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2004-2005-2006-2007
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
NATIONAL HEALTH AMENDMENT (NATIONAL HPV
VACCINATION PROGRAM REGISTER) BILL 2007
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Health and Ageing
the Honourable Tony Abbott MP)
NATIONAL HEALTH AMENDMENT (NATIONAL HPV VACCINATION
PROGRAM REGISTER) BILL 2007
OUTLINE
This Bill amends the National Health Act 1953 to establish a National Human
Papillomavirus (HPV) Vaccination Program Register (the Register) to ensure the
successful implementation of the National HPV Program.
The need for this Bill arose from an announcement by Government in November 2006
to fund free HPV vaccine for females in the 12 to 26 year old age group through the
National Immunisation Program with the aim of reducing the incidence of cervical
cancer. The establishment of a HPV Register was also announced at that time.
The Bill:
· removes obstacles associated with the collection of personal and HPV
vaccination information and the disclosure of Commonwealth assigned
identifiers, such as the Medicare number for the purposes of the Register;
· establishes the Register and provides for the recording of certain personal
information about individuals participating in the HPV Program. It also
details the purposes of the Register;
· provides for individuals whose details are entered on the Register to have their
details removed, on written request and requires the keeper of the Register to
comply with any such written request;
· allows for cross referencing of information about the vaccination status of
females from the Register with Pap smear, cervical cytology or cervical cancer
registers maintained by States and Territories;
· recognises that some personal information (such as names, address, date of
birth and Medicare card number) already in the possession or control of the
Commonwealth may need to be disclosed to, and used by, the Department of
Health and Ageing in order to facilitate the operation of the Register and, to
this end, the Bill:
o authorises the disclosure of personal information for the purpose of
Information Privacy Principle (IPP) 11.1(d) of the Privacy Act 1988;
and
o authorizes the use of personal information for purposes other than the
purpose of collection for the purpose of IPP 10(1)(c) of the Privacy Act
1988 provided that the disclosure is made to a body or class of bodies
which will be prescribed in regulations or to a vaccination provider for
the purpose of administering HPV vaccine; and
· facilitates the payment of a small administrative fee to general practitioners
who provide information to the Register relating to individuals in the 12 to 18
year old age group who are vaccinated with HPV vaccine.
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FINANCIAL IMPACT STATEMENT
There is no financial impact for the Bill.
Funding for the Register was approved by the Prime Minister on 20 February 2007 as
part of an additional $103.5 million over five years allocated for the implementation
of the HPV Program. A total cost of $8-$11 million has been allocated to build and
operate the Register over 3 years.
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NATIONAL HEALTH AMENDMENT (NATIONAL HPV VACCINATION
PROGRAM REGISTER) BILL 2007
NOTES ON CLAUSES
Clause 1 Short Title.
This clause provides that the Bill may be cited as the National Health Amendment
(National HPV Vaccination Program Register) Act 2007 which will amend the
National Health Act 1953 to insert provisions to establish and maintain a National
HPV Vaccination Program Register.
Clause 2 Commencement.
This clause provides that the provisions of the Bill will commence on the day it is
given Royal Assent.
Clause 3 Schedule(s).
Provides that each Act that is specified in a Schedule to this Bill is amended or
repealed as set out in the applicable items in the Schedule.
SCHEDULE 1 - Amendments
Amends the National Health Act 1953 (National Health Act) to insert after section 9B
Section 9BA The National HPV Vaccination Program Register.
Section 9BA The National HPV Vaccination Program Register
Subsection (1) requires the Commonwealth to establish and maintain a register which
will be called the National HPV Vaccination Program Register (the Register).
Subsection (2) describes the type of information that can be collected for the purposes
of the Register.
