Process is Due: The World Health Organization Prequalification of Medicines Público

Abstract

A lack of access to essential medicines is a significant—but largely preventable— contributor to mortality, primarily in low-income countries. The World Health Organization (WHO)—through its Prequalification of Medicines Programme—prequalifies drugs that meet minimum quality standards and are used in the treatment of certain conditions, such as HIV and tuberculosis. To date, nearly all of the drugs that the WHO has prequalified have been produced in middle- and high-income countries. 

Many international drug procurement entities and donors require the drugs they purchase from low- and middle-income countries be prequalified. These purchasers represent a sizeable portion of the essential medicines market. This has effectively made the Prequalification Programme a de factodrug approval authority for manufacturers in many low-and middle-income countries. However, there is currently no way for manufacturers to challenge a prequalification decision before an independent body.  

This Comment argues that the WHO is failing to uphold customary international due process law, specifically the right to a fair trial, because it does not provide manufacturers whose products are denied prequalification or removed from the prequalification list the opportunity to challenge the decision before an independent body. It also argues that providing these manufacturers the opportunity to challenge an adverse decision is important because of the WHO’s emphasis on human rights promotion and the great power the Programme holds over many manufacturers. It proposes that the WHO adopt an Independent Review Panel before which manufacturers may challenge the Prequalification Programme’s decision to reject or de-list a product.  

This Comment also proposes that the WHO— to facilitate the production of essential medicines in low-income countries—give manufacturers in these countries access to an additional approval pathway called “conditional prequalification.” Conditional prequalification would likely provide eligible manufacturers—whose products meet a lower defined threshold of compliance with good manufacturing practices than is currently required—access to additional segments of the essential medicines market. Conditional prequalification would be contingent upon manufacturers’ adherence to a plan to achieve full compliance within a specified time period.

Table of Contents

Introduction............................................................................................................. 1

I. Access to Essential Medicines and Prequalification............................................. 10

A. Strategies for Increasing Access to Quality Essential Medicines...............................11

B. Prequalification Process.........................................................................................16

C. Prequalification Program: The Developing World’s Drug Approval Agency. ............23

D. Left Out: Drug Manufacturers in Low-Income Countries.........................................25

E. Good Manufacturing Practices Pose a Particular Challenge for Manufacturers

in Low-Income Countries..............................................................................................27

II. Due Process in International Law........................................................................30

A. Customary International Law Applies to International Organizations....................31

B. Companies May Avail Themselves of Human Rights Protections.............................37

C. Process is Due.......................................................................................................39

D. WHO: Human Rights Promotion and Power...........................................................47

III. World Bank Inspection Panel: A Model for Review.............................................52

IV. A Two-Part Solution to the Prequalification Challenges....................................55

A. Prequalification Independent Review Panel............................................................55

B. Conditional Prequalification..................................................................................61

Conclusion................................................................................................................69

About this Master's Thesis

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School	Rollins School of Public Health
Department	Hubert Department of Global Health
Degree	M.P.H.
Submission	Master's Thesis
Language	English
Research Field	Health Sciences, Public Health Law Health Sciences, Pharmacy
Palavra-chave	World Health Organization Prequalification of Medicines Programme
Committee Chair / Thesis Advisor	Dabney P. Evans, Emory University

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