Submission to the 2013 Review of Medicines and Poisons Scheduling Arrangements - Australian Dental Association

The submission period for this review commenced on 2 April 2013.

Page last updated: 09 May 2013

System of access controls for goods containing scheduled substances

Section 52E Secretary to take certain matters into account in exercising powers

    5 - Is the process whereby the Secretary has regard to the Scheduling Policy Framework, the recommendations or advice by the ACMS and/or ACCS or another relevant committee or expert clear and transparent? If not, how could the arrangements be improved?

The ADA is concerned that while the delegate's decision outlines the material they considered, not all of this material is publicly available.

For example, the delegate made a decision about the ADA's Scheduling proposal (herein referred to as ‘the ADA's proposal') that was referred to the October 2012 joint meeting of the Advisory Committee on Chemicals Scheduling and Advisory Committee on Medicines Scheduling (ACCS-ACMS #4). The ADA's Scheduling proposal was about teeth whiteners containing hydrogen peroxide and carbamide peroxide.

The delegate's decision on the ADA's proposal stated that it considered the following (bold text ADA's emphases):

    • The scheduling application (not publicly available).
    • The independent evaluation report (not publicly available).
    • The applicant's comments on the evaluation report (not publicly available).
    • The advice of the ACCS-ACMS joint meeting (not publicly available).
    • The pre-meeting public submissions.
    • Subsection 52E(1) of the Therapeutic Goods Act 1989.
    • Scheduling Policy Framework scheduling factors.
    • Other relevant information.
The ADA requests the Department adopt a policy that makes publicly available all reports and applications that are considered by the delegate in making their scheduling decisions. The public are entitled to understand the basis for the original application, and the material that has been considered by the delegate, including the applicant's comments responding to the evaluation report, to better understand the basis for the decision.

The ADA does not believe there is a justifiable basis for lack of transparency in this respect.

Considering that the scheduling framework, as currently constituted, does not provide an avenue for administrative review, greater transparency to the public in the form suggested above is the very least that should be done. This greater transparency provides an opportunity for the public, if they are interested, to engage in discussion and debate on the issues before the delegate. Furthermore, this transparency offers a chance for the public to be better informed about the scheduling framework.

Section 52B and Section 52C and Section 52CA Functions of the ACMS and ACCS and associated Regulations

    6 - Have the new arrangements for the ACMS and/or ACCS met the objective to provide for more flexible, efficient and effective operation of the scheduling of substances? Have the objectives of the amendments been met?

The ADA supports the role and operation of the ACMS and ACCS. In particular, the ADA supports the process whereby those committees can request for independent evaluation reports to provide further advice in relation to specific Scheduling proposals.

However, the ADA believes the Department should be more transparent about who was appointed to perform the independent evaluation report, what their qualifications and credentials are, and the process involved for how they were appointed to perform the evaluation. Scheduling proposals concern chemicals and medicines which, if not managed appropriately, pose risks to public safety. Therefore, evaluators (whose advice is relied on by the ACMS/ACCS), should themselves be transparent to the public about their qualifications.

While the ADA disagreed with the review and summation of the independent evaluation report made on the ADA's proposal, it supports this process.

Avenues for review

    22 - What has been the impact on your organisation or sector of the lack of an administrative review process, if any? Please provide a specific example.

As mentioned above, the ADA would urge that as far as possible, all reports that the delegate considered in making its decision be made publicly available to improve transparency and accountability.