Summary

The Committee on Enhancing Global Health Security through International Biosecurity and Health Engagement Programs was asked to examine U.S. programs that promote international health security, provide the principles that guide such programs for success, and advise the Department of Defense (DOD) Biological Threat Reduction Program (BTRP) on how to coordinate with other agencies and organizations to achieve established goals and ensure that biosafety and biosecurity remain priorities. The committee was also tasked with identifying the most important unaddressed security risks, explaining the overall mission to help align budget and policy priorities, and articulating a 5-year strategic vision for BTRP operating within the larger health security space. This study was sponsored by BTRP, which is part of the Cooperative Threat Reduction (CTR) Program.

CTR’s programs were reexamined by Congress around 2007, to account for the changing security environment after national security efforts had expanded to include countering terrorism much more prominently (Benkert, 2007). In 2009, CTR’s programs were given broader geographic scope and authority. This enabled particularly the DOD Cooperative Bioengagement Program (the name of BTRP at that time) to work in many more countries, employing a broader set of capacity-building tools to facilitate, for example, biosurveillance and joint research, and to secure storage of clinical samples from affected individuals. This report is another reexamination of DOD’s international health security efforts in the context of further evolution of the broader security environment that now incorporates an emphasis on state-level threats.

DOD international engagement in health-related activities has historically resulted in a direct benefit for the United States by advancing knowledge of infectious disease epidemiology and the development of medical countermeasures as well as fostering good will and trust with international partners. As noted, the threats and risks of state-sponsored activity or terrorist misuse of infectious disease and biology for harm have changed over the past 20 years. Nonetheless, the scientist-to-scientist

engagement approach to threat reduction, opening channels of communication around common technical interests in relevant health challenges, continues to be an effective approach to threat reduction and enhanced security for the U.S. military and the homeland. Indeed, international engagement is one of the most cost-effective tools available to prevent adverse events, and prevention is much more cost-effective than responding to an outbreak. By providing value to host countries’ efforts to diminish their risk of serious outbreaks, enhance disease surveillance, and increase the speed of response and averting the varied consequences, bioengagement also reduces the risk to the United States. In this context, the BTRP mission aligns with the National Defense Strategy of 2018, which is the current operating framework for all DOD programs, including programs that address biological threats. Beyond the National Defense Strategy (2018), the National Security Strategy (2019), National Strategy for Countering Weapons of Mass Destruction Terrorism (2018), National Biodefense Strategy (2018), and Global Health Security Strategy (2019) all contribute to BTRP’s operating framework for preventing and detecting biological threats. Furthermore, the Global Health Security Strategy outlines roles and responsibilities for DOD, which include scientific engagement and threat reduction. Because of the evolving landscape of biological threats, the broader set of tools used by BTRP is needed now more than ever, especially as BTRP is well suited to promote norms against theft and malicious exploitation of peaceful biological sciences, and against the development of offensive biological weapons capabilities.

AMBIGUITIES AND FUNCTIONAL SIMILARITIES MAKE NATURAL, ACCIDENTAL, AND INTENTIONAL THREATS DIFFERENT MANIFESTATIONS OF THE SAME FAMILY OF CHALLENGES

The National Security Strategy, the National Biodefense Strategy, and the Global Health Security Strategy include within the scope of biological threats naturally occurring, accidental, and intentional biological incidents, and also include the concept of interlinked human, animal, plant, and environmental health (called One Health). BTRP’s mission in addressing these threats is difficult because the threats and the social, political, and physical environments in which they arise are increasingly

changing at a faster rate than over the previous decades of the program’s history.

Greater global connectivity increases the ease of transmission and broadens the reach of infection, which in turn demands faster, more effective response. Given the speed of travel around the globe, an individual in one country with a highly communicable disease can arrive in any other country in approximately 24 hours or less. Outbreak timelines are being compressed and as a result so is the time available to plan and implement an effective response to an outbreak.

