Australia’s medical regulator on Wednesday rejected a bid to approve psychedelics for therapeutic use, saying the risks of the drugs outweigh the potential mental health benefits. In a final decision from the Therapeutic Goods Administration (TGA), the agency declined to approve an application to amend Australia’s poison standards by reclassifying psilocybin and MDMA as Schedule 8 controlled substances instead of their current status as prohibited substances under Schedule 9.

Under the decision, psychedelic drugs will not be available for use as therapeutic drugs to treat serious mental health conditions, a practice that is gaining acceptance by many therapists. Studies have shown the drugs have the potential to treat depression, anxiety and addiction. 

But the TGA noted that much of the research to date has been conducted in strictly controlled environments, potentially limiting the practical therapeutic value of psychedelics. The agency also cited a fear that legalizing the drugs for therapeutic use would lead to misuse of the drugs in non-clinical applications.

“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,” the TGA wrote in its December 15 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,” the author of the agency’s decision wrote. “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 Royal Australian and New Zealand College of Psychiatrists did not support the application to reclassify psilocybin and MDMA, according to the TGA’s statement. The Australian Medical Association also weighed in, calling for more research using larger, high-quality studies to determine the safety and effectiveness of using the drugs therapeutically.

Decision a ‘Step Backward’ for Australia

Dr. John Huber, the founder and CEO of psychedelic therapy consultation platform Tripsitter Clinic, says that “Australia’s decision to reject the use of MDMA and psilocybin mushrooms for clinical use is a step backward.” 

“The declaration that there is not enough research limits Australia’s ability to conduct any research on the benefits of psychedelic therapy,” Huber wrote in an email to High Times. “This form of thinking suppresses progress and portrays 1960s ideologies. The pandemic greatly impacted people’s mental health, and political leaders need to get up to speed and expand access to mental health services in this time of need.”

The CEO of Hawaii-based psychedelic medicines startup Ei.Ventures, David Nikzad, noted that the decision by the TGA is inconsistent with recent psychedelic reform efforts. Canada has taken steps to make psilocybin available to therapists for clinical use, and the legality of magic mushrooms in Jamaica has led to the rise of psychedelic retreats in the Caribbean nation.

Additionally, Oregon has legalized psilocybin for supervised mental health treatment and several U.S. municipalities including Oregon, Detroit, Seattle, Oakland and Denver have passed measures to decriminalize some psychedelic drugs and entheogenic plants and fungi.

“We find this very disappointing and counter to the larger trend of psychedelics being decriminalized or approved for medical use in numerous jurisdictions globally,” Nikzad said. “We hope that Australia comes around once the studies underway give further credence to earlier work that shows the effectiveness of psilocybin use for positive mental health outcomes in clinical settings.”

“It’s really a shame that this outdated thinking is stifling advancement in the important arena of psychedelics and mental health when these natural products could help so many people with depression, anxiety and other mental health issues,” he added.

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