House Of Representatives

Explanatory Memorandum

(Circulated by authority of the Minister for Health, The Hon Sussan Ley MP)

OUTLINE

This Bill acts to address the legislative consequential amendments required with the enactment of the Australian Immunisation Register Bill 2015 and deal with consequential and transitional matters arising from the enactment of that Act, and for related purposes.

As part of the 2015-2016 Federal Budget, the Government has approved the expansion of the Australian Childhood Immunisation Register (ACIR) to become the Australian Immunisation Register (AIR), which will capture all vaccines given, from birth to death, through General Practice and community clinics because of the No Jab, No Pay Budget measure. The ACIR currently records vaccinations given to children aged less than seven years. Approval was also given to expand the National HPV Vaccination Program Register (HPV Register) to become the Australian School Vaccination Register (ASVR) which will capture all adolescent vaccinations given through school programs from the start of the 2017 school year. Legislative amendments are required to provide for the expanded registers.

The ACIR will be expanded in two stages. From 1 January 2016, it will be expanded to collect and record vaccinations given to young individuals under the age of 20 years. This is required to implement the Government's 'No Jab No Pay' Budget measure. From late 2016, it will be expanded further to cover all vaccinations given from birth to death. This is to accommodate the addition of zoster virus (shingles) vaccine (Zostavax) to the National Immunisation Program for persons aged 70 years.

The ACIR is currently provided for under Part IVA of the Health Insurance Act 1973 and the HPV Register is provided for under section 9BA of the National Health Act 1953. Given the extent of the register expansion work, it is considered timely to create a new, consolidated legislative framework for the establishment and ongoing management of Australian immunisation registers, including the AIR and ASVR. In this context, proposed legislation has been drafted which consists of the following components:

(a)

the Australian Immunisation Register Bill 2015;

(b)

the Australian Immunisation Register (Consequential and Transitional Provisions) Bill 2015;

(c)

the Australian Immunisation Register Rule 2015.

Consequential to the Australian Immunisation Register Bill 2015 being enacted, the following legislation needs to be amended;

•

The Health Insurance Act 1973 - repeal Part IVA- Australia Childhood immunisation Register provisions also amendment to section 130 to authorise disclosure of Medicare enrolment data

•

National Health Act 1953 - repeal section 9BA- National HPV- Vaccination Program Register provisions

•

Freedom of Information Act 1982 - include reference to Australian Immunisation Register Act 2015 in Schedule 3 which will exempt Register information from disclosure under section 38 of the Act in response to a freedom of information request

•

A New Tax System (Family Assistance) Act 1999 - Modify to allow the definition of a 'recognised immunisation provider' to be consistent with the meaning of recognised vaccination provider in the new immunisation register Bill.

•

Healthcare Identifiers Act 2010 - Repeal the definition for the Australian Childhood Immunisation Register (ACIR) which links to the Health Insurance Act 1973 and refer instead to the Register operated under the new Australian Immunisation Register Act 2015.

•

Child Support (Registration and Collection) Act 1988 - to prescribe that the Australian Immunisation Register Act 2015 is a 'designated program Act'.

•

Human Services (Medicare) Act 1973- to prescribe that the Australian Immunisation Register Act 2015 is a 'designated program Act'.

•

Human Services (Centrelink) Act 1997- to prescribe that the Australian Immunisation Register Act 2015 is a 'designated program Act'.

•

Australian Immunisation Registers Act 2015 - to expand to collect information on vaccinations given to all individuals not just those under7 years of age.

This Bill will come into effect the same day that the Australian Immunisation Register Bill 2015 gains Royal Assent and will have transitional amendments commencing in three stages. If the Australian Immunisation Register Bill 2015 does not commence, the provisions do not commence at all.

Financial Impact Statement

As part of the 2015-16 Federal Budget, the Government has committed $9.2 million over four years to expand the HPV Register and $27.2 million over four years to expand the ACIR to capture adult immunisation data.

Statement of compatibility with human rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Australian Immunisation Register (Consequential and Transitional Provisions) Bill 2015

This Bill is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Bill

This Bill acts to address the legislative consequential amendments required with the enactment of the Australian Immunisation Register Bill 2015 and deal with consequential and transitional matters arising from the enactment of that Act, and for related purposes.

As part of the 2015-2016 Federal Budget, the Government has approved the expansion of the Australian Childhood Immunisation Register (ACIR) to become the Australian Immunisation Register (AIR), which will capture all vaccines given, from birth to death, through General Practice and community clinics because of the No Jab, No Pay Budget measure. The ACIR currently records vaccinations given to children aged less than seven years. Approval was also given to expand the National HPV Vaccination Program Register (HPV Register) to become the Australian School Vaccination Register (ASVR) which will capture all adolescent vaccinations given through school programs from the start of the 2017 school year. Legislative amendments are required to provide for the expanded registers.

