Clarifying the legal landscape of psilocybin regulation: A medico-legal perspective

Authors

Octavian Brinzei

Published

April 28 2025

Introduction

The regulation of psilocybin-assisted therapy (PSILO-AT) has emerged as a pivotal issue in global health policy, with jurisdictions adopting widely varying approaches. Some have instituted medical regulatory frameworks, while others have permitted non-medical access through decriminalisation or legal loopholes. This disparity creates confusion for practitioners, researchers and policymakers seeking to understand the scope of psilocybin's legal status in specific regions.

Federal laws in the United States, Denmark and Canada represent frameworks for restricted medical access, focusing on emergency or special circumstances rather than widespread therapeutic use. Conversely, jurisdictions such as the State of Oregon, the State of Colorado, the Province of Alberta and the Commonwealth of Australia have embraced full medical regulation, providing clear governance for the therapeutic application of psilocybin and PSILO-AT. These differences highlight the complexity of navigating psilocybin regulation globally.

This paper consolidates the laws and decisions underpinning psilocybin's medical regulation, excluding jurisdictions where access is limited to non-medical or decriminalised contexts. By doing so, it aims to create a comprehensive medico-legal resource for understanding psilocybin's International therapeutic governance.

Jurisdictions with comprehensive medical access to psilocybin

State of Oregon, United States

On 3 November 2020, the State of Oregon introduced Oregon Measure 109, a ballot initiative permitting citizens to vote on health policy reform concerning the medical regulation of PSILO-AT (Ballotpedia, 2020). The measure was approved by a majority of 55.75% of voters, leading to the incorporation of provisions for PSILO-AT into Oregon's statutory law1 (Secretary of State, 2019).

Province of Alberta, Canada

On 5 October 2022, shortly after the announcement that PSILO-AT could be made available at the Federal level in Canada, the Lieutenant Governor in Council of Alberta filed an amendment2 to supersede the Mental Health Regulation3 to accommodate for PSILO-AT4 (Alberta Government, 2022). This amendment established medical governance permitting psychiatrists to prescribe PSILO-AT5 (Alberta Government, 2023).

State of Colorado, United States

On 8 November 2022, the State of Colorado introduced Colorado Proposition 122, a ballot initiative allowing citizens to vote on health policy reform concerning the medical regulation of PSILO-AT (Ballotpedia, 2022). The measure was approved by a majority of 53.64% of voters, resulting in the enactment of PSILO-AT into Colorado's statutory law6 (Colorado General Assembly, 2023).

Commonwealth of Australia

On 1 July 2023, the Therapeutic Goods Administration (TGA), Department of Health and Aged Care, Australian Government, amended Federal Australian statutory legislation to establish psychiatric medical standards for prescribing PSILO-AT7 (TGA, 2023).

Jurisdictions with limited medical access to psilocybin

Government of Canada

On 12 December 2020, the Department of Health, Government of Canada, issued a Notice of Intent in the Canada Gazette to restore access to restricted psychedelic substances through Health Canada's Special Access Program (SAP) (Government of Canada, 2020). Following extensive consultation, on 6 May 2022, Her Excellency the Governor General in Council enacted an amendment8 pursuant to the Controlled Drugs and Substances Act9 and the Food and Drugs Act10. This amendment linked Health Canada's proposal to increasing access to the restricted psychedelic drug psilocybin through SAP (Government of Canada, 2021). While the Canada Gazette noted that these amendments could be interpreted as a step towards the legalisation of PSILO-\AT for therapeutic purposes, it clarified that the regulatory changes were intended solely for emergency treatment and implemented medical oversight of PSILO-AT.

Kingdom of Denmark

On 1 January 2022, the Danish Government enacted statutory provisions11 establishing a regulatory pathway for medical access to psilocybin (Ministry of the Interior and Health, 2021). Under this framework, psilocybin12 is restricted to medical and scientific purposes13, with regulatory mechanisms authorising the issuance of licenses to pharmacies, including hospital pharmacies, as well as to dispensing and distributing veterinarians and licensed physicians. These licensees are permitted to prescribe and dispense psilocybin for therapeutic use in accordance with the established guidelines. The authority for approving psilocybin for medical purposes resides with the Minister of Health, acting on the recommendations of the Danish Health Authority14 (Ministry of the Interior and Health, 2019).

United States of America

On 30 March 2023, the United States enacted Federal statutory legislation15 to clarify access to psilocybin for terminally ill patients (Blumenauer, 2023). This legislation establishes a regulatory framework allowing terminally ill patients to access drugs with no currently accepted medical use16, provided these drugs have successfully completed Phase 1 clinical trials. Psilocybin, which has received ‘breakthrough therapy designation’ from the Food and Drug Administration (FDA), United States, falls within the scope of this framework. The FDA is tasked with implementing this Federal scheme, ensuring terminally ill patients have access to psilocybin under the provisions of the Federal Right to Try Clarification Act. The FDA has also released a fact sheet detailing the process for public access to the program (FDA, 2023).

Perspective

Jurisdictions with formal medical regulation of psilocybin demonstrate varying levels of legislative maturity and clarity. In Australia, the TGA recently amended Federal law to allow psychiatrists to prescribe psilocybin for specific psychiatric indications under medical supervision. Similarly, Alberta's amendment to the Mental Health Regulation established governance for psychiatrists to prescribe psilocybin, reflecting a structured approach to medical integration.

In the United States, Oregon and Colorado have pioneered state-level medical regulation, with voter-approved initiatives that fully integrate psilocybin into their respective health systems. These jurisdictions provide models for comprehensive psilocybin governance, encompassing cultivation, distribution and administration within medical frameworks.

At the Federal level, however, the United States has yet to adopt full medical regulation. Access to psilocybin remains limited to specific research or therapeutic contexts under Special Access Schemes, mirroring the frameworks established by Denmark and Canada. Denmark's statutory recognition of psilocybin authorises ‘medical use’ but limits access through licensing requirements for pharmacies and licensed practitioners. Similarly, Canada's SAP facilitates emergency psilocybin access but restricts widespread therapeutic application, emphasising its role as an access mechanism in select cases rather than for general psychiatric prescriptions.

This analysis deliberately omits countries where psilocybin is accessible through non-medical ‘healing retreats’, decriminalisation or legalisation for spiritual and self-growth purposes. These contexts, while important, fall outside the scope of medical regulation and complicate efforts to delineate psilocybin's therapeutic governance.

Conclusion

The global regulatory landscape for psilocybin and PSILO-AT remains highly variable, with significant differences in the scope and clarity of medical governance. By distinguishing between frameworks for restricted medical access and fully integrated medical regulation, this paper seeks to provide a clear, accessible resource for understanding psilocybin's legal status in jurisdictions with approved therapeutic use. Enhanced clarity in this area is essential to support informed decision-making by practitioners, policymakers and stakeholders navigating the complex medico-legal environment of psilocybin regulation.

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