1 Review of Legislation Governing Drugs, Poisons & Controlled Substances 2

Contents

Background to scheduling arrangements 2

1 Review of legislation governing drugs, poisons & controlled substances 2

1.1 Scheduling arrangements 6

1.1.1 Scheduling Policy Framework 6

1.1.2 National Coordinating Committee on Therapeutic Goods 7

1.1.3 The Poisons Standard 7

1.2 Scheduling principles 8

1.2.1 National Drugs and Poisons Schedule Committee (NDPSC) 9

1.2.2 Advisory Committees 10

1.3 Change in the scheduling regime 10

1.3.1 Legislative changes 10

1.3.2 Procedural changes 11

1.4 General comparison between the two scheduling arrangements 12

1.4.1 Transition arrangements 14

1.4.2 Review of decisions 14

APPENDICES 17

Appendix 1 – Current arrangements for scheduling flowcharts 17

i

Background to scheduling arrangements

1  Review of legislation governing drugs, poisons & controlled substances

The Final Report of the National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation (the ‘Galbally Report’) was presented to the Australian Health Ministers’ Conference (AHMC) in January 2001. This report was prepared following a review conducted under an independent chair, Ms Rhonda Galbally, then Managing Director, Australian International Health Institute. Ms Galbally was assisted by a Steering Committee comprising representatives of the Australian Government and state and territory governments.

This was one of a number of reviews undertaken under the National Competition Agreement to which all of the states and territories and the Australian Government are parties.[1] The Council of Australian Governments (COAG) asked for a review to examine state and territory legislation that imposed controls on supply and use of drugs, poisons and controlled substances in Australia.

Recommendation 7 of the final report recommended that ‘all Commonwealth, State and Territory governments agree that:

a) The Therapeutic Goods Act 1989 and relevant sections of State and Territory legislation be amended to:

·  change the title of the Standard for the Uniform Scheduling of Drugs and Poisons to the Standard for the Uniform Scheduling of Medicines and Poisons;[2] and

·  disband the National Drugs and Poisons Schedule Committee (NDPSC) and replace it with two separate committees – the Medicines Scheduling Committee, responsible for scheduling human medicines; and the Poisons Scheduling Committee, responsible for scheduling agricultural, veterinary and household chemicals – and that:

−  membership of the Committees include a mix of jurisdictional representatives, appropriate experts and representatives of relevant government and community sectors;

−  decisions of both the Medicines Scheduling Committee and the Poisons Scheduling Committee be decided by a majority vote of the members provided that majority also includes a majority of the jurisdictions; and

−  the decisions of both Committees be included in the Standard for the Uniform Scheduling of Medicines and Poisons.

b) The Therapeutic Goods Act 1989 and the Agricultural and Veterinary Chemicals Code Act 1994 and related subordinate legislation be amended, as necessary, to enable the Therapeutic Goods Administration, in the case of human medicines, and the National Registration Authority for Agricultural and Veterinary Products, in the case of agricultural and veterinary products, acting on the advice of the Commonwealth health portfolio in relation to public health matters to:

·  make decisions about the labelling and packaging of medicines and agvet products during evaluation of those products;

·  recommend the schedule in which a new substance should be included; and

·  recommend changes to the schedule of a substance where, in evaluating new formulations, new presentations and new uses of substances currently included in the Standard for the Uniform Scheduling of Medicines and Poisons, a significant change in the risk profile of the substance is identified.

c) The Therapeutic Goods Act 1989 be amended to enable the costs of operating the Medicines Scheduling Committee and the Poisons Scheduling Committee to be fully recovered by implementing a charge for re-scheduling applications by industry.’

The Australian Health Ministers’ Advisory Council (AHMAC) established a working party in February 2001 to assist in the preparation of a response to the final report and its recommendations.[3]

In preparing its response, the AHMAC working party took into account the comments of the Primary Industries Ministerial Council, as some of the final report’s recommendations had implications for the regulation of veterinary medicines and agricultural and veterinary chemicals. The AHMAC working party also took into account the proposal to establish the Australia New Zealand Therapeutic Products Authority (ANZTPA) (referred to at that time as the Trans-Tasman Agency), and recommended that the final report’s recommendations be implemented in a trans-Tasman context.

