The proposed United States legislation on data exclusivity prohibits generic competitors from using the data gathered to test a drug’s safety and efficacy for the public as part of their application to the Food and Drug Administration.
“Data exclusivity requires buyers to pay prices protected from normal competition,” says Sandra Adamini, the lead author of the study. “It might even apply if the patent has expired.” Drug companies argue that data exclusivity is needed beyond twenty-year patent protection in order to earn back large investments in research and to provide an incentive for more innovation.
The study, “Policy Making on Data Exclusivity in the European Union: From Industrial Interests to Legal Realities,” by Adamini, Hans Maarse, Esther Versluis, and Donald W. Light, examines the results of actions undertaken by advocates for the pharmaceutical industry inside the European Commission, who initiated ten-year data exclusivity price protection and managed revisions to the legislation. The authors demonstrate that there is no evidence that patents held by pharmaceutical companies are not already sufficient, or that these government-mandated higher prices increase innovation.
The study also highlights the risks of the legislation if it passes in the U.S., and the resultant impact on developing countries, where data exclusivity makes drugs for cancer, HIV-AIDS, and other serious conditions prohibitively expensive. Physicians working for international humanitarian organizations, such as Doctors Without Borders, have also reported how the lack of generic competition makes drugs they need for their patients unaffordable in developing countries. The U.S. Federal Trade Commission, which fosters competition, has stated that data exclusivity price protections for biological drugs are not necessary.
This study is accessible for free at http://jhppl.dukejournals.org/cgi/reprint/34/6/979.
For more information on the Journal of Health Politics, Policy and Law, please visit http://www.dukeupress.edu/jhppl.
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