3

ASSESSMENTS OF NEEDS, CHALLENGES, AND RESOURCES (PLENARY SESSION)

Chair: Seval Korkmaz

In view of the complexity of both containment labs and the human and agricultural health challenges containment labs aim to ameliorate, a detailed examination of specific situations often helps in optimizing allocation of resources. This session was intended to provide an overview of local assessments including what they are, what purpose they serve, who should be involved in a local assessment, and what information might be included in an assessment.

Session chair Seval Korkmaz (Abdi Ibrahim, Turkey) opened by explaining that she has established many types of pharmaceutical laboratories that comply with Good Manufacturing Practices (GMP) and that each required a unique assessment. She then introduced the speakers and their topics indicating that the first talk would present many of the common needs and resources that might be considered while doing an assessment and that the second would give an example of a regional assessment.

PLENARY PRESENTATIONS

Global Biosafety and Biosecurity Challenges: Options for Nations with Limited Resources

J.   Craig Reed (Inspirion Biosciences, United States) described biosafety and biosecurity needs that are common in low-resource countries and the challenges associated with using the available resources to address those needs. He based his talk on a co-authored paper that has been submitted for publication (Heckert et al., 2011).

Dr. Reed first observed that all resources, including those of both donors and recipients, are limited and stressed the need for capacity building efforts that lead to self-sufficiency. He defined low resource countries as those with a United Nations Human Development Index less than 0.85, which roughly corresponds to a gross national income less than $10,000 per capita.

Low resource countries typically share a common set of needs. These include safe containment lab capacity, biosafety and disease surveillance equipment, diagnostic reagents that are handled and stored properly, trained staff, training opportunities, reliable utility service, and a regulatory framework for biosafety.

Dr. Reed explained that while a number of resources are available to address these needs each presents challenges:

•   International engagement programs, such as those funded by the United States, can address many needs, but the process, which often is managed by large defense contractors with high personnel turnover and complicated contracts, may overwhelm recipients. Additionally, this money may come with regulations created by the donor without input from the recipient.

•   Donors sometimes introduce over-engineered and energy-intensive equipment, protocols that require large amounts of consumables, and solutions that emphasize technology over technique. He argued that this is due to the mistaken notion that approaches that work in western countries can simply be applied without modification in other countries.



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3 ASSESSMENTS OF NEEDS, CHALLENGES, AND RESOURCES (PLENARY SESSION) Chair: Seval Korkmaz In view of the complexity of both containment labs and the human and agricultural health challenges containment labs aim to ameliorate, a detailed examination of specific situations often helps in optimizing allocation of resources. This session was intended to provide an overview of local assessments including what they are, what purpose they serve, who should be involved in a local assessment, and what information might be included in an assessment. Session chair Seval Korkmaz (Abdi Ibrahim, Turkey) opened by explaining that she has established many types of pharmaceutical laboratories that comply with Good Manufacturing Practices (GMP) and that each required a unique assessment. She then introduced the speakers and their topics indicating that the first talk would present many of the common needs and resources that might be considered while doing an assessment and that the second would give an example of a regional assessment. PLENARY PRESENTATIONS Global Biosafety and Biosecurity Challenges: Options for Nations with Limited Resources J. Craig Reed (Inspirion Biosciences, United States) described biosafety and biosecurity needs that are common in low-resource countries and the challenges associated with using the available resources to address those needs. He based his talk on a co-authored paper that has been submitted for publication (Heckert et al., 2011). Dr. Reed first observed that all resources, including those of both donors and recipients, are limited and stressed the need for capacity building efforts that lead to self-sufficiency. He defined low resource countries as those with a United Nations Human Development Index less than 0.85, which roughly corresponds to a gross national income less than $10,000 per capita. Low resource countries typically share a common set of needs. These include safe containment lab capacity, biosafety and disease surveillance equipment, diagnostic reagents that are handled and stored properly, trained staff, training opportunities, reliable utility service, and a regulatory framework for biosafety. Dr. Reed explained that while a number of resources are available to address these needs each presents challenges: • International engagement programs, such as those funded by the United States, can address many needs, but the process, which often is managed by large defense contractors with high personnel turnover and complicated contracts, may overwhelm recipients. Additionally, this money may come with regulations created by the donor without input from the recipient. • Donors sometimes introduce over-engineered and energy-intensive equipment, protocols that require large amounts of consumables, and solutions that emphasize technology over technique. He argued that this is due to the mistaken notion that approaches that work in western countries can simply be applied without modification in other countries. 27

