Psilocybin in the real world: Regulatory, ethical, and operational challenges in Australia’s clinical landscape
Australian & New Zealand Journal of Psychiatry December 17, 2025 Megan Dutton, Paul Schwenn, Jules Mitchell et al. 1 citation
Australia reclassified psilocybin as a Schedule 8 substance for treatment-resistant depression, a major policy shift. Implementation faces challenges: limited prescriber access, no Australian Register of Therapeutic Goods-listed products, lack of standardized training, and high costs. Ethical issues include informed consent, cultural safety, and therapeutic fidelity in trauma-informed care. Recommendations include national training accreditation, fidelity monitoring, and research into neurobiologically informed stratification models for treatment. These steps aim to ensure safe, equitable, and evidence-based integration of psilocybin-assisted therapy into Australia's mental health system.