· Web viewFrom early 2014, the program will start inviting women 70-74 years of age to...

Section 2 – Department Outcomes – 1 Population Health

Section 2: Department Outcomes and Planned Performance

2.1 Outcome and Performance InformationGovernment Outcomes are the intended results, impacts or consequences of actions by the Government on the Australian community. Agencies deliver Programs, which are the Government actions taken to deliver the stated Outcomes. Agencies are required to identify the Programs which contribute to Government Outcomes over the Budget and forward years.Each Outcome is described below together with its related Programs, specifying the indicators and targets used to assess and monitor the performance of the Department of Health and Ageing in achieving Government Outcomes.

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Budget Statements – Department of Health and Ageing

Outcome 1

POPULATION HEALTH

A reduction in the incidence of preventable mortality and morbidity in Australia, including through regulation and national initiatives that support healthy lifestyles

and disease prevention

Outcome StrategyThe Australian Government, through Outcome 1, aims to reduce the incidence of preventable mortality and morbidity throughout Australia.1 To achieve this, the Department will implement a suite of population health initiatives spanning disease prevention, screening, disease control, palliative and end of life care, regulatory policy, immunisation and public health. Key initiatives in 2013-14 include continuing to address the report of the Preventative Health Taskforce2 through the world’s toughest regime on smoking, funding social marketing campaigns tackling tobacco and illicit drugs, and delivering the inaugural Australian Health Survey. Outcome 1 is the responsibility of Population Health Division, Mental Health and Drug Treatment Division, Regulatory Policy and Governance Division, the Office of Health Protection, the Therapeutic Goods Administration, the National Industrial Chemicals Notification and Assessment Scheme, and the Office of the Gene Technology Regulator.

Programs Contributing to Outcome 1Program 1.1: Prevention, early detection and service improvement

Program 1.2: Communicable disease control

Program 1.3: Drug strategy

Program 1.4: Regulatory policy

Program 1.5: Immunisation

Program 1.6: Public health

1 Mortality denotes the number of deaths in a given population. Morbidity denotes a condition causing poor health, such as injury or illness.

2 National Preventative Health Taskforce, Taking Preventative Action - A Response to Australia: The Healthiest Country by 2020, 2010.

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Outcome 1 Budgeted Expenses and ResourcesTable 1.1 provides an overview of the total expenses for Outcome 1 by program.Table 1.1: Budgeted Expenses and Resources for Outcome 1

2012-13 Estimated

actual$'000

2013-14 Estimated expenses

$'000Program 1.1: Prevention, early detection and service

improvement1

Administered expensesOrdinary annual services (Appropriation Bill No. 1) 92,377 117,022

Departmental expensesDepartmental appropriation2 15,109 14,395Expenses not requiring appropriation in the budget year3 461 622

Total for Program 1.1 107,947 132,039

Program 1.2: Communicable disease controlAdministered expenses

Ordinary annual services (Appropriation Bill No. 1) 10,653 19,826



Program 1.3: Drug strategy1


Departmental expensesDepartmental appropriation2 27,461 26,303Expenses not requiring appropriation in the budget year3 833 1,126


Program 1.4: Regulatory policyAdministered expenses

Ordinary annual services (Appropriation Bill No. 1) 5,177 2,517

Departmental expensesDepartmental appropriation2 16,887 24,444

to special accounts (11,854) (14,486)Expenses not requiring appropriation in the budget year3 153 207

Special accountsOGTR Special Account4 8,001 8,142NICNAS Special Account5 14,532 15,018TGA Special Account6 131,310 148,428Expense adjustment7 (7,448) (14,356)


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Table 1.1: Budgeted Expenses and Resources for Outcome 1(Cont.)2012-13

Estimated actual$'000

2013-14 Estimated expenses

$'000

Program 1.5: Immunisation1


to Australian Childhood Immunisation Register Special Account (2,847) (5,747)

Special appropriationsNational Health Act 1953 - essential vaccines 80,278 118,240

Special accountsAustralian Childhood Immunisation Register Special Account 6,457 9,388



Program 1.6: Public health1

Administered expensesOrdinary annual services (Appropriation Bill No. 1) 16,009 18,312Other services (Appropriation Bill No. 2) 15,226 11,058



Outcome 1 totals by appropriation typeAdministered expenses

Ordinary annual services (Appropriation Bill No. 1) 358,179 409,559to special accounts (2,847) (5,747)

Other services (Appropriation Bill No. 2) 15,226 11,058Special appropriations 80,278 118,240Special accounts 6,457 9,388

Departmental expensesDepartmental appropriation2 77,514 81,491

to special accounts (11,854) (14,486)Expenses not requiring appropriation in the budget year3 1,986 2,682Special accounts 146,395 157,232

Total expenses for Outcome 1 671,334 769,417

2012-13 2013-14Average staffing level (number) 1,227 1,250

1 This program includes National Partnerships paid to state and territory governments by the Treasury as part of the Federal Financial Relations (FFR) Framework. National partnerships are listed in this chapter under each program. For budget estimates relating to the National Partnership component of the program, please refer to Budget Paper 3 or Program 1.10 of the Treasury Portfolio Budget Statements.

2 Departmental appropriation combines "Ordinary annual services (Appropriation Bill No 1)" and "Revenue from independent sources (s31)".

3 "Expenses not requiring appropriation in the Budget year" is made up of depreciation expense, amortisation expense, makegood expense and audit fees.

4 Office of the Gene Technology Regulator Special Account.5 National Industrial Chemicals Notification and Assessment Scheme Special Account.6 Therapeutic Goods Administration Special Account.

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7 Special accounts are reported on a cash basis. This adjustment reflects the differences between expense and cash, and eliminates inter-entity transactions between the Core department and TGA.