Global trends facilitate potential misuse of biology, including increased access to biological information, new techniques to manipulate pathogens that do not require sophisticated or expensive technology, and willingness to breach norms against misuse. Easier access to relevant knowledge and much more effective tools for previously unimagined biological research and technology capabilities can also set the stage for accidents. Methods for engineering and synthesizing microbial pathogens have already enabled competent molecular biologists to construct viable infectious pathogens simply from genetic sequence information. Digitalization of biology and design of new technologies to manipulate biological materials challenge current biological governance and oversight structures within and outside the United States. Threats are also increasing due to the development of more numerous and effective vectors for pathogen transmission, including in some cases, an increase in the number, type, and composition of vectors and an increase in the number, types, and characteristics of strains that can infect those vectors, as well as reduced time needed to move biological threats across vast geographical areas. The changing climate has, and will continue to have, significant effects on outbreak location, severity, and incidence rate, in part driven by alterations in the habitats and range of insect and animal pathogen vectors and proximity to wildlife. These trends are accelerating as science and modern transportation advance and move at greater speed.

While the threat of intentional use of biological weapons by state or non-state entities has not diminished, the threat from natural events currently dominates the infectious disease landscape. But the origins of outbreaks may be ambiguous. The boundaries between risk and threat continue to blur and converge at a quickening pace. As the National Biodefense Strategy of 2018 states,

This suggests the need for more common strategies to prevent both risks and threats, and to be prepared to act rapidly and effectively when the need arises. The consequences of not doing so can be great, as we have seen in West Africa from 2014 to 2016, and currently in the Democratic Republic of the Congo. Naturally occurring disease can seriously destabilize countries and regions, occurring as a “perfect storm” in settings in which civil society is fragmented, authority is fragile, and resources to address emerging outbreaks are limited. Intentional introduction of disease agents can have a similarly destabilizing effect, and may be even more challenging if they have been deliberately modified to be more destructive and/or to resist existing medical countermeasures.

The committee finds that in addition to having similar consequences, natural, accidental, and intentional incidents or outbreaks have functional similarities and there are advantages to addressing them as different manifestations of the same family of challenges. They may have ambiguous origins but the capabilities needed to address them overlap, including common prevention, detection, response, and recovery initiatives. Ultimately, many of the needs of force protection and national healthcare infrastructure for response to infectious disease threats and safety may be similar or the same in virtually all cases. An integrated view of biological threats also prevents bureaucratic boundaries from interfering with partnerships and progress.

DOD, including the Defense Threat Reduction Agency (DTRA) and BTRP, is aware of these realities. While the existing norms and treaty commitments against the use of biological weapons have not been breached on a large scale in recent decades, there are clear indications that these moderating forces are strained.

How can the United States be prepared to anticipate and respond to the myriad of potential existing and emerging threats? How can the United States and the international community receive early warnings or even be cognizant of developing threats? What parts of the U.S. government, and which department or entity within the multiple components of government, are capable, prepared, and willing to address these threats? The committee believes it will take many U.S. government programs

working together with other governments and nongovernmental partners to address these challenges. DOD has an essential role to play in that effort.

A DIVERSE TEAM OF ORGANIZATIONS IS NEEDED TO ADDRESS THE COMPLEX THREAT LANDSCAPE

The overall mission of addressing biological threats encompasses anticipation, deterrence, prevention, detection, response, mitigation, and recovery. Action or intervention is possible at every stage, and different components of the U.S. government effort have advantages in one or another part of the mission, or in different partner countries, and so may be better able to intervene and eliminate, reduce, or mitigate risks at the most opportune and effective stage of development in different contexts. For example, the Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), military medical units, the World Health Organization, the Global Health Security Agenda (GHSA), the United Nations Food and Agriculture Organization, World Organisation for Animal Health, the African CDC, Pan American Health Organization, and academic researchers each have unique capabilities and relationships. GHSA, which is described in the section beginning on page 39, is a group of countries, international organizations, nongovernmental organizations (NGOs), and private-sector companies that have come together to advance a world safe and secure from infectious disease threats by making new, concrete commitments to elevate global health security as a national level priority (GHSA, 2019). Because the international landscape for addressing biological threats involves many nongovernmental, governmental, and intergovernmental actors, effective coordination and communication are critical to ensuring success of biological threat reduction programs (see Appendix C).

