Preventing Suicide and Suffering

Through the work of MMA and our many supporters we are helping medical practitioners who are seeking approvals at the Commonwealth Government level (via the TGA’s Special Access Scheme-B pathway) so that they can prescribe the use of medical grade psilocybin and medical grade MDMA as part of a short course of psychotherapy in medically controlled environments for individual consenting patients suffering from treatment-resistant depression or treatment-resistant Post-Traumatic Stress Disorder. A significant number of these approvals have now been given by the TGA. However, barriers remain at the State and Territory levels around Australia because of a legislative failure within these jurisdictions to distinguish between the recreational and medical use of these substances.

We also run the Certificate in Psychedelic-Assisted Therapies (CPAT) course for mental health practitioners, the only course of its kind in the Southern Hemisphere. This is crucial to ensuring that we have a pool of highly trained medical practitioners and therapists to provide these treatments when all necessary government approvals have been given. By the end of 2021 we will have trained nearly 100 health practitioners and we expect to train a further 200 in 2022. The course faculty is led by two outstanding clinical leaders and contains many of the leading researchers, psychiatrists, therapists, pharmacologists, researchers and other clinical experts in this field in the World. The testimonials that we have received from participants about the quality and relevance of the course have been outstanding.

We have applied for the rescheduling of medical grade psilocybin and medical grade MDMA when used as part of therapy in medically controlled environments from Schedule 9 (Prohibited Substances) to Schedule 8 (Controlled Medicines) of the Commonwealth Government’s Standard for the Uniform Scheduling of Medicines and Poisons (often referred to as the Poisons Standard). Rescheduling will open up legislative permit pathways in individual States and Territories around Australia to enable medical practitioners who receive an approval from the TGA to use one of these medicines as part of therapy for a specific patient to also be able to apply for the necessary medical consent from the Government of the State or Territory where they and their patient reside.

Earlier this year the TGA announced the establishment of an independent inquiry to advise on whether the requirements for a Schedule 8 medicine had been established.
On 30 September 2021, the TGA published the findings of the Independent Panel Review which confirmed that research supported the conclusion that these medicines were well tolerated by patients when given in a medically controlled environment and produced statistically significant results. These findings confirm the advice that we have previously received from our own experts which formed the basis of our rescheduling application.

The next stage of the rescheduling process is for the Independent Panel’s report to be considered by the TGA’s Advisory Committee on Medicines Scheduling in early November with a final decision being made by the Government Delegate and published by the TGA in early December.
Given the findings of the Independent Review Panel we are very hopeful that the proposed rescheduling will occur. Please note that rescheduling only provides patient access approval pathways around Australia on an individual patient by patient basis and State and Territory Governments will still need to develop approval policies and consider each patient application on its merits. However, rescheduling will be a defining moment in Australia because for the first time there will be real hope that patients suffering from treatment resistant conditions will be able to access these therapies from trained medical practitioners and therapists (working together as part of a team) thereby giving these patients the chance to experience a treatment that has not only been shown to be safe in overseas trials but also to provide the patient with a real chance of getting well.