A proposal for measuring the degree of public health-sensitivity of patent legislation in the context of the WTO TRIPS Agreement.

OBJECTIVE This study aims to propose a framework for measuring the degree of public health-sensitivity of patent legislation reformed after the World Trade Organization's TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement entered into force. METHODS The methodology for establishing and testing the proposed framework involved three main steps:(1) a literature review on TRIPS flexibilities related to the protection of public health and provisions considered "TRIPS-plus"; (2) content validation through consensus techniques (an adaptation of Delphi method); and (3) an analysis of patent legislation from nineteen Latin American and Caribbean countries. FINDINGS The results show that the framework detected relevant differences in countries' patent legislation, allowing for country comparisons. CONCLUSION The framework's potential usefulness in monitoring patent legislation changes arises from its clear parameters for measuring patent legislation's degree of health sensitivity. Nevertheless, it can be improved by including indicators related to government and organized society initiatives that minimize free-trade agreements' negative effects on access to medicines.