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Bills Digest no. 55 2005–06
National Health Amendment (Immunisation Program) Bill 2005
WARNING:
This Digest was prepared for debate. It reflects the legislation as introduced
and does not canvass subsequent amendments. This Digest does not have
any official legal status. Other sources should be consulted to determine
the subsequent official status of the Bill.
CONTENTS
Passage History
Purpose
Background
Main Provisions
Concluding Comments
Endnotes
Contact Officer & Copyright Details
Passage History
National Health
Amendment (Immunisation Program) Bill 2005
Date Introduced: 14 September 2005
House: House of Representatives
Portfolio: Health and Ageing
Commencement: Sections1,
2 and 3 commence on Royal Assent. Schedule 1, Parts 1 and 2 commence
either on a date to be fixed by Proclamation or six months after Royal
Assent, which ever is the earlier.
The purpose of the Bill is to amend
the National Health Act 1953 to give the Pharmaceutical Benefits
Advisory Committee (PBAC) responsibility for advising the government
on the funding of vaccines under the National Immunisation Program.
Since 1997 advice on funding for vaccines under the
National Immunisation Program has been provided to the government
by the Australian Technical Advisory Group on Immunisation (ATAGI).
The Bill proposes to amend the National Health Act to make PBAC responsible
for providing this advice, thus absolving ATAGI of this responsibility.
The National Immunisation Program is a joint Commonwealth
and state/territory government program which provides free vaccines
for major vaccine preventable diseases, such as diphtheria, tetanus,
whooping cough, polio, measles, mumps, rubella, and Hepatitis B.(1)
Commonwealth funding for vaccines under the National
Immunisation Program is provided through grants from the Commonwealth
to the states and territories.(2) The states and territories
then provide the vaccines free of charge to providers to administer
to the community.(3)
In 1997 the government established ATAGI to advise
and make recommendations on the technical and scientific elements
of the National Immunisation Program, and on funding and policy issues.(4)
ATAGI’s membership includes doctors, immunisation experts, other medical
professionals, a consumer representative and a representative from
the Department of Health and Ageing.(5)
Since 1997, ATAGI recommendations have informed the
development and implementation of changes to the Australian Standard
Vaccination Schedule (which includes a list of all vaccines considered
by the National Health and Medical Research Council (NHMRC) to be
‘best practice’) and the National Immunisation Program.(6)
In the 2005–06 Budget, the government announced that
the funding advisory functions of ATAGI—that is, the role of providing
advice to the Minister on which vaccines should be included in the
National Immunisation Program—would be transferred to the Pharmaceutical
Benefits Advisory Committee (PBAC). PBAC is the body which advises
the government on pharmaceuticals to be listed on the Pharmaceutical
Benefits Scheme (PBS).(7)
PBAC is a statutory body established under the National
Health Act 1953 which advises the government on which drugs and
medicinal preparations should be made available as pharmaceutical
benefits on the PBS. No new drug can be made available on the PBS
without a recommendation from PBAC.(8) In considering whether
to recommend the inclusion of a new drug or medicine on the PBS, PBAC
considers the drug or medicine’s clinical effectiveness, safety and
cost-effectiveness (value for money) compared to alternative treatments.(9)
PBAC’s membership includes doctors, other health professionals and
a consumer representative.(10)
The government argues that PBAC is the logical choice
for the role of providing funding advice on vaccines, since ‘PBAC
has developed a reputation as a world leader in the rigorous application
of evidence-based assessment in developing funding recommendations’.(11)
Further, according to Health Parliamentary Secretary Christopher Pyne’s
second reading speech, the PBAC process ‘is being copied by other
countries around the world. It is only reasonable that we apply it
to Government expenditure on vaccines here in Australia’.(12)
As noted above, the Bill will implement the decision
announced in the 2005–06 Budget to transfer the funding advisory functions
of ATAGI to PBAC. The government’s rationale for the changes is that
they are needed to ‘strengthen cost-effectiveness evaluations of vaccines,
and streamline the process for considering vaccines funded under the
National Immunisation Program and the Pharmaceutical Benefits Scheme’.(13)
According to the Explanatory Memorandum, 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 to publicly fund them’.(14) The government
argues that this will be achieved by utilising the well-established,
rigorous decision-making processes of the Pharmaceutical Benefits
Advisory Committee (PBAC) for vaccine funding recommendations’.(15)
The Australian Technical Advisory Group on Immunisation will continue
to provide clinical advice on vaccines to the Health Minister (and
in fact will receive increased funding to do so) but will no longer
advise on vaccine funding under the National Immunisation Program.(16)
Thus, the new vaccine funding advisory structure
is designed to consolidate strengths in existing processes and structures:
according to information provided by the Department of Health and
Ageing during Senate Estimates hearings in June 2005, by relieving
ATAGI of any role in advising on funding of vaccines, the new arrangements
will allow ATAGI to ‘do what it really does best, which is to make
clinical recommendations about the use of vaccines’.(17)
Likewise, transferring the responsibility for providing advice on
funding and cost-effectiveness to PBAC is designed to draw on PBAC’s
expertise in this area. According to the Secretary of the Department
of Health, Jane Halton:
The reality is that cost-benefit analysis is actually
a highly specialised activity. ATAGI has done a fantastic job over
the last however many years, but the volume of work and the level
of technical expertise that is required in respect of vaccines and
analysis has become infinitely more complicated in the last few years.
