Contents

1Executive summary

1.1Purpose

1.2Making a submission

2What this review is about

2.1Legislative requirement for the review

2.2How the scope of the review has been established

2.3Objective of the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009

Key questions regarding the objectives of the amendments:

2.4System of access controls

Key questions regarding the system of access controls:

2.5Outcomes of administration

Key questions regarding the outcomes of administration

2.6Effect of the amendments on the therapeutic goods industry

2.7Avenues for review

Key questions regarding the avenues for review

2.8Other matters

3Data needed to inform the review

3.1s52EC(3)(a): system of access controls

3.2s52EC(3)(b): outcomes of administration

3.2.1Request for an amendment to the Poisons Standard

3.3s52EC(3)(b) effect on the therapeutic goods industry

3.4s52EC(3)(d): Avenues of review of decisions

4Process overview

4.1The panel

4.1.1Consultation strategy

4.1.2Opportunities to provide formal written submissions

4.1.3Opportunities to participate at a forum

4.1.4Opportunities to have face-to-face meetings or teleconference

4.2Project milestones

ACRONYMS

APPENDICES

Appendix 1 – Part 6-3 of the Therapeutic Goods Act 1989

Appendix 2 – Making a submission

1

1Executive summary

1.1Purpose

The Therapeutic Goods Act 1989 (Section 52EC) specifies that an independent review of the arrangements for the scheduling of substances (medicines and chemicals) implemented in July 2010, must be conducted and that the review must start before 1 July 2013. On 31January 2013, the Minister for Health and Ageing, the Hon Tanya Plibersek appointed a panel to conduct the review. The review will focus on the operation of Part 6-3 of the Therapeutic Goods Act 1989(see Appendix 1) with particular reference to the amendments made by the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009.The members of the review panel appointed by the Minister are:

  • 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, Environmental Health of the Public Health Branch, Department of Health, Victoria
  • Ms 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 review formally commenced with the first meeting of the panel on 12 March 2013. In accordance with Section 52EC the review must be completed within 6 months.

This paper has been prepared by the panel to provide information for stakeholders on what the review is about, its scope, the information needed to inform the review and the process for the review including how stakeholders can make submissions and provide input to the review.Background information and references relevant to the review are provided in Part B.

Stakeholders wishing to participate in the review can find additional information on the Department of Health and Ageing website

1.2Making a submission

Submissions must be received by the panel through the Department of Health and Ageing by 5pm, Monday 29April2012. The panel has developed a submission template to assist stakeholders in developing their submission. The submission template includes a series of questions. The questions are not intended to limit the scope ofcomment stakeholders might wish to make against the terms of reference of the review. The questions are to assist the panel to gather information it has identified as important to inform the review. Please use the form at Appendix 2 to make your submission.

Submissions must be lodged electronically.

Email:

Please note: The Australian Government Department of Health and Ageing will publish submissions on its website as public documents where they will remain indefinitely.

All Government operated and funded websites meet the legal requirements of the Disability Discrimination Act 1992. This involves conformance to the Web Content Accessibility Guidelines 2.0 administrated by the World Wide Web Consortium, the international standards body for the internet. In order to meet these requirements, submissions must bein a Word or RTF format and mustnot contain images (such as pictures, graphs or tables) unless they are accompanied by alternative text that describes their meaning. Files provided as .pdf are not acceptable.

Submissions will also be shared with relevant Commonwealth agencies and any consultants engaged to assist with the review.

For submissions made by individuals, all personal details other than your name and the state or territory in which you reside will be removed from your submission before it is published.

Submissions, or parts thereof, that are intended to remain confidential should be clearly marked as such and justification provided. Submitters should be aware that confidential submissions may still be subject to access under freedom of information law.

Copyright in submissions resides with the author(s), not with the Australian Government.

2What this review is about

2.1Legislative requirement for the review

The Therapeutic Goods Act 1989 specifies that an independent review of the arrangements for the scheduling of substances (medicines and chemicals) must be conducted.Specifically the review must look into the operation of Part 6-3 of the Therapeutic Goods Act 1989 with particular reference to the amendments made by the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009and must start before 1 July 2013. The terms of reference for the review are contained in section 52EC of the Therapeutic Goods Act 1989:

(1)The Minister must cause an independent review of the operation of this Part [6-3 of the Therapeutic Goods Act 1989] to be conducted, with particular reference to the amendments to this Part made by the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (the amendments).

(2)The review must:

(a) start not later than 1July 2013; and

(b) be completed within 6 months.

(3)The review must report on:

(a)the system of access controls for goods containing scheduled substances established by this Part;

(b)the outcomes of the administration of scheduled substances by the Secretary and by the committees established by this Part;

(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 by the committees established by this Part;

and may make recommendations for further changes to the scheduling regime.

