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A4
INTERNATIONAL LAW AND EQUITABLE ACCESS TO VACCINES AND ANTIVIRALS IN THE CONTEXT OF 2009-H1N1 INFLUENZA

David P. Fidler, J.D.22

Indiana University

Introduction

The emergence and spread of a novel strain of influenza A (H1N1) in 2009 (hereinafter 2009-H1N1 influenza A) has confronted states and intergovernmental organizations with yet another set of global health challenges. Key among these challenges has been the perceived need to increase access for low-income countries to vaccine and antivirals effective against 2009-H1N1 influenza A. Meeting this need has been framed as a challenge that implicates global equity, justice, and solidarity. Experts, including the Director-General of the World Health Organization (WHO), have called for developed countries to share 2009-H1N1 influenza A vaccines they have ordered with low-income countries in the name of equity, justice, morality, and solidarity. Margaret Chan, the WHO Director-General, argued in July 2009 that “The lion’s share of these limited [2009-H1N1 influenza A vaccine] supplies will go to wealthy countries. Again we see the advantage of affluence. Again we see access denied by an inability to pay” (Chan, 2009a). Similarly, Lawrence O. Gostin argued in connection with access to vaccine for 2009-H1N1 influenza A that “[s]erious questions of social justice arise when wealth, rather than need, becomes the primary allocation criterion” (Gostin, 2009). Laurie Garrett of the Council on Foreign Relations and Tadashi Yamada of the Bill & Melinda Gates Foundation have likewise argued that the United States and other developed countries have a moral obligation to make vaccine for 2009-H1N1 influenza A available to low-income countries (Garrett, 2009a; Yamada, 2009).

In addition, in light of both the ongoing virus and benefit sharing controversies connected with highly pathogenic avian influenza A (H5N1) (HPAI-H5N1) and the access problems sparked by the 2009-H1N1 influenza A virus, the challenge of access to knowledge products related to influenza has become a major issue of global health governance. For Garrett, the access issue concerning 2009-H1N1 influenza A vaccines constitutes a core challenge facing global governance and international cooperation (Garrett, 2009b). The Bill & Melinda Gates Foundation has argued that “[d]eveloped countries and vaccine manufacturers should urgently agree upon a mechanism to ensure access to vaccine by developing

22

James Louis Calamaras Professor of Law and Director of the Center on American and Global Security, Indiana University, Bloomington.



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137 APPENDIX A A4 INTERNATIONAL LAW AND EQUITABLE ACCESS TO VACCINES AND ANTIVIRALS IN THE CONTEXT OF 2009-H1N1 INFLUENZA David P. Fidler, J.D.22 Indiana University Introduction The emergence and spread of a novel strain of influenza A (H1N1) in 2009 (hereinafter 2009-H1N1 influenza A) has confronted states and intergovernmental organizations with yet another set of global health challenges. Key among these challenges has been the perceived need to increase access for low-income coun- tries to vaccine and antivirals effective against 2009-H1N1 influenza A. Meeting this need has been framed as a challenge that implicates global equity, justice, and solidarity. Experts, including the Director-General of the World Health Organiza- tion (WHO), have called for developed countries to share 2009-H1N1 influenza A vaccines they have ordered with low-income countries in the name of equity, justice, morality, and solidarity. Margaret Chan, the WHO Director-General, argued in July 2009 that “The lion’s share of these limited [2009-H1N1 influenza A vaccine] supplies will go to wealthy countries. Again we see the advantage of affluence. Again we see access denied by an inability to pay” (Chan, 2009a). Similarly, Lawrence O. Gostin argued in connection with access to vaccine for 2009-H1N1 influenza A that “[s]erious questions of social justice arise when wealth, rather than need, becomes the primary allocation criterion” (Gostin, 2009). Laurie Garrett of the Council on Foreign Relations and Tadashi Yamada of the Bill & Melinda Gates Foundation have likewise argued that the United States and other developed countries have a moral obligation to make vaccine for 2009-H1N1 influenza A available to low-income countries (Garrett, 2009a; Yamada, 2009). In addition, in light of both the ongoing virus and benefit sharing controver- sies connected with highly pathogenic avian influenza A (H5N1) (HPAI-H5N1) and the access problems sparked by the 2009-H1N1 influenza A virus, the chal- lenge of access to knowledge products related to influenza has become a major issue of global health governance. For Garrett, the access issue concerning 2009- H1N1 influenza A vaccines constitutes a core challenge facing global governance and international cooperation (Garrett, 2009b). The Bill & Melinda Gates Foun- dation has argued that “[d]eveloped countries and vaccine manufacturers should urgently agree upon a mechanism to ensure access to vaccine by developing 22 James Louis Calamaras Professor of Law and Director of the Center on American and Global Security, Indiana University, Bloomington.

