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4 Biosecurity-Related Activities of Other Organizations Many external organizations have a wide variety of biosecurity programs already under way in developing countries outside the former Soviet Union (FSU). This chapter and appendixes E, F, G, and H describe many of the programs that are directly relevant to the interests of the Biological Threat Reduction Program (BTRP). These organizations are primarily departments and agencies of the govern- ments of developed countries, and particularly the United States; international organizations; and other public- and private-sector entities based in developed countries that operate in developing countries. Biosecurity has been a major thrust of the international activities of only a few of these organizations, how- ever. Most of the organizations provide developing countries outside the FSU with economic development assistance, opportunities for cooperation in the biological sciences, or both. Many programs that are not designed as biosecurity programs should nevertheless contribute to reducing the risks from proliferation of materials, equipment, technologies, or expertise that could be used for bioterrorism purposes. In particular, some organizations provide important financial or technical support or both in strengthening local security, agricultural, health, educational, and scientific systems. As noted throughout this report, these systems can contribute to the efforts to counter bioterrorism. Of course, the nonbiosecurity programs will continue to focus on their primary missions, but many are increasingly taking into account the biosecurity dimensions of their activities as the global interest in this issue rapidly grows. Some of the U.S. entities are within the Department of Defense (DOD) complex. Others in the United States and abroad have pursued broad interna- tional development agendas for decades. Some of these and other more recent entrants into the field of international development are sharply focused on 

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 COUNTERING BIOLOGICAL THREATS addressing global health or international agricultural problems. In summary, the entities of interest for this report may be included within the following categories of organizations: • Current contractors and other partners of BTRP • Health-related components of DOD • Other U.S. government departments and agencies • International organizations • Ministries of foreign affairs, foreign assistance agencies, and develop- ment banks • Industrial and professional associations, foundations, and nongovern- mental organizations The organizations that are considered in this report are only a sampling of the entities with programs relevant to BTRP’s interests. However, they are among the organizations with the largest programs related to biosecurity. Other national and international entities—probably numbering in the many dozens—have smaller programs of interest. Both large and small programs provide the international framework within which BTRP will be operating as it expands geographically. Collectively, the activities of these organizations offer many opportunities for BTRP to obtain up-to-date information on conditions in the countries of interest. They have experience in pursuing approaches that have been effective in specific countries. They also have encountered pitfalls in operating abroad. In some cases, they are well positioned to partner with organizations with similar or complementary interests in planning and carrying out a variety of approaches. The feasibility and desirability of such partnerships should be of special interest to BTRP. ORGANIZATIONS THAT DIRECTLY SUPPORT BTRP ACTIVITIES BTRP provides funds to an extensive array of support organizations for activities in the FSU. BTRP also cooperates with many others with related inter- ests. Some of these BTRP partners are included both in the list of stakeholders in Appendix D and in Appendixes E and F, where they are recognized as also having their own programs independent of BTRP financial support. The organizations that work for BTRP include, primarily, integrating con- tractors, which were discussed in Chapter 3. Their contracts are usually 5 years in duration. Collectively, the contracts currently provide for a level of support exceeding $1.5 billion over 5 years, thereby enabling BTRP to use these con- tractual arrangements quickly to provide a broad spectrum of services. Each integrating contractor has several subcontractors on its team, with universities, nonprofit organizations, and for-profit companies involved.

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 BIOSECURITY-RELATED ACTIVITIES OF OTHER ORGANIZATIONS BTRP makes smaller awards for other more specialized contracts and interagency agreements. These contractors and interagency partners provide unique expertise and experience that require individualized arrangements. A few universities and nongovernmental organizations are involved in such arrangements. While BTRP has positions for only 22 government employees, more than 1,200 people are currently working on BTRP activities as employees of contrac- tors or participating through interagency arrangements, with BTRP providing the necessary funds. These support organizations bring considerable experience and scientific credibility to BTRP. Several U.S. contractors have employees stationed in one or more of the FSU countries where BTRP is active. But BTRP staff will surely require enlargement as BTRP addresses new challenges outside the FSU. Particular attention should be given to new employees with experience working in international development and others who are trained to address a broad range of common diseases. Examples of U.S. government organizations that received funding from BTRP in Fiscal Year (FY) 2008 for support activities include the following: • U.S. Army Medical Research Institute for Infectious Diseases: $2 million • Walter Reed Army Institute of Research: $2 million • Armed Forces Institute of Pathology: $1.2 million • Centers for Disease Control and Prevention (CDC): $7.3 million Each of these four organizations also has related program interests outside the FSU and has its own limited funding to support such programs. In coun- tries where they have more experience than DOD/DTRA (Defense Threat Reduction Agency), larger allocations of BTRP funds to such partners may be in order. Presented below are comments on the activities of several important orga- nizations with relevant activities of their own in developing countries outside the FSU. They are the Department of State, selected entities of DOD, the U.S. Agency for International Development (USAID), CDC, the World Bank, and several private-sector organizations. Against this background, together with the supplemental information provided in the appendixes, several recommenda- tions concerning BTRP relationships with other organizations are set forth. Department of State The biological nonproliferation activities of the Department of State are of special importance for two reasons. First, the department has the most extensive activities of any organization worldwide designed explicitly to address biosecu- rity threats in developing countries outside the FSU. It has pioneered working

