Status of World-Level Laboratory Biorisk

¶ … Status of World-Level Laboratory Biorisk Management

Recent innovations in biotechnology have contributed to improved healthcare and agricultural productivity, among others, in ways that have substantively contributed to the well-being of humankind. A concomitant of these innovations, though, has been an increased potential for biorisk hazards that can have enormous adverse consequences. In this regard, Finley emphasizes that, "Unfortunately, even as these advanced technologies are helping to improve the human condition, their inherent 'dual-use' potential makes them equally attractive to those who seek to do harm. The same equipment used to produce a life-saving vaccine might also incubate a biological agent for terrorist use" (p. 53). Likewise, as vividly depicted in the recent motion picture, "Contagion," ongoing biotechnological research has the potential to introduce even more virulent strains of existing pathogens in ways that can easily outpace the ability of humanity to respond, resulting in a global pandemic that could kill billions of people in a short period of time (Finley, 2010). More troubling still, the current growth of the biotechnology industry suggests that the potential for disaster will continue to increase well into the foreseeable future. In response to this dire situation, the international community has formulated a variety of approaches as discussed further below.

International Responses for Biorisk Reduction

According to the World Health Organization (WHO), the potential for uncontrolled disease outbreaks has never been greater. In this regard, WHO's fact sheet on the Global Outbreak Alert and Response Network emphasizes that, "Today, there is growing recognition that an outbreak anywhere can potentially represent an emergency of international public health concern. Outbreaks threaten the health of the world's population. They require regional and global alert and response mechanisms to ensure rapid access to technical advice and resources and to support national public health capacity" (Global Outbreak Alert and Response Network Fact Sheet, 2011, p. 1). Because the problem is global in scope and complex in nature, WHO also stresses that it is impossible for a single country or organization to adequately respond to such events, making a multifaceted international approach necessary (Global Outbreak Alert and Response Network Fact Sheet, 2011).

The main international response to biorisks today is the International Health Regulations (IHR 2005). All of the signatories to IHR 2005 (the "State Parties") have formally agreed to assess, develop and maintain their respective national core capacities for surveillance and response and among the eight core capacities listed is "Laboratory" with the oversight of laboratory biorisk being achieved through the application of appropriate biosafety and laboratory biosecurity measures (Strengthening laboratory core capacity, 2011).

Notwithstanding a substantial investment of national resources and improvements in biorisk management over the past 10 years or so, many countries have not taken the steps that are needed to ensure industry regulators and in many cases, laboratory personnel are unaware of the need and relevant requirements of IHR 2005 (Strengthening laboratory core capacity, 2011). Furthermore, there has been a lack of progress in improving regulatory and oversight mechanisms as well (Strengthening laboratory core capacity, 2011). As WHO emphasizes, "In addition, basic information relating to laboratory design and operating parameters is often confusing, with a lack of evidence to underpin many commonly used controls (Strengthening laboratory core capacity, 2011, p. 1).

Because resources are by definition scarce, it is not surprising that these needs have taken a backseat in many emerging nations which are especially challenged by the implementation of best industry practices that have been developed in laboratories around the world based on the wide range of environments in which these facilities operate. Irrespective of how knowledgeable and aware laboratory personnel may be concerning the requirements of IHR 2005, though, there remains a need to ensure that sufficient support services are available to operate these laboratories (Strengthening laboratory core capcity, 2011). As the biorisk staff at WHO also emphasize, "However, effective supplier networks, maintenance provision and other basic measures are often unavailable to those most in need. At present there is no global strategy in this area to ensure that investments are planned and implemented appropriately to meet these needs. Without such strategic planning, biorisk management runs the danger of failing to deliver solutions that allow countries to build stand-alone capability" (Strengthening laboratory core capacity, 2011, p. 1).

Currently, best industry practices in biorisk management involves specific expertise and guidance concerning high-consequence pathogens; this advice should include training concerning safe handling and control of disease agents that represent significant health risks, as well as those that have the potential for adverse economic impact and public concern (Biorisk reduction, 2011). Regardless of the laboratory setting or source of a given disease event, the overarching objective of biorisk reduction is "to ensure that current scientific knowledge regarding viral hemorrhagic fevers, epidemic-prone orthopoxviruses, and emerging severe zoonotic diseases affecting humans, is maintained in order to apply the most appropriate guidance for treatment, control, and safety to mitigate the risks" (Biorisk reduction, 2011, p. 2). Although training is an essential component of biorisk management practices, the expertise needed to effectively manage outbreaks is earned in the field, as well as through (a) ongoing management of clinical and laboratory environments, (b) networking with subject matter experts, and (c) developing partnerships with stakeholders (Biorisk reduction, 2011). Because the source of outbreak events can be anthropomorphic or natural, as well as accidental or intentional, the need for flexibility in responding to these events requires specific knowledge to help prepare State Parties for the unexpected (Biorisk reduction, 2011).

