Emory Law Journal

Process Is Due: The World Health Organization Prequalification of Medicines
Connor Fuchs *Online Editor, Emory Law Journal, Volume 68; Emory University School of Law, J.D., 2018; Emory University Rollins School of Public Health, M.P.H., 2018; University of Arkansas, B.A., 2014. I would like to thank my faculty advisor, Professor Margo Bagley, for her patient guidance and for introducing me to the Prequalification Programme. I would also like to thank Emory Law Journal members Richard Kubiak, Sarah Lipinski, Fiona O’Carroll, and Bob Sherrier for their excellent feedback and edits. Finally, thank you to my family for always supporting me—none of what I achieve would be possible without them.

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.

 

Introduction

More than a quarter of the world’s population lacks access to essential medicines. 1Access to Med. Found., The 2016 Access to Medicine Index: Methodology 2015, at 1, 6 (2015), http://apps.who.int/medicinedocs/documents/s22176en/s22176en.pdf; Paul Hunt, Special Rapporteur on the Right to Health, Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines, U.N. Doc. A/63/263, annex, at 15 (Aug. 11, 2008). This lack of access results in ten million preventable deaths per year—four million in Africa and South-East Asia alone. 2 Hunt, supra note 1. 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. 3See Jicui Dong & Zafar Mirza, Supporting the Production of Pharmaceuticals in Africa, 94 Bull. World Health Org. 71, 71 (2016). 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. 4Id. But, an estimated 80% or more of all pharmaceuticals in Africa are imported. 5Id. (estimating that imported pharmaceuticals make up 79% of those consumed in Africa); Tefo Pheage, Dying from a Lack of Medicines, Afr. Renewal Online, Dec. 2016–Mar. 2017, http://www.un.org/africarenewal/magazine/december-2016-march-2017/dying-lack-medicines (estimating that 98% of pharmaceuticals consumed in Africa are produced outside of the continent). This misalignment can increase the cost of the drugs and leave people vulnerable to supply interruptions. 6Id. 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 FPPs 7 This Comment uses the terms “drugs” and “FPPs” interchangeably. and no prequalified APIs were manufactured in low-income countries 8See Dong & Mirza, supra note 3.—the countries in greatest need of these medicines. 9 Petra Brhlikova et al., Aid Conditionalities, International Good Manufacturing Practice Standards and Local Production Rights: A Case Study of Local Production in Nepal, 11 Globalization & Health 1, 4 (2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4470019/pdf/12992_2015_Article_110.pdf.

Although the goal of the WHO is not to supplant national drug regulatory authorities, 10About WHO, World Health Org., http://www.who.int/about-us (stating that the goal of the WHO is to “build[] a better, heathier future for people all over the world”) (last visited Nov. 25, 2018). 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 withdrawal 11 This Comment uses both “withdrawal” and “delisting” to refer to situations in which a product’s prequalification is withdrawn or cancelled. or denial of prequalification of their products. This lack of review raises international due process concerns, 12 This Comment uses “due process” to refer specifically to procedural due process. particularly a manufacturer’s right to a fair trial. In addition, essential medicines 13 The WHO defines essential medicines as “those that satisfy the priority health care needs of the population.” Essential Medicines, World Health Org., http://www.who.int/medicines/services/essmedicines_def/en/ (last visited Nov. 25, 2018). This definition encompasses more medicines than the ones the WHO currently prequalifies. However, there is significant overlap between the two categories. are overwhelmingly needed in low-income countries, but prequalified essential medicines are almost exclusively produced in middle- and high-income countries. 14 Dong & Mirza, supra note 3. 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. 15World Health Org., Forty-Seventh Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations: WHO Technical Report Series No. 981, at 28 (2013) [hereinafter WHO Expert Committee Report No. 981]. The Prequalification of Medicines Program also involves the review and approval of “quality control laboratories.” Id. at 30. Although the quality control laboratories are important, this Comment will focus only on the prequalification of FPPs and APIs. 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.” 16Skhumbuzo Ngozwana et al., African Union, Pharmaceutical Manufacturing Plan for Africa: Business Plan 32 (2012) (“Without exception, [international donor entities and non-governmental organizations] require that products be prequalified by WHO or approved by a stringent regulatory authority.”). These procurement agencies do not currently consider any drug regulatory authorities in LMICs to be “stringent.” 17 Generally, the definition of “stringent regulatory authority” only includes authorities that participate in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), as well as special regulatory schemes found in Canada, the European Union, or the United States; members of the ICH currently include the United States, the European Union, some European countries, Japan, and Australia. See, e.g., The Global Fund to Fight AIDS, Tuberculosis and Malaria, Guide to Global Fund Policies on Procurement and Supply Management of Health Products 15 (2017); Unitaid, Quality Assurance of Health Products 2 n.6 (2017). The WHO uses a nearly identical definition of stringent regulatory authority. See World Health Org., Clarification with Respect to a Stringent Regulatory Organization as Applicable to the Stringent Regulatory Authority (SRA) Guideline 1 (2017), https://extranet.who.int/prequal/sites/default/files/documents/75%20SRA%20clarification_February2017_0.pdf. Thus, gaining the WHO prequalification stamp of approval is effectively the only way for manufacturers in LMICs to sell their products to international drug procurement entities and donors—a large and profitable share of the essential medicines market in these countries. 18See, e.g., Ngozwana et al., supra note 16 (“The majority of the market for [anti-retrovirals] is controlled by the international donor entities and Non Governmental Organisations (NGOs).”).

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. 19See World Health Org., Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries: An Overview of Findings from 26 Assessment Reports, at 16 (2010); Brhilkova et al., supra note 9, at 9. 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 Brhilkova et al., supra note 9, at 9.

The lack of access to quality-assured essential medicines results in the deaths of millions of people each year. 21 Hunt, supra note 1; Pheage, supra note 5. Individuals in low-income countries disproportionately succumb to diseases that can be easily treated with timely access to quality medicines. 22See Pheage, supra note 5. In 2015, an estimated 1.6 million people in Africa alone died from malaria, tuberculosis, and HIV-related illnesses. 23Id. This lack of access has been driven by a host of factors, including unaffordable drug prices and an inadequate supply of medicines. 24Margaret Chan, Ten Years in Public Health: 2007–2017, at 14–15 (2017). 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. 25See, e.g., Ngozwana et al., supra note 16, at 6; Frederick M. Abbott & Jerome H. Reichman, The Doha Round’s Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines Under the Amended TRIPS Provisions, 10 J. Int’l Econ. L. 921, 97779 (2007); Kinsley Rose Wilson et al., The Make or Buy Debate: Considering the Limitations of Domestic Production in Tanzania, 8 Global Health 1, 1–2 (2012).

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 dangers of substandard medicines. 26 Ellen F.M. ‘t Hoen et al., A Quiet Revolution in Global Public Health: The World Health Organization’s Prequalification of Medicines Programme, 35 J. Pub. Health Pol’y 137, 154 (2014). 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. 27See supra note 10 and accompanying text.

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.” 28Restatement (Third) of the Foreign Relations Law of the United States § 102(2) (Am. Law Inst. 1987). Customary international law is binding on international organizations, such as the WHO, as well as states. 29See Lisa Clarke, Responsibility of International Organizations Under International Law for the Acts of Global Health Public-Private Partnerships, 12 Chi. J. Int’l L. 55, 73 (2011); infra Section II.A. 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. 30See Bardo Fassbender, Targeted Sanctions Imposed by the UN Security Council and Due Process Rights, 3 Int’l Orgs. L. Rev. 437, 445–46 (2006). Here, the WHO—through the Prequalification Program—is performing a governmental function in deciding to grant, deny, or withdraw a product’s prequalification. Additionally, an adverse decision implicates manufacturers’ cognizable right to engage in commercial activity, particularly because of these decisions’ large economic implications. 31Infra Section II.B.

This Comment argues that the WHO should implement a two-part solution to protect and advance international due process principles and to spur the production of pharmaceuticals in low-income countries. First, the WHO should introduce an independent review panel, comprised of independent subject matter experts from geographically and economically diverse regions. Giving manufacturers whose products are either denied prequalification or delisted the opportunity to contest such a ruling before this panel would bring the Prequalification Program into compliance with international procedural due process principles. This Comment argues that the introduction of this review mechanism would also comport with the WHO’s emphasis on human rights promotion and the Prequalification Program’s immense authority. The introduction of an independent review panel would bring practical benefits, such as improving the accuracy of a prequalification decision, increasing the accountability of the Prequalification team, and increasing manufacturer confidence in, and respect for, prequalification decisions.

Second, this Comment argues that the WHO should institute a procedure that enables manufacturers in lower income countries 32 This Comment uses “lower income countries” to refer to those countries whose gross national income per capita is below or equal to $1,580 in 2017. Manufacturers in these lower income countries would be eligible for “conditional prequalification.” As will be discussed, infra Section III.B., “lower income countries” encompasses all low-income countries and the poorest middle-income countries, as defined by the World Bank. to have their drugs “conditionally” prequalified, based on a lower defined threshold of compliance with WHO GMPs than is currently required. The still relatively high level of compliance, coupled with additional oversight, would be a practical way to increase the supply of quality-assured drugs produced in low-income countries. The prequalification would be “conditional” because manufacturers’ approval for a drug would be contingent upon their adherence to a WHO-approved plan that leads to full GMP compliance within a specified period. Conditional prequalification has the potential to increase the supply of—and subsequent access to—essential medicines, help develop the pharmaceutical industries in lower income countries, bring economic benefits to these countries, and incentivize manufacturers in lower income countries to fully comply with WHO GMPs.

This Comment begins with an overview of the Prequalification Program’s procedures and the important role the Program plays in providing people in LMICs access to high-quality essential medicines. Part I also lays out the challenges, including GMP compliance, that manufacturers in low-income countries face when attempting to have their products prequalified. Part II discusses procedural due process under international law and concludes that the WHO should allow its decisions to be reviewed by an independent and impartial body. Part III examines the review mechanism of another international organization—the World Bank’s Inspection Panel—which offers lessons on how to structure the proposed Prequalification independent review panel. Part IV sets forth the suggested Prequalification independent review panel, as well as the conditional prequalification proposal for manufacturers in lower income countries. This Comment concludes by suggesting that these proposed changes would lead to substantial health, economic, and institutional gains.

I. Access to Essential Medicines and Prequalification

Improving access to high-quality essential medicines has had a central place on the international development agenda for at least the last roughly two decades. 33See G.A. Res. 70/1, Transforming Our World: The 2030 Agenda for Sustainable Development, at 16 (Oct. 21, 2015) (“Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.”); id. at 17 (“[P]rovide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health . . . .”); G.A. Res. 55/2, United Nations Millennium Declaration, ¶ 20 (Sept. 8, 2000) (“We also resolve . . . [t]o encourage the pharmaceutical industry to make essential drugs more widely available and affordable by all who need them in developing countries.”). Despite significant progress over the last forty years, 34 It is estimated that the fraction of people globally without access to life-saving medicines decreased from “less than half the world’s population” in 1975 to about one-third in 1999. World Health Org., The World Medicines Situation 61 (2004). far too many lives are still lost due to a lack of timely access to effective and affordable drugs for preventable or treatable diseases. 35See Hunt, supra note 1; Pheage, supra note 5. In response to concerns about the quality of essential medicines that international donors and drug procurement entities were purchasing, U.N. partners created the Prequalification of Medicines Programme in 2001. 36 A.J. van Zyl, WHO Prequalification of Medicines Programme, 25 WHO Drug Info. 231, 231 (2011). Since that time, the Prequalification Program’s role and influence has increased dramatically.

A. Strategies for Increasing Access to Quality Essential Medicines

Two of the most prominent strategies to increase access to quality essential medicines are ensuring greater supply of generic medicines and increasing the production of drugs—typically generics—in the countries where they are most needed. Affordability is a critical component of access. 37MDG Gap Task Force, U.N., Delivering on the Global Partnership for Achieving the Millennium Development Goals 35 (2008). The WHO has recognized that generic medicines play an important role in making medicines more affordable. 38Id. at 41. The manifestation of this strategy can be seen in the WHO’s Essential Medicines List, which serves as the basis for many national essential medicines lists. 39Reed F. Beall, Patents and the WHO Model List of Essential Medicines (18th Edition): Clarifying the Debate on IP and Access 1 fig.1 (2016). About 95% of the medicines on the latest WHO list are generic products. 40Id. at 2.

Generic drugs are “identical—or bioequivalent—to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.” 41 Rafael Alfonso-Cristancho et al., Definition and Classification of Generic Drugs Across the World, 13 Applied Health Econ. & Health Pol’y S5, S6 (Supp. 2015) (citing the FDA’s definition). Generics are legally marketed and sold after the expiry of any patent and market exclusivities on the pioneer drug, or under a voluntary or compulsory license from the manufacturer of the pioneer product. 42See World Trade Org., TRIPS and Pharmaceutical Patents 7 (2006), https://www.wto.org/english/tratop_e/trips_e/tripsfactsheet_pharma_2006_e.pdf.

Generics are almost always cheaper than their brand-name equivalents because of the lower upfront research and development costs borne by manufacturers, as well as the greater market competition that normally follows the introduction of generic medicines. 43MDG Gap Task Force, supra note 37, at 41; Generic Drug Facts, FDA, https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm167991.htm (last updated June 4, 2018). To gain approval in many regulatory systems, including the WHO’s Prequalification Program, generic drug manufacturers are not required to replicate the costly and time-consuming animal and human clinical studies required of pioneer drugs. 44See, e.g., World Health Org., Generic Medicines, 30 WHO Drug Info. 370, 37071 (2016); Generic Drug Facts, supra note 43. They must simply demonstrate that the generic product provides the same clinical benefits to humans as an already approved drug. 45Generic Drug Facts, supra note 43. Demonstrating bioequivalence typically requires human trials, but only in about twenty-four to thirty-six individuals, compared to the hundreds or thousands of human subjects required in the clinical trials of pioneer drugs. FDA Ensures Equivalence of Generic Drugs, FDA, https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm134444.htm (last updated Dec. 4, 2017). In addition, once applicable patent and market exclusivities on a brand-name drug expire, multiple generic drugs are often introduced into the marketplace within a short time frame, typically resulting in increased competition and lower costs. 46Generic Drug Facts, supra note 43. One notable exception to the entry of multiple generics is for drugs intended to treat rare conditions, for which there is a small market. 47See, e.g., Andrew Pollack, Drug Goes from $13.50 a Tablet to $750, Overnight, N.Y. Times (Sept. 20, 2015), https://www.nytimes.com/2015/09/21/business/a-huge-overnight-increase-in-a-drugs-price-raises-protests.html (describing the lack of competition (and large price increases) surrounding a sixty-two-year old drug, Daraprim—for which there were no effective patents or exclusivities—used to treat a rare condition, toxoplasmosis).

Another strategy to increase access to essential medicines is through the expansion of the domestic pharmaceutical manufacturing capacity in countries with the highest disease burden. 48See, e.g., Ngozwana et al., supra note 16, at 6; Abbott & Reichman, supra note 25; Wilson et al., supra note 25, at 2. The African Union 49 The African Union is an intergovernmental organization comprised of fifty-five member states. Member State Profiles, African Union, https://au.int/memberstates (last visited Nov. 25, 2018). Its vision is “[a]n integrated, prosperous and peaceful Africa, driven by its own citizens and representing a dynamic force in global arena.” Vision and Mission, African Union, https://au.int/en/about/vision (last visited Nov. 25, 2018). has strongly endorsed this strategy:

[T]he development of the sector will provide a basis for sustainable treatment programmes as the contribution that donors can make plateaus or even begins to diminish. The sector can also make a contribution to economic growth through enhanced exports, increased intra-African trade, emergence of supportive industries and the reduced reliance on imports that use up precious hard currency and for which only limited regulatory oversight by our national regulatory authorities is possible. 50Ngozwana et al., supra note 16, at 6.