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 COUNTERING BIOLOGICAL THREATS with developing countries in this field and has significant budgetary resources to this end, with about $25 million focused on developing countries outside the FSU during FY 2008 and a comparable amount set aside for FY 2009. Second, the department has a lead role in the interagency process in Washington, which is designed to coordinate government-wide approaches to biosecurity in the developing countries. This responsibility is also discussed in Chapter 5. Thus, it has both experience and a mandate that are of considerable importance as BTRP begins to expand into developing countries beyond the FSU. Geographically, engagement efforts are focused on areas where the depart- ment considers that there is the greatest biological risk, with substantial efforts under way in South and Southeast Asia, particularly Pakistan, Indonesia, and the Philippines, as well as in the Middle East. These regions will probably con- tinue to be of high priority in FY 2009. The program is expanding regionally to cover areas in Africa and Latin America, as well as continuing efforts in Eurasia. The department has established field offices in Manila, Jakarta, and Islamabad, with a regional training hub planned for Thailand. Global assistance is directed in the following areas: • Strengthening laboratory biosafety and biosecurity, including best practices, standard operating procedures, personnel reliability programs, and enhanced physical security measures • Ensuring safe, secure, and sustainable laboratory buildings, education, planning, management, and operations • Enhancing molecular diagnostics and disease surveillance networks • Fostering collaborative research projects in priority areas to engage scientists and promote sustainable implementation • Advancing host-nation commitments to the International Health Regu- lations (IHR), particularly as they pertain to best practices, laboratory capacity development, and areas surrounding laboratory biosafety and biosecurity • Promoting global cooperation on biosecurity standards, regulations, and legislation The legislative basis for the Department of State’s activities is set forth in Box 4-1. As an example of the Department of State’s approach, Box 4-2 describes activities in Brazil. Recommendation 4-1: DOD should continue to be an active participant in the interagency nonproliferation process by responding whenever possible to requests of the Department of State and the National Security Council to deploy BTRP assets in countries beyond the FSU and by taking the initiative to advocate deployments that can effectively enhance the overall national effort.

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 BIOSECURITY-RELATED ACTIVITIES OF OTHER ORGANIZATIONS BOX 4-1 Biosecurity Engagement Program of the Department of State “The Secretary of State shall establish a program to combat bioterrorism worldwide by providing training, equipment, and financial and technical (including legal) assistance in such areas as biosecurity, biosafety, pathogen surveillance, and timely response to outbreaks of infectious disease, and by providing increased opportunity for scientists who possess expertise that could make a material contribution to the development, manufacture, or use of biological weapons to engage in remunerative careers that promote public health and safety.” SOURCE: Chapter 9, Part II, Foreign Assistance Act of 1961, as amended by the Security Assis- tance Act of 2008, Section 584A, Global Pathogen Security Program. BOX 4-2 Department of State’s Approach in Brazil • Work through U.S. embassy and ministries to promote transparency • Support Brazil as a regional leader on biosecurity through threat reduction collaboration • Organize biosafety and biosecurity workshops • Encourage university participation in awareness-raising meetings • Support the Brazilian Biosafety Association • Enhance bilateral relations through the U.S.-Brazil Joint Commission on Sci- ence and Technology SOURCE: Department of State, November 2008. Department of Defense Appendix E identifies many of the components of DOD that have pro- grams with biosecurity dimensions in the developing countries beyond the FSU. In recent years, relevant DOD activities in addition to BTRP have involved specialists from more than 100 developing countries and are continuing to expand. Activities have included foreign participants in training programs and international scientific meetings in the United States. Also, many U.S. specialists have participated in on-the-ground activities in various countries. For decades, more than a dozen medically oriented units of DOD have

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 COUNTERING BIOLOGICAL THREATS been involved in health-related activities in developing countries. Usually these efforts have been aimed at ensuring the protection of U.S. military forces sta- tioned abroad. At the same time, some activities contribute to capacity building in developing countries directly and indirectly. DOD’s Global Emerging Infections Surveillance and Response System (GEIS), involving several DOD entities, is particularly relevant to BTRP’s inter- ests. The specific focus areas of GEIS include respiratory diseases, especially influenza; gastroenteritis syndromes; febrile illness syndromes, especially den- gue and malaria; antimicrobial resistance; and sexually transmitted infections. In addition, four broadly based surveillance areas span all emerging infectious diseases of concern: mortality surveillance, electronic data capture for surveil- lance, syndromic surveillance, and modeling. Five overseas research laboratories are important components of DOD’s medical system. About one-fourth of their budgets are for disease surveil- lance and response. Most of the remainder of their budgets supports research. Examples of their activities are as follows: • U.S. Naval Medical Research Unit 3 (NAMRU-3), which is located in Cairo but also has regional responsibilities, has become the World Health Orga- nization (WHO) influenza reference laboratory for the eastern Mediterranean region and is working in many countries in the Middle East and Central Asia. • At the U.S. Naval Medical Research Unit 2 (NAMRU-2) in Jakarta and the Naval Medical Research Center Detachment in Lima, an Early Warning Outbreak Recognition System has expanded, facilitating regional networks to provide outbreak recognition. • The Armed Forces Research Institute of Medical Sciences in Bangkok has a satellite laboratory in Nepal, which detected and provided advance notice of influenza virus genetic changes that later emerged globally, allowing better vaccine strain selection worldwide. • The U.S. Army Medical Research Unit in Kenya has strengthened its program to become one of the few laboratories in Africa that can provide reli- able disease data from sub-Saharan Africa. The activities of the GEIS system are discussed in detail in a recent report of the Institute of Medicine.1 Two particularly relevant recommendations of that report are set forth in Box 4-3. As pointed out in Chapter 3, BTRP must exert care as to how it expands 1 Institute of Medicine Committee for the Assessment of DoD-GEIS Influenza Surveillance and Response Programs and Board on Global Health. 2007. Review of the DoD-GEIS Influenza Programs: Strengthening Global Surveillance and Response. Washington, D.C.: The National Academies Press. Available online at www.nap.edu/catalog.php?record_id=. Accessed De- cember 2, 2008.

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 BIOSECURITY-RELATED ACTIVITIES OF OTHER ORGANIZATIONS BOX 4-3 DOD Health-Related Activities DOD Coordination with Other Organizations “DOD-GEIS should further strengthen its coordination and collaboration on pandemic influenza and other emerging infectious diseases with all U.S. partners, both domesti- cally and in its overseas operations. These partners include HHS [U.S. Department of Health and Human Services], CDC, the National Institutes of Health, FDA [U.S. Food and Drug Administration], USDA [U.S. Department of Agriculture], the Department of State, the U.S. Agency for International Development, the Department of Homeland Security, and other relevant U.S. government efforts.” Expanding Mission of DOD’s Overseas Laboratories “DOD should issue a directive reaffirming that these traditionally research-oriented laboratories, particularly overseas, have a public health mission with respect to the host country and region; the directive should also provide strategic direction on the balance of military medicine-related research and public health activities.” SOURCE: Institute of Medicine Committee for the Assessment of DoD-GEIS Influenza Surveil- lance and Response Programs and Board on Global Health. 2007. Review of the DoD-GEIS Influenza Programs: Strengthening Global Surveillance and Response. Washington, D.C.: The National Academies Press. Pp. 222 and 209, respectively. into developing countries outside the FSU. As indicated in Box 4-4, DOD spe- cialists who are working abroad are sometimes skeptical about being aligned with BTRP. Other senior DOD officials consider such attitudes a legacy of the past, when turf and budget concerns were high. They argue that now budgets are much greater and the realities of bioterrorism have become clearer. In their view, discomfort within DOD with BTRP activities is rapidly being replaced with determination to gain acceptance of BTRP by governments of distant countries. During discussions with committee members, senior officials and biosecu- rity specialists in several countries of Asia, Africa, and Latin America expressed the view that cooperation with BTRP based on mutual interests and benefits would be welcomed. These foreign colleagues did not anticipate reluctance on the part of their governments in this regard. They noted that their countries have cooperated with DOD in a variety of areas and that continuation of such cooperation could be arranged without difficulty. While this was a very small sampling, the convergence of opinions that were solicited seems important.

