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3 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZR
3.1 Final decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)
3.1.4 Final decision in relation to sildenafil
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and not amend the current Poisons Standard in relation to sildenafil:
In making this final decision, the Delegate considered the following material:
- The application to amend the current Poisons Standard with respect to sildenafil;
- The five public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
- The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
- The nine public submissions, received in response to the interim decision consultation under regulation 42ZCZP of the Regulations;
- Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
- The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
- The Scheduling handbook: Guidance for amending the Poisons Standard.
Reasons for the final decision (including findings on material questions of fact)
I have made a final decision to confirm my interim decision to not amend the current Poisons Standard with respect to sildenafil. My reasons for making the final decision are those set out in the interim decision.
In making my final decision, I have taken into account the material detailed in the interim decision and the public submissions received before the second closing date in response to the call for further submissions published on 13 October 2020 under regulation 42ZCZP of the Regulations.
I note the public submission on the interim decision from the Pharmaceutical Society of Australia, which reiterates their earlier submission, supporting the applicant's down-scheduling proposal. However, no new information has been provided to mitigate my concern that the down-scheduling of sildenafil may lead to risk for consumers accessing sildenafil without medical intervention and lack of follow up. I remain of the firm view that the medical practitioner oversight is required and the current scheduling of sildenafil under Schedule 4 is appropriate.