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Summary

INTERNATIONAL INTEREST IN RUSSIA’S CAPABILITIES TO COMBAT INFECTIOUS DISEASES

A concerted global effort is needed to combat both naturally occurring and intentionally introduced infectious disease agents. Russia, with its vast ecological diversity and large, well-trained scientific workforce, should be a leader in efforts to prevent, detect, and respond to the emergence and resurgence of infectious diseases at home and abroad.

The international community clearly recognizes that disease-related developments in Russia have profound global implications. Many Western countries have therefore initiated cooperative programs in Russia aimed at preventing the proliferation of biological materials and expertise to countries with hostile intentions. Other international efforts have been directed toward countering the possibility of terrorist groups acquiring biological capabilities. Still other programs have been driven by the conviction that shared scientific expertise leads to mutual benefits in the broader effort to improve public health. Thus, the importance of cooperative efforts for both Russia and its partners has been widely recognized. In addition to cooperative programs, the Russian government has developed a conceptual framework for strengthening the country’s public health system. Relevant ministries also are well aware of the need to improve the means of combating agricultural diseases, promote research and development, and support the emergence of biotechnology firms. However, because implementation of such concepts continues to be severely constrained financially, international financial support will continue to be important.



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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security Summary INTERNATIONAL INTEREST IN RUSSIA’S CAPABILITIES TO COMBAT INFECTIOUS DISEASES A concerted global effort is needed to combat both naturally occurring and intentionally introduced infectious disease agents. Russia, with its vast ecological diversity and large, well-trained scientific workforce, should be a leader in efforts to prevent, detect, and respond to the emergence and resurgence of infectious diseases at home and abroad. The international community clearly recognizes that disease-related developments in Russia have profound global implications. Many Western countries have therefore initiated cooperative programs in Russia aimed at preventing the proliferation of biological materials and expertise to countries with hostile intentions. Other international efforts have been directed toward countering the possibility of terrorist groups acquiring biological capabilities. Still other programs have been driven by the conviction that shared scientific expertise leads to mutual benefits in the broader effort to improve public health. Thus, the importance of cooperative efforts for both Russia and its partners has been widely recognized. In addition to cooperative programs, the Russian government has developed a conceptual framework for strengthening the country’s public health system. Relevant ministries also are well aware of the need to improve the means of combating agricultural diseases, promote research and development, and support the emergence of biotechnology firms. However, because implementation of such concepts continues to be severely constrained financially, international financial support will continue to be important.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security In 2003, a committee of the National Research Council (NRC),1 building on a decade of experience promoting U.S.-Russian engagement in biological research and in close consultation with Russian colleagues, initiated a study that would set forth a realistic vision for the development of the biosciences and biotechnology in Russia over the next ten years. Further, the committee considered practical steps that could be taken by Russia, independently or collaboratively with international partners, to move toward the achievement of that vision. The specific charge to the NRC committee responsible for this assessment was as follows: This project will present a 5 to 10 year vision of an environment in Russia for biological research and production activities that encourages efforts to prevent bioterrorism and the proliferation of potentially dangerous biological agents and expertise while addressing public health, agricultural, industrial, environmental, and scientific challenges. The project will address both: (1) the positive contributions to peaceful science, economic, and social development that can be made by biological institutions; and (2) the possibilities of misdirection of materials and expertise to terrorist groups or to states seeking biological weapons capabilities. Also, the project will suggest near-term steps that can be taken by the Russian government, by Russian institutions, and by the international community to contribute to the development of such an environment. U.S.-Russian cooperative programs will receive special attention, since during the past several years they have played a key role in reducing the likelihood of bioleakage (the spread of biological materials and expertise) from Russian institutions. Thus, the report should be of interest to officials and specialists in both Russia and the United States and also to the broader scientific community around the world. A VISION FOR STRENGTHENING PUBLIC HEALTH AND SECURITY Of primary importance is the evolution of a stronger, more flexible public health system in Russia that is increasingly integrated into global networks as they respond to endemic and emerging diseases. These enhanced capabilities could contribute to a significant reduction of vaccine-preventable and drug-curable infections in both humans and animals in Russia, which would include: (1) more effective utilization of disease prevention measures; (2) increased effectiveness at national and local levels in controlling arthropod vectors and animals that serve as reservoirs for zoonotic diseases; and (3) a more effective global approach to combating infections through stronger and more active cooperation with international partners. 1   See Appendix A for committee biographies.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security To achieve this goal, the committee recommends strengthening Russian policies and programs by: focusing on surveillance, laboratory diagnostics, and development of countermeasures (e.g., drugs and vaccines) capable of addressing diseases in the broadest sense improving capabilities to detect and diagnose new, reemerging, and antibiotic-resistant pathogens in both rural and urban settings, including upgraded communication systems to provide timely and accurate information integrating human and animal disease surveillance monitoring food and water supplies for safety and potability supporting well-focused research projects that strengthen the base of fundamental scientific knowledge strengthening programs to commercialize scientific findings within a regulatory framework that supports public health and protects agriculture developing an improved understanding of the relationships between infectious agents and important non-communicable chronic diseases, a priority of growing global interest supporting the emergence of a strong domestic biotechnology sector that enhances efforts to combat infectious diseases affecting the Russian population developing and implementing effective security procedures at hundreds of facilities that can propagate, store, or distribute pathogens which, if diverted, could be used for bioterrorism; an important initial step would be to conduct a careful nationwide inventory of strains and consolidate many collections where appropriate promoting broad transparency of Russian research and other public health prevention and control activities involving dangerous pathogens, in order to reduce international apprehensions regarding the possible misuse of Russian research or the unauthorized diversion of infectious agents; comparable transparency would also be expected in other countries recruiting, training, and retaining an expanded cadre of biomedical scientists, medical doctors, veterinarians, plant pathologists, epidemiologists, and other relevant specialists equipped with modern technology and positioned to deal with infectious disease threats Russia has the government institutions, legal framework, technical expertise, human resources, and distinguished tradition of scientific excellence needed to support these developments. But there is an urgent need to strengthen Russia’s recently reduced capabilities in many areas. Fortunately, the economic situation in Russia is slowly improving, and the implementation of effective health and agricultural policies is much closer to being achieved than it was just two or three years ago. In particular

