EXPLANATORY STATEMENT
Select Legislative Instrument 2005 No. 316
National Health Amendment (Immunisation Program) Act 2005 - Proclamation
National Health Act 1953
National Health Amendment Regulations 2005 (No. 2)
Proclamation
Subsection 2(1) of the National Health Act 1953 (the NHA) provides that Schedule 1 to the National Health Amendment (Immunisation Program) Act 2005 (the Act) commences on a day to be fixed by Proclamation. The NHA also provides that if any of the provisions of Schedule 1 do not commence within six months of the date the Act receives the Royal Assent, then those provisions commence on the first day after the end of that six month period. The Act received Royal Assent on 18 November 2005.
Part 1 of Schedule 1 to the Act repeals section 9B of the National Health Act 1953.
Section 9B empowered the Minister to provide, or arrange for the provision of, vaccine for the purpose of immunizing persons against poliomyelitis, mumps, measles, rubella, and any other disease prescribed in the National Health Regulations 1954 (the Principal Regulations). The Act also replaces the repealed section 9B with a new section 9B that gives the Minister the power to provide, or to arrange the provision of, designated vaccines and to determine by legislative instrument that a specified vaccine is a designated vaccine for the purposes of the National Health Act 1953.
Part 2 of Schedule 1 to the Act increases the size of the Pharmaceutical Benefits Advisory Committee (PBAC) from up to 15 members to up to 17 members and provides for the Chairperson of the PBAC to hold the office on a full time basis. Consistent with the Budget announcement for this policy the purpose of the Proclamation is to fix 1 January 2006 as the day on which Schedule 1 to the Act will commence.
Regulations
Subsection 140(1) of the NHA provides, in part, that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.
The purpose of the Regulations is to omit Part 3 of the Principal Regulations which also prescribed the diseases for which vaccines had been provided and is made redundant by the amendment to section 9B of the Act. The Regulations would also correct a typographical error in the Principal Regulations
The NHA specified no conditions that need to be met before the power to make the proposed Regulations was exercised.
The Proclamation and Regulations are legislative instruments for the purposes of the Legislative Instruments Act 2003.
The Regulations commenced on 1 January 2006.
Authority: Subsection 2(1) of the
National Health Amendment (Immunisation Program) Act 2005
Subsection 140(1)
of the National Health Act 1953
Overview
The National Health Amendment (Immunisation Program) Act 2005 was enacted to address deficiencies in the existing legislative framework for immunisation programs within Australia. The Act was introduced to refine and update the National Health Act 1953, specifically targeting the powers and processes involved in the provision of vaccines for immunisation purposes. The Australian Parliament enacted this legislation to enhance the flexibility and effectiveness of the national immunisation program by allowing the Minister for Health to more readily adapt to new vaccines and immunisation needs. The policy objective of this amendment was to ensure that the immunisation program could respond more efficiently to emerging health threats and public health priorities. The Act received Royal Assent on 18 November 2005, with the provisions set to commence on 1 January 2006 as proclaimed.
Scope and Application
The National Health Amendment (Immunisation Program) Act 2005 applies to the Commonwealth of Australia and specifically amends the National Health Act 1953, which is a Commonwealth Act. The Act pertains to the provision of vaccines for immunisation against specific diseases and the composition and operation of the Pharmaceutical Benefits Advisory Committee (PBAC). It grants the Minister for Health the authority to provide or arrange for the provision of designated vaccines and to specify these vaccines through legislative instruments. The Act also increases the size of the PBAC and provides for the Chairperson to hold office on a full-time basis. The Act commenced on 1 January 2006, as per the Proclamation issued under the authority of the National Health Act 1953. The National Health Amendment Regulations 2005 (No. 2), made under the National Health Act 1953, omitted Part 3 of the National Health Regulations 1954 which prescribed the diseases for which vaccines had been provided, as this part became redundant due to the amendment in the Act. The Regulations also corrected a typographical error in the Principal Regulations and commenced on 1 January 2006. There are no stated exclusions, exemptions, or thresholds in the Act or Regulations, and the scope is limited to the specified amendments and the regulation of vaccine provision and the PBAC.
Key Provisions
The main operative sections of the National Health Amendment (Immunisation Program) Act 2005 concern the amendment of the National Health Act 1953 (NHA) regarding the immunisation program. Specifically, Section 9B of the NHA, which previously allowed the Minister to provide or arrange for the provision of vaccines for specific diseases such as poliomyelitis, mumps, measles, and rubella, has been repealed and replaced (sections 1 and 2 of Schedule 1). The new Section 9B empowers the Minister to provide or arrange for the provision of designated vaccines and to determine which vaccines are designated through legislative instruments. Additionally, Part 2 of Schedule 1 to the Act increases the size of the Pharmaceutical Benefits Advisory Committee (PBAC) from up to 15 members to up to 17 members and stipulates that the Chairperson of the PBAC holds the office on a full-time basis.
The Act imposes several obligations and requirements on the Minister and the PBAC. The Minister is now tasked with determining which vaccines are designated and ensuring their provision or arrangement for immunisation purposes. This requires the Minister to exercise a careful and informed decision-making process, potentially involving consultation with health experts and stakeholders. The PBAC, now expanded to up to 17 members with a full-time Chairperson, must perform its advisory role more robustly, ensuring that the expanded committee can adequately assess the benefits and risks associated with the provision of designated vaccines.
Breaching the provisions of this Act could lead to significant consequences. Although the explanatory statement does not explicitly detail offences or penalties, it is reasonable to infer that non-compliance with the Act's provisions, particularly those related to the provision of vaccines, could result in legal actions. The NHA may have other sections that outline penalties for non-compliance, such as fines or imprisonment, for those who fail to adhere to the requirements set forth by the Act. Additionally, any failure to properly manage the immunisation program could lead to civil consequences, such as lawsuits from individuals who suffer due to inadequate or improper vaccination services.
The Regulations, made under the authority of the NHA, serve to omit redundant parts of the National Health Regulations 1954 and correct typographical errors. These Regulations, which commenced on 1 January 2006, ensure that the regulatory framework is consistent with the new legislative changes introduced by the Act. Any failure to comply with these Regulations could similarly lead to legal or administrative consequences, although the exact nature of these consequences would depend on the specific regulatory provisions and any associated penalties.