Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science Volume 12, Number 5, 2014 ª Mary Ann Liebert, Inc. DOI: 10.1089/bsp.2014.0023
Legal and Regulatory Capacity to Support the Global Health Security Agenda Ryan Morhard and Rebecca Katz
On February 13, 2014, 27 nations, along with 3 international organizations, launched the Global Health Security Agenda (GHSA). The intent of GHSA is to accelerate progress in enabling countries around the world to prevent, detect, and respond to public health emergencies—capacities to be achieved through 9 core objectives. Building national, regional, and international capacity includes creating strong legal and regulatory regimes to support national and international capacities to prevent, detect, and respond to public health emergencies. Accordingly, establishing and reinforcing international and national-level legal preparedness is central to advancing elements of each of the 9 objectives of the GHSA.
O
n February 13, 2014, 27 nations, along with 3 international organizations, launched the Global Health Security Agenda (GHSA).1 The intent of GHSA is to accelerate progress in enabling countries around the world to prevent, detect, and respond to public health emergencies— capacities to be achieved through 9 core objectives. Building national, regional, and international capacity includes creating strong legal and regulatory regimes to support national and international capacities to prevent, detect, and respond to public health emergencies. These legal and regulatory frameworks may not always be the first step taken by nations, nor the highest priority, but all other capacities rely on a strong legal and regulatory foundation to ensure long-term functionality and sustainability as new capacities become engrained into national and international systems. This article describes the ways in which law may be integral to accomplishing elements of each of the 9 objectives of the GHSA.
Background Law, and the duties, relationships, frameworks, regulations, and policies it engenders, is a cornerstone of strengthening
national, regional, and global ability to prevent, detect, and respond to infectious disease threats. Deficiencies in law can undermine effective response to public health emergencies. Accordingly, establishing and reinforcing international and national-level legal preparedness is central to advancing elements of each of the 9 objectives of the GHSA. Legal preparedness describes the legislation, regulations, and policies that support a public health system’s ability to prevent, detect, and respond to an emergency. In the United States, attention to this distinct aspect of preparedness heightened following 9/11 and the anthrax terror attacks, when an array of legislation governing public health response to infectious disease was enacted at the federal (eg, Public Health Security and Bioterrorism Preparedness Response Act,2 Public Readiness and Emergency Preparedness [PREP] Act,3 Pandemic and All-Hazards Preparedness Act4) and state (eg, Model State Emergency Health Powers Act5) levels. Likewise, globally, the past decade has seen revisions of the International Health Regulations,6 enactment of the Pandemic Influenza Preparedness (PIP) Framework,7 and other international treaties, such as the World Health Organization (WHO) Framework Convention on Tobacco Control.8 The United States participates in a host of formal partnerships—multilateral (eg,
At the time this article was written, Ryan Morhard, JD, was an Associate at the UPMC Center for Health Security, Baltimore, Maryland. Rebecca Katz, PhD, MPH, is an Associate Professor in the Milken Institute School of Public Health, George Washington University, Washington, DC. 254
MORHARD AND KATZ
Global Health Security Initiative9), trilateral (North American Plan for Animal and Pandemic Influenza10), and bilateral (eg, US-Mexico Early Warