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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

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Outcome Strategy

Outcome 1 aims to reduce the incidence of preventable mortality and morbidity in Australia. To achieve this, the Government is reforming the health system to place a greater emphasis on the importance of keeping people healthy and out of hospital, and implementing its response to the report of the Preventative Health Taskforce. The department worked to achieve this Outcome by managing initiatives under the programs outlined below.

This chapter reports on the major activities undertaken by the department during the year, reporting against each of the major activities and performance indicators published in the Outcome 1 chapter of the 2010-11 Health and Ageing Portfolio Budget Statements (PB Statements) and the 2010-11 Health and Ageing Portfolio Additional Estimates Statements (PAES). It also includes a table summarising the estimated and actual expenditure for this Outcome.

Outcome 1 was managed in 2010-11 by the Population Health Division, the Mental Health and Chronic Disease Division, the Office of Health Protection, the Regulatory Policy and Governance Division, the Acute Care Division, Business Group, the Therapeutic Goods Administration, the National Industrial Chemicals Notification and Assessment Scheme, and the Office of the Gene Technology Regulator. The department’s state and territory offices also contributed to the achievement of this Outcome.

In addition to the measures reported under this Outcome, the department funds a number of preventative health and cancer activities through Outcome 10.

Program Name	Program Objectives in 2010-11
Program 1.1: Chronic Disease – Early Detection and Prevention	Work with state and territory governments to reduce chronic disease by supporting early detection and prevention of cancer through screening initiatives (cancer related initiatives in Outcome 10 also support this objective); and promoting healthy lifestyle choices to reduce the risk of diabetes.
Program 1.2: Communicable Disease Control	Reduce the incidence of blood borne viruses and sexually transmissible infections, including human immunodeficiency virus (HIV), chlamydia, syphilis, gonorrhoea and viral hepatitis.
Program 1.3: Drug Strategy	Reduce binge drinking and risky alcohol consumption, reduce the harmful effects of tobacco use; and reduce the demand, supply and harm caused by illicit drug use and other substance misuse.
Program 1.4: Regulatory Policy	Provide direction and national leadership in food regulation and policy issues, maintain and enhance the therapeutic goods regulatory framework, provide for the safe and sustainable use of industrial chemicals, and protect the health and safety of people and the environment by regulating dealings with genetically modified organisms.
Program 1.5: Immunisation	Work with state and territory governments to reduce the incidence of vaccine preventable disease and ensure optimal immunisation coverage rates by improving the efficiency and effectiveness of the Immunise Australia program.
Program 1.6: Public Health	Reduce pressure on the health system by building a public health workforce capacity; improve child, youth, women’s and men’s health; and promote healthy lifestyle choices to improve public health outcomes.

Major Achievements

Upgraded 29 BreastScreen Australia services to digital mammography from analogue technology.
Launched the National Partnership Agreement on Preventive Health National Tobacco Campaign and ‘Swap It’ Campaign.
Developed world first legislation to mandate the plain packaging of tobacco products.
Released the National Drug Strategy 2010-2015.
Conducted public consultations on plain packaging of tobacco products.
Commenced the 2011-13 Australian Health Survey; the nation’s largest ever health survey.
Released the National Women’s Health Policy 2010.
Established the Australian National Preventive Health Agency.
Under the National Partnership Agreement on Preventive Health, implementation plans for Healthy Children and Healthy Workers Initiatives were endorsed for all jurisdictions, supporting health promotion and programs that focus on reducing the prevalence of lifestyle related chronic disease in adults and children.
Launched Joint Statement of Commitment: Promoting Good Health at Work, under the Healthy Workers Initiative.
An Intergovernmental Agreement was signed between the Australian Government and state and territory Governments to establish the Food Standards Code Interpretation Service.
Provided advice, support and secretariat services to an independent panel on food labeling law and policy, led by Dr Neal Blewett AC. The panel’s work culminated in the report Labelling Logic: Review of Food Labelling Law and Policy (2011) on 28 January 2011.
The Therapeutic Goods Administration has embarked on a three year organisational and structural reform process. In 2010-11, this involved internally restructuring to align with the functional streams covering pre-and post-market regulatory services and corporate services.
National Industrial Chemicals Notification and Assessment Scheme introduced new administrative regulatory arrangements for nanoforms of new industrial chemicals from 1 January 2011.
National Industrial Chemicals Notification and Assessment Scheme developed a risk-based framework for prioritising and assessing the human health and environmental impact of the approximately 38,000 unassessed chemicals on the Australian national inventory.

Challenges

Ensuring the availability of effective programs and resources that reduce the impact of overweight and obesity in the Australian population.
Lower than anticipated number of participants in lifestyle modification programs for people at high risk of type 2 diabetes.
Increasing demand by women for breast cancer screening as more women enter the target age group of 50 to 69 years of age. The number of women in the target age range will increase from 2.47 million in 2010 to 2.79 million and 2.96 million in 2015 and 2020 respectively – ABS Cat 3222.0 Series B.
Ensuring that divergent stakeholder views were addressed by the National Industrial Chemicals Notification and Assessment Scheme in the development of the risk-based framework for prioritising and assessing the Australian national inventory of chemical substances.

Trends

The proportion of people in Australia aged 14 years or older who smoked tobacco daily has declined from 16.6% in 2007 to 15.1% in 2010.
The number of adults in the population who were overweight or obese increased from 56.3% in 1995 to 61.3% in 2007-08, according to National Health Survey data. Over the same period, the number of children aged 5-17 who were overweight or obese also increased from 20.9% to 24.7%.
In 2010, about one in five people drank alcohol at levels that put them at risk of harm over their lifetime (more than two standard drinks per day on average), and this proportion remained relatively unchanged since 2007 (20.3% in 2007 and 20.1% in 2010).
The proportion of people in Australia aged 14 years or older who had used an illicit drug in the previous 12 months rose from 13.4% in 2007 to 14.7% in 2010.
Since the inception of BreastScreen Australia and the National Cervical Screening Program in 1991, there has been a reduction of 29%¹ and 51%² in the rates of breast cancer and cervical cancer mortality respectively.

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Program 1.1: Chronic Disease – Early Detection and Prevention

Program 1.1 aims to work with state and territory governments to reduce chronic disease by supporting early detection and prevention of cancer through screening initiatives (cancer related initiatives in Outcome 10 also support this objective); and promoting healthy lifestyle choices to reduce the risk of diabetes.

Early Cancer Detection through Population Based Screening Programs

The National Bowel Cancer Screening Program aims to reduce the incidence of and mortality from bowel cancer through early detection of abnormalities and where bowel cancer has developed. Cancers can be detected at an early stage in order to maximise the effectiveness of treatment. Bowel cancer comprises 13.1% of all invasive cancers diagnosed in 2007, and is the second most commonly diagnosed cancer in Australia. Randomised controlled trials have demonstrated that screening using FOBT can reduce overall mortality from bowel cancer by 15 – 33% and reduce incidence by 20%.

The National Bowel Cancer Screening Program involves screening people who have no noticeable symptom with an FOBT, which detects small amounts of blood in the bowel motion. Eligible people are sent an invitation package, including an FOBT kit to be completed in their own home and mailed to a pathology laboratory for analysis. Participants with a positive FOBT result³ are advised to discuss the result with their doctor, who will generally refer them for further investigation; usually a colonoscopy.

During 2010-11, the department continued to invite people in the eligible age groups (50, 55 and 65 years) to participate in screening under phase 2 of the National Bowel Cancer Screening Program. A total of 852,000 eligible Australians were sent Faecal Occult Blood Test (FOBT) kits during this period with a participation rate of 45%. Of these, 29,844 participants received a positive result and were provided with appropriate follow-up service. The department also continued to issue replacement kits to people affected by the remediation process (May to November 2009). The participation rate in 2010-11 was higher than expected due to a range of factors including a raised general public awareness of the program.

Qualitative Deliverable:	A quality colonoscopy workforce to support the National Bowel Cancer Screening Program.
2010-11 Reference Point:	Work with key stakeholders to make available additional training for practitioners conducting colonoscopies.
Result: Deliverable met.
The department funded Queensland Health to develop a national training program for colonoscopists in consultation with the profession. The Gastroenterological Society of Australia was also funded to develop certification and re-certification processes for colonoscopy. A key outcome from the project will be a national ongoing self sustaining model for training, certification and re-certification of proceduralists performing colonoscopy.
Quantitative KPI:	Percentage of people participating in the National Bowel Cancer Screening Program.
2010-11 Target:	39.3%	2010-11 Actual:	45.1%
Result: Indicator met.
The increase in program participation in 2010-11 was influenced by a range of factors including media coverage of the remediation process which increased general public awareness of the program.

In addition, a series of pilots were conducted in Queensland, Victoria, South Australia, and the Northern Territory during phase 2 of the program to trial alternative, more effective ways of encouraging Aboriginal and Torres Strait Islander participation in bowel cancer screening.

Quantitative Deliverable:	Percentage of up to 2.5 million eligible Australians sent invitations and likely to participate in the second phase of the National Bowel Cancer Screening Program.
2010-11 Target:	38%	2010-11 Actual:	34%
Result: Deliverable met.
Approximately 852,000 kits were sent out to all eligible Australians in 2010-11. The lower actual percentage of eligible Australians is due to the 2010-11 target being an estimation only of the eligible population in that year.

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Supporting Early Cancer Detection and Prevention

In 2010-11, the department continued to work with the states and territories to provide free mammographic screening through the BreastScreen Australia Program, targeted at well women 50 to 69 years of age. The roll‑out of digital mammography technology continued across BreastScreen Australia services, and with the exception of the Northern Territory, all states and territories received an upgrade to digital mammography technology. Twenty-nine new mammography machines were provided for fixed, relocatable and mobile BreastScreen Australia services – three in the Australian Capital Territory, five in New South Wales, eight in Queensland, one in South Australia, three in Tasmania, two in Victoria and seven in Western Australia. The rollout of digital mammography will be completed by June 2013. Since the introduction of the BreastScreen Australia Program in 1991, breast cancer mortality in Australia has fallen by more than 29%.

Quantitative KPI:	Percentage of women in target groups participating in the BreastScreen Australia Program.
2010-11 Target:	56.9%	2010-11 Actual:	54.9%
Result: Indicator not met.
The latest data indicates that in 2007-08, 54.9% of women aged 50 to 69 years had a screening mammogram through BreastScreen Australia. While this is below the target of 56.9%, the number of women screened has increased from 2,242,133 in 2006-07 to 2,307,802 in 2007‑08.⁴ This means an additional 65,669 women accessed BreastScreen Australia services, of which 11,026 women were in the target age group.

The department also continued to work closely with state and territory governments in the areas of early detection and prevention of cervical cancer through the National Cervical Screening Program. In 2010-11, the department supported the development of a colposcopy quality improvement program and worked with the Australian Institute of Health and Welfare to refine the program’s monitoring process. Since the introduction of the National Cervical Screening Program in 1991, the mortality of cervical cancer has been halved.

Quantitative KPI:	Percentage of women in target groups participating in the National Cervical Screening Program.
2010-11 Target:	61.1%	2010-11 Actual:	61.2%
Result: Indicator met.
The latest data for the National Cervical Screening Program shows increased participation in women aged 20 to 69 years. In 2007-08, 61.2% of women in this age group participated in the program. This amounts to approximately 3.6 million women participating in the program.⁵

Qualitative Deliverable:	Stakeholders participate in program development through a range of avenues.
2010-11 Reference Point:	Stakeholders participated in program development through avenues such as regular consultative committees, conferences, stakeholder engagement forums, surveys, submissions on departmental discussion papers and meetings.
Result: Deliverable met.
The department worked closely with key stakeholders, including state and territory governments, professional groups and colleges to deliver BreastScreen Australia and the National Cervical Screening Program. The department took part in quarterly meetings with state and territory program managers for both screening programs, and provided support to the screening subcommittee, a jurisdictionally representative committee overseeing screening issues in Australia. The department also worked with key stakeholders, including professional groups, to oversee BreastScreen Australia’s accreditation system. It also worked with jurisdictions to inform the development of a project to support BreastScreen Australia’s workforce.

Promote Lifestyle Modifications to Reduce the Risk of Diabetes

Type 2 diabetes is the most common form of diabetes and accounts for approximately 92% of the burden of diabetes on individuals and the health system. It is largely preventable with modifiable risk factors including obesity, low physical activity and an unhealthy diet.

In 2010-11, the department continued to work closely with the Australian General Practice Network (AGPN) to promote and improve uptake of lifestyle modification programs under the Council of Australian Governments’ Diabetes – Reducing the Risk of Type 2 Diabetes initiative. This was done in collaboration with state and territory governments and aims to help delay or possibly prevent the development of Type 2 diabetes by targeting its risk factors.

The AGPN, through Divisions of General Practice, offered seed and pilot grant projects to increase the provision and uptake of lifestyle modification programs and promote the activity to general practice. An online minimum data collection system was put in place to capture and measure de-identified biometric data and referral information of participants to help understand the uptake of lifestyle modification programs. Funding for the lifestyle modification programs ceases on 30 June 2012. From July 2011, a pilot of the Coordinated Care for Diabetes reform will trial a new model of care to improve the quality of care for Australians living with diabetes.

Whole of Program Performance Information

Qualitative Deliverable:	Produce relevant and timely evidence-based policy research.
2010-11 Reference Point:	Relevant evidence-based policy research produced in a timely manner.
Result: Deliverable met.
The department continued to provide timely evidence-based policy research and advice through a number of avenues in 2010-11.

Quantitative Deliverable:	Percentage of variance between actual and budgeted expenses.
2010-11 Target:	≤ 0.5%	2010-11 Actual:	-19.2%
Result: Deliverable not met.
The actual expenses for Program 1.1 varied from budgeted expenses by 19.2%. This underspend is attributable, in part, to the National Bowel Cancer Screening Program, which temporarily suspended issuing invitations in 2009 due to a problem identified with the Faecal Occult Blood Test (FOBT) kits. To ensure that the remediation process was comprehensive and all those affected received new kits, and all eligible people subsequently invited, funds were rephased from 2009-10 to 2010-11. The quantum of funds rephased was not required. In addition, the underspend relating to the COAG Diabetes Program is due to this program being demand driven, and it had low uptake in 2010-11.

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Program 1.2: Communicable Disease Control

Program 1.2 aims to reduce the incidence of blood borne viruses and sexually transmissible infections, including human immunodeficiency virus (HIV), chlamydia, syphilis, gonorrhoea, herpes simplex virus-2, human papilloma virus and viral hepatitis.

Reduce the Prevalence of Blood Borne Viruses and Sexually Transmissible Infections

In 2010-11, the department continued its partnership approach by working with states and territories, research organisations and community based organisations to deliver programs aimed at reducing the impact of blood borne viruses and sexually transmissible infections on individuals and the community.

The department focussed on implementing the priority actions identified in the five National Strategies for blood borne viruses and sexually transmissible infections 2010-13. The department worked closely with the Blood Borne Virus and Sexually Transmissible Infections Subcommittee of the Australian Health Ministers Advisory Council and the Ministerial Advisory Committee on Blood Borne Viruses and Sexually Transmissible Infections to progress these actions. Areas of key focus in 2010-11 were on issues of discrimination and stigma, legal barriers to reducing the prevalence of blood borne viruses and sexually transmissible infections, and research into emerging issues. In partnership with states and territories and in consultation with the Communicable Disease Network of Australia, the department is developing a Surveillance and Monitoring Plan, which is expected to be finalised by late 2011, which will be a primary tool for measuring the success of the strategies.

