Australia Opened a Restricted Prescribing Pathway for MDMA and Psilocybin

On 3 February 2023, Australia’s Therapeutic Goods Administration rescheduled MDMA and psilocybin from prohibited substances to controlled medicines for narrowly defined psychiatric use. The decision took effect on 1 July 2023. It permits specifically authorized psychiatrists to prescribe MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression.

For Tania Jong, co-founder of Mind Medicine Australia, the decision was both improbable and intensely personal. When her husband Peter showed her the regulatory document, she assumed it had to be an error. The pair had spent years making and remaking the case after prior applications were rejected at both interim and final stages. Once the decision sank in, she said, they began “dancing around the kitchen.”

The framework mattered because it was not a general legalization regime. The TGA material shown during the discussion specifies that prescribing is limited to psychiatrists authorized through its Authorised Prescriber Scheme. MDMA is available for PTSD and psilocybin for treatment-resistant depression; both remain controlled medicines administered within a clinical system.

The rescheduling decision created the legal route. It did not itself create the clinics, trained therapists, public understanding, payment mechanisms, data systems, or treatment protocols required to make that route usable. De Jong’s central claim is that Mind Medicine Australia worked on those separate layers in parallel, because regulatory permission without delivery infrastructure would leave patients with a right that few could exercise.

An applicant psychiatrist, as de Jong describes the process, must specify the medicine, dose, treatment setting, protocols, and safeguards. The application is reviewed by the TGA and an independent ethics committee. The model is therefore therapy-led and supervised, not access to a drug alone.

The initial scale remains modest against the need de Jong describes. She said more than 20 clinics had opened around Australia and roughly 400 patients had received treatment at the time of the discussion. In her account, that is an important proof of implementation, but a small fraction of the Australians living with PTSD or depression.

Mind Medicine Australia’s estimate was that treatment initially leaned toward MDMA-assisted therapy for trauma—roughly a 70/30 split over psilocybin, though psilocybin use was increasing. Many psychiatrists, she said, began with MDMA because they felt more comfortable administering it.

De Jong did not enter the field as a clinician, researcher, or drug-policy advocate. She described herself as someone who had barely consumed alcohol, did not drink coffee, and had never used drugs. In 2015, a post by Tim Ferriss led her to Michael Pollan’s New Yorker article “The Trip Treatment,” about psilocybin research.

The article prompted a question that became central to her later work: if research subjects with severe depression could have consequential therapeutic experiences, what might these treatments mean for people carrying trauma, chronic distress, or despair?

She and her husband first explored the subject outside Australia after failing to qualify for a European clinical trial because neither had a psychiatric diagnosis. They were introduced to a guide in the Netherlands and undertook psilocybin sessions that de Jong describes as transformative but difficult. Her fear beforehand was acute enough that she emailed her accountant instructions in case something happened to her.

The sessions, she said, changed how she experienced nature, strengthened her relationship with her husband, and took roughly a year to integrate. Her description is not of a quick conversion or a simple positive experience. Material relating to family and ancestry surfaced; she initially believed she would never repeat the experience. A later session was, in her telling, even more profound.

The practical question followed from the personal one. The couple had already founded charities and had encountered people dealing with homelessness, disability, unemployment, domestic violence, addiction, depression, and intergenerational trauma. De Jong’s view was that mental illness and trauma often sit beneath these forms of disadvantage. If psychedelic-assisted therapy had affected them so strongly, she wondered whether it could offer an option for people whose suffering was more acute.

That conclusion led to a deliberate period of immersion. The couple attended conferences, watched lectures, met researchers, and sought out figures including Rick Doblin, Roland Griffiths, Robin Carhart-Harris, and David Nutt. Doblin encouraged de Jong in 2018 to establish an Australian charity focused on the field. Mind Medicine Australia launched in February 2019.

Australia, in de Jong’s account, had very little domestic infrastructure at that point. One trial was being developed for end-of-life anxiety and distress, while much of the relevant evidence, clinical practice, and scientific leadership sat overseas. The task was not only to advocate for rescheduling. It was to make a case that Australia could introduce a controlled treatment pathway without waiting for every piece of infrastructure to emerge organically.

The formal objective was to move MDMA and psilocybin from Schedule 9, Australia’s category for prohibited substances, to Schedule 8, the category for controlled medicines used under clinical conditions. Mind Medicine Australia’s first approach to the TGA came in late 2020, according to de Jong. The organization submitted an application at the regulator’s encouragement, but it was rejected at both interim and final stages.

A subsequent application was also rejected at the interim stage. De Jong’s account of the strategy is notably procedural: the TGA had to provide reasons for its decisions, and those reasons became the basis for revised submissions. Peter de Jong focused on answering the regulator’s stated concerns rather than treating rejection as a final answer.

