Please Take 5 Minutes to Support Those Suffering from Existential Distress Towards End of Life to Have the Choice to Access Psilocybin-Assisted Therapy

We need your help - the TGA’s Public Submission Period is Now Open

The Palliative Care Psychedelic-Assisted Therapy Coalition has submitted an application to amend the psilocybin entry in the poisons’ standard, allowing its use for patients experiencing existential distress related to a life-limiting illness.

As a part of this process, there is a Public Submission period, which is open now.

Submissions closes at 5pm AEST on Wednesday May 21st.

Please make a submission to support this important initiative.

“I’m living still in that 3 monthly cycle, scan to scan to scan, and you don’t know what’s coming down the pipe. But as each one goes by I’m getting better at dealing with it, and I honestly think that that is the gift that started from this journey that I did with psilocybin”

Jo Farrell was diagnosed with stage 4 cancer in June 2022. In November she traveled to the Netherlands where psilocybin is legal, with the hope of learning to live with her diagnosis. She shares how this experience has helped her to live her life with a stage 4 cancer diagnosis. You can view the full video here.

“Those 3-4 hours of precious and blissful time were so much more comfort to me than the last 7 years filtered through the cancer treatment factory”

Bruno took part in a research trial at St Vincent’s, investigating Psilocybin-assisted therapy for existential distress associated with life-threatening illness. He passed away from cancer in 2022. In the eulogy he prepared before his death, Bruno spoke with gratitude about the comfort he found through his psilocybin experience. We honour Bruno’s memory and extend our heartfelt thanks to his family for generously sharing this video in support of the End Wise initiative.

Background Information

The Palliative Care Psychedelic-Assisted Therapy Coalition - in collaboration with Australia’s leading organisations in psychedelics and ethics - has submitted an application to amend the schedule 8 entry for psilocybin. If successful this application will:

  1. Recognise existential distress associated with life-limiting illness as an indication for psilocybin-assisted therapy, when used as part of the TGA’s Authorised Prescriber scheme.

  2. Enable doctors working in palliative care to become Authorised Prescribers for psilocybin, allowing them to support patients experiencing profound existential suffering towards the end of life.

The full application lodged by the Palliative Care Psychedelic-Assisted Therapy Coalition can be viewed using the button below. It contains the proposed amendment, a summary of the evidence base, as well as a letter of support from Australian and International leaders in the psychedelic field.

How to Make a Submission

  1. Click the button below to go to the TGA’s Consultation Hub

  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 all 5 proposals for this round. Psilocybin(e) is the second entry. See the screenshot below showing an entry that is supporting the proposal to allow access to psilocybin-assisted therapy for existential distress

  5. 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.

  6. For all other proposals, you can select “No comment”

Add a written statement to explain your reasons for supporting this initiative in the text box. For all other proposals you can select “no comment”

Some Guidance for Your Written Submission

In completing the written part of your submission you may want to comment on any of the following:

  1. Your experience of existential distress (ED) either as a clinician, a patient or someone who has a family member or friend who suffers or did suffer.

  2. Prevalence of ED is reported to be as high 51.8% in patients with cancers (Bovero et al., 2023). ED is a rational and human response to the great unknown of death. However, this shift of mental state unconsciously prevents the terminally ill getting the best of the little time they have left. ED erodes quality of life. Fear doesn’t prevent death, it prevents a full life.

  3. Current anti-depressant medications are inadequate for major depression in the context of cancer and have been found to offer no clear superiority over placebo (Ostuzzi et al., 2018). Even when they are effective, they have side effects for many people, including weeks or months to optimise (or even assess) efficacy. Treatment innovation is desperately necessary.

  4. Over the past decade, numerous high-quality clinical trials have demonstrated psilocybin’s strong safety and efficacy profile, particularly in alleviating anxiety, demoralisation and existential despair among patients nearing the end of life. Multiple international trials (e.g., NYU, Johns Hopkins, UCLA) have shown rapid and sustained reductions in depression and anxiety for people with terminal diagnoses. Go to http://bit.ly/434TOgS (page 26) for a literature review of psilocybin trials.  

