Australia stands on the cusp of a mental healthcare revolution. From 1 July, psychedelics will legally be able to be prescribed for the treatment of depression and post-traumatic stress disorder.
This means that Australians will then be legally able to take MDMA and psilocybin, the active chemical in magic mushrooms. That is, if both they and their relevant healthcare providers can meet exacting and expensive criteria.
In February, the Therapeutic Goods Administration made the decision to down-schedule both MDMA and psilocybin to Schedule 8 drugs, making them prescribable. Those changes are now soon-to-be in effect.
The treatments, however, are not entirely understood. When the TGA announced their decision, there was shock in the medical community. Some said the move was groundbreaking. Others said it was reckless.
Despite the concern, this is happening. Serious medical bodies are anxious about the appropriate handling of the next steps and have spent months in preparation for the changes. The Royal Australian and New Zealand College of Psychiatrists (RANZCP), for example, have recently stated that patient safety must be central as Australia enters this new era of mental healthcare
“There is some compelling research, the evidence is growing, and psychedelic-assisted therapy may offer hope to a small number of patients where other treatments have been attempted without lasting success,” said Professor Richard Harvey, Chair of the RANZCP’s Psychedelic-Assisted Therapy Steering Group.
“But psychedelic-assisted therapy is not a miracle cure that promises rapid recovery.
“Psychedelic-assisted therapy is in its infancy. There is more we need to know, and it’s paramount that treatment only occurs in highly supportive and structured environments, comparable to what you’d see in a clinical trial setting”.
As it stands, there are no accredited training courses for this treatment and no one is sure how long the approval process will take. Once approved, psychiatrists will only be allowed access to the drugs through pharmacists holding Schedule 8 permits, which they themselves also have to have. Written permission for these permits has to be obtained through their state or territories’ Department for Health.
The reason some medical practitioners are raring to jump through all of these hoops is because the treatments have the potential to be “life-changing.” There is no shortage of reports from people who have had them about the vast and significant improvements in their lives. There is also no shortage of reports about what can happen if things go wrong.
“There is potential for psychedelic substances to cause fear, panic and re-traumatisation. Without careful clinical judgement and clear communication with people seeking treatment, there are risks,” Harvey said.
Now that Australia has opened this Pandora’s Box, here’s what’s going to happen next and how patients will get psychedelic therapy in Australia.
What Happens Now for Psychedelic Therapy in Australia
In truth, very little. The TGA has fired the starting gun but for patients and therapists alike, it will be a very long and arduous process to be able to give and receive these treatments.
“I’m not sure that there’s any service or clinic that’s ready to go on the first of July. I would be very surprised if there was,” Professor Suresh Sundram told The Latch.
Sundram is the Head of the Department of Psychiatry and Co-Investigator within the Clinical Psychedelic Lab at Monash University. While he told The Latch that he knows there is “a lot of interest” from therapists in delivering these treatments, very few will initially be able to.
The TGA stipulates that anyone working with these substances must be a psychiatrist with the approval of a Human Research Ethics Committee (HREC). From 1 July, they will be able to start this application process. They must also acquire a Schedule 8 permit from their state or territory regulator in order to handle and deliver MDMA and psilocybin to patients. These are not simple box-ticking exercises.
Guidelines and Rules
Last week, the Royal Australian and New Zealand College of Psychiatrists (RANZCP) released a set of guidelines for psychiatrists interested in treating people with psychedelics. The guidelines state that treatment should be given by people done so before, that it must be given by two health professionals, one of whom is medically certified, and that the patient must give deeply informed consent.
Cautious preliminary guidelines from @RANZCP on the medicinal use of of MDMA & psilocybin.
The recent decisions by the the TGA make more sense when coupled to the development of professional guidelines.
And an adult dialogue on these products is welcome. https://t.co/4oeQcoDLks
— David Caldicott (@ACTINOSProject) June 26, 2023
“The number of practitioners who have experience in delivering this treatment is exceedingly small,” psychotherapist Sean O’Carroll told The Latch. “We’ve probably got more than half of them in the Monash lab”.
O’Carroll works within the Clinical Psychedelic Lab to develop and deliver training to therapists who want to work in with these drugs. In his view, this is going to be a very slow-moving process, and rightly so.
“I think there is real concern about how this will roll out,” he said.
“My sense is that, post July 1, this treatment will not be widely available. You could be forgiven for thinking that, when the TGA made its announcement, one year down the track we’d have thousands of people receiving this treatment.
“I think, off the back of the guidelines from the Royal College of Psychiatrists, it’s going to be fewer than that”.
In O’Carroll’s estimation, there are fewer than 50 people in Australia with the requisite experience to deliver these treatments. Many of them will be spending much of their time training others to do the work. But who exactly does get approved is a bigger question.
