Response to Proposed amendments to Drugs, Poisons and Controlled Substances Regulations 2017 (access controls for MDMA and psilocybine)

The Australian Psychological Society (APS) is pleased to respond to the current consultation which proposes to amend the Drugs Poisons and Controlled Substances Regulations 2017 (the Regulations) in response to the recent Therapeutic Goods Administration (TGA)announcement. In particular, this relates to the down scheduling of Psilocybin(e) and MDMA to be considered Schedule 8 substances in certain situations.

Overall, the APS supports the proposed amendments in an attempt to maximise the safety of patients while Australian and international research is ongoing. In particular, it is important to collect data regarding the safety and tolerability of these substances as these emerging treatments are prescribed in Australia.

In many respects, the prescription of psychedelic substances from July 2023 is akin to very early translational research. Given this, we support the Victorian Government's approach to collect safety and efficacy information as necessary and support the restriction of prescribing psychedelic substances to psychiatrists with Authorised Prescriber Approval. However, we suggest further consultation with potential prescribers to ensure that sufficient and appropriate information is collected.

The APS supports the suggested restriction to limit the direct supply of Schedule 8 MDMA or psilocybin to only be permitted to be administered in supervised clinical settings. The APS would like to strongly emphasise the psychological processes involved in the preparation, delivery [active drug session(s)], and integration of psychological content revealed by psychedelic substances.

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