After facing years of stigma, Australian psychiatrists can legally prescribe MDMA and psilocybin starting July 1, 2023. This is a groundbreaking victory that marks the end of what has been an unjust demonization for far too long.
The decision took everyone by surprise. History has been made as the Therapeutic Goods Administration (TGA) officially approved MDMA and Psilocybin for therapeutic use in Australia. We couldn’t be more excited about this news.
People struggling with treatment-resistant depression now have access to psilocybin thanks to recent regulatory changes.
To access certain drugs, the rescheduling process has shifted them from a Schedule 9 (‘Prohibited Substance’) to a Schedule 8 (‘Controlled Drug’). It is essential to note that only psychiatrists who are specifically trained can prescribe these medicines and they must be prescribed for those affected by two particular conditions.
To prescribe MDMA and Psilocybin, psychiatrists must meet two criteria that are consistent with the most extensive clinical research available for each medication: MDMA is used to treat PTSD while Psilocybin (or “Psilocybine”) can be prescribed for individuals suffering from treatment-resistant depression. If more evidence regarding their effectiveness and safety in other contexts arises, The Therapeutic Goods Administration will evaluate applications to amend these regulations accordingly.
Despite still being prohibited in most cases, the decision to allow certain drugs under very limited circumstances was highly praised by Dr David Caldicott of Australian National University’s Emergency Medicine Department as an “encouraging step” away from years of criminalization.
The recreational drug MDMA is commonly referred to as ecstasy, while psilocybin can be found in magic mushrooms and induces psychedelic effects.
Decades ago, both drugs were subject to experimental and therapeutic use before being criminalized. Now psychiatric professionals can be granted permission by the authorities to administer MDMA as a treatment for post-traumatic stress disorder and psilocybin as a remedy for depression that does not respond well to other treatments.
Developed in 1912 as an appetite suppressant, Ecstasy was initially utilized for therapeutic purposes by American therapists during the 1970s. It was found to have a calming effect on patients, allowing them to confront previously too-painful memories without fear or shame.
MDMA made its way to Australia in the 1980s as an entertainment drug; however, just a few years later in 1987, it was declared illegal.
Australia is home to many species of hallucinogenic mushrooms, however, it’s illegal to possess or distribute psilocybin.
According to Caldicott, it is now indisputable that controlled usage of MDMA and psilocybin can have a significant effect on health problems traditionally resistant to modern treatments. In particular, this regulated dosage could be especially beneficial for Australian veterans returning from military service.
Australia has made a breakthrough decision to make psychedelic therapies accessible, but concerns about who will be able to access them remain.
Although excitement is in the air, experts caution that there are still numerous unresolved questions regarding who will be able to access these treatments come July 1st as well as if Australia has rushed into rollout without collecting sufficient evidence on how to safely and effectively implement them.
For a psychiatrist to gain authorization to distribute medicine, the process could be lengthy and arduous. First, psychiatrists must receive approval from Australia’s Authorised Prescriber Scheme which includes endorsement by a Human Research Ethics Committee and then the TGA. To be approved, they will need evidence demonstrating their clinical justification for said treatment plan as well as proper management of treatment processes with appropriate procedures in place to protect patients. Despite these requirements being established already, it is yet unclear what exactly these protocols would look like in practice according to the TGA’s standards.
Indigenous communities have used psychedelics for thousands of years, yet Western researchers only began to explore their possible uses around the mid-1900s.
It is not a safe practice to have just any psychiatrist or psychologist administering psychedelic therapies. As Ruffell stated, Indigenous practices worldwide require five-to-ten years of training to be proficiently capable of working with these substances. We must never assume that psychiatric and psychological qualifications are all we need when it comes to psychedelics; proper education and preparation go hand in hand for effective results.
A further impediment to receiving these treatments could be the financial cost, as health insurance companies are unlikely to cover them. It is more than likely that this therapy will only be accessible to those who have the means and can afford it, according to Daniel Perkins.
It is extraordinary that Australia leads the way in terms of psilocybin use, with Oregon being the first US state to permit adults to use it “under a certified facilitator” at the start of 2023. Though MDMA remains an unapproved investigational drug in America right now, experts have speculated that by 2024, it will be approved by FDA for the treatment of PTSD symptoms.
Recently, North American researchers have given their approval to begin testing psychedelic substances in London – a highly anticipated move.
Another major endeavor, the PAREA project is committed to equipping Europe with the necessary knowledge and resources for successful psychedelic-assisted therapies.
With Switzerland’s restricted permission for psychiatrists to utilize LSD and MDMA as part of psychotherapy, the outcome in Australia will likely determine if other countries choose to do the same. As Ruffell remarked, “The eyes of the world will be fixed on Australia now.” It is only through safe results that these drugs can be used properly and more widely accessible in therapy settings across nations worldwide.
If you’d like to review the Decision, please visit the TGA website.