The U.S. government will be most effective and efficient if it identifies and prioritizes the threats it wishes to counter and applies resources through the channels that are best poised to address the associated needs. Strong interagency coordination must drive these prioritization and resource allocation efforts if the needs are to be addressed.

No U.S. government program currently has or should be expected to have the authority or the capability to act on every aspect of the global health security challenge; but today, organizational divisions and boundaries interfere with realizing improvements in efficiency and cost-effectiveness. To address that problem, BTRP needs to be part of a durable

interagency coordination mechanism that addresses the full set of biological threats and risks, wherein the agencies best suited to each task are given the necessary tools. An effective mechanism will have greater geographic and programmatic flexibility and will demonstrate better awareness and prevention of threat development, and more timely response, and will partner effectively within DOD, with other U.S. government agencies, and with other nations, as well as with NGOs, the private sector, and academia. Likewise, an effective interagency mechanism will avoid unnecessary duplication, identify and close gaps, and explore possible synergies.

DOD Has Unique Capabilities to Address Evolving Biological Threats

As noted, DOD is not the only or even the central mission holder in an integrated effort to address biological threats. However, DOD’s programs provide a security focus, while most other U.S. government departments and agencies involved in global health security programs are primarily focused on health and biosafety challenges, and less on biosecurity. Moreover, in contrast to CDC and USAID programs, the mission of DOD’s (but not necessarily the principle mission of BTRP’s) programs is first and foremost to support deployed U.S. military forces, U.S. interests overseas, and the homeland (Philpott, 2019).

DOD has long held essential, interwoven parts of the bioengagement mission, ranging from force protection to protection of U.S. civilians overseas, to protection of the homeland, to prevention of indirect harm to the United States and its interests that may result from disruption of critical functions, such as transportation and trade. International bioengagement by DOD contributes to military readiness, planning, and force protection important for U.S. national security. For example, the U.S. Army and U.S. Navy overseas laboratories provide important information on endemic and emerging outbreaks and have helped to identify and validate medical countermeasures or prevention strategies, while promoting and sustaining the critical personal relationships of trust where they operate. These relationships are essential for the necessary transparent exchange of information and insight. DOD’s efforts can be aided by working with international organizations, networks, consortia, and the public/private sector at times when partner countries are skeptical of the U.S. military presence. In certain areas of the world, and in certain contexts, partner

countries may be more comfortable with United Nations-based agencies or BTRP-type organizations than with DOD directly.

BTRP plays an important role in DOD’s engagement to reduce biological threats, and can play an even greater role. BTRP establishes critical lines of communication about biological threats, from any origin, with foreign governments and responsible individuals; supports operational and situational awareness where it can operate; invests in building capacity that improves biosecurity; and generates information that ultimately provides additional security to the United States. The kind of engagement BTRP conducts promotes individual relationships of trust. Understanding and trust between technically competent individuals, particularly over the long term, contributes further to trust and understanding among leaders in ministries and governments. Where trust exists, transparency increases. BTRP is perfectly placed within DOD to engage with global partners to create the necessary common ground to address biosafety and biosecurity priorities. At the same time, for no added cost, cultures of trust help to stabilize nations and regions, making them less welcome areas of operation for sub-state groups or individuals with ill intent. While the important role BTRP plays may be too far in the background to be recognized by higher-level military and political leadership, it is highly effective, particularly relative to its very small portion of the DOD budget.

