EXPLANATORY STATEMENT
Subject: Therapeutic Goods Act 1989
Amendment No. 3 to the Poisons Standard 2008
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 National Drugs and Poisons Schedule Committee (the Committee) to amend the current Poisons Standard or prepare a document (a new Poisons Standard) that includes schedules containing the names or descriptions of substances, in substitution for the current Poisons Standard.
The Committee is established under Part 6-3 of the TG Act (refer to section 52B). The Committee consists of Commonwealth, State and Territory government members and other persons appointed by the Minister for Health and Ageing such as technical experts and representatives of various sectoral interests. Part 6-3 of the TG Act establishes the Committee as a statutory body, sets out its functions and activities and its responsibilities for the Poisons Standard, such as the publication of decisions by the Committee and the making of amendments.
The Poisons Standard consists of decisions of the Committee regarding classification of drugs and poisons into nine different Schedules signifying the degree of risk and 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 2008. The amendments to the Poisons Standard 2008 set out in Schedule 1 of this instrument consist of decisions made by the Committee at its October 2008 meeting and confirmed at its February 2009 meeting. These amendments commence on 1 May 2009.
The statutory procedures set out under the TG Act and the Therapeutic Goods Regulations 1990 (the Regulations) require that any proposed amendments to the Poisons Standard undergo a consultation process that involves inviting and considering public submissions (described in regulations 42ZCU and 42ZCV of the Regulations), before making a decision in relation to the scheduling of drugs and poisons. Regulations 42ZCY and 42ZCZ set out the requirements relating to the public notification of any amendment to the Poisons Standard. These requirements include inviting persons who made a valid public submission (as described in regulation 42ZCV of the Regulations) before the amendment was made to make a further submission, and a requirement that the Committee must consider any such further submissions that are in compliance with the Regulations, before determining whether to confirm, vary or set aside the amendment to the Poisons Standard.
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 52EA(2) of the TG Act).
The Schedules of poisons and drugs 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 about prescription medicines (included in Schedule 4 of the Poisons Standard), over the counter medicines (included in Schedule 3 and not included in Appendix H of the Poisons Standard) and medicines included in Schedule 8 of the Poisons Standard in specified media such as magazines, newspapers, television, radio, cinematograph films and certain displays.
Invitations for public submissions to these amendments to the Poisons Standard were advertised in the Gazette on 13 August 2008. Public submissions received were taken into consideration at the October 2008 meeting. The Committee’s decisions from the October 2008 meeting were published on 26 November 2008. Invitations for the second round of submissions were advertised in the Gazette on 26 November 2008 and taken into consideration at the February 2009 meeting. Any variations made at the February 2009 meeting to the October 2008 decisions were published on 8 April 2009. The stakeholders have been aware of the initial amendments since 26 November 2008 and any further amendments to these since 8 April 2009.
A regulatory impact statement does not accompany this instrument as the amendments to the
Poisons Standard set out in this instrument are regarded as having low impact on industry in general and are considered to be necessary public health measures in order to provide appropriate and safe access to the substances contained in the amendments. The process for amending the Poisons Standard involves significant consultation with industry stakeholders and, as such, they are already aware of these amendments (as detailed above) which are to be implemented by States and Territories on 1 May 2009.
Overview
The Therapeutic Goods Act 1989 is a pivotal piece of Australian legislation aimed at ensuring the quality, safety, efficacy, and timely availability of therapeutic goods both within Australia and for export. Enacted by the Commonwealth Parliament, this Act establishes a robust framework for the regulation of therapeutic goods and ensures a uniform approach across the States and Territories for controlling the availability, accessibility, and safe handling of poisons. The Therapeutic Goods Administration (TGA) administers this Act and, under its authority, the National Drugs and Poisons Schedule Committee was established to make decisions regarding the classification of drugs and poisons, which are encapsulated in the Poisons Standard. The Poisons Standard categorises substances into different schedules based on their risk and the level of control needed over their public availability. The 2008 Amendment No. 3 to the Poisons Standard, introduced through the instrument F2009L01257, reflects decisions made by the Committee to update these classifications. The amendment process involved a thorough public consultation to ensure that the changes addressed public health needs effectively while considering industry impacts. These amendments, which took effect on 1 May 2009, are designed to provide appropriate and safe access to the substances involved, aligning with the policy objective of the Therapeutic Goods Act.
Scope and Application
The Therapeutic Goods Act 1989 (TG Act) is the overarching legislation that governs the regulation of therapeutic goods in Australia, ensuring their quality, safety, efficacy, and timely availability, whether for domestic use or export. The Act also establishes a uniform framework for the States and Territories to regulate the availability and accessibility, and safe handling of poisons. The Therapeutic Goods Administration (TGA) administers the Act. The Act allows the National Drugs and Poisons Schedule Committee (the Committee), a statutory body established under Part 6-3 of the TG Act, to amend the Poisons Standard, which classifies drugs and poisons into various Schedules indicating the level of risk and recommended control over their availability. The Poisons Standard is integral to both Commonwealth and State/Territory regulations concerning therapeutic goods. This particular amendment to the Poisons Standard, effective from 1 May 2009, follows decisions made by the Committee at its October 2008 and February 2009 meetings and involves a comprehensive consultation process, including public submissions and notifications as outlined in the Therapeutic Goods Regulations 1990. The amendments are considered necessary public health measures with minimal impact on industry.
Key Provisions
The primary sections of the legislation (F2009L01257) relate to amendments to the Poisons Standard 2008, as set out in the Therapeutic Goods Act 1989. The legislation (subsection 52D(2) of the TG Act) authorises the National Drugs and Poisons Schedule Committee to amend the Poisons Standard. These amendments, which were made by the Committee at its October 2008 and February 2009 meetings, involve decisions on the classification of drugs and poisons into various Schedules, which indicate the level of risk and control required over their availability to the public. The changes, which commenced on 1 May 2009, are detailed in Schedule 1 of the instrument and are part of the Poisons Standard. The Poisons Standard is a legislative instrument that classifies substances into nine Schedules based on their risk level and recommended control measures.
The obligations and requirements imposed by the Act on the parties or entities it governs include the necessity for the National Drugs and Poisons Schedule Committee to undertake a comprehensive consultation process before making any decisions regarding the scheduling of drugs and poisons. This process involves inviting public submissions and considering them before making final decisions. The committee must also consider any further submissions made in response to public notifications of amendments to the Poisons Standard, as per regulations 42ZCU to 42ZCZ of the Therapeutic Goods Regulations 1990. The committee's decisions are published, ensuring transparency and allowing stakeholders to be aware of the amendments. Additionally, the Poisons Standard is referenced under State and Territory legislation for regulatory purposes, and the Commonwealth also takes into account the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes under the Therapeutic Goods Act 1989.
The legislation includes provisions for offences, penalties, and civil or criminal consequences for breaches. Although the specific maximum penalties are not detailed in the explanatory statement, it is clear that the Act imposes strict controls and regulatory measures to ensure the safe handling and availability of therapeutic goods. The Act and the Therapeutic Goods Regulations 1990 prohibit the publication of advertisements about certain medicines in specified media, highlighting the seriousness with which the regulation of therapeutic goods is approached. Any breach of these provisions could result in civil or criminal penalties, although the exact nature and severity of these penalties would be determined by the relevant courts and regulatory bodies. The Act's focus on public health measures and the necessary controls over therapeutic goods underscores the importance of compliance with its provisions.