Australia has become the world’s first country to legalize the clinical prescribing of psychedelics for certain mental health disorders. The country’s drug watchdog, the Therapeutic Goods Administration (TGA), will allow psychiatrists to prescribe MDMA, better known as ecstasy, to those who have post-traumatic stress disorder (PTSD) and magic mushrooms for some types of depression that have not responded to other treatments. The move comes as international research on psychedelics shows promising results. However, drugs are still considered illegal in many countries worldwide, and experts are still trying to understand their long-term effects.
The TGA’s decision allows psychiatrists to work closely with patients before, during, and after taking MDMA or psilocybin in a controlled medical setting. The drugs are thought to act in conjunction with psychotherapy sessions, creating “complex synergistic effects” that appear to improve patients’ symptoms. The TGA also said the drugs are safe when used in the dosages studied in recent trials and that patients will be monitored closely.
It is the first time any country has legalized the clinical use of psychedelics to treat mental illness. However, researchers in other countries have been working on the potential benefits for decades. Some say the new Australian rules could spur similar efforts in other countries. Rick Doblin, the founder of the non-profit MAPS organization that carried out one of the 2021 psychedelic-assisted therapy trials in Oregon, says the news from Australia will help speed up the approval process.
In Australia, authorized psychiatrists will be the only ones who can write drug prescriptions. They must get the same ethics approvals usually required for a clinical trial and then obtain regulatory authorization through a provider program. This will ensure that the doctors are adequately trained to offer psychedelic-assisted psychotherapy.
Experts are still working to understand the risks and side effects of psychedelics, and they caution that the new regulations do not mean the drugs will be made widely available. They say that the drugs will likely be restricted to patients with PTSD or untreated depression and that three sessions involving psychedelics and psychotherapy will cost about Aus$ 15,000 ($9,900).
The new regulations may reduce the risk of for-profit clinics cropping up and cashing in on the therapy, but they will not eliminate it. The TGA will require authorized prescribers to report the number of patients they treat, the type of conditions they treat, and any adverse events they encounter. They must also keep detailed records of the drugs they administer.
Mike Musker, a mental health researcher at the University of South Australia, says it will be essential to ensure the treatment is carefully monitored and that patients should not expect it to be a case of taking a pill and going away. He estimates that each psychedelic-assisted therapy session will last about eight hours, and therapists will stay with patients throughout the process.
