Office of Chemical Safety
Review of Medicines and Poisons Scheduling Arrangements
This page contains information about the review of the medicines and poisons (substances) scheduling arrangements as mandated under Section 52EC of the Therapeutic Goods Act 1989 (the Act).
- Dr Eva Bennet-Jenkins (Chair), former CEO of the Australian Pesticide and Veterinary Medicines Authority (APVMA)
- Ms Barbara Belcher, a former First Assistant Secretary of the Department of Prime Minister and Cabinet
- Ms Jan Bowman, former Assistant Director of the Public Health Branch, Department of Health, Victoria
- Anne Trimmer, CEO of the Medical Technology Association of Australia (MTAA)
- Mr Chris Healey, former Director of the Drugs and Poisons Policy and Regulation Unit, Queensland Health.
The Australian Government Department of Health and Ageing (DoHA) through an independent panel is facilitating the review of the medicines and poisons (substances) scheduling arrangements as mandated under Section 52EC of the Therapeutic Goods Act 1989 (the Act). It will have particular regard to amendments made by Parliament to Part 6-3 of the Act in 2009 and will report on:
(a) the system of access controls for goods containing scheduled substances
(b) the outcomes of the administration of scheduled substances by the Secretary and by the associated committees
(c) the effect of the amendments on the therapeutic goods industry and on individual parties within the industry
(d) whether there are adequate avenues for review of decisions made by the Secretary
and may make recommendations of further changes to the scheduling regime.
Panel
On 31 January 2013, the Minister for Health and Ageing, the Hon Tanya Pliberseck appointed a panel to conduct the review. Members include:The panel met for the first time on 12 March 2013.
Background
The Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 provided for revised scheduling arrangements that commenced on 1 July 2010. This included the conferral of the power to make amendments to the Poisons Standard from the National Drugs and Poisons Scheduling Committee (NDPSC) to the Secretary of DoHA.The amendments replaced the decision making NDPSC with two expert advisory committees - the Advisory Committee on Medicines (ACMS) and the Advisory Committee on Chemicals (ACCS) - both of which provide advice to the Secretary in relation to the scheduling of medicines and chemicals respectively. The Scheduling Policy Framework (SPF) stipulates certain applications where the Secretary must refer a scheduling matter to an advisory committee.
Information for stakeholders
The Review of arrangements for scheduling substances required under section 52EC of the Therapeutic Goods Administration Act 1989 - information for stakeholders outlines all the areas that the panel will be considering during the course of the review.Review of arrangements for scheduling substances Part 6-3 of the Therapeutic Goods Act 1989 - Information for stakeholders - Part A - What this review is about (Word 199 KB).
Review of arrangements for scheduling substances Part 6-3 of the Therapeutic Goods Act 1989 - Information for stakeholders - Part B - Background to scheduling arrangements (Word 415 KB).
Public Submissions
The review invites public submissions.
Stakeholders are invited to make submissions by email to Scheduling Review on the submission template in Microsoft WORD format. To download a copy of the submission template (Word 41 KB).The consultation period commences on Tuesday 2 April 2013 and submissions must be received by the Department of Health and Ageing no later than 5pm Monday 29 April 2013.
Submissions are accessible to the public.
Next Steps
The Scheduling Review Panel will consider all relevant submissions received by the due date in the required format in the preparation its report. Submissions will be made public on this website and shared with relevant Commonwealth agencies and consultants engaged to assist with the review. Submissions, or parts thereof, that are intended to remain confidential should be clearly marked as such and justifications provided. Submitters should be aware that confidential submissions may still be subject to access under Freedom of Information law.Stakeholder forums
The panel may hold forums for stakeholders to clarify issues raised in submissions. If you wish to receive an invitation to one of these forums, please email Scheduling Review before 5pm Friday 3 May 2013.Completion of the review
The review is expected to be completed by 30 September 2013.The report of the review will be available to members of the public after the Minister has tabled it in Parliament.
For more information on the review please email the Scheduling Review Taskforce.
Submissions
The submission period for this review is now closed. Due to the time frame established by Parliament under section 52EC (2) (b) of the Therapeutic Goods Act 1989, the Scheduling Review Panel is unable to accept late submissions.The following organisations and individuals have provided a submission to the review:
