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2004-2005
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
NATIONAL HEALTH AMENDMENT
(IMMUNISATION PROGRAM) BILL 2005
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Health and Ageing,
the Honourable Tony Abbott MP)
NATIONAL HEALTH AMENDMENT
(IMMUNISATION PROGRAM) BILL 2005
OUTLINE
The purpose of this Bill is to amend the National Health Act 1953 (the Act) to improve
vaccine funding advisory arrangements for the Government's funded National Immunisation
Program (NIP) as announced in the 2005-06 Budget.
The intention of the Bill is to ensure that the vaccine funding advisory arrangements place
emphasis on cost-effectiveness assessment, and to provide a transparent and robust
framework for evaluating vaccines and making decisions on whether or not to publicly fund
them. The amendments set out in this Bill provide for a stronger focus on cost-effectiveness
assessment by utilising the established transparent and rigorous decision-making processes of
the Pharmaceutical Benefits Advisory Committee (PBAC) for vaccine funding
recommendations.
The amendments:
Allow the Minister to provide or arrange for the provision of designated vaccines;
Will not affect the power of the Minister under the Quarantine Act 1908 to provide or
arrange for the provision of vaccines;
Allow the Minister, by a legislative instrument, to determine that a specified vaccine
is a designated vaccine;
Extend the role of the Pharmaceutical Benefits Advisory Committee (PBAC) to
assume responsibility for evaluating the cost-effectiveness of vaccines in order to
provide a more consistent and transparent process for recommending vaccines for
Australian Government funding;
Allow the PBAC to specify in its recommendation to the Minister, those
circumstances under which a vaccine should be a designated vaccine;
Allow the PBAC to advise the Minister on any other matter (referred to it by the
Minister) in relation to the provision of designated vaccines;
Limit the powers of the Minister to provide or arrange the provision of new vaccines
to only those vaccines which were funded under section 9B of the Act prior to the
commencement of this amending legislation, or are recommended by the PBAC to be
designated vaccines;
Ensure that before the Minister removes a vaccine from the list of designated vaccines
he or she obtains advice from the PBAC. The PBAC's advice must be tabled in both
Houses of Parliament;
Increase the total membership of the PBAC by two members, and provide that the
position of PBAC Chairperson is a full-time position; and
Provide that the person who was the Chairperson of the PBAC immediately before the
commencement of the amendments, will continue to hold the office of Chairperson.
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FINANCIAL IMPACT STATEMENT
The PBAC will receive additional funding of $7.8 million over the next 4 financial years to
expand its role to include evaluating the cost-effectiveness of new vaccines for funding under
the NIP.
2005-06 2006-07 2007-08 2008-09 4 Yr Total
$m $m $m $m
$1.7 $2.0 $2.0 $2.0 $7.8
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NATIONAL HEALTH AMENDMENT
(IMMUNISATION PROGRAM) BILL 2005
NOTES ON CLAUSES
Clause 1 - Short title
1. Clause 1 is a formal provision specifying the short title of the Bill
Clause 2 - Commencement
2. Clause 2 provides that sections 1, 2 and 3 will commence on Royal Assent. Schedule 1,
Parts 1 and 2 will commence on a day to be fixed by Proclamation, but in the event that they
do not commence within 6 months (beginning on the day on which the Act receives Royal
Assent), they will commence on the first day after that period.
Clause 3 - Schedule(s)
3. Clause 3 provides that each Act specified in a Schedule to the amending Act is
amended or repealed as set out in the applicable items in the Schedule.
SCHEDULE 1 - Amendment of National Health Act 1953
Part 1 - Immunisation program
Item 1 - Subsection 4(1)
4. Item 1 inserts a definition of "designated vaccine" in subsection 4(1) of the Act.
"Designated vaccine" is defined as having "the meaning given by subsection 9B(2)".
Item 2 - Subsection 4(1)
5. Item 2 inserts a definition of "vaccine" in subsection 4(1) of the Act. The definition
limits "vaccine" to mean "a vaccine used for the purpose of immunising persons"
Item 3 - Section 9B
6. Item 3 repeals Section 9B of the Act and substitutes several new provisions:
Proposed new subsection 9B(1) provides that the Minister may provide or arrange for
the provision of designated vaccines.
Proposed new subsection 9B(2) provides that the Minister may determine that a
specified vaccine is a designated vaccine. The determination is a legislative instrument
and is subject to the provisions of the Legislative Instruments Act 2003.
Proposed new subsection 9B(3) provides that a vaccine may be specified by reference
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to any or all of such details as brand; formulation; active ingredient; strength; and
number and timing of doses in a course of immunisation.
Proposed new subsection 9B(4) provides that proposed new subsection 9B(3) does not
limit the way a vaccine may be specified.
Proposed new subsection 9B(5) provides for the Minister to specify, in the
determination made under section 9B(2), the circumstances in which the vaccine may
be provided.