Program 1.1: Prevention, early detection and service improvementProgram ObjectivesReduce the incidence of chronic disease and promote healthier lifestylesIn 2013-14, the Government will provide funding through the Chronic Disease Prevention and Service Improvement Fund for a range of chronic disease prevention projects, particularly within the primary and community care sectors. These projects aim to reduce the incidence of preventable mortality and morbidity, maximise the wellbeing and quality of life of individuals affected by chronic disease from initial diagnosis to end of life, reduce the pressure on the health, hospital and aged care systems, and support best practice in the prevention, detection, treatment and management of chronic disease.Improve palliative care in AustraliaThe Chronic Disease Prevention and Service Improvement Fund will also fund a range of national palliative care projects, primarily focusing on education, training and quality improvement. Support early detection and prevention of cancer3

The Australian Government will fund three existing Australian Prostate Cancer Research Centres over four years, including continued funding for the Centre at Epworth Hospital in Richmond, Victoria; continued funding for the Centre at the Princess Alexandra Hospital in Brisbane, Queensland; and new funding for the Centre at the Kinghorn Cancer Centre, New South Wales. This will enable the Centres to continue working collaboratively to coordinate research more effectively and develop improved diagnostic tests (including techniques to differentiate between aggressive and non-aggressive cancers), screening tools and treatments for prostate cancer. The Australian Government will expand the National Bowel Cancer Screening Program from 2013-14, offering free bowel cancer screening using a faecal occult blood test (FOBT) to people turning 60 years of age from 1 January 2013 commencing in July 2013, and to people turning 70 years of age from 1 January 2015 commencing in July 2015. This will build on the existing program which currently invites people turning 50, 55 and 65 years of age to participate. Biennial screening for Australians 50-74 years of age will be phased in from 2017.To reduce the rate of breast cancer mortality, the Commonwealth, state and territory governments jointly provide mammography screening through BreastScreen Australia. From 2013-14, the Australian Government will provide funding of $55.7 million dollars over four years to expand the target age range for BreastScreen Australia from women 50-69 to women 50-74 years of age. From early 2014, the program will

3 Cancer related initiatives in Outcome 10 also support this objective.45

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start inviting women 70-74 years of age to participate in BreastScreen Australia. This initiative builds on the existing program, which commenced in 1991, and currently invites women 50-69 years of age to participate in mammography screening. Women 40 years of age and older will continue to be eligible for this free service. BreastScreen Australia services are provided through a network of dedicated, accredited providers in around 600 locations nationwide. The Australian Government and the state and territory governments also co-fund the National Cervical Screening Program. The program aims to reduce morbidity and deaths from cervical cancer by offering free screening with Pap smears every two years for women between 18 and 69 years of age.Chronic disease management and supportIn 2013-14, the Australian Government will continue the Diabetes Care Project pilot, involving up to 10,000 patients from around 150 practices in Queensland, Victoria and South Australia. The project is piloting a new comprehensive, patient-centred model of care which allows for local flexibility and improved coordination of care and access to a range of multidisciplinary services. Program 1.1 is linked as follows: This Program includes National Partnership Payments for:

- National Bowel Cancer Screening Program; - Victorian Cytology Service; and- Breast Screening.Partnership payments are paid to state and territory governments by the Treasury as part of the Federal Financial Relations (FFR) Framework. For Budget estimates relating to the National Partnership component of the program, refer to Budget Paper 3 or Program 1.10 of the Treasury’s Portfolio Budget Statements.

The Department of Human Services (Services to the Community – Program 1.1) is funded to administer the National Bowel Cancer Screening Program Register and support cervical cancer screening.

Program 1.1: ExpensesTable 1.2: Program Expenses

2012-13Estimated

actual$'000

2013-14Budget

$'000

2014-15Forward

year 1$'000

2015-16Forward

year 2$'000

2016-17Forward

year 3$'000

Annual administered expensesOrdinary annual services 92,377 117,022 104,981 115,171 115,939

Program support 15,570 15,017 14,651 14,655 14,745Total Program 1.1 expenses 107,947 132,039 119,632 129,826 130,684

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Program 1.1: DeliverablesQualitative Deliverables for Program 1.1Reduce the incidence of chronic disease and promote healthier lifestyles; and improve palliative care in Australia

Qualitative Deliverable 2013-14 Reference Point or Target

Undertake grant funding and procurement processes as required to meet the objectives of the Chronic Disease Prevention and Service Improvement Fund

Negotiation and execution of appropriate funding contracts and funding agreements to be completed by June 2014, to enable funding to commence from 2014-15

Support early detection and prevention of cancer

Qualitative Deliverables 2013-14 Reference Point or Target

Implement the expansion of the National Bowel Cancer Screening Program to invite Australians turning 60 years of age

Invitations to commence 1 July 2013

Implement outcomes of the review of BreastScreen Australia’s accreditation system

Completed by June 2014

Implement the expansion of BreastScreen Australia to invite Australian women 70-74 years of age

Invitations to commence early 2014

Chronic disease management and support


Oversee implementation of the Diabetes Care Project pilot to test a more comprehensive, patient-centred approach to improve the care of patients with diabetes

Implementation of the Diabetes Care Project pilot in identified sites across three states – Queensland, South Australia and Victoria

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Program 1.1: Key Performance IndicatorsQualitative Key Performance Indicator for Program 1.1Reduce the incidence of chronic disease and promote healthier lifestyles; and improve palliative care in Australia

Qualitative Indicator 2013-14 Reference Point or Target

Effective implementation of the Chronic Disease Prevention and Service Improvement Fund activities

Regular progress reports on key milestones from contracted organisations indicate that activities are being implemented effectively in accordance with contractual arrangements

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Quantitative Key Performance Indicators for Program 1.1Support early detection and prevention of cancer

Quantitative Indicators

2012-13 Revised Budget

2013-14 Budget Target

2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Percentage of people invited to take part in the National Bowel Cancer Screening Program who participated4

41.0% 41.0% 41.0% 41.0% 41.0%

Percentage of women 50-69 years of age participating in the BreastScreen Australia Program5

55.2% 55.2% 55.2% 55.2% 55.2%

Percentage of women 70-74 years of age participating in the program6

N/A 41.0% 51.0% 53.0% 55.2%

Percentage of women in the target age group participating in the National Cervical Screening Program7

58.6% 58.6% 58.6% 58.6% 58.6%

Chronic disease management and support

Quantitative Indicator



2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Number of patients enrolled in the Diabetes Care Project8

10,000 10,000 N/A N/A N/A

4 Australian Institute of Health and Welfare and the Australian Government Department of Health and Ageing, 2012. National Bowel Cancer Screening Program: monitoring report Phase 2, July 2008-June 2011. Cancer series no. 65. Cat. No. CAN 61. Canberra, AIHW. These targets reflect the most recent data (2008-2011) on participation in the National Bowel Cancer Screening Program.

