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.