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 2009 (No.3)
Legislation
Subsection 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. 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 (2) may specify the circumstances in which the vaccine may be provided.
Purpose
The purpose of the National Health (Immunisation Program – Designated Vaccines) Determination 2009 (No.3) (the New Determination) is to designate vaccines in accordance with subsection 9B(2) of the Act, and specify circumstances in which designated vaccines may be provided.
A designated vaccine may be provided free of charge to eligible people under the National Immunisation Program, in the circumstances set out in the New Determination.
Background
On 19 July 2009, the Pharmaceutical Benefits Advisory Committee (PBAC) made a positive recommendation to the Minister for Health and Ageing to extend the National Immunisation Program seasonal influenza vaccination to individuals identified as ‘at risk’ of influenza with effect from 1 January 2010.
Subsection 9B(7) of the Act provides that a vaccine must not be specified in a determination under subsection 9B(2) unless the PBAC has recommended to the Minister that it be a designated vaccine. PBAC has recommended that “subsidised access to influenza vaccine for persons at special risk of adverse consequences from infections of the lower respiratory tract be moved from the PBS to the NIP. The individuals targeted by this measure should be those who are identified as being at high risk according to the 9th Edition of the Australian Immunisation Handbook, and should not include carers of those at risk.”
In addition, in July 2009, the PBAC made a positive recommendation to the Minister regarding the addition of a third pneumococcal vaccine, Synflorix® for listing on the NIP.
Instrument Description
The National Health (Immunisation Program - Designated Vaccines) Determination 2009 (No.2) (‘the Previous Determination’) was made on 1 October 2009 and came into effect on 13 October 2009. It is now necessary to change the circumstances in which a number of
designated vaccines may be provided. The Previous Determination is being revoked and re-made rather than being amended.
The Determination is substantively the same as the Previous Determination, except for the following changes:
- Updated seasonal influenza strains for 2010 as recommended by the World Health Organization (WHO);
- The addition of new circumstances under which influenza vaccines can be given under the National Immunisation Program (NIP), in relation to individuals identified as ‘at risk’ of influenza under section 7(4) of the Determination. These changes are consistent with the Australian Immunisation Handbook 2008 (9th Edition);
- A new seasonal influenza vaccine brand Influvac has been added as a result of the Request for Tender for the ‘New At Risk Cohort’ for supply of seasonal influenza vaccines;
- Amending the ‘Number and timing of doses’ of the existing Influenza Vaccines to include indications for infants over 6 months of age and formulation; and
- Addition of Synflorix®, a 10-valent pneumococcal vaccine for use in infants.
These changes only affect the contents of subsection 7(4) and Items 205, 206 and 109 of Schedule 1 of the Previous Determination.
Impact and Effect
The impact of this change is to broaden the cohort of people eligible for free influenza vaccine under the NIP and increase the number of influenza and pneumococcal vaccines listed on the NIP. The New Determination also specifies the strains of influenza virus which will make up the trivalent seasonal vaccine for the 2010 influenza season.
Consultation
All pharmaceutical companies that have an influenza vaccine registered for use in Australia by the Therapeutic Goods Administration (TGA) were invited to submit a tender for the supply of influenza vaccine to the new cohort.
The PBAC advice of July 2008 in relation to eligibility for influenza vaccine under the NIP was provided to the public via the Department’s website in August 2008. The Public Summary Document regarding the rationale for these recommendations is available at www.health.gov.au.
A communication strategy has been developed to increase awareness and understanding amongst the target audiences of:
- the availability of a free influenza vaccination from 1 January 2010;
- how they can obtain a free “flu shot”;
- the benefits of being vaccinated against influenza; and
- the need to be vaccinated against both H1N1 and seasonal influenza.
In relation to the addition of Synflorix®, the Australian Technical Advisory Group on Immunisation (ATAGI) was provided with an opportunity to examine and comment on the submission provided to the PBAC by the pharmaceutical company supplying the vaccine.
The National Immunisation Committee (NIC) including each state and territory was also consulted on the inclusion of this vaccine on the NIP.
The outcome of the consultations concluded that stakeholders were supportive of the inclusion of Synflorix® to the NIP schedule. Letters will be sent to all relevant stakeholders to advise them of the change once the New Determination takes effect.
The Office of Best Practice Regulation has been consulted regarding the need for a Regulation Impact Statement (RIS). The advice received was that a RIS is not necessary as the amendment is a minor or machinery matter.