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 COUNTERING BIOLOGICAL THREATS BOX 4-4 Skepticism over Role of BTRP in Developing Countries “Our laboratory commanders and staff take great pains to distance themselves from the counter-bioterrorism programs of DOD, as even the perception of such an agenda on the part of our host national sponsors could compromise our ability to gain their support for collaborative projects to combat such important public health threats as pandemic influenza.” SOURCE: Senior official, Naval Medical Research Center, September 2008. With care and sensitivity when designing programs, and with the backing of DOD’s leadership, BTRP should be able to overcome hesitancy within other DOD units to support an expansion of BTRP. Transfers of BTRP funds to DOD’s overseas laboratories for participation in BTRP programs may be appro- priate at times and could well influence internal enthusiasm for an expanded BTRP presence. Such transfers could be particularly important in countries where sensitivities to an expanded DOD presence may be high, but where the overseas laboratories have already established positive relationships. Also, care is needed to prevent confusion in the field about the role of BTRP’s contractors and that of the DOD laboratories, as well as other BTRP partners. Mistakes in this regard could affect access to local institutions that have been traditional partners with U.S. organizations at precisely the time when there may be unprecedented opportunities for BTRP and its U.S. con- tractors and grantees to strengthen relations with important local institutions and specialists. Recommendation 4-2: BTRP should work closely with other DOD entities that are involved in activities that support biosecurity in developing countries, drawing on the familiarity of these entities with conditions on the ground and their sensitivity to important issues in dealing with local leaders of government organizations and facilities in the countries of interest. U.S. Agency for International Development USAID has extensive and unique experience in the life sciences, albeit not explicitly directed to biosecurity, in carrying out programs in developing countries. It should be an important partner of BTRP in activities beyond the FSU. The relationship between USAID and BTRP has not been strong in the

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 BIOSECURITY-RELATED ACTIVITIES OF OTHER ORGANIZATIONS FSU. Indeed, on occasion there have been important conflicts in approaches: for example, lack of coordination of software to be used for disease surveillance and analysis systems. Three central offices of USAID, as well as USAID’s missions abroad, have significant activities relevant to BTRP’s interests. Several programs of the cen- tral offices are as follows: 1. Bureau of Global Health: USAID is responsible for managing a health budget of more than $5 billion for FY 2009. A large percentage of the budget is to support the President’s HIV/AIDS and malaria initiatives. Other USAID health programs are directed to avian influenza, tuberculosis, neglected tropical diseases, child survival and maternal health, and water supply and sanitation. Crosscutting all of these activities are efforts to strengthen health systems on a broad basis. USAID has identified the following key problems in controlling diseases: • Helping countries meet the requirements of the IHR • Integrating laboratories and other existing infrastructure into surveil- lance systems • Expanding human capacity in the field of epidemiology and creating rapid response teams • Resolving health system problems, such as laboratory strengthening, through performance-oriented initiatives with planned outcomes Many of USAID’s interests overlap BTRP’s interests, and USAID’s formidable experience in global health should be an asset that is utilized more fully by BTRP. 2. Office of Agriculture: Much of USAID’s interest in biotechnology is focused on food-related issues and opportunities to increase agricultural pro- ductivity. USAID believes that biotechnology can play an important role in solving critical food shortages in several countries. Of course, such solutions will not come easily, but over time the likelihood of still greater contributions from biotechnology than in past decades seems high. In this regard, controlling agricultural diseases has been an area of interest for decades. BTRP’s focus on human and animal diseases and interest in the increased application of biotech- nology, when coupled with USAID’s extensive agriculture experience, should be helpful in encouraging broad approaches by BTRP and other agencies that are addressing disease challenges in the agricultural sector. 3. Global Development Alliance: This cooperative effort between USAID and U.S. private-sector organizations to jointly finance and carry out activities of mutual interest has repeatedly been hailed by the U.S. government as a suc-

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00 COUNTERING BIOLOGICAL THREATS cessful new model for international development. Hundreds of American firms and nongovernmental organizations (NGOs) have been involved, although there are few, if any, examples of biology-oriented projects that would be of immediate interest to BTRP. Nevertheless, the program should provide les- sons learned as to how BTRP might expand its efforts to harness the relevant strengths of the international private sector in developing countries. 2 Recommendation 4-3: BTRP should strengthen its relationships with USAID in Washington and in the field. One or more jointly funded projects would be an effective step in this regard. Centers for Disease Control and Prevention BTRP has for years recognized the importance of benefiting from the achievements of CDC’s worldwide network for disease surveillance and response. As indicated in Box 4-5, experienced practitioners in strengthening disease surveillance activities in the developing countries recognize the poten- tial for development of complementary approaches of CDC and BTRP. BOX 4-5 Joint CDC-BTRP Activities “CDC overseas facilities are often weak and understaffed. If BTRP partners with CDC, both could benefit.” SOURCE: Senior medical adviser, The World Bank, September 2008. CDC has a unique history of linking domestic and global public health research and practices to improve health outcomes in resource-constrained settings. Today, CDC has more than 200 employees in more than 50 countries throughout the world, in addition to its activities in the United States. More- over, CDC employs and trains local staff from each of its platform countries and is an important partner in worldwide efforts to build public health capacity. CDC’s global health work supports the newly revised IHR through a connected network of growing partners within the U.S. government, WHO, and other multinational organizations and governments. 2 Details on the program are available online at www.usaid.go/our_work/global_partnerships/ gda/.

