Regenerative Medicine and the Bioethics of Globalization, Justice and Hegemony

This volume examines regenerative medicine (RM) through a global bioethics lens that foregrounds the structural asymmetries, epistemic exclusions, and governance disparities shaping its development and uptake. RM refers to a range of innovative therapies, clinical interventions, and research activities aimed at repairing or replacing damaged or diseased human cells, tissues, and organs, with an emphasis on conditions currently considered incurable.

While RM is often discussed using examples, standards, and governance models from high-income countries (the so-called Global North ), much less is documented about its realities in low- and middle-income countries (LMICs), particularly in the Global South. These contexts are frequently overlooked in ways that understate their contributions, impose ill-fitting external frameworks, or perpetuate assumptions of absence or inactivity. Such omissions contribute to epistemic injustice, in which certain perspectives, priorities, and knowledge systems are marginalized in global health innovation.

Responding to this imbalance, the present work assembles interdisciplinary contributions from scholars and practitioners deeply engaged with RM in LMICs. It adopts a collaborative bioethics approach that does not treat ethics as an afterthought to technological progress, but as integral to how innovation is imagined, governed, and shared. The collection employs a reconnaissance mode of inquiry to reveal underexplored practices, governance dynamics, and normative perspectives, allowing for locally grounded accounts that resist the constraints of dominant narratives.

The chapters in the volume are organized in two parts:
Foundational Critiques Analytical treatments of epistemic injustice, global asymmetries, and ethical pluralism in RM.
National Case Studies Country-specific explorations of RM governance, practice, and ethics in diverse settings across Africa, Asia, and Eastern Europe.

By illuminating both the commonalities and divergences that emerge from these contexts, this book offers a richer, more inclusive account of RM and its ethical governance. It challenges the hegemony of Global North perspectives and points toward bioethical frameworks that are pluralistic, context-sensitive, and globally responsive.

Autorentext

Ubaka Ogbogu is a Professor and the Katz Chair in Health Law and Science Policy in the Faculty of Law at the University of Alberta. He is the Chair of the University of Alberta s Research Ethics Board 2 and a Member of the Royal Society of Canada s College of New Scholars, Artists and Scientists. Dr. Ogbogu is a recipient of the Confederation of Alberta Faculty Associations Distinguished Academic Early Career Award. He holds a doctorate in law from the University of Toronto, a Master of Laws degree from the University of Alberta, and undergraduate degrees in law from the University of Benin, Nigeria, and the Nigerian Law School.

Dr. Ogbogu's scholarly work focuses broadly on the ethical, legal, and societal implications of novel and emerging biotechnologies and related research. His recent work engages with the global governance of regenerative medicine, highlighting issues of epistemic injustice, structural inequities, and the underrepresentation of low- and middle-income country perspectives in bioethics and innovation policy. Through this work, he examines how context-sensitive, collaborative, and pluralistic approaches to ethics can address disparities in the development and distribution of cutting-edge health technologies.
Dr. Ogbogu has served on several boards and councils with a direct focus on regenerative medicine governance and policy, including the Council of Canadian Academies Expert Panel on Somatic Gene and Engineered Cell Therapies, the Canadian Institutes of Health Research Stem Cell Oversight Committee, and the International Society for Stem Cell Research Task Force on Guidelines for Stem Cell Research and Clinical Translation.
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Donrich Thaldar** is a full Professor of Law at the University of KwaZulu-Natal, Durban, where he chairs the Health Law & Ethics Research Interest Group. He is currently principal investigator of an NIH-funded project that investigates the legal aspects of data science in health innovation in Africa. Professor Thaldar also has a private law practice, where he specializes in strategic litigation in reproductive law (reprolaw). Before starting his academic career in 2017, he practiced as an advocate at the Pretoria Bar. He served as legal counsel or as amicus curiae in several landmark cases in the field of reprolaw in South Africa. Some highlights are: The first case that considered the concept of designer children (2016); the first case of posthumous conception (2018); the first case of gamete withdrawal from a comatose person (2020); and the first case about the enforceability of a sperm donor agreement (2021); and a successful legal challenge to the constitutionality of the statutory prohibition on non-medical preimplantation sex selection (2022).

Nishakanthi Gopalan is a Senior Lecturer at the Medical Humanities and Ethics Unit (MedHEU), Faculty of Medicine, Universiti Malaya (UM), Kuala Lumpur, Malaysia, and Programme Coordinator for the Master of Health Research Ethics (MOHRE), the first postgraduate programme in health research ethics in Southeast Asia. MOHRE was developed in collaboration with the Berman Institute of Bioethics at Johns Hopkins University through a Fogarty International Center bioethics training grant, MOHRE focuses on building regional capacity in culturally attuned health research ethics. Dr. Gopalan holds a PhD in research ethics, and her scholarship centres on bioethics, research ethics, and the governance of emerging technologies, with particular emphasis on low- and middle-income country contexts.

She serves on the Universiti Malaya Research Ethics Committee (UMREC) and the Universiti Malaya Medical Centre Medical Research Ethics Committee (UMMC-MREC), and is an editorial board member of the Asian Bioethics Review. Her research and publications explore the ethical, legal, and social implications of emerging technologi

Inhalt

Part I: Foundational Critiques Epistemic Injustice and Global Asymmetries.- Chapter 1. Reframing Regenerative Medicine: Global Asymmetries and Ethical Futures.- Chapter 2. Towards Epistemic Justice: Regenerative Medicine Activity and Governance in Low- and Middle-Income Countries.- Chapter 3. A Case for Inclusive Global Governance for Regenerative Medicine.- Chapter 4. Integrating Regenerative Medicine into Medical Curricula in the Global South: A Tanzanian Perspective.- Part II: National Case Studies Governance, Context, Constraint, and Endogenous Innovation.- Chapter 5. Translation and Commercialisation of Regenerative Medicine in South Africa: Navigating the Regulatory Landscape.- Chapter 6. Regenerative Medicine at the Tip of Africa: Far-Reaching Consequences of Slow Progress.- Chapter 7. The Kenyan Legal and Policy Framework for Stem Cell Research.- Chapter 8. Stem Cell and Genetic Engineering for Regenerative Medicine: An Indian Perspective.- Chapter 9. Ethical Crossroads and Regulatory Pathways: Navigating Regenerative Medicine in Malaysia.- Chapter 10. Regenerative Medicine in China: Current Regulatory Challenges and Global Advancements.- Chapter 11 Regenerative Medicine and Advanced Therapy Medicinal Products in Ukraine: Research, Regulation and Challenges in a Time of War.