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Will Australia be the First Country to Reap the Benefits of Psychedelic Medicines? Rescheduling Proposal Submitted to TGA

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On the 1st of September the nonprofit Mind Medicine Australia submitted a proposal to the Australian Therapeutic Goods Association (TGA), the regulatory body in charge of  the island country’s drug scheduling. This proposal was submitted in hopes of reclassifying psilocybin and MDMA from prohibited substances to controlled medicines.

If this proposal is successful, Australia will become the first country in the world to reschedule these substances for therapeutic purposes, potentially giving thousands of people access to life-saving treatments, and setting a precedent that has the potential to influence global policy and attitudes towards psychedelics.

If the application is successful, psychiatrists and addiction specialists will be able to access psychedelic medicines far more easily, allowing them to augment their current therapies to generate more effective treatments. This is especially important in the current context, as 1 in 5 Australians suffer from chronic mental illness, and suicide rates across Australia are on the rise. These newly-developed therapy solutions could be a very important tool in combating the mental health epidemic plaguing the country, and the wider global community.

Not only could this application allow patients easier access to these treatments, but it could also allow for much easier development of new solutions to mental health issues; potentially meaning a lot more research and innovation in less time. This has the potential to allow for important medical advancement in the next few years, especially considering the promising results from international research efforts.

One of the newly developed psilocybin based treatments for clinical depression developed by COMPASS pathways (IPO forthcoming) was awarded “breakthrough therapy” status by the FDA, which is reserved for candidates where research indicates significant superiority to existing medicines. This expected benefits of this treatment are so significant that the FDA approved Expanded Access Schemes to allow people to undertake these therapies before the clinical trials have even concluded.

If you would like to support this cause, Mind Medicine Australia is encouraging people to lodge submissions with the TGA in support of their proposal. These submissions will be open until the 28th of September, and you can learn more here.

On the 3rd of February 2021, the TGA will announce an interim decision on the matter, which will then be confirmed on the 22nd of April after a second round of submissions is taken into account. To stay informed about the changes in psychedelics regulations around the world, and other industry news, you can sign up to our weekly newsletter.

Written by Will Matthews for Psilocybin Alpha.

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