Will the current framework protect consumers effectively?
The age of personalised medicine has seen the rapid emergence of a direct-to-consumer (DTC) genetic testing industry.1 While various forms of DTC testing have been available for many years, the emergence of DTC genetic testing is raising new concerns relating to the accuracy of predictions, and potential harms to consumers given there is typically no individualised genetic counselling.2 DTC testing also has the capacity to increase pressure on an already overstretched health care system if confused consumers seek assistance from health practitioners in interpreting test results.3
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- 1. Magnus D, Cho MK, Cook-Deegan R. Direct-to-consumer genetic tests: beyond medical regulation? Genome Med 2009; 1: 17.
- 2. Caulfield T, Ries NM, Ray PN, et al. Direct-to-consumer genetic testing: good, bad or benign? Clin Genet 2009; 77: 101-105.
- 3. Maguire AL, Burke W. Health system implications of direct-to-consumer personal genome testing. Public Health Genomics 2011; 14: 53-58.
- 4. Hogarth S, Javitt G, Melzer D. The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues. Annu Rev Genomics Hum Genet 2008; 9: 161-182.
- 5. Kricka LJ, Fortina P, Mai Y, Patrinos GP. Direct-access genetic testing: the view from Europe. Nat Rev Genet 2011; 12: 670.
- 6. Borry P, van Hellemondt RE, Sprumont D, et al. Legislation on direct-to-consumer genetic testing in seven European countries. Eur J Hum Genet 2012; 20: 715-721. doi: 10.1038/ejhg.2011.278.
- 7. Australian Law Reform Commission and Australian Health Ethics Committee. Essentially yours: the protection of human genetic information in Australia. ALRC 96. Canberra: Australian Government, 2003. http://www.alrc.gov.au/publications/report-96 (accessed Feb 2013).
- 8. Australian Government Department of Health and Ageing, Therapeutic Goods Administration. Overview of the new regulatory framework for in vitro diagnostic medical devices (IVDs). 2011. http://www.tga.gov.au/pdf/ivd-framework-overview.pdf (accessed Apr 2012).
- 9. Australian Government Department of Health and Ageing, Therapeutic Goods Administration. The regulation of nutrigenetic tests in Australia. 2010. http://www.tga.gov.au/industry/ivd-nutrigenetic-tests.htm (accessed Apr 2012).
- 10. Australian Government Department of Health and Ageing, Therapeutic Goods Administration. Classification of IVD medical devices. http://www.tga.gov.au/industry/ivd-classification.htm (accessed Mar 2013).
- 11. Australian Government. Therapeutic Goods (Excluded purposes) Specification 2010. http://www.comlaw.gov.au/Details/F2010L01889 (accessed Mar 2013).
- 12. Australian Government. Explanatory statement, Therapeutic Goods (Excluded Purposes) Specification 2010. http://www.comlaw.gov.au/Details/F2010L01889/Explanatory%20Statement/Text (accessed Feb 2013).
- 13. Australian Government. Therapeutic Goods (Medical Devices) Regulations 2002 - Schedule 4. http://www.austlii.edu.au/au/legis/cth/consol_reg/tgdr2002400/sch4.html (accessed Mar 2013).
We thank Margaret Otlowski, Don Chalmers and John Liddicoat for critical feedback on early drafts of this paper. This research was supported by Australian Research Council Discovery Grant DP11010069.
Dianne Nicol receives support from the Australian Research Council.