EXPLANATORY STATEMENT
Select Legislative Instrument No. 236, 2015
Issued by the Authority of the Minister for Health
Health Insurance Act 1973
Health Insurance Amendment (Australian Immunisation Register) Regulation 2015
Outline
Subsection 133(1) of the Health Insurance Act 1973 (the Act) provides, in part, that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.
Part IVA of the Act provides for the establishment and maintenance of the Australian Childhood Immunisation Register (the Register), and specifies the functions and powers of the Chief Executive Medicare (CEM) in relation to the Register.
Section 46B of the Act prescribes the CEM’s functions in relation to the Register, including the recording in the Register of all immunisation encounters that are notified to the CEM by recognised immunisation providers or prescribed bodies.
Subparagraph 46E(1)(a)(ii) of the Act provides that, for the purpose of performing the CEM’s functions in relation to the Register, the CEM or delegate may give information about the immunisation of children to a prescribed body for such a purpose. The bodies to which information in the register may be given are prescribed in Schedule 1A to the Health Insurance Regulations 1975 (the Principal Regulations).
Regulation 22A of the Principal Regulations provides authority for the CEM to define prescribed bodies. Where prescribed bodies are mentioned within the Act, within paragraph 46B (b), subparagraph 46E (1) (a) (ii), subparagraph 46E (1) (e) (ii), paragraph 46E (2) (b) and paragraph 46E (3) (c), the CEM has authority to define them as bodies authorised to obtain information that is contained within the Register. The prescribed bodies are listed within Schedule 1A of the Principal Regulations.
The purpose of the Health Insurance Amendment (Australian Immunisation Register) Regulation 2015 (the proposed Regulation) is to repeal Regulation 22A and Schedule 1A from the Principal Regulations in its entirety. This is required following development of new consolidated legislation that authorises the keeping of Australia’s immunisation registers. The purpose of the Australian Immunisation Register Act 2015 (the Immunisation Register Act) and the Australian Immunisation Register (Consequential and Transitional Provisions) Act 2015 is to:
- Create a consolidated legislative framework to govern the operation of Australian immunisation registers;
- Expand the age range covered by the Australian Childhood Immunisation Register (ACIR) from children under seven years of age to ‘young individuals’ under 20 years of age (commencing from 1 January 2016);
- Expand the ACIR to become the Australian Immunisation Register (AIR) to capture all vaccinations given to people from birth to death commencing from September 2016; and
- Expand the National Human Papillomavirus (HPV) Vaccination Program register (HPV Register) to become the Australian School Vaccination Register (ASVR) under the broad umbrella of the AIR which will capture all adolescent vaccinations given through school programs commencing from the start of the 2017 school year.
The Immunisation Register Act states within section 31, that the Minister may by legislative instrument, make rules prescribing matters required or necessary by the Act. Under the Principal Regulations, the ability to list prescribed bodies are a function under Regulation 22A. The newly established Australian Immunisation Register Rule 2015 under the Immunisation Register Act defines the bodies which are authorised to have access to protected information contained within the register. Protected information means personal information, relevant identifying information or information that is commercial-in-confidence obtained under the Immunisation Register Act or derived from information obtained or disclosed under this Act. The prescribed bodies include state and territory health departments, Primary Health Networks, bodies facilitating research relating to vaccines, and officers, employees or contractors of prescribed bodies.
The Immunisation Register Act will lay the foundations for future work towards one integrated system that captures and reports on all vaccines given in Australia from birth to death, providing one ‘front door’ for consumers and immunisation providers.
Over the past decade a wide range of immunisation stakeholders have advocated the benefits of a whole-of-life immunisation register for Australia.
The Department of Health has consulted with peak bodies, health experts and state and territory health departments represented on the National Immunisation Committee and the Australian Technical Advisory Group on Immunisation, to seek their views on the essential components of a fully effective whole-of-life register and adolescent school-based register. Ongoing engagement is a key part of the implementation phase, as the expanded registers will play a key role in contributing to improved vaccination rates in Australia to ensure better health outcomes for all Australians throughout their life.
The Department of Human Services, the Department of Social Services, the Office of Parliamentary Council, the Attorney-General’s Department (including the Office of the Australian Information Commissioner) were all consulted during the development of the Immunisation Register Act, the Australian Immunisation Register Rule 2015 and consequential changes following Royal Assent of the Bill.
Details of the Health Insurance Amendment (Australian Immunisation Register) Regulation 2015 are described in the Attachment.
The Act specifies no conditions that need to be satisfied before the power to make the proposed Regulation may be exercised.
The Regulation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The Regulation commences on 1 January 2016.
The Minute recommends that the Regulation be made in the form proposed.
Authority: Subsection 133(1) of the
Health Insurance Act 1973
ATTACHMENT
Details of the proposed Health Insurance Amendment (Australian Immunisation Register) Regulation 2015
1 – Name of Regulation
This section provides that the title of the Regulation is the Health Insurance Amendment (Australian Immunisation Register) Regulation 2015.
2 – Commencement
This section provides for the Regulation to commence on 1 January 2016.
3 – Authority
This section provides that the Health Insurance Amendment (Australian Immunisation Register) Regulation 2015 is made under the Health Insurance Act 1973.
4 – Schedule(s)
This section provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1 – Amendments
Item [1] – Regulation 22A
Regulation 22A of the Health Insurance Regulations 1975 (the Principal Regulations) is to be repealed in its entirety. This regulation provides for certain bodies to be prescribed so that they can receive information regarding an individual’s vaccination status directly from the register. With the enactment of the Australian Immunisation Register Bill 2015, the prescribed bodies to whom register information can be provided will be listed in the Australian Immunisation Register Rule 2015. Legal authority for the ACIR to operate in the future will no longer be provided for under the Health Insurance Act 1973.
