Epidemiology, quality control and consumer access in the medical marketplace: the changing landscape of human genetic technology regulation in Australia.

Advances in genetics, genetic therapeutics and the application of genetic technologies to many aspects of human life have challenged the capacity of regulatory authorities and legislative processes the world over. In Australia, developments in the "new genetics" prompted the government to initiate a major inquiry into the protection of human genetic information, resulting in the production and publication of Report 96, titled "Essentially Yours: The Protection of Human Genetic Information in Australia" in 2003. This article examines the recommendations set out in this report and how they have provided Australia with a framework to deal with the advances in human genetic technologies, using the examples of direct-to-consumer personal genome testing and whole-genome sequencing.