Australia has become the first country to classify psychedelic drugs as medicines by legalising MDMA and psilocybin for the treatment of mental health conditions at a national level.

The Therapeutic Goods Administration (TGA), Australia's medicines regulator, has authorised psychiatrists to prescribe both drugs to eligible patients for controlled clinical use from 1 July 2023.

The decision to legalise the drugs for psychedelic-assisted therapy, announced in February, positions Australia as the world's first country to down-schedule psychedelics for clinical treatments. The drugs have been reclassified from Schedule 9 (prohibited substances) to Schedule 8 (controlled drugs), strictly for medical use within the context of psychedelic-assisted psychotherapy.

Watch Sky News Australia's report on the legalisation of MDMA and psilocybin with RANZCP Psychedelic Therapy Steering Group’s Chairman Professor Richard Harvey. Credit: Sky News Australia

MDMA, commonly known as ecstasy, can now be prescribed to patients diagnosed with post-traumatic stress disorder (PTSD). Psilocybin, the psychoactive component found in the psilocybe genus of mushrooms, has been approved for the treatment of treatment-resistant depression.

With an estimated two million Australians affected by PTSD and depression, the therapeutic potential of psychedelics has been hailed as a transformative evolution in psychiatry.

Psychiatrists must obtain pre-approval for prescriptions, as well as a clinical justification for their proposed treatment. They must also adhere to a comprehensive treatment protocol, including dosing information and the number of therapy sessions. Protocols are subject to approval by an ethics committee, aligning with established clinical trial standards.

Psychedelic therapy typically involves one to three full-day, high-dose sessions supported by pre and post-psychotherapeutic care overseen by trained therapists. Clients set their intentions for each session and receive the psychedelic drug in the morning. The effects of the drug last approximately six to eight hours, after which the clients are assessed for their readiness to return to baseline consciousness. A support person accompanies them for the following 24 hours.

Individuals with a history of psychosis, heart conditions or other serious illnesses may be excluded. The drugs will be limited to supervised clinical settings, with no provision for home use.

Considering that no other country has rescheduled these substances for clinical use nationwide, the number of individuals who have experienced psychedelic therapy remains relatively small.

While other countries such as Canada, Costa Rica, Israel, Jamaica and Switzerland have explored the compassionate use of psychedelics, Australia's recent national classification sets it apart.

The U.S. Food and Drug Administration (FDA) designated psilocybin as a "breakthrough therapy" in 2018, expediting the development and review process for drugs aimed at treating serious conditions. U.S. states, such as Oregon and Colorado, have taken steps towards legalising and decriminalising psychedelics.

Researchers studying psychedelics have received federal grants and the FDA recently released draft guidance for clinical trials testing psychedelic drugs as potential treatments for various medical conditions. However, the American Psychiatric Association has not yet endorsed the use of psychedelics in treatment, emphasising the need for further research into their efficacy and risks.

FDA releases guidance for psychedelic research


While the outcomes of clinical trials have shown consistently positive results with large effect sizes for benefits and minimal adverse effects, researchers remain cautious about the translation of these findings to real-world settings. Preliminary data suggests encouraging long-term outcomes, but more research is needed to support these claims.

Affordability is also a significant issue, with treatment costs estimated between AUD $15,000 and $25,000 per patient in Australia. Another concern involves the potential for incompetent clinicians flooding the field.

Despite these concerns, the progress in drug policy is generating excitement among researchers, offering the possibility of more personalised and suitable treatments without the restrictions of clinical trials and rigid protocols.


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