Australia becomes first country to approve psychedelics as form of medicine

Australia is reclassifying them as “controlled substances” and making them available for use in managed medical settings.

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Starting July 1, Australia will authorize qualified psychiatrists to prescribe psychedelic use in a managed medical settings. The Therapeutic Goods Administration (TGA) said MDMA, or ecstasy, is approved for post-traumatic stress disorder and psilocybin, or magic mushrooms, for treatment-resistant depression.

Psychiatrists must first receive clearance from a Human Research Ethics Committee and be approved under the TGA’s authorized prescriber program before they can prescribe psychedelics.

“These measures are necessary because there is only limited evidence that the substances are of benefit in treating mental illnesses, and only in controlled medical settings,” TGA said in a statement.

In order to be approved, psychiatrists “must demonstrate their training, robust patient selection and evidence-based treatment protocols, as well as patient monitoring,” The Guardian reported, along with “satisfy governance and reporting criteria.” The psychiatrists will also have to apply for a license to import psychedelics because they aren’t currently approved substances in Australia.

“We need to take some baby steps rather than one giant leap,” Vinay Lakra, the Royal Australian and New Zealand College of Psychiatrists president and associate professor, said. “So this is a baby step in the right direction and what it does is allow us to do things in an appropriately safe way for everyone … and if necessary take a step back as well.”

While continuing global research and clinical trials show that psilocybin, which is the active ingredient in psychedelic mushrooms, can treat mental health conditions, such as depression, some researchers caution against the approval of psychedelics as a form of medicine because “more large-scale trials are needed.”

“We still need to find out why these substances are helping patients i.e. the clinical mechanism of action is still unknown,” Katrin Preller, group leader at the University of Zurich, said. “In addition, we need larger trials. Furthermore, we need to find out what the optimal way is to conduct the non-pharmacological part of psychedelic-assisted therapy.”

This move makes Australia the first country world-wide to authorize psychedelics as medicine.

“These drugs work to improve your mood, and they do seem to have quite a long lasting effect from one single dose, apparently,” Peter Duggan, a CSIRO scientist, said.

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