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0 BIOSECURITY-RELATED ACTIVITIES OF OTHER ORGANIZATIONS CDC has scientific experts and programs in influenza, HIV/AIDS, tubercu- losis, malaria, polio, food safety and foodborne disease, environmental health, zoonoses, laboratory testing and safety, quarantine migration, strategic com- munication, and information technology. Driving CDC’s global health efforts is the ability to utilize its assets effectively and link these capabilities to the larger pool of global health resources in each of WHO’s six regions. In 2004, CDC began the Global Disease Detection Program (GDD) to develop and strengthen global health capacity for identifying and responding to emerging infections and bioterrorist threats around the world. Today, GDD Regional Centers are located in Kenya, Thailand, Guatemala, China, Egypt, and Kazakhstan. Programs and resources in these countries are linked to head- quarters and interconnected to respond to disease outbreaks anywhere in the world. The scientists who work in these programs are a valuable U.S. source of expertise in infectious disease detection and control (ranging from leader- ship in the control of common infectious syndromes such as pneumonia, to cutting-edge laboratory detection of rare viruses such as Ebola and severe acute respiratory syndrome coronavirus). In nonemergency settings, CDC works with country partners to build public health capacity in disease detection and response interventions that help to strengthen systems that will be used in times of crisis. In response to major international emergencies or large-scale disease outbreaks, CDC typically functions as a member of the Global Outbreak Alert and Response Network, which is coordinated by WHO. Finally, CDC’s global reputation in strengthening public health systems cooperatively with ministries of health and WHO is a product of the Field Epidemiology Training Program (FETP). Operating in 29 countries, FETP has more than 1,000 graduates, many of whom hold leadership positions within ministries of health in their own countries. Box 4-6 sets forth important lessons learned by CDC. Other U.S. Government Organizations For the past few years, the nonproliferation group of U.S. government organizations has included the Department of State, DOD, HHS, USDA, the Department of Energy, and the Environmental Protection Agency (EPA). The nonproliferation funding for HHS, USDA, and EPA has flowed through the Department of State, although the available funds to support their activities declined significantly to less than $3 million during FY 2008. As previously noted, BTRP also funds activities involving components of HHS, particularly CDC. In addition, USDA, with important lessons to share from its involvement in nonproliferation programs in the FSU (see Box 4-7), has become a recipient of BTRP funds. Somewhat belatedly, the Department of Homeland Security is now also being included in the nonproliferation policy and program discus- sions, as further discussed in Chapter 5.

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0 COUNTERING BIOLOGICAL THREATS BOX 4-6 Lessons Learned by CDC • Ensure the program is consistent with local priorities. • Avoid taking personnel from other important local programs. • Ensure local buy-in of activity. • Ensure program compatibility and integration with existing local activities, structures, methods, and equipment. • Avoid high-technology solutions for low-technology environments and ensure availability of replacement equipment and parts. • Minimize reliance on foreign experts. • Design a system that is affordable and can be maintained locally. • Design a system that is capable of coping with unpredictable changes in the operating environment. • Have a monitoring and evaluation component. • Resolve implementation issues early. SOURCE: CDC expert, presentation to the committee, July 2008. Each of the nonproliferation-oriented departments and agencies has sup- ported other activities of relevance to biosecurity in developing countries, either through their core budgets or through interagency arrangements. For example, the National Institutes of Health, and particularly the National Insti- tute of Allergy and Infectious Diseases, have been major funders of cooperative research projects on disease issues in Africa, Asia, and elsewhere. USDA has interagency arrangements with USAID in many fields related to agricultural biosecurity. Also, the Animal and Plant Health Inspection Service and the For- eign Agricultural Service of USDA are important organizations keeping abreast of developments abroad in the agricultural field. BTRP’s expanding relationships with CDC, USDA, and other agencies will be of increasing importance as BTRP attempts to expand into developing coun- tries, where government suspicions about U.S. military interests abound. Such BTRP partners can both contribute to the technical basis for BTRP programs and help build international confidence in the positive objectives of BTRP. In some cases, they may be more appropriate than BTRP to be the lead agency in the country of interest to BTRP. World Bank The World Bank and the other international development banks have for decades financed major health and agricultural programs that intersect with

