1996-1997
1.2: Health Regulation
The 1996-97 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.
Objective
- To ensure that:
- therapeutic goods available in Australia are safe, efficacious and of assured quality and made available to the community in a timely manner; and
- community exposure to potential health hazards posed by food-borne disease, chemicals and the use and transport of radioactive material is minimised.
Goals
- Safety, efficacy and quality of therapeutic goods available in Australia equal to that of comparable countries.
- Pre-market assessment of therapeutic goods and agricultural and veterinary chemicals conducted within a reasonable time and to high standard.
- Uniform and appropriate food standards and codes of practice which encourage industry innovation whilst protecting the health and safety of consumers.
- A coordinated trans-Tasman national surveillance, monitoring and compliance strategy for food safety.
- Occupational and public exposures to radiation in medicine, industry and research are kept as low as reasonably achievable and within dose limits. Codes of Practice and other guidance documents relevant to radiation protection are readily available and consistently promulgated.
- Safety of nuclear plant at Australian Nuclear Science and Technology Organisation (ANSTO) at least equal to that of comparable countries.
Strategies
- Enforce manufacturing standards for therapeutic goods by assessing and licensing all manufacturers and suppliers marketing therapeutic goods in Australia.
- Pre-market assessment procedures for therapeutic goods that ensure a balance between product quality, safety and timely availability.
- Comprehensive, risk-based, post-market monitoring of therapeutic goods.
- 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, amend and review the Food Standards Code. Continue implementation of the treaty with New Zealand to establish a joint food standards setting system. Enhance the coordination of food surveillance.
- Assess the significance of radiation sources and their implications for public and occupational exposure, set recommended Australian standards for exposure to radiation and encourage and work towards national uniformity in the regulation of practices which may give rise to radiation exposure.
- 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.
- Review in conjunction with the States and Territories and implement a nationally-agreed regulating framework for transportation, the safety of transport of spent fuel and radioactive waste by the Commonwealth.
Performance Indicators and Targets
Effectiveness
- The safety and quality of marketed therapeutic products measured by the proportions of products on the Australian Register of Therapeutic Goods (ARTG) subject to complaints and problem reports or identified as failing to comply with the required standards through post-market monitoring.
Target: Less than five per cent failure rate of audited products. - The number and percentage of public health recommendations in relation to chemicals and environmental contaminants accepted/adopted by the relevant regulatory bodies.
Target: 90 per cent. - The level of food-related illness in the community and the effectiveness of the nationally coordinated arrangements for food surveillance and recalls.
Targets:- Develop baseline data.
- Completion of analysis of sampling by the 1995-96 Australian Market Basket Survey.
- Food recalls initiated within 24 hours of formal notification and 100 per cent of recall reports obtained from industry.
- Average annual exposures of radiation workers to radiation, as assessed through the exposure records maintained in the National Radiation Dose Register.
Target: Occupational and public exposures determined to be as low as reasonably achievable, and less than dose limits.
Efficiency
- The time taken to approve products for inclusion on the Australian Register of Therapeutic Goods and to make public health recommendations on agricultural and veterinary chemicals products compared to statutory deadlines or set as efficiency targets through agreement with peak industry organisations.
Targets:- All time frames are met for registration and listing of prescription and over the counter drug products and medical devices.
- Recommendations on agricultural and veterinary chemicals are made within statutory time frames.
- Reduction in the number of general proposals (i.e. 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.
Target: 50 per cent reduction in such proposals; 10 per cent reduction in time. - Timely completion of guidance documents on occupational and public radiation protection, and timely advice to the Commonwealth on nuclear safety issues.
Target: Planned timelines are met.
Quality
- Feedback from industry, consumers and State, Territory and other Commonwealth regulatory bodies that regulatory information, recommendations and guidance documents are of a high standard and have made a positive contribution to achieving regulatory objectives.
Equity
- Measures in place to address specific product safety issues in identified population user groups such as women and children.
