EXPLANATORY STATEMENT
Subject: Therapeutic Goods Act 1989
Poisons Standard Amendment No.3 of 2011
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 September 2011.
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, changes to include specified substances in the Poisons Standard for the first time and editorial amendments to correct errata.
A number of these changes were made following the provision of advice from the ACMS and the ACCS. The Scheduling Policy Framework provides guidance to assist delegates in making a decision on whether a matter would benefit from being referred to an advisory committee for advice.
Public comment was invited on those matters referred to the ACMS and the ACCS, which related to proposals to amend the Schedules in relation to the substances asenapine, cefquinome, dequantel, mavacoxib, metofluthrin, rupatadine and tapentadol. The invitation to comment was advertised on the TGA website (www.tga.gov.au) from 15 December 2010, and closed on 19 January 2011. Public submissions were taken into consideration at the February 2011 meetings of the ACMS and the ACCS. Further public comment was subsequently invited on the delegate’s interim decisions on 27 April 2011, with a closing date of 11 May 2011. The delegate’s final decisions in relation to these matters were published on the TGA website on 1 June 2011.
The other amendments set out in this instrument added a number of new substances apixaban, bispyribac, canakinumab, eculizumab, fingolimod, ticagrelor, toceranib and vernakalant to the Poisons Standard for the first time. These decisions were delegate-only decisions that were not open to public consultation, as the decisions related to chemicals and medicines that have not previously been included in the Poisons Standard. For some of these previously unscheduled medicines, consultation in relation to scheduling was undertaken with the sponsor of the substances.
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).
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, aims to regulate the quality, safety, efficacy, and timely availability of therapeutic goods within Australia and for export. The Act provides a comprehensive framework for the control of poisons, ensuring safe handling and access. The Therapeutic Goods Administration (TGA) administers the Act and is responsible for maintaining the Poisons Standard, which classifies substances into various schedules based on the degree of control needed over their availability. This Act allows for amendments to the Poisons Standard to be made by the Secretary or a delegate, ensuring the scheduling reflects current safety standards and public health needs. The purpose of the Poisons Standard Amendment No. 3 of 2011 is to update the Poisons Standard by incorporating new substances and modifying existing entries to align with the latest scientific and medical advice. These amendments, which include changes to the scheduling of certain substances, were informed by expert committees and public consultation, aiming to maintain and enhance the safety and accessibility of therapeutic goods.
Scope and Application
The Therapeutic Goods Act 1989 (TG Act) establishes a regulatory framework for the quality, safety, efficacy, and timely availability of therapeutic goods within Australia and for goods exported from Australia. This Act applies to all therapeutic goods, including medicines, medical devices, and blood and blood components, as well as to entities involved in their manufacture, importation, supply, and advertising. The Therapeutic Goods Administration (TGA), under the Department of Health, administers the TG Act. The Act provides for the scheduling of substances to control their supply to the public, aiming to prevent poisoning and misuse. The Poisons Standard, which classifies substances into nine schedules based on the degree of control required, is a critical component of this regulatory framework and is amended under the authority of the TG Act. These amendments are made by the Secretary to the Department of Health and Ageing or their delegate, with advice from expert committees such as the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS). The amended Poisons Standard is referenced by state and territory legislation for regulatory purposes and is also considered by the Commonwealth for enforcement under the TG Act. The Act allows for certain exclusions and thresholds, and its application can be extended or restricted through subordinate instruments.
Key Provisions
The main operative sections of the Therapeutic Goods Act 1989 (TG Act) include sections 52B, 52C, and 52D, which establish the Advisory Committee on Medicines Scheduling (ACMS) (section 52B) and the Advisory Committee on Chemicals Scheduling (ACCS) (section 52C), and empower the Secretary or a delegate to amend the Poisons Standard (section 52D). The Poisons Standard consists of the Secretary’s or a delegate’s decisions regarding the classification of poisons into different Schedules, signifying the degree of control over their availability to the public. This amendment, the Poisons Standard Amendment No. 3 of 2011, updates the Poisons Standard 2011, with changes to existing entries, additions of new substances, and editorial corrections (Schedule 1). These amendments commenced on 1 September 2011.
The TG Act imposes several obligations and requirements on the parties and entities it governs. Firstly, it mandates the establishment of the ACMS and ACCS to provide advice and recommendations on scheduling decisions. The Secretary or a delegate must consult these committees when making decisions that could significantly impact public health and safety. The Act also requires the Secretary or a delegate to maintain and update the Poisons Standard to reflect current medical and scientific knowledge and to ensure the safe and effective use of therapeutic goods. Additionally, the Act mandates that certain substances be classified into appropriate Schedules, which in turn informs the regulatory controls that apply to their supply, advertising, and use.
Under the TG Act, breaches of the Poisons Standard can lead to various offences and penalties. For instance, unauthorised supply of scheduled substances can result in criminal charges and substantial fines. Advertising prescription medicines and over-the-counter medicines in ways that contravene the scheduling provisions is also an offence, carrying potential penalties. The Act also provides for civil penalties for breaches related to the advertising of substances in Schedules 9 or Appendix C of the Poisons Standard, which are substances that are highly dangerous and strictly controlled. The specific penalties are not detailed in the explanatory statement, but they typically include fines that can be significant, reflecting the seriousness of the health risks involved.
The TG Act and the associated Poisons Standard are critical in ensuring that therapeutic goods available in Australia meet high standards of quality, safety, and efficacy. By classifying substances into different Schedules, the Act and the Poisons Standard create a framework that restricts the availability and use of potentially harmful substances, thereby protecting public health. The involvement of expert advisory committees and the requirement for public consultation in certain decisions help to ensure that the scheduling decisions are informed by the latest scientific evidence and public health considerations.