Who Will Deliver Psychedelic Therapy in Australia?
Although the RANZCP has published guidelines, as Sundram put it, “these are just guidelines.” There is nothing to say that they have to be adhered to, although it’s very unlikely that the TGA will be authorising anyone who appears reckless in their approach.
“The failsafe mechanism by which both the TGA and the College have said this is all going to be looked after closely is through so-called local ethics committees,” Sundram explained. These committees will have to approve both the prescriber and their proposed method of delivery.
“However, these ethics committees will have no experience with the treatments or with the agents and a lot of ethics committees may not even know who the clinicians are.
“So, the so-called ‘fail-safe mechanism’ is not necessarily failsafe at all”.
Psychedelic Therapy Cost
While just finding someone to carry out this treatment is initially going to be a big issue, the cost is perhaps going to be a more enduring one. By some estimations, a course of psychedelic-assisted psychotherapy could cost in the region of $25,000 to $35,000. It is, after all, a hugely involved, months-long process requiring constant psychiatrist visits.
“There might be ways around that,” Sundram said. Cost-benefit analysis could show that a one-off course of therapy at $25,000 saves the taxpayer more in the long run compared to years of Medicare-covered therapy and pharmaceuticals. But that, of course, would require government intervention. This is not likely to happen soon.
An Experiment in Accountability
In a sense, what Australia is wading into is a bold experiment. There would be few people in this country whose lives have not been touched in some shape or form by a mental health crisis. Roughly 8 to 9 lives are lost per day in Australia to suicide and current treatments on offer are clearly inadequate. That is even more reason to ensure we get this right.
“The word you used, ‘experiment’, is probably not a bad one, though I don’t think we want to think of it like that,” O’Carroll said.
“The people I speak to who are interested in delivering this treatment have safety front of mind.
“Everyone is aware that in a sense, we’re all in it together. That any bad outcome is bad for everyone. Obviously for the patient, but also for the entire field. So, hopefully, we’re going to be keeping one another honest and keeping one another accountable”.
How to Get Psychedelic Therapy in Australia
So, the big question is ‘How do you get psychedelic therapy in Australia?’ Having read this far, you’ll be aware that these treatments are unlikely to become available any time soon. A good first point of call for someone interested in beginning this journey would be their primary healthcare provider.
“Start with your current healthcare provider and then, in collaboration with them, explore whether or not this might be a promising treatment pathway,” O’Carroll explained.
“Not everyone will be eligible to receive this treatment. In fact, it’ll be very restrictive in the first instance.
“There are a whole lot of screening criteria that people will go through to see whether they’re actually eligible for this treatment. It’s quite restrictive at this point and for good reason”.
According to the TGA, GPs will be able to refer patients to a suitable psychiatrist who can carry out these treatments. A psychiatrist will then evaluate a patient’s mental health history as well as social and genetic risk factors for adverse effects.
Clearly, you will need to have a diagnosis of either PTSD or depression on your medical records in order to be eligible. You would also need to be able to demonstrate having undertaken a number of previous mental health interventions for your condition.
If you fit all of that criteria, can find an Authorised Prescriber, and can cover the associated costs, then you will be able to undergo psychedelic therapy.
Bear in mind that the treatment is primarily a therapeutic model, lasting two to five months. The drug experience makes up only a fraction of the time you’ll be spending in therapy.
When Will Psychedelic Therapy Become Available?
Sundram estimates that treatment will become available in “a relatively short period of time.”
Mind Medicine Australia, the organisation that submitted the application to have MDMA and psilocybin re-scheduled, have said that they will be tracking clinics in Australia offering the treatments. Currently, there are no such clinics available, but we will update this page when they start to open.
Psychedelic Therapy Is Worth the Wait
While the delays and the costs will be endlessly frustrating to anyone who is suffering, O’Carroll highlights that delivering treatment is a monumentally complex task.
“Understand just how hard it is to do the psychotherapy piece of this well, and how much skill and training and attention that requires, and how easy it is to do that poorly,” he said.
Although O’Carroll is worried that very poor delivery could result in harm, he’s also concerned that delivery could simply be low-quality, with equivalent results.
“My main concern is that we’re just going to have underwhelming outcomes and that people will sort of shrug their shoulders and say, ‘Well, we thought there might have been there but there isn’t’.”
Anything worth doing is worth doing right. Right, unfortunately, takes time. The new changes and the virtually overwhelming barriers to access will be little consolation to anyone who desperately needs help. But if those people can hang on, the wait may just be worth it.
Australia owes it to its people, and to the world, to move cautiously, and double-check all the variables. Doing so will hopefully, in O’Carroll’s words, lead to “people having a profoundly healing experience.”