Therapeutic Goods Amendment (Scheduling Advisory Committee Members) Regulations 2019

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00109 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

 

Therapeutic Goods Act 1989

     

Therapeutic Goods Amendment (Scheduling Advisory Committee Members) Regulations 2019

 

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Act also provides a framework for the States and Territories to adopt a uniform approach to controlling the availability and accessibility of poisons in Australia, to ensure their safe handling. The Therapeutic Goods Administration (the TGA), which is part of the Department of Health (the Department), is responsible for administering the Act.

 

Subsection 63(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

Part 6-3 of the Act establishes two advisory committees, the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), both constituted in accordance with the regulations, to provide advice to the Secretary on scheduling matters.

 

The purpose of the Therapeutic Goods Amendment (Advisory Committee Members) Regulations 2019 (the Regulations) is to make two minor amendments to the Therapeutic Goods Regulations 1990 (the TG Regulations). The first amendment is to allow the Minister for Health to appoint two additional members to each of the ACMS and ACCS (i.e. up to 8 appointed members in total). The second consequential amendment is to allow the required quorum attendance of two-thirds to be adjusted half.

 

Currently under the TG Regulations, the membership of the ACMS and ACCS consists of nominated members (one member nominated by the Commonwealth and one member nominated by each State and Territory) and up to 6 members who may be appointed by the Minister for Health. These appointed members must have expertise in at least one of a number of specified fields of expertise, for example toxicology or pharmacology, and clinical pharmacology.

 

As some of the fields of expertise for appointed members for these two committees are quite broad, the Regulations are designed to better reflect this breadth and range of expertise. For example, a community pharmacist, hospital pharmacist and consultant pharmacist are all examples of persons who may be covered by the ‘pharmacy practice’ field.  This will enhance the capacity for each committee to provide high quality advice to the Secretary on scheduling matters.  

 

The Regulations also make a minor, consequential amendment to the TG Regulations, to replace the current requirement for two thirds of the members of each of these committees to be present at a meeting for there to be a quorum, with a new quorum requirement that half of the members of each committee must be present.

 

This reflects that there may be instances where the increase in the number of members may otherwise affect the ability to achieve a quorum at some meetings. This also brings the quorum requirements for these committees into line with other advisory committees established in Divisions 1A-1EB of Part 6 of the TG Regulations (e.g. the Advisory Committee on Medicines).

 

Details of the Regulations are set out in the Attachment.

 

The Act specifies no conditions that need to be satisfied before the power to make the Regulations may be exercised.

 

The Regulations are a legislative instrument for the purposes of the Legislation Act 2003.

 

The Regulations commence the day after they are registered on the Federal Register of Legislation.

 

Consultation

 

The TGA contacted the Chairs of the ACMS and ACCS in December 2018 in relation to the proposed increase in appointed members. Both Chairs indicated support for the measure.

 

 

Authority:  Subsection 63(1) of the Therapeutic Goods Act 1989

ATTACHMENT

 

Details of the Therapeutic Goods Amendment (Scheduling Advisory Committee Members) Regulations 2019

 

Section 1 – Name

This section provides for the Regulations to be referred to as the Therapeutic Goods Amendment (Scheduling Advisory Committee Members) Regulations 2019.

 

Section 2 – Commencement

This section provides for the commencement of the Regulations on the day after registration.

 

Section 3 – Authority

This section provides that the Regulations are made under the Therapeutic Goods Act 1989 (the Act).

 

Section 4 – Schedules

This section provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Regulations has effect according to its terms.

 

 

Schedule 1 – Amendments

 

Therapeutic Goods Regulations 1990

 

Item 1– Subregulation 42ZCC(1)

Under subregulation 42ZCC(1) of the Therapeutic Goods Regulations 1990 (the TG Regulations), the Advisory Committee on Medicines Scheduling (the ACMS) comprises each nominated member (these are a member nominated by the Commonwealth and a member nominated by each State and the Australian Capital Territory and the Northern Territory, under subsection 52B(3) of the Act) and no more than 6 appointed members. Subregulation 42ZCD(1) explains that an appointed member must be appointed in writing by the Minister.