Qualitative Deliverable:	Implementation plans for revised National Strategies completed.
2010-11 Reference Point:	Plans completed by December 2010.
Result: Deliverable met.
The department developed the Implementation Plan for the five National Strategies on Blood Borne Viruses and Sexually Transmissible Infections, in consultation with stakeholders. The Implementation Plan was endorsed by the Blood Borne Virus and Sexually Transmissible Infections Subcommittee and Ministerial Advisory Committee on Blood Borne Viruses and Sexually Transmissible Infections in November 2010, and provided to the Australian Population Health Development Principal Committee for information.
Quantitative Deliverable:	Percentage of jurisdictions and stakeholders implementing priority action areas.
2010-11 Target:	100%	2010-11 Actual:	100%
Result: Deliverable met.
All jurisdictions and other stakeholders are identified in the Implementation Plan as having responsibilities for progressing specified priority action areas from the National Strategies. Jurisdictions work through the Blood Borne Virus and Sexually Transmissible Infections Subcommittee to progress the action areas where needed. Proposals for funding for community based organisations were negotiated based on their alignment with Priority Action Areas under the National Strategies for Blood Borne Viruses and Sexually Transmissible Infections.
Qualitative KPI:	Funded activities are in line with priority actions outlined in the National Strategies.
2010-11 Reference Point:	Implementation of new strategies accepted by all stakeholders Effective communicable disease prevention and detection in accordance with sound evidence base, measured through a positive impact on notification rates of blood borne viruses and sexually transmissible infections.
Result: Indicator met.
The implementation of the National Strategies is being progressed by stakeholders, including community based organisations and research centres funded by the department. Members of the Blood Borne Virus and Sexually Transmissible Infections Subcommittee, and the Ministerial Advisory Committee on Blood Borne Viruses and Sexually Transmissible Infections collaborated on a number of activities to share information and ensure a consistent national approach. The annual number of new HIV diagnoses has remained relatively stable at around 1,000 over the past four years. The per capita rate of diagnosis of hepatitis B infection in Australia in 2005–09 was stable at around 31 per 100,000 population, while the per capita rate of diagnosis of hepatitis C infection has declined from 59.3 per 100,000 in 2005 to 51.9 per 100,000 population in 2009. The population rate of diagnosis of gonorrhoea was stable in 2005–09 at 36 per 100,000 population, while the rate of diagnosis of infectious syphilis doubled from 3.2 in 2005 to 6.6 in 2007 and declined to 5.8 in 2009.
Qualitative Deliverable:	The Ministerial Advisory Committee on Blood Borne Viruses and Sexually Transmissible Infections provides advice to the Minister.
2010-11 Reference Point:	Advice provided is timely and of a high quality.
Result: Deliverable met.
The Ministerial Advisory Committee on Blood Borne Viruses and Sexually Transmissible Infections met three times in 2010-11, and provided regular advice to the Minister on issues of national importance in relation to blood borne viruses and sexually transmissible infections, in accordance with their terms of reference.

As part of its commitment to innovative health promotion, the department continued to provide funding for education and prevention programs delivered by organisations representing at risk populations, and for the national Sexually Transmissible Infections Prevention Campaign. This campaign aims to raise awareness of sexually transmissible infections and encourage behavioural changes that will help reduce the prevalence and spread of sexually transmissible infections amongst young people. In 2010-11, a condom tin design competition attracted over 500 entries and 7,000 votes. The condom tins which feature the winning designs are being provided to young people at music festivals to promote the campaign messages.

Qualitative Deliverable:	The National Sexually Transmissible Infections Prevention program’s Sexual Health Campaign undergoes its major evaluation.
2010-11 Reference Point:	The major evaluation of the Sexual Health Campaign is completed by June 2011.
Result: Deliverable substantially met.
The Sexual Health Campaign is at the final stages of completion and a tender process has commenced to engage a consultant to conduct the campaigns evaluation. The evaluation will take into account the tracking research which was undertaken earlier in the Sexual Health Campaign. The evaluation is scheduled for completion in August 2011.

In 2010-11, the department supported AusAID on a number of international activities. These included supporting the Australian delegation to the United Nations High Level Meeting in New York, which delivered a new United Nations Declaration on HIV/AIDS, and the visit to Australia by the Executive Director of UNAIDS, Mr Michel Sidibé.

Quantitative Deliverable:	Number of Divisions of General Practice participating in pilot testing of chlamydia screening in general practice.
2010-11 Target:	6	2010-11 Actual:	383 GPs
Result: Deliverable substantially met.
The initial intent was to contract with Divisions of General Practice; however the department ultimately contracted the University of Melbourne to implement the pilot program. Through the University of Melbourne, 38 Divisions of General Practice were subsequently consulted on the promotion of the pilot, with the result that 383 general practitioners participated in the program.
Qualitative Deliverable:	The Chlamydia Pilot Testing Program is evaluated.
2010-11 Reference Point:	Evaluation completed by June 2011.
Result: Deliverable met.
The Evaluation of the Chlamydia Targeted Grants Program was completed by Healthcare Management Advisors in September 2010. The Healthcare Management Advisors report considered a number of models in relation to testing for chlamydia. The report found that most projects were able to demonstrate success in achieving an effective screening program.
Quantitative KPI:	Number of newly diagnosed cases of chlamydia infection.
2010-11 Target:	70,000-75,000	2010-11 Actual:	Over 76,000
Result: Indicator met.
During 2010-11, the department continued education and prevention programs aimed at improving knowledge, attitudes and behaviours among target populations, including the promotion of sexually transmissible infection testing, to reduce the burden of sexually transmissible infections on individuals and the community. Chlamydial infection is often asymptomatic and people affected may not seek treatment. The continuing upward trend in the detection of this infection is a positive achievement, as increased detection can lead to increases in treatment and a subsequent reduction in the longer term complications that can be associated with untreated chlamydia, which include infertility.

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Whole of Program Performance Information

Qualitative Deliverable:	Produce relevant and timely evidence-based policy research.
2010-11 Reference Point:	Relevant evidence-based policy research produced in a timely manner.
Result: Deliverable met.
In 2010-11, the department funded four national research centres to provide epidemiological data and undertake clinical and social research in blood borne virus and sexually transmissible infections, HIV and hepatitis virology research, and research focusing on sex, health and society. The department is working with the Ministerial Advisory Committee on Blood Borne Viruses and Sexually Transmissible Infections Research Priorities Working Group on the relevance and application of research in the blood borne virus and sexually transmissible infections policy area.
Qualitative Deliverable:	Stakeholders participate in program development through a range of avenues.
2010-11 Reference Point:	Stakeholders participated in program development through avenues such as regular consultative committees, conferences, stakeholder engagement forums, surveys, submissions on departmental discussion papers and meetings.
Result: Deliverable met.
The Ministerial Advisory Committee on Blood Borne Viruses and Sexually Transmissible Infections met three times, and the Blood Borne Virus and Sexually Transmissible Infections Subcommittee met four times in 2010-11. These committees oversaw the finalisation of the Implementation Plan for five National Strategies addressing Blood Borne Viruses. The department supported the Australasian Sexual Health, Viral Hepatitis and HIV Conferences. These key national conferences encourage stakeholder engagement, and foster collaboration between research bodies, policy makers and community based organisations. The department, in conjunction with AusAID, also participated in consultation with civil society in relation to Australia’s input to the June 2011 United Nations Declaration on HIV/AIDS.

Quantitative Deliverable:	Percentage of variance between actual and budgeted expenses.
2010-11 Target:	≤ 0.5%	2010-11 Actual:	-0.89%
Result: Deliverable substantially met.
This minor underspend is a result of small variations in demand for the provision of in-vitro device test kit validation for HIV and Hepatitis C virus in Australia.

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Program 1.3: Drug Strategy

Program 1.3 aims to reduce binge drinking and risky alcohol consumption; reduce the harmful effects of tobacco use; and reduce the demand, supply and harm caused by illicit drug use and other substance misuse.

Curb Excessive Alcohol Consumption

In 2010-11, the department continued to implement the National Binge Drinking Strategy. A further 645 sporting organisations joined the Good Sports Program, which seeks to build a culture of responsible drinking, bringing the total to 4,320 clubs.

The department has also continued partnerships with stakeholders in industry and in the health sector to promote awareness and promotion of key messages about responsible alcohol consumption and to target groups at risk of binge drinking. Through a partnership with state and territory police and health departments under the National Binge Drinking Strategy, the department continued to implement the Early Intervention Pilot Program. This has enabled young people who have contact with the police and are at risk from harmful drinking to be supported by the health system where they will receive information and counselling to encourage a change in attitudes and behaviours. Early findings from the program show that it is resulting in more positive interactions between police and young people.

The Community Level Initiatives community grants have also targeted binge drinking in the community. It involved two rounds of funding for a total of 38 community groups (19 projects in each round) that developed local solutions to promote the prevention and reduction of binge drinking by young people, specifically targeting the 12-24 years age group. Feedback from round one indicated that young people became more aware of the harms of excessive drinking through education while other events provided the opportunity for youths in their community to participate in alcohol-free activities.

Another component of the Community Level Initiatives, the Club Champions Program, involved seven sporting organisations (the Australian Football League, the Australian Rugby Union, the National Rugby League, Cricket Australia, Netball Australia, Football Federation Australia, and Swimming Australia) which developed and delivered sport-specific alcohol education and training programs tailored to complement the existing alcohol programs. These programs promoted responsible drinking messages; such as those in the Australian Guidelines to Reduce Health Risks from Drinking Alcohol; and the principles of the National Alcohol Code of Conduct.

The department continued the development and distribution of a range of communications materials to raise community awareness with respect to the Australian Guidelines to Reduce Health Risks from Drinking Alcohol. In 2010-11, 778,000 items were distributed including promotional products and communication materials designed to educate the Australian community about the standard drink concept and the health risks of excessive alcohol consumption.⁶

In November 2010, the government announced that implementation of the National Binge Drinking Strategy expansion would be led by the Australian National Preventive Health Agency (ANPHA). The expansion will include:

$25 million over four years for a community sponsorship fund as an alternative to alcohol sponsorship for community sporting and cultural organisations;
$20 million over four years for community level initiatives designed to tackle binge drinking; and
$5 million over four years for enhanced alcohol telephone counselling and referral services.

The department will continue to work closely with ANPHA throughout the implementation of the measure in 2011-12.

Quantitative KPI:	Number of clubs participating in the Good Sports Program.
2010-11 Target:	3,390		2010-11 Actual:		4,320
Result: Indicator met.
More than 600 additional sporting clubs joined the program in 2010-11, bringing the total number of clubs participating in the program to 4,320.
Quantitative KPI:	Number of young people referred to counselling under innovative early intervention programs.
2010-11 Target:	250	2010-11 Actual:		885
Result: Indicator met.
State and territory police and health departments worked with young people to ensure those participating in underage drinking activities were moved from engagement with police to the health system where they received information and counselling to encourage a change in attitudes and behaviors.
Quantitative Deliverable:	Number of grants established under the expanded National Binge Drinking Strategy community level initiatives.
2010-11 Target:	20	2010-11 Actual:		Nil
Result: Deliverable not met.
The implementation of this measure will be led by ANPHA, which commenced operation on 1 January 2011 and has initially focussed on establishing appropriate financial, administrative and governance infrastructure to support the roll-out of the measures. A total of 38 Community Level Initiative grants funded under rounds one and two of the National Binge Drinking Strategy continued to be rolled out and produced positive results, suggesting raised community awareness and targeting of key at-risk groups. These groups included young people who had been in contact with police, young Indigenous people and young people engaged with sporting communities.
Qualitative KPI:	Community Level Initiative grants raise awareness of the dangers of binge drinking.
2010-11 Reference Point:	Evaluation concludes that the Community Level Initiative grants meet their objectives in raising awareness of the dangers of binge drinking.
Result: Indicator not met.
Evaluation will not be finalised until October 2011 so formal conclusions cannot be drawn about whether objectives have been met. Early reports, however, suggest grants are raising awareness particularly among target groups in the community.
Quantitative KPI:	Percentage of population 18 years of age and over at risk of long-term harm from alcohol.
2010-11 Target:	<14.8%		2010-11 Actual:		10.5%
Result: Indicator met.
The 2010 National Drug Strategy Household Survey Report indicates that a total of 10.5% of people aged 18 years or over drink at levels which could potentially cause harm in the longer term.
Qualitative Deliverable:	Establish a sponsorship fund to include alcohol sponsorship replacement grants to local community organisations, support additional community level initiatives and provide enhanced telephone counselling services and alcohol referrals.
2010-11 Reference Point:	Establishment of sponsorship fund by the end of 2010.
Result: Deliverable not met.
The implementation of this measure will be led by ANPHA, which commenced operation on 1 January 2011 and has initially focussed on establishing appropriate financial, administrative and governance infrastructure to support the roll-out of the measures. Funding has now been transferred to ANPHA to enable implementation of this deliverable in 2011-12.

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Reduce Prevalence of Smoking

In 2010-11, the department worked to implement the comprehensive package of tobacco reforms announced by the Government in April 2010, including the world-leading plain packaging legislation, internet advertising legislation and major social marketing campaigns, and continued to implement the Government’s record program of support for Aboriginal and Torres Strait Islander communities to reduce smoking rates.

The department conducted developmental research, with advice from an expert advisory group, on the optimal design for the plain packaging of tobacco products, conducted targeted consultations with tobacco manufacturers on anti-counterfeiting measures and with large and small retailers and peak bodies on handling issues in a retail setting. The department conducted a public consultation on the draft plain packaging legislation and cigarette packaging design, which closed on 6 June 2011. Over 260 submissions were received from public health organisations, non-government organisations, the tobacco industry (manufacturers and importers), tobacco retailers and interested individuals, which informed further development of the legislation.

The department finalised legislation to regulate Australian internet advertising of tobacco products, aiming to bring advertising restrictions on the internet into line with restrictions in other retail settings. The legislation was introduced into the Parliament on 22 March 2011.

During 2010-11, two anti-smoking social marketing campaigns were launched: The National Partnership Agreement on Preventive Health Tobacco Social Marketing Campaign (the National Tobacco Campaign) and the National Tobacco Campaign – More Targeted Approach (the More Targeted Approach Campaign).

The National Tobacco Campaign, which the department delivered on behalf of the Australian National Preventive Health Agency, is intended to help reduce smoking prevalence amongst the general population. The primary target audiences for this campaign are daily smokers aged 18-40 years and recent quitters aged 18-40 years. The campaign aims to encourage current smokers to attempt to quit, support current quit attempts and help reduce their chance of relapse. A new television commercial ‘Cough’, was developed and launched under this campaign.

The More Targeted Approach Campaign is a complementary campaign aimed at high-need and hard to reach groups. The groups include: people from culturally and linguistically diverse backgrounds; pregnant women and their partners; people living in socially disadvantaged areas; people with mental illness; and prisoners. Materials targeting culturally and linguistically diverse populations and pregnant women and their partners were developed and launched in 2010-11.

images from the National Tobacco Campaign
Text version of this image

The department also developed the first ever national television commercial specifically targeting Aboriginal and Torres Strait Islander smokers. ‘Break the Chain’, launched in March 2011, aims to build a higher level of personal acknowledgement of the health impacts of smoking among Indigenous Australians.

With funding from the National Partnership Agreement for Closing the Gap in Indigenous Health Outcomes, the department supported the roll-out of regional Tackling Smoking and Healthy Lifestyle workers to the first 20 of 57 regions nationally. Funding was provided to Aboriginal Community Controlled Health Organisations (ACCHOs) and other health organisations providing services to Aboriginal and Torres Strait Islander peoples to host, train and support these teams of health promotion workers. The first national workshop of host organisations and workers was held in Canberra in December 2010 to provide induction training and build networks across this new national workforce.

Dr Tom Calma, engaged as National Coordinator – Tackling Indigenous Smoking in March 2010, provided vital national leadership to this initiative, drawing on advice from a technical reference group of Indigenous and tobacco control experts.

The department continued to support 18 innovative tobacco control projects under the $14.5 million Indigenous Tobacco Control Initiative, with lessons learned from these projects being applied to the implementation of the COAG measure.

In November 2010, the department led an Australian delegation to the Conference of the Parties to the WHO Framework Convention on Tobacco Control (FCTC), which made a number of key decisions to support FCTC implementation, including the adoption of guidelines for implementation of Article 12 (education, communication, training and public awareness) and Article 14 (demand reduction measures concerning tobacco dependence and cessation), and partial guidelines for implementation of Articles 9 and 10 (regulation of the contents of tobacco products and regulation of tobacco product disclosures).

The department also commissioned an evaluation of the National Tobacco Strategy 2005-2009. A new National Tobacco Strategy is to be developed in consultation with states and territories and experts in 2011-12 through the Intergovernmental Committee on Drugs Standing Committee on Tobacco.

Qualitative Deliverable: Complete research on the most appropriate specifications for plain packaging and develop the Regulatory Impact Statement.

2010-11 Reference Point: Research and Regulatory Impact Statement commenced by
end 2010.

Result: Deliverable substantially met.

Consumer studies were conducted from November 2010 to February 2011. An Expert Advisory Group provided advice to the department on research and design.
The Office of Best Practice Regulation advised the department that a Regulatory Impact Statement for the plain packaging measure was no longer required, following the Government’s announcement on 29 April 2010. A post implementation review will be conducted in 2013-14.

Qualitative KPI: Plain packaging of tobacco products reduces the attractiveness and appeal of tobacco products; reduces the ability of the pack to mislead consumers about the harms of smoking and increases the visibility of mandated health warnings.

2010-11 Reference Point: Research to be undertaken in 2010-11 finds that plain packaging
will meet objectives.

Result: Indicator met.

Consumer research was conducted through late 2010 and early 2011 on the proposed design of plain packaging to ensure the design was optimal in achieving the public health objectives of the measure.

Qualitative Deliverable: Implement social marketing campaign to raise awareness of the dangers of smoking and encourage and support attempts to quit.

2010-11 Reference Point: Social marketing campaigns commencing by early to mid 2011.

Result: Deliverable met.

The National Partnership Agreement on Preventive Health Tobacco Campaign was launched with television, radio, print, outdoor and online advertising. The National Tobacco Campaign – More Targeted Approach also launched in early 2011, targeting hard to reach audiences with radio, print and online advertising. The Indigenous campaign (‘Break the Chain’) launched in March 2011 with television, radio and print advertising. Public relations activity has supported the advertising.

Qualitative KPI: The National Tobacco Campaign raises awareness among target audience of the dangers of smoking.

2010-11 Reference Point: An evaluation scheduled for August 2010 finds that the National Tobacco Campaign has raised awareness among target audiences of the dangers of smoking.

Result: Indicator met.

Tracking research conducted by The Social Research Centre demonstrates the campaign to have met its objectives in relation to reach and message communication. It also appears to have influenced the target audience’s awareness of, and attitudes towards, the negative health consequences of smoking, intentions to quit or remain a non-smoker and the quitting behaviour of regular smokers.

The department also launched complementary campaigns in early 2011. The More Targeted Approach Campaign aims to reduce smoking prevalence among high-need and hard to reach groups including: pregnant women; prisoners; people with mental illness; people from culturally and linguistically diverse (CALD) backgrounds; and people living in socially disadvantaged areas. The second complementary campaign which is Indigenous-specific will contribute to the goal of halving Indigenous smoking rates.

An Expert Advisory Committee, including experts in tobacco control, informed the strategic development and implementation of the campaigns. A Campaign Reference Group, comprising representatives from each state and territory government, shares and coordinates activities across national and state level activities.

Quantitative Deliverable: Number of regions in which Indigenous tobacco workforce recruited.

2010-11 Target: 20 2010-11 Actual: 21

Result: Deliverable met.

Funding agreements were signed with 21 organisations around Australia to establish regional Tackling Smoking and Healthy Lifestyle Teams, and recruitment commenced in all regions. An organisation in the ACT region was also funded to host a Tobacco Action Worker and a Healthy Lifestyle Worker.

Quantitative KPI: Percentage of population 18 years of age and older who are daily smokers.

2010-11 Target: <19.6% 2010-11 Actual: 15.9% (2010 National Drug Strategy Household Survey)

Result: Indicator met.

The 2010 National Drug Strategy Household Survey showed that 15.9% of Australians aged 18 years or over smoked daily compared with 17.5% in 2007. The 2010-11 target was based on ABS Australian Health Survey figures. Updated figures from this survey are not yet available.

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Qualitative Deliverable:	Complete research on the most appropriate specifications for plain packaging and develop the Regulatory Impact Statement.
2010-11 Reference Point:	Research and Regulatory Impact Statement commenced by end 2010.
Result: Deliverable substantially met.
Consumer studies were conducted from November 2010 to February 2011. An Expert Advisory Group provided advice to the department on research and design. The Office of Best Practice Regulation advised the department that a Regulatory Impact Statement for the plain packaging measure was no longer required, following the Government’s announcement on 29 April 2010. A post implementation review will be conducted in 2013-14.
Qualitative KPI:	Plain packaging of tobacco products reduces the attractiveness and appeal of tobacco products; reduces the ability of the pack to mislead consumers about the harms of smoking and increases the visibility of mandated health warnings.
2010-11 Reference Point:	Research to be undertaken in 2010-11 finds that plain packaging will meet objectives.
Result: Indicator met.
Consumer research was conducted through late 2010 and early 2011 on the proposed design of plain packaging to ensure the design was optimal in achieving the public health objectives of the measure.
Qualitative Deliverable:	Implement social marketing campaign to raise awareness of the dangers of smoking and encourage and support attempts to quit.
2010-11 Reference Point:	Social marketing campaigns commencing by early to mid 2011.
Result: Deliverable met.
The National Partnership Agreement on Preventive Health Tobacco Campaign was launched with television, radio, print, outdoor and online advertising. The National Tobacco Campaign – More Targeted Approach also launched in early 2011, targeting hard to reach audiences with radio, print and online advertising. The Indigenous campaign (‘Break the Chain’) launched in March 2011 with television, radio and print advertising. Public relations activity has supported the advertising.
Qualitative KPI:	The National Tobacco Campaign raises awareness among target audience of the dangers of smoking.
2010-11 Reference Point:	An evaluation scheduled for August 2010 finds that the National Tobacco Campaign has raised awareness among target audiences of the dangers of smoking.
Result: Indicator met.
Tracking research conducted by The Social Research Centre demonstrates the campaign to have met its objectives in relation to reach and message communication. It also appears to have influenced the target audience’s awareness of, and attitudes towards, the negative health consequences of smoking, intentions to quit or remain a non-smoker and the quitting behaviour of regular smokers.

Quantitative Deliverable:	Number of regions in which Indigenous tobacco workforce recruited.
2010-11 Target:	20	2010-11 Actual:	21
Result: Deliverable met.
Funding agreements were signed with 21 organisations around Australia to establish regional Tackling Smoking and Healthy Lifestyle Teams, and recruitment commenced in all regions. An organisation in the ACT region was also funded to host a Tobacco Action Worker and a Healthy Lifestyle Worker.
Quantitative KPI:	Percentage of population 18 years of age and older who are daily smokers.
2010-11 Target:	<19.6%	2010-11 Actual:	15.9% (2010 National Drug Strategy Household Survey)
Result: Indicator met.
The 2010 National Drug Strategy Household Survey showed that 15.9% of Australians aged 18 years or over smoked daily compared with 17.5% in 2007. The 2010-11 target was based on ABS Australian Health Survey figures. Updated figures from this survey are not yet available.

Minimise Harm from Drug Use

In 2010-11, the department led the development of the new National Drug Strategy 2010-2015, under the auspices of the Ministerial Council on Drug Strategy and the Intergovernmental Committee on Drugs, for which the department provided secretariat support. The department led consultations with stakeholders in November 2010, on a draft of the strategy, which was finalised and agreed by Ministers in February 2011.

The department continued to provide funding support for drug and alcohol treatment services delivered by over 200 non-government organisations nationally through the Non-Government Organisation Treatment Grants Program (NGOTGP) and the COAG Improved Services for People with Drug and Alcohol Problems and Mental Illness (Improved Services Initiative). An evaluation of the NGOTGP was completed and work initiated to develop a new quality framework for these programs.

In December 2010, the Minister for Health and Ageing launched a new phase of the National Drugs Campaign.⁷ The campaign aims to contribute to a reduction in the uptake of ecstasy, cannabis, methamphetamines (ice or speed) and other illicit drugs among young Australians by raising awareness of the harms associated with drug use, and encouraging and supporting decisions not to use.

In March 2011, the department led an Australian delegation to the Commission on Narcotic Drugs, a specialist commission of the Economic and Social Council of the United Nations. The department led the development of a resolution calling for a better balance between control of, and access to, opiate medications. The resolution will see model laws on drug control updated by the United Nations Office on Drugs and Crime which will assist in improving access to essential pain relief and other life saving medications in developing countries, while maintaining appropriate safeguards for control.

Target Illicit Drug Use

In 2010-11, the department continued to reinforce young people’s knowledge of the harms and risks associated with illicit drugs through the National Drugs Campaign. The focus for 2010-11 was addressing the rising use of ecstasy within the Australian community, with continued effort to reduce the use of methamphetamines (speed and ice) and cannabis. The primary target audience for the campaign was youth aged 15-21 years at risk of using ecstasy and/or other illicit drugs.

The campaign utilised primary prevention communications through advertising, youth marketing, public relations and promotions, campaign resources and online communication activities. Research will determine the strategic direction of the campaign in 2011-12 and beyond.

Qualitative Deliverable:	Provide up-to-date information to young people on the risks and harms of illicit drug use.
2010-11 Reference Point:	The production of new creative materials and the delivery of Phase Five of the National Drugs Campaign with a renewed focus on ecstasy.
Result: Deliverable met.
The Campaign ran from December 2010 to June 2011 and utilised primary prevention communications through advertising, youth marketing, public relations and promotions, campaign resources and online communication activities.
Qualitative KPI:	The National Drugs Campaign raises awareness among target audiences of the dangers of drugs.
2010-11 Reference Point:	An evaluation scheduled for August 2010 finds that the National Drugs Campaign has raised awareness among target audiences of the dangers of drugs.
Result: Indicator met.
Research conducted by The Social Research Centre to evaluate the campaign identified significant increases in agreement across a range of statements related to the dangers and potential negative consequences of drug use, particularly ecstasy.

In 2010-11, the department continued to provide support and contract management services to over 200 non-government organisations through the NGOTGP and the COAG Improved Services for People with Drug and Alcohol Problems and Mental Illness (Improved Services Initiative) to operate a range of alcohol and drug treatment services and to build their capacity to better manage and treat people with co-existing alcohol and other drug issues and mental illness (co-morbidity).

Quantitative Deliverable:	Number of services funded to deliver the Non-Government Organisation Treatment Grants Program.
2010-11 Target:	197		2010-11 Actual:		197
Result: Deliverable met.
In 2010-11, the department through the Non-Government Organisation Treatment Grants Program continued to support 197 non-government organisations to deliver a wide range of treatment options for the misuse of alcohol and other drugs.
Quantitative Deliverable:	Number of services funded under the capacity building grants component of the COAG Mental Health Improved Services Initiative for People with Drug and Alcohol Problems and Mental Illness (Improved Services Initiative).
2010-11 Target:	122		2010-11 Actual:		122
Result: Deliverable met.
The department supported 122 non-government drug and alcohol treatment services to build their capacity to better identify and manage clients with substance use and mental illness (comorbidity).
Quantitative KPI:	Percentage of population 14 years of age and older recently (in the last 12 months) using an illicit drug.
2010-11 Target:	<13.4%	2010-11 Actual:		14.7%
Result: Indicator not met.
The 2010 National Drug Strategy Household Survey showed that 14.7% of Australians aged 14 years or older had used an illicit drug in the previous 12 months, an increase from 13.4% in 2007. This increase was largely due to an increase in the proportion of population using cannabis. In 2011-12, the department will continue to work in partnership with law enforcement agencies, state, territory and local governments, treatment service providers, housing and homelessness services, and local communities under the National Drug Strategy 2010-2015. The strategy aims to build safe and healthy communities by minimising alcohol, tobacco and other drug-related health, social and economic harms among individuals, families and communities.
Quantitative KPI:	Number of sites covered by regional national network of Indigenous campaign coordinators.
2010-11 Target:	20	2010-11 Actual:		21
Result: Indicator met.
Funding agreements were signed with 21 organisations around Australia to establish Regional Tackling Smoking and Healthy Lifestyle Teams headed up by Regional Tobacco Coordinators (operational name for Indigenous campaign coordinators). An organisation in the ACT region was also funded to host a Tobacco Action Worker and a Healthy Lifestyle Worker. Over a three year period, teams will be recruited in 57 regions to give national coverage. Regional Tobacco Coordinators and teams of Tobacco Action Workers will work with local communities to develop social marketing and health promotion approaches that resonate with communities, families and individuals.

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Whole of Program Performance Information

Qualitative Deliverable:	Produce relevant and timely evidence-based policy research.
2010-11 Reference Point:	Relevant evidence-based policy research produced in a timely manner.
Result: Deliverable met.
The department continued to fund the three drug strategy research centres of excellence (National Drug and Alcohol Research Centre, National Drug Research Institute and National Centre for Education and Training on Addiction) to provide and disseminate high-quality research that contributes to evidence-informed policy and practice by health, law enforcement and education services. The department continued to fund the Australian Institute of Health and Welfare to complete the 2010 National Drug Strategy Household Survey and the Centre for Excellence in Indigenous Tobacco Control to disseminate information on best practice in this area.

Qualitative Deliverable:	Stakeholders participate in program development through a range of avenues.
2010-11 Reference Point:	Stakeholders participated in program development through avenues such as regular consultative committees, conferences, stakeholder engagement forums, surveys, submissions on departmental discussion papers and meetings.
Result: Deliverable met.
The department engaged with the Australian National Council on Drugs and the Alcohol and other Drugs Council of Australia, the peak national representative body on alcohol and other drug issues on a range of matters and projects including: funding of drug and alcohol treatment services; Asia-Pacific alcohol and drug issues; Indigenous drug and alcohol issues; development of Australia’s National Drug Strategy 2010-2015; health reform funding and structure submissions; and the National Drugs Campaign. The department facilitated the development of the National Drug Strategy 2010-2015 in collaboration with the states and territories, including stakeholder forums and submission based consultations.
Quantitative Deliverable:	Percentage of variance between actual and budgeted expenses.
2010-11 Target:	≤ 0.5%	2010-11 Actual:	-7.0%
Result: Deliverable not met.
The underspend relates to delays in implementing the National Binge Drinking Strategy Expansion funds.

