Outcome 1 – Population Health

prev page | TOC | next page

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

Major Achievements

• Passage of the world’s first tobacco plain packaging measures. The Tobacco Plain Packaging Act 2011 received royal assent on 1 December 2011, and the Tobacco Plain Packaging Regulations 2011 as they relate to cigarettes were approved by the Executive Council on 7 December 2011 and amended on 8 March 2012 to incorporate additional specifications for plain packaging of non-cigarette tobacco products.
• Renegotiated the National Partnership Agreement on Preventive Health for an additional three years to 2017-18.
• Continued success of BreastScreen Australia and the National Cervical Screening Program in reducing the impact of breast and cervical cancer on Australian women.
• Finalisation of tender process for the supply of seasonal influenza vaccine and pandemic influenza vaccine for Australia.
• Coordinated the Forum on Food Regulation response to the Review of Labelling Logic: Food Labelling Law and Policy.
• Released the Government’s response to major reviews of the regulatory framework for therapeutic goods – TGA reforms: a blueprint for the TGA’s future.
• Expansion of the National Bowel Cancer Screening Program, under the 2012-13 Budget measure, to include 60 and 70 year olds in 2013 and 2015 and to phase in biennial screening from 2017-18.

Challenges

• Responding to domestic and international legal challenges to Australia’s new requirements for plain packaging of tobacco products.
• Managing the increased demand for breast cancer screening as more women enter the target age group of 50 to 69 years of age.
• Ensuring that all vaccines are administered exactly according to the conditions of their registration.
• Reaching an agreement with states and territories on the reward methodology for the National Partnership Agreement on Preventive Health.

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 prevention and is implementing its response to the report of the Preventative Health Taskforce through Taking Preventative Action, which puts the prevention of chronic and preventable disease at the forefront of the nation’s health system. The Department is working to keep people healthy and out of hospital through the programs outlined below.

Program 1.1: Prevention, Early Detection and Service Improvement

Through the Chronic Disease Prevention and Service Improvement Fund, Program 1.1 provides a flexible funding pool for initiatives in chronic disease service improvement and prevention.

Chronic Disease Prevention and Service Improvement Fund

The Chronic Disease Prevention and Service Improvement Fund (the Fund)²⁰ was established in July 2011 consolidating activities from a number of existing chronic disease and prevention programs,²¹ providing a large, flexible funding pool to support activities that address the rising burden of chronic disease.

The objectives of the Fund are to support targeted action related to chronic disease prevention and service improvement, particularly within the primary and community sectors to: reduce the incidence of preventable mortality and morbidity; maximise the wellbeing and quality of life of individuals affected by chronic disease; reduce the pressure on the health and hospital system including aged care; and support best practice in the prevention, detection, treatment and management of chronic disease.

During 2011-12, the Department consulted with stakeholders on implementation arrangements, developed operational guidelines, and conducted the first open grant funding round. Funding will commence in 2012-13.

In mid-2011, the Department wrote to over 80 stakeholders to advise them about the establishment of the Fund. In September 2011, the Department released a discussion paper and undertook public consultations which helped to inform the development of operational guidelines for the Fund.

The Department released operational guidelines for the Fund on 14 November 2011, which coincided with the advertising of the first open grant funding round. The guidelines are available on the Department’s website.

The Department extended all relevant contracts to 30 June 2012 for funding recipients whose grants were for an ongoing service, if that grant was due to expire prior to that date.

Future grant funding round time frames will be advertised annually on the Department’s website.

Healthy Eating

In 2011-12, the Department continued to address poor dietary habits and promote healthier food choices for all Australians under the Food and Health Dialogue. The Dialogue is a voluntary collaboration between government, the food industry and the public health sector. 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, simmer sauce, soup and savoury pie sectors, and sodium and saturated fat targets were agreed with the processed meat sector. Cheese, savoury crackers, potato/corn and extruded snacks, instant noodles and condiments sectors will be engaged over 2012-13.

In 2011-12, the number of publications distributed was much higher than anticipated and demand for the resources continues. The target figure refers to complete kits disseminated. The resources are also available on an individual basis and the actual figure refers to the total number of resources distributed in 2011-12.

Obesity

It is expected that the Guidelines will be finalised and released for implementation in 2012-13.

Diabetes

During 2011-12, the Department worked closely with McKinsey and Company and the Diabetes Advisory Group to oversee the development and commence implementation of the Diabetes Care Project in Queensland, South Australia and Victoria. This pilot project is designed to assess new multidisciplinary models for managing chronic disease in primary health care, building on existing reforms to models of service delivery such as Medicare Locals (see Outcome 5 – Primary Care for more information on Medicare Locals).

The pilot aims to benefit patients and medical professionals. Patients will benefit from a more tailored and coordinated multidisciplinary approach to their diabetes care planning and will be able to manage their diabetes more effectively. General practices will have more flexibility in managing care for people who have diabetes, more visibility over the integrated care of patients and their own performance, and reduced administration. Allied health professionals will benefit from greater involvement in the care of patients and in the wider health care team. Patient enrolment commenced in 2011-12 and will be finalised in 2012-13.

Throughout 2012-13, the Department will continue to work with McKinsey and Company to implement the pilot, including patient enrolment and collecting data for the formal evaluation phase in 2013-14. The evaluation of the pilot will assist the Department to identify the most effective models of care for diabetes and other chronic diseases.

In 2011-12, the Department and the Diabetes Advisory Group met three times. The Advisory Group oversaw the implementation of the Diabetes Care Project in three states: Queensland; South Australia; and Victoria. Enrolment of practices in the pilot commenced in February 2012 and was completed in July 2012. Enrolment of patients commenced in April 2012.

The Department established key performance indicators with McKinsey and Company to ensure activities under the Diabetes Care Project pilot are implemented effectively. Reporting is through fortnightly teleconferences, bi-monthly executive face-to-face meetings and quarterly progress reports. McKinsey and Company provided the Department with the first quarterly progress report in May 2012.

Finalisation of the clinical guideline development process requires endorsement from the National Health and Medical Research Council. At the end of 2011-12, the guideline relating to the Identification and Management of Diabetic Foot Disease had been endorsed.

As at 30 June 2012, there were 161 Indigenous health care sites participating in the Quality Assurance for Aboriginal and Torres Strait Islander Medical Services (QAAMS) pathology program.

The Program continues to improve access to diabetes-related pathology testing by providing funding for external quality assurance of pathology testing undertaken at the point of care in participating Aboriginal Community Controlled Health Services and Aboriginal Medical Services. Funding also provides training and ongoing support for health care workers at participating Indigenous health care sites.

As at 30 June 2012, 161 Indigenous health care sites participated in the QAAMS pathology program.

Eye Health

During 2011-12, the Department continued to fund activities to raise awareness about eye health and vision care to prevent avoidable blindness in the community. Funding of the Macular Degeneration Foundation allowed the organisation to continue to raise awareness in the community and educate health professionals about macular degeneration. Vision 2020 Australia continued to receive funding to work with eye health organisations and the Government to raise the profile of eye health and vision care issues in Australia.

Information and resources continue to be made available on the Department’s and the National Health and Medical Research Council’s websites to support health professionals and the broader community.

Asthma and Linked Chronic Respiratory Conditions

Organisations funded to deliver asthma management activities provided appropriate progress reports on raising awareness about asthma and linked respiratory conditions in schools and the community across Australia. They also provided national asthma and linked respiratory training to primary health care practitioners and improved the access to medical specialists for Indigenous communities living in rural and remote locations of South Australia.

The first (asthma and lung function) of several asthma consumer and health professional brochures was updated in 2011-12. Information and resources continue to be made available on the Department’s and the National Asthma Council’s websites²³ to support health professionals and the broader community.

During 2011-12, 99 educational and refresher respiratory workshops were conducted across Australia for GPs, practice nurses and Aboriginal health workers.

Arthritis and Osteoporosis

Organisations funded to deliver musculoskeletal activities provided appropriate progress reports on increased community access to arthritis and osteoporosis information and self-management of the condition.

Osteoporosis Australia reported on the outcome at the Osteoporosis Summit which provided health professionals, researchers, and government agencies with the latest emerging evidence about bone health and preventing osteoporosis. Development of an interactive website with supporting resources is underway to actively engage consumers in maintaining bone health and preventing bone disease.

Resources for arthritis and osteoporosis consumer and health professionals were updated in 2011-12. Information and resources continue to be made available on the Department’s and the Australian Institute of Health and Welfare’s websites²⁴ to support health professionals and the broader community.

Prostate Cancer

In 2011-12, the Department continued to support the operation of two dedicated prostate cancer research centres: the Australian Prostate Cancer Research Centre at Epworth, located at the Epworth Hospital in Melbourne; and the Australian Prostate Cancer Centre – Queensland, located at the Princess Alexandra Hospital in Brisbane and managed by the Queensland University of Technology.

The two centres are making significant progress on comprehensive research programs. The centres will continue to work together in 2012-13, to improve the understanding and management of the disease and expand the evidence base in the areas of early detection, diagnosis and treatment of prostate cancer. The Department will continue to monitor the progress of both centres in 2012-13.

The Australian Prostate Research Centre and the Australian Prostate Cancer Centre – Queensland each produced two progress reports in 2011-12, plus comprehensive research, business and corporate plans. All reports submitted met the agreed requirements.

Palliative Care

The Department has engaged the Australian Institute of Health and Welfare to develop a measurement framework for the National Palliative Care Strategy. The Strategy will require the agreement of the Australian, state and territory governments and is expected to be finalised by June 2014.

