Zoe CormierIn the first three parts of our Psychedelic Law series, we examined the realities and difficulties of launching psychedelic-assisted therapies in the U.S., UK, and Canada. In our final in the series, we examine how Australia’s theoretically groundbreaking psychedelic legalization may not be what it seems.
Australia, a land most often associated with its dangerous wildlife and charismatic, crocodile-wrangling biologists, is currently the darling of the psychedelic world, having made headlines by fully allowing the prescription of psilocybin and MDMA as of July 1st, 2023. Mind Medicine Australia is pledging to supply the drugs obtained from Canadian start-up Optimum Health at “no cost” for clinical trials.(1)
Australia’s Therapeutic Goods Administration (TGA) approved MDMA and psilocybin for treating post-traumatic stress disorder (PTSD) and treatment-resistant depression, respectively, starting July 1. This decision marks Australia as the first country to legalize these substances in a medical setting, beating out the U.S. Food and Drug Administration (FDA), despite its designation of psilocybin and MDMA as “breakthrough” therapies several years ago.(2)
However, a deeper examination reveals that the situation is more complex than initial reports suggest. Despite the progressive image portrayed in international media, including BBC reports on Australia legalizing psychedelics for mental health, the actual implementation of this legislation faces several hurdles. Since the 2022 announcement, not a single prescription has been issued.(2)
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Bite-sized news stories proclaiming “Australia legalizes psychedelics for mental health” certainly give that impression. But drilling into the legalese, paperwork, and fine print reveals the reality is not as simple or impressive as the headlines convey.
In Australia, though prescriptions for MDMA and psilocybin are technically legal, zero have been issued since the 2022 announcement due to several factors: psychiatrists have not been trained to issue them, and though Mind Medicine Australia plans to issue the MAPS-developed Certificate in Psychedelic-Assisted Therapies (CPAT), no centers currently exist to train therapists to a competent level. There has been no “implementation” of the law.
“For now, this is not the miracle that has been advertised in the news – it’s a regulatory breakthrough that is only on paper,” says Dr. Jack Allocca, psychedelic neuroscientist at The University of Melbourne Florey Department of Neuroscience and Mental Health. “Some speculate that it was aimed to please certain individuals who are well connected to the government. Others suspect it’s nothing more than a PR stunt. It could just be that it takes time to put a law into practice, given that the bureaucratic burden on the whole process is very heavy. Either way, nobody seems to have a clear idea yet when this will become a reality or why the law was changed this way.”
Psychedelic Medicine is Legally Available, but Entirely Out of Reach
Psychiatrist Fernando Espi Forcen of Massachusetts General Hospital observes the shift from the anti-drug hysteria of the war on drugs to the beginnings of a mental wellness revolution. “Psychedelics have gone from fringe to fashionable,” said Forcen, in an interview with Psychiatric News. “Today, wealthy individuals can arrange a psilocybin retreat in Jamaica or have an authentic ayahuasca experience in Peru.” Yet, most Australians don’t have access to psychedelic medicine, legal or otherwise.(3)
Despite the excitement surrounding Australia’s decision, there are practical challenges ahead. While there is robust data supporting MDMA’s use for PTSD, including the recently completed, MAPS-sponsored, Phase III clinical trials, psilocybin’s approval for depression is more surprising due to the relatively early stage of its clinical trials.(4)
In his interview, Espi underscores the distinction between legalizing these treatments and making them feasible and affordable, with the costs of a full treatment course potentially reaching 25,000 Australian dollars. Australia’s healthcare system, comprising both public and private elements, has not yet indicated significant financial support for these therapies, posing a barrier to widespread access.(3)
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Further complicating the rollout of these therapies in Australia is the lack of guidelines from the TGA on therapy delivery standards. The process involves physicians setting their protocols and seeking approvals, raising questions about minimum requirements and safety measures.
Another issue can be found in the process for a psychiatrist to become an Authorized Prescriber (AP) for MDMA or psilocybin, which is quite stringent. It involves approval from the Human Research Ethics Committee (HREC) and the Therapeutic Goods Administration (TGA), and psychiatrists must submit six-monthly reports on patient numbers and serious adverse effects. This comprehensive reporting is supposed to ensure ongoing monitoring and evaluation of the drug’s usage and its impact on patients. However, some clinicians fear the regulation governing access to these drugs might be insufficient.(5)
There has also been some pushback from medical providers concerned about addiction and misuse. While MDMA and psilocybin are not considered highly addictive substances, there is a political and social concern about exposing patients to these substances, which are also commonly used recreationally. The treatments in Australia are conducted in a highly controlled setting, with patients undergoing clinical assessment before considering such treatment. However, policymakers stress that the strict regulatory framework established by the TGA is intended to mitigate the risks associated with the use of these substances.(5)
We will have to wait and see what the future has in store for the Aussies. However, given that Oregon also made headlines with their announcement of legal training programs for psychedelic therapists and then made the news again when the Synthesis Institute filed for bankruptcy, leaving students “in limbo,” we should be somewhat cautious. Exciting announcements are one thing – delivering on them is another.
Sources
1. Haridy, R. (2023). Australia to prescribe MDMA and psilocybin for PTSD and depression in world first. Nature. https://doi.org/10.1038/d41586-023-02093-8
2. MDMA and Psilocybin are now legal in Australia. Here’s what you need to know. (2023, June 19). Forbes Australia. https://www.forbes.com.au/covers/innovation/psychedelics-therapy-will-be-legal-in-july-heres-what-you-need-to-know/
3. Australia has legalised MDMA to treat mental health. Is Europe next? (2023, July 3). Euronews. https://www.euronews.com/next/2023/07/03/australia-just-legalised-mdma-to-treat-mental-health-could-europe-do-the-same
4. Mitchell, J. M., Ot’alora G. , M., van der Kolk, B., Shannon, S., Bogenschutz, M., Gelfand, Y., Paleos, C., Nicholas, C. R., Quevedo, S., Balliett, B., Hamilton, S., Mithoefer, M., Kleiman, S., Parker-Guilbert, K., Tzarfaty, K., Harrison, C., de Boer, A., Doblin, R., & Yazar-Klosinski, B. (2023). MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature Medicine, 29, 1–8. https://doi.org/10.1038/s41591-023-02565-4
5. Zagorski, N. (2023). Australia Legalizes Psychedelics for Use in Depression, PTSD Therapy. Psychiatric News, 58(09). https://doi.org/10.1176/appi.pn.2023.09.9.20
This material is not intended as a replacement or substitute for any legal or medical advice. Always consult a medical professional about your health needs. Psychedelics are widely illegal in the United States, and readers should always be informed about local, state, and federal regulations regarding psychedelics or other drugs.
David Connell
