- Email: [email protected]
Global Governance Structure for Infectious Disease: An Enforceable Strategy
Global Governance Structure for Infectious Disease: An Enforceable Strategy By Harvey Rubin and Nicholas Saidel Harvey Rubin is Executive Director of the Institute for Strategic Threat Analysis & Response (ISTAR) at the University of Pennsylvania. Nicholas Saidel is Associate Director of the Institute for Strategic Threat Analysis & Response (ISTAR) at the University of Pennsylvania.
Abstract: Emerging trends suggest a more inclusive and collaborative approach to addressing international infectious disease issues, but without an overarching governance structure and judicial forum in place, outcomes will remain suboptimal. This essay outlines and analyzes several initiatives currently underway and proposes a new comprehensive global governance structure for infectious disease. This proposed structure has built-in incentives for states—from both the developed and developing world—to meet their regulatory obligations and integrates the myriad non-state actors operating in this space, including NGOs and the private sector. It also incorporates an adjudicative body that is able to enforce compliance and resolve issues of contention. Lastly, this essay identifies innovative funding mechanisms and contemplates the venue best suited to host and administer this new global governance structure for infectious disease with a focus on UN-based models.
Mohamed Camara, a teacher at Le Salem School, in Conakry, Guinea, talks to students about Ebola safety and prevention. (Dominic Chavez/World Bank)
T
he 2014 Ebola crisis exposed numerous governance gaps in global infectious disease control. The response of the World Health Organization (WHO) was late and the tragically high death toll revealed institutional defects in the international regime managing this space. Even now in early 2016, the ripple effects
© 2016 Published for the Foreign Policy Research Institute by Elsevier Ltd.
doi: 10.1016/j.orbis.2016.02.003
Spring 2016 | 279
RUBIN & SAIDEL
of Ebola are having a devastating effect in Sierra Leone. Its national health system is crippled: numerous health facilities are now closed, many healthcare workers have either quit or died, patients fearful for their lives are keeping themselves and their children away from clinics that provide essential primary care and vaccinations, and corruption within the system is rampant. Even some pregnant women prefer to give birth at home, concerned that the standard of care at local hospitals is dangerously inadequate. Many experts conclude that “for each person Ebola has killed through direct infection, more than one Sierra Leonean will perish from the secondary effects of the crisis.”1 If there is anything positive that may emerge from the Ebola disaster, it is its potential role as the catastrophic catalyst that will change how the global community governs infectious disease control—to ensure that nothing like this ever happens again. An ambitious global health agenda was set on August 2, 2015 when the 193 member states of the UN reached a consensus on a document that constitutes the much anticipated 17 Sustainable Development Goals (SDGs). These goals, targeting poverty, hunger, equality issues, health and the environment, among others, were formally adopted on September 25, 2015. In order to meet the objectives laid out in Goal 3, namely, to: “Ensure healthy lives and promote well-being for all at all ages,” cooperation and coordination among UN member states will be essential.2 Goal 3, inter alia, aims to reduce drastically childhood mortality rates, end epidemics such as AIDS, combat communicable diseases by supporting research and development for vaccines and essential medicines, render existing vaccines and therapeutics affordable and accessible to all, and increase health financing in the developing world to strengthen national healthcare workforces and capacity-building for risk detection. This is all supposed to happen by the year 2030. While it is within the mission of the UN to identify and tackle the crises we now face in global health, it will take more than government-to-government collaboration under the umbrella of the WHO to accomplish Goal 3. As we have stated elsewhere, to meet the formidable challenges posed by Goal 3, a new Global Governance Structure for Infectious Disease (GGSID) is needed—one that includes and binds the full range of stakeholders operating in this space.3 Independent Initiatives toward Global Governance Though currently acting under no central authority, nongovernmental organizations, the private sector, and philanthropic foundations are already working to form the basis for such a new architecture for infectious disease control with a more integrated network. This is part of a broader movement to build global governance structures in a variety of areas such as climate change, nuclear security, http://foreignpolicy.com/2015/12/07/ebola-is-now-killing-people-who-arent-eveninfected-sierra-leone/. 2 https://sustainabledevelopment.un.org/post2015/transformingourworld. 3 Harvey Rubin and Nicholas Saidel, “Global agency needed for battling infectious diseases,” New Scientist, Oct. 25, 2014, https://www.newscientist.com/article/mg22429921-400-globalagency-needed-for-battling-infectious-diseases/. 1
280 | Orbis
Global Governance Structure for Infectious Diseases
and cyber security. An example within the infectious disease space is the World Alliance against Antibiotic Resistance (WAAR), an organization created outside the auspices of the WHO that seeks to raise awareness of the antibiotic resistance issue. As WAAR points out, overuse of antibiotics is a threat to international security—4050 percent of antibiotics are prescribed unnecessarily. WAAR, now supported by a diverse set of partners including politicians, doctors, healthcare workers, and policymakers representing 55 countries, released a “declaration against antibiotic resistance” in June 2014 that provided a concise list of action items to deal with the pressing antibiotic resistance problem. The WHO and other agencies such as the World Organization for Animal Health (OIE) and the Food and Drug Administration (FDA), because of politics, ostensible conflicts of interest and no incentive to cooperate with NGOs, did not lend their official support for the declaration even though all said the topic was of paramount importance.4 In this instance, two details are instructive: First, WAAR’s actions demonstrate a strategic shift to create and implement new binding structures outside of the traditional WHO-International Health Regulations (IHR) focused framework, and second, the presently disjointed governance system proved to be an obstacle to achieving more institutional support for a much-needed cause. This only underscores the need for a new, more inclusive governance system that incentivizes cooperation across the board. A second example of actors in the infectious disease space exploring new, more comprehensive governance options is the Commission on a Global Health Risk Framework (GHRF).5 This Commission was formed in the wake of the inadequate global response to the Ebola outbreak in West Africa. Victor Dzau and Judith Rodin, co-chairs of the International Oversight Group of the GHRF, rightly point out that the inadequacy of the response was directly related to disincentives for the private sector “to proactively develop lifesaving products” and “regulatory barriers and poor coordination.” They concluded that “a unifying framework for managing global public health events is needed,” thus charging the independent Commission to “recommend a more effective global architecture for mitigating the threat of epidemic infectious diseases.” The Commission includes not only medical doctors, but also experts in finance and economics, lawyers, and bankers. Even within the customary UN framework, there is a new-found momentum toward a more transparent and collaborative approach. The WHO now recognizes the need for a harmonized information sharing system whereby important R&D data can be shared globally and stored centrally. The idea is not only to track research and results, but also funding streams so that future investments can have the most impact —especially with respect to the public health needs in the developing
Jean Carlet, “The World Alliance Against Antibiotic Resistance: Consensus for a Declaration,” Clinical Infectious Diseases. 60 (2015), pp. 1,837-1,841. 5 Victor Dzau and Judith Rodin, “Creating a Global Health Risk Framework,” New England Journal of Medicine, Aug. 5, 2015. 4
Spring 2016 | 281
RUBIN & SAIDEL
world. To this end, in June 2015, the WHO issued a call for papers to inform the establishment of the Global Observatory for Health Research and Development.6 The Center for Disease Control is playing the principal role in another initiative called the Global Health Security Agenda (GHSA). The GHSA, as explained by the CDC, “seeks to accelerate progress toward a world safe and secure from infectious disease threats and to promote global health security as an international security priority.”7 Its objectives are to: “Prevent and reduce the likelihood of outbreaks—natural, accidental, or intentional; detect threats early to save lives; [and] respond rapidly and effectively using multi-sectorial, international coordination and communication.” While there are laudable elements to the GHSA, it is still a patchwork response with no overarching regulatory architecture outside of the outdated and ineffective WHO/IHR framework. While its white paper mentions a “whole-of-society” approach, no clear-cut role for NGOs or other civil society participants is defined. Moreover, it does not identify the role of the private sector or the significant impact public-private partnerships can have in global infectious disease control, for instance, in solving the vaccine cold chain problem. Leveraging the infrastructure and expertise of the private sector is crucial to optimizing our collective ability to detect, report, respond to, and ultimately, prevent infectious disease outbreaks. By focusing on national programs, the GHSA misses a major opportunity. For instance, regarding the issue of dual use research of concern (DURC), the GHSA white paper recommends the passage of “country specific” legislation. However, national laws on DURC are only at the beginning and internationally harmonized legislation is needed. The absence of a globally recognized legal standard leads to confusion and the increased risk of publishing sensitive material that could be exploited by nefarious actors. Moreover, although attention is given to vaccinepreventable deaths, the document does not indicate how to overcome the significant obstacles that new medicines and vaccines face (e.g., fast-track approval, quick resolution of IP and liability issues) during an epidemic. The GHSA certainly is well funded. For example, during the September 2015 GHSA high-level meeting in Seoul, the Republic of Korea pledged $100 million, and in July 2015 the United States pledged to invest more than $1 billion in resources to expand the GHSA.8 However, throwing money at the inherently flawed WHO-IHR system not only diverts much needed resources, it also further entrenches the status quo. As the GHSA is primarily a national government-to-government based cooperative endeavor, it is a piecemeal approach to a holistic problem. The white paper, which assigns discrete projects known as “action packages” to countries in coordination with mostly UN affiliated agencies, does not reference a unified 6 Taghreed Adam et al., “Informing the establishment of the WHO Global Observatory on Health Research and Development: a call for papers,” Health Research Policy and Systems, 13: 9. (2015). 7 http://www.cdc.gov/globalhealth/security/ghsagenda.htm. 8 https://www.whitehouse.gov/blog/2015/09/16/uniting-seoul-extinguish-epidemic-threatsthrough-global-health-security-agenda; https://www.whitehouse.gov/the-pressoffice/2015/11/16/fact-sheet-us-commitment-global-health-security-agenda.