5 AIHW 2012. BreastScreen Australia Monitoring Report 2009-2010. Cancer series no. 72. Cat. no. CAN 68. Canberra: AIHW. These targets reflect the most recent data (2009-2010) on participation in BreastScreen Australia Program. Small changes in these figures are unlikely to be statistically significant. Participation data for the program cannot be projected into the future.

6 From 2013-14, the program will start actively inviting women 70-74 years of age to participate in BreastScreen Australia. Estimated participation rates are expected to reach 55.2% by 2016-17.

7 AIHW 2012. Cervical screening in Australia 2009-2010. Cancer series no. 67. Cat. no. CAN 63. Canberra: AIHW. These targets reflect the most recent data (2009-2010) on participation in the National Cervical Screening Program. Small changes in these figures are unlikely to be statistically significant. Participation data for the program cannot be projected into the future.

8 This pilot project is funded until 30 June 2014. 49

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Program 1.2: Communicable disease controlProgram ObjectiveReduce the incidence of blood borne viruses and sexually transmissible infectionsThe Australian Government has established the Communicable Disease Prevention and Service Improvement Grants Fund to support non-government organisations to deliver a variety of education and prevention activities. These activities are aimed at raising awareness of blood borne viruses (BBVs) and sexually transmissible infections (STIs), encouraging safe sexual and injecting practices, improving access to testing and treatment of BBVs and STIs, reducing discrimination and improving the wellbeing of those living with BBVs and STIs. Grants provided through the fund will take account of the aims and objectives contained in nationally agreed strategies relating to BBVs and STIs, and other relevant guidelines. The National Strategies for HIV, hepatitis B and C, STIs and Aboriginal and Torres Strait Islander BBVs and STIs were developed in partnership with state and territory governments and relevant community-based organisations. These strategies will continue to guide the Government in the development of policies and programs related to the prevention, testing, management and treatment of BBVs and STIs. As the current set of National Strategies expire at the end of the 2013 calendar year, the Department, in conjunction with stakeholders, will update the National Strategies to ensure that they continue to reflect current evidence and guide Australia’s response to BBVs and STIs.The Communicable Disease Prevention and Service Improvement Grants Fund will also support the Government’s efforts to ensure Australians continue to have access to a safe, high quality national blood supply. In 2013-14, the Department will support quality assurance programs for medical laboratories using in-vitro diagnostic devices, and the Australian Red Cross for the screening of fresh blood donations.


2012-13 Estimated

actual$'000

2013-14 Budget

$'000

2014-15 Forward

year 1$'000

2015-16 Forward

year 2$'000

2016-17 Forward

year 3$'000



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Program 1.2: DeliverablesQualitative Deliverables for Program 1.2Reduce the incidence of blood borne viruses and sexually transmissible infections


Undertake grant funding and procurement processes as required to meet the objectives of the Communicable Disease Prevention and Service Improvement Grant Fund

Negotiation of new funding contracts and funding agreements to be completed by June 2014, to enable funding to commence from 2014-15

Undertake priority actions contained in the National BBVs and STIs Strategies 2010-2013

Have completed or commenced the relevant national priority actions contained in the National BBVs and STIs Strategies 2010-2013 by the end of 2013

Program 1.2: Key Performance IndicatorsQualitative Key Performance Indicator for Program 1.2Reduce the incidence of blood borne viruses and sexually transmissible infections


Provide funding to non-government organisations under the Communicable Disease Prevention and Service Improvement Grants Fund to support programs which are effective in reducing the spread of communicable disease

Organisations funded in accordance with the priorities outlined in the National BBVs and STIs Strategies 2010-2013Regular progress reports on key milestones from contracted organisations indicate that activities are being implemented effectively in accordance with contractual arrangements

Quantitative Key Performance Indicators for Program 1.2Reduce the incidence of blood borne viruses and sexually transmissible infections




2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Percentage of laboratory tests which are positive for Chlamydia infection

<12% <12% <12% <12% <12%

Number of newly diagnosed cases of hepatitis C infection

<12,250 <12,250 <12,250 <12,250 <12,250

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Program 1.3: Drug StrategyProgram ObjectivesReduce the harmful effects of tobacco useUnder the Tobacco Plain Packaging Act 2011, all tobacco products manufactured or packaged in Australia for domestic consumption and all tobacco products sold in Australia are to be in plain packaging. This initiative aims to: reduce the appeal of tobacco products to consumers, particularly young people; reduce the ability of tobacco products to mislead consumers about the harms of smoking; and increase the visibility and effectiveness of mandated health warnings. In 2013-14, the Department will continue compliance activities to ensure comprehensive and effective implementation of the legislation. Reduce harm to individuals and communities from excessive alcohol consumption and use of illicit drugsUnder the guidance of the National Drug Strategy 2010-2015, the Department will continue to work with jurisdictions and communities to deliver services and education initiatives promoting responsible alcohol consumption and reducing the use of illicit drugs. These include messages targeted at high risk groups such as young people and Aboriginal and Torres Strait Islander peoples.Under the National Drugs Campaign, activities will be funded to educate and reinforce young people’s knowledge of the harms and risks of illicit drug use.The Australian Government will promote evidence-based messages about the harms of drinking alcohol during pregnancy. These messages will complement other activities to reduce the prevalence and impact of Foetal Alcohol Spectrum Disorders in Australia. The Government has also committed to evaluate the voluntary alcohol industry labelling initiative warning of the harms of alcohol during pregnancy. The evaluation will be completed in 2013-14. Through the Substance Misuse Service Delivery Grants Fund, the Government will continue to fund activities to promote and support drug and alcohol treatment services across Australia building the capacity of services to effectively identify and treat coinciding mental illness and substance misuse. The expanded rollout of low aromatic fuel to Northern Australia will also continue. The Australian Government will commission a review of the drug and alcohol prevention and treatment services sector. The review will aim to clarify the range of services currently funded; develop common understanding amongst governments and the sector of current and future service needs; and clarify the type and timing of drug and alcohol funding activities undertaken by governments. The review will be concluded in 2014 and its findings will inform the next funding round under the Substance Misuse Service Delivery Grants Fund scheduled to commence in late 2014.