However, for the benefits of affordable essential medicines to be realized, the drugs produced domestically must be of an acceptable quality. Ensuring adequate quality has proven to be incredibly challenging, with some experts labeling the problem of substandard medicines a potential “public-health crisis.” 51 Atholl Johnston & David W. Holt, Substandard Drugs: A Potential Crisis for Public Health, 78 British J. Clinical Pharmacology 218, 218 (2014). Substandard medicines “are authorized medical products that fail to meet either their quality standards or their specifications, or both.” 52 World Health Org. Res. A70/23, annex, Member State Mechanism on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, at 34 (Mar. 20, 2017). Substandard medicines do not include deliberately counterfeit drugs.

People living in LMICs are particularly vulnerable to being supplied substandard drugs. 53 Johnston & Holt, supra note 51, at 229 (noting that patients may also be supplied substandard medicines in developed countries, but at a very low rate). The drug regulatory authorities in many LMICs lack the necessary resources and capacity to vigilantly monitor the quality of drugs within their territory. 54 Raffaella Ravinetto et al., Fighting Poor-Quality Medicines in Low- and Middle-Income Countries: The Importance of Advocacy and Pedagogy, 9 J. Pharmaceutical Pol’y & Prac. 1, 2 (2016). For example, it is estimated that 34% of drugs in sub-Saharan African are substandard or counterfeit. 55 Tariq Almuzaini et al., Substandard and Counterfeit Medicines: A Systematic Review of the Literature, 3 BMJ Open 1, 4 (2013). The conditional prequalification proposal, as well as the independent review panel to a lesser extent, would help alleviate these dual concerns of supply and quality by stimulating the production of quality-assured essential medicines in lower income countries. Increasing access to quality-assured essential medicines continues to be a challenging, but critically important, task.

B. Prequalification Process

Recognizing the significant risk that substandard medicines pose, U.N. partners established the Prequalification Program as a pilot project in 2001. 56 van Zyl, supra note 36. The Program was initiated by the Interagency Pharmaceutical Coordination Group, a group of senior pharmaceutical advisors from U.N. agencies including the WHO and other international organizations (such as the African Development Bank and the Global Fund to Fight AIDS, Tuberculosis, and Malaria), who meet every six months to better coordinate their pharmaceutical policies and the technical advice they give. The Interagency Pharmaceutical Coordination Group, World Health Org., https://www.who.int/medicines/areas/policy/ipc/en/ (last visited Nov. 25, 2018). At the time (and still to this day), most generic drugs used in LMICs were manufactured in India. 57 ‘t Hoen et al., supra note 26, at 138. However, international procurement entities had reservations about whether the Indian drug regulatory authorities were able to adequately assess the quality of these generic drugs. 58Id. These concerns were further elevated by the recognition that low-cost, quality-assured generic drugs were needed to combat the HIV/AIDS epidemic. 59Id. at 142; see also World Health Org., WHO Prequalification: Progress Report 1 (2013). Largely in response to these developments, WHO Member States asked the organization to assess the quality of medicines so that international procurement entities could ensure the drugs they purchased met recognized standards of quality. 60 ‘t Hoen et al., supra note 26, at 138. In March 2001, the Prequalification of Medicines Programme was launched, initially as a pilot project. 61 WHO, The Interagency Pharmaceutical Coordination Group: Ten Years of IPC: Report on Achievements 1996–2006, at 3 (2007), http://www.who.int/medicines/publications/IPC_En.pdf.

The Prequalification Program is technically a U.N. program that the WHO administers. 62WHO Expert Committee Report No. 981, supra note 15. The purpose of the Prequalification Program has remained the same during its relatively brief history: “to assess the quality, safety, and efficacy of medicinal products.” 63Prequalification of Medicines by WHO, World Health Org. (Jan. 31, 2013), http://www.who.int/news-room/fact-sheets/detail/prequalification-of-medicines-by-who. However, the types of medicines it prequalifies has expanded. Initially, the WHO only prequalified FPPs used to treat HIV/AIDS, tuberculosis, and malaria. Now, hepatitis C medications, zinc, and products used for reproductive health are also eligible for prequalification. 64Id.; see In the Lead-Up to Paris AIDS Conference, WHO Prequalifies First Generic Hepatitis C Medicine and First HIV Self-Test, World Health Org., http://www.who.int/medicines/news/2017/1st_generic-hepC_1stHIVself-test-prequalified/en/ (last visited Nov. 25, 2018). Zinc is used in the treatment of children with acute diarrhea. Prequalification of Medicines by WHO, supra note 63. An FPP—as the name implies—is the “finished dosage form of a pharmaceutical product, which has undergone all stages of manufacture, including packaging in its final container and labelling.” 65World Health Org., Forty-Fifth Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations: WHO Technical Report Series No. 961, at 375 (2011) [hereinafter WHO Expert Committee Report No. 961]. In October 2010, the WHO began prequalifying APIs. 66WHO Expert Committee Report No. 981, supra note 15. An API is the biologically active ingredient in a drug that is intended to have a “direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have [a] direct effect in restoring, correcting or modifying physiological functions in human beings.” 67WHO Expert Committee Report No. 961, supra note 65, at 374–75.

There are five general components of the Prequalification process: (1) invitation, (2) dossier submission, (3) assessment, (4) site inspection, and (5) decision. 68Prequalification of Medicines by WHO, supra note 63. First, the WHO, Joint United Nations Programme on HIV and AIDS, United Nations Children’s Fund, and UNITAID 69 “Unitaid is an international organisation that invests in innovations to prevent, diagnose and treat HIV/AIDS, tuberculosis and malaria more quickly, affordably and effectively. . . . Unitaid is a hosted partnership of the [WHO].” About Us, Unitaid, https://unitaid.eu/about-us/#en (last visited Nov. 25, 2018). invite all interested manufacturers to submit an expression of interest for specified medications. 70Prequalification of Medicines by WHO, supra note 63. Second, interested manufacturers may submit comprehensive data—called the dossier—on the specified pharmaceutical product. 71Id. The dossier includes data on the purity of ingredients in the product, the stability of the product, clinical data, and product samples that allow for chemical and pharmaceutical analysis. 72WHO Expert Committee Report No. 961, supra note 65, at 380; Prequalification of Medicines by WHO, supra note 63. Third, the submitted dossier is evaluated by a group of experts from the WHO and national regulatory authorities 73 Prequalification of Medicines by WHO, supra note 63. that the WHO appoints. 74WHO Expert Committee Report No. 961, supra note 65, at 381. Fourth, following the review of submitted data, inspectors visit manufacturing sites to check compliance with WHO GMPs. 75Id. The inspection team is made up of experts appointed by the WHO, preferably from national regulatory authorities, and coordinated and led by a WHO staff member. 76Id. at 382. Compliance with the GMPs is a particularly challenging step of the Prequalification process for manufacturers and will be discussed in more detail below. 77Infra Section I.E. Finally, the Prequalification Program renders a decision on whether to include the FPP or API on its respective prequalified list. 78Prequalification of Medicines by WHO, supra note 63. Marketing approval from the national regulatory authority in the country of manufacture is a precondition for WHO Prequalification. 79U.N., Local Production of Pharmaceuticals and Related Technology Transfer in Developing Countries: A Series of Case Studies by the UNCTAD Secretariat 250 (2011). However, national regulatory authorities in many LMICs are underfunded and lack the technical capacity to enforce stringent standards. 80 Sten Olsson et al., Pharmacovigilance Activities in 55 Low- and Middle-Income Countries: A Questionnaire-Based Analysis, 33 Drug Safety 689, 691 (2010) (finding that only 47% of countries surveyed reported having “a budget for pharmacovigilance activities”); infra Section I.E.

Manufacturers whose drugs achieve prequalification must submit data and information for re-qualification every five years or as requested by the Prequalification Program. 81WHO Expert Committee Report No. 961, supra note 65, at 386. The WHO also inspects manufacturers’ facilities “at least once every three years.” 82Id. If a prequalified product is found to be noncompliant with prequalification standards, the WHO may suspend or remove the product (and manufacturing sites) from the list of prequalified products. 83Id. at 38687. A manufacturer may also voluntarily withdraw its product from the WHO Prequalification list. 84See, e.g., Fiona Fleck, Ranbaxy Withdraws All Its AIDS Drugs from WHO List, 329 British Med. J. 1205, 1205 (2004) (“Ranbaxy, an Indian generic drug company, has withdrawn all of its AIDS medicines from the World Health Organization’s list of recommended drugs, not because they are unsafe or of poor quality, but because they may not be as effective as they should be, a spokeswoman for WHO said.”).

If a manufacturer’s drug is delisted from the prequalified list or denied prequalification, there is no formal way to challenge that decision before an independent and impartial review body. As will be discussed in Part II, this lack of an independent review body raises serious concerns about whether the WHO is adhering to international procedural due process principles. The proposed independent review panel would bring the WHO into compliance with these principles. However, there are currently two stages of the prequalification process that involve some kind of informal review. The first opportunity is after the applicant’s dossier has been assessed. The “applicant may request a hearing or meeting” with the team that reviewed its dossier to clarify any identified issues. 85WHO Expert Committee Report No. 961, supra note 65, at 381. The other opportunity is following the site visit after the WHO issues an inspection report to the manufacturer that details the findings from its visit. 86Id. at 383. WHO guidance states that any disagreements between the applicant manufacturer and the WHO are resolved according to a standard operating procedure. 87Id. However, this standard operating procedure is not publicly available. 88 The fact that the standard operating procedures are not publicly available raises its own set of concerns that are beyond the purview of this Comment.

A 2010 survey conducted by the WHO Prequalification team revealed that manufacturers who had previously had at least one product prequalified were generally not satisfied with the Program’s problem resolution mechanisms. 89See WHO, WHO Prequalification Programmes, 24 WHO Drug Info. 293, 296 (2010). Overall, the Prequalification assessors and inspectors were meeting or exceeding these manufacturers’ expectations for service delivery. 90Id. But, manufacturers identified several areas in which they felt the Prequalification Program was coming up short, including “[o]pportunities for in-person communication during the assessment process[,] . . . [q]uestion/problem resolution during assessment[,] . . . [c]onsistency of membership in the team of assessors throughout the process[,] . . . [and l]ocal/national representation in on-site inspection teams.” 91Id. It should be emphasized that respondents in this survey were limited to those who had at least one product prequalified. 92Id. To gain a more complete view of manufacturers’ opinions of the Prequalification Program, it would be necessary to survey manufacturers who have applied for, but never prevailed in, having a drug prequalified; unfortunately, this information is currently unavailable. The WHO states that the results of this survey would be used to improve the current Program, an important goal given the great influence the Program has in many LMICs. 93Id. at 293.

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

The WHO—through its Prequalification Program—has in many ways become the de facto drug approval authority in many LMICs. The governments of LMICs often use the WHO’s list of prequalified medicines to guide their decisions on which medicines to purchase. 94WHO Prequalification Financing Model – Questions and Answers, World Health Org., http://who.int/medicines/news/prequal_finance_model_q-a/en/ (last visited Nov. 25, 2018). Some African drug authorities, in particular, have used WHO prequalification as a proxy in their own drug assessment and approval processes. 95 Mary Moran et al., Registering New Drugs for Low-Income Countries: The African Challenge, 8 PLoS Med. 1, 3 (2011). Similarly, large drug procurement entities—including U.N. agencies and the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund)—require the drugs they purchase from LMIC-based manufacturers to be prequalified, except in very limited circumstances. 96See Procurement Agencies, World Health Org., https://extranet.who.int/prequal/information/medicines-purchasing-organizations (last visited Nov. 25, 2018); Sourcing and Management of Health Products, Medicines, Global Fund, https://www.theglobalfund.org/en/sourcing-management/quality-assurance/medicines/ (last visited Nov. 25, 2018) (“[I]mplementing Principal Recipients have three options when selecting which antiretrovirals, antituberculosis medicines and antimalarial medicines to purchase. They can choose medicines that have been either: 1. Prequalified by the World Health Organization Prequalification Programme[;] 2. Authorized for use by a Stringent Drug Regulatory Authority[; or] 3. Recommended for use by the Expert Review Panel.”). The Global Fund Expert Review Panel is only an option in the rare circumstance when “only one or no product is available on the global market . . . .” Id. Additionally, no drug authorities in LMICs currently qualify as “stringent.” See discussion supra note 17.

These actors—LMIC governments, international donors, and international drug procurement agencies—represent a substantial portion of the market for medicines, particularly essential medicines, in LMICs. 97See Ngozwana et al., supra note 16. Unfortunately, pinpointing the precise share of the essential medicines market that these actors occupy is not currently possible “due to a lack of comparable data on pharmaceutical expenditures” in many LMICs. 98Ye Lu et al., World Health Org., The World Medicines Situation 2011: Medicine Expenditures 2 (2011); see also Manjiri Bhawalkar & Abeba Taddese, Guide to Tracking Pharmaceutical Expenditures in a Health System 1 (2014) (noting that a lack of uniform methodology for collecting detailed pharmaceutical expenditure data in LMICs inhibits comparisons of pharmaceutical expenditures between countries). Data from 2006 indicated that public expenditures represented 23.1% of total pharmaceutical spending in low-income countries and 33.5% in lower middle-income countries. 99Lu et al., supra note 98, at 7 tbl.1.2. The report, however, cautions that the low income numbers do not capture the spending of international donors and drug procurement entities, such as U.N. agencies, the Global Fund, or the United States President’s Emergency Plan for AIDS Relief (often referred to by its acronym: PEPFAR). 100See id. at 7 n.1. The amount of money these donors and procurement entities spent on pharmaceuticals increased significantly after 2006. Id. From fiscal year 2005 through 2011, the congressionally funded PEPFAR program purchased more than $1.2 billion in antiretroviral drugs to treat those infected with HIV. U.S. Gov’t Accountability Off., GAO-13-483, President’s Emergency Plan for AIDS Relief: Drug Supply Chains Are Stronger, but More Steps Are Needed to Reduce Risks 1 (2013). International donors and procurement entities alone purchase billions of dollars of medication annually for distribution in low-income countries. 101Prequalification of Medicines by WHO, supra note 63. The Prequalification Program stamp of approval is therefore critical for many LMIC-based drug manufacturers’ profitability and sustainability.

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

Although critically important, it has been nearly impossible for drug manufacturers in low-income countries to get their products prequalified. In April 2015, only three out of 419 WHO prequalified FPPs, and none of the prequalified APIs were produced by a manufacturer in a low-income country. 102 Brhlikova et al., supra note 9. Of the 419 FPPs, 119 were produced by high-income country manufacturers while 297 were produced by middle-income country manufacturers. Id. Of the prequalified APIs, 3 were produced by high-income country manufacturers and 75 were produced by middle-income manufacturers. Id. The results of a 2012 study examining all of the generic FPP and API dossiers—from both low-income and non-low-income countries—that had been submitted for Prequalification between 2007 and 2010 provides an interesting contrast. 103 Wondiyfraw Z. Worku et al., Deficiencies in Generic Product Dossiers as Submitted to the WHO Prequalification of Medicines Programme, 9 J. Generic Meds. 63, 64 (2012). The authors—primarily WHO Prequalification officials—found that of the 178 dossiers accepted for review, 104Id. at 63, 65. 245 dossiers had been submitted, but 45 (18.37%) were rejected either because “the product was not invited to the programme or later due to the applicant’s failure to respond to the PQP queries in a timely fashion (maximum 1 year).” Id. at 67. 60 (33.71%) had been prequalified as of December 2011, while 54 (30.33%) had been cancelled or withdrawn. 105Id. at 72. One notable finding is that HIV dossiers contained substantially fewer deficiencies than did tuberculosis, malaria, and reproductive health dossiers for both FPPs and APIs. Id. at 73. The remaining 64 dossiers were presumably still under assessment at the time of the study.

Although the data from these two studies do not reveal whether manufacturers from low-income countries are applying for prequalification and getting rejected or simply not applying, they do reveal three important trends. First, the numbers unequivocally demonstrate that the medicines being prequalified are not being produced in low-income countries they are often destined for. Second, they show that the large international donor and national LMIC market is out of reach for current and potential manufacturers of essential medicines who are based in low-income countries. Finally, they suggest that the WHO’s strategy of increasing the manufacturing capacity in countries with the highest disease burden is largely failing.