1. February 2019
   Mind Medicine Australia launches, with the stated aim of building access to psychedelic-assisted therapies in Australia.
2. Late 2020
   The organization approaches the TGA about rescheduling MDMA and psilocybin; its early application is ultimately rejected.
3. 2021
   Mind Medicine Australia begins its Certificate in Psychedelic-Assisted Therapies, before the new prescribing route exists.
4. 2022
   A revised rescheduling campaign combines public consultation, clinician engagement, a David Nutt roadshow, and a presentation to TGA and Department of Health staff.
5. 3 February 2023
   The TGA announces its final decision to reschedule MDMA for PTSD and psilocybin for treatment-resistant depression.
6. 1 July 2023
   Authorized psychiatrists can begin prescribing under the new Australian framework.

The campaign paired iterative regulatory work with public organizing. Mind Medicine Australia created templates and precedents intended to make public submissions easier to prepare. It established more than 30 local chapters across Australia and New Zealand, and held webinars and presentations for politicians, clinicians, business leaders, and community audiences. De Jong estimated that the group gave thousands of presentations over the course of the campaign.

The resulting consultation response, she said, included more than 13,000 submissions supporting the final application, with more than 98% in favor of rescheduling. She described it as the largest number of public submissions the TGA had received for a medicine-rescheduling decision.

The point was not merely to create numerical pressure. The campaign tried to make the issue intelligible to several groups with different concerns: families looking for options after treatment failures; clinicians who would need to administer therapy; politicians and public servants concerned with safety; and payers that might eventually face the cost.

The organization’s larger lesson for advocates is that a rescheduling application is only one instrument. The work also involves building public legitimacy, professional capability, scientific relationships, and a credible answer to the question regulators reasonably ask next: if authorization is granted, who will treat patients, under what protocols, and with what accountability?

De Jong calls the strategy “building the ecosystem.” In practice, that meant clinical training, an advisory panel, public education, research support, clinics, payer engagement, and a patient-support fund. These were not functions granted by the TGA. They were organizational efforts Mind Medicine Australia says it developed around the restricted prescribing pathway.

Training began in 2021, before clinical access commenced. De Jong said Mind Medicine Australia’s Certificate in Psychedelic-Assisted Therapies has trained more than 750 clinicians, including psychiatrists, psychologists, doctors, nurses, occupational therapists, social workers, and counselors.

That sequencing was strategic. If access arrived before a workforce existed, authorization could remain mostly theoretical. Training also created a network of clinicians who could bring the issue to professional bodies and participate in the public debate. De Jong says the training was one reason the group could mobilize clinicians alongside patients and families during the rescheduling campaign.

Mind Medicine Australia also assembled an advisory panel of roughly 75 scientists, clinicians, researchers, and advocates. De Jong’s recruitment method was direct: travel, meet people, explain the Australian objective, and ask. At a Usona conference in Wisconsin, she spoke about what she hoped to achieve in Australia and sang at the event. The relationships she formed there gave her access to researchers including Carhart-Harris and Griffiths.

David Nutt became a particularly important collaborator. De Jong invited him to speak at Mind Medicine Australia’s 2019 launch at the University of Melbourne. He later returned to Australia several times, including for the 2022 roadshow that culminated in a presentation to TGA and Department of Health personnel.

Ferriss draws a practical lesson from this history: seemingly peripheral facts can create access to people and institutions. A cold email, an invitation to speak, a conference appearance, an unusual skill, or an introduction through a mutual contact may matter as much as a formal policy memo. De Jong’s version is similar but more operational: people often say yes if asked, and a movement needs to be prepared to ask repeatedly.

The most consequential persuasion effort in de Jong’s account came late in the second rescheduling process. In 2022, Mind Medicine Australia brought Nutt to Australia for public town halls, stakeholder events, and meetings with policymakers. It also asked the TGA to permit a presentation to Department of Health and TGA staff.

The head of the TGA initially estimated that perhaps 10 or 15 people would attend. De Jong said 140 joined, some in the room and some remotely.

The event paired research evidence with family testimony. A woman identified as Vanessa spoke about her husband, Franco, who had developed severe depression despite having no previous history of it. His family sought medical care, tried antidepressants and other treatments, saw specialists, and maintained a 20-page record of interventions.

Vanessa had earlier contacted de Jong to ask whether Franco could receive psychedelic-assisted therapy. At the time, the answer was no. Legal treatment abroad was not feasible because Franco was too unwell to travel, while the family did not want to seek illegal treatment in Australia. Franco later died. Vanessa told the TGA audience that she believed access to the therapies might have meant her husband was still alive and their daughter still had a father.