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138 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC countries” (Bill & Melinda Gates Foundation, 2009). WHO’s influenza specialist Keiji Fukuda told a meeting of the Institute of Medicine’s Forum on Microbial Threats in September 2009 that the access question “is the flash point right now, for global solidarity. . . . It is the fundamental issue of our times. . . . Benefit- sharing is the central global issue of our time” (Garrett, 2009b, p. 12). Fukuda also argued that countries must develop a better global framework to address access challenges before the next influenza or other highly transmissible disease crisis breaks over the world (Fukuda, 2009). This paper explores the call for a global framework on access to influenza vaccines and antivirals from legal and political perspectives. The analysis reveals that the path to creation of such a global framework is strewn with significant obstacles that are not overcome by incantations of the need for “equity, justice, and solidarity.” Legally, international law specific to global health and generally on the allocation and creation of resources provides few, if any, precedents for establishing a global access framework. Politically, the self-interested calcula- tions of developed states with respect to supplies of influenza vaccines and anti- virals do not create a firm basis for an international agreement on sharing. The decision by a number of developed countries on September 17, 2009, to share a percentage of their 2009-H1N1 influenza A vaccine supplies (White House, 2009), the U.S. postponement of its donation pledge because of domestic vac- cine shortages, and the problems the donation program faced by the end of 2009 illustrate the harsh international politics of vaccine sharing, rather than revealing increasing commitment to greater equity, justice, and solidarity with people in low-income countries. Access to Vaccines and Antivirals in Connection with 2009-H1N1 Influenza A As responses to the 2009-H1N1 influenza A pandemic have unfolded, WHO officials and other experts have identified the problem that low-income countries will not have significant access to vaccine developed for the 2009-H1N1 influenza A virus (Chan, 2009a; Fidler, 2009; Fukuda, 2009; Garrett, 2009c; Gostin, 2009; Yamada, 2009) and may also face shortages of antiviral treatments (President’s Council of Advisors on Science and Technology, 2009; Whalen, 2009). The prob- lem of equitable access to vaccine for influenza strains is not a new issue, having cropped up controversially in connection with access to vaccine for HPAI-H5N1 from 2007 to the present (Fidler, 2008). The reappearance of yet another contro- versy involving equitable access to influenza vaccine has stimulated arguments that the international community needs to avoid suffering through this problem with each new potentially dangerous influenza strain. Rather than ad hoc, reac- tive responses that favor access for countries with more wealth and power, the proposed solution involves crafting a global framework that will guide access to vaccines, antivirals, and potentially other kinds of response technologies and supplies (e.g., masks).

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139 APPENDIX A At the meeting of the Institute of Medicine’s Forum on Microbial Threats on 2009-H1N1 influenza A held in September 2009, WHO’s Fukuda repeat- edly mentioned the need for a global framework to prevent access crises from occurring in the future (Fukuda, 2009). Fukuda noted the ineffectiveness and inefficiency of the reactionary, ad hoc attempts to increase vaccine access for 2009-H1N1 influenza A. Fukuda’s reasons why a global framework is necessary echo those given in other analyses of this issue: (1) developing this global access framework would achieve global equity, solidarity, and justice; and (2) creat- ing and operating the global framework is in the enlightened self-interest of all countries, including developed countries, with respect to handling the challenges pandemics pose. These calls for a global access framework represent arguments in favor of the negotiation and implementation of a new kind of global health governance mechanism. Foreign Policy Skepticism About the Need for a Global Access Framework in the Wake of 2009-H1N1 Influenza A Although the calls for a global access framework to produce more equity, soli- darity, justice, and enlightened self-interest generally resonate well in the global health community, foreign policy makers present a more skeptical audience, and understanding this skepticism is important to grasping the difficulty of creating a global access framework. Proponents for such a framework often assert that it is needed because access to vaccine for pandemic influenza (or other dangerous viral pathogens) should not be allocated according to the ability to pay (Chan, 2009a; Gostin, 2009; Yamada, 2009). However, as the foreign policy skeptic might point out, virtually all health-related resources—vaccines, antibiotics, potable water, sanitation, health care, prenatal services, and education—reflect access dispari- ties between rich and poor within and among countries. What makes the access concerns with respect to 2009-H1N1 influenza A so special that the international community must create a global access response to this global health problem? Public health experts have raised concerns on these grounds, which would reinforce the foreign policy skeptic’s view of the matter. In response to the appeal by the United Nations (UN) and WHO at the end of September 2009 for $1.5 bil- lion to buy vaccines and antivirals for low-income countries, Christopher Murray, Director of the Institute for Health Metrics and Evaluation at the University of Washington, argued that “[g]iven that the world spends about $22 billion on all global health problems, is it really wise to spend $1.5 billion only on swine flu? I would prioritize other areas like maternal and child health, where the need is urgent and huge” (Cheng, 2009). Similarly, Philip Stevens of the London-based International Policy Network asserted that “WHO is peddling an alarmist, unsci- entific agenda to raise funds. The U.N. is operating on pure conjecture that we will face anarchy and chaos in the developing world should the virus mutate” (Cheng, 2009).

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140 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC One response to this foreign policy and public health skepticism is that WHO declared the 2009-H1N1 influenza A outbreak a pandemic on June 11, 2009 (Chan, 2009b), the first time in over 40 years that the world has experienced an influenza pandemic. However, one of the biggest controversies surrounding 2009-H1N1 influenza A has been the pandemic declaration by WHO. Critics have attacked the criteria used by WHO in its pandemic alert system to declare the existence of a pandemic, mainly because the criteria do not include virus severity as a factor. As Garrett argued, “The problem is that there is no relation- ship between the geographically characterized WHO Pandemic Influenza Phases system and the severity of disease threat to human beings” (Garrett, 2009b, p. 5 [emphasis in original]). The failure of the alert system to include any severity criterion brought the system into disrepute, and WHO agreed that it would revise the system to reflect virus severity (Hitt, 2009). WHO’s Fukuda even expressed regret about the manner in which WHO applied its pandemic alert system to 2009-H1N1 influenza A (Fukuda, 2009). WHO’s willingness to change the system it was try- ing to apply convinced many people that the world was experiencing a pandemic that was not really a pandemic. The mild nature of the epidemiological impact of the 2009-H1N1 influenza A virus, to date, has reinforced the sense that the pandemic declaration lacks credibility, particularly when many other infectious diseases cause more morbidity and mortality than 2009-H1N1 influenza A has caused or, at present, promises to cause. Wealth disparities also adversely affect responses to these infectious disease threats and cause life-saving resources to be allocated on the basis of ability to pay. Thus, the argument that 2009-H1N1 influenza A deserves heightened treatment diplomatically because it was declared a pandemic is not persuasive. Skepticism about the call for a global access framework in light of 2009- H1N1 influenza A involves other doubts. One such doubt arises from confusing messages communicated by global health experts, who argue, on the one hand, that low-income countries must get vaccine access for equity, solidarity, and justice reasons, but, on the other hand, who often argue for more international health aid because such countries suffer from inadequate domestic capacities to execute health programs because of shortages of healthcare workers, weak or nonexistent response capacities, and fragile or broken health systems. For example, Sangeeta Shashikant, a legal advisor to the Third World Network, argued in connection with access to vaccine for 2009-H1N1 influenza A that “[t]here is no mechanism to make sure we will get the medicines to those who need them” (Whalen, 2009). Dr. Christophe Fournier, President of the Medecins Sans Frontieres (MSF) International Council, identified “[t]he lack of health care workers, medicine and supplies in many countries . . . [as] a legitimate cause for grave concern” in connection with addressing the 2009-H1N1 influenza A threat (MSF, 2009a). The Gates Foundation’s Principles to Guide Global Allocation of Pandemic Vaccine also drew attention to this problem, although more obliquely,

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141 APPENDIX A by stating that: “[a]ll countries obtaining pandemic vaccine should ensure that mechanisms are in place to provide the vaccine to their populations, to ensure that this scarce resource is not wasted, and donors should be prepared to provide resources and technical assistance to help countries bolster these mechanisms” (Bill & Melinda Gates Foundation, 2009). The tension between the messages insisting on access but warning of inca- pacities to deliver vaccines and antivirals effectively raises the problem that increasing global access to vaccines and antivirals in such a context might pro- duce equity without epidemiological benefit. In the context of antivirals, improper use related to inadequate capacities can lead to resistant strains, which could spread and erode the utility of antiviral medications for larger populations in connection with 2009-H1N1 influenza A and potentially other strains of influenza as well. As the President’s Council of Advisors on Science and Technology put it, “[r]esistance to these [antiviral] agents, especially oseltamivir, as a result of viral mutation or genetic recombination, can be a major factor limiting antiviral effectiveness” (President’s Council of Advisors on Science and Technology, 2009, p. 35). In the case of resistant strains, the global health damage of ineffective use or misuse of antivirals might overshadow public health benefits procured through greater access in low-income countries. Another skeptical question concerns why low-income countries have not raised the issue of the vaccine and antiviral access crisis previously during annual seasonal influenza outbreaks when the access problems (e.g., limited supply com- bined with great wealth disparities) are essentially the same. As Yamada pointed out, “the sobering truth is that even if production were switched over completely from seasonal influenza vaccine to pandemic influenza vaccine, there would not be nearly enough for everyone in the world” (Yamada, 2009, p. 1129). The lack of adequate production capacities in the event of an influenza pandemic has been raised many times before, as has the need to increase aggregate global produc- tion for influenza vaccines during interpandemic years (e.g., Fedson, 2004). But, before the emergence of HPAI-H5N1 and 2009-H1N1 influenza A, no access crisis over global inequity, lack of solidarity, and injustice materialized. This reality raises the possibility that politics, as much or more than equity, solidarity, and justice, might be playing a role in the current controversy triggered by access to vaccines and antivirals concerning 2009-H1N1 influenza A. A more specific foreign policy reason submitted for why access to vaccine for 2009-H1N1 influenza A is politically important (and, thus, by extension, a proactive global framework) concerns the possibility, raised by Garrett at the September 2009 meeting of the Forum on Microbial Threats, that low-income countries would link access to vaccine to progress on negotiations important to developed countries, including the Doha Development Round negotiations in the World Trade Orga- nization (WTO) and the climate change negotiations taking place in Copenhagen in December 2009. However, threatening to scupper the Doha Round and the Copenhagen negotiations over access to 2009-H1N1 influenza A vaccine is not

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142 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC credible if the motivation behind the linkage threat is to improve global health equity, solidarity, and justice. The potential global health benefits that successful conclusion of the Doha Round (e.g., poverty reduction) and the Copenhagen talks (e.g., cutting greenhouse gas emissions and addressing mitigation and adaptation strategies) could create, especially for low-income countries, far outweigh the prob- lems associated with vaccine access to 2009-H1N1 influenza A, especially because the impact of the virus has, to date, been relatively mild. In the event, health con- cerns, whether about vaccine access for 2009-H1N1 influenza A or climate change generally, did not feature in the Copenhagen negotiations (Garrett, 2009c). Global Framework Challenges: Legal Considerations Foreign policy skepticism about the need for a global access framework in the wake of 2009-H1N1 influenza A does not mean that calls for such a frame- work have no impact or policy importance. Overcoming skepticism requires, however, navigating the complexity of negotiating an effective global access framework. This challenge raises the need to understand legal and political con- siderations that would arise in a diplomatic push for a global access framework either specific to 2009-H1N1 influenza A or more generally. In terms of legal considerations, negotiating a global access framework will involve using or refer- encing international law. Part of the point of creating such a framework is to move the international community away from ad hoc, reactive approaches to vaccine and drug access to a more formal, rational, and harmonized strategy. Thus, this section looks at three important issues concerning international law’s potential role in the creation of a global access framework: (1) what existing international health agreements contribute to the goal of a global access framework; (2) how other efforts to increase access to vaccines and drugs for other diseases inform the idea for a global access framework; and (3) how, more generally, international law is used in creating and allocating resources. Existing Global Health Legal Regimes A number of international legal regimes that support global health exist, but none include any express obligations related to increasing access to health- related resources. Four examples suffice to demonstrate this point. First, the WHO Constitution is one of the most important international health treaties, but it does not contain any legally binding provisions that require WHO member states to increase access to health-related resources for low-income countries. The importance of increasing such access is identified in the preamble’s principle that “[t]he extension to all peoples of the benefits of medical, psychological and related knowledge is essential to the fullest attainment of health” (WHO, 1946), and WHO has exercised its powers to help low-income countries get better access to vaccines, drugs, and other health technologies. But, as the controversies over

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143 APPENDIX A access, among others, to HIV/AIDS drugs, medicines for neglected communi- cable diseases, and vaccines and antivirals in connection with HPAI-H5N1 and 2009-H1N1 influenza A demonstrate, the WHO Constitution does not provide a firm foundation on which to build a global access framework. Second, some international human rights treaties contain what is called a “right to health,” which might provide some legal traction for moving forward a global access framework (e.g., Office of the United Nations High Commissioner for Human Rights, 1966, Article 12). However, the obligations related to the right to health in human rights treaties focus mainly on a State Party’s responsibilities for its own population. Hence, the right to health has more significance for equi- table access within a country’s jurisdiction. Although the right to health includes an undertaking “to take steps . . . through international assistance and coopera- tion” (Article 2.1), this “duty to assist” other nations remains general in nature and generates controversies about its scope and substance. Efforts to clarify these international obligations in the right to health, such as that attempted in General Comment No. 14 on the Right to Health (Committee on Economic, Social, and Cultural Rights, 2000, paras. 34-37), have not resolved the disagreements. Thus, the right to health does not provide a strong legal foundation on which to build a global access framework. In addition, the United States is not a party to any human rights treaty that contains the right to health, so framing the legal basis for a global access framework through this right does not attract the interest or participation of the United States. Third, other existing international legal regimes for global health also pro- vide no rules or norms that could provide deep anchor points for creation of a global access framework. For example, although the International Vaccine Institute (IVI) is an intergovernmental organization among 40 States Parties established by treaty to conduct research, training, and technical assistance for vaccines needed in developing countries (IVI, 2009), the IVI is not mentioned in the debates about equitable access to pandemic vaccines. It has not been identi- fied as relevant to either the HPAI-H5N1 or the 2009-H1N1 influenza A access controversies because it does not work on influenza vaccines. Similarly, the groundbreaking International Health Regulations 2005 (IHR 2005) do not include any provisions that directly advance more equitable access to vaccines and drugs. The most relevant part of the IHR 2005 is the weak obligation for States Parties “to undertake to collaborate with each other, to the extent possible . . . in the provision or facilitation of technical coopera- tion and logistical support, particularly in the development, strengthening and maintenance of the public health capacities required under these Regulations” (IHR 2005, Article 44.1(b)). Even though the WHO Director-General declared 2009-H1N1 influenza A a public health emergency of international concern under the IHR 2005 (WHO, 2009a), the access crisis illustrates that the IHR 2005’s obligation to undertake to collaborate to the extent possible has not provided a solid basis on which to improve access to vaccine and antivirals.

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144 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC Other Efforts to Increase Access to Vaccines and Drugs The lack of solid grounding for equitable access in existing international legal regimes supporting global health does not mean that efforts to increase such access have been few and far between. Many activities to increase access to vac- cines and drugs have been undertaken through a number of different strategies: • Efforts by intergovernmental organizations, such as WHO (WHO, 2009b), the Pan American Health Organization (PAHO, 2009), the United Nations Children’s Fund (UNICEF, 2009), and the United Nations Development Programme, to purchase and distribute vaccines and drugs in low-income countries, including the WHO effort to develop a stockpile of vaccine for HPAI-H5N1 (World Health Assembly, 2007); • Bilateral activities by donor countries to make vaccines or drugs more available to low-income countries (e.g., the President’s Emergency Plan for AIDS Relief [PEPFAR], 2009); • Advocacy by nongovernmental organizations (NGOs) for improved access to vaccines and drugs for populations in poor countries (e.g., the Campaign for Access to Essential Medicines operated by Medecins sans Frontieres [MSF, 2009b]); • Donations by private-sector pharmaceutical companies of vaccines or drugs for diseases that mainly affect low-income countries (e.g., the donation by Sanofi-Aventis of 100 million doses of 2009-H1N1 vaccine to WHO [WHO, 2009c]); • Innovative research, delivery, and financing mechanisms designed to increase access to vaccines and drugs in poor countries (e.g., GAVI Alliance, 2009; Global Fund to Fight AIDS, Tuberculosis, and Malaria, 2009; the International Finance Facility for Immunization, 2009; Advance Market Commitments for Vaccines, 2009; and various public-private part- nerships, such as the Multilateral Initiative on Malaria, 2009); and • The assertion of sovereignty over viruses to create leverage to try to ensure that virus sharing for global surveillance leads to benefit sharing in terms of access to vaccines (e.g., Indonesia’s assertion of “viral sover- eignty” over HPAI-H5N1 samples [Fidler, 2008]). Although they represent diverse strategies, these examples share common features that raise questions about the feasibility of a global access framework. First, each example reflects the dominance of ad hoc approaches to access prob- lems, often connected with specific diseases, which is the kind of approach that the idea for a global framework seeks to avoid. Thus, these examples do not provide a template for the global framework objective. Second, the examples reveal fragmentation in the efforts made to increase access. Examples are numerous, but there is little evidence that coordination takes

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145 APPENDIX A place among all these efforts or that any over-arching strategy guides these access initiatives. In fact, the proliferation of efforts, especially in the area of innovative governance and financing mechanisms, is part of what has produced concerns about the cacophony that exists in global health governance today (Fidler, 2007). This reality means that these various efforts do not provide precedents for a framework that seeks to guide access policies globally in advance of the next pandemic. Finally, none of these access initiatives, except the assertion of “viral sover- eignty,” has any specific basis in international law. Intergovernmental organiza- tions that purchase and distribute vaccines and drugs to poor countries undertake these activities under their general international legal authorities provided by their constitutions or charters. But, as described earlier with respect to the WHO Constitution, these general provisions are not specific to the challenge of increas- ing access to vaccines or drugs. The GAVI Alliance, the Global Fund, the Inter- national Finance Facility for Immunization, the Advance Market Commitment for Vaccines, and the Multilateral Initiative on Malaria are all not based in international legal instruments and, thus, create no binding legal obligations on states that participate. As described more later, claims of sovereignty, although well grounded in international law, cause problems for efforts to increase equi- table access and, in the process, improve global solidarity and promote a more just world. Increasing Access to Antiretrovirals: A Good Model? One of the more successful efforts to increase access to health treatments has been the global activities aimed at making antiretrovirals (ARVs) more accessible to persons in low-income countries infected with HIV/AIDS. These activities have involved passionate and politically savvy activism by human rights groups and other NGOs and have triggered controversies over protecting intellectual property rights for pharmaceuticals in international trade agreements. The promi- nence of, and progress made by, this global campaign deserves a closer look in connection with the desire to have a global access framework. In short, does the movement to increase access to ARVs provide a model for advancing the objec- tive of a global access framework? Analysis of the global ARV access campaign reveals that this campaign is not a good model for a global access framework, especially with respect to the close association of the framework idea and the threat posed by pandemic influenza. First, the global ARV campaign was heavily shaped by human rights thinking and activism, largely because HIV/AIDS produced consequences that connected with human rights issues, including discrimination, stigma, gender issues, sexual orientation concerns, and the presence of a massive epicenter in one of the poorest regions of the world, sub-Saharan Africa. Pandemic influenza does not generate the same kind of human rights profile as HIV/AIDS, which means that human

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146 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC rights-centric HIV/AIDS strategies do not translate well into the influenza con- text. In addition, the success of the campaign for greater ARV access has also produced serious global health concerns, such as a perceived response imbalance that privileges treatment over prevention (e.g., Garrett, 2008). With influenza, the major objective is to increase prevention through the use of vaccines, so, again, the ARV access campaign does not fit the pandemic influenza problem that has sparked interest in the creation of a global access framework. International Law and the Allocation of Resources Given the lack of traction that health-specific international agreements and access-specific efforts in global health provide for the global access frame- work idea, perhaps general international law related to the allocation of valu- able resources might provide some insights to inform the desire to craft such a framework. Unfortunately, this approach does not provide a pathway to progress. In terms of tangible, physical resources, such as oil, timber, or commodities, the leading principle of resource allocation in international law is sovereignty, which privileges territorial control and extensions of sovereignty or exclusive control over offshore and ocean resources (e.g., the extension of coastal state sovereignty or exclusive control seaward through international legal rules on the territorial sea, contiguous zone, continental shelf, and exclusive economic zone) (Churchill and Lowe, 1999). The principle of sovereignty also acts as the principle of resource alloca- tion in contexts more directly relevant to the idea of a global access frame- work. As revealed in the controversy over virus and benefits sharing concerning HPAI-H5N1, states have sovereignty, and thus exclusive control, over viruses and other biological materials found within their territories or locations under their jurisdiction. The negotiations on virus and benefits sharing with respect to HPAI-H5N1 have accepted, as an allocation principle, the sovereignty-based approach found in the Convention on Biological Diversity, as illustrated by the World Health Assembly’s recognition of “the sovereign right of States over their biological resources” (World Health Assembly, 2007). In addition, sovereignty determines the allocation of ownership and control of vaccines and drugs—the country in which vaccines and drugs are manufac- tured has sovereignty over such resources until they leave its territory, and the country into which vaccines and drugs are imported or sold then has sovereignty over them under international law. Thus, any strategy to increase access to vac- cines and drugs through a global framework faces a “triple sovereignty problem” because the strategy has to address claims of sovereignty where the virus strains are isolated, where vaccines or drugs are manufactured, and then where vaccines and drugs are sold or exported.

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147 APPENDIX A International Law and the Creation of Resources International law can also play a role in the creation of resources. States frequently use international law to generate certain types of resources, access to which is in their mutual self-interests. For example, states use international law to increase flows of information among themselves because better information awareness lowers the transaction costs of collective action. Examples of this strat- egy can be found in many areas of international law, including infectious disease control (e.g., IHR 2005), law enforcement cooperation (e.g., mutual legal assis- tance treaties), and counterterrorism policies (e.g., information sharing provisions of counterterrorism treaties). Similarly, states use international law to create more intangible resources, such as access to economic markets (e.g., agreements under the WTO) and security alliances (e.g., North Atlantic Treaty Organization). Market access is valuable to countries because it allows them to tap into the trade benefits grounded in the theory of comparative advantage. Security alliances per- mit states to deter and defend against potential military threats more efficiently than they could accomplish without international cooperation. However, the record of international law is weaker with respect to creating resources, access to which generates competition and diverging interests among states. The international system has long experienced controversies between rich and poor countries over “technology transfer” scenarios in which the poor countries seek access to technologies and capabilities in the possession of rich countries or their multinational enterprises. These controversies were prominent during the 1970s when low-income countries sought access to advanced tech- nologies under the rubric of the New International Economic Order in order to improve equity and justice for poor countries (UN General Assembly, 1974). The recent intergovernmental negotiations on HPAI-H5N1 virus and benefit sharing have stalled over failure by the negotiating countries to agree to technology transfers from developed countries in exchange for sharing virus specimens by low-income countries (Fukuda, 2009). This inability to reach an accord with respect to HPAI-H5N1 replicates the older pattern of states failing to cut effective deals concerning technology trans- fers. The common thread across the history of “technology transfer” efforts to create and distribute resources is that equity, solidarity, and justice only provide weak incentives for states to create cooperative governance mechanisms. This longstanding pattern in international politics poses problems for the desire to create a global access framework because this framework will have to address the problem of unequal access to valuable technological resources for health, as has been seen in the “difficult and divisive” (Chan, 2009a) negotiations on public health, innovation, and intellectual property rights generally and virus and benefit sharing specifically.

