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Pathways, processes and protections: Australia's clinical and direct-to-consumer genetic testing spaces


Charbonneau, J and Nicol, D, Pathways, processes and protections: Australia's clinical and direct-to-consumer genetic testing spaces, Journal of Law and Medicine, 28, (2) pp. 370-388. ISSN 1320-159X (2021) [Refereed Article]

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Copyright 2021 Thomson Reuters Australia


Health-related genetic testing, once exclusively within the medical space, is now available within the commercial space. This paradigm shift from medical to consumer presents challenges to regulators, health care professionals and individuals. This section reports on pathways, processes and protections afforded to Australians whether genetic test results are provided by medical professionals or commercial players. While a complex web of protections is available within Australia's medical space, those accessing commercial testing rely on the same protections afforded all consumers in all marketplace transactions. There is also potential for these two initially bifurcated pathways to merge, either by business model or individual choice. Individuals pursuing commercial options obtain personal genetic information, which they self-interpret and, if they choose, share with family, medical professionals and online. While this section focuses on health-related genetic testing, it gives insight into what will undoubtedly be continued incursions into the medical space by commercial players.

Item Details

Item Type:Refereed Article
Keywords:clinical genetic testing, Therapeutic Goods Administration, direct-to-consumer genetic testing, in vitro diagnostic medical devices
Research Division:Law and Legal Studies
Research Group:Law in context
Research Field:Medical and health law
Objective Division:Law, Politics and Community Services
Objective Group:Justice and the law
Objective Field:Law reform
UTAS Author:Charbonneau, J (Ms Jan Charbonneau)
UTAS Author:Nicol, D (Professor Dianne Nicol)
ID Code:145687
Year Published:2021
Funding Support:Australian Research Council (DP110100694)
Deposited By:Law
Deposited On:2021-08-02
Last Modified:2021-09-01
Downloads:12 View Download Statistics

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