E. Good Manufacturing Practices Pose a Particular Challenge for Manufacturers in Low-Income Countries

The limited available evidence indicates that compliance with GMPs poses a particular challenge for drug manufacturers in low-income countries. 106 Brhlikova et al., supra note 9, at 9. GMPs are used by the Prequalification Program, as well as national regulatory agencies, 107WHO, WHO Prequalification of Medicines Programme: WHO Launches the PQD Collaborative Registration Procedure, 27 WHO Drug Info. 325, 325 (2013). “to ensure the quality, safety and efficacy” of medicines. 108See, e.g., World Health Org., Forty-Eighth Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations: WHO Technical Report Series No. 986, at 90 (2014) [hereinafter WHO Expert Committee Report No. 986]. GMPs prescribe minimum standards with which manufacturers must comply throughout every stage of the manufacturing process. 109Id. At the national and Prequalification levels, GMPs are enforced by making compliance a precondition to market entry and prequalification, respectively. 110See, e.g., Current Good Manufacturing Practice (CGMP) Regulations, FDA, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm (last updated Nov. 1, 2018); Prequalification of Medicines by WHO, supra note 63. If detected and enforced, failure to comply with GMPs may result in the denial or withdrawal of a drug’s marketing authorization. 111See, e.g., Current Good Manufacturing Practice (CGMP) Regulations, supra note 110; Prequalification of Medicines by WHO, supra note 63. GMPs are aimed at ensuring “products are consistently produced and controlled according to the quality standards appropriate to their intended use and . . . . managing and minimizing the risks inherent in pharmaceutical manufacture . . . .” 112WHO Expert Committee Report No. 986, supra note 108.

Pharmaceutical regulators and industry groups in more than 100 countries—primarily LMICs—use the WHO’s GMPs. 113 Joseph D. Nally, Worldwide Good Manufacturing Practices, in Good Manufacturing Practices for Pharmaceuticals 335, 339 (Joseph D. Nally ed., 6th ed. 2007). However, manufacturers in low-income countries generally do not comply with GMPs at a level that would allow the drugs they produce to be prequalified. 114See, e.g., World Health Org., supra note 19, at 16, 21; Brhlikova et al., supra note 9, at 8 (“Domestic producers report that compliance with the stringent standards of GMP is a major obstacle for domestic production of affordable pharmaceutical products.”). The WHO conducted an assessment of the regulatory systems in twenty-six sub-Saharan African countries and found that nine of the countries did not require that manufacturers have any GMP certification; “only five . . . had published GMP guidelines meeting WHO standards[;]” and of the countries that did require compliance, they were generally poorly enforced. World Health Org., supra note 19. This is due in part to manufacturers lacking the requisite financial resources and technical expertise, as well as operating in countries with weak national medical regulatory authorities. 115See World Health Org., supra note 19, at 6, 8, 12, 21; Brhlikova et al., supra note 9, at 9. The drug regulatory authorities of many low-income countries do not require GMP compliance, poorly enforce compliance, or publish standards that do not fully adhere to the minimum requirements of the WHO’s GMPs. 116World Health Org., supra note 19. This allows manufacturers to continue to operate regardless of adherence to stringent GMPs. 117 Brhlikova et al., supra note 9, at 9. These factors contribute to make compliance with the WHO’s GMPs particularly challenging for manufacturers in lower income countries who seek to have their drugs prequalified.

In sum, this Comment has drawn three crucial conclusions about the WHO’s Prequalification Program, with particular focus on GMPs, and how that Program affects access to essential medicines in LMICs. First, far too many people—especially in low-income countries—do not have access to quality-assured essential medicines. Second, the Prequalification Program has performed a critical role in helping to ensure essential medicines meet minimum quality, safety, and effectiveness standards. Third, by adopting this gatekeeper role, the WHO—through the Prequalification Program—has become the de facto drug approval authority in many low-income countries that currently lack the capacity to verify the quality of many of the drugs in their territory. However, manufacturers whose products are denied prequalification or delisted have no formal way to challenge the WHO’s decision before an independent body, which raises substantial international due process concerns.

II. Due Process in International Law

Historically, international law exclusively governed the relationships between states. 118 Paul B. Stephan, Privatizing International Law, 97 Va. L. Rev. 1573, 1574 n.1 (2011) (citing Jeremy Bentham, Principles of International Law, in 2 The Works of Jeremy Bentham 550 (John Bowring ed., Edinburgh, Simpkin, Marshall & Co. 1843)). However, this view that sovereigns are the sole actors in international law is now obsolete. 119Id. at 1574. It is now generally accepted that international organizations are also bound by at least some aspects of international law. 120See Clarke, supra note 29. Customary international law requires international organizations to provide individuals and companies the opportunity to be heard before an independent and impartial tribunal when the organization is performing a governmental or quasi-governmental function that determines the rights and obligations of these individuals and companies. 121 Fassbender, supra note 30, at 473–74; see also International Covenant on Civil and Political Rights art. 14, Dec. 19, 1966, 999 U.N.T.S. 171; Convention for the Protection of Human Rights and Fundamental Freedoms art. 6, Nov. 4, 1950, 213 U.N.T.S. 222 [hereinafter European Convention on Human Rights]; G.A. Res. 217 A (III), Universal Declaration of Human Rights art. 10 (Dec. 10, 1948) [hereinafter Universal Declaration of Human Rights]. The WHO is performing a governmental function in administering the Prequalification Program, specifically in its decision to grant, deny, or revoke a product’s prequalification. Further, under the European Court of Human Rights’ jurisprudence, entities have a cognizable right to engage in commercial activity, particularly when the economic consequences of an adverse decision are significant. 122See infra note 167 and accompanying text. Therefore, this Comment argues that by failing to provide manufacturers whose drugs are denied prequalification or delisted the opportunity to challenge the WHO’s decision before an impartial tribunal, the WHO is failing to uphold international due process principles. It also argues that the WHO should provide these manufacturers the opportunity to challenge a denial or delisting because of the WHO’s emphasis on human rights promotion and the Prequalification Program’s great power over many manufacturers.

A. Customary International Law Applies to International Organizations

International organizations are bound by at least some aspects of international law, in particular customary international law. The major sources of international law include international agreements or treaties, customary international law, and “the general principles of law recognized by civilized nations.” 123 Statute of the International Court of Justice art. 38, ¶ 1. Additionally, “[j]udicial decisions and the teachings of the most highly qualified publicists of the various nations, as subsidiary means for the determination of rules of law.” Id. Customary international law has been defined as the “general and consistent practice of states followed by them from a sense of legal obligation.” 124Restatement (Third) of the Foreign Relations Law of the United States § 102(2) (Am. Law Inst. 1987). States must follow customary international law, except when they have consistently objected to a particular law each time the opportunity has arisen or they expressly contract around it. 125Id. § 102 cmt. j; Roozbeh (Rudy) B. Baker, Customary International Law in the 21st Century: Old Challenges and New Debates, 21 Eur. J. Int’l L. 173, 176 (2010). States, however, are always bound by customs that are considered jus cogens126 Vienna Convention on the Law of Treaties art. 53, opened for signature May 23, 1969, 1155 U.N.T.S. 331. Literally meaning “compelling law,” jus cogens are “peremptory norm[s] of general international law.” 127Id.; Restatement (Third) of the Foreign Relations Law of the United States § 102 cmt. k (Am. Law Inst. 1987); Kamrul Hossain, The Concept of Jus Cogens and the Obligation Under the U.N. Charter, 3 Santa Clara J. Int’l L. 72, 73 (2005).Jus cogens are rules that are so widely “accepted and recognized by the international community of States as a whole” that derogation is not permitted. 128 Vienna Convention on the Law of Treaties, supra note 126. Examples of jus cogens include the prohibitions against genocide, slavery, and the use of force principles found in the U.N. Charter. 129Restatement (Third) of the Foreign Relations Law of the United States § 102 n.6 (Am. Law Inst. 1987).

International organizations are obligated to respect international law, including jus cogens 130 Kristina Daugirdas, How and Why International Law Binds International Organizations, 57 Harv. Int’l L.J. 325, 346 (2016) (“Jus cogens norms bind IOs [(international organizations)] because states cannot, by treaty, establish IOs that are authorized to violate jus cogens norms.”) (citations omitted). and customary international law. 131 Clarke, supra note 29. But see Daugirdas, supra note 130, at 331–35 (“In short, the answers that scholars have given to the question of whether general international law binds IOs include: maybe, sometimes, and always.”). In an advisory opinion, the International Court of Justice found that “[i]nternational organizations are subjects of international law and, as such, are bound by any obligations incumbent upon them under general rules of international law, under their constitutions or under international agreements to which they are parties.” 132 Interpretation of the Agreement of 25 March 1951 Between the WHO and Egypt, Advisory Opinion, 1980 I.C.J. Rep. 73, 89–90 (Dec. 20, 1980). Although the International Court of Justice has not always used the term “general international law” consistently, it generally includes at least customary international law. See Clarke, supra note 29; Daugirdas, supra note 130, at 333. But see Daugirdas, supra note 130, at 331–34, for an argument that the International Court of Justice’s WHO-Egypt opinion does not shed much light on international organizations’ obligations. Further, to contract around customary international law, parties to an agreement must do so expressly. 133 Daugirdas, supra note 130, at 348. This has led to the conclusion that international organizations are bound by customary international law unless the member states of that organization have expressly conveyed their intent to deviate from it. 134Id.

Although at least one commentator has argued that procedural due process in civil cases should constitute jus cogens135 S.I. Strong, General Principles of Procedural Law and Procedural Jus Cogens, 122 Pa. St. L. Rev. 357 (2018). the European Court of Human Rights—an influential court with a rich body of case law—has previously stopped short of such a recognition. 136 Al-Dulimi. v. Switzerland, App. No. 5809/08, Eur. Ct. H.R. 1, 65–66 (2016), http://hudoc.echr.coe.int/eng/?i=001-164515. It has, however, observed that the right to bring a civil claim before an independent tribunal is “one of the universally recognised fundamental principles of law . . . .” 137 Golder v. United Kingdom, 18 Eur. Ct. H.R. 1, 17 (1975). Even if the right to bring a civil claim before an independent tribunal is not considered a rule of jus cogens, the WHO should still respect this principle because it is a part of customary international law. 138 Fassbender, supra note 30, at 444 (“On the basis of constitutional and statutory rules and practices common to a great number of States of all regions of the world, and as guaranteed by universal and regional human rights instruments, rights of due process, or ‘fair trial rights,’ have been generally recognized in international law protecting individuals from arbitrary or unfair treatment by State organs.”).

Although due process is nearly always discussed in terms of obligations that a state owes individuals, the United Nations and its organs are now bound by these principles because they are increasingly asked to perform “tasks of global governance that go beyond its traditional purposes and functions.” 139Id. at 467. The evolving authority of the United Nations (and its organs) is part of a larger shift in global governance, including in the area of regulatory decision-making. 140 Richard B. Stewart, The Global Regulatory Challenge to U.S. Administrative Law, 37 N.Y.U. J. Int’l L. & Pol. 695, 695 (2005). Global actors, including international organizations, now perform regulatory functions once reserved almost exclusively for states. 141Id.

It is often said that the Universal Declaration of Human Rights (UDHR) and International Covenant on Civil and Political Rights (ICCPR) form two-thirds of the International Bill of Human Rights. 142See e.g., Hurst Hannum, The Status of the Universal Declaration of Human Rights in National and International Law, 25 Ga. J. Int’l & Comp. L. 287, 340–41 & n.221 (1995–1996). The other document forming this Bill of Rights is the International Covenant on Economic, Social, and Cultural Rights. Id. at 341 n.221. Unlike the ICCPR, the UDHR is not a binding treaty. 143 Mary Ann Glendon, The Rule of Law in the Universal Declaration of Human Rights, 2 Nw. U. J. Int’l Hum. Rts. 1, 4 (2004); Anne Lowe, Note, Customary International Law and International Human Rights Law: A Proposal for the Expansion of the Alien Tort Statute, 23 Ind. Int’l & Comp. L. Rev. 523, 537 (2013). However, many of the provisions found in both of these documents, including the right to a fair trial, are now widely considered customary law, which generally binds even non-parties. 144See, e.g., Abdullahi v. Pfizer, Inc., 562 F.3d 163, 176 (2d Cir. 2009) (recognizing the ICCPR as customary international law); Lowe, supra note 143 (“[E]ven though the UDHR is not a binding treaty, it is considered to be a source of customary international law, and, therefore, imposes binding international legal obligations.”). These two seminal documents contain provisions expressly guaranteeing procedural due process, specifically the right to a fair trial. Article 10 of the UDHR states: “[e]veryone is entitled in full equality to a fair and public hearing by an independent and impartial tribunal, in the determination of his rights and obligations and of any criminal charge against him.” 145 Universal Declaration of Human Rights, supra note 121. Using similar language, Article 14 of the ICCPR provides: “[i]n the determination of any criminal charge against him, or of his rights and obligations in a suit at law, everyone shall be entitled to a fair and public hearing by a competent, independent and impartial tribunal established by law.” 146 International Covenant on Civil and Political Rights, supra note 121. The bifurcation of these provisions into “rights and obligations” and “criminal charges” makes clear that the right to a fair trial provided by these documents—and now customary law—applies to both civil and criminal cases. Article 6(1) of the European Convention on Human Rights (ECHR) 147 Formally, it is called the Convention for the Protection of Human Rights and Fundamental Freedoms. closely tracks the language of Article 14 of the ICCPR. It states that “[i]n the determination of his civil rights and obligations or of any criminal charge against him, everyone is entitled to a fair and public hearing within a reasonable time by an independent and impartial tribunal established by law.” 148 European Convention on Human Rights, supra note 121. The ECHR explicitly applies in both the civil and criminal context.

Although entities can contract around customary international law, there is no evidence that the WHO Constitution or the Expert Committee Report that formally endorsed the Prequalification Program even contemplated—much less expressed a desire to deviate from—procedural due process. Therefore, the WHO is obligated to respect procedural due process rights, specifically the right to a fair trial.

B. Companies May Avail Themselves of Human Rights Protections

The theory that international organizations exercising governmental authority over an individual are obligated to respect due process standards is rooted in human rights law. 149 Fassbender, supra note 30. Since applicants to the Prequalification Program are companies, including corporations, an important question becomes whether human rights apply to companies or if this body of law is reserved only for natural persons. In other words, do companies have legal personality under human rights law that would grant them rights similar to those afforded to individuals?

Looking at the language of these international human rights agreements, as well as the practice of regional human rights bodies, companies often do in fact enjoy basic human rights, including the right to be heard before an independent tribunal. 150 See, e.g., Lucien J. Dhooge, Human Rights for Transnational Corporations, 16 J. Transnat’l L. & Pol’y 197, 211–13 (2007). There are, however, limits on corporations’ human rights. For a discussion of these limits, see Julian G. Ku, The Limits of Corporate Rights Under International Law, 12 Chi. J. Int’l L. 729, 751–53 (2012). The broad language found in the right to a fair trial provisions of these international human rights agreements lends credence to the argument that companies enjoy this right. 151 Dhooge, supra note 150. The drafters of these documents used intentionally broad language, rather than limiting it to simply “human beings.” 152Id. Article 10 of the UDHR, Article 14 of the ICCPR, and Article 6 of the ECHR state that “everyone” or “all persons” shall be entitled to a fair hearing before an independent and impartial tribunal. 153 International Covenant on Civil and Political Rights, supra note 121; European Convention on Human Rights, supra note 121; Universal Declaration of Human Rights, supra note 121. Additionally, companies have long been able to bring claims in the European Court of Human Rights. 154 European Convention on Human Rights, supra note 121, at art. 34 (“The Court may receive applications from any person, non-governmental organisation or group of individuals . . . .”); see Winfried H.A.M. van den Muijsenbergh & Sam Rezai, Corporations and the European Convention on Human Rights, 25 Pac. McGeorge Global Bus. & Dev. L.J. 43, 49 (2012) (“Among the Convention rights always and easily deemed applicable to corporations are the right to a fair trial . . . .”). A prime justification for extending human rights, particularly due process protections, to companies is that companies, including corporations, are “merely associations of individuals united for a special purpose.” 155 Pembina Consol. Silver Mining & Milling Co. v. Pennsylvania, 125 U.S. 181, 189 (1888) (holding that the Fourteenth Amendment extends to corporations). Therefore, companies do enjoy human rights protections.

C. Process Is Due

Having established that the WHO is generally bound by international procedural due process rules and that companies have legal personality under international human rights law, this Comment now turns to whether the Prequalification Program, in particular, must provide participants access to an independent and impartial tribunal. The United Nations has previously grappled with a similar question in a different context. 156 Fassbender, supra note 30, at 441. In 2005, the U.N. General Assembly commissioned Professor Bardo Fassbender to conduct a study on the due process concerns involved in the U.N. Security Council’s (UNSC) targeted sanctions regime, specifically UNSC Resolution 1267, which sanctions individuals and entities belonging to or associated with Al Qaeda or the Taliban. 157Id. at 440–42. The listing and delisting of these individuals, in particular, raised significant due process concerns. 158Id. at 442–43.

Fassbender concluded that, under customary international law, the United Nations and its organs must provide procedural due process if two conditions are met. 159Id. at 467, 474. First, the United Nations or its organs must be exercising “governmental or quasi-governmental authority” over individuals or entities. 160Id. at 467 (quoting Karel Wellens, Remedies Against International Organisations 89 (2002)). Second, the United Nations or its organs must be “taking action that adversely affects, or has the potential of adversely affecting, the rights and freedoms of individuals.” 161Id. at 474 (emphasis added). In the civil context the three human rights documents discussed above—the UDHR, ICCPR, and ECHR—phrase this second condition as an action that determines an individual’s “rights and obligations.” 162See supra note 153 and accompanying text. As discussed, companies may assert this right to due process, specifically the right to a hearing before an independent tribunal. 163See supra note 149–55 and accompanying text.

The Prequalification Program’s decision to list and delist medicines satisfies both criteria. First, the WHO, which is an organ of the United Nations, is exercising a governmental or quasi-governmental function—through its Prequalification Program—when it decides to grant, deny, or withdraw prequalification approval. The approval and removal (or delisting) of pharmaceutical products is a function primarily carried out by national governments. 164 Warren A. Kaplan & Richard Laing, Paying for Pharmaceutical Registration in Developing Countries, 18 Health Pol’y & Plan. 237, 237 (2003). One exception is the European Union’s centralized procedure, which allows a company to obtain a single market authorization for all of the member states in the European Union. Ines M. Vilas-Boas & C. Patrick Tharp, The Drug Approval Process in the U.S., Europe, and Japan, 3 J. Managed Care & Specialty Pharmacy 459, 461 (1997). The WHO itself states that “[m]edicines regulation is essentially a public function.” 165 World Health Org., Building Quality-Assured Manufacturing Capacity in Nigeria, 28 WHO Drug Info. 425, 429 (2014). Additionally, the ultimate purpose of the Prequalification Program—the protection of public health 166See supra note 63 and accompanying text.—has historically been a government function. Therefore, the WHO is exercising a governmental, or at the very least quasi-governmental, function in the administration of its Prequalification Program.

Second, the Prequalification Program is determining (or taking an action that has a potentially adverse effect on) an entity’s cognizable right when it makes the decision to deny prequalification or delist an already prequalified product. The European Court of Human Rights has held that the right to a fair trial covers the right to engage in commercial activity, particularly when an adverse decision would carry significant economic consequences. 167See Tre Traktörer AB v. Sweden, 159 Eur. Ct. H.R. (ser. A) 3, 19 (1989); Benthem v. Netherlands, 97 Eur. Ct. H.R. (ser. A) 4, 16 (1985); Nuala Mole & Catharina Harby, The Right to a Fair Trial: A Guide to the Implementation of Article 6 of the European Convention on Human Rights, in 3 Human Rights Handbooks 13 (2d ed. 2006), https://rm.coe.int/168007ff49. Compare I.T.C. Ltd. v. Malta, App. No. 2629/06, Eur. Ct. H.R. 1, 11 (2007), http://hudoc.echr.coe.int/eng?i=001-84144 (holding that one of the losing bidders for a public contract had no civil right to the award of the contract for the purposes of a right to a fair trial), with Araç v. Turquie, App. No. 69037/01, Eur. Ct. H.R. 1, 4 (2006), http://hudoc.echr.coe.int/eng?i=001-76944, translated by Google Translate (finding that a civil right was at issue for person who was excluded from all future public tenders because of the serious economic consequences of the exclusion).

The European Court of Human Rights has held that the denial as well as revocation of a license interferes with a legal person’s “civil” right 168 European Convention on Human Rights, supra note 121. The European Court of Human Rights uses the term “civil right” to refer to non-criminal rights covered by the right to a fair trial provision. Id. for the purposes of receiving a fair trial. 169Tre Traktörer AB, 159 Eur. Ct. H.R. (ser. A) at 19; Benthem, 97 Eur. Ct. H.R. (ser. A) at 16; see also Mole & Harby, supra note 167 (citing cases involving licenses that the court held were covered by the right to a fair trial). In Benthem v. Netherlands, the court held that a person possesses a civil right when someone’s application for a license is denied. 170Benthem, 97 Eur. Ct. H.R. (ser. A) at 16. The applicant in Benthem sought a license to establish and operate a gas station. 171Id. at 9–10. Municipal authorities initially granted the license, but on appeal, determined that the license should be refused. 172Id. at 10–11. The European Court of Human Rights held that the dispute over the license denial implicated a civil right within the purview of the right to a fair trial. 173Id. at 16. Additionally, the court specifically rejected the government’s argument that this dispute did not concern a substantive right because Mr. Benthem could obtain a license for a different location. 174Id. “[A] change of this kind—which anyway would have involved an element of chance since it would have required a fresh application whose success was in no way guaranteed in advance—might have had adverse effects on the value of the business and of the goodwill . . . .” 175Id. (emphasis added). Thus, Mr. Benthem was entitled to a fair trial before an independent tribunal following the denial of his license application. 176Id. at 16–17.

The European Court of Human Rights came to the same conclusion—namely that a civil right is at issue—when a license is revoked. In Tre Traktörer AB v. Sweden, a restaurant that had previously been licensed to serve alcohol had its license revoked by a local administrative board. 177 Tre Traktörer AB v. Sweden, 159 Eur. Ct. H.R (ser. A) 3, 13 (1989). After a rather long procedural journey, the County Administrative Board—following an order by the National Board of Health and Welfare—revoked the restaurant’s alcohol license. 178Id. at 12–13. The restaurant then appealed this decision back to the National Board of Health and Welfare, which declined to review the County Administrative Board’s decision. 179Id. at 13. The European Court of Human Rights found that the revocation of the license “adverse[ly] [affected] . . . the goodwill and value of the restaurant.” 180Id. at 19. The court therefore held that the alcohol license conferred a right on the restaurant and thus the former licensee was entitled to a fair trial before an independent tribunal. 181Id. The court also held that neither the County Administrative Board nor the National Board of Health and Welfare constituted an independent tribunal. Id. at 20.

In contrast to the earlier licensing cases, the European Court of Human Rights has more recently considered the right to engage in commercial activity in the context of bids for a public tender. 182See I.T.C. Ltd v. Malta, App. No. 2629/06, Eur. Ct. H.R. 1, 11 (2007), http://hudoc.echr.coe.int/eng?i=001-84144; Araç v. Turquie, App. No. 69037/01, Eur. Ct. H.R. 1, 5 (2006), http://hudoc.echr.coe.int/eng?i=001-76944. These recent decisions—I.T.C. Ltd. v. Malta and Araç v. Turquie—indicate that the court is more likely to find that a party possesses a right to engage in commercial activity when an adverse decision would result in significant economic consequences, such as being excluded from multiple—rather than just one—contract. 183See I.T.C. Ltd., Eur. Ct. H.R. at 11; Araç, Eur. Ct. H.R. at 5.

In I.T.C. Ltd. v. Malta, the Maltese Ministry for Youth and Arts issued a public call for tenders related to a national event, for which three companies submitted bids. 184I.T.C. Ltd., Eur. Ct. H.R. at 2. Following the announcement of the winning bid, one of the companies that was not awarded the contract attempted to challenge the Ministry’s decision in the judicial system. 185Id. at 3–5. The European Court of Human Rights held that “[t]he issuance of a call for tenders did not give any tenderer any enforceable civil right against the issuer.” 186Id. at 8. The court distinguished I.T.C. Ltd. from the case decided a year earlier, Araç v. Turquie, in which the court held that an applicant for a public tender did possess an enforceable civil right. 187Araç, Eur. Ct. H.R. at 5. In Araç, the applicant was excluded not only from the tender at issue, but also all future tendering processes. 188Id. at 4–5. “The [Araç] decision thus entailed very [different] significant economic consequences for him.” 189I.T.C. Ltd., Eur. Ct. H.R. at 11. Therefore, it appears that the court takes account of the economic consequences at stake in determining whether a legal person possesses a cognizable right for the purposes of a fair trial.

Here, the Prequalification Program’s decision to deny or withdraw a drug’s prequalification is interfering with a manufacturer’s civil right to engage in commercial activity under both the licensing and more recent public tender lines of cases. Under both lines, manufacturers enjoy this right because an adverse decision by the Prequalification Program substantially restricts their ability to engage in commercial activity—now and in the future—and carries significant economic consequences for the manufacturers.

Similar to the denial of a license application in Benthem, and the revocation of a license in Tre Traktörer AB, the denial or revocation of a product’s prequalification status affects the “value and goodwill” of the manufacturer’s operation. As the court made clear in Benthem, the fact that a manufacturer can reapply for approval does not make the right to engage in commercial activity unenforceable. 190 Benthem v. Netherlands, 97 Eur. Ct. H.R. (ser. A) 4, 16 (1985). The WHO’s decision to grant, deny, or withdraw a product’s prequalification has a significant impact on manufacturers’ profitability and sustainability. 191See supra Section I.D. In other words, there are “direct links between the grant of the license and the entirety of the applicant’s commercial activities.” 192Benthem, 97 Eur. Ct. H.R. (ser. A) at 16; see also supra Section I.C.

Under the public tender cases, manufacturers under the Prequalification Program are more similar to the applicant in Araç than the one in I.T.C. Ltd. Like the applicant in Araç193Araç, Eur. Ct. H.R. at 5. a manufacturer whose product is denied prequalification or delisted is excluded not from one contract, but from all contracts with drug procurement entities that require the drugs they purchase to be prequalified. As discussed, this category of purchasers constitutes a sizeable and profitable portion of the essential medicines market. 194See supra Section I.C. Therefore, an adverse decision by the Prequalification Program carries significant economic consequences. Under customary international law, manufacturers whose drugs are denied prequalification or delisted are entitled to a fair hearing before an independent tribunal.

D. WHO: Human Rights Promotion and Power

In addition to alleviating due process concerns, the WHO should allow manufacturers whose products are delisted or denied prequalification the opportunity to challenge such a decision due to its role as a promoter of human rights and the immense power it exerts over many drug manufacturers. Just prior to his 2017 selection as WHO Director-General, Dr. Tedros Adhanom Ghebreyesus stated that he was “committed to transforming the way that WHO operates. A more effective and efficient WHO will strengthen the entire U.N. system. . . . Too often, human rights and gender equity are secondary considerations when U.N. organizations develop programming. This is outdated and must change.” 195 Benjamin Mason Meier, Human Rights in the World Health Organization: Views of the Director-General Candidates, 19 Health & Hum. Rts. J. 293, 294 (2017). Although Dr. Tedros was mainly referring to an individual’s right to health, 196Id. his statement underscores the important role that international organizations, including the WHO, play in not only the protection, but promotion, of human rights.

The WHO was created as a norm-setting agency, with human rights at the organization’s core. 197See generally L.O. Gostin et al., The Normative Authority of the World Health Organization, 129 Pub. Health 854, 855 (2015) (discussing the mission, authority, and functions of the WHO). The WHO Constitution begins with the proclamation that “[t]he enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being . . . .” 198Constitution of the World Health Organization pmbl., opened for signature July 22, 1946, 62 Stat. 2679. Although historically the WHO’s human rights focus has been on the right to health, there is a need for it to expand the rights it protects and promotes in a way that is commensurate with its growing authority. By failing to provide Prequalification applicants the ability to challenge an adverse decision, the WHO has not only missed an opportunity to advance human rights principles, but is actually lagging behind some countries.

For example, a manufacturer who applies to have its drug approved by the European Medicines Agency 199 This is specifically referring to the Centralized Procedure. Similar to the Prequalification Program, approval through the Centralized Procedure enables entities to effectively gain authorization to distribute (or market) their product in multiple countries. Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 Laying Down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency, 2004 O.J. (L 136) 1 (EC); Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use, 2001 O.J. (L 311) 67 (EC); Vilas-Boas & Tharp, supra note 164. may have a denial reviewed by the European Court of Justice. 200 Case T-74/00, Artegodan GmbH v. Comm’n of the European Communities, 2002 E.C.R. II-4948, II-4952, II-5019–21; see Levan Makhashvili & Paul Stephenson, Differentiating Agency Independence: Perceptions from Inside the European Medicines Agency, 9 J. Contemp. Eur. Res. 4, 910 (2013) (citing R. Daniel Kelemen, The Politics of ‘Eurocratic’ Structure and the New European Agencies, 25 W. Eur. Pol. 93, 99 (2002) (“In addition, the European Court of Justice (ECJ) monitors the actions and decisions of the EMA ([European Medicines Agency]) and, at the request of EU institutions or citizens, can further scrutinise its functioning.”)); Johannes Saurer, The Accountability of Supranational Administration: The Case of European Union Agencies, 24 Am. U. Int’l L. Rev. 429, 46162 (2009) (providing an overview of the EMA-specific jurisprudence on when an action may be challenged in court). Similarly, in the United States, manufacturers whose applications for generic drug approval 201 The discussion of the FDA approval process will focus exclusively on the FDA review of generic drug applications. This is done for two reasons: (1) the review procedure at this stage of the process is substantially similar for brand name and generic manufacturers that an examination of one will suffice; and (2) most of the drugs that are prequalified by the WHO are generic products. Worku et al., supra note 103, at 63–64. are denied or withdrawn may either request a hearing with the FDA or seek judicial review in a U.S. court of appeals. 202 21 C.F.R. § 314.200(c)(1) (2018); 21 C.F.R. § 314.235(b) (2018). If an applicant opts for a hearing with the FDA and is still displeased with the agency’s decision, it retains the ability to appeal that decision to a U.S. court of appeals. 203 21 C.F.R. § 314.235(b). It should be noted, however, that courts accord FDA decisions substantial deference. 204 Fed. Power Comm’n v. Fla. Power & Light Co., 404 U.S. 453, 463 (1972) (“[W]hen resolution of that question depends on ‘engineering and scientific’ considerations, we recognize the relevant agency’s technical expertise and experience, and defer to its analysis unless it is without substantial basis in fact.”). Courts also do not perform their own fact-finding, but rather review only the information that the agency possessed at the time it made its decision. 205 Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 420 (1971); Bristol-Myers Squibb Co. v. Shalala, 923 F. Supp. 212, 216 (D.D.C. 1996) (citing Camp v. Pitts, 411 U.S. 138, 142 (1973)). These examples demonstrate that the WHO has thus far missed an opportunity to promote robust due process protections.

