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J Obstet Gynaecol Can. 2017 Jan;39(1):10-17. doi: 10.1016/j.jogc.2016.09.004. Epub 2016 Oct 17.

Non-invasive Prenatal Testing and the Unveiling of an Impaired Translation Process.

Author information

1
Health Law Institute, Faculty of Law, University of Alberta, Edmonton AB.
2
School of Public Health, University of Montreal, Montreal QC.
3
Faculties of Law and Pharmacy & Pharmaceutical Sciences, University of Alberta, Edmonton AB.
4
Centre for Intellectual Property Policy, Faculty of Law, McGill University, Montreal QC.
5
Centre of Genomics and Policy, McGill University, Montreal QC; UMR 1027, Inserm, Université Toulouse III - Paul Sabatier, Toulouse, France.
6
School of Public Health, University of Alberta, Edmonton AB.
7
Centre for Law, Technology and Society, University of Ottawa, Ottowa ON.
8
Health Law Institute, Faculty of Law, University of Alberta, Edmonton AB; Centre for Law, Technology and Society, University of Ottawa, Ottowa ON.
9
Centre of Genomics and Policy, McGill University, Montreal QC.
10
Bachelor of Arts & Science Program, Trent University, Peterborough ON.
11
Alden March Bioethics Institute, Albany Medical College, Albany, NY.
12
Faculty of Medicine and Dentistry, University of Alberta, Edmonton AB.
13
Department of Molecular Biology, Medical Biochemistry and Pathology, CHU de Québec, Université de Laval, Québec QC.

Abstract

Non-invasive prenatal testing (NIPT) is an exciting technology with the potential to provide a variety of clinical benefits, including a reduction in miscarriages, via a decline in invasive testing. However, there is also concern that the economic and near-future clinical benefits of NIPT have been overstated and the potential limitations and harms underplayed. NIPT, therefore, presents an opportunity to explore the ways in which a range of social pressures and policies can influence the translation, implementation, and use of a health care innovation. NIPT is often framed as a potential first tier screen that should be offered to all pregnant women, despite concerns over cost-effectiveness. Multiple forces have contributed to a problematic translational environment in Canada, creating pressure towards first tier implementation. Governments have contributed to commercialization pressure by framing the publicly funded research sector as a potential engine of economic growth. Members of industry have an incentive to frame clinical value as beneficial to the broadest possible cohort in order to maximize market size. Many studies of NIPT were directly funded and performed by private industry in laboratories lacking strong independent oversight. Physicians' fear of potential liability for failing to recommend NIPT may further drive widespread uptake. Broad social endorsement, when combined with these translation pressures, could result in the "routinization" of NIPT, thereby adversely affecting women's reproductive autonomy. Policymakers should demand robust independent evidence of clinical and public health utility relevant to their respective jurisdictions before making decisions regarding public funding for NIPT.

KEYWORDS:

Commercialization; ethics; gynaecology; obstetrics; prenatal screening

PMID:
28062017
DOI:
10.1016/j.jogc.2016.09.004

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