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Introduction

THE CONTEXT FOR THIS REPORT

Rapid advances in biological science and technology have led to new and improved medications and medical procedures, new and safer foods, and new and diversified energy sources that are revolutionizing the way people live. The desire of nations to develop capabilities to participate in this revolution is unbounded. At the same time, there is a growing global challenge to ensure that biological capabilities are directed toward the betterment—and not the malicious detriment—of the lives of people throughout the world.

Meanwhile, infectious diseases continue to threaten human health and agriculture. Every day, tens of thousands of people throughout the world die from infections. As the recent outbreak of severe acute respiratory syndrome (SARS) so dramatically demonstrated, deadly diseases can spread rapidly around the world. All nations need to work together to prevent disease pandemics and to respond vigorously when outbreaks occur. Russia can be among the leaders in the global effort to avoid such catastrophes.

Since the disintegration of the Soviet Union in 1991, U.S.-Russian cooperation in biological science and technology has increased significantly. Cooperative programs provide many opportunities to apply strong Russian scientific capabilities to activities that benefit both Russia and its partners. Yet the existing U.S. programs, which address biological issues in Russia, continually face political, scientific, and financial difficulties that jeopardize their long-term sustainability. An important theme of this report is the significance of expanding cooperation in ways that overcome and eventually reduce such impediments.



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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security Introduction THE CONTEXT FOR THIS REPORT Rapid advances in biological science and technology have led to new and improved medications and medical procedures, new and safer foods, and new and diversified energy sources that are revolutionizing the way people live. The desire of nations to develop capabilities to participate in this revolution is unbounded. At the same time, there is a growing global challenge to ensure that biological capabilities are directed toward the betterment—and not the malicious detriment—of the lives of people throughout the world. Meanwhile, infectious diseases continue to threaten human health and agriculture. Every day, tens of thousands of people throughout the world die from infections. As the recent outbreak of severe acute respiratory syndrome (SARS) so dramatically demonstrated, deadly diseases can spread rapidly around the world. All nations need to work together to prevent disease pandemics and to respond vigorously when outbreaks occur. Russia can be among the leaders in the global effort to avoid such catastrophes. Since the disintegration of the Soviet Union in 1991, U.S.-Russian cooperation in biological science and technology has increased significantly. Cooperative programs provide many opportunities to apply strong Russian scientific capabilities to activities that benefit both Russia and its partners. Yet the existing U.S. programs, which address biological issues in Russia, continually face political, scientific, and financial difficulties that jeopardize their long-term sustainability. An important theme of this report is the significance of expanding cooperation in ways that overcome and eventually reduce such impediments.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security In addition to the United States, other countries have also joined with Russia in combating infectious diseases. These bilateral and multilateral efforts indicate that the international community clearly recognizes the profound global implications of biology-related developments in Russia. These programs have also had a significant effect on Russia’s approach to these issues as well. Within the context of Russian participation in Western initiatives over the past decade, the Russian government’s vision for the nation’s future in public health and related fields has evolved. Policies designed to realize that vision are significantly influenced by approaches advocated by western partners and demonstrated through programs funded internationally. In addition to a vision for the future, the Russian government has developed a conceptual framework for strengthening the public health system of the country on a continuing basis. Relevant ministries are also well aware of the need to develop more coherent policies and programs for combating agricultural diseases, for promoting research and development, and for supporting the emergence of biotechnology firms. But implementation of such efforts is severely constrained financially, therefore international support will continue to be important. Against this background, in 2003, a committee of the National Research Council (NRC), building on a decade of promoting U.S.-Russian engagement in biological research, initiated this study to be conducted in close consultation with Russian colleagues. The objective was to set forth a realistic vision for the development of the biosciences and biotechnology in Russia over the next ten years. The committee was to consider practical steps that could be taken independently by Russia, or collaboratively with international partners, to move toward achievement of that vision. The Nuclear Threat Initiative, a private foundation, and the NRC provided financial support for the study. This report presents the findings and recommendations of the committee developed over the course of the multi-year study. It addresses both contributions to peaceful scientific, economic, and social development of Russia’s biology-oriented institutions and the prevention of the misdirection of materials and expertise to terrorist groups or to states seeking biological weapons capabilities. In general, a strong public health system, coupled with an active research base and a commercially viable biotechnology sector, can contribute to the achievement of both goals. The development of an infrastructure to help control infectious diseases and the potential contributions of international cooperation to support such an infrastructure are the focal points of this report. The specific charge to the NRC committee responsible for this study 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 relevant public health, agricultural, industrial, environmental, and scientific challenges. The project will address both: (1) the

