Diagnostic Kits/The dangers of diagnostic monopolies: Difference between revisions

Revision as of 10:38, 2 October 2009

Cook-Deegan, R., Chandrasekharan, S. & Angrist, M., 2009. The dangers of diagnostic monopolies. Nature, 458(7237), 405-406.

"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.

@@ Line 9: / Line 9: @@
 *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.