National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 2) 2018

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00714 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 (No 2) 2018

 

Authority

Subsection 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.  Subsection 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.  Subsection 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 (No.2) 2018 (the Variation Determination) is to make amendments to the National Health (Immunisation Program - Designated Vaccines) Determination 2014 (No.1) (the Determination), including:

  • repealing subsection 7(1) of the Determination and substituting with a new subsection that provides revised circumstances in which the vaccine mentioned in subsection 7(1) of the Determination can be provided under the National Immunisation Program (NIP);
  • repealing Item 110 in Schedule 1 of the Determination and substituting with a new item that provides revised circumstances in which the vaccine mentioned in Item 110 of Schedule 1 of the Determination can be provided under the NIP; and
  • amending typographical and grammatical errors contained in Items 103, 207D and 207E of Schedule 1 of the Determination.

 

Background

Pharmaceutical Benefits Advisory Committee (PBAC) recommendations

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

In March 2018, the PBAC recommended a change to the current NIP listing for 13vPCV (Prevenar 13) under the National Health Act 1953 for the prevention of pneumococcal disease.

Government approval

On 21 May 2018, the Minister for Health agreed to amend the current listing for Prevenar 13 as designated vaccines for the purposes of subsection 9B(2) of the Act. It will take effect from the day after registration.


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 vaccines 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 the day after registration.

 

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 (NO. 2) 2018

 

1. Name of the Determination

Section 1 provides that the title of the Determination is the National Health (Immunisation Program – Designated Vaccines) Variation Determination (No 2)2018 (the Variation Determination).

 

2. Commencement

Section 2 provides that the Determination commence on the day after registration.

 

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)

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

 

Schedule 1  Amendments

 

Item 1 - Subsection 7 (1)

Item 1 repeals Subsection 7(1) in the Determination and substitutes it with a new Subsection 7(1). The new Subsection 7(1) provides revised circumstances in which the vaccine mentioned in the subsection can be provided under the National Immunisation Program (NIP).

 

Item 2 – Schedule 1, Item 103

Item 2 includes corrections to wording and typographical errors that appeared in the former version of Item 103.

 

Item 3 - Schedule 1, Item 110

Item 3 repeals Item 110 in Schedule 1 in the Determination and substitutes it with a new Item 110. The new Item 110 provides revised circumstances in which the vaccine mentioned in the item can be provided under the NIP.

 

Item 4 – Schedule 1, Item 207D

Item 4 includes corrections to wording and typographical errors that appeared in the former version of Item 207D.

 

Item 5 – Schedule 1, Item 207E

Item 5 includes corrections to wording and typographical errors that appeared in the former version of Item 207E.

 

 

 


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 (No.2) 2018

 

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 (No. 2) 2018 (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).

Pneumococcal disease – Prevenar 13

Prevenar 13 (Pfizer) is a vaccine for the prevention of pneumococcal disease caused by Streptococcus pneumoniae in adults and children aged more than 6 weeks of age.

 

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 Rights 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 (No. 2) 2018 amends the National Health (Immunisation Program - Designated Vaccines) Determination 2014, which specifies vaccines that are provided under the National Immunisation Program (NIP) for the purposes of the National Health Act 1953. This Variation Determination was introduced to update the circumstances under which certain vaccines can be provided, rectify typographical and grammatical errors, and align with the Pharmaceutical Benefits Advisory Committee's recommendations. Enacted by the Minister for Health under subsection 9B(2) of the National Health Act 1953, the policy objective of the Variation Determination is to ensure the continued provision of effective and safe vaccines through the NIP, thereby protecting public health and fulfilling the right to health as recognised in international human rights instruments. In March 2018, the Pharmaceutical Benefits Advisory Committee recommended updating the NIP listing for the 13-valent pneumococcal conjugate vaccine (13vPCV or Prevenar 13) for the prevention of pneumococcal disease. Following this recommendation, the Minister for Health approved the amendment on 21 May 2018, and the Variation Determination was registered and commenced on 23 September 2018. This legislative instrument ensures that eligible individuals can continue to access designated vaccines, supporting the progressive realisation of the highest attainable standard of physical and mental health for all Australians.

Scope and Application

The National Health (Immunisation Program – Designated Vaccines) Variation Determination (No. 2) 2018 applies to the listing and provision of designated vaccines for the purposes of the National Health Act 1953. This legislative instrument amends the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1) to update the listing of vaccines under the National Immunisation Program (NIP). Specifically, it revises the circumstances in which the 13-valent pneumococcal conjugate vaccine (13vPCV), known as Prevenar 13, can be provided under the NIP, as recommended by the Pharmaceutical Benefits Advisory Committee. This Determination is made under the authority of the Minister for Health and comes into effect on the day after registration. It is applicable nationally and governs the eligibility of vaccine suppliers to participate in procurement processes for the supply of vaccines on the NIP. There are no stated exclusions or thresholds in this Determination, but it does provide for the specification of circumstances under which designated vaccines may be provided. The Determination also includes corrections to typographical and grammatical errors in the previous listing.

Key Provisions

The National Health (Immunisation Program – Designated Vaccines) Variation Determination (No 2) 2018 (the Variation Determination) amends the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination) under the authority of Subsection 9B(2) of the National Health Act 1953 (the Act). The Variation Determination specifies revised circumstances in which the vaccine for the prevention of pneumococcal disease (Prevenar 13) can be provided under the National Immunisation Program (NIP) (subsection 7(1) and Item 110 of Schedule 1) and corrects typographical and grammatical errors in Items 103, 207D and 207E of Schedule 1 of the Determination. This Variation Determination commences on the day after registration. 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 vaccines on the NIP. The Variation Determination imposes obligations on suppliers of designated vaccines to comply with the specified circumstances in which the vaccines can be provided under the NIP. This includes ensuring that the vaccines are provided in accordance with the revised provisions set out in subsection 7(1) and Item 110 of Schedule 1. Additionally, suppliers must correct any typographical and grammatical errors in Items 103, 207D and 207E of Schedule 1 of the Determination. Failure to comply with these obligations may result in legal consequences. The Variation Determination does not explicitly outline offences, penalties, or civil/criminal consequences for breaches. However, failure to comply with the obligations imposed by the Determination may result in legal action being taken against the supplier of the designated vaccine. The specific consequences for non-compliance would depend on the nature and severity of the breach and would be determined by the relevant authorities or courts. It is important for suppliers to ensure compliance with the provisions of the Variation Determination to avoid any potential legal repercussions.

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