The EU as a Political Determinant of Global Health: The Case of Research and Development Incentives for Orphan Medicines and Biotechnology.

Context: The European Union (EU) governs global health through its constituent laws, institutions, actors, and policies. However, it is unclear whether or how these political factors interact to position the EU as a political determinant of global health. Methods: The authors conduct a case study of the political factors influencing the adoption of the EU's Biotechnology Directive 98/44/EC and Orphan Medicines Regulation 141/2000. Findings: The European Commission (EC) generally framed both of its proposals around economical and biomedical paradigms aligned with the needs of the EU's industry and patients, whereas the European Parliament (EP) contested some of these frames and proposed amendments supporting global access to medical products. The political factors influencing the adoption (in the Biotechnology Directive) or rejection (in the Orphan Regulation) of the EP's amendments include the complementarity between the EP and EC proposals, the EP's power in the intra- and interinstitutional negotiating process, the existence and support of civil society, and the alignment with member state priorities in the Council. Conclusions: In the late 1990s, the EU was an internally fragmented and politicized player concerning global health matters. These political factors should be considered for a coherent post-2022 EU strategy on global health. [ABSTRACT FROM AUTHOR]