282 | Orbis
Global Governance Structure for Infectious Diseases
organizational structure to which these countries and agencies are answerable. In other words, pledged commitments are voluntary and can be withdrawn at any time. The white paper does not mention enforceability except to say memoranda of understanding (MOUs) will, in some cases, be necessary—and this is only in the case of an international emergency. However, MOUs, for the most part, are not legally enforceable or binding. The GHSA’s September 2015 Seoul Declaration, which loftily and dogmatically calls on “all countries to make an effort to strengthen their existing national health systems and to fully and rapidly comply with health security responsibilities required by the World Health Organization’s International Health Regulations,” ends with the caveat: “The declaration is our collective effort rather than a legally binding document”9 (emphasis added). By over-relying on existing models that fail to address current governance shortcomings such as no consequences for willful and non-willful noncompliance, and by not tackling the built-in disincentives associated with the IHRs, the GHSA falls short as an overall solution to the universal crisis we now face. Enforceability. The issue of enforceability is key. Effective global infectious disease governance cannot exist without enforcement mechanisms for noncompliance. Article 56 of the IHRs, the section that deals with the settlement of disputes, does not speak to the compliance issue but rather to disputes between member states and those between the WHO and a member state concerning the interpretation or application of the IHRs.10 Even regarding these disputes, Article 56 takes a passive approach, recommending arbitration, which states may accept as compulsory or refer to the World Health Assembly (WHA). Most significant, there is absolutely no language in Article 56 that establishes a protocol for recourse against state parties that do not meet the substantive requirements set forth in the IHRs. Fortuitously, recent high level discussions have touched on this subject, though at the margins. For instance, the Harvard Global Health Institute-London School of Hygiene & Tropical Medicine Independent Panel on the Global Response to Ebola recently published an article recommending ten ways to strengthen what it calls “the global system for outbreak prevention and response.” While the recommendations fall short, they do mention the need for “monitoring national core capacities,” the institutionalization of “accountability through an independent commission for disease outbreak prevention and response,” and sustaining “highlevel political attention through a Global Health Committee of the Security Council.” The panel’s last recommendation is significant in that it brings the UN Security Council (UNSC) into the global governance regime. As detailed below, the UNSC can issue binding resolutions and, thus, theoretically could penalize failure to comply with the IHRs or its equivalents under the GGSID. While the panel urges the UNSC to set up a Global Health Committee, it shies away from stating how this group will
9
http://www.ghsa2015seoul.kr/SeoulDeclaration.pdf. http://apps.who.int/iris/bitstream/10665/43883/1/9789241580410_eng.pdf.
10
Spring 2016 | 283
RUBIN & SAIDEL
“address alleged non-compliance,” except for the weak recommendation that it will bring “high-level attention to health threats.”11 This is simply not enough. As it stands now, the WHO regime wholly fails on the issue of enforceability. Though countries’ failure to comply with the IHRs during the Ebola outbreak awoke the UN to the issue of enforceability—a panel was recently created to explore the possibility of enforcement measures—any attempts to encroach on national sovereignty will likely be met with skepticism and denunciation by member states. Also, monitoring for compliance is not currently within the mandate of the WHO-IHR regime: states currently self-assess whether they have met their obligations. In many cases, recognizing there is no penalty for noncompliance aside from “shame and blame” tactics, states often freely admit their failure in areas such as capacity building. For the WHO to monitor state compliance with the IHRs, a complicated overhaul of the current system likely would be necessary. Infectious diseases pose as grave a threat to humanity as does a nuclear arms race. Thus, the global arms control governance regime is instructive here in terms of its using sanctions for enforcement. The GGSID, as detailed below, has a built-in judicial forum that will bind parties to its regulatory structure—allegations of nonperformance will be judged and penalties assessed if stakeholders are found noncompliant. At the other end of the spectrum, incentives are also built into the GGSID to minimize the likelihood of noncompliance and the need to exact punitive measures. This “carrot and stick” approach will produce a more rigorous and robust governance structure that will yield better results and more proactive involvement from stakeholders. Blueprint for a New Comprehensive Global Governance Structure Judicial Forum. We contend that the global crisis in preventing, controlling and treating infectious diseases demands the creation of a new, multi-component and interconnected implementation regime under the umbrella of a governance structure, comprised of experts from the developed and developing world in science, medicine, political theory, law, finance, economics and security. This governance structure has two components—a judicial forum and a deliberative body. The cornerstone of any governance structure is its judicial system, for example, the Dispute Settlement Body of the World Trade Organization. We propose a judicial forum empowered to adjudicate disputes and enforce its rulings. Interpretive disputes regarding specific GGSID regulations will be litigated within the judicial forum. This forum will be unique in that its jurisdiction will extend beyond state parties. Its broad reach will allow individuals, private sector entities, and NGOs to have standing in order to bring actions against each other, as well as governmental entities, for alleged 11 Suerie Moon et al., “Will Ebola change the game? Ten essential reforms before the next pandemic,” The report of the Harvard-LSHTM Independent Panel on the Global Response to Ebola, The Lancet, http://dx.doi.org/10.1016/S0140-6736(15)00946-0.
284 | Orbis
Global Governance Structure for Infectious Diseases
violations of GGSID regulations, breaches of contractual duties and multi-lateral agreements, allegations of bad faith, and other claims that arise. The primary goal of this judicial forum is to establish a transparent and fair system of adjudication that will hold parties accountable for derogation of their duties as prescribed within the governance structure. The GGSID envisions a twotiered conflict resolution structure (lower and appellate courts) that will not only adjudicate disputes but also, like the International Atomic Energy Association’s (IAEA) Office of Legal Affairs, will respond to stakeholder inquiries and issue advisory opinions to assist them as they navigate through ethical, technical, medical, procedural, and nuanced compliance issues, among others. For example, our proposed judicial forum would have been helpful in resolving the problem that surfaced during the H5N1 debate where different authorities provided inconsistent and conflicting rulings on the issue of publishing potentially dangerous DURC research.12 Similar to a petition for a writ of certiorari in the U.S. federal court system, the individual researcher(s), in this case, could have applied for judicial forum review, which likely would have been granted due to the ripe and far-reaching nature of the issue presented. Exacting monetary penalties from developed world governments, wellfunded international NGOs, and financially secure private sector entities that were found negligent or otherwise in breach of their duties, by the judicial forum is feasible and would, in small part, help fund the GGSID. More difficult, however, is the question of what penalties to assess against noncompliant state actors in the developing world. This question is challenging to answer as any financial penalties may undermine the very system the GGSID is attempting to create. If developing countries are hit with monetary penalties, this may impede their efforts to build capacity for surveillance, detection, and response to an outbreak—a paradoxical outcome. Therefore, the judicial forum may assign more creative and novel approaches to developing states that are found noncompliant. Judgments against such states could include suspension from membership on GGSID governing bodies such as the judicial forum, the deliberative body, and GGSID advisory committees. Other types of judgments could revoke applications to be part of, or host, collaborative scientific endeavors solicited by the GGSID. While a primary objective of the GGSID, and the judicial forum in particular, is to ensure that voices from the developing world are heard, this interest must be balanced against the competing goals of implementation and enforcement. Deliberative Body. The judicial forum will be complemented by a deliberative body also composed of a multidisciplinary group of experts from the public and private sectors who represent the developed and developing world. The main Michael Imperiale, “Dual Use Research after the Avian Influenza Controversy,” Bulletin of the Atomic Scientists. 17:19, Sept. 11, 2012, http://thebulletin.org/dual-use-research-after-avianinfluenza-controversy. 12
Spring 2016 | 285
RUBIN & SAIDEL
function of this deliberative body is to draft regulations that will be tailored specifically to the diverse set of participants’ core competencies and limitations. It will serve as the policy and strategy backbone of the GGSID, and will house and oversee the subordinate administrative bodies necessary for GGSID execution. Regulations passed by majority vote by the deliberative body will be adopted by national governments as domestic legislation and will bind non-state actors as well, i.e. participating NGOs and civil society, private sector members of the GGSID, and participating international agencies operating in the infectious disease space. In lieu of an executive “branch,” the deliberative body will have a rotating leadership cabinet not unlike the UNSC. This cabinet will have representatives from all sectors of society and will have the power to set the policy agenda, break tie votes among the deliberative body, and make real-time decisions in the event of global public health events. It will render judgments on exigent matters such as declaring international emergencies, allocating funding, deploying international rapid response teams, and identifying roles for capable NGOs such as Doctors without Borders and the GAVI Alliance (formerly the Global Alliance for Vaccines and Immunization). Currently, there is no international body, aside from the state-centric WHA, empowered to reconcile legitimate differences of opinion on infectious disease issues. Such issues include DURC, sharing of data, intellectual property and liability issues and the appropriate allocation of resources during a pandemic, all of which implicate the competing goals of security, national sovereignty, scientific progress, academic free speech, and fundamental human rights. Establishing customized measurable and, perhaps most importantly, achievable milestones for stakeholders will often require the deliberative body to assist in matching potentially synergetic public and private partners. At first blush, one might be skeptical that the private sector has the will or the proper incentives to be a formal part of the GGSID. Nevertheless, profits and infectious disease control are not mutually exclusive concepts. The private sector can be enticed into partnerships with ministries of health, relevant NGOs, and international organizations notwithstanding allegiance to their shareholders and monetary gains. Appeals to corporate social responsibility and community relations aside, private sector entities can profit from public/private partnerships—especially ones whose nexus is located in a new or unsaturated market in the developing world. For private sector partners, increased brand recognition, increased market penetration, entry into new markets, preserving the existing customer base and gaining new customers are all attractive concepts. Relaxed barriers to market entry (e.g., tariffs and taxes) would also motivate a private sector entity to forge a relationship with public entities and with the GGSID. For pharmaceutical- and vaccine-related issues like supply chain management, data capturing and analysis, inventory optimization, and other relevant proficiencies, the public sector will also be incentivized to formalize a public/private partnership—a mutually beneficial effort. While the IHRs are a good start to a regulatory framework for global infectious disease control, history has demonstrated its inadequacy—its disincentivizing structure with respect to reporting of outbreaks, its inability to contend with poor states which are unable to build capacity for surveillance and response, and its lack of an enforcement mechanism. The SDGs, as noted by the
286 | Orbis
Global Governance Structure for Infectious Diseases
Rockefeller Foundation, will require trillions of dollars to implement—an amount that dwarfs the combined resources of the philanthropic and governmental health sectors.13 Recently, the SDG Philanthropy Platform—a partnership between the United Nations Development Program and very large philanthropic organizations— highlighted its exclusion in the implementation of the SDGs. “Governments alone cannot address the critical challenges of sustainable development, nor can we expect philanthropy to achieve its maximum potential operating in isolation,” said UNDP administrator Helen Clark. “The SDG Platform for Philanthropy will create the linkages necessary to achieve the SDGs, and, ultimately, a more just and equitable society.”14 Core Structural Components. The GGSID is the solution to the current crisis in global governance for infectious disease. This governance structure’s four core components are as follows: (1) Integrate, coordinate and harmonize international standards for surveillance and reporting of data and knowledge of infectious diseases for use in a centralized database using advanced information technology to ensure timeliness, interoperability and security, including but not limited to epidemiological data, bioinformatics, information about new and ongoing clinical trials, data regarding new compounds and targets, standardized material transfer agreements and a host of services and skills; (2) Integrate, coordinate, harmonize and expand a network of international basic science and translational research centers that will support fundamental investigations into the pathophysiology of certain microbial threats to global health; (3) Integrate, coordinate, harmonize and expand capabilities for the production and distribution of vaccines, therapeutics and diagnostics expressly for emerging and reemerging infections; and (4) Integrate, coordinate, harmonize, monitor and anticipate any changes in international standards for best laboratory, regulatory, and ethical practices.