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Program 1.4: Regulatory Policy

Program 1.4 aims to provide direction and national leadership in food regulation and policy issues, maintain and improve the therapeutic goods regulatory framework, provide for the safe and sustainable use of industrial chemicals, and enhance the efficient use of the gene technology regulatory system.

Sub-Program 1.4.1: Food Regulatory Policy

Sub-Program 1.4.1 aims to provide responsible national and international leadership in food regulation policy by promoting and supporting a consistent approach to development of food standards and food regulation.

Develop Food Standards and Food Regulatory Policy

The department undertakes a variety of activities to develop food standards and food regulation policy and advice. This involves working closely with a range of stakeholders such as industry representatives, Food Standards Australia New Zealand (FSANZ), state and territory government departments and the New Zealand Government.

In 2010-11, the department worked to protect the health and safety of the population by ensuring that the food regulatory arrangements are supported by an evidence-based system and high level policy direction. In order to achieve this, the department successfully progressed an Intergovernmental Agreement (the Agreement) through the Council of Australian Governments which was signed in February 2011. The Agreement confirmed the Australian Government and state and territory government commitment to supporting FSANZ commencing operation of a Code Interpretation Service.⁸ Interpreting and implementing the Food Standards Code can place significant regulatory imposts and cost burden on industry.

This service seeks to reduce that burden by providing a central point for advice on standards in Chapters 1 and 2 of the Food Standards Code. The advice will be provided by FSANZ in consultation with state and territory food regulation enforcement agencies and the advice will be adopted and applied as part of the states and territories’ monitoring and enforcement activities. The service became operational on 1 July 2011.

Qualitative Deliverable:	Provide advice to Food Standards Australia New Zealand and stakeholders.
2010-11 Reference Point:	Advice provided is timely and relevant.
Result: Deliverable met.
Advice provided to FSANZ and stakeholders was timely and relevant.

On 6 July 2010, the amended Agreement between the Government of Australia and the Government of New Zealand concerning a joint food standards system came into effect. The amendments aim to reduce unnecessary barriers to trade; adopt a joint system for food standards; provide for timely development, adoption and review of food standards; and facilitate the sharing of information.

Quantitative Deliverable:	Percentage of Food Standards Assessment Report Notifications on which Minister is briefed.
2010-11 Target:	100%	2010-11 Actual:	100%
Result: Deliverable met.
The Minister was briefed on all 22 Notifications received by the department.

The department continued to provide secretariat support to an independent panel on food labeling law and policy, led by Dr Neal Blewett. The panel’s work culminated in the report Labelling Logic: Review of Food Labelling Law and Policy (2011) (the Review), which was presented to the Hon Catherine King as Chair of the Australia and New Zealand Food Regulation Ministerial Council on 28 January 2011. The Review received more than 7,000 submissions and sustained a high degree of interest. The department is coordinating the response to the 61 recommendations of the Review by working closely with the relevant portfolio agencies such as FSANZ, other Australian Government departments and the Australia and New Zealand Food Regulation Ministerial Council. A draft response is due to be considered by the Ministerial Council in December 2011.

The department also provided advice, support and secretariat services to the Australia and New Zealand Food Regulation Ministerial Council and its subcommittees, which work cooperatively with the food regulatory system protect consumer health and safety.

Qualitative Deliverable:	Provide advice to Australia and New Zealand Food Regulation Ministerial Council (ANZ FRMC).
2010-11 Reference Point:	Advice provided is timely and relevant.
Result: Deliverable met.
All papers and advice to the ANZFRMC relating to the two meetings held in 2010-11 were timely and relevant.
Quantitative KPI:	Percentage of agenda papers sent out on time to the Ministerial Council and its subcommittees.
2010-11 Target:	>80%	2010-11 Actual:	96%
Result: Indicator met.
All papers received by the department on the due date were distributed on time. Those received late were distributed within 48 hours of receipt.
Qualitative KPIs:	Effective provision of advice to stakeholders.
2010-11 Reference Point:	Stakeholder satisfaction measured through acceptance of advice.
Result: Indicator met.
The department regularly provides timely, accurate and relevant advice on food regulation policy matters. In 2010-11, the department responded to more than 10,233 letters from the public about food regulation matters.

Whole of Sub-Program Performance Information

Qualitative Deliverable:	Stakeholders participate in program development through a range of avenues.
2010-11 Reference Point:	Stakeholders participated in program development through avenues such as regular consultative committees, conferences, stakeholder engagement forums, surveys, submissions on departmental discussion papers and meetings.
Result: Deliverable met.
Stakeholders: provided input into the regulatory impact assessment process for the Code Interpretation Service; were briefed on Codex Committee on Food Labelling meetings and activities; and attended conferences and engagement forums in relation to the Review of Food Labelling Law and Policy.
Qualitative Deliverable:	Produce relevant and timely evidence based policy research.
2010-11 Reference Point:	Relevant evidence-based policy research produced in a timely manner.
Result: Deliverable met.
In 2010-11, the department provided high quality policy advice for ministerial consideration of draft food standards. The department managed the associated secretariat functions; coordinated the Australia New Zealand Food Regulation Ministerial Council (ANZFRMC) consideration and provided food policy advice to Food Standards Australia New Zealand (FSANZ); and ensured input was provided to all notifications from FSANZ to ANZFRMC in relation to applications and proposals to amend the Australia New Zealand Food Standards Code.
Quantitative Deliverable:	Percentage of variance between actual and budgeted expenses.
2010-11 Target:	≥ 0.5%	2010-11 Actual:	8,842%
Result: Deliverable not met.
The variance relates to a provision for a doubtful debt for the Therapeutic Goods Administration in relation to the enforcement of the Therapeutic Goods Administration Act 1989.

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Sub-Program 1.4.2: Therapeutic Goods

Sub-Program 1.4.2 aims to ensure that therapeutic goods manufactured or supplied in, or exported from, Australia are of high quality, and are safe and effective to use for their intended purpose, and to implement further reforms to Australia’s regulatory framework.

Therapeutic Goods Regulation

In 2010-11, the Therapeutic Goods Administration (TGA) continued to regulate therapeutic goods under a national framework to ensure their quality, safety and effectiveness. To do this, the TGA, using a risk management approach, carried out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard, and manufactured in accordance with the Principles of Good Manufacturing Practice. At the same time, the TGA continued to ensure that the Australian community had access, within a reasonable timeframe, to therapeutic advances.

Quantitative Deliverable:

Number of therapeutic goods tested.

2010-11 Target:

≥ 800

2010-11 Actual:

865

Result: Deliverable met.

In 2010-11, the TGA, through the Office of Laboratories and Scientific Services, tested 865 products consisting of 2,422 samples. In addition, the TGA completed protocol release evaluations for 376 batches of biological medicines. This compares with 771 products and 1,991 samples in 2009-10, and 1,024 products and 2,300 samples in 2008-09.

Quantitative Deliverable:

Average number of working days taken to assess reports of
alleged breaches and initiate an appropriate response.

2010-11 Target:

2010-11 Actual:

Result: Deliverable met.

In 2010-11, the TGA received 1,242 alleged offence reports of breaches of the Therapeutic Goods Act 1989 from stakeholders, including members of the public, industry, local and international law enforcement agencies, and regulatory agencies. This compares with 1,009 in 2009-10, 1,068 reports in 2008–09 and 1,107 in 2007–08. The TGA acknowledged receipt, in writing, of all identifiable complaints within 10 working days.
The TGA completed 923 investigations of alleged offence reports, with 639 formal warnings issued to persons or companies. Four persons or companies were charged and convicted of 99 criminal offences and civil penalty contraventions.

Quantitative Deliverable:

Number of licensing and surveillance audits performed.

2010-11 Target:

Domestic: 300
Overseas: 125

2010-11 Actual:

Domestic: 256
Overseas: 163

Result: Deliverable substantially met.

In 2010-11, the TGA performed:

256 audits of Australian manufacturers, representing 85% of the target, this compares with 333 audits in 2009-10; and
163 audits of overseas manufacturers, representing 130% of the target, this compares with 136 audits in 2009-10.

Quantitative Deliverable:

Number of completed evaluations of prescription medicines.

2010-11 Target:

Category 1: 420
Category 2: 0
Category 3: 1,350

2010-11 Actual:

Category 1: 518
Category 2: 0
Category 3: 1,234

Result: Deliverable substantially met.

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 2 refers to an application to register a prescription medicine where two independent evaluation reports from acceptable countries are available.
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.

	2006-07	2007-08	2008-09	2009-10	2010-119
Category 1	406	438	445	404	521
Category 2	0	0	0	0	0
Category 3	966	1,203	1,197	1,316	1,249

Quantitative KPI:

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

2010-11 Target:

100%

2010-11 Actual:

97%

Result: Indicator substantially met.

The TGA completed 33 of 34 (97%) s60 internal reviews recording the entry of therapeutic goods into the Australian Register of Therapeutic Goods within the legislated timeframes.

Quantitative KPI:

Percentage of consumer information (AusPARS, CMI and PIs) published on the TGA website within the target timeframe.

2010-11 Target:

100%

2010-11 Actual:

100%

Result: Indicator met.

114 Australian Public Assessment Reports were published on the TGA website in 2010-11. The TGA also provided enhanced access to prescription medicine information by facilitating access to up-to-date Consumer Medicine Information (CMI) and Product Information (PI) (for health professionals and consumers) on the TGA website.
In 2010-11, over 900 new PI documents and over 903 updates were made to existing PI documents and 1,253 new CMI sheets were made available with 648 updates to existing CMI documents on the TGA website.

Quantitative KPI:

Percentage of licensing and surveillance audits completed within target timeframes.

2010-11 Target:

Domestic: 100%
Overseas: 90%

2010-11 Actual:

Domestic: 87%
Overseas: 82%

Result: Indicator substantially met.

In 2010-11, the TGA performed:

256 audits of Australian manufacturers, with 222 (87%) performed within the target timeframe. This compares with 333 audits in 2009-10, of which 285 (86%) were performed within target timeframes. There were 19 overdue domestic audits at the end of 2010-11.
163 audits of overseas manufacturers with 133 (82%) performed within the target timeframe. This compares with 136 audits in 2009-10, of which 127 (94%) were performed within target timeframes. There were 16 overdue overseas audits at the end of 2010-11.

Quantitative KPI:

Percentage of prescription medicine evaluations completed within target timeframes.

2010-11 Target:

Category 1: 100%
Category 2: 100%
Category 3: 100%

2010-11 Actual:

Category 1: 99.4%
Category 2: N/A
Category 3: 99.8%

Result: Indicator substantially met.

The TGA performed 518 (99.4%) Category 1 and 1,234 (98.8%) Category 3 evaluations for prescription medicines within legislated timeframes (255 and 45 working days, respectively); no Category 2 evaluations; and 76 (100%) Design Examination Conformity Assessments for medical devices within the 255 day legislative timeframe.

In mid 2009, the TGA began an organisation and structural reform process to address a number of key issues including:

increased transparency and accountability for regulatory decisions;
a structure that supports a more robust regulatory framework with greater consistency in regulatory decision making across product sectors; and
improved monitoring of the safety of products on the market and better use of TGA resources.

In 2010-11, work has been undertaken in all three areas with a new organisational structure being implemented.

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Revised Scheduling Arrangements for Medicines and Other Chemicals

Until 30 June 2010, Medicine and Poison scheduling¹⁰ decisions were made by the National Drugs and Poisons Schedule Committee (NDPSC), an independent expert committee established under now repealed provisions of the Therapeutic Goods Act 1989 (the Act). From 1 July 2010, new provisions of the Act authorised the Secretary of the Department of Health and Ageing, or a delegate, to make scheduling decisions.

The revised arrangements also established two expert advisory committees, the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), as statutory committees under the Act to advise and make recommendations to the Secretary of the Department of Health and Ageing in relation to the scheduling of medicines and chemicals, respectively. The revised arrangements improve the way that substances are scheduled, supporting safe access and availability of medicines and chemicals to the Australian public.

Qualitative Deliverable:	Revised scheduling arrangements for medicines and other chemicals implemented.
2010-11 Reference Point:	The revised regulatory and administrative arrangements for scheduling are implemented within the required timeframes.
Result: Deliverable met.
Both the ACMS and the ACCS are now operational.

In-vitro diagnostic devices (IVD) Framework

From March 2010, the TGA implemented a new regulatory framework for in-vitro diagnostic devices (IVDs).

The Australian Health Ministers’ Advisory Council (AHMAC) approved the development of a regulatory model and endorsed the development of a new IVD regulatory framework, aligned with international best practice. AHMAC agreed that the project would ensure a safe, collaborative and rigorous approach to the regulation of IVDs, thereby increasing public confidence in the IVDs available. The new framework is aligned with international best practice such that: all IVDs undergo pre-market assessment in line with their risk classification; it ensures no importation of inferior quality IVDs (no dumping); there is no additional regulatory burden for Australian manufacturers who already export to Europe and the USA; and there is a strong requirement for post market monitoring and mandatory reporting timeframes for serious adverse events.

A four year transition period for all IVDs began on 1 July 2011.

Qualitative Deliverable: New regulatory frameworks for in-vitro diagnostic (IVDs) and for biologicals implemented.

2010-11 Reference Point: In-vitro diagnostic and biologicals frameworks are implemented within required timeframes.

Result: Deliverable met.

A new regulatory framework for IVDs was implemented in March 2010 and was refined through 2010-11 in order to align with international best practice such that all IVDs undergo pre-market assessment in line with their risk classification. A new regulatory framework for biologicals was implemented from 31 May 2011.

Qualitative Deliverable:	New regulatory frameworks for in-vitro diagnostic (IVDs) and for biologicals implemented.
2010-11 Reference Point:	In-vitro diagnostic and biologicals frameworks are implemented within required timeframes.
Result: Deliverable met.
A new regulatory framework for IVDs was implemented in March 2010 and was refined through 2010-11 in order to align with international best practice such that all IVDs undergo pre-market assessment in line with their risk classification. A new regulatory framework for biologicals was implemented from 31 May 2011.

Biologicals Framework

On 31 May 2011 the TGA introduced a new regulatory framework for biologicals following extensive consultation with consumers, health professionals and industry. The framework is based on a recommendation endorsed by all Australian State and Territory Health Ministers and results in improved regulation of human tissues and cellular therapies. The new framework provides improved clarity by applying different levels of pre-market regulation to biological products, based on the risks associated with the use of each product. In addition, the framework has been designed with the flexibility to accommodate emerging technologies. All products within the scope of the new biological framework will need to comply with the requirements made under the new legislation.
The TGA is working with the Australian Organ and Tissue Donation Transplantation Authority to finalise arrangements for meeting the direct regulatory costs incurred to industry for TGA regulatory activity, such as application, evaluation and manufacturing site audit fees, for Australian publicly funded facilities and not-for-profit hospital supply units as recommended by Australian State and Territory Health Ministers.

Product specific standards and the first version of the Australia Regulatory Guidelines for Biologicals, which will support the framework for biologicals, were implemented in early July 2011.