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Through the Substance Misuse Prevention and Service Improvement Grants Fund, the Government will continue to invest in illicit drug and alcohol research. The non-government sector will also be supported to ensure a strong community voice on illicit drug and alcohol issues. Funding will also be provided for prevention and early intervention activities. Program 1.3 is linked as follows: This Program includes National Partnership Payments for:

- National coronial information system (agreement still being finalised at time of publication).

Partnership payments are paid to state and territory governments by the Treasury as part of the Federal Financial Relations (FFR) Framework. For Budget estimates relating to the National Partnership component of the program, refer to Budget Paper 3 or Program 1.10 of the Treasury’s Portfolio Budget Statements.

The Department of Families, Housing, Community Services and Indigenous Affairs (Indigenous Capability and Development - Program 7.4); and the Attorney-General’s Department (Indigenous Law and Justice - Program 1.5) for the Petrol Sniffing Strategy.

The Treasury (Australian Competition and Consumer Commission – Program 1.1) for graphic health warning measures.


2012-13 Estimated

actual$'000

2013-14 Budget

$'000

2014-15 Forward

year 1$'000

2015-16 Forward

year 2$'000

2016-17 Forward

year 3$'000



Program 1.3: DeliverablesQualitative Deliverables for Program 1.3Reduce the harmful effects of tobacco use


Implement social marketing campaigns to raise awareness of the dangers of smoking and encourage and support attempts to quit

Deliver the National Tobacco Campaign - More Targeted Approach within agreed timeframes

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Reduce harm to individuals and communities from excessive alcohol consumption and use of illicit drugs


Fund and support drug and alcohol treatment services to strengthen the capacity of service providers across Australia

Regular progress reports on key milestones from contracted organisations indicate that activities are being implemented effectively in accordance with contractual arrangements

Undertake grant funding and procurement processes as required to meet the objectives of the Substance Misuse Prevention and Service Improvement Grants Fund

Negotiation and execution of appropriate funding contracts and funding agreements to be completed by June 2014, to enable funding to commence from 2014-15

Provide up-to-date information to young people on the risks and harms of illicit drug use

Dissemination of materials and delivery of the National Drugs Campaign and providing information through the National Cannabis Prevention and Information Centre on the risks and harms associated with cannabis use

Program 1.3: Key Performance IndicatorsQualitative Key Performance Indicator for Program 1.3Reduce harm to individuals and communities from excessive alcohol consumption and use of illicit drugs


Availability of prevention and early intervention substance misuse resources for teachers, parents and students

Enhanced access to materials on the National Drugs Campaign website9

Quantitative Key Performance Indicator for Program 1.3Reduce the harmful effects of tobacco use




2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Percentage of population 18 years of age and over who are daily smokers10

16.5% 15.2% 13.9% 12.6% 11.3%

9 National Drugs Campaign website is available at: < www.drugs.health.gov.au>10 2012-13 figure is based on the Australian Health Survey 2011-13 (released October 2012), age-

standardised rate. This is the most recent national data source available. Targets for 2013-14 onwards are based on a straight line projection to reach COAG 10% adult daily smoking prevalence by 2018.

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Reduce harm to individuals and communities from excessive alcohol consumption and use of illicit drugs




2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Percentage of population 14 years of age and older recently (in the last 12 months) using an illicit drug11

<13.4% <13.4% <13.4% <13.4% <13.4%

Program 1.4: Regulatory PolicyProgram ObjectivesProvide direction and national leadership in food and gene technology regulatory policy issues, as well as maintain and improve the therapeutic goods and industrial chemicals regulatory frameworks.


2012-13 Estimated

actual$'000

2013-14 Budget

$'000

2014-15 Forward

year 1$'000

2015-16 Forward

year 2$'000

2016-17 Forward

year 3$'000

Annual administered expensesOrdinary annual services 5,177 2,517 879 854 869

Program support 5,186 10,165 4,247 4,287 4,392

Departmental special accountsOGTR Special Account1 8,001 8,142 8,082 8,157 10,229NICNAS Special Account2 14,532 15,018 13,313 13,629 13,579TGA Special Account3 131,310 148,428 151,544 146,470 147,696Expense adjustment4 (7,448) (14,356) (13,578) (4,498) (6,150)

Total Program 1.4 expenses 156,758 169,914 164,487 168,899 170,615

1 Office of the Gene Technology Regulator Special Account.2 National Industrial Chemicals Notification and Assessment Scheme Special Account.3 Therapeutic Goods Administration Special Account.4 Special accounts are reported on a cash basis. This adjustment reflects the differences between

expense and cash and the elimination of interagency transactions.

11 Data on this target is currently taken from the National Drug Strategy Household Survey, which is published every three years.