Primary Care Collaboratives Program

The target for the number of practices participating in the Australian Primary Care Collaboratives Program has been exceeded. During 2011-12, work focused on the area of diabetes prevention and management and increasing quality improvement knowledge and skills within Medicare Locals.

All practices participating in the program have reported improvements to patient care. Participating practices are introducing systems to ensure patients with diabetes receive evidence-based care and improvements have been demonstrated in clinical measures.

Other Activities for Early Cancer Detection through Population Based Screening Programs

Breast Cancer Screening

During the year, 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. Since the introduction of the BreastScreen Australia Program in 1991, breast cancer mortality in Australia has fallen by more than 29 per cent.²⁵

Figure 1.1: Breast Cancer Mortality (all ages)

Text version of Figure 1.1

The increase in participation has occurred at the same time as an increase in the number of women in the target population. The Program continues to protect Australian women from breast cancer with a decline of approximately 29% in breast cancer mortality since 1991.²⁷ The roll-out of digital mammography, and strategies to support the Program’s workforce, will help increase the capacity of the Program to screen women. The Department will continue to work with states and territories to maintain participation in the Program.

In 2011-12, the Department undertook work to streamline BreastScreen Australia’s accreditation system, including the 173 National Accreditation Standards. The Department also worked closely with key stakeholders and state and territory governments to implement strategies to support the Program’s radiology and radiography workforce. This work will continue in 2012-13, with the development of online training tools which utilise digital mammography technology and the implementation of workforce enhancement strategies at the local level.

The national roll-out of digital mammography technology continued across BreastScreen Australia services during 2011-12. This included the purchase of equipment to transition from analogue to digital mammography technology across state and territory BreastScreen Australia sites, including ancillary equipment, mobile vans and supporting IT systems. Highlights in 2011-12 included the opening of the first of four new mobile digital mammogram units for regional Western Australia, the opening of four newly digitised clinics across South Australia and the installation of digital technology at five BreastScreen Victoria sites.

Cervical Screening

The Department also continued work in the areas of early detection and prevention of cervical cancer through the National Cervical Screening Program, working closely with state and territory governments to deliver the Program. A review of cervical screening policy called the Renewal of the National Cervical Screening Program, commenced in 2011.

Since the introduction of the National Cervical Screening Program in 1991, there has been a 55 per cent reduction in the mortality from cervical cancer.²⁸

Figure 1.2: Cervical Cancer Mortality (all ages)

Text version of Figure 1.2

There was a 1% increase in the actual number of women participating in cervical screening. The decline in participation (the first true decline in a decade) reflects an increase in the number of women in the target population. The decline in the percentage of women in the target population participating may be the result of some young women, vaccinated for the human papillomavirus (HPV) incorrectly assuming that they no longer need to have Pap smears.

The renewal of the National Cervical Screening Program commenced in November 2011. The renewal aims to ensure that all Australian women, HPV vaccinated and non-vaccinated, have access to a cervical screening program that is safe, acceptable, effective, efficient and based on current evidence. The renewal will be undertaken in stages and will: assess the evidence for screening tests and pathways, the screening interval, age range and commencement for both vaccinated and non-vaccinated women; determine the most cost-effective screening pathway and program model; investigate options for improved national data collection systems and registry functions to enable policy, planning, service delivery and quality management; and assess the feasibility and acceptability of the renewed program for women. It is expected that the renewal will be completed by June 2014. 

Bowel Cancer Screening

In the 2011-12 Budget, the Australian Government agreed to the continuation of the National Bowel Cancer Screening Program and confirmed its status as an ongoing program. During 2011-12, approximately 1 million eligible Australians aged 50, 55 and 65 were invited to participate in the Program. The Program has demonstrated that using faecal occult blood tests (FOBT) for screening can detect cancers and pre-cancerous lesions. Under phase two of the Program more than 1,100 suspected or confirmed cancers and more than 3,300 pre-cancerous lesions were detected and removed from program participants. Almost 80 per cent of bowel cancers removed were in the two earliest stages of cancer spread.

In the 2012-13 Budget, the Australian Government committed to expand the National Bowel Cancer Screening Program to include 60 and 70 year olds. Australians turning 60 from 1 January 2013 will be invited to undertake screening from July 2013 and those turning 70 from 1 January 2015 will be invited to undertake screening from July 2015.

The Government also announced that biennial screening for all Australians aged from 50 to 74 years will be phased in from 2017-18, consistent with the interval for bowel screening (every two years) recommended in the National Health and Medical Research Council clinical guidelines.

From 2012-13, the Department will be working with program partners, including state and territory governments to implement this expansion, taking into account workforce capacity and ensuring the key elements of the screening pathway are supported including: register functions that manage invitations; the supply of FOBT kits and pathology services; follow-up activities for participants who have a positive result; and the provision of information to and from health professionals and quality assurance mechanisms.

Eligible Australians who turned 50, 55 and 65 years of age in 2011 have been invited to undertake screening in the National Bowel Cancer Screening Program between 1 July 2011 and 30 June 2012. Participation rates reflect the proportion of invitees who provide a test for analysis. As there is a time lag between an invitation and the return of a test, the participation rate for any year is not able to be accurately calculated until this data is available. Participation rates for 2011 will be reported in the AIHW National Bowel Cancer Screening Program Annual Monitoring report which will be published in June 2013. It is estimated that the target for 2011-12 will be substantially met. 

Whole of Program Performance Information

The Department continued to provide timely evidence-based policy research and advice through a number of avenues including: funding the production of regular statistical bulletins on areas of male health; funding of research in relation to men’s sexual and reproductive health and associated conditions; the evaluation of the Stephanie Alexander Kitchen Garden Program; and the production of the Social Health Atlas.

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 enhance BreastScreen Australia’s accreditation system and workforce.

During 2011-12, the Department managed Program 1.1 funds effectively and achieved a variance of -0.01%.

Program 1.2: Communicable Disease Control

Communicable Disease Prevention and Service Improvement Grants Fund

The Communicable Disease Prevention and Service Improvement Grants Fund (the Fund)³¹ was established in July 2011 consolidating activities from four existing programs to respond to blood borne viruses (BBVs) and sexually transmissible infections (STIs),³² providing a large, flexible funding pool to support activities that address the prevention of communicable diseases and promoting appropriate treatment and management.

The objectives of the Fund are to better support activities that promote awareness and prevention of BBVs and STIs among Australians, and that promote appropriate treatments, education and management for BBVs and STIs. In addition the Fund will ensure that Australia is provided with appropriate structures to deliver a safe blood supply and the ongoing availability of quality assurance programs for medical laboratories that provide associated testing services. The Fund priorities will take account of the aims and objectives contained in nationally agreed strategies bearing on BBVs and STIs, and other relevant guidelines and Australian Government health policies such as the HIV and viral hepatitis testing policies.

During 2011-12, the Department consulted with stakeholders on the development of the guidelines for the Fund, and held an open funding round for public health promotion and prevention activities for BBVs and STIs. As a result of this round, new funding agreements were negotiated with the successful applicants to provide services to priority populations in the community.

The Department commenced consultations with stakeholders on the Communicable Disease Prevention and Service Improvement Grants Fund in September 2011. Consultation included the public release of a discussion paper on the development of the Fund guidelines and an invitation to provide written feedback, as well as a face-to-face information session with key stakeholders.

The Department released operational guidelines for the Fund on 14 November 2011. The guidelines are available on the Department’s website.

The Department extended all relevant contracts to 30 June 2012 for funding recipients whose grants were for an ongoing service, if that grant was due to expire prior to that date.

The Invitation to Apply documentation and fund guidelines for the Fund were published in November 2011. This included information on the requirements and priorities for funding under the open grants round for 2012-13 to 2013-14.

Blood Borne Viruses

The Department continued to support education and prevention programs under the National Sexually Transmissible Infections Strategy 2010-2013 which aims to improve knowledge, attitudes and behaviours among target populations.

In 2011-12, the Department commenced a review of the National Strategies to take into account new research on prevention and Australia’s commitments to the 2011 United Nations Political Declaration on HIV/AIDS and the associated targets for HIV reduction. In doing so the Department liaised closely with the Blood Borne Viruses and Sexually Transmissible Infections Subcommittee of the Australian Health Protection Principal Committee and the Ministerial Advisory Committee on Blood Borne Viruses and Sexually Transmissible Infections.

In December 2011, the project plan for a mid-term review of activities undertaken within the framework of the National Strategies for blood borne viruses and sexually transmissible diseases was approved. The review comprises the first report under the National Surveillance and Monitoring Plan, qualitative reporting from stakeholders on the progress of priority action areas, and ongoing monitoring of all activities funded through the Communicable Disease Prevention and Service Improvement Grants Fund. The review is expected to be completed by late 2012.

The Ministerial Advisory Committee on Blood Borne Viruses and Sexually Transmissible Infections met three times in 2011-12 and provided regular advice to the Minister on issues of national importance through the Chair’s Report to the Minister and other means in relation to blood borne viruses and sexually transmissible infections.

Jurisdictions continue to work through the Blood Borne Viruses and Sexually Transmissible Infections Subcommittee of the Australian Health Protection Principal Committee to progress action areas where needed. Community-based organisations are funded through the Communicable Disease Prevention and Service Improvement Grants Fund to address priority action areas, which include: health promotion and prevention; early detection and intervention; access to care and support; and surveillance and research.

