1Review of Legislation Governing Drugs, Poisons & Controlled Substances

1Review of Legislation Governing Drugs, Poisons & Controlled Substances

Contents

Background to scheduling arrangements

1Review of legislation governing drugs, poisons & controlled substances

1.1Scheduling arrangements

1.1.1Scheduling Policy Framework

1.1.2National Coordinating Committee on Therapeutic Goods

1.1.3The Poisons Standard

1.2Scheduling principles

1.2.1National Drugs and Poisons Schedule Committee (NDPSC)

1.2.2Advisory Committees

1.3Change in the scheduling regime

1.3.1Legislative changes

1.3.2Procedural changes

1.4General comparison between the two scheduling arrangements

1.4.1Transition arrangements

1.4.2Review of decisions

APPENDICES

Appendix 1 – Current arrangements for scheduling flowcharts

1

Background to scheduling arrangements

1Review 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 substancesin 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 Territorylegislation 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 itwith two separate committees – the Medicines Scheduling Committee,responsible for scheduling human medicines; and the Poisons SchedulingCommittee, responsible for scheduling agricultural, veterinary andhousehold chemicals – and that:

−membership of the Committees include a mix of jurisdictionalrepresentatives, appropriate experts and representatives of relevantgovernment and community sectors;

−decisions of both the Medicines Scheduling Committee and thePoisons Scheduling Committee be decided by a majority vote of themembers provided that majority also includes a majority of thejurisdictions; and

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

b)The Therapeutic Goods Act 1989 and the Agricultural and VeterinaryChemicals Code Act 1994 and related subordinate legislation be amended, asnecessary, to enable the Therapeutic Goods Administration, in the case ofhuman medicines, and the National Registration Authority for Agricultural andVeterinary Products, in the case of agricultural and veterinary products, actingon the advice of the Commonwealth health portfolio in relation to public healthmatters 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 operatingthe Medicines Scheduling Committee and the Poisons Scheduling Committee to be fully recovered by implementing a charge for re-scheduling applications byindustry.’

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]

1.1Scheduling 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.

1.1.1Scheduling 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.

1.1.2National 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.

1.1.3The 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.

The Poisons Standard is a legislative instrument for the purposes of the Legislative Instruments Act 2003. In order to ensure certainty in the continuing application of state and territory laws, the Poisons Standard is not a disallowable instrument. Scheduling decisions are legislative, the lawfulness of the Secretary’s decision is not reviewable under the Therapeutic Goods Act 1989, in the AAT or in Federal Court.

A consolidated Poisons Standard is published each year. Scheduling decisions that occur throughout the year are included in any one of the amendments to the Poisons Standard which are published three times a year. These amendments must be read in conjunction with the current consolidated Poisons Standard.

The Poisons Standard is available on the ComLaw website[11]or may be purchased from National Mail and Marketing, as the SUSMP, for $85.50.[12]

1.2Scheduling principles

The Secretary, when making a decision to amend the Poisons Standard must take into account the matters stipulated under subsection 52E (1) of the Act. This includes the

a)the risks and benefits

b)the purpose for which the substance is to be used

c)the toxicity

d)the dosage, formulation, labelling, packaging and presentation

e)the potential for abuse

f)any other matters the Secretary considers necessary to protect public health.

Under subsection 52E (2)(b) of the Act, the Secretary must comply with any guidelines of the AHMAC and its subcommittee, the NCCTG, and must have regard to any recommendations or advice of the ACMS or the ACCS.

The NCCTG has given effect to subsection 52E (2)(b) by issuing the SPF. Chapter 3 of the SPF covers the basics of scheduling and the principles applied to the classification of medicines and chemicals.

Having considered the above matters, the Secretary can then determine which of the nine schedules in Poisons Standard is most appropriate.

1.2.1National Drugs and Poisons Schedule Committee (NDPSC)

Prior to 30 June 2010, scheduling decisions were made by the NDPSC. The NDPSC was a statutory committee established under the Therapeutic Good Act 1989 and Therapeutic Goods Regulations 1990 to classify drugs and poisons (substances) for inclusion in the Poisons Standard. The NDPSC met three times a year - in February, June and October.

Under the NDPSC, submissions to amend the Poisons Standard came from a variety of avenues. These include via:

  • Australian Pesticides and Veterinary Medicines Authority (APVMA) including its product registration and review processes
  • TGA including its registration process and TGA committees e.g. Adverse Drug Evaluation Committee
  • NICNAS
  • NZ Medicines Classification Committee
  • states and territories
  • submissions from stakeholders i.e. professional bodies, companies etc
  • general public.

Committee members could also raise a submission.

All submissions were considered at the NDPSC meetings. The NDPSC also considered and noted other areas of interest including the harmonisation of NZ schedules with Australia.

Submissions from stakeholders and the general public (applicants) where encouraged to be submitted on an approved template. Applicants were requested to supply data to support their submission.

Submissions and their supporting data were often subject to an external evaluation, if deemed appropriate by the NDPSC Secretariat. The NDPSC Secretariat could also evaluate certain aspects of submissions. This was to support the NDPSC by providing sufficient data for it to consider at its meetings.

When considering complex issues, the NDPSC would form working groups to conduct further investigations. Working groups included the Drafting Advisory Panel, the Fluorides Working Group, the Atropine Working Group, the Codeine Working Group, the Essential Oils Working Group and the Schedule 5/6 Storage Requirements Working Group.

The NDPSC was also mindful of the need to avoid undermining any current registration processes when receiving applications from stakeholders or the general public.

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