Part E. Patents and Human Health

Part E examines the impact of gene patents and licences on the Australian healthcare system and on healthcare provision. It also discusses whether the Patents Act should provide a defence for the use of patented inventions in medical treatment.

Chapter 19 discusses the potential impact of gene patents on the healthcare system, how gene patents may contribute to the cost of healthcare, and the possible implications of gene patents for healthcare funding. The chapter suggests that health departments need to be more active in monitoring the impact of gene patents and licences on the healthcare system. The chapter makes recommendations with respect to: the economic evaluation of genetic medical technologies; examination of the financial impact of gene patents on the delivery of healthcare services in Australia; the possible role of government funding and purchasing power in relation to genetic materials and technologies; and how health departments, with advice from the proposed Human Genetics Commission of Australia, may better manage legal and other issues relating to gene patents. The ALRC recommends that where particular gene patent applications, patents or patent licensing practices are considered to have an adverse impact on medical research or the cost-effective provision of healthcare, health departments should consider whether to exercise any of the existing legal options to facilitate access to the inventions.

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. Chapter 20 focuses on the impact of patent laws and practices on medical genetic testing—the source of most concern in Australia and overseas about the impact of gene patents on healthcare. The chapter notes that in the United States gene patent holders are actively enforcing their rights against laboratories. However, there is little evidence that the same is true in Australia, despite growing concern about this possibility. Concerns about exclusive licensing of patents related to genetic tests include the potential impact on costs, access to testing, the quality of testing, and innovation in the development of new or improved testing techniques. The chapter discusses how recommendations elsewhere in the Report may assist in dealing with these problems.

Chapter 21 discusses the arguments for and against the introduction of a medical treatment defence in the Patents Act. Although there was some support for the introduction of such a defence, the ALRC makes no recommendation along these lines. A general medical treatment defence, as found in United States legislation, would seldom apply to medical treatment involving gene patents because these usually involve products and processes for use outside the human body. In relation to a defence applying specifically to the use of patented genetic materials and technologies in medical treatment, the ALRC has concluded it is premature to propose a significant diminution of patent rights where there is no demonstrated harm, particularly as such a reform has the potential to reduce innovation and investment in some areas of medical technology.