EXPLANATORY STATEMENT
Issued by the Authority of the delegate of the Minister for Health and Ageing
National Health Act 1953
National Health (Immunisation Program – Designated Vaccines) Determination 2011 (No.1)
Legislation
Subsection 9B(1) of the National Health Act 1953 (‘the Act’) states that the Minister for Health and Ageing (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 this Act. Subsection 9B(5) provides that in addition to specifying a vaccine, a determination under subsection 9B(2) may specify the circumstances in which the vaccine may be provided.
Purpose
The purpose of the National Health (Immunisation Program – Designated Vaccines) Determination 2011 (No.1) (the Determination) is to determine which vaccines are designated vaccines for the purposes of subsection 9B(2) of the Act.
A designated vaccine may be provided free of charge to eligible people under the National Immunisation Program (NIP), in the circumstances set out in the Determination.
Background
Subsection 9B(7) of the Act provides that a vaccine must not be specified in a determination made pursuant to subsection 9B(2) unless the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended to the Minister that it be a designated vaccine.
In July 2010, PBAC made a recommendation to the Minister that a 13-valent pneumococcal vaccine, (Prevenar 13®) be listed on the NIP with the same circumstances of use as the existing 7-valent pneumococcal vaccine, which is now to be known as Prevenar 7®.
In November 2010, PBAC made a further recommendation to the Minister that the Prevenar 13® listing be extended to include a single supplementary (catch up) dose for children aged between 12 and 35 months who have completed their primary pneumococcal vaccination with Prevenar 7®, to provide them with protection against an additional six serotypes.
Instrument Description
The National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No.3) (‘the Previous Determination’) was made on 23 December 2009 and came into effect on 9 February 2010. The previous Determination is being revoked and re-made to alter the circumstances in which the vaccine Synflorix® (10-valent pneumococcal vaccine) may be provided, to add two new vaccines and to make minor edits to the age references in the circumstances where various vaccines may be provided.
The previous Determination has been amended as follows:
- Section 7 no longer contains a reference to the Item number for the vaccine Synflorix as this vaccine should not be provided in the circumstances set out in section 7 of the Determination.
- Item 109 of the Schedule has been amended to include Prevenar 13® and the circumstances for administration of a supplementary dose.
- Subsequent Items (Items 111 and 112) of the Schedule have been renumbered.
- Minor edits have also been made to Items 101, 102, 103, 104, 105, 106, 107, 108, 110, 201, 202, 207, 208, 209, 210, 211, 212, 213, 214, 215, 301, 302, 303, 304, 305 and 306 of the Schedule.
Impact and Effect
The impact of these changes is an increase to the number of pneumococcal vaccines listed on the NIP.
The new pneumococcal vaccine provides protection against thirteen strains of pneumococcal disease. This comprises an increase in protection against an additional three to six strains of pneumococcal disease compared to the existing pneumococcal vaccines on the NIP. This includes protection against a strain which causes most of the invasive pneumococcal disease currently affecting children.
Consultation
The PBAC advice in relation to Prevenar 13® was provided to the public on the Department of Health and Ageing website. The Public Summary Documents regarding the rationale for the recommendations is available at www.health.gov.au.
The Australian Technical Advisory Group on Immunisation was provided with an opportunity to examine and comment on the submission provided to PBAC by the pharmaceutical company supplying Prevenar 13®.
On 25 February 2011, the Minister issued a media release announcing the Government’s intention to list Prevenar 13® on the NIP. On 10 May 2011, the Australian Government announced its intention to list the Prevenar 13® supplementary dose on the NIP in the 2011‑2012 Budget.
The Office of Best Practice Regulation has advised that as the proposal would be likely to have no or low impact on business and the not-for-profit sector, a Regulation Impact Statement is not required.
The Determination commences the day after registration on the Federal Register of Legislative Instruments.
The Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The National Health (Immunisation Program – Designated Vaccines) Determination 2011 (No. 1) was introduced to address the need for updating and clarifying the vaccines provided under the National Immunisation Program (NIP) as stipulated in the National Health Act 1953. Enacted by the Minister for Health and Ageing, the primary objective of this Determination is to specify which vaccines qualify as designated vaccines, thereby determining their eligibility for inclusion in the NIP and their provision free of charge to eligible individuals. This legislative instrument was necessitated by the Pharmaceutical Benefits Advisory Committee’s recommendations to include the 13-valent pneumococcal vaccine, Prevenar 13®, on the NIP, alongside an additional supplementary dose for children aged between 12 and 35 months. The Determination revises the previous 2009 version to incorporate these new vaccines, adjust the circumstances under which certain vaccines are provided, and make minor amendments to age references. The changes aim to enhance the protection against pneumococcal diseases by increasing the number of strains covered by the vaccines listed on the NIP, ultimately improving public health outcomes.
Scope and Application
The National Health (Immunisation Program – Designated Vaccines) Determination 2011 (No.1) applies to the Minister for Health and Ageing who has the authority under the National Health Act 1953 to determine which vaccines are designated vaccines for the purposes of providing them under the National Immunisation Program (NIP). This Determination specifies that certain vaccines, including Prevenar 13® and Synflorix®, are designated vaccines and outlines the circumstances under which they may be provided free of charge to eligible people. The Determination revokes and replaces the National Health (Immunisation Program – Designated Vaccines) Determination 2009 (No.3) to reflect the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and to incorporate amendments concerning the provision of various vaccines. This legislative instrument has a national reach and applies across Australia, impacting the provision of vaccines under the NIP. The Determination does not specify exclusions or thresholds, but it does extend the application of the Act by identifying specific vaccines and the conditions for their administration. The Determination itself does not create new rights or obligations but rather provides the framework for the implementation of the NIP as prescribed by the National Health Act 1953.
Key Provisions
The main sections of the National Health (Immunisation Program – Designated Vaccines) Determination 2011 (No.1) (the Determination) include the specification of vaccines that are designated for the purposes of the National Health Act 1953 (the Act). Under section 9B(2) of the Act, the Minister for Health and Ageing can, by legislative instrument, determine that a specified vaccine is a designated vaccine. This Determination specifies the circumstances under which these vaccines may be provided, as allowed under section 9B(5) of the Act. The Determination revokes and re-makes the previous National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No.3) to alter the circumstances in which the vaccine Synflorix® may be provided, to add two new vaccines, and to make minor edits to the age references in the circumstances where various vaccines may be provided. The determination is intended to increase the number of pneumococcal vaccines listed on the National Immunisation Program (NIP) and to provide broader protection against pneumococcal disease.
The obligations imposed by the Act on the parties or entities it governs include the provision of designated vaccines and goods or services associated with, or incidental to, the provision or administration of these vaccines. This is specified under section 9B(1) of the Act. The Determination further details the specific vaccines and the circumstances in which they can be provided free of charge to eligible people under the NIP. The Pharmaceutical Benefits Advisory Committee (PBAC) must recommend that a vaccine be a designated vaccine before it is specified in a determination under section 9B(7) of the Act. This requirement ensures that the vaccines listed in the Determination are recommended based on their efficacy and necessity for public health.
The Determination includes provisions for offences, penalties, or civil/criminal consequences for breach. While the Determination itself does not specify penalties, breaches of the National Health Act 1953 or related regulations may result in penalties under the Act or other applicable legislation. For example, unauthorised provision of designated vaccines or goods/services could lead to civil or criminal penalties, including fines and imprisonment. The specific penalties would depend on the nature and severity of the breach, as well as any relevant provisions in the National Health Act or other related statutes. It is important for entities and individuals to comply with the provisions of the Determination to avoid any potential legal consequences.