National Health (Immunisation Program – Designated Vaccines) Variation Determination 2014 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01822 Not in force Legislative Instrument

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 EXPLANATORY STATEMENT

 

Issued by the Authority of the delegate of the Minister for Health

 

National Health Act 1953

 

National Health (Immunisation Program – Designated Vaccines) Variation Determination 2014 (No.1)

Legislation

Section 9B(1) of the National Health Act 1953 (the Act) states that the Minister may provide, or arrange for the provision of, designated vaccines and goods or services that are associated with, or incidental to, the provision or administration of designated vaccines.  Section 9B(2) provides that the Minister may, by legislative instrument, determine that a specified vaccine is a designated vaccine for the purposes of this Act.  Section 9B(5) provides that in addition to specifying a vaccine, a determination under subsection (2) may specify the circumstances in which the vaccine may be provided.

 

Purpose

The purpose of the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2014 (No.1) (the Variation) is to expand the cohorts of people eligible to receive the designated trivalent influenza vaccine (the Vaccine) under the National Immunisation Program (NIP).

 

Background

Section 9B(7) of the Act relevantly provides that a vaccine must not be specified in a determination under section 9B(2) unless the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended to the Minister for Health that it be a designated vaccine.

 

Between the March 2014 and July 2014 meetings, the PBAC recommended out-of-session that the eligibility for influenza vaccination under the NIP be expanded to include Aboriginal and/or Torres Strait Islander children aged from 6 months to less than 5 years.

 

Instrument Description

The National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) was made on 29 August 2014.

 

This Variation expands the cohort of people eligible for the Vaccine under the NIP.  The Variation also  changes the terms “Aboriginal or a Torres Strait Islander” and “Aboriginal and Torres Strait Islander” to the term “Aboriginal and/or Torres Strait Islander.  This change has been made for consistency and inclusiveness purposes.  

The Variation  is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

The Variation commences on 1 January 2015.

 

Consultation

The Office of Best Practice Regulation considers that regulatory amendments that update the listing of vaccines on the National Immunisation Program and their associated price to be machinery in nature.  Therefore in accordance with section 18(2)(a) of the Legislative Instruments Act 2003 it has been determined that further consultation is unnecessary.

NOTES ON SECTIONS

 

Section 1 – Name of Determination

 

This section provides that the title of the Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2014 (No.1).

 

Section 2 – Commencement

 

This section provides for the Determination to commence on 1 January 2015.

 

Section 3 – Variation

 

This section provides that Schedule 1 varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1).

 

Schedule 1 – Variations


Statement of Compatibility with Human Rights

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

 

National Health (Immunisation Program – Designated Vaccines) Variation
Determination 2014 (No.1)

 

This legislative instrument is 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 legislative instrument varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Previous Determination), which designates vaccines in accordance with subsection 9B(2) of the National Health Act 1953, and specifies circumstances in which designated vaccines may be provided.

 

The variation adds an additional cohort to the list of those cohorts eligible for influenza vaccines under the NIP.

 

Human rights implications

This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. 

 

The National Immunisation Program (NIP) assists the advancement of this human right by providing free access for eligible people to designated vaccines.  This is a positive step towards attaining the highest standard of health for all Australians, by protecting individuals and the community against vaccine preventable disease.  Efficient operational arrangements for the NIP support effective administration of the Program.

 

The NIP is also consistent with the advancement of Article 1 of the ICESCR.  Since vaccination is not mandatory in Australia this enables the right to self-determination.

 

Conclusion

This legislative instrument is compatible with human rights because it advances the protection of human rights as outlined above.

 

Gayle Anderson

Assistant Secretary

Office of Health Protection

Department of Health

 

Overview

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2014 (No.1) was introduced to expand the eligibility criteria for the trivalent influenza vaccine under the National Immunisation Program (NIP). Enacted under the authority of the Minister for Health, this determination aligns with the legislative powers granted by Section 9B(2) of the National Health Act 1953, which allows for the specification of designated vaccines by legislative instrument. The primary objective of this variation is to include additional cohorts, specifically Aboriginal and/or Torres Strait Islander children aged 6 months to less than 5 years, to benefit from the influenza vaccination program. This determination follows a recommendation by the Pharmaceutical Benefits Advisory Committee and aims to enhance public health outcomes by broadening the scope of those protected against vaccine-preventable diseases. The variation came into effect on 1 January 2015, ensuring that the expanded immunisation coverage would be implemented without delay.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2014 (No.1) applies to the Minister for Health, as it pertains to the provision of designated vaccines and associated goods or services under the National Health Act 1953. Specifically, this variation expands the eligibility for the trivalent influenza vaccine under the National Immunisation Program to include Aboriginal and/or Torres Strait Islander children aged from six months to less than five years. This determination is a legislative instrument, commencing on 1 January 2015, and operates nationally under the Commonwealth jurisdiction. The Variation is made in accordance with the recommendations of the Pharmaceutical Benefits Advisory Committee and is designed to enhance public health by increasing vaccine accessibility and thereby improving immunisation rates within the specified demographic. No specific exclusions or thresholds are outlined within the text, but the determination does specify the circumstances under which the vaccine may be provided, which are detailed in the accompanying schedule.

Key Provisions

The main operative sections of the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2014 (No.1) primarily revolve around the specification of the trivalent influenza vaccine as a designated vaccine under the National Health Act 1953 (the Act). Section 9B(2) of the Act allows the Minister to designate a specified vaccine, and this Determination expands the eligibility for this vaccine under the National Immunisation Program (NIP) to include Aboriginal and/or Torres Strait Islander children aged from 6 months to less than 5 years. The Determination also includes adjustments to terminology for consistency and inclusiveness, changing the terms “Aboriginal or a Torres Strait Islander” and “Aboriginal and Torres Strait Islander” to “Aboriginal and/or Torres Strait Islander.” Section 3 of the Determination formally varies the previous National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) to reflect these changes, effective from 1 January 2015. The obligations and requirements imposed by this Determination on the parties or entities it governs are primarily centred on the provision and administration of the designated trivalent influenza vaccine. The Minister, as the authority under Section 9B(1) of the Act, is tasked with arranging the provision of this vaccine to the newly eligible cohorts. This includes ensuring that the vaccine is made available to Aboriginal and/or Torres Strait Islander children aged from 6 months to less than 5 years in a manner consistent with the NIP. Additionally, the Determination mandates that any operational arrangements for the NIP must be efficient and effective to ensure the successful administration of the Program. In terms of offences, penalties, or civil/criminal consequences for breach, the Determination itself does not specify penalties. However, any failure to comply with the provisions of the National Health Act 1953 could result in legal consequences, including fines or other penalties as prescribed under the Act. For instance, Section 9B(7) of the Act stipulates that a vaccine must not be specified unless recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). Non-compliance with this recommendation could lead to legal repercussions, although specific penalties are not detailed in this Determination. The human rights compatibility statement assures that this Determination is consistent with international human rights obligations, particularly those outlined in the International Covenant on Economic, Social and Cultural Rights (ICESCR).

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