The WHO should allow manufacturers whose drugs are denied prequalification or delisted the opportunity to challenge such a decision due also to the great power the Prequalification Program holds over many manufacturers. In 1928, Clyde Eagleton wrote that “[p]ower breeds responsibility” to describe states’ responsibilities under international law. 206Clyde Eagleton, The Responsibility of States in International Law 206 (1928); see also Clarke, supra note 29, at 65. Scholars began to apply this idea to international organizations, as their roles and powers expanded. 207 Clarke, supra note 29, at 65 (citing E. Paasivirta & P.J. Kujjper, Does One Size Fit All?: The European Community and the Responsibility of International Organizations, 36 Neth. Y.B. Int’l L. 169, 173 (2005)). As international organizations increasingly act in ways that affect the “social, political, economic and legal status of individuals,” their responsibility to be accountable for their decisions increases as well. 208Id. (quoting Gerhard Hafner, Accountability of International Organizations—A Critical View, in Towards World Constitutionalism 585, 592–93, 629 (Ronald St. John MacDonald & Douglas M. Johnston eds., 2005)). The WHO—in deciding to award prequalification to a manufacturer—consistently makes decisions that have a significant impact on an applicant’s profitability and sustainability. 209See supra Section I.C. Due to this power, the WHO’s Prequalification Program should have structural mechanisms in place to make it more accountable for its decisions. Allowing manufacturers whose drugs are denied prequalification or delisted the opportunity to challenge such a decision would ensure the WHO is promoting human rights and help alleviate concerns that it is unaccountable.

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

The WHO is not the only international organization to face calls for the introduction of a review body. 210 Granted, at least some of those calls to the WHO are coming from this Comment. In 1993, the World Bank’s Board of Executive Directors 211 The World Bank is a global partnership with 189 member countries dedicated to reducing poverty by providing zero or low interest loans, credits, grants, and technical assistance to developing countries. Who We Are, World Bank, http://www.worldbank.org/en/who-we-are (last visited Nov. 25, 2018). created an Inspection Panel in response to charges—both internal and external—that the Bank was not considering the sometimes negative social and environmental effects of the loans it was administering. 212 Yvonne Wong & Benoit Mayer, The World Bank’s Inspectional Panel: A Tool for Accountability?, in 6 The World Bank Legal Review 495, 496 (Jan Wouters et al. eds., 2015). This Comment will look to the World Bank Inspection Panel to offer lessons on how to structure the proposed WHO Prequalification independent review panel.

The Inspection Panel is made up of a diverse group of appointed individuals. The President of the World Bank nominates three people from different states, and then the panelists are appointed by the Executive Directors to serve non-renewable five year terms. 213 International Bank for Reconstruction and Development (IBRD), Res. 93-10 (Sept. 22, 1993), http://siteresources.worldbank.org/EXTINSPECTIONPANEL/Resources/ResolutionMarch2005.pdf; The World Bank, The Inspection Panel: Annual Report: July 1, 2017–June 30, 2018, at 5 (2018). The Panel is tasked with receiving and investigating allegations that the World Bank has not complied with “its operational policies and procedures.” 214 Wong & Mayer, supra note 212. The Inspection Panel can consider claims brought by (1) at least two individuals affected by the project, (2) an entity representing affected individuals, or (3) the Executive Director or Board of Executive Directors, which can order the Panel to investigate a certain loan. 215Id. at 502. Prior to bringing a claim, there is an exhaustion of remedies requirement: individuals or representative claimants must assert that they have brought their concerns to Bank Management, and—in the complainant’s view—the Management’s response was inadequate. 216Id. at 503. The Panel is an investigatory body, whose ultimate goal is to bring World Bank projects into conformity with its own operational policies and procedures. 217Id. at 514–15. Therefore, the Panel does not compensate individuals who have been negatively affected by a loan. 218Id. at 514. Rather, it presents its findings to the World Bank’s Board, which then decides how to proceed. 219Id. at 515. Panel proceedings typically lead to an action plan, which on occasion has included the cancellation or revocation of funding for the project in question. 220Id.

While not perfect, the Inspection Panel has been credited with bringing about more careful decision-making and encouraging the Bank to take corrective actions. First, the mere presence of the Panel encourages staff to be more cognizant of the Bank’s policies and to more diligently monitor their projects. 221Id. at 51617. Second, the Panel’s findings can prompt the Board of Executive Directors to take corrective action when a project is not in full compliance. 222Id. at 516.

The Inspection Panel, however, has also faced criticism that its practices both limit utilization and participation and raise questions about the Panel members’ independence. According to some, there are linguistic and cultural barriers that impede people from filing claims, which may ultimately result in underutilization of the Panel. 223Id. at 50708 (noting that the World Bank’s working language is English, and filing a claim against an authority may run counter to the norms and values of some cultures). Additionally, some claimants have stated that they are largely sidelined during the Panel’s investigation and deliberation processes. 224Id. at 511–12. Finally, there have been doubts about the true independence of the Panel since panelists are appointed by the Executive Director and claims must be approved by the Board of Executive Directors to proceed. 225Id. at 510–12. The experience of the Inspection Panel can provide guidance on how to structure the proposed Prequalification independent review panel.

IV. A Two-Part Solution to the Prequalification Challenges

This Comment proposes a two-part solution to address both the international due process concerns and the lack of pharmaceutical production in low-income countries. First, as discussed above, the WHO should allow drug manufacturers whose drugs are denied prequalification or delisted the opportunity to be heard in front of an independent panel. Second, the WHO should institute a procedure that enables manufacturers in lower income countries to have their drugs “conditionally” prequalified. Conditional prequalification would require manufacturers to meet a lower defined threshold of GMP compliance that ensures manufacturers’ facilities have basic quality control mechanisms. The prequalification is “conditional” because manufacturers’ approval for a drug is contingent upon their adherence to a plan, approved by the WHO, that leads to full GMP compliance within a defined time period. This Comment will now address these two parts in turn.

A. Prequalification Independent Review Panel

The WHO should create a review panel comprised of an odd number of independent experts that—upon request from manufacturers—will review decisions to withdraw or deny prequalification. As explained below, an independent review panel would not only provide manufacturers with robust due process protections, but also ensure the accuracy of prequalification decisions, increase the accountability of Prequalification staff members, and instill more confidence in the decisions of the Prequalification team.

Beginning with the composition of the panel, the WHO Prequalification independent review panel should adopt the approach of the World Bank Inspection Panel with respect to diversity of representation and term limits. 226See supra note 213 and accompanying text. It is important that the Prequalification Review Panel represent a geographically and economically diverse group of countries to encourage the greatest level of actual and perceived independence, fairness, and credibility. The following example could be one way to achieve such a panel.

The panel could consist of seven people, each serving a term of five years. The panelists’ terms would be staggered to ensure panel continuity. 227 The staggering of terms would, of course, require some of the initial panelists to serve less than five-year terms (e.g., two initial panelists serve three-year terms, two serve four-year terms, and the other three serve for the full five years). Individuals would be allowed to serve more than once, but not in successive terms. One panelist would come from each of the six WHO regions: the African Region, Region of the Americas, South-East Asia Region, European Region, Eastern Mediterranean Region, and Western Pacific Region. 228WHO Regional Offices, World Health Org., http://www.who.int/about/regions/en/ (last visited Nov. 25, 2018). The seventh and final panelist would be appointed by the U.N. agencies that procure prequalified drugs. The seventh panelist could—but would not be required to—be an employee of a U.N. agency. All of the panelists should have expertise in the area of pharmaceuticals. Similar to criticisms of the World Bank Inspection Panel, 229See supra notes 223–25 and accompanying text. questions may be raised about the independence of the panelists. To assuage some of these concerns, there could be a cooling-off rule for regional panelists: individuals are not eligible to be a regional panelist for some specified period (e.g., five years) after they have been directly employed by the WHO or served on a Prequalification assessment or inspection team. These measures would satisfy the international law requirement of providing applicants a hearing before an independent and impartial tribunal. 230See supra Section II.A.

Applicant manufacturers would be able to bring before the panel challenges based on a rejection of their dossier or a finding of noncompliance with the GMPs. There would, however, be an exhaustion of remedies requirement, similar to the World Bank Inspection Panel. 231Supra Part III. The FDA and the European Court of Human Rights appeal procedures contain a similar requirement. European Convention on Human Rights, supra note 121, at art. 26 (“The Commission may only deal with the matter after all domestic remedies have been exhausted . . . .”); supra Section II.D. The manufacturer would be required to raise its concerns with the Prequalification team and make a good faith effort to resolve any disputes before filing a claim with the independent panel. For the panel to overturn a prequalification decision, at least 60% of the panelists would need to vote in favor of such a measure. 232 For a full panel of seven individuals, five of the seven panelists would need to vote in favor of overturning the prequalification decision. However, if one or more panelist were absent, the required number of votes would change accordingly. Requiring a 60% threshold for reversals is intended to guard from an overly active panel and build in limited deference to the Prequalification team.

For products that are delisted, the panel could either uphold or reverse the WHO’s decision. The panel would uphold the delisting of a product when it agrees with the Prequalification team that there are immediate deficiencies in the safety or effectiveness of a product. The panel would reverse the WHO’s delisting of a product—and restore its prequalification status—when the evidence indicates that the product remains both safe and effective, and is manufactured in compliance with GMPs.

For manufacturers that are applying to have their product(s) prequalified, the panel could (1) uphold the Prequalification team’s decision, (2) reverse a denial and grant prequalification, (3) grant the proposed “conditional” approval that will be discussed in section B of this Part, or (4) change the Prequalification team’s grant of conditional prequalification to “full” prequalification. 233 “Full” prequalification refers to the current prequalification granted by the WHO. It is used to distinguish between the proposed “conditional prequalification” and the current system. First, the panel would uphold a WHO denial of prequalification when there are material deficiencies in the applicant’s dossier submission or noncompliance with GMPs. Second, the panel would reverse a WHO denial of Prequalification if it determines the facts clearly show that an applicant’s dossier submission and manufacturing facilities comply with the Prequalification requirements. Third, the panel could grant conditional approval if the manufacturer’s dossier submission is satisfactory, the manufacturer is from an eligible country, 234See infra Section IV.B. and its compliance with GMPs is not fully satisfied but meets the minimum standards discussed in section B of this Part. Finally, the panel would change a conditional prequalification result to full prequalification if it determines there is clear evidence demonstrating that the applicant’s dossier submission and compliance with GMPs warrant such a change.

In deciding what information to review, the panel should adopt the approach of U.S. courts 235See supra Section II.D. and review only the information that the Prequalification team possessed at the time it made its decision. 236 Accordingly, the Panel would not make a site or inspection visit to the facility, but would rely on the report of the inspection team. Limiting the reviewable information to only what is contained in the administrative record safeguards against lengthy and costly discovery and litigation. 237See generally Paula Hannaford-Agor & Nicole L. Waters, Estimating the Cost of Civil Litigation, 20 Caseload Highlights 1, 7 (2013) (discussing the costs and inefficiencies of litigation). A lack of financial and human resources is already a concern for both the WHO 238 Eigil Sørensen, Challenges for the World Health Organization, J. Nor. Med. Ass’n (Jan. 2018), https://tidsskriftet.no/en/2018/01/kronikk/challenges-world-health-organization. and many manufacturers. 239See, e.g., Brhilikova et al., supra note 9, at 8 (discussing the problems encountered in the authors’ Nepali study, including “financial constraints”). Therefore, a procedure that is efficient, in terms of cost and time, is in the best interests of all parties.

The Panel, however, should depart from U.S. courts’ high level of agency deference, 240See, e.g., Chevron U.S.A. Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 844 (1984). and review each case de novo. A primary justification for U.S. courts’ deference to agency decisions is that judges do not possess the same expertise as agency officials. 241See, e.g., id. at 865. Here, the Prequalification Panel would be comprised of subject matter experts. Thus, the justification of deferring to the agency—in this case the WHO Prequalification team—is absent.

As discussed in Part III above, international law principles require the WHO to provide manufacturers whose products have been denied prequalification or delisted an opportunity for a hearing before a competent, independent, and impartial body. The independent review panel would satisfy this obligation. Such a Panel would also bring practical benefits. First, the Panel would ensure that prequalification decisions are accurate. It logically follows that having a group of seven widely respected subject matter experts review a decision would increase its accuracy. Second, similar to the World Bank Inspection Panel, the mere existence of the Prequalification Panel puts additional pressure on the Prequalification team to take care in its decisions to prequalify drugs or not. The possibility of bad publicity and loss of credibility associated with prequalifying an unsafe drug is likely to safeguard against the Prequalification team over-approving applications in an effort to avoid having decisions overturned by the Panel. Finally, stemming from these first two benefits, manufacturers would likely have more confidence in, and respect for, the decisions of the Prequalification team, if they had the opportunity to appeal negative decisions. It is possible that this confidence would increase the number of manufacturers from across the world—including lower income countries—that apply for prequalification. Even so, it would likely take more than the creation of an appeals process to facilitate the production of quality drugs in lower income countries. A modified prequalification process available to manufacturers based in these countries, such as the proposed condition prequalification, has the potential to do just that: increase the supply of quality-assured medicines produced in lower income countries.

B. Conditional Prequalification

Conditional prequalification would be an approval pathway available only to manufacturers producing FPPs and APIs in lower income countries. For their drugs to be conditionally prequalified, manufacturers in these countries would be required to meet a defined threshold of GMP compliance that is below what is required for full prequalification, but one that ensures the drugs are safe and effective, and that the facilities in which they are produced have basic quality control mechanisms in place. The prequalification would be conditioned upon manufacturers adhering to a WHO-approved plan that leads to full compliance within a specified period.

The criteria used to determine the countries in which manufacturers would be eligible for conditional prequalification would mirror the economic standards used by Gavi, the Vaccine Alliance. 242 “Gavi is an international organisation - a global Vaccine Alliance, bringing together public and private sectors with the shared goal of creating equal access to new and underused vaccines for children living in the world’s poorest countries.” About Gavi, the Vaccine Alliance, Gavi, Vaccine Alliance, http://www.gavi.org/about/ (last visited Nov. 25, 2018). In addition to having a certain three-year gross national income per capita, countries applying for Gavi support must also satisfy other criteria, as dictated by the specific vaccine they are applying for. See Transition Process, Gavi, Vaccine Alliance, https://www.gavi.org/support/sustainability/transition-process/ (last visited Nov. 25, 2018). The Gavi eligibility criteria generally capture countries that have the highest disease burdens and lowest drug production rates. 243See Gavi’s Mission, Gavi, Vaccine Alliance, https://www.gavi.org/about/mission/ (last visited Nov. 25, 2018). To be eligible for conditional prequalification, the manufacturer’s drugs would have to be produced in a country with an average gross national income per capita of $1,580 or less over the past three years. 244Countries Eligible for Support, Gavi, Vaccine Alliance, http://www.gavi.org/support/sustainability/countries-eligible-for-support/ (last visited Nov. 25, 2018). The $1,580 figure would be the 2018 level, subsequently adjusted annually for inflation. Currently, manufacturers in forty-seven countries would be eligible for conditional prequalification. 245Id. The Gavi level of $1,580 is desirable for conditional prequalification because it includes not only “low-income” countries 246 Under 2019 fiscal year classifications, countries with a gross national income per capita below $995 are classified as low-income. World Bank Country and Lending Groups, World Bank, https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups (last visited Nov. 25, 2018). but also a limited number of poorer “middle-income” countries, as classified by the World Bank. 247Id. Making manufacturers in all middle-income countries eligible for conditional prequalification would be overly inclusive as the economic conditions in these countries vary significantly: middle-income countries are defined as having a gross national income per capita between $996 to $12,055. 248Id. Manufacturers in a country such as India—a middle-income country with a well-developed generic pharmaceutical industry—do not need the conditional prequalification approval pathway. 249See Vanaja Krishnan, India’s Pharmaceutical Market Set to Hit $100bn by 2025, Eur. Pharm. Rev. (Aug. 8, 2017), https://www.europeanpharmaceuticalreview.com/news/65288/indias-pharmaceutical-100bn/. If a country’s gross national income per capita increases above the threshold level, that country will “graduate,” and no new manufacturers based in these countries will be eligible for conditional prequalification. If a manufacturer has multiple facilities, only some of which are in eligible countries, only the drugs produced in the eligible countries may be conditionally prequalified.

For a manufacturer to take advantage of conditional prequalification, both the FPP and its API must be produced in an eligible country. It is not necessary that the same manufacturer produce both the API and FPP—just that both are produced in eligible countries. If both are produced in eligible countries but by different manufacturers, both the API and the FPP would be eligible for conditional prequalification. This requirement ensures that the benefits of local production of medicines are largely captured. If conditional prequalification only required that the FPP be produced in an eligible country, it is conceivable that much of the actual production of the drug would occur outside an eligible country and then be shipped into an eligible country for the final step of production. In this scenario, the economic benefits of local production would be reduced and the populations in lower income countries would still be susceptible to supply interruptions because the ingredients would have to be imported. Alternatively, allowing an API to be conditionally prequalified and then shipped out of an eligible country for final assembly is no different—from the consumer’s perspective—from a drug that was produced entirely outside of an eligible country. Therefore, to be eligible for conditional prequalification, both the FPP and its API must be produced in eligible countries.

