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THE DONOR POPULATION AND ITS GOALS IN PROVIDING BIOLOGICAL LABORATORY CAPACITY FOR LOW-RESOURCE SETTINGS

WHO FUNDS LABORATORIES IN LOW-RESOURCE SETTINGS?

As noted in Chapter 1, national governments, international organizations, development banks, public interest foundations, and private-sector entities are all funders of biological laboratories in low-resource settings. Health institutes, research agencies, academic institutions, and scientific professional societies also play roles. However, not all of the organizations that provide support for biological laboratories actually financing their construction. Some may provide equipment, reagents, and other needed supplies. Others may pay for enhancements of existing labs so that they can perform more complex and higher level work. Others may provide expert personnel to train developing country lab workers and guide research projects. All of these forms of aid are important to the sustainability and effectiveness of biological labs. The scope of the diversity of support organizations can be gleaned from the table of partial information on laboratories in Appendix E.

WHAT NEEDS ARE FUNDERS TRYING TO MEET?

To tackle this question, participants described the goals of funding organizations. For example, one country has a strong national policy for combating infectious diseases and therefore maintains programs in five African countries to provide enhanced laboratory functions, long-term training of human resources, and contributions to regional networks. This country also works in Asia and Central America. A participant stated that the donor’s perspective is threefold: (1) Is there a true need for a BSL-3 facility? (2) What are the human and financial resources needed to sustain such a facility? (3) What is the likely management capacity for a particular

laboratory, including biosafety factors? The “funding” modalities for this country’s donations include grants, loans, and technical cooperation.

The overall goal of development banks is to reduce poverty and improve life. Banks can only provide funding, which includes to support the development of labs to improve health and fight diseases such as drug-resistant malaria and tuberculosis. Banks receive requests across the full spectrum, from aid for diagnostics to creation of national and international reference labs. Some development bank work in Africa follows the One Health approach that encompasses human and animal health. The World Bank evaluates recipient needs against the Joint External Evaluations associated with the International Health Regulations (IHR) to provide diagnostic and surveillance capabilities. To assess veterinary needs, the World Bank uses the World Organisation for Animal Health (OIE) Tool for the Evaluation of Performance of Veterinary Services (the PVS Pathway Evaluation Tool). It also tries to follow a regional approach to avoid duplication and promote efficiency through resource sharing. However, evaluation remain a big challenge, and the Bank relies on partners from OIE, the United Nations’ Food and Agriculture Organization (FAO), the World Health Organization (WHO), and other outside experts for technical help. It is critical to get the project right in the planning phase.

A participant noted that funders are generally asked first to support a BSL-4 laboratory. When they refuse, they are asked to support a BSL-3 laboratory. This concerns funders, because “BSL” level is a form of branding that has led, in some cases, to a political demand rather than a need-driven demand, which can result in the proliferation of unsustainable high-containment labs that cannot maintain quality or function according to design.

Another participant stated that several funder nations’ work is motivated by public health needs, seeking to strengthen health systems through capacity building. He noted that “biosecurity” is difficult to define, has a range of meanings for different people, and can be viewed from many angles.

Another participant noted that a broad set of experts from both donor and recipient countries agree that a diversity of serious problems exist with lab sustainability. A recent OIE report calls for multidisciplinary, multi-sectoral, and collaborative solutions for these issues. Here are its key conclusions:

1. A functioning, appropriately resourced laboratory contributes to prosperity, stability and security at national, regional, and global levels.

2. Laboratory facilities (including their infrastructure, engineering, and flexibility of design) must be “fit for purpose” and thus adapted to the local context and risks.
3. Sustainability of laboratory biosafety and biosecurity, quality management, and business continuity are inextricably linked.
4. Political buy-in, governance of laboratories, and empowerment of laboratory staff are key to the sustainability of a laboratory.
5. Sustainability will be improved by networking and sharing of information and best practices at all levels (local, national, regional, and international).
6. The adoption of risk-based and evidence-based approaches will make a positive contribution to sustainable laboratory biosafety and biosecurity.
7. Creative and open-minded thinking and innovation are key to improving laboratory sustainability. This includes reframing the problem, satisfying basic needs, and reasoning around the functions of the laboratory.
8. A sustainability strategy must also consider sustainable approaches to education, training, and retention of competencies.
9. Business models for sustainable laboratories and capacity building benefit from utilizing private-public-partnership models, which engage private sector users and suppliers.

