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Author Obi, Evaristus Chiedu,
Title Post-trial access to drugs in developing nations : global health justice / Evaristus Chiedu Obi.
Imprint Cham, Switzerland : Springer, [2017]

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View online
Author Obi, Evaristus Chiedu,
Series Advancing global bioethics ; volume 7
Advancing global bioethics ; v. 7.
Subject Drug accessibility -- Developing countries.
Drug development.
Health Services Accessibility.
Developing Countries.
Description 1 online resource.
Contents Abstract; Acknowledgments; Contents; Chapter 1: Global Health Inequalities and the Quest for Justice; 1.1 Introduction: Contextualizing the Debate; 1.2 Global Health Inequalities; 1.2.1 Developed and Developing Countries; Inequalities of Life and Death; Causes of Death and Disability; Diseases of Poverty; 1.2.2 Social Determinants of Health; Health and Socio-economic Status; Relative Income; Education; Social Class; International Practices and Developing Nations; 1.3 Global Health Justice; 1.3.1 Developing Countries and HIV/AIDS. The Scope of HIV/AIDS Epidemics1.3.1.2 The Demographic Effects; The Economic Effects; 1.3.2 Distributive Justice and Global Research; The Concept of Distributive Justice; Theoretical Approaches to Distributive Justice; 1.3.3 Research Responsiveness to Host Populations; Ethical Issues; Different Perspectives; 1.4 Summary of Book Chapters; Chapter 2: Global Clinical Research; 2.1 Introduction; 2.2 Informed Consent; 2.2.1 Ethical Components of Informed Consent; Different Senses of Informed Consent. Essential Components of Informed ConsentDisclosure of Information; Cultural Barriers and Disclosure Requirement; Cultural Barriers and Disclosure of Risks and Research Study Design; Comprehension of Information; Language Barriers and Lower Level of Literacy; Cultural Beliefs and Health, Disease and Biomedical Procedures; Therapeutic Misconception; Innovative Strategies; Voluntary Participation; Coercion and Undue Inducement; Decisional Authority; 2.3 Ethics Review Committees; 2.3.1 Composition and Responsibilities of Ethics Review Committees. Composition of Ethics Review Committees2.3.1.2 Responsibilities of Ethics Review Committees; Ethics Review Committee and Post-trial Access; 2.4 Conclusion; Chapter 3: Post-Trial Access to Drugs in Developing Nations; 3.1 Introduction; 3.2 Intellectual Property Law; 3.2.1 Origin and Meaning of Intellectual Property Rights; Rights-Based Defenses; Utilitarian Defenses; 3.2.2 Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS); Background; TRIPS Agreement and Access to Drugs in Developing Countries; Patents.
Doha Declaration and TRIPS and Public HealthPost Doha -- The WTO Decision of August 2003; US Trade Policy; Non-Patent Factors; 3.3 Social Responsibility and Access Strategies; 3.3.1 The Social Responsibility of Pharmaceutical Companies; Theoretical Approaches; Global Pharmaceutical Companies; 3.3.2 Access Strategies; Private Donations; Price Reductions and Differential Pricing; International Collaborative Initiatives and Public-Private Partnerships; Complusory Licensing; 3.4 Conclusion.
Summary This book begins the discourse on post-trial access to drugs in developing countries. Underlying ethical issues in global health inequalities and global health research serve as the context of the debate. Due to rampant allegations of violations of rights of research participants, especially in developing countries, it discusses the regulatory infrastructure and ethical oversight of international clinical research, thus emphasizing the priority of safeguarding the rights of research participants and host populations as desiderata in conducting clinical trials in developing countries. This is the first book that analyzes the major obstacles of affordable access to drugs in developing countries - patent and non-patent factors and how they can be overcome through a middle ground approach and a new paradigm to establish global health justice which includes national and global health responsibilities. The book also deals extensively with all complex aspects of the discourse on affordable access to drugs in developing countries, including intellectual property law, international regulations, political and cultural systems, international trade agreements. Furthermore it contains a robust ethical debate and in-depth analysis. The book crafts a paradigm of global health justice involving a sliding scale of national and global responsibilities for the realization of the right to health in general and access to drugs in particular.
Bibliography Note Includes bibliographical references.
ISBN 9783319600284 (electronic bk.)
3319600281 (electronic bk.)
OCLC # 999407732
Additional Format Print version: Obi, Evaristus Chiedu. Post-trial access to drugs in developing nations. Cham, Switzerland : Springer, [2017] 9783319600260 3319600265 (OCoLC)987282470

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