Rules for Psychedelic-Assisted Therapy in Australia
The Royal Australian and New Zealand College of Psychiatrists (RANZCP) has released its guidelines for psychedelic-assisted therapy (PAT) in Australia, which is set to become legal as of July 1, albeit only under restricted circumstances.
These guidelines will significantly influence how psychiatrists can provide psychedelic-assisted therapy (PAT) in Australia for at least the next 6-12 months. So, it is vital that everyone hoping to provide psychedelic therapy services and allied offerings, such as integration therapy, understand its contents and implications.
In this post, I'll explain the critical guidelines in easy-to-understand terms and suggest some implications for the practice of psychedelic therapy and psychedelics in general in Australia.
How did we get here?
In early 2023, Australia's Therapeutic Goods Administration (TGA) decided to allow psychiatrists to conduct psychedelic-assisted therapy under certain restricted circumstances as of July 1, 2023. This followed a long campaign by nonprofit advocacy groups, most notably Mind Medicine Australia (MMA), and communities to reschedule psilocybin and MDMA to allow better therapeutic access.
Part of the process the TGA set out was that the Royal Australian and New Zealand College of Psychiatrists (RANZCP) had to produce guidance for its members on providing psychedelic-assisted therapy. To this end, they formed the Psychedelic-Assisted Therapy Steering Group, which consists of clinicians and academics, plus one member of the RANZCP Community Collaboration Committee with Lived Experience.
Through the work of this committee and its members who have an interest or experience in research and practice of psychedelic-assisted therapy, the RANZCP has produced clinician resources, including a psychedelic FAQ for psychiatrists and two clinical memorandums: Therapeutic use of psychedelic substances and Therapeutic use of MDMA for PTSD and psilocybin for treatment resistant depression. In the discussion below, I'll focus on the latter, as it's the most recent and most detailed guidance released so far.
A psilocybin session at Johns Hopkins. Source: https://commons.wikimedia.org/wiki/File:Johns_Hopkins_psilocybin_session_room-SessionRm_2176x.jpg
Key Regulations for Psychedelics
Before looking at the clinical considerations, it is worth being clear on the regulations that will be in place and what they mean.
In Australia from July 1 2023, the Therapeutic Goods Administration (TGA) will amend the Poisons Standard to add MDMA and psilocybin, permitting their use as controlled drugs only in Post Traumatic Stress Disorder (PTSD) and Treatment Resistant Depression (TRD), respectively. The use of MDMA and psilocybin to treat any conditions other than PTSD and TRD, respectively, remain restricted under the existing Schedule 9.
Psilocybin can only be prescribed for depression where multiple treatments have failed. MDMA can only be prescribed for PTSD. In both cases, they will be considered controlled rather than prohibited drugs. Psilocybin and MDMA are just as illegal as ever in Australia when used outside these circumstances, and anyone who says otherwise is mistaken.
Prescription is permitted only by registered psychiatrists after Human Research Ethics Committee (HREC) approval of a detailed treatment protocol.
Only registered psychiatrists can prescribe psilocybin or MDMA if a research ethics committee (HREC or IRB) approves the treatment protocol.
TGA approval under the Authorised Prescriber Scheme is also required.
There will also be TGA paperwork. (There is always TGA paperwork, just ask an approved cannabis prescriber here.)
In addition to the approval of the psychiatrist to prescribe, it is likely that a Schedule 8 permit from State or Territory regulators will be required to treat individual patients.
States largely follow TGA scheduling, but they set their own health and drug laws & regulations. In the recent past, state health authorities have refused to permit the treatment even when the TGA has allowed case-by-case exemptions to existing scheduling to undertake psychedelic-assisted therapy.
The product to be prescribed must be specified, and must be manufactured according to principles of Good Manufacturing Practice (GMP).
No natural mushrooms will be prescribed. Synthetic GMP psilocybin & MDMA only.
Key Guidelines Explained
The TGA sets out a range of guidelines throughout the clinical memorandum, with the essential points detailed under "Considerations for use of psychedelic-assisted therapy (PAT)." They are, roughly, as follows:
Patients must be capable of understanding the risks and benefits of psychedelic-assisted therapy for them in their particular psychological, medical, and social context.
Patients must have the capacity to give fully informed consent. This includes understanding safety considerations, the likelihood of treatment efficacy, safety considerations, and what to expect before, during and after treatment.
