EXPLANATORY STATEMENT
Subject: Therapeutic Goods Act 1989
Poisons Amendment (2017 Measures No. 1) Instrument 2017
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 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 Therapeutic Goods Administration (the TGA), which is part of the Department of Health, is responsible for administering the TG Act.
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.
Subsection 52D(2) of the TG Act (which is in Part 6-3) provides for the Secretary of the Department of Health, 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.
The Poisons Standard consists of decisions of the Secretary, regarding the classification of poisons into the different Schedules, signifying the degree of control recommended to be exercised over their availability to the public.
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 on matters relating to medicines and chemicals scheduling decisions.
The purpose of this instrument is to amend the Poisons Standard February 2017. The effect of the amendments is to remove the following substances from Schedule 6 of the Poisons Standard (including references to the substances in other parts of the Poisons Standard):
- m-aminophenol;
- Resorcinol;
- 2-chloro-6-(ethylamino)-4-nitrophenol;
The amendments also alter the wording of the entry for 2,4-diaminophenoxyethanol in schedule 6 and in Part 3 of Appendix F of Part 5 of Schedule 1 of the Poisons Standard February 2017.
These chemicals were included in the February 2017 Poisons Standard following a delegate-only decision and consultation with the applicant. On publication of the delegate-only decisions, information was received from industry that the wording of the entries may require further amendment to account for the use of these chemicals in other industry sectors. Three chemicals have been withdrawn from the Poisons Standard, and the entry for 2,4-diaminophenoxyethanol has been amended to reflect the entry in the Poisons Standard November 2016 while these decisions are reviewed and advice is sought from the scheduling committees in accordance with the procedures set out in Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990.
The Poisons Standard 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 TG Act). Because 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 instrument commences on 1 February 2017, which means the amendments to the Poisons Standard February 2017 contained in this instrument are effective on and from that day.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the quality, safety, efficacy and timely availability of therapeutic goods in Australia, ensuring that they are safe for use or export. The Act establishes a uniform system of controls and provides a framework for state and territory governments to adopt a consistent approach to the control of medicines and poisons, ensuring safe handling and accessibility. Administered by the Therapeutic Goods Administration, the Act includes provisions for the scheduling of substances, allowing for restrictions on their supply to the public to minimise risks of poisoning and misuse. This includes the Poisons Standard, which classifies substances into schedules based on the recommended degree of control over their availability. The Act also establishes expert advisory committees to provide advice on medicines and chemicals scheduling.
The Poisons Amendment (2017 Measures No. 1) Instrument 2017 amends the Poisons Standard to remove certain substances from Schedule 6, and alter the wording of another entry, following consultation and industry feedback. This instrument, which is not subject to disallowance under the Legislation Act 2003, became effective on 1 February 2017. These amendments aim to correct entries that may have been inaccurately included in the February 2017 Poisons Standard, pending further review and advice from the relevant scheduling committees.
Scope and Application
The Therapeutic Goods Act 1989, as amended by the Poisons Amendment (2017 Measures No. 1) Instrument 2017, governs the quality, safety, efficacy, and availability of therapeutic goods in Australia. This Act applies to all persons and entities involved in the manufacture, supply, or import of therapeutic goods within Australia, including the use of scheduled substances. The Act provides for a uniform system of access controls for goods containing scheduled substances, aiming to minimise the risks of poisoning and misuse of these substances. The Therapeutic Goods Administration, a part of the Department of Health, administers the Act. Part 6-3 of the TG Act allows for the scheduling of substances, with the Secretary of the Department of Health having the authority to amend the Poisons Standard, which dictates the classification of substances into schedules that reflect the degree of control over their availability. The Act also establishes expert advisory committees that provide advice on scheduling decisions. The amendments to the Poisons Standard, effective from 1 February 2017, involve the removal of specific substances from Schedule 6 and modifications to the wording of certain entries to better reflect industry usage, pending further review and advice from the relevant scheduling committees. The instrument is not subject to disallowance under the Legislation Act 2003, and thus, does not require a statement of compatibility with human rights under the Human Rights (Parliamentary Scrutiny) Act 2011.
Key Provisions
The main operative sections of the Poisons Amendment (2017 Measures No. 1) Instrument 2017 involve the amendment of the Poisons Standard, which is a legislative instrument under the Therapeutic Goods Act 1989 (section 102). This instrument removes certain chemicals from Schedule 6 of the Poisons Standard and alters the wording of the entry for 2,4-diaminophenoxyethanol to address industry concerns about the chemicals' use in other sectors. Specifically, m-aminophenol, resorcinol, and 2-chloro-6-(ethylamino)-4-nitrophenol are removed from Schedule 6 (section 52D(2)). Additionally, the entry for 2,4-diaminophenoxyethanol is amended to reflect the entry in the Poisons Standard November 2016 (section 52D(2)). These changes are effective from 1 February 2017.
The obligations and requirements imposed by this instrument primarily concern the Therapeutic Goods Administration (TGA), which is responsible for administering the Therapeutic Goods Act 1989. The TGA must ensure that the Poisons Standard is amended as specified, reflecting the removal of the mentioned chemicals from Schedule 6 and the alteration of the 2,4-diaminophenoxyethanol entry. Furthermore, the TGA must facilitate the process of consulting with industry and the relevant scheduling committees to review the decisions and provide appropriate advice. This involves adhering to the procedures set out in Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990.
There are no offences or penalties specified in this instrument. However, failure to comply with the amended Poisons Standard could potentially lead to regulatory action under the Therapeutic Goods Act 1989. Such action may include fines or other civil or criminal consequences, depending on the nature and extent of the non-compliance. The maximum penalties for breaches of the Therapeutic Goods Act 1989 can be substantial, including fines of up to $1.1 million for corporations and up to $220,000 for individuals, depending on the specific offence and circumstances. The legislation also allows for the possibility of imprisonment in certain cases.
In summary, the Poisons Amendment (2017 Measures No. 1) Instrument 2017 amends the Poisons Standard by removing certain chemicals from Schedule 6 and altering the wording of the entry for 2,4-diaminophenoxyethanol. The TGA is responsible for implementing these changes and ensuring compliance with the amended standard. While there are no explicit penalties in this instrument, non-compliance with the Therapeutic Goods Act 1989 can result in significant fines and, in some cases, imprisonment.