The first National Blood Borne Virus and Sexually Transmissible Infections Surveillance and Monitoring Plan was developed in 2011. The Plan was endorsed by the Blood Borne Viruses and Sexually Transmissible Infections Subcommittee of the Australian Health Protection Principal Committee and the Ministerial Advisory Committee on Blood Borne Viruses and Sexually Transmissible Infections. The Plan is the primary quantitative tool for reporting against the indicators in the suite of five national strategies for blood borne viruses and sexually transmissible infections.

In 2011-12, the Department provided funding to seven community-based organisations for health promotion and education programs. All organisations delivered their outputs addressing priority populations and priority action areas, in line with the National Strategies Implementation Plans.

Based on the number of notifications reported to the National Notifiable Diseases Surveillance System and the number of Chlamydia testing services reported under the Medicare Benefits Scheme, the estimated percentage of laboratory tests that were positive for chlamydial infection was 8%. This is a slight decrease from previous years where the proportion of positive tests for Chlamydia has been around 9%.

As over 80% of Chlamydia infection notifications are amongst people aged 15-29 years, the Department continues to support promotion of sexually transmissible infection testing which enables early detection and treatment, and reduces the longer term complications that can be associated with untreated Chlamydia.

The number of new HIV diagnoses in Australia during 2011 was 1,138. This is an increase of 8.3% over the number of diagnoses in 2010, with the increase primarily among men who have sex with men.

Up to 2010, the annual number of new HIV diagnoses was relatively stable at around 1,000, following a steady increase from 719 cases in 1999.Trends in the population rate of newly diagnosed HIV infections differs across Australia. Although, transmission of HIV in Australia continues to occur primarily through sexual contact between men, around a quarter of diagnoses are attributed to heterosexual contact and 2% to intravenous drug use.

The number of newly diagnosed cases of hepatitis C infections notified to the National Notifiable Diseases Surveillance System in 2011-12 was 10,119. Since 2000-01, total rates have declined by around 50%, with the greatest reductions observed in the earlier years. These reductions followed a peak in notified cases associated with the detection and notification of prevalent cases that occurred in the late 1990s.

The highest rate of reported hepatitis C transmission continues to occur among persons aged 20-29 years and primarily among those with a history of injecting drug use. In 2010, an estimated 297,000 people living in Australia had been exposed to the virus, with around 168,000 having chronic hepatitis C infection. 

Whole of Program Performance Information

In 2011-12, the Department funded four national research centres to provide epidemiological data and undertake clinical and social research in blood borne viruses and sexually transmissible infections, HIV and hepatitis virology research and research focusing on sex, health and society. The Department continued to work with the joint Ministerial Advisory Committee on Blood Borne Viruses and Sexually Transmissible Infections, and Blood Borne Viruses and Sexually Transmissible Infections Subcommittee Research Priorities Working Group on the relevance and application of research in the blood borne virus and sexually transmissible infections policy area.

The Ministerial Advisory Committee on Blood Borne Viruses and Sexually Transmissible Infections and the Blood Borne Viruses and Sexually Transmissible Infections Subcommittee of the Australian Health Protection Principal Committee met three times in 2011-12. These committees oversaw the implementation of the five National Strategies for Blood Borne Viruses and Sexually Transmissible Infections.

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.

This minor underspend is a result of small variations in demand for quality assurance and quality control services undertaken for laboratories using in-vitro HIV, Hepatitis B or Hepatitis C test kits.

Program 1.3: Drug Strategy

Substance Misuse Prevention and Service Improvement Grants Fund

The Substance Misuse Prevention and Service Improvement Grants Fund (the Fund)³⁴ was established in July 2011, consolidating activities from a number of existing programs³⁵ and providing a flexible funding pool for organisations supporting prevention of substance misuse and other national activities under the National Drug Strategy.

The objective of the Fund is to support prevention of substance misuse and to promote service improvement within the drug and alcohol and related sectors. The Fund’s specific priority areas are to:

• enhance the capacity of the sector to undertake drug and alcohol research which informs national substance misuse prevention and service improvement efforts;
• provide an evidence base for drug and alcohol policy through targeted data collection particularly in areas of emerging national concern;
• support the development of national policy through providing support for national advocacy and representation of the drug and alcohol sector;
• prevent substance misuse and promote evidence-based messages about alcohol and other drugs through credible and relevant information campaigns and early intervention activities; and
• support other national substance misuse prevention activity arising from the National Drug Strategy.

During 2011-12, the Department consulted with stakeholders on implementation arrangements, developed operational guidelines, and conducted the first grant funding round. Funding will commence in 2012-13. This first round of funding will support the National Drug Strategy by improving research and data capacity. It will also provide funding to support preventative activities including for the continuation of Drug Action Week and associated activities.

In mid-2011, the Department wrote to stakeholders to advise them about the establishment of the Fund. In September 2011, the Department released a discussion paper and undertook public consultations which helped to inform the development of operational guidelines for the Fund.

The Department released operational guidelines for the Fund on 14 November 2011, which coincided with the advertising of the first open grant funding round. The guidelines are available on the Department’s website.

The Department extended all relevant contracts to 30 June 2012 for funding recipients whose grants were for an ongoing service, if that grant was due to expire prior to that date.

Future grant funding round time frames will be advertised annually on the Department’s website. 

International Engagement

In March 2012, the Department led Australia’s 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 international cooperation in responding to the potential risks to public health and safety posed by new psychoactive substances (for example, synthetic cannabis). The resolution seeks to encourage information sharing between international agencies and governments on the emergence of substances frequently marketed as ‘legal’ alternatives to illicit drugs, as well as on appropriate regulatory measures for their control.

The ANCD held three community forums in 2011-12, the outcomes of which were broadcast in public communiqués.³⁶

The National Cannabis Information and Prevention Centre continued to raise awareness of the harms related to cannabis use, particularly targeting Aboriginal and Torres Strait Islander peoples and youth. Significant activities included:

• training for alcohol and other drug workers and youth workers;
• development of an education package targeted at executive and occupational health and safety staff within sentinel workforces (construction and hospitality);
• publication of a large number of bulletins discussing the latest research regarding cannabis use and associated harms, including information on the risks of cannabis use during pregnancy to the mother and her child; and
• a music competition for Aboriginal and Torres Strait Islander peoples to engage them and discuss the negative effect of cannabis on their communities.

Substance Misuse Service Delivery Grants Fund

The Substance Misuse Service Delivery Grants Fund (the Fund)³⁷ was established in July 2011 consolidating activities from a number of existing programs³⁸ and providing a flexible funding pool for services that treat substance misuse.

The objective of the Fund is to better promote and support drug and alcohol treatment services across Australia to build capacity and to effectively identify and treat coinciding mental illness and substance misuse. The Fund aims to improve the health and social outcomes of those Australians with substance use issues.

The Fund also supports services targeting Aboriginal and Torres Strait Islander people and vulnerable groups including people from rural and remote locations and those experiencing homelessness.

The Fund has six priority areas:

• supporting non-government drug and alcohol treatment services;
• assisting Indigenous communities to provide service delivery in alcohol and other drug treatment;
• supporting those services targeting Aboriginal and Torres Strait Islander people to increase the effectiveness of, and access to, drug and alcohol treatment;
• reducing the prevalence and impact of petrol sniffing by continuing to support the supply of low aromatic fuel;
• supporting people from culturally and linguistically diverse (CALD) backgrounds, including improving the capacity of treatment services; and
• supporting the development and implementation of a range of social marketing campaigns.

During 2011-12, the Department consulted with stakeholders on implementation arrangements and developed operational guidelines and conducted the first funding round for the Fund. Organisations funded under this funding round have been offered three-year funding agreements to undertake activities relating to drug and alcohol treatment services.

Consultation across the drug and alcohol treatment sector was completed prior to the Invitation to Apply process opening on 14 November 2011. The Fund’s discussion paper was published on the Department’s website and interested stakeholders were notified of its release by email, and through the national ‘ADCA Update’, a free bulletin board service for the drug and alcohol treatment sector. The consultation period began on 25 August and concluded on 12 September 2011 to allow interested stakeholders, including prospective applicants, an opportunity to provide input to inform the development of the fund guidelines. Twenty-one submissions were received.

The Fund guidelines were released on 14 November 2011. The guidelines are available on the Department’s website.

The Department extended all relevant contracts to 30 June 2012 for funding recipients whose grants were for an ongoing service, if that grant was due to expire prior to that date.

Future grant funding round time frames will be advertised annually on the Department’s website.

There has been some delay in the development of a quality framework and funding model for drug and alcohol treatment services. The Department is continuing to work with the Expert Steering Committee on Drug and Alcohol Treatment Services to progress this work.

The Department undertook communications activities in the Goldfields region of Western Australia to support the introduction of low aromatic Opal fuel to this new region. Communication activities were also undertaken in existing roll-out regions to address the ongoing need to educate residents, key stakeholders and tourists about the effectiveness and reliability of low aromatic Opal fuel and its role in reducing petrol sniffing.

Data on the prevalence of petrol sniffing was collected from 21 Indigenous communities. Results from the data collection will be available once the four year monitoring project has concluded in June 2014.

Reduce Prevalence of Smoking

The Department supported the development of a draft for consultation of the National Tobacco Strategy 2012-2018, under the auspices of the Intergovernmental Committee on Drugs, Standing Committee on Tobacco. Public consultation was conducted on the draft Strategy during June 2012 which will inform the finalisation of the Strategy in 2012-13.