BTRP cannot do it all. Resources are limited, and BTRP as well as other partners must address the perennial mandate to produce the best outcome as efficiently as possible. Not only is it right to use funds efficiently and effectively, it will also strengthen BTRP. By building sound working relationships with other U.S. government, NGO, and global networks of experts, BTRP can leverage its resources more effectively and be better attuned to threats, risks, and even successes around the world. Common interests with potential partners abroad may include epidemiology, genetic engineering, point-of-care or other field-enabled diagnostic methodologies, and disease surveillance and response. Working together on these common interests may be of direct benefit to the host country (whether those partners are from the country’s military or other relevant parts of government) as well as to the United States. Recognizing differing cultural contexts and aligning interests, resources, and outcomes can achieve greater effectiveness for all partners.

THE NEED TO ANTICIPATE, DETECT, AND RESPOND RAPIDLY TO THREATS

To address the family of natural, accidental, and intentional incidents effectively and efficiently, the U.S. government must be able to anticipate, detect, and respond rapidly to these threats. This begins with identifying risk factors, needs, and opportunities. Disease surveillance extends beyond detection of disease outbreaks to noting and responding to the conditions that feed and lead to infectious disease risks and threats. For example, inadequate domestic clinical and research laboratory infrastructure or poor domestic public healthcare infrastructure, and inadequate numbers of subject-matter experts to prevent and respond to infectious diseases may allow an outbreak to occur where it may have otherwise been preventable. Effective disease surveillance must also be paired with sustained analytical efforts, allowing for the identification of opportunities to guide intervention prior to an outbreak.

The size of the global workforce with expertise in enormously powerful new biotech capabilities has increased greatly, raising new concerns regarding individual or small group attempts to create new deadly or drug-resistant strains of pathogens. Advances in science have increased the ability to manipulate virulence and/or create drug- and vaccine resistance in an unsophisticated laboratory environment in almost any country. Timely information on such dangerous pursuits, gained from a network of trusted international partners, is now more valuable than ever.

Cooperative programs are likely to function most effectively when personal engagement has occurred and the people involved from the relevant agencies and organizations know and trust one another before a biological crisis occurs. BTRP’s history provides positive examples of such advanced engagement that allowed for rapid response that would otherwise have been unavailable (e.g., early response to the 2014 Ebola outbreak in Guinea) (U.S. DOD, 2015).

Success at anticipating and responding to perceived threats or opportunities is varied and sometimes imprecise. Cases in which it is feasible to anticipate and identify a specific need, and in which one can, in advance of an incident, identify the specific biosecurity consequences of not engaging are rare. However, there are also cases when analysts have reason to believe that an adverse event is likely to emerge in a country or a small region, even if they do not know exactly what it will be and when it will occur. The important counterthreat action in such cases is to

establish a flexible capability to detect and respond quickly when something does arise.

BTRP’s resources are relatively small and have been shrinking in recent years (see Appendix B for recent funding levels for BTRP). For this, and other geopolitical and epidemiological reasons, BTRP should not engage an international state or partner just because it can; rather, such engagement should be informed, strategic, and likely to yield benefits. For BTRP to take the “strategic view” will require careful articulation of why engagement is required, where it would be required, and with what resources, including human resources.

THE NEED FOR GEOGRAPHIC AND PROGRAMMATIC FLEXIBILITY

Geographic flexibility is essential for effective and efficient implementation of bioengagement efforts. More rapid evolution and emergence of threats from infectious disease, and increased bureaucratic complexity at DOD, as at any large organization, led the committee to recommend greater geographic and programmatic flexibility for BTRP. This would enable BTRP to engage in a geographic region before a situation becomes critical and a response much more expensive—and sometimes less effective—than it would have been years or even months earlier.

As with the flexibility to engage around the world where biorisks and biothreats currently exist or are anticipated to emerge geographically, BTRP would be well positioned to address the full range of challenges (natural, accidental, intentional) if it also had the programmatic flexibility to address risks that may emerge beyond the boundaries of traditional disciplinary research. Transdisciplinary and interdisciplinary research can generate new scientific findings that are less well understood from the perspective of potential biothreats and biorisks. Because engagements are with humans, not technologies or pathogens, BTRP should be proactively communicating with its counterparts in engaged countries and have the programmatic flexibility to undertake broadly relevant activities in true partnership with their host-country colleagues. This will invariably result in greater relevance of the program with the engaged country and its personnel, and increase the likelihood of success and thus sustainability with domestic personnel and resources. Mutually beneficial programs are the only ones that will be sustainable for the long term.

