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  11. Trust Beyond Borders: European External Regulatory Influence On Access To Medicines

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

Pramiti Parwani1,2,3, Katrina Perehudoff1,2,3, Anniek de Ruijter1,2

  • 1https://ror.org/04dkp9463University of Amsterdam, Amsterdam Law School, Law for Health and Life, Netherlands.

The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics
|August 13, 2025

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View abstract on PubMed

Summary
This summary is machine-generated.

European institutions like the European Medicines Agency (EMA) and European Patent Office (EPO) build "technocratic trust" with low- and middle-income countries (LMICs) through assistance and collaboration, extending their regulatory influence.

Area of Science:

  • Global Health Governance
  • Pharmaceutical Regulation
  • International Relations

Background:

  • European institutions exert significant regulatory influence globally.
  • Understanding the mechanisms of this external regulatory impact is crucial for global health.

Purpose of the Study:

  • To investigate the institutional dynamics behind European external regulatory impact on pharmaceutical governance in low- and middle-income countries (LMICs).
  • To analyze the role of the European Medicines Agency (EMA) and European Patent Office (EPO) in this process.

Main Methods:

  • Qualitative analysis of institutional dynamics.
  • Focus on technocratic outreach and collaboration between European regulatory bodies and LMIC regulators.

Main Results:

Keywords:
European Medicines Agency (EMA)European Patent Office (EPO)European Regulatory BodiesPharmaceuticals Access

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  • "Technocratic trust" is a key dynamic, characterized by a one-sided relationship where LMIC regulators trust European agencies.
  • Influence is extended through technical assistance, collaboration, and work-sharing.
  • International frameworks reinforce the perceived trustworthiness of the EMA and EPO.

Conclusions:

  • European regulatory power is extended through trust-building mechanisms, potentially impacting LMIC regulatory autonomy.
  • This research highlights implications for pharmaceutical markets and access in LMICs within global health governance.
Trust