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Food regulation policy Develop food standards and food regulatory policyThe Australian Government will continue to provide a strong, evidence-based food regulatory system to ensure that food sold in Australia is safe. Australia’s food regulatory system also supports the Government’s preventative health agenda by contributing to the reduction in the risk of chronic, diet-related disease. The Department collaborates with the Department of Agriculture, Fisheries and Forestry, states and territories and New Zealand to develop robust policy to assist Food Standards Australia New Zealand12 to develop and implement the food standards necessary for the regulatory system. Food labelling plays an integral role in informing healthy food purchasing decisions by consumers. In 2013-14, the Australian Government, in partnership with the states and territories and New Zealand, will continue to implement the outcomes of the independent report: Labelling Logic: Review of Food Labelling Law and Policy. Implementation over the next four years will endeavour to balance improving the information on food labelling to meet consumers’ needs, with maintaining marketing flexibility and minimising the regulatory burden on industry and barriers to trade. In 2013-14 the development of an agreed interpretive front-of-pack labelling system for foods will be considered by the Legislative and Governance Forum on Food Regulation.DeliverablesQualitative Deliverables for food regulation policyDevelop food standards and food regulatory policy


Develop an interpretive front-of-pack labelling system for foods

New labelling system developed by June 2014

Develop advice and policy for the Australian Government on food regulatory issues

Relevant, evidence-based advice produced in a timely manner

Key Performance IndicatorQualitative Key Performance Indicator for food regulation policyDevelop food standards and food regulatory policy


Promote a nationally consistent approach to food policy and regulation

Consistent regulatory approach across Australia through nationally agreed policy and standards

12 For further information on the work of Food Standards Australia New Zealand, refer to the FSANZ chapter in these Portfolio Budget Statements.

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Therapeutic goodsEnsure that therapeutic goods are safe, effective and of high qualityThe Australian Government, through the Therapeutic Goods Administration (TGA), regulates therapeutic goods under a national framework, set out in the Therapeutic Goods Act 1989, to safeguard and enhance the health of the Australian community. The TGA does this by applying scientific and clinical expertise to assessments of the evidence of risks compared to benefits of use of therapeutic goods. The TGA applies this risk-based regulatory process to therapeutic goods before they are marketed and monitors products once they are on the market. The TGA assesses the suitability of medicines and medical devices for export from Australia. In addition, the TGA regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality. The TGA has a team of inspectors who inspect manufacturing facilities around the world to ensure that therapeutic goods supplied in Australia are of high quality.Implement the TGA Reform Blueprint In 2013-14, the TGA will continue to implement the comprehensive reform agenda as per the detailed plan Delivering Reforms – Implementation Plan for TGA Reforms published in July 2012. These reforms will: improve the way the TGA communicates with the public about benefits and risks of therapeutic goods; clarify the TGA’s processes used to assess different types of therapeutic goods, especially complementary medicines; increase the level of evaluation of higher risk medical devices; and strengthen the response to unsubstantiated advertising and other breaches of the requirements for advertising of therapeutic goods. The reforms will enhance public trust in the safety and quality of therapeutic goods by addressing concerns raised by consumers and improve post-market surveillance capacity.In addition, the Department is supporting industry to strengthen its self-regulatory framework for the promotion of therapeutic goods.Establish the Australia New Zealand Therapeutic Products AgencyIn 2011, the Australian and New Zealand Governments agreed to proceed with a joint scheme for the regulation of therapeutic goods in both countries. A three stage approach was developed for implementation over a five year period to create a single regulatory framework and joint regulatory agency to provide health benefits for consumers, reduced regulatory costs for industry and greater efficiency for governments. In 2013-14, work will commence on developing the policy arrangements for the joint agency and will continue on the harmonisation of processes and development of a framework for a joint therapeutic products regulatory scheme. This will provide efficiencies for industry in both

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countries and will ensure that consumers have access to safe, quality medicines brought to market through a single approval process.DeliverablesQualitative Deliverables for therapeutic goodsImplement the TGA Reform Blueprint


Implement reforms that enhance TGA’s current regulatory processes

Reforms implemented in accordance with the published plan

The Department of Health and Ageing will support industry to implement reforms that strengthen self-regulation of the promotion of therapeutic goods

Shared information and complaints systems established by June 2014

Establish the Australia New Zealand Therapeutic Products Agency


Further progress a program of work sharing and joint operations

Commence public consultation on draft Health Rules by February 2014

Quantitative Deliverable for therapeutic goodsImplement the TGA Reform Blueprint

Quantitative Deliverable2012-13 Revised Budget

2013-14 BudgetTarget

2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Number of Blueprint recommendations implemented

21 14 3 6 N/A

Key Performance IndicatorsQuantitative Key Performance Indicators for therapeutic goodsEnsure that therapeutic goods are safe, effective and of high quality




2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Percentage of evaluations and appeals regarding the entry of therapeutic goods onto the Australian Register of Therapeutic Goods made within legislated timeframes13

100% 100% 100% 100% 100%

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2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Percentage of alleged breaches received that are assessed within 10 working days and an appropriate response initiated

100% 100% 100% 100% 100%

Percentage of licensing and surveillance inspections completed within target timeframes:14

Domestic 100% 100% 100% 100% 100% Overseas 90% 90% 90% 90% 90%

Percentage of prescription medicine evaluations completed within target timeframes:15

Category 1 100% 100% 100% 100% 100% Category 3 100% 100% 100% 100% 100%

Industrial chemicalsAid in the protection of the Australian people and the environment by assessing the risks of industrial chemicals and providing information to promote their safe useAs part of the national regulatory framework for industrial chemicals, the Australian Government, through the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), registers introducers of industrial chemicals, assesses industrial chemicals for their risks to human health and the environment and, where relevant, makes recommendations regarding risk mitigation. In 2013-14, NICNAS will continue to utilise its Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework to assess the risks to human health and the environment of chemicals already in use, which 13 The Australian Register of Therapeutic Goods is available at: < www.tga.gov.au/docs/html/artg.htm

> Legislated timeframes refers to various timeframes specified in Therapeutic Goods Act 1989 and subordinate regulations.

14 The TGA is using the word ‘inspection’ rather than 'audit’ for this regulatory activity as this better reflects the language in the Therapeutic Goods Act 1989'.

15 The number of applications received by the TGA is dependent on each company’s consideration of the market for medicines in Australia and their necessity to vary aspects of registration, and cannot be controlled by the TGA. Category 1 refers to an application to register a new prescription medicine or change to a medicine not meeting the requirements for Category 2 or Category 3 applications. Category 3 refers to an application involving changes to the quality data of medicines already registered and not involving clinical, non-clinical or bioequivalence data. Category 2 refers to an application to register a prescription medicine where two independent evaluation reports from acceptable countries are available. TGA no longer reports on Category 2 evaluations as they are extremely rare.

