Psychedelics Rejected for Therapeutic Use in Australia

The country’s medical regulator has rejected an application to have MDMA and psilocybin legalised for clinical use, citing a lack of evidence.
Gavin Butler
Melbourne, AU
Psychedelic researchers have supported the medical regulator's decision. Photo by James MacDonald/Bloomberg via Getty Images

Psychedelic drugs will not be legalised for therapeutic use in Australia, the country’s medical regulator has declared.

The Therapeutic Goods Administration (TGA) rejected an application on Wednesday to amend Australia’s poisons standard and downscale drugs like psilocybin and MDMA from Schedule 9 – prohibited substances – to Schedule 8 – controlled substances. 

The decision means that the drugs cannot be used as part of psychotherapy treatment for mental illnesses, depression and post-traumatic stress disorder, even under the authorisation of a treating psychiatrist or specialist addiction physician in a medically controlled environment.


In a statement, the TGA claimed its decision was based on a fear that legalising the use of the substances in therapeutic settings could lead to them being misused or abused in non-clinical contexts.

“The benefit is very limited because psilocybin studies indicate only potential therapeutic value in circumstances where the treatment was provided to subjects within the setting of a clinical trial,” said the author of the final decision. 

“In relation to the risks, I am satisfied that psilocybin poses a high danger for both acute and long-term effects if abused or misused by way of access outside of strictly controlled medical and scientific research settings.” 

“Given this increased risk to individuals of acute and long-term effects, a high level of control across the supply chain commensurate with Schedule 9 is warranted.”

The author further noted that most of the submissions supporting the downscaling of both psilocybin and MDMA were from individuals who were consumers or patients with a personal interest in how the drugs were scheduled, as well as experts who had previously provided input on the matter.

The Royal Australian and New Zealand College of Psychiatrists (RANZCP) did not support the proposal to reschedule the drugs, according to the TGA’s statement, while the Australian Medical Association (AMA) reportedly suggested that more high-quality research using larger scale studies need to be completed in order to determine the safety and efficacy of using psilocybin or MDMA for mental illness.


While the TGA’s decision is an effective reinforcement of the status quo, it’s out of step with a growing number of jurisdictions in other parts of the world. Last November, Oregon became the first state in the U.S. to legalise psilocybin for mental health treatment in supervised settings, while Canada has started allowing people with depression to legally consume the psychedelic. Researchers in the U.S. are also currently conducting a second Phase 3 trial into the efficacy of MDMA-assisted therapy, and if it proves successful, then the Food and Drug Administration (FDA) could approve the substance for therapeutic use by 2023.

Dr Martin Williams, executive officer of Psychedelic Research in Science and Medicine (PRISM), said he agreed with the TGA’s decision not to reschedule either of the drugs in Australia.

“While excellent late-phase clinical research is ongoing around the world, and the results so far have been very promising, we agree that the standards of evidence required for formal approval and implementation still need to be met,” said Williams, in a statement emailed to VICE. “Our firm support for the eventual rescheduling of psilocybin and MDMA … is based on the emerging evidence from local and international research demonstrating that these drugs may be used as safe and effective adjuncts to psychotherapy in the treatment of refractory mental illness. 


“Meanwhile, Australian research needs to be conducted to ensure successful implementation in the local environment, to engage our medical community, and to pave the way towards appropriate training and accreditation of Australian mental health professionals in this game-changing area of mental health practice.”

Dr Stephen Bright, founding member and director of PRISM, similarly highlighted concerns that rescheduling could “open the door to unsafe and unethical practices.”

“This was not a surprise for me,” he told VICE. “Australia was never going to be the first country in the world to make these drugs medicines … Our focus remains on completing the research we are engaged in that will put Australia in a better position to [do that].”

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