June 20th marks World Psychedelic Day, and for Australians it has special significance this year.
This is because in just a few days psychiatrists will be able to apply to become Authorised Prescribers of MDMA and psilocybin. Authorised Prescribers will be able to prescribe these substances as part of therapy, in controlled clinical settings for patients with treatment-resistant depression (psilocybin) and treatment resistant post-traumatic stress disorder (MDMA). To become an Authorised Prescriber, psychiatrists are required to submit an application to a Human Research Ethics Committee (HREC) and to the Therapeutic Goods Administration (TGA).
The TGA’s Authorised Prescriber scheme is the culmination of Mind Medicine Australia’s (MMA) rescheduling applications lodged in March 2022 and our objections to the interim decisions lodged in November 2022. The decision to reschedule and implement a compassionate access pathway recognises the tens of thousands of Australians who lodged their submissions in support, and the fact that treatment resistant patients aren’t benefitting from currently available treatments. Australia can be very proud of the fact that we are the first nation in the World to reschedule these medicines for medical purposes. Australia is now an innovative leader in the treatment of mental illness.
As Australia begins to deliver psychedelic-assisted therapies, MMA is supporting the roll out through a number of programs:
Establishing a register to record treatment outcomes
MMA is working with the university sector to establish a registry that will allow psychiatrists to record treatment outcomes. The collection of real world data will be pivotal to evaluating the success of the Authorised Prescriber scheme, to inform future regulatory change and expanded access.
MMA'S Certificate in Psychedelic-Assisted Therapies (CPAT)
Since 2021 Mind Medicine Australia has trained 240 psychiatrists, psychologists, psychotherapists, GPs, physicians, addiction specialists, mental health nurses, social workers and occupational therapists through its Certificate in Psychedelic-Assisted Therapies (CPAT). This training was recently described by Professor David Nutt as the “world’s leading CPAT training” on ABC Radio National and features a world class International Faculty. Many graduates have described the course as life-changing and the most outstanding professional development program they have completed. It is important to note that psychedelic-assisted therapies require a multidisciplinary team approach, so that whilst psychiatrists will be screening patients and prescribing treatments where suitable, the actual treatments are likely to be supervised by a range of therapists.
Our 2023 intakes begin in July and are fully subscribed. Upon graduating, another 120 clinicians will have successfully completed training in the delivery of psychedelic-assisted therapies.
In addition to training, ongoing clinical supervision is considered best practice for prescribers and therapists working in the field. We’re extremely excited to be launching a clinical supervision program for graduates of our CPAT program in July, which will ensure they have the guidance they need to begin practicing safely and effectively.
Supervision will be led by leading clinicians in PAT from around the world, including Dr William Richards (USA), Dr Ben Sessa (UK), Dr Lauren Macdonald (UK), Sara Reed (USA) and Dr Brian Richards (USA).
Supply of Psilocybin and MDMA
MMA has arranged for psilocybin and MMA to be supplied to Australian psychiatrists via a partnership with Optimi Health, a manufacturer of GMP psilocybin and MDMA based in Canada. Licensed pharmacists holding Schedule 8 permits will be responsible for holding and delivering the medicines around Australia. The supply chain will be tightly controlled at all times in strict accordance with Australian and State/Territory regulatory requirements.
This supply agreement will ensure there is medicine available onshore, making it considerably easier for Authorised Prescriber psychiatrists to access it for their patients.
Supporting those who cannot afford treatments
MMA has set up a Patient Support Fund (PSF). The PSF will receive donations from large to small philanthropists, and hopefully governments around Australia, to support those who cannot afford the full costs of treatments. We welcome donations here: https://mindmedicineaustralia.
This initiative is designed to help bridge the funding gap before funds from Health Funds and from the Australian Government’s Medical Benefits Scheme become available to patients in the future. The economic case for this and the need to reduce human suffering is overwhelming.
In addition to the PSF, MMA is advocating with health funds and other potential funding sources, to encourage them to begin funding these treatments.
These programs will support the psychiatrists and their teams delivering MDMA and psilocybin assisted therapies for patients with PTSD and treatment resistant depression, and the patients seeking to benefit from them. They will ensure positive outcomes as Australia leads the way in the delivery of psychedelic-assisted therapies.
In commenting on the way forward for Australia, Professor David Nutt, Head of Neuropsychopharmacology at Imperial College, said: “This is a landmark day for the tens of thousands of Australian families who are blighted by depression and PTSD as they will have access to powerful new treatments with unique mechanisms of action. And congratulations to Australia for leading the world in this vital treatment innovation.”
Executive Director of MMA, Tania de Jong AM said: “We are so pleased that some of the immense suffering being experienced in families, communities and organizations around the nation can be alleviated through these transformational therapies.”