Data exclusivity and public health under the TRIPS agreement

The Agreement on Trade Related Aspects of Intellectual Property Rights (the `TRIPS Agreement') is the first international agreement to set certain minimum standards for the protection of test data submitted to national drug regulatory authorities in order to obtain marketing approval for pharmaceuticals. This protection has created a sui generis proprietary right in undisclosed information, akin to a patent right. The TRIPS regime for test data protection is also popularly known as data exclusivity, although there is some controversy as to whether the TRIPS data protection provisions actually establish a data exclusivity regime or not. There has been much concern as to the effect that the TRIPS framework for test data protection may have on access to medicines, even though this issue has not yet attracted the same level of academic commentary or analysis in comparison to the impact of the TRIPS patents regime. The standard of test data protection required by the TRIPS Agreement and the implications for access to medicines in developing countries are issues that are yet to be fully examined and understood.