Australia Becomes First Country to Approve Psychedelic Therapy

Australia’s decision to approve psychedelic treatment in therapy sessions has made it the first country to classify substances as medicines at a national level. The approval will allow the use of psilocybin, found in psilocybin mushrooms (magic mushrooms), for treatment-resistant depression, and MDMA for Post-Traumatic Stress Disorder (PTSD).

Australian media reports indicate that the therapy carries a significant price tag, with a single course potentially costing tens of thousands of dollars.

MDMA, commonly known as the party drug ecstasy, is a synthetic substance classified as a hallucinogen. Its effects include heightened energy levels, enhanced sensory experiences, and a distortion of time perception. Magic mushrooms, grown naturally, contain the active compound psilocybin, causing hallucinogenic effects.

While Australia is the first country to regulate psychedelics as medications at a national level, clinical trials involving psychedelics are also underway in other countries such as the US, Canada, and Israel. These trials aim to explore the therapeutic benefits of these substances and their applications in treating various mental health conditions.

Australia’s recently implemented regulation has officially allowed approved psychiatrists to prescribe MDMA for post-traumatic stress disorder (PTSD) and psilocybin for depression since 1 July.

Mind Medicine Australia (MMA) advocated for psychedelic treatments and trained health professionals involved in procuring and prescribing these drugs. To become an authorised prescriber of MDMA and psilocybin, Australian psychiatrists must apply to an ethics committee and the Therapeutic Goods Administration (TGA), the country’s drugs regulator. The process involves sourcing and supplying both drugs and includes supervision from multidisciplinary teams, psychiatrist sessions, and private clinics.

MMA advocacy efforts, which highlighted the substantial number of submissions from thousands of Australians whose existing mental health treatments are ineffective, played a critical role in obtaining TGA approval for psychedelic treatments.

Australia’s approach to rolling out clinical prescriptions for psychedelics and the pricing of these treatments will be closely observed over the next few months.

Meanwhile, Australia’s prominent medical and mental health organisations are at the forefront of resistance to psychedelic treatments.

According to Kristen Morely, a professor of addiction medicine at the University of Sydney, the scientific and medical community has expressed significant caution regarding the use of psychedelics in therapy.

The Australian Medical Association (AMA) and the Royal Australian and New Zealand College of Psychiatrists (RANZCP) have expressed concerns regarding the use of psychedelics. They remain cautious about the risks and uncertainties associated with these treatments. They raise the need for key points to be carefully considered and addressed in psychedelic-assisted therapies.

Both the AMA and the RANZCP have called for extensive, large-scale studies and improved research into psychedelic treatments.

Professor Richard Harvey, chair of the RANZCP’s Psychedelic-Assisted Therapy Steering Group, agreed that psychedelic-assisted therapy might provide hope for a small number of individuals who have tried other treatment options without success. However, he stressed the importance of recognising that it is not a miracle cure.

He stressed the need for a ‘cautious, considered, and informed’ approach, highlighting the potential for psychedelic substances to induce fear, panic, and re-traumatisation in some vulnerable individuals. Professor Harvey expressed concern that if patients’ experiences do not match their expectations of this therapy, distress could result.

Professor Harvey concluded that psychedelic-assisted therapy is still in its infancy and emphasised that there is much more to understand before drawing definitive conclusions.

According to Professor Susan Rossell, a cognitive neuropsychologist at Melbourne’s Swinburne University, psychedelics indeed have the potential for therapeutic use. However, she believes that the recent move occurred too quickly, raising concerns about the need for a more cautious and measured approach to implementation.

Professor Rossell, currently investigating the effects of psilocybin on depression, emphasised the necessity for further research to assess the long-term outcomes of this therapy. The findings could shed light on the effectiveness and safety of psilocybin-assisted treatments in addressing depression.

In February, the TGA reclassified MDMA and psilocybin, enabling their therapeutic use. The TGA characterised these drugs as ‘relatively safe’ when administered within a ‘medically-controlled environment’ for patients dealing with ‘serious mental health conditions’.

The regulator clarified that, as of now, there are no approved products containing MDMA or psilocybin for therapeutic use. However, the recent reclassification allows psychiatrists to access and legally supply certain medications containing these substances.