Abstract

In February 2023, the Australian medicines regulator (the Therapeutic Goods Administration, TGA) announced its decision to reclassify psilocybin and MDMA as controlled (rather than prohibited) drugs under certain conditions, enabling their use in psychedelic-assisted therapy. This made Australia one of the first – if not the first- country to formally regulate these substances as medicines, but under strict conditions. Conditions include strict limitation of MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression and requirement for a human research and ethics committee to approve the treatment protocol. Since products containing MDMA or psilocybin are not yet commercial medicines, approval by the TGA of the substances to be administered and the overall protocol is also required. The substances can only used under the direct supervision of a specialist psychiatrist and used on the treatment premises as part of a protocol.

The new arrangements commenced 1 July 2023. Access to psychedelics for use in other than these conditions is still only permitted through approved clinical trials.

This presentation will cover the factors influencing the decision making process, which attracted very significant media and public interest in Australia. It will also look at some related issues that are having to be resolved, such as the interface between the new arrangements and other laws that may make manufacture or possession of these substances a criminal offence in Australia. Australia also has a federal system of government and addressing the interactions between national and individual state laws has also been important.