4

Phase 2: An Era of Sustained Cooperation

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THE UNCERTAIN FUTURE OF RUSSIA

Predicting conditions in Russia 5 to 10 years into the future is uncertain. Russia's national security apparatus, its economic reform agenda, and even its system of political governance are under considerable stress; changes in all of these areas are likely. Depending on the character of such changes, the consequences for defense scientists and public health activities in that country could be substantial. Program recommendations for the distant future concerning national security and public health issues thus should be flexible.

At the same time, U.S.-Russian relations are continually evolving, with bilateral cooperation in areas of national security being particularly sensitive to the state of political relations. In addition, bilateral cooperation directed toward dangerous pathogens cannot be isolated from diplomatic progress in resolving disagreements about compliance with the Biological Weapons Convention (BWC). The committee believes that an ideal outcome involving the BWC and expanded bilateral cooperation would be a synergistic effect, with high-payoff scientific cooperation improving the climate for diplomatic progress and improved political understanding paving the way for broader scientific interaction. The bilateral cooperation envisaged would be a tangible manifestation of U.S. and Russian commitments to Article X of the BWC, which calls for cooperation in the prevention of diseases.

Another area of uncertainty is the future interest of countries in addition to the United States and Russia in a global approach for expanding activities directed toward dangerous pathogens. Whatever the level of interest, however, there is no substitute for U.S. leadership in encouraging Russia to adopt transparency measures, such as those described below, for a broad range of facilities and activities. Thus, efforts to globalize activities should be welcomed, but they are not a substitute for strengthening U.S.-Russian cooperation.

A MODEL FOR SUSTAINED COOPERATION

Despite the foregoing uncertainties, the committee decided to offer a model of a desirable and realistic program of sustained bilateral cooperation. Such a model, referred to here as Phase 2, could provide a goal toward which U.S. and Russian officials and specialists can direct their energies. Ideally, as the Pathogens Initiative carried out during Phase 1 approaches its end in fiscal year (FY) 2002, the enthusiasm in both countries for bilateral cooperation should have reached such a high level that Phase 2 activities can build on past successes without interruption.

Development of this model does not mean that the Pathogens Initiative would be useful only if a Phase 2 program develops beginning in 2003. Indeed, the benefits of the Pathogens Initiative identified in previous chapters should be realized in both Phase 1 and Phase 2. At the same time, a Phase 2 program could enable the two countries, as well as others, to utilize these benefits more fully and make additional contributions to international security, economic development, public health, and international science.



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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation 4 Phase 2: An Era of Sustained Cooperation ◆ ◆ ◆ ◆ ◆ THE UNCERTAIN FUTURE OF RUSSIA Predicting conditions in Russia 5 to 10 years into the future is uncertain. Russia's national security apparatus, its economic reform agenda, and even its system of political governance are under considerable stress; changes in all of these areas are likely. Depending on the character of such changes, the consequences for defense scientists and public health activities in that country could be substantial. Program recommendations for the distant future concerning national security and public health issues thus should be flexible. At the same time, U.S.-Russian relations are continually evolving, with bilateral cooperation in areas of national security being particularly sensitive to the state of political relations. In addition, bilateral cooperation directed toward dangerous pathogens cannot be isolated from diplomatic progress in resolving disagreements about compliance with the Biological Weapons Convention (BWC). The committee believes that an ideal outcome involving the BWC and expanded bilateral cooperation would be a synergistic effect, with high-payoff scientific cooperation improving the climate for diplomatic progress and improved political understanding paving the way for broader scientific interaction. The bilateral cooperation envisaged would be a tangible manifestation of U.S. and Russian commitments to Article X of the BWC, which calls for cooperation in the prevention of diseases. Another area of uncertainty is the future interest of countries in addition to the United States and Russia in a global approach for expanding activities directed toward dangerous pathogens. Whatever the level of interest, however, there is no substitute for U.S. leadership in encouraging Russia to adopt transparency measures, such as those described below, for a broad range of facilities and activities. Thus, efforts to globalize activities should be welcomed, but they are not a substitute for strengthening U.S.-Russian cooperation. A MODEL FOR SUSTAINED COOPERATION Despite the foregoing uncertainties, the committee decided to offer a model of a desirable and realistic program of sustained bilateral cooperation. Such a model, referred to here as Phase 2, could provide a goal toward which U.S. and Russian officials and specialists can direct their energies. Ideally, as the Pathogens Initiative carried out during Phase 1 approaches its end in fiscal year (FY) 2002, the enthusiasm in both countries for bilateral cooperation should have reached such a high level that Phase 2 activities can build on past successes without interruption. Development of this model does not mean that the Pathogens Initiative would be useful only if a Phase 2 program develops beginning in 2003. Indeed, the benefits of the Pathogens Initiative identified in previous chapters should be realized in both Phase 1 and Phase 2. At the same time, a Phase 2 program could enable the two countries, as well as others, to utilize these benefits more fully and make additional contributions to international security, economic development, public health, and international science.

