Australia has become the first country in the world to re-classify the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) as medicines.
The Therapeutic Goods Administration (TGA) announced earlier in the month that beginning on July 1, authorized psychiatrists will be allowed to prescribe MDMA for the treatment of post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression — currently the only two conditions with sufficient evidence for “potential benefits in certain patients,” according to the news release.
“For these specific uses, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard,” the TGA wrote. “For all other uses, they will remain in Schedule 9 (Prohibited Substances) which largely restricts their supply to clinical trials.”
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The update marks a surprising U-turn for the TGA, as they previously declined to de-schedule the drugs in 2021 and called it a “final decision.” The new decision follows “extensive public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling,” according to the regulator.
But this doesn’t mean that access to the two newly-reclassified drugs will now be easy. While TGA has yet to lay down the rules and measures for prescribing them to patients with the two very specific conditions, the regulator mentioned that psychiatrists will need to be authorized to prescribe them.
To be authorized, Wired reported that psychiatrists will need to go through a series of endorsements and approvals. They will need to be “approved under Australia’s Authorised Prescriber Scheme, which means being endorsed by a human research ethics committee and then the TGA.” And to be endorsed, they will need to “prove that they can clinically justify the treatment regime, that they will have proper governance over the treatment process, and that they will be using suitable measures to protect patients.”
The reclassification will only be the first of many steps on a long and winding road for the drugs to be legally used for treatment, but the development is still a historic first on a global level.
In related news, Quebec in December became the first province to approve health coverage for psilocybin-assisted psychotherapy. Psilocybin is used in the treatment of some cases of depression, anxiety, PTSD, and addiction in Canada, but only with a legal exemption and approval from Health Canada.
Information for this briefing was found via TGA, Wired, and the sources and companies mentioned. The author has no securities or affiliations related to this organization. Views expressed within are solely that of the author. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