13 Muhammad Yunus, Judith Rodin, “Save the World, Turn a Profit,” Bloomberg View, Sept. 25, 2015. 14 http://philanthropynewsdigest.org/news/philanthropy-leaders-call-for-greater-role-inglobal-development-goals?utm_campaign=news%7C2015-0925&utm_source=pnd&utm_medium=email.
Spring 2016 | 287
RUBIN & SAIDEL
This proposed governance structure creates powerful incentives for the varied set of public and private sector stakeholders to participate and for enforcement. The unique characteristic of the proposed organizational structure is the interdependence of its components. We argue that this interdependence adds significant value to the existing, more limited structures, and contributes to the feasibility and compliance with the structure. In its essence, the interdependent structure ensures that participating in one component of the structure is contingent upon participating in all components, perhaps not at the same level, but according to a phased, mutually agreed upon algorithm that takes into account economic and human resources capabilities. For example, in order to gain access to the centralized database, participants would pledge to implement best laboratory and regulatory practices. The GGSID acknowledges the disparate financial capabilities of participants and, therefore, envisions an in-kind cooperative network based on a modified, forward-looking version of the principle of common but differentiated responsibilities. Utilizing this principle, developed states may have a primary responsibility to fund the GGSID research centers whereas developing states may provide scientists, epidemiological and other data (that under the current IHR regime may go unreported due to disincentives) and specimens that could help prevent the next epidemic. Proposed Global Governance Structure for Infectious Diseases
288 | Orbis
Global Governance Structure for Infectious Diseases
Venue. Challenges still remain, such as how to get stakeholders, especially states that regard national sovereignty as a fundamental value, to commit to a compulsory, subpoena-issuing, adjudicative body. To enlist and bind state and nonstate actors to a common cause without violating the operation of existing international legal regimes, national sovereignty rights, individual privacy rights, NGO by-laws, and constraints within academic research presents myriad obstacles. However, there are many options to be explored and a balance must be struck that takes into account the competing values at play. Treaty, protocol, and convention based arrangements are options to consider, as are contractually binding agreements that may be better suited to incorporate non-state actors. A related question is what body will administer the GGSID and host the judicial forum and deliberative body necessary to build a concrete body of law that can be relied upon as precedent and guide future decisions. Criteria for such an institution could include: (1) An international staff committed to research and practice; (2) promotion of knowledge of justice, law, peace, security, social and economic development; (3) ability to synthesize national and international knowledge and cultivate an inclusive vision of issues; (4) ability to convene across disciplines; and (5) a respected, trusted and neutral body with international standing. The UN meets all of the above criteria. Beyond that, the UN acknowledges the role of non-state actors in international affairs. As one commentator notes: “The proliferation of non-state actors has meant there are many more potentially powerful contributors to global governance. […] This implies a different structure, process, and function for how governance operates on the global level: specifically, that states or stat-based entities no longer exist as a monopoly in global affairs.”15 Civil society (e.g., an NGO with consultative status at the UN) is able to submit white papers and oral testimony regarding issues before the GA. Furthermore, the UN Global Compact at the Millennium Summit of 2000 and, more recently, the UN Secretary General’s High Level Panel of Eminent Persons on the Post-2015 Millennium Agenda, both point to a UN more cognizant of the role of civil society, as well as corporations and individuals in the areas of sustainable development, monitoring, and human rights.16 The mission of the UN also naturally aligns with the notion of global solidarity, a concept that is crucial to solving the problem we now face. The UN has yet to integrate comprehensively what David Fidler calls the “unstructured plurality” of non-state actors.17 By assimilating the GGSID fully into the UN regime, this important governance gap as it applies to infectious disease would be filled. The centrality of the GGSID’s judicial forum requires examining potentially viable extant frameworks. There are at least five different dispute resolution mechanisms that could apply to a global governance structure for infectious disease. 15 Thomas Weiss et al., “The Rise of Non-State Actors in Global Governance,” One Earth Future Foundation (2013),http://acuns.org/wp-content/uploads/2013/11/gg-weiss.pdf. 16 Thomas Weiss et al., “The Rise of Non-State Actors in Global Governance.” 17 Julio Frenk, Suerie Moon, “Governance Challenges in Global Health,” New England Journal of Medicine, March 7, 2013; David Fidler, “Architecture amidst anarchy: global health's quest for governance,” Global Health Governance 2007, pp.1-17.
Spring 2016 | 289
RUBIN & SAIDEL
Establishing an International Arbitration Tribunal Pursuant to Article 33 of the UN Charter Article 33 of the UN Charter states: “The parties to any dispute, the continuance of which is likely to endanger the maintenance of international peace and security, shall, first of all, seek a solution by negotiation, enquiry, mediation, conciliation, arbitration, judicial settlement, resort to regional agencies or arrangements, or other peaceful means of their own choice.”18 If the General Assembly (GA) were to ratify a “Convention on Infectious Disease,” a provision within the Convention could create a dispute resolution mechanism as provided for in Article 33. The Convention on the Law of the Sea is informative in this regard. Citing Article 33, Part XV of the Convention on the Law of the Sea creates dispute resolution procedures, and Article 287 defines the parameters of an independent International Tribunal for the Law of the Sea that sits in Hamburg, Germany. Notably, the Tribunal has jurisdiction over private entities. “The Tribunal has jurisdiction over any dispute concerning the interpretation or application of the Convention, and over all matters specifically provided for in any other agreement which confers jurisdiction on the Tribunal (Statute, article 21). The Tribunal is open to States Parties to the Convention (i.e. States and international organizations which are parties to the Convention). It is also open to entities other than States Parties, i.e., States or intergovernmental organizations which are not parties to the Convention, and to state enterprises and private entities ‘in any case expressly provided for in Part XI or in any case submitted pursuant to any other agreement conferring jurisdiction on the Tribunal which is accepted by all the parties to that case’” (Statute, article 20).19 Referral to the Good Offices of the Secretary General Article 98 of the Charter provides that the Secretary General, in addition to acting in that capacity in all meetings of the General Assembly, of the Security Council, of the Economic and Social Council and of the Trusteeship Council, “shall perform such other functions as are entrusted to him by these organs.”20 These often include functions in the field of the prevention and the peaceful settlement of disputes.21 Article 99 of the Charter provides that the Secretary General may “bring to the attention of the Security Council any matter that in his opinion may threaten
http://www.un.org/en/sections/un-charter/chapter-vi/index.html. https://www.itlos.org/en/the-tribunal/. 20 http://legal.un.org/repertory/art98/english/rep_supp10_vol6_art98_e_advance_final.pdf. 21 http://peacemaker.un.org/peacemaking-mandate/secretary-general. 18 19
290 | Orbis
Global Governance Structure for Infectious Diseases
international peace and security.”22 The good offices and mediation roles of the Secretary General in the prevention and the peaceful settlement of disputes derive from the Charter and have been developed through extensive practice. The range of activities carried out by the Secretary General has included good offices, mediation, facilitation, dialogue processes and even arbitration.23 The Secretary General may take action himself or may appoint special representatives and envoys to carry out good offices and mediation on his behalf. Numerous representatives of the Secretary General also engage in peace talks or crisis diplomacy while overseeing UN political or peacekeeping missions in the field, which may have mandates to help nations and regions, resolve conflicts and tensions peacefully.24 The mediation role of the good offices of the Secretary General has a vaguely worded basis that can be interpreted widely or narrowly depending on who is in office. Former Secretary General Boutros Boutros-Ghali said that “good offices” is “a very flexible term as it may mean very little or very much.”25 Historically, this role has been centered on resolving discrete political, territorial, resource, or military disputes (e.g., negotiating a ceasefire or an armistice agreement). Thus, a permanent court presiding on infectious disease issues does not seem to fit clearly within the good offices’ mandate. Moreover, it is structurally problematic for the good offices of the Secretary General to involve itself with non-state actors. The role of the Secretary General or his or her appointees, as evidenced by its name, is more of a mediation role as opposed to a court of final appeal. While Article 99 states that issues requiring enforcement can be referred to the Security Council, this referral system would not be sufficient for the day-to-day management of the GGSID or for the rulings required for the docket of cases submitted to the judicial forum. Nonetheless, by treaty or convention, parties to the GGSID could confer jurisdiction to the good offices of the Secretary General and make his or her appointees’ rulings binding. In addition, the GA or UNSC, under Article 98, could “entrust” the good offices with the role of hosting the GGSID. As the Office of the Secretariat is an executive body with a wealth of manpower and resources that can harness the expertise of civil society and the specialized offices of the UN, it is a potentially good candidate for a venue for the GGSID—one worthy of further exploration—notwithstanding the challenges mentioned above. The International Court of Justice The International Court of Justice was established by the Charter of the United Nations, which provides that all member states of the United Nations are ipso http://www.un-documents.net/ch-15.htm. http://peacemaker.un.org/peacemaking-mandate/secretary-general. 24 http://peacemaker.un.org/peacemaking-mandate/secretary-general. 25 Statement of the Secretary-General, UN Doc. SG/SM/3525, as reported in The United Nations Handbook on the Peaceful Settlement of Disputes between States, UN Doc. OLA/COD/2394, p 35, http://www.un.org/law/books/HandbookOnPSD.pdf. 22 23