 

This item amends subregulation 42ZCC(1) to increase the maximum number of members that the Minister may appoint to the ACMS, from 6 to 8. This measure is intended to allow the membership of the ACMS to better reflect the breadth within some of the fields of expertise for members of the committee listed in subregulation 42ZCC(2), e.g. ‘pharmacy practice’ and ‘medical practice’.

 

Item 2 – Regulation 42ZCN

Regulation 42ZCN of the TG Regulations requires that for a quorum to exist at a meeting of the ACMS, two thirds of the committee’s membership must be present.

 

This item makes a minor, consequential amendment to regulation 42ZCN to replace the requirement for two thirds of the committee’s membership to be present for a quorum to exist with a new requirement for half of the committee’s membership to be present in order to reach this threshold.

 

This measure reflects the effect of item 1 in relation to increasing the total membership of the ACMS, and recognises that there may be instances where that increase may otherwise affect the ability of the committee to reach a quorum at some meetings.

 

It also brings the quorum requirements for the ACMS into line with the quorum requirements for the advisory committees established in Divisions 1A-1EB of Part 6 of the TG Regulations (regulation 41I refers).

 

Items 3 and 4 – Subregulation 42ZCS(1) and regulation 42ZCZD

These items make equivalent amendments to those made by items 1 and 2 above, in respect of the Advisory Committee on Chemicals Scheduling.

 


Statement of Compatibility with Human Rights

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Therapeutic Goods Amendment (Scheduling Advisory Committee Members) Regulations 2019

 

The Therapeutic Goods Amendment (Scheduling Advisory Committee Members) Regulations 2019 (the Regulations) are compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the Legislative Instrument

The Regulations are made under subsection 63(1) of the Therapeutic Goods Act 1989 (the Act), and amend the Therapeutic Goods Regulations 1990 (TG Regulations), principally to allow the Minister for Health to appoint two additional members to each of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) (increasing the current maximum of 6 appointed members to 8 appointed members for each of these committees).

 

One of the objects of the Act is to provide a framework for the States and Territories to adopt a uniform approach to controlling the availability and accessibility of poisons in Australia according to the degree of risk they present, to ensure their safe handling.

 

Part 6-3 of the Act establishes the ACMS and the ACCS to provide advice to the Secretary on scheduling matters, and makes it clear that these committees are to be constituted in accordance with the regulations.

 

Currently under the TG Regulations, the membership of the ACMS and ACCS consists of nominated members (one member nominated by the Commonwealth and one member nominated by each State and Territory) and up to 6 members who may be appointed by the Minister for Health. These appointed members must have expertise in at least one of a number of specified fields of expertise, for example toxicology or pharmacology, and clinical pharmacology.

 

As some of the fields of expertise for appointed members for these two committees are quite broad, the Regulations are designed to better reflect this breadth and range of expertise. For example, a community pharmacist, hospital pharmacist and consultant pharmacist are all examples of persons who may be covered by the ‘pharmacy practice’ field.  This will enhance the capacity for each committee to provide high quality advice to the Secretary on scheduling matters. 

 

The Regulations also make a minor, consequential amendment to the TG Regulations, to replace the current requirement for two thirds of the members of each of these committees to be present at a meeting for there to be a quorum, with a new quorum requirement that half of the members of each committee must be present.

 

This reflects that there may be instances where the increase in the number of members may otherwise affect the ability to achieve a quorum at some meetings. This also brings the quorum requirements for these committees into line with the quorum requirements for the other advisory committees established in Divisions 1A-1EB of Part 6 of the TG Regulations (e.g. the Advisory Committee on Medicines).

 

Human rights implications

As the Regulations do not introduce any changes to the TG Regulations other than to implement the measures outlined above, they do not engage any of the applicable rights or freedoms.

 

Conclusion

This legislative instrument is compatible with human rights as it does not raise any human rights issues.