  5. Studies show that Psychedelic Assisted Therapy (PAT), particularly psilocybin in the context of informed, appropriate therapy, can result in an increased sense of meaning, interconnectedness, and acceptance of death (Shnayder et al., 2022). The profound mystical experiences induced by psilocybin facilitate emotional processing, encouraging spiritual insights and personal transformation (Griffiths et al., 2016).

  6. PAT and palliative care share common goals and principles centred on holistic well-being and the alleviation of suffering, making a strong case for their integration. Both approaches aim to improve the experience of dying, which is a human condition, not only a medical one. PAT is a unique therapeutic modality that complements traditional palliative care interventions by addressing psychological and spiritual dimensions often overlooked in conventional treatments. 

  7. PAT is a compassionate answer to pain, suffering and indignity. Some people are suffering intolerably while dying. Creating a safe, legal pathway for accessing PAT towards end of life allows for more compassionate choices than our current laws permit. PAT is a merciful answer to insoluble pain, suffering and indignity in terminal illness.

  8. PAT aligns with the fundamental goals of palliative care: to relieve suffering, enhance quality of life, and respect patient autonomy. Just as our society has come to accept Voluntary Assisted Dying (VAD) as a choice for patients experiencing intractable end-of-life suffering, so too should patients have the option of psilocybin-assisted therapy if they are enduring existential distress. Denying such an option, particularly given the robust evidence for safety and efficacy, undermines patient-centred care. 

  9. Allowing psilocybin for this indication would reflect the same compassion and respect for patient autonomy that underpins the rationale behind VAD. We respectfully request that the TGA expand psilocybin’s scheduling to include end-of-life existential distress, thereby granting patients a scientifically grounded, ethically managed option for relief at a time they need it most. 

  10. A cognitively competent individual should have self-determining choices about their dying process if this does not interfere with the rights of others. As sovereign beings we are ethically entitled, and should have a legal right, to be protected from unnecessary suffering at the end of life.  

  11. International precedents: In Switzerland, since 2014 palliative care specialists and psychiatrists have successfully integrated psilocybin therapy in controlled, therapeutic frameworks to alleviate end-of-life psychological distress. In Oregon, USA psilocybin services became legal for individuals who meet the criteria set forth in the Oregon Psilocybin Services Act in 2023. The ‘Special Access Program of Health Canada has granted exemptions for certain individuals to use psilocybin for medical purposes, including palliative care. This accumulated data underscores the urgent need to make psilocybin-assisted therapy available to Australians facing life-limiting illnesses.

 FAQs

  • Yes!

    Every submission counts. In 2023, when psilocybin & MDMA was successfully rescheduled, the TGA received roughly 13,000 submissions, with over 95% in favour of rescheduling.

    In the decision, they made note of the number of submissions, demonstrating the need for new treatment options. It’s important we demonstrate similar widespread support.

  • The TGA’s public submission period is an important part of the rescheduling process.  A summary of the submissions received will be provided by the TGA to the Advisory Committee on Medicines Scheduling (ACMS) when it meets to consider our applications between the 17th and 19th June 2025.  Whether you are a health practitioner, researcher, someone with experience of mental illness or an interested member of the public the TGA is interested in your views.

    The ACMS provides a recommendation to the Delegate appointed by the Secretary of the Department of Health who actually makes the decision. This committee has 17 members, of which 8 are appointed by the Commonwealth Government and 9 are appointed by State and Territory Governments around Australia.

  • No, anyone can make a submission. Everyone's voice counts.

  • You are welcome to make an anonymous submission.

    You can select during the process whether to allow your submission to be made public or whether to maintain privacy.

  • No. Submissions are accepted from international supporters.

This is Your Chance to Support Choice, Compassion and Dignity for Those Nearing the End of Their Lives

The submission period ends May 21st 2025.

Please take action now, and share this page with your colleagues & friends.

If this proposal is not approved now, access to psilocybin-assisted therapy for end of life distress will be delayed for at least another 15 months. For many Australians facing a terminal diagnosis, that wait will be too long.

We have an ethical responsibility to act - to ensure that those nearing the end of life are offered meaningful, evidence-based options for relief, connection and peace.

Click the button below to make your submission.