The other requirements manufacturers would have to meet for their drugs to gain conditional prequalification would be identical to those for full prequalification except in regard to GMP standards. 250 Thus, for example, the requirements a manufacturer’s product dossier would need to meet would be identical regardless of whether the manufacturer was granted full or conditional prequalification. The GMP standards would be the only difference between conditional and full prequalification for two primary reasons: (1) it does not appear that all deviations from full GMP compliance represent a safety risk 251See Kay Weyer et al., U.N. Indus. Dev. Org., Kenya GMP Roadmap: A Stepwise Approach for the Pharmaceutical Industry to Attain WHO GMP Standards 12 (2014). and (2) GMP compliance is a particularly difficult step in the prequalification process for many manufacturers based in lower income countries. 252 Chimezie Anyakora et al., Cost Benefit of Investment on Quality in Pharmaceutical Manufacturing: WHO GMP Pre- and Post-Certification of a Nigerian Pharmaceutical Manufacturer, 17 BMC Health Serv. Res. 665 (2017); supra Section I.E.

The GMP standards for conditional prequalification would not be as stringent as current WHO GMP standards, but would be strong enough to provide acceptable assurances that conditionally prequalified drugs are safe. This Comment will not propose specifics regarding the minimum standards that manufacturers would have to meet to be conditionally prequalified. That is a determination undoubtedly best left to experts, such as the WHO Expert Committee on Specifications for Pharmaceutical Preparations. But one way in which quality could be ensured is through the more frequent submission—compared to that required for full prequalification—of product samples to allow for consistent testing of a product’s safety.

It appears that not all facilities which fail to comply with the full WHO GMPs are in danger of producing unsafe drugs, as demonstrated by a study conducted in Kenya. 253Weyer et al., supra note 251. In an effort to bring drug manufacturers in the country into compliance with WHO GMPs, the research team in the Kenya study initially examined the current manufacturing practices of seven Kenyan pharmaceutical companies and assessed each company’s compliance with WHO GMP standards. 254Id. at 5, 13. As part of the study, the team divided GMP compliance into two broad categories: “site” compliance and “quality management system” compliance. 255Id. at 10. Site refers primarily to the “physical . . . premises, utilities and equipment used for pharmaceutical manufacturing.” 256Id. It includes aspects ranging from whether the facility has designated, self-contained areas where hazardous products are produced to whether there is sufficient space at the site. 257Id. at 27. The quality management system, on the other hand, refers to “all documentation systems and procedures used by a company to ensure GMP compliance,” 258Id. at 10. including things such as the establishment of product sampling procedures and frequencies. 259Id. at 37.

The team assigned a score of 1, 2, or 3 for both site and quality management system compliance, with a 1 corresponding to general compliance with WHO GMPs for that indicator, and a 3 representing inadequate compliance. 260Id. at 10–12. Companies tended to score better on the quality management system variable than the site variable. 261Id. at 16. A company that had “[a] systematic approach in line with WHO GMP[s] in place and implemented” (a score of 1 on quality management system) and a “[s]ite [that] shows significant deficiencies from WHO GMP, but does not impair production safety” (a score of 2 on site) would not be fully compliant with WHO GMPs. 262Id. at 12. Thus, their drugs would not be prequalified. 263Id. at 7, 12. Manufacturers that fall into this category would be prime candidates for conditional prequalification because production safety would not be impaired.

A manufacturer whose product meets the conditional prequalification minimum standards would be required to adhere to a WHO-approved plan that would bring its facilities and operations into compliance with the full GMPs within a specified time period. Repeated failures to meet the goals in the approved plan could result in the WHO cancelling or withdrawing its conditional prequalification until the manufacturer makes the necessary changes. The WHO’s decision to withdraw a product’s conditional prequalification would, at the manufacturer’s request, be subject to review by the Prequalification independent review panel.

Conditional prequalification has the potential to increase the supply of—and subsequent access to—essential medicines, help develop the pharmaceutical industries in lower income countries, bring economic benefits to these countries, and incentivize manufacturers in lower income countries to fully comply with WHO GMPs. Because of the potential of conditional prequalification, drug purchasers, pharmaceutical manufacturers in lower income countries, and the general population in these countries—particularly individuals in need of essential medicines—would all likely benefit from such a system. The benefits to each of these three stakeholders will be analyzed in turn.

Drug purchasers stand to gain from a system like conditional prequalification. As discussed in Part I, there is a shortage of high-quality essential medicines. This inevitably leads to drug procurement entities and LMIC governments either not purchasing enough drugs or purchasing drugs of a questionable quality. 264See supra Section I.A. Conditionally prequalified drugs would signal to potential purchasers that a drug has been produced under regulatory oversight, but that the GMPs followed are not quite as rigorous as those followed by fully prequalified drugs. This represents a significant improvement over the status quo, in which people in need either go without essential medicines because of a shortage or only have access to medicines of an unknown quality.

Current and potential pharmaceutical manufacturers in lower income countries would also benefit from conditional prequalification because they would gain immediate and long-term access to additional segments of the essential medicines market. Manufacturers would likely have immediate access to a greater share of the market because they could demonstrate that their drugs were produced under some level of regulatory oversight. At the same time, manufacturers whose drugs are conditionally prequalified would be incentivized to have their products achieve full prequalification. Moreover, manufacturers whose drugs are conditionally prequalified would be incentivized to have their products achieve full prequalification because procurement entities would likely purchase prequalified drugs before conditional ones, and noncompliance with the WHO-approved plan to achieve full prequalification would be grounds for revoking a product’s conditional status. Once these manufacturers achieve full prequalification, they would then gain access to the important international drug procurement entities market. Access to these additional segments of the market could lead to a significant expansion of the pharmaceutical industry in lower income countries. This expansion would bring with it attendant economic benefits, namely “enhanced exports, . . . emergence of supportive industries and the reduced reliance on imports that use up precious hard currency . . . .” 265Ngozwana et al., supra note 16, at 6.

Finally, and most importantly, the general population in lower income countries, including those currently without access to quality-assured essential medicines, would likely benefit the most from conditional prequalification. Conditional prequalification has the potential to both increase access to essential medicines and bring benefits associated with a more developed pharmaceutical industry to persons living in these countries. First, supply is a key component of access, and conditional prequalification has the potential to increase the supply of—and subsequent access to—drugs in lower income countries. Second, a more developed domestic pharmaceutical industry would likely provide additional economic opportunities for persons living in lower income countries. Higher income is associated with better health: both at the individual and population levels. 266See infra notes 267–68 and accompanying text. Wealthier people are generally healthier than their poorer counterparts; 267 Fiona Imlach Gunasekara et al., Change in Income and Change in Self-Rated Health: Systematic Review of Studies Using Repeated Measures to Control for Confounding Bias, 72 Soc. Sci. & Med. 193, 201 (2011) (finding “a small positive association” between individual income increase and self-rated health, based on thirteen studies conducted in four different countries). and people living in higher income countries generally enjoy greater overall health than those living in lower income countries. 268 Michael Marmot, The Influence of Income on Health: Views of an Epidemiologist, Health Aff. 31, 37 (2002) (citing World Bank, World development Report (1993)). Additionally, the overall economic benefits attached to the growth of a domestic pharmaceutical industry has the potential to lead to greater individual purchasing power and increased government subsidization of essential medicines. Therefore, the introduction of a conditional prequalification pathway has the potential to benefit drug purchasers, pharmaceutical manufacturers in lower income countries, and the general population in these countries but particularly those in need of essential medicines.

Conclusion

WHO’s Prequalification Program has contributed greatly to improving the quality of essential medicines purchased by international donors and drug procurement entities. Due to the market share these donors and procurers occupy, as well as the fact that many of them require the drugs they purchase to be prequalified, the Prequalification Program has become akin to a drug approval authority in many LMICs.

Stemming from this authority to take actions that adversely affect applicants, the Prequalification Program is obligated to respect international due process principles, including the guarantee of a fair trial. Instituting an independent review panel before which manufacturers whose products are denied prequalification or delisted could appeal their cases would ensure the program is respecting these principles. Creating an independent review panel would also align with the WHO’s role as a promoter of human rights and be commensurate with the great power it exerts over many manufacturers.

Although important from a human rights perspective, it is unclear whether the independent review panel alone would increase access to essential medicines. One way to improve access to essential medicines is by strengthening the domestic manufacturing capacity in countries with the highest disease burden. Unfortunately, nearly all the FPPs and APIs that have been prequalified have been produced by manufacturers in middle- and high-income countries. By adopting a procedure like conditional prequalification, the WHO would increase the likelihood that a pharmaceutical industry capable of producing quality-assured medicines develops in these lower income countries. Conditional prequalification could also help ensure that individuals living in these countries enjoy greater access to essential medicines and the economic benefits that come with a developed pharmaceutical industry.

 

Footnotes

1Access to Med. Found., The 2016 Access to Medicine Index: Methodology 2015, at 1, 6 (2015), http://apps.who.int/medicinedocs/documents/s22176en/s22176en.pdf; Paul Hunt, Special Rapporteur on the Right to Health, Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines, U.N. Doc. A/63/263, annex, at 15 (Aug. 11, 2008).

2 Hunt, supra note 1.

3See Jicui Dong & Zafar Mirza, Supporting the Production of Pharmaceuticals in Africa, 94 Bull. World Health Org. 71, 71 (2016).

4Id.

5Id. (estimating that imported pharmaceuticals make up 79% of those consumed in Africa); Tefo Pheage, Dying from a Lack of Medicines, Afr. Renewal Online, Dec. 2016–Mar. 2017, http://www.un.org/africarenewal/magazine/december-2016-march-2017/dying-lack-medicines (estimating that 98% of pharmaceuticals consumed in Africa are produced outside of the continent).

6Id.

7 This Comment uses the terms “drugs” and “FPPs” interchangeably.

8See Dong & Mirza, supra note 3.

9 Petra Brhlikova et al., Aid Conditionalities, International Good Manufacturing Practice Standards and Local Production Rights: A Case Study of Local Production in Nepal, 11 Globalization & Health 1, 4 (2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4470019/pdf/12992_2015_Article_110.pdf.

10About WHO, World Health Org., http://www.who.int/about-us (stating that the goal of the WHO is to “build[] a better, heathier future for people all over the world”) (last visited Nov. 25, 2018).

11 This Comment uses both “withdrawal” and “delisting” to refer to situations in which a product’s prequalification is withdrawn or cancelled.

12 This Comment uses “due process” to refer specifically to procedural due process.

13 The WHO defines essential medicines as “those that satisfy the priority health care needs of the population.” Essential Medicines, World Health Org., http://www.who.int/medicines/services/essmedicines_def/en/ (last visited Nov. 25, 2018). This definition encompasses more medicines than the ones the WHO currently prequalifies. However, there is significant overlap between the two categories.

14 Dong & Mirza, supra note 3.

15World Health Org., Forty-Seventh Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations: WHO Technical Report Series No. 981, at 28 (2013) [hereinafter WHO Expert Committee Report No. 981]. The Prequalification of Medicines Program also involves the review and approval of “quality control laboratories.” Id. at 30. Although the quality control laboratories are important, this Comment will focus only on the prequalification of FPPs and APIs.

16Skhumbuzo Ngozwana et al., African Union, Pharmaceutical Manufacturing Plan for Africa: Business Plan 32 (2012) (“Without exception, [international donor entities and non-governmental organizations] require that products be prequalified by WHO or approved by a stringent regulatory authority.”).

17 Generally, the definition of “stringent regulatory authority” only includes authorities that participate in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), as well as special regulatory schemes found in Canada, the European Union, or the United States; members of the ICH currently include the United States, the European Union, some European countries, Japan, and Australia. See, e.g., The Global Fund to Fight AIDS, Tuberculosis and Malaria, Guide to Global Fund Policies on Procurement and Supply Management of Health Products 15 (2017); Unitaid, Quality Assurance of Health Products 2 n.6 (2017). The WHO uses a nearly identical definition of stringent regulatory authority. See World Health Org., Clarification with Respect to a Stringent Regulatory Organization as Applicable to the Stringent Regulatory Authority (SRA) Guideline 1 (2017), https://extranet.who.int/prequal/sites/default/files/documents/75%20SRA%20clarification_February2017_0.pdf.

18See, e.g., Ngozwana et al., supra note 16 (“The majority of the market for [anti-retrovirals] is controlled by the international donor entities and Non Governmental Organisations (NGOs).”).

19See World Health Org., Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries: An Overview of Findings from 26 Assessment Reports, at 16 (2010); Brhilkova et al., supra note 9, at 9.

20 Brhilkova et al., supra note 9, at 9.

21 Hunt, supra note 1; Pheage, supra note 5.

22See Pheage, supra note 5.

23Id.

24Margaret Chan, Ten Years in Public Health: 2007–2017, at 14–15 (2017).

25See, e.g., Ngozwana et al., supra note 16, at 6; Frederick M. Abbott & Jerome H. Reichman, The Doha Round’s Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines Under the Amended TRIPS Provisions, 10 J. Int’l Econ. L. 921, 97779 (2007); Kinsley Rose Wilson et al., The Make or Buy Debate: Considering the Limitations of Domestic Production in Tanzania, 8 Global Health 1, 1–2 (2012).

26 Ellen F.M. ‘t Hoen et al., A Quiet Revolution in Global Public Health: The World Health Organization’s Prequalification of Medicines Programme, 35 J. Pub. Health Pol’y 137, 154 (2014).

27See supra note 10 and accompanying text.

28Restatement (Third) of the Foreign Relations Law of the United States § 102(2) (Am. Law Inst. 1987).

29See Lisa Clarke, Responsibility of International Organizations Under International Law for the Acts of Global Health Public-Private Partnerships, 12 Chi. J. Int’l L. 55, 73 (2011); infra Section II.A.

30See Bardo Fassbender, Targeted Sanctions Imposed by the UN Security Council and Due Process Rights, 3 Int’l Orgs. L. Rev. 437, 445–46 (2006).

31Infra Section II.B.

32 This Comment uses “lower income countries” to refer to those countries whose gross national income per capita is below or equal to $1,580 in 2017. Manufacturers in these lower income countries would be eligible for “conditional prequalification.” As will be discussed, infra Section III.B., “lower income countries” encompasses all low-income countries and the poorest middle-income countries, as defined by the World Bank.

33See G.A. Res. 70/1, Transforming Our World: The 2030 Agenda for Sustainable Development, at 16 (Oct. 21, 2015) (“Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.”); id. at 17 (“[P]rovide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health . . . .”); G.A. Res. 55/2, United Nations Millennium Declaration, ¶ 20 (Sept. 8, 2000) (“We also resolve . . . [t]o encourage the pharmaceutical industry to make essential drugs more widely available and affordable by all who need them in developing countries.”).

34 It is estimated that the fraction of people globally without access to life-saving medicines decreased from “less than half the world’s population” in 1975 to about one-third in 1999. World Health Org., The World Medicines Situation 61 (2004).

35See Hunt, supra note 1; Pheage, supra note 5.

36 A.J. van Zyl, WHO Prequalification of Medicines Programme, 25 WHO Drug Info. 231, 231 (2011).

37MDG Gap Task Force, U.N., Delivering on the Global Partnership for Achieving the Millennium Development Goals 35 (2008).

38Id. at 41.

39Reed F. Beall, Patents and the WHO Model List of Essential Medicines (18th Edition): Clarifying the Debate on IP and Access 1 fig.1 (2016).

40Id. at 2.

41 Rafael Alfonso-Cristancho et al., Definition and Classification of Generic Drugs Across the World, 13 Applied Health Econ. & Health Pol’y S5, S6 (Supp. 2015) (citing the FDA’s definition).

