Poisons Standard February 2022

EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

Poisons Standard February 2022

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 incorporated by reference 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.

Similarly, 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 February 2022, in substitution for the previous Poisons Standard, the Poisons Standard October 2021. The Poisons Standard February 2022 repeals and replaces the Poisons Standard October 2021, principally to incorporate a number of changes to existing entries, and to include 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.

Public comment was invited in relation to the proposed amendments that were referred to the June 2021 ACCS, ACMS and Joint ACMS-ACCS meetings, as follows:

• an invitation to comment in relation to bufexamac was published on the TGA website on 27 April 2021, with a closing date of 27 May 2021. A further invitation to comment in relation to this proposal was published on 30 September 2021, with a closing date of 1 November 2021;
• an invitation to comment in relation to methanol was published on the TGA website on 27 April 2021, with a closing date of 27 May 2021. A further invitation to comment in relation to this proposal was published on 13 October 2021, with a closing date of 11 November 2021;
• an invitation to comment in relation to amygdalin and hydrocyanic acid was published on the TGA website on 27 April 2021, with a closing date of 27 May 2021. A further invitation to comment in relation to this proposal was published on 30 September 2021, with a closing date of 1 November 2021;
• an invitation to comment in relation to 2-amino-5-methylphenol was published on the TGA website on 4 May 2021, with a closing date of 4 June 2021. A further invitation to comment in relation to this proposal was published on 13 October 2021, with a closing date of 11 November 2021.

The final decisions in relation to the above substances were published on the TGA website on 20 December 2021.

The Poisons Standard February 2022 also incorporates eight new substances in the Poisons Standard for the first time, including specific entries for molnupiravir, nirmatrelvir, infigratinib, ponesimod, selinexor, selumetinib, sotorasib and tepotinib in Schedule 4. A number of these substances were also listed in Appendix L, including ponesimod, selinexor and selumetinib. Other substances incorporated into the Poisons Standard for the first time include gliptins, isotianil, chromium trichloride hexahydrate, metobromuron, kinetin, rescalure, fluoxapiprolin and disodium manganese EDTA.

Notification of amendments to the Poisons Standard in relations to New Chemical Entities (NCEs) and final decisions (without interim decision) made pursuant to regulation 42ZCZU (delegate-only decisions) were published on the TGA website on 24 January 2022.

A small number of further, more minor amendments and corrections have also been incorporated in the Poisons Standard February 2022, including to ensure that cross-references are included in relevant index entries, improve consistency, remove duplicate index entries and correct typographical errors (for instances, to remove duplicate index entries for phosphorus).

The decisions to incorporate new substances in the Poisons Standard for the first time, and to make minor amendments and corrections, were made as delegate-only decisions in accordance with the SPF. These were considered sufficiently straightforward and did not require public consultation.

The Poisons Standard February 2022 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 Poisons Standard February 2022 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.

In providing that disallowance does not apply to an instrument made under paragraphs 52D(2)(a) or (b) of the Act, subsection 52D(4A) of the Act appropriately recognises that instruments made under these paragraphs form part of an intergovernmental scheme, which should not be subject to unilateral disallowance by the Commonwealth Parliament, consistent with section 44 of the Legislation Act. Under this scheme, the current Poisons Standard principally provides a set of recommendations to the states and territories as to the appropriate level of controls that should apply to medicines and poisons.

The states and territories regulate such substances by electing to apply the current Poisons Standard as a law within their own jurisdiction. In this way, the current Poisons Standard does not have direct application in its own right. If the current Poisons Standard was to be subject to disallowance, this would impact the current uniform system of restrictions in Australia relating to the supply of scheduled substances, and would lead to confusion and different approaches across different states and territories with respect to their handling, storage, possession and supply of scheduled substances.

Further, as inclusion of new medicines in the current Poisons Standard is often a consequence of the granting of marketing approval of new medicines under the Act, it is likely that disallowance would also lead to delays for Australian patients in accessing new and effective treatments.

The Poisons Standard February 2022 commences on 1 February 2022.