Australian approval of MDMA and psilocybin a ‘baby step in the right direction’, medical experts say

Psychiatrists have cautiously welcomed the ability to prescribe MDMA and psilocybin, saying it’s a “baby step in the right direction”.

The Therapeutic Goods Administration announced on Friday that, from July, approved psychiatrists would be able to prescribe MDMA (ecstasy) for post-traumatic stress disorder and psilocybin (found in magic mushrooms) for treatment-resistant depression.

The move makes Australia the first country in the world to officially recognise psychedelics as medicines.

Related: Australia to allow prescription of MDMA and psilocybin for treatment-resistant mental illnesses

The Royal Australian and New Zealand College of Psychiatrists president, associate professor Vinay Lakra, said the college “cautiously welcomed” the decision, and had been monitoring ongoing research in the area.

“We need to take some baby steps rather than one giant leap,” he 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.”

He said while there were still some outstanding questions about how the process would work, there were various built-in safeguards.

Psychiatrists will need to get approval by a human research ethics committee, then approval under the TGA’s authorised prescriber scheme. To get those approvals they must demonstrate their training, robust patient selection and evidence-based treatment protocols, as well as patient monitoring. They must also satisfy governance and reporting criteria.

“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,” the TGA said in a statement.

“In addition, patients may be vulnerable during psychedelic-assisted psychotherapy because of their altered state of consciousness.”

Because there are are currently no approved Australian substances, the psychiatrist would also have to apply for a licence to import them.

“I think what that does is it gives everyone some time to test those processes,” Lakra said.

“It also provides the safeguards to make sure that everyone is doing the right thing and is supported in the provision of these treatments.”

One concern, he said, is that allowing people to access these substances might make them drop out of clinical trials, which could slow down the research.

Related: Criminalising nicotine vaping in Australia could cause ‘further harm’, drug experts warn

Dr David Caldicott, a senior clinical lecturer in emergency medicine at the Australian National University, said the drugs had been demonised for decades as part of the “ill-conceived, ideological ‘war on drugs’”.

Sarah-Catherine Rodan, a PhD student at the University of Sydney who is the lead investigator on a psilocybin trial, said the reclassification of psilocybin to schedule eight (a controlled substance) from schedule nine (a prohibited substance) should be extended to all treatment-resistant psychiatric disorders including “nicotine/alcohol dependence, obsessive compulsive disorder, and end-of-life distress”.

“In Australia, there are clinical trials investigating psilocybin in substance abuse, generalised anxiety disorder, end-of-life anxiety, anorexia nervosa, as well as depression,” she said.

“Currently, researchers will have to go through the process of handling psilocybin as a schedule nine drug and this approval does not change this.

“I hope that the TGA will consider rescheduling psilocybin for all treatment-resistant psychiatric disorders so there is greater capacity for researchers to explore its therapeutic potential.”

Petra Skeffington, associate professor in clinical psychology at Murdoch University, advised caution, saying the training would have to be adequate.

“With the potential for increased access to MDMA and psilocybin-assisted therapies, it is now critically important that high-quality therapist training be made available to promote safe therapeutic conditions when working with these medications,” she said.

The CSIRO scientist Peter Duggan told the ABC it was an “intriguing and exciting” prospect.

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