National Health Amendment (Immunisation Program) Act 2005

Administered by Department of Health, Disability and Ageing

Legislation au C2005A00140 In force Act

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No. 140, 2005

An Act to amend the National Health Act 1953, and for other purposes

Contents

1 Short title

2 Commencement

3 Schedule(s)

Schedule 1—Amendment of the National Health Act 1953

Part 1—Immunisation program

Part 2—Pharmaceutical Benefits Advisory Committee

National Health Amendment (Immunisation Program) Act 2005

No. 140, 2005

An Act to amend the National Health Act 1953, and for other purposes

[Assented to 18 November 2005]

The Parliament of Australia enacts:

1 Short title

This Act may be cited as the National Health Amendment (Immunisation Program) Act 2005.

2 Commencement

(1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provision(s)	Commencement	Date/Details
1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table	The day on which this Act receives the Royal Assent.	18 November 2005
2. Schedule 1, Part 1	A single day to be fixed by Proclamation. However, if any of the provision(s) do not commence within the period of 6 months beginning on the day on which this Act receives the Royal Assent, they commence on the first day after the end of that period.	1 January 2006 (see F2005L04086)
3. Schedule 1, Part 2	A single day to be fixed by Proclamation. However, if any of the provision(s) do not commence within the period of 6 months beginning on the day on which this Act receives the Royal Assent, they commence on the first day after the end of that period.	1 January 2006 (see F2005L04086)

Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.

(2) Column 3 of the table contains additional information that is not part of this Act. Information in this column may be added to or edited in any published version of this Act.

3 Schedule(s)

Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.

Schedule 1—Amendment of the National Health Act 1953

Part 1—Immunisation program

1 Subsection 4(1)

Insert:

designated vaccine has the meaning given by subsection 9B(2).

2 Subsection 4(1)

Insert:

vaccine means a vaccine for the purpose of immunising persons.

3 Section 9B

Repeal the section, substitute:

9B Provision of vaccines

(1) The Minister may provide, or arrange for the provision of, designated vaccines.

Designated vaccines

(2) The Minister may, by legislative instrument, determine that a specified vaccine is a designated vaccine for the purposes of this Act.

Note: For variation and revocation, see subsection 33(3) of the Acts Interpretation Act 1901.

(3) A vaccine may be specified by reference to any or all of the following:

(a) brand;

(b) formulation;

(d) strength;

(e) number and timing of doses in a course of immunisation.

(4) Subsection (3) does not limit the ways in which a vaccine may be specified.

(5) In addition to specifying a vaccine, a determination under subsection (2) may specify the circumstances in which the vaccine may be provided.

(6) If any such circumstances are specified, subsection (1) only authorises the provision of the vaccine in those circumstances.

(7) A vaccine must not be specified in a determination under subsection (2) unless:

(a) the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that the vaccine be a designated vaccine; or

(b) at any time during the 60‑day period ending immediately before the commencement of this subsection, the vaccine was provided under repealed section 9B of this Act.

(8) Before:

(a) revoking a determination under subsection (2); or

(b) varying a determination under subsection (2) in such a way that a vaccine ceases to be a designated vaccine;

the Minister must obtain the written advice of the Pharmaceutical Benefits Advisory Committee in relation to the proposed revocation or variation.

(9) An advice under subsection (8) is to be tabled in each House of the Parliament with the revocation or variation to which the advice relates.

(10) This section does not limit the vaccine‑related powers conferred on the Minister by the Quarantine Act 1908.

4 After subsection 101(4A)

Insert:

Functions relating to vaccines

(4B) The Pharmaceutical Benefits Advisory Committee must:

(a) make recommendations to the Minister from time to time about the vaccines it considers should be designated vaccines (see section 9B); and

(b) advise the Minister about any other matter concerning the operation of section 9B referred to it by the Minister.

(4C) For the purpose of deciding whether to recommend to the Minister that a vaccine be a designated vaccine, the Committee must give consideration to the effectiveness and cost of immunisation involving the use of the vaccine, including by comparing the effectiveness and cost of immunisation involving the use of the vaccine with the effectiveness and cost of alternative options, whether or not involving the use of other vaccines.

(4D) If immunisation involving the use of a particular vaccine (the first vaccine) is substantially more costly than an alternative vaccine:

(a) the Committee must not recommend to the Minister that the first vaccine be a designated vaccine unless the Committee is satisfied that the first vaccine, for some individuals, provides a significant improvement in efficacy or reduction of toxicity over the alternative vaccine; and

(b) if the Committee recommends to the Minister that the first vaccine be a designated vaccine—the Committee must include in its recommendation a statement that the Committee is satisfied as mentioned in paragraph (a).

(4E) Subsection (4D) does not limit subsection (4C).

(4F) If the Committee is of the opinion that a vaccine should be a designated vaccine, but should only be provided under subsection 9B(1) in certain circumstances, the Committee must, in its recommendation under subsection (4B), specify those circumstances.

Note 1: The following heading to subsection 101(3) is inserted “Functions relating to drugs and medicinal preparations”.