BTRP evaluates progress in its engagements on a regular basis. If this is part of a larger DOD and interagency evaluation of efforts in a country or region, then these evaluations afford opportunities to refine the approach to engagement. This could mean modifying BTRP staffing needs, reworking the composition of partners, revising their roles, creating new networks, and sharing lessons learned and best practices. It may also prompt the interagency or the programs to thoughtfully terminate unproductive partnerships. Since it is very difficult to scale the success of BTRP’s engagements, just hiring contractors and providing a project budget will not necessarily lead to proportional gains in success.

To allow for the greatest return on the investments made with increased flexibility, BTRP would benefit from an increased number of technical experts in the program. With more technical experts, decisions on how to best support countries as they strengthen their capabilities to detect, diagnose, and report on diseases can be more effective. It takes experience to discern what is really required to help a country partner, particularly when there are a variety of requests and solutions offered from multiple directions.

THE IMPORTANCE OF RECRUITING AND RETAINING THE MOST EFFECTIVE BTRP PROFESSIONALS

Connections to people and their institutions are the common thread through all of BTRP’s efforts, whether for biosurveillance, establishing norms, building laboratory capacity, strengthening biosafety and biosecurity rules and practices, or enabling rapid and effective response. While cooperative threat reduction programs have focused on technical solutions for the past 30 years, with some significant success, it is also clear that human relationships of trust developed through long-term engagements contribute both directly and indirectly to national security, and can even be deterrents to aberrant behavior.

When an outbreak occurs, such relationships can cut through the chaos of the moment and streamline the rapid implementation of a healthcare and public health response. Further, trusted relationships can help experts who have previously worked together to potentially obtain and secure samples of infectious diseases, making it markedly more likely that clinical research and trials of medical countermeasures or vaccines can be approved and implemented in time to gather sufficient information to assess safety and efficacy of the modality being studied.

Global networks of individuals and organizations with a common interest in biosecurity threats and risk reduction can become powerful tools for communication, thought leadership, security, and stability. Multilateral networks at the intergovernmental level allow people to work together and leverage investments in funding, which, in turn, foster more opportunities for information exchange, development of personal relationships, and appropriate action. One such effort is the successful implementation of the networking concepts under GHSA. BTRP has supported some of the biosafety/biosecurity components of GHSA and thereby has extended the impact of its own resources, expanded its influence, and promoted an improvement in functional capacity of the involved nations in a strategic manner. While less structured, another such effort in which BTRP has been involved is One Health, which encompasses an integrated approach linking human, animal, plant, and environmental health (as described in the section beginning on page 73).

By enabling BTRP to more effectively engage globally and be proactive in relevant activities, BTRP can provide DOD leadership with a perspective on biosecurity and disease threats from the ground level up. To the extent that BTRP can promote such professional networks among military and civilian scientists, public health, animal health, and plant health practitioners from the United States and partner countries, the benefits of engagement will be perceived more rapidly. Protection of U.S. military forces or U.S. citizens in a country at risk of an outbreak is enhanced when collaborations and trained healthcare workers are in place before cases are discovered. This report provides examples of such successes.

Essential linkages between BTRP and partners abroad require greater involvement of BTRP staff rather than through the contract process with non-DOD experts. Understanding and implementing mission-critical initiatives can be difficult to transfer to external contractors. Bringing more human resources into BTRP itself can allow for selection of staff based on critical skills necessary to build relationships. These skills include the ability to listen attentively and understand the needs, thoughts, culture, and history of the partners, even when they differ from U.S. biosecurity perspectives.

