Data exclusivity in international trade agreements: What consequences for access to medicines

“Data exclusivity” is a term covering measures some governments, especially the US, are seeking to include in bilateral and regional trade agreements. The implications of such measures need to be understood, because they could have far-reaching ramifications for access to medicines.

Data exclusivity refers to a practice whereby, for a fixed period of time, drug regulatory authorities do not allow the registration files of an originator to be used to register a therapeutically equivalent generic version of that medicine. Data exclusivity is completely separate from patents. In fact, the strongest impact may be felt in a country where there is no patent for a medicine - if data exclusivity is granted this will provide a monopoly for a set period (e.g. five years).

This short briefing paper outlines the consequences of data exclusivity for access to medicines and explains why countries are not obliged to agree to it.