University of Amsterdam.
J Health Polit Policy Law. 2024 Oct 1;49(5):911-938. doi: 10.1215/03616878-11257032.
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.
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.
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.
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.
欧盟通过其组成法律、机构、行为体和政策来管理全球卫生。然而，目前尚不清楚这些政治因素是否以及如何相互作用，从而使欧盟成为全球卫生的政治决定因素。
作者对影响欧盟通过生物技术指令 98/44/EC 和罕见病药品法规 141/2000 的政治因素进行了案例研究。
欧盟委员会（EC）通常将其两项提案都围绕着与欧盟工业和患者需求一致的经济和生物医学范式构建，而欧洲议会（EP）则对其中一些框架提出质疑，并提出了支持全球获得医疗产品的修正案。影响 EP 修正案通过（在生物技术指令中）或否决（在罕见病法规中）的政治因素包括 EP 和 EC 提案之间的互补性、EP 在机构间谈判过程中的权力、民间社会的存在和支持，以及与理事会中成员国优先事项的一致性。
在 20 世纪 90 年代末，欧盟在全球卫生问题上是一个内部分裂和政治化的参与者。对于 2022 年后欧盟的全球卫生战略，应该考虑这些政治因素。