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security the Russian leadership is coming under increasing pressure from politicians and the public as the consequences of deteriorating public health—unproductive workers, unfit military conscripts, debilitated pensioners, and underachieving children—become increasingly apparent Russian investments in health-related programs are increasing, and Russian research institutions are now successfully competing for external resources as Russia’s economy improves, its embryonic biotechnology industry is charting an ever more optimistic course and is beginning to achieve success sensitivity within the Russian government to the dangers of bioterrorism, as well as recognition of the steps needed to reduce this threat, are rising This report sets forth four key themes, or pillars, for countering infectious diseases in Russia. They represent the committee’s view of priority areas for development over time. FOUR PILLARS FOR COUNTERING INFECTIOUS DISEASES Pillar One: Improving Surveillance and Response Over the long term, enhanced surveillance capabilities in Russia would improve the country’s ability to: (1) determine the incidence and prevalence of endemic and emerging diseases in humans, animals, and plants; and (2) detect and identify infectious agents within a national reference laboratory system that is connected to the global system of the World Health Organization. This will require a strong, state-of-the-art capacity to investigate disease outbreaks, which builds on Russia’s long history of successful epidemiology and disease surveillance. Specific suggestions for achieving this goal are set forth below. The committee recognizes, however, that there are other dimensions of surveillance that also deserve consideration, particularly in the area of animal and plant monitoring. • Establish two model State Sanitary Epidemiological Surveillance Centers (SSESCs) for surveillance, diagnosis, analysis, and communication of information concerning infectious disease episodes. One center would be at the regional (oblast) level, and a related one would be at the local level within the same region. It is recommended that these model centers be placed in a region where financial resources have traditionally been less plentiful, most likely in a region distant from Moscow or St. Petersburg. This would be an important step in establishing standards that could serve as a model for upgrading the entire SSESC network over the long term. Because SSESCs are the primary organizations for reporting disease trends and outbreaks, particularly at the local level, they are also an important resource for surveillance oversight in Moscow. The model centers should be internally linked via electronic communications