To ensure the TGA has a good understanding of our stakeholders’ information needs, the TGA has established a Communications Reference Group that includes relevant industry and consumer representative bodies. The reference group is assisting with the development of explanatory guidelines for external stakeholders.

Whole of Sub-Program Performance Information

Qualitative Deliverable:	Stakeholders participate in program development through a range of avenues.
2010-11 Reference Point:	Stakeholders participated in program development through avenues such as regular consultative committees, conferences, stakeholder engagement forums, surveys, submissions on departmental discussion papers and meetings.
Result: Deliverable met.
The TGA continued to involve consumers, health professionals, and industry in TGA deliberations through expert committees. In addition, the Government appointed a panel comprising consumers, health professionals and industry to review transparency of the TGA activities. This panel reported to the Secretary of the Department of Health and Ageing on 30 June 2011.
Quantitative Deliverable:	Percentage of variance between actual and budgeted expenses.
2010-11 Target:	≤ 0.5%	2010-11 Actual:	-4.4%
Result: Deliverable not met.
The actual level of TGA’s cost recovered activities in 2010-11 was lower than the forecast prepared at the Additional Estimates. Therefore both revenue and expenses were lower than budget though net surplus of $0.933m was close to the budgeted surplus of $0.586m. The variance of $11.189m (-9%) between the 2010-11 budget estimate of $118.133m and the 2010-11 actual outcome of $106.944m is the result of less than expected expenditure in a number of areas including Salaries $5.0m, Consultants $1.0m, IT $0.5m, Overseas and Domestic Travel of $0.8m, Other supplier and corporate expenses of $2.9m, and delayed Capital Works of $1.0m. This under expenditure was offset by and the result of less than expected revenue largely in the areas of Evaluation Fees, Application Fees and Conformity Assessments.

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Sub-Program 1.4.3: Industrial Chemicals

Sub-Program 1.4.3 aims to ensure that uses of industrial chemicals are safe for human health and the environment, and to further improve the efficiency of the regulatory framework, for industry and the community.

Protect Human Health and the Environment

In 2010-11, the department, through the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), continued to protect human health and the environment through the promotion of safe and sustainable use of industrial chemicals. This was achieved through the pre-market assessment of 282 industrial chemicals not previously used in Australia, as well as assessing industrial chemicals already in use.

Qualitative Deliverable:	Assess hazards and risks of industrial chemicals to public health, occupational health and safety and the environment based on the best available scientific knowledge and evidence.
2010-11 Reference Point:	Assessments completed within legislated timeframes.
Result: Deliverable substantially met.
NICNAS completed 282 assessments of chemicals new to Australia and three existing chemical assessments. The majority of new chemicals assessments were completed within legislated timeframes, and the existing chemical assessments met legislated timeframes. Delays for new chemicals assessments were either due to the complexity of the assessment, or to a period of intense assessment activity. For industrial chemicals already in use in Australia, NICNAS completed the draft assessment of Diethyl Phthalate (DEP) and the N-(n-butyl) thiophosphoric triamide (NBPT) secondary notification. In addition, a review of the current scientific research on Multiple Chemical Sensitivity (MCS) was finalised. The assessments are science based, using information on the chemical and its hazard provided by industry, and comprehensive literature reviews, to develop a conservative estimate of the risk.
Quantitative KPI:	Percentage of new chemical assessments considered within legislated timeframes.
2010-11 Target:	96%	2010-11 Actual:	95%
Result: Indicator substantially met.
In 2010-11, a total of 282 new chemicals assessment certificates and permits were issued consisting of 165 assessment certificates and 117 permits. For these assessments, 96% of reports for assessment certificates were completed within legislated timeframes, 97% of assessment certificates issued on time and 89% of permits were issued on time.
Quantitative KPI:	Percentage of new chemicals assessed which are safer and less hazardous.
2010-11 Target:	80%	2010-11 Actual:	74%
Result: Indicator substantially met.
The regulatory requirement for chemicals being introduced into Australia was revised in 2008-09 to facilitate the introduction of less hazardous and lower risk chemicals by industry. The percentage of new chemicals assessed that are safer and less hazardous fell from 81% in 2009-10 to 74% in 2010-11. This decrease can in part be attributed to the doubling of the number of Commercial Evaluation Chemical (CEC) permits issued this year, while the number of certificates and other permits have either decreased slightly or remained steady. In the last three years the proportion of chemicals introduced under CEC permits that are safer and less hazardous has remained relatively constant at 36-40%, despite fluctuations in the actual numbers of permits issued. CEC permits are for chemicals introduced for the purposes of a commercial evaluation at a limited number of sites and their use is controlled through permit conditions. They do not include chemicals used in consumer products. Excluding CEC permits, the percentage would increase to 80%.

NICNAS also undertook reviews of major existing chemicals through publication of reports on the NBPT secondary notification, and completion of the first stage of the draft assessment of DEP. In addition, a review of the current scientific research on MCS was finalised and advice provided on priority areas for further study to assist in developing a clinical basis for the diagnosis and treatment of individuals with this condition.

Qualitative Deliverable:	Several major reviews of existing chemicals of concern finalised.
2010-11 Reference Point:	Five reviews finalised by 30 June 2011.
Result: Deliverable substantially met.
In 2010-11, NICNAS completed three reviews of major existing chemicals of concern, the final report on diethylhexyl phthalate (DEHP), draft assessment of DEP and the NBPT secondary notification. Three other reviews (one phthalate, a secondary notification and one flame retardant) were substantially progressed and are expected to be finalised in 2011-12.
Quantitative KPI:	Percentage of legislated timeframes adhered to for assessment of existing chemicals.
2010-11 Target:	100%	2010-11 Actual:	100%
Result: Indicator met.
NICNAS met all the legislated timeframes for the assessment of existing chemicals in 2010-11. There is a statutory two stage consultation process, including timeframes. In the first stage, the assessment report is forwarded to the importers/manufacturers of the chemical that applied for assessment and in the second stage the report is released for public comment. Both these stages have 28 day timeframes each for stakeholder input and for NICNAS to consider any comments. There are defined processes for gazettal of these activities.

In 2010-11, NICNAS worked extensively with stakeholders to develop a risk-based framework for prioritising and assessing the human health and environmental impact of the approximately 38,000 unassessed chemicals on the Australian national inventory.¹¹ A significant portion of the activities to optimise the efficacy and efficiency of the framework have been completed. During 2011-12, NICNAS will continue to focus on preparations for implementation of this major project. The framework will deliver more timely information about the hazards and risks associated with the use of industrial chemicals and identify those chemicals which require risk mitigation measures to ensure safe use.

Quantitative Deliverable:	Percentage of NICNAS Priority Existing Chemicals recommendations developed in consultation with relevant stakeholders.
2010-11 Target:	100%	2010-11 Actual:	100%
Result: Deliverable met.
NICNAS Priority Existing Chemicals recommendations during 2010-11 were all developed in consultation with relevant stakeholders. Significant revisions were made to the draft report on MCS following two rounds on public comment periods conducted prior to finalising the report. Public comments were invited on the recommendations for NBPT prior to finalising this report. Recommendations for DEP were developed in consultation with stakeholders responsible for implementation of NICNAS assessment recommendations and will be subject to public comment in 2011‑12.

From 1 January 2011, NICNAS introduced new administrative regulatory arrangements for nanoforms of new industrial chemicals, to ensure that scientific uncertainties concerning the possible risks to human health, safety and the environment are identified and appropriately managed, to the benefit of the community and industry. During 2011-12, NICNAS will focus on changes to processes for nanoforms of existing industrial chemicals.

Qualitative Deliverable:	Implementation of regulatory framework on industrial nanomaterials.
2010-11 Reference Point:	Framework for new chemicals implemented by 30 June 2011. Framework options for existing chemicals progressed during 2010-11.
Result: Deliverable met.
NICNAS consulted on, and introduced, new administrative arrangements for nanoforms of new industrial chemicals from 1 January 2011. During 2010-11 work progressed on framework options for the regulation of nanoforms of existing chemicals for public consultation in 2011-12.

NICNAS further strengthened international linkages through formalisng bilateral arrangements. This included signing a Memorandum of Understanding with the European Chemicals Agency (ECHA) to facilitate technical cooperation, encourage harmonisation to reduce duplication, and support the sharing of experience about operations, regulatory capacities and the dissemination of information. NICNAS also signed a Confidentiality Agreement with the United States Food and Drug Administration to allow greater exchange of information with NICNAS. Both these arrangements will assist promoting the safe use of industrial chemicals for humans and the environment.

Qualitative Deliverable:	Influence international assessments, regulatory approaches, and methodologies for incorporation, as appropriate into Australian industrial chemicals assessment and management systems.
2010-11 Reference Point:	Active participation in international harmonisation activities and progression of bilateral relationships.
Result: Deliverable met.
NICNAS continued its influential role in international harmonisation activities. NICNAS received positive support for its regulatory reform of industrial nanomaterials at a meeting of the OECD working party on manufactured nanomaterials.

Regulatory reform of cosmetics continued in 2010-11. NICNAS prepared legislative amendments to enable eligible cosmetic chemicals to be listed on the Australian national inventory. As part of the consultation process which shaped the amendments, NICNAS exposed the draft Bill on two occasions to key NICNAS stakeholder committees.

In 2010-11, NICNAS progressed improvements to two key business systems. NICNAS tendered for an online registration facility for importers and manufacturers of industrial chemicals, as well as scoped and updated the NICNAS website to improve accessibility and usability of the substantial chemical safety information. In 2011-12, NICNAS will focus on completing these two key business efficiencies, to ensure a more user friendly public interface for its IT systems. Both of these initiatives contribute to enhancing efficiency and effectiveness of the regulatory framework by replacing outmoded business systems.

Quantitative KPI: Percentage of chemical companies compliant with NICNAS registration obligations, payment of fees and annual reporting.

2010-11 Target: 55%
2010-11 Actual:

Not applicable

Result: Not applicable.

This key performance indicator has been replaced in the 2011-12 Portfolio Budget Statements with “Percentage of known industrial chemical introducers registered and compliant” as it better clarifies the impact of the NICNAS Compliance and Enforcement Program on NICNAS registration activities.

Quantitative KPI: Percentage increase in visitor sessions to NICNAS website.

2010-11 Target: 5% 2010-11 Actual: Decrease 6%

Result: Indicator not met.

In 2010-11, NICNAS had a 6% decrease in visitor sessions to its website. However visitor sessions remain strong and are above those of 2008-09. During 2011-12, the NICNAS website will be redesigned to improve accessibility and useability of its extensive chemical safety information.

Quantitative Deliverable: Percentage of reports on assessed chemicals posted to the NICNAS website.

2010-11 Target: New chemicals: 100%
Existing Chemicals: 100% 2010-11 Actual: New chemicals: 100%
Existing Chemicals: 100%

Result: Deliverable met.

NICNAS published all new chemicals assessment reports and finalised existing chemicals assessment reports on its website.¹²

Quantitative KPI: Percentage of customer satisfaction with chemical safety information.

2010-11 Target: 95% 2010-11 Actual: Data not available

Result: Indicator not assessed.

This key performance indicator has been removed from the 2011-12 Portfolio Budget Statements because the revised NICNAS stakeholder survey no longer captures these data.

NICNAS continued to consult with its key stakeholders, such as the chemical industry, the community (including employees working with chemicals), the Australian Government and state and territory governments, through national networks, advisory committees and information activities. A key public consultation during 2010-11 was on the development of the NICNAS Cost Recovery Impact Statement (CRIS) through release of a discussion paper, public submission process, public meetings and online survey. Issues raised by stakeholders will be considered in the draft CRIS scheduled to be released for stakeholder consultation in 2011-12.

Qualitative KPI: Effectiveness of regulatory and scientific advice.

2010-11 Reference Point: High level uptake of NICNAS regulatory recommendations by stakeholders

Result: Indicator met.

There has been high level uptake of NICNAS regulatory recommendations by stakeholders, for example:

the Scheduling Delegate confirmed the NICNAS recommendation and decided that DEHP should not be used as an ingredient in cosmetics and a permanent ban on children’s plastic products with more than 1% DEHP was introduced by the Australian Competition and Consumer Commission (ACCC);
the Scheduling Delegate decided to schedule triclosan in the Poisons Standard under Schedule 6 when used in cosmetics, as recommended in a NICNAS report published in 2009; and
the NICNAS recommendation on the hazard classification for NBPT is now included in Safe Work Australia’s Hazardous Substances Information System (HSIS).

Quantitative KPI: Percentage of customers satisfied with NICNAS training.

2010-11 Target: 95% 2010-11 Actual: 100%

Result: Indicator met.

NICNAS feedback to its training during 2010-11 was very positive and sessions covered introduction to obligations and responsibilities under the Industrial Chemicals (Notifications and Assessment) Act 1989, regulation of industrial nanomaterials in Australia and obligations for introducers of new chemicals. Similar activities are planned for 2011-12.

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Quantitative KPI:	Percentage of chemical companies compliant with NICNAS registration obligations, payment of fees and annual reporting.
2010-11 Target:	55%	2010-11 Actual:	Not applicable
Result: Not applicable.
This key performance indicator has been replaced in the 2011-12 Portfolio Budget Statements with “Percentage of known industrial chemical introducers registered and compliant” as it better clarifies the impact of the NICNAS Compliance and Enforcement Program on NICNAS registration activities.
Quantitative KPI:	Percentage increase in visitor sessions to NICNAS website.
2010-11 Target:	5%	2010-11 Actual:	Decrease 6%
Result: Indicator not met.
In 2010-11, NICNAS had a 6% decrease in visitor sessions to its website. However visitor sessions remain strong and are above those of 2008-09. During 2011-12, the NICNAS website will be redesigned to improve accessibility and useability of its extensive chemical safety information.
Quantitative Deliverable:	Percentage of reports on assessed chemicals posted to the NICNAS website.
2010-11 Target:	New chemicals: 100% Existing Chemicals: 100%	2010-11 Actual:	New chemicals: 100% Existing Chemicals: 100%
Result: Deliverable met.
NICNAS published all new chemicals assessment reports and finalised existing chemicals assessment reports on its website.¹²
Quantitative KPI:	Percentage of customer satisfaction with chemical safety information.
2010-11 Target:	95%	2010-11 Actual:	Data not available
Result: Indicator not assessed.
This key performance indicator has been removed from the 2011-12 Portfolio Budget Statements because the revised NICNAS stakeholder survey no longer captures these data.

Qualitative KPI:	Effectiveness of regulatory and scientific advice.
2010-11 Reference Point:	High level uptake of NICNAS regulatory recommendations by stakeholders
Result: Indicator met.
There has been high level uptake of NICNAS regulatory recommendations by stakeholders, for example: the Scheduling Delegate confirmed the NICNAS recommendation and decided that DEHP should not be used as an ingredient in cosmetics and a permanent ban on children’s plastic products with more than 1% DEHP was introduced by the Australian Competition and Consumer Commission (ACCC); the Scheduling Delegate decided to schedule triclosan in the Poisons Standard under Schedule 6 when used in cosmetics, as recommended in a NICNAS report published in 2009; and the NICNAS recommendation on the hazard classification for NBPT is now included in Safe Work Australia’s Hazardous Substances Information System (HSIS).
Quantitative KPI:	Percentage of customers satisfied with NICNAS training.
2010-11 Target:	95%	2010-11 Actual:	100%
Result: Indicator met.
NICNAS feedback to its training during 2010-11 was very positive and sessions covered introduction to obligations and responsibilities under the Industrial Chemicals (Notifications and Assessment) Act 1989, regulation of industrial nanomaterials in Australia and obligations for introducers of new chemicals. Similar activities are planned for 2011-12.

