Australian Regulatory Framework Psychedelic Therapies

Glancing at headlines these days there appears to be a consistent stream of positive news breaking out all over the world about the potential therapeutic benefits of psychedelics, including a declaration from the FDA that psilocybin is a “breakthrough therapy.” Australia has also been involved in conducting some of the research and there are ongoing clinical trials that focus on ketamine for the treatment of depression, and psilocybin for the relief of anxiety in terminally ill patients.

In July 2020, Mind Medicine launched an application to down schedule psilocybin from a Schedule 9 Poison (prohibited drug) to a Schedule 8 Poison (prescription medicine). This was rejected by the TGA, and also opposed by the AMA, pending insufficient evidence and the need for more high-quality research using larger-scale studies.

Given the fact that there are now plans to construct an institute entirely dedicated to psychedelic medicines in Melbourne, as well as the recent news of Little Green Pharma being granted an Schedule 9 licence to produce psilocybin for clinical trials, the question that naturally arises is: “What is the future of psychedelics in Australia?”

There are many other resources that detail the background of the research and the very promising nature of psychedelics as therapeutic substances, so I am going to use this blog primarily as a thought experiment on how psychedelics could be practically integrated into the current Australian regulatory framework.

There are a few key areas to discuss:

1. The current regulatory framework for psychedelics vs medicinal cannabis.
2. The clinical model for psychedelic-assisted therapy and its limitations.
3. The most practical way to go forward without re-inventing the wheel.
4. Key considerations for the future.

Before we start I am going to clarify two things:

First, when I refer to psychedelics I am talking specifically about hallucinogenic psychoactive substances such as psilocybin, DMT, Peyote, etc. as well as any other substance that could be used under the psychedelic-assisted therapy model (e.g. MDMA for PTSD).

Secondly, there are drug substances that are being used to investigate different health outcomes (I’m thinking primarily of ketamine). In this case, the psychedelic-assisted therapy model will not apply when the substance is administered under different clinical parameters, e.g. ketamine for depression versus ketamine for surgical pain relief.

1. Current Regulatory Framework for Psychedelics vs Medicinal Cannabis

It is easy to assume that psychedelics will follow in the wake of the medicinal cannabis industry, however, medicinal cannabis and psychedelics are two very different pharmacological compounds with very different clinical applications. For brevity, the table below provides a very high-level summary:

2. The Clinical Model for Psychedelic-Assisted Therapy

The current framework for psychedelic-assisted therapy proceeds as follows:

1. Preparation – a licenced and trained therapist takes the patient through a talk therapy session to prepare them for the application of the drug and focus of the therapy/trauma.
2. Application – the patient arrives at the clinic and is given the psychedelic under the monitoring and guidance of the trained therapist. It is often recommended for two therapists to be present.
3. Integration – the patient undergoes more talk therapy post-session to reconcile the psychedelic experience in the context of the specific trauma.

Steps 2 and 3 are repeated once more, after which a follow up is conducted after 6 months.

Given this model, it is clear that psychedelics will not be able to be accessed in the same way as medicinal cannabis as they must be administered in a controlled setting under the supervision of a licenced therapist (likely to be registered medical practitioners and/or psychologists who have received specific training).

3. How Would Psychedelic-Assisted Therapies Fit into the Australian Framework?

Given the administrative burden that would come from developing an entirely new framework to integrate the use of psychedelics into the Australian systems, I would like to present an alternative. Bear in mind the following scenario rests heavily on whether psychedelic-assisted therapy is approved as a treatment, and psychedelics (or specific psychedelic substances) are down scheduled from Schedule 9 to Schedule 8.

The controls required for the administration of psychedelics are quite similar to a model that already exists in Australia, which could be adapted to suit the new therapy framework.

I’m talking specifically about Methadone clinics.

Methadone, classed as a Schedule 8 poison, is administered in specialist clinics under Methadone Maintenance Treatment (MMT) protocols for opioid detoxification.

Given that the Methadone topic can be negatively charged, I will ask the reader to take one step back and to only look at the regulatory design as it appears to be a promising model to leverage off for future psychedelic regulations. The following key points have been adapted from the Victorian Clinical Guidelines for MMT:

• The substance is legally available under S8 on a doctor’s prescription, provided the doctor has an S8 permit from the State Health Department, and is licenced in delivering psychedelic-assisted therapies.
• The system is based on supervised dosing, where treatment is delivered by a doctor, or from a specialist treatment service (under the psychedelic-assisted therapies model). The treatment team includes a doctor, a counsellor and a dosing service.
• In general, these specialist services only accept clients referred from GPs.
• The counsellor and/or doctor is available to discuss problems, goals and anything else that is important to the therapeutic process.

Given the known restrictions in the administration of psychedelics, that sounds like a pretty compatible framework to me.

4. Key Considerations for the Future of Psychedelics

I have a few questions that are mostly focused on the regulators and the manufacturers, namely:

1. Will the Office of Drug Control become involved in controlling psychedelic cultivation and manufacture as they do medicinal cannabis, or will it be left to the Australian State and Territories to control?
2. Will those producing psychedelics want to focus on herbal cultivation, or will they leverage the option to synthesize the pure psychedelic chemical in vitro?
3. Will psychedelic-assisted therapies be limited to certain health conditions?

On the last point, to throw in an additional twist to this thought experiment, Michael Pollan, author of the heralded “How to Change Your Mind,” which focused on psychedelics and what they can teach us, made an interesting point during the Fantastic Fungi Global Summit. He stated the following:

“I hope that we have figured out the proper container to offer psychedelic experiences to well people, or people simply struggling with the normal unhappiness and anxieties of life.”

There is an initiative in America called “Oregon Measure 109”, which has created a program for administering psilocybin products to individuals aged 21 years or older. In this program clients would be allowed to purchase, possess, and consume psilocybin at a service centre under the supervision of a facilitator after undergoing a preparation session.

During the design of the future Australian psychedelic-assisted therapy framework, I believe there should be some consideration as to whether the treatment options should be limited to specific conditions, or whether there is some scope to open up the treatment to those who don’t suffer from such extreme health conditions.

While psychedelics and psychedelic-assisted therapy is still in its infancy in Australia, it will certainly be interesting to see how the field and the regulations develop in the future.

Want more?

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• What is the difference between GACP and GMP?
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• Psychedelic Therapies in Australia – the next steps forward