Global Congress #IP Week 2021 - The Impact of Data Exclusivity on Pharmaceutical Import Prices

Global Talk by Michael Palmedo, PIJIP
UTC 16:45 | EDT 12:45

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Michael Palmedo

Abstract

Trade agreements contain numerous TRIPS+ intellectual property provisions designed to enhance branded producers’ monopoly powers. One of these provisions is data exclusivity, a form of intellectual property protection that prevents generic entry by preventing generic firms from relying on the originator’s test results to win regulatory approval.

In a recent paper, I use COMTRADE data over a 15-year period to estimate the change in pharmaceutical import prices in a set of 42 countries. I find that the annual increase in price per kilogram of drug imports for these 42 countries was between 2.4 and 4.5 percentage points higher in countries that had implemented data exclusivity than in countries that had not implemented it.

The COVID-19 pandemic has brought renewed attention to the relationship between intellectual property and access to medical products. While U.S. trade policy has embraced the TRIPS waiver as it pertains to vaccines, it has not signaled a willingness to reassess its stance on intellectual property and medicines more generally. The pandemic is an opportunity for such a reassessment.