(4)The review must be conducted by a panel which must comprise not less than three, and not more than five, persons with relevant expertise.

(5)As part of the review, the panel must invite and consider public submissions.

(6)The panel must give the Minister a written report of the review.

(7)The Minister must cause a copy of the report to be laid before each House of the Parliament within 15 sitting days of that House after the day on which the Minister receives the report.

Part 6-3 of the Act provides the basis for a uniform system in Australia of access controls for goods containing scheduled substances and is provided in full at Appendix 1

2.2How the scope of the review has been established

The panel has considered its terms of reference and established the scope of the review as outlined in Sections 2.3 - 2.8.

In setting the scope of the current review, the panel also took account of other contextual documents, such as:

  • the Explanatory Memorandum which accompanied the amendments[1]
  • the relevant sections of the Hansard from 9 September 2009[2]
  • the report of the Senate Standing Committee on Community Affairs Inquiry into Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009[3]
  • submissions to the above inquiry[4]
  • Chemicals and Plastics Regulation Productivity Commission Research Report July 2008 (the PC report).[5]

The panel noted a key observation of the PC report:

  • Existing regulations generally appear to be effective in achieving their public health goals, but some reforms are warranted to improve that effectiveness and to overcome inefficiencies.

2.3Objective of the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009

The Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (the amendments) provided for, inter alia, the replacement of the National Drugs and Poisons Schedule Committee (NDPSC) that was responsible for making scheduling decisions with:

  • the Secretary (of the Department of Health and Ageing) responsible for scheduling decisions; and
  • two expert advisory committees that provide advice and make recommendations to the Secretary.

Decisions of the Secretary are incorporated into the Poisons Standard, which remains as a single, complete reference for the scheduling classification of both medicinal and chemical substances.

Other amendments made changes to the definitions relating to the scheduling of substances and enabled updated instruments and documents to apply to the Poisons Standard as they are revised. The legislative character of the Poisons Standard was not altered and it remained as a legislative instrument exempt from disallowance under the Legislative Instruments Act 2003.

The objective of the amendments was to provide for more flexible, efficient and effective arrangements for the scheduling of substances. The amendments are a part of (but are not intended to cover all) reforms to poisons scheduling and regulation arising out of the National Competition Review of Drugs and Poisons and Controlled Substances Legislation undertaken by Rhonda Galbally (the Galbally Review) of 2001 and the Chemicals and Plastics Regulation Productivity Commission Research Report of 2008.

Key questions regarding the objectives of the amendments:

  1. Have the new arrangements met the objectives of providing a more flexible, efficient and effective operation of the scheduling of substances? Have the objectives of the amendments been met?
  2. Have any areas of operation become less flexible, efficient and effective compared with the former NDPSC decision making model? Please provide examples to illustrate your points.
  3. In terms of the operation of Part 6-3 do you have any suggestions how the scheduling arrangements can be improved?

In relation to Section 52EC(1) the panel determined that in reviewing the operation of
Part 6-3it accepts that the poisons scheduling framework continues to be an effective and appropriateframework for access controls for poisons and medicines.

The panel will be aware of, but will not be specifically investigating, other broader ongoing reforms in the chemicals and plastics sector and/or by government, such as those being overseen by the Standing Committee on Chemicals[6] and the Transition to the Australia New Zealand Therapeutic Products Agency (ANZTPA).[7]

2.4System of access controls

In relation to 52EC(3)(a) ‘the system of access controls for goods containing scheduled substances established by this Part’ (emphasis added) the panel takes the systemto comprise:

  • s52D(2) - the Secretary
  • s52(D)2(a)-(b) - the powers of the Secretary to amend or prepare a new Poisons Standard on his or her own initiative or following an application under 52EAA of the Act, or via referral to an advisory committee
  • s52E the matters the Secretary is to take into account in exercising powers i.e. that in amending or replacing the current Poisons Standard the Secretary must:

–52E(2) (a)-(b) - comply with any guidelines of the Australian Health Ministers’ Advisory Council (AHMAC) and its subcommittee, the National Co-ordinating Committee on Therapeutic Goods (NCCTG)[8]

–52E(3) - have regard to any recommendations or advice of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS)

  • 52EAA - the process for applications for amendments to the Poisons Standard and the provisions relating to accessing additional information.

The panel may therefore make specific recommendations in relation to any or all parts of this system, including the Scheduling Policy Framework.

The panel will also review compliance with use of the scheduling application form developed by the secretariat and what effect noncompliance with the use of the preferred form has on the process. The panel may also review the impact, if any, of the current arrangements for the publication of the Poisons Standard (in the form of the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP).

Key questions regarding the system of access controls:

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

  1. Are the matters to which the Secretary must have regard when amending the Poisons Standard appropriately described and effective? If not, what amendments would you suggest?
  2. 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?
  3. Is the Scheduling Policy Framework helpful in understanding the application and review process? If not, what amendments would you suggest?

