Due to the strict safeguards in place, we are advising consumers that it may be some time before treating psychiatrists have the necessary approvals and supplies to commence MDMA and psilocybin treatment of certain mental illnesses. There are strict controls on importation and supply of these products.
Since 1 July 2023, psychiatrists can be authorised to prescribe products containing 3,4‑methylenedioxy‑methamphetamine (MDMA) or psilocybin for use in psychedelic assisted psychotherapy to treat specific mental health conditions.
MDMA may be prescribed for the treatment of post-traumatic stress disorder (PTSD). Psilocybin may be prescribed for treatment-resistant depression (TRD). For these specific uses, psilocybin and MDMA have been listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard.
To be able to prescribe MDMA or psilocybin for these conditions, a psychiatrist must be an Authorised Prescriber (AP) under the TGA's Authorised Prescriber scheme. Before seeking approval to be an AP, the psychiatrist must first obtain approval from a Human Research Ethics Committee (HREC).
As psychedelic assisted therapies are not well established, the controls under the AP scheme will ensure the safe and appropriate use of MDMA or psilocybin. Psychiatrists will need to show they have the necessary training, competency and robust evidence-based treatment protocols that appropriately control the risks to patients.
We do not expect widespread prescribing of MDMA or psilocybin as the treatments are limited to those with specific mental health conditions who have been resistant to approved treatments. Psychiatrists will continue to first consider treatment with approved medications included on the Australian Register of Therapeutic Goods (ARTG).
Before patients for whom approved medicines are not effective can receive MDMA or psilocybin treatment, psychiatrists must carefully assess whether the benefits are expected to outweigh the risks in those patients.
The Royal Australian and New Zealand College of Psychiatrists (RANZCP) has developed guidance for psychiatrists to help prevent adverse outcomes for patients prescribed MDMA and psilocybin. As the evidence base for these therapies is evolving, the guidance will be reviewed and updated as more data, and the experiences of psychiatrists and patients, become available. We will continue to work with the RANZCP to monitor the safety of these treatments outside clinical trial settings.
There are also strict Commonwealth and state or territory regulations that apply to anyone seeking to import, manufacture or supply MDMA or psilocybin as Schedule 8 medicines for authorised psychiatrists to give to their patients. These regulations are stricter than for most Schedule 8 medicines.
Importers and manufacturers must be appropriately authorised by law before importing or manufacturing MDMA or psilocybin for supply to an AP. This includes obtaining the necessary licences and permits from the TGA or the Office of Drug Control and ensuring that any authorisations to deal with Schedule 8 medicines, which may be required under the relevant state or territory law, are granted.
In July 2023, we will publish additional guidance for those seeking to deal with MDMA or psilocybin as Schedule 8 medicines to assist them in complying with the restrictions that are in place.