Whole of Sub-Program Performance Information

Qualitative Deliverable:	Stakeholders participate in program development through a range of avenues.
2010-11 Reference Point:	Stakeholders participated in program development through avenues such as regular consultative committees, conferences, stakeholder engagement forums, surveys, submissions on departmental discussion papers and meetings.
Result: Deliverable met.
In 2010-11, NICNAS held a 20^th anniversary symposium and three meetings for each of its key advisory groups – the Industry Government Consultative Committee and Community Engagement Forum. The NICNAS Stakeholder Survey conducted during August 2010 received over 1,000 online responses with an action plan developed for further work during 2011-12. Stakeholder consultations were held for the Cost Recovery Impact Statement, assessment work and on reform activities. NICNAS provided speakers to a number of key national and international conferences, with a focus on industrial nanomaterials and assessment work.
Quantitative Deliverable:	Percentage of variance between actual and budgeted expenses.
2010-11 Target:	≤ 0.5%	2010-11 Actual:	-4.3%
Result: Deliverable not met.
Expenses for capital projects and revenue and expenses for NICNAS’s cost recovered activities were lower than initially anticipated.

Sub-Program 1.4.4: Gene Technology Regulation

Sub-Program 1.4.4 aims to protect the health and safety of people and the environment by regulating dealings with genetically modified organisms (GMOs).

Gene Technology Regulation

The Gene Technology Regulator (the Regulator), supported by the department’s Office of the Gene Technology Regulator (the Office), administers the Commonwealth Gene Technology Act 2000 and corresponding state and territory legislation to protect the health and safety of Australians and the environment by regulating dealings with genetically modified organisms. The functions of the Regulator are prescribed in the legislation.

The Regulator, through the Office, focused on protecting the health and safety of people and the environment by administering a responsive, efficient, effective and science-based national scheme for the regulation of gene technology that revolves around a system of prohibitions and approvals. In 2010-11, the Regulator consulted technical and scientific experts, state and territory governments, Australian Government agencies and the wider community on the assessment of all intentional release licence applications¹³ to ensure that the assessments were robust and based on current science. In accordance with the requirements of gene technology legislation,¹⁴ the Office monitored the conduct of licensed dealings¹⁵ with genetically modified organisms (GMOs) and continued to maintain a comprehensive record of approved GMO dealings on the Office’s website¹⁶ for the general public.

In 2010-11, the Regulator finalised the review of the Gene Technology Regulations 2001 (the Regulations) which had continued from the previous reporting period, and the Gene Technology Amendment Regulations 2011 (the Amendment Regulations) were made on 2 June 2011.

Qualitative Deliverable:	Review of the Gene Technology Regulations 2001.
2010-11 Reference Point:	Finalise amendments in mid 2010-11 and implement the revised regulations by end of 2010-11.
Result: Deliverable substantially met.
The review culminated in the making of the Gene Technology Amendment Regulations 2011 on 2 June 2011. The commencement date was 1 September 2011 which allowed time for stakeholders to comply with the changes. The Office substantially met the target for this deliverable but the finalisation and making of the Amendment Regulations 2011 was delayed, because additional consultation was required following feedback from stakeholders in June 2010. The Office initiated a program to inform regulated organisations of the changes, including through the 4^th National Institutional Biosafety Committee Forum in June 2011.

The Amendment Regulations ensure classification and regulation of dealings with GMOs remains commensurate with current scientific understanding of risk and will assist the regulated community to better understand and comply with their legislative obligations.

Qualitative Deliverable:	Thorough assessment and management of risks posed by GMOs or as a result of gene technology.
2010-11 Reference Point:	Risks posed by GMOs or gene technology managed appropriately.
Result: Deliverable met.
In 2010-11, the Regulator prepared comprehensive risk assessments and risk management plans for proposed activities with GMOs. Stringent licence conditions were imposed, where appropriate, to ensure containment of GMOs and management of identified risks. There was a high level of compliance with the gene technology legislation and risks to human health or the environment were managed appropriately.

During this period, the Regulator also developed, in consultation with stakeholders, revised Guidelines for the Transport, Storage and Disposal of GMOs. The Guidelines will support the operation of the Amendment Regulations and both will commence on 1 September 2011.

Qualitative Deliverable:	Consultation with key stakeholders on draft guidelines and on licence applications for intentional release of GMOs into the environment.
2010-11 Reference Point:	Seek feedback from stakeholders on draft guidelines and intentional release licence applications in a timely and transparent manner in accordance with the legislation.
Result: Deliverable met.
In January 2011, the Regulator sought feedback from key stakeholders on draft Guidelines for the Transport, Storage and Disposal of GMOs which were developed to support the proposed Amendment Regulations 2011. The majority of submissions indicated broad support for the proposed revised guidelines and the Regulator issued the guidelines on 2 June 2011. The new guidelines will come into effect from 1 September 2011. The Regulator consults a wide range of stakeholders including the public before making a decision on whether to issue any intentional release licence in accordance with the gene technology legislation. During 2010-11, the Regulator consulted on six intentional release applications. Consultation periods exceeded the minimum specified timeframe of 30 days stipulated in the legislation.

These above activities contributed to ensuring a responsive, efficient and effective regulatory scheme that protects people and the environment and minimises regulatory burden.

Qualitative KPI:	Protect people and the environment through identification and management of risks from GMOs.
2010-11 Reference Point:	High level of compliance with the gene technology legislation and no adverse effect on human health or environment from GMOs.
Result: Indicator met.
Routine monitoring and auditing of the regulated community demonstrated a high level of compliance with the gene technology legislation. The Office identified a small number of minor non-compliances or alleged breaches during routine monitoring of containment facilities and licensed dealings involving GMOs. In all instances, the Regulator determined that findings of non-compliances presented negligible risk to human health and safety or to the environment, were minor in nature, involved negligible or zero culpability, and were resolved by reminders, education and/or cooperative compliance. No adverse effects on human health or environment from GMOs were reported.
Qualitative KPI:	Facilitate cooperation and prevent duplication in the implementation of GMO regulation.
2010-11 Reference Point:	High degree of cooperation with relevant regulatory agencies.
Result: Indicator met.
The Regulator consulted with other relevant regulatory agencies prior to making decisions for all intentional release licence applications for GMOs to ensure that any risks to human health or the environment are managed effectively through coordinated action plans and decision-making. The Office facilitated cooperation and harmonisation through the ‘Regulators Forum’ and its working group activities during 2010-11, and through bilateral cooperation with relevant regulators.

In 2011-12, the Regulator and the Office participated in the ‘Regulators Forum’ to exchange information between relevant regulatory agencies (Food Standards Australia New Zealand, National Industrial Chemicals Notification and Assessment Scheme, Therapeutic Goods Administration, Australian Pesticides and Veterinary Medicines Authority and the Biosecurity Services Group within the Department of Agriculture, Fisheries and Forestry).

The Office also engaged actively in international fora focussing on the harmonisation of the risk assessment and regulation of GMOs including the Organisation for Economic Cooperation and Development and Cartagena Protocol on Biosafety.

The Office was also invited to contribute to capacity building workshops on risk assessment and regulation of GMOs including in the region covered by the Association of South/South East Asian Nations and in West Africa. The Office also hosted a study tour from the Malaysian Department of Biosafety.

Quantitative KPI:	Percentage of licence decisions made within statutory timeframes.
2010-11 Target:	100%	2010-11 Actual:	100%
Result: Indicator met.
The Regulator made decisions on all licence applications within the applicable statutory timeframes, maintaining the 100% record of previous reporting periods. There were no appeals of decisions made by the Regulator.
Quantitative Deliverable:	Percentage of GMO licences issued under the Gene Technology Act 2000 that are entered onto a publicly accessible record on the Office’s website.
2010-11 Target:	100%	2010-11 Actual:	100%
Result: Deliverable met.
During 2010-11, the Regulator issued six licences for intentional release of GMOs into the environment. The Office entered the licences and decision documents for the six licences onto the publicly accessible GMO Record page on the Office’s website.¹⁷
Quantitative Deliverable:	Percentage of field trial sites and higher level containment facilities inspected.
2010-11 Target:	20%	2010-11 Actual:	40% and 23%
Result: Deliverable met.
Field trial sites are inspected to monitor for compliance with licence conditions so that risks to human health and safety and the environment are managed. In 2010-11, the Office inspected 40% of current and post-harvest genetically modified crop field trial sites. The field trial sites inspected were spread across South Australia, Western Australia, New South Wales, Victoria, Queensland and the Australian Capital Territory. Genetically modified crop field trials inspected included canola, wheat, barley, cotton, Indian mustard, papaya, pineapple and white clover. The Office also inspected 23% of higher level containment facilities.
Quantitative Deliverable:	Percentage of variance between actual and budgeted expenses.
2010-11 Target:	≤ 0.5%	2010-11 Actual:	-0.5%
Result: Deliverable met.
During 2010-11, the Office managed their funding responsibly and achieved a result of -0.5%, in-line with the target.

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Program 1.5: Immunisation

Program 1.5 aims to reduce the incidence of vaccine preventable disease and ensure optimal immunisation coverage rates by improving the efficiency and effectiveness of the Immunise Australia program, in consultation with states and territories.

Improve Immunisation

Immunisation is an important part of the Australian Government’s strategy to reduce preventable mortality and morbidity. In 2010-11, the department, through the National Immunisation Program, continued to support the provision of immunisations to the Australian community and maintain a high level of immunisation coverage. High immunisation coverage provides better protection against major vaccine preventable diseases and reduces the incidence of these diseases in the community. The program targets a range of vaccine preventable diseases: measles, mumps, rubella, polio, pneumococcal disease, pertussis (whooping cough), rotavirus, varicella (chickenpox), diphtheria, tetanus, hepatitis B, meningococcal C and Haemophilus influenzae type b for children less than seven years of age; human papillomavirus for females only, hepatitis B (catch-up), varicella (catch-up) and a combined diphtheria, tetanus and pertussis (booster) for adolescents; seasonal influenza vaccine for Australians from six months of age and over that are medically at risk of complications from influenza infection; influenza and pneumococcal disease for older Australians and hepatitis A and pneumococcal disease for Indigenous Australians.

In 2010-11, the Government approved the inclusion of two new vaccines on the National Immunisation Program. Prevenar 13^®, a vaccine to protect against 13 strains of pneumococcal disease, to replace Prevenar 7^®, which provides protection against seven strains of the disease and Menitorix^®, a vaccine providing protection against two diseases: Haemophilus influenzae type b and Neisseria meningitidis group C (meningococcal C). The Government also announced funding for the provision of a supplementary dose of Prevenar 13^®for children aged between 12 and 35 months of age Prevenar 13^®is expected to be available from 1 July 2011. Menitorix^® is expected to be available on the National Immunisation Program in 2011-12 following completion of vaccine procurement processes.

Quantitative KPI:	Improve the immunisation coverage rates among children 60‑63 months of age.
2010-11 Target:	90%	2010-11 Actual:	89.2%
Result: Indicator substantially met.
Immunisation rates in 2010-11 continued to be high with the national immunisation coverage rate for children aged 60-63 months being 89.2% as at 31 March 2011, compared with 89.6 % as at 31 March 2010.
Quantitative KPI:	Maintain the immunisation coverage rates among children 24‑27 months of age.
2010-11 Target:	92.7%	2010-11 Actual:	91.9%
Result: Indicator substantially met.
Immunisation rates in 2010-11 continued to be high with the national immunisation coverage rate for children aged 24 -27 months being 91.9 % as at 31 March 2011, compared with 92.4 % as at 31 March 2010.

Adverse Events Following Immunisation

In December 2010, Professor John Horvath AO was commissioned to undertake an independent review of Australia’s management of vaccine adverse events following the withdrawal of seasonal influenza vaccines for children in the 2010 influenza season. The Horvath Review¹⁸ was released on 25 May 2011. The review found that the Australian adverse events management system has a number of strengths: it compares internationally to passive surveillance systems in other countries and was able to detect the safety signals associated with the 2010 seasonal influenza vaccine, undertake a rigorous investigation and take appropriate action.

The review found that once the first batch of adverse case reports had been received by the Therapeutic Goods Administration, its regulatory actions were appropriate and timely. The decision by the Chief Medical Officer to suspend use of all seasonal influenza vaccines for children was also considered by the review as appropriate and proportionate to the risk.

The review also made seven high level recommendations. The department is progressing the recommendations which will be implemented over a period of two years.
The initial work will focus on:

establishing a working group to consider and recommend the most suitable governance arrangements for monitoring and responding to vaccine safety issues in Australia and to make recommendations for an improved system of governance for vaccine safety monitoring (Recommendation 1); and
establishing a Working Party of Experts to define surveillance objectives and establish protocols and procedures for managing adverse events following immunisation (Recommendation 2). Nationally agreed protocols for program action and communication are to be in place prior to the commencement of immunisation for the 2012 influenza season.

Quantitative Deliverable:		Number of completed tenders under the Commonwealth Own Purpose Expense arrangements.
2010-11 Target:		3	2010-11 Actual:	0
Result: Deliverable not met.
The department undertook a procurement process to secure the supply of seasonal and pandemic influenza vaccine in 2010-11. The process has taken longer than expected due to the many technical issues that arose during the assessment process, including the suspension of the paediatric influenza vaccine for children under five years of age; a review of paediatric influenza vaccines for children under 10 years of age by Australian Technical Advisory Group on Immunisation for the 2011 season; and issues around the reduced shelf life of pandemic H1N1 vaccine. Influenza bridging deeds were executed to provide pandemic and seasonal influenza vaccine supply in 2011. Deed execution for the supply of seasonal influenza and pandemic vaccines for 2012-16 is expected to be completed in the first quarter of 2011-12.
Qualitative KPI:	Implementation of the Commonwealth Own Purpose Expense arrangements are effective.
2010-11 Reference Point:	Positive feedback is received through the Stage 1 implementation evaluation.
Result: Indicator not met.
The department will conduct a post tender evaluation in 2011 following completion of the tender process for the supply of seasonal and pandemic influenza vaccine.

Rotavirus Vaccination and Intussusception

In 2010-11 new evidence from Australian and overseas studies suggested a small increased risk of intussusception (a form of bowel obstruction) in infants following rotavirus vaccination. The link was detected following post-marketing surveillance established at the commencement of the rotavirus vaccination program. The Therapeutic Goods Administration and the Australian Technical Advisory Group on Immunisation considers that the overall risk benefit balance of rotavirus vaccines remains positive and that rotavirus vaccination should continue. Prior to the introduction of rotavirus vaccine, an estimated 10,000 hospital admissions occurred annually in children under five years due to rotavirus gastroenteritis. Since the introduction of rotavirus vaccination on to the National Immunisation Program emergency department visits for acute gastroenteritis in young children have declined and hospitalisations for rotavirus gastroenteritis in the under five year age group have been reduced by over 70%.

In February 2011, the Chief Medical Officer issued advice to general practice managers, paediatricians and immunisation providers on the small risk of Intussusception and information for parents about the risk was circulated to all providers.

