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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 J+Law+Med+Ethics
2014 ; 42 Suppl 1
(0 1
): 51-66
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Economic regulation of next-generation sequencing
#MMPMID25298291
Evans BJ
J Law Med Ethics
2014[Fal]; 42 Suppl 1
(0 1
): 51-66
PMID25298291
show ga
Next-generation sequencing broadens the debate about appropriate regulatory
oversight of genetic testing and may force scholars to move beyond familiar
privacy and health and safety regulatory issues to address new problems with
industry structure and economic regulation. The genetic testing industry is
passing through a period of profound structural change in response to shifts in
technology and in the legal environment. Making genetic testing safe and
effective for consumers increasingly requires access to comprehensive genomic
data infrastructures that can support accurate, state-of-the-art interpretation
of genetic test results. At present, there are significant barriers to access and
there is no sector-specific regulator with power to ensure appropriate data
access. Without it, genetic testing will not be safe for consumers even when it
is performed at CLIA-certified laboratories using tests that have been
FDA-cleared or approved. This article explores the emerging structure of the
genetic testing industry and describes its present economic regulatory vacuum. In
view of this gap in regulation, the article explores whether generally applicable
law, particularly antitrust law, may offer solutions to the industry's data
access problems. It concludes that courts may have a useful role to play,
particularly in Europe and other jurisdictions where the essential facilities
doctrine enjoys continued vitality. After Verizon Communications v. Law Offices
of Curtis V. Trinko, the role of U.S. federal courts is less certain. Congress
has demonstrated willingness to address access issues as they emerged in other
infrastructure industries in recent decades. This article expresses no preference
between legislative and judicial solutions. Its aim is simply to highlight an
emerging economic regulatory issue which, if left unresolved, presents real
health and safety concerns for consumers who receive genetic tests.
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