Proposed new subsection 9B(6) provides that where the Minister specifies the
circumstances in which a vaccine may be provided, proposed new subsection 9B(1)
only authorises the provision of the vaccine in those circumstances.
Proposed new subsection 9B(7) limits the Minister's power to specify a vaccine as a
designated vaccine under proposed subsection 9B(2) unless at any time during the 60-
day period ending immediately before the commencement of the proposed new section
9B, the vaccine was provided under the repealed section 9B of the Act, or where the
PBAC has recommended the vaccine to be a designated vaccine.
Proposed new subsection 9B(8) provides that the Minister must obtain written advice
from the PBAC before revoking or varying a determination made under proposed new
subsection 9B(2). This is consistent with the obligations placed on the Minister, under
subsection 85(2AB) of the Act, for declaring that a drug or medicinal preparation, or a
class of drugs or medicinal preparations, should cease to be a pharmaceutical benefit
for the purposes of Part VII of the Act.
Proposed new subsection 9B(9) provides that the PBAC's advice under section 9B(8)
must be tabled in both Houses of Parliament together with the revocation or variation to
which the advice relates. This is consistent with the obligations placed on the Minister,
under subsection 85(2AC) of the Act, for declaring that a drug or medicinal
preparation, or a class of drugs or medicinal preparations, should cease to be a
pharmaceutical benefit for the purposes of Part VII of the Act.
Proposed new subsection 9B(10) provides that section 9B does not limit the powers
conferred on the Minister by the Quarantine Act 1908.
Item 4 - After Subsection 101(4A)
7. Item 4 inserts several new provisions after subsection 101(4A) of the Act:
Proposed new subsection 101(4B) extends the functions of the PBAC to make
recommendations to the Minister regarding designated vaccines for the purposes of
section 9B. Proposed new subsection 101(4B) also provides for the Minister to refer
any other matter concerning the operation of proposed new section 9B to the PBAC for
advice. For example the Minister may ask the PBAC to advise on whether a vaccine
should continue to be a designated vaccine, or whether the circumstances in which a
designated vaccine is provided should be altered.
Proposed new subsection 101(4C) requires the PBAC, for the purposes of deciding
whether to recommend that a vaccine be a designated vaccine, to consider the
effectiveness and cost of using the vaccine. The PBAC may compare the vaccine under
consideration with alternative options whether or not involving the use of alternative
vaccines.
Proposed new paragraph 101(4D)(a) provides that the PBAC must not recommend to
the Minister that a vaccine that is more expensive than an alternative vaccine be a
designated vaccine unless the PBAC is satisfied that the more expensive vaccine
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provides significant improvement in efficacy or reduction of toxicity over the
alternative vaccine.
Proposed new paragraph 101(4D)(b) provides that if the vaccine is substantially more
expensive than an alternative vaccine, the PBAC is required to include a statement
regarding the significant improvement in efficacy or reduction of toxicity of the more
expensive vaccine in its recommendation under proposed new paragraph 101(4D)(a).
Proposed new section 101(4E) provides that section 101(4D) does not limit the PBAC's
powers under proposed new subsection 101(4C).
Proposed new subsection 101(4F) provides that if the PBAC considers that a vaccine
should be a designated vaccine, but should only be provided under proposed new
subsection 9B(1) in certain circumstances, the PBAC must specify those circumstances
in its recommendation to the Minister under proposed new subsection 101(4B).
Item 5 - At the end of paragraph 101A(1)(b)
8. Section 101A(1)(b) of the Act requires the PBAC, if the Minister requires in writing, to
establish a sub-committee to assist the PBAC in advising the Minister on any other matter
concerning the operation of Part VII of the Act that is referred to the PBAC by the Minister
under subsection 101(3) of the Act. Item 5 adds the vaccine advisory function set out in
proposed new subsection 101(4B), to this provision.
Part 2 - Pharmaceutical Benefits Advisory Committee
Item 6 - Subsection 100A(2)
9. This item amends subsection 100A(2) of the Act to increase the membership of the
PBAC by two.
Item 7 - After subsection 100A(5)
10. This item inserts new subsection 100A(5A) of the Act to provide for the PBAC
Chairperson to be a full-time position. This is to cater for the expected increase in PBAC
workload.
Item 8 - Subsection 100A(6)
11. This item amends subsection 100A(6) of the Act to clarify that other than the
Chairperson, all members of the PBAC hold office on a part-time basis.
Item 9 -Transition to full-time office - Chairperson of the Pharmaceutical Benefits
Advisory Committee
12. Item 9 provides that the person who was the Chairperson of the PBAC immediately
before the commencement of this item, is taken to hold that office on a full-time basis.
Item 9 also provides that this amendment does not prevent the person from ceasing to hold
the office of Chairperson.
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