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security positive contributions to peaceful scientific, 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. The committee recognizes that the recommendations set forth in this report will be meaningful only if they are embraced by Russian officials and specialists as well as by American and other international counterparts. Therefore, the report draws on extensive interactions between committee members and Russian colleagues over the course of 18 months in an effort to ensure that the recommendations are realistic, with a reasonable chance of broad acceptance in Russia. At the same time, the committee has been sensitive to the interests of Russia’s partners, especially U.S. government departments and agencies. The committee believes that these partners will be receptive to many of the recommendations presented in the report. As indicated in Appendix B, committee members and staff visited more than 30 relevant government organizations, research centers, commercial firms, and educational institutions in Russia and consulted with more than 100 knowledgeable Russian officials and specialists during the course of the study. In addition, they attended three conferences in Russia on topics addressed during the study, and they invited leading Russian specialists to participate in a special meeting on the themes of the study in the United States. Similarly, dozens of American and European officials, specialists, and interested observers who are familiar with Russian policies, activities, and attitudes were consulted. Thus, the recommendations set forth in this report are well grounded in authoritative views on the conditions, developments, and trends in Russia. Russian government bodies, international organizations, foreign aid agencies, and other Western organizations operating in Russia have issued related reports on trends, expectations, and limitations in biological science and technology. Several of the most important publications are cited in this report. However, for many of the issues discussed in the report, limited or no written documentation was available to the committee. Therefore, the judgments of the committee were based in large measure on the discussions and personal observations of committee members and staff. For well-informed Russian colleagues, there may be little information and few ideas that are new in this report. Many of them have argued for years that a principal problem facing almost all Russian organizations is the lack of funds for salaries, equipment, start-up capital for commercial ventures, and operating expenses. The committee is optimistic, however, that even for our best-informed colleagues

