Australia expands psychedelic therapy access with updated prescriber rules

Australia's Therapeutic Goods Administration published updated recommendations for its Authorized Prescriber scheme covering psilocybin and MDMA therapies, broadening therapist eligibility and treatment settings. The changes follow a stakeholder consultation that closed May 19, 2026.

Under the revised framework, therapy teams must include at least one therapist registered with a National Board, with the second practitioner drawn from a wider pool including psychotherapists, counselors, social workers, and Aboriginal and Torres Strait Islander health workers. The authorized psychiatrist must remain physically present during medicine administration.

Treatment locations can now extend beyond hospital settings to any medically supervised environment meeting safety standards, including secure storage for Schedule 8 substances and proximity within 15 minutes of an emergency department.

Optimi Health Corp. (NASDAQ: OPTH), which supplies MDMA and psilocybin products from its Canadian facility to the Australian program, stated the changes address workforce capacity needs, particularly in rural areas. The company manufactures GMP-compliant psychedelic pharmaceuticals for the scheme, which allows psychiatrists to prescribe MDMA for PTSD and psilocybin for treatment-resistant depression.

The TGA reported no serious adverse events under the scheme since December 2025, with safety data collected through required reporting to Human Research Ethics Committees and the Australian Interventional Pharmacotherapy and Psychedelic Assisted Psychotherapy Research Registry.

Reimbursement coverage now spans public payers including the Department of Veterans' Affairs, National Disability Insurance Scheme, and WorkCover schemes, alongside private insurers including Medibank.

Mind Medicine Australia's Certificate in Psychedelic-Assisted Therapy program has trained over 750 clinicians, providing 127 continuing professional development hours and clinical experience pathways recognized by regulatory bodies.

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