A Deeper Look into the Legalisation of Psychedelic Therapy in Australia: Concerns and Controversies

Australia’s decision to legalise the use of MDMA and psilocybin for therapeutic purposes has been hailed as a groundbreaking move in the field of mental health treatment. However, this decision has also sparked a range of concerns and controversies among healthcare professionals and the wider community.

Too much, too soon?

One of the main concerns raised by experts is the perceived hastiness of the approval process. The TGA had rejected calls to reschedule MDMA and psilocybin for medical use as recently as December 2021. Critics argue that the TGA’s unexpected decision may have been rushed, with insufficient consideration given to the potential long-term effects of these substances. They stress the need for more rigorous research into the safety and efficacy of these substances before they become a mainstream treatment option.

The Risk of Adverse Outcomes

The use of psychedelics in therapy is not without risks. While international studies have shown promising results in using psychedelics to treat mental health conditions, experts have urged caution and called for more research into their long-term effects before making them a mainstream treatment. There is also a concern about the potential misuse of these substances outside of a controlled therapeutic setting.

The TGA has stressed that the drugs have only been approved for use under controlled medical settings by authorised psychiatrists. All other uses of psilocybin and MDMA will remain prohibited. Despite these precautions, the need for more data on the long-term effects of these substances is emphasised by critics of the TGA’s decision.

A Treatment for the Wealthy?

The implementation of psychedelic-assisted therapy (PAT) in Australia has raised significant concerns about the costs associated with this form of treatment. The therapy involves multiple preparation sessions, a dosing session that lasts up to 10 hours, and subsequent integration sessions over weeks or months. When all expenses are factored in, including the drugs themselves, supervision from multidisciplinary teams, psychiatrist sessions, and hiring a private clinic, costs could spiral.

Without a government subsidy to help cover the cost of the medications, psychiatrists estimate that patients will have to pay as much as AU$25,000 and more out of pocket for psychedelic-assisted therapy. This high cost of treatment might make the treatment inaccessible to most Australians, potentially turning it into a treatment option only for the wealthy. This underscores the need for careful consideration of cost-effectiveness and accessibility when implementing such innovative treatments.

Training Gaps

The TGA has limited prescribing only to psychiatrists who have undertaken specific training and are authorised. However, there is currently no authorised training in Australia. Critics suggest that the same organisations that have lobbied for regulatory change are planning to run training, arguing this is a conflict of interest.

Sourcing Medication

The TGA has not approved any products containing psilocybin or MDMA for use in Australia, meaning the psychiatrists will have to source and supply unapproved medicines themselves. Medical-grade manufacturing facilities in Australia for specific drugs are still under development. As a result, agreements have been made with foreign suppliers to ensure a steady supply. Most of these suppliers are based in Canada, benefiting from their industry's early development.

The complexities involved in importing these drugs will likely affect their availability in Australia, potentially delaying access for patients initially. Nevertheless, Australian companies are pioneering the establishment of manufacturing facilities for substances like psilocybin and MDMA. These facilities are subject to stringent regulations and, in some instances, operate under licenses from either foreign suppliers or local producers.

Regulatory Challenges

The current Australian regulatory framework for prescribing psilocybin and MDMA is seen by some as overly restrictive. Psychiatrists must be approved by the TGA and demonstrate they have the necessary training, competency, and robust evidence-based treatment protocols. However, Critics argue that these regulations could lead to patients seeking out psychedelic drugs from ‘underground sources’, potentially putting their health at risk.

The Call for Urgent Reform

In response to these concerns, the Australian Multidisciplinary Association for Psychedelic Practitioners (AMAPP) has called for a comprehensive review of the current rules, regulations, and guidelines for the use of psychedelic medicines. The group, consisting of doctors, psychiatrists, psychologists, nurses, paramedics, and social workers, argues that the current regulatory system is ‘unworkable’ and ‘overly restrictive’, potentially leading to patients seeking out psychedelic drugs from 'underground sources’. They argue that a more flexible and patient-centred approach is needed to ensure the safe and effective use of these substances in therapy.

AMAPP Chair Dr. Anthony Bloch has expressed that the current regulations are ‘counterproductive’ and limited by too much bureaucracy, at a time when a ‘mental health epidemic’ is taking over Australia and its healthcare systems. The group is advocating for increased flexibility and sharing of treatment roles and responsibilities by psychiatrists and therapists.

However, Australian General Practioners are urging caution moving forward, emphasising the need to ‘get it right’ when it comes to safe and effective treatments. They are particularly concerned about the potential for misuse or abuse of these substances outside of a controlled therapeutic setting.

This highlights the importance of careful regulation, ongoing research, and open dialogue among healthcare professionals, patients, and policymakers.