42See World Trade Org., TRIPS and Pharmaceutical Patents 7 (2006), https://www.wto.org/english/tratop_e/trips_e/tripsfactsheet_pharma_2006_e.pdf.

43MDG Gap Task Force, supra note 37, at 41; Generic Drug Facts, FDA, https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm167991.htm (last updated June 4, 2018).

44See, e.g., World Health Org., Generic Medicines, 30 WHO Drug Info. 370, 37071 (2016); Generic Drug Facts, supra note 43.

45Generic Drug Facts, supra note 43. Demonstrating bioequivalence typically requires human trials, but only in about twenty-four to thirty-six individuals, compared to the hundreds or thousands of human subjects required in the clinical trials of pioneer drugs. FDA Ensures Equivalence of Generic Drugs, FDA, https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm134444.htm (last updated Dec. 4, 2017).

46Generic Drug Facts, supra note 43.

47See, e.g., Andrew Pollack, Drug Goes from $13.50 a Tablet to $750, Overnight, N.Y. Times (Sept. 20, 2015), https://www.nytimes.com/2015/09/21/business/a-huge-overnight-increase-in-a-drugs-price-raises-protests.html (describing the lack of competition (and large price increases) surrounding a sixty-two-year old drug, Daraprim—for which there were no effective patents or exclusivities—used to treat a rare condition, toxoplasmosis).

48See, e.g., Ngozwana et al., supra note 16, at 6; Abbott & Reichman, supra note 25; Wilson et al., supra note 25, at 2.

49 The African Union is an intergovernmental organization comprised of fifty-five member states. Member State Profiles, African Union, https://au.int/memberstates (last visited Nov. 25, 2018). Its vision is “[a]n integrated, prosperous and peaceful Africa, driven by its own citizens and representing a dynamic force in global arena.” Vision and Mission, African Union, https://au.int/en/about/vision (last visited Nov. 25, 2018).

50Ngozwana et al., supra note 16, at 6.

51 Atholl Johnston & David W. Holt, Substandard Drugs: A Potential Crisis for Public Health, 78 British J. Clinical Pharmacology 218, 218 (2014).

52 World Health Org. Res. A70/23, annex, Member State Mechanism on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, at 34 (Mar. 20, 2017).

53 Johnston & Holt, supra note 51, at 229 (noting that patients may also be supplied substandard medicines in developed countries, but at a very low rate).

54 Raffaella Ravinetto et al., Fighting Poor-Quality Medicines in Low- and Middle-Income Countries: The Importance of Advocacy and Pedagogy, 9 J. Pharmaceutical Pol’y & Prac. 1, 2 (2016).

55 Tariq Almuzaini et al., Substandard and Counterfeit Medicines: A Systematic Review of the Literature, 3 BMJ Open 1, 4 (2013).

56 van Zyl, supra note 36. The Program was initiated by the Interagency Pharmaceutical Coordination Group, a group of senior pharmaceutical advisors from U.N. agencies including the WHO and other international organizations (such as the African Development Bank and the Global Fund to Fight AIDS, Tuberculosis, and Malaria), who meet every six months to better coordinate their pharmaceutical policies and the technical advice they give. The Interagency Pharmaceutical Coordination Group, World Health Org., https://www.who.int/medicines/areas/policy/ipc/en/ (last visited Nov. 25, 2018).

57 ‘t Hoen et al., supra note 26, at 138.

58Id.

59Id. at 142; see also World Health Org., WHO Prequalification: Progress Report 1 (2013).

60 ‘t Hoen et al., supra note 26, at 138.

61 WHO, The Interagency Pharmaceutical Coordination Group: Ten Years of IPC: Report on Achievements 1996–2006, at 3 (2007), http://www.who.int/medicines/publications/IPC_En.pdf.

62WHO Expert Committee Report No. 981, supra note 15.

63Prequalification of Medicines by WHO, World Health Org. (Jan. 31, 2013), http://www.who.int/news-room/fact-sheets/detail/prequalification-of-medicines-by-who.

64Id.; see In the Lead-Up to Paris AIDS Conference, WHO Prequalifies First Generic Hepatitis C Medicine and First HIV Self-Test, World Health Org., http://www.who.int/medicines/news/2017/1st_generic-hepC_1stHIVself-test-prequalified/en/ (last visited Nov. 25, 2018). Zinc is used in the treatment of children with acute diarrhea. Prequalification of Medicines by WHO, supra note 63.

65World Health Org., Forty-Fifth Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations: WHO Technical Report Series No. 961, at 375 (2011) [hereinafter WHO Expert Committee Report No. 961].

66WHO Expert Committee Report No. 981, supra note 15.

67WHO Expert Committee Report No. 961, supra note 65, at 374–75.

68Prequalification of Medicines by WHO, supra note 63.

69 “Unitaid is an international organisation that invests in innovations to prevent, diagnose and treat HIV/AIDS, tuberculosis and malaria more quickly, affordably and effectively. . . . Unitaid is a hosted partnership of the [WHO].” About Us, Unitaid, https://unitaid.eu/about-us/#en (last visited Nov. 25, 2018).

70Prequalification of Medicines by WHO, supra note 63.

71Id.

72WHO Expert Committee Report No. 961, supra note 65, at 380; Prequalification of Medicines by WHO, supra note 63.

73 Prequalification of Medicines by WHO, supra note 63.

74WHO Expert Committee Report No. 961, supra note 65, at 381.

75Id.

76Id. at 382.

77Infra Section I.E.

78Prequalification of Medicines by WHO, supra note 63.

79U.N., Local Production of Pharmaceuticals and Related Technology Transfer in Developing Countries: A Series of Case Studies by the UNCTAD Secretariat 250 (2011).

80 Sten Olsson et al., Pharmacovigilance Activities in 55 Low- and Middle-Income Countries: A Questionnaire-Based Analysis, 33 Drug Safety 689, 691 (2010) (finding that only 47% of countries surveyed reported having “a budget for pharmacovigilance activities”); infra Section I.E.

81WHO Expert Committee Report No. 961, supra note 65, at 386.

82Id.

83Id. at 38687.

84See, e.g., Fiona Fleck, Ranbaxy Withdraws All Its AIDS Drugs from WHO List, 329 British Med. J. 1205, 1205 (2004) (“Ranbaxy, an Indian generic drug company, has withdrawn all of its AIDS medicines from the World Health Organization’s list of recommended drugs, not because they are unsafe or of poor quality, but because they may not be as effective as they should be, a spokeswoman for WHO said.”).

85WHO Expert Committee Report No. 961, supra note 65, at 381.

86Id. at 383.

87Id.

88 The fact that the standard operating procedures are not publicly available raises its own set of concerns that are beyond the purview of this Comment.

89See WHO, WHO Prequalification Programmes, 24 WHO Drug Info. 293, 296 (2010).

90Id.

91Id.

92Id.

93Id. at 293.

94WHO Prequalification Financing Model – Questions and Answers, World Health Org., http://who.int/medicines/news/prequal_finance_model_q-a/en/ (last visited Nov. 25, 2018).

95 Mary Moran et al., Registering New Drugs for Low-Income Countries: The African Challenge, 8 PLoS Med. 1, 3 (2011).

96See Procurement Agencies, World Health Org., https://extranet.who.int/prequal/information/medicines-purchasing-organizations (last visited Nov. 25, 2018); Sourcing and Management of Health Products, Medicines, Global Fund, https://www.theglobalfund.org/en/sourcing-management/quality-assurance/medicines/ (last visited Nov. 25, 2018) (“[I]mplementing Principal Recipients have three options when selecting which antiretrovirals, antituberculosis medicines and antimalarial medicines to purchase. They can choose medicines that have been either: 1. Prequalified by the World Health Organization Prequalification Programme[;] 2. Authorized for use by a Stringent Drug Regulatory Authority[; or] 3. Recommended for use by the Expert Review Panel.”). The Global Fund Expert Review Panel is only an option in the rare circumstance when “only one or no product is available on the global market . . . .” Id. Additionally, no drug authorities in LMICs currently qualify as “stringent.” See discussion supra note 17.

97See Ngozwana et al., supra note 16.

98Ye Lu et al., World Health Org., The World Medicines Situation 2011: Medicine Expenditures 2 (2011); see also Manjiri Bhawalkar & Abeba Taddese, Guide to Tracking Pharmaceutical Expenditures in a Health System 1 (2014) (noting that a lack of uniform methodology for collecting detailed pharmaceutical expenditure data in LMICs inhibits comparisons of pharmaceutical expenditures between countries).

99Lu et al., supra note 98, at 7 tbl.1.2.

100See id. at 7 n.1. The amount of money these donors and procurement entities spent on pharmaceuticals increased significantly after 2006. Id. From fiscal year 2005 through 2011, the congressionally funded PEPFAR program purchased more than $1.2 billion in antiretroviral drugs to treat those infected with HIV. U.S. Gov’t Accountability Off., GAO-13-483, President’s Emergency Plan for AIDS Relief: Drug Supply Chains Are Stronger, but More Steps Are Needed to Reduce Risks 1 (2013).

101Prequalification of Medicines by WHO, supra note 63.

102 Brhlikova et al., supra note 9. Of the 419 FPPs, 119 were produced by high-income country manufacturers while 297 were produced by middle-income country manufacturers. Id. Of the prequalified APIs, 3 were produced by high-income country manufacturers and 75 were produced by middle-income manufacturers. Id.

103 Wondiyfraw Z. Worku et al., Deficiencies in Generic Product Dossiers as Submitted to the WHO Prequalification of Medicines Programme, 9 J. Generic Meds. 63, 64 (2012).

104Id. at 63, 65. 245 dossiers had been submitted, but 45 (18.37%) were rejected either because “the product was not invited to the programme or later due to the applicant’s failure to respond to the PQP queries in a timely fashion (maximum 1 year).” Id. at 67.

105Id. at 72. One notable finding is that HIV dossiers contained substantially fewer deficiencies than did tuberculosis, malaria, and reproductive health dossiers for both FPPs and APIs. Id. at 73.

106 Brhlikova et al., supra note 9, at 9.

107WHO, WHO Prequalification of Medicines Programme: WHO Launches the PQD Collaborative Registration Procedure, 27 WHO Drug Info. 325, 325 (2013).

108See, e.g., World Health Org., Forty-Eighth Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations: WHO Technical Report Series No. 986, at 90 (2014) [hereinafter WHO Expert Committee Report No. 986].

109Id.

110See, e.g., Current Good Manufacturing Practice (CGMP) Regulations, FDA, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm (last updated Nov. 1, 2018); Prequalification of Medicines by WHO, supra note 63.

111See, e.g., Current Good Manufacturing Practice (CGMP) Regulations, supra note 110; Prequalification of Medicines by WHO, supra note 63.

112WHO Expert Committee Report No. 986, supra note 108.

113 Joseph D. Nally, Worldwide Good Manufacturing Practices, in Good Manufacturing Practices for Pharmaceuticals 335, 339 (Joseph D. Nally ed., 6th ed. 2007).

114See, e.g., World Health Org., supra note 19, at 16, 21; Brhlikova et al., supra note 9, at 8 (“Domestic producers report that compliance with the stringent standards of GMP is a major obstacle for domestic production of affordable pharmaceutical products.”). The WHO conducted an assessment of the regulatory systems in twenty-six sub-Saharan African countries and found that nine of the countries did not require that manufacturers have any GMP certification; “only five . . . had published GMP guidelines meeting WHO standards[;]” and of the countries that did require compliance, they were generally poorly enforced. World Health Org., supra note 19.

115See World Health Org., supra note 19, at 6, 8, 12, 21; Brhlikova et al., supra note 9, at 9.

116World Health Org., supra note 19.

117 Brhlikova et al., supra note 9, at 9.

118 Paul B. Stephan, Privatizing International Law, 97 Va. L. Rev. 1573, 1574 n.1 (2011) (citing Jeremy Bentham, Principles of International Law, in 2 The Works of Jeremy Bentham 550 (John Bowring ed., Edinburgh, Simpkin, Marshall & Co. 1843)).

119Id. at 1574.

120See Clarke, supra note 29.

121 Fassbender, supra note 30, at 473–74; see also International Covenant on Civil and Political Rights art. 14, Dec. 19, 1966, 999 U.N.T.S. 171; Convention for the Protection of Human Rights and Fundamental Freedoms art. 6, Nov. 4, 1950, 213 U.N.T.S. 222 [hereinafter European Convention on Human Rights]; G.A. Res. 217 A (III), Universal Declaration of Human Rights art. 10 (Dec. 10, 1948) [hereinafter Universal Declaration of Human Rights].

122See infra note 167 and accompanying text.

123 Statute of the International Court of Justice art. 38, ¶ 1. Additionally, “[j]udicial decisions and the teachings of the most highly qualified publicists of the various nations, as subsidiary means for the determination of rules of law.” Id.

124Restatement (Third) of the Foreign Relations Law of the United States § 102(2) (Am. Law Inst. 1987).

125Id. § 102 cmt. j; Roozbeh (Rudy) B. Baker, Customary International Law in the 21st Century: Old Challenges and New Debates, 21 Eur. J. Int’l L. 173, 176 (2010).

126 Vienna Convention on the Law of Treaties art. 53, opened for signature May 23, 1969, 1155 U.N.T.S. 331.

127Id.; Restatement (Third) of the Foreign Relations Law of the United States § 102 cmt. k (Am. Law Inst. 1987); Kamrul Hossain, The Concept of Jus Cogens and the Obligation Under the U.N. Charter, 3 Santa Clara J. Int’l L. 72, 73 (2005).

128 Vienna Convention on the Law of Treaties, supra note 126.

129Restatement (Third) of the Foreign Relations Law of the United States § 102 n.6 (Am. Law Inst. 1987).

130 Kristina Daugirdas, How and Why International Law Binds International Organizations, 57 Harv. Int’l L.J. 325, 346 (2016) (“Jus cogens norms bind IOs [(international organizations)] because states cannot, by treaty, establish IOs that are authorized to violate jus cogens norms.”) (citations omitted).

131 Clarke, supra note 29. But see Daugirdas, supra note 130, at 331–35 (“In short, the answers that scholars have given to the question of whether general international law binds IOs include: maybe, sometimes, and always.”).

132 Interpretation of the Agreement of 25 March 1951 Between the WHO and Egypt, Advisory Opinion, 1980 I.C.J. Rep. 73, 89–90 (Dec. 20, 1980). Although the International Court of Justice has not always used the term “general international law” consistently, it generally includes at least customary international law. See Clarke, supra note 29; Daugirdas, supra note 130, at 333. But see Daugirdas, supra note 130, at 331–34, for an argument that the International Court of Justice’s WHO-Egypt opinion does not shed much light on international organizations’ obligations.

133 Daugirdas, supra note 130, at 348.

134Id.

135 S.I. Strong, General Principles of Procedural Law and Procedural Jus Cogens, 122 Pa. St. L. Rev. 357 (2018).

136 Al-Dulimi. v. Switzerland, App. No. 5809/08, Eur. Ct. H.R. 1, 65–66 (2016), http://hudoc.echr.coe.int/eng/?i=001-164515.

137 Golder v. United Kingdom, 18 Eur. Ct. H.R. 1, 17 (1975).

138 Fassbender, supra note 30, at 444 (“On the basis of constitutional and statutory rules and practices common to a great number of States of all regions of the world, and as guaranteed by universal and regional human rights instruments, rights of due process, or ‘fair trial rights,’ have been generally recognized in international law protecting individuals from arbitrary or unfair treatment by State organs.”).

139Id. at 467.

140 Richard B. Stewart, The Global Regulatory Challenge to U.S. Administrative Law, 37 N.Y.U. J. Int’l L. & Pol. 695, 695 (2005).

141Id.

142See e.g., Hurst Hannum, The Status of the Universal Declaration of Human Rights in National and International Law, 25 Ga. J. Int’l & Comp. L. 287, 340–41 & n.221 (1995–1996). The other document forming this Bill of Rights is the International Covenant on Economic, Social, and Cultural Rights. Id. at 341 n.221.

