Proposal for Strengthening Scientific Cooperation among States Parties

David Heymann, MD (Director, Emerging and Other Communicable Diseases Surveillance and Control, World Health Organization)

David Fidler, JD (Federation of American Scientists Working Group on Biologial Weapons Verification and Indiana University Law School)

Barbara Hatch Rosenberg, PhD (Director, Federation of American Scientists Working Group on Biological Weapons Verification and State University of New York at Purchase)

The emergence of infectious diseases as a global problem in the late twentieth century has made a global system for monitoring emerging diseases an urgent necessity to protect the health of people all over the world. Components of such a system are under development by the World Health Organization (WHO) and individual countries, but the recognition and diagnosis of new outbreaks, especially in the developing world, will remain the weak link for the foreseeable future. A global network of outbreak-monitoring centers, each with its own regional network, is urgently needed to provide early warning so that outbreaks can be contained and epidemics prevented.

We propose that WHO establish a discrete, new program to fill this gap, and that the States Parties to the Biological Weapons Convention (BWC) undertake to support it. A description of the proposed Network of Early Warning Sites ("Network") is found in later sections of this proposal.

Contributions by States Parties

WHO will need extra-budgetary resources to support this program. Although the Network would advance global health significantly, the cost is not great--about $7 M per year. The BWC States Parties, which are obliged under Article X of the Convention to cooperate scientifically for the prevention of disease, are a highly appropriate source of support. To be successful the network will need contributions from every State Party, whether in the form of financial contributions (to the program's Trust Fund at WHO), donated materials or services, and/or participation and cooperation at the clinical level.

As a step in strengthening implementation of Article X, we suggest that the protocol under negotiation require all States Parties to contribute to the Network program in whatever form(s) their circumstances permit. All contributions would be made directly and independently by individual States Parties to the Network program at WHO. The prospective BWC Organization will not act as an intermediary or play a substantive role in the program, which will be conducted solely by WHO.

Advantages to States Parties

Requiring the States Parties to support the proposed Network program at WHO would produce many benefits, including:

The program will benefit all countries by providing early warning to prevent the spread of disease beyond national borders;
It will strengthen the infectious disease capabilities of key institutions in the developing world, making them vital regional resources for lifting the burden of infectious disease;
It will give priority to States Parties in terms of Center locations and training, when possible to do so without compromising the objectives of the program;
It will increase scientific cooperation among the countries of each region and among the different regions of the world,
--without jeopardizing intellectual property and
--without duplicating or overlapping any existing activity;
It will complement existing infectious disease programs, thereby increasing the effectiveness of them all;
It will utilize existing services, whenever possible, and coordinate them for maximum benefit at little or no added cost;
It will use the established, neutral channels at WHO for rapid reporting of better, more comprehensive outbreak data;
It will provide universal benefits in terms of rational choices for vaccine development and better infectious disease control everywhere; and
It will serve as a means for fulfilling obligations of States Parties under the BWC and its Protocol, and will provide a positive incentive for adherence.

The Need for Global Monitoring

Numerous recent episodes of emerging and re-emerging infections attest to our continuing vulnerability to infectious diseases. These include the global AIDS pandemic, the continuing spread of dengue viruses, the now-frequent appearance of hitherto unrecognized diseases such as the hemorrhagic fevers, the resurgence of old scourges like tuberculosis and cholera in new, more severe forms, and the economic and environmental dangers of similar occurrences in animals and plants. Infectious diseases are the major killer, and there is reason to believe that the emergence of previously unknown diseases and the re- emergence of old ones are both increasing sharply. The causes include such social changes as mass population movements, rural-to-urban migration, accelerated urbanization, population growth, rapid transport, global trade, new food technologies and new life styles as well as environmental changes such as altered land use patterns and irrigation, that increase the risk or human exposure to animal reservoirs and vector-bome infections. These are global problems. A new infection may first come to light in a circumscribed area, but in suitable circumstances the infection can span continents within days or weeks, as influenza periodically demonstrates.

