Australia approved the use of psilocybin for treatment-resistant depression in 2023, becoming the first nation to formally integrate the drug into clinical practice. New Zealand, by contrast, kept psilocybin as a Class A controlled drug and confined it almost entirely to research until mid-2025, when it opened a single, tightly bounded route to clinical prescribing without changing the drug’s legal status. Australia’s reform in particular offers an opportunity to examine not simply whether legal change expands access, but whether a health system can translate a national rescheduling into safe and effective clinical practice. In both countries, though, the lesson points the same way: shifting a drug’s legal status, or working around it, is only the beginning, and the greater challenge lies in developing the clinical infrastructure, regulatory oversight, workforce capacity and ethical safeguards required to deliver psychedelic-assisted therapy responsibly.
Australia: a national pathway, built fast
In July 2023, Australia’s Therapeutic Goods Administration rescheduled psilocybin from a Schedule 9 (prohibited) to Schedule 8 (controlled) drug, specifically for treatment-resistant depression, a world first that positioned the country as a deliberate leader in psychedelic policy. The decision was unusual in its mechanics. Scheduling changes are normally made by a TGA delegate acting on advice from the agency’s expert committee, the Advisory Committee on Medicines Scheduling (ACMS), after public consultation. In this case the committee had recommended against rescheduling and an earlier interim decision in 2020 had rejected it, yet the delegate’s final determination reversed course, resting largely on an independent expert panel review and roughly 3,500 public submissions that were, on inspection, mostly individual opinion rather than expert evidence. It was in this sense a ‘delegate-only’ decision, and it landed in a health system whose clinical infrastructure was not yet built to receive it. Rescheduling, in other words, ran ahead of readiness, which is precisely why it is critical to read beyond the legal headline and examine the implementation story.
The reform did not create open access to psilocybin, but rather a tightly controlled prescribing channel. Only psychiatrists who are Fellows of the Royal Australian and New Zealand College of Psychiatrists and registered with the Australian Health Practitioner Regulation Agency can apply to become Authorised Prescribers of psilocybin. Each applicant must clear a layered approval chain: Human Research Ethics Committee approval of a detailed clinical protocol, then TGA authorisation via the Special Access Scheme and Authorised Provider system, then any state or territory poisons permissions, with a required biannual reporting of patient numbers and adverse events. Eligible patients are adults with treatment-resistant depression (where “resistance” means documented failure of at least two prior treatments, one of which must be an adequate course of a registered medicine) and not considered high risk (e.g., no personal or family history of psychosis).
New Zealand: caution, then a single crack in the door
For most of recent history, New Zealand had no legally accessible prescribing route for psilocybin. Psilocybin remained a Class A controlled drug under the Misuse of Drugs Act 1975, leaving clinical trials as effectively the only legal way to access it. This precautionary stance sits alongside a backdrop of considerable unmet need: an estimated 8.8% of adults reported needing but not receiving mental health support in the twelve months prior to the New Zealand Health Survey (2021/22). Psychedelic use in the country rose from 2.0% in 2018/19 to 3.1% in 2023/24, producing a recognised phenomenon of Kiwis self-administering psychedelics for therapeutic purposes, typically sourced from illicit markets or by foraging.
Then, in June 2025, Medsafe, the medicines regulatory body, granted a single psychiatrist the first-ever approval to prescribe medicinal psilocybin for treatment-resistant depression outside of a research setting. Approval was given through Regulation 22 of the Misuse of Drugs Regulations 1977, which permits Medsafe to approve specific practitioners to prescribe, supply, and administer otherwise-restricted psychedelic drugs for a defined clinical purpose. As such, the approval is practitioner-specific: it applies only to that one psychiatrist. They must use pharmaceutical-grade products, take personal responsibility for sourcing and quality, work to a defined, independently peer-reviewed treatment protocol covering screening, consent, dosing, rescue medication and follow-up, with ongoing record-keeping and reporting to Medsafe.
