Mind Medicine Australia Urges TGA to Reverse Interim Decision on Psilocybin for End-of-Life Distress

Mind Medicine Australia (MMA) has publicly released a formal objection to the Therapeutic Goods Administration’s interim decision not to extend psilocybin access to terminally ill patients experiencing end-of-life distress. The advocacy charity published the objection on 3 August 2026 under the heading “TGA: Please Reverse Your Cruel Interim Decision”.

The decision MMA wants reversed

The objection concerns an application to amend the Poisons Standard so that psilocybin could be supplied, as part of psychotherapy in medical settings, to patients experiencing existential distress at the end of life. MMA lodged the application together with the End Wise coalition in March 2025, according to MMA’s own account of its TGA engagement.

In an interim decision published in late May 2026, the TGA’s delegate proposed to reject the change. As reported by the Regulatory Affairs Professionals Society (RAPS), the delegate’s stated reasons included that the supporting clinical trials were small and lacked methodological rigour, that a Cochrane review of the evidence found mixed results with high uncertainty, that existential distress is not a recognised diagnostic category in standard psychiatric manuals with no validated diagnostic tools, and that the proposal’s prescriber identification and clinical review pathways were ambiguous. Public comments on the interim decision closed on 3 July 2026.

What MMA argues

In the 3 August release, MMA chair Peter Hunt AM argues that declining to allow the supervised clinical use of psilocybin for dying patients is inconsistent with Australia’s voluntary assisted dying laws, which are now in force in every state. The release also contends that the interim decision overlooks what MMA characterises as the delegate’s own acknowledgment of the therapy’s safety in supervised clinical settings. These are MMA’s arguments as an advocacy organisation with a stated position on this issue; the TGA has not responded publicly to the release.

What happens next

A final scheduling decision remains pending, and the TGA has not published a date for it. Until any change is made, nothing about Australian access has altered: under the Authorised Prescriber scheme, specifically authorised psychiatrists may prescribe psilocybin only for treatment-resistant depression, and MDMA only for post-traumatic stress disorder. Psilocybin is not an approved option in Australian palliative care, and outside the clinical pathway it remains illegal to possess or supply in every state and territory.

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