At the international level, the World Health Organization's Emerging and Dangerous Pathogens Laboratory Network (EDPLN) has a stated goal of coordinating activities and responses to human and animal health sector threats through the support of the laboratory readiness and response of countries for rapid detection and containment of outbreaks of emerging and dangerous pathogens, novel and acute endemic threats as outlined in the IHR (2005). At present, the EDPLN is comprised of global and regional networks of high security human and veterinary diagnostic laboratories that collaborate in an effort to:

1. Share their knowledge, biological materials and experimental research results in real time to support the diagnostic functions of international responses to rapidly detect and contain global epidemic threats due to novel, emerging and dangerous pathogens; and,

2. Facilitate the transfer of safe and appropriate diagnostic technologies, practices and training to regional networks and national laboratories in the zones of emergence of these diseases to enhance diagnostic readiness for earlier diagnosis and management of outbreaks and infections of emerging and acute endemic disease threats (Global alert and response, 2011)..

The EDPLN laboratories are part of the Global Outbreak Alert and Response Network's (GOARN) response team (Global Outbreak Alert and Response Network, 2011). The GOARN response team consists of scientists who are expert in the field who provide evidence-based strategies, tools and practices for rapid detection and containment of outbreaks of novel, emerging and dangerous pathogens in order to minimize their impact on public health, health systems and economies of affected areas (Global alert and response, 2011). According to WHO's description of the GOARN initiative, "The GOARN is a technical collaboration of existing institutions and networks who pool human and technical resources for the rapid identification, confirmation and response to outbreaks of international importance. The Network provides an operational framework to link this expertise and skill to keep the international community constantly alert to the threat of outbreaks and ready to respond" (Global alert and response, 2011, p. 1).

The GOAR Network contributes towards improved biorisk management through the following:

1. Combating the international spread of outbreaks;

2. Ensuring that appropriate technical assistance reaches affected states rapidly; and,

3. Ccontributing to long-term epidemic preparedness and capacity building (Global Outbreak Alert & Response Network, 2011, p. 2).

The specific objectives of the EDPLN include the following:

1. Laboratory Response WG for developing a functional mechanism for combining early outbreak information and evidence-based scientific advise to establish a coherent laboratory response for each new EDP outbreak situation, given the syndrome, available local and international resources, and considering the diagnostic testing, patient monitoring and transmission control roles and needs.

2. Assay and Reagents Development WG for improving network coordination on assay, reagent and reference materials development, production and distribution for EDPLN syndromes, diseases, and agents, and on assessment and evaluation of emerging assay and reagent technologies and their field application.

3. Technology Transfer and Training WG for facilitating the safe transfer of technology and training appropriate to the intended role of reference, national and field laboratories and personnel operating in-lab and deployed environments, with clinical response teams in the zones of emergence of these diseases.

4. International Engagement WG for articulating and communicating key laboratory readiness and response issues and leveraging other international initiatives and organizations to achieve common objectives (e.g. biosafety and biosecurity, specimen transport, intellectual property, specimen/strain repository, ethical issues).

5. Applied Research - Human-Animal Interface WG for developing and communicating the underpinning principles and capacities for conducting applied research activities required to support outbreak control activities (e.g. capacities for ecological and environmental sampling and diagnostics for candidate reservoir species) (Global alert and response, 2011).

The response by the United States to biorisk management at the national level provides a useful example of what can be accomplished with the right resources and vision. For instance, in December 2009, the U.S. government published its "National Strategy for Countering Biological Threats," representing the basic framework for the U.S. response to emerging bioterrorism threats. In the State of the Union address in 2010, President Barack Obama mentioned the National Strategy as an approach that "will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease." The implementation and oversight of this initiative is the responsibility of the U.S. Department of State's Biosecurity Engagement Program (BEP). This agency is tasked with promoting the National Strategy through efforts targeted at improving biorisk management and infectious disease surveillance practices around the world. To this end, the BEP has strengthened its commitment to the African continent, including countries in North Africa, the Horn of Africa, as well as the South Africa. In addition, the BEP has launched programs in those regions that are characterized by the highest terrorism and infectious disease outbreak threats, with West Africa and the Congo Basin being preeminent among these regions (Jenkins, 2011).

At the national level, the U.S. strategy for biorisk management is focused on a two-fold approach that uses indirect, preventative measures based on the goals of the Biological Weapons Convention (BWC), which are (a) collaboration with State Parties to improve the security of laboratories that work with dangerous pathogens and (b) to improve global disease surveillance (e.g., the ability to detect and rapidly contain outbreaks of infectious disease, whether they are natural, accidental, or deliberate in origin) (Tucker, 2010). According to Tucker (2010), the 23-page National Strategy for Countering Biological Threats document was distributed all of the members of the annual meeting of states-parties to the BWC in Geneva in December 2009. Whereas the Bush administration's biosecurity policies focused on mitigating the consequences of a biological attack through a major investment in threat assessment research, early-detection systems such as BioWatch, the development of medical countermeasures under Project BioShield in 2004, and other domestic preparedness measures, the Obama strategy places a far greater emphasis on prevention (Pupura, 2007). Noting the two-phase approach used for the Bioshield initiative, Mayer (2007) adds that, "The [Bioshield I and II] proposals offered a sweeping array of reforms to coordinate national biodefense efforts and stimulate private development of medical countermeasures for deadly biowarfare agents" (p. 1753).