Psychedelics can now be legally used as medicine in Australia in a world-first approval that is aimed at treating acute mental health conditions.
From Saturday, MDMA and psilocybin — better known as ecstasy and magic mushrooms — are cleared for post-traumatic stress disorder (PTSD) and treatment-resistant depression.
The approval was granted because of the lack of effective treatment options and preliminary data suggesting the hallucinogens may be uniquely positioned to benefit patients, according to the Therapeutic Goods Administration (TGA), the country’s regulatory authority.
Still, a raft of rules will make it difficult for most people to get their hands on the psychedelics.
Only registered psychiatrists who have the ethics approvals normally needed to conduct clinical trials and who have gained regulatory authorisation through a provider programme will be allowed to prescribe them.
The TGA said no medical professionals are currently approved to prescribe the treatments as applications only opened on Saturday.
The US state of Oregon in January legalised the adult use of psilocybin, the active hallucinogenic component of “magic mushrooms”, but only under the supervision of a licensed psilocybin facilitator and only at a state-sanctioned psilocybin service centre. The first such licence was granted in May.
In Australia, the cost of psychedelic treatment may also be a barrier for many people. Daniel Perkins, co-executive director of the Psychae Institute and a senior research fellow at the University of Melbourne, estimates that a course of treatment including psychedelic-supported therapy sessions could cost between A$15,000 (US$9,900) and A$25,000.
It’s still early days when it comes to research on the use of psychedelics for the treatment of health conditions. Their long-term benefits and risks are not known and it is unclear how long the initial improvements seen among many patients will last.
‘Game-changer’
“It’s a game-changer for psychiatry in that it’s one of the biggest evolutions in the past 70 years,” said Mike Musker, an enterprise fellow in the mental health and suicide prevention research and education group at the University of South Australia. “Psychedelics provide a profound change in mood.”
Treatment may lead to empathetic feelings and enhanced connections with others, said Musker, who also serves on the medical advisory board of Goodmind Therapeutics, a clinic that plans to offer psychedelic-assisted therapy. It can also change a person’s level of consciousness, giving them an “awe-like” experience, he said.
No specific products have been approved in Australia, which means healthcare providers or the facilities they work with will have to import the hallucinogens for their patients.
The decision to regulate MDMA and psilocybin as controlled substances, first announced in February, was made by an unidentified senior medical officer at the TGA and reversed previous rulings — including one as recent as October 2022 — that classified both as prohibited substances.
While the TGA said that the therapeutic value of the chemicals hasn’t been established, the restrictions they put in place around administering them and the known benefits and risks make the approval appropriate. Outside of the narrow medical setting, both MDMA and psilocybin remain illegal in Australia.
