Bills Digest no. 7 2007–08
National Health Amendment (National HPV Vaccination
Program Register) Bill 2007
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
Financial implications
Main provisions
Conclusion
Endnotes
Contact officer & copyright details
Passage history
National Health
Amendment (National HPV Vaccination Program Register) Bill
2007
Date introduced:
20 June 2007
House: House of Representatives
Portfolio: Health and Ageing
Commencement:
On Royal
Assent
Links:
The
relevant links to the Bill, Explanatory Memorandum and second
reading speech can be accessed via BillsNet, which is at http://www.aph.gov.au/bills/.
When Bills have been passed they can be found at ComLaw, which is
at http://www.comlaw.gov.au/.
The purpose of the Bill is to amend the
National Health Act 1953 in order to establish and
maintain a National Human Papillomavirus (HPV) Vaccination Program
Register. It also allows for payments to be made to General
Practitioners for the provision of vaccination information on the
Register.
Cervical cancer kills around 200 women in
Australia each year, although the incidence and mortality of the
disease in recent years has been decreasing. In 2004 the mortality
rate for cervical cancer was 1.8 per 100,000 women, compared to 4.0
per 100,000 in 1991, the year the National Cervical Cancer
Screening Program (NCSP) commenced. [1] Australia has one of the lowest
incidences of cervical cancer, largely attributable to the NCSP,
which it is estimated prevents around 70 per cent of squamous
cervical cancers. [2]
The NCSP, a joint program of the Australian
and state and territory governments, aims to reduce morbidity and
deaths from cervical cancer, cost-effectively, by encouraging women
to have regular Pap smears which can detect cervical abnormalities.
The Program includes a nationally agreed screening policy, Pap test
registers in each State and Territory, accreditation of pathology
laboratories and quality management strategies across the screening
pathway. [3] The NCSP
total cost to governments is around $89.1 million per year.
[4]
Cervical cancer can be caused by infection
with certain strains of the Human Papilloma Virus (HPV). HPV is a
sexually transmitted virus which is extremely common among people
who have had sexual contact it has been estimated that 4 in 5
people will have experienced infection with HPV. [5] Although DNA from HPV is found in
99.7 per cent of cervical cancers, cervical cancer is a rare
outcome of HPV infection. [6] Most infected women do not go on to develop cervical
cancer.
In June 2006 the first vaccine that protects
against some of the cancer causing strains of HPV, Gardasil , was
registered for use in Australia by the Therapeutic Goods
Administration (TGA) for the prevention of cervical cancer in women
and girls aged 9 to 26 years (and prevention of HPV infection in
males aged 9 to 15). [7] On 30 March 2007 Cervarix (manufactured by
GlaxoSmithKline) became the second HPV vaccine to obtain TGA
approval, in this case, for the prevention of cervical cancer in
women aged 10 to 45 years. [8] Both vaccines protect against the two HPV strains
responsible for 70 80 per cent of cervical cancers types 16 and
18.
Gardasil is manufactured and distributed in
Australia by CSL Limited, which has granted the worldwide license
to Merck. [9] The
vaccine s development was based in part on research by former
Australian of the Year, Professor Ian Frazer. The vaccine protects
against four of the more than 100 strains of HPV, including two of
the cancer causing strains. [10] It also protects against 90 per cent of strains
that cause genital warts. [11]
An application to list Gardasil on the
National Immunisation Program (NIP) was made by the sponsor, CSL
Limited, to the Pharmaceutical Benefits Advisory Committee (PBAC)
in early November 2006. PBAC is the independent expert body which
advises the government on listing drugs under the Pharmaceutical
Benefits Scheme (PBS), and, from January 2006, makes decisions to
fund vaccines under the NIP (prior to this the Australian Technical
Advisory Group on Immunisation (ATAGI) performed this
function).