Nutt followed with a presentation on research findings and clinical evidence. De Jong says there was “not a dry eye” after Vanessa spoke. But the organization’s intended argument was not that grief should substitute for evidence. It was that regulators should recognize a risk on both sides of the decision. Maintaining prohibition does not preserve a neutral status quo for people who have exhausted available treatment options.

Mind Medicine Australia heard similar appeals from patients, families, clinicians, and politicians seeking help for relatives or constituents, de Jong said. The organization could not provide medicines before the rules changed, but those requests formed part of its argument that delay carried human costs.

That claim did not resolve the underlying disagreement. Some researchers and clinicians believed access should remain confined to trials until more evidence was available. De Jong says she encountered researchers who wanted another five to 10 years of research, including replications of studies already conducted in other countries.

Her position was not that research should stop. Mind Medicine Australia has helped fund work on potential uses of psilocybin for eating disorders, obsessive-compulsive disorder, and other conditions. The disagreement was narrower but consequential: whether the evidence for MDMA in PTSD and psilocybin in treatment-resistant depression was sufficient for tightly supervised access, or whether Australia should wait for more domestic research.

De Jong repeatedly resists treating MDMA or psilocybin as casual or stand-alone interventions. The Australian model she describes involves screening, preparation, monitored medicine sessions, and post-session integration. Treatment commonly unfolds over three to four months.

The therapy component is not standardized into one mandated modality. Clinicians trained through Mind Medicine Australia may draw on Internal Family Systems, trauma-informed approaches, and other therapeutic methods. De Jong favors this flexibility, arguing that a cookie-cutter model does not suit either individual patients or clinicians with different skills.

The flexibility has limits. In her account, patients need appropriate screening and preparation before dosing, and substantial help afterward in translating an altered-state experience into daily life. Nutrition, exercise, social connection, and behavioral change may all matter in integration. A patient who returns to the same damaging circumstances, substance use, relationships, or routines may not sustain improvement.

Ferriss frames the same point in terms of a “critical window” of neuroplasticity. Psychedelics may make longstanding beliefs and behaviors more changeable, he argues, but they do not automatically create new habits, environments, incentives, or support systems. The opportunity has to be used.

De Jong reported remission rates of roughly 60% to 80% among Australian patients treated so far and said no serious adverse events had been reported to the TGA. She characterized those figures as resembling results seen in overseas trials. Ferriss contrasted them with what he described as 10% to 15% remission rates for existing PTSD treatments.

The next strategic question is whether real-world outcomes hold up as access expands. Mind Medicine Australia funded, but does not control, a registry at the Australian National University, developed with Professor Paul Fitzgerald. The registry collects patient data from baseline through treatment and follow-up. De Jong said results had not yet been published, but expects periodic publication as more cases are collected.

For her, the registry is clinically and politically important. It could show whether remission persists outside small trials, identify shortcomings, establish a safety record, and make future discussions with government and payers less dependent on aspiration. The registry remained unpublished at the time of the discussion, so its evidence was still prospective rather than a demonstrated result.

Rescheduling did not solve access. Treatment is expensive largely because it requires extensive clinical time, not because the medicines themselves are costly. De Jong said a course at the Mind Medicine Australia Clinic in Abbotsford, Melbourne—operated through a joint venture with the publicly traded company Incannex—can begin at about A$8,000 for one treatment and rise to approximately A$25,000 for a fuller three- to four-month course with medicine sessions and integration.

In U.S. terms, the discussion placed that at roughly $5,000 for an initial treatment and up to about $15,000 for a more extensive course. MDMA may involve up to three medicine sessions, de Jong said, while psilocybin protocols may involve up to two.

The major expenses are screening, preparation, long dosing sessions, therapists’ time, and integration. Ferriss noted that a dosing session can take five or six hours. When two clinicians are present for portions of care, the labor cost rises further.

That creates a structural tension. High-supervision standards are intended to protect patients, particularly because many seeking above-ground treatment are severely unwell. But those same standards limit capacity and price many people out. De Jong’s position is not that safeguards should be removed. It is that regulators should distinguish necessary protections from administrative requirements that do not materially improve care.

One example was a prior rule under which only clinical psychologists could act as lead therapists. Mind Medicine Australia wrote to the TGA with a case for allowing other qualified practitioners. De Jong said the rule was subsequently broadened.

The organization is also considering how group integration, group treatment models, video recording, and different staffing configurations might change the cost structure. De Jong says every clinic records sessions. That raises an operational question: in some circumstances, could one clinician with video oversight provide adequate support? Ferriss also argues that group treatment may reduce costs and, potentially, improve outcomes through shared experience and peer witnessing. Neither treats these ideas as automatic substitutes for clinical judgment or regulatory review.

