1997-1998
Australia's Commonwealth Department of Health and Family Services, Budget Document 1997-98
Recent government initiatives arising from the Industry Commission inquiry into the pharmaceutical industry include a new program to follow the existing Factor (f) scheme, extension of standard (20 year) patent terms and the new data exclusivity regime.
Fact Sheet 18
Therapeutic Goods Administration
Recent government initiatives arising from the Industry Commission inquiry into the pharmaceutical industry include a new program to follow the existing Factor (f) scheme, extension of standard (20 year) patent terms and the new data exclusivity regime. These initiatives, plus a review of labelling requirements recommended by the Small Business Deregulation Task Force, will contribute to industry viability and international competitiveness.In this context, the Government will increase the operational cost recovery from industry for the regulation of therapeutic products, moving to 75 per cent in 1997-98 (rather than by 1998-99 as outlined in last year's Budget) and to full cost recovery from 1998-99.
This measure will result in an increase in revenue of some $32 million over the next four years. The Therapeutic Goods Administration (TGA) has been progressively increasing the level of cost recovery from industry since 1992-93, and the cost recovery target for 1996-97 was 58 per cent. With industry turnover now estimated to be more than $4 billion, the proposed increased industry contribution represents a very small percentage of this amount.
The effect of the measure on revenue over the next four years will be an increase as follows:
| 1997-98 $m | 1998-99 $m | 1999-2000 $m | 2000-2001 $m |
| 3.1 | 9.9 | 9.7 | 9.8 |
At the same time, the TGA will implement a range of reforms flowing from the Government's response to the recent independent review of the TGA. These measures are intended to free up business from complicated regulatory requirements, promote greater efficiencies, boost the already high standard of medicinal products produced in Australia and to assist Australian industry in being more competitive in the international arena.
The changes will include:
- increased use of medicinal evaluation reports and decisions from comparable overseas regulatory bodies;
- examination of export arrangements to remove unnecessary regulatory obstacles for Australian manufacturers and exporters; and
- maximising opportunities for mutual recognition or harmonisation of Australia's regulatory requirements with those of countries with comparable standards. Consumers are also expected to benefit by having more timely access to new products and to the information necessary to ensure appropriate use.
Over the next few years, the TGA will continue to develop a world class regulatory system for therapeutic products which also takes account of the Australian community's attitudes and expectations in relation to self-medication and the role of preventive and complementary medicines.
The TGA will also pursue a regulatory partnership with New Zealand, including harmonised and joint standards for therapeutic products, and will look at setting up a single joint regulatory agency. Further efficiency gains will be made by adopting the European Union classification system for self-regulation of low-risk medical devices and by implementing the Mutual Recognition Agreement with the European Union.
Contact: Terry Slater, First Assistant Secretary, Therapeutic Goods Administration. Phone: (06) 232 8200
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