CANBERRA — In an Australian psychedelic-assisted therapy session, the person most responsible for what happens if a patient’s mind goes somewhere dangerous can now walk out partway through. That is the practical effect of a rule change from the Therapeutic Goods Administration, and it has split the clinicians who run the country’s world-first program roughly down the middle.
Since 2023, Australia has allowed authorised psychiatrists to prescribe MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression, the first national regulatory pathway of its kind anywhere in the world. Under the original rules, the prescribing psychiatrist had to remain physically present for the entire session, from the moment the drug was administered through however many hours the experience lasted. The TGA has now dropped that requirement. A session can proceed with a single AHPRA-registered health practitioner in the room, which can mean a clinical psychologist, a general doctor, a mental health nurse or an occupational therapist, alongside a second staff member, with the authorised psychiatrist no longer obligated to stay for the duration.
The Royal Australian and New Zealand College of Psychiatrists has not been quiet about what it thinks of that change. In a formal letter to the regulator, the college said removing the requirement for a psychiatrist’s continuous presence poses what it called an unjustifiable risk to patient safety, a phrase precise enough that it reads less like professional caution and more like a warning the college wants on the record before something goes wrong.
The stakes are not hypothetical. Psilocybin and MDMA sessions can trigger transient anxiety at the mild end and, at the severe end, psychosis, paranoid delusions or hallucinogen persisting perception disorder, a condition in which visual disturbances from the drug experience do not fully resolve. Through the end of 2025, Australia’s program had treated 65 psilocybin patients and 123 MDMA patients with zero officially reported adverse events, a clean record that sounds reassuring until set against a separate multi-country study finding that roughly one in three past-year psychedelic users report some adverse effect. The gap between those two numbers is not necessarily a contradiction. It may simply mean Australia’s small, closely watched cohort has not yet had the case that tests the system, and system is precisely the word RANZCP is using in its objection.
Not every clinician working in the field sees the old rule as the safeguard RANZCP describes. Some researchers have argued for years that requiring a psychiatrist’s continuous physical presence made the therapy prohibitively expensive and functionally inaccessible outside a handful of major cities, a critique that a peer-reviewed analysis published this year in the Australian and New Zealand Journal of Psychiatry laid out in granular detail. By last August, only twelve psychiatrists nationwide were authorised prescribers, treatment can cost upwards of twenty thousand dollars per patient with no Pharmaceutical Benefits Scheme or Medicare coverage, and the layered approval structure has concentrated prescribing capacity inside major urban academic institutions, leaving patients elsewhere with essentially no path to the treatment at all. That paper’s authors were not arguing for less oversight. They wanted a national training accreditation board, a centralised adverse-event registry and expanded eligibility for other prescribers working under structured supervision, a more complicated system rather than a looser one.
That is the tension the TGA’s change has actually stepped into. Both camps agree the current program has real problems. They disagree, sharply, on whether the fix is to widen who can safely run a session or to keep the psychiatrist chained to the chair regardless of cost. The regulator picked the first answer without waiting for the registry, the accreditation board or the centralised safety data the researchers said should come first.
The pattern is not unique to psychedelics or to Australia. The FDA’s decision to let Zyn nicotine pouches carry a lower-risk marketing claim came weeks after the agency ousted the commissioner who had resisted a similar industry-friendly loosening, and Australia’s own drug-access system has been absorbing its own pressures this year, as the looming withdrawal of the opioid dependence drug Sublocade has shown. In each case, a regulator loosened or reshuffled a safeguard while the clinicians closest to patients were still arguing the evidence was not ready for it.
What nobody currently has is real-time data on what the new rule actually produces. Adverse events in Australia’s program are reported to the TGA biannually rather than continuously, which means the first hard evidence of whether unaccompanied sessions are producing more crises, fewer, or no measurable difference at all will not surface for months. Until then, the disagreement between a professional college warning of unjustifiable risk and researchers arguing the old system priced out the patients who needed it most will keep playing out in the same rooms the psychiatrists can now choose to leave.
