Mind Medicine Australia Formally Challenges TGA Interim Decision on Psilocybine-Assisted Therapy for End-of-Life Distress
On 29 May 2026, the TGA’s Delegate issued an Interim Decision refusing the joint application by Mind Medicine Australia and palliative care group EndWise to extend the Schedule 8 scheduling of psilocybine for use in psychotherapy for patients experiencing existential distress at the end of life.
We have reviewed the decision in full. It does not hold.
We are calling on clinicians, researchers, palliative care workers, patients, carers and concerned members of the public to make submissions against the interim decision and in support of the Mind Medicine Australia/Endwise application. The weight of clinical evidence, professional expertise, and public support that informed this application has not changed. The benefit we have now is we can all directly address the delegate’s arguments in the Interim Decision and highlight their lack of cohesion, compassion and fairness.
Make your submission before 3 July 2026: https://consultations.tga.gov.
What This Decision Means
The TGA has refused to allow terminally ill Australians access to psilocybine-assisted therapy for end-of-life existential distress: the fear, anxiety, and psychological suffering that accompanies a terminal diagnosis.
This was not an application to make psilocybine freely available. It was an application to extend an already-approved, already-regulated therapeutic framework to one of the most vulnerable patient populations in Australia: people who have been told they are going to die.
- 99.1% of public submissions supported it, including submissions from palliative care clinicians and medical professionals.
- Three major clinical trials at Johns Hopkins University, New York University, and St Vincent’s Hospital, Melbourne, each reported strong efficacy and no significant adverse events.
- The TGA’s own Delegate acknowledged that the therapy is safe and well-tolerated.
The application was refused anyway.
The Legal and Ethical Contradiction the TGA Has Not Addressed
Under Voluntary Assisted Dying legislation, now active in virtually every Australian state and territory, a terminally ill patient may legally choose to end their own life, provided they have an advanced, progressive, incurable condition, are experiencing intolerable suffering, and death is expected within 6 to 12 months.
The TGA’s Delegate has determined that this same patient cannot give informed consent to receive psilocybine-assisted therapy, a treatment the Delegate’s own decision acknowledges is well tolerated, with no severe adverse events reported across clinical trials.
We recognise that VAD legislation and TGA scheduling decisions operate under separate legal frameworks. That separation does not resolve the contradiction. It deepens it. The Australian state and federal system, taken together, permits a terminally ill person to legally choose death. According to this Interim Decision, it does not permit them to choose comfort and acceptance.
The delegate has not addressed this contradiction. We do not believe it can be addressed to justify the TGA’s negative decision.
What Was Applied For
In March 2025, Mind Medicine Australia and EndWise submitted a joint application to extend psilocybine scheduling to include end-of-life existential distress. The proposed controls were deliberately rigorous and modelled directly on the framework already approved by the TGA for treatment-resistant depression:
- Prescribers required to hold specific training in psilocybine-assisted therapy for end-of-life distress
- Diagnosis and treatment plan independently confirmed by at least one specialist reviewer
- Written informed consent required from the patient
- Treatment protocols approved by a Human Research Ethics Committee and the TGA
- Administration restricted to medically controlled, supervised environments. The patient could never take the medication home.
This was not a fringe application. It was a carefully constructed, evidence-based proposal built on a regulatory framework that the TGA had already approved and considered fit for purpose.
What the TGA’s Own Decision Concedes
The Interim Decision makes several concessions that are difficult to reconcile with its refusal to approve the application.
The Delegate’s own findings:
- Psilocybine is well tolerated by patients.
- No severe negative side effects were reported across the relevant clinical trials.
- 590 of 595 public submissions, 99.1%, supported the application, including submissions from palliative care clinicians and medical professionals.
- Psilocybine-assisted therapy represents, in the delegate’s own words: “a compassionate tool that restores dignity and agency at the end of life”.
The Delegate then refused the application.
The refusal rests primarily on the advice of the Advisory Committee on Medicines Scheduling (ACMS), whose minutes have not been made public, and whose membership, by the Delegate’s own account, includes no specialists in palliative care.