Spring 2016 | 291
RUBIN & SAIDEL
facto parties to the Court's Statute. The International Court of Justice acts as a world court. The Court has a dual jurisdiction: It decides, in accordance with international law, disputes of a legal nature that are submitted to it by States (jurisdiction in contentious cases); and it gives advisory opinions on legal questions at the request of the organs of the United Nations or specialized agencies authorized to make such a request (advisory jurisdiction). The Court has no jurisdiction to deal with applications from individuals, non-governmental organizations, corporations or any other private entity. It cannot provide them with legal counseling or help them in their dealings with the authorities of any State whatever.26 However, a State may take up the case of one of its nationals and invoke against another State the wrongs which its national claims to have suffered at the hands of the latter; the dispute then becomes one between states. If a new global governance structure for infectious disease sat at the UN, states parties to any agreement—be it through treaty or convention—could confer jurisdiction to the International Court of Justice for adjudicating disputes and issuing advisory opinions. Notably, judgments delivered by the Court (or by one of its Chambers) in disputes between States are binding upon the parties concerned. Article 94 of the United Nations Charter lays down that “each Member of the United Nations undertakes to comply with the decision of [the Court] in any case to which it is a party.”27 The International Court of Justice’s focus on UN member states limits the feasibility of this court as one suited to adjudicate disputes between the diverse set of stakeholders proposed herein. Referral to the United Nations Security Council The UNSC is a 15-member body of the UN, five of which are permanent, charged with maintaining international peace and security. Each member represents a member state of the United Nations. Pursuant to Chapter VI of the UN Charter entitled “Pacific Settlement of Disputes,” the UNSC is able to make recommendations to member states that are unable to resolve a matter through bilateral negotiation, mediation or other arbitrative mechanisms.28 Any UNSC recommendation arising under the UNSC’s Chapter VI powers is not binding. Conversely, by virtue of its powers under Chapter VII of the UN Charter, the UNSC is the only principal organ of the UN that can make binding resolutions (e.g., sanctions and the deployment of UN Peacekeepers). These binding resolutions are limited to threats to peace, alleged breaches of the peace and acts of aggression.29 Traditionally, the UNSC’s powers under Chapter VII have been interpreted narrowly so as to apply to mostly military matters. Arguably, UNSC 2177 expanded the UNSC’s Chapter VII powers to health related issues. The resolution was adopted in September 2014 during the Ebola crisis, calling for member states to take action to prevent the spread of the deadly http://www.icj-cij.org/information/index.php?p1=7&p2=2. http://www.icj-cij.org/information/index.php?p1=7&p2=2. 28 http://www.un.org/en/sc/repertoire/settlements.shtml. 29 http://www.un.org/en/sc/repertoire/actions.shtml, 26 27
292 | Orbis
Global Governance Structure for Infectious Diseases
virus. While not explicitly invoking its authority under Chapter VII, UNSC Resolution 2177 implicitly broadened the scope of its Chapter VII powers by declaring the Ebola outbreak “a threat to international peace and security” (the terminology of Chapter VII).30 While this was not the first time the UNSC linked health and security—in 2000, it issued UNSC Resolution 1308 regarding HIV/AIDS—UNSC 2177 was the most unequivocal statement associating peace and security with a matter of global public health.31 It is unclear how the UNSC will proceed along the lines of “securitizing health,” a controversial topic among experts in the global public health space. If this linkage between health and security becomes a trend within the UNSC, it is possible that it could host the GGSID and the judicial forum. Its appeal is that it can enforce its decisions, but like other regimes within the UN, it is currently not suited to bind non-state actors. Also, as it is comprised of only member state representatives, it would lack the diverse stakeholder authority for which the GGSID calls and runs the risk of politicization. In short, like the good offices of the Secretary General, the UNSC is an option worth consideration for hosting and administering the GGSID and its judicial forum. International Centre for Settlement of Investment Disputes The International Centre for Settlement of Investment Disputes (ICSID) is a member of the World Bank Group which, in turn, has Observer Status at the UN. ICSID was established in 1966 by the Convention on the Settlement of Investment Disputes between States and Nationals of Other States.32 An award rendered under the ICSID Convention is enforceable as a final judgment of courts in every ICSID Member State.33 Awards rendered in other ICSID administered cases are enforceable under the New York Convention. Like the International Tribunal for the Law of the Sea, private entities—i.e., individual investors, can have standing in this court against states which they attest are in violation of an agreement, treaty, international law, or contract. The parties to the case can play a role in choosing the “conciliators” who will rule on the issue in question.34 Among the dispute resolution mechanisms mentioned herein, this model, along with the International Tribunal for the Law of the Sea, is probably the most appropriate as a template for the adjudicative body needed for the GGSID and its judicial forum.
http://www.un.org/en/ga/search/view_doc.asp?symbol=S/RES/2177%20%282014%29. http://theglobalobservatory.org/2014/12/security-council-response-ebola-action/. 32 https://icsid.worldbank.org/ICSID/StaticFiles/basicdoc/intro.htm. 33 https://icsid.worldbank.org/apps/ICSIDWEB/process/Pages/Recognition-andEnforcement-Convention-Arbitration.aspx. 34https://icsid.worldbank.org/apps/ICSIDWEB/about/Documents/Special%20features%20 of%20ICSID.pdf. 30 31
Spring 2016 | 293
RUBIN & SAIDEL
Financing How to finance the GGSID is another challenge. Typical funding streams such as Big Philanthropy, assistance from the G7/G20 nations, and aid from the World Bank and the International Monetary Fund could all be utilized, but innovative financing is also required for global infectious disease control to be both workable and sustainable. To this end, the GGSID will explore creative methods to access the capital markets and entice private sector investments. Creative and fruitful enterprises joining the public and private sectors have emerged and should be built upon. One innovative mechanism that could help ameliorate financing obstacles for R&D for certain diseases is non-profit investment in for-profit companies in order to access the capital markets. One case is the Cystic Fibrosis Foundation’s investment in Vertex Pharmaceuticals, a biotech company that works on developing drugs to combat this lethal disease.35 The infusion of $120 million in funding helped speed up the development of Kalydeco, a drug that treats an underlying cause of cystic fibrosis. While critics point to the high cost of the drug and the notion that non-profit foundations should not be in the business of making profits—a conflict of interest they say—the Cystic Fibrosis Foundation now has $3.3 billion in its coffers to further its mission of helping patients suffering from cystic fibrosis. This huge profit is a result of the Foundation’s sale of its royalty rights to Royalty Pharma. Moreover, within the private sector, there is growth in the market for social impact investing, i.e. investments that provide a return in terms of monetary profits, but which help achieve a social good. Wall Street demonstrates there is an appetite for these types of investments and some estimates claim the market could grow to $3 trillion. Goldman Sachs, for example, issues various social impact bonds and funds to address social challenges such as recidivism and lack of access to quality education. Other cutting-edge financial instruments are being developed to allow foundations, “socially minded” business, and nonprofits access to the global financial markets. For example, the Rockefeller Foundation and Yunus Social Business jointly developed the “social success note.” Investors provide capital (e.g., a loan) to an organization that provides a social good. The organization is required to pay back the loan, but if it hits a predetermined social target, a partnering foundation will provide the investor with an “impact payment” for the social good linked to the initial investment. If the target is not met, the organization is still required to pay back the loan.36 A New Structure The current trend toward a more inter-connected landscape in infectious disease governance is a good sign, but there is much more that needs to be done. The present incoherent international regime for infectious disease control requires a Andrew Pollack, “Deal by Cystic Fibrosis Foundation Raises Cash and Some Concern,” New York Times, Nov, 19, 2014. 36 Muhammad Yunus, Judith Rodin, “Save the World, Turn a Profit,” Bloomberg View, Sept. 25, 2015. 35
294 | Orbis
Global Governance Structure for Infectious Diseases
new overarching structure with a primary and comprehensive focus on infectious diseases, one that will harmonize, integrate and coordinate the existing relevant legal structures that deal with infectious disease issues—including the WHO, World Intellectual Property Organization law, the Biological and Toxin Weapons Convention, the WTO, Trade-Related Aspects of Intellectual Property Rights, the IMF, human rights law, and others. By incorporating existing networks, the GGSID will synergize efforts already underway. Just as important, its built-in incentive structure will bring what are now independent ventures (e.g., WAAR, GHRF, social impact investing, non-profit access to capital markets) into a common framework within which decisions concerning issues of global infectious disease can be made. Until a central authority is empowered to govern global infectious disease control, we will continue to see noble, constructive, yet suboptimal undertakings such as the ones outlined above.