The world’s first plain packaging legislation, the Tobacco Plain Packaging Act 2011 and the associated Trade Marks Amendment (Tobacco Plain Packaging) Act 2011 received royal assent on 1 December 2011. The plain packaging legislation removes one of the last forms of tobacco advertising by prohibiting the use of logos, brand imagery, symbols, other images, colours and promotional text on tobacco packaging and products. All tobacco products manufactured or packaged in Australia from 1 October 2012 for domestic consumption will be required to be in plain packaging of a drab dark brown colour, and all tobacco products for retail sale in Australia will be required to be sold in plain packaging by 1 December 2012. The Department also worked with the Treasury and the Australian Competition and Consumer Commission to develop the Competition and Consumer (Tobacco) Information Standard 2011 which requires new, larger graphic health warnings on all tobacco products from 1 December 2012 in line with the plain packaging requirements.

During 2011-12, the tobacco industry initiated a number of legal challenges against the Government with regard to the tobacco plain packaging legislation. The Department, along with the Attorney-General’s Department and the Department of Foreign Affairs and Trade, has worked to defend the domestic and international challenges to the legislation.

A range of research³⁹ was undertaken throughout 2010-11 to inform the development of new graphic health warnings required under the Competition and Consumer (Tobacco) Information Standard 2011.

Due to delays in Parliamentary passage of the legislation, the Government introduced amendments to the Tobacco Plain Packaging Bill in order to allow a longer lead time for implementation of the Bill. All tobacco products manufactured or packaged in Australia will be required to be in plain packaging by 1 October 2012 (previously 20 May 2012). All tobacco products for retail sale in Australia will be required to be sold in plain packaging by 1 December 2012 (previously 1 July 2012). Changing these dates has led to a necessary change in implementation time frames, and the Department will finalise a compliance and enforcement framework in 2012-13.

In 2011-12, the More Targeted Approach element of the National Tobacco Campaign continued to provide targeted education campaigns aimed at high need groups that are hard to reach through mainstream anti-smoking campaigns. The target audiences are: people from culturally and linguistically diverse (CALD) backgrounds; people living in areas of socio-economic disadvantage; pregnant women and their partners; people with mental illness; and prisoners.

The Department developed, and in March 2011 launched, the first ever national Aboriginal and Torres Strait Islander anti-smoking television campaign, ‘Break the Chain’.

After the initial launch in early 2011, the National Tobacco Campaign – More Targeted Approach recommenced in January 2012, targeting hard to reach audiences with radio, print and online advertising.

The 2011-12 phase of the National Drugs Campaign was launched on 18 December 2011 with a continued focus on ecstasy. Through a mix of advertising, sponsorships and youth marketing activities, the campaign engages youth by highlighting the dangers of ecstasy use in high-risk settings where illicit drug use is more likely to take place.

Following its initial commencement in February 2011, the More Targeted Approach campaign recommenced on 29 January 2012 and ran until 30 June 2012. The media buy included in-venue television, selected magazine and press, and out-of-home formats focused on regions with high populations of target groups. This complemented the mainstream National Tobacco Campaign media activity in 2011-12 across national television, press, online and outdoor formats.

Targeting pregnant women and their partners, the ‘Quit for good today and give your baby a healthy start’ print and online materials were launched from 6 June 2011 and were also included in the new media buy which commenced on 29 January 2012. This included out-of-home placement of campaign information in public washrooms.

During 2011-12, formative research was conducted with prisoners and with people with mental illness, and the Department undertook further work to determine appropriate activities and materials for these target populations based on these findings.

An independent evaluation has shown that the National Drugs Campaign has been effective in raising awareness of the harms and risks associated with illicit drug use and influencing the behaviour of its target audience.

The Department led the Australian delegation at negotiations in Geneva from 29 March to 4 April 2012 at which the final text of the draft Protocol to Eliminate Illicit Trade in Tobacco Products was agreed. The Protocol is the first to be developed under the auspices of the World Health Organization Framework Convention on Tobacco Control (FCTC), itself the first global public health treaty. The draft Protocol will be considered for adoption by the FCTC Conference of the Parties in November 2012. If adopted, it will become a treaty-level text, binding on those parties which sign and ratify it.

A national network of Regional Tackling Smoking and Healthy Lifestyle teams is being rolled out across 57 regions. The third and final tranche of 20 teams will be operational in the second half of 2012. The teams are developing locally responsive social marketing campaigns and health promoting activities to address high smoking rates in Indigenous communities.

The AIHW’s 2010 National Drug Strategy Household Survey (July 2011), reported that 15.9% of Australians aged 18 years or over smoked daily (compared with 17.5% in 2007), and that 15.1% aged 14 years or over smoked daily (compared with 16.6% in 2007). The 2011-12 target was estimated based on ABS National Health Survey figures from 2007-08. Updated figures from this survey are expected in late 2012.

On 1 January 2011, the Government established the Australian National Preventive Health Agency (ANPHA). Upon the establishment of the Agency, the Government transferred carriage of the National Tobacco Campaign from the Department to ANPHA. Reporting on the National Tobacco Campaign will be contained in ANPHA’s 2011-12 Annual Report. The National Tobacco Campaign – More Targeted Approach activity and the Indigenous-specific anti-smoking social marketing activity remains with the Department.

Curb Excessive Alcohol Consumption

In 2011-12, the Department worked closely with the Australian National Preventive Health Agency (ANPHA) to support the transfer of management of the expansion phase of the National Binge Drinking Strategy, and assisted ANPHA with components of the strategy over this period, including the development of a quality framework to support provision of telephone counselling for drug and alcohol problems. The community-level initiatives funded by the Department under the National Binge Drinking Strategy (2008-09 to 2011-12) concluded in June 2012, and the Department has managed the transition of funding of the Good Sports Program to ANPHA under the expanded phase of the strategy. The Department has continued to work with state and territory police and health officials through the Early Intervention Pilot Program to offer a form of diversion to young people who come into contact with law enforcement as a result of harmful alcohol consumption. The Government has agreed to extend this initiative until 30 June 2013 to enable full evaluation and embedding of the pathways and learnings into sustainable service delivery.

The Department has also continued to fund projects which support better understanding and management of Foetal Alcohol Syndrome, and raise awareness of the 2009 National Health and Medical Research Council Australian Guidelines to Reduce Health Risks from Drinking Alcohol, particularly the risk of consuming alcohol during pregnancy.

The 2011–12 actual figure of 10.5% is based on the data from the 2010 National Drug Strategy Household Survey and uses the 2001 risk definitions as stated in the National Health and Medical Research Council Australian Alcohol Guidelines Health Risks and Benefits.

Discussions with key stakeholders continue to inform future policy development.

On 1 January 2011, the Government established ANPHA. In June 2011, the Government transferred carriage of the National Binge Drinking Strategy expansion measures from the Department to ANPHA. Reporting on the Strategy will be contained in ANPHA’s 2011-12 Annual Report.

On 1 January 2011, the Government established ANPHA. In June 2011, the Government transferred carriage of the National Binge Drinking Strategy expansion measures from the Department to ANPHA. Reporting on the Strategy will be contained in ANPHA’s 2011-12 Annual Report.

On 1 January 2011, the Government established the ANPHA. In June 2011, the Government transferred carriage of the National Binge Drinking Strategy expansion measures from the Department to ANPHA. Reporting on the Strategy will be contained in ANPHA’s 2011-12 Annual Report.

Sustainable partnerships were developed that will provide a basis for reducing the harms caused by alcohol consumption in these communities.

The evaluation showed that activities that involved community partnerships were raising awareness of the harms caused by alcohol consumption.

On 1 January 2011, the Government established the ANPHA. In June 2011, the Government transferred carriage of the National Binge Drinking Strategy expansion measures from the Department to the Agency. Reporting on the Strategy will be contained in ANPHA’s 2011-12 Annual Report.

As at April 2012, the number of clubs participating in the Good Sports Program had exceeded expectations and with Western Australia also coming on board in mid-2012, the number of clubs is continuing to grow.

Anecdotal evidence shows that youth participating in early intervention program activities are less likely to re-offend.

Whole of Program Performance Information

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.

Evidence-based policy research was also commissioned by the Department to inform policy development on tobacco control issues including plain packaging and graphic health warnings, tobacco product regulation, and the development of anti-smoking materials for the More Targeted Approach campaign.

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; participation in the development of the National Drug Strategy Sub Strategies; health reform funding and structure submissions; and the National Drugs Campaign.

The Department provided opportunities for stakeholders to have input into policy and program development through avenues such as the public consultation on the draft National Tobacco Strategy 2012-2018, and consultation on the regulations for plain packaging of tobacco products and on graphic health warnings.

The underspend is mainly attributable to the Substance Misuse Service Delivery Grants fund. There were delays in the establishment of bulk storage facilities in the Northern Territory and Queensland, which are required to support the expanded rollout of low aromatic fuel. These delays were due to the complexity associated with establishing the new facilities which resulted in extended contract negotiations. The remainder relates to drug and alcohol treatment service provider capacity issues, delays in contract finalisation for reasons such as staff recruitment and retention and difficulty securing services in remote Indigenous communities.

Program 1.4: Regulatory Policy

Sub-Program 1.4.1: Food Regulation Policy

Facilitate Food Regulatory Policy Informed By Evidence

In 2011-12, the Department undertook a variety of activities to support the development of food standards, food regulation policy and advice. This involved working closely with a range of stakeholders including industry representatives, Food Standards Australia New Zealand (FSANZ), states and territories and the New Zealand Government.

The Department continued to protect the health and safety of the population by ensuring that the food regulatory arrangements were supported by an evidence-based system and high level policy direction.