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28 Biosecurity Challenges • He recommended that donors and recipients agree on both financial and managerial transition plans so that the recipient is ultimately able to run the facility without further aid. • Elected officials, Ministers, and senior laboratory management can help formulate a national plan, allocate budgets for maintenance and improvements, and establish regulatory frameworks. Typically, however, educational and awareness-raising activities are required to engage the desired leaders. • The local economy, ideally, should provide services, reagents, and equipment, but development and investment are typically required before this can become a reality. • Technical information is commonly available from a variety of sources including regional biosafety associations, the International Federation of Biosafety Associations (IFBA), and government ministries, but the information often requires translation and distribution. • Similarly, online resources, such as the IFBA1 and American Biological Safety Association2 (ABSA) websites, offer a wealth of training materials and examples of guidelines and standards, but most need translation into the local language. Furthermore, many training programs do not use adult education techniques, making them less effective than they could be. Dr. Reed said that regional biosafety associations can help communicate with the government, establish local credentialing systems, offer twinning and mentoring services, and distribute training materials, but the capacity of many is still developing. Ideally, donors would work with regional and national biosafety organizations to avoid duplicating training and other efforts. Dr. Reed also addressed the benefits of recipients developing a national implementation plan that balances human and animal disease efforts, creates a national regulatory framework, focuses on laboratory consolidation rather than expansion, emphasizes international collaborative relationships, and identifies funding for creating a professional biosafety society and national biosafety training centers. Biosafety and Biosecurity Challenges in the Caribbean Region Valerie Wilson (Caribbean Med Labs Foundation [CMLF], Trinidad and Tobago) shared the results of a recent regional biosafety assessment by CMLF.3 Ms. Wilson started by introducing CMLF and the 23 countries in the Caribbean region that it serves. The member countries speak different languages and vary widely in population and per capita income. She noted that the Caribbean is the most tourism dependant region in the world with visitors from North America, Europe, China, and India, and that the large number of tourists makes the region vulnerable to a number of communicable diseases, which could have a major impact on the economy and the local population. She explained that CMLF’s objectives include developing a supportive environment for high quality regional laboratory services; advocating at the highest levels for laws, regulations, and laboratory accreditation; mobilizing resources to strengthen laboratories; and creating a regional sustainability strategy. To best determine how to achieve its goals, CMLF undertook a regional assessment. CMLF asked medical labs, public health labs, veterinary labs, agriculture labs, labs that test for zoonotic diseases, and food and water labs a total of 204 questions in 20 categories addressing 1 Available at: http://www.internationalbiosafety.org/english/index.asp. Accessed August 29, 2011. 2 Available at: http://www.absa.org/index.html. Accessed August 29, 2011. 3 Caribbean Med Labs Foundation. Available at: http://cmedlabsfoundation.net. Accessed August 29, 2011.

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29 Assessments of Needs, Challenges, and Resources national infrastructure, the World Health Organization (WHO) International Health Regulations (IHR), and laboratory safety standards. In her presentation, Ms. Wilson focused on the responses of the major medical and public health laboratories in 13 countries, two of which have BSL-3 labs that are used mainly for tuberculosis testing. Overall, the assessment indicated that major gaps in biosafety implementation exist in the Caribbean region. She noted a lack of national policies and regulatory mechanisms for biosafety; a lack of systems for biorisk assessment at both the national and laboratory level; challenges in finding time for staff, including biosafety officers, to devote to safety functions; limited adoption and monitoring of safety standards; and limited access to BSL-3 facilities. Furthermore, while approximately half the respondents indicated that their country had a formal laboratory network, rarely did the networks include animal testing labs, and formal collaborations between Ministries of Health and Agriculture on zoonotic diseases were uncommon. Respondents all reported that lab coats and gloves were available. Respiratory protection was usually available when needed, but only about half the respondents indicated that respirators were used correctly. Just over half reported that biological safety cabinets (BSCs) are certified annually. After noting that capacity building for the implementation of safety systems is urgently needed, Ms. Wilson ended by describing two developments that promise to improve regional and national systems. First, development of national reference laboratories has progressed significantly in the past 5-10 years, with Haiti, the Dominican Republic, Guyana, Suriname, and Jamaica establishing labs. Second, the Caribbean Epidemiology Centre (CAREC), which was founded in 1985 and is administered by the Pan-American Health Organization and WHO, is transitioning into the Caribbean Public Health Agency, which will serve as a regional reference laboratory for communicable diseases. CAREC previously served as a regional network hub, but recently the regional network fragmented into smaller, geographically based networks. She mentioned that the small size of the countries and a sense of regional identity support and facilitate regional solutions and that the CAREC network had a strong tradition of sharing information to allow creation of a regional picture. Nonetheless, she indicated that a regional network of laboratories will require development of systems for allowing efficient transport, navigating of customs procedures, ensuring quality results, and obtaining financing. DISCUSSION While most of the discussion focused on assessments of individual countries considering containment labs, one individual felt that decisions about where to place labs would be handled better on the regional or international, rather than the national, level. In addition to the considerations identified by the speakers, some participants also suggested looking at a location’s ability to absorb donor resources, considering alternatives to containment labs, and involving people who will be working in the lab. Some indicated that the assessment process itself is an area in which some countries are interested in receiving assistance. One person mentioned that external parties might have greater capabilities to compile figures and statistics and noted that the Defense Threats Reduction Agency (DTRA) recently created a bio-risk management program to build international capacity in this area. Several people noted that while donors can provide useful information, countries should seek information from other sources as well and suggested that donors should be careful not to rush the process. Many indicated that while obtaining broad participation is beneficial, countries need to ensure that they are full participants in the process. Participants also commented on both the importance of realistically estimating the cost of a new facility as well as determining whether the expected benefits justify those costs. Given the high cost of imports, one person stressed that generating an accurate budget requires

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30 Biosecurity Challenges ascertaining which materials and expertise can and cannot be obtained locally. Another wondered about the cost of preventing one infection and speculated that in some cases improving the safety and facilities of BSL-2 diagnostic labs or spending the money on other aspects of public health altogether might be a better investment. Several encouraged countries to examine how containment labs fit in with their national public health priorities.