Earlier this month, the Therapeutic Goods Administration (TGA) surprised many in the Australian psychedelic community by announcing the rescheduling of psilocybin and MDMA from Schedule 9 (Prohibited Substances) to Schedule 8 (Controlled Drugs) under the Poisons Standard. ‘The decision,’ the TGA noted in a press release, ‘acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses. It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting.’

The change, which comes into effect from 1 July this year, will allow for specialist psychiatrists to prescribe these drugs as adjuncts to talk therapy in two ways only: MDMA (the active ingredient in ecstasy) for post-traumatic stress disorder, and psilocybin (found in magic mushrooms although synthesised for medical use) for treatment-resistant depression. Outside of these uses, both drugs will remain Schedule 9 Prohibited Substances, for the most part restricting their supply to clinical trials.

To prescribe either MDMA or psilocybin, psychiatrists will need approval from a human research ethics committee, and authorisation from the TGA under the Authorised Prescriber Scheme—necessary for accessing ‘unapproved therapeutic goods’. Furthermore, as medical cannabis expert Rhys Cohen pointed out in a Twitter thread, psychiatrists wishing to prescribe MDMA or psilocybin from July will still have to contend for the disapproval of the Royal Australian and New Zealand College of Psychiatrists, the official position of which remains that the ‘clinical use of psychedelic substances should only occur under research trial conditions.’

While some researching or working in the field of psychedelics apparently had foreknowledge of the TGA decision, it seems most—including me—were blindsided. In December last year, the TGA made the interim decision to leave unchanged the scheduling of psilocybin and MDMA in the Poisons Standard. It noted that ‘the currently limited evidence of benefit for both substances is outweighed by the risks to patients and public health from any increased access.’ Few in the psychedelic community expected the TGA’s final position to diverge from its interim decision, but that’s precisely what happened.

The reaction to the TGA’s rescheduling of psilocybin and MDMA has been mixed, with wary optimism predominating. On the one hand, it feels like another small but significant retreat from the moral panic-fuelled ‘war on drugs’ which has seen the study of psychedelics more or less outlawed since the 1960s. Although not the first instance of a country authorising psychedelics for limited clinical use—this has already happened through various compassionate and expanded access programs in Canada, the US, Israel, and Switzerland—the TGA decision is also nevertheless pioneering in formally reclassifying psilocybin and MDMA as medicines (in conjunction with psychotherapy). The decision may even lead to a new paradigm for the treatment of mental health disorders given the highly promising results of clinical trials overseas, which have in many cases provided (albeit limited) evidence of the safety and efficacy of psychedelic-assisted psychotherapy in the treatment of depressive and anxiety disorders.

On the other hand, the rescheduling leaves many questions unanswered, including those asked by the TGA itself in response to the initial submission which sought the amendment. Broadly speaking, these questions can be summarised as:

• Delivery—given the paucity of relevant training in Australia, who will administer psychedelic-assisted therapy, and, in the absence of established protocols, what procedures will they use?
• Access—who will be able to access these treatments? It’s not known how much a course of psychedelic-assisted therapy will cost, but it’s certain to be significantly more than comparable treatments, factoring in the price of the drug (no psychedelics are currently on the Australian Register of Therapeutic Goods or the Pharmaceutical Benefits Scheme), and the convention of multiple six- to eight-hour dosing sessions with two therapists and support staff in bespoke treatment rooms. We would do well to remember that financial hardship is strongly correlated with increased psychological distress, which is to say that the people who may benefit the most from new mental healthcare interventions may also be those least able to pay for them.
• Efficacy—while the results of clinical studies have been auspicious, most are small and many don’t conform to the ‘gold standard’ of randomised double blind placebo control trials (for obvious reasons, psychedelics are notoriously difficult to blind). Little is known about the longterm effects of psychedelics administered in clinical settings.
• Safety—what does informed consent look like in psychedelic-assisted therapy? Even more so than in other forms of therapy, patients under the influence of psychedelics are vulnerable and suggestible, and patient abuse at the hands of unscrupulous therapists is far from unheard of. Anecdotal reports like this one also suggest that psychedelic-assisted therapy can for some patients prove not just inefficacious, but (re)traumatising in itself.

On top of these unresolved issues sit two further questions, both of which go to the nature of the sociocultural container in which psychedelic-assisted therapy in Australia will inevitably find itself. The first is whether a psychedelic scramble by pharmaceutical companies and other profit-driven stakeholders will compromise clinical outcomes. Indeed, some, like psychiatrist and former Australian of the Year Patrick McGorry, have questioned whether the TGA decision in itself was the result of ‘intense private lobbying/special pleading by a zealous private group?’ (i.e. Mind Medicine Australia, the controversial advocacy organisation run by an opera singer and a former investment banker that was the subject of a Four Corners investigation last year).

The second is what the seemingly rapid progress of the medical model of psychedelics in Australia means for our understanding of mental illness. Simply replacing SSRI antidepressants with yet another supposed pharmacological cure-all without addressing the social determinants of distress would be a grave mistake, further enshrining the neoliberal values which have done so much to bring about the mental health crisis in the first place. Therapy plus MDMA for veterans with PTSD is all very well, but if we’re not also asking why their PTSD exists in the first place—the fighting of illegal and unnecessary wars of aggression for one—then we are only treating its symptoms, not the underlying causes.

It’s too soon to say what the results of the TGA rescheduling will be. ‘It may,’ as Head of Clinical Psychedelic Research at Monash University, Paul Liknaitzky, recently wrote, ‘turn out to be a watershed moment with dramatic effects on the field globally’ (Rick Doblin, the founder and executive director of MAPS, has said the Australian decision could expedite the approval process of MDMA and psilocybin in the US). Conversely, as Dr Prashanth Puspanathan told the Australian Financial Review, it ‘could be a shitshow.’

Either way, the TGA has placed Australia in the highly unusual position of having a still fledgling psychedelic research field, where training, knowledge, and infrastructure lag behind much of the rest of the world, and simultaneously an enviably progressive access scheme (Australia is also, oddly, perhaps the only country in the world in which psychedelic trials have received state-funded grants). What remains to be seen is whether the rescheduling of psilocybin and MDMA points to the field’s maturation in this country or simply ends up as yet another deplorable example of regulatory capture in Australia. A great deal is at stake, not the least of which is the wellbeing of the millions of Australians who will experience a mental health disorder at some point in their life.

Photo by Marco Allegretti on Unsplash