In the last quarter of 2003, AHMC unanimously endorsed the AHMAC working party’s response to the final report out-of-session and agreed that the response and the final report should be forwarded to COAG for consideration. COAG endorsement of the final report and the AHMAC Working Party response was completed out-of-session on 28June 2005.

In 2006 the Council of Australian Governments (COAG) identified chemicals and plastics as a ‘regulatory hotspot’, and a Ministerial Taskforce was established to develop a streamlined and harmonised national system of chemicals and plastics regulation. COAG also agreed that the Productivity Commission would undertake a study to assist the work of the Taskforce. Chemicals and Plastics Regulation Productivity Commission Research Report July 2008 (the PC report)[4] is the culmination of the Commission’s study.

The Productivity Commission proposed building a governance framework that enhances national uniformity by addressing failures at four levels.

·  Level 1 — policy development and regime oversight. A national function through ministerial councils supported by intergovernmental agreements:

–  Chemicals policy coordination should be supported by an officer-level, cross-council standing committee on chemicals.

·  Level 2 — assessment of chemical hazards and risks. An Australian Government science-based function undertaken under statutory independence:

–  the industrial chemicals agency should undertake assessments, not set risk management standards.

·  Level 3 — risk management standards setting. A national function by expert-member agencies operating within the policy frameworks of the ministerial councils:

−  poisons scheduling should be separated from drugs

−  maximum residue levels for domestically produced foods that are set by APVMA should be automatically included in the food standards code, with right of change by FSANZ and the Australia and NZ Food Regulation Ministerial Council

−  while replacement of the workplace safety agency (ASCC)[5] by an independent agency is supported, it should not be a tripartite representative body

−  the effectiveness of new model regulations for transport needs to be monitored

−  an environmental risk management standards body should be established

−  risk management of chemicals of security concern (including ammonium nitrate) should adopt the Commission’s governance framework.

·  Level 4 — administration and enforcement. Generally jurisdiction specific:

−  all standards should be adopted in a uniform or nationally consistent manner by administering agencies

−  control of use of agvet chemicals should be consolidated under the APVMA but delivered through service level agreements by the states and territories.[6]

On 7 December 2009 as part of its response to Recommendation 3.1 of the Productivity Commission’s Report, COAG signed a Memorandum of Understanding on chemicals and plastics, which established a new national governance framework to help achieve a streamlined and harmonised national regulatory system and ultimately reduce the regulatory burden on business. The Standing Committee on Chemicals (SCOC) is part of the new governance framework. SCOC is responsible to COAG and has reported through the Business Regulation and Competition Working Group (BRCWG) until the BRCWG ceased on 31 December 2012, after which the SCOC commenced reporting directly to COAG.

SCOC's role is to:

·  co-ordinate the implementation of the new governance framework for the regulation of chemicals and plastics

·  monitor the timeliness, effectiveness and consistency of reforms of chemicals and plastics regulation

·  provide advice and make recommendations as appropriate to BRCWG, COAG and relevant ministerial councils on how chemicals and plastics policy initiatives that have cross-portfolio or cross-jurisdictional implications might be best progressed

·  provide an ongoing forum for assessing the consistency of chemicals-specific policy settings across the relevant policy areas, including: public health; workplace health and safety; transport safety; environment protection; and national security

·  oversee a coordinated national approach to regulatory reform of chemicals and plastics and the consistent application of chemical hazard and risk-assessment methodologies and international standards such as the Globally Harmonised System of Classification and Labelling of Chemicals

·  support the coordinated development of regulatory proposals that have cross-portfolio implications, including the conduct of regulatory impact assessments.[7]

Chapter 5.1 of the PC report dealt directly with poisons scheduling and regulation. The recommendations made in relation to this were:

Recommendation 5.1 - That the Australian Health Ministers’ Conference should:

·  proceed as soon as feasible with implementing its proposed reforms to separate poisons and medicines scheduling processes, including that poisons scheduling decisions be made by the Secretary of the Department of Health and Ageing, upon advice from a Chemicals Scheduling Committee

·  undertake a review of the Australian Health Ministers’ Advisory Council model for poisons two years after commencement, including:

−  an analysis of the consistency between the recommendations of the Chemicals Scheduling Committee and the decisions of the Secretary of the Department of Health and Ageing

−  an analysis of the impact of the model on national uniformity of poisons regulations.