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security in Russia, the report will help focus discussions and decisions on policies and programs with the highest payoff—now and in the future—in a country that is still recovering from the enormous economic shocks of the past decade. While funds are obviously important, Russian colleagues are also aware of the importance of appropriate policies, priorities, and incentives for combating infectious diseases. As an example of the intentions of the Russian government, Government Decree #1187-r of August 21, 2003, set forth a plan for the stimulation of innovation and the support of venture capital investments.1 The plan covers the creation of governmental support mechanisms for conducting major projects aimed at: (1) creating competitive, science-intensive products; (2) developing systems for sharing scientific and technical information; (3) improving conditions for production of high-tech products; and (4) reducing commercial risks for innovative activities. However, securing sufficient funding to provide a stimulus in these areas has, and may well continue to be, a challenge into the future. Rather than repeat the efforts of others, or attempt to address all aspects of biological science and technology, the committee decided to focus on a few key dimensions of Russia’s biological research, production, and service infrastructure about which it can make well-founded judgments. Indeed, it simply would not have been possible within the time and financial constraints of this study to cover all aspects of these fields. Thus, as suggested earlier, this report concentrates on disease agents, particularly those that could pose a threat to large population groups, whether introduced through natural or terrorist means. The committee did not attempt to address the biological capabilities and related activities of the Russian Ministry of Defense. The ministry’s activities in biological research and development are believed to be significant, and they should be oriented not only toward supporting narrowly defined military missions but also to reinforcing broader public health efforts. But the committee simply did not have sufficient authoritative information to make judgments on the policies, programs, or future role of Russian military and military-related organizations. The committee did consider the activities at some institutions that were once involved in Soviet military activities, especially the institutes affiliated with Biopreparat, since committee members had considerable experience in interacting with these organizations (see Box 4.1). In addition, the committee did not consider issues associated with international negotiations to strengthen the Biological Weapons Convention, even though these negotiations have implications for international scientific cooperation. The committee believed that an analysis of the process of international negotiations 1   The reference to this decree was provided to the committee by a senior Russian researcher in October 2004. The decree outlines a plan for the stimulation of innovation and support of venture capital investment.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security would have detracted from fulfilling its primary charge and therefore decided to concentrate on other aspects of Russia’s future in bioscience and technology. As previously noted, a recurrent theme throughout the report is the need for additional funding. There are a number of funding sources for health-related and agriculture-related activities in Russia, in particular Russian ministries and agencies, foreign governments, and international organizations. The committee considered the possibility of developing a conceptual framework for evaluating the relative importance of approaches that are recommended in this report. However, each funding source has its own priorities and criteria, therefore such a framework would be of little use. At the same time, the committee has been mindful of the need for more detailed analyses of the costs and benefits of each recommendation, and such analyses should be undertaken by the responsible Russian organizations that have access to more detailed and more authoritative information concerning costs. Nevertheless, the committee considered the funding capabilities of relevant organizations when developing its recommendations. Of particular significance will be the interest of senior Russian government officials in the recommendations, since they must make policy judgments concerning the allocation of resources. Slow Recovery of Russian Capabilities in Biological Science and Technology Russia has a vast array of biological research and development facilities staffed by tens of thousands of scientists, engineers, and technicians who are capable of contributing in many ways to public health, agricultural, and industrial activities. Russia’s ecological diversity and expanse are unparalleled, and its specialists have a long and distinguished history in research and epidemiological investigations of many infectious agents of global interest. They have developed valuable banks of biological specimens and scientific data, including materials and information from remote areas of Russia and nearby countries where outbreaks of disease are of continuing concern. Clearly, significant portions of Russia’s technical strength have declined in recent years, but the nation’s remaining biological expertise is still of considerable importance. The early years of this millennium find Russia slowly recovering from the financial difficulties of the 1990s. Economic challenges have engendered worldwide concern that Russia may have inadequately controlled biological assets, including organisms in storage areas and laboratories, in addition to the well-known specialized knowledge of many researchers. Dangerous strains and relevant technologies could be tempting targets for nefarious parties determined to misuse advances in biology to destroy their adversaries. Fortunately, the political and economic trends that affect health and agriculture identified below are generally favorable. Therefore, achieving the ten-year vision for Russia set forth in Chapter 2 is much closer to reality than it would have been just two or three years ago.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security Both politicians and the general public recognize the dire consequences of the deterioration of the health of the population in Russia. Unproductive workers, unfit military conscripts, debilitated pensioners, and underachieving children are causing increasing public demands for greater allocations of government resources to the prevention and treatment of widespread health problems. These problems include HIV/AIDS, tuberculosis, hepatitis, influenza, measles, and nosocomial infections that affect large segments of the population.2 Russian investments in health-related research programs are increasing, and Russian research institutions are successfully competing for external resources. This allows research institutes greater control in determining their research agendas. They are no longer tied directly to the priorities of foreign organizations which were once the primary funding source for many institutes. As Russia’s economy improves, its embryonic biotechnology industry is charting an ever more optimistic course and is beginning to achieve success. Many Russian entrepreneurs understand what is needed to compete effectively in an evolving market economy, both in concept and in practice. They are also devising approaches to overcome the difficulties of marketing products domestically and internationally in both the agricultural and public health arenas. Although Russian investors are often hesitant to risk their funds in biotechnology endeavors, a few—particularly those backed in part by government financing—have begun to take risks. Sensitivities within the Russian government regarding the dangers of bioterrorism and a recognition of the steps needed to reduce this threat are increasing (see Box I.1). Of particular concern is the possible misuse of infectious agents that cause anthrax, plague, and smallpox. Extremists or mercenaries with ties to Chechen separatists seem to be of the greatest concern in this regard within Russia. Despite these advances, the recovery period from the economic collapse of the 1990s will be long, and the emergence of demands from paying customers for biotechnology products will be delayed accordingly. Government resources for enhancing health care at the regional and local levels in Russia will undoubtedly remain modest for many years to come. All the while, skepticism will continue to mount in Russia about the quality and effectiveness of imported drugs from developing countries, even though such imports may be omnipresent on Russian store shelves. Nevertheless, discernible progress in combating infectious diseases can be made if political will and available resources are carefully directed at the priority topics suggested in this report. The Russian government must, of course, continue to develop its own vision of the future, and this report should provide useful 2   The dire state of the public health care system in Russia is discussed in C. Dye, 2005.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security BOX I.1 A Russian Perspective on the Bioterrorism Threat “Realization of the threat by government agencies is deepening, but it is still in the embryonic stage and not manifested in tangible counter-measures. The growing concern is a consequence of the concern on the part of experts who have been vocal in communicating their views.” SOURCE: Russian biological scientist (November 2004). ideas to that end. Yet neither the Russian government nor the international community will be able, in the near term, to finance all of the additional activities that are needed. Therefore, necessary activities should be supported incrementally, beginning as soon as possible. It is essential when setting priorities, however, that the Russian leadership establish a comprehensive framework for addressing all aspects of combating infectious disease. Recent events in Russia indicate progress in this regard. In 1997 the Duma passed a law requiring the development of a concept for improving the public health and the medical science situation (see Appendix C). Since that time various government ministries have been developing goals and objectives for policies and programs that carry out that concept (see Appendix D for an example of this effort). This report provides additional ideas and recommendations that should be helpful in further efforts to transform that concept into practical results, which benefit the population of Russia and contribute to global health more broadly. Throughout the course of this study, the organizational structure of the Russian government underwent substantial changes (see, for example, Box I.2 on new, high-level organizational responsibilities for health-related activities and Appendix E for the responsibilities of the new Federal Service for Supervision in the Sphere of Health and Social Development). While a reformed array of ministries, agencies, and committees took shape during 2004, the new Ministry of Education and Science almost immediately proposed a reconfiguration of the hundreds of public research institutions that are active in all areas of science, particularly those affiliated with the academies of sciences of the country. As this report went to press, the debate over whether and how to reduce the number of research institutions was under way. While this report discusses the need to concentrate limited resources at selected centers of excellence, there has been no effort to analyze alternative configurations of Russia’s research complex.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security BOX I.2 Organizational Structure for Health Activities in Russia Ministry of Health and Social Development Federal Agency for Health and Social Development Federal Medical-Biological Agency Federal Service for Surveillance of Consumer Rights Protection and Social Welfare Federal Service for Surveillance of Health and Social Development SOURCE: Ministry of Health and Social Development (May 2005). U.S. Interest in Cooperation The U.S. interest in bilateral cooperation with Russia in the fields of biological science and technology has been stimulated in part by the following factors: high potential of Russia’s biological research and industrial complex to support both civilian and military programs significance of efforts by the Russian government during the past several years to revitalize research capabilities and apply them to solving social and economic problems Russia’s vast ecological diversity, which offers unique environments for research in the life sciences and provides opportunities for detecting the early emergence and movement of dangerous diseases of global importance marketing opportunities within Russia for western companies that provide biological products and services Many of the cooperative activities promoted by the U.S. government during the past decade have been nonproliferation programs designed to help prevent the spread of Russian expertise to countries and groups that may attempt to develop biological capabilities for purposes hostile to U.S. interests. Directly related cooperative programs supported by the U.S. government are aimed at improving the security of biological strains and related materials within Russian facilities in an effort to prevent their acquisition by unauthorized persons with nefarious intentions. Thus, U.S. government-sponsored programs have involved a variety of research groups in Russia that include many scientists who had participated either directly or indirectly in the Soviet biological weapons program. The principal bilateral programs are described in the text and appendixes of this report. Smaller cooperative programs—financed by the U.S. government and by