In 2011-12, the Department continued to respond to advances in scientific knowledge and evidence, stakeholder feedback, and developments in food regulatory practice at a national level. The Australian Government also has the opportunity to influence the development of food regulation at the international level through the Department’s membership of the Codex Committee on Food Labelling.

In 2011, the Department coordinated the response to Labelling Logic: Review of Food Labelling Law and Policy (2011) (the Review) by working closely with relevant Portfolio agencies including FSANZ, other Australian government departments, states and territories and New Zealand. The response to the Review included an agreement to develop a single interpretive front-of-pack labelling system by December 2012.

The Food Regulation Standing Committee (FRSC) is responsible for leading the development of this new labelling system, in cooperation with industry, public health and consumer stakeholders. The FRSC has established a Steering Committee and Project Committee to progress the work on Front-of-Pack Labelling, both chaired by the Department’s Secretary. The Project Committee has commissioned two working groups to report on technical design, and on implementation, evaluation and education. The work of these committees and working groups will continue into 2012-13.

A response to the Labelling Logic: Review of Food Labelling Law and Policy (2011) report was provided to the Forum at its December 2011 meeting.

The Forum agreed its response,⁴¹ which included proposed actions for the next five years, to improve the information on food labels to meet consumer needs, while maintaining marketing flexibility and minimising the regulatory burden on industry and barriers to trade.

The Department continued to provide advice, support and secretariat services to the Legislative and Governance Forum on Food Regulation (convening as the Australia and New Zealand Food Regulation Ministerial Council) and its subcommittees, which work cooperatively with the food regulatory system to protect consumer health and safety.

All papers and advice to the Forum relating to the two meetings held in 2011-12 were timely and relevant.

The Department assisted with the development of two interpretive guidance documents for publication on the FSANZ website as part of the development of a centralised interpretive advisory function.

All papers received by the Department on the due date were distributed on time. Those received late were distributed within 48 hours of receipt.

The Minister was briefed on all Notifications received by the Department.

 Whole of Sub-Program Performance Information

In 2011-12, the Department provided high quality policy advice for ministerial consideration of draft food standards. The Department managed the associated secretariat functions; coordinated the Legislative and Governance Forum on Food Regulation consideration and provided food policy advice to FSANZ; and ensured input was provided to all notifications from FSANZ to the Legislative and Governance Forum on Food Regulation in relation to applications and proposals to amend the Australia New Zealand Food Standards Code.

Opportunities to participate in program development included:

• stakeholder briefings on Codex Committee on Food Labelling meetings and activities;
• stakeholder meetings on the development of a Stakeholder Engagement Strategy for the Joint Food Regulation System; and
• stakeholder meetings and engagement forums on the implementation of the Government’s response to the Review of Food Labelling Law and Policy.

The actual expenses for Sub-Program 1.4.1 were 39.4% below budget expectations. The minor surplus pertains to unspent appropriation after the Department fulfilled all the associated secretariat support functions for the Food Regulation Standing Committee during 2011-12.

Sub-Program 1.4.2: Therapeutic Goods

Therapeutic Goods Regulation

In 2011-12, the TGA continued to regulate therapeutic goods under a national framework, using a risk management approach. A range of assessment and monitoring activities were carried out 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 time frame, to therapeutic advances.

The TGA assessed all alleged breaches within 10 working days and initiated an appropriate response in 100% of the instances notified.

In 2011-12, the TGA performed:

• 297 audits of Australian manufacturers, representing 99% of the target (256 audits were performed in 2010-11); and
• 143 audits of overseas manufacturers, representing 114% of the target (163 audits were performed in 2010-11).

The TGA completed 48 of 50 section 60 reviews regarding the entry of therapeutic goods onto the Australian Register of Therapeutic Goods within legislated time frames.

In 2011-12, 677 new PI documents and 951 updates were made to existing PI documents and 473 new CMI sheets were made available with 422 updates to existing CMI documents on the TGA website. The TGA also published 53 AusPARs.

Results for 2011-12 showed a decrease in the number of audits meeting the target time frames. The primary reason for this decrease was the high number of audits not completed in 2010-11 which had a flow on effect in the 2011-12 number of audits completed within the time frame.

The TGA performed 438 (99.5%) Category 1 and 1,298 (99.4%) Category 3 evaluations for prescription medicines within legislated time frames (255 and 45 working days respectively).

Response to Major Reviews

In December 2011, the Government released its response, TGA Reforms: a blueprint for the TGA’s future (the Blueprint), to a number of major reviews of therapeutic goods regulation that have been undertaken over the previous 18 months. The Blueprint was produced following an extensive process of consultation and collaboration with consumers, health care professionals and industry bodies. Major reviews included:

• the review to improve the transparency of the TGA;
• public consultations on the regulatory framework for advertising therapeutic goods;
• the Auditor-General’s report on Therapeutic Goods Regulation: Complementary Medicines;
• a working group examining the regulation of complementary medicines and reasons for low compliance rates;
• public consultations on the medical devices regulatory framework;
• the Working Group on Promotion of Therapeutic Products; and
• the Health Technology Assessment Review.

The TGA will implement the reforms and recommendations contained in the Blueprint over the next four years.

The reforms will enhance the regulatory framework, ensuring that it remains adaptable to new scientific developments and emerging community expectations. The reforms will also improve the Australian community’s understanding of the TGA’s regulatory processes and decisions, and enhance public trust in the safety and quality of therapeutic goods.

A comprehensive plan will guide implementation to 2015 with progress reports made available through the TGA website.⁴⁵ Initial work has focused on:

• releasing a searchable database of adverse drug reactions;
• consultations with stakeholders on improvements to labelling and packaging requirements to assist consumers and health practitioners;
• consultations with stakeholders on the levels and kinds of evidence to support indications for listed medicines;
• releasing an online system for the reporting of problems with medical devices;
• the reclassification of joint replacement implants to require a higher level of pre-market regulatory assessment;
• the further development of the TGA website to meet the information needs of all stakeholders; and
• the Advertising regulatory framework, Options for reform, report published on the TGA website.

The implementation of the agreed TGA Transparency Reforms was incorporated into the Blueprint. The TGA has made progress on delivering a number of recommendations from the review to improve the transparency of the TGA that was published in July 2011. For example the provision of a clear explanation on the TGA website of the risk based framework and the release of an online system for the reporting of problems with medical devices.

The implementation of the agreed advertising improvements was incorporated into the Blueprint. Recommendation 1 from the public consultations on the Regulatory Framework for advertising therapeutic goods recommended the publication of the Advertising regulatory framework, Options for reform report which was published on the TGA website in May 2012.

Whole of Sub-Program Performance Information

TGA stakeholders continue to be involved in activities to update and streamline the Australian regulatory framework for therapeutic goods. Specific areas of collaboration included:

• a review to improve the transparency of the TGA;
• public consultations on the regulatory framework for advertising therapeutic goods;
• a working group examining the regulation of complementary medicines and reasons for low compliance rates;
• public consultations on the medical devices regulatory framework;
• the Working Group on Promotion of Therapeutic Products;
• the Health Technology Assessment Review; and
• the business process review program for prescription medicines and over-the-counter medicines.

Cost recovered activity in 2011-12 was higher than forecast at Additional Estimates due largely to a greater than expected number of applications, evaluations and inspections. Expenses were over budget by $0.839 million after undertaking that additional work. Overall TGA recorded an operating surplus in 2011-12.

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 2011-12, the Department, through the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), continued to protect human health and the environment by promoting safe and sustainable use of industrial chemicals.

This was achieved through the pre-market assessment of 288 industrial chemicals not previously used in Australia, as well as assessing industrial chemicals already in use.

NICNAS continued to consult with its key stakeholders, such as the chemical industry, the community (including employees who work with chemicals), the Australian Government and state and territory governments, through national networks, advisory committees and information activities.

In 2011-12 the Department, in collaboration with the Department of Finance and Deregulation, commenced the review of the NICNAS scheme. The review will inform a Better Regulation Ministerial Partnership (BRMP) between the Minister for Health and the Minister for Finance and Deregulation.

As an initial step in the review, in November 2011 the Department sought input from stakeholders on possible reforms to the industrial chemicals regulatory system. The Department released a discussion paper in June 2012 describing possible reform options and seeking written submissions from stakeholders. The complex nature of the industrial chemical regulatory environment and the diverse views of industry and community stakeholders present challenges to the review as discussions continue about possible reform options.

During 2012-13, the Department will continue to work with NICNAS and other stakeholders to develop a regulatory reform package that would appropriately rebalance the industrial chemical regulatory framework to enhance both the competitiveness of the Australian chemical industry and public health and environmental outcomes.

The Framework for the accelerated assessment and prioritisation of industrial chemicals in Australia was finalised, with details of the Framework and program for Stage One chemicals released on 15 June 2012. From July 2012, NICNAS will begin assessing around 3,000 existing industrial chemicals on the Australian Inventory of Chemical Substances – AICS using the Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework.

During 2011-12, NICNAS evaluated the awareness and take-up of new administrative arrangements for nanoforms of new industrial chemicals which took effect from 1 January 2011. NICNAS also developed framework options for the regulation of nano-forms of existing chemicals. These options will be the subject of public consultation in 2012-13.

Two Priority Existing Chemical (PEC) reviews for chemicals of concern were completed:

• Diethyl Phthalate (DEP) in November 2011; and
• Hexabromocyclododecane (HBCD) in June 2012.

The initial stage of the report on Diisononyl Phthalate (DINP) was completed in June 2012.