Paragraph (2)(a) allows the collection of personal information about the person being
vaccinated such as their name, address, the date of birth and their Medicare card
number. In the case of a child or other person incapable of managing their own
affairs, it also allows the names and addresses of guardians to be collected. This
information will be needed in future for the purpose of cross matching the HPV
vaccination status of individuals vaccinated with HPV vaccine against information
held on Pap smear, cervical cytology or cervical registers which are maintained by
states and territories. This information is also required for contacting individuals
about matters relating to the HPV Program.
Collection of the Medicare card number is necessary to facilitate updating of personal
information on the Register which has the capacity to become outdated in the course
of time. In an individual's lifetime a number of elements of the data collected at the
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time of vaccination will change. These can include in the case of females, their name,
the Medicare card number for example when they become independent of their
parents or in the event of marriage. The address will certainly change several times.
This means that the only element of information that will not change on the Register
is the date of birth and their HPV vaccination status.
Information Privacy Principle (IPP) 8 of the Privacy Act 1988 requires the record
keeper to check the accuracy of personal information before use. As a stand alone
system the personal information held on the Register is likely to become dated. It is
proposed, therefore, to put administrative arrangements in place with Medicare
Australia as provided for by the Medicare Australia Act 1973 to enable periodic
updates of personal information held in the Register to occur.
Paragraph (2)(f) allows for information to be collected about the vaccine that is being
administered to an individual including the brand name, the dose, batch number and
expiry date.
Under the current HPV vaccination regime each individual should have three doses of
vaccine to complete the course of HPV vaccination. Gardasil® is currently the only
brand of vaccine that has been designated under section 9B of the National Health Act
for use in the HPV Program. In the future, however, there are likely to be different
brands of vaccine approved for the HPV Program. Different vaccine brands are not
expected to be interchangeable. Therefore, information must be held about the type of
vaccine being administered to ensure that all doses are administered within the
recommended clinical timeframes and to ensure that an individual receives all doses
of the same brand of vaccine. It is also important to hold information about batch
numbers in case some batches of vaccine are less effective or faulty in some way.
Paragraph (2)(c) allows information to be collected about the person who administers
HPV vaccine to a person. This information will include a name and identifying
number for the vaccination provider. General practitioners will be invited to apply to
be vaccination providers for the purposes of the Register and details will be sought
from them so that a small administrative payment can be directed to their nominated
bank account, or forwarded to their address, for any information they notify to the
Register about individuals in the 12 to 18 year old age group to whom they have
administered HPV vaccine.
As the HPV Program is being primarily conducted through a school based vaccination
program, parents must give consent to their children being vaccinated. Paragraph
(2)(e) provides for the name and contact details of the consenting parents to be
collected. This is for the purpose of contacting them in relation to any matter
affecting the vaccination of their child or the HPV Program.
Information under this paragraph will also be collected about where and when the
vaccine was administered. This information will be used for the purpose of compiling
statistics on participation rates in HPV Program by geographical area.
Paragraph (2)(b) allows information to be collected about the indigenous status of a
female. The health status of people from an indigenous background has been
identified as `high risk' and remains of significant concern to the Government.
4
Statistics demonstrate that the immunisation rate among indigenous people is
considerably lower than for the non indigenous population. The incidence of cervical
cancer among indigenous women is five time higher that in the non indigenous
population. This field on the Register is optional to complete.
Section 9BA Subsection (3) sets out that the purpose of the Register is to ensure the
successful implementation of the HPV Program and that in doing so it will facilitate a
number of services or functions.
Subsection (3) paragraph (a).
Paragraph (3)(a) establishes and allows for the maintenance of an electronic database
which will allow for monitoring of individuals who are vaccinated with HPV vaccine.
There is no compulsion for females to be vaccinated and participation in the HPV
Program is voluntary. Nor is there any compulsion for individuals to have their
personal or vaccination details entered onto the HPV Register.
The tight time frame in which the school based HPV Vaccination Program needed to
be rolled out and the fact that the functionality of the Register had not fully been
determined at the time, created some difficulty in being able to address all the issues
associated with consent and privacy. Whilst parents are required to give consent to
their child being vaccinated, they were not asked to consent or otherwise to having
their child's personal information placed in the Register. Parents were advised that
information collected on the vaccination consent forms would be entered onto a State
or Territory database and later transferred to the Register but they were not asked to
consent to this.