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security U.S.-based private foundations—have supported the exchange of individual scientists and the development of collaborative research projects not limited to former Russian military-oriented specialists. In the commercial sector, a few U.S. companies have supported biological research projects and manufacturing of biological products in Russia, sometimes with U.S. government assistance. However, most Western biology-oriented companies have limited their investments in Russia. The financial risks are often too great despite the high qualifications of potential Russian partners. They have preferred to seek quick sales of a few products while waiting to see how the environment for broader business ventures in Russia develops. A few international companies are developing major efforts to sell vaccines, drugs, and diagnostic products that have been produced abroad in Russia. Several have shown interest in establishing their own production facilities in Russia when there are financial incentives, particularly through foreign assistance programs. In sum, most cooperative efforts have been in the scientific arena rather than the commercial arena. The positive influence of cooperative programs, both public and private, in sustaining Russian research efforts during a time of economic deprivation should not be underestimated. Background Provided by Related NRC Reports and Consultations in Russia During the past decade, the Institute of Medicine, with support from a variety of U.S. government organizations and private foundations, has published numerous reports that address microbial threats to populations worldwide, highlight new concerns over bioterrorism, and review the adequacy of U.S. laws and regulations in the control of dangerous pathogens. For example, the 1992 report Emerging Infections: Microbial Threats to Health in the United States warned leaders in the United States and abroad that infectious diseases are becoming an increasing security threat. The 1997 report America’s Vital Interest in Global Health underscored the significance of the spread of infectious diseases across boundaries at accelerating rates. The 2003 report Microbial Threats to Health highlighted the connections between biological, environmental, social, and political factors that complicate the development of meaningful and sustainable solutions to address infectious diseases. The related report, Countering Agricultural Bioterrorism, undertaken by the NRC’s Board on Agriculture at the request of the U.S. Department of Agriculture, also provided helpful background for conducting this study (see Appendix F for a list of recent reports about developments in global health published by the National Academies). In 1997, the National Academies released Controlling Dangerous Pathogens, A Blueprint for U.S.-Russian Cooperation. This report, financed by the U.S. Department of Defense (DOD), provided an important framework for new cooperative activities. It emphasized the benefits to both countries—particularly the scientific, public health, security, and political benefits—of an expanded bilateral

