In a major positive development, Australia is rescheduling psilocybin and MDMA to approve authorized medical use.
On the back of growing calls for their re-evaluation and legalization for medical use, as well as a growing body of research suggestive of profound therapeutic benefits, psilocybin (the psychoactive component of magic mushrooms) and MDMA (3,4-methylenedioxy-methamphetamine) have been reclassified in Australia, enabling authorized psychiatrists to prescribe these substances for medical use.
The change will provide access to MDMA-assisted therapy for patients suffering from PTSD, and to psilocybin-assisted therapy for patients with treatment-resistant depression.
This move towards psychedelic-assisted treatments, backed by a growing body of scientific evidence demonstrating clinical efficacy, is a significant achievement for Australia and sets a positive example for the rest of the world. The new classification of psilocybin and MDMA serves as a benchmark for the medical use of psychedelic substances.
The Therapeutic Goods Administration (TGA) announced on Friday that it has officially approved the use of psilocybin for the treatment of treatment-resistant depression and MDMA for the treatment of PTSD. The decision comes on the back of accumulating evidence from clinical trials demonstrating the promising therapeutic potential of these substances as adjuncts to supportive psychotherapy.
Starting July 1st, 2023, psilocybin and MDMA, currently prohibited substances in Schedule 9 of the Poisons Standard, will be moved to Schedule 8 and reclassified as controlled drugs. Schedule 8 drugs are considered to have a legitimate therapeutic use, but can only be obtained with a prescription, and their supply, possession, and use are strictly regulated.
The decision to reclassify psilocybin and MDMA was reached after TGA received applications for their reclassification in the Poisons Standard, underwent extensive public consultation, considered a report from an expert panel, and received advice from the Advisory Committee on Medicines Scheduling.
Some, however, including medical cannabis industry expert, Rhys Cohen, have publicly expressed concerns surrounding accessibility. Cohen has warned that we could see a repeat of the early aftermath of medical cannabis legalization in Australia, with patients waiting prolonged periods for an official decision as to whether they can access these substances.
The prescribing of psilocybin and MDMA will only be available through authorized psychiatrists. According to the TGA, psychedelic therapy will be limited to psychiatrists given their specialized training and experience in diagnosing and treating patients with serious mental health conditions using novel therapeutic approaches.
To prescribe psilocybin or MDMA, psychiatrists must first be approved under the Authorized Prescriber Scheme by the TGA, following the approval of a human research ethics committee. According to the TGA, the Authorized Prescriber Scheme allows for the issuance of prescribing permissions with stringent measures in place to guarantee patient safety.
Cohen has expressed that it may be a challenge for psychiatrists to obtain Authorized Prescriber status, however. Psychiatrists seeking authorization must demonstrate that they have the proper procedures and expertise in place to guarantee the safe and effective use of these drugs to treat treatment-resistant depression and PTSD.
Furthermore, the necessity for psychiatrists to be present for the duration of 8-hour-long psychedelic treatment sessions, in addition to several preparatory and integrative therapy sessions held either side, makes it less financially accessible. Unfortunately, many Australians may not be able to afford this newly approved psychedelic treatment.
Paul Liknaitzky, Head of Clinical Psychedelic Research at Monash University, and the first person to establish a clinical psychedelic lab in Australia, recently shared additional concerns voiced by clinicians and researchers involved in psychedelic clinical trials in Australia.
Though there is consensus that advancements in drug policy and the possibility of better access to more personalized, appropriate treatment for those in need, free from the strict protocols of clinical trials, is very exciting, some professionals fear that the available evidence may still be insufficient and that it may be too soon to introduce clinical services. There are also concerns that inexperienced or insufficiently equipped healthcare professionals might inundate the field, and that there may be inadequate supervision of training and treatment, which could negatively affect patient outcomes.
As of yet, the criteria for sufficient psychedelic training remains uncertain, and there seems to be no requirement for authorized prescribers to be supervised by experienced specialists in psychedelic therapy — for which there are established safety protocols.
While Liknaitzky maintains that psychiatrists play a crucial role in the collaborative care model, he stresses that they will require extensive training in psychedelic therapy and continued supervision to effectively provide what is a very delicate and complex form of drug-assisted psychotherapy. He also advises that authorized psychiatrists should establish collaborative care teams with psychologists and therapists to optimize treatment.
The recent ruling recognizes the limited options available for patients suffering from treatment-resistant mental illnesses. It marks a unique and positive step forward in providing alternative therapy options for those who suffer from difficult-to-treat, crippling psychiatric conditions and who have been advocating for such a change for a prolonged period.
Given the potential vulnerability of patients during psychedelic-assisted psychotherapy, the TGA has confirmed that necessary measures must be put in place to safeguard them. The TGA has also confirmed that, as of now, MDMA and psilocybin are the only two psychedelic substances with enough evidence of clinical safety and efficacy in patients.
The rescheduling of MDMA and psilocybin by the Australian government is a positive step forward and brings hope. Although it may take some time to observe the effects of this change, it is indeed a positive development.
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