Really, that is what the PBAC does par excellence. I think the government’s
decision is a reflection of what is a new world in this area. So giving
that part of the job to the group who have actually demonstrated expertise
is a fairly logical conclusion.(18)
While there is sound logic in making PBAC responsible
for advising on vaccine funding and cost-effectiveness, immunisation
experts have raised questions about how effective the ‘streamlined’
process will be, particularly as little detail has yet been provided
about exactly how the new advisory structure will work.(19)
Questions may also be raised about the government’s
claim that transferring the role of providing advice on vaccine funding
from ATAGI to PBAC will improve the transparency of the funding advisory
process.(20) While PBAC is recognised as having pioneered
the use of cost-benefit analysis in deliberations on recommending
pharmaceuticals for subsidy (as the government points out), questions
have been raised in the past about the transparency of PBAC’s
processes, as there is no public disclosure of the evidence considered
in its decision-making process (according to PBAC, this is because
legal issues usually prevent disclosure).(21)
The government also announced during the 2005 Budget
that PBAC would be moved towards operating on a cost-recovery basis
from July 2007—that is, pharmaceutical companies will have to pay
to have their submissions for new drugs to be listed on the PBS to
be considered by PBAC.(22) At this stage, it is unclear
how advice on vaccines will be provided under PBAC’s cost-recovery
arrangements (that is, whether vaccine manufacturers will be subject
to the same fee-paying arrangements as other pharmaceutical companies
or if special arrangements for consideration of vaccines will be made).
Some commentators have expressed concern about the impact of the move
towards cost recovery on PBAC’s capacity to perform its functions
independently.(23) It is worth noting in this context that
a similar body, the Therapeutic Goods Administration (TGA)—which regulates
medicines, medical devices, and other chemicals—has operated on a
cost recovery basis for some time now, and this arrangement has been
subject to criticism. For example, according to the former president
of the Australian Medical Association, Dr Bill Glasson, cost-recovery
‘jeopardises both the transparency and legitimacy of TGA processes’.(24)
Thus, another potential concern raised by the changes proposed in
this Bill is the impact of PBAC’s move towards cost-recovery on the
rigour and independence of its advisory processes in the future.
Since their announcement on budget night, the changes
proposed by the National Health Amendment (Immunisation Program) Bill
have proven to be controversial: the former Chairman of the Australian
Technical Advisory Group on Immunisation recently resigned from the
position, reportedly in response to the changes and a lack of consultation
about them.(25) Further, as noted above, immunisation experts
have expressed scepticism about whether the changes will achieve their
stated goals.(26)
Further, some critics of the proposed changes have
argued that the transfer of funding advisory functions from ATAGI
to PBAC is motivated more by political reasons than a desire to strengthen
and streamline the advisory process. For example, Labor health spokeswoman
Julia Gillard argues that the decision to remove the role of advising
on vaccine funding from ATAGI is ‘political payback pure and simple’,
following a difference of opinion between the government and the Advisory
Group on funding of pneumococcal vaccine.(27) In 2002 ATAGI
recommended that the vaccine for pneumococcal disease be included
on the Australian Standard Vaccination Schedule. The government initially
decided not to include the pneumococcal vaccine in the National Immunisation
Program (later citing a worldwide shortage in vaccine supply as the
reason for its decision).(28) In June 2004, after the issue
of funding for pneumococcal vaccine had been the subject of considerable
media and political attention,(29) the government announced
that the pneumococcal vaccine would be funded through the National
Immunisation Program.(30) Labor argues that ATAGI’s recommendation
that the pneumococcal vaccine be funded created a politically embarrassing
situation for the government, and it is now being stripped of its
funding advisory role as a consequence.
As noted above, the Opposition has accused the government
of stripping back the powers of ATAGI as ‘political payback’ for having
embarrassed the government over pneumococcal vaccine funding. Neither
the Australian Democrats nor the Greens have commented publicly on
the proposed changes.
