TGA Rescheduling Submissions
Mind Medicine Australia has submitted Australia’s first applications to Australia’s Therapeutic Goods Administration (TGA) to reschedule psilocybin and MDMA so that they can be more easily used as clinical therapies for the treatment of mental illnesses. The rescheduling would move these medicines from Schedule 9 of the Uniform Scheduling of Medicines and Poisons (which deals with Prohibited Substances) to Schedule 8 (which deals with Controlled Medicines). The changes proposed by Mind Medicine Australia will not affect existing legal controls on illicit use or supply.
The rescheduling will enable psychiatrists and specialist addiction physicians to more easily access these medicines to augment therapy for patients suffering from key mental illnesses such as depression, PTSD and for the depression and anxiety often associated with a terminal illness diagnosis (and hopefully in the future for substance abuse, OCD, anorexia and early stage dementia). It will also relieve a significant part of the regulatory burden associated with undertaking trials with these medicines in Australia.
We are inviting you to support our applications for the rescheduling of these two medicines. The rescheduling of these medicines would be a historic moment for all of us!
- Wednesday 26th August 2020 – TGA publishes notices seeking submissions on the proposed rescheduling by Friday 25 September.
- Monday the 28th of September 2020 – The final date for making a submission closing at 5 pm AEST. Following the submission of public comments, the submission will be reviewed by an expert committee.
- Wednesday the 3rd of February 2021 – An interim decision will be published by the TGA inviting comments from those who made a public submission in the first round. Therefore, it is important to make a comment in the first round if you would like to comment on the interim decision.
- Thursday the 4th of March – Submissions for comments on the TGA’s interim decisions close at 5pm AEST.
- Thursday 22 April 2021 – Publication of notice of the final decision.
“I have personally had three patients complete suicide in the past 5 months. All three patients were fully treated with the best available treatments including antidepressant therapy, psychotherapy, and intensive case management. It is frustrating and heart-breaking to have complete treatment failure in the majority of my patients with the best currently available therapies. I currently have another patient suffering end of life anxiety after a diagnosis of rapidly progressing motor neurone disease. She has requested psilocybin-assisted psychotherapy as she has tried every other available treatment without any relief of her symptoms. The evidence favouring the use of psilocybin to assist with end of life anxiety also appears very promising and there appear to be no side effects.” – Jessica Hickmott, Psychiatrist
“Current first line therapies for post-traumatic stress disorder have limited efficacy, with pharmacological treatments usually requiring costly and potentially side-effect prone daily use. Only 20-30% of PTSD sufferers fully respond to pharmacotherapy. Tragically, many of these patients are former soldiers and emergency responders who have spent their lives serving our nation” – Jesse Schnall, Junior Medical Doctor
”The most complex patients I see engage in regular therapy for years. For many, sub-optimal early life relationships and experiences have resulted in deeply ingrained belief systems which consider the patient to be unlovable, unworthy, and a source of shame. These “self-stories” are embedded within the Default Mode Network, a large-scale brain network which is highly active in rumination and self-criticism, and highly impervious to reason and re-framing. Traditional therapy can be beneficial, however the enormous commitment of time and finances required to begin to “re-story” these belief systems can be a challenge and is often an exclusory factor.” – Caroline Dale, Clinical Psychologist
“Being born Jewish and having lost many of my relatives in the Holocaust, I’ve lived with inter generational trauma for as long as I can remember. I was never really aware of what exactly was holding me back until I experienced supervised psilocybin treatments in the Netherlands. Since then I have been able to release and heal much of this trauma and also washed away lifetimes of collective trauma that we all carry along with us. I feel a deeper sense of identity, greater insight, compassion and connection. This has helped me to be more authentic and vulnerable in my relationships and has improved my productivity and creativity. It’s like all these missing parts of myself have been found. I am more integrated and much calmer.” – Tania de Jong AM, co-Founder of Mind Medicine Australia and lived experience
“In my case, conventional treatments over a number of years have resulted in a greatly reduced quality of life and long-term dependence on prescription medication, as well as significant monetary costs and damage to my professional carrier, all without resolving the health conditions that have led to such treatments. Over the last two years I desperately explored alternatives to the conventional treatments and have identified psilocybin as the most promising medication for my condition.” – Terry Catipovski, Patient with lived experience
“I have had my own personal struggle with treatment-resistant depression for over two years and have experienced firsthand the displeasure of trialling twelve currently approved treatments, many of which have worsened my condition in the form of extra pyramidal side effects, kidney damage and cognitive impairment. I can only dream of what my life could have looked like if psilocybin was approved when I was in dire need of life-saving treatment.“ – Dr Nicola Santarossa, General Practitioner
Within in an hour I completely came back into existence. I felt connected again to my body and mind. I was no longer a walking corpse but instead was re-discovering freedom again. It was the experience of being able to see, to smell, to taste and hear the world in the way it should be. The calmness within my soul combined with the electricity of life felt enormous in comprehension. My brain was functioning normally again for the first time in 18 years.” – Jerry Gigez, Patient with lived experience
“Mental health statistics in Australia and globally support the proposition that current treatments are woefully inadequate. There has been no effective innovation, no effective alternatives developed for many decades in regard to anti-depressants and PTSD. The pharmaceutical industry vacated the innovation space long ago.” – Andrew Robb, Chairman of the Robb Group