In July 2023 Australia became the first country in the world to allow psychiatrists to prescribe psilocybin and MDMA but 6 months later less than 10 clinicians are approved to authorise the drugs for their patients.
Is this slow pace a sign of a cautious system working as it should, or are roadblocks being put in place by a nascent regulatory system? And, is the high cost of the treatment going to lead to more patients seeking the drugs through underground sources?
In a Melbourne clinic on 19 January, a quietly historic moment took place. A patient was legally administered MDMA as part of a therapeutic program to treat severe PTSD. The treatment was the first in Australia to take place outside of a controlled clinical trial, but due to an unexpected regulation the 2 primary therapists running the session, from the Monarch Mental Health Group, had to travel from NSW to complete it.
It’s complicated…
The regulatory change last year came as a surprise to many working in the field of psychedelic medicine. On the back of heavy lobbying from advocacy group Mind Medicine Australia, the announcement funnelled psychedelic medicine through a novel system called the Authorised Prescriber Scheme.
The scheme allows psychiatrists to prescribe either MDMA for PTSD or psilocybin for treatment-resistant depression after they have completed an application process requiring them to get approval from a Human Research Ethics Committee (HREC). Once an HREC has backed an application – including all details of clinical practice such as who administers the drugs and accompanying therapy – the TGA gives its stamp of approval and psychiatrists can begin prescribing the treatments.
Through a Freedom of Information request, Cosmos can exclusively reveal that as of the beginning of December there were only 3 approved Authorised Prescribers (APs) in Australia, with 4 more pending applications. Further investigation indicates less than 10 APs are now approved at the time of writing.
Alongside this complicated AP process, each Australian state has imposed extra requirements on the treatment such as controls on how the drugs are stored. The WA government, for example, has also required each patient to be registered and approved by the state.
Michael Winlo, CEO of Perth-based company Emyria, soon to start the state’s first MDMA for PTSD treatments, says these extra regulations are all part of the process and, at least in the case of WA, not extremely onerous.
“What they’re really checking for is they want to know where the drug is going. Where’s it moving. And so their main interest is in vetting and evaluating the supply chain,” Winlo says.
NSW on the other hand has established perhaps the country’s most stifling regulation. It has required all psychedelic medicine dosing sessions to take place in a “private health facility which is licensed in the mental health class.” This essentially means the state will not allow psychedelic clinics to operate as standalone clinical spaces.
They want to know where the drug is going. Where’s it moving.
Michael Winlo
Monica Schweickle, lead on Monarch’s clinical psychology program for psychedelic therapy, says this NSW regulation will limit their ability to scale up accessibility to the treatment.
“I don’t know where the state government will land on this,” says Schweickle. “I’m not sure if they will change it. We did write to the Health Minister when we learned of this and they wrote back a general response that confirmed they acknowledged our concerns. And that’s what they decided for now.”
Too slow, or just right?
Martin Williams, executive director of PRISM (Psychedelic Research in Science and Medicine), is circumspect about the slow rollout. Williams co-founded PRISM nearly 15 years ago with the goal of supporting psychedelic research in Australia. He now works on several ongoing psychedelic-assisted psychotherapy clinical trials.
“I think everything has taken the kind of time that we felt would be appropriate,” Williams explains. “I think if there had been this mad rush, that would have been really worrying.”
Anthony Bloch, Chair of AMAPP (Australian Multidisciplinary Association for Psychedelic Practitioners) is a little more critical of the rollout. Bloch was part of a small group trained in psychedelic therapy that immediately saw a policy vacuum after the TGA announced the regulatory change in early 2023. AMAPP was established in the hopes of becoming the central advisory source for both clinicians and government agencies.
Bloch sees the slow approach as a double-edged sword. Approving these substances as legitimate medicines countered half a century of messaging calling the drugs harmful and dangerous. But without clear systems of access built into the regulatory change, the drugs will quickly become difficult for patients to access and underground, unregulated practitioners are likely to flourish.
“[The TGA] sent the message that these drugs actually do have a role, they are actually beneficial,” says Bloch. “What happens then, when you deny access, is people will go into the underground. And there is no regulation. There is no oversight, and there’s no accountability. And there’s real damage and real harm happening from underground therapy practices.”
This isn’t cheap
Further limiting the current availability of these treatments is the proposed cost. Winlo indicates Emyria’s cost for a course of MDMA therapy for PTSD will be $30,000. That price covers an entire 12-16 week treatment including 3 day-long MDMA sessions and many preparation and integration therapy sessions.
Monarch is working at a similar price point of $25,000 for a comparable protocol. Monarch expects that total cost to be reduced via a piecemeal array of targeted Medicare rebates, but the best-case scenario right now is patients will be at least $15,000 out of pocket.
When you deny access, is people will go into the underground
Anthony Bloch
The frustrating reality of psychedelic medicine in Australia for prospective patients is that things will be expensive for quite some time. Stephen Bright, a researcher at Edith Cowan University and co-director of PRISM, says it will be years before these kinds of psychedelic therapies are comprehensively subsidised by public health insurers such as Medicare. Over the next year, he suggests the first sign of change to look out for is a private health insurer going out on a limb and deciding to fund these therapies.
Psychedelic medicine: “It’s legal, but….”
So psychedelic medicine is legal in Australia. Clinics are opening and treatments are commencing. But the road ahead is not straightforward.
Many researchers Cosmos talked to expressed significant nervousness around the coming year. Following a decade of optimistic publicity touting a new psychedelic renaissance in medicine, many patients are suffused with excitement about these novel treatments. But they will not work for everyone, and it still isn’t clear who will respond badly to these treatments, or how long the benefits last in those who respond well.
According to Williams, up to 95% of applicants to his clinical trials have to be turned away because they don’t satisfy the selection criteria. This covers anything from poor cardiovascular or liver health to pre-existing psychiatric issues that could interfere with the treatment. Some of these patients will likely now seek the treatments in the public sphere and Williams wonders how quickly the rigorous exclusion criteria established by clinical trials will be relaxed when the financial imperatives of a commercial clinic take hold.
Bright expects this will inevitably lead to some troubling media stories about psychedelic medicine. The pendulum swinging away from the blind optimism of recent years.
“If I paid $30,000 for treatment, and 1 year later, I’m unwell again, I’m probably going to go to the media and talk about that,” Bright suggests.
Bloch is more optimistic, hoping that AMAPP can help coordinate different state and federal regulatory bodies hastening the responsible rollout of these treatments. He says the demand for psychedelic medicine is huge, and now it’s legally available it’s crucial to find ways to make the treatment accessible while also maintaining safety standards.
“I get all these very heartbreaking messages from people that have been struggling with mental health all their lives,” Bloch says. “And they say this is their final hope. I’ve got to say to them, we’re just not there yet. For therapists to be saying to their clients who they’ve known for years: Yes, yes. It is legal… But…”