EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Poisons Standard Amendment (Boric Acid and Picramic Acid) Instrument 2021
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 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 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 current Poisons Standard consists principally of the Standard for the Uniform Scheduling of Medicines and Poisons. It 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 the scheduling of medicines and chemicals.
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 to 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 the Poisons Standard Amendment (Boric Acid and Picramic Acid) Instrument 2021 (“the Amendment Instrument”) is to amend the Poisons Standard February 2021 to correct the inadvertent omission of an amendment to the substance boric acid and to correct the inadvertent inclusion of the substance picramic acid.
A delegate of the Secretary recently made a final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (“the Regulations”) to include a number of amendments to the entry for boric acid. This decision was intended to take effect on 1 February 2021 and to have been implemented by inclusion in the Poisons Standard February 2021. However, the amendments were inadvertently omitted from the Poisons Standard February 2021 when it was registered on 24 December 2020. The delegate’s decision reflecting the date of effect as 1 February 2021 was published on the TGA website on 26 April 2019 in accordance with the requirements of regulation 42ZCZS of the Regulations.
A delegate of the Secretary recently made a final decision under regulation 42ZCZR of the Regulations to include picramic acid in Schedule 6, Part 2 of Appendix E, Part 3 of Appendix F and the Index of the Poisons Standard. This decision was intended to take effect on 1 October 2021 and to have been implemented by an amendment to the Poisons Standard, or inclusion in a new Poisons Standard, from that date. However, picramic acid was inadvertently included in the Poisons Standard October 2020, and in the Poisons Standard February 2021 (which repeals and replaces the Poisons Standard October 2020). The delegate’s decision reflecting the intended date of effect of 1 October 2021 was published on the TGA website on 24 August 2020, in accordance with the requirements of regulation 42ZCZS of the Regulations.
The Amendment Instrument amends the Poisons Standard February 2021 to give effect to the delegate’s final decisions in relation to both of these substances, by adding the amendments to the entry for boric acid and removing the entries for picramic acid in accordance with the final decisions.
The Poisons Standard Amendment (Boric Acid and Picramic Acid) Instrument 2021 is a legislative instrument for the purposes of the Legislation Act 2003.
However, section 42 of the Legislation Act 2003 relating to disallowance does not apply (subsection 52D(4A) of the Act refers). As the Amendment Instrument 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 Amendment (Boric Acid and Picramic Acid) Instrument 2021 commences on 1 February 2021.