20 December 2024
EU pharmaceutical laws shape more than just Europe—they influence global legal systems, pharmaceutical practices, and patient access to medicines worldwide. This paper explores how mechanisms like conditionality, socialisation, externalisation, and mimicry drive the global spread of EU norms, with a focus on developing economies. Using the proposal to revise the EU’s pharmaceutical legislation as a case study, this paper applies these diffusion pathways to (1) new rules for environmental risk assessments for antimicrobials; (2) new rules for reporting of public funding for medicines R&D; and (3) revised clinical test data and market protection, including a transferrable exclusivity voucher. This analysis reveals how innovative proposals could transform global health systems, with potential global implications for medicine access and regulation.
This publication is part of the “Global access to medicines through EU law and policy” project of the Veni talent research programme which is financed by the Dutch Research Council (NWO).