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Test Data Exclusivity: An Elusive Pursuit to Strike a Balance Between Affordable Drugs and Investment Incentives

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Kim,  Daria
MPI for Innovation and Competition, Max Planck Society;

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Citation

Kim, D. (2023). Test Data Exclusivity: An Elusive Pursuit to Strike a Balance Between Affordable Drugs and Investment Incentives. In E. Bonadio, & P. R. Goold (Eds.), The Cambridge Handbook of Non-Creative Intellectual Property (pp. 54-72). Cambridge: Cambridge University Press.


Cite as: https://hdl.handle.net/21.11116/0000-0007-B7F3-8
Abstract
Test data exclusivity (TDE) is a regulatory mechanism of suspending price competition in the drug market rationalised on the grounds of protecting innovation incentives of originator companies. Under international trade law, it is considered a subset of intellectual property (IP). While its impact on innovation remains ambiguous, TDE has been criticised at length as an impediment to affordable medicine and the right to health, an obstacle to transparency in medical research, a case of ‘ratcheting up’ of international IP standards, and a threat to TRIPS flexibilities.