A Medico-Legal Perspective of Psilocybin and MDMA Expanded Access Approvals in Australia

Introduction

The evolution of psychedelic medicine regulation in Australia has been shaped by multiple administrative and legal considerations. One of the most significant historical records in this progression is Freedom of Information (FOI) request 4104, which provides official documentation of Special Access Scheme-B (SAS-B) approvals for MDMA and psilocybin between January 1, 2018, and November 21, 2022.

This FOI release is not a new development but a historic regulatory record that predates the Authorised Prescriber (AP) model introduced in 2023. It serves as a key administrative law document, providing transparency into the Australian medical regulator, Therapeutic Goods Administration(TGA), decision-making process on psychedelic access before the rescheduling of MDMA and psilocybin in 2023. Importantly, this dataset was one of the two main administrative law bases cited in the rescheduling process, demonstrating how early approvals under SAS-B contributed to the regulatory shift.

This blog presents FOI 4104 as an objective regulatory tool, outlining how SAS-B functioned in facilitating controlled access to non-ARTG-listed psychedelic substances and how these approvals informed broader policy changes.


Understanding the FOI Request: A Record of SAS-B Approvals

FOI 4104 contains information on all applications for MDMA and psilocybin submitted through SAS-B between 2018 and 2022. SAS-B is a regulatory pathway that enables access to unapproved therapeutic goods on a case-by-case basis, comparable to Canada’s Special Access Program. Unlike clinical trials or general market availability, SAS-B approvals are issued for specific patient cases under medical supervision.

The FOI data confirms that all applications lodged under SAS-B for these substances were granted, with a total of 17 approvals:

  • New South Wales (NSW): 15 approvals
  • Victoria (VIC): 2 approvals

While the number of applications was relatively low, these approvals represent early regulatory precedents that shaped Australia’s approach to psychedelic access.

 

The Administrative Role of FOI 4104 in the Rescheduling Process

The rescheduling of MDMA and psilocybin on July 1, 2023 to Schedule 8 (Controlled Drugs) for use by psychiatrists marked a turning point in Australian drug regulation. Prior to this, two main administrative law bases supported the case for rescheduling, one of which was FOI 4104.

This document provided objective evidence that:

  • SAS-B was a functioning regulatory pathway for psychedelic access.
  • The TGA had already granted approvals under existing legal frameworks.
  • The regulatory system was capable of overseeing safe and controlled access to MDMA and psilocybin outside of a clinical trials setting.

By demonstrating that MDMA and psilocybin could be lawfully prescribed under existing mechanisms, FOI 4104 reinforced the case for broader regulatory reform.

 

SAS-B in the Context of Psychedelic Regulation

The FOI 4104 approvals highlight a structured but limited use of SAS-B for MDMA and psilocybin psychedelic access prior to the AP model. Unlike the Authorised Prescriber scheme, which allows ongoing prescribing authority, SAS-B requires individual case-by-case applications and does not create generalised approval for a substance.

This distinction underscores the regulatory function of SAS-B as an early access mechanism, rather than a scalable framework for long-term prescribing. However, its role in setting legal precedents for psychedelic medicine cannot be overlooked.

 

Why FOI 4104 Matters Today

Even though SAS-B approvals for MDMA and Psilocybin are no longer the primary access route following the July 2023 rescheduling, FOI 4104 remains a key document for understanding how Australia transitioned toward formalised psychedelic therapy.

This record:

  • Demonstrates historical regulatory decisions that shaped current policies.
  • Confirms TGA’s administrative approach to evaluating psychedelic substances.
  • Provides transparency into how Australia managed early psychedelic approvals.

By presenting FOI 4104 as an objective tool, this blog highlights its significance not only as a regulatory archive but as a foundation for the policy changes that followed.

 

Conclusion

FOI 4104 is a historic regulatory document that records Australia’s first formal approvals for MDMA and Psilocybin under SAS-B. With 17 confirmed approvals granted before the 2023 rescheduling, this dataset played a critical role in demonstrating the viability of psychedelic access under existing frameworks.

As one of the two main administrative law bases for rescheduling, FOI 4104 helped shape the legal and policy landscape of psychedelic medicine in Australia. While SAS-B approvals for these substances are no longer required under the AP model, this document remains an important reference in understanding Australia’s regulatory evolution.

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