Australia becomes first country to recognise psychedelics as medicines

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.

“The details so far from the TGA are thin. There’s 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.