Australia: Mind Medicine “The TGA has issued an interim decision refusing an application by Mind Medicine Australia and Endwise to allow authorised palliative care specialists to prescribe psilocybin-assisted therapy for patients experiencing severe end-of-life existential distress.”

The TGA has issued an interim decision refusing an application by Mind Medicine Australia and Endwise to allow authorised palliative care specialists to prescribe psilocybin-assisted therapy for patients experiencing severe end-of-life existential distress. This decision comes despite strong clinical evidence of safety, promising efficacy data, and overwhelming public support — with more than 99% of public submissions supporting the proposal.

For terminally ill Australians facing profound psychological suffering, this is a cruel decision that denies access to a treatment which may help bring peace, meaning and dignity at the end of life.

Public submissions are open until 5pm 31 July 2026 (AEST), and we urgently need your voice. We’d be grateful if you could make a submission — and please note that your partners and colleagues are also welcome to submit on your behalf or alongside you. It only takes a few minutes.

To learn more, visit the Endwise website: https://www.endwise.au/get-involved

Here are the quick and easy steps to OPPOSE the TGA’s Interim Decision:

1. Click the link below to go to the TGA’s Consultation Hub: https://consultations.tga.gov.au/tga/scheduling-interim-decision-psilocybine-june-2025/consultation/subpage.2020-08-24.4118714205/
2. Read the information on the opening pages and click “Continue” to move through the forms
3. Fill out your personal details, select “individual” or “organisation”, and select whether you are a “Consumer/Patient”, “Registered Healthcare Practitioner”, “Professional Researcher” or “Responding out of Personal Interest”
4. On the “Consultation Page” you will see the proposal to amend the Controlled drugs (Schedule 8) entry of psilocybine (also referred to as psilocybin) to include a new indication to allow supply for existential distress towards end of life.
5. Then select the option to NOT SUPPORT the interim decision. See the screenshot below

6. In the “Short-text response” you can write a statement explaining your reasoning for supporting this initiative. If you have prepared a written statement, you can upload a PDF at the bottom of the page.
7. Finally, progress through the other pages and submit.

Thank you so much for your support — it truly matters.

With warm wishes and deep gratitude,
MMA Team