Review of the management of adverse events associated with Panvax and Fluvax
4.1 The National Immunisation ProgramThe National Immunisation Program (NIP) is a collaborative program between the Australian and state and territory governments which aims to increase national immunisation rates for vaccines on the NIP schedule. The program, which is implemented as the Immunise Australia program, funds free vaccines for eligible Australians, administers the Australian Childhood Immunisation Register (ACIR) and communicates information about immunisation to the general public and health professionals.
The NIP is a broad ranging program which has grown considerably in cost and complexity since its establishment in 1997. The number of diseases the program aims to protect against has doubled and the program now includes adults as well as children. Annual expenditure on vaccines alone has risen from $13 million in 1996/97 to an estimated $322.6 million in 2010/11.
Vaccines are included in the NIP only after evaluation of their quality, safety and effectiveness and of the cost-effectiveness of the vaccine for its intended use in the Australian population.
4.2 Governance of the NIPAustralia has a complex series of governance arrangements for the NIP. The Program is a collaborative one, based on scientific evidence and technological developments, which requires the interaction of a large number of organisations and bodies, whose roles are outlined below. These arrangements have worked well in the past, due to a high level of cooperation based on good personal relationships, supported by formal arrangements for cross-membership of relevant committees.
Australian GovernmentThe Australian Government provides national leadership in the development, implementation and evaluation of immunisation policy. It also funds vaccine purchase in the NIP, provides funds to Medicare Australia for the ACIR and the General Practice Immunisation Incentives Scheme (GPII) and undertakes or funds a number of other services that support the NIP, including the provision of parental incentives.
The Australian Government Department of Health and Ageing (DoHA) has administrative responsibility for the Government’s immunisation policy and the NIP. This responsibility is carried out by the Immunisation Branch (IB) of the Office of Health Protection (OHP). The vaccine regulator, TGA, is an agency of the Department and works closely with the IB on issues affecting the NIP. The CMO provides advice to the Secretary of the Department and the Minister for Health and Ageing on immunisation policy and program issues.
State and territory governmentsState and territory governments, through their health authorities, are responsible for purchasing vaccines1, managing the distribution of vaccines to public and private immunisation providers, undertaking local education and communication activities, running school-based immunisation programs and contributing to ACIR notification payments. In addition to managing AEFI surveillance in their jurisdictions, public health officers and immunisation coordinators ensure that there is appropriate clinical management of AEFI cases and that local health professional, consumer and media concerns about vaccine safety are addressed.
The National Immunisation Committee (NIC)The NIC oversees the development, implementation and delivery of the NIP. The Committee is chaired by the Assistant Secretary of the IB and comprises all the Jurisdictional Immunisation Coordinators (JIC) and representatives of general practice as well as a consumer, the National Indigenous Immunisation and GP Immunisation Coordinators and the NCIRS. The NIC reports to the Australian Health Protection Committee (AHPC) via the Communicable Diseases Network Australia (CDNA).
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The Communicable Diseases Network Australia (CDNA)The CDNA coordinates communicable disease surveillance, prevention and control in Australia and provides strategic advice to governments and other agencies. The Committee comprises representatives of the Commonwealth, State and Territory Government and the New Zealand Government health departments and other experts in communicable diseases.
The Australian Health Protection Committee (AHPC)The AHPC is a principal committee of the Australian Health Ministers’ Advisory Committee and coordinates the national approach to preventing and responding to public health emergencies communicable disease threats and environmental threats to public health. The Committee is chaired at Deputy Secretary level by the DoHA and includes among its core members the CMO and the State and Territory Chief Health Officers (CHOs).
The Australian Health Ministers’ Advisory Committee (AHMAC)The AHMAC advises the Australian Health Ministers' Conference (AHMC) on strategic issues relating to the coordination of health services across the nation and, as applicable, with New Zealand and operates as a national forum for planning, information sharing and innovation.
It comprises the Head (plus one other senior officer) of each of the Australian Government, State and Territory and New Zealand Health Authorities and the Australian Government Department of Veterans' Affairs.
The Australian Health Ministers’ Council (AHMC)The AHMC comprises all Australian Government, State, Territory and New Zealand Ministers with direct responsibility for health matters and the Australian Government Minister for Veterans' Affairs.
The Australian Technical Advisory Group on Immunisation (ATAGI)The ATAGI is an independent expert body that provides technical advice to the Minister for Health and Ageing on the medical administration of vaccines available in Australia, including those on the NIP. It also provides advice to the Pharmaceutical Benefits Advisory Committee (PBAC) on the scientific evidence on the effectiveness and use of vaccines in Australian populations. In developing its advice, the ATAGI consults with other relevant committees on matters relating to the implementation of immunisation policies, procedures and vaccine safety. Members include a consumer representative and health professionals with expertise in immunology, vaccine research, paediatrics, infectious diseases, public health, epidemiology, general practice and nursing.
The National Centre for Immunisation Research and Surveillance (NCIRS)The NCIRS, a national research centre located at the Children’s Hospital at Westmead, Sydney, undertakes immunisation related research and provides technical advice to the DoHA to support delivery of the NIP. As part of its role with DoHA, the NCIRS provides technical support to ATAGI and its Working Parties; undertakes epidemiological analysis and reporting on vaccine preventable diseases, vaccine coverage and vaccine adverse events; undertakes program evaluations; and develops information and printed material to support education and training for immunisation providers.
In addition to the standing advisory committees, DoHA may convene ad hoc committees to provide advice in particular circumstances, for example, the Expert Advisory Panel on Vaccine Testing convened by TGA to advise on the laboratory aspects of the investigation into the Fluvax adverse events.
Other bodies with a role are the Pharmaceutical Benefits Advisory Committee (PBAC), which makes recommendations to the Minister for Health and Ageing on vaccines for inclusion in the NIP, and the National Health and Medical Research Council (NHMRC) which endorses the Australian Immunisation Handbook developed by ATAGI.
All of these bodies and organisations have an interest in the safety and effectiveness of vaccines and of the vaccination program, but currently the governance and reporting arrangements for vaccine safety issues are not clear.
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1The purchasing of vaccines is in transition to become an Australian Government responsibility by 2014.