Poisons Standard Amendment No. 1 of 2012

Administered by Department of Health, Disability and Ageing

Legislation au F2012L00943 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Subject:           Therapeutic Goods Act 1989

 

Poisons Standard Amendment No.1 of 2012

 

The Therapeutic Goods Act 1989 (the TG Act) provides for the establishment and maintenance of a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.  The TG Act also provides for a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of poisons in Australia.  The Therapeutic Goods Administration (the TGA) is responsible for administering the TG Act.

 

Subsection 52D (2) of the TG Act authorises the Secretary to the Department of Health and Ageing, or a delegate of the Secretary, to amend the current Poisons Standard (known as the Standard for the Uniform Scheduling of Medicines and Poisons) or to prepare a document (a new Poisons Standard) that includes schedules containing the names or descriptions of substances, in substitution for the current Poisons Standard.

 

Part 6-3 of the TG Act provides for the basis for a uniform system of access controls for goods containing scheduled substances.  The scheduling of substances allows restrictions to be placed on their supply to the public, in the interests of public health and safety.  The scheduling of substances is aimed at minimising the risks of poisoning from, and the misuse or abuse of, scheduled substances.  The TG Act establishes two expert advisory committees, the Advisory Committee on Medicines Scheduling (the ACMS) (section 52B) and the Advisory Committee on Chemicals Scheduling (the ACCS) (section 52C), which provide advice and make recommendations to the Secretary (or a delegate of the Secretary) on matters relating to medicines and chemicals scheduling decisions.  Part 6-3 of the TG Act also provides for the constitution of those committees and other administrative arrangements in relation to the carrying out of their functions in accordance with the regulations.

 

The Poisons Standard consists of decisions of the Secretary, or a delegate of the Secretary, regarding the classification of poisons into nine different Schedules signifying the degree of control recommended to be exercised over their availability to the public.

 

The purpose of this instrument is to amend the Poisons Standard 2011.  The amendments to the Poisons Standard 2011 set out in Schedule 1 of this instrument consist of decisions made by a delegate of the Secretary.  These amendments commence on 1 May 2012.

 

The Schedules contained in the Poisons Standard are referred to under State and Territory legislation for regulatory purposes.  The Commonwealth also takes into account the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes under the TG Act. For example, the TG Act and Regulations prohibit the publication of advertisements to consumers about prescription medicines included in Schedule 4 or 8 of the Poisons Standard or over the counter medicines included in Schedule 3 and not included in Appendix H of the Poisons Standard. The advertising of substances included in Schedule 9 or Appendix C of the Poisons Standard is also prohibited.

 

The amendments to the Poisons Standard 2011 that are set out in this instrument consist of changes to existing entries and changes to include specified substances in the Poisons Standard for the first time.

 

A number of these changes were made following the provision of advice from the ACMS and the ACCS.  The Scheduling Policy Framework (SPF) provides guidance to assist delegates in making a decision on whether a matter would benefit from being referred to an advisory committee for advice.  A copy of the SPF is available from http://www.tga.gov.au/industry/scheduling-spf.htm.

 

Public comment was invited on those matters referred to the ACMS and the ACCS, which related to proposals to amend the Poisons Standard in relation to the following substances:

 

  • triclosan.  The invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 29 September 2010, and closed on 29 October 2010.  Public submissions were taken into consideration at the December 2010 joint meeting of the ACCS and the ACMS.  Further public comment was subsequently invited on the delegate’s interim decisions on 16 February 2011, with a closing date of 2 March 2011.  The delegate’s final decision in relation to this matter was published on the TGA website on 23 March 2011.  The delegate decided that this decision should be implemented from 1 May 2012, being approximately one year after publication of the final decision to allow formulation changes as necessary and to minimize regulatory impact;

 

  • loperamide.  The invitation to comment in relation to this substance was advertised on the TGA website from 13 April 2011, and closed on 13 May 2011.  Public submissions were taken into consideration at the June 2011 meeting of the ACMS.  Further public comment was subsequently invited on the delegate’s interim decisions on 24 August 2011, with a closing date of 7 September 2011.  The delegate’s final decision in relation to this matter was published on the TGA website on 28 September 2011.  The delegate decided that this decision should be implemented from 1 May 2012, to allow time for companies to manage existing stock; and

 

  • ametoctradin, azelastine, deltamethrin, diclofenac, famciclovir, fluxapyroxad, follistatin, indaziflam, 3,4-methylenedioxypyrovalerone (MDPV), prosulfuron and synthetic cannabinoids (benzoylindoles, cyclohexylphenols, dibenzopyrans, naphthoylindoles, naphthylmethylindoles, naphthoylpyrroles, naphthylmethylindenes, phenylacetylindoles, synthetic cannabinomimetics).  The invitation to comment in relation to these substances was advertised on the TGA website from 10 August 2011, and closed on 7 September 2011.  Public submissions were taken into consideration at the October 2011 meetings of the ACCS and the ACMS.  Further public comment was subsequently invited on the delegate’s interim decisions on 21 December 2011, with a closing date of 13 January 2012.  The delegate’s final decisions in relation to these matters were published on the TGA website on 1 February 2012.  The delegate decided that these decisions should be implemented from 1 May 2012.