2.5Outcomes of administration

In relation to 52EC(3)(b), the ‘outcomes of the administration of scheduled substances by the Secretary and by the committees established by this Part’, the panel will consider matters related to efficiency, effectiveness, timeliness and quality of decision making by focussing on matters such as:

  • 52A - definitions – in particular, the change to the definition of ‘substance’
  • 52B, 52C, 52CA and 52D - the framework consisting of the ACCS, ACMS and the Secretary, including the extent to which the Secretary can access appropriate expert advice via the ACCS and ACMS
  • the regulations relating to the functions of the ACCS and ACMS, and how they are constituted and hold meetings
  • the regulations relating to how joint meetings are conducted and whether or not such meetings simplify the consideration of substances that have uses as both chemicals and medicines
  • the robustness and timeliness of scheduling decisions, with a particular focus on stakeholder satisfaction that public health outcomes have been maintained or strengthened
  • the cost of decision making and amendments to the Poisons Standard.

Key questions regarding the outcomes of administration

52A Definition

  1. Does the definition of ‘substance’ appropriately reflect the substances that may be considered for scheduling by the Secretary and which the committees may consider and advise the Secretary on? If not, how should the definition be amended? What would be the material impact on your organisation if it were to be amended in this way?

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

  1. Are the establishment, functions and membership of the ACMS and/or ACCS appropriately described in the Act? If not, how could they be better described? What would be the material impact on your organisation if the Actwere amended in this way?
  2. 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?
  3. Have any areas of operation become less flexible, efficient and effective compared with the former NDPSC decision making model? Please provide examples to illustrate your points.
  4. In terms of the operation of the committees do you have any suggestions how the arrangements can be improved?

Section 52D Amendments to the Poisons Standard and associated Regulations

  1. Is the process by which the Secretary makes amendments to the Poisons Standard appropriately described and effective? If not, what amendments would you suggest?
  2. Is the process whereby the Secretary makes amendments to the Poisons Standard clear and transparent? If not, how could the arrangements be improved?
  3. How have the new administrative arrangements benefited your organisation or sector in relation to a proposal to amend the Poisons Standard? Where possible, please provide comparative data for the following two periods: June 2008-June 2010 and October 2010-October 2012.
  4. Have the new administrative arrangements had any negative impact on your organisation or sector in relation to a proposal to amend the Poisons Standard? Where possible, please provide comparative costs for the following two periods: June 2008-June 2010 and October 2010-October 2012.
  5. Have the new administrative arrangements had an impact on the time taken between your proposal to amend the Poisons Standard and the final decision to amend (or not) the Poisons Standard? Where possible, please provide comparisons in timeframe relevant to decisions made during the following two periods: June 2008-June 2010 and October 2010-October 2012 and how they have impacted on your organisation or sector.

Section 52EAA Application for amendment of the Poisons Standard

  1. Are the administrative arrangements for applications (including the template application form) to be made to the Secretary sufficiently clear and transparent?
  2. What would be the material impact on your organisation if the Secretary mandated that all applications for amendment of the Poisons Standard be submitted electronically (and on the template application form)?

Although the terms of reference do not specifically require that the review consider the Regulations, the panel considers that some key matters regarding amendments to the Poisons Standard and are within scope. As little relevant data is readily available, the panel is seeking specific feedback from stakeholders regarding access to notices and decisions.

Division 3D of the Regulations Proposed amendments to the Poisons Standard

  1. Have you had any difficulty accessing notices regarding the intention of the Secretary to amend the Poisons Standard? If so, what was that difficulty and how did it affect your organisation or sector?
  2. Have you had any difficulty accessing public submissions received in response to a proposed amendment of the Poisons Standard? If so, what was that difficulty and how did it affect your organisation or sector?
  3. Have you had difficulty accessing decisions made by the Secretary to amend the Poisons Standard and/or the reasons for the decision and/or the date of effect of the decision? If so, what was that difficulty and how did it affect your organisation or sector?

2.6Effect of the amendments on the therapeutic goods industry

In relation to 52EC(3)(c), ‘the effect of the amendments on the therapeutic goods industry and on individual parties within the industry’ the panel noted that the new arrangements have been operating for less than two years. It will, however, consider what impact the amendments have had on industry in terms of time to market (and thus cost/benefits to industry and the general public), transparency and robustness of the scheduling decisions making process. In addition to the therapeutic goods industry, the panel will also consider the impacts on other industry sectors for which Part 6-3 is relevant. While the panel will consider financial benefits/costs arising from the timeliness of decision-making and amendments to the Poisons Standard, it will not be making specific enquiries into the area of cost recovery. Matters relating to cost recovery will be addressed through a separate Department of Health and Ageing project (the timing of which has not yet been established).