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0 BIOSECURITY-RELATED ACTIVITIES OF OTHER ORGANIZATIONS BOX 4-7 USDA’s Project Selection and Project Evaluation Criteria Selection Criteria • Project that will advance the missions of both the Department of State and the Agriculture Research Service • Project that is truly interactive • High probability of success and sustainability through publications and products • Committed principal investigators—in the United States and in the partner country—who are effective and willing to make exchange visits • Adequate facilities abroad (including compliance with animal welfare requirements) Evaluation of Effectiveness • Number of exchange visits • Number of scientists involved • Hours of training provided • Monetary value of equipment provided • Patents filed • Publications and international conference presentations SOURCE: Adapted from a presentation to the committee by an Agricultural Research Service official, July 24, 2008.a a References to weapons scientists have not been included, since they are relevant only in very special cases outside the FSU. the biosecurity interests of BTRP. Disease prevention and control are consid- erations in many bank programs designed to improve health care or increase agricultural production. Also, because of the size and impact of major bank loans, a representative of one of the banks who is located in the field, such as the World Bank country director, often becomes a de facto coordinator for the international community interested in health or agriculture system improve- ments in the developing country of interest, working as cochair with a local official of a consultative committee. An important aspect of the activities of the banks is the attention given to early comprehensive analyses of the local situation in the specific field of inter- est. These analyses provide important background for lending decisions and should be of interest to BTRP. Also, many loans give emphasis to training of local specialists who are to be involved in implementing the loan. Unfortunately,

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0 COUNTERING BIOLOGICAL THREATS despite the obviously important role of the banks, BTRP has had few interac- tions with the development banks to date. As of 2008, the World Bank annually commits $1-2.5 billion in new loans in the field of health and disperses amounts in the same range from existing loans. The other banks in the aggregate commit and disperse a comparable amount. Until recently, the World Bank had emphasized loans targeted on spe- cific diseases. However, the bank is currently transitioning to a new emphasis on strengthening the entire health system, often in partnership with the United Nations International Children’s Fund and WHO, which have stronger scien- tific capabilities. In the agricultural area, the activities of the banks include large agricultural loans, although diseases are much less of a focus area. Given the sizes of the portfolios of disease-related activities of the interna- tional development banks in Asia, Africa, Latin America, and Europe, as well as the World Bank, these organizations should be of special interest to BTRP. In some cases, such an international development bank might be an appropriate lead organization in a country of interest to BTRP. International Organizations The roles of WHO, the Food and Agricultural Organization, and the World Organization for Animal Health are of particular relevance to BTRP. 3 The interests and capabilities of these organizations are sometimes taken into account in the design and implementation of BTRP projects. For example, BTRP is giving considerable attention to the local responses to the International Heath Regulations of 2005, which provide an international standard for health- related activities. These regulations, which are in the early stage of implementa- tion, require the signatories to . . . develop, strengthen, and maintain core national public health capacities at the primary, intermediary, and national levels in order to detect, assess, notify, and report events [that may constitute a public health emergency of international concern] and to respond promptly and effectively to public health risks and emergencies. Recommendation 4-4: BTRP should adopt progress toward the host country’s effective implementation of the International Health Regulations, including actions concerning public health emergencies, as an important measurement of success in countries where it mounts major efforts. (See the related discus- sion of metrics in Chapter 3.) Also of interest are the global funds (for example, the Global Fund to 3 Key documents include the WHO Constitution of 1948; World Health Assembly Resolution 55.16 (2002); International Health Regulations, Resolution 58.3 (2005); and World Health As- sembly Resolution 58.29 (2005).

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0 BIOSECURITY-RELATED ACTIVITIES OF OTHER ORGANIZATIONS Fight AIDS, Tuberculosis and Malaria), trust funds, and other special funds set up under the umbrella of WHO. They are increasingly used as channels for assistance to counter pervasive disease problems. Of growing importance are the expanding interests of regional organiza- tions in biosecurity. Broadly based regional health organizations such as the Pan American Health Organization are beginning to embrace biosecurity as an important issue. The Asia-Pacific Economic Cooperation organization and other political groups also convene meetings and provide guidance concerning bioterrorism. Specialized regional organizations provide venues for discussions and training in selected areas of biosecurity, such as the African Biosafety Asso- ciation. Undoubtedly, additional governmental and nongovernmental regional organizations will become more active participants in this field in the months and years ahead. Recommendation 4-5: BTRP should give greater attention to the biosecurity roles of the international development banks and of international and regional organizations. In coordination with the Department of State and USAID, BTRP should regularly consult with these organizations concerning the fur- ther development of BTRP activities. The Private Sector Many foundations, professional and trade associations, and other nongov- ernmental organizations have programs directed to global health and interna- tional agriculture. However, with several exceptions, to date their programs have had relatively little direct impact on biosecurity concerns in developing countries. Their significance will undoubtedly increase in the future; however, a few of the larger foundations with international programs in these fields are well positioned to have more focused impacts on biosecurity concerns in the near term. They include the Gates Foundation, the Rockefeller Foundation, the Wellcome Trust, and Google.org. Google.org, a newcomer to international development, has already com- mitted $30 million in grants to identify hot spots where diseases may emerge, to detect new pathogens and outbreaks earlier, and to respond quickly to prevent local threats from becoming global crises. More specifically, its projects are intended to • enhance the use of automated systems for effective disease surveillance; • improve pathogen discovery and understanding of those classes of viruses that pose the greatest threat; and

