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.1 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. This article examines the legal framework for test data protection under the TRIPS Agreement and the obligations it creates for Member States in relation to data exclusivity. It investigates the extent to which the TRIPS test data protection requirements impose fetters on compulsory licensing and the question of whether the right to keep undisclosed information confidential can be dispensed with through the compulsory licensing mechanism. The article considers the connection between test data protection and the need to safeguard public health, with particular focus on the implications for access to medicines in developing countries. It is posited that developing countries are not likely to derive any real benefit from data exclusivity, other than as a possible boost to investment in the local pharmaceutical industry. However, developing countries are still obliged to comply with their obligations under the TRIPS Agreement, including introducing data protection legislation, which could delay the availability of generic medicines. The article argues that data exclusivity should not be a barrier to the use of compulsory licences and that it may be possible to rely on the grounds for compulsory licensing under the TRIPS Agreement to satisfy the exceptions to TRIPS data exclusivity requirements. It takes the view that the promotion of free trade and development of pharmaceutical manufacturing capacity will go a long way in alleviating some of the challenges relating to access to medicines that may be caused by data exclusivity and intellectual property (IP) protection.