This browser is not actively supported anymore. For the best passle experience, we strongly recommend you upgrade your browser.
Skip to main content
United Kingdom | EN-GB

Add a bookmark to get started

Cortex - Life Sciences Insights

| 1 minute read

World-first: Australia to approve psilocybin and MDMA for the treatment of certain mental health conditions

Australia is the first country in the world to legalise the prescription of psilocybin and MDMA to assist in the treatment of certain mental health conditions, thereby recognising psychedelic substances as medicines.

On 3 February 2023, the Australian Therapeutic Goods Administration (the regulator of medicines and medical devices in Australia) announced its final decisions regarding the scheduling of psilocybin and MDMA. 

Psilocybin is a psychedelic compound that is produced by fungi, which has mind-altering effects, including altering a person’s thinking, sense of time and emotions.  MDMA (3,4-methylenedioxymethamphetamine) is a synthesised psychoactive drug which has effects including increasing an individual’s feeling of empathy and kindness, and feelings of being socially accepted and connected to others. 

From 1 July 2023, psychiatrists authorised under the TGA’s Authorised Prescriber scheme will be able to prescribe medicines containing psilocybin and MDMA for the treatment of certain mental health conditions.

How are psilocybin and MDMA currently regulated?

Presently, both psilocybin and MDMA are listed in Schedule 9 of the Australian Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard).  Substances listed in Schedule 9 of the Poisons Standard are prohibited substances, which are illegal to produce, possess or sell (except when used in medical or scientific research).

What are the upcoming changes and their effects?

From 1 July 2023, psilocybin and MDMA will be re-classified to Schedule 8 of the Poisons Standard. Substances listed in Schedule 8 are controlled drugs, which have restrictions on manufacture, supply, distribution and possession.

The effect is that psychiatrists approved by the TGA will be able to prescribe:

  • psylocibin to patients for the treatment of treatment-resistant depression; and
  • MDMA to patients for the treatment of post-traumatic stress disorder. 

The TGA has indicated that these are the only conditions for which there is sufficient evidence to support the use of psylocibin and MDMA as treatments. 

Presently there are no medicines on the Australian Register of Therapeutic Goods (ARTG) containing psylocibin or MDMA that have been evaluated by the TGA for efficacy, safety and quality. Nevertheless, from 1 July 2023, authorised psychiatrists will be able to prescribe unapproved medicines (not listed on the ARTG) to their patients for the treatment of the above conditions.

The personal possession of psilocybin and MDMA (other than as prescribed for the above conditions) will remain illegal and subject to strict criminal and monetary penalties.

For more industry insights from DLA Piper’s Life Sciences team, click here to subscribe to the sector’s dedicated blog, Cortex.