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

The Australian government's recent rescheduling of psilocybin and MDMA for limited clinical use has raised regulatory challenges for psychedelic-assisted therapy. Through a desktop review, interviews with experts, and framework analysis, researchers developed a taxonomy of regulatory matters across six domains. Three domains—Service Establishment, Practitioner, and Treatment Delivery—contain many matters with uncertainty or conflicting views, such as where services should be located and which professionals qualify as therapists. The remaining domains—Patient Evaluation, Drug Supply, and Service Oversight—are relatively settled, with established regulation or consensus that regulation is unnecessary. The taxonomy offers a roadmap for health services and policymakers.

Study at a glance

Abstract

Objectives: The Australian government recently rescheduled psilocybin and 3,4-methylenedioxymethamphetamine for limited clinical uses. This change has raised various regulatory concerns and challenges for the field of psychedelic-assisted therapy. To provide clarity, we aimed to comprehensively catalogue the matters relating to psychedelic-assisted therapy that are or could be regulated. Methods: We conducted a desktop review of the literature and current regulatory sources, semi-structured interviews with professionals who had expertise in fields relating to psychedelic-assisted therapy and a framework analysis to generate a taxonomy of relevant regulatory matters. In relation to each matter, we further identified what type of regulation (if any) currently applies to that matter, any uncertainty as to how the matter should be addressed in clinical practice in the context of current regulation and whether there are conflicting views as to how the matter could or should be further regulated. Results: The taxonomy is structured into six main regulatory domains, three of which have a substantial proportion of matters with uncertainty or conflicting views: Service Establishment, Practitioner, and Treatment Delivery. Key examples of such matters include the location of services and facilities required, which professionals are eligible to become psychedelic therapists, and with what qualifications and experience. Matters in the remaining three domains, Patient Evaluation, Drug Supply and Service Oversight, appear by comparison relatively settled, with regulation either well-established or thought unnecessary. Conclusions: The taxonomy provides a roadmap for health services establishing and implementing a psychedelic-assisted therapy program, or for government and other policymakers when determining areas that may require further regulation.