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security with SSESCs throughout the country, and externally with the World Health Organization and other member nodes of the international disease surveillance community. The model centers could provide training and have surge capacity to address outbreaks and other crisis situations not only in their own geographical areas but also in nearby regions of the country while also providing up-to-date information to Moscow. Regardless of the locations of the model centers, significant investments will be required to: (1) establish them either through upgrading existing facilities or constructing new facilities; and (2) upgrade additional centers based on lessons learned at the model centers. • Integrate Russia’s anti-plague network fully into the national public health surveillance system and then into global systems. Even though the Russian anti-plague monitoring facilities have largely remained isolated from the international community, perhaps due to security sensitivities dating from the Soviet era, they continue to be an essential component of Russian efforts to prevent and control infectious diseases of local, national, and global interest. Their data banks and their strain collections are valuable resources and should be fully drawn upon when building modern disease prevention and control programs that include geographic monitoring, laboratory diagnosis, reference identification, and intervention. Transformation from an internal to an external orientation could begin with modest investments to update disease surveillance within Russia, first by strengthening the equipment and communication capabilities of the five anti-plague institutes, and then by initiating international cooperation. Pillar Two: Meeting Pathogen Research Challenges Focusing laboratory research, and the resources to support that research, would help Russia advance public health and control agricultural diseases more effectively. Two related suggestions for achieving this goal are as follows: Concentrate financial support at carefully selected research groups that are, or have the potential to become, centers of scientific excellence. Several hundred key Russian laboratories, each of which employs one or more integrated groups of scientists working toward common goals, are, or could be, essential core elements of the Russian public health and agriculture research infrastructures in the future. These important laboratories warrant special financial support provided through a competitive peer review process to enhance the programs of their research groups. Criteria for determining special financial support might include: (1) scientific excellence and relevance of research activities to public health and agriculture priorities of the Russian government; (2) recent achievements of the research groups in advancing specific areas of science and in contributing to important human, animal, and plant disease prevention and control programs of the Russian government; (3) demonstrated capabilities of the

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security laboratory scientists, particularly the rising scientific leaders within the research groups; and (4) a tradition of cooperating with, and facilitating the development of, other Russian research groups that share research interests. Upgrade laboratory facilities and equipment for appropriate infectious disease-related research at selected laboratories throughout the country. Recent emphasis in Russia on using limited research funds primarily to meet payrolls has been accompanied by a dramatic decline in facility and equipment assets at research institutions, including the ability to maintain and disseminate data and to communicate rapidly both domestically and internationally. In turn, this erosion of equipment capabilities has resulted in a loss of competitiveness in the search for international financial support as well as a decline in research productivity. Meanwhile, many of the best Russian researchers have, out of frustration, emigrated to foreign laboratories where they can work using modern equipment. Costs of adequately equipping even the several hundred research units identified as centers of excellence will be very high, and the primary source of funds must be the Russian government. Therefore, considerable attention should be given to establishing a fair and open competitive process for selecting the recipients of funding. This process should lead to a concentration of resources to support the equipment needs of the strongest research groups. Training could also be a component of such programs to ensure optimum use of equipment. Pillar Three: The Promise of Biotechnology Facilitating the development of an internationally competitive biotechnology sector would also enable Russia to more fully support the control of infectious diseases. To this end, Russia needs an innovation system that encompasses all aspects of the process from start to finish: from basic molecular biology through applied research and development; intellectual property and regulatory systems; scale-up and production capabilities; commercial financing and manufacturing capabilities; and marketing and product distribution expertise. Specific suggestions for achieving this goal are as follows: Develop a business environment that encourages investment in biotechnology activities in Russia. In particular, the following factors will encourage domestic or foreign investors to risk their capital in Russia: consistent tax policies, intellectual property rights that reward scientific success, streamlined procedures for licensing facilities and approving products, and the continuous availability of initial funds. In some cases, government cost-sharing may be warranted during a transition period. In short, the Russian government should recognize the unique challenges faced by the biotechnology sector and take specific steps to help support the emergence of a vibrant and sustainable core of biotechnology firms. Among those firms may be some linked to well-established research institutes that are, or in time will become, internationally competitive.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security Promote investment in biotechnology niches that are well suited for activities based in Russia. Some market niches for Russian firms have not been fully exploited. One approach the Russian government may take to promote investment is to encourage the local production of some items which are currently imported. For example, the development and enforcement of government procurement policies that favor high-quality Russian-made products at competitive prices could be very helpful in the short term. A complementary approach is for Russian manufacturers to target markets for products such as diagnostic kits and other relatively straightforward technologies in the countries of the former Soviet Union, where longtime connections give Russian firms a considerable advantage over foreign firms trying to penetrate these markets. Pillar Four: The Human Resource Base Nurturing a new generation of young scientific leaders in the basic and applied sciences and technologies is essential to the advancement of infectious disease prevention and control. Specific suggestions for reaching this goal are as follows: Encourage postdoctoral scientists to remain in Russia as practicing scientists through mentoring programs that prepare them for positions of leadership in various fields that support the control of infectious diseases. There is now a shortage of biological scientists in the 30- to 45-year-old age range with important knowledge and skills related to infectious diseases. A positive step toward overcoming this trend has already been taken by the Russian government on a small scale through a limited number of federal grants designated for young scientists. Another approach that might have a greater effect is for both the Russian government and Western governments to provide financial support to those institute directors who are also prepared to use their institute’s resources on a matching basis to provide improved working conditions and scientific challenges. This will help ensure an increased flow of young talent into permanent research and related positions. Also, a program of re-entry grants might encourage young scientists to return to Russia upon completion of training abroad. Continuously expand the professional competence of specialists in fields related to infectious disease, particularly enhancing their ability to address multidisciplinary challenges through advanced training programs. Advanced training could be offered at the leading national and regional research and monitoring centers, and particularly at the two model centers recommended earlier. In some cases, Russian specialists have fallen behind simply because they have not had modern equipment and broadband access to the Internet. In other cases, they have been isolated from international developments, and their skill levels have suffered accordingly. Training should, to the extent possible, provide opportunities for visits and hands-on experience at international research and monitoring