The participant who referenced the OIE report believes that progress in this arena requires a “consortium approach” by multiple international organizations and donors. In particular, the report urges the human and animal health entities to work together in a coordinated way to facilitate forward progress. Another participant shared a concern about the training and mentoring of laboratory personnel, which extends beyond biosafety training to building careers, learning leadership skills, and engaging people in meaningful activities. Another participant noted the difference between training and education and added that his organization is conducting a study to assess the feasibility of creating a training hub in Africa. Although the issues for human vs. animal health are similar, the animal sector is much less well funded.

WHERE ARE THE LABS THAT HAVE ALREADY BEEN DONATED AND ARE THEY OPERATING AS ANTICIPATED?

Frances Sharples gave a brief presentation on the data compiled from several sources on the location of existing containment labs in low-

resource countries.¹ The countries defined by the World Bank (2017) as Low-Income Economies and Lower Middle-Income Economies (see Appendix D) and are located in the following regions:

• Southeast Asia/Pacific
• South Asia
• Central Asia/Eastern Europe
• Middle East/North Africa
• West and Central Africa
• East Africa
• Southern Africa
• Central America and Caribbean

A table with a list of these countries organized alphabetically and the data obtained for each is located in Appendix E. The data include the number of BSL-2/3 and in one case (India) BSL-4 facilities in each country; the type of laboratory (i.e., its purpose; the funder, if known; its status (i.e., operational, nonoperational, under construction, if known); and its capabilities in terms of what tests can be performed and what categories of work (e.g., research, surveillance, sample testing), if known.

Dr. Sharples summarized the lab location information as follows:

• No single source provides a comprehensive list of lab locations and operational information.
• Many small, low-resource countries have one or a few BSL-3s and/or BSL-2s for diagnostics of region-relevant human diseases (TB, malaria, HIV), and several have one or a few BSL-3s and BSL-2s for region-relevant animal disease issues.
• Labs that possess Biological Select Agents and Toxins (BSAT) usually have pathogens relevant to diseases prevalent in their localities, such as plague (Yersinia pestis), Lassa fever in West

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¹ The data were obtained from: Dr. Barbara Johnson, Biosafety Biosecurity International, and a consultant to the project, who provided information and also compiled most of the lab location data; the U.S. Defense Threat Reduction Agency’s Biological Materials Information Program with the assistance of Dr. Mark Hansberger; Drs. Daniel B. Jernigan, Steve Monroe, Kevin Karem, and Inger K. Damon of the U.S. Centers for Disease Control and Prevention; and Dr. Craig Reed, CEO, Inspirion Biosciences. Much of the information on laboratories is either unavailable or difficult to source. In addition, some sources of information were probably not found for the compilation of Table E.

• Africa, and Rift Valley fever in East Africa. Note that the “BSAT” designation is a U.S. classification for the most hazardous pathogens, and is not used by many other nations. The organizers do not know whether comparable designations by each of the countries on the list exist.

• Funding comes from international organizations, host and foreign governments, foundations, corporate entities, and other sources, but information was not always available about the specific funder(s).
• Some laboratories receive operation and maintenance or equipment funds from donors, although sometimes only when confronting outbreak situations.
• The list contains many unknowns and some data discrepancies. For example, a recent presentation by a director of laboratories in India provided a map of only 16 BSL-3s, while the data in the larger list indicate 44 BSL-3s in India.

Dr. Sharples concluded with the comment that a comprehensive list of laboratory location and operational data would inform the funder community’s evaluation of needs and options. During the lively discussion that followed her presentation, several participants stated that they know that some of the data in the list for particular countries are inaccurate and many additional laboratories that can perform diagnostic testing are not included in the list.

