EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Poisons Standard December 2019
The Therapeutic Goods Act 1989 (“the Act”) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in, or exported from, Australia. The Act also provides a framework for State and Territory governments to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of medicines and poisons in Australia. The Act is administered by the Therapeutic Goods Administration (“the TGA”), within the Australian Government Department of Health.
Part 6-3 of the Act (sections 52AA to 52EC) 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.
Subsection 52D(2) of the Act empowers the Secretary to amend the current Poisons Standard (which consists of the Standard for the Uniform Scheduling of Medicines and Poisons (section 2 of the Poisons Standard refers)) 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.
The Poisons Standard reflects decisions of the Secretary or a delegate of the Secretary regarding the classification of medicines and poisons into the different Schedules, signifying the degree of risk and the control recommended to be exercised over their availability to the public.
The Act establishes two expert advisory committees, the Advisory Committee on Medicines Scheduling (“ACMS”) (section 52B of the Act refers) and the Advisory Committee on Chemicals Scheduling (“ACCS”) (section 52C of the Act refers), which provide advice and make recommendations to the Secretary on matters relating to medicines and chemicals scheduling decisions.
The Schedules contained in the Poisons Standard are referred to under State and Territory legislation for regulatory purposes. This enables restrictions to be placed on the supply of scheduled substances to the public, according to the degree of risk associated with the substances and the level of control recommended over their availability, in the interest of public health and safety.
The Commonwealth takes into account the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes under the Act. For example, the Act prohibits the publication or broadcasting of advertisements to consumers about prescription medicines containing substances included in Schedule 4 or Schedule 8 to the Poisons Standard, or over-the-counter medicines containing substances included in Schedule 3 and not included in Appendix H of the Poisons Standard. The advertising of substances included in Schedule 9 or Schedule 10 of the Poisons Standard is also prohibited.
The Scheduling Policy Framework (“the SPF”) provides guidance on whether a decision concerning the scheduling of substances under the Poisons Standard would benefit from being referred to ACMS or ACCS for advice. A copy of the SPF can be found at https://www.tga.gov.au/publication/ahmac-scheduling-policy-framework-medicines-and-chemicals.
The purpose of this instrument is to make a new Poisons Standard, the Poisons Standard December 2019, in substitution for the previous Poisons Standard, the Poisons Standard October 2019 (which commenced on 1 October 2019, and which is repealed and replaced by this new Poisons Standard).
The Poisons Standard December 2019 incorporates the introduction of a new substance to the Poisons Standard for the first time – talazoparib in Schedule 4.
A small number of minor amendments were also included in this instrument, including editorial amendments to the current entries for calcium hydroxylapatite and dextropropoxyphene and to include index entries for thymosin beta 4 (thymosin β4), fibroblast growth factors and TB-500.
The decision to introduce the new substance and to make the above minor amendments were delegate-only decisions that were not open to public consultation as they were considered, in accordance with the SPF, to be sufficiently straightforward as to not require consultation.
The Poisons Standard December 2019 is a legislative instrument for the purposes of the Legislation Act 2003 (“the LA”). However, section 42 (disallowance) of the LA does not apply (refer to subsection 52D(4A) of the Act). As it is not disallowable, subsection 9(1) of the Human Rights (Parliamentary Scrutiny) Act 2011 does not require that the instrument be accompanied by a statement of compatibility with the human rights recognised under that Act.
The Poisons Standard December 2019 commences on 1 December 2019.
Overview
The Therapeutic Goods Act 1989 was enacted to establish a national system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods in Australia, ensuring a uniform approach to the regulation of medicines and poisons across the states and territories. This legislation addresses the need for consistent regulation of therapeutic goods to protect public health and safety. The Act is administered by the Therapeutic Goods Administration (TGA), within the Australian Government Department of Health, and empowers the Secretary to amend or prepare the Poisons Standard, which classifies substances based on the level of risk and recommended control over their availability. The Act aims to minimise the risks of poisoning and misuse of scheduled substances by providing a framework for access controls and advertising restrictions.
The Poisons Standard December 2019, an amendment to the Poisons Standard, introduces the substance talazoparib to Schedule 4, and includes minor amendments to the entries for certain substances, as well as new index entries. This instrument, which is not subject to disallowance or the requirement for a statement of compatibility with human rights, aims to update the scheduling of substances in accordance with the Scheduling Policy Framework, reflecting the most current recommendations and decisions by the Secretary or their delegate. The updated Poisons Standard commenced on 1 December 2019.
Scope and Application
The Therapeutic Goods Act 1989 provides a national framework for the regulation of therapeutic goods in Australia, aiming to ensure their quality, safety, efficacy, and timely availability. This Act applies to all therapeutic goods that are used in, or exported from, Australia and encompasses a wide range of products including medicines, medical devices, and blood and blood components. It is administered by the Therapeutic Goods Administration (TGA) within the Australian Government Department of Health. Part 6-3 of the Act establishes a uniform system of access controls for goods containing scheduled substances, managed through the Poisons Standard, which classifies substances into different schedules based on their risk levels and recommends appropriate controls over their availability. The Act also empowers the Secretary to amend the Poisons Standard or prepare a new one, reflecting decisions about the classification of medicines and poisons. The schedules in the Poisons Standard are integral to state and territory legislation, enabling restrictions on the supply of scheduled substances to the public in the interest of public health and safety. The Act does not extend to substances classified under Schedule 9 or Schedule 10, which are completely restricted and cannot be supplied to the public. Additionally, advertising certain scheduled substances to consumers is prohibited under the Act. The scheduling of substances and the application of the Act are subject to expert advice from the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling, ensuring that decisions are informed by expert knowledge.
Key Provisions
The Therapeutic Goods Act 1989 (sections 52AA to 52EC) sets up a comprehensive system for the regulation of therapeutic goods in Australia, including medicines and poisons. This Act facilitates a national approach to ensure the quality, safety, and efficacy of these goods, which are used domestically or exported. A significant part of this regulatory framework is the Poisons Standard, which classifies substances into various schedules (section 52D) based on their risk level and the degree of control required over their distribution. The Poisons Standard, maintained by the Therapeutic Goods Administration (TGA), plays a crucial role in determining how substances are handled and supplied, aiming to protect public health and safety.
Under this Act, the Secretary has the authority to amend the Poisons Standard or create a new one (subsection 52D(2)). The current Poisons Standard, as of December 2019, introduces a new substance, talazoparib, into Schedule 4, reflecting its classification based on risk and necessary controls. Additionally, it includes minor amendments to existing entries and new index entries for substances like thymosin beta 4, fibroblast growth factors, and TB-500. These changes were made without public consultation as they were considered straightforward and in line with the Scheduling Policy Framework.
Entities and individuals governed by the Act must comply with the Poisons Standard, ensuring that the supply, advertising, and handling of scheduled substances adhere to the specified controls. For example, the Act prohibits advertising prescription medicines containing Schedule 4 or Schedule 8 substances to consumers, as well as over-the-counter medicines with Schedule 3 substances not included in Appendix H, and substances in Schedule 9 or Schedule 10. These restrictions are designed to prevent misuse and potential harm from these substances.
Breaches of the Poisons Standard and the Therapeutic Goods Act can lead to various civil or criminal penalties. The exact penalties depend on the nature and severity of the breach but can include fines and imprisonment. The Act does not specify maximum penalties for each offence, but they are determined by the courts based on the circumstances of each case. Compliance is enforced by the TGA, which has the authority to take action against entities or individuals who fail to adhere to the regulations set forth in the Poisons Standard and the Act.