THE IMPORTANCE OF BROADER AWARENESS ABOUT BTRP’S EXPERIENCE AND EXPERTISE

As described throughout this report, BTRP has a broad portfolio of bioengagement projects and activities to advance biosecurity across the world as a means of protecting deployed U.S. military forces, U.S. interests overseas, and the homeland. BTRP has gained a great deal of experience and expertise working in a wide range of countries and regions on a host of critical issues. The depth and scope of this experience, however, is not well known within DOD or across the U.S. government, including key congressional committees, and among international partners. Likewise, the range of skills and assets that BTRP can contribute to addressing extant and evolving biorisks and biothreats is also not as well known as it should be. To maximally contribute to U.S. and international efforts to reduce risks from natural, accidental, or intentional outbreaks and other bioincidents, BTRP must be allowed the resources and the platforms to articulate its successes. Further, BTRP must be encouraged to offer its expertise and resources to other partners within and beyond DOD that may be addressing current or anticipated challenges.

BTRP must establish working relationships within DOD before they are needed. Particularly, regular open and frank communication must be ongoing between BTRP and combatant commands; the Office of the Assistant Secretary of Defense for Special Operations/Low-Intensity Conflict; Office of the Assistant Secretary of Defense for Health Affairs; the Office of the Secretary of Defense for Policy; various military medical research and development laboratories (to include sites Outside Contiguous United States); and other relevant DOD partners. If BTRP can establish these partnerships, including by sharing its successes and available expertise more broadly, it will further broaden the base of understanding about BTRP and its mission and programs.

The wide range of people and government, nongovernment, and commercial organizations that are involved in one or more aspect of addressing biosafety and biosecurity requires more diligent awareness of others’ programs and initiatives, their areas of geographic and substantive engagement, and where goals and objectives of different groups and organizations may overlap or diverge. As a result, to increase the positive outcomes of its work, BTRP must be present and active at meetings and conferences where other potential partners, especially those from partner countries, are in attendance. Through such outreach and networking, BTRP can grow its awareness and understanding of others’ work, and

increase its opportunities for establishing and maintaining trusted relationships.

During the early days of the Nunn-Lugar CTR Program in the former Soviet Union, a small senior advisory group was used very effectively by DTRA, not only to assist with scientific reviews of projects under consideration for U.S. funding, but also, importantly, to advocate for the CTR Program. A group of senior experts, including non-U.S.-based experts with relevant experience, even serving on a volunteer basis, could add a robust foundation to BTRP’s efforts, increase the sustainability of proposed approaches, and improve international perceptions and acceptance of BTRP. One potentially important contribution of such a group could be helping to link BTRP professionals, BTRP-supported experts, and other partners together through regional and global networks. Participation in science conferences, introduction of experts across regions and/or areas of scientific expertise, and exchanges of scientific publications and visits may also enhance BTRP’s impact.

THE STRATEGIC VISION FOR BTRP

Over the next 5 years, DOD/BTRP should encourage, engage, support, and help drive the U.S. government’s development of a durable interagency mechanism that draws on military, medical, diplomatic, and other expertise to address the full set of biological threats and risks (human, animal, plant) to deployed U.S. military forces, U.S. interests abroad, and the homeland, seeking to intervene and eliminate, reduce, or mitigate threats at the most opportune and effective stage of development. An effective mechanism will have greater geographic and programmatic flexibility and communication links; will demonstrate better awareness and prevention of threat development and more timely response; and will partner effectively within DOD, with other U.S. government agencies, as well as with other nations, NGOs, the private sector, and academia. Likewise, an effective interagency mechanism will avoid unnecessary duplication, identify and close gaps, and explore possible synergies.

With the rapid pace of change in the biosciences, a span of 5 years can seem like an even shorter period. Indeed, anticipation of threats that may emerge from natural occurrences, accidental incidents, or intentional actions may be considered an impossible exercise. Yet, building on two decades of experience and expertise by implementing the pillars of the proposed strategic vision articulated here, DOD’s BTRP is well poised to

seize opportunities prior to events and respond efficiently and effectively should an event occur, thereby improving the biosecurity of deployed U.S. service personnel and civilians abroad, and strengthening security of the United States itself.

The committee’s recommendations, which are highlighted in Chapter 6 of this report, are as follows: