Global Rules for Global Health: Why We Need An Independent, Impartial WHO

Over the past few years the World Health Organization (WHO) has been undergoing a significant reform process. The immediate trigger was a budget crisis in 2010 that spurred massive lay-offs at the global agency. But at a more fundamental level, deeper systematic changes in global health governance have made reform imperative. While WHO reform draws relatively little attention outside diplomatic circles in Geneva, at stake are critical issues that will impact public health everywhere. This article’s key messages are: Recent outbreaks of MERS highlight the need for a global response to infectious disease The WHO has had a crucial role in developing rapid information sharing on new infectious threats and fair arrangements for access to drugs and vaccines and to research and development The WHO is the only international agency that can broker such global rules but is badly underfunded to perform this core function The MERS outbreaks offer an opportunity to reform WHO financing

Will markets be master or servant to health at the World Bank?

In the 18 years since a six part series by Abbasi in The BMJ argued that the World Bank merits greater attention from the health community, the institution has received little scrutiny from global health scholars.1 This is despite its substantial and growing role in the health sector. A recently published series of articles by Sridhar and colleagues does much to fill this gap.2-6 The authors paint a detailed picture of the bank’s historical activities, growing investments, and considerable evolution in its approaches to health. They also critically analyse more recent developments. Whether considering the growth of health related trust funds at the bank,3 its role in universal health coverage,4 the recently launched global financing facility for women and children’s health,5 or the pandemic emergency financing facility,6 the series persistently grapples with two key questions: firstly, can the bank’s market oriented approach be consistent with health equity objectives such as the globally endorsed goal of universal health coverage? Secondly, how can the bank’s immense economic and intellectual power be appropriately governed

Wealthy Countries Should Share Vaccine Doses Before It Is Too Late: The Greater Good Depends on Ending the Pandemic Everywhere

The world is on the brink of failing a critical test, which is whether the international community is willing or able to end a global pandemic without leaving anyone behind. Wealthy countries have bought up vast vaccine supplies, leaving poorer ones with extreme scarcity. An international initiative known as the COVID-19 Global Vaccine Access Facility (COVAX) aims to distribute vaccines widely and equitably, but is not only short of funds. Even if it reaches its 2021 target, COVAX will reach only a small portion of lower-income countries’ populations this year. Along with moral demands of equitable global distribution, wealthy countries have deep humanitarian reasons, as well as economic, geostrategic and, critically, health reasons for equitable distribution, as without global protection, no country is safe from COVID-19. Wealthy countries should vastly expand their efforts beyond present COVAX support to enable far more equitable global distribution. First, they should reallocate a portion of the doses they have secured for themselves – beyond excess doses to include those that they were going to use for their own populations – particularly as the United States and Europe get their own surges under control, during which time they are also vaccinating vulnerable populations. They should accept slower herd immunity for themselves to enable the world to move at a more equal pace in protecting national populations. Second, they should commit at least 2% of COVID-19 spending to response and recovery in low- and middle-income countries, amounting to $260 billion to-date, with more to follow. This would cover funding for accelerating distribution of vaccines, therapies, and diagnostics globally and provide vital humanitarian and social protection funds. Third, wealthy countries should ensure equitable distribution domestically and that vulnerable populations are quickly protected globally, including internally displaced people, asylum seekers, refugees, and stateless people. And fourth, they should work with the World Health Organization and other countries to spearhead and fund a global facility, with binding rules, for the equitable distribution of vaccines, therapeutics, and diagnostics

A win-win solution?: A critical analysis of tiered pricing to improve access to medicines in developing countries

Background: Tiered pricing - the concept of selling drugs and vaccines in developing countries at prices systematically lower than in industrialized countries - has received widespread support from industry, policymakers, civil society, and academics as a way to improve access to medicines for the poor. We carried out case studies based on a review of international drug price developments for antiretrovirals, artemisinin combination therapies, drug-resistant tuberculosis medicines, liposomal amphotericin B (for visceral leishmaniasis), and pneumococcal vaccines. Discussion: We found several critical shortcomings to tiered pricing: it is inferior to competition for achieving the lowest sustainable prices; it often involves arbitrary divisions between markets and/or countries, which can lead to very high prices for middle-income markets; and it leaves a disproportionate amount of decision-making power in the hands of sellers vis-à-vis consumers. In many developing countries, resources are often stretched so tight that affordability can only be approached by selling medicines at or near the cost of production. Policies that “de-link” the financing of R&D from the price of medicines merit further attention, since they can reward innovation while exploiting robust competition in production to generate the lowest sustainable prices. However, in special cases - such as when market volumes are very small or multi-source production capacity is lacking - tiered pricing may offer the only practical option to meet short-term needs for access to a product. In such cases, steps should be taken to ensure affordability and availability in the longer-term. Summary: To ensure access to medicines for populations in need, alternate strategies should be explored that harness the power of competition, avoid arbitrary market segmentation, and/or recognize government responsibilities. Competition should generally be the default option for achieving affordability, as it has proven superior to tiered pricing for reliably achieving the lowest sustainable prices

Global rules for global health: why we need an independent, impartial WHO

Over the past few years the World Health Organization (WHO) has been undergoing substantial reform. The immediate trigger was a budget crisis in 2010 that spurred massive staff cuts. But at a more fundamental level, deeper systematic changes in global health governance have made reform imperative.1 Though WHO reform draws relatively little attention outside diplomatic circles in Geneva, at stake are critical concerns that will affect public health everywhere. The essential role of WHO is most often appreciated when outbreaks of infectious disease cross borders, such as the newly identified Middle East respiratory syndrome (MERS) coronavirus, which has infected 636 people since 2012 and has a death rate of about one in three.2 With an increasing number of cases being reported, fears exist that it could infect thousands of people, similar to the SARS (severe acute respiratory syndrome) coronavirus in 2002-03.3 The international response to MERS has been more rapid than to SARS at least partly because of global structures that have facilitated epidemiological assessment, international information sharing, and the development of potential treatments. In an increasingly interconnected and interdependent world, global rules negotiated among governments are crucial for facilitating international cooperation and for protecting the health of the world’s population. Sometimes adhering to these rules requires governments to forgo some of their sovereignty and to trust an international organisation to act impartially and independently for the common good. One of the fundamental reasons for the creation of WHO in 1948 was to ensure that governments would “compromise their short-term differences in order to attain the long-run advantages of regularized collaboration on health matters.”4 Although many global health problems can be dealt with outside of WHO, the negotiation, agreement, and monitoring of compliance with global health rules can realistically take place only in WHO’s main decision making body, the World Health Assembly. WHO possesses unique political legitimacy because its membership encompasses all countries in the United Nations. This legitimacy allows WHO to convene governments and others (such as civil society, experts, and business) to negotiate rules, resolve differences, and reach consensus—all key elements of stewardship, a core function of the global health system.5 MERS exemplifies at least three areas of global rule making that are crucial for protecting global health: rapid information sharing on new infectious threats, fair arrangements for access to drugs and vaccines, and research and development of technologies and other interventions

Driving a decade of change: HIV/AIDS, patents and access to medicines for all

Since 2000, access to antiretroviral drugs to treat HIV infection has dramatically increased to reach more than five million people in developing countries. Essential to this achievement was the dramatic reduction in antiretroviral prices, a result of global political mobilization that cleared the way for competitive production of generic versions of widely patented medicines. Global trade rules agreed upon in 1994 required many developing countries to begin offering patents on medicines for the first time. Government and civil society reaction to expected increases in drug prices precipitated a series of events challenging these rules, culminating in the 2001 World Trade Organization’s Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health. The Declaration affirmed that patent rules should be interpreted and implemented to protect public health and to promote access to medicines for all. Since Doha, more than 60 low- and middle-income countries have procured generic versions of patented medicines on a large scale. Despite these changes, however, a “treatment timebomb” awaits. First, increasing numbers of people need access to newer antiretrovirals, but treatment costs are rising since new ARVs are likely to be more widely patented in developing countries. Second, policy space to produce or import generic versions of patented medicines is shrinking in some developing countries. Third, funding for medicines is falling far short of needs. Expanded use of the existing flexibilities in patent law and new models to address the second wave of the access to medicines crisis are required. One promising new mechanism is the UNITAID-supported Medicines Patent Pool, which seeks to facilitate access to patents to enable competitive generic medicines production and the development of improved products. Such innovative approaches are possible today due to the previous decade of AIDS activism. However, the Pool is just one of a broad set of policies needed to ensure access to medicines for all; other key measures include sufficient and reliable financing, research and development of new products targeted for use in resource-poor settings, and use of patent law flexibilities. Governments must live up to their obligations to protect access to medicines as a fundamental component of the human right to health

Reimagining Global Health Governance in the Age of COVID-19

The COVID-19 pandemic reminds us that no country acting alone can respond effectively to health threats in a globalized world. Global governance is necessary to coordinate the global health response. Yet, the COVID-19 pandemic has revealed deep fissures in global health governance, with international organizations facing obstacles from nationalist governments in managing a common threat. The COVID-19 pandemic is reframing global health governance. Considering key structural limitations in meeting enormous challenges, how can we best realize global solidarity in an age of populist nationalism? With the sheer scale of human, social, and economic upheaval, we face an imperative to strengthen global health institutions and governance

Intervening in global markets to improve access to HIV/AIDS treatment: an analysis of international policies and the dynamics of global antiretroviral medicines markets

<p>Abstract</p> <p>Background</p> <p>Universal access to antiretroviral therapy (ART) in low- and middle-income countries faces numerous challenges: increasing numbers of people needing ART, new guidelines recommending more expensive antiretroviral (ARV) medicines, limited financing, and few fixed-dose combination (FDC) products. Global initiatives aim to promote efficient global ARV markets, yet little is known about market dynamics and the impact of global policy interventions.</p> <p>Methods</p> <p>We utilize several data sources, including 12,958 donor-funded, adult first-line ARV purchase transactions, to describe the market from 2002-2008. We examine relationships between market trends and: World Health Organization (WHO) HIV/AIDS treatment guidelines; WHO Prequalification Programme (WHO Prequal) and United States (US) Food and Drug Administration (FDA) approvals; and procurement policies of the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM), US President's Emergency Plan for AIDS Relief (PEPFAR) and UNITAID.</p> <p>Results</p> <p>WHO recommended 7, 4, 24, and 6 first-line regimens in 2002, 2003, 2006 and 2009 guidelines, respectively. 2009 guidelines replaced a stavudine-based regimen ($88/person/year) with more expensive zidovudine- ($154-260/person/year) or tenofovir-based ($244-465/person/year) regimens. Purchase volumes for ARVs newly-recommended in 2006 (emtricitabine, tenofovir) increased >15-fold from 2006 to 2008. Twenty-four generic FDCs were quality-approved for older regimens but only four for newer regimens. Generic FDCs were available to GFATM recipients in 2004 but to PEPFAR recipients only after FDA approval in 2006. Price trends for single-component generic medicines mirrored generic FDC prices. Two large-scale purchasers, PEPFAR and UNITAID, together accounted for 53%, 84%, and 77% of market volume for abacavir, emtricitabine, and tenofovir, respectively, in 2008. PEPFAR and UNITAID purchases were often split across two manufacturers.</p> <p>Conclusions</p> <p>Global initiatives facilitated the creation of fairly efficient markets for older ARVs, but markets for newer ARVs are less competitive and slower to evolve. WHO guidelines shape demand, and their complexity may help or hinder achievement of economies of scale in pharmaceutical manufacturing. Certification programs assure ARV quality but can delay uptake of new formulations. Large-scale procurement policies may decrease the numbers of buyers and sellers, rendering the market less competitive in the longer-term. Global policies must be developed with consideration for their short- and long-term impact on market dynamics.</p