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Independent Expert Panel on MDMA and psilocybin

Systematic literature review of the therapeutic value, benefits and risks of MDMA and psilocybin for the treatment of mental health conditions

30 September 2021

The Therapeutic Goods Administration (TGA) Scheduling Delegate (decision maker) has deferred the final decision on applications to down-schedule MDMA and psilocybin from schedule 9 (prohibited drug) to schedule 8 (controlled drug) pending a review into the therapeutic value, risks and benefits to public health outcomes for these substances. On 5 August 2021, the TGA announced that an Independent Expert Panel had been established to undertake the review. The review has now been completed and the Panel's report is published below.

Independent Expert Panel Report

An evaluation of the therapeutic value, benefits and risks of methylenedioxymethamphetamine (MDMA) and psilocybin for the treatment of mental, behavioural or developmental disorders.

Timing of final decision

The Panel's report will be considered by the Advisory Committee of Medicines Scheduling (ACMS) at the 3 November 2021 meeting. The Delegate's final decision is anticipated to be published the first week of December 2021.

Terms of Reference

The Independent Expert Panel was established to undertake a systematic literature review of the roles of MDMA and psilocybin for the treatment of mental health conditions.

The review is to report findings on the current state of the evidence of therapeutic value, benefits and risks of MDMA and psilocybin for the treatment of mental health conditions, including the size of effect, the quality of evidence and the applicability of the evidence to real-world use in Australia, currently and into the future.

The review excludes pre-clinical trials (i.e. experimental pharmacology studies in test tube or animal models).

The Panel is not a decision making or approval body, and their role is to provide a publicly available report which will be considered by the delegate and the Advisory Committee for Medicines Scheduling.

Panel Members

Professor Mark Connor

Professor Mark Connor is a molecular pharmacologist with expertise in analgesics and psychoactive drugs, particularly cannabinoids and opioids, with extensive research experience in the USA, UK, and Australia. Currently, his work focuses on the pharmacology of synthetic cannabinoids and the molecular effects of phytocannabinoids.

Professor Connor holds a Bachelor of Science (Hons) and PhD in Pharmacology. He is currently the Associate Dean, Higher Degree Research, Department of Biomedical Sciences, Macquarie University.

Professor Steve Kisely

Professor Steve Kisely is a psychiatrist and public health physician with health services research experience in the UK, Australia, and Canada. He obtained fellowship of the relevant Colleges in the UK, Australasia and Canada, as well as of the Australasian Chapter of Addiction Medicine. He is also an accredited member of the faculties of adult psychiatry, addiction (FAP) and consultation psychiatry (FCLP) of the Royal Australian & New Zealand College of Psychiatrists.

Professor Kisely holds a Doctor of Medicine (Research Doctor of Philosophy and Doctor of Medicine. Professor Kisely is currently Professor of Psychiatry, School of Medicine, The University of Queensland.

Professor Andrew Somogyi

Professor Andrew Somogyi Professor Somogyi is Professor in Clinical and Experimental Pharmacology. He is a practicing pharmacist and has a research program centred on elucidating the mechanisms and factors contributing to altered human drug response in pain therapeutics, infectious diseases, depression, and transplantation through pharmacokinetic, metabolism, pharmacodynamic and pharmacogenomic studies. He is a member of the Editorial Advisory Committee and Company Director of the Australian Medicines Handbook.

Professor Somogyi holds a Certificate of Pharmacy, Diploma of Hospital Pharmacy, Master of Science, and a PhD (Clinical Pharmacology). Professor Somogyi is currently a Professor of Pharmacology, Adelaide Medical School, Faculty of Health and Medical Sciences, The University of Adelaide.

Contact details

For enquiries regarding the review or to contact the Panel please email MDMApsilocybinreview@health.gov.au.