The initial application to list the vaccine
was rejected by PBAC on the basis of uncertainty about duration of
effect and unfavourable cost effectiveness. [12] The price to government was
reportedly $625 million over four years. [13] Further, PBAC had not been satisfied
on the long term effectiveness of the vaccine, whether a booster
would be required and how women requiring a booster would be
identified, and the long term effects of the vaccine on the
incidence of cervical cancer. [14] PBAC also expressed concerns over possible
unintended harmful consequences if vaccinated girls and women
decide to not participate in the NCSP. [15]
Following a request from the Health Minister,
PBAC agreed to consider a new application from CSL, in which some
of the main concerns raised by PBAC were addressed. The second
application included a price reduction, additional information
about its long-term effectiveness, and the provision of risk-share
arrangement for possible booster doses. [16] Gardasil was subsequently approved
for inclusion on the NIP at an extraordinary PBAC meeting in late
November 2006. [17]
When the Health Minister announced the vaccine
s approval, he made assurances that the accelerated time frame of
the approval process had not compromised the quality of the PBAC
decision-making, and emphasised the need for women to continue to
undergo regular Pap smears. [18] Current guidelines recommend routine screening
with Pap smears every two years for women who have no history of
cervical abnormalities, from the age of 18 (or within a year of
commencement of sexual activity). [19]
As noted above, in November 2006 the
government announced it would fund the HPV vaccine Gardasil for
girls and young women aged 12 to 26 years old through the National
Immunisation Program (NIP). [20] Under the NIP the Australian government funds the
states and territories to purchase vaccines listed in the National
Vaccine Schedule (NVS). In 2006-07 vaccine expenditure through the
NIP totalled $283 million. [21]
The five-year HPV vaccination program with
revised funding of $475.9 million to 2010-11 has since commenced in
all states and territories. [22] The HPV vaccine is being administered to girls
aged between 12 and 13 years in three injections over a period of
six months. Vaccination is not compulsory, with consent required
before the vaccine is administered. [23] Media reports suggest that uptake of
the school vaccination program has been high. [24]
Clinical evidence from trials of the vaccine
show that Gardasil is most effective in preventing pre-cancerous
lesions (CIN 2 and 3) when administered before sexual activity
commences. Effectiveness declines as the number of sexual partners
increases. [25]
In addition, from July 2007 until July 2009,
the vaccine will also be available free to girls and women aged up
to 26 years, through GPs and community providers. [26] The PBAC estimates that in the
first four years of the HPV Program more than 200,000 doses of
Gardasil would be administered. [27]
When government funding for Gardasil was
announced, it was also announced that CSL had agreed to assist with
the costs of any future booster program (if required) and in the
establishment of a national HPV register to link vaccination data
with later cervical screening records. [28] In its initial rejection of Gardasil
PBAC had expressed concerns about the long-term efficacy of the
vaccine and the need for a mechanism (such as a registry) to
identify females who may subsequently need a booster dose. CSL s
commitment to a risk-share arrangement to provide for a booster
program was a factor in the PBAC decision to recommend the vaccine
for the NIP. [29]
In March 2007 the government announced $100
million in funding to the states and territories to implement the
HPV program, establish the HPV Register and run an education
campaign. [30]
The main purposes of the HPV Register as
outlined in the Second Reading speech include:
-
the recording of the details of individuals who
participate in the HPV program which will allow statistics on
participation rates to be compiled
-
the recording of vaccination information which
can be compared with information recorded in Pap smear, cervical
cytology and cervical cancer registers so as to assess the
effectiveness of the HPV program over time
-
enabling the notification of participants of
the HPV program if booster doses are required, or determine
vaccination status or to certify completion of the vaccination
course
-
collecting statistics to inform health
authorities, health care providers and the public about the HPV
program
-
informing participants (or parents of
participants) of developments with the HPV program
-
recording details of vaccination providers,
and
-
allowing for a participant (or parent of a
participant) in the HPV program to have personal details removed
when a request is made in writing.
[31]
Indigenous status will also be recorded on the
Register (although this field will be optional).
GPs administering the vaccine to individuals
in the 12 to 18 year age group will be eligible for an
administrative payment. Similar payments to GPs are provided under
the General Practice Immunisation Incentives Scheme to encourage
GPs to provide immunisation services to children under seven.
