Most of the world is still waiting for regulators to approve psychedelic-assisted therapy. Australia did something different. On July 1, 2023, it became the first country to reclassify MDMA and psilocybin so that specially authorized psychiatrists could prescribe them: MDMA for post-traumatic stress disorder (PTSD), and psilocybin for treatment-resistant depression. Three years on, what has happened?

How the scheme works

Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), did not approve these drugs as marketed products. Instead it uses the Authorised Prescriber scheme, which lets a psychiatrist apply for permission to prescribe an unapproved medicine to patients who need it. The psychiatrist must be authorized, treatment must follow regulatory requirements, and some states require notification to health authorities before a patient is treated.

Slow uptake

The numbers have been small. In the first six months, only one patient was reportedly prescribed MDMA and none received psilocybin, and only up to six psychiatrists were authorized at that time. Mind Medicine Australia, an advocacy group, estimated about 80 patients were treated in 2024. A legal summary citing reported figures put roughly 87 patients through MDMA-assisted therapy and 47 through psilocybin-assisted therapy as of September 2025, while more than 600 therapists had completed recognized training. A professional conference program in 2026 described “over 100” participants treated in the three years of the scheme. The bottleneck is the small number of authorized prescribers, not a shortage of trained therapists.

What has changed in 2026

After a consultation that closed in May 2026, the TGA published updated recommendations that, according to a company press release from a supplier, broaden who can be on a therapy team and allow treatment outside hospital settings. Coverage is also described as expanding beyond private payment, including some private insurer coverage. Because this description comes from a company with a commercial interest, treat the details as claims to verify against the regulator’s own documents.

What critics are saying

The scheme has been controversial. Commentators writing in The Conversation raised concerns, noting:

• Evidence limits. The FDA rejected MDMA therapy in 2024 partly over data and conduct concerns (see Article 22), yet Australia allowed prescribing.
• Therapist conduct. Allegations of misconduct, including sexual abuse, in U.S. trials were a factor in the FDA’s decision, and critics argue oversight must be strong.
• Advertising. The TGA has issued more than a dozen warning letters about unlawful promotion of these drugs by clinics, researchers, and media.
• Cost and access. Treatment is expensive and rare, so it reaches very few of the people who might need it.

What supporters are saying

Supporters argue that for patients with severe, treatment-resistant illness, waiting years for further trials is itself harmful, and that a regulated pathway with trained clinicians is safer than underground use. Companies supplying the drugs describe the real-world safety record as clean, though self-reported commercial claims are not independent evidence. Independent, peer-reviewed outcome data from the Australian program is still limited.

What Canadians can learn

Canada’s Special Access Program (Article 19) is a similar idea at a smaller scale, with approvals decided case by case. Australia shows that:

1. A regulated prescriber pathway is possible without full market approval.
2. Demand does not translate immediately into volume, since training, funding, and prescriber authorization all take time.
3. Oversight, advertising rules, and therapist training standards matter.
4. Good outcome tracking is essential, or the world learns little from the experiment.

The takeaway

Australia’s experiment is the best real-world test of prescribed psychedelic therapy outside a trial, but it is small, young, and short of independent data. Watch for published outcomes before drawing big conclusions.

Sources: Optimi Health press releases (May 2026, Feb 2026); The Conversation analysis; AAPi 2026 conference program; Astris Law summary of reported patient numbers. Several sources are commercial or advocacy-linked.