Following finalisation of the DEP report, the Scheduling Delegate made a final decision to amend Appendix C entries for both DEP and Dimethyl Phthalate to include body lotion for human use containing more than 0.5%, which was implemented on 1 September 2012. In addition, three draft PEC reports were prepared for consultation in early 2012-13.

A key public consultation was conducted on the NICNAS Cost Recovery Impact Statement (CRIS). The CRIS process was completed in readiness for implementation – in a staged manner – from 1 July 2012.

NICNAS continued its influential role in international harmonisation activities. In particular, NICNAS received positive support for its regulatory reform of industrial nanomaterials at a meeting of the OECD Working Party on Manufactured Nanomaterials. In recognition of its efforts, NICNAS was elected to chair the OECD Task Force on Hazard Assessment.

Memorandum of Understanding signed with ECHA on 20 May 2011 (reported in 2010-11 Annual Report).

NICNAS Priority Existing Chemicals recommendations during 2011-12 were all developed in consultation with relevant stakeholders.

NICNAS published all new chemicals assessment reports and all finalised existing chemicals assessment reports on its website.⁴⁶

NICNAS responded to 92% of inquiries within 24 hours.

In 2011-12, a total of 288 new chemicals assessment certificates and permits were issued consisting of 174 assessment certificates and 114 permits. For these assessments, 95% of reports were completed within legislated time frames, 96% of assessment certificates were issued on time and 95% of permits were issued on time.

NICNAS met all the legislated time frames for the assessment of existing chemicals in 2011-12. There is a statutory two-stage consultation process, including time frames. 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. Each of these stages has 28-day time frames for stakeholder input and for NICNAS to consider any comments. There are legislative processes for gazettal of these activities.

NICNAS completed 95% of AICS searches within five working days.

There has been high level uptake of NICNAS regulatory recommendations by government and industry stakeholders, for example: Following finalisation of the Diethyl Phthalate (DEP) report, the Scheduling Delegate made a final decision to amend Appendix C entries for DEP and Dimethyl Phthalate to include body lotion for human use containing more than 0.5%, which was implemented 1 September 2012.

Three notifications for nanomaterials were received during the year. NICNAS determined that they were chemicals which did not require a nano-specific assessment due to the material not being present in the nano-form.

A number of notifiers declared other chemicals not to be nano-forms. These results combined with responses and feedback to several NICNAS training sessions indicated that the NICNAS requirements for nano-forms of new chemicals are well understood.

Dedicated audit, monitoring and debt recovery activities have resulted in 99% of known industrial chemical introducers registered with NICNAS for the 2011-12 year. Registration numbers exceeded those of 2010-11 by 5%, with over 700 introducers registering with NICNAS for the first time in 2011-12.

Feedback on NICNAS training sessions during the year was very positive. 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 2012-13.

In 2011-12, NICNAS had a 9% increase in visitor sessions from 2010-11 to its website.

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. The percentage of new chemicals assessed that are safer and less hazardous increased 3% from 74% in 2010-11 to 77% in 2011-12.

Whole of Sub-Program Performance Information

Stakeholder consultations were held for the CRIS, NICNAS assessments, the BRMP review of NICNAS 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.

During 2011-12, the Department, through NICNAS, managed Sub-Program 1.4.3 funds effectively and achieved a variance of -0.3%.

Sub-Program 1.4.4: Gene Technology Regulation

Gene Technology Regulation

The Gene Technology Regulator (the Regulator), supported by the Department’s Office of the Gene Technology Regulator (OGTR), administers the national scheme for the regulation of gene technology to protect the health and safety of people and the environment by regulating certain dealings with genetically modified organisms (GMOs). The functions of the Regulator are prescribed in the Gene Technology Act 2000.⁴⁷

In 2011-12, OGTR kept pace with advances in scientific knowledge and developments in regulatory practice to ensure that the assessments of applications required under the gene technology legislation are robust, based on current science and represent international best practice. OGTR engaged in international harmonisation activities and consulted with experts and key stakeholders on the assessment of licence applications for the release of GMOs into the environment. OGTR’s key stakeholders are state and territory governments, Australian Government agencies, regulated communities (hospitals, universities and research organisations) and the biotechnology industry (including agricultural and medical companies). OGTR also consulted with the general public to promote mutual understanding and timely resolution of issues of concern.

OGTR provided advice to the Department in relation to the review of operation of the Gene Technology Act 2000. In 2011-12, OGTR completed implementation of changes arising from amendments to the Gene Technology Amendment Regulations 2011, including providing information and assistance to regulated organisations. Additionally, in consultation with stakeholders, OGTR conducted rolling reviews to ensure that the Regulations, guidelines and processes remain current with advances in gene technology and understanding of risks.

Following completion of the review of the Regulations in June 2011, the Regulator implemented the Gene Technology Amendment Regulations 2011 which commenced on 1 September 2011. The Amendment Regulations ensure classification and regulation of dealings with GMOs remains commensurate with current scientific understanding of risk, and assists the regulated community to better understand and comply with their legislative obligations.

In 2011-12, the Regulator prepared comprehensive risk assessments and risk management plans for proposed dealings with GMOs. Stringent conditions were imposed for 6 licences for release of GMOs into the environment and 11 licences for dealings with GMOs in contained facilities. These conditions ensured containment of GMOs and management of identified risks.

In accordance with the requirements of gene technology legislation, OGTR monitored the conduct of licensed dealings⁴⁸ with GMOs and maintained a comprehensive record of approved GMO dealings on OGTR’s website⁴⁹ for the general public.

During 2011-12, the Regulator issued 6 licences for intentional release of GMOs into the environment. The OGTR entered the licences and decisions documents for all 6 licences onto the publicly accessible GMO Record on the OGTR’s website.⁵⁰ In this period, OGTR focused on improving accessibility of information that is of interest to the public and continued to make decision documents available on the website.

Field trial sites are inspected to monitor compliance with licence conditions so that risks to human health and safety and the environment are managed. In 2011-12 OGTR inspected 44% of field trial sites. The sites inspected were spread across South Australia, Western Australia, Northern Territory, New South Wales, Victoria, Queensland and the Australian Capital Territory. Genetically modified crop field trials inspected included canola, banana, wheat, barley, cotton, sugarcane and white clover.

The OGTR also inspected 33% of higher level containment facilities to ensure compliance with certification conditions. These inspections focus on the integrity of the physical structure of the facility and on the general laboratory practices followed in that facility.

Routine monitoring of the regulated community demonstrated a high level of compliance with the gene technology legislation. The OGTR 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 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 the environment were reported.

The Regulator made decisions on all licence applications within the applicable statutory time frames, maintaining the 100% record of previous reporting periods. There were no appeals of decisions made by the Regulator.

During this period, the Regulator revised, in consultation with key stakeholders, Guidelines for Certification of Physical Containment Level 3 Facilities. The Guidelines support the operation of the Amendment Regulations 2011 that commenced on 1 September 2011.

The Regulator consults technical and scientific experts, state and territory governments, Australian Government agencies and the public before making a decision on whether to issue any intentional release licence. During 2011-12, the Regulator consulted on 7 intentional release applications. All consultation periods exceeded the minimum specified time frame of 30 days as stipulated in the legislation.

OGTR continued bilateral arrangements with other Australian Government regulators, such as Food Standards Australia New Zealand;⁵¹ the Therapeutic Goods Administration;⁵² the Australian Pesticides and Veterinary Medicines Authority; Department of Agriculture, Fisheries and Forestry’s Biosecurity (previously, Australian Quarantine and Inspection Service); and the National Industrial Chemicals Notification Assessment Scheme;⁵³ to enhance coordinated decision-making and avoid duplication in regulation of GMOs and GM products. These activities deliver a risk-based, responsive, efficient and effective regulatory system that protects Australian people and the environment.

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 Regulator and OGTR facilitated cooperation and harmonisation through the ‘Regulators Forum’ and its working group activities during 2011-12. This included an inter-agency workshop on risk analysis and activities initiated for a proposed public awareness and confidence project. Bilateral cooperation with relevant regulators also continued.

OGTR also engaged actively in international forums focusing on the harmonisation of the risk assessment and regulation of GMOs including with the Organisation for Economic Cooperation and Development, World Health Organization and Cartagena Protocol on Biosafety.

OGTR was also invited to contribute to capacity building workshops and conferences on risk assessment and regulation of GMOs including in the region covered by the Association of South/South East Asian Nations, and in New Zealand, USA and Europe. OGTR also hosted a study tour for delegates from the Kenyan Biosafety Authority.

Whole of Sub-Program Performance Information

This underspend is due to delays in receiving invoices for MoU related charges.

Program 1.5: Immunisation

Improve Immunisation

Improve the Efficiency of the National Immunisation Program

In 2011-12, the Department finalised the tender process for the supply of seasonal and pandemic influenza vaccine over the next five years. All tenders were considered against criteria, which included matters of safety, efficacy, quality and cost.

The three successful tenderers chosen were considered the best value for money to the Commonwealth. They were: CSL Biotherapies Pty Ltd, Sanofi-Aventis Australia Pty Ltd and GlaxoSmithKline Australia Pty Ltd. This mix of suppliers provides security of supply and allows the national vaccination program to commence on 15 March each year to ensure protection of people well in advance of the influenza season. It also ensures priority access for Australia to pandemic vaccine in the event that a pandemic is declared. Seasonal influenza vaccine for the 2012 influenza season was purchased under these new arrangements.

