Protection of clinical test data and public health: A proposal to end the stronghold of data exclusivity

Abstract

Test data demonstrating the efficacy, safety and quality of a medicine is required by drug regulatory agencies before a new treatment obtains marketing approval and can be made available to patients. Because test data can be costly and time-consuming to produce, certain countries have 'data exclusivity' regimes that restrict use of test data to the originator company for a period of time. Generic and biosimilar companies rely on originator test data to obtain marketing approval for generic products, so data exclusivity periods can delay entry of lower-cost treatments to the market. While data exclusivity is not required by the World Trade Organization, countries such as the United States and the European Union often push their stronger data exclusivity provisions on other countries through free trade agreements (FTAs). While a small number of countries have waivers to data exclusivity for cases of emergency or other public health need, most do not. This can hamper the timely and affordable availability of needed medicines. Waivers to data exclusivity should be included in legislation to protect public health, and other ways to protect test data against unfair commercial use should be explored.