The ACIR will be expanded in two stages. From 1 January 2016, it will be expanded to collect and record vaccinations given to young individuals under the age of 20 years. This is required to implement the Government's 'No Jab No Pay' Budget measure. From late 2016, it will be expanded further to cover all vaccinations given from birth to death. This is to accommodate the addition of zoster virus (shingles) vaccine (Zostavax) to the National Immunisation Program for persons aged 70 years.

The ACIR is currently provided for under Part IVA of the Health Insurance Act 1973 and the HPV Register is provided for under section 9BA of the National Health Act 1953. Given the extent of the register expansion work, it is considered timely to create a new, consolidated legislative framework for the establishment and ongoing management of Australian immunisation registers, including the AIR and ASVR. In this context, proposed legislation has been drafted which consists of the following components:

(a)

the Australian Immunisation Register Bill 2015;

(b)

the Australian Immunisation Register (Consequential and Transitional Provisions) Bill 2015;

(c)

the Australian Immunisation Register Rule 2015.

Consequential to the Australian Immunisation Register Bill 2015 being enacted, the following legislation needs to be amended;

•

The Health Insurance Act 1973 - repeal Part IVA- Australia Childhood immunisation Register provisions also amendment to section 130 to authorise disclosure of Medicare enrolment data.

•

National Health Act 1953 - repeal section 9BA- National HPV- Vaccination Program Register provisions.

•

Freedom of Information Act 1982 - include reference to Australian Immunisation Register Act 2015 in Schedule 3 which will exempt Register information from disclosure under section 38 of the Act in response to a freedom of information request.

•

A New Tax System (Family Assistance) Act 1999 - Modify to allow the definition of a 'recognised immunisation provider' to be consistent with the meaning of recognised vaccination provider in the new immunisation register Bill.

•

Healthcare Identifiers Act 2010 - Repeal the definition for the Australian Childhood Immunisation Register (ACIR) which links to the Health Insurance Act 1973 and refer instead to the Register operated under the new Australian Immunisation Register Act 2015.

•

Child Support (Registration and Collection) Act 1988 - to prescribe that the Australian Immunisation Register Act 2015 is a 'designated program Act'.

•

Human Services (Medicare) Act 1975- to prescribe that the Australian Immunisation Register Act 2015 is a 'designated program Act'.

•

Human Services (Centrelink) Act 1997- to prescribe that the Australian Immunisation Register Act 2015 is a 'designated program Act'.

•

Australian Immunisation Registers Act 2015 - to expand to collect information on vaccinations given to all individuals not just those under7 years of age.

This Bill will come into effect the same day that the Australian Immunisation Register Bill 2015 gains Royal Assent and will have transitional amendments commencing in three stages. If the Australian Immunisation Register Bill 2015 does not commence, the provisions do not commence at all.

Human rights implications

The Bill engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The Bill assists the advancement of this human right by providing access for eligible people to the Australian registry that records vaccine administered. Enhancing the mechanism in which immunisation are recorded will contribute to an enriched monitoring and provides invaluable statistics on health-related issues. This is a positive step towards attaining the highest standard of health for all Australians, by protecting individuals and the community through enhanced monitoring of vaccine preventable disease. Current legislation describing immunisation registers are within the Health Insurance Act 1973 and the National Health Act 1953 (NHA) and provides for immunisation records for children up to the age of seven and school-aged. The new legislation and the expansion of the Register promote the right to health and the accessibility of individual records for whole of life, not just the young. The Bill provides for the Register to be expanded to capture data to all individuals not just those individuals under 20 years of age. The process for accessing immunisation information will be the same throughout life providing a consistent approach for individuals and healthcare providers.

This Bill engages Article 17 the International Covenant on Civil and Political Rights (ICCPR) by the provision that the Register can collect, store, use and disclose personal information. Within the Part 2, subsection 9(a) of the Australian Immunisation Register Bill 2015 (AIR Bill) in which these consequential changes are relating too, are provisions for the collection of relevant identifying information for individuals who had or could have, a relevant vaccination. Personal Information from the Medicare database is disclosed to the register under the offence provisions contained within s130 of the Health Insurance Act 1973 to pre-populate the register with personal information of individuals. This information is then deemed as protected information under the AIR Bill and protected under the secrecy provisions in Part 4, which maintains the protection of personal information. Individual privacy is maintained and not diminished within this proposed AIR Bill.