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security engagement program involving Russian institutions that had been engaged in biodefense activities during the Soviet era. Since that time, the NRC has sent several scientific teams to Russia to conduct peer reviews of Russian research proposals that were considered within the framework of DOD’s nonproliferation efforts funded by the Cooperative Threat Reduction program (also known as the Nunn-Lugar program). Additional recent visits to Russian institutes by members of this committee have been supplemented by a wide range of consultations with U.S. and Russian policy officials and entrepreneurs about developments in Russia well beyond defense-related activities and have provided further insights that are incorporated into this report. This report expands the focus of the 1997 National Academies report Controlling Dangerous Pathogens. While the earlier report concentrated on bilateral programs of potential interest to DOD, this report places the issues in a much broader global context and emphasizes steps that should be undertaken by both the Russian government and international partners. The economic conditions, the priorities attached to public health issues, and the concerns over bioterrorism in Russia have changed dramatically since 1997. Moreover, the size and scope of U.S.-Russian collaborative efforts have expanded greatly in recent years. Still, like the 1997 report, this effort should be useful to those officials and specialists in the two countries who are developing plans for future U.S.-Russian cooperation in preventing, detecting, or controlling the ever-present danger of infectious disease outbreaks whether they are naturally occurring or intentionally introduced. As other countries expand their interest in cooperating with Russia, the lessons that have been learned in the course of this study should be helpful to them. ORGANIZATION OF THE REPORT Chapter 1 presents a brief review of the context for U.S.-Russian cooperation in addressing the threats of infectious diseases that lie ahead. It sets forth important aspects of a vision for Russia’s development of biological science and biotechnology over the next 10 years and briefly describes the current state of Russian policies and programs in this field. Chapters 2 through 5 discuss four topics that are of central importance to the evolution of a stronger research and technology infrastructure in Russia. They are as follows: strengthening Russia’s surveillance capabilities for detecting, diagnosing, and reporting outbreaks of both well-known and newly-emerging diseases (Chapter 2) focusing laboratory research and epidemiology to support priority public health programs and related agricultural programs more effectively (Chapter 3) developing a high-quality biotechnology sector that in time will reduce

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security dependence on imports of foreign vaccines and drugs while providing improved and affordable support to the health and agriculture sectors (Chapter 4) nurturing a new generation of young Russian leaders in biological science and technology (Chapter 5) Progress in each of these areas can improve the basis for achieving a vibrant and sustainable capacity to address both the immediate and the long-term social, economic, and security needs of Russia that are intertwined with biological science and technology. Such progress can also provide new opportunities for international engagement that benefits the global community more directly. Chapter 6 of this report highlights several cross-cutting issues directly related to expanded and more effective U.S.-Russian cooperative activities. It calls for a new high-level intergovernmental commission to promote cooperation. A further significant goal is the continued integration of former defense facilities and associated technical personnel into the broader civilian scientific infrastructure of the country. Sources of financing to sustain programs that help prevent the emergence and reemergence of infectious diseases are also important. New funding sources can reduce obstacles to international cooperation while encouraging a true partnership between the scientific communities of Russia and the United States. Finally, a number of figures, tables, boxes, and appendixes provide supplemental information and perspectives on recent developments in Russia. The committee does not endorse these documents and comments nor the accuracy of the data presented, but the committee believes that they contribute to the context for the report.