Spring 2016 | 295
Abstract: Emerging trends suggest a more inclusive and collaborative approach to addressing international infectious disease issues, but without an overarching governance structure and judicial forum in place, outcomes will remain suboptimal. This essay outlines and analyzes several initiatives currently underway and proposes a new comprehensive global governance structure for infectious disease. This proposed structure has built-in incentives for states—from both the developed and developing world—to meet their regulatory obligations and integrates the myriad non-state actors operating in this space, including NGOs and the private sector. It also incorporates an adjudicative body that is able to enforce compliance and resolve issues of contention. Lastly, this essay identifies innovative funding mechanisms and contemplates the venue best suited to host and administer this new global governance structure for infectious disease with a focus on UN-based models.
Mohamed Camara, a teacher at Le Salem School, in Conakry, Guinea, talks to students about Ebola safety and prevention. (Dominic Chavez/World Bank)
T
he 2014 Ebola crisis exposed numerous governance gaps in global infectious disease control. The response of the World Health Organization (WHO) was late and the tragically high death toll revealed institutional defects in the international regime managing this space. Even now in early 2016, the ripple effects
© 2016 Published for the Foreign Policy Research Institute by Elsevier Ltd.
doi: 10.1016/j.orbis.2016.02.003
Spring 2016 | 279
RUBIN & SAIDEL
of Ebola are having a devastating effect in Sierra Leone. Its national health system is crippled: numerous health facilities are now closed, many healthcare workers have either quit or died, patients fearful for their lives are keeping themselves and their children away from clinics that provide essential primary care and vaccinations, and corruption within the system is rampant. Even some pregnant women prefer to give birth at home, concerned that the standard of care at local hospitals is dangerously inadequate. Many experts conclude that “for each person Ebola has killed through direct infection, more than one Sierra Leonean will perish from the secondary effects of the crisis.”1 If there is anything positive that may emerge from the Ebola disaster, it is its potential role as the catastrophic catalyst that will change how the global community governs infectious disease control—to ensure that nothing like this ever happens again. An ambitious global health agenda was set on August 2, 2015 when the 193 member states of the UN reached a consensus on a document that constitutes the much anticipated 17 Sustainable Development Goals (SDGs). These goals, targeting poverty, hunger, equality issues, health and the environment, among others, were formally adopted on September 25, 2015. In order to meet the objectives laid out in Goal 3, namely, to: “Ensure healthy lives and promote well-being for all at all ages,” cooperation and coordination among UN member states will be essential.2 Goal 3, inter alia, aims to reduce drastically childhood mortality rates, end epidemics such as AIDS, combat communicable diseases by supporting research and development for vaccines and essential medicines, render existing vaccines and therapeutics affordable and accessible to all, and increase health financing in the developing world to strengthen national healthcare workforces and capacity-building for risk detection. This is all supposed to happen by the year 2030. While it is within the mission of the UN to identify and tackle the crises we now face in global health, it will take more than government-to-government collaboration under the umbrella of the WHO to accomplish Goal 3. As we have stated elsewhere, to meet the formidable challenges posed by Goal 3, a new Global Governance Structure for Infectious Disease (GGSID) is needed—one that includes and binds the full range of stakeholders operating in this space.3 Independent Initiatives toward Global Governance Though currently acting under no central authority, nongovernmental organizations, the private sector, and philanthropic foundations are already working to form the basis for such a new architecture for infectious disease control with a more integrated network. This is part of a broader movement to build global governance structures in a variety of areas such as climate change, nuclear security, http://foreignpolicy.com/2015/12/07/ebola-is-now-killing-people-who-arent-eveninfected-sierra-leone/. 2 https://sustainabledevelopment.un.org/post2015/transformingourworld. 3 Harvey Rubin and Nicholas Saidel, “Global agency needed for battling infectious diseases,” New Scientist, Oct. 25, 2014, https://www.newscientist.com/article/mg22429921-400-globalagency-needed-for-battling-infectious-diseases/. 1
280 | Orbis
Global Governance Structure for Infectious Diseases
and cyber security. An example within the infectious disease space is the World Alliance against Antibiotic Resistance (WAAR), an organization created outside the auspices of the WHO that seeks to raise awareness of the antibiotic resistance issue. As WAAR points out, overuse of antibiotics is a threat to international security—4050 percent of antibiotics are prescribed unnecessarily. WAAR, now supported by a diverse set of partners including politicians, doctors, healthcare workers, and policymakers representing 55 countries, released a “declaration against antibiotic resistance” in June 2014 that provided a concise list of action items to deal with the pressing antibiotic resistance problem. The WHO and other agencies such as the World Organization for Animal Health (OIE) and the Food and Drug Administration (FDA), because of politics, ostensible conflicts of interest and no incentive to cooperate with NGOs, did not lend their official support for the declaration even though all said the topic was of paramount importance.4 In this instance, two details are instructive: First, WAAR’s actions demonstrate a strategic shift to create and implement new binding structures outside of the traditional WHO-International Health Regulations (IHR) focused framework, and second, the presently disjointed governance system proved to be an obstacle to achieving more institutional support for a much-needed cause. This only underscores the need for a new, more inclusive governance system that incentivizes cooperation across the board. A second example of actors in the infectious disease space exploring new, more comprehensive governance options is the Commission on a Global Health Risk Framework (GHRF).5 This Commission was formed in the wake of the inadequate global response to the Ebola outbreak in West Africa. Victor Dzau and Judith Rodin, co-chairs of the International Oversight Group of the GHRF, rightly point out that the inadequacy of the response was directly related to disincentives for the private sector “to proactively develop lifesaving products” and “regulatory barriers and poor coordination.” They concluded that “a unifying framework for managing global public health events is needed,” thus charging the independent Commission to “recommend a more effective global architecture for mitigating the threat of epidemic infectious diseases.” The Commission includes not only medical doctors, but also experts in finance and economics, lawyers, and bankers. Even within the customary UN framework, there is a new-found momentum toward a more transparent and collaborative approach. The WHO now recognizes the need for a harmonized information sharing system whereby important R&D data can be shared globally and stored centrally. The idea is not only to track research and results, but also funding streams so that future investments can have the most impact —especially with respect to the public health needs in the developing
Jean Carlet, “The World Alliance Against Antibiotic Resistance: Consensus for a Declaration,” Clinical Infectious Diseases. 60 (2015), pp. 1,837-1,841. 5 Victor Dzau and Judith Rodin, “Creating a Global Health Risk Framework,” New England Journal of Medicine, Aug. 5, 2015. 4
Spring 2016 | 281
RUBIN & SAIDEL
world. To this end, in June 2015, the WHO issued a call for papers to inform the establishment of the Global Observatory for Health Research and Development.6 The Center for Disease Control is playing the principal role in another initiative called the Global Health Security Agenda (GHSA). The GHSA, as explained by the CDC, “seeks to accelerate progress toward a world safe and secure from infectious disease threats and to promote global health security as an international security priority.”7 Its objectives are to: “Prevent and reduce the likelihood of outbreaks—natural, accidental, or intentional; detect threats early to save lives; [and] respond rapidly and effectively using multi-sectorial, international coordination and communication.” While there are laudable elements to the GHSA, it is still a patchwork response with no overarching regulatory architecture outside of the outdated and ineffective WHO/IHR framework. While its white paper mentions a “whole-of-society” approach, no clear-cut role for NGOs or other civil society participants is defined. Moreover, it does not identify the role of the private sector or the significant impact public-private partnerships can have in global infectious disease control, for instance, in solving the vaccine cold chain problem. Leveraging the infrastructure and expertise of the private sector is crucial to optimizing our collective ability to detect, report, respond to, and ultimately, prevent infectious disease outbreaks. By focusing on national programs, the GHSA misses a major opportunity. For instance, regarding the issue of dual use research of concern (DURC), the GHSA white paper recommends the passage of “country specific” legislation. However, national laws on DURC are only at the beginning and internationally harmonized legislation is needed. The absence of a globally recognized legal standard leads to confusion and the increased risk of publishing sensitive material that could be exploited by nefarious actors. Moreover, although attention is given to vaccinepreventable deaths, the document does not indicate how to overcome the significant obstacles that new medicines and vaccines face (e.g., fast-track approval, quick resolution of IP and liability issues) during an epidemic. The GHSA certainly is well funded. For example, during the September 2015 GHSA high-level meeting in Seoul, the Republic of Korea pledged $100 million, and in July 2015 the United States pledged to invest more than $1 billion in resources to expand the GHSA.8 However, throwing money at the inherently flawed WHO-IHR system not only diverts much needed resources, it also further entrenches the status quo. As the GHSA is primarily a national government-to-government based cooperative endeavor, it is a piecemeal approach to a holistic problem. The white paper, which assigns discrete projects known as “action packages” to countries in coordination with mostly UN affiliated agencies, does not reference a unified 6 Taghreed Adam et al., “Informing the establishment of the WHO Global Observatory on Health Research and Development: a call for papers,” Health Research Policy and Systems, 13: 9. (2015). 7 http://www.cdc.gov/globalhealth/security/ghsagenda.htm. 8 https://www.whitehouse.gov/blog/2015/09/16/uniting-seoul-extinguish-epidemic-threatsthrough-global-health-security-agenda; https://www.whitehouse.gov/the-pressoffice/2015/11/16/fact-sheet-us-commitment-global-health-security-agenda.
