(NEW YORK) — Australian regulators announced in February that psychiatrists will be able to prescribe psilocybin and MDMA as medication for certain mental health conditions starting July 1 of this year. The move makes Australia the first nation to approve the legal use of MDMA and psilocybin.

This is a major regulatory step forward as medical interest in the use of psychedelic substances for the treatment of mental health conditions has surged in recent years, and as other countries — including the United States — loosen restrictions on their use.


“Australia is creating an interesting model that could pave the way forward for the rest of the world,” Dr. Michael Alpert, a psychiatrist at Harvard Medical School who studies MDMA-assisted psychotherapy for PTSD, told ABC News.

Australia’s new rules allow MDMA to be prescribed for post-traumatic stress disorder (PTSD) and psilocybin to be prescribed for treatment-resistant depression (TRD). Several pivotal research studies suggested the legitimacy of these treatments as new tools in the treatment of mental illness.

A trial published in May 2021, for example, found that MDMA (otherwise known by street names “Molly” and “ecstacy”) can help people suffering from PTSD when given with talk therapy. In the study, one group of people with PTSD received MDMA along with talk therapy, and the other took a placebo with identical talk therapy. This treatment went on for 18 weeks.


Ultimately, 67% of those in the MDMA-assisted therapy group no longer had PTSD after three sessions, compared to 32% in the placebo with therapy group.

Experts think MDMA helps PTSD by adjusting fear and memory circuits in the brain and bolstering social behaviors.

Psilocybin, which is the active ingredient found in “magic mushrooms,” creates psychedelic effects by altering neurotransmitters in the body. Researchers think it may help with depression by altering serotonin to create a positive mental state of interconnectedness, termed a “mystical experience” in research studies.


In a 2021 trial, psilocybin worked just as well as the antidepressant escitalopram, with significant improvements in well-being noted in the psilocybin group.

Many other governments, organizations and businesses have looked favorably upon these research findings, speculating that FDA approval, marketing and distribution of this new class of medication may be imminent.

The U.S. Department of Health and Human Services is anticipating an eventual FDA approval of MDMA and psilocybin treatments, according to a letter from the department in May 2022. Financial experts estimate the market for psychedelic treatments will soon be valued in the billions.


Despite the promise of psychedelic drugs, they also place users in a vulnerable state due to their altered mental status during treatment, said Alpert of Harvard Medical School. As MDMA and psilocybin become legalized for prescription in Australia, the country is thinking proactively about how to ensure proper surveillance and quality of treatment.

They have specified that the medications may only be prescribed by psychiatrists in medically controlled environments. They’re requiring specific training for clinicians to create safe therapeutic conditions, which includes medical and psychiatric evaluation prior to use, monitoring of response, and supportive integration therapy.

“Australia will need to have clinicians demonstrate some familiarity working with these substances, provide a sort of additional training requirement or possibly some degree of clinical supervision while getting started, as well as accountability measures to identify a standard of care for these treatments and consequences for violations,” Alpert said.


Although no other countries have legalized psychedelics for depression and PTSD, others are taking steps to make them more accessible. Canada approved MDMA and psilocybin for those suffering from “life-threatening mental illnesses” in 2022. A number of South American countries, including Brazil, Colombia, Ecuador and Peru, have legal frameworks to allow the use of other psychedelics.

In the United States, many cities and states are taking steps to loosen legal restrictions around psychedelics. The city of Denver, Colorado was first to decriminalize psilocybin, removing legal penalties for possession in 2019. Other cities, including Santa Cruz, California, and Cambridge, Massachusetts, followed suit in 2021.

Oregon became the first state to decriminalize psilocybin and legalize it for therapeutic use in 2020. The drugs are not officially approved for medical use, but the state issues permits to trained facilities allowing them to offer sessions using the drug. Colorado passed similar guidelines in 2022.


Whether the United States will follow Australia’s lead and lift restrictions on MDMA and psilocybin at the federal level is still to be determined. Researchers are still gathering data and regulatory systems are still being developed to ensure that psychedelics are safe, effective and can be responsibly administered.

Experts working in this space will be keeping a close eye on how the Australian policies play out, Alpert says.

“It will be interesting to see what Australia is going to do to ensure that patients receive a consistent standard of care when receiving these services. Proper implementation will be key in ensuring that patients have access to life saving treatments for diseases that lack other great options,” he said.


Nicholas Nissen, M.D., is an author, host of the “Brain Health with Dr. Nissen” podcast and a contributor to the ABC News Medical Unit.

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