Australia has become the first country to approve the medical use of MDMA and psilocybin
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08.02.2023

Australia has become the first country to approve the medical use of MDMA and psilocybin

MDMA psilocybin Australia
Credit: Unsplash

Authorised psychiatrists will be able to prescribe MDMA to treat post-traumatic stress disorder and psilocybin for depression.

Australia has just become the very first country in the world to officially recognise MDMA and psilocybin (the active ingredient in magic mushrooms) as legitimate medicines, approving them for medical treatment.

Late last week (Friday, February 3), the Therapeutic Goods Administration (TGA) announced that the medical use of MDMA and Psilocybin will be rescheduled from Schedule 9 (Poisons Standard) to Schedule 8 (Controlled Substance) on a restricted basis. This means that from July 1 2023, psychiatrists who become authorised prescribers for this purpose will soon be able to prescribe these substances as part of therapy for patients with treatment-resistant depression (psilocybin) and treatment-resistant post-traumatic stress disorder (MDMA).

Stay up to date with what’s happening in and around Melbourne here.

The TGA’s decision to reschedule these substances for medical purposes on a restrictive basis is the culmination of Mind Medicine Australia’s (MMA) applications lodged in March 2022 and their objections to the interim decisions lodged in November 2022.

The decision recognises the enormous number of Australians who lodged their submissions in support and the fact that treatment-resistant patients aren’t benefitting from currently available treatments. Mind Medicine Australia (MMA) shared that Australia should be ‘proud of the fact that we are the first nation in the World to reschedule these medicines for medical purposes and Australia is now an innovative leader in the treatment of mental illness’.

Mind Medicine Australia is arranging for these medicines to be supplied through licensed pharmacists holding Schedule 8 permits. The supply chain will be tightly controlled at all times in strict accordance with Australian and State/Territory regulatory requirements.

In commenting on the decision and the way forward for Australia, Professor David Nutt, Head of Neuropsychopharmacology at Imperial College, said: “I am delighted that Australia is continuing to lead the way in psychedelic treatment research after the earlier AMRC research grant initiative. This new scheduling decision gives hope to the many tens thousands of patients with depression and PTSD for whom current treatments fail. The data collection plan will provide Real World Evidence of the value of these treatments that is likely to change medical practice around the world. I am working hard to ensure the UK catches up with Australia!”

In regards to the process for psychiatrists to become authorised prescribers, they 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.

“Since 2021 Mind Medicine Australia has trained 240 psychiatrists, psychologists, psychotherapists, GPs, physicians, addiction specialists, mental health nurses, social workers and occupational therapists through its Certificate in Psychedelic-Assisted Therapies (CPAT). This training was recently described by Professor David Nutt as the “world’s leading CPAT training” on ABC Radio National and features a world class international Faculty,” MMA shared.

“Many graduates have described the course as life-changing and the most outstanding professional development program they have completed. The course is also recognised by graduates’ professional colleges and associations through Continuing Professional Development (CPD) credits. It is important to note that psychedelic-assisted therapies require a multidisciplinary team approach, so that whilst psychiatrists will be screening patients and prescribing treatments where suitable, the actual treatments are likely to be supervised by a range of therapists.”

Mind Medicine Australia will shortly be making an exciting announcement about its Certificate in Psychedelic-Assisted Therapies and launching dates for 2023 intakes.

The news comes as a widening consensus builds among researchers across the world around the potential benefits of the psychoactive drugs to treat certain conditions. 

You can read the TGA’s full announcement and the Delegate’s Final Decision here.