Defining the scope of the Inquiry

Terms of Reference

1.4 The Terms of Reference, which define the scope of the Inquiry, are reproduced at the beginning of this Report. The ‘operative part’ of the Terms of Reference require the ALRC to examine the impact of patent laws and practices, as they relate to ‘genes and genetic and related technologies’. This is to be done in three contexts:

• the conduct of research and its subsequent application and commercialisation;

• the Australian biotechnology sector; and

• the cost-effective provision of healthcare.

1.5 The ALRC was also asked to report on what changes may be required to address any problems identified in current laws and practices, ‘with the aim of encouraging the creation and use of intellectual property to further the health and economic benefits of genetic research and genetic and related technologies’. Thus, although the focus of the Inquiry was on patent laws and practices, other intellectual property issues (such as copyright in genetic databases) were relevant to the final recommendations. This was all to be done ‘with a particular focus on human health issues’.

1.6 In addition to the operative section, the Terms of Reference asked the ALRC to have regard to a number of considerations in conducting its Inquiry. These may be summarised as follows:

• the role of intellectual property rights in promoting technological innovation;

• the potential for human genetics to improve the quality of life of all Australians;

• the ethical, legal and social issues arising from intellectual property in genes and genetic technologies;

• the national interest in using genetic technologies in agriculture and industry;

• trade and investment issues affecting intellectual property; and

• international obligations and practices, both existing and proposed.

1.7 To recount these wide ranging considerations is to emphasise the complex nature of the Inquiry and the many contexts in which the patenting of genetic materials and technologies may be relevant. One dimension of the Inquiry is the effect of gene patents on human health and medical research; another is the effect of gene patents on industry and economic development. Spanning both areas are the constraints imposed by ethical and social considerations, and by Australia’s obligations under international treaties. An analysis of these issues, and the degree to which the constraints affect practical options for reform, are canvassed in subsequent chapters.

Related matters not under investigation

1.8 There are several matters that fall outside the scope of the Inquiry, although they are associated with intellectual property and genetic information. In July 2003, the ALRC released an Issues Paper, Gene Patenting and Human Health (IP 27), which discussed these matters in some detail.^[5] In summary, the excluded areas are as follows:

• The Inquiry was confined to examining patent laws and practices as they relate to genes or genetic technologies in specified contexts, and reporting on what changes may be required to intellectual property laws to address any problems identified. It was not a general review of Australian law in relation to patents or other intellectual property rights. However, some proposals for reform have a wider application because of the practical or legal difficulty of confining reform to gene patents.

• The Inquiry did not generally consider the impact of gene patents associated with plants and animals. However, where an animal’s genetic material is used to develop a therapeutic product or process to be used in human medical treatment, the patent issues may be relevant to human health and thus fall within the scope of the Inquiry.

• Finally, the Inquiry did not extend to genetic research on humans for purposes unrelated to human health. For example, patents over genetic tests used to determine biological kinship, or used in DNA profiling for law enforcement purposes, were regarded as falling outside the scope of the Inquiry.