The Next Controversy in Genetic Testing: Clinical Data as Trade Secrets?

European Journal of Human Genetics (2012), 1-4, DOI:10.1038/ejhg.2012.217

4 Pages Posted: 1 Mar 2013

See all articles by Bob Cook-Deegan

Bob Cook-Deegan

Arizona State University (ASU) - School for the Future of Innovation in Society

John M. Conley

University of North Carolina School of Law

James P. Evans

University of North Carolina (UNC) at Chapel Hill - School of Medicine

Daniel B. Vorhaus

Robinson, Bradshaw & Hinson, P.A.

Date Written: February 27, 2013

Abstract

Sole-source business models for genetic testing can create private databases containing information vital to interpreting the clinical significance of human genetic variations. But incomplete access to those databases threatens to impede the clinical interpretation of genomic medicine. National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing. They can create incentives for sharing data and interpretive algorithms in several ways, including: promoting voluntary sharing; requiring laboratories to share as a condition of payment for or regulatory approval of laboratory services; establishing – and compelling participation in – resources that capture the information needed to interpret the data independent of company policies; and paying for sharing and interpretation in addition to paying for the test itself.

US policies have failed to address the data-sharing issue. The entry of new and established firms into the European genetic testing market presents an opportunity to correct this failure.

Keywords: trade secret, patent, Myriad, BRCA, database

Suggested Citation

Cook-Deegan, Robert M and Conley, John M. and Evans, James P. and Vorhaus, Daniel B., The Next Controversy in Genetic Testing: Clinical Data as Trade Secrets? (February 27, 2013). European Journal of Human Genetics (2012), 1-4, DOI:10.1038/ejhg.2012.217. Available at SSRN: https://ssrn.com/abstract=2226006

Robert M Cook-Deegan (Contact Author)

Arizona State University (ASU) - School for the Future of Innovation in Society ( email )

PO Box 875603
Tempe, AZ 85287-560
United States

John M. Conley

University of North Carolina School of Law ( email )

Van Hecke-Wettach Hall, 160 Ridge Road
CB #3380
Chapel Hill, NC 27599-3380
United States
919-962-8502 (Phone)

James P. Evans

University of North Carolina (UNC) at Chapel Hill - School of Medicine ( email )

Daniel B. Vorhaus

Robinson, Bradshaw & Hinson, P.A. ( email )

101 North Tryon St.
Suite 1900
Charlotte, NC 28246
United States

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