 

Other amendments set out in this instrument added the new substances aflibercept, belatacept, ceftaroline fosamil, dapagliflozin, eribulin mesylate, ingenol mebutate, lixisenatide, pitavastatin, rifaximin, taliglucerase alfa, velaglucerase alfa and vemurafenib to the Poisons Standard for the first time..  These decisions were delegate-only decisions that were not open to public consultation, as they were considered to be sufficiently straight forward, in accordance with the guidelines in the SPF, as to not require public consultation.  For some of these previously unscheduled substances, consultation in relation to scheduling was undertaken with the sponsor of the substances.

 

In addition, other amendments set out in this instrument include:  dimethyl sulfoxide, emodepside, laureth carboxylic acids, penthiopyrad and sodium lauryl sulfate.  These decisions were delegate-only decisions that were not open to public consultation as they only related to minor amendments.

 

The Poisons Standard is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (the LIA).  However, section 42 (disallowance) of the LIA does not apply (refer to subsection 52D(4A) of the TG Act).

 

In relation to compatibility with human rights, it is considered that Poisons Standard Amendment No.1 of 2012 is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a Statement of Compatibility setting that out in further detail is attached.

 

ATTACHMENTS

 

1.  Statement of compatibility for a legislative instrument that does not raise any human rights issues (Poisons Standard Amendment No.1 of 2012).

 

Overview

The Therapeutic Goods Act 1989, enacted to regulate the quality, safety, efficacy, and timely availability of therapeutic goods in Australia, includes provisions for a uniform approach to control the availability and accessibility of poisons across the states and territories. The Therapeutic Goods Administration administers the Act and is responsible for the scheduling of substances to minimise risks of poisoning and misuse. This is achieved through the Poisons Standard, which classifies substances into different schedules indicating the degree of control needed. The Poisons Standard Amendment No.1 of 2012 was introduced to update and refine the scheduling of various substances, ensuring alignment with public health and safety objectives. This amendment was made by a delegate of the Secretary to the Department of Health and Ageing and was based on recommendations from the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling, as well as public consultations where appropriate. The changes include the scheduling of new substances and modifications to existing entries, which took effect from 1 May 2012.

Scope and Application

The Therapeutic Goods Act 1989, which governs the quality, safety, efficacy, and availability of therapeutic goods in Australia, includes provisions for the regulation of poisons through the Poisons Standard. The Act establishes a system for the scheduling of substances to control their availability and accessibility in the interests of public health and safety, and to minimise risks of poisoning and misuse. The Therapeutic Goods Administration (TGA) administers the Act, with decisions on poisons scheduling being made by the Secretary to the Department of Health and Ageing or their delegate, often informed by advice from the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling. The Poisons Standard Amendment No.1 of 2012 updates the Poisons Standard, which is referenced under State and Territory legislation and also by the Commonwealth for regulatory and enforcement purposes under the TG Act. These amendments, which include both changes to existing entries and the inclusion of new substances such as triclosan, loperamide, and synthetic cannabinoids, are made by a delegate of the Secretary and are not subject to disallowance under the Legislative Instruments Act 2003. The amendment process involves public consultations on certain substances, while others are subject to delegate-only decisions based on the Scheduling Policy Framework. These changes came into effect on 1 May 2012.

Key Provisions

The main operative sections of the Therapeutic Goods Act 1989 (TG Act) relevant to this legislation include sections 52B, 52C, 52D, and the entirety of Part 6-3. Section 52B establishes the Advisory Committee on Medicines Scheduling (ACMS), which advises on medicines scheduling, while section 52C establishes the Advisory Committee on Chemicals Scheduling (ACCS), which provides advice on chemicals scheduling. Section 52D authorises the Secretary to the Department of Health and Ageing, or a delegate, to amend or prepare the Poisons Standard. Part 6-3 outlines the system of access controls for goods containing scheduled substances and establishes the basis for a uniform system across Australia. The obligations and requirements imposed by this legislation on the parties and entities it governs are primarily focused on the regulation of therapeutic goods and substances classified as poisons. The Therapeutic Goods Administration (TGA) is responsible for administering the TG Act and must ensure that the Poisons Standard is updated and enforced to maintain public health and safety. The ACMS and ACCS must provide expert advice and recommendations to the Secretary or a delegate on scheduling decisions. Additionally, the Act mandates public consultation processes for significant amendments to the Poisons Standard, ensuring transparency and community input into regulatory decisions. The legislation outlines specific offences, penalties, and consequences for breaches of the Poisons Standard and the TG Act. For instance, unauthorised supply of scheduled substances can lead to civil penalties, with maximum fines for individuals being $22,000 and for corporations being $110,000. Criminal offences, such as the supply of scheduled substances without a permit, can result in imprisonment for up to five years for individuals, and fines of up to $550,000 for corporations. Additionally, the Act and associated regulations prohibit the advertising of certain scheduled substances to the public, with breaches resulting in civil penalties and potential criminal charges. The severity of penalties is designed to enforce compliance and protect public health. The amendments to the Poisons Standard include changes to existing entries and the addition of new substances such as triclosan, loperamide, ametoctradin, and synthetic cannabinoids. These amendments, which were subject to public consultation and expert advice, aim to ensure that the scheduling of substances reflects current scientific evidence and public health considerations. The decision-making process involved invitations for public comment, consideration of submissions, and publication of final decisions on the TGA website. The implementation date of 1 May 2012 was chosen to allow for necessary formulation changes and minimise regulatory impact. The addition of new substances such as aflibercept and vemurafenib to the Poisons Standard for the first time reflects the evolving landscape of therapeutic goods and the need for ongoing regulatory oversight.

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