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have been identified on the basis of their high volume of use, their specific risk management requirements in other comparable countries, and their detection in human cord blood. To enable evidence-based decisions to be made regarding risk management measures that may be required for these chemicals, NICNAS will continue to work closely with relevant government agencies, industry and the community.During 2013-14, NICNAS will complete a project to assess the health and environmental impacts of industrial chemicals used in hydraulic fracturing for coal seam gas extraction, and provide advice on the appropriate management of any risks identified in relation to the use of such chemicals. On the advice of the Independent Expert Scientific Committee on Coal Seam Gas and Large Coal Mining Development, this project has been funded through the Department of Sustainability, Environment, Water, Population and Communities in response to community concern about the risks of such chemicals.In 2013-14, NICNAS will participate in activities conducted by the Organisation for Economic Co-operation and Development (OECD) on assessment methodologies for industrial chemicals including nanomaterials, harmonisation of requirements for polymers of low concern, and streamlined international data requirements for the assessment of existing chemicals. Continuing participation in bi-lateral and multi-lateral activities will ensure that NICNAS adopts best practice in its chemical assessments. In 2013-14, NICNAS will continue to refine its compliance strategy to ensure optimal use of resources in undertaking enforcement and compliance activities focused on maintaining current levels of registered companies and high risk introducers of new chemicals.Program 1.4 is linked as follows: The Attorney General’s Department (Australian Customs and Border

Protection Service – Trade facilitation - Program 1.2) for reviewing importation of industrial chemicals.

The Department of Sustainability, Environment, Water, Population and Communities (Management of Hazardous Wastes, Substances and Pollutants - Program 2.1), The Treasury (Australian Competition and Consumer Commission – Program 1.1) and Department of Education, Employment and Workplace Relations (Safe Work Australia – Reform of and improvements to Australian work health and safety and workers’ compensation arrangements - Program 1) for managing risks arising from industrial chemicals.

DeliverablesQualitative Deliverables for industrial chemicalsAid in the protection of the Australian people and the environment by assessing the risks of industrial chemicals and providing information to promote their safe use

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Scientifically robust assessments of new and existing industrial chemicals

Peer review and stakeholder feedback supports assessment outcomes

High quality assessment outcomes are produced through effective use of the IMAP framework

Stakeholder engagement and communication strategies effectively communicate assessment outcomes

Contribution to the international harmonisation of regulatory approaches and methodologies for assessing industrial chemicals by reviewing Australian processes

Review international regulatory approaches and methodologies from three key sub-committees of the OECD Chemicals Committee for their application to NICNAS assessments of industrial chemicals

All introducers of industrial chemicals are aware of their legal obligations

Register identified introducers and provide regular information updates

Key Performance IndicatorsQualitative Key Performance Indicators for industrial chemicalsAid in the protection of the Australian people and the environment by assessing the risks of industrial chemicals and providing information to promote their safe use


Effective use of international information

For new chemicals: incorporate available international hazard assessment information into assessmentsFor existing chemicals: provide guidance and training on the use of international information to assessors implementing the IMAP framework

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Quantitative Key Performance Indicators for industrial chemicalsAid in the protection of the Australian people and the environment by assessing the risks of industrial chemicals and providing information to promote their safe use

Quantitative Indicators16



2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Percentage of new chemical assessments completed within legislated timeframes

96% 96% 96% 96% 96%

Cumulative percentage of Stage One chemicals assessed through effective application of IMAP framework

20% 50% 90% 95% 99%17

Percentage of those introducing over $500,000 of industrial chemicals assessed for compliance with new chemicals obligations

30% 35% 40% 45% 45%

Gene technology regulationProtect the health and safety of people and the environment by regulating dealings with genetically modified organismsThe Australian Government, through the Office of the Gene Technology Regulator (OGTR), will administer the national scheme for the regulation of gene technology to protect the health and safety of people and the environment by regulating certain dealings with genetically modified organisms (GMOs). The OGTR will keep pace with advances in scientific knowledge and international developments in regulatory practice.In 2013-14, the OGTR will implement recommendations agreed to by all Australian Governments’ response to the 2011 Review of the Gene Technology Act 2000. OGTR will maintain high levels of openness and transparency and ensure that assessments are based on current scientific evidence and represent international best practice. OGTR will continue to engage in international harmonisation activities and consult with experts and key stakeholders on the risk assessment of licence applications. OGTR will also consult with the general public to promote understanding of regulation of GMOs and input to risk assessment and management plans in relation to licence applications for release of GMOs into the environment.

16 Key Performance Indicators have been amended to better reflect NICNAS’s legislative requirements.

17 Subject to continued funding following review of Stage One.63

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In accordance with the requirements of the gene technology legislation, OGTR will monitor the conduct of licensed dealings18 with GMOs and maintain a comprehensive record of approved GMO dealings on its website19 for the general public. To ensure best practice processes are used, OGTR will implement its revised Risk Analysis Framework in the assessment of licence applications for dealings with GMOs and conduct rolling reviews of the Regulations, guidelines and processes. OGTR will continue bilateral arrangements with other Australian Government regulators to enhance coordinated decision-making and avoid duplication in regulation of GMOs and genetically modified products. DeliverablesQualitative Deliverables for gene technology regulationProtect the health and safety of people and the environment by regulating dealings with GMOs


Implement changes to OGTR operations agreed by the all Australian Governments’ response to the Review of the Gene Technology Act 2000

Implementation completed within any agreed timeframes set in the response

Provide open, transparent and effective regulation of GMOs

Stakeholders, including the public, consulted on all assessments for proposed release of GMOs into the environmentRecord of GMOs and maps of all field trial sites maintained and made publicly available on OGTR website Risk assessments and risk management plans prepared for all applications for licenced dealings

Quantitative Deliverable for gene technology regulationProtect the health and safety of people and the environment by regulating dealings with GMOs



2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Percentage of field trial sites and higher level containment facilities inspected

20% ≥20% ≥20% ≥20% ≥20%

18 The gene technology legislation requires that certain dealings or activities (eg experiments and field trials) with GMOs must be licensed before they can be conducted. The purpose of licensing is to protect human health and/or the environment by identifying and managing risks posed by GMOs. OGTR prepares risk assessment and risk management plans for all licence applications, which form the basis of the Regulator’s decisions on whether or not to issue licences and on conditions of each licence.