Individuals may request that personal information is not disclosed from the register as described in subsection 11(2) of the AIR Bill. Persons cannot make a record of, disclose or otherwise use this information if this is contrary to such a request. Limitations on disclosure of personal information are expressed within subsection 22(2) of the AIR Bill. A person may only disclose personal information to third parties, if the persons does so for the purposes of the register described in Section 10 of the AIR Bill and is a listed person described under subparagraph 22(2). The authorized categories of persons in proposed subsection 22(2) are persons who are an employee of the Commonwealth (or authority of the Commonwealth), a prescribed body, a recognised Australian vaccination provider, if the person is a parent/guardian of a child or is an officer or employee engaged by the Commonwealth to perform work relating to the purposes of the register. Authorised persons may only disclose personal information for limited purposes including if, the person does so in accordance with the purpose under the Act, the person is required to do so by the law, the person does so for the purpose of a coronial inquiry. The expressed limitation on who can access and disclose personal information is explicit to the purposes of the Register and those authorised dealings with protected information under subparagraph 22(2)(b) of the AIR Bill.

The Minister (or his or her delegate) may also disclose personal information if they are satisfied that it is in the public interest to do so. An example is where a child protection agency requests information when investigating the welfare of a child. Section 23 of the AIR Bill creates an offence for making a record, using or disclosing personal information where not authorised. In the 2014-2015 financial year, more than 18,000 authorisations occurred for this purpose.

Persons who obtain information or disclose information and are not authorised to do so under subsection 22(2) of the AIR Bill are subject to imprisonment for 2 years or 120 penalty units, or both. Specific exemptions to this offence relates to the person to whom the protect information relate to is described in Section 27 of the AIR Bill. These sanctions are described and designed to encourage adherence to the intent of the Bill whilst maintaining privacy provisions.

The authorisations of used and disclosure of personal information are reasonable, appropriate and necessary for the objectives and purposes of the Bill and adequately describes persons who are requiring access to the immunisation Register to achieve this objectives of the ACIR. The provisions in the Bill also provide individuals with freedom to access their own personal information. The limiting provisions surrounding the access of personal information are well described. The limitations for purposes for which the information can be disclosed are a reasonable and proportionate use of individual's personal information.

Conclusion

The Bill is compatible with human rights because it advances the protection of human rights as outlined above and to the extent that it may also limit human rights, those limitations are reasonable, necessary and proportionate.

Notes on clauses

Clause 1 - Short Title

This clause provides that the Bill, once enacted, may be cited as the Australian Immunisation Register (consequential and Transitional Provisions) Act 2015.

Clause 2 - Commencement

This Clause provides the commencement dates for the provisions in the Bill. The transitional arrangements described in the Bill will facilitate immunisation program continuity and seamless implementation to the new expanded registers.

From 1 January 2017, 12 months after the Australian Immunisation Register Act 2015 commencement date the final provisions will commence. This is to facilitate the establishment of the new Australian School Vaccination Register (ASVR) which is expected to be operational beginning of the 2017 school year. The time for these provisions to be enacted will enable correct procurement guidelines to be followed and development of the Register.

Schedule 2 is scheduled to commence on either a day fixed by proclamation or the end of 12 months after royal assent. The expansion of the Australian childhood Immunisation Register (ACIR) to cover all individuals, which are provided for in the amendments in Schedule 2, will not be ready to be implemented prior to October 2016. Therefore 12 months has been provided for Schedule 2 to commence. None of the provisions in the Bill will commence if the Australian Immunisation Register Act 2015 does not commence.

Clause 3 - Schedules

Provides that each Act that is specified in the Schedule to this Bill is amended or repealed as set out in the applicable items in the Schedule.

SCHEDULE 1 - Amendments commencing 1 January 2016

A New Tax System (Family Assistance) Act 1999

1. Subsection 3(1) definition of recognised immunisation provider

The definition of a 'recognised immunisation provider' within the Act is to be repealed and replaced to include reference to the Australian Immunisation Register Act 2015.

This amendment will clarify that the definition of a 'recognised immunisation provider' used has the same meaning as the definition used in the Australian Immunisation Register Act 2015.

Child Support (Registration and Collection) Act 1988

2. Subsection 16AB(3) (After paragraph (c) of the definition of a designated program Act

The Australian Immunisation Register Act 2015 is to be included in the definition of designated program Act in the subsection 16AB(3) to allow current administration practises described within the Child Support (Registration and Collection) Act 1988 to continue to apply under the new legislation.

Freedom of Information Act 1982

3. Schedule 3

This amendment will allow information in the Register to be exempt from disclosure under section 38 of the Freedom of Information Act 1982 in response to a freedom of information request.