To ensure that persons, or the parents or guardians of a child or a person incapable of
managing their own affairs, are aware of the Register and what disclosures will be
made of the information held on the Register, the Department will develop a range of
information products. These products will be distributed to persons who have been
vaccinated and will include details about how an individual may have their or their
child's personal information removed from the Register. In the interim, unless an
express request is made, by the person being vaccinated or a parent or guardian of a
vaccinated person, not to have their details entered on the Register then the
information which is detailed under subsection (2) will be collected for the Register.
In addition, General Practitioners will be reminded that they have an obligation to
obtain consent from their clients at the time of the vaccination event before entering
information in to the Register.
Subsection (3) Paragraph (b).
Paragraph (3)(b) allows for the personal and vaccination information on the Register
to be cross referenced with information from Pap smear, cervical cytology or cervical
cancer registers which are currently kept by state and territory health authorities. This
will be done at some time in the future when the younger cohort of females currently
receiving HPV vaccine begin having Pap smears every two years in accordance with
the National Cervical Screening Guidelines.
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Vaccination with HPV vaccine will not preclude females from continuing to have Pap
smears performed every two years from the time they become sexually active. The
need for this will continue until tangible data is collected demonstrating the
effectiveness of the HPV vaccine in reducing cervical cancer. This data will provide
information for policy direction for both the HPV and Cervical Screening Programs in
the future. For the most part this data will be gathered in a de-identified form,
however, there may be longitudinal studies undertaken in some cases where
identifiable personal information may need to be used. In these instances the
information will be handled in accordance with the National Centre for Immunisation
Research and Surveillance of Vaccine Preventable Diseases Guidelines.
Subsection (3) Paragraph (c).
Paragraph (3)(c) establishes a mechanism for the Register to contact persons
participating in the HPV Program for a number of purposes associated with
vaccination. At specified intervals the Register will generate notices to vaccinated
persons, or to the parents or guardians of vaccinated children or persons incapable of
managing their own affairs, advising them when a dose of vaccine has been missed
and remind them when the next dose of HPV vaccine is due. At some time in the
future `booster' doses of HPV vaccine may be required to ensure the effectiveness of
the vaccine is maintained. The database will facilitate a notification system for these
purposes.
Subsection (3) Paragraph (d).
Paragraph (3)(d) allows for the database to maintain a record of vaccinations
administered to each person. At the completion of a course of vaccination, or at any
time at the request of the person, or the parent or guardian of a child or person
incapable of managing their own affairs, the Register will have the capacity to
generate a letter of certification that the course of vaccination has been completed, or
a list of doses given, and will contain the details of the brand of HPV vaccine, the
batch number and the dates on which each dose was administered. This will provide a
record of vaccination for the individual concerned.
Subsection (3) Paragraph (e).
Paragraph (3)(e) facilitates a notification mechanism about new developments
associated with HPV and related matters to vaccinated individuals, parents or
guardians of vaccinated individuals and vaccination providers. This will include any
material of a technical or statistical nature relating to cervical cancer, new and
emerging HPV vaccines and related matters. De-identified statistical information may
also be published to raise awareness in the general population about HPV and to
promote the HPV Program.
Subsection (3) Paragraph (f).
Paragraph (3)(f) allows for payments to be made to general practitioners for providing
information to the Register about individuals in the 12-18 year old age group to whom
they administer HPV vaccine. This will ensure that the vaccination information
relating to any person on the Register is as current and as complete as possible.
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Vaccination providers who are registered nurses and who work within a public health
system will not be paid for entering vaccination information to the Register.
Only vaccination providers who are recognised for the purposes of the Register will
be able to interrogate information on the HPV Register about an individual to whom
they are administering a dose of HPV vaccine. This is to so they can check the
sequence of vaccination, the brand of vaccine to ensure the female receives the same
brand on each occasion and to enter information about the dose of vaccine that they
are administering.