Following an increase in febrile convulsions associated with influenza vaccine in children in 2010, the former Chief Medical Officer, Professor John Horvath AO, was commissioned in October 2010 to conduct a review into the reporting of, and responses to, adverse events following immunisation. The Review of the management of adverse events associated with Panvax and Fluvax (the Horvath Review) identified a number of strengths in the Australian system for vaccine safety and provided seven recommendations. The Department is progressing the implementation of these recommendations including the establishment of a Vaccine Safety Committee and agreement on nationally consistent reporting arrangements for adverse events following immunisation.

In response to the cases of febrile convulsions in children, Fluvax® (CSL influenza vaccine) continues not to be approved by the Therapeutic Goods Administration for use in children under the age of five years and caution is advised for its use in children between five and nine years of age.

To address the inadvertent administration of this vaccine to children, the Department has been working with the New South Wales Clinical Excellence Commission to examine the systematic factors, as well as behaviours, actions and inactions that resulted in the improper use of the vaccine, and the system changes that could be implemented to prevent these events occurring in the future.

Strengthen Vaccine Coverage

Prevenar 13® replaced Prevenar 7® as the childhood vaccine for invasive pneumococcal disease from 1 July 2011 as it provides protection against a greater number of disease strains. A supplementary dose program which provided an additional dose of Prevenar 13® to children aged one to three years of age who had already been vaccinated with Prevenar 7®, ran from 1 October 2011 to 30 September 2012.

Finalisation of the Essential Vaccines Procurement Strategy has been delayed as a result of revisions undertaken with jurisdictional stakeholders. Final consultations on the draft are underway. The Strategy is expected to be finalised in early 2012-13.

The Strategy will provide a clear direction for future improvement. The main areas of focus have been agreed with stakeholders and key priorities identified. The Strategy has been drafted and is expected to be finalised and submitted to Health Ministers by the end of 2012-13. The implementation plan will be developed following endorsement of the Strategy by Health Ministers.

The tender process for the supply of seasonal and pandemic influenza vaccine took considerably longer than anticipated due to the unexpected complexity of the process and the need to obtain advice from technical experts on safety issues in the light of adverse events associated with paediatric vaccine in the 2010 influenza season. Delays in completing the tender can be substantially attributed to the need for the Commonwealth to seek expert technical advice and reconsider its position with regard to CSL’s vaccine. The adverse events were an unexpected complication which could not be anticipated. In addition, future tender processes are not expected to be as complex as seeking to combine the procurement of seasonal and pandemic influenza vaccine. A second tender for meningococcal C and Haemophilus Influenzae type B vaccine was released in May 2012 and closed June 2012.

All benchmarks have been reported against and all payments have been made on time to states and territories. All states and territories have met the requirements to receive payment.

In 2011-12, data from the National Notifiable Diseases Surveillance System showed a continued downward trend, or maintained trends, in notifications of vaccine preventable diseases. These trends were initiated following the introduction of new vaccine programs such as the National Meningococcal C Program in 2003 and the Universal Pneumococcal Immunisation program in 2005. As a result of high vaccination coverage in Australia, in 2011-12 the number of cases of many vaccine preventable diseases such as measles, rubella, Haemophilus Influenzae type B, diphtheria and tetanus remained low, occurring mostly in people arriving in Australia from countries where these diseases remain endemic or among susceptible non-vaccinated Australians.

Immunisation rates in 2011-12 continued to be high with the national immunisation rate for children aged 60-63 months being 90.0% compared to 89.3% for 2010-11.

Immunisation rates in 2011-12 continued to be high with the national immunisation rate for children aged 24-27 months being 92.6% compared to 92.7% in 2010-11. 

Whole of Program Performance Information

The Commonwealth continues to work closely with states and territories to meet the desired outcomes of the National Partnership Agreement on Essential Vaccines which sets out the objectives, performance indicators and roles and responsibilities for delivering the National Immunisation Programs.

Throughout 2011-12, the Department convened regular meetings of the National Immunisation Committee, Jurisdictional Immunisation Coordinators and the Australian Technical Advisory Group on Immunisation to inform program and policy advice for the programs.

In implementing the recommendations from the Horvath Review, the Department consulted with vaccine experts, peak bodies, immunisation providers, consumers and states and territories. An Implementation Steering Committee and several working groups, with representation from a range of stakeholders, continue to progress the implementation of the Horvath Review recommendations.

The National Immunisation Program is a demand driven program that fluctuates to meet the needs of the Australian public. There was a lower than expected take up of essential vaccines.

Program 1.6: Public Health

Health Social Surveys Fund

The Health Social Surveys Fund (the Fund)⁵⁴ was established in July 2011 consolidating administrative and funding arrangements for the 2011-13 Australian Health Survey, the Australian Longitudinal Study of Women’s Health and the development of the Australian Longitudinal Study on Male Health.⁵⁵

The objective of the Fund is to establish a comprehensive evidence-base that will underpin the development, implementation, monitoring and evaluation of relevant health policies.

During 2011-12, Department progressed the projects under the Fund. In the long-term they will provide data to support the evidence-base for the development, implementation and evaluation of health policy.

Key stakeholders identified by the Department were provided with a discussion paper outlining the new fund arrangements and priorities in November 2011. Submissions to the consultation discussion paper were incorporated in the development of the Fund guidelines where appropriate.

The Department released operational guidelines for the Fund on 20 June 2012. The guidelines are available on the Department’s website.

In 2011-12, collection of data for the Australian Health Survey (AHS) continued in the general population and was completed in June 2012. During 2011-12, planning continued for the Aboriginal and Torres Strait Islanders component of the AHS, including obtaining ethics clearance from the Departmental Ethics Committee and from jurisdictional/local ethics committees to undertake the biomedical component of the survey. The Aboriginal and Torres Strait Islanders segment of the AHS commenced in the field in early May 2012 and is expected to be completed by July 2013.

In 2011-12, necessary foundation work for the design and establishment of the Australian Longitudinal Study on Male Health was achieved. This included: establishment of all governance and infrastructure arrangements; development of the conceptual framework for exploring social determinants of male health; design and cognitive testing of all survey instruments for boys, their parents, youth and men; ethics clearances from the University of Melbourne Human Research Ethics Committee; development of study branding and communication and preparations for piloting of instruments and sampling approaches.

Planning and arrangements for conducting a wave enumeration of the ‘10 to Men’ study, which will commence in the field in 2013, is well underway. Data from the study will contribute significantly to our understanding of male health and the social determinants that influence length and quality of life.

The Australian Institute of Health and Welfare’s second male health bulletin, Health of Australia’s males: a focus on five population groups was released on 15 June 2012 by the Minister for Indigenous Health. The Bulletin examines five male population groups at risk of poor health: Aboriginal and Torres Strait Islander males; those living in regional and remote areas; males living in socio-economically disadvantaged areas; males born overseas; and older males.

In 2011-12, the Australian Longitudinal Study on Women’s Health (ALSWH) commenced surveying of the new young cohort of women born 1989-94. This new work will allow exploration of shifts in young women’s health status since the commencement of the study in 1996 as well as in their attitudes to health and their health seeking behaviours. 2011-12 also saw commencement of more frequent surveying of the oldest cohort of women, born 1921-26 and now nearing and in their nineties, in order to maximise the contribution these women can make to the knowledge base on healthy ageing.

In addition, the ALSWH 2011 major report was released – Rural, remote and regional differences in women’s health: Findings from the Australian Longitudinal Study on Women’s Health. This report examines differences in women’s health as well as women’s access to and use of health services according to where they live in Australia.

The ALSWH continues to make a significant contribution to the evidence base on women’s health which informs the Australian Government’s commitments under the National Women’s Health Policy 2010.

The 2010 Australian National Infant Feeding Survey Report was released on 20 December 2011. The Infant Feeding Guidelines were reviewed by experts in May 2012 and are on track to be released in 2012.

The 2011-2013 Australian Health Survey continued enumeration in the general population and was completed in June 2012. The Australian Bureau of Statistics (ABS) will release high level survey results in the general population in October 2012 with more detailed survey results available from May 2013.

The survey in the Aboriginal and Torres Strait Islander population commenced enumeration in early May 2012 with enumeration scheduled to be completed by July 2013. High level results in the Aboriginal and Torres Strait Islander population will be available in September 2013, with more detailed results available from June 2014.

In addition, the Department is funding the ABS to increase the sample size of the Aboriginal and Torres Strait Islander component to improve the accuracy and robustness of the data collected.

Nationally representative data is being collected on health status, health service usage and health behaviours including diet and physical activity. Objective measures of obesity, blood pressure and biomedical indicators of nutrition and chronic disease is being collected on a voluntary basis.

Improve Child and Youth Health

The Australian Government recognises the importance of developing specific programs and strategies to address the health needs of children and young people. In 2011-12 the Department continued to work across government agencies to inform child and youth policy issues and to progress national strategies that focus on the health and wellbeing of children, young people and families such as the National Early Childhood Development Strategy and the National Framework for Protecting Australia’s Children.

During 2011-12, the Department continued to implement the Stephanie Alexander Kitchen Garden National Program aimed at teaching children in years three to six about growing, harvesting, preparing and sharing healthy food. The Department will continue to fund the national program for an additional three years from 2012-13.

In October 2011, the fourth round of funding for the Program was announced with an additional 50 schools approved for funding. One school has since withdrawn. 177 schools have participated in the Program since it commenced in 2008-09.

The independent evaluation was completed in June 2012. The evaluation has revealed that students responded positively to a ‘hands on’ learning approach and student kitchen and food choices improved as a result of the participating in the Program. The evaluation has also recommended that the application process be simplified and a mechanism for schools to share their implementation approaches with other schools be considered.

These findings will be incorporated into the revised model from 2012-13.