Pneumococcal Vaccination in Older Australians

In March 2011, a cluster of seven severe local injection site reactions in older Australians following pneumococcal vaccination reported to the by New South Wales Health led to a batch recall of a pneumococcal vaccine, Pneumovax 23^®. On 19 April 2011, the Therapeutic Goods Administration issued a precautionary advice to doctors not to give patients a second dose of the vaccine pending completion of an investigation into an increased rate of adverse events in people receiving the vaccine a second time. The reactions included reports of pain and swelling at the site where the vaccination was given. A working group involving representatives from the Therapeutic Goods Administration, Australian Technical Advisory Group on Immunisation, and Australian Technical Advisory Group on Immunisation’s Pneumococcal working group was established to investigate the apparent increased notifications of severe local reactions. This work is ongoing.

Data Collection

National Human Papillomavirus Vaccination Register

The department secured ongoing funding for the continued administration of the National Human Papillomavirus Vaccination Register. This register plays an essential role in monitoring and evaluating the National Human Papillomavirus Vaccination Program by recording information about Human Papillomavirus vaccine doses administered through this program. The ongoing administration of the Human Papillomavirus Vaccination Register will continue to provide the capacity to monitor Human Papillomavirus Vaccine coverage for over 100,000 females vaccinated each year.

The National Human Papillomavirus Vaccination Program Register was established to monitor vaccinations of the three dose course of Gardasil^® for young women in Australia. This register is designed to, among other things, generate reminder letters and overdue reports, and enable individuals to be recalled in the event that booster doses are required in the future. Reminder letters will improve awareness and understanding of the need for the human papillomavirus vaccine and ongoing cervical screening, as well as promote completion of vaccine course.
Data on vaccination coverage with human pappilomavirus vaccine was released in April 2011. Nearly three out of four (73%) girls aged 12 and 13 years, and nearly 72% of girls aged 14 and 15 years have been fully vaccinated with the three doses of human papillomavirus vaccine needed to protect them from the strains of human papillomavirus that can lead to cervical abnormalities and cancer. Australia’s coverage rate for human papillomavirus vaccination at 15 years (73%) is high compared to European countries. Only Denmark has a similar coverage rate (73%). The coverage rate of other European countries ranges from 29-56%.

Adult Vaccination Surveys – 2006 and 2009

The 2009 Adult Vaccination Survey, the seventh national survey in the current series, was published on the Australian Institute of Health and Welfare’s website¹⁹ on 3 March 2011. The department also published the 2006 Adult Vaccination Survey on its website²⁰on 3 March 2011.

The results of the survey of 10,231 Australians aged 18 years or older show a slight drop-off in the influenza vaccination coverage rate since 2004, the coverage rate of the influenza vaccine still remains high. In 2004, the coverage rate was 79.1% and it dropped slightly to 74.6% in 2009. The pneumococcal vaccination coverage rate increased from 53.0% to 54.4% in 2009. The vast majority of the vaccinations under these programs were provided free of charge under the National Immunisation Program.

National Immunisation Strategy

In 2010-11, the National Immunisation Committee, which comprises representatives from the department, all state and territory health departments, key stakeholder groups and a consumer, oversaw the continued development of the National Immunisation Strategy. This strategy will provide a planning framework for future directions and initiatives in immunisation and vaccine preventable diseases at the national level.

Qualitative Deliverable:	Develop the National Immunisation Strategy.
2010-11 Reference Point:	National Immunisation Strategy completed in 2010-11.
Result: Deliverable not met.
The finalisation of the National Immunisation Strategy was delayed due to an extended stakeholder consultation period which included a national key stakeholder forum. The strategy is expected to be completed and considered by health ministers in 2011-12.

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National Partnership Agreement for Essential Vaccines

The National Partnership Agreement for Essential Vaccines outlines the roles and responsibilities of the department and the states and territories in the delivery of the National Immunisation Program and the transition arrangements for Commonwealth procurement of National Immunisation Program vaccines.

The transition to national purchasing is being implemented progressively over a number of years. The National Partnership Agreement for Essential Vaccines provides transitional capacity to fund states and territories directly for vaccines each will purchase until a national supply deed is in place. The National Partnership Agreement for Essential Vaccines arrangement will improve the efficiency and long-term sustainability of the National Immunisation Program.

In 2010-11, the performance indicator definitions for the assessment of reward payment benchmarks under the National Partnership Agreement for Essential Vaccines were endorsed by the Australian Health Ministers’ Advisory Committee. These performance benchmarks relate to: maintaining or increasing vaccine coverage for children four years of age and Indigenous Australians; maintaining or improving coverage in areas where vaccine coverage is low; and for maintaining or decreasing wastage and leakage of vaccines.

To meet the criteria for reward payments, two out of four benchmarks need to be met. It is anticipated that incentive payments, made up of reward and facilitation payments will lead to improvements in the cost-effectiveness of service delivery. For 2009-10, the Council of Australia Governments Reform Council report shows that all states and territories met the minimum requirement. This first report was released on 30 June 2011.

Whole of Program Performance Information

Qualitative Deliverable:		Produce relevant and timely evidence-based policy research.
2010-11 Reference Point:		Relevant evidence-based policy research produced in a timely manner.
Result: Deliverable met.
The Therapeutic Goods Administration, supported by the National Centre for Immunisation Research and Surveillance and Australian Technical Advisory Group on Immunisation, conducted an investigation into an apparent increase in intussusception among babies in the first one to seven days after receiving the first dose of rotavirus vaccine. As a result, the department developed information for providers and parents on the risks and benefits of this vaccine. The Horvath Review²¹ was undertaken to identify improvements that could be made to the reporting arrangements for adverse events following immunisation with a focus on transparency and effective communications. The review was released on 25 May 2011. The department funds the National Centre for Immunisation Research and Surveillance to undertake surveillance of vaccine preventable diseases and evaluate immunisation programs to support policy development.
Qualitative Deliverable:	Stakeholders participate in program development through a range of avenues.
2010-11 Reference Point:	Stakeholders participated in program development through avenues such as regular consultative committees, conferences, stakeholder engagement forums, surveys, submissions on departmental discussion papers and meetings.
Result: Deliverable met.
The department continues to work closely with states and territories to meet the desired outcomes of the National Partnership Agreement for Essential Vaccines which sets out key objectives, performance indicators and roles and responsibilities for delivering the National Immunisation Program. The department convened regular meetings of the National Immunisation Committee and the Jurisdictional Immunisation Coordinators to provide policy and program advice to the department on the program. The department hosted a key stakeholder forum to inform the priorities for the National Immunisation Strategy in 2010. This was a unique forum in which representatives from a broad range of organisations involved in immunisation came together to discuss the key issues to be addressed by the Strategy.

Quantitative Deliverable:	Percentage of variance between actual and budgeted expenses.
2010-11 Target:	≤ 0.5%	2010-11 Actual:	-15.2%
Result: Deliverable not met.
The National Immunisation Program is a demand driven program that fluctuates to meet the needs of the Australian public. A lower than expected take up of essential vaccines contributed to this underspend.

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Program 1.6 Public Health

Program 1.6 aims to reduce pressure on the health system by building a public health workforce capacity; improving child, youth, women’s and men’s health; and promoting healthy lifestyle choices to improve public health outcomes.

Promote the Adoption of Healthy Lifestyles

In 2010-11, the department continued to implement and provide oversight and coordination of the eleven initiatives under the National Partnership Agreement on Preventive Health (NPAPH). The NPAPH aims to address the rising prevalence of lifestyle related chronic diseases by implementing programs and activities that promote healthy behaviours in the daily lives of Australians.

In June 2011, a further 33 Local Government Areas (LGAs) joined the Health Communities Initiative tasked with using grants to deliver effective community based physical activity and healthy eating programs. The target population is disadvantaged adults predominately not in the paid workforce.

Quantitative Deliverable:	Number of grants to local governments administered through the Healthy Communities Initiative.
2010-11 Target:	45	2010-11 Actual:	45
Result: Deliverable met.
The 33 LGAs successful under the second phase of the Healthy Community Initiative were announced in June 2011. The third phase funding round was opened in early July 2011.

In 2010-2011, the department worked with the states and territories to implement the Healthy Children and Healthy Workers Initiatives under the NPAPH, which enables healthy lifestyle programs to be implemented in settings such as child care centres, schools and workplaces. The department supported this implementation through the collaborative development of a policy framework to guide the development of implementation plans, which have now all been approved by the Commonwealth Minister for Health and Ageing. The National Charter, The Joint Statement of Commitment: Promoting Good Health at Work was signed by peak representative employer groups and Unions and launched August 2011. The department will continue development in 2011-12 of national standards and benchmarking, national awards for healthy workplace achievements and a national workplace health promotion toolkit and portal to support employers to implement healthy living programs.

Image from the ‘Swap it – don’t stop it’ campaign featuring Eric the Swapper. The image shows what the free new iPhone application for the campaign would like on a mobile screen.

Image from the ‘Swap it – don’t stop it’ campaign featuring Eric the Swapper. The image shows what the free new iPhone application for the campaign would like on a mobile screen.

The department also facilitated agreement among states and territories to the Framework for Measuring Performance Benchmarks under the NPAPH in November 2010. The framework provides an agreed approach to measuring the Partnership’s performance benchmarks, which will be reported on in June 2013 and December 2014.
In March 2011, the department launched on behalf of the Australian National Preventive Health Agency phase two of the NPAPH ‘Measure Up’ campaign. The ‘Swap It, Don’t Stop It’ campaign aims to motivate and actively encourage changes in behaviour to reduce the prevalence and impact of chronic disease related to lifestyle choices. The campaign focuses on the areas of nutrition and physical activity. The ‘Swap It, Don’t Stop It’ campaign is also using new media to engage with Australians including:

a free handy new iPhone app which encourages people to make healthier food and lifestyle choices without giving up all the things they love; and
the ‘Swap It, Don’t Stop It’ Facebook page where members of the Facebook community share their own swaps, and motivate each other to keep on swapping!

Qualitative Deliverable: Roll-out two major advertising activities promoting healthy body weight under the ‘Measure Up’ campaign.

2010-11 Reference Point: Phase 2 advertising materials, based on Phase 1 evaluation recommendations to strengthen the ‘how’ message, launched by late 2010 and repeated early to mid 2011. Advertising activities may include the use of television, radio, print, online and outdoor media to disseminate key messages to target audiences.

Result: Deliverable met.

Phase Two of the ‘Measure Up’ campaign launched on 13 March 2011. ‘Swap It, Don’t Stop It’ campaign advertising included television, print, radio, online and outdoor executions and ran through to 30 June 2011.

Qualitative KPI: Social marketing campaign messages reach adults at key life stages and high risk groups and demonstrate:

increased awareness of the link between lifestyle risk factors and some chronic disease (poor nutrition, physical inactivity, unhealthy weight);
increased appreciation that lifestyle change is an urgent priority;
improved attitudes towards achieving recommended changes in healthy eating, physical activity and healthy weight; and
increased confidence in achieving the desired changes and appreciation of the significant benefits of achieving these changes.

2010-11 Reference Point: Research and evaluation using National Computer-Assisted Telephone Interviewing (CATI) tracking surveys demonstrate campaign messages have reached adults at key life stages and high risk groups.

Result: Indicator met.

Evaluation research conducted by The Social Research Centre demonstrates the campaign to have met its objectives in relation to reach and message communication.

In 2010-11, the department continued to address poor dietary habits and promote healthier food choices for all Australians through reformulation activities with industry under the Food and Health Dialogue. The primary aim of the dialogue is to reduce sodium, sugar, saturated fat and energy and increase fibre, wholegrain, fruit and vegetable content of commonly consumed foods. Sodium targets were agreed with the bread, breakfast cereal and simmer sauce sectors, and sodium and saturated fat targets were agreed with the processed meat sector. The soup and processed poultry sectors will be engaged in July and August 2011 respectively.

In November 2010, an additional 42 primary schools joined the Stephanie Alexander Kitchen Garden National Program, bringing the total of participating schools to 128.

Quantitative Deliverable: Number of government primary schools to implement the Stephanie Alexander Kitchen Garden National Program.

2010-11 Target: ≤ 50% 2010-11 Actual: 42

Result: Deliverable substantially met.

The fourth and final funding round for the Stephanie Alexander Kitchen Garden National Program opened in May 2011.

Qualitative Deliverable:	Roll-out two major advertising activities promoting healthy body weight under the ‘Measure Up’ campaign.
2010-11 Reference Point:	Phase 2 advertising materials, based on Phase 1 evaluation recommendations to strengthen the ‘how’ message, launched by late 2010 and repeated early to mid 2011. Advertising activities may include the use of television, radio, print, online and outdoor media to disseminate key messages to target audiences.
Result: Deliverable met.
Phase Two of the ‘Measure Up’ campaign launched on 13 March 2011. ‘Swap It, Don’t Stop It’ campaign advertising included television, print, radio, online and outdoor executions and ran through to 30 June 2011.

Qualitative KPI:	Social marketing campaign messages reach adults at key life stages and high risk groups and demonstrate: increased awareness of the link between lifestyle risk factors and some chronic disease (poor nutrition, physical inactivity, unhealthy weight); increased appreciation that lifestyle change is an urgent priority; improved attitudes towards achieving recommended changes in healthy eating, physical activity and healthy weight; and increased confidence in achieving the desired changes and appreciation of the significant benefits of achieving these changes.
2010-11 Reference Point:	Research and evaluation using National Computer-Assisted Telephone Interviewing (CATI) tracking surveys demonstrate campaign messages have reached adults at key life stages and high risk groups.
Result: Indicator met.
Evaluation research conducted by The Social Research Centre demonstrates the campaign to have met its objectives in relation to reach and message communication.

Quantitative Deliverable: Number of participants in lifestyle modification programs.

2010-11 Target: 54,000 2010-11 Actual: approx 2,940

Result: Deliverable not met.

The actual uptake of lifestyle modification programs remained below anticipation. Strategies put in place to promote and support participation in lifestyle modification programs have improved program infrastructure and increased community awareness, but these efforts did not lead to adequate increases in uptake.

Quantitative Deliverable: Number of Healthy Eating and Physical Activity resources provided to the community.

2010-11 Target: 3,000 2010-11 Actual: 4,732

Result: Deliverable met.

The Healthy Eating and Physical Activity Guidelines for Early Childhood Settings (Get Up & Grow) resources provide early childhood education and care settings (centre based care, family day care and preschools) and attending families with practical information on healthy eating and physical activity for children aged 0 to 5 years.

There was a high demand for the resources with approximately 4.732 sets of resources ordered between July 2010 and June 2011. The Get Up & Grow resources are ordered or downloaded directly from the department’s website.²²

Build Capacity and Improve the Health of Target Groups

Strengthening the Evidence Base

The Australian Health Survey (AHS) will provide a wealth of information on the population’s food and nutrient intakes, chronic disease risk factors, prevalence of disease and use of medical services, with the potential to crosslink data such as a person’s food intake, physical activity, obesity and diabetes risk factors as well as providing comparable data to that from previous national health surveys for effective monitoring. Participants will gain valuable insights into their own and their children’s health status, and researchers and governments will benefit from insights on factors contributing to chronic disease, which will allow more informed policy decisions and program development.