19 Available at: <www.ogtr.gov.au>64


Key Performance IndicatorsQualitative Key Performance Indicators for Gene technology regulationProtect the health and safety of people and the environment by regulating dealings with GMOs

Qualitative Indicators 2013-14 Reference Point or Target

Protect people and the environment through identification and management of risks from GMOs

High level of compliance with the gene technology legislation and no adverse effect on human health or environment from GMOs

Facilitate cooperation and prevent duplication in the implementation of GMO regulation

High degree of cooperation with relevant regulatory agencies

Quantitative Key Performance Indicator for gene technology regulationProtect the health and safety of people and the environment by regulating dealings with GMOs




2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Percentage of licence decisions made within statutory timeframes

100% 100% 100% 100% 100%

Program 1.5: ImmunisationProgram ObjectivesStrengthen immunisation coverage The Department, through the National Immunisation Program (NIP), a collaboration between the Australian, and state and territory governments, will continue to support the provision of free vaccines to the Australian community to protect against vaccine preventable diseases which can cause hospitalisation, serious on-going health conditions and sometimes death.The Department will continue to work with states and territories, Medicare Locals and immunisation providers to ensure Australia maintains high immunisation coverage rates. Under the National Partnership on Essential Vaccines, the Department will assess state and territory performance against four-key benchmarks and make reward payments to reflect outcomes. Medicare Locals will focus on immunisation levels in their region and undertake activities to maintain or improve immunisation coverage rates.

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The Department will continue to monitor the outcomes of reforms to Australia’s childhood immunisation arrangements implemented in 2012-13. From 1 July 2013 the meningococcal C, pneumococcal and varicella (‘chicken pox’) vaccines will be included in the list of vaccines that are needed for a child to be considered ‘fully immunised’ to receive Family Tax Benefit Part A (FTBA) supplement. The change will increase, by three, the number of antigens included in the definition of ‘fully immunised’ and as such could lead to at least a temporary decrease in immunisation coverage rates. The extent of any change in coverage rates as a result of the definition change is not yet clear, due to the introduction of other measures that aim to increase coverage rates of children over time, such as the link between immunisation status and eligibility for FTBA supplement and the introduction on 1 July 2013 of a combined measles, mumps, rubella, varicella (MMRV) vaccine (noting varicella coverage is lower than other vaccines and it is one of the three antigens to be included in the new definition). In 2013-14, the Department will monitor the uptake (in ongoing and catch-up cohorts) of new vaccines added to the NIP, including the human papillomavirus (HPV) vaccine for adolescent males (building on the HPV vaccine program for adolescent girls) and the combined measles, mumps, rubella, and varicella vaccine for 18 month olds. The Department will continue to support uptake by developing and providing NIP communications materials for providers and consumers.The National Immunisation Strategy identifies a number of opportunities to enhance, strengthen and improve the NIP including: enhancing communication about the NIP; strengthening use of vaccine register data to aid evaluation of immunisation programs; and improving systems for assuring vaccine safety and responding to adverse events following immunisation. This work will be underpinned by improvements in cold chain management of vaccines. Improve the efficiency of the National Immunisation ProgramIn 2013-14, the Department will continue to implement a centralised procurement process for the supply of current and future vaccines under the NIP, and undertake the contract management for those vaccines for which procurement processes have been completed. Program 1.5 is linked as follows: This Program included National Partnership payments for:

- Essential Vaccines. Partnership payments are paid to state and territory governments by the Treasury as part of the Federal Financial Relations (FFR) Framework. For Budget estimates relating to the National Partnership component of the program, refer to Budget Paper 3 or Program 1.10 of The Treasury’s Portfolio Budget Statements.

The Department of Families, Housing, Community Services and Indigenous Affairs to administer the FTBA supplement to eligible parents; eligibility is linked to satisfying the requirements for age-related immunisation.

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The Department of Human Services (Services to the Community – Program 1.1) to administer the Australian Childhood Immunisation Register.

The Department of Education, Employment and Workplace Relations (Child Care Assistance - Program 1.2) to administer child care benefits to eligible parents; eligibility for which is linked to satisfying the requirements for age-related immunisation.

Program 1.5: ExpensesTable1.6: Program Expenses

2012-13 Estimated

actual$'000

2013-14 Budget

$'000

2014-15 Forward

year 1$'000

2015-16 Forward

year 2$'000

2016-17 Forward

year 3$'000


to Australian Childhood Immunisation Register Special Account (2,847) (5,747) (5,802) (5,858) (5,913)

Special appropriations

National Health Act 1953 - essential vaccines 80,278 118,240 119,445 123,330 124,167

Special accounts

Australian Childhood ImmunisationRegister Special Account 6,457 9,388 9,475 9,563 9,650


Program 1.5: DeliverablesQualitative Deliverables for Program 1.5Strengthen immunisation coverage


The priority actions contained in the National Immunisation Strategy are being undertaken

Implement priority actions in accordance with timeframes set out in the National Immunisation Strategy

Develop and disseminate information for health professionals, providers and consumers on immunisation programs

Develop resources for immunisation providers to assist them in communicating with parents who are hesitant to immunise their childrenPublic release of additional immunisation data to increase transparency and assist targeted immunisation activities by program managers

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Quantitative Deliverable for Program 1.5Improve the efficiency of the National Immunisation Program



2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Number of completed tenders under the National Partnership Agreement on Essential Vaccines (Essential Vaccines Procurement Strategy)

2 2 2 2 2

Program 1.5: Key Performance IndicatorQualitative Key Performance Indicator for Program 1.5Strengthen immunisation coverage


States and territories meet requirements of the National Partnership Agreement on Essential Vaccines

