Process Is Due: the World Health Organization Prequalification of Medicines

• Citation: Vol. 68 No. 3
• Publication year: 2019

Process Is Due: The World Health Organization Prequalification of Medicines

Connor Fuchs

PROCESS IS DUE: THE WORLD HEALTH ORGANIZATION PREQUALIFICATION OF MEDICINES

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 to be prequalified. These purchasers represent a sizeable portion of the essential medicines market. This has effectively made the Prequalification Programme a de facto drug 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 delist 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 period.

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Introduction.............................................................................................645

I. Access to Essential Medicines and Prequalification...........650

A. Strategies for Increasing Access to Quality Essential Medicines .................................................................................. 650
B. Prequalification Process .......................................................... 653
C. Prequalification Program: The Developing World's Drug Approval Agency ...................................................................... 656
D. Left Out: Drug Manufacturers in Low-Income Countries........ 658
E. Good Manufacturing Practices Pose a Particular Challenge for Manufacturers in Low-Income Countries ........................... 659

II. Due Process in International Law............................................660

A. Customary International Law Applies to International Organizations ........................................................................... 661
B. Companies May Avail Themselves of Human Rights Protections ................................................................................ 664
C. Process Is Due .......................................................................... 665
D. WHO: Human Rights Promotion and Power ........................... 670

III. World Bank Inspection Panel: A Model for Independent Review..............................................................................................672
IV. A Two-Part Solution to the Prequalification Challenges . 674

A. Prequalification Independent Review Panel ............................ 674
B. Conditional Prequalification .................................................... 678

Conclusion.................................................................................................683

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Introduction

More than a quarter of the world's population lacks access to essential medicines.¹ This lack of access results in ten million preventable deaths per year-four million in Africa and South-East Asia alone.² One major factor contributing to this lack of access is the fact that drugs are not produced in the places where they are most needed.³ Africa, for example, is home to a large share of the global disease burden, including 70% of the world's HIV cases and 90% of malaria deaths.⁴ But, an estimated 80% or more of all pharmaceuticals in Africa are imported.⁵ This misalignment can increase the cost of the drugs and leave people vulnerable to supply interruptions.⁶ The finished pharmaceutical products (FPPs) and active pharmaceutical ingredients (APIs) that have been prequalified by the World Health Organization (WHO) reflect this larger trend of geographic production misalignment. As of April 2015, less than 1% of prequalified FPPs⁷ and no prequalified APIs were manufactured in low-income countries⁸ -the countries in greatest need of these medicines.⁹

Although the goal of the WHO is not to supplant national drug regulatory authorities,¹⁰ its Prequalification of Medicines Programme (Prequalification Program) has become the de facto drug approval authority for essential medicine manufacturers operating in many low- and middle-income countries (LMICs). Despite wielding this considerable authority, there is no formal independent review mechanism by which manufacturers can challenge a withdrawal¹¹ or

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denial of prequalification of their products. This lack of review raises international due process concerns,¹² particularly a manufacturer's right to a fair trial. In addition, essential medicines¹³ are overwhelmingly needed in low-income countries, but prequalified essential medicines are almost exclusively produced in middle- and high-income countries.¹⁴ To remedy this misalignment, which is resulting in negative health and economic consequences, the WHO should add another prequalification pathway for manufacturers of drugs produced in low-income countries.

Prequalification is a process through which the WHO assesses and approves the product quality and manufacturing processes of FPPs and APIs that are used to combat priority diseases, including HIV, tuberculosis, and malaria.¹⁵ Many international drug procurement entities and donors, including U.N. agencies, only purchase medicines for priority diseases that have been prequalified by the WHO or another "stringent regulatory authority."¹⁶ These procurement agencies do not currently consider any drug regulatory authorities in LMICs to be "stringent."¹⁷ Thus, gaining the WHO prequalification stamp of approval is effectively the only way for manufacturers in LMICs to sell their products to

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international drug procurement entities and donors-a large and profitable share of the essential medicines market in these countries.¹⁸

The evidence indicates that compliance with the WHO's Good Manufacturing Practices (GMPs)-a prerequisite for prequalification-is particularly challenging for manufacturers based in low-income countries because of financial constraints, a lack of technical expertise, and inconsistent or nonexistent enforcement of GMP standards by national regulatory authorities.¹⁹ This lack of enforcement allows manufacturers who do not comply with stringent GMPs to continue to operate, but results in an exclusion from the international donor market.²⁰

The lack of access to quality-assured essential medicines results in the deaths of millions of people each year.²¹ Individuals in low-income countries disproportionately succumb to diseases that can be easily treated with timely access to quality medicines.²² In 2015, an estimated 1.6 million people in Africa alone died from malaria, tuberculosis, and HIV-related illnesses.²³ This lack of access has been driven by a host of factors, including unaffordable drug prices and an inadequate supply of medicines.²⁴ Strategies to address these challenges include the proliferation of low-cost generic medicines, as well as a strengthening of the domestic pharmaceutical manufacturing industries in countries with the highest disease burdens.²⁵

Given the Prequalification Program's approval authority, the WHO possesses great power over both consumers and drug manufacturers in low-income countries. On the one hand, the WHO performs an essential role in countries with weak regulatory authorities, protecting consumers from the

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dangers of substandard medicines.²⁶ But, on the other hand, the WHO is failing to uphold customary international due process principles, specifically the right to a fair trial, because it does not allow manufacturers whose products are denied prequalification or delisted an opportunity to challenge these decisions. Similarly, by failing to give manufacturers a way to challenge a denial or delisting, the WHO is ignoring its immense power and deviating from its role as a promoter of human rights.²⁷

Customary international law refers to rules that emanate from the "general and consistent practice of states[,]" which are followed out of "a sense of legal obligation."²⁸ Customary international law is binding on international organizations, such as the WHO, as well as states.²⁹ Specifically, customary international law obligates international organizations that are performing a governmental or quasi-governmental function to provide persons whose rights and freedoms may be infringed an opportunity to be heard before an independent and impartial tribunal.³⁰ Here, the...