[32]
The Bill provides for the establishment,
functioning and maintenance of the proposed HPV Register.
There has been a considerable level of
commentary concerning the HPV vaccine (but little on the issue of
the HPV Register). Much of the early commentary was in response to
the initial decision by PBAC to reject listing Gardasil . Concerns
over safety and the appropriateness of vaccinating young girls have
also been raised.
The initial PBAC decision to reject the
application to list the vaccine was met with considerable
criticism. A cross-party group of 22 women parliamentarians were so
concerned that they wrote to the Prime Minister, who subsequently
expressed his view that the drug would be subsidised. [33]
Some argued that the high cost of the vaccine
was justified. Julia Gillard MP described the estimated $34 million
annual cost of a school immunisation program as good value for
money , and Professor Ian Frazer disputed the PBAC view that the
vaccine was not cost-effective, arguing that the vaccine could
reduce costs by preventing up to 15,000 surgical operations a year
. [34] In response,
the Chair of the PBAC Professor Lloyd Sansom defended their
decision, warning that if we have only 10 years until a booster is
needed, then it s not such a good health outcome we re buying .
[35] Professor
David Henry of the University of Newcastle went as far as to accuse
critics of the PBAC as playing into the hands of the drug companies
. [36] The Health
Minister also defended the PBAC, saying it s only because of the
PBAC that drug companies can t demand blank cheques . [37]
The commercial interests at stake during the
period when CSL was trying to negotiate an agreement with
government also received comment. In November 2006 one
pharmaceutical industry newsletter noted there is a lot at stake
because if CSL could persuade the government to fund a sole
supplier four year HPV program it will effectively keep rival
product Cerverix out of the market. [38] A report had also emerged in The
Age that rival Cerverix may offer longer lasting protection
against cervical cancer. [39] The commercial pressure on CSL was also recognised by
the Health Minister. [40] However, the re-application process was quickly
resolved in favour of the listing of Gardasil , with CSL making a
number of concessions, including on price.
In response to a question over the government
s perceived intervention in the listing process, the Health
Minister described the negotiating process with CSL as very good
resulting in important ongoing concessions . [41] Some commentators have continued
to question the speed of the approval process, its commercial
implications for CSL, and the experimental nature of HPV
vaccination. [42]
One commentator noted that the approval process highlights a very,
very uncomfortable relationship between the pharmaceutical industry
and the PBAC . [43]
Other commentary has focused on safety
concerns and issues around sexuality, following the commencement of
the HPV vaccination program. Safety issues were raised in the media
when reports emerged of school girls who had been vaccinated
suffering adverse effects. These effects were reportedly serious
enough to require hospitalisation in at least five cases in
Melbourne. [44]
Some side effects were already known. According to the Consumer
Medicine Information leaflet, common reported adverse effects
include local redness and swelling around the injection site,
fever, dizziness, nausea, and vomiting. Less common effects include
difficulty breathing and fainting. [45] Notwithstanding these reports of
known adverse effects, the government has assured parents that the
vaccine is safe. [46]
But questions over the longer term effects of
the vaccine remain. Recent trial evidence reported in the New
England Journal of Medicine found that while incidence of
cancers caused by HPV types 16 and 18 declined in a vaccinated
group, overall incidence of disease continued to increase. This has
raised concerns that other cancer causing HPV strains may be
filling the biologic niche left after the elimination of types 16
and 18. [47]
Concerns over the ages of girls targeted for
vaccination have also been raised. In March this year the Right to
Life Association in WA raised concerns that the vaccine might
create not only moral dilemmas but physical dilemmas for young
girls regarding the appropriate age for the onset of sexual
activity, and was advising parents of girls under 18 not to
participate in the program. [48] There followed reports that some parents in WA
were withholding consent to have their daughters vaccinated through
the school programs. Although parents were concerned about side
effects, it was also reported that some parents thought that the
vaccine was only necessary if their daughter was sexually active.
[49] In South
Australia reports emerged that two private schools had decided not
to make the vaccine available because of the schools beliefs .
