Outcome 1: Population Health > Performance Information

Result: Not applicable.

No major programs funded under the National Public Health Program were due for evaluation in 2007–08.

Result: Indicator substantially met.

The Public Health Education Program implemented a contestable funding pool to address emerging public health priorities (ie biosecurity, Indigenous health, nutrition and physical exercise) in line with the 2005 PHERP Phase 3 review recommendations.

Contestable funding is available for time limited projects directed at fulfilling specific workforce education, training and capacity building requirements. Funding is provided through a contestable funding process which allows for projects to be funded to meet emerging public health priorities. The Department progressed the review's recommendation to develop a National Quality Framework, including draft core competencies for postgraduate public health education. Developing the framework involved consultation and workshops with key stakeholders.

The Department also realigned all core program funding objectives and outcomes to reflect the 2005 review recommendations; and strengthened accountability requirements for the overall program.

Result: Indicator met.

Ministers were satisfied with the advice provided by the Department for Australian Government decision-making. This is on par with ministerial satisfaction in 2006–07.

Result: Indicator met.

The Department provided high quality and timely evidence-based policy research to support the work of the new Preventative Health Taskforce, which was established by the Government on 9 April 2008 as a key source of advice in refocusing the health system on prevention. This included developing background papers addressing overweight and obesity, and future directions in preventative health. The Department also sourced background papers covering alcohol, tobacco and international perspectives on the prevention of chronic disease from internationally recognised experts. These documents were provided to the taskforce for its 23 June 2008 meeting and will be used to inform the development of the National Preventative Health Strategy.

As part of the Evaluation of BreastScreen Australia, the Department completed qualitative research on the views of BreastScreen Australia participants and non-participants within the target and eligible population, as well as health practitioners, to determine the program's acceptability and barriers to participation. The research is one of several projects which will inform the evaluation. The evaluation final report will be submitted to the Australian Health Ministers' Advisory Council in 2009.

An economic evaluation of the National Bowel Cancer Screening Program was undertaken in 2007–08. The evaluation was completed in September 2007 and informed planning for the next phase of the National Bowel Cancer Screening Program which commenced on 1 July 2008.

The Department also managed a consultancy which resulted in the discussion paper Review of Evidence Regarding Chronic Disease Prevention in Aboriginal and Torres Strait Islander Communities.

Result: Indicator not met.

Actual expenses varied from budgeted expenses by -2.83%.

Result: Indicator met.

During 2007–08, the Department offered a wide range of stakeholders the opportunity to participate in policy and program development. For example the Department:

• directly engaged State and Territory Governments in a collaborative effort to develop a national integrated strategic approach to chronic disease management and prevention, through the Australian Population Health Development Principal Committee;
• consulted with the states and territories and breast cancer stakeholder organisations to inform the BreastScreen Australia Evaluation;
• utilised the National Bowel Cancer Screening Program Advisory Group to provide expert advice on the program's development and implementation. Through the advisory group, State and Territory Governments, health professionals, consumers and government agencies including Medicare Australia and the Australian Institute of Health and Welfare were given the opportunity to contribute to the program's strategic policy direction; and
• convened the National Pregnancy Counselling Expert Advisory Committee, a group of expert clinicians and community representatives, to provide advice and input on the management and evaluation of the National Pregnancy Support Helpline.

Result: Indicator substantially met.

The Therapeutic Goods Administration completed the evaluation of 99.7% of Category 1 ³ (363/364) and 100% of Category 3 (1,182/1,182) evaluations within legislated timeframes (255 and 45 working days, respectively). No Category 2 evaluations were undertaken in 2007–08 (see Table 2.3.1.2). One Category 1 evaluation was completed in 259 working days rather than the 255 day statutory timeframe. Procedures were reviewed to prevent a recurrence of the incident.

Source: Data extract from Strategic Integrated Management Environment System – Prescription Medicines Subsystem.

During 2007–08, 100% of the 79 Design Examination Conformity Assessments for medical devices were completed within the 255 day legislated timeframe. Recommendations arising from a business process review are being implemented to deal with the backlog arising from a combination of the late transitions of product by industry to the new regulatory framework and higher than predicted application rates. The Department anticipates the implementation of these business improvement measures will address the backlog issue.

The Gene Technology Regulator conducted 33 licence application evaluations, with 100% completed within the legislated timeframe. The Regulator also approved eight accreditation applications and 244 certifications of facilities, all within legislated timeframes. There were no appeals of decisions made by the Gene Technology Regulator.

The National Industrial Chemicals Notification and Assessment Scheme achieved a rate of 96% of evaluations within legislated timeframes and considered 288 notifications for new chemicals. Of these notifications, 197 assessment certificates and 122 permits were issued. These figures include some notifications received in 2006–07. Some of the notifications received this year will have certificates or permits issued in 2008–09. There were no Administrative Appeals Tribunal appeals during the year.

Result: Indicator met.

In 2007–08, the Department completed 145 registration human health assessment reports, meeting 98.3% of agreed timeframes. All registration assessment reports were accepted by the Australian Pesticides and Veterinary Medicines Authority.

The Department completed 19 new human health risk assessments under the existing chemical review program – nine priority chemicals were identified, and a further ten priority chemicals amended. The Department consolidated advice on previously assessed chemicals and published reviews, including input on public comments and additional studies. 100% of pesticide review work orders were completed within the agreed timeframes.

The Department established or amended 148 public health standards for pesticides following their review, 100% of which were made within the agreed timeframe.

