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National Health Amendment (National HPV Vaccination Program Register) Bill 2007

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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.

 

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. 



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 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.  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.

 

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.  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.

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.