary in their level of phytocannabinoids. The most important two of these to consider are tetrahydrocannabinol (THC) and cannabidiol (CBD). Products tend to be formulated which contain mostly THC, mostly CBD or a combination of both. These products typically also contain lesser amounts of the other trace cannabinoids such as CBG, CBC, THCA, THCV and CBDA as well as terpenoids, flavonoids and other plant compounds.
Whole or 'full-spectrum' plant extracts are produced in a way that preserves the balance of all the different cannabinoids and terpenoids in the plant. Other extracts are filtered and manufactured in a way that maximised the presence of one particular cannabinoid such as CBD.
There is a belief that the therapeutic benefits of cannabinoids such as CBD, are improved when maintained in a full-spectrum extract – this is often referred to as 'the entourage effect'.
Synthetically produced cannabinoids
Cannabinoids such as THC and CBD can be produced in a laboratory using organic chemistry techniques. The THC, CBD and other cannabinoid molecules produced in this way are identical to those found in the plant. This is more of a 'pharmaceutical' approach to cannabinoid production and avoids the many issues involved in growing cannabis plants.
The information held in these pages is intended to be an educational resource to direct patients and medical practitioners more clearly and safely to work in this emerging medical landscape.