Big, if True: Did Australia Legalize MDMA and Psilocybin?

Has Australia legalized MDMA and psilocybin?

No. It’s not that simple. The TGA in Australia only changed its policy to allow for the use of MDMA for PTSD and psilocybin for TRD by government-registered psychiatrists. No other psychedelic substances or mental health conditions are being considered at this time.

Will MDMA and psilocybin be available to just anyone?

No. MDMA and psilocybin will only be prescribed by medical practitioners who are also Authorized Prescribers. Authorized Prescribers, must obtain written informed consent from each patient, arrange for supply of the drug, monitor the patient during and after treatment, and report any adverse events.

Will the Australian government be supplying MDMA and psilocybin?

No. Prescribers will acquire MDMA and psilocybin from companies, called “sponsors,” seeking approval of the substances. Sponsors will monitor the use of the “unapproved” goods, and report adverse events and product defects to the TGA. Sponsors must also provide biannual reports to the TGA on drug supply.

Will MDMA and psilocybin be rescheduled in Australia?

Yes, but not by much. MDMA and psilocybin will be reclassified in the Australian drug schedule from Schedule 9 to Schedule 8, but only for the purposes of the APS. Schedule 9 lists substances that have a high potential for misuse and abuse. In Schedule 8, both MDMA and psilocybin will be permitted for human therapeutic use but maintain restrictive regulatory controls on their availability.

Is Australia the first to allow psychedelic-assisted therapies?

No. Israel, the United States, and Canada have programs for psychedelic-assisted therapies to treat mental health conditions. These countries are allowing the use of “unapproved” (pre-approval) substances outside of clinical trials for people who are not responding to approved treatments for intractable conditions. This is commonly referred to as “compassionate use.” 

Distinctions in Australian MDMA and Psilocybin Policy

The Therapeutic Goods Administration (TGA) in Australia recently announced a new policy allowing for the limited use of psychedelic-assisted therapies in the treatment of posttraumatic stress disorder (PTSD) and treatment-resistant depression (TRD) through an Authorized Prescriber Scheme (APS). The news has been met with excitement around the world from drug policy reformers. We’ve received lots of questions about it, so we’ve put this policy decision in context to understand its possible impact.

In MAPS’ release, we wrote that because the US, Israel, and Canada have all permitted the use of some psychedelic(s) for what is often called “compassionate use,” Australia is the fourth nation to take comparable action. We use the umbrella term “compassionate use” because each national jurisdiction uses different processes and language to achieve similar outcomes: providing access outside of clinical trials to unapproved drugs, based on the existence of some evidence of efficacy and safety for patients with particularly intractable conditions or conditions not responsive to currently approved treatment options.

Like the U.S. Controlled Substances Act, Australia’s drug control system includes schedules (from 1 to 9) for drugs with special rules governing their supply, distribution, prescription, and use. Unlike the United States, where Schedule 1 is the most restrictive, Australia’s is the opposite where 9 is the most restrictive. The TGA’s recent decision moves MDMA and psilocybin — solely for the purposes of the APS — from schedule 9 into schedule 8, which creates an opportunity for a prescriber to apply for permission to access the presently-unapproved drugs for specifically enumerated conditions (PTSD and treatment-resistant depression, respectively) for a certain class of patients. This scheme is related to (and often conflated in the media with) the Australian Special Access Scheme (SAS), which lets prescribers request permission to access an unapproved drug on a single, patient-by-patient basis. 

The single-patient SAS is comparable to Canada’s Section 56(1) exemption process whereby prescribers seek exemptions from certain drug controls to provide a single patient with an unapproved drug. For comparison, in the U.S. “compassionate use” is provided for on a limited basis via Expanded Access and Right-to-Try schemes, with varying levels of regulatory involvement as well as burdens on the provider and supplier. In 2019, Israel’s Health Ministry allowed for compassionate use of MDMA, a policy change that permitted MAPS PBC to conduct part of its Phase 3 MDMA-assisted therapy for PTSD research there.

Under the TGA APS for psilocybin and MDMA, interested psychiatrists will need to apply to become an authorized prescriber based on rigorous eligibility requirements, including the training in an acceptable treatment protocol (no protocols approved by the relevant authorities currently exist), and be approved by a Human Research Ethics Committee (HREC) or the College (the Australian equivalent of a Board) before being approved as an Authorized Prescriber. Importantly, psychiatrists who have been authorized to prescribe the substances under the AP scheme are required to comply with the relevant legislation of the state or territory in which they practice.

It is unclear, this early on, what protocol characteristics may be required to approve an application. The relevant HREC’s and the TGA may require additional aspects, such as exhaustion of existing treatment options, to approve an authorization.

In our experience, therapeutic support is a critical element of MDMA- or psilocybin-assisted therapy. We are eager to see how Australia’s researchers, regulators, and providers develop infrastructure for training and appropriate provision of care for patients who are eligible to access psilocybin or MDMA under the APS. 

We are encouraged by the TGA decision and are hopeful that it continues to work collaboratively with providers, manufacturers, and prospective patients to implement a safe, effective and successful program.

NOTE
The safety and efficacy of psychedelic-assisted therapies are currently under investigation. No psychedelic-assisted therapy has been approved by the FDA or other regulatory authorities; no therapy works for everyone; and all therapies, even in clinical settings, carry risks.