Media Release: 16th December 2021
TGA Rescheduling of Psilocybin and MDMA: Delegate’s Final Decision
On December 15th, the Therapeutic Goods Administration (TGA) announced the Delegate’s decision to not reschedule psilocybin and MDMA from Schedule 9 (Prohibited Substances) to Schedule 8 (Controlled Medicines) of the Poisons Standard.
The Delegate’s decision states that:
“Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and not amend the current Poisons Standard in relation to psilocybin [and MDMA]”
Citing research published by Dr Martin Williams, the Executive Director of PRISM, and colleagues, the decision notes that the Delegate “agree[s] with the findings from a paper published with the Australian clinical context in mind (referenced in a public submission in response to the Expert Report and interim decision) that translation from a clinical trial setting to the community will depend on adequate expertise, procedures and ethical standards”
Commenting on the TGA announcement, Dr Williams said:
“PRISM’s initial submissions in response to the rescheduling applications for psilocybin and MDMA stated partial support, contingent upon the accumulation of an acceptable level of research evidence and the subsequent development of an expert-led implementation framework. While excellent late-phase clinical research is ongoing around the world, and the results so far have been very promising, we agree that the standards of evidence required for formal approval and implementation still need to be met.
“Our firm support for the eventual rescheduling of psilocybin and MDMA, alongside inclusion on the Australian Register of Therapeutic Goods, is based on the emerging evidence from local and international research demonstrating that these drugs may be used as safe and effective adjuncts to psychotherapy in the treatment of refractory mental illness. Meanwhile, Australian research needs to be conducted to ensure successful implementation in the local environment, to engage our medical community, and to pave the way towards appropriate training and accreditation of Australian mental health professionals in this game-changing area of mental health practice.”
Fellow PRISM Director, Dr Stephen Bright, stated:
“My concern was that the application for rescheduling, as submitted, did not go far enough to ensure adequate clinical governance for the use of these powerful therapeutic drugs.
“Without an established and integrated system of clinical governance for the provision of psychedelics, rescheduling alone may open the door to unsafe and unethical practices. Appropriate training in this novel and paradigm-changing approach is still broadly lacking, even among mental health professionals.”
Melissa Warner, Secretary of PRISM, added:
“This process has sparked vital discussion on how to implement psychedelic medicines safely. This is an important forward step in the ongoing conversation with the TGA, and we fully support its process of consultation and inclusion.
“The successful 109 Ballot in Oregon (USA) and its two-year implementation plan is a leading example of how to approach the development of a legal framework for psychedelic-assisted therapy through regulatory oversight, expert consultation and collaborative planning. The process of implementing a new and radically different therapeutic model deserves a nuanced and considered approach.”
About PRISM
Psychedelic Research in Science & Medicine (PRISM) Ltd is a DGR-1 Health Promotion charity, established in 2011 to initiate, coordinate, and support formal research into the applications of medicinal psychedelics and related technologies. PRISM is globally connected and provides scientific expertise for clinical trial and technology development for medicinal psychedelics and consciousness research. PRISM supports clinical research for the treatment and prevention of conditions for which current therapies provide limited relief.
Not-for-profit organisations such as PRISM in Australia, alongside MAPS and Usona in the USA, have been initiating, funding and communicating research examining the effectiveness of psilocybin and MDMA in combination with psychotherapy to treat a range of mental health conditions. Our aim is to support clinical research and governance within the Australian healthcare system, so it has the capacity to provide this treatment.
For more information, please visit: www.prism.org.au
Please note the following are available for interview:
- Dr Martin Williams, PRISM Executive Director (Monash University)
- Dr Steve Bright, PRISM Director (Edith Cowan University)
- Melissa Warner, PRISM Secretary (University of Melbourne)
For further information, or to arrange an interview, please contact Dr Martin Williams, Dr Steve Bright or Melissa Warner: martin@prism.org.au , steveb@prism.org.au, melissa@prism.org.au
