European institutions are widely recognised for exercising regulatory power in an increasingly globalised pharmaceutical market, exporting standards across jurisdictions and sectors. This paper examines the institutional dynamics that enable European regulatory influence on pharmaceutical governance in low- and middle-income countries (LMICs), focusing on two key European regulatory bodies: the European Medicines Agency (EMA)  and the European Patent Office (EPO). 

The study identifies trust as a central institutional dynamic underpinning European external regulatory engagement. Through mechanisms such as: 

• Technical assistance 

• Institutional collaboration 

• Regulatory work-sharing with LMIC authorities 

European agencies help cultivate what the authors describe as a one-sided relationship of “technocratic trust.” This trust is further reinforced by international regulatory frameworks that position institutions such as the EMA and EPO as reliable and authoritative regulators. In turn, this dynamic enables these agencies to expand their regulatory influence globally. 

By critically examining how trust-building practices may shape regulatory autonomy in LMICs, this research contributes to broader discussions on European regulatory power in global health governance. The findings also highlight important implications for the development of pharmaceutical markets and equitable access to medicines in LMIC settings. 

This paper was published in a Symposium entitled ‘Public Health, Markets, and Law’ in the Journal of Law, Medicine & Ethics, and guest edited by Dr Mina Hosseini and Professor Imelda Maher of University College Dublin.  

This paper was published as part of Dr. Parwani’s PhD project, conducted at Law for Health and Life in collaboration with the Amsterdam Institute for Global Health and Development and the INDIGO project “Effective and Affordable flu Vaccine for the World”, funded by the European Union Horizon 2020 program  and the Department of Biotechnology, Ministry of Science and Technology, Government of India. Dr. Perehudoff’s contribution was funded by her NWO Veni project ‘Global access to medicines through EU law and policy’.