20.1 Gene patents may have an impact on the development and provision of healthcare involving medical genetic testing and novel therapies such as gene therapy, the production of therapeutic proteins, and the use of stem cells. This chapter focuses on the impact of patent laws and practices on medical genetic testing. In Australia and overseas, concerns about the impact of gene patents on healthcare have most often been expressed in relation to this aspect of healthcare.[1] Issues relating to stem cells are addressed in Chapter 15.

20.2 There is a range of possible adverse consequences of existing patent laws and practices, including: monopoly control and the cost of testing; the quality of testing and medical practice; and innovation in the development of new or improved testing techniques. This chapter discusses these concerns and the ALRC’s views in relation to them. The Inquiry has examined a number of questions about the impact of gene patents on various aspects of healthcare provision and submissions and consultations comprehensively addressed these issues. This chapter discusses the responses received by the Inquiry and the implications for reform of patent law and practice.

[1] A particular focus has been on gene patents over the BRCA1 and BRCA2 genes, mutations of which are implicated in the development of some forms of breast and ovarian cancer.