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

Posted: 17 May 2019

See all articles by Blake Murdoch

Blake Murdoch

University of Alberta - Health Law Institute

Vardit Ravitsky

University of Montreal, Dept of Social and Preventive Medicine

Ubaka Ogbogu

Faculty of Law & Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta

Sarah Ali-Khan

McGill University - Faculty of Law

Gabrielle Bertier

McGill University

Stanislav Birko

University of Montreal

Tania Bubela

University of Alberta - Faculty of Public Health

Jeremy de Beer

University of Ottawa - Common Law Section

Charles Dupras

University of Montreal

Meika Ellis

University of Alberta - Health Law Institute

Palmira Granados

McGill University - Centre for Genomics and Policy

Yann Joly

McGill University - Centre for Genomics and Policy

Kalina Kamenova

Trent University

Zubin K Master

Albany Medical College - Alden March Bioethics Institute

Mike Paulden

University of Alberta

Francois Rousseau

Université Laval - Faculty of Medicine

Timothy Caulfield

University of Alberta - Health Law Institute

Date Written: May 2, 2019

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, Obstetrics, Gynaecology, Prenatal Screening, Ethics

Suggested Citation

Murdoch, Blake and Ravitsky, Vardit and Ogbogu, Ubaka and Ali-Khan, Sarah and Bertier, Gabrielle and Birko, Stanislav and Bubela, Tania and de Beer, Jeremy and Dupras, Charles and Ellis, Meika and Granados, Palmira and Joly, Yann and Kamenova, Kalina and Master, Zubin K and Paulden, Mike and Rousseau, Francois and Caulfield, Timothy, Non-Invasive Prenatal Testing and the Unveiling of an Impaired Translation Process (May 2, 2019). Available at SSRN: https://ssrn.com/abstract=3381913

Blake Murdoch

University of Alberta - Health Law Institute ( email )

Law Centre
Edmonton, Alberta T6G 2H5
Canada

Vardit Ravitsky

University of Montreal, Dept of Social and Preventive Medicine ( email )

C.P. 6128 succursale Centre-ville
Montreal, Quebec H3C 3J7
Canada

Ubaka Ogbogu

Faculty of Law & Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta ( email )

Edmonton, Alberta T6G 2H5
Canada
7804929055 (Phone)
7804924924 (Fax)

Sarah Ali-Khan

McGill University - Faculty of Law ( email )

3644 Peel Street
Montreal H3A 1W9, Quebec
Canada

Gabrielle Bertier

McGill University ( email )

1001 Sherbrooke St. W
Montreal, Quebec H3A 1G5
Canada

Stanislav Birko

University of Montreal ( email )

C.P. 6128 succursale Centre-ville
Montreal, Quebec H3C 3J7
Canada

Tania Bubela

University of Alberta - Faculty of Public Health ( email )

11405 - 87 Ave.
Edmonton, Alberta T6G 1C9
Canada
(780) 492-9335 (Phone)

Jeremy De Beer (Contact Author)

University of Ottawa - Common Law Section ( email )

57 Louis Pasteur Street
Ottawa, K1N 6N5
Canada

Charles Dupras

University of Montreal ( email )

C.P. 6128 succursale Centre-ville
Montreal, Quebec H3C 3J7
Canada

Meika Ellis

University of Alberta - Health Law Institute ( email )

Law Centre
Edmonton, Alberta T6G 2H5
Canada

Palmira Granados

McGill University - Centre for Genomics and Policy ( email )

740 Dr. Penfield Avenue, Suite 5200
Montreal, Quebec H3A 0G1
Canada

Yann Joly

McGill University - Centre for Genomics and Policy ( email )

740 Dr. Penfield Avenue, Suite 5200
Montreal, Quebec H3A 0G1
Canada

Kalina Kamenova

Trent University ( email )

1600 West Bank Drive
Peterborough, Ontario K9J 7B8
Canada

Zubin K Master

Albany Medical College - Alden March Bioethics Institute ( email )

47 New Scotland Avenue, MC 153
Albany, NY 12208
United States

Mike Paulden

University of Alberta ( email )

Edmonton, Alberta T6G 2R3
Canada

Francois Rousseau

Université Laval - Faculty of Medicine

2214 Pavillon J-A. DeSeve
Quebec G1K 7P4
Canada

Timothy Caulfield

University of Alberta - Health Law Institute ( email )

Law Centre
Edmonton, Alberta T6G 2H5
Canada

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