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0 COUNTERING BIOLOGICAL THREATS • strengthen efforts to bring molecular sequencing capacity closer to hot spot countries.4 The Sloan Foundation has also embraced biosecurity as a priority issue. The foundation provides grants in this field to a variety of organizations rang- ing from universities to international organizations such as Interpol and WHO. While the grants are modest—totaling about $2.5 million annually—they nev- ertheless have been helpful in introducing a broad range of important govern- ment officials and scientists to the field of biosecurity. About 20 major research-based biopharmaceutical companies headquar- tered primarily in the developed countries have established the Global Health Progress initiative to address health care challenges in the developing countries. They emphasize networks of partnerships with governments, citizen groups, and other organizations. The program reports more than 70 organizations involved in these partnerships. The initiative emphasizes the following activities: • Strengthening health care systems • Donating and discounting medicines • Developing and delivering innovative diagnostics • Providing health care assistance during emergencies and disasters • Conducting research and development on new medicines • Developing new policy ideas and solutions Global Health Progress has recently published a special report on the activities of its members in developing countries, which is available online at www.globalhealthprogress.org. It is particularly interested in the 14 neglected tropical diseases identified by WHO.5 Its growing network should be of interest to BTRP and to other organizations concerned about biosecurity in developing countries. At the same time, as indicated in Box 4-8, the companies apparently do not consider their assets in developing countries to be at risk. They may be overly optimistic in this regard, because not only are large-scale fermentation, milling, and lyophilization activities of concern but also activities of small firms and academics with connections to the large companies deserve attention. However, the committee has no specific information to indicate that such assets are at risk. Turning more directly to biotechnology companies, successful firms head- quartered in the United States are in the early stages of establishing overseas affiliates in developing countries that have assets that, if misused, could enhance 4 Additional details are available online at www.google.org/predict.html. Accessed October 14, 2008. 5 A list of these neglected diseases is available online at www.who.int/features/factfiles/neglect- ed_tropical_diseases/ntd_facts/en/index.html.

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0 BIOSECURITY-RELATED ACTIVITIES OF OTHER ORGANIZATIONS BOX 4-8 Security of Assets of International Pharmaceutical Companies “Our companies have few, if any, assets—materials or equipment—in developing countries that would be of interest to bioterrorists. At the same time, our companies have tight security to protect their intellectual property. As to the dedication of company employees to company security policies, they value their jobs, for which the salaries are generous by local standards.” SOURCE: Senior official, Pharmaceutical and Research Manufacturers of America (PhARMA), October 2008. the capabilities of terrorist groups. The current emphasis of such firms, accord- ing to the Biotechnology Industry Organization (BIO), is on greater access to innovative medicines at lower prices, improvements in drug safety, advance- ment of the agricultural revolution, the growth of renewable energy with near- zero carbon footprints, and a cleaner environment. Of course, compliance with regulations in the United States is very important. BIO has 1,400 member firms, including 1,000 members interested in research and development. 6 Internationally, BIO’s interest has focused on developments pursuant to the Biological Weapons Convention, which BIO believes should now empha- size expanded confidence-building measures that would increase transparency. Such steps could, of course, intersect with intellectual property concerns of private firms. BIO is currently trying to attract more foreign members. Compli- ance of a broad membership with the bioethics principle set forth in Box 4-9 would be of direct relevance to BTRP’s interests. The International Council for the Life Sciences, with initial financial sup- port from the Nuclear Threat Initiative foundation, is one of the most active NGOs in promoting improved disease surveillance and response capabilities in developing countries. Its action-oriented programs have highlighted some of the challenges in upgrading surveillance activities in developing countries and the value of partnerships that include scientists, practitioners, and funders. Embryonic surveillance networks that it is sponsoring are located in the Israel- Palestine-Jordan region and the Mekong Delta. 6 Biotechnology Industry Organization. 2008. 2007-2008 Milestones. Available online at www. bio.org/speeches/pubs/milestone0/00-00_BIO_Milestones_WEB.pdf. Accessed November 30, 2008.

