TGA Rescheduling of Psilocybin and MDMA Independent Expert Review Panel Report

PRISM: Psychedelic Research in Science and Medicine 
Media Release: 1st of October 2021

TGA Rescheduling of Psilocybin and MDMA

Independent Expert Review Panel Report 

Today, the Australian Therapeutic Goods Administration (TGA) published an Independent Expert Review Panel report assessing published clinical research evidence related to the proposed rescheduling of psilocybin and MDMA from Schedule 9 (Prohibited Substances) to Schedule 8 (Controlled Medicines) of the Poisons Standard.

The report by the TGA states that:

“We conclude that MDMA and psilocybin may show promise in highly selected populations but only where these medicines are administered in closely clinically supervised settings and with intensive professional support.”

“In most of the studies psilocybin and MDMA were combined with psychotherapy. A major unknown is the degree to which the psychedelic/psychotherapy interaction is dependent on the specific type of psychotherapy administered. This raises the question as to whether clinical practice would need to follow a specific protocol.”

Commenting on the report, the Executive Director of PRISM, Dr Martin Williams, said:

“PRISM welcomes the Independent Expert Review Panel’s report, which is based on an appropriately informed review of the published research literature relating to clinical trials of MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder (PTSD) and social anxiety associated with autism, and psilocybin-assisted psychotherapy for the treatment of anxiety and depression related to terminal illness, and obsessive-compulsive disorder (OCD).”

“PRISM’s initial submissions in response to the rescheduling applications for psilocybin and MDMA stated partial support, contingent on the accumulation of an acceptable level of research evidence and the subsequent development of an expert-led implementation framework. Whilst excellent late-phase clinical research is ongoing around the world, and the results so far have been very promising, we maintain our position that the standards of evidence required for formal approval and implementation still need to be met. 

“Our firm support for the eventual rescheduling of psychedelics, and their 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 Director of PRISM, 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 unethical and unsafe practices. Appropriate training in this novel and paradigm-changing approach is still broadly lacking, even among mental health professionals.

“From this point on, it will be essential that the National Health and Medical Research Council (NHMRC) supports research to ensure that we can maximise the potential benefits to patients while minimising risks. Similarly, it is crucial that the Australian Health Practitioner Regulation Agency (AHPRA) works to develop the appropriate clinical governance to ensure that patients are protected from unethical and unsafe practices that might emerge among those providing service delivery in psychedelic-assisted psychotherapy.”

Melissa Warner, Secretary of PRISM, added:

“This process has sparked vital discussion on how best 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), with 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 merits 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 Ltd in Australia, alongside MAPS and Usona in the USA, have been initiating, funding and communicating research examining the effectiveness of psilocybin and MDMA 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 psychedelic-assisted therapies to those in need of 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 Vice President (Edith Cowan University)
• Melissa Warner, PRISM Secretary (University of Melbourne)

For further information, or to arrange an interview, please contact Dr Martin Williams: martin@prism.org.au (0419 678 918), Dr Steve Bright: s.bright@ecu.edu.au(0414 143 773) or Melissa Warner: melissa@prism.org.au (0415 645 469).