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148 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC Enlightened Self-Interest, Smart Public Health? Perhaps sensing that calling for a global access framework by appealing to equity, solidarity, and justice is not sufficient, proponents of greater access often argue that increasing such access to vaccines and drugs represents enlightened self-interest and smart public health. In terms of 2009-H1N1 influenza A, the argument is that the sharing of vaccine by developed countries with low-income countries will produce more benefits for developed countries than not sharing. One of those benefits is that sharing actually will increase public health protection for rich and poor countries alike. For example, Gostin argued that “[e]quitable access to a vaccine against swine influenza is not merely a moral imperative. It is also critically necessary to safeguard global health” (Gostin, 2009). Whether these arguments from self-interest and public health are persuasive is, however, subject to doubt. For purposes of analysis, assume that developed and developing countries are facing a mild pandemic, such as the current one associated with 2009-H1N1 influenza A. A decision to share vaccine for a mild influenza strain might yield some positive public health benefits in poor countries (assuming such countries can effectively use the donated vaccine), but the public health payoff in devel- oped countries of such benefits will not likely be significant because the strain in question only causes mild impact. In addition, the political benefits to developed countries of donating vaccine are limited because the global public health impact of the donated vaccine during a mild pandemic will probably not be dramatic, if it could even be measured convincingly. This reasoning helps explain why some public health experts, as noted earlier, question the expenditure of large sums of money on vaccine for the mild 2009-H1N1 influenza A pandemic when other, more pressing global health problems remain neglected. In the context of a severe pandemic, developed countries will know that the virulent influenza virus will infect their populations, probably in multiple waves, even if low-income countries use donated vaccine supplies properly. In facing this probable threat, developed countries will have political and public health self-interests to keep as much vaccine as possible to protect their popu- lations from the successive cycles of the severe strain. This analysis reveals that political self-interests of developed countries to share 2009-H1N1 influ- enza A vaccine with low-income countries are strongest in a context—a mild pandemic—in which the public health impact of the vaccine’s use may not be impressive. Important to keep in mind with respect to this analysis is that WHO has agreed to revise its pandemic influenza alert system to include a criterion reflect- ing the severity of influenza strains. What this promised change means is that the next time WHO declares the existence of a pandemic, the influenza strain will be causing more severe public health damage on a widespread scale than 2009- H1N1 influenza A has caused. As noted earlier, this scenario is the one in which

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149 APPENDIX A developed countries with access to vaccine will be least likely to be willing to share generously with poor countries. This scenario is also why developed coun- tries are unlikely to agree to a global access framework that limits their ability to obtain and use vaccine to protect their populations from a severe pandemic influenza strain. Epidemiological Uncertainties, Political Dilemmas The call for a global access framework faces other obstacles as well, such as the political dilemmas created by epidemiological uncertainties associated with pandemic influenza viruses. These epidemiological uncertainties create incen- tives for developed countries not to want to develop a global access framework. The unstable, constantly changing nature of influenza viruses creates short-term epidemiological uncertainty because a virus strain may undergo genetic shift and produce a more severe public health impact. If such a mutation occurred, countries would need more vaccine and antivirals for their populations, giving those with access an incentive to keep as much as possible and minimize sharing. Thus, this short-term epidemiological uncertainty creates incentives for states that likely will have access to vaccines and antivirals not to agree, in advance, to a global access framework that might leave them with fewer resources to fight a damaging influenza outbreak. A longer-term epidemiological uncertainty leads to a similar disincentive. The 2009-H1N1 influenza A pandemic is the first influenza pandemic to occur in 40 years. The next pandemic may occur tomorrow or decades from now. Given that the next pandemic might be many years away, countries may not have strong incentives to incur the transaction costs of negotiating and implement- ing a global access framework for a threat that may, or may not, appear in the distant future. Donations of Vaccine for 2009-H1N1 Influenza A On September 17, 2009, nine developed countries announced that they would make 10 percent of their 2009-H1N1 influenza A vaccine supplies available to low-income countries through WHO (White House, 2009). Later in September, the UN System Coordinator for Avian and Human Influenza announced that other countries would also be donating 10 percent of their 2009-H1N1 influenza A vaccine supplies for use in low-income countries (Evans, 2009). The nature and timing of these donations confirms the analysis presented in this paper. These donations were not made until two developments occurred. First, clinical tests of the 2009-H1N1 influenza A vaccine revealed that adults could be immunized with a one-dose injection rather than the anticipated two-dose regimen. This unexpected result from the clinical trials essentially doubled the available sup- ply of vaccine, making it possible for developed countries to continue to have

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150 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC enough vaccine to cover their entire populations and still donate a percentage for use in low-income countries. None of the donating developed countries has left itself short of vaccine for its own population in making donations for low-income countries. The donation decision was, therefore, relatively cost-free politically and from a self-interested public health perspective. Second, the donations were announced after the epidemiological data con- firmed that the 2009-H1N1 influenza A pandemic was a mild pandemic globally. The data from regions affected by 2009-H1N1 influenza A were telling a similar story of a mild strain rather than the feared killer strain reminiscent of the 1918- 1919 influenza catastrophe. Although influenza viruses are wickedly unstable, the consistent data were not revealing warning signs of dangerous mutations in the circulating strain. With more and better data in hand confirming the pandemic as rather mild, the decision to donate vaccine for low-income countries became, politically and from a self-interested public health perspective, easier, especially when developed countries retained more than enough vaccine after donations to cover their entire populations. In short, developed countries that decided to donate vaccine to low-income countries have done so in a context in which the political and public health risk of donation was minimal. The nature and timing of these donation decisions suggests that the incen- tives for developed countries to agree in advance to a global access framework are not significant, especially if developed countries can continue to use their superior power and resources to get priority access to vaccines and drugs, pro- tect their entire populations, minimize political costs, and—if the epidemiologi- cal circumstances are favorable—appear generous. The next declared influenza pandemic will be more severe because WHO has indicated that it will change its pandemic alert system to reflect virus severity, so the political and public health risks will be higher the next time. As analyzed earlier, the foreseeability of such escalated risks will make developed countries less inclined to tie their hands through a global access framework. The decision the United States made at the end of October 2009 to postpone its vaccine donation because of shortages of 2009-H1N1 influenza A vaccine for its domestic population (Agence-France-Presse, 2009) also illustrates the weak- ness of incentives for developed countries to share vaccine when they perceive they face a serious domestic threat from influenza. This decision came just over a month after the announcement of the 10 percent donation pledge, providing an indication of how uncertainty with influenza and with vaccines can change a country’s perceived national interests on sharing vaccine. In mid-December 2009, WHO provided an update on the donation effort, which revealed that donation pledges of vaccine, supplies, and funds had yet to meet any of the identified needs (see Table A4-1) and that WHO had only placed vaccine orders for three developing countries (Afghanistan, Azerbaijan, and Mongolia).

