Epidemiology, quality control and consumer access in the

J Law Med · Mar 2013

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.

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- Jacqueline Savard.
- Centre for Values, Ethics and the Law in Medicine (VELiM), School of Public Health, The University of Sydney. jacqueline.savard@sydney.edu.au
- J Law Med. 2013 Mar 1; 20 (3): 595-603.
AbstractAdvances 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.

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

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