Currently the information in the Registers is protected from disclosure under the relevant secrecy provisions (Subsection 130(1) of the Health Insurance Act 1973 for the Australian Childhood Immunisation Register (ACIR) and subsection 135A(1) of the National Health Act 1953 for the National Human Papilloma virus Vaccination Program Register (HPV Register)(secrecy provisions). The secrecy provisions are specified in Schedule 3 of the Freedom of Information Act 1982 and therefore information in the Registers is exempt from disclosure under section 38 of the FOI Act in response to a freedom of information request.

In order to maintain the exemption from disclosure under the Freedom of Information Act 1982 the legislation requires amendment to Schedule 3 of the Act to include the offence provision in the proposed legislation.

Healthcare Identifiers Act 2010

4. Section 5 (definition of Australian Childhood Immunisation Register)

The Healthcare Identifiers Act 2010 will be amended to repeal the definition of the Australian Childhood Immunisation Register (ACIR) which links to the Health Insurance Act 1973 and refer to the register operated under the Australian Immunisation Register Act 2015. This provision will allow vaccination information recorded in the ACIR Register to be transferred to an individual's Personally Controlled Electronic Health Record (PCEHR) if they have consented for the information to be uploaded to the PCEHR. It will facilitate use and disclosure of healthcare identifiers for the purposes of the Register and this disclosure will not be an offence under 26 of the Healthcare Identifiers Act 2010.

Health Insurance Act 1973

5. Part IVA

This clause will repeal Part IVA of the Health Insurance Act 1973 in its entirety. This part of the Health Insurance Act 1973 provides for the operation of the Australian Childhood Immunisation Register (ACIR). The legislative powers for the ACIR will be transitioned to the new Australian Immunisation Register Bill 2015 effective 1 January 2016.

6. Subsections 130(3B), (3C), (3D), (3E), (3F) and (3G)

The subsections of 130 mentioned are to be repealed on the commencement of the Australian Immunisation Register Bill 2015 effective 1 January 2016. These provisions within the Health Insurance Act 1973 create offences specifically relating to the handling of information on the Australia Childhood Immunisation Register. The offence provisions describe the generated offence in relation to the unauthorised disclosure of personal or sensitive information. The new Australian Immunisation Register Act 2015 has offence provisions that will replace these provisions.

7. Subsection 130(5F)

Within this subsection a provision is to be inserted that will allow information that is acquired under the Health Insurance Act 1973 to be disclosed to the Register kept under Part 2 of the Australian Immunisation Registers Act 2015. Medicare information retained under the Health Insurance Act 1973 needs to be disclosed to the Register to allow the Register to continue to operate as it currently does. This provision will facilitate the transfer of personal information from the Medicare database to the Register and create an exception to the offence under 130 of the Health Insurance Act 1973.

8. and 9. Subsection 130(11) and 130 (13)

Specific reference to 46E of the Health Insurance Act 1973 is to be omitted from subsections 130(11) and 130(13). From 1 January 2016, the 46E provision residing under Part IVA-, the Australian Childhood Immunisation Register is to be repealed.

Human Services (Centrelink) Act 1997

10. Subsection 40A(3) (after paragraph (b) of the definition of designated program Act)

The Australian Immunisation Register Act 2015 is to be included in the definition of designated program Act within subsection 40A(3) to allow current administration practises described within the Human Services (Centrelink) Act 1997 to continue to apply under the new legislation.

Human Services (Medicare) Act 1973

11. Subsection 43A(3) (after paragraph (b) of the definition of designated program Act)

The Australian Immunisation Register Act 2015 is to be included in the definition of designated program Act within subsection 43A(3) to allow current administration practises described within the Human Services (Medicare) Act 1973 to continue to apply under the new legislation.

National Health Act 1953

12. Subparagraph 9BA(6)(a)(iii)

Section 9BA(6) of the National Health Act 1953 currently specifies that information in the HPV Register can be disclosed to a prescribed body, as defined in Part IVA of the Health Insurance Act 1973. This will amend the paragraph to refer to a prescribed body within the meaning of the Australian Immunisation Register Act 2015.

13. Paragraph 135(5C)(c)

Within this paragraph omission of the "powers; or" and substitute to "powers".

14. Paragraph 135 (5C)(d)

Specific reference to the HPV Register is made in this paragraph and is no longer required as 9BA will be repealed.

SCHEDULE 2 - Amendments commencing later in 2016

This schedule amends the Australian Immunisation Register Act 2015 to reflect the expansion of the Australian Childhood Immunisation Register (ACIR) to become the Australian Immunisation Register. The ACIR is being expanded to become a whole-of-life register which will record details of vaccinations given, from birth to death, administered through General Practices or community clinics.

