Limited Rescheduling Decision Makes Australia the First Country to Officially Recognise the Drugs as Medicines

In a surprising move, Australia’s Therapeutic Goods Administration (TGA) has announced that it will permit the prescribing of MDMA and Psilocybin from the 1^st of July.

The change comes via a rescheduling of medicines containing the drugs from Schedule 9 (‘Prohibited Substance’) to Schedule 8 (‘Controlled Drug’). Importantly, prescriptions may only be written by certain psychiatrists, for patients suffering from two specific conditions.

The two indications for which psychiatrists will be able to prescribe these two psychedelics align with the most mature clinical research for each: MDMA for PTSD and Psilocybin (or, “Psilocybine”, in TGA parlance) for treatment-resistant depression (TRD). If “sufficient new evidence” emerges regarding the efficacy and safety of these two drugs in other conditions, the agency will consider applications to make further amendments.

Meanwhile, only “specifically authorised psychiatrists” can prescribe such treatments, meaning those approved under the Authorised Prescriber Scheme. These psychiatrists must also obtain approval to use these two drugs from a human research ethics committee.

The agency recognised that, “patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.” “It was decided that by limiting prescribing to authorised psychiatrists and for TRD or PTSD the benefits for patients and public health will be greater than the risks”, it continued.

What’s more, as alluded to above, the rescheduling only applies to medicines containing psilocybin and MDMA. As such, MDMA and psilocybin will only be rescheduled for the specific use cases outlined above, with all other uses of the drugs remaining Schedule 8 (i.e., prohibited). In practice, this means that MDMA and psilocybin will only be made legally available to these two patient populations, as well as clinical trial participants. This is known as bifurcated scheduling, and will likely be the case for psychedelic drug approvals in jurisdictions like the U.S., too.

The move will also ease the regulatory burden on researchers looking to conduct clinical trials in these conditions.

In explaining its decision, the regulator said that it “acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses.”

Speaking to ABC News, psychedelic researcher Stephen Bright explained that the decision makes “Australia the first country in the world to officially recognise MDMA and psilocybin as medicines”.

The move is certainly remarkable, and one that looks very different from local measures seen across the world like in the U.S., where Oregon’s Psilocybin Services explicitly preclude providers from practicing medicine. It also differs from decriminalisation efforts and successes seen across the world. Indeed, at around the same time that the Australian federal government quashed psilocybin and MDMA rescheduling in its October 2022 interim decision, the Australian Capital Territory announced it would decriminalise small amounts of the two drugs, along with others.

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Groups in Australia have been pushing for the rescheduling of these two drugs for quite some time. In September 2020, we covered the non-profit Mind Medicine Australia’s rescheduling proposal when it was originally submitted to the TGA, in an article we titled, Will Australia be the First Country to Reap the Benefits of Psychedelic Medicines?

Later, in our 2021 Year in Review, we identified Australia as one of four spotlight countries in terms of psychedelic drug policy reform. Despite the fact that the September 2020 proposal was ultimately rejected in December 2021 following two rounds of consideration, we thought it newsworthy that the issue was, “firmly on the national agenda in the land down under”.

We also noted that, just weeks after the rejection of the rescheduling proposal, the federal government in Australia carved out $15m in grants for psychedelic research. “Beyond its cash value”, we wrote, the move “sends a strong message that Australia is open for psychedelics research.” Indeed, Australia is becoming an increasingly popular locale for psychedelic drug developers, given its generous R&D tax incentive, which sees 43.5% of eligible clinical expenditures rebated.

While there was no substantive development on the regulatory front, at least publicly, funding from government bodies continued to some extent throughout the interim period. In Spring 2022, the country’s national science agency (CSIRO) announced that it would begin work on ‘medicinal psychedelics’, working with Australian companies to, “improve existing psychedelic products and develop new ones,” including working on the manufacturing processes for up to 15 psychedelic compounds.

Then, just a few months ago in October 2022, the agency published its interim decision to not amend the current Poisons Standard in relation to psilocybin or MDMA.

Following that decision, the TGA solicited submissions from the public, receiving nearly seven thousand comments throughout a month’s comment period. The vast majority of comments (three quarters) opposed the interim decision, instead calling for a rescheduling of the drugs.

This significant corpus of submissions was considered as part of the present decision, TGA acknowledged, noting: “The number of such submissions is a reasonable indicator of the scope and gravity of the issues for individual and public health”.

At its core, however, the decision was made in accordance with the country’s Therapeutic Goods Act 1989, with reference to the country’s Scheduling Policy Framework and the advice of the Advisory Committee on Medicine Scheduling. An Independent Expert Panel on MDMA and psilocybin, which was published in December 2021, and the aforementioned submissions from a variety of stakeholders, also informed the decision.

Ultimately, the decisions were made by, “a senior medical officer at the TGA”, not the Minister for Health and Aged Care, or Government.

It’s also worth pointing out that, as in other countries like the U.S., state and territory governments may not integrate federal drug schedules or classifications uniformly. “It is a matter for states and territories to decide if and when to make any changes to offences under their legislation relating to accessing psilocybin and MDMA as Schedule 8 substances”, the TGA noted.

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The fact remains that there are no approved medicines containing either MDMA or psilocybin in Australia (or any other country, for that matter). This is in spite of enormous investments made by drug developers like MAPS PBC and COMPASS Pathways, both of which have received breakthrough therapy designations from the FDA for the compounds and indications that are the subject of TGA’s rule change.

It is clear that the evidence produced by these sponsored trials is contributing in large part to the moving of the regulatory needle. The recent publication of COMPASS Pathways’ Phase 2b trial of its synthetic psilocybin in treatment-resistant depression was the only published study directly cited among the materials considered in the TGA’s final decision in relation to the decision, for example. It will be interesting to see if, and how, these drug developers react to this regulatory development.

It will also be interesting to see what the legal supply of unapproved therapeutic products containing psilocybin or MDMA might look like. TGA has suggested that imports of products containing the drugs will likely be permitted, given relevant licenses are in place, or it may be possible that dosage forms be compounded domestically by a pharmacist. In its guidance to healthcare professionals, the TGA further explained that both a license and a permit to import are required for the drugs.

The regulator notes that, “clinical trials have shown promise when they are used in combination with psychotherapy conducted in strictly controlled medical settings.”

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These developments Down Under will likely inspire and buoy other efforts across the world, not least the AIMS petition to reschedule psilocybin from Schedule I to Schedule II in the U.S., a grassroots effort to reschedule psilocybin in the UK, and international initiatives like ITPRI.

A PDF of the Decision may be retrieved from TGA here.