National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L01186 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Issued by the Authority of the Minister for Health

 

National Health Act 1953

 

National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No.2)

 

Authority

Section 9B(1) of the National Health Act 1953 (the Act) provides 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 the Act.  Section 9B(5) provides that in addition to specifying a vaccine, a determination may specify the circumstances in which the vaccine may be provided.

 

Purpose

The purpose of the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No.2) (the Variation Determination) is to make amendments to the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) (the Determination), including:

  • adding item 218A of Schedule 1 of the Determination to the list of items set out in subsection 7(11) of the Determination that provide additional circumstances in which relevant items of Schedule 1 of the Determination may be provided; and
  • adding a  9-valent human papillomavirus vaccine (Gardasil 9) as item 218A to Schedule 1 of the Determination for individuals aged at least 12 but less than 14 years who are eligible to receive human papillomavirus vaccine through the National Immunisation Program (NIP)

 

Background

Pharmaceutical Benefits Advisory Committee (PBAC) recommendations

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

In July 2017, the PBAC recommended that:

 

  • 9-valent human papillomavirus (9vHPV) vaccine (Gardasil 9) be made available as a designated vaccine for the purpose of funding through the NIP as a 2-dose schedule for 12-13 year olds as part of a school based immunisation program for the prevention of HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.

 

Government approval

On 12 September 2017, the Minister for Health, approved Gardasil 9 to be a designated vaccine for the purposes of subsection 9B(2) of the Act. It will take effect from 18 September 2017.

Details

The Determination commenced on 23 September 2014.  Once a vaccine is listed in the Determination, the supplier of that vaccine is eligible to participate in any procurement processes undertaken by the Department of Health for the supply of vaccine on the NIP.

 

Consultation

The Office of Best Practice Regulation has advised that regulatory amendments that update the listing of vaccines on the NIP and their associated price to be machinery in nature.  Therefore it has been determined that further consultation is unnecessary.

 

Details of the Determination are set out in the Attachment.

 

The Determination commences on 18 September 2017.

 

The Determination is a legislative instrument for the purposes of the Legislation Act 2003.

Authority:     Subsection 9B(2) of the

 National Health Act 1973

 

ATTACHMENTS

 

DETAILS ON THE NATIONAL HEALTH (IMMUNISATION PROGRAM – DESIGNATED VACCINES) VARIATION DETERMINATION 2017 (NO. 2)

 

 

 

1. Name of the Determination

Section 1 provides that the title of the Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No 2).

 

2. Commencement

Section 2 provides that the Determination commence on 18 September 2017.

 

3. Authority

Section 3 provides that the Determination is made under subsection 9B(2) of the National Health Act 1953.

 

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

Section 4 provides that the Determination varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1).

 

Schedule 1 Amendments

 

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

 

Item 1- subsection 7(11)

Item 1 repeals subsection 7(11) in the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1) and substitutes it with a new subsection 7(11). The new subsection 7(11) provides additional circumstances in which Item 218A of Schedule 1 of the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1) can be provided under the National Immunisation Program.

 

Item 2 – Item added to Schedule

Item 2 adds item 218A to Schedule 1 of the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1). Item 218A of Schedule 1 provides the details of the Gardasil 9 immunisation and the circumstances in which this item can be provided under the National Immunisation Program.

 

 


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 2017 (No.2)

 

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 National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No. 2) (the Variation Determination) varies the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination), which determines that a specified vaccine is a designated vaccine for the purposes of subsection 9B(2) of the National Health Act 1953 (the Act).

The Variation Determination adds a new 9-valent human papillomavirus vaccine (Gardasil 9) for individuals aged at least 12 but less than 14 years who are eligible to receive human papillomavirus vaccine through the National Immunisation Program (NIP). In addition, the Variation Determination adds Gardasil 9 to subsection 7(11), allowing individuals up to the age of 19 years to catch-up on 2 doses of missed Gardasil 9 vaccinations.

 

Human Rights Implications

This Variation Determination engages the right to health as set out in Article 12 of the International Covenant on Economic, Social and Cultural Right 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 Variation Determination 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. 

Conclusion

The Variation Determination is compatible with human rights as it promotes the right to health.

 

Masha Somi

Assistant Secretary Immunisation Branch

Office of Health Protection

Department of Health

 

 

Overview

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No. 2) was enacted to amend the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1), updating the list of designated vaccines under the National Health Act 1953. This legislation was introduced to address the need for incorporating new vaccines into the National Immunisation Program (NIP) as recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). The Minister for Health approved the inclusion of the 9-valent human papillomavirus (9vHPV) vaccine (Gardasil 9) for 12 to 13-year-olds as part of a school-based immunisation program. The policy objective is to enhance public health by ensuring that eligible individuals have access to necessary vaccines, thereby preventing vaccine-preventable diseases and promoting overall health standards. The Determination is a legislative instrument made under the authority of the National Health Act 1953, and it ensures that the NIP remains current with medical recommendations and public health needs.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No.2) applies to individuals aged at least 12 but less than 14 years who are eligible to receive human papillomavirus vaccines through the National Immunisation Program (NIP) and expands access to the 9-valent human papillomavirus vaccine (Gardasil 9) to include this age group. The Determination also amends the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) to include Gardasil 9 under subsection 7(11) of Schedule 1, allowing individuals up to the age of 19 years to catch up on missed doses. The Determination is made under section 9B(2) of the National Health Act 1953, which provides that the Minister may, by legislative instrument, determine that a specified vaccine is a designated vaccine for the purposes of the Act. The Determination does not exclude or exempt any individuals or entities from its application, and there are no stated thresholds. The Determination may be extended or restricted through subordinate instruments, but no such instruments are mentioned in the Explanatory Statement.

Key Provisions

The main operative sections of the National Health (Immunisation Program – Designated Vaccines) Variation Determination 2017 (No.2) (the Variation Determination) pertain to the amendment of the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination) under subsection 9B(2) of the National Health Act 1953 (the Act). Specifically, the Variation Determination adds a new 9-valent human papillomavirus vaccine (Gardasil 9) for individuals aged at least 12 but less than 14 years who are eligible to receive human papillomavirus vaccine through the National Immunisation Program (NIP) and includes this vaccine in subsection 7(11), allowing individuals up to the age of 19 years to catch-up on 2 doses of missed Gardasil 9 vaccinations (Section 1, 2, and 4). The Variation Determination imposes several obligations and requirements on parties and entities it governs. Firstly, it mandates that any vaccine listed in the Determination is eligible to participate in procurement processes undertaken by the Department of Health for the supply of vaccine on the NIP (Section 9B(1)). Secondly, it requires that the Pharmaceutical Benefits Advisory Committee (PBAC) must recommend that a vaccine be a designated vaccine before it can be specified in a determination under section 9B(2) of the Act (Section 9B(7)). Thirdly, the Determination ensures that the Minister for Health approves the vaccine as a designated vaccine for the purposes of the Act (Section 9B(2) and 9B(5)). Breach of the provisions within the Variation Determination may lead to civil or criminal consequences. However, the explanatory statement does not detail specific offences, penalties, or consequences for breach. Given the nature of the Determination, violations could potentially involve civil penalties or criminal charges depending on the specific breach and the context in which it occurs. For example, failure to comply with procurement processes or misrepresentation of eligibility for vaccine supply could lead to legal repercussions. The exact penalties would be determined by the applicable laws and regulations governing the National Immunisation Program.

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