Psilocybin is a naturally occurring psychedelic prodrug compound produced by more than 200 species of fungi. Commonly found in tablet or crystal form, MDMA is a potent psychoactive drug with stimulant properties that produces experiences of empathy and sympathy. Both are currently prohibited in Australia, but will soon be available for therapeutic use. In so doing, Australia will position itself as among the first countries to provide a legal pathway to psychedelic therapies.
Medicines and other therapeutic products are regulated nationally in Australia by the Therapeutic Goods Administration (TGA). Using a scheduling system, the TGA classifies medicines and chemicals and controls how they are made available to the public.
Substances are classified into Schedules according to the level of regulatory control over their availability that is considered necessary to protect public health and safety.
The Schedules are published in the Poisons Standard and are given legal effect through state and territory legislation. The Poisons Standard is a record of decisions made by the TGA on the classification of medicines and chemicals into the Schedules. Schedule 8 concerns controlled drugs, being medicines thought to require strict legislative controls, such as opioid analgesics. Schedule 9 is for prohibited substances, which are those considered to have no therapeutic use while also being open to abuse, such as heroin. Presently, psilocybin and MDMA are both Schedule 9 prohibited substances. The use of Schedule 9 substances is limited to authorised research and analytical purposes.
On February 3rd 2023, the TGA published an amendment to the Poisons Standard that will take effect on July 1st 2023. From that date, psilocybin may be used for treatment-resistant depression (TRD) and MDMA may be used for post-traumatic stress disorder (PTSD). For those purposes, respectively, the substances will be controlled drugs classified in Schedule 8. For all other purposes, they will remain prohibited in Schedule 9.
From July 1st 2023, each substance may be prescribed or supplied, for the permitted purpose, only by a medical practitioner with an authority governing that substance. They may also be used in approved clinical trials. Only psychiatrists with the necessary authority are considered by the TGA to have the training and expertise to diagnose and appropriately treat the relevant conditions. In Australia, a consultation with a psychiatrist generally requires a referral from a general medical practitioner.
The reclassification of certain uses of psilocybin and MDMA occurred because the TGA concluded that the benefits to patients and public health now outweigh the risks, even though there are yet no established treatment protocols. The TGA regards the reclassifications as aligned with the current body of clinical evidence, which is limited to TRD for psilocybin and PTSD for MDMA. The body of evidence demonstrating efficacy of these substances for the treatment of other conditions is considered insufficient to justify increased access for therapeutic use.
In its decision, the TGA noted that therapeutic uses of psilocybin and MDMA are largely prohibited outside clinical trials in many countries, including Canada, New Zealand, the U.K., and the E.U. Nonetheless, the TGA conceded that therapeutic uses of these substances are under review in many countries, including the US, where the FDA has designated MDMA as a “breakthrough” therapy for TRD.