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151 APPENDIX A TABLE A4-1 Overview of Resource Mobilization (millions) Gapa Resource Need Pledges Vaccines (doses) 200.0 178.4 21.6 Syringes 200.0 74.5 125.5 Safety boxes 2.0 0.5 1.5 US$ for global operations 62.6 35.7 26.9 US$ for in-country operations 170.0 31.3 138.7 aIs equal to the difference between needs and pledges. SOURCE: WHO (2009d). Getting Beyond Global Clichés: Global Access Framework Components A key political and diplomatic factor that will affect whether countries might answer the call for creating a global access framework will be the con- tent of the framework. Proponents of creating this framework have to articulate what would be required in order to achieve the goals of equity, solidarity, and justice. Many arguments that have been made in favor of greater vaccine and anti- viral access in the context of 2009-H1N1 influenza A provide no details about what the global framework should contain and how countries should negotiate such a framework. The task of filling out those details has to take into account the thus-far-unsuccessful negotiations on virus and benefit sharing concerning HPAI-H5N1—negotiations which are grappling with the central issues facing the access challenge for 2009-H1N1 influenza A. In others words, building a global access framework would take place under the dark cloud that the HPAI-H5N1 controversy and failed negotiations have produced in global health. In addition, a simple list of possible components of a global access frame- work reveals the potential enormity, complexity, and difficulty of any negotia- tions on creating such a framework (see Box A4-1). The negotiations for a global access framework would likely be long and complicated. New international health governance mechanisms can take long periods of time to negotiate. For example, the IHR 2005 took a decade to reach an agreement, 12 years from the start of the revision process to the IHR 2005’s entry into force, and 17 years before state parties have to be in full compliance with the IHR 2005. In addition, most experts acknowledge that WHO member states would not have adopted the IHR 2005 without the painful shock administered by the 2003 outbreak of severe acute respiratory syndrome (SARS). The experience with the IHR 2005 does not, of course, mean that every other global health negotiation will take as long to be completed, but it stands as a warning that expectations of a quickly negotiated, agreed upon, and implemented global access framework are unrealistic.

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152 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC BOX A4-1 Possible Components of a Global Access Framework • echanisms to increase global vaccine and antiviral production capacities, M both in aggregate terms and in geographical diversity; • rovisions to increase interpandemic demand for seasonal influenza vaccines P and antivirals; • eans to improve preparedness and response capabilities (potentially through M strategies that link up with implementation of the IHR 2005); • pproaches to stimulate research and development of new vaccine and anti­ A viral manufacturing technologies and techniques and to improve other scien­ tific knowledge (e.g., concerning use of adjuvants); and • emarcation of clear “triggers” for preparedness and response actions in the D pandemic alert system. Conclusion This paper has highlighted that calls for creating a global framework to increase equity, solidarity, and justice through improved access to vaccines and antivirals for poor countries face serious obstacles. In the context of the current “mild” H1N1 pandemic, the rhetoric of “equity, solidarity, and justice” is not necessarily very convincing with respect to this public health problem, especially when compared to other, more serious global health problems also plagued by health resources being allocated on the basis of ability to pay. Unfortunately, no good models, templates, or precedents for a global access framework exist in international law specific to health or in general international law on alloca- tion and creation of resources. Political incentives not to create a global access framework are significant whether a pandemic threat is mild or severe. These sobering conclusions suggest that proponents of a global access framework, who draw on the harsh lessons of the 2009-H1N1 influenza A pandemic, need to devise a sophisticated political strategy, as well as an epidemiological one, to achieve this goal. References Advance Market Commitments for Vaccines. 2009. http://www.vaccineamc.org/ (accessed Octo- ber 12, 2009). Agence France-Presse. 2009 (October 29). Americans first before U.S. gives H1N1 flu vaccine, http:// newsinfo.inquirer.net/breakingnews/world/view/20091029-232857/Americans-first-before-US- gives-H1N1-flu-vaccineexec (accessed January 5, 2010).

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