If the proposed amendments to the Regulations are accepted, we encourage the Victorian Government to take steps toward addressing the high probability of inequitable access to MDMA- and psilocybine-assisted therapy during the initial period of implementation (which could last years) due to high cost. [...] Do you support the proposal to require Authorised Prescribers prescribing Schedule 8 MDMA and Schedule 8 psilocybine in Victoria to notify the Secretary to the Department of Health? If so, why? If not, why not? We have no objection to the proposed notification requirement, although consultation revealed concern about the potential increase in regulatory burden that is not required for other medici. [...] Do you anticipate Authorised Prescribers in Victoria might have any difficulties with complying with the proposed notification requirements? The proposed notification should be viewed in the overall context of the burden of becoming an Authorised Prescriber (AP) and implementing protocols for clinically-managed care – Penington Institute is wary of the likely scarcity of APs due to the overall com. [...] If not, why? Similar to our response to Question 1, in the context of implementing the Therapeutic Goods Administration’s February 2023 decision, we support the proposal to limit supply of Schedule 8 MDMA and psilocybine to supervised clinical settings, but reiterate that in the context of probable prolonged period of high treatment costs and lack of Commonwealth subsidies, these amendments 4 Aust. [...] Do you have any comments of potential unintended consequences of the proposed amendments to the Regulations? As our responses to the preceding questions indicate, our primary concern is the creation of a system that privileges a small set of patients able to pay the high cost of treatment, while the vast majority of potential beneficiaries are excluded.
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