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Psilocybin in the real world: Regulatory, ethical, and operational challenges in Australia’s clinical landscape

Summary

Australia has approved psilocybin as a treatment for severe depression, but the rollout faces major practical challenges. Only a handful of psychiatrists are authorized to prescribe it, treatment costs over $20,000 per person, and there are no standardized training programs for therapists. The therapy can profoundly alter patients’ beliefs and worldviews, raising ethical concerns about proper support during and after treatment. The article proposes solutions including national training standards, better funding access, and stronger safeguards for vulnerable patients.

Background

Australia reclassified psilocybin as a Schedule 8 substance for treatment-resistant depression in 2023, positioning the country as a global leader in psychedelic medicine regulation. However, implementation has revealed substantial challenges in clinical infrastructure, prescriber access, and therapeutic delivery despite regulatory approval.

Objective

To critically examine the regulatory, ethical, and operational complexities surrounding psilocybin-assisted therapy provision in Australian clinical practice and propose structural recommendations to support safe and equitable deployment.

Results

Key findings identify limited prescriber access (only 13 authorized prescribers across 5 states as of September 2025), absence of ARTG-listed products, lack of standardized training pathways, and significant cost barriers ($20,000-$30,000 AUD per treatment course). Ethical concerns include informed consent complexities, cultural safety, and therapeutic fidelity risks.

Conclusion

The authors propose comprehensive governance frameworks including national training accreditation, stratification models using biomarkers, fidelity monitoring tools, and equitable funding mechanisms. Implementation of these recommendations can position Australia as a leader in establishing a robust, evidence-based, and accessible framework for psilocybin-assisted therapy within psychiatric practice.
  • Published in:Australian and New Zealand Journal of Psychiatry,
  • Study Type:Review,
  • Source: 10.1177/00048674251398677, PMID: 41405025
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