Mind Medicine Australia submits Australia’s first applications to reschedule psilocybin and MDMA

They write…..

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 by lodging your own supporting submissions with the TGA. The rescheduling of these medicines would be a historic moment for all of us!

Why is Rescheduling so Important?

Rescheduling is critical for 3 major reasons:

  1. To Expand the Medical Treatment Paradigm in Australia in a Major Way. Trials to date have shown that these medicines when used as part of therapy with proper treatment protocols in a medically controlled environment can provide high remission rates for key classes of mental illness (see above) when compared to current treatments (such as antidepressants and conventional therapy), require only 2 -3 dosed sessions with the medicines (in contrast to permanent or long-term use of pharmaceutical substances such as antidepressants) and have minimal side effects (again in contrast to pharmaceuticals such as antidepressants).
  2. To Educate Australians. To educate all key stakeholders in our medical system (eg medical practitioners, other health workers, politicians, regulators, people suffering from mental illness and other members of the general public) that these substances can be used positively and safely in a medically controlled environment to broaden the treatment paradigm for mental illnesses in Australia and substantially reduce the incidence of mental illness in our community.
  3. To Remove Stigma. To help the general community understand that the prohibition of psychedelics was politically motivated by a disgraced President of the United States (President Nixon), was not based on any scientific or medical rationale, and that the failure of our system to recognise that these substances can be used effectively as medicines in a medically controlled environment is detrimental to the health and welfare of a huge number of Australians.

Key Dates:

  • 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.

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