EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Poisons Standard (No.2) June 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 (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 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 (No.2) June 2020, in substitution for the previous Poisons Standard, the Poisons Standard June 2020, which was registered on 27 May and was to commence on 1 June 2020, and which is repealed and replaced by this new Poisons Standard. As the Poisons Standard June 2020 was to repeal the Poisons Standard February 2020, this new Poisons Standard also repeals the Poisons Standard February 2020.
The Poisons Standard (No.2) June 2020 incorporates a small number of minor changes compared to the Poisons Standard June 2020, principally to correct an inadvertent formatting error in the header for Schedule 3 to the Poisons Standard June 2020 (which refers to Schedule 4, rather than Schedule 3) to avoid confusion and to ensure clarity in this regard (other more minor formatting changes are also incorporated).
The Poisons Standard (No.2) June 2020 also reflects all of the measures that were set out in the Poisons Standard June 2020.
In particular, the Poisons Standard June 2020 incorporated a number of changes compared to the Poisons Standard February 2020, involving 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 and/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 substances amended or added to the Poisons Standard June 2020 (and reflected in the Poisons Standard (No.2) June 2020), public comment was invited on matters referred to the March 2019 ACMS meeting, November 2019 ACMS meeting, November 2019 ACCS meeting and November 2019 Joint ACMS-ACCS meeting as follows:
- the invitation to comment in relation to calcifediol monohydrate, paracetamol (liquid formulations), hyoscine butylbromide, lidocaine, momfluorothrin, tetraniliprole, methiozolin and lambda-cyhalothrin was published on the TGA website on 29 August 2019, with a closing date of 26 September 2019;
- the invitation to comment in relation to caffeine, sumatriptan and zolmitriptan was published on the TGA website on 19 September 2019, with a closing date of 17 October 2019;
- the invitation to comment in relation to mometasone was published on the TGA website on 13 December 2018, with a closing date of 21 January 2019. A further invitation to comment in relation to mometasone was published on the TGA website on 19 September 2019, with a closing date of 17 October 2019; and
- the invitation to comment in relation to paracetamol (modified release) was published on the TGA website on 13 December 2018, with a closing date of 21 January 2019.
The delegates’ final decisions were published on the TGA website in relation to:
- sumatriptan, zolmitriptan, mometasone, calcifediol, paracetamol (liquid formulations), hyoscine butylbromide, lidocaine, caffeine, momfluorothrin, tetraniliprole, methiozolin and lambda-cyhalothrin on 7 May 2020; and
- paracetamol (modified release) on 22 August 2019.
A notice of a delegate-only decision in relation to paracetamol (modified release) was published on the TGA website on 7 May 2020, and notices of delegate-only decisions in relation to the agricultural and veterinary chemicals acequinocyl, Agrobacterium radiobacter (Rhizobium rhizogenes) and nonanoic acid were also published on that date.
The Poisons Standard June 2020 also introduced a number of new substances to the Poisons Standard for the first time. These included a number of specific entries for cabotegravir, cezauridine, decitabine, defibrotide, dulaglutide, fosnetupitant, larotrectinib, ozanimod, ripretinib, tafamidis and tucatinib in Schedule 4.
The Poisons Standard June 2020 also incorporated a small number of minor amendments, including editorial amendments to the current entries for glycolic acid, guanidine, hydroxychloroquine and propyl nitrite.
The decisions to introduce the new substances and to make the above technical and minor amendments were delegate-only decisions that were not open to public consultation as these decisions were considered, in accordance with the SPF, to be sufficiently straightforward as to not require consultation.
The Poisons Standard (No.2) June 2020 is a legislative instrument for the purposes of the Legislation Act 2003. However, section 42 of that Act relating to disallowance does not apply (refer to subsection 52D(4A) of the Act). As the 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 (No.2) June 2020 commences on 1 June 2020.