Australia: TGA say “there is not yet “established therapeutic value” of psilocybin and MDMA” after latest push for rescheduling

Here’s what Mind Medicine in Australia are saying post the latest TGA missive

Six months ago, we asked for your help to show the regulators that we are sick of being denied fair access to the highest standard of health care available, and that Australians demand fair access to safe and clinically controlled psychedelic-assisted therapy.

It is a basic human right to have access to safe and effective medicines under the UN Right to Health. This is a human right which we are currently breaching as a society, and one that history will not judge us kindly for.


Our goal was ambitious… Up until our rescheduling applications to the TGA for psilocybin and MDMA, Cannabis was the biggest public submission campaign to date, with roughly 6000 submissions made.


We wanted to match, or even top that to represent YOUR voice. You are an Australian citizen that applies a common sense approach to risk, is well informed with emerging research and you don’t have your head buried in the sand when it comes to the very serious issue of mental health.


The good news is, we did it.


With your help, we were able to drive a whopping 13,155 submissions for this campaign – 6,650 for Psilocybin and 6,505 for MDMA!

And incredibly, over 98% of these showed either full or partial support for rescheduling.


This means you were just part of the biggest public advocacy effort for medicine rescheduling in Australian history.


So for that, please accept our enormous gratitude and love.


In fact, it was so large that the TGA had to delay even coming back with their decision because, as they told us directly, they were overwhelmed by an “extremely large amount of public interest”.


So that’s the good news, we sent them a message, loud and clear.


But like all battles for truth and fairness, it is not over.


Despite this public demand and strong scientific evidence to support these safe and effective therapies, the TGA has still come back with their Interim Decision saying there is not yet “established therapeutic value” of psilocybin and MDMA.


And that even for someone that is treatment resistant, has tried everything else, and is on the verge of committing suicide…they cannot access these medicines legally in Australia.


According to them, psychedelic-assisted therapy, under the guidance of AHPRA trained psychiatrists and psychotherapists, that have been trained by world leaders like Bill Richards, David Nutt and others from our CPAT faculty that have actually done psychedelic-assisted therapy when it was legal in 60s…. is still too risky. Even if someone has tried everything and is on the verge of suicide.


To be frank, we find this incredibly sad, inhumane and unfair to all those suffering people who would like access to these therapies and who see the global evidence that these therapies can be used safely with very positive results in controlled settings.


The TGA’s response also contains an inexplicably misleading statement as highlighted below:


“In the case of MDMA, expanded patient access schemes have been instituted in countries including the United States, Israel and Switzerland under compassionate grounds for the treatment of PTSD.


These are analogous to the current use of the Special Access Scheme in Australia, which allows patient access to Schedule 9 substances with approval under particular circumstances.”


Not a single patient has been able to access these therapies in Australia via the Special Access Scheme-B, despite over 20 patients being granted permits through their doctors by the TGA. This is because of the dysfunctional way our Federal system for Schedule 9 medicines works. The unbearable suffering of so many people and the failure of current treatments to help them is the entire reason why we are pursuing rescheduling.


This Interim Decision is now put out to the public to comment until the 24th of November, and we need your help to tell them what you think about this draft decision.

So here’s what you can do to help:

1. Visit our TGA Interim Decision page to learn about the delegate’s response to rescheduling and our rebuttal to their points.

2. Take 5 minutes to voice your opposition to the decision not to reschedule MDMA and psilocybin under the highly restricted conditions put forward in MMA’s applications.

3. Spread the word – every one of us needs to do everything we can to raise awareness of this important issue and build even greater support for giving treatment resistant patients an access pathway to these treatments.

View MMA’s response to the TGA’s Interim Decision and show your opposition to that decision>>

Again, thank you for helping us right this social wrong and advance the state of mental health care in this country. Together we can help so many suffering Australians so that they have the chance to get well and lead happy and meaningful lives.


The night is darkest before the dawn.




MMA Team

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