De Jong expects expansion from a small base. She said Australia had moved from one or two authorized prescribing psychiatrists at the beginning of 2024 to 120 later that year. The number of trained therapists rose from roughly 80 in the first year to 750, while treated patients rose from a handful to nearly 400. Her conservative estimate was that 5,000 people might be treated over the next three years.

Payment is therefore as important as authorization. De Jong says Mind Medicine Australia began engaging potential payers early, especially the Department of Veterans’ Affairs. Veterans and first responders were a strategic focus because of service-related trauma and suicide.

The organization also created a Patient Support Fund, supported through philanthropy, to subsidize treatment for people unable to meet the upfront cost. The displayed fund material says it can contribute up to 50% of costs, capped at A$10,500 per patient. Its stated fundraising target was A$2.5 million.

De Jong’s cost argument is long-term: an expensive intervention may reduce lifetime spending if it lowers recurrent care, unemployment, disability, hospitalization, or crisis intervention. She cited economic modeling associated with Doblin and MAPS projecting savings above $100,000 per patient in some cases. That supports her argument for payer involvement; it is not presented as a guaranteed saving for Australian patients or government budgets.

The Australian campaign was not universally admired for its style. The ABC News Australia material shown during the discussion offers the clearest counterweight to de Jong’s account of persistence.

Ferriss read a statement attributed to Professor Skerritt, who said he had on several occasions told TGA staff to put Mind Medicine Australia’s methods aside and focus on “the medical criteria and the scientific criteria and the regulatory issues only.” Skerritt also reportedly counseled Mind Medicine Australia that it might be harming its own case by being “so aggressive,” adding that he had lost count of the number of emails the group had sent to staff.

The displayed ABC extract also reported that a committee of experts and state regulators advising the TGA was displeased by Mind Medicine Australia’s direct outreach. It quoted an unnamed TGA insider saying the committee was “not pleased” that the organization had contacted members directly to influence the meeting considering down-scheduling.

The criticism was not only about tone. Psychiatrist and Orygen chief executive Patrick McGorry was quoted asking whether psilocybin access beyond research trials was premature and whether approval could be confidently separated from “intense private lobbying/special pleading by a zealous private group.” That is a challenge to the legitimacy of the process, not merely a complaint about excessive email.

De Jong accepts that she can be too forceful and says she has become more willing to stop knocking when a door is clearly shut. Her account of personal change is that psychedelic experiences made her more accepting: rather than repeatedly trying to force entry through a closed door, she now looks for other opportunities.

But she does not accept that a less insistent campaign would have achieved the regulatory outcome. In this case, she says, the group had to keep moving around, over, or through obstacles. The organization used professional networks developed over decades, approached institutions directly, engaged lobbyists, convened experts, organized supporters, and pressed for action through governance delays.

Her defense is that the campaign rested on data, science, and clinical evidence rather than favors. The source preserves the tension rather than resolving it: advocates saw urgency and a system that could delay access indefinitely; some regulators, advisers, and clinicians saw direct lobbying that risked overwhelming or distorting a scientific process.

De Jong also offers a more internal warning. Mind Medicine Australia attracted people with lived experience of mental illness or trauma, some of whom wanted to help while also seeking healing themselves. The organization initially tried to be highly inclusive, she said, but found that some prospective staff had not disclosed conditions that made a high-stress campaign difficult to sustain.

Changing law and building institutions can mean rejection, public criticism, and personal attacks. De Jong says she underestimated the intensity and at times found herself “lying on the carpet crying.” Her practical advice is to distinguish substantive criticism that can improve the work from resistance that a campaign must withstand—and to build a team resilient enough for both.

Australia’s framework is open-ended in de Jong’s understanding, but its future remains under active negotiation through protocols, reporting, cost, and workforce capacity. Mind Medicine Australia is pursuing an extension of psilocybin access for end-of-life stress and anxiety, and continues to write to the TGA when it identifies rules it considers unnecessarily restrictive.

The difficult question is not simply whether more compounds or diagnoses might eventually be included. It is whether a system designed for patients with severe PTSD or treatment-resistant depression can expand while retaining credible screening, trained practitioners, supervision, evidence collection, and integration support.

De Jong is explicit that broader access should not mean casual access. Most people entering above-ground clinical treatment, she says, are seriously unwell. They need proper screening, highly trained clinicians, and strong support for returning to daily life after treatment. Ferriss agrees that the medicines are not a magic bullet: patients can remain vulnerable if their old environments, incentives, relationships, and behaviors remain unchanged.

That leaves Australia with a live implementation project. The restricted authorization of MDMA for PTSD and psilocybin for treatment-resistant depression created an opening. The subsequent test is whether the model can generate credible real-world evidence, finance care for people without substantial means, expand the clinical workforce, and reduce unnecessary cost without treating safeguards as a dispensable inconvenience.