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security centers where Russian specialists could become familiar with work at the cutting edge of science. MODIFYING THE APPROACH TO BILATERAL COOPERATION Involvement by the United States in Russia’s biotechnology sector has largely been driven by U.S. priorities, which are to: (1) prevent the proliferation of dual-use expertise, technologies, and organisms to countries and groups with hostile intentions; and (2) redirect former Soviet bioweapon scientists and engineers to civilian activities, particularly in the areas of human health, agriculture, and environmental protection. In addition, U.S. bilateral and other foreign assistance efforts in the health and agricultural sectors have focused on controlling diseases of particular concern in Russia, such as tuberculosis, HIV/AIDS, and viral hepatitis. Several western firms have made small investments in biological activities in Russia; others have entered into short-term contracts with Russian scientists. Finally, several international foundations have supported biomedical projects relevant to infectious diseases in Russia. However, much more needs to be done in light of new challenges and new opportunities for cooperation. The following three initiatives are designed to improve the effectiveness of cooperation in bioscience and biotechnology in order to achieve both Russian and U.S. objectives: Establish a bilateral U.S.-Russian intergovernmental commission on the prevention and control of infectious diseases. An emphasis on cooperative programs that address infectious diseases of global significance to human and animal populations of Russia and the United States, and particularly diseases of special importance in Eurasia, could be a very important focus of initial cooperation. The U.S.-Japan program, begun in 1965, could serve as a model for the commission. Subgroups of the commission might be established to consider the following topics: (1) epidemiology and surveillance of emerging diseases; (2) laboratory sciences, including detection, diagnosis, identification, and reference systems; (3) information systems and technologies; (4) biosafety and biosecurity; (5) advanced training; and (6) promotion of collaborative scientific relationships. Initially, financial support for activities of the commission and the projects it endorses would have to come largely from the U.S. government. But a near-term goal would be for each side to cover its own costs during meetings and at the bench. An early task for the commission could be to consider the recommendations presented in this report and the contributions of existing bilateral cooperative efforts in implementing the recommendations. Complete the integration of former Soviet biodefense facilities that are no longer involved in defense activities into the civilian research and production infrastructure of the country. A specific suggestion for achieving this goal is to increasingly involve in nonproliferation programs those Russian specialists who

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security did not participate in defense activities but who have important expertise related to disease prevention and control. Focus U.S. and other western programs on establishing true partnerships in Russia. Two specific steps toward achieving this goal are to: (1) increase the role of Russian scientists and science administrators in designing cooperative programs and projects; and (2) increase Russian financial contributions to cooperative programs as a key to sustainability and as evidence that the programs reflect Russian national priorities. Collectively, the recommendations in this report could help restore Russia’s ability to join with the United States and the broader international community in leading an expanded global effort to control infectious diseases. The proposed bilateral intergovernmental commission can play a pivotal role toward this end.