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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation ORGANIZATIONAL ARRANGEMENTS FOR A PHASE 2 PROGRAM If bilateral cooperation develops rapidly as a result of the Pathogens Initiative, the intergovernmental coordinating mechanism suggested in Chapter 3 becomes increasingly important. During Phase 2, a formal structure for intergovernmental coordination would be essential. One approach for Phase 2 would be to establish an intergovernmental commission, supported by national coordinating bodies, to guide and coordinate cooperative efforts related to dangerous pathogens. The national security and public health aspects of a significantly expanded program of cooperation appear sufficiently important to warrant consideration of a commission dedicated exclusively to this topic. Although the two governments might decide to use another approach, for the purposes of this discussion it is assumed that a commission would be the coordination mechanism of choice. From the beginning, the commission would be aware of all joint programs involving dangerous pathogens, but it would be committed to facilitating, not complicating, implementation of previously existing bilateral programs. The commission would be responsible for a variety of activities such as the following. Establishing priorities and providing overall guidance for all aspects of cooperation—both new and existing activities—and, on a selective basis, reviewing and evaluating progress in implementing activities of special interest Approving new cooperative activities Making financial commitments for cooperative activities Ensuring coordination between new projects and related existing projects and assisting the arrangement of logistics support Disseminating both scientific reports and public information about activities of broad interest Developing bilateral arrangements that address issues such as intellectual property rights, mechanisms for the rapid importation of essential equipment and supplies, and living accommodations for visiting scientists and their families. Much of the technical work of the commission would be carried out by bilateral expert groups in areas such as research cooperation, joint efforts in epidemiology, and common requirements for biosafety. Some topics of likely interest to such groups are addressed later in the discussion of technical aspects of the program. The national coordinating body in the United States should build on experience during the Pathogens Initiative, which calls for collaborative efforts of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and nongovernment sector. Coordination of bilateral and multilateral activities would probably require greater attention during Phase 2. Also, linkages with joint efforts on other public health concerns should be strong. GENERAL CHARACTERISTICS OF PHASE 2 Given the legacy of mutual mistrust in this field, an era of sustained cooperation should emphasize transparency at several levels. Building on the initial experience in implementing transparency arrangements associated with specific joint projects, Phase 2 would call for broader transparency arrangements for handling dangerous pathogens at the institutional and national levels, as well as at the project level. A number of components of the Phase 2 program would build on early experience gained within the framework of the Pathogens Initiative. Therefore, details of these activities should be modified as

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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation such experience accumulates. Some of the suggested components of Phase 2 may be incorporated at an earlier date into the Pathogens Initiative if cooperation develops more rapidly than anticipated. When fully developed—perhaps in 7 to 10 years—the Phase 2 program would provide a framework for cooperative activities in many aspects of the handling and use of dangerous pathogens in both countries. It would be sufficiently broad in scope that any research, development, or production group with interests in dangerous pathogens in either country would be eligible to participate in cooperative projects. The scientific activities of research teams in both countries would be reported regularly, and the teams would welcome visits to their facilities and detailed discussions of their activities whenever possible. Cooperation would include joint projects at high-hazard facilities and visits by foreign specialists to familiarize themselves with such facilities. It also would include joint efforts to protect and account for any strains of infectious agents that are of mutual interest. Finally, cooperation in biosafety could help ensure that activities involving dangerous pathogens are being handled responsibly in both countries. The need to protect intellectual property rights and control the dissemination of information that is sensitive because of potential application to biological weapons (BW) is clear. Such requirements, however, should not unnecessarily exclude activities from consideration when cooperative programs are being developed. By the time Phase 2 is being implemented, the parties to the BWC may have adopted a verification protocol; in this case, procedures concerning access to facilities and information of all types might already have been specified. Such procedures could serve as guidance for implementation of the broadly based program envisaged during Phase 2. If such a protocol is not in place, the commission suggested earlier would be even more important and would have to develop procedures on its own to expand the scope of transparency developed during the Pathogens Initiative. Joint research projects would continue to be the core of activities under the purview of the commission. However, another key aspect in addressing both political and scientific concerns would be steps in both countries to promote effective national regulations for controlling dangerous pathogens. Effective enforcement procedures and sharing of experiences would be particularly important in confidence building. Over time, the commission would seek to establish additional confidence-building measures. In particular, its goal would be the development of rules to govern a comprehensive exchange of information between the two countries on the handling and use of dangerous pathogens. Ideally, the general characteristics of all significant research and related facilities involved with dangerous pathogens in both countries would be known to each government. The activities of research teams would be regularly reported, as would the strains of infectious agents held for research and related purposes. As with the cooperative activities proposed, measures to ensure adequate protection of intellectual property and other sensitive information in a manner that does not undercut the broader transparency objectives should be developed. 1 Currently, such comprehensive exchange of information is difficult if not impossible to achieve, but as trust between the two countries grows, greater openness should become possible. Moreover, because of concerns about biosafety and terrorism, there is increasing government interest, at least in the United States, in developing such requirements for reporting to national authorities. Thus, there may be both an international and a national basis for bilateral confidence building through expanded exchanges of information. 1   For example, in the United States a mechanism for protecting proprietary chemicals and providing adequate information for regulatory purposes is well developed and may serve as a precedent for application in the field of biology.

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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation TECHNICAL ASPECTS OF THE PROGRAM The following sections describe specific approaches in several areas, together with an estimate of their implementation costs to the U.S. government beyond current investments. Adjustment of some of these suggestions and of the cost estimate will inevitably emerge during more detailed program discussions within the U.S. government and with Russian officials. Research Collaboration Specialists representing the scientific interests of both countries would meet at least annually to develop agendas for joint research projects for subsequent approval by the two governments. When Phase 2 reaches maturity, the research program would probably be somewhat larger than that of the Pathogens Initiative, perhaps 30 percent. Growth to this level is based on several considerations. First, some Russian specialists likely will continue to play key roles in legitimate military research activities during the Pathogens Initiative because they are reluctant to abandon their assured sources of income for participation in an international program that may be only temporary. However, after five years of continuous collaboration, these specialists should recognize the importance and sustainability of the program, and some could be expected to become applicants for participation in an expanded program. Second, interest in the United States should grow, particularly if the Pathogens Initiative is successful in attracting young U.S. specialists who experience firsthand the benefits of international scientific cooperation. Although the committee supports modest growth, it believes that the program should be capped to ensure the high quality of the projects supported. As noted in Chapter 3, this maximum level of activity is driven by both the importance of limiting the number of facilities involved in work on dangerous pathogens and the manpower pools of specialists available in the two countries to address important public health issues in a highly specialized field. The following approach, which could be formally established by the commission, appears appropriate for the expanded program during Phase 2: Annual or semiannual competitions should be held among Russian institutions and investigators for financial support for projects, including review of applications for support of research on selected pathogens as in the Pathogens Initiative. Other dangerous pathogens and cross-cutting research projects that individual investigators propose for support would probably receive much greater emphasis. Joint U.S.-Russian peer review panels should be established to select projects for support. Final government approvals should be obtained and arrangements made for financial support, including limited U.S. support for Russian activities through the International Science and Technology Center (ISTC) as discussed below or through an equally effective mechanism if the character of the ISTC were to change in the years ahead. Epidemiology During Phase 2, special attention would be given to research related to the epidemiology of diseases associated with dangerous pathogens, although some activities might be initiated on a limited scale during Phase 1. Combined capabilities in this field should have major public health benefits in combating the spread of diseases both nationally and worldwide through the following mechanisms. Rapid exchanges of significant information on trends and unusual occurrences of diseases associated with dangerous pathogens in the United States and Russia are very important. Some Russian institutions require additional electronic equipment for such communication, and this need should be considered within the context of specific joint projects, as discussed in Chapter 3. Also, joint workshops

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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation would be useful in developing a general consensus on the frequency of and mechanisms for data exchanges and the variety and format of data to be exchanged. This effort should be consistent with the interests of the World Health Organization (WHO), and should support its Weekly Epidemiology Reports. Related to the international exchange of data is the need to strengthen the internal capabilities of Russia to rapidly assess and process information about disease trends and outbreaks. Projects that enable selected institutes, particularly key members of Biopreparat, to contribute to the national effort of the Ministry of Health should be considered. Bilateral workshops and joint research projects should be directed to identifying and developing improved technologies for the diagnosis of agents and diseases of concern. During outbreaks in one country of certain diseases linked with dangerous pathogens, specialists in the other country should be encouraged to forward relevant information and identify ways in which they could be most helpful in assessing and responding to such outbreaks. When appropriate, specialists from the other country would be invited to review information and assist in assessments if they have special expertise that could be helpful. Russian specialists who are involved in field investigations should be encouraged to apply for participation in CDC training programs. Research projects related to epidemiology that involve both former Soviet BW institutes and civilian institutions, (for example, institutes of the Biopreparat complex teamed with those of the Ministry of Health or Academy of Medical Sciences) are of special interest. Indeed, strengthening internal organizational linkages within Russia is essential if its defense scientists are to play a significant role in the national public health effort. Biosafety The objective of efforts in both countries in the area of biosafety would be to promote consistency in biosafety criteria and practices research laboratories or other facilities that handle dangerous pathogens. Such efforts would help provide assurance (1) that infectious agents are handled in conformance with the WHO Laboratory Biosafety Manual2 and (2) that infectious agents are not transferred to parties who are not authorized to handle them. Also, ensuring that regulations for vaccinations and biosafety procedures are consistent will facilitate reciprocal visits to high-hazard laboratories. The commission should concentrate on reviewing the development, implementation, and enforcement of national systems in the United States and Russia for controlling the handling and use of dangerous pathogens. It should encourage each government to develop and use approaches that are both effective and transparent, thereby contributing to mutual confidence about compliance with international obligations. In considering the regulatory framework, the commission might examine, for example, the working lists of infectious agents already set forth in regulations and guidance documents, procedures for registering facilities with national authorities, national requirements for transferring agents nationally and internationally, biosafety criteria for facilities, requirements for disposal of agents, and training of scientists and support personnel. Among the mechanisms for cooperation related to biosafety are the following approaches: Regular exchanges of information on the state of development of national regulatory systems; Special exchanges of data on specific activities of particular interest to each country, such as research being carried out at biocontainment or other specialized facilities; and 2   World Health Organization. 1993. Laboratory Biosafety Manual, 2nd Ed. Geneva: WHO.

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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation Reciprocal visits to selected facilities by biosafety experts on the basis of invitation. ESTIMATED COSTS It is expected that as Phase 2 is developed, the Russian participating institutions will be in a position to pay increasingly more of their costs of these cooperative activities. Also, an orderly transition between funding of the Pathogens Initiative and financial support for projects in Phase 2 is recommended. In particular, as indicated in Table E-2, the funding of three-year projects during the last two years of the Pathogens Initiative should provide an important base of activities for the first two years of Phase 2. The time needed for full development of Phase 2 depends in large measure on the Russian economy and the priority given to efforts directed toward dangerous pathogens. Because the Russian economy will probably remain weak for a decade or more, U.S. support will be necessary for some Russian activities. In particular, U.S. contributions to Russian expenses might concentrate on (1) purchases of specialized equipment and supplies for experiments in Russia that are directly linked to experiments in the United States and (2) international travel of selected Russian participants who otherwise might not be able to travel to the United States. However, U.S. funds should be used primarily to cover the costs of U.S. participants. Without considering inflation, the cost to the United States of carrying out activities during Phase 2 is estimated at approximately $10 million per year. About $5 million (50 percent) would support the expenses of U.S. collaborators, with each of an estimated 60 collaborators (20 new collaborators undertaking three-year projects each year) receiving an average of $80,000 per year for their activities. An additional $2 million (20 percent) would be for administrative expenses related to U.S. participation in the commission and its expert groups, which would have five full-time staff members. About $1 million (10 percent) would be used for workshops, project development activities, and planning and evaluation meetings between Russian and U.S. specialists. The remaining $2 million (20 percent) would support the requirements of Russian specialists that are beyond their own means: small pieces of equipment for experiments of special interest to the United States and associated project related international travel for some participants (at an estimated cost of $35,000 per year per project). Sustained U.S. funding for Phase 2 would undoubtedly require agreement between the executive branch and Congress on a line item in the budget of a selected agency. It is premature to speculate which agency should have financial responsibility. ANTICIPATED BENEFITS The Phase 2 program would provide financial, scientific, and information-sharing incentives for the two countries to broaden and sustain linkages between their specialists. The impact of specific joint efforts on public health and other problems is difficult to predict, but Russian and U.S. specialists are in a strong position to contribute substantially in this area of increasing worldwide concern. A likely effect of a sustained program would be adjustment of the structure of the Russian research enterprise dealing with dangerous pathogens. Research projects would be increasingly concentrated at a handful of the best institutions in the country that emerge as centers of excellence. Some weaker institutions would slowly lose their ability to conduct research on dangerous pathogens and would have even greater difficulty commanding financial support for such work than during the current crisis period. Special efforts would be necessary to ensure that the stronger institutions are prepared to absorb some scientists from the weaker institutes lest they be tempted to transfer their know-how to states of

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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation proliferation concern. Although consolidation in the Russian research complex would appear to be inevitable, such consolidation should be carefully managed. If the United States and Russia are able to work together constructively over the long term, the tone of international diplomacy in this field could be significantly improved, resulting in new and important mitigation of the threat of proliferation and terrorism and improved U.S.-Russian relations in an area that too frequently has been punctuated with acrimony. In addition, long-term joint efforts would make major contributions to reducing global risks from emerging and reemerging infectious diseases.