On the 29th of February 2016 the Australian Parliament passed legislation allowing the cultivation of cannabis for medical and research purposes. Following on from this the licensing regime came into effect on the 30th of October 2016.
Three categories of license relating to cannabis activities were available:
Cultivation or production, or both
State governments also provide legislation governing the wholesale supply and movement of cannabis products to patients.
SAS B applications have doubled year on year since 2019, with more than 122,000 applications for treatment processed in 2021.
This number does not account for the patients being supplied under the SAS Category A authorised prescriber scheme, this scheme allows a prescriber to be approved to prescribe a class of patient without the need to apply for a SAS B approval on a case by case basis.
Authorised Prescriber (AP) numbers are also growing rapidly, and more than 3,800 prescribers are now registered according to TGA data.
On the 21st of December 2020, the TGA announced a decision that nicotine vaping products would become Schedule 4 prescription-only medicines within the Poisons Standard from 1 October 2021. This means that when a consumer purchases these products online from an overseas supplier, they legally require a prescription from an Australian doctor.*
The TGA based its decision on evidence that nicotine vaping products act as a gateway to smoking in youth.
Rescheduling vaping products as prescription-only balances the need to prevent young Australians from taking-up nicotine vaping products, while allowing current smokers to access these products for smoking cessation.
Under medical supervision, vaping products allow the reduction in active ingredient through metered dosage over time, potentially providing better cessation outcomes for long term smokers.
Psilocybin & MDMA
In early 2021 the TGA commissioned an expert panel to evaluate emerging psychoactive therapeutics psilocybin and MDMA for the treatment of mental health conditions. The final report released in November 2021 was based on a systematic literature review and meta-analysis to assess their therapeutic value, benefits and risks. Six of the eight studies on MDMA reviewed were on post-traumatic stress disorder, one on anxiety due to a life-threatening disease and the other on social anxiety in adults with autism. For psilocybin, six studies were for anxiety or depression for a life-threatening disease, two on treatment-resistant depression and one on obsessive-compulsive disorder.
The TGA made a determination not to reschedule these substances from Schedule 9 to Schedule 8 within the Poisons Standard, however the expert panel concluded that MDMA and psilocybin may “show promise in highly selected populations”.
The determinations author also commented: "I agree with the committee that the preliminary findings from clinical trials, although in early phases, evaluated by the panel are promising".
Australian companies remain committed to exploring the therapeutic use of psychedelic substances through developing further research-based evidence.
Supply chain efficiency, transparency and strict control that engenders confidence in the industry while facilitating access to suitable treatments to meet increasing demand
Industry advocacy and responsible stewardship
Patient and prescriber education