16.1 The Terms of Reference require the ALRC to consider the impact of current patenting laws and practices related to genes and genetic and related technologies on the Australian biotechnology sector. The biotechnology sector, including pharmaceutical companies, is heavily dependent on patents because of the large costs involved in developing some products and because many products are readily copied.

16.2 This chapter describes the structure and features of the biotechnology sector in Australia. It also describes the pharmaceutical industry in Australia, as the pharmaceutical industry is part of the biotechnology sector, and biotechnology drug products form an important output of the sector. However, the pharmaceutical industry also operates in areas outside biotechnology and the industry is often differentiated from other biotechnology companies in statistics about the biotechnology sector.

16.3 The biotechnology sector also encompasses areas outside the scope of this Inquiry, including those related to agriculture, food processing, manufacturing and environmental management. The Australian Biotechnology Report 2001 defines biotechnology as:

The application of all natural sciences and engineering in the direct or indirect use of living organisms or parts of organisms, in their natural or modified forms, in an innovative manner in the production of goods and services (including for example therapeutics, foodstuffs, devices, diagnostics, etc) and/or to improve existing industrial processes. The market application of outputs is typically in the general areas of human health, food production, industrial bio-processing and other public good and environmental settings.[1]

16.4 As the Terms of Reference require the ALRC to focus on the human health implications of gene patenting, this definition of biotechnology encompasses areas that fall outside the scope of this Inquiry. Consequently, much of the description in this chapter is of the sector as a whole because it is not always possible to find statistics that differentiate between industries within the sector.[2]

[1] Biotechnology Australia, Freehills and Ernst & Young, Australian Biotechnology Report (2001), 3. The Australian Bureau of Statistics is currently considering the development of a formal definition for biotechnology to work as a generally accepted standard: Science and Innovation Mapping Taskforce, Mapping Australian Science and Innovation (2003), 310.

[2] The Australian Bureau of Statistics has recognised the lack of statistical information about biotechnology in Australia, and has indicated that development work is now underway on a biotechnology survey to be conducted in respect of 2003–04: Australian Bureau of Statistics, ‘Biotechnology Statistics’, Science and Technology Statistics Update, December 2003, [4], [4.2].