The ACMS Objections Do Not Withstand Scrutiny
The ACMS raised three concerns. Each warrants examination.
- On diagnostic criteria for existential distress: The committee argued that the application lacked clarity on how existential distress would be defined. Existential distress at the end of life is, by its nature, a subjective patient experience. It is assessed by the patient in consultation with their treating palliative care specialist, the two parties with the most direct and complete clinical knowledge of the case.
Standardised diagnostic criteria for a condition that is inherently personal would not strengthen patient protection. The existing clinical relationship, combined with the proposed rigorous oversight controls, is the appropriate safeguard. The committee has not explained what diagnostic standard it would find acceptable, nor why the framework approved for treatment-resistant depression, which also involves subjective symptom assessment, is insufficient here.
- On prescriber accreditation: The committee argued the accreditation process lacked clarity. The application proposed adopting the identical accreditation framework already approved by the TGA for psilocybine-assisted therapy for treatment-resistant depression: demonstrated clinical experience, specific training, and treatment protocols approved by a Human Research Ethics Committee and the TGA. If that framework is sufficient for one indication, the committee has not explained, and the Interim Decision does not explain, why it is insufficient for another.
- On dispensing controls: The same Schedule 8 dispensing mechanisms that govern psilocybine for treatment-resistant depression, and that govern ketamine and morphine, substances with significantly higher misuse potential, were proposed here. No explanation has been offered for why controls considered adequate for those substances are inadequate in this context.
The Reliance on Palliative Care Australia
The Delegate placed significant weight on a submission from Palliative Care Australia, which recommended awaiting the outcomes of more advanced clinical trials before amending the current scheduling.
This position has two problems.
- First, it is not a timeline. It is an indefinite deferral. The St Vincent’s Hospital trial, one of three major trials cited in the Delegate’s own decision, took six years to complete. Patients experiencing end-of-life existential distress do not have six years. In many cases, they do not have six months.
- Second, this argument has been made before in this exact context, and it did not prevail. When Mind Medicine Australia applied in 2023 to reschedule psilocybine for treatment-resistant depression, the Royal Australian and New Zealand College of Psychiatrists opposed the application on identical grounds: insufficient evidence, await more advanced trials. That application succeeded. The evidence base for psilocybine in end-of-life distress mirrors the trajectory of the treatment-resistant depression evidence base at the time of that successful application: multiple completed trials at leading institutions, consistent safety outcomes, strong signals of efficacy, and no significant adverse events in Australian clinical practice since the 2023 rescheduling.
The Regulatory Standard Being Applied Is the Wrong One
Rescheduling an existing substance for a new indication is not the same as registering a new medicine. The unapproved medicines pathway exists precisely for situations where there is no registered treatment for a serious condition and where existing evidence, while not yet at registration threshold, supports cautious, controlled access.
The conditions in this application clearly meet that standard. A terminal diagnosis is among the most serious conditions a patient can face. There are no currently registered medicines designed specifically to treat end-of-life existential distress.
The safety of psilocybine in medically controlled environments is undisputed. The Delegate’s own decision confirms it. The TGA’s Delegate applied a standard of certainty appropriate to full medicine registration to a decision that the legislation does not require to meet that standard. That is the wrong test, applied to the wrong threshold, in the wrong direction for the patient.
Next Steps
The Interim Decision is not final. The public consultation period is open until 3 July 2026.
Mind Medicine Australia will be lodging a detailed formal submission. We are working with legal and medical advisors and will pursue every available avenue within the regulatory framework.
We are calling on clinicians, researchers, palliative care workers, patients, carers and concerned members of the public to make submissions against the interim decision and in support of the Mind Medicine Australia/Endwise application. The weight of clinical evidence, professional expertise, and public support that informed this application has not changed. The benefit we have now is we can all directly address the delegate’s arguments in the Interim Decision and highlight their lack of cohesion, compassion and fairness.
Make your submission before 3 July 2026: https://consultations.tga.gov.
For further information and interviews please contact:
- Peter Hunt AM, Chair, Mind Medicine Australia +61 419 271 483 peter@mindmedicineaustralia.
org or hello@mindmedicineaustralia. org