282 | Orbis
Global Governance Structure for Infectious Diseases
organizational structure to which these countries and agencies are answerable. In other words, pledged commitments are voluntary and can be withdrawn at any time. The white paper does not mention enforceability except to say memoranda of understanding (MOUs) will, in some cases, be necessary—and this is only in the case of an international emergency. However, MOUs, for the most part, are not legally enforceable or binding. The GHSA’s September 2015 Seoul Declaration, which loftily and dogmatically calls on “all countries to make an effort to strengthen their existing national health systems and to fully and rapidly comply with health security responsibilities required by the World Health Organization’s International Health Regulations,” ends with the caveat: “The declaration is our collective effort rather than a legally binding document”9 (emphasis added). By over-relying on existing models that fail to address current governance shortcomings such as no consequences for willful and non-willful noncompliance, and by not tackling the built-in disincentives associated with the IHRs, the GHSA falls short as an overall solution to the universal crisis we now face. Enforceability. The issue of enforceability is key. Effective global infectious disease governance cannot exist without enforcement mechanisms for noncompliance. Article 56 of the IHRs, the section that deals with the settlement of disputes, does not speak to the compliance issue but rather to disputes between member states and those between the WHO and a member state concerning the interpretation or application of the IHRs.10 Even regarding these disputes, Article 56 takes a passive approach, recommending arbitration, which states may accept as compulsory or refer to the World Health Assembly (WHA). Most significant, there is absolutely no language in Article 56 that establishes a protocol for recourse against state parties that do not meet the substantive requirements set forth in the IHRs. Fortuitously, recent high level discussions have touched on this subject, though at the margins. For instance, the Harvard Global Health Institute-London School of Hygiene & Tropical Medicine Independent Panel on the Global Response to Ebola recently published an article recommending ten ways to strengthen what it calls “the global system for outbreak prevention and response.” While the recommendations fall short, they do mention the need for “monitoring national core capacities,” the institutionalization of “accountability through an independent commission for disease outbreak prevention and response,” and sustaining “highlevel political attention through a Global Health Committee of the Security Council.” The panel’s last recommendation is significant in that it brings the UN Security Council (UNSC) into the global governance regime. As detailed below, the UNSC can issue binding resolutions and, thus, theoretically could penalize failure to comply with the IHRs or its equivalents under the GGSID. While the panel urges the UNSC to set up a Global Health Committee, it shies away from stating how this group will
9
http://www.ghsa2015seoul.kr/SeoulDeclaration.pdf. http://apps.who.int/iris/bitstream/10665/43883/1/9789241580410_eng.pdf.
10
Spring 2016 | 283
RUBIN & SAIDEL
“address alleged non-compliance,” except for the weak recommendation that it will bring “high-level attention to health threats.”11 This is simply not enough. As it stands now, the WHO regime wholly fails on the issue of enforceability. Though countries’ failure to comply with the IHRs during the Ebola outbreak awoke the UN to the issue of enforceability—a panel was recently created to explore the possibility of enforcement measures—any attempts to encroach on national sovereignty will likely be met with skepticism and denunciation by member states. Also, monitoring for compliance is not currently within the mandate of the WHO-IHR regime: states currently self-assess whether they have met their obligations. In many cases, recognizing there is no penalty for noncompliance aside from “shame and blame” tactics, states often freely admit their failure in areas such as capacity building. For the WHO to monitor state compliance with the IHRs, a complicated overhaul of the current system likely would be necessary. Infectious diseases pose as grave a threat to humanity as does a nuclear arms race. Thus, the global arms control governance regime is instructive here in terms of its using sanctions for enforcement. The GGSID, as detailed below, has a built-in judicial forum that will bind parties to its regulatory structure—allegations of nonperformance will be judged and penalties assessed if stakeholders are found noncompliant. At the other end of the spectrum, incentives are also built into the GGSID to minimize the likelihood of noncompliance and the need to exact punitive measures. This “carrot and stick” approach will produce a more rigorous and robust governance structure that will yield better results and more proactive involvement from stakeholders. Blueprint for a New Comprehensive Global Governance Structure Judicial Forum. We contend that the global crisis in preventing, controlling and treating infectious diseases demands the creation of a new, multi-component and interconnected implementation regime under the umbrella of a governance structure, comprised of experts from the developed and developing world in science, medicine, political theory, law, finance, economics and security. This governance structure has two components—a judicial forum and a deliberative body. The cornerstone of any governance structure is its judicial system, for example, the Dispute Settlement Body of the World Trade Organization. We propose a judicial forum empowered to adjudicate disputes and enforce its rulings. Interpretive disputes regarding specific GGSID regulations will be litigated within the judicial forum. This forum will be unique in that its jurisdiction will extend beyond state parties. Its broad reach will allow individuals, private sector entities, and NGOs to have standing in order to bring actions against each other, as well as governmental entities, for alleged 11 Suerie Moon et al., “Will Ebola change the game? Ten essential reforms before the next pandemic,” The report of the Harvard-LSHTM Independent Panel on the Global Response to Ebola, The Lancet, http://dx.doi.org/10.1016/S0140-6736(15)00946-0.
284 | Orbis
Global Governance Structure for Infectious Diseases
violations of GGSID regulations, breaches of contractual duties and multi-lateral agreements, allegations of bad faith, and other claims that arise. The primary goal of this judicial forum is to establish a transparent and fair system of adjudication that will hold parties accountable for derogation of their duties as prescribed within the governance structure. The GGSID envisions a twotiered conflict resolution structure (lower and appellate courts) that will not only adjudicate disputes but also, like the International Atomic Energy Association’s (IAEA) Office of Legal Affairs, will respond to stakeholder inquiries and issue advisory opinions to assist them as they navigate through ethical, technical, medical, procedural, and nuanced compliance issues, among others. For example, our proposed judicial forum would have been helpful in resolving the problem that surfaced during the H5N1 debate where different authorities provided inconsistent and conflicting rulings on the issue of publishing potentially dangerous DURC research.12 Similar to a petition for a writ of certiorari in the U.S. federal court system, the individual researcher(s), in this case, could have applied for judicial forum review, which likely would have been granted due to the ripe and far-reaching nature of the issue presented. Exacting monetary penalties from developed world governments, wellfunded international NGOs, and financially secure private sector entities that were found negligent or otherwise in breach of their duties, by the judicial forum is feasible and would, in small part, help fund the GGSID. More difficult, however, is the question of what penalties to assess against noncompliant state actors in the developing world. This question is challenging to answer as any financial penalties may undermine the very system the GGSID is attempting to create. If developing countries are hit with monetary penalties, this may impede their efforts to build capacity for surveillance, detection, and response to an outbreak—a paradoxical outcome. Therefore, the judicial forum may assign more creative and novel approaches to developing states that are found noncompliant. Judgments against such states could include suspension from membership on GGSID governing bodies such as the judicial forum, the deliberative body, and GGSID advisory committees. Other types of judgments could revoke applications to be part of, or host, collaborative scientific endeavors solicited by the GGSID. While a primary objective of the GGSID, and the judicial forum in particular, is to ensure that voices from the developing world are heard, this interest must be balanced against the competing goals of implementation and enforcement. Deliberative Body. The judicial forum will be complemented by a deliberative body also composed of a multidisciplinary group of experts from the public and private sectors who represent the developed and developing world. The main Michael Imperiale, “Dual Use Research after the Avian Influenza Controversy,” Bulletin of the Atomic Scientists. 17:19, Sept. 11, 2012, http://thebulletin.org/dual-use-research-after-avianinfluenza-controversy. 12
Spring 2016 | 285
RUBIN & SAIDEL
function of this deliberative body is to draft regulations that will be tailored specifically to the diverse set of participants’ core competencies and limitations. It will serve as the policy and strategy backbone of the GGSID, and will house and oversee the subordinate administrative bodies necessary for GGSID execution. Regulations passed by majority vote by the deliberative body will be adopted by national governments as domestic legislation and will bind non-state actors as well, i.e. participating NGOs and civil society, private sector members of the GGSID, and participating international agencies operating in the infectious disease space. In lieu of an executive “branch,” the deliberative body will have a rotating leadership cabinet not unlike the UNSC. This cabinet will have representatives from all sectors of society and will have the power to set the policy agenda, break tie votes among the deliberative body, and make real-time decisions in the event of global public health events. It will render judgments on exigent matters such as declaring international emergencies, allocating funding, deploying international rapid response teams, and identifying roles for capable NGOs such as Doctors without Borders and the GAVI Alliance (formerly the Global Alliance for Vaccines and Immunization). Currently, there is no international body, aside from the state-centric WHA, empowered to reconcile legitimate differences of opinion on infectious disease issues. Such issues include DURC, sharing of data, intellectual property and liability issues and the appropriate allocation of resources during a pandemic, all of which implicate the competing goals of security, national sovereignty, scientific progress, academic free speech, and fundamental human rights. Establishing customized measurable and, perhaps most importantly, achievable milestones for stakeholders will often require the deliberative body to assist in matching potentially synergetic public and private partners. At first blush, one might be skeptical that the private sector has the will or the proper incentives to be a formal part of the GGSID. Nevertheless, profits and infectious disease control are not mutually exclusive concepts. The private sector can be enticed into partnerships with ministries of health, relevant NGOs, and international organizations notwithstanding allegiance to their shareholders and monetary gains. Appeals to corporate social responsibility and community relations aside, private sector entities can profit from public/private partnerships—especially ones whose nexus is located in a new or unsaturated market in the developing world. For private sector partners, increased brand recognition, increased market penetration, entry into new markets, preserving the existing customer base and gaining new customers are all attractive concepts. Relaxed barriers to market entry (e.g., tariffs and taxes) would also motivate a private sector entity to forge a relationship with public entities and with the GGSID. For pharmaceutical- and vaccine-related issues like supply chain management, data capturing and analysis, inventory optimization, and other relevant proficiencies, the public sector will also be incentivized to formalize a public/private partnership—a mutually beneficial effort. While the IHRs are a good start to a regulatory framework for global infectious disease control, history has demonstrated its inadequacy—its disincentivizing structure with respect to reporting of outbreaks, its inability to contend with poor states which are unable to build capacity for surveillance and response, and its lack of an enforcement mechanism. The SDGs, as noted by the
286 | Orbis
Global Governance Structure for Infectious Diseases
Rockefeller Foundation, will require trillions of dollars to implement—an amount that dwarfs the combined resources of the philanthropic and governmental health sectors.13 Recently, the SDG Philanthropy Platform—a partnership between the United Nations Development Program and very large philanthropic organizations— highlighted its exclusion in the implementation of the SDGs. “Governments alone cannot address the critical challenges of sustainable development, nor can we expect philanthropy to achieve its maximum potential operating in isolation,” said UNDP administrator Helen Clark. “The SDG Platform for Philanthropy will create the linkages necessary to achieve the SDGs, and, ultimately, a more just and equitable society.”14 Core Structural Components. The GGSID is the solution to the current crisis in global governance for infectious disease. This governance structure’s four core components are as follows: (1) Integrate, coordinate and harmonize international standards for surveillance and reporting of data and knowledge of infectious diseases for use in a centralized database using advanced information technology to ensure timeliness, interoperability and security, including but not limited to epidemiological data, bioinformatics, information about new and ongoing clinical trials, data regarding new compounds and targets, standardized material transfer agreements and a host of services and skills; (2) Integrate, coordinate, harmonize and expand a network of international basic science and translational research centers that will support fundamental investigations into the pathophysiology of certain microbial threats to global health; (3) Integrate, coordinate, harmonize and expand capabilities for the production and distribution of vaccines, therapeutics and diagnostics expressly for emerging and reemerging infections; and (4) Integrate, coordinate, harmonize, monitor and anticipate any changes in international standards for best laboratory, regulatory, and ethical practices.