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0 COUNTERING BIOLOGICAL THREATS BOX 4-9 Appropriate Uses of Biotechnology “The Biotechnology Industry Organization has a long-standing policy of opposing the use of biotechnology to develop weapons of any sort that contain pathogens or tox- ins aimed at killing or injuring humans, crops, or livestock. We will not undertake any research intended for use in developing, testing, or producing such weapons.” SOURCE: BIO. 2008. Bioethics Statement of Principles. Available online at www.bio.org/bioethics/ background/principles.asp. Accessed October 17, 2008. Recommendation 4-6: As BTRP carries out activities in developing countries beyond the FSU, it should work with the Department of State and other appro- priate government departments to encourage the private sector to become more actively engaged in biosecurity activities in these countries. Joint funding of high-visibility projects would be a good beginning in this regard. In particular, BTRP should significantly expand its partnerships with U.S. companies with biological research and production activities in the developing countries. The experience of the Global Development Alliance Program of USAID, which was discussed above, may offer important lessons as to coop- eration with the U.S. private sector in supporting specific projects of broad U.S. interest. BENEFITING FROM THE EXPERIENCE OF OTHER ORGANIZATIONS BTRP has experience in interacting with many organizations with comple- mentary interests that have been active in the FSU. In developing countries beyond the FSU, the array of relevant foreign organizations will be larger, with a stronger emphasis on international development and with less experience in some aspects of biosecurity. Sharing experiences among organizations and iden- tifying ways to develop mutually supporting activities are increasingly important as the U.S. government, and particularly DOD, expand biosecurity activities in the developing countries. In summary, dozens of U.S. government departments and agencies, agen- cies of other governments, international organizations, pharmaceutical and biotechnology companies, and other nongovernmental organizations are involved in activities related directly or indirectly to biological threat reduction

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0 BIOSECURITY-RELATED ACTIVITIES OF OTHER ORGANIZATIONS in developing countries. BTRP can benefit from drawing on the capabilities, experiences, and activities of many of these organizations. At the same time, BTRP interventions could inadvertently disrupt important activities of other external organizations that might not be in a position to match financial incen- tives offered by BTRP. Three recommendations are offered to help ensure that BTRP’s involve- ment in developing countries is based on up-to-date information on the activi- ties of other external organizations and takes full advantage of opportunities for partnering that are mutually beneficial. These recommendations recognize the need to involve local officials and specialists in consultations concerning the activities of the multiplicity of donors and other organizations that are involved. At the same time, they recognize the importance of not overburdening local officials with excessive discussions. Recommendation 4-7: BTRP should expand its highly successful annual pro- gram review conferences, which bring together its specialists with specialists from host-country organizations and specialists of other external organizations involved in biosecurity activities in regions where BTRP has programs or plans to initiate programs. More than 200 officials and specialists from 15 countries attended the 2008 conference in Garmisch, Germany. The discussions of recent develop- ments in the biological sciences, achievements of BTRP-supported projects and future plans, and plans of other funding organizations as well as the FSU countries themselves stimulated considerable interest within both government and scientific circles. The only shortcoming of the conference was the limita- tion on time that prevented more detailed discussions of particularly interesting developments, a shortcoming that can be overcome by increasing the number of parallel sessions. Recommendation 4-8: BTRP should station regional or country representa- tives in areas where new activities are initiated with responsibility for keeping abreast of related activities and for promoting synergies among BTRP activi- ties and related interests of other organizations. After BTRP begins to engage in a country, the most effective way to keep abreast of activities in the country that intersect or could intersect with BTRP activities is a specialist on the ground in or near the country of interest. The BTRP specialist might be stationed at a DOD overseas research laboratory, at a U.S. embassy, or at another appropriate institution. There are too many local organizations with interests in the life sciences and too many foreign providers of assistance in health, agriculture, and other relevant fields to stay current with developments on the ground only by making occasional visits. Such awareness

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0 COUNTERING BIOLOGICAL THREATS of related activities should be a priority interest of BTRP as it seeks to establish its niche in the country. Recommendation 4-9: DTRA should frequently consult with appropriate local officials concerning coordination of activities of both local and external orga- nizations, but such consultations should be designed so as not to create an excessive burden on limited local capabilities to devote personnel to BTRP coordination concerns. Once BTRP begins to engage with a specific country, specialists from the two countries should be working together regularly. At the same time, repre- sentatives of BTRP should periodically meet with senior officials to ensure that the busy officials are involved in the process to the extent possible, recognizing the many other demands on the time of key officials. Communication channels among specialists and officials within developing countries are not always well developed and utilized, and BTRP can play an important role in ensuring that responsible officials are not caught by surprise as engagement proceeds.