Diagnostic Kits/The dangers of diagnostic monopolies

Cook-Deegan, R., Chandrasekharan, S. & Angrist, M., 2009. The dangers of diagnostic monopolies. Nature, 458(7237), 405-406. (Institute for Genome Sciences and Policy, Duke University, Durham, North Carolina)

• "few empirical studies to help form an accurate picture of how patents affect clinical genetic testing"
• eight case studies
  • on access to genetic tests for ten conditions (prepared for Secretary’s Advisory Committee on Genetics, Health and Society)
• Effect of patents generally
  • not a great harm
  • not a great help
• Effect of patents on price
  • tests without a monopoly are priced similarly to tests with a monopoly
  • other pricing factors
    • economy of scale
    • health plan reimbursement
• Effect of patents as an incentive for test development
  • Patents do not appear to be a necessary motivation, academic labs often offer testing soon after publication
  • The restriction on the market is exclusive licenses
• Effect of patents on standards of care
  • Monopoly rights holders can often set the standard of care (because they are the only tester)
• Effect of exclusive licensing
  • ‘penumbra effect’
    • tests with genes in common lead to one lab having a functional monopoly over the group of diseases that require the common gene or mutation
• There is a growing discussion about whether non-exclusively license should be required for diagnostic patents
  • When technologies arise form public funding, the government has the power to "decide coverage and reimbursement for tests" which has been a largely unused power under the 1980 Bayh-Dole Act.
  • "60% of genetic testing laboratories are within universities."
  • 2007 Association of University Technology Managers (AUTM) said “licenses should not hinder clinical research, professional education and training, use by public health authorities, independent validation of test results or quality verification and/or control”. (Available at www-leland.stanford.edu/group/OTL/industry/resources/whitepaper-10.pdf)

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