APS response to the proposal to restrict permits for Schedule 9 poisons to clinical trials in VIC

The APS was pleased to respond to the consultation which proposes to restrict permits for Schedule 9 substances for human therapeutic use to Research Ethics Committees approved clinical trials. As we have outlined in our Position Statement, Psychologists and psychedelic-assisted therapy, the APS welcomes the emergence of safe, evidence-based treatment options. Schedule 9 substances have, by their nature, not (yet) shown therapeutic value and likely to present a high risk for misuse. Given this, we support the amendments which restrict their use in the context of a National Health and Medical Research Council registered Human Research Ethics Committee. Such restrictions have the following three benefits inter alia:

1. Clinical trials are conducted by clinicians and researchers with demonstrable, relevant expertise
2. Trial protocols require strict procedures to identify and act upon adverse events should they occur. Not only is this in the patient’s best interest, it will help inform the scientific literature of the safety of the substance
3. Clinical trials will also require an explicit and traceable informed consent process to ensure that the participant has the best chance in understanding the current scientific knowledge of the drug, the potential side effects, and risks of participating.

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