[50]
Opposition to HPV vaccination in the United
States has focused on the moral dimension of mandated vaccination
of young girls, for example, parental concern that vaccination will
have a disinhibiting effect and promote promiscuity in their
daughters. [51] It
has also been argued that opposition to vaccination also reflects a
wider trend in parental concern over vaccination more generally.
[52]
Nevertheless, these moral concerns do not
appear to be widely replicated in the Australian context. Uptake of
the vaccination program has been high, with unconfirmed reports
that the consent rate so far exceeds 80 per cent. [53]
As noted above, there has been little
commentary concerning the HPV Register itself. There was some
discussion at Senate Estimates hearings in May concerning the lag
in time between the rollout of the HPV vaccination program and the
introduction of legislation to establish the Register.
Senator MOORE Minister, this may well be a
question for you rather than for the department. With a program
like this, where we knew it was happening and we knew we would have
to collect data, I am interested that the register legislation was
not in place at least at the same time as the rollout started. I
want to find out whether it is common to have a lag like that. All
immunisation is subject to public scrutiny because people have very
strong views about it, as everybody here knows. But this one in
particular has caused a degree of discussion leading up to the time
of implementation. My expectation was that the processes around
capturing the information and also ensuring that everybody knows
what is going on would have been in place.
[54]
The Senate Committee also asked on notice for
an explanation as to the reason a separate Register was required,
and for details of the cost.
Senator MOORE I will not labour the point it is
just that my interest has been caught by this. But in terms of the
process there are existing school based immunisation programs. I
would imagine that data is being collected on those and passed on.
I am interested as to why there needs to be specific legislation
and the kind of register discussion that you have mentioned today
to add
Gardasil.
[55]
The HPV Register will allow health authorities
to compare participation rates of vaccinated women in the national
cervical cancer screening program (NCSP) to see if the rate of
participation declines over time. Concerns that the HPV vaccine
program may undermine the highly successful cervical cancer
screening program were raised by PBAC when it first reviewed
Gardasil . PBAC was concerned that the risk of contracting cervical
cancer may actually increase, if vaccination were to replace
screening.
There is a risk of unintended harmful
consequences to patients if vaccinated females do not continue to
participate in the NCSP, even though this would also tend to reduce
the overall costs of screening, including managing pre-cancerous
health states. For instance, if vaccination were to substitute for
cervical screening, costs savings would occur, but the cervical
cancer lifetime risk would increase from 0.78% (cervical screening
only) to 1.173% (vaccination only).
[56]
Other medical experts argued that a mass
vaccination program could address inequities in the current
cervical screening program whereby certain groups, such as
indigenous women, have lower participation in the NCSP. [57] The need to monitor
the effectiveness of the vaccination program, and address the
incorporation of vaccination status into state and territory
cervical cytology registers were both highlighted in a recent issue
of the Medical Journal of Australia.
[58] The same
article also questioned the future role of the NCSP, in an
environment where a mass vaccination program is available, and the
capacity of the cytology workforce to manage the NCSP may be
limited. [59]
Some concerns have emerged in the medical
sector concerning the delayed establishment of the HPV Register and
the impact this may have on GPs. GPs who have commenced
administering the HPV vaccine as part of the program, are being
advised by the Divisions of General Practice to record vaccination
data in order to be able to claim remuneration from the government
after the legislation has passed. [60]
The HPV vaccine has been shown to be highly
effective against the HPV types that cause the vast majority of
cervical cancer, when administered early. If vaccination is
delayed, its effectiveness declines. However, questions remain over
the long term effectiveness of the vaccine, its impact on the NCSP,
and future adverse effects.
Recent evidence, outlined above, suggesting
that other cancer causing strains may occupy the biological niche
left after the elimination of HPV types 16 and 18, was not
available to the PBAC. But the emergence of such evidence
underscores the PBAC view that a Register is necessary in order to
monitor the effectiveness of the vaccine over time. As noted above,
CSL s commitment to assist with the establishment of the HPV
Register was a major factor in the PBAC s approval of the
vaccine.
