Australia has become the first country to recognise psychedelics as medicines, after the Therapeutic Goods Administration took researchers by surprise and approved the psychedelic substances in magic mushrooms and MDMA for use by people with certain mental health conditions.

MDMA and psilocybin, the active ingredient in magic mushrooms, will be considered schedule 8 drugs – meaning they’re approved for controlled use when prescribed by a psychiatrist – from July this year after the TGA acknowledged there were few other options for patients with specific treatment-resistant mental illnesses.

The changes will allow MDMA to be used to treat post-traumatic stress disorder, and psilocybin for treatment-resistant depression. They will still be considered prohibited substances – or schedule 9 drugs – for all other usages.

“Prescribing will be limited to psychiatrists, given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions,” a TGA statement published on Friday said. Psychiatrists will also first need to be approved by the TGA’s authorised prescriber scheme.

However, the TGA has not yet evaluated any approved products that contain psilocybin or MDMA, meaning psychiatrists will have to access and legally supply unapproved medicines for the specific authorised uses.

Stephen Bright, the director of the Psychedelic Research in Science and Medicine charity, said the decision made Australia the first country to recognise psychedelics as medicines, but it was not anticipated by the sector. “It was unexpected given that Australia is such a conservative country,” he said.

‘There are no products available, and aside from myself and a handful of colleagues, there’s no-one trained to provide the treatment.’

Stephen Bright, director of Psychedelic Research in Science and Medicine

“The details so far from the TGA are thin. There are no products available, and aside from myself and a handful of colleagues, there’s no-one trained to provide the treatment. We’re waiting for a bit more information, to get an idea of what this looks like in practice.”

Associate Professor David Caldicott, an emergency department doctor who appeared at the Royal Commission into Defence and Veteran Suicide to advocate the drugs be used for returned soldiers suffering from psychological trauma, said he was pleasantly surprised by Friday’s decision.

Caldicott said opposition to the use of MDMA in therapeutics had long been a question of politics rather than science.

MDMA was first developed by a pharmaceutical company in the early 20th century, and was used by some psychiatrists in the late 1970s and early 1980s. However, the drug was banned in the USA in 1985, after it began to be used recreationally.

“[It’s] terribly sad because the evidence suggests that there’s potentially quite a lot of use in using it,” Caldicott said.

“The conditions for which these drugs might be used [post-traumatic stress disorder and treatment-resistant depression] are currently conditions for which you’re basically destined to a lifetime of drug use. Whereas the MDMA particularly is used to facilitate psychotherapy, only for a few doses.”

However, Professor Susan Rossell, a cognitive neuropsychologist who has led Australia’s biggest trial examining psilocybin for treatment-resistant depression, said she was very cautious about the decision.
“These treatments are not well established at all for a sufficient level of broad-scale implementation,” she said. “We’ve got no data on long-term outcomes at all, so that worries me a lot, which is one of the reasons why I’m doing my very large study.”

The TGA’s decision said it considered several thousands of written public submissions in making its call, and that the benefits to patients paired with tight controls outweighed the risks.

“The number of such submissions is a reasonable indicator of the scope and gravity of the issues for individual and public health,” it said. “The submissions confirm the need for greater access to alternative treatments for patients with persistent mental health conditions where currently available treatments have not been effective.”

The judgment said registered psychiatrists had the training and expertise to diagnose and appropriately treat conditions, when there was emerging evidence of the substances’ use.

In particular, it cited a study on single-dose use of psilocybine in the New England Journal of Medicine, published in November, which the TGA said had further strengthened “the already promising body of evidence” for psilocybine’s efficacy in treatment-resistant depression.