The Current International Response

WHO has responded by establishing the Division of Emerging and Other Communicable Diseases Surveillance and Control (EMC). EMC's strategy includes:

Revision of the International Health Regulations (IHR) to require member states to report a spectrum of communicable disease syndromes of international public health importance; the new regulations, now being field-tested, will be reviewed and proposed for adoption within two years.
Establishment of electronic linkages to facilitate rapid reporting of outbreaks to WHO by national Ministries of Health and WHO Collaborating Centers.
Timely distribution to the public, via the World Wide Web, of outbreak information received from governments. EMC also provides unconfirmed outbreak information on a confidential basis to international organizations and WHO Collaborating Centers that have a need to know.
Technical assistance, including manuals, standards and guidance, for the strengthening of national surveillance systems, which form the backbone of WHO's present outbreak monitoring system.

The weak link in this global monitoring strategy is the collection of clinical/epidemiological data. At present, no country in the world has an adequate national infectious disease monitoring system, and most are extremely weak in this respect. Some of the most important geographical regions, in terms of disease emergence, are the weakest.

Good outbreak data collection worldwide will require large resource allocations, and the necessary resources are not generally available. It is not realistic to wait for each government to improve its own outbreak monitoring sufficiently to participate as a vital component of a global system. Rather, international resources will have to be concentrated on a small network of strategically located centers, each of which will establish a regional sentinel network of its own to conduct active monitoring of outbreaks.

A network of outbreak-monitoring. centers will be a critical adjunct to the reporting system WHO is already developing. It will augment WHO's present efforts and make it possible to exploit existing programs more completely. Together they will form a fully-functional (although not universal) global monitoring system. WHO is unable to establish the Network, however, without external support. No sources for adequate support are anticipated, and no similar program is under consideration elsewhere. The BWC States Parties could find no more appropriate means for scientific cooperation under Article X than the support of this program.

Network Centers

A group of existing medical centers, strategically located geographically, will be prioritized for support to carry out active monitoring of the syndromes defined in the revised International Health Regulations, under the direction of a central office at WHO. The Centers invited to participate in the program may be national or private medical establishments. They will serve as global sentinels to provide early warning of dangerous outbreaks. Each Center will develop a broad diagnostic capability in order to serve as a regional resource that can save critical time by diagnosing specimens of unknown nature with a variety of tests at one stop. Few if any regions have this capability at present. Each Center will set up its own clinical/epidemiological outreach network in the form of a regional sentinel system. The participating Centers will be designated as WHO Collaborating Centers and will work closely with other programs at WHO.

The Centers will report outbreak information via electronic communications directly to WHO which will respond with aid to contain outbreaks when necessary and will handle the Centers' reports as it does all information received from WHO Collaborating Centers: it will release officially sanctioned reports publicly and confine other information to its confidential Outbreak Verification List. The network's central office will analyse infectious disease trends, create databases and stimulate research and development of needed vaccines and therapies.

The network will test procedures that could be adopted by national outbreak monitoring programs and other, more specialized WHO Collaborating Centers.

The Centers will be located in developing regions with relatively high likelihood of disease emergence and weak monitoring capabilities. The number of Centers will depend on the funding available; it will be important to have adequate funds for each designated Center. As an initial goal, eleven Centers could be selected, with a possible distribution as follows: India, Southeast Asia, China, Middle East, North Africa, Francophone Sub-Saharan Africa, Anglophone Sub-Saharan Africa, Amazon, one or two other regions in Latin America, and Russia. In addition, several institutions in North America, Europe, and Australia/Pacific could be invited to participate at their own expense.

Central Office

The Network's activities will be directed by its own central office at WHO. The office will oversee the program closely and will build the capabilities of the Centers in the developing world by providing communications, training, analytical equipment and reagents, and other assistance, as well as salaries for additional scientists when needed. The central office will maintain a quality control program to assure that standards set by the EMC Division are met. It will provide detailed instructions and guidance as needed.

In carrying out its functions, the central office will collaborate closely with other WHO offices and will use, to the extent possible, services that already exist at WHO, the Centers, and other (self-supporting) institutions. The central office will contract for those services or request their provision. For example, materials for quality control, diagnostic reagents, specialized reference laboratory services, and epidemiological training might be contributed on a cost basis or free of charge.

The central office will arrange for the training of Center personnel at central locations that will provide them with the best teachers and an opportunity to form international connections. The International Clinical Epidemiology Network (INCLEN), which has twelve Regional Clinical Epidemiology Resource Centers and many other active participating centers around the world, has expressed interest in conducting training for the Network.

Training of personnel for the regional network of each Center will take place at the Center itself, so that the regional associates will form bonds with each other and become familiar with the Center as their regional resource.

Program Chronology

The program will be conducted in two phases. The first phase, about five years, will consolidate the Centers' capabilities for regional outreach and for active monitoring for the selected syndromes. The second phase will extend monitoring to include the remaining syndromes specified in the revised International Health Regulations. If successful, the Network will then expand gradually to include new Centers. It would also be desirable for the Centers to evolve into international research centers similar to the International Centre for Diarrhoeal Disease Research (ICDDR) in Bangladesh, carrying out research on prevention and cure as well as performing active monitoring and diagnosis and responding to prevent epidemics. The Network program will encourage this development but will not include it.

Initiation of the Program

If donors show sufficient interest in the proposal, an international conference will be called to begin detailed planning of the program and set its establishment in motion. A preliminary conference on the concept has already been held by the Rockefeller Foundation at Bellagio, Italy in February, 1996. The conference will determine the syndromes for initial surveillance, considering both feasibility and medical need. The conference will also determine the best candidates for network Centers, weighing them on the basis of a) location, in terms of global infectious disease threats and regional need; b) present laboratory, clinical and epidemiological capabilities; and c) potential for development and outreach.

The program will be a discrete entity under WHO. It will be structured so that it is politically insulated and guided by scientific oversight. The structure will include:

A Scientific Steering Committee (SSC consisting of 10-15 outside scientific experts with broad geographical representation, appointed in consultation (in future) with SSC members. The SSC will set priorities and strategy and provide advice.
A Program Director, appointed with advice from the SSC, who will implement the program and propose office staff appointments.
A Centers Committee composed of Center Directors or their deputies, which will work with the Program Director to coordinate activities, exchange information and solve problems.
A dedicated Trust Fund located at WHO

Since the Network will benefit all nations, it is proper for it to be multilaterally supported by contributions to a dedicated Trust Fund from international organizations and the States Parties to the BWC and its Protocol. Direct contributions to individual Centers or governments for network activities would not, in general, be consistent with an integrated network. However, ancillary bilateral aid for specific purposes may be solicited by the central office. Success will depend on the integrated functioning of all the Centers and of all aspects of the program. Assurance of adequate extra-budgetary funding through the Trust Fund will be necessary before WHO can start the program.

Financial contributions to the Trust Fund, as well as contributions in kind and other forms of cooperation, would fulfill the obligations of both developing and, developed States Parties to cooperate for the prevention of disease.

A rough cost estimate for a network of eleven Centers for the first five-year period, based on data from the Pan-American Health Organization's surveillance system for two syndromes (acute flaccid paralysis and fever-and-rash), was similar to a more detailed estimate based on information obtained from EMC and a number of other health organizations. The five-year cost will be approximately US $ 35 M or $ 7 M per year. The global benefits of the program will far outweigh this modest cost.

A Proposal for Strengthening Scientific Cooperation among States Parties to the Biological Weapons Convention through a Network of Early Warning Sites for Monitoring Emerging Infectious Diseases