PBAC will receive $7.8 million in additional funding
over the next four years to expand its current role to include providing
advice on funding vaccines, as shown in table 1.
| 2005–06
($m) |
2006–07
($m) |
2007–08
($m) |
2008–09
($m) |
Total
($m) |
| 1.7 |
2.0 |
2.0 |
2.0 |
7.8 |
As noted above, the Government also announced during
the Budget that ATAGI would receive additional funding ($5 million
over 4 years) to ‘strengthen its ongoing role in providing evidence-based
clinical advice on the medical administration of vaccines’.(32)
The following amendments proposed by the Bill relate
to the National Health Act 1953.
Items 1 and 2 insert new definitions of ‘vaccine’
and ‘designated vaccine’ into subsection 4(1) of the Act. ‘Designated
vaccines’ will be defined as those vaccines which the Minister ‘may
provide, or arrange for the provision of’ (through the National Immunisation
Program) (as defined by proposed new subsection 9B(2))
Item 3 repeals the existing section 9B of
the Act and inserts a new section 9B, under which the Minister may
provide or arrange for the provision of designated vaccines. The
proposed new section specifies that the Minister cannot determine
that a particular vaccine is a designated vaccine unless PBAC has
made a recommendation to this effect. The new section will specify
that the Minister cannot revoke or amend a determination that a particular
vaccine will be a designated vaccine unless PBAC has made a recommendation
to this effect. The new section will require that any advice provided
by PBAC to this effect will have to be tabled in both Houses of Parliament.
The new section also specifies that the vaccine-related powers conferred
on the Minister by the Quarantine Act 1908 are not limited
by the new section 9B.
Item 4 inserts new subsections in section
101 of the Act expanding the powers of PBAC to provide advice to the
Minister on vaccines for the purposes of proposed new section 9B.
Proposed new subsection 4C specifies that PBAC must consider the cost-effectiveness
of vaccines in deciding whether to recommend that a vaccine be a designated
vaccine, and proposed new subsection 4D specifies that PBAC cannot
recommend a vaccine that is more expensive than an alternative vaccine
be a designated vaccine ‘unless the PBAC is satisfied that the more
expensive vaccine provides significant improvement in efficacy or
reduction of toxicity over the alternative vaccine’.(33)
Proposed new subsection 4F allows for the PBAC to recommend that designated
vaccines only be provided in certain circumstances (for example, to
people in certain age groups).
Item 5 amends subsection 101A(1)(b) to require
PBAC to establish a sub-committee to assist PBAC in its vaccine funding
advisory role if directed to do so by the Minister.
Items 6 and 7 amend subsection 100A(2) to
increase the membership of the PBAC by two, and to make the role of
PBAC Chairperson a full-time role (this is to account for the expected
increase in PBAC’s workload as a result of its expanded role). Item
8 amends subsection 100A(6) of the Act to clarify that members
of PBAC other than the Chairperson are part-time office-holders, and
item 9 makes transitional arrangements for the move to the
PBAC Chairperson becoming a full-time position.
As noted above, there appear to be sound reasons
for moving the role of providing vaccine funding advice from ATAGI
to PBAC. However, for the various reasons canvassed in the Background
section above the measures proposed by this Bill are likely to attract
some controversy.
-
Immunise Australia website, see http://immunise.health.gov.au/nip/nip_final.pdf
(accessed 9 October 2005).
-
Budget Paper No. 3—Federal Financial Relations 2004–05, p. 44.
-
Christopher Pyne, Parliamentary Secretary to the Minister for
Health and Ageing, ‘National Health Amendment (Immunisation Program)
Bill 2005’, House of Representatives, Debates, 14 September
2005, p. 3.
-
Department of Health and Ageing website, see http://www.health.gov.au/internet/wcms/Publishing.nsf/Content/health-pubhlth-strateg-immunis-termfofr.htm
and http://www.seniors.gov.au./internet/wcms/Publishing.nsf/Content/cda-pubs-cdi-2003-cdi2702-htm-cdi2702o.htm
(accessed 9 October 2005).
-
Department of Health and Ageing website, see http://www.seniors.gov.au./internet/wcms/Publishing.nsf/Content/cda-pubs-cdi-2003-cdi2702-htm-cdi2702o.htm
(accessed 9 October 2005).
-
Department of Health and Ageing website, see http://www.seniors.gov.au./internet/wcms/publishing.nsf/Content/cda-pubs-cdi-2003-cdi2702-htm-cdi2702o.htm
(accessed 9 October 2005).
-
Budget paper No. 2—Budget Measures 2005–06, p. 198.
-
Department of Health and Ageing website, see http://www.seniors.gov.au./internet/wcms/publishing.nsf/Content/health-pbs-general-listing-committee.htm#pbac
(accessed 9 October 2005).
-
Department of Health and Ageing, see http://www.health.gov.au/internet/wcms/publishing.nsf/Content/health-pbs-general-list_on_pbac.htm
(accessed 10 October 2005).
-
Department of Health and Ageing, see http://www.seniors.gov.au./internet/wcms/publishing.nsf/Content/health-pbs-general-listing-pbacmembership.htm
(accessed 10 October 2005).
-
Pyne, op. cit.
-
ibid.
-
Budget paper No. 2—Budget Measures 2005–06, p. 198.
-
Explanatory Memorandum, p. 1.
-
ibid.
-
Tony Abbott, Minister for Health and Ageing, ‘Health Budget Fact
Sheet 4—Protecting the nation against health threats’, Media
release, 10 May 2005, see http://parlinfoweb.parl.net/parlinfo/Repository1/Media/pressrel/JGAG60.pdf
(accessed 10 October 2005); B. Nogrady, ‘Government defends vaccine
approval process restructure’, Australian Doctor, 17
June 2005, p. 2.
-
Community Affairs Legislation Committee, Budget estimates hearings,
2 June 2005.
-
ibid.
-
Nogrady, ‘Government defends vaccine
approval process restructure’, op. cit.; B. Nogrady, ‘Vax group
head quits after restructure’, Australian Doctor, 17
June 2005, p. 2.
-
Abbott, ‘Health Budget Fact Sheet 4—Protecting the nation against
health threats’, op. cit.
-
M. Howe, ‘All change at the PBAC’, Australian Doctor, 23
March 2001, p. 33; K. Harvey, ‘Free trade and the cost of medicines’,
Access, vol. 6, no. 3, May–June 2004, pp. 19–24.
-
Tony Abbott, Minister for Health and Ageing, ‘Health Budget Fact
Sheet 3: Pharmaceutical Benefits Scheme: to be reinforced’, Media
release, 10 May 2005, see http://parlinfoweb.parl.net/parlinfo/Repository1/Media/pressrel/JGAG60.pdf
(accessed 10 October 2005).
-
See, for example, T. Faunce, Submission to Productivity Commission
Inquiry Impact of Advances in Medical Technology on Healthcare
Expenditure in Australia, 1 July 2005, see http://www.pc.gov.au/study/medicaltechnology/subs/_Toc519695877
(accessed 10 October 2005).
-
Bill Glasson, ‘Speech to Harvard Health Australia, The American
Club, Sydney, 16 September 2004’, Media Release, Australian
Medical Association, 16 September 2004.
-
Nogrady, ‘Vax group
head quits after restructure’, op. cit.
-
ibid.; Nogrady, ‘Government defends vaccine
approval process restructure’, op. cit.
-
Julia Gillard, Shadow Minister for Health, Transcript—Doorstop
Interview, Parliament House, Canberra, 11 May 2005 , see http://parlinfoweb.parl.net/parlinfo/Repository1/Media/pressrel/TSZF60.pdf
(accessed 10 October 2005). See also Julia Gillard, Shadow Minister
for Health, ‘The 2005-06 Howard Government Health Budget—Taking
a Scalpel to Health’, Address to the Brighton Branch of the ALP,
14 May 2005, see http://parlinfoweb.parl.net/parlinfo/Repository1/Media/pressrel/LD1G60.pdf
(accessed 10 October 2005).
-
D. Wroe, ‘Newborns to get free vaccinations’, The Age, 14
May 2005 , p. 5.
-
See, for example, M. King, ‘Children are dying but Howard refuses
to help’, Courier-Mail, 13 April 2004, p. 13; L. Gooch,
‘Australia ‘dropped the ball’ on vaccine’, The Age, 14
May 2005, p. 5; J. Frenkel, ‘Political games with children’, Herald-Sun,
11 May 2004, p. 19.
-
Tony Abbott, Minister for Health and Ageing, Transcript: Announcement
of the Pneumococcal Vaccination Program, Doorstop Interview, 11
June 2004, see http://parlinfoweb.parl.net/parlinfo/Repository1/Media/pressrel/OOYC60.pdf
(accessed 10 October 2005).
-
Explanatory Memorandum, p. 2.
-
Abbott, ‘Health Budget Fact Sheet 4—Protecting the nation against
health threats’, op. cit.
-
Explanatory Memorandum, pp. 4–5.
Dr Angela Pratt
11 October 2005
Bills Digest Service
Information and Research Services
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using information available at the time of production. The views expressed
do not reflect an official position of the Information and Research Service,
nor do they constitute professional legal opinion.
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ISSN 1328-8091
© Commonwealth of Australia 2005
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