143 Mary Ann Glendon, The Rule of Law in the Universal Declaration of Human Rights, 2 Nw. U. J. Int’l Hum. Rts. 1, 4 (2004); Anne Lowe, Note, Customary International Law and International Human Rights Law: A Proposal for the Expansion of the Alien Tort Statute, 23 Ind. Int’l & Comp. L. Rev. 523, 537 (2013).

144See, e.g., Abdullahi v. Pfizer, Inc., 562 F.3d 163, 176 (2d Cir. 2009) (recognizing the ICCPR as customary international law); Lowe, supra note 143 (“[E]ven though the UDHR is not a binding treaty, it is considered to be a source of customary international law, and, therefore, imposes binding international legal obligations.”).

145 Universal Declaration of Human Rights, supra note 121.

146 International Covenant on Civil and Political Rights, supra note 121.

147 Formally, it is called the Convention for the Protection of Human Rights and Fundamental Freedoms.

148 European Convention on Human Rights, supra note 121.

149 Fassbender, supra note 30.

150 See, e.g., Lucien J. Dhooge, Human Rights for Transnational Corporations, 16 J. Transnat’l L. & Pol’y 197, 211–13 (2007). There are, however, limits on corporations’ human rights. For a discussion of these limits, see Julian G. Ku, The Limits of Corporate Rights Under International Law, 12 Chi. J. Int’l L. 729, 751–53 (2012).

151 Dhooge, supra note 150.

152Id.

153 International Covenant on Civil and Political Rights, supra note 121; European Convention on Human Rights, supra note 121; Universal Declaration of Human Rights, supra note 121.

154 European Convention on Human Rights, supra note 121, at art. 34 (“The Court may receive applications from any person, non-governmental organisation or group of individuals . . . .”); see Winfried H.A.M. van den Muijsenbergh & Sam Rezai, Corporations and the European Convention on Human Rights, 25 Pac. McGeorge Global Bus. & Dev. L.J. 43, 49 (2012) (“Among the Convention rights always and easily deemed applicable to corporations are the right to a fair trial . . . .”).

155 Pembina Consol. Silver Mining & Milling Co. v. Pennsylvania, 125 U.S. 181, 189 (1888) (holding that the Fourteenth Amendment extends to corporations).

156 Fassbender, supra note 30, at 441.

157Id. at 440–42.

158Id. at 442–43.

159Id. at 467, 474.

160Id. at 467 (quoting Karel Wellens, Remedies Against International Organisations 89 (2002)).

161Id. at 474 (emphasis added).

162See supra note 153 and accompanying text.

163See supra note 149–55 and accompanying text.

164 Warren A. Kaplan & Richard Laing, Paying for Pharmaceutical Registration in Developing Countries, 18 Health Pol’y & Plan. 237, 237 (2003). One exception is the European Union’s centralized procedure, which allows a company to obtain a single market authorization for all of the member states in the European Union. Ines M. Vilas-Boas & C. Patrick Tharp, The Drug Approval Process in the U.S., Europe, and Japan, 3 J. Managed Care & Specialty Pharmacy 459, 461 (1997).

165 World Health Org., Building Quality-Assured Manufacturing Capacity in Nigeria, 28 WHO Drug Info. 425, 429 (2014).

166See supra note 63 and accompanying text.

167See Tre Traktörer AB v. Sweden, 159 Eur. Ct. H.R. (ser. A) 3, 19 (1989); Benthem v. Netherlands, 97 Eur. Ct. H.R. (ser. A) 4, 16 (1985); Nuala Mole & Catharina Harby, The Right to a Fair Trial: A Guide to the Implementation of Article 6 of the European Convention on Human Rights, in 3 Human Rights Handbooks 13 (2d ed. 2006), https://rm.coe.int/168007ff49. Compare I.T.C. Ltd. v. Malta, App. No. 2629/06, Eur. Ct. H.R. 1, 11 (2007), http://hudoc.echr.coe.int/eng?i=001-84144 (holding that one of the losing bidders for a public contract had no civil right to the award of the contract for the purposes of a right to a fair trial), with Araç v. Turquie, App. No. 69037/01, Eur. Ct. H.R. 1, 4 (2006), http://hudoc.echr.coe.int/eng?i=001-76944, translated by Google Translate (finding that a civil right was at issue for person who was excluded from all future public tenders because of the serious economic consequences of the exclusion).

168 European Convention on Human Rights, supra note 121. The European Court of Human Rights uses the term “civil right” to refer to non-criminal rights covered by the right to a fair trial provision. Id.

169Tre Traktörer AB, 159 Eur. Ct. H.R. (ser. A) at 19; Benthem, 97 Eur. Ct. H.R. (ser. A) at 16; see also Mole & Harby, supra note 167 (citing cases involving licenses that the court held were covered by the right to a fair trial).

170Benthem, 97 Eur. Ct. H.R. (ser. A) at 16.

171Id. at 9–10.

172Id. at 10–11.

173Id. at 16.

174Id.

175Id. (emphasis added).

176Id. at 16–17.

177 Tre Traktörer AB v. Sweden, 159 Eur. Ct. H.R (ser. A) 3, 13 (1989).

178Id. at 12–13.

179Id. at 13.

180Id. at 19.

181Id. The court also held that neither the County Administrative Board nor the National Board of Health and Welfare constituted an independent tribunal. Id. at 20.

182See I.T.C. Ltd v. Malta, App. No. 2629/06, Eur. Ct. H.R. 1, 11 (2007), http://hudoc.echr.coe.int/eng?i=001-84144; Araç v. Turquie, App. No. 69037/01, Eur. Ct. H.R. 1, 5 (2006), http://hudoc.echr.coe.int/eng?i=001-76944.

183See I.T.C. Ltd., Eur. Ct. H.R. at 11; Araç, Eur. Ct. H.R. at 5.

184I.T.C. Ltd., Eur. Ct. H.R. at 2.

185Id. at 3–5.

186Id. at 8.

187Araç, Eur. Ct. H.R. at 5.

188Id. at 4–5.

189I.T.C. Ltd., Eur. Ct. H.R. at 11.

190 Benthem v. Netherlands, 97 Eur. Ct. H.R. (ser. A) 4, 16 (1985).

191See supra Section I.D.

192Benthem, 97 Eur. Ct. H.R. (ser. A) at 16; see also supra Section I.C.

193Araç, Eur. Ct. H.R. at 5.

194See supra Section I.C.

195 Benjamin Mason Meier, Human Rights in the World Health Organization: Views of the Director-General Candidates, 19 Health & Hum. Rts. J. 293, 294 (2017).

196Id.

197See generally L.O. Gostin et al., The Normative Authority of the World Health Organization, 129 Pub. Health 854, 855 (2015) (discussing the mission, authority, and functions of the WHO).

198Constitution of the World Health Organization pmbl., opened for signature July 22, 1946, 62 Stat. 2679.

199 This is specifically referring to the Centralized Procedure. Similar to the Prequalification Program, approval through the Centralized Procedure enables entities to effectively gain authorization to distribute (or market) their product in multiple countries. Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 Laying Down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency, 2004 O.J. (L 136) 1 (EC); Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use, 2001 O.J. (L 311) 67 (EC); Vilas-Boas & Tharp, supra note 164.

200 Case T-74/00, Artegodan GmbH v. Comm’n of the European Communities, 2002 E.C.R. II-4948, II-4952, II-5019–21; see Levan Makhashvili & Paul Stephenson, Differentiating Agency Independence: Perceptions from Inside the European Medicines Agency, 9 J. Contemp. Eur. Res. 4, 910 (2013) (citing R. Daniel Kelemen, The Politics of ‘Eurocratic’ Structure and the New European Agencies, 25 W. Eur. Pol. 93, 99 (2002) (“In addition, the European Court of Justice (ECJ) monitors the actions and decisions of the EMA ([European Medicines Agency]) and, at the request of EU institutions or citizens, can further scrutinise its functioning.”)); Johannes Saurer, The Accountability of Supranational Administration: The Case of European Union Agencies, 24 Am. U. Int’l L. Rev. 429, 46162 (2009) (providing an overview of the EMA-specific jurisprudence on when an action may be challenged in court).

201 The discussion of the FDA approval process will focus exclusively on the FDA review of generic drug applications. This is done for two reasons: (1) the review procedure at this stage of the process is substantially similar for brand name and generic manufacturers that an examination of one will suffice; and (2) most of the drugs that are prequalified by the WHO are generic products. Worku et al., supra note 103, at 63–64.

202 21 C.F.R. § 314.200(c)(1) (2018); 21 C.F.R. § 314.235(b) (2018).

203 21 C.F.R. § 314.235(b).

204 Fed. Power Comm’n v. Fla. Power & Light Co., 404 U.S. 453, 463 (1972) (“[W]hen resolution of that question depends on ‘engineering and scientific’ considerations, we recognize the relevant agency’s technical expertise and experience, and defer to its analysis unless it is without substantial basis in fact.”).

205 Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 420 (1971); Bristol-Myers Squibb Co. v. Shalala, 923 F. Supp. 212, 216 (D.D.C. 1996) (citing Camp v. Pitts, 411 U.S. 138, 142 (1973)).

206Clyde Eagleton, The Responsibility of States in International Law 206 (1928); see also Clarke, supra note 29, at 65.

207 Clarke, supra note 29, at 65 (citing E. Paasivirta & P.J. Kujjper, Does One Size Fit All?: The European Community and the Responsibility of International Organizations, 36 Neth. Y.B. Int’l L. 169, 173 (2005)).

208Id. (quoting Gerhard Hafner, Accountability of International Organizations—A Critical View, in Towards World Constitutionalism 585, 592–93, 629 (Ronald St. John MacDonald & Douglas M. Johnston eds., 2005)).

209See supra Section I.C.

210 Granted, at least some of those calls to the WHO are coming from this Comment.

211 The World Bank is a global partnership with 189 member countries dedicated to reducing poverty by providing zero or low interest loans, credits, grants, and technical assistance to developing countries. Who We Are, World Bank, http://www.worldbank.org/en/who-we-are (last visited Nov. 25, 2018).

212 Yvonne Wong & Benoit Mayer, The World Bank’s Inspectional Panel: A Tool for Accountability?, in 6 The World Bank Legal Review 495, 496 (Jan Wouters et al. eds., 2015).

213 International Bank for Reconstruction and Development (IBRD), Res. 93-10 (Sept. 22, 1993), http://siteresources.worldbank.org/EXTINSPECTIONPANEL/Resources/ResolutionMarch2005.pdf; The World Bank, The Inspection Panel: Annual Report: July 1, 2017–June 30, 2018, at 5 (2018).

214 Wong & Mayer, supra note 212.

215Id. at 502.

216Id. at 503.

217Id. at 514–15.

218Id. at 514.

219Id. at 515.

220Id.

221Id. at 51617.

222Id. at 516.

223Id. at 50708 (noting that the World Bank’s working language is English, and filing a claim against an authority may run counter to the norms and values of some cultures).

224Id. at 511–12.

225Id. at 510–12.

226See supra note 213 and accompanying text.

227 The staggering of terms would, of course, require some of the initial panelists to serve less than five-year terms (e.g., two initial panelists serve three-year terms, two serve four-year terms, and the other three serve for the full five years).

228WHO Regional Offices, World Health Org., http://www.who.int/about/regions/en/ (last visited Nov. 25, 2018).

229See supra notes 223–25 and accompanying text.

230See supra Section II.A.

231Supra Part III. The FDA and the European Court of Human Rights appeal procedures contain a similar requirement. European Convention on Human Rights, supra note 121, at art. 26 (“The Commission may only deal with the matter after all domestic remedies have been exhausted . . . .”); supra Section II.D.

232 For a full panel of seven individuals, five of the seven panelists would need to vote in favor of overturning the prequalification decision. However, if one or more panelist were absent, the required number of votes would change accordingly.

233 “Full” prequalification refers to the current prequalification granted by the WHO. It is used to distinguish between the proposed “conditional prequalification” and the current system.

234See infra Section IV.B.

235See supra Section II.D.

236 Accordingly, the Panel would not make a site or inspection visit to the facility, but would rely on the report of the inspection team.

237See generally Paula Hannaford-Agor & Nicole L. Waters, Estimating the Cost of Civil Litigation, 20 Caseload Highlights 1, 7 (2013) (discussing the costs and inefficiencies of litigation).

238 Eigil Sørensen, Challenges for the World Health Organization, J. Nor. Med. Ass’n (Jan. 2018), https://tidsskriftet.no/en/2018/01/kronikk/challenges-world-health-organization.

239See, e.g., Brhilikova et al., supra note 9, at 8 (discussing the problems encountered in the authors’ Nepali study, including “financial constraints”).

240See, e.g., Chevron U.S.A. Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 844 (1984).

241See, e.g., id. at 865.

242 “Gavi is an international organisation - a global Vaccine Alliance, bringing together public and private sectors with the shared goal of creating equal access to new and underused vaccines for children living in the world’s poorest countries.” About Gavi, the Vaccine Alliance, Gavi, Vaccine Alliance, http://www.gavi.org/about/ (last visited Nov. 25, 2018). In addition to having a certain three-year gross national income per capita, countries applying for Gavi support must also satisfy other criteria, as dictated by the specific vaccine they are applying for. See Transition Process, Gavi, Vaccine Alliance, https://www.gavi.org/support/sustainability/transition-process/ (last visited Nov. 25, 2018).

243See Gavi’s Mission, Gavi, Vaccine Alliance, https://www.gavi.org/about/mission/ (last visited Nov. 25, 2018).

244Countries Eligible for Support, Gavi, Vaccine Alliance, http://www.gavi.org/support/sustainability/countries-eligible-for-support/ (last visited Nov. 25, 2018).

245Id.

246 Under 2019 fiscal year classifications, countries with a gross national income per capita below $995 are classified as low-income. World Bank Country and Lending Groups, World Bank, https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups (last visited Nov. 25, 2018).

247Id.

248Id.

249See Vanaja Krishnan, India’s Pharmaceutical Market Set to Hit $100bn by 2025, Eur. Pharm. Rev. (Aug. 8, 2017), https://www.europeanpharmaceuticalreview.com/news/65288/indias-pharmaceutical-100bn/.

250 Thus, for example, the requirements a manufacturer’s product dossier would need to meet would be identical regardless of whether the manufacturer was granted full or conditional prequalification.

251See Kay Weyer et al., U.N. Indus. Dev. Org., Kenya GMP Roadmap: A Stepwise Approach for the Pharmaceutical Industry to Attain WHO GMP Standards 12 (2014).

252 Chimezie Anyakora et al., Cost Benefit of Investment on Quality in Pharmaceutical Manufacturing: WHO GMP Pre- and Post-Certification of a Nigerian Pharmaceutical Manufacturer, 17 BMC Health Serv. Res. 665 (2017); supra Section I.E.

253Weyer et al., supra note 251.

254Id. at 5, 13.

255Id. at 10.

256Id.

257Id. at 27.

258Id. at 10.

259Id. at 37.

260Id. at 10–12.

261Id. at 16.

262Id. at 12.

263Id. at 7, 12.

264See supra Section I.A.

265Ngozwana et al., supra note 16, at 6.

266See infra notes 267–68 and accompanying text.

267 Fiona Imlach Gunasekara et al., Change in Income and Change in Self-Rated Health: Systematic Review of Studies Using Repeated Measures to Control for Confounding Bias, 72 Soc. Sci. & Med. 193, 201 (2011) (finding “a small positive association” between individual income increase and self-rated health, based on thirteen studies conducted in four different countries).

268 Michael Marmot, The Influence of Income on Health: Views of an Epidemiologist, Health Aff. 31, 37 (2002) (citing World Bank, World development Report (1993)).

*Online Editor, Emory Law Journal, Volume 68; Emory University School of Law, J.D., 2018; Emory University Rollins School of Public Health, M.P.H., 2018; University of Arkansas, B.A., 2014. I would like to thank my faculty advisor, Professor Margo Bagley, for her patient guidance and for introducing me to the Prequalification Programme. I would also like to thank Emory Law Journal members Richard Kubiak, Sarah Lipinski, Fiona O’Carroll, and Bob Sherrier for their excellent feedback and edits. Finally, thank you to my family for always supporting me—none of what I achieve would be possible without them.