Concerns that the HPV vaccine program may
undermine the highly successful cervical cancer screening program
were raised by PBAC when it first reviewed Gardasil . However, the
HPV Register will allow health authorities to see if participation
rates of vaccinated women in the screening program declines over
time.
Questions have been raised over the future
viability of the NCSP where mass vaccination is available. The NCSP
which costs around $90 million annually, is considered
cost-effective. The PBAC expressed concern that vaccination may
unintentionally lower participation rates in the NCSP and lead to
an increase in cervical cancer lifetime risk.
Nevertheless, a significant proportion of
women do not participate in cervical cancer screening (around 39
per cent of women aged 20-69). [61] Those unscreened may be at risk of contracting
disease. These women may consider vaccination a preferable
intervention. However, as neither Gardasil nor Cerverix currently
protect against all forms of cancer causing HPV, ongoing screening
is recommended. The information held on the HPV Register will allow
for a campaign promoting the benefits of screening to be directly
targeted to those women who may choose to forego screening.
However, in order to address ongoing concerns
over safety and efficacy, particularly among parents of school aged
girls, a broader ongoing education and communication campaign may
be required.
The Explanatory Memorandum explains that
because of the tight time frame in which the school based HPV
vaccination program was implemented, issues around consent and
privacy were not fully addressed. Although receiving little
attention in any commentary, concerns over consent and privacy may
yet emerge. While written consent is required for vaccination, no
consent was sought to have personal vaccination details recorded on
the Register itself prior to the rollout of the school based
vaccination program.
However, the Bill allows for women, or parents
of vaccinated girls, to have their details removed from the HPV
Register, if an explicit request is made in writing the so-called
opt off provision. Unless a written request is made to opt off the
Register, personal details of those vaccinated under the program
will be automatically recorded on the Register. This opt off
provision may raise some concerns, although it is unclear if it
would deter anyone from proceeding with vaccination.
The Explanatory Memorandum notes there is a
strong argument to provide an opt off provision for the Register,
as opposed to an opt in provision. [62] This is because when presented with a
choice to opt in many may choose to do nothing, thus reducing the
level of data collected and eroding the effectiveness of the
Register.
Overseas evidence supporting the opt off
consent model, (which in this particular case was for consent to
store patient s clinical medical records electronically), show that
overwhelmingly, few patients had concerns at having their records
stored in this manner, with only a small number choosing to opt off
such a system. [63]
State cytology and cervical cancer registers already allow for
women to decline to have their details recorded (that is, to opt
off ), but evidence shows that only a small percentage elect to opt
off (around one or two per cent). [64]
This model of consent, it is argued, can also
reduce the administrative burden on the program, because the
patient s consent does not need to be explicitly sought or
recorded. [65]
On the other hand, an opt in system can give
patients more control over what personal details are recorded
because it requires patients to give explicit permission to have
their personal details entered on the database. The advantage of an
opt in system for the Register is that patients are able to weigh
the risks and benefits of consent, just as they are given this
opportunity when asked to consent to the vaccination itself.
Patients who may be sensitive about the recording of their personal
data can choose to not have their data recorded, yet see the
benefits of protection and proceed with vaccination. A system of
consent that allows for a patient to opt in can therefore provide
the patient with greater confidence in the security of the system,
reduce their anxiety and encourage their ongoing participation in
the program over time.
Although the Bill provides for an opt off
system of consent regarding personal details being entered on the
Register, GPs who participate in the HPV Program are being
encouraged to seek consent: Immunisation providers are encouraged
to register patients on the HPV register, subject to them providing
their consent . [66] This approach could be seen to be at odds with the
principles of the opt off system applied to the school vaccination
phase of the program, although the Department confirmed that the
opt off provision in the Bill will apply to all participants in the
program once the legislation comes into effect. [67] However, some may question
whether the speedy implementation of the vaccination program has
resulted in an erosion of choice.
