Two countries, two different approaches to the use of medical psilocybin
- Anish Marella
- 2 days ago
- 10 min read
Written by Anish Marella
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.
It was not intended as a one-off exception, however. By mid-2026, uptake remained cautious: a second doctor had gained approval, a dedicated training course had begun upskilling a further cohort of clinicians, and only around ten private patients had been treated. Regulation 22 nonetheless functions as a standing pathway rather than a single dispensation, and in July 2025 Medsafe published formal application guidelines so that other qualifying practitioners could seek the same approval, each assessed case by case on patient safety and the prescriber’s experience. Drug Science advises anyone interested in becoming a psychedelic practitioner in New Zealand to undertake the PsyTrain training program.
Two models, two starting points
Both countries now permit prescribing psilocybin outside of clinical trials, arriving there by different routes: Australia rescheduled the substance itself, while New Zealand left its drug classification untouched and instead used an existing provision to approve one named practitioner. One approach changed the category; the other made a narrow exception within it. Both managed to become among the first countries in the world to move psilocybin from the clinical trial/research setting into clinical care.
Going first: the issues neither model has fully solved
Being a first mover means building the road while driving on it, and both countries are encountering the same underlying challenge from different angles: the science behind psilocybin’s benefits has outpaced the systems needed to deliver it well. Neither has yet to answer the questions that only surface upon real-world implementation: how to assure consistent quality of the therapy itself, rather than just the drug; how to monitor outcomes across scattered providers; how to integrate a wholly novel treatment into mental-health systems built around very different medicines; and how to generate enough real-world data to keep refining the model.
Each system also carries issues unique to the access pathway it chose. In Australia, rescheduling the substance created access in principle, but left the surrounding infrastructure to catch up. By late 2024, roughly ten psychiatrists had been authorised, rising to around 13 by September 2025. No psilocybin products had been listed on the Australian Register of Therapeutic Goods, and thus clinics must rely on imported formulations available under specific exemptions. A course of treatment is also not insured by the Pharmaceutical Benefits Scheme or Medicare, and costs roughly AUD $20,000 to $35,000. Legal access and real access, as it showed, were not the same thing.
New Zealand’s approach produces the opposite shape of problem: because it works through a practitioner-specific approval, access is controlled and consistent but also extremely narrow, resting on individual approvals that must be sought one at a time.
Workforce and fidelity: the part the drug can’t do
The reality of psilocybin is that, unlike paracetamol, you cannot simply take it home with instructions to “take two and call me in the morning.” Instead, it must be delivered as part of a carefully structured therapeutic programme in which the medicine is only one component of the treatment. Therapeutic outcomes depend heavily on the quality of patient preparation, the support provided during what can be a long and psychologically demanding dosing session, and the integration work that follows. Therefore, enormous caution is placed on the competence of the clinicians delivering the therapy.
Australia still lacks a nationally standardised training framework, leaving education fragmented and largely in private hands, which makes consistent quality hard to guarantee. There is also the debate about what good preparation even looks like. One study found that Australian psychologists see lived experience with psychedelics as valuable for building empathy and rapport and enhancing insight and credibility, but not as something that should be mandatory. Instead, the consensus favoured strong encouragement rather than a prerequisite. What clinicians did consider non-negotiable was formal training, supervision, robust consent and the systematic monitoring of outcomes and adverse events, the latter which lets the field learn from itself as it scales.
Whose medicine is it? The Indigenous question
There is also an ethical dimension that sits beneath all of the regulatory detail, and it is easy to miss if psilocybin is treated purely as a pharmaceutical. Psilocybin-containing mushrooms and related plant medicines have been used within Indigenous healing and ceremonial traditions for centuries, long before Western clinical trials measured them on depression-rating scales. As these substances are absorbed into commercial, biomedical systems, Indigenous communities have raised concerns, not limited to but including:
traditional knowledge being appropriated and commodified
traditional medicines being patented
the principle of free, prior and informed consent going unhonoured, and
an economic asymmetry in profits earned by Western facilitators compared to Indigenous practitioners.
In other words, the worry is not abstract: it is that a healing practice can be extracted from the communities that originated them without providing anything in return.
New Zealand brings this into unusually sharp focus, because the tension is written into the law itself. Under the Misuse of Drugs Act 1975, tangata whenua (Indigenous people of the land) are prohibited from using native Psilocybe species as traditional medicine, a position that conflicts with the Crown’s obligations to protect the Māori (the indigenous Polynesian peoples of Aotearoa). The Māori perspective of health treats wellbeing as four interconnected walls of a house: spiritual (taha wairua), mental and emotional (hinengaro), family and social (whānau) and physical (tinana), offering a model of healing that the narrowly biomedical, symptom-focused clinical protocols rarely accommodate. The practical question this raises is whether emerging services are designed with Indigenous communities and worldviews or simply around them.
Building psychedelic medicine responsibly, then, means more than safe dosing and good paperwork; it means treating knowledge systems as genuine contributors to how care is designed, rather than as historical background or raw material to be drawn on.
Australia and New Zealand both show that changing a drug’s legal status, or working around it, is only the first step in translating psychedelic science into care. The long-term success of psilocybin-assisted therapy will depend on whether health systems can build the scientific, clinical, ethical and regulatory infrastructure to deliver it responsibly, sustainably and equitably.
What the UK can learn
For the UK, the picture looks different again: psilocybin remains a Schedule 1, Class A substance under the Misuse of Drugs Act 1971, and clinical access is currently confined to trials. In December 2023 the Advisory Council on the Misuse of Drugs recommended freeing Schedule 1 research from Home Office licensing; the government has yet to respond, and no proposal exists regarding the question of clinical access. Two routes to access remain under discussion: rescheduling to Schedule 2, mirroring the 2018 change for cannabis-based products for medicinal use, which would allow clinicians on the GMC Specialist Register to prescribe psilocybin as an unlicensed medicine, or "special", as they do now with cannabis. The other route, the conventional route, is full MHRA marketing authorisation following completed clinical trials, which adheres more neatly to the regulatory pathway for licensed medicines, but is measured in years rather than months.
Either route would meet further obstacles that neither Australia nor New Zealand has had to fully resolve: reimbursement. NICE's health technology assessment (HTA) framework is built around evaluating a single pharmacological product against a comparator, and psychedelic-assisted therapy does not fit that model cleanly. Psychedelic-assisted therapy constitutes a ‘complex intervention’ whereby the drug and the psychotherapy that surrounds it are not separable components. This is compounded by the fact that European HTA bodies generally require trials against an active comparator rather than placebo to establish added therapeutic value, which standard psychedelic-assisted therapy trials have found difficult to meet. Without a bespoke methodology for assessing this kind of intervention, NICE guidance, and the funding decisions that follow from it, will be difficult to produce.
Australia and New Zealand suggest that the choice of legal route matters less than the preparation for implementation: whichever path the UK takes, it will be confronted by the same public health requirements already visible abroad; a funding model that does not restrict access to those who can pay privately, a standardised training framework, an outcome-monitoring database considered from the outset, and a HTA process capable of assessing a combined drug-and-therapy intervention. Deferring the required infrastructure until the legal question is resolved is the same sequencing error Australia and New Zealand are now attempting to correct in hindsight. This is something Drug Science is attempting to resolve through its ‘Evidence 2 Implementation’ project in collaboration with revered individuals, institutions and parliamentarians. Advocating for a collaborative review of the gaps that currently exist and the bridges required within and across regulatory and legal organisations, so that the UK can provide psilocybin treatment within months not years of regulatory approval.
