Authorised psychiatrists are now able to prescribe MDMA and psilocybin for PTSD and treatment-resistant depression, respectively, from 1 July.
In February 2023, Australia made changes to its drug scheduling to enable the prescription of MDMA and psilocybin for patients.
The move was made in light of the current lack of treatment options for patients, with Australia’s Therapeutic Good Administration (TGA) stating that these two conditions are the only ones for which there is currently sufficient evidence for potential benefits in certain patients.
Under the new classification, the substances will change from Schedule 9 which is prohibited substances, to Schedule 8, which is controlled drugs, of the Poisons Standard.
The decision was made following multiple applications to the TGA to reclassify the substances in the Poisons Standard, as well as public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling.
The development makes Australia the first country in the world to regulate psilocybin and MDMA as mental health treatments.
Professor David Nutt, Head of Neuropsychopharmacology at Imperial College, who was involved with advocating to the TGA for the rescheduling, said: “This is a landmark day for the tens of thousands of Australian families who are blighted by depression and PTSD as they will have access to powerful new treatments with unique mechanisms of action. And congratulations to Australia for leading the world in this vital treatment innovation.”
Mind Medicine Australia (MMA), which is currently offering a Certificate in Psychedelic-Assisted Therapies (CPAT) for healthcare professionals training in psychedelic-assisted therapies (PAT), were also heavily involved with rescheduling applications lodged in March 2022 and objections to the interim decision lodged in November 2022.
Tania de Jong AM, Executive Director of Mind Medicine Australia, which has also arranged for psilocybin and MDMA to be supplied to Australian psychiatrists via a partnership with Optimi Health, stated: “We are so pleased that some of the immense suffering being experienced in families, communities and organisations around the nation can be alleviated through these transformational therapies.”
Professor Chris Langmead, Deputy Director, and Better Medicines Theme Leader of the Neuromedicines Discovery Centre at the Monash Institute of Pharmaceutical Sciences (MIPS), commented: “The TGA’s decision took many by surprise and, understandably, there have been questions from some regarding the timing of the decision.
“However, whether the sector likes it or not, Australia is now at the forefront of research in this field globally, and we need to seize the opportunity.
“Despite the profound prevalence of difficult-to-treat mental illness throughout the community, very few advancements in new safe and effective treatments have emerged over the last 50 years – this simply isn’t good enough.
“My hope is that the TGA’s decision will pave the way for the development of new safe, effective and widely accessible medicines to significantly improve the lives of those living with mental illness.”
While the move has been largely welcomed by the industry and advocates of psychedelic medicine, others have suggested it was rushed.
Speaking to Nature, Alan Davis, director of the Center for Psychedelic Drug Research and Education at Ohio State University in Columbus, told the publication that: “It was too soon to make these changes before the research could fully determine clinical efficacy and safety.”
Professor Susan Rossell, of the Centre for Mental Health, Swinburne University of Technology, Hawthorn, Australia, and collegues penned a report in May questioning why the TGA did not consult Australian researchers and clinicians with experience in psilocybin-assisted psychotherapy for treatment-resistant major depressive disorder.
They wrote: “While down-scheduling from S9 to S8 may help with the administration of clinical trials, this does not appear to be the motivation behind the TGA decision. Instead, it seems the TGA has yielded to pressure from the public and lobby groups to increase access to these experimental treatments, outside of clinical trials.”
They go on to note that “sufficient levels of evidence have not yet been generated for broad-scale implementation to be justified” and that, while initial results have been promising, “many questions remain” such as best models of care, long-term safety, differentiating patients who will benefit from psychedelics and those who it may be detrimental for.
