1.2: Health regulation

The 1997-1998 Portfolio Budget Statements, informs Senators and Members of Parliament of the proposed allocation of resources to portfolios outcomes and their objectives and targets including the agencies within the Health and Family Services portfolio.

In this section:

Budget measures

Objectives

To administer a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods used in or exported from Australia.
To ensure that community exposure to potential health hazards posed by food-borne disease, chemicals and radiation is minimised.

Priority outcomes

Safety, quality, efficacy and timely availability of therapeutic goods in Australia equal to that of comparable countries.
Timely pre-market assessment of agricultural and veterinary chemicals of a high standard.
Nationally uniform and appropriate food regulations which protect public health and safety while promoting trade and commerce in the food industry.
Improved food surveillance and monitoring arrangements for Australia and New Zealand.
Occupational and public exposures to radiation in medicine, industry and research are kept as low as reasonably achievable and within dose limits.
Safety of the nuclear plant at the Australian Nuclear Science and Technology Organisation is maintained to a standard in line with international best practice.

Strategies

Audit manufacturers of therapeutic goods for compliance with the principles of Good Manufacturing Practice.
Apply an appropriate level of pre-market evaluation and post-market monitoring of therapeutic goods based on an assessment of their potential hazard.
Provide expert toxicological and policy advice on public health aspects of chemicals to relevant agencies and bodies within Australia, and provide relevant information to the public.
Develop and implement a nationally consistent food regulatory system, including a national food hygiene standard with agreed systems for food surveillance, food business notification, risk classification and auditing of food businesses.
Coordinate the trans-Tasman surveillance, monitoring and compliance strategy for food safety.
Develop, amend and review the Food Standards Code and continue to establish a joint food standards setting system with New Zealand.
Assess the significance of radiation sources and their implications for public and occupational exposure and, jointly with the States and Territories, develop Australian standards for exposure to radiation.
Provide a framework for safety of operation of nuclear plant and conduct assessments for permanent and temporary sources of radiation risk in line with international best practice.
Contribute to the development of international standards and policies on therapeutic goods, chemicals, and nuclear safety.

Performance assessment: indicators and targets

Effectiveness

Indicator	Target	Information source and reporting frequency
The safety and quality of marketed therapeutic products measured by the proportion of products on the Australian Register of Therapeutic Goods (ARTG) subject to safety related complaints and problem reports or identified as failing to comply with required standards through post market monitoring (Priority Outcome 1;Strategies 1,2 )	Less than five per cent failure rate of audited products	Therapeutic Goods Administration (TGA) Quarterly Performance Reports, including: TGA Laboratory Testing; Recalls; Problem Investigation; and ARTG Operations
Number and percent of public health recommendations in relation to chemicals and environmental contaminants which meet statutory deadlines and which are accepted or adopted by relevant regulatory bodies (Priority Outcome 2; Strategy 3)	Recommendations on agricultural and veterinary chemicals are made within statutory timeframes 95 per cent of recommendations are accepted or adopted	Tracking System/TGA Quarterly Reports National Registration Authority (NRA) and National Industrial Chemicals Notification and Assessment Scheme (NICNAS) decisions Quarterly Reports
Nationally consistent food regulation and effective, nationally coordinated arrangements for food surveillance and recalls in place (Priority Outcomes 3, 4; Strategies 4,5)	Agreement by industry and governments on measures which achieve food safety objectives while reducing the regulatory burden on industry New food hygiene standard in place and agreement with stakeholders regarding the development of systems All food recalls initiated within 24 hours of formal notification and 100 per cent of recall reports obtained from industry	Reports to Minister, Governments and structured feedback, including from industry and consumer groups Not applicable Australian and New Zealand Food Authority (ANZFA) log of recalls Annual
Uptake and adoption by States and Territories of national radiation protection recommendations and guidelines (Priority Outcome 5; Strategies 5,6,7)	100 per cent uptake resulting in in dose exposure less than dose limits and showing a reducing trend	Personal Radiation Monitoring Service Annual Report and data from the National Radiation Dose Registry

Efficiency

Indicator	Target	Information source and reporting frequency
Numbers and costs of decisions on applications for therapeutic goods and reviews and assessments of chemicals, and time taken (Priority Outcomes 1, 2; Strategies 2,3)	Five per cent increase in decisions and shorter average decision making time for therapeutic goods Two per cent reduction in average cost per chemical appraisal compared to the previous year	TGA Quarterly Performance Reports Activity Based Costing Study, TGA and NRA Quarterly Reports
Reduction in the number of general applications and proposals (ie those not related to the Review of the Food Standards Code) to vary the Food Standards Code, and in the time taken to recommend variations (Priority Outcome 3; Strategy 4)	25 per cent reduction in general applications and proposals Five per cent reduction per application in time taken to make recommendations to the Australia New Zealand Food Standards Council	ANZFA FACTS database Annual

Quality

Indicator	Target	Information source and reporting frequency
Feedback from industry, consumers and other stakeholders regarding regulatory information, recommendations and guidance documents (Priority Outcomes 1, 2, 3; Strategies 3,4,5,7 )	High level of satisfaction Documentation is of a high standard and has made a positive contribution to achieving regulatory objectives	Industry-Government Consultative Committee (IGCC) Every six months Structured feedback from stakeholders including State, Territory and New Zealand Health Authorities
The accuracy and competence of scientific and technical measurements related to radiation safety that is provided to clients (Priority Outcome 5; Strategies 5,7)	Maintain 100 per cent agreement with international bodies in intercomparison exercises	Results of participation in intercomparison exercises
Timely advice to the Commonwealth on radiation and on nuclear safety issues (Priority Outcomes 5, 6; Strategies 5,6, 7)	100 per cent of replies to ministerial correspondence received on time Minister's office satisfied with timing on other advice	Departmental records of ministerial and other correspondence completed or outstanding Regular feedback from Minister's office

Equity

Indicator	Target	Information source and reporting frequency
Measures to address specific product safety issues in identified population target groups (Priority Outcome 1; Strategy 2)	Initiatives in place and information made available to patients and prescribers	Reports from specific working parties eg Working Party on the Registration of Drugs for Children

Performance assessment: evaluation

No major evaluations are planned for this Sub-program in 1997-98.

How the program is resourced: reconciliation of appropriations to the program and summary of portfolio outlays (Excel 54 KB)

Variations to Program Outlays 1996-97 to 1997-98 (Excel 24 KB)