Economic regulation of next-generation sequencing

J Law Med Ethics. Fall 2014;42 Suppl 1(0 1):51-66. doi: 10.1111/jlme.12162.

Abstract

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.

Publication types

  • Legal Case
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Genetic Testing / legislation & jurisprudence
  • Genome, Human*
  • Government Regulation*
  • High-Throughput Nucleotide Sequencing / economics*
  • Humans
  • Industry / legislation & jurisprudence*
  • Patents as Topic
  • Sequence Analysis, DNA*
  • United States