Trust Beyond Borders: European External Regulatory Influence on Access to Medicines.

Abstract

European institutions are widely recognized as wielding regulatory power in a globalized market, exporting its standards across borders and between sectors. This paper asks what institutional dynamics catalyze European external regulatory impact on pharmaceutical governance in low- and middle-income countries (LMICs). The research focuses on two European regulatory bodies, the European Medicines Agency (EMA) and the European Patent Office (EPO), and explores the dynamics of their technocratic outreach beyond European borders. We find that trust is a key underlying institutional dynamic facilitating some forms of European external relations. The agencies extend their influence through technical assistance, collaboration, and work-sharing with LMIC regulators, fostering a one-sided relationship of "technocratic trust." This trust, reinforced by international regulatory frameworks that position the EMA and EPO as "trustworthy" regulators, enables these agencies to expand their regulatory influence beyond Europe. By critically examining the impact of this trust-building on LMICs' regulatory autonomy, this research contributes to the broader discourse on European regulatory power in global health governance and highlights potential implications for pharmaceutical markets and access in LMICs.