Practitioners must have undertaken comprehensive training in psychedelic-assisted therapy. This must include knowledge of physical and psychological effects, interactions, and practical aspects of delivering this therapy. Training must recognize the importance of professional boundaries. (Note that, despite the hype and expense of PAT training, the RANZCP has not endorsed or approved any existing training program, presumably including both MAPS and MMA offerings)
Psychotherapy must be delivered by a dyad of (i.e., two) professionals, one of which must be a medical practitioner.
Psychiatrists must consider factors around set and setting, patient expectations, patient vulnerability, and prior discussion of using touch during dosing sessions.
The TGA recommends the minimum standard of training for those (other than the prescribing psychiatrist) involved in overseeing patients as a clinical psychologist. The RANZCP found this ambiguous and recommends that all practitioners involved at least hold Australian Health Practitioner Regulation Agency (AHPRA) registration or equivalent.
Ongoing practitioner supervision is recommended.
Psychedelic-assisted therapy must be delivered as holistic care, requiring proper infrastructure, multidisciplinary teams, and robust monitoring, management and reporting mechanisms for side effects and adverse events.
In terms of public education & awareness, the RANZCP makes clear its opinion that the illicit use of psychedelics, even when intended to be therapeutic, poses a significant risk to the community. They note that illicitly sourced psychedelics may be of unknown composition, and there is no oversight of training or behaviour for underground practitioners, asserting that there should be strategies to direct people to legal forms of psychedelic-assisted therapy.
What This Means for Psychedelic-Assisted Therapy in Australia
Some of the implications of these regulations and guidelines should be obvious. But it's worth noting a few, just to be precise.
Given the need for training, approvals, and infrastructure, there is unlikely to be an explosion of psychedelic-assisted therapy on July 1. That said, I know there is considerable interest in being involved in PAT across the country from medical and allied health professionals.
Because HRECs must approve the protocols, it is likely that, initially, at least, they will closely follow those used in clinical research of psychedelics. This will likely include exclusion criteria, meaning many people with more complex needs and case histories may be unable to access treatment, even if they can find an approved prescriber. (This will be a challenge, as approved prescribers cannot openly advertise their status.)
If AHPRA registration is essential, direct involvement with PAT will be restricted to medical practitioners, nurses, psychologists, pharmacists, etc. The centrality of AHPRA registration has implications for underground practitioners who wish to move towards a more legal work practice. While medical training is undoubtedly helpful for psychedelic facilitation teams, this also potentially risks excluding people with extensive traditional knowledge or lived experience from being part of the delivery of PAT in Australia.
The need for therapeutic dyads that include medical practitioners, prescribing psychiatrists, and inpatient infrastructure reinforces the view that initial patient costs could run to tens of thousands of dollars for a course of treatment. None of this will be covered by government funding or health insurance. This is not to say that therapeutic dyads or high-quality facilities are harmful or unnecessary. But they won't be cheap.
This should be food for thought for anyone thinking or claiming they will be making vast amounts of money from producing or importing GMP psilocybin or MDMA for the Australian medical market in the near future. If money is to be made this way, it will be a long time coming.
And I can safely say that the RANZCP will not be supporting non-clinical reforms such as decriminalization or a broader view of healing outside of medicalization any time soon. If anything, their expressed views are the opposite of this.
Finally, if it isn't apparent, this won't be like medical cannabis in Australia – not for many years, at least. Nor will it resemble what's happening in Oregon, Colorado or at psychedelic retreats in countries where such activities are less restricted.
What Now?
In terms of psychedelic-assisted therapy, in some ways, we'll wait to see how things shake out. Will MMA/Mind Medicine Institute or MAPS training get endorsement, or will psychedelic education finally move into mainstream universities? Will RANZCP loosen its recommendations over time? Will unscrupulous practitioners undermine public support for psychedelic therapy? Will the newly formed Australian Multidisciplinary Association for Psychedelic Practitioners (AMAPP) get traction for its accreditation guidelines? Right now, it's a little too soon to tell.
Nonetheless, it should be clear to reformers and harm reduction advocates that these changes only increase the importance of their work and the need for broader changes to drug law in Australia. Likewise, the work of patient advocates is just beginning.
The key takeaways from these changes are that psychedelic-assisted therapy will be highly restricted and medicalized in Australia in the near future and that, in my opinion, considerable additional reform and reconceptualization around drug law and mental health are still required.
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