On February 3, 2023, Australia’s Therapeutic Goods Administration (ATGA), a medical authority under the Department of Health and Aged Care, announced a change to the country’s regulatory classification of psilocybin and methylenedioxymethamphetamine (MDMA), allowing the compounds to be prescribed by psychiatrists for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD), respectively. The decision was made after the government determined that there was sufficient medical and scientific evidence to support the conclusion that the substances will be beneficial for these conditions. This dramatic change makes Australia the first major country to legalize the therapeutic use of these substances.
Similar to the United States’ oversight pursuant to the Controlled Substances Act (CSA), Australia regulates psychoactive substances using a complex framework of scheduling called the “Poisons Standard”. The Poisons Standard is maintained by the ATGA (in the U.S. this takes place through the U.S. Drug Enforcement Administration in coordination with the U.S. Food and Drug Administration), which is mandated with maintaining and updating the Standard with public input. Unlike the CSA, the Poisons Standard utilizes nine rather than five schedules, with Schedule 9 including “Prohibited Substances.”
As a result of the change by the ATGA, after July 1, 2023, MDMA will be allowed to be prescribed for the treatment of PTSD, and psilocybin similarly will be allowed to be prescribed for the treatment of TRD. Specifically, both substances will be moved from Australia’s Schedule 9 (which are almost entirely prohibited) to Schedule 8 “Controlled Drugs” (i.e., requiring a prescription), giving authorized psychiatrists the legal ability to prescribe MDMA and psilocybin for these limited purposes.
At this time, there are no medical products containing MDMA and psilocybin that have been approved by the ATGA, and psychiatrists will only be able to prescribe MDMA and/or psilocybin in Australia if they satisfy the following conditions: (1) the psychiatrist has obtained approval from a Human Research Ethics Committee that is registered with the National Health and Research Council of Australia; and (2) the psychiatrist has obtained approval from the ATGA.
It is important to note that, outside of the therapeutic access structure described above, psilocybin and MDMA will continue to be classified and regulated as Schedule 9 “Prohibited Substances”. Accordingly, the nonprescribed possession, use, and transfer of MDMA or psilocybin remains illegal in Australia. Schedule 9 compounds are only permitted to be used for medical and scientific research, including clinical trials.
While Australia’s change in its regulatory approach to psychedelics will not have a direct impact on the U.S. regulation of psychedelics, its progressive decision comes at a time when there is a great hope for the future of U.S. federal psychedelics policy reform. Among other recent U.S. federal developments, on May 13, 2022, the Substance Abuse and Mental Health Services Administration (SAMSHA) under the U.S. Department of Health responded to requests from legislators in the House of Representatives to engage in more research into the possible medical uses of these substances. In their response, SAMSHA directly agreed with the Representatives, stating that “SAMSHA . . . is exploring the prospect of establishing a Federal Task Force to monitor and address the numerous complex issues associated with emerging substances,” and that “collaboration across federal agencies with outside stakeholders will be the most effective way to ensure we are thoughtfully coordinating work on . . . MDMA and psilocybin.” While a task force has not yet been created to date, the statement shows a willingness of the current U.S. administration to advance scientific and medical research into the therapeutic value of psychedelic substances.
In addition, a new caucus dedicated to pushing for greater federal funding into research on medical uses of psychedelics has been created in the U.S. Congress. This caucus, now known as the “Psychedelics Advancing Therapies” (PATH) Caucus, intends to ensure that greater attention is given to candidates of both political parties that seek to advance psychedelics policy reform in the United States.
Thank you to our legal extern, Nick Glezman, from the University of Denver Sturm College of Law for his assistance with this research. This article contains general educational information – it is not to be interpreted as a legal opinion or legal advice.