13 Muhammad Yunus, Judith Rodin, “Save the World, Turn a Profit,” Bloomberg View, Sept. 25, 2015. 14 http://philanthropynewsdigest.org/news/philanthropy-leaders-call-for-greater-role-inglobal-development-goals?utm_campaign=news%7C2015-0925&utm_source=pnd&utm_medium=email.
Spring 2016 | 287
RUBIN & SAIDEL
This proposed governance structure creates powerful incentives for the varied set of public and private sector stakeholders to participate and for enforcement. The unique characteristic of the proposed organizational structure is the interdependence of its components. We argue that this interdependence adds significant value to the existing, more limited structures, and contributes to the feasibility and compliance with the structure. In its essence, the interdependent structure ensures that participating in one component of the structure is contingent upon participating in all components, perhaps not at the same level, but according to a phased, mutually agreed upon algorithm that takes into account economic and human resources capabilities. For example, in order to gain access to the centralized database, participants would pledge to implement best laboratory and regulatory practices. The GGSID acknowledges the disparate financial capabilities of participants and, therefore, envisions an in-kind cooperative network based on a modified, forward-looking version of the principle of common but differentiated responsibilities. Utilizing this principle, developed states may have a primary responsibility to fund the GGSID research centers whereas developing states may provide scientists, epidemiological and other data (that under the current IHR regime may go unreported due to disincentives) and specimens that could help prevent the next epidemic. Proposed Global Governance Structure for Infectious Diseases
288 | Orbis
Global Governance Structure for Infectious Diseases
Venue. Challenges still remain, such as how to get stakeholders, especially states that regard national sovereignty as a fundamental value, to commit to a compulsory, subpoena-issuing, adjudicative body. To enlist and bind state and nonstate actors to a common cause without violating the operation of existing international legal regimes, national sovereignty rights, individual privacy rights, NGO by-laws, and constraints within academic research presents myriad obstacles. However, there are many options to be explored and a balance must be struck that takes into account the competing values at play. Treaty, protocol, and convention based arrangements are options to consider, as are contractually binding agreements that may be better suited to incorporate non-state actors. A related question is what body will administer the GGSID and host the judicial forum and deliberative body necessary to build a concrete body of law that can be relied upon as precedent and guide future decisions. Criteria for such an institution could include: (1) An international staff committed to research and practice; (2) promotion of knowledge of justice, law, peace, security, social and economic development; (3) ability to synthesize national and international knowledge and cultivate an inclusive vision of issues; (4) ability to convene across disciplines; and (5) a respected, trusted and neutral body with international standing. The UN meets all of the above criteria. Beyond that, the UN acknowledges the role of non-state actors in international affairs. As one commentator notes: “The proliferation of non-state actors has meant there are many more potentially powerful contributors to global governance. […] This implies a different structure, process, and function for how governance operates on the global level: specifically, that states or stat-based entities no longer exist as a monopoly in global affairs.”15 Civil society (e.g., an NGO with consultative status at the UN) is able to submit white papers and oral testimony regarding issues before the GA. Furthermore, the UN Global Compact at the Millennium Summit of 2000 and, more recently, the UN Secretary General’s High Level Panel of Eminent Persons on the Post-2015 Millennium Agenda, both point to a UN more cognizant of the role of civil society, as well as corporations and individuals in the areas of sustainable development, monitoring, and human rights.16 The mission of the UN also naturally aligns with the notion of global solidarity, a concept that is crucial to solving the problem we now face. The UN has yet to integrate comprehensively what David Fidler calls the “unstructured plurality” of non-state actors.17 By assimilating the GGSID fully into the UN regime, this important governance gap as it applies to infectious disease would be filled. The centrality of the GGSID’s judicial forum requires examining potentially viable extant frameworks. There are at least five different dispute resolution mechanisms that could apply to a global governance structure for infectious disease. 15 Thomas Weiss et al., “The Rise of Non-State Actors in Global Governance,” One Earth Future Foundation (2013),http://acuns.org/wp-content/uploads/2013/11/gg-weiss.pdf. 16 Thomas Weiss et al., “The Rise of Non-State Actors in Global Governance.” 17 Julio Frenk, Suerie Moon, “Governance Challenges in Global Health,” New England Journal of Medicine, March 7, 2013; David Fidler, “Architecture amidst anarchy: global health's quest for governance,” Global Health Governance 2007, pp.1-17.
Spring 2016 | 289
RUBIN & SAIDEL
Establishing an International Arbitration Tribunal Pursuant to Article 33 of the UN Charter Article 33 of the UN Charter states: “The parties to any dispute, the continuance of which is likely to endanger the maintenance of international peace and security, shall, first of all, seek a solution by negotiation, enquiry, mediation, conciliation, arbitration, judicial settlement, resort to regional agencies or arrangements, or other peaceful means of their own choice.”18 If the General Assembly (GA) were to ratify a “Convention on Infectious Disease,” a provision within the Convention could create a dispute resolution mechanism as provided for in Article 33. The Convention on the Law of the Sea is informative in this regard. Citing Article 33, Part XV of the Convention on the Law of the Sea creates dispute resolution procedures, and Article 287 defines the parameters of an independent International Tribunal for the Law of the Sea that sits in Hamburg, Germany. Notably, the Tribunal has jurisdiction over private entities. “The Tribunal has jurisdiction over any dispute concerning the interpretation or application of the Convention, and over all matters specifically provided for in any other agreement which confers jurisdiction on the Tribunal (Statute, article 21). The Tribunal is open to States Parties to the Convention (i.e. States and international organizations which are parties to the Convention). It is also open to entities other than States Parties, i.e., States or intergovernmental organizations which are not parties to the Convention, and to state enterprises and private entities ‘in any case expressly provided for in Part XI or in any case submitted pursuant to any other agreement conferring jurisdiction on the Tribunal which is accepted by all the parties to that case’” (Statute, article 20).19 Referral to the Good Offices of the Secretary General Article 98 of the Charter provides that the Secretary General, in addition to acting in that capacity in all meetings of the General Assembly, of the Security Council, of the Economic and Social Council and of the Trusteeship Council, “shall perform such other functions as are entrusted to him by these organs.”20 These often include functions in the field of the prevention and the peaceful settlement of disputes.21 Article 99 of the Charter provides that the Secretary General may “bring to the attention of the Security Council any matter that in his opinion may threaten
http://www.un.org/en/sections/un-charter/chapter-vi/index.html. https://www.itlos.org/en/the-tribunal/. 20 http://legal.un.org/repertory/art98/english/rep_supp10_vol6_art98_e_advance_final.pdf. 21 http://peacemaker.un.org/peacemaking-mandate/secretary-general. 18 19
290 | Orbis
Global Governance Structure for Infectious Diseases
international peace and security.”22 The good offices and mediation roles of the Secretary General in the prevention and the peaceful settlement of disputes derive from the Charter and have been developed through extensive practice. The range of activities carried out by the Secretary General has included good offices, mediation, facilitation, dialogue processes and even arbitration.23 The Secretary General may take action himself or may appoint special representatives and envoys to carry out good offices and mediation on his behalf. Numerous representatives of the Secretary General also engage in peace talks or crisis diplomacy while overseeing UN political or peacekeeping missions in the field, which may have mandates to help nations and regions, resolve conflicts and tensions peacefully.24 The mediation role of the good offices of the Secretary General has a vaguely worded basis that can be interpreted widely or narrowly depending on who is in office. Former Secretary General Boutros Boutros-Ghali said that “good offices” is “a very flexible term as it may mean very little or very much.”25 Historically, this role has been centered on resolving discrete political, territorial, resource, or military disputes (e.g., negotiating a ceasefire or an armistice agreement). Thus, a permanent court presiding on infectious disease issues does not seem to fit clearly within the good offices’ mandate. Moreover, it is structurally problematic for the good offices of the Secretary General to involve itself with non-state actors. The role of the Secretary General or his or her appointees, as evidenced by its name, is more of a mediation role as opposed to a court of final appeal. While Article 99 states that issues requiring enforcement can be referred to the Security Council, this referral system would not be sufficient for the day-to-day management of the GGSID or for the rulings required for the docket of cases submitted to the judicial forum. Nonetheless, by treaty or convention, parties to the GGSID could confer jurisdiction to the good offices of the Secretary General and make his or her appointees’ rulings binding. In addition, the GA or UNSC, under Article 98, could “entrust” the good offices with the role of hosting the GGSID. As the Office of the Secretariat is an executive body with a wealth of manpower and resources that can harness the expertise of civil society and the specialized offices of the UN, it is a potentially good candidate for a venue for the GGSID—one worthy of further exploration—notwithstanding the challenges mentioned above. The International Court of Justice The International Court of Justice was established by the Charter of the United Nations, which provides that all member states of the United Nations are ipso http://www.un-documents.net/ch-15.htm. http://peacemaker.un.org/peacemaking-mandate/secretary-general. 24 http://peacemaker.un.org/peacemaking-mandate/secretary-general. 25 Statement of the Secretary-General, UN Doc. SG/SM/3525, as reported in The United Nations Handbook on the Peaceful Settlement of Disputes between States, UN Doc. OLA/COD/2394, p 35, http://www.un.org/law/books/HandbookOnPSD.pdf. 22 23