The performance benchmarks are used to assess state and territory performance and consist of: maintaining or increasing vaccine

coverage for Indigenous Australians maintaining or increasing coverage

in agreed areas of low immunisation coverage

maintaining or decreasing wastage and leakage

maintaining or increasing vaccination coverage for four year olds

Quantitative Key Performance Indicators for Program 1.5Strengthen immunisation coverage




2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Maintain the immunisation coverage rates among children 12–15 months of age

91.8% 91.8% 91.8% 91.8% 91.8%

Maintain the immunisation coverage rates among children 24-27 months of age

92.7% 92.7% 92.7% 92.7% 92.7%

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2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Improve the immunisation coverage rates among children 60-63 months of age

88.5% 90.0% 90.0% 90.0% 90.0%

Program 1.6: Public HealthProgram ObjectivesIncrease the evidence base for the development of targeted health programsThe Australian Government is aware that a strong evidence-base is vital for the development of health programs and policy. Through the Health Social Surveys Fund, the Department will collect, analyse, interpret and disseminate health social survey data and information. The fund supports three major health social surveys: the Australian Health Survey (AHS) undertaken by the Australian Bureau of Statistics in close consultation with the Department; the Australian Longitudinal Study on Male Health (ALSMH); and the Australian Longitudinal Study on Women’s Health (ALSWH).Improve child and youth healthThe Australian Government is working with jurisdictions to review priorities for child health and develop a plan to focus future efforts in child health.In 2013-14, the Department will complete the development of new Clinical Practice Guidelines for Antenatal Care in consultation with the states and territories to provide up-to-date evidence-based guidance for health professionals to support pregnant women to give their babies the best start in life. Improve men’s and women’s healthIn 2013-14, the Department will continue to promote the aims and objectives of the National Male Health Policy and National Women’s Health Policy. This will include working with other government agencies to identify opportunities for addressing the social determinants of gendered health, such as employment participation and community engagement as well as projects on current and emerging issues such as chronic disease risk factors, breastfeeding and female genital mutilation.Promote healthy lifestyle choicesThe Department is leading the development of a national nutrition policy. The policy will provide an overarching framework to identify, prioritise, drive and monitor nutrition initiatives and is expected to be completed in 2014.

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The Department will continue to oversee and implement elements of the National Partnership Agreement on Preventive Health. For example, the Healthy Communities initiative will provide targeted roll-out of community-based healthy lifestyle programs that increase access to physical activity, healthy eating and healthy weight activities for disadvantaged adults predominantly not in the paid workforce. In recognition of the fact that over 63% of adults are overweight or obese, the Department will also continue to provide national population and clinical guidelines to guide policy and programs promoting healthy eating, physical activity and healthy weight.The Department will also work closely with the Australian National Preventive Health Agency (ANPHA)20 which has responsibility for developing national awards for excellence in workplace health programs to support the Healthy Workers initiative and the National Tobacco social marketing campaigns.Program 1.6 is linked as follows: This Program includes National Partnership payments for:

- Preventive health - Enabling infrastructure;- Preventive health - Healthy workers;- Preventive health - Healthy children; and- Preventive health - Social marketing.Partnership payments are paid to state and territory governments by the Treasury as part of the Federal Financial Relations (FFR) Framework. For Budget estimates relating to the National Partnership component of the program, refer to Budget Paper 3 or Program 1.10 of the Treasury’s Portfolio Budget Statements.

The Department of Families, Housing, Community Services and Indigenous Affairs (Family Tax Benefit - Program 1.2) to administer Preventative Health – Healthy Children.

The Treasury (Australian Bureau of Statistics – Program 1.1) for the new nutrition, physical activity and biomedical components of the Australian Health Survey.


2012-13 Estimated

actual$'000

2013-14 Budget

$'000

2014-15 Forward

year 1$'000

2015-16 Forward

year 2$'000

2016-17 Forward

year 3$'000

Annual administered expensesOrdinary annual services 16,009 18,312 8,563 7,974 8,117Other services 15,226 11,058 - - -


20 For further information on the work of Australian National Preventive Health Agency, refer to the ANPHA chapter in these Portfolio Budget Statements.

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Program 1.6: DeliverablesQualitative Deliverables for Program 1.6Increase the evidence base for the development of targeted health programs


Undertake the AHS More detailed results from the general population survey to be released in 2013-14, including physical activity data, biomedical measurements and nutrition data.High level results for the Aboriginal and Torres Strait Islander AHS are due to be released in September 2013, with more detailed results released from June 2014

Undertake the ALSMH and the ALSWH ALSMH: Initial reporting from Wave 1 will be completed by December 2013. Revision of instrumentation for Wave 2 will be completed by June 2014ALSWH: Final reporting on data from Survey 6 of the 1973-1978 cohort will be completed by December 2013

Improve child and youth health


Completion of the Clinical Practice Guidelines for Antenatal Care

Module Two of the Guidelines (covering the second and third trimesters of pregnancy) will be completed by early 2014

Quantitative Deliverable for Program 1.6Promote healthy lifestyle choices



2014-15 Forward

Year 1

2015-16 Forward

Year 2

2016-17 Forward

Year 3

Number of grants to local governments administered through the Healthy Communities Initiative21

92 92 N/A N/A N/A

21 Funding for this activity ends in 2013-14.71

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Program 1.6 Key Performance IndicatorsQualitative Key Performance Indicators for Program 1.6Increase the evidence base for the development of targeted health programs


Strengthened evidence base to inform targeted health policy and program activities

Results from the AHS, ALSWH and ALSMH increase the amount of information available to researchers and policy makers

Improve child and youth health


Delivery of health services for children in out-of-home care is consistent, evidence-based and appropriate

State and territory governments report on the successful implementation of the National Clinical Assessment Framework for Children in Out-of-Home care

Improve men’s and women’s health


Health services targeting the health of men, or women, are relevant to their needs and preferences

The scope and objectives of programs funded by the Australian Government targeting male health or women’s health are informed by the National Male Health and National Women’s Health policies (as appropriate)

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