Note 2: The following heading to subsection 101(5) is inserted “Procedure”.

5 At the end of paragraph 101A(1)(b)

Add “or (4B)”.

Part 2—Pharmaceutical Benefits Advisory Committee

6 Subsection 100A(2)

Omit “15”, substitute “17”.

7 After subsection 100A(5)

Insert:

(5A) The Chairperson holds office on a full‑time basis.

8 Subsection 100A(6)

After “Committee”, insert “(other than the Chairperson)”.

9 Transition to full‑time office—Chairperson of the Pharmaceutical Benefits Advisory Committee

(1) This item applies to a person who was the Chairperson of the Pharmaceutical Benefits Advisory Committee immediately before the commencement of this item.

(2) After the commencement of this item, the person is taken to hold office as Chairperson of the Pharmaceutical Benefits Advisory Committee on a full‑time basis.

(3) Subitem (2) does not prevent the person from ceasing to hold that office.

[Minister’s second reading speech made in—

House of Representatives on 14 September 2005

Senate on 12 October 2005]

(139/05)

Overview

The National Health Amendment (Immunisation Program) Act 2005, enacted by the Parliament of Australia, was introduced to address gaps in the immunisation program by amending the National Health Act 1953. This legislation aimed to refine the framework for the provision of designated vaccines, ensuring that the process aligns with public health needs and cost-effectiveness considerations. The Act allows the Minister for Health to specify vaccines for immunisation purposes, contingent on recommendations from the Pharmaceutical Benefits Advisory Committee and other criteria. Additionally, it mandates the Committee to evaluate vaccines based on their effectiveness, cost, and potential benefits over alternative options, thus ensuring that public resources are used efficiently and effectively. The Act also introduced amendments to the Pharmaceutical Benefits Advisory Committee, including making the Chairperson's position full-time and adjusting certain procedural aspects. The changes were designed to enhance the Committee's capacity to advise on immunisation-related matters, thereby strengthening the overall immunisation program. The provisions of the Act came into effect on various dates, with some provisions starting on the day of Royal Assent (18 November 2005) and others on 1 January 2006, as specified in the commencement table.

Scope and Application

The National Health Amendment (Immunisation Program) Act 2005 amends the National Health Act 1953 to enhance the framework for immunisation programs within Australia. This Act applies to the Minister for Health, who is authorised to provide or arrange the provision of designated vaccines, and to the Pharmaceutical Benefits Advisory Committee, which is tasked with making recommendations about the vaccines that should be designated. The amendments extend to the definition of terms such as "vaccine" and "designated vaccine", with the latter being determined by the Minister through legislative instruments and subject to specific criteria including recommendations from the Advisory Committee and past usage under repealed provisions. The Act also adjusts the composition and functions of the Pharmaceutical Benefits Advisory Committee, making the Chairperson's role full-time and expanding their responsibilities to include advice on vaccines. The Act’s provisions commenced on 18 November 2005, with specific amendments relating to the immunisation program coming into effect on 1 January 2006. The Act's jurisdictional reach is national, as it amends a Commonwealth Act, thereby affecting health policies and practices across Australia.

Key Provisions

The National Health Amendment (Immunisation Program) Act 2005 amends the National Health Act 1953 to introduce provisions relating to the immunisation program. Under this Act, the Minister for Health is empowered to provide or arrange for the provision of designated vaccines, as defined in section 9B(2) of the Act. Section 9B outlines the process by which the Minister may determine a specified vaccine as a designated vaccine, taking into account recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) or historical provision of vaccines under the repealed section 9B of the National Health Act 1953. The Act mandates that the PBAC must provide recommendations to the Minister on vaccines that should be designated, considering factors such as effectiveness, cost, and potential improvements over alternative vaccines, as stipulated in subsections 4B to 4F of the Act. The Act imposes specific obligations on both the Minister and the PBAC. The Minister is required to obtain written advice from the PBAC before revoking or varying a determination that specifies a vaccine as designated, as outlined in section 9B(8). This advice must be tabled in Parliament, ensuring transparency and accountability in the decision-making process. The PBAC, on the other hand, must make recommendations to the Minister regarding designated vaccines and provide advice on any matters related to the operation of section 9B, as detailed in subsections 4B and 4C. Additionally, if the PBAC believes a vaccine should be designated but only under certain circumstances, it must specify those circumstances in its recommendation, as stated in subsection 4F. Breaches of the obligations and requirements set forth in the Act may lead to various consequences. For instance, providing a vaccine without meeting the criteria outlined in section 9B could result in unauthorised actions under the National Health Act 1953. The Act does not explicitly detail specific penalties for breaches but refers to the broader framework of the National Health Act 1953, which may include fines or other administrative penalties for non-compliance. Furthermore, the requirement to table PBAC advice in Parliament ensures that any failures to comply with the advisory process are subject to public scrutiny and potential political repercussions.

Area of Law: Health Law
Instrument: Act
Concepts: Commencement Provisions; Reporting & Disclosure Obligations; Regulatory Standards

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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.

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