Budget Measures
Savings
Therapeutic Goods Administration - Increased Industry Contributions
Financial Implications
1996-97 $m | 1997-98 $m | 1998-99 $m | 1999-00 $m |
-3.0 | -6.1 | -9.3 | -9.5 |
Reduced Budget outlays of $18.5 million over three years will be achieved via a stepped approach to increased cost recovery as follows:
Cost Recovery Targets | ||
1996-97 | 1997-98 | 1998-99 |
58% | 67% | 75% |
Purpose of Measure
The purpose of this budget measure is to provide savings over the next three years by increasing cost recovery for the regulation of therapeutic goods.The Therapeutic Goods Administration (TGA) currently recovers 50 per cent of its operating costs from industry via fees and charges. The rate of cost recovery is to be increased to 75 per cent over the next three years.
Expected Implementation Strategies for Measure
Increases to Fees and Charges will be implemented over the next three years via amendments to Therapeutic Goods Regulations and Therapeutic Goods (Charges) Regulations. The proposed increases will be achieved in accordance with established Government-Industry protocols via the Industry-Government Consultative Committee.Intended Impacts of Measure
In return for increased industry contributions TGA will pass on improved productivity and efficiency gains such as a reduction in evaluation times over a three year period; adoption of the European Union Classification System with self-regulation of low risk medical devices which will reduce approval times; and pursuit of a Mutual Recognition Agreement with the European Union to provide Australian suppliers with automatic approval in selected overseas countries.Retention of 25% direct Government funding recognises the need for continued capacity for the regulation of the therapeutic goods industry independent of that industry.
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Australia New Zealand Food Authority (ANZFA) - Increased Cost Recovery
Financial Implications
1996-97 $m | 1997-98 $m | 1998-99 $m | 1999-00 $m |
-0.5 | -1.6 | - | - |
Purpose of Measure
The purpose of this budget measure is to provide savings by increasing cost sharing in the area of food regulation.Expected Implementation Strategies for Measure
Assess the capacity of ANZFA to meet statutory obligations and industry expectations within the new resources base and investigate markets for the sale of expertise and develop this service provision capacity.Negotiate a cost sharing strategy with industry, State and Territory governments and the New Zealand Government.
Intended Impacts of Measure
Increase industry's contribution to costs of maintaining national safe food arrangements.Clarify the capacity of ANZFA to raise funds to cover the costs of performing its statutory functions by selling expertise.
Reallocation of Funding for Administration of Re-opening Transfers From Commonwealth Superannuation Scheme to Public Sector Superannuation Scheme
1996-97 $m | 1997-98 $m | 1998-99 $m | 1999-00 $m |
-0.01 | - | - | - |
Across-the-Board Reduction of 2% in Running Costs - Department
1996-97 $m | 1997-98 $m | 1998-99 $m | 1999-00 $m |
-0.2 | -0.2 | -0.2 | -0.2 |
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Across-the-Board Reduction of 2% in Running Costs - Therapeutic Goods Administration
1996-97 $m | 1997-98 $m | 1998-99 $m | 1999-00 $m |
-0.4 | -0.4 | -0.4 | -0.4 |
Across-the-Board Reduction of 2% in Running Costs - Australia New Zealand Food Authority
1996-97 $m | 1997-98 $m | 1998-99 $m | 1999-00 $m |
-0.1 | -0.2 | -0.1 | -0.1 |
Across-the-Board Reduction of 2% in Running Costs - Nuclear Safety Bureau
1996-97 $m | 1997-98 $m | 1998-99 $m | 1999-00 $m |
-0.02 | -0.02 | -0.02 | -0.02 |
Whole of Government Telecommunications Savings Initiatives - Australia New Zealand Food Authority
1996-97 $m | 1997-98 $m | 1998-99 $m | 1999-00 $m |
- | -0.01 | -0.01 | -0.02 |
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