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:
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.
The cost-sharing approach to registration data. This approach gives generic firms an automatic right to use originators’ data, but requires them to pay a share of the documented costs of generating the data, proportionate to the size of the markets in which they are selling their product.
Provision of data exclusivity. This approach gives those firms submitting original registration data an effective marketing monopoly for a specified period of time and is likely to result in denials of access to medicines.
Public health variants of the data-exclusivity approach. These modifications and clarifications to a strict and inflexible data-exclusivity rule can advance public health objectives by limiting the scope of the data exclusivity provided, or by creating exceptions to data exclusivity.
With data exclusivity now perhaps the most controversial and heated element of international negotiations and discussions over intellectual property-related issues involving pharmaceuticals, countries need to be aware of the wide array of TRIPS-compliant policy options that they have for affording data protection.