National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No. 1)

Overview

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No.1) was enacted to amend the existing immunisation program under the National Health Act 1953 by adding a new cohort of children aged approximately 18 months to the list of those eligible for the diphtheria-tetanus-acellular-pertussis (DTPa) vaccine. This variation was authorised by the Minister for Health under section 9B(2) of the Act, following a recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) at their November 2014 meeting. The Variation Determination, which commenced on 1 June 2015, aims to enhance public health by broadening the eligibility for the DTPa vaccine, thereby protecting both individuals and the broader community from vaccine-preventable diseases. The legislative instrument is considered compatible with human rights as it advances the right to the highest attainable standard of physical and mental health, as outlined in the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No. 1) applies to the Minister for Health, who is empowered under section 9B(2) of the National Health Act 1953 to determine specified vaccines that are provided or arranged for under the Act. This variation specifically amends the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) by adding a new cohort of children aged approximately 18 months eligible for the diphtheria-tetanus-acellular-pertussis (DTPa) vaccine. The geographic reach of this legislation is national, as it applies throughout Australia under Commonwealth jurisdiction. The Variation Determination is consistent with the human rights recognised in the International Covenant on Economic, Social and Cultural Rights, particularly advancing the right to the highest attainable standard of physical and mental health. The Variation Determination does not specify any exclusions, exemptions, or thresholds beyond the criteria outlined for the DTPa vaccine eligibility. Any further specifications or amendments to the immunisation program would be made through additional legislative instruments.

Key Provisions

The main operative sections of the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2015 (No.1) are found in Section 3, which specifies that Schedule 1 varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1). This Variation Determination adds a new cohort of children, aged approximately 18 months, to the list of those eligible for the diphtheria-tetanus-acellular-pertussis (DTPa) vaccine. The purpose of this variation is to expand the scope of the National Immunisation Program by including a new group of beneficiaries who will receive the DTPa vaccine under the National Health Act 1953. The Act imposes specific obligations on the Minister for Health to provide or arrange for the provision of designated vaccines and related goods or services. Under Section 9B(2) of the Act, the Minister can specify which vaccines are designated and under what circumstances they may be provided. This ensures that the immunisation program is well-defined and targeted, allowing for efficient and effective distribution of vaccines. The Variation Determination aligns with these obligations by specifying the additional cohort eligible for the DTPa vaccine and clarifying the circumstances under which the vaccine can be administered. Failure to comply with the provisions of the Act and the Variation Determination can result in legal consequences. Although the specific offences, penalties, or consequences are not detailed in the explanatory statement, it is reasonable to infer that breaches of the Act could lead to civil or criminal penalties, depending on the nature and severity of the breach. Penalties could include fines or other sanctions as prescribed by relevant legislation, reflecting the importance of adhering to the immunisation program's guidelines to protect public health. The Variation Determination is designed to be compatible with human rights, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), which concern the right to the highest attainable standard of physical and mental health. By expanding access to the DTPa vaccine, the Determination supports the progressive realisation of this right. Furthermore, since vaccination is not mandatory in Australia, the Determination also respects Article 1 of the ICESCR, which pertains to self-determination. This compatibility ensures that the Determination upholds fundamental human rights while fulfilling its public health objectives.