Spring 2016 | 291
RUBIN & SAIDEL
facto parties to the Court's Statute. The International Court of Justice acts as a world court. The Court has a dual jurisdiction: It decides, in accordance with international law, disputes of a legal nature that are submitted to it by States (jurisdiction in contentious cases); and it gives advisory opinions on legal questions at the request of the organs of the United Nations or specialized agencies authorized to make such a request (advisory jurisdiction). The Court has no jurisdiction to deal with applications from individuals, non-governmental organizations, corporations or any other private entity. It cannot provide them with legal counseling or help them in their dealings with the authorities of any State whatever.26 However, a State may take up the case of one of its nationals and invoke against another State the wrongs which its national claims to have suffered at the hands of the latter; the dispute then becomes one between states. If a new global governance structure for infectious disease sat at the UN, states parties to any agreement—be it through treaty or convention—could confer jurisdiction to the International Court of Justice for adjudicating disputes and issuing advisory opinions. Notably, judgments delivered by the Court (or by one of its Chambers) in disputes between States are binding upon the parties concerned. Article 94 of the United Nations Charter lays down that “each Member of the United Nations undertakes to comply with the decision of [the Court] in any case to which it is a party.”27 The International Court of Justice’s focus on UN member states limits the feasibility of this court as one suited to adjudicate disputes between the diverse set of stakeholders proposed herein. Referral to the United Nations Security Council The UNSC is a 15-member body of the UN, five of which are permanent, charged with maintaining international peace and security. Each member represents a member state of the United Nations. Pursuant to Chapter VI of the UN Charter entitled “Pacific Settlement of Disputes,” the UNSC is able to make recommendations to member states that are unable to resolve a matter through bilateral negotiation, mediation or other arbitrative mechanisms.28 Any UNSC recommendation arising under the UNSC’s Chapter VI powers is not binding. Conversely, by virtue of its powers under Chapter VII of the UN Charter, the UNSC is the only principal organ of the UN that can make binding resolutions (e.g., sanctions and the deployment of UN Peacekeepers). These binding resolutions are limited to threats to peace, alleged breaches of the peace and acts of aggression.29 Traditionally, the UNSC’s powers under Chapter VII have been interpreted narrowly so as to apply to mostly military matters. Arguably, UNSC 2177 expanded the UNSC’s Chapter VII powers to health related issues. The resolution was adopted in September 2014 during the Ebola crisis, calling for member states to take action to prevent the spread of the deadly http://www.icj-cij.org/information/index.php?p1=7&p2=2. http://www.icj-cij.org/information/index.php?p1=7&p2=2. 28 http://www.un.org/en/sc/repertoire/settlements.shtml. 29 http://www.un.org/en/sc/repertoire/actions.shtml, 26 27
292 | Orbis
Global Governance Structure for Infectious Diseases
virus. While not explicitly invoking its authority under Chapter VII, UNSC Resolution 2177 implicitly broadened the scope of its Chapter VII powers by declaring the Ebola outbreak “a threat to international peace and security” (the terminology of Chapter VII).30 While this was not the first time the UNSC linked health and security—in 2000, it issued UNSC Resolution 1308 regarding HIV/AIDS—UNSC 2177 was the most unequivocal statement associating peace and security with a matter of global public health.31 It is unclear how the UNSC will proceed along the lines of “securitizing health,” a controversial topic among experts in the global public health space. If this linkage between health and security becomes a trend within the UNSC, it is possible that it could host the GGSID and the judicial forum. Its appeal is that it can enforce its decisions, but like other regimes within the UN, it is currently not suited to bind non-state actors. Also, as it is comprised of only member state representatives, it would lack the diverse stakeholder authority for which the GGSID calls and runs the risk of politicization. In short, like the good offices of the Secretary General, the UNSC is an option worth consideration for hosting and administering the GGSID and its judicial forum. International Centre for Settlement of Investment Disputes The International Centre for Settlement of Investment Disputes (ICSID) is a member of the World Bank Group which, in turn, has Observer Status at the UN. ICSID was established in 1966 by the Convention on the Settlement of Investment Disputes between States and Nationals of Other States.32 An award rendered under the ICSID Convention is enforceable as a final judgment of courts in every ICSID Member State.33 Awards rendered in other ICSID administered cases are enforceable under the New York Convention. Like the International Tribunal for the Law of the Sea, private entities—i.e., individual investors, can have standing in this court against states which they attest are in violation of an agreement, treaty, international law, or contract. The parties to the case can play a role in choosing the “conciliators” who will rule on the issue in question.34 Among the dispute resolution mechanisms mentioned herein, this model, along with the International Tribunal for the Law of the Sea, is probably the most appropriate as a template for the adjudicative body needed for the GGSID and its judicial forum.
http://www.un.org/en/ga/search/view_doc.asp?symbol=S/RES/2177%20%282014%29. http://theglobalobservatory.org/2014/12/security-council-response-ebola-action/. 32 https://icsid.worldbank.org/ICSID/StaticFiles/basicdoc/intro.htm. 33 https://icsid.worldbank.org/apps/ICSIDWEB/process/Pages/Recognition-andEnforcement-Convention-Arbitration.aspx. 34https://icsid.worldbank.org/apps/ICSIDWEB/about/Documents/Special%20features%20 of%20ICSID.pdf. 30 31
Spring 2016 | 293
RUBIN & SAIDEL
Financing How to finance the GGSID is another challenge. Typical funding streams such as Big Philanthropy, assistance from the G7/G20 nations, and aid from the World Bank and the International Monetary Fund could all be utilized, but innovative financing is also required for global infectious disease control to be both workable and sustainable. To this end, the GGSID will explore creative methods to access the capital markets and entice private sector investments. Creative and fruitful enterprises joining the public and private sectors have emerged and should be built upon. One innovative mechanism that could help ameliorate financing obstacles for R&D for certain diseases is non-profit investment in for-profit companies in order to access the capital markets. One case is the Cystic Fibrosis Foundation’s investment in Vertex Pharmaceuticals, a biotech company that works on developing drugs to combat this lethal disease.35 The infusion of $120 million in funding helped speed up the development of Kalydeco, a drug that treats an underlying cause of cystic fibrosis. While critics point to the high cost of the drug and the notion that non-profit foundations should not be in the business of making profits—a conflict of interest they say—the Cystic Fibrosis Foundation now has $3.3 billion in its coffers to further its mission of helping patients suffering from cystic fibrosis. This huge profit is a result of the Foundation’s sale of its royalty rights to Royalty Pharma. Moreover, within the private sector, there is growth in the market for social impact investing, i.e. investments that provide a return in terms of monetary profits, but which help achieve a social good. Wall Street demonstrates there is an appetite for these types of investments and some estimates claim the market could grow to $3 trillion. Goldman Sachs, for example, issues various social impact bonds and funds to address social challenges such as recidivism and lack of access to quality education. Other cutting-edge financial instruments are being developed to allow foundations, “socially minded” business, and nonprofits access to the global financial markets. For example, the Rockefeller Foundation and Yunus Social Business jointly developed the “social success note.” Investors provide capital (e.g., a loan) to an organization that provides a social good. The organization is required to pay back the loan, but if it hits a predetermined social target, a partnering foundation will provide the investor with an “impact payment” for the social good linked to the initial investment. If the target is not met, the organization is still required to pay back the loan.36 A New Structure The current trend toward a more inter-connected landscape in infectious disease governance is a good sign, but there is much more that needs to be done. The present incoherent international regime for infectious disease control requires a Andrew Pollack, “Deal by Cystic Fibrosis Foundation Raises Cash and Some Concern,” New York Times, Nov, 19, 2014. 36 Muhammad Yunus, Judith Rodin, “Save the World, Turn a Profit,” Bloomberg View, Sept. 25, 2015. 35
294 | Orbis
Global Governance Structure for Infectious Diseases
new overarching structure with a primary and comprehensive focus on infectious diseases, one that will harmonize, integrate and coordinate the existing relevant legal structures that deal with infectious disease issues—including the WHO, World Intellectual Property Organization law, the Biological and Toxin Weapons Convention, the WTO, Trade-Related Aspects of Intellectual Property Rights, the IMF, human rights law, and others. By incorporating existing networks, the GGSID will synergize efforts already underway. Just as important, its built-in incentive structure will bring what are now independent ventures (e.g., WAAR, GHRF, social impact investing, non-profit access to capital markets) into a common framework within which decisions concerning issues of global infectious disease can be made. Until a central authority is empowered to govern global infectious disease control, we will continue to see noble, constructive, yet suboptimal undertakings such as the ones outlined above.
Spring 2016 | 295