On February 3, the Therapeutic Goods Administration published an interim decision not to reschedule psychedelic substances, including MDMA and psilocybin, to schedule 8 of the poisons standard.
A final decision is expected from the TGA in April.
A rescheduling, if permitted, would mean these substances could be registered as future medicines and would have also improved patient access under special access schemes.
This would therefore allow for more safe, controlled research into the efficacy of psychedelics as a mental health treatment in Australia.
The facts are that Australia is facing a mental health crisis that is showing no signs of abating.
According to a June Productivity Commission report, 1 in 5 Australian adults have a chronic mental illness.
The cost of mental illness to the Australian economy is staggering, estimated at $220 billion a year.
At Emerald Clinics, a large proportion of patients referred to us for cannabinoid-based medicines have mental health concerns such as major depression, anxiety disorders and addiction.
Many of these conditions are only exacerbated by the past and ongoing effects of the COVID-19 pandemic.
What is clear is that new avenues to alleviating the crisis are crucial, both for the wellbeing of our community and the strength of our economy.
In considering the submission, the TGA raised concerns about the level of clinical evidence to maintain patient safety.
While the TGA's caution is reasonable, the level of research conducted in highly-respected institutions like Johns Hopkins, Yale, Imperial College and other major European and North American universities has provided enough promising efficacy data to move forward in Australia.
Studies have shown that psilocybin, when used properly, seems to have minimal adverse side effects, especially in contrast to antidepressants.
And it seems to be effective, with 84 per cent of participants in a John Hopkins study of 1993 individuals reporting psychological benefits.
It is being used by medical practitioners as part of expanded Access Schemes in the US, Switzerland, Israel and on a case-by-case basis in Canada.
MDMA in a controlled clinical setting has also shown limited misuse, abuse or overdose potential internationally and has low toxicity at therapeutic doses.
Phase 2 and interim phase 3 results suggest it can be effective in conjunction with psychotherapy for PTSD.
At Emyria, in conjunction with Mind Medicine Australia, we are further working to alleviate the TGA's concerns and provide the platform to allow patients with major mental health concerns access to these promising new treatments while also support research through the development of an evidence-generating clinical model for psilocybin and MDMA.
The model employs controlled and evidenced-based study protocols, detailed schedules of licensed and validated assessments of clinical and patient-reported outcomes, digital technology, training manuals and data governance frameworks to ensure thorough, quality, best-practice data gathering.
In addition, it employs appropriately credentialed clinicians to ensure with utmost patient safety at all times, clinical-trial grade data management systems and processes and a fit-for-purpose facility with close proximity to psychologists, psychiatrists and physicians.
We believe this model will provide much of the infrastructure the TGA believed was lacking in its initial assessment - and strongly believe that by using the principles of a learning health system, we can protect public safety and accelerate the registration and care model of psilocybin, while alleviating the suffering of so many Australians.
Dr Michael Winlo is the managing director of Emyria and its subsidiary Emerald Clinics.