Recommendation 5.2 - State and territory governments should:

·  adopt poisons scheduling decisions made by the Department of Health and Ageing directly by reference, as published in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)

·  uniformly adopt regulatory controls for poisons through either a template or model approach, as published in the SUSMP

·  continue to report any variations to nationally-agreed poisons scheduling or regulatory decisions at the state and territory level to the Australian Health Ministers’ Conference, and include a statement of reasons for the variations.

Recommendation 5.3 - Where a poison is adequately covered under workplace substances regulations and there is demonstrated compliance with those regulations, state and territory governments should exempt workplace users from poisons controls.[8]

1.1  Scheduling arrangements

The scheduling of substances occurs within a complex framework consisting of:

·  the Scheduling Policy Framework (SPF)

·  the National Coordinating Committee on Therapeutic Goods (NCCTG)

·  the Poisons Standard

·  principles established within the Act.

These are described below.

1.1.1  Scheduling Policy Framework

The SPF sets out the national system for applying access restrictions on all poisons, medicines for human therapeutic use and veterinary, agricultural, domestic and industrial chemicals where there is a potential risk to public health and safety. The SPF has been developed by the NCCTG, a subcommittee of AHMAC that oversees the development of a national approach to regulatory policy and administrative protocols relating to scheduling in Australia. Provisions for scheduling are set out in the Act and the Regulations. The key aspects to the agreed model under the SPF include:

·  a single point of reference for scheduling policy through the NCCTG

·  the Secretary of the Department of Health and Ageing being the decision maker on the scheduling of medicines and chemicals and other changes to the Poisons Standard

·  two separate committees: the ACMS and ACCS to advise the decision maker(s)

·  a single Poisons Standard as the Commonwealth legislative instrument

·  a single scheduling secretariat to ensure ongoing consistency and cohesiveness of the process.

1.1.2  National Coordinating Committee on Therapeutic Goods

The NCCTG was established by Order of the Federal Executive Council on 17 March 1971. The 1971 Order was revoked in October 1986 to facilitate the establishment of NCCTG as a committee of the AHMAC.

The terms of reference of the NCCTG are to:

1. develop, implement and maintain a uniform national approach to the regulations and controls over therapeutic goods and chemicals used by the public
2. contribute to projects relevant to the development of uniform regulations and controls over therapeutic goods and chemicals
3. share knowledge on matters relevant to the regulation of therapeutic goods and chemicals
4. provide policy guidance on amending the Poisons Standard to decision-makers and advisory committees (the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling)
5. consider and report to the Clinical, Technical and Ethical Principal Committee (CTEPC) on any matter referred to the NCCTG by CTEPC
6. report and make recommendations to the Australian Health Ministers' Advisory Council (through CTEPC) on agreed principles and desired outcomes of the regulation of therapeutic goods and chemicals, including the specific health issues related to people of Aboriginal and Torres Strait Islander origin.[9]

In response to a review of committees initiated by AHMAC, it has been proposed that the NCCTG be replaced by short-term ad hoc working group(s), rather than continue as a standing committee. This proposal is still under consideration by the two principal committees that would be most impacted by such an AHMAC decision: the Hospitals Principal Committee and the Community Care and Population Health Principal Committee.

1.1.3  The Poisons Standard

The Poisons Standard[10] contains the decisions made under section 52D of the Therapeutic Goods Act 1989 and serves two purposes:

1.  It contains the classification of medicines and poisons into schedules which sets the levels of control on the availability of these substances and are recommendations to states and territories to adopt in their own legislation

2.  It contains model provisions for labelling, containers, storage and possession of poisons in general which are intended to be adopted for use in state and territories.

It is envisaged that states and territories will adopt the scheduling recommendations in the Poisons Standard and give effect to them through their relevant drugs and poisons legislation. States and Territories adopt the Poisons Standard in a variety of ways i.e. by reference or specifically stipulated in legislation. Each jurisdiction reserves the right to implement a different scheduling decision to that included in the Poisons Standard to accommodate local circumstances.

Certain advertising, labelling and packaging requirements may also be a consequence of scheduling, but are the subject of other Commonwealth registration schemes. These include the registration of all pharmaceuticals under the Therapeutic Goods Act 1989, the registration of agricultural and veterinary chemicals under the Agricultural and Veterinary Chemicals Act 1994 and the regulation of industrial chemicals under the Industrial Chemicals (Notification and Assessment) Act 1989.