The Healthy Eating and Physical Activity Guidelines for Early Childhood Settings, which provide evidence-based practical information and advice on nutrition and physical activity for children 0 to 5 years, have been adapted for Aboriginal and Torres Strait Islander communities. Dissemination of the resources will occur in 2012-13.

Promote the Adoption of Healthy Lifestyles

During 2011-12, the Department continued its role of overseeing the implementation of the 11 initiatives under the National Partnership Agreement on Preventive Health (NPAPH) which aims to address the rising prevalence of lifestyle related chronic diseases by implementing programs and activities to promote healthy behaviours in the lives of Australians.

In June 2012, the Department successfully negotiated with jurisdictions to extend the time frame of the NPAPH to 2017-18. The extended time frame will allow more time for behaviour change to occur and jurisdictions to achieve the performance benchmarks outlined in the Agreement.

In December 2012, funding to 47 local government councils was announced under the Healthy Communities Initiative (HCI). The implementation of the HCI is also supported by a Healthy Living Network registration portal,⁵⁶ which provides a list of registered programs whereby community

members can search for activities and services in their local area. The Healthy Living Network went ‘live’ on 28 March 2012.

The Department has also continued to deliver the soft infrastructure component of the Healthy Workers Initiative which includes the development of a resource portal for employers.

Individual elements of the Healthy Workers Initiative are progressing within the agreed time frames. The Healthy Workers Toolkit Portal has been developed and will be launched in the second half of 2012. The quality assurance standards have been finalised and the development of the website to support the standards will commence from the 2012-13 financial year. The development of the National Awards for Healthy Workplaces has been transferred to the Australian National Preventive Health Agency.

The last phase of the Healthy Communities Initiative opened in July 2011 with the final 47 Local Government Councils announced on 6 December 2011. All 92 Local Government Councils are now implementing a range of healthy-lifestyle programs for the target group in their communities.

Whole of Program Performance Information

The Department continued to provide timely evidence-based policy research and advice through a number of avenues in 2011-12. The Australian Health Survey, Australian Longitudinal Study of Women’s Health and Australian Longitudinal Study on Male Health provide data to support the evidence-base for the development, implementation and evaluation of health policy.

In 2011-12, the Department and the ABS continued to work on a comprehensive data output strategy for the Australian Health Survey (AHS), including liaising with a variety of stakeholders on an ongoing basis. During 2011-12, extensive consultation continued for the Aboriginal and Torres Strait Islander segment of the AHS, including with peak Indigenous bodies and the Department’s Indigenous Technical Panel.

The underspend is largely attributable to unspent appropriation after the Department successfully negotiated with the Department of Finance and Deregulation, the appropriation transfer arrangements, via section 32 of the Financial Management and Accountability Act 1997, to establish the Australian National Preventive Health Agency. In addition, some programs finished the year with minor underspends.

Outcome 1 – Financial Resources Summary

1. Departmental appropriation combines ‘Ordinary annual services (Appropriation Bill 1)’ and ‘Revenue from independent sources (s31)’.
2. 'Expenses not requiring appropriation in the current year' is made up of depreciation expense, amortisation, make good expense and audit fees. This estimate also includes approved operating losses – please refer to the departmental financial statements for further information.
3. Special Accounts are reported on a cash basis. The adjustment reflects the difference between cash and expenses.

20. In the 2011-12 Budget the Australian Government announced the consolidation of 159 whole or part Health and Ageing programs within 18 flexible Funds. The Chronic Disease Prevention and Service Improvement Fund is one of the 18 Funds that came into operation from 1 July 2011. The establishment of flexible Funds will, over time, reduce red-tape for funding recipients in line with the National Compact, provide increased flexibility to government to respond to emerging health and ageing issues, and deliver better value for money and evidence-based funding.
21. A full list of activities consolidated into each flexible Fund is provided at Part 3.6: Activities Consolidated to Establish Flexible Funds.
22. Funding for this activity ends in 2011-12 and the majority of the target audience have received resources.
23. Available at: www.health.gov.au and www.nationalasthma.org.au
24. Available at: www.health.gov.au and www.aihw.gov.au
25. Australian Institute of Health and Welfare, 2011. BreastScreen Australia monitoring report 2008-2009 Cancer series no. 63. Cat. No.
    CAN 60. AIHW, Canberra.
26. Australian Institute of Health and Welfare, 2010. BreastScreen Australia monitoring report 2006-2007 and 2007-2008. Cancer series no. 55. Cat. No. CAN 51. AIHW, Canberra.
27. Australian Institute of Health and Welfare, 2011. BreastScreen Australia monitoring report 2008-2009. Cancer series no. 63. Cat. No. CAN 60. AIHW, Canberra.
28. Australian Institute of Health and Welfare, 2012. Cervical screening in Australia 2009-2010. Cancer series no. 67. Cat. No. CAN 63. AIHW, Canberra.
29. Australian Institute of Health and Welfare, 2010. Cervical screening in Australia 2007-2008 data report. Cancer series no. 54. Cat. No.
    CAN 50. AIHW, Canberra.
30. Australian Institute of Health and Welfare and the Australian Government Department of Health and Ageing, 2009. National Bowel Cancer Screening Program: Annual monitoring report 2009. Cancer series no. 49. Cat. No. CAN 45. AIHW, Canberra.
31. In the 2011-12 Budget the Australian Government announced the consolidation of 159 whole or part Health and Ageing programs within 18 flexible Funds. The Communicable Disease Prevention and Service Improvement Grants Fund is one of the 18 Funds that came into operation from 1 July 2011. The establishment of flexible Funds will, over time, reduce red-tape for funding recipients in line with the National Compact, provide increased flexibility to government to respond to emerging health and ageing issues, and deliver better value for money and evidence-based funding.
32. A full list of activities consolidated into each fund is provided at Part 3.6: Activities Consolidated to Establish Flexible Funds.
33. Now known as the Australian Health Protection Principal Committee.
34. In the 2011-12 Budget the Australian Government announced the consolidation of 159 whole or part Health and Ageing programs within 18 flexible Funds. The Substance Misuse Prevention and Service Improvement Grants Fund is one of the 18 Funds that came into operation from 1 July 2011. The establishment of flexible Funds will, over time, reduce red-tape for funding recipients in line with the National Compact, provide increased flexibility to government to respond to emerging health and ageing issues, and deliver better value for money and evidence-based funding.
35. A full list of activities consolidated into each fund is provided at Part 3.6: Activities Consolidated to Establish Flexible Funds.
36. Available at: www.ancd.org.au
37. In the 2011-12 Budget the Australian Government announced the consolidation of 159 whole or part Health and Ageing programs within 18 flexible Funds. The Substance Misuse Service Delivery Grants Fund is one of the 18 Funds that came into operation from 1 July 2011. The establishment of flexible Funds will, over time, reduce red-tape for funding recipients in line with the National Compact, provide increased flexibility to government to respond to emerging health and ageing issues, and deliver better value for money and evidence-based funding.
38. A full list of activities consolidated into each fund is provided at Part 3.6: Activities Consolidated to Establish Flexible Funds.
39. Available at: www.yourhealth.gov.au
40. KPI has been amended from the 2011-12 Portfolio Budget Statements to correctly include the percentage population 18 years of age or over who are daily smokers.
41. Available at: www.foodlabellingreview.gov.au/internet/foodlabelling/publishing.nsf/content/home
42. The number of applications received by the TGA is dependent on each company’s consideration of the market for medicines in Australia and their necessity to vary aspects of registration, and cannot be controlled by the TGA. Category 1 refers to an application to register a new prescription medicine or change to a medicine not meeting the requirements for Category 3 applications. Category 3 refers to an application involving changes to the quality data of medicines already registered and not involving clinical, non-clinical or bioequivalence data. Category 2 refers to an application to register a prescription medicine where two independent evaluation reports from acceptable countries are available. TGA no longer reports on Category 2 evaluations as they are extremely rare.
43. The Australian Register of Therapeutic Goods is available at: www.tga.gov.au/docs/html/artg.htm. Legislated time frames relates to 255 day legislative time frame for Design Examination Conformity Assessments for medical devices and for Category 1 prescription medicines applications.
44. AusPARs, CMI and PIs are Australian Public Assessment Reports, Consumer Medicines Information and Product Information documents for prescription medicines available through the TGA website at: www.tga.gov.au/pmeds/pmeds.htm.
45. Available at: www.tga.gov.au
46. Available at: www.nicnas.gov.au
47. Available at: The gene technology legislation requires that certain dealings or activities with genetically modified organisms (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. OGTR 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 OGTR.
49. Available at: www.ogtr.gov.au
50. Available at: www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ir-1
51. For further information on the activities of FSANZ, refer to sub-program 1.4.1: Food Regulatory Policy.
52. For further information on the activities of the TGA, refer to sub-program 1.4.2: Therapeutic Goods.
53. For further information on the activities of NICNAS, refer to sub-program 1.4.3: Industrial Chemicals.
54. In the 2011-12 Budget the Australian Government announced the consolidation of 159 whole or part Health and Ageing programs within 18 flexible Funds. The Health Social Surveys Fund is one of the 18 Funds that came into operation from 1 July 2011. The establishment of flexible Funds will, over time, reduce red-tape for funding recipients in line with the National Compact, provide increased flexibility to government to respond to emerging health and ageing issues, and deliver better value for money and evidence-based funding.
55. A full list of activities consolidated into each fund is provided at Part 3.6: Activities Consolidated to Establish Flexible Funds.
56. Available at: www.healthylivingnetwork.com.au

prev page | TOC | next page