International Soft Law and Safe Blood Transfusion Systems: WHO Standards and National Implementation

ASM Mahmudul Hasan

doi:10.37241/jatss.2026.155

Authors

ASM Mahmudul Hasan Karabük University, Faculty of Economics and Administrative Sciences, Department of International Relations, Karabük /Türkiye https://orcid.org/0000-0001-8833-5101

DOI:

https://doi.org/10.37241/jatss.2026.155

Keywords:

international soft law, global health governance, blood regulation, World Health Organization, voluntary blood donation

Abstract

Introduction: The article explores how international soft law has developed national blood transfusion safety systems by utilizing the normative frameworks of the World Health Organization (WHO). Although there is currently no binding treaty for blood safety in place globally, the WHO has developed a multi-layered governance pathway that creates norms through various forms of documentation, including: World Health Assembly (WHA) Resolutions; Strategic Action Plans; Technical Guidelines; and Benchmarking Mechanisms.

Method: Using legal doctrinal analysis, norm-diffusion theory, and regulatory-governance analysis, and drawing on comparative case studies of China, India, and Bangladesh, this article examines how non-binding WHO standards shape domestic blood legislation, institutional design, and regulatory practice.

Results or Findings: The study finds that there is a significant degree of normative convergence around 5 core principles including: (1) Voluntary and Non-remunerated Blood Donation; (2) Universal Testing for Infection; (3) Centralized Blood System Governance; (4) Hemovigilance; and (5) Quality Management Systems. However, due to issues such as structural inequality, fragmentation of institutions and limited resources, the implementation of these principles has been uneven.

Discussion or Conclusion: The study concludes by stating that the WHO utilizes its authority through an epistemic form of legitimacy, technical expertise, benchmarking and norm entrepreneurship and does not rely on coercion to enforce compliance. By framing blood governance as a hybrid model of transnational administrative regulation, this study advances the scholarship on global health law and regulatory governance and highlights the efficacy of soft law as a form of de facto regulation in highly technical environments.

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