 

Greg Hunt, Minister for Health

 

 

 

 

Overview

The Therapeutic Goods Act 1989 (the Act) was enacted to establish a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods used in Australia or exported from Australia, and to provide a framework for the States and Territories to adopt a uniform approach to controlling the availability and accessibility of poisons in Australia to ensure their safe handling. Administered by the Therapeutic Goods Administration, which is part of the Department of Health, the Act allows the Governor-General to make regulations necessary or convenient to carry out or give effect to the Act. One such regulation, the Therapeutic Goods Amendment (Scheduling Advisory Committee Members) Regulations 2019, made under subsection 63(1) of the Act, amends the Therapeutic Goods Regulations 1990 to allow the Minister for Health to appoint two additional members to each of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling. This amendment is designed to better reflect the breadth and range of expertise within the specified fields for appointed members, such as toxicology, pharmacology, and clinical pharmacology. The Regulations also adjust the quorum requirement from two-thirds to half of the members of each committee to ensure that the increase in members does not affect the ability to achieve a quorum at some meetings. The Regulations, which are a legislative instrument for the purposes of the Legislation Act 2003, commenced the day after they were registered on the Federal Register of Legislation. The Therapeutic Goods Administration consulted the Chairs of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling in December 2018, who both indicated support for the proposed measure. The Regulations are compatible with human rights as they do not engage any of the applicable rights or freedoms and do not raise any human rights issues.

Scope and Application

The Therapeutic Goods Act 1989 (TGA Act) applies to therapeutic goods used in or exported from Australia, and its primary objective is to ensure the quality, safety, efficacy, and timely availability of such goods. The TGA Act establishes a national regulatory framework managed by the Therapeutic Goods Administration (TGA), a division of the Department of Health. The Act provides a uniform approach for states and territories to regulate the availability and accessibility of poisons to ensure their safe handling. The scope of the Act encompasses various entities, including manufacturers, importers, and suppliers of therapeutic goods. The TGA Act has a national jurisdictional reach, applying across Australia, and it also provides mechanisms for subordinate instruments to extend or restrict its application. The Therapeutic Goods Amendment (Scheduling Advisory Committee Members) Regulations 2019, made under subsection 63(1) of the TGA Act, amend the Therapeutic Goods Regulations 1990 to allow the Minister for Health to appoint up to eight additional members to the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), enhancing the expertise and advice provided on scheduling matters. This amendment also adjusts the quorum requirement from two-thirds to half of the committee members to account for the increased membership, aligning it with other advisory committees under the TGA. The Regulations do not introduce any changes that would engage applicable rights or freedoms, and are compatible with human rights as they do not raise any human rights issues.

Key Provisions

The Therapeutic Goods Amendment (Scheduling Advisory Committee Members) Regulations 2019 (the Regulations) make two key amendments to the Therapeutic Goods Regulations 1990 (the TG Regulations). Firstly, the Regulations allow the Minister for Health to appoint up to eight members to each of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) (Section 2 of the Schedule). This is an increase from the current maximum of six appointed members for each committee (subregulation 42ZCC(1) of the TG Regulations). Secondly, the Regulations amend the quorum requirements for these committees, allowing a meeting to proceed if at least half of the members are present, rather than requiring two-thirds of the members to be present (regulation 42ZCN of the TG Regulations). The Act imposes several obligations on the parties and entities it governs. It requires the establishment of two advisory committees, the ACMS and the ACCS, which are to provide advice to the Secretary on scheduling matters (Part 6-3 of the Act). The Act also mandates that these committees are to be constituted in accordance with the regulations (subsection 52B(3) of the Act). Additionally, the Act requires the Minister for Health to appoint members to these committees who possess expertise in specified fields such as toxicology, pharmacology, and clinical pharmacology (subregulation 42ZCC(2) of the TG Regulations). Breaches of the Act or the Regulations may result in various consequences, though the Explanatory Statement does not specify particular offences or penalties. Generally, under the Therapeutic Goods Act 1989, violations can lead to civil penalties, criminal charges, and potential imprisonment. For instance, offences involving the supply of therapeutic goods that do not comply with the Act can attract fines up to $1.65 million for corporations and $330,000 for individuals, in addition to imprisonment terms (subsection 33DA(2) of the Act). Similarly, the Therapeutic Goods Regulations 1990 can impose penalties for non-compliance, although the specific penalties are not detailed in the Explanatory Statement. These consequences underscore the importance of adhering to the legislative requirements governing the quality, safety, and efficacy of therapeutic goods in Australia.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.