Moving Theory into Practice : Human Rights Impact Assessments of Intellectual Property Rights in Trade Agreements

This article explores the development of methodologies for human rights and right to health-specific impact assessment (RTHIA) of trade-related intellectual property rights. These methodologies seek to respond to the restrictive impact of international and bilateral trade rules on domestic and global policy options to ensure access to affordable medicines in low and middle-income countries. RTHIA methodologies are emerging from human rights impact assessments, themselves an offshoot from the broader field of social and health impact assessment. A right to health specific impact assessment allows policy makers to prospectively predict the impact of intellectual property rights on domestic medicines policy, and ergo on the realization of legal duties under the international human right to the highest attainable standard of health. The effective implementation of such an assessment provides an evidence base for broadening policy space in these countries towards improving access to generic and affordable patented medicines. Yet there has been little consensus to date on key questions of principle, methodology and implementation. We overview current literature and practice in this regard in order to assess the current state of the field and the prospects for wider-scale implementation. We first assess the growing international focus on the impact of trade-related intellectual property rights on access to medicines. We then explore the emergence of impact assessments in relation to health and human rights. Finally, we analyse the practical, methodological, political and theoretical challenges of RTHIA, and overview developments in practice and scholarship that suggest effective responses to these challenges