Item [2] – Schedule 1A
Schedule 1A of the Principal Regulations is to be repealed in its entirety. The schedule lists the prescribed bodies who can receive information regarding an individual’s vaccination status directly from the ACIR.
The Principle Regulations list the prescribed bodies as Divisions of General Practice; Rural Divisions of General Practice; and state and territory health departments. With the establishment of Primary Health Networks (PHN) and the dissolution of the Divisions of General Practice and Rural Divisions of General Practice the listed prescribed bodies need to be updated.
The updated list of prescribed bodies within the Australian Immunisation Register Rule 2015 include, state and territory health departments, Primary Health Networks, bodies that facilitate research relating to vaccines that include; the Australian Institute of Health and Welfare, the Australian Bureau of Statistics, the Australian Institute of Family Studies and the Sydney Children’s Hospital Network (Randwick and Westmead), which may otherwise be known or referred to as the National Centre for Immunisation Research and Surveillance.
Statement of Compatibility with Human Rights
Prepared in accordance with part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
HEALTH INSURANCE AMENDMENT (AUSTRALIAN IMMUNISATION REGISTER) REGULATION 2015
This Rule 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.
Outline
Subsection 133(1) of the Health Insurance Act 1973 (the Act) provides, in part, that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.
Part IVA of the Act provides for the establishment and maintenance of the Australian Childhood Immunisation Register (the Register), and specifies the functions and powers of the Chief Executive Medicare (CEM) in relation to the Register.
Section 46B of the Act prescribes the CEM’s functions in relation to the Register, including the recording in the Register of all immunisation encounters that are notified to the CEM by recognised immunisation providers or prescribed bodies.
Subparagraph 46E(1)(a)(ii) of the Act provides that, for the purpose of performing the CEM’s functions in relation to the Register, the CEM or delegate may give information about the immunisation of children to a prescribed body for such a purpose. The bodies to which information in the register may be given are prescribed in Schedule 1A to the Health Insurance Regulations 1975 (the Principal Regulations).
Regulation 22A of the Principal Regulations provides authority for the CEM to define prescribed bodies. Where prescribed bodies are mentioned within the Act, within paragraph 46B (b), subparagraph 46E (1) (a) (ii), subparagraph 46E (1) (e) (ii), paragraph 46E (2) (b) and paragraph 46E (3) (c), the CEM has authority to define them as bodies authorised to obtain information that is contained within the Register. The prescribed bodies are listed within Schedule 1A of the Principal Regulations.
The purpose of the Health Insurance Amendment (Australian Immunisation Register) Regulation 2015 (the proposed Regulation) is to repeal Regulation 22A and Schedule 1A from the Principal Regulations in its entirety. This is required following development of a new consolidated legislation that authorises the keeping of Australia’s immunisation registers. The purpose of the Australian Immunisation Register Act 2015 (the Immunisation Register Act) and the Australian Immunisation Register (Consequential and Transitional Provisions) Act 2015 is to:
- Create a consolidated legislative framework to govern the operation of Australian immunisation registers;
- Expand the age range covered by the Australian Childhood Immunisation Register (ACIR) from children under seven years of age to ‘young individuals’ under 20 years of age (commencing from 1 January 2016);
- Expand the ACIR to become the Australian Immunisation Register (AIR) to capture all vaccinations given to people from birth to death commencing from September 2016; and
- Expand the National Human Papillomavirus (HPV) Vaccination Program register (HPV Register) to become the Australian School Vaccination Register (ASVR) under the broad umbrella of the AIR which will capture all adolescent vaccinations given through school programs commencing from the start of the 2017 school year.
The Immunisation Register Act states within section 31 that the Minister may, by legislative instrument, make rules prescribing matters required or necessary by the Act. Under the Principal Regulations, the ability to list prescribed bodies are a function under Regulation 22A. The newly established Australian Immunisation Register Rule 2015 under the Immunisation Register Act, defines the bodies which are authorised to have access to protected information contained within the register. Protected information means personal information, relevant identifying information or information that is commercial-in-confidence obtained under the Immunisation Register Act or derived from information obtained or disclosed under this Act. The prescribed bodies include state and territory health departments, Primary Health Networks, bodies facilitating research relating to vaccines, and officers, employees or contractors of prescribed bodies.
The Immunisation Register Act lays the foundations for future work towards one integrated system that captures and reports on all vaccines given in Australia from birth to death, providing one ‘front door’ for consumers and immunisation providers.
Over the past decade a wide range of immunisation stakeholders have advocated the benefits of a whole-of-life immunisation register for Australia.
The Department of Health has consulted with peak bodies, health experts and state and territory health departments represented on the National Immunisation Committee and the Australian Technical Advisory Group on Immunisation, to seek their views on the essential components of a fully effective whole-of-life register and adolescent school-based register. Ongoing engagement is a key part of the implementation phase, as the expanded registers will play a key role in contributing to improved vaccination rates in Australia to ensure better health outcomes for all Australians throughout their life.
The Department of Human Services, the Department of Social Services, the Office of Parliamentary Council, the Attorney-General’s Department (including the Office of the Australian Information Commissioner) were all consulted during the development of the Immunisation Register Act, the Australian Immunisation Register Rule 2015 and consequential changes following Royal Assent of the Bill.
Human rights implications
This Rule does not engage any of the applicable rights or freedoms.
Conclusion
The Rule is compatible with human rights.
The Hon Sussan Ley MP, the Minister for Health