EXPLANATORY STATEMENT
Subject: Therapeutic Goods Act 1989
Poisons Standard Amendment No. 2 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 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.
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 2012. The amendment to the Poisons Standard 2012 set out in Schedule 1 of this instrument consists of one decision made by a delegate of the Secretary. This amendment commences on 8 August 2012.
The Schedules contained in the Poisons Standard are referred to under State and Territory legislation for regulatory purposes, which enables restrictions to be placed on the supply of scheduled substances to the public, according to the degree of risk and the degree of control recommended to be exercised over their availability in the interests of public health and safety.
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 Schedules 4 or 8 of the Poisons Standard or over the counter medicines that are 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 amendment to the Poisons Standard 2012 that is set out in this instrument consists of a single decision to include a specified substance –
1,3-dimethylamylamine (DMAA) -in the Poisons Standard for the first time.
This change was made following the provision of advice from the ACMS, and in accordance with the procedures set out in Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990 for amending the Poisons Standard when a proposed amendment is referred to an expert advisory committee. The Scheduling Policy Framework (SPF) provides guidance to assist delegates in making a decision as to 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 a proposal to amend the Poisons Standard in relation to DMAA. The invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 26 April 2012, and closed on 25 May 2012. Public submissions received were taken into consideration at the June 2012 meeting of the ACMS.
Further public comment was subsequently invited on the delegate’s interim decision on 20 July 2012, with a closing date of 25 July 2012. The delegate’s final decision in relation to this matter was published on the TGA website on 1 August 2012. The delegate took the view that this decision should be implemented from 8 August 2012, as the scheduling of DMAA is considered to be an urgent measure necessary to protect public health in light of the potential for use of this substance to cause harm to users.
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. 2 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.
ATTACHMENT
1. Statement of compatibility for a legislative instrument that does not raise any human rights issues (Poisons Standard Amendment No. 2 of 2012).
Overview
The Therapeutic Goods Act 1989 (TG Act) was enacted to establish and maintain a regulatory system ensuring the quality, safety, efficacy, and timely availability of therapeutic goods within Australia and for export. The Act also provides a framework for the States and Territories to control the availability, accessibility, and safe handling of poisons across Australia. Administered by the Therapeutic Goods Administration (TGA), the Act includes provisions for scheduling substances to minimise risks such as poisoning and misuse. The Poisons Standard, which classifies poisons into different Schedules based on the recommended degree of control over their public availability, is a key instrument under the TG Act. The Poisons Standard Amendment No. 2 of 2012 was introduced to address the need for tighter controls on certain substances, following expert advice and public consultation, to protect public health and safety. This amendment involved the inclusion of 1,3-dimethylamylamine (DMAA) into the Poisons Standard for the first time, reflecting the urgent need to restrict its availability due to potential health risks.
Scope and Application
The Therapeutic Goods Act 1989 (TG Act) governs the regulation of therapeutic goods in Australia, including the scheduling and control of substances to ensure public health and safety. Under this Act, the Therapeutic Goods Administration (TGA) is responsible for administering the controls over therapeutic goods, which includes the scheduling of substances in the Poisons Standard. The Poisons Standard, which is amended by legislative instruments such as the Poisons Standard Amendment No. 2 of 2012, classifies substances into nine schedules based on the degree of control required over their availability and accessibility. This amendment specifically addresses the scheduling of 1,3-dimethylamylamine (DMAA), a substance newly included in the Poisons Standard following advice from the Advisory Committee on Medicines Scheduling and consideration of public submissions. The amendment is effective from 8 August 2012, reflecting the urgent need to protect public health due to the potential risks associated with DMAA. The scheduling decisions in the Poisons Standard are implemented under state and territory legislation, which allows for regulatory measures to restrict the supply of scheduled substances according to their risk profile. The amendment does not fall under the disallowance provisions of the Legislative Instruments Act 2003, and it has been assessed as compatible with human rights as outlined in the attached Statement of Compatibility.
Key Provisions
The Therapeutic Goods Act 1989 (TG Act) provides a comprehensive framework for the regulation of therapeutic goods in Australia, including a system for controlling the quality, safety, efficacy and availability of these goods. Section 52D(2) of the TG Act authorises the Secretary to the Department of Health and Ageing, or a delegate, to amend the Poisons Standard or to prepare a new Poisons Standard, which includes schedules containing the names or descriptions of substances. This is the basis for regulating the availability and accessibility of poisons in Australia, aiming to minimise risks of poisoning and misuse. The scheduling of substances allows restrictions to be placed on their supply to the public, in the interests of public health and safety. The Act establishes two expert advisory committees, the Advisory Committee on Medicines Scheduling (section 52B) and the Advisory Committee on Chemicals Scheduling (section 52C), which provide advice and make recommendations to the Secretary regarding medicines and chemicals scheduling decisions.
The Poisons Standard consists of decisions of the Secretary or a delegate regarding the classification of poisons into nine different Schedules. These Schedules signify the degree of control recommended to be exercised over their availability to the public. The amendment to the Poisons Standard 2012, which is the focus of this instrument, involves the inclusion of 1,3-dimethylamylamine (DMAA) in the Poisons Standard for the first time. This change was made following advice from the Advisory Committee on Medicines Scheduling (ACMS) and in accordance with the procedures set out in Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990 for amending the Poisons Standard when a proposed amendment is referred to an expert advisory committee. Public comment was invited on this proposal, and submissions were considered at the June 2012 meeting of the ACMS. The final decision was published on the Therapeutic Goods Administration (TGA) website on 1 August 2012, with an implementation date of 8 August 2012, deemed necessary to protect public health.
The Poisons Standard Amendment No. 2 of 2012 imposes several obligations and requirements on parties and entities it governs. Firstly, it mandates that substances such as DMAA, once included in the Poisons Standard, are subject to specific controls on their supply and availability to the public. This includes restrictions on advertising certain scheduled substances, as outlined in the TG Act and Regulations. Entities involved in the supply of these substances must comply with these restrictions to avoid legal repercussions. The amendment also requires that any advertisements for prescription or over-the-counter medicines must adhere to the specific scheduling criteria, particularly for substances listed in Schedules 3, 4, 8, and Appendix C. Furthermore, entities must ensure that their products are classified and labelled correctly according to the Poisons Standard, which may involve additional record-keeping and reporting obligations.
The inclusion of DMAA in the Poisons Standard also introduces specific offences and penalties for breaches under the TG Act. For example, supplying or advertising a scheduled substance in a manner inconsistent with the Poisons Standard could result in criminal penalties, including fines and imprisonment. The Act specifies that the maximum penalty for contravening the provisions related to the supply of scheduled substances can be substantial, with fines up to $220,000 for individuals and $1,100,000 for corporations, along with potential imprisonment terms. Additionally, civil penalties may apply for breaches of advertising regulations, which can include fines up to $220,000 for individuals and $1,100,000 for corporations. The TG Act also provides for the seizure and destruction of non-compliant goods, further enforcing compliance with the scheduling requirements.