Subsection (4).
This subsection makes provision for an individual to request to have any personal
information removed from the Register. Similarly, it allows a parent or guardian of a
vaccinated person to request the removal of personal information about that person
from the Register. The request must be made in writing and the Commonwealth,
under this provision, is required to comply with the written request as soon as
practicable.
There is a strong argument in the Public Health domain to make provisions which
would allow people to be able to 'opt off' the register because as a general principle if
people are asked to 'opt on' or `opt off' particularly when the request needs to be made
in writing, then significant numbers of people may choose to do nothing. As a
consequence, minimal data would be collected for the purposes of providing
information on the effectiveness of the HPV vaccine in preventing cervical cancer if a
consent or `opt on' system is implemented.
Subsection (5).
IPP 10 under section 14 of the of the Privacy Act 1988 requires a record keeper who
possesses a record that contains personal information that was collected for a
particular purpose to use that information only for the purpose for which it was
collected unless certain exempting criteria are met under IPP 10. Paragraph (1)(c)
allows the record keeper to use this information for another purpose if the purpose is
authorised by or under law.
This provision authorises personal information on the Register to be used for purposes
associated with the Register.
Subsection (6).
IPP 11 under section 14 of the of the Privacy Act 1988 provides that a record keeper
who possesses a record that contains personal information must not disclose that
information to a person, body or agency other than the individual concerned unless
certain exempting criteria are met under IPP 11. Paragraph (1)(d) allows for such
disclosure if it authorised by or under law.
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This provision authorises the disclosure of information on the Register for purposes
associated with the Register provided that it is disclosed to a body or a class of bodies
prescribed in regulations or a prescribed body for the purposes of Part IVA of the
Health Insurance Act 1973 (Health Insurance Act).
Bodies that are prescribed for the purposes of Part IVA of the Health Insurance Act
include State and Territory Health Departments, State and Territory Divisions of
General Practice, The National Centre for Immunisation, Research and Surveillance
of Vaccine Preventable Diseases, the NSW, Victorian, Queensland, Western
Australian, South Australian and Tasmanian Rural Division Co-ordinating Units, and
State or Territory Aboriginal and Torres Strait Islander Health Care Networks (where
they exist).
Subsection (7).
This subsection provides definitions and interpretation of terms used for the purposes
of the Bill.
Eligible person is a person who is entitled to receive free HPV vaccine in
accordance with the eligibility criteria under the National HPV Vaccination Program,
which may change over time. Those currently entitled to receive the vaccine are
females in the 12 to 26 year old age group. After July 2009 females in the 18 to 26
year old age group will no longer be entitled to free vaccine through the HPV
Program as it is anticipated that all females in that age group (who agree to
vaccination) will have been vaccinated by that time. The school based program will
continue on an ongoing basis for 12 and 13 year old females when they enter the first
year of high school.
HPV vaccine is a human papillomavirus vaccine which has been designated under
section 9B of the National Health Act. Currently Gardasil® is the only HPV vaccine
designated for use in the HPV Program but new vaccines are likely to be designated in
the future.
Personal information is information kept on the Register about a person which
may reasonably identify a person and includes details of name, address, gender, date
of birth and their Medicare card number.
Vaccination provider this is a person who is either a general practitioner who has
notified his or her details to the Register for the purposes of being entitled to enter
personal and vaccination information to the Register about clients in the 12 18 year
old age group to whom he or she administers HPV vaccine and who is entitled to
receive an administrative payment for doing this.
A vaccination provider can also be a person who is entitled to practice as a nurse in
the state or territory by virtue of holding either registration or enrolment with the
relevant regulatory body in that State or Territory. The nurse must also be authorised
to administer HPV vaccine by a State or Territory Health Department and be notified
by that authority to the Register. Nurses are not entitled to an administrative payment
fee for entering information to the Register.
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