ABSTRACT

This chapter considers four broad sets of options for countries in implementing the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Article 39.3 and, more generally, in setting policy in the area of data exclusivity. It evaluates these options from the perspective of how they will facilitate or obstruct access to essential medicines. The options are:

1 Bans on misappropriation. This approach provides the lowest level of protection for registration data that is compatible with TRIPS. It bans parties from fraudulently or dishonestly gaining access to registration data and using it to seek marketing approval.