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A taxonomy of regulatory and policy matters relevant to psychedelic-assisted therapy in Australia

Summary

Australia has recently approved psilocybin and MDMA for treating severe depression and PTSD when used with professional therapy support. This paper creates a comprehensive guide outlining all the regulatory, professional, and safety considerations needed to safely deliver these treatments in clinical settings. The researchers interviewed 11 experts and reviewed existing research to identify 102 specific matters that need clear guidelines, such as what qualifications therapists need, where treatments can be delivered, how patients should be screened, and what safety measures are essential.

Background

Australia recently rescheduled psilocybin and MDMA as Schedule 8 substances for limited clinical use, making it the first national jurisdiction in the 21st century to formally recognize these substances as medicines. This regulatory change has created various regulatory concerns and challenges for implementing psychedelic-assisted therapy programs in clinical settings.

Objective

To comprehensively catalogue the matters relating to psychedelic-assisted therapy that are or could be regulated in Australia, identify current regulatory status, uncertainties in clinical practice, and areas with conflicting views on future regulation.

Results

A comprehensive taxonomy of 102 regulatory matters organized into six domains: Service Establishment, Practitioner, Drug Supply, Patient Evaluation, Treatment Delivery, and Service Oversight. Three domains (Service Establishment, Practitioner, Treatment Delivery) contained substantial uncertainty or conflicting views, while the remaining three appeared relatively settled with established regulation.

Conclusion

The taxonomy provides a roadmap for health services implementing psychedelic-assisted therapy programs and for policymakers determining areas requiring further regulation, particularly in service establishment, practitioner qualifications, and treatment delivery protocols.
  • Published in:Australian and New Zealand Journal of Psychiatry,
  • Study Type:Policy Analysis, Taxonomy Development,
  • Source: PMID: 38628079, DOI: 10.1177/00048674241240597
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