Information held on the Register will be used
mainly to evaluate the HPV vaccination program on cervical cancer
rates, issue reminders and contact participants if booster doses
are required. However, personal information may also be used in
future longitudinal studies. In such circumstances, the Explanatory
Memorandum explains, the handling of such information will be
subject to appropriate guidelines. Further, the privacy provisions
of the Bill provide that only prescribed bodies or persons can
access data on the Register.
Privacy legislation prevents the disclosure of
personal information held by a record keeper. However, it provides
for disclosure when authorised by law. This Bill allows for
disclosure to be made to a body or person provided these are
prescribed in separate regulations, or under the Health
Insurance Act 1973 (HIA). Section 46E of the HIA already
allows for personal information that is held on the Australian
Childhood Immunisation Register to be disclosed to specified
persons or bodies.
Information on the safety and efficacy of a
drug after it is released to the market, or post-marketing
surveillance, is an important tool for pharmaceutical companies.
Such information can assist the further development of the drug or
in developing new drugs. Although pre-marketing clinical trials
assess the safety and performance of a drug, information gathered
in the post-marketing phase reflects the performance of the drug in
the real world, rather than under controlled trial conditions, and
provides valuable information to the drug maker.
The type of information held on the Register
could, therefore, have high commercial value, as well as its value
in informing public policy. There is no evidence that access to any
data on the Register would be granted to a commercial body only
those bodies prescribed through regulation or under the HIA Act
have access to the data. Nevertheless, given the controversy
surrounding the PBAC approval process and questions over the
influence of commercial interests in the process, confidence in the
confidential nature of the Register may need to be further
strengthened. For example, access to data on the Register could be
overseen by an ethics committee where requests to access data for
research purposes are received.
As noted above, the government obtained a
commitment from CSL to assist in the cost of establishing and
maintaining the HPV Register, and this commitment was a factor in
the PBAC s approval of Gardasil .
The Explanatory Memorandum estimates the cost
of the Register to be between $8 to 11 million. So far, however,
there is no indication as to what contribution, if any, CSL has
provided to the establishment of the Register. Nor is it clear if
the manufacturer of the second HPV vaccine approved for use in
Australia will also be making a contribution to the cost of the
Register or other aspects of the program. At this time Cerverix has
not received approval from the PBAC to be listed on the National
Immunisation Program.
The Explanatory Memorandum states that there
is no financial impact as funding for the Register was approved by
the Prime Minister in February 2007, as part of a $103.5 million
funding package to the states and territories for the
implementation of the HPV program. A total cost of $8 to $11
million to establish and operate the Register is allocated,
according to the Explanatory Memorandum.
The Bill proposes to insert new
section 9BA into the National Health Act
1953, to establish the National HPV Vaccination Program
Register. The provisions of the Bill are detailed in the
Explanatory Memorandum, and summarised below.
New subsections 9BA(1) and
9BA(2) establish and describe the content of the HPV
Register. Content may include personal details, address and
Medicare number, details about the administration of the HPV
vaccine, the immunisation provider and the vaccine used.
New subsection 9BA(3)
describes the purpose of the Register. This is to ensure the
successful implementation of the National HPV Vaccination Program,
by establishing and maintaining an electronic database of records
of vaccination participants, which can monitor the effectiveness of
the HPV vaccine, notify participants if doses are missed or
boosters required, certify completion of vaccination, promote
health by providing information and pay GPs who enter details in
the Register.
New subsection 9BA(4) details
the opt out provision of the Bill. It allows for a person or parent
or guardian of a child, to request in writing that their details be
removed from the Register.
New subsections 9BA(5) and
9BA(6) address privacy issues, allowing the
disclosure of personal information held on the Register to
prescribed bodies, either through regulation or as prescribed in
the Health Insurance Act 1973, or to a vaccination
provider.
Conclusion
The Bill seeks to establish and maintain a
National HPV Vaccination Program Register, to support the rollout
of the government funded National HPV vaccination program. The need
for a Register was noted by the independent pharmaceutical advisory
body which approved the HPV vaccine Gardasil for the National
Immunisation Program, because of ongoing safety and efficacy issues
relating to the vaccine.