David Harper started the next discussion with remarks informed by his work with Chatham House. Most recently Chatham House and Global Affairs Canada held a series of meetings that focused on improving the sustainability of laboratories built in partnerships between funding organizations and recipient countries or organizations. When he started the Sustainable Laboratories Initiative at Chatham House,² his first intuition was to map the environment but was quickly disabused of the notion. Playing devil’s advocate, Mr. Harper asked the participants, why are we trying to map the environment? What drives our need to create such a map? In terms of norms and standards for sustainable laboratories, what will we learn from a map to drive the work forward? The answers to these questions notwithstanding, it is equally important for stakeholders to have a conversation about the energy and resources that should be devoted to mapping, given that a comprehensive map—that captures not only public

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² For a description of the Sustainable Laboratories Initiative at Chatham House, see https://www.chathamhouse.org/about/structure/global-health-security/sustainable-laboratories-initiative#.

health, but also animal and environmental health and the security sector—is probably an impossibility.

Mr. Harper questioned whether such maps really help the funding community to assess needs and options. One strand of the Chatham House work was described in a summary of a workshop focused on development of a tool to facilitate the initial dialogue between potential funding and recipient partners. In that tool, the partners are asked: Why do you need a laboratory? What work will be performed there? What alternatives exist? Who else have you approached to help build the capacity? The questions and answers may not be country specific: for example, in Nigeria, with a federal system, the questions and answers might be state specific and even city specific. The funding partner should initiate that conversation, and the recipient country needs to consider and provide that information. There needs to be some a due diligence process with appropriate verification and validation of the risks. This is challenging. At a recent meeting held in Abuja, Nigeria, participants from recipient countries said that some recipients might need help to build their expertise and capacity to do so.

An earlier speaker said he would be concerned about a local risk assessment if the local organizations do not have the expertise to do the assessment. There is a feedback loop: If the partners need a local risk assessment then it is incumbent on the people concerned, recipient and funding partner, ensure that that capacity is available in the country or locality. So returning to the point about maps, Harper argued that while it is good to have information, it should add value.

Mr. Harper noted that Chatham House partnered with the African Academy of Sciences in Nairobi to convene urban preparedness and resilience experts from Ghana, Nigeria, South Africa, and Kenya in December 2017. A group of participants who work in different but similar areas (e.g., public health military service, emergency management, veterinary service) told Mr. Harper that they had never met each other before. When studying the public health side in a nation that provides funding, he found that two offices in the same organization (not just the same government) were not liaising with each other on activities in the same country. Specifically, one office was establishing a laboratory in a country with which it was working closely on the Ebola crisis, but was unaware of directly relevant activity by another office in the same organization. The Nairobi meeting, like this Amsterdam workshop, brought together experts who should work together but almost never have the opportunity to meet. The true real merit of the current workshop was to bring together different constituencies and experts to increase awareness of others’ activities and hopefully coordination.

A workshop participant stated that, because not every project can be funded, donors carefully select their investments, building toward the goal of establishing a sustainable and effective network of laboratories. It is difficult to make those decisions without knowing what already exists and who else is working in that region. It is also important to establish whether the recipient country’s regulators are aware of all of the laboratories in its territory and whether they can monitor them. Beyond the desire for a map as a means to understand the status quo, these are legitimate reasons to have one, he argued. Mr. Harper questioned the definition of a “sustainable and effective network of laboratories.” Is it a set of human, animal, or plant laboratories? Is it locations that store pathogens? He asserted that it is better to address specific needs than to develop a comprehensive map, even if it were possible, because the cost versus the reward is too high. Resource mapping for an individual decision may be more valuable.

Another participant pointed out that the Joint External Evaluation reports under the Global Health Security Agenda recommended creation of an overview of laboratories that work with dangerous pathogens. The Netherlands has created a pilot project database called the national inventory of dangerous pathogens, for work in Uganda. This database helps to fulfill obligations under the Biological Weapons Convention, which calls for countries to ensure the safety and security of dangerous pathogens, and which cannot be accomplished without knowing what is done and where. Another participant noted the need for donors to be aware of other funders in a country to leverage opportunities to build regional capabilities. However, a map or list of laboratory locations could serve a “dual use” in that people could use it with malicious intentions.

