EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Poisons Standard October 2020
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 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 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 this instrument is to make a new Poisons Standard, the Poisons Standard October 2020, in substitution for the previous Poisons Standard, the Poisons Standard July 2020, which was registered on 9 July 2020 and commenced on 10 July 2020, and which is repealed and replaced by this new Poisons Standard.
The Poisons Standard October 2020 incorporates a number of changes to the Poisons Standard July 2020. These amendments principally involve changes to existing entries, and the inclusion of a number of specified substances in the Poisons Standard for the first time. A number of these changes were made following the provision of advice from the ACCS or the ACMS, 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.
In relation to amendments made to existing entries that are reflected in the Poisons Standard October 2020, public comment was invited on matters referred to the March 2020 ACMS, ACCS and Joint ACMS-ACCS meetings, as follows:
- the invitation to comment in relation to aclonifen, carbetamide, flurbiprofen, fexofenadine, pentobarbital and picramic acid, was published on the TGA website on 20 December 2019, with a closing date of 10 February 2020;
- the invitation to comment in relation to marker dyes and pigments was published on the TGA website on 6 January 2020, with a closing date of 10 February 2020;
- the invitation to comment in relation to arbutin was published on 11 April 2019, with a closing date of 13 May 2019. A further invitation to comment in relation to arbutin was published on the TGA website on 20 December 2019, with a closing date of 10 February 2020.
The delegates’ final decisions were published on the TGA website in relation to arbutin, aclonifen, carbetamide, flurbiprofen, fexofenadine, marker dyes and pigments, pentobarbital and picramic acid on 24 August 2020.
A notice of delegate-only decisions in relation to agricultural and veterinary chemicals fomesafen sodium, polyoxin D zinc salt, selenium, sodium bromide and tigilanol tiglate was also published on the TGA website on 24 August 2020.
In addition, the Poisons Standard October 2020 also incorporates an amendment to the entry in Schedule 3 to the Poisons Standard for the substance salbutamol.
On 23 March 2020, an amendment was made to the Poisons Standard February 2020 by the Poisons Standard Amendment (Hydroxychloroquine and Salbutamol) Instrument 2020 (“the Amendment Instrument”)), in relation to salbutamol, in order to ensure the continued availability of medicines containing this substance in Australia during the public health emergency caused by the outbreak of the disease known as coronavirus disease (COVID-19). The Amendment Instrument commenced on 24 March 2020.
The Poisons Standard October 2020 amends the salbutamol entry in Schedule 3 for the purpose of easing and clarifying the restrictions that were imposed on the dispensing of salbutamol by the Amendment Instrument. This was a delegate-only decision, and the delegate’s decision was published on the TGA website on 29 September 2020.
The Poisons Standard October 2020 also incorporates the introduction of a number of new substances to the Poisons Standard for the first time. These include a number of specific entries for elexacaftor, onasemnogene abeparvovec, opicapone and trientine in Schedule 4.
The Poisons Standard October 2020 also incorporates amendments to correct the inadvertent omission of fentanyl in Appendix K, to ensure that medicines containing this substance be labelled with a warning that highlights their potential to cause sedation. Amendments have also been made to include phosphoric acid and acitretin in Appendix F to reflect concerns relating to the need for warning statements and general safety directions for these substances.
The decisions to introduce the new substances and to make the above 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 October 2020 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 October 2020 commences on 1 October 2020.