The department launched the first AHS in March 2011 with the Australian Bureau of Statistics (ABS). The department has a memorandum of understanding with the ABS to undertake the AHS, which comprises the existing National Health Survey (NHS) and National Aboriginal and Torres Strait Islander Health Survey (NATSIHS) as well as two new surveys – the National Nutrition and Physical Activity Survey (NNPAS) and the National Health Measures Survey (NHMS). These surveys will cover a representative sample of both children and adults, including Aboriginal and Torres Strait Islander people, and will for the first time collect objective measures of nutritional status and chronic disease risk factors as well as self-reported data.

The department collaborated with the ABS with input from technical experts to design the AHS. A pilot test of all survey operations was undertaken for the general population in January 2011 prior to the commencement of the survey in March 2011. Cognitive and focus group testing of survey instruments was undertaken in urban and remote Indigenous communities in late 2010, a pilot test in urban areas and pre-test of AHS components for remote populations were conducted in March and April 2011. A full pilot test of the AHS for the Aboriginal and Torres Strait Islander population is planned for October 2011, with the Aboriginal and Torres Strait Islander wave of the AHS due to commence in March 2012.

Australian National Preventive Health Agency

During 2010-11, with support from the department, the Government established the Australian National Preventive Health Agency (ANPHA). The Australian National Preventive Health Agency Act 2010 was passed by Parliament on 17 November 2010 with the commencement of ANPHA occurring on 1 January 2011. The establishment of ANPHA was a key element of the COAG agreed National Partnership Agreement on Preventive Health and a recommendation of the National Health and Hospitals Reform Commission.

ANPHA has been established to assist in driving Australia’s prevention agenda. This includes providing evidence-based advice to health ministers; supporting the development of evidence and data on the state of preventive health and the effectiveness of preventive health interventions in Australia; and putting in place national guidelines and standards to guide preventive health activities. The agency is continuing work on national social marketing campaigns relating to tobacco use and obesity. It will also manage a preventive health research fund focusing on translational research.

Qualitative Deliverable:	Support the Australian National Preventive Health Agency as it builds capacity to undertake its core functions.
2010-11 Reference Point:	Agency is established and able to provide evidence-based advice to Health Ministers, manage a research fund and oversee national preventive health surveillance.
Result: Deliverable met.
With support from the department, ANPHA commenced operation on 1 January 2011. The department developed key corporate governance processes, systems and documents to assist the agency in its early establishment stage.
Qualitative KPI:	National audit of preventive health workforce provides useful guidance for policy.
2010-11 Reference Point:	National audit of preventive health workforce provides a basis for the development strategies to limit deficits in workforce capacity.
Result: Substantially met.
In 2010-11, the department received the final Workforce Audit Report from the Human Capital Alliance. Following final consideration by the implementation working group the final report will be forwarded to ANPHA for consideration in developing a National Workforce Strategy for preventive health.

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Improve Child, Youth, Women’s and Men’s Health

Women and men have different health needs and these will vary at different stages of life. Health services and policies need to reflect gender differences that stem from the biological, psychological, economic, social, political and cultural determinants of health.

The National Women’s Health Policy 2010 was developed through national consultations involving over 700 participants and 170 written submissions. The policy was developed in the context of broader health care reform and provides a framework for immediate and longer term activities that will be delivered with a strong focus on the prevention of chronic disease and control of risk factors. A new addition, Australia’s National Male Health Policy, was released in May 2010 and is supported by initiatives such as grants to men’s sheds, the development of materials that educate men about specific health issues and the establishment of Australia’s first longitudinal study of male health. The study was established in June 2011 and will provide a rich source of information on specific areas of male health for the Australian community. The study will complement the Australian Longitudinal Study on Women’s Health which has been informing policy development over the last 17 years. In 2010-11 a new cohort of “Generation Y” women were added to the study to provide valuable information on the changes and challenges to women’s health over time across a broader range of age groups.

The Australian National Breastfeeding Strategy 2010-2015 (the strategy) was endorsed by Australian Health Ministers on 13 November 2009. Responsibility for implementing the strategy is shared with the states and territories, under leadership from the department. During 2010-11, the department established a Breastfeeding Jurisdictional Senior Officials Group (BJOG) to facilitate collaboration between governments. BJOG members exchanged information on jurisdictions’ breastfeeding related programs and began engaging on policy considerations associated with the re-emergence of donor human milk banks and revisiting Australia’s response to the World Health Organization’s International Code of Marketing of Breast-milk Substitutes (WHO Code).

Breastfeeding is a healthy way to feed infants and helps protect children against a range of conditions, including diarrhoea, respiratory and ear infections in infants, and obesity and chronic diseases in later life. Breastfeeding also benefits maternal health by reducing risks for breast cancer, ovarian cancer, type 2 diabetes and osteoporosis.²³

The department funded several breastfeeding related activities in 2010-11 including an Australian national infant feeding survey conducted between November 2010 and January 2011; development of breastfeeding data indicators; revision of the Infant Feeding Guidelines for Health Workers; and targeted research and consultation on infant growth charts.
The department also supports breastfeeding mothers and their families by providing access to expert breastfeeding advice and support through the Australian Breastfeeding Association. This includes a 24 hour peer to peer support helpline²⁴ and education and training programs for volunteer counsellors and health professionals.

Quantitative KPI:	Number of people to contact the National Breastfeeding Helpline.
2010-11 Target:	72,000	2010-11 Actual:	over 83,000
Result: Indicator met.
The National Breastfeeding Helpline received over 83,000 thousand calls to helpline in 2010-11 up from 81,433 in 2009-10. The Helpline continues to provide peer to peer support for breastfeeding mothers and their families.

Whole of Program Performance Information

Qualitative Deliverable:	Produce relevant and timely evidence-based policy research.
2010-11 Reference Point:	Relevant evidence-based policy research produced in a timely manner.
Result: Deliverable met.
To improve prevention across the health system, in 2010-11, the department funded the Public Health Information Development Unit to provide information and advice based on collection, collation and analysis of statistics on public health.
Qualitative Deliverable:	Stakeholders participate in program development through a range of avenues.
2010-11 Reference Point:	Stakeholders participated in program development through avenues such as regular consultative committees, conferences, stakeholder engagement forums, surveys, submissions on departmental discussion papers and meetings.
Result: Deliverable met.
In 2010-11, the Australian Health Survey (AHS) commenced for the general population, following finalisation and pre-testing of new survey instruments for the nutrition, physical activity and biomedical components and a full pilot test of all survey operations in January 2011. During 2010-11, planning continued for the Aboriginal and Torres Strait Islander segment of the AHS, including extensive consultation with peak Indigenous bodies and the department’s Indigenous Technical Panel.
Quantitative Deliverable:	Percentage of variance between actual and budgeted expenses.
2010-11 Target:	≤ 0.5%	2010-11 Actual:	3.5%
Result: Deliverable not met.
The variation in program expenditure related to a number of preventive health projects with higher than anticipated implementation costs.

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Outcome 1 – Financial Resources Summary

	(A) Budget Estimate¹ 2010-11 $’000	(B) Actual 2010-11 $’000	Variation (Column B minus Column A) $’000
Program 1.1: Chronic Disease - Early Detection and Prevention
Administered Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	41,141	31,993	( 9,148)
Departmental Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	5,108	5,225	117
Revenues from other sources (s31)	233	281	48
Unfunded depreciation expense	130	170	40
Operating loss / (surplus)	-	-	-
Total for Program 1.1	46,612	37,669	( 8,943)
Program 1.2: Communicable Disease Control
Administered Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	26,057	25,676	( 381)
Departmental Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	3,256	3,330	74
Revenues from other sources (s31)	148	179	31
Unfunded depreciation expense	83	108	25
Operating loss / (surplus)	-	-	-
Total for Program 1.2	29,544	29,293	( 251)
Program 1.3: Drug Strategy
Administered Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	146,036	133,164	( 12,872)
Departmental Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	22,762	23,281	519
Revenues from other sources (s31)	1,038	1,252	214
Unfunded depreciation expense	581	757	176
Operating loss / (surplus)	-	2	2
Total for Program 1.3	170,417	158,456	( 11,961)
Program 1.4: Regulatory Policy
Administered Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	89	7,870	7,781
Departmental Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	10,721	10,738	17
to Special Accounts	( 9,998)	( 9,998)	-
Revenues from other sources (s31)	33	40	7
Unfunded depreciation expense	18	24	6
Operating loss / (surplus)	-	-	-
Special Accounts
OGTR Special Account	8,306	8,268	( 38)
NICNAS Special Account	11,498	10,988	( 510)
TGA Special Account	118,133	106,944	( 11,189)
Expense adjustment²	( 6,727)	( 2,750)	3,977
Unfunded depreciation expense	-	46	46
Total for Program 1.4	132,073	132,170	97
Program 1.5: Immunisation
Administered Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	16,600	16,041	( 559)
to Australian Childhood Immunisation Register
Special Account	( 5,779)	( 6,799)	( 1,020)
Special appropriations
National Health Act - 1953 - essential vaccines	49,062	39,926	( 9,136)
Special Accounts
Australian Childhood Immunisation Register Special Account	9,494	9,198	( 296)
Departmental Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	2,160	2,209	49
Revenues from other sources (s31)	98	119	21
Unfunded depreciation expense	55	72	17
Operating loss / (surplus)	-	-	-
Subtotal for Program 1.5	71,690	60,766	( 10,924)
Program 1.6: Public Health
Administered Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	26,660	27,846	1,186
Other Services (Annual Appropriation Bill 2)	7,841	7,841	-
Departmental Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	14,814	15,152	338
Revenues from other sources (s31)	675	815	140
Unfunded depreciation expense	378	492	114
Operating loss / (surplus)	-	2	2
Total for Program 1.6	50,368	52,148	1,780
Outcome 1 Totals by appropriation type
Administered Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	256,583	242,590	( 13,993)
to Special Accounts	( 5,779)	( 6,799)	( 1,020)
Other Services (Annual Appropriation Bill 2)	7,841	7,841	-
Special appropriations	49,062	39,926	( 9,136)
Special Accounts	9,494	9,198	( 296)
Departmental Expenses
Ordinary Annual Services (Annual Appropriation Bill 1)	58,821	59,935	1,114
to Special Accounts	( 9,998)	( 9,998)	-
Revenues from other sources (s31)	2,225	2,686	461
Unfunded depreciation expense	1,245	1,669	424
Operating loss / (surplus)	-	4	4
Special Accounts	131,210	123,450	( 7,760)
Total expenses for Outcome 1	500,704	470,502	( 30,202)
Average Staffing Level (Number)	1,055	1,068	13
¹Budgeted appropriations taken from the 2011-12 Health and Ageing Portfolio Budget Statements and re-aligned to the 2010-11 outcome structure. ² Special accounts are reported on a cash basis. This adjustment reflects the difference between cash and expense.

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¹ Australian Institute of Health and Welfare (AIHW) 2010. BreastScreen Australia monitoring report 2006-2007 and 2007-2008. Cancer series No. 55. Cat. No. CAN 51. Canberra: AIHW.
² AIHW 2010. Cervical Screening in Australia 2006-2007: data report. Cancer series No. 54. Cat. No. CAN 50. Canberra: AIHW.
³ A positive FOBT indicates that blood is present in the sample. The presence of blood may not necessarily be due to cancer and may be due to other conditions.
⁴ AIHW 2010. BreastScreen Australia monitoring report 2006-2007 and 2007-2008. Cancer series No. 55. Cat. No. CAN 51. Canberra: AIHW.
⁵ AIHW 2010. Cervical Screening in Australia 2006-07: data report. Cancer Series No. 54. Cat. No. CAN 50. Canberra: AIHW.
⁶ Available at: www.alcohol.gov.au
⁷ Available at: www.drugs.health.gov.au
⁸ Available at: www.foodstandards.gov.au/foodstandards/codeinterpretationservice/
⁹ Data extract from TGA’s Strategic Integrated Management Environment System – Prescription Medicines Subsection.
¹⁰Scheduling is a national classification system that controls how medicines and poisons are made available to the public. Medicines and poisons are classified into Schedules according to the level of regulatory control over the availability of the medicine or poison, required to protect public health and safety.
¹¹ Available at: http://nicnas.gov.au/About_NICNAS/Reforms/Review_Of_The_Existing_Chemicals_Program.asp
¹² Available at: www.nicnas.gov.au
¹³ Intentional release licence applications are submitted by organisations that propose to conduct dealings ranging from limited and controlled releases (e.g. field trials) through to more extensive general or commercial releases of genetically modified organisms. The purpose of licensing is to protect human health and/or the environment by identifying and managing risks posed by genetically modified organisms. The Office prepares the risk assessment and risk management plans for all licence applications which form the basis of Regulator’s decisions on whether or not to issue licences and on conditions of each licence.
¹⁴ Available at: www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/legislation-2
¹⁵ The gene technology legislation requires that certain dealings or activities with GMOs must be licensed before they can be conducted. Organisations that intend to conduct such dealings (e.g. experiments, field trials etc) with GMOs must submit licence applications to the Regulator. The purpose of licensing is to protect human health and/or the environment by identifying and managing risks posed by GMOs. The Office prepares risk assessment and risk management plans for all licence applications, which form the basis of Regulator’s decisions on whether or not to issue licences and on conditions of each licence. This is one of the ongoing core activities of the Office.
¹⁶ Available at: www.ogtr.gov.au
¹⁷ Available at: www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ir-1
¹⁸ Available at: www.immunise.health.gov.au
¹⁹Available at: www.aihw.gov.au
²⁰ Available at: www.health.gov.au
²¹ Available at: www.immunise.health.gov.au
²² Available at: www.health.gov.au or by contacting National Mailing and Marketing on 1800 020 103.
²³ National Health and Medical Research Council, 2003. Dietary Guidelines for Children and Adolescents in Australia, NHMRC, Canberra, pp 5-8. House of Representatives Standing Committee on Health and Ageing 2007, The Best Start: Report on the inquiry into the health benefits of breastfeeding, Australian Parliament House, Canberra, pp 40-43.
²⁴ The phone number for the Breastfeeding Helpline is: 1800 mum 2 mum (18006862686). Information regarding the helpline can be accessed at: www.breastfeeding.asn.au/products/counselling.asp#phone

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Quantitative Deliverable:	Number of government primary schools to implement the Stephanie Alexander Kitchen Garden National Program.
2010-11 Target:	≤ 50%	2010-11 Actual:	42
Result: Deliverable substantially met.
The fourth and final funding round for the Stephanie Alexander Kitchen Garden National Program opened in May 2011.

Quantitative Deliverable:	Number of participants in lifestyle modification programs.
2010-11 Target:	54,000	2010-11 Actual:	approx 2,940
Result: Deliverable not met.
The actual uptake of lifestyle modification programs remained below anticipation. Strategies put in place to promote and support participation in lifestyle modification programs have improved program infrastructure and increased community awareness, but these efforts did not lead to adequate increases in uptake.
Quantitative Deliverable:	Number of Healthy Eating and Physical Activity resources provided to the community.
2010-11 Target:	3,000	2010-11 Actual:	4,732
Result: Deliverable met.
The Healthy Eating and Physical Activity Guidelines for Early Childhood Settings (Get Up & Grow) resources provide early childhood education and care settings (centre based care, family day care and preschools) and attending families with practical information on healthy eating and physical activity for children aged 0 to 5 years. There was a high demand for the resources with approximately 4.732 sets of resources ordered between July 2010 and June 2011. The Get Up & Grow resources are ordered or downloaded directly from the department’s website.²²