A participant stated that focusing on biosafety and biosecurity mapping is more important than mapping laboratories because the presence of a high- containment lab is a poor proxy for biosecurity risk. In other words, it may not be important to map the locations of particular types of labs (e.g., BSL-3s) because, in low-resource countries, dangerous pathogens are, of necessity, handled in whatever facility is available, even BSL-1 laboratories. More relevant information is where particular techniques, such as viral isolation, are practiced, and how pathogens are stored. Diagnostic labs doing polymerase chain reaction (PCR) or enzyme-linked immunosorbent assay (ELISA) are not a risk.

Another participant agreed that a map of laboratory locations would not be useful, and advocated for requiring recipients to map resources. Funders must understand the recipient’s needs and what capabilities already exist in their country. Also needed is evaluation of the sophistication of recipient labs and their support system. The skilled-

worker challenge could be addressed through professional associations as well as networks of practitioners across sectors to share best practices. However, it can be difficult for these societies to operate in some countries.

Several participants mentioned the need for skilled workers. One participant suggested asking potential recipients “What are you capable of doing?” and “Are the necessary skilled workers and equipment in place?” rather than “What do you want to do?” Another participant explained that WHO has a substantial training program and widely distributes its Laboratory Biosafety Manual (LBM). However, the LBM practices were formulated before the development of PCR, so some of its guidelines are outdated and are undergoing revision (see Chapter 2.)

A participant said that a mapping of public health assets is absolutely fundamental to inform the donor decision making process, because otherwise we accept that “more is more, and more is good,” which is not always true. It is relatively easy to identify publicly funded lab assets, but it is more difficult to locate facilities provided by the private sector and academia. Resources should be allocated in the best ways possible, which entails knowing not only where the laboratories are located, but also what connections exist. Asset mapping could also be overlaid with risk mapping to seek designs based on optimal resource distribution. Such mapping would be money well spent because containment labs are extremely costly (e.g., $35 million for BSL-3 laboratories in Zambia and Ethiopia).

Another participant commented that adding to existing laboratories may be a better strategy than new construction, which should never be entered into lightly. Another participant said that the scale of the number of laboratories below BSL-3 is huge. For example, Pakistan believes that it has 4,000 to 6,500 laboratories, but only 2,500 are mapped. However, not all of them deal with indigenous high-hazard pathogens.

A participant agreed that the locations of laboratories should be driven by local risk assessments and needs, but a map of BSL-3 and -4 laboratories is needed from a defense/security perspective to ensure that these labs are secure and that pathogens are being handled appropriately. Another participant noted that it is important to know how long funding will remain available. A third person agreed that we need to map the techniques that are in use and the pathogens being worked with or stored. Out of necessity, researchers will perform the work at whatever level facility is available, which is a concern. Another important piece of information is the operational status of existing labs.

A participant stated that mapping the location of pathogens for security purposes is puzzling. Pathogens regularly pass through clinical and

diagnostic labs wherever they are endemic, and maps of disease in broad regions are currently available. It is important to distinguish laboratories that store an isolated pathogen for research and reference from the places where it can be found in nature. Furthermore, it is not clear that a person or group with malevolent intent will use the appropriate BSL lab for the pathogen, or any lab at all.

A participant stated that evidence-based biosafety is necessary in resource-limited contexts to keep cost and complexity down. Evidence should inform the risk-assessment process and policy, allow for logical prioritization, lead to learning from past lessons, and result in optimization of resources.

Another participant asked whether donors have a preference for building new facilities rather than supporting existing facilities. At least one donor government does, but no one else in the room answered this question, perhaps because the answer depends on the particular donor or is not precisely known. One participant answered only that his government does not like to create brand new labs. It prefers to enhance or expand an existing laboratory that is deemed suitable for the purpose. Another participant agreed that expanding the capacity of existing facilities can be better than new construction, but “mapping” is still required to determine those needs. The participant who believes strongly that mapping per se is not useful underscored the need for clarity about what is being mapped. Samples of hazardous pathogens are extensive where these are endemic. What the donor wants is important, but a laboratory will only be sustainable if attention is also paid to what the recipient wants.

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