Information held on the Register will be used
by government to evaluate the effectiveness of the HPV program in
reducing cervical cancer rates, and inform the future policy
direction of the national cervical screening program. There is a
suggestion that the NCSP be reviewed in light of the HPV
vaccination program, although regular Pap smears are still
recommended.
Information held on the Register will be used
to provide information to participants in the HPV program, remind
them of missed doses or inform them of the requirement for booster
doses. In addition personal information held on the Register may be
made available to prescribed bodies or persons for longitudinal
analysis. Although privacy provisions apply, confidence that
personal information will remain confidential and not be accessed
inappropriately may need to be further strengthened. Although
participants in the HPV Vaccination Program can opt off the
Register at any time by making a written request, the absence of
consent in the initial phase may raise concerns.
The funding of the HPV vaccine Gardasil was
widely welcomed in the community, although concerns over the long
term safety and efficacy of the vaccine remain. The moral and
ethical dimensions of vaccinating young girls have also been
raised. Such issues can resonate in the community, especially where
they involve children and the onset of sexual activity.
The ongoing cost of the Register is a small
component of the total cost of the HPV Program. In any case the
manufacturer has undertaken to contribute to the establishment and
maintenance of the Register. The cost-sharing commitment from CSL
was a factor in the PBAC s approval of the vaccine, but the exact
nature of their contribution remains unclear. This lack of clarity
over the contribution of the vaccine manufacturer may contribute to
criticism of the approval process, and further highlights the
continuing sensitivity around relationships between governments and
pharmaceutical companies.
Endnotes
[6]. NHMRC, op. cit,
p. 9.
[10]. NHMRC, op.
cit, p. 10.
[11]. Hon. Bruce
Billson, National Health Amendment (National HPV Vaccination
Program Register) Bill 2007,
Second Reading Speech, House of Representatives
Hansard, 20 June, 2007, p. 7.
[16]. PBAC,
Public summary document, op. cit, p. 5.
[21]. Hon. Bruce
Billson, op. cit.
[22]. Hon. Bruce
Billson, op cit. The original funding announcement was for $436
million over four years.
[27].
Pharmaceutical Benefits Advisory Committee, Public summary
document, op. cit, p. 4.
[28]. Hon. Tony Abbott,
Government funds Gardasil , op. cit.
[29]. See the PBAC,
Public Summary Document, op. cit, p. 5.
[31]. Hon. Bruce
Billson, op. cit.
[32]. Around $18.8
million in payments were made to GPs in 2005-06. Medicare
Australia, Annual Report 2005-06, Canberra, Medicare
Australia, 2006, p. 116.
[33]. Michelle
Grattan On health, women Senators march together to do battle
Sun Herald, 12 November, 2006, p. 31. See also Cathy
O Leary, PM promises cash for cervical cancer vaccine West
Australian 10 November, 2006.
[34]. Annabel
Stafford, Cancer vaccine too costly, op. cit.
[37]. Annabel
Stafford, No proof cancer drug lasts op. cit.
[38]. Political
pressure and the PBAC , Pharma in Focus, 27 Nov 3 Dec,
2006.
[46]. Department of
Health and Ageing, The National HPV Vaccination Program
Frequently asked questions for parents of girls in school, op.
cit.
[47]. George F
Sawaya and Karen Smith-McCune, op. cit.
[53]. Rada Rouse,
op. cit.
[54]. Senate
Standing Committee on Community Affairs, Health and Ageing
Portfolio,
Estimates Discussion , Hansard, 30 May 2007, p. 4.
[56]. PBAC,
Public summary document, op. cit, p. 4.
[58]. ibid. Pap
smear, cervical cytology or cervical registers are maintained by
the states and territories.
[60]. Rada Rouse,
HPV register not ready , Medical Observer, 6 July 2007, p.
1.
[61]. Australian
Institute of Health and Welfare, Cervical screening in
Australia 2004-05, op. cit, p. ix.
[64]. Australian
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[67]. Personal
communication.
Amanda Biggs
1 August 2007
Social Policy Section
Parliamentary Library
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