The National Drugs and Poisons Scheduling Committee made 99 scheduling decisions during the year (20 agricultural and veterinary chemicals, 68 medicines, 11 chemicals and six other changes to the Standard). Of the 99 scheduling decisions, five were subject to post meeting comment and all but two were accepted. There were three amendments of the Standard for the Uniform Scheduling of Drugs and Poisons, 22nd edition; and one to the consolidated Standard for the Uniform Scheduling of Drugs and Poisons, 23rd edition.

Result: Indicator met.

Four hundred and ten audits were performed during the year and 395 (96.3%) were performed within the target timeframe. There were no overdue audits at the end of the financial year.

Result: Indicator met.

The Office of Laboratories and Scientific Services maintained testing of therapeutic goods during major ongoing refurbishments of laboratory facilities. Eight hundred and eighteen products were tested, which consisted of 2,038 samples in 2007–08. In addition, protocol release evaluations were completed for 676 batches of biological medicines.

Result: Indicator met.

The Office of the Gene Technology Regulator significantly exceeded this target: 51% of field trials were inspected in 2007–08. No significant risks to human health or the environment were identified.

Result: Indicator substantially met.

The Department granted a total of 5,170 licences and permits authorising the import, export and manufacture of controlled drug substances. 95.4% of licenses and permits were issued within the applicable timeframe which substantially met the target of 97.0%.

Over two million legitimate movements of controlled drugs between establishments were monitored and reported to state and territory health agencies within agreed timeframes. The Department also fully met the reporting requirements of the United Nations International Narcotics Control Board through the provision of estimates and statistical data concerning the scientific and medical use of drugs.

Result: Indicator substantially met.

The Therapeutic Goods Administration investigated 1,017 alleged breaches under the Therapeutic Goods Act 1989. During 2007–08, 1,017 new referrals breaches were received from stakeholders including members of the public, industry, local and international law enforcement and regulatory agencies, with 913 investigations completed. Three hundred and seventy-six formal warnings were issued to persons/companies and 13 persons/companies were charged with 96 criminal offences.

The Office of the Gene Technology Regulator assessed 21 reports (100%) of alleged breaches of the Gene Technology Act 2000 within 10 working days.

The National Industrial Chemicals Notification and Assessment Scheme assessed all forty-six reports of breaches within 10 working days and initiated appropriate responses.

Result: Indicator met.

The Therapeutic Goods Administration undertook formal stakeholder consultations in a number of areas, including:

• improved access to product information and consumer medicines information and improving business practices in the Therapeutic Goods Administration;
• regulation of labelling and packaging therapeutic products in Australia;
• the development of Rules and Standards to apply under the Australia New Zealand Therapeutic Products Authority; and
• the streamlining of business processes associated with the regulation of medical devices.

Also during the year there were regular meetings with the TGA-Industry Consultative Committee and bilateral meetings with industry stakeholders. Regular consultation meetings were also held with the Consumers Health Forum and Choice.

In 2007–08, the inaugural meeting of the new Gene Technology Ethics and Community Consultative Committee was held.

The National Industrial Chemicals Notification and Assessment Scheme consulted with stakeholders on proposals for regulatory change. These proposals included the:

• development of a standard for cosmetics;
• revision of the framework for the existing chemicals assessment program;
• review of the regulation of chemicals in hard surface disinfectants; and
• the implications of the emerging field on nanotechnology on assessment processes.

The scheme used a range of consultation mechanisms including: new advisory committees; release of written proposals with a public submission process (disinfectants); and public meetings. The scheme also used its Community Engagement Charter as a guide to the conduct of all consultations with the wider community.

Result: Indicator met.

The Therapeutic Goods Administration continued its cooperative arrangements with key international regulatory agencies in 2007–08 and actively participated in international forums. This included:

• working with the Biologics and Genetic Therapies Directorate of Health Canada on a Parallel Review Project. The project will provide a mechanism for sharing information on the evaluation processes between Canada and Australia, with the two agencies reviewing one or more submissions in parallel;
• working on the variation of the Australia-European Community Mutual Recognition Agreement with the Department of Foreign Affairs and Trade and the former Department of Industry, Tourism and Resources;
• progression of the implementation and confidence building phase of the Australia/Canada Memorandum of Understanding on Quality Management Systems for Medical Devices with Health Canada; and
• consulting with Health Canada, the US Food and Drug Administration, the European Commission, the Health Sciences Authority (Singapore), the Ministry of Health (Malaysia), and the State Food and Drug Administration (China), as well as other regional regulators.

The Office of the Gene Technology Regulator participated in:

• the Organisation for Economic Co-operation and Development Working Group on the Harmonisation of Regulatory Oversight in Biotechnology;
• the European Food Safety Authority Scientific Forum on Environmental Risk Assessment of GM Plants;
• the Australian delegation to the Fourth Meeting of the Parties to the Cartagena Protocol on Biosafety; and
• the Australian delegation to the Australian Group Plenary regarding biological weapons control.

In 2007–08, the National Industrial Chemicals Notification and Assessment Scheme:

• formalised its bilateral arrangement with Canada for cooperation on new chemical assessments, formally recognising the Canadian system. This improves the efficiency of Australia's processes by utilising Canadian assessments performed under particular circumstances;
• played an active role in the Organisation for Economic Co-operation and Development Taskforce on Existing Chemicals by reviewing assessments for the High Production Volume Program, as a member of the steering group for the project tracking the phase-out of hazardous perfluorinated chemicals and the introduction of safer alternatives;
• contributed to the work of the New Chemicals taskforce, by acting as one of the sponsoring countries under the new chemicals co-notification program, and leading the work aimed at achieving harmonisation of the criteria for polymers of low concern; and
• participated in the leadership group for the Working Party on Manufactured Nanomaterials, and was responsible for leading the development of a database on relevant research.