Psilocybin (the active ingredient of magic mushrooms) and MDMA (the active ingredient in ecstasy) are psychedelic or hallucinogenic drugs that can change how a person sees things and feels.
In 2023, Australia became the first country to allow authorised psychiatrists to deliver psilocybin therapy for treatment-resistant depression and MDMA for post-traumatic stress disorder (PTSD) that hadn't responded to other treatments.
This had to be administered by a psychiatrist, with the clinician remaining in the room during the entire session.
Australia's regulator, the Therapeutic Goods Administration, has now relaxed these requirements. The psychiatrist is now able to leave the room after administering the drug.
A "therapist" is required to be in the room with the patient. This can either be either a clinical psychologist, doctor, nurse with mental health experience, or an occupational therapist. A second staff member is also required.
So how did we get here? And what might happen next?
The 'golden age' of psychedelic research
Some psychedelics have been used for thousands of years in many countries for healing purposes. Other newer substances are made synthetically.
Psychedelic research in the western world started in 1938 when Swiss chemist Albert Hofmann created and subsequently consumed LSD.
The 1940s to 1960s is sometimes called the golden age of psychedelic research . Thousands of studies were conducted on tens of thousands of patients for a range of mental health and other conditions.
However, this research work abruptly ceased in the 1960s due to political pressures, along with tightening regulations on drug research.
Criticisms of psychedelic research at that time also included concerns around small sample sizes in studies, lack of adequate controls, bias and researchers' "exuberant advocacy" of yet-unproven treatment modalities.
Psychedelics had also seeped out of the laboratory at the time when the "war on drugs" was raging.
Psychedelic research effectively stopped in 1967 when these drugs were placed in Schedule 1 of the United Nations Convention on Drugs. This suggested they had no accepted medical use and were a risk for harm and dependence.
What changed in 2023?
Since 2023, a registered psychiatrist who obtained approval under the TGA's Authorised Prescriber Scheme has been allowed to administer MDMA and psilocybin to a patient in their care.
This scheme involves ethical approval to prescribe these substances for their patients.
This therapy is called psychedelic-assisted psychotherapy . The environment where the drug is taken is carefully controlled and the patient receives support throughout the treatment.
Australia's decision to allow psychiatrists to prescribe psychedelics for depression and PTSD seemed to come out of the blue. But it followed strong lobbying by the public and interest groups.
At the time, clinical researchers and specialists questioned the lack of consultation with experts in the field, as many of the guidelines and processes to support access had not yet been developed.
Are they safe and effective?
These treatments have not undergone the usual extensive testing to determine effective doses for different conditions and to properly understand the likely side effects and concerns.
This evidence is typically required for regulatory approval of a medicine and for subsidy in the Pharmaceutical Benefits Scheme (PBS).
Evidence of the efficacy of psilocybin in treatment-resistant depression and MDMA in treatment-resistant PTSD remains limited and mixed.
So the treatments are still considered experimental.
What are the risks?
Side effects can include minor symptoms such as short-term anxiety, an elevated heart rate, nausea and dizziness.
They can include psychosis, paranoid delusions and long-term mood disturbances.
There is also a rare condition called hallucinogen persisting perception disorder . This is where hallucinations return or persist after treatment.
A recent multi-country study found that in people who had used psychedelics in the past year, around one-third had suffered an adverse effect.
However, of the 65 people who accessed psilocybin and 123 who accessed MDMA through Australia's psychedelic-assisted psychotherapy model to the end of 2025, no adverse events were reported. This could be due to patients being appropriately screened and selected, but this is unclear.
Debate about needing a psychiatrist present
The Royal Australian and New Zealand College of Psychiatrists has criticised the removal of the requirement for an authorised psychiatrist be physically present during the psychedelic-assisted psychotherapy.
Although some clinical trials did not require a psychiatrist to be present the whole time, they often included a range of other safeguards for patients that are not in place in private practices.
Other experts have argued that needing to have a psychiatrist in the room made the treatments too expensive and hard to access.
Without medical access, some experts argue , patients would access psychedelics from unregulated illegal sources, with unknown strength and possible contaminants, and greater risks.
Illegally sourcing psychedelics also bypasses important screening steps that check for drug and disease interactions before administration and therapist support throughout treatment.
Beware of hype and commercialisation
Psychedelics have entered clinical practice settings while evidence on efficacy and safety is still incomplete. Providing access to treatments before this data is available is unusual and contrasts with how most medicines are accessed in Australia.
The roll-out of medicinal cannabis in Australia provides a sobering example of what to avoid.
Cannabis manufacturers have been able to run clinics and supply products. This has meant cannabis has been prescribed without the usual checks and balances, or the usual separation between prescribing and supply.
Patients are readily prescribed cannabis when it's not clinically indicated, increasing the potential for harm .
The TGA changes could lead to similar commercialisation of psychedelic therapies. Companies are already increasing production to meet the potential demand for these drugs.
We're also seeing a rise in marketing and advocates overstating the effects of these treatments.
What needs to happen to protect patients?
Possible future safeguards for psychedelics and psychedelic-assisted therapy include:
standardising the training practitioners receive for psychedelic-assisted therapy
a national registry of patient and clinician reports of outcomes, overseen by the TGA. This includes harms incurred during psychedelic-assisted therapy
ensuring regulatory changes are supported by evidence to safeguard patient interest.
Psychedelic research is still in its infancy, and the efficacy of these therapies is still to be proven. Ongoing robust research is required for therapies that could potentially be of benefit to people.
But we need regulation to follow evidence, rather than the other way around. The challenge is striking the right balance between patient access and safety.
Thileepan Naren has received speaking honoraria, travel and conference support from Camurus.
Myfanwy Graham receives funding from the Australian National Health and Medical Research Council. She has received state government and Department of Health, Disability and Ageing funding for independent reviews on medicinal cannabis. She has served as a consultant for the United Nations Office on Drugs and Crime, World Health Organization and U.S. National Academies of Sciences, Engineering and Medicine. She is an appointed member of the Therapeutic Goods Administration's Medicinal Cannabis Expert Working Group. This article does not represent the views of the TGA or the Expert Working Group.
Suzanne Nielsen receives funding from the Australian National Health and Medical Research Council, the Medical Research Future Fund, The Ian Potter Foundation and Jack Brockhoff foundation, and has led work funded by state and federal governments. She has received funding from Worksafe, the Department of Veterans' Affairs and the Therapeutic Goods Administration to provide independent evidence reviews on medical cannabis. She is the president of the Australasian Society for Professionals on Alcohol and other Drugs.