Australian Immunisation Registers Act 2015

1. Section 3 Simplified outline of the Act

The outline will be repealed to remove reference to 'young individuals'. From October 2016, the Register will record vaccination information of all Australian's, not just the young.

2.-8. Section 4 (definitions)

Makes amendments to the definitions as follows;

•

Definition of "purposes of the ACI Register" will be repealed.

•

"Purposes of the AI Register" will be added as a definition as the register will no longer be known as the Australian Childhood Immunisation Register but the Australian Immunisation Register.

•

A definition of a legal personal representative is to be added. The definition includes parents or guardians of a person under the age of 18 years, a trustee of an estate or a person who holds an enduring power of attorney.

•

Definition of "young individual" is being repealed. The Register is expanding to cater for all individuals, not just individuals less than 20 years.

•

subparagraph (b)(i) of the definition of "recognised vaccination provider" needs to be amended to reflect the name change of the Register.

•

subparagraph (d)(i) of the definition of "relevant identifying information" will be amended to omit reference to a parent or guardian and add instead reference to legal personal representative.

9. Part 2 (heading)

The heading of Part 2 includes reference to the ACI Register. This amendment repeals the reference and substitutes;

'Part 2- Australia Immunisation Register'

10-33.

Specific clauses and paragraphs within the Australian Immunisation Register Act 2015 refer to young individual. The expansion of the register requires these paragraphs to be amended to reflect all individuals not just the young. 'Young individual' or 'young individual's' are to be replaced with 'individual' or 'individuals' in Section 7, Section 9, Section 10, and Section 12.

Similarly, within Part 2, references of the "Australia Childhood Immunisation Register" or "ACI register" are contained within Section 7, Section 8, Section 9, Section 13, Section 21 and Section 22. These amendments omit references to the ACI Register within the above mentioned sections and substitution reference to the newly formed "Australian Immunisation Register" or "AI register".

21.-33. Section 10(2), Subsection 11(1) (Note), Subsection 11(2) and subsection 26(2)

Amendments to these provisions are made to include disclosure of information to a legal personal representative which includes a parent or guardian of a person ages less than 18 years. The expansion of the Register means the Register will include not only include collection of information about the very young but individuals who may be incapable of managing his or her affairs and may have trustee of an estate or a person who holds an enduring power of attorney managing their health affairs.

Healthcare Identifiers Act 2010

34. Section 5 (definition of Australian Childhood Immunisation Register)

The definition of the ACIR used in the Healthcare Identifiers Act 2010 is to be repealed.

35. Subparagraph 22D(2)(a)(ii)

The subparagraph will be updated to allow information included on the Australian Immunisation Register kept under Australian Immunisation Register Act 2015 to be transferred to an individual's PCHER. It will facilitate use and disclosure of healthcare identifiers for the purposes uploading information to an individual's PCEHR and will not be an offence under 26 of the Healthcare Identifiers Act 2010.

SCHEDULE 3 - Amendments commencing 1 January 2017

From 1 January 2017, the National Human Papilloma virus Vaccination Program Register (HPV Register) will be expanded to become the Australian School Vaccination Register (ASVR). The expansion will facilitate the inclusion of any vaccines administered through a school-based immunisation program. Amendments are made to the Australian Immunisation Register Act 2015 and the National Health Act 1953 to reflect this expansion.

Australian Immunisation Register Act 2015

1. Subsection 8(2)

A note is to be included at the end of the subsection to mention that parts of the register could be kept separately and be known by different names. The Australia School Vaccination Register may be maintained separately to the information recorded about early childhood and adult vaccinations.

2. Paragraph 22(2)(f)

Within this paragraph omission of the 'coroner or' and substitute to 'coroner'.

3. Paragraph 22(2)(g)

With the HPV Register administration powers being transferred to sit under the new Australian Immunisation Register Act 2015 the provisions referencing the National Health Act 1953 are no longer required.

National Health Act 1953

4. Section 9BA

This clause repeals section 9BA of the National Health Act 1953 (NHA) in its entirety. This part of the NHA provided for the operation of the HPV Register. From 1 January 2017, the HPV Register will no longer be operational as it will be replaced by Australian School Vaccination Register (ASVR). The legislative powers for the ASVR are transitioned to the new Australian Immunisation Registers Act 2015 effective 1 January 2017.

5. Paragraph 135(5C)(c)

Within this paragraph omission of the 'powers; or' and substitute to 'powers.'.

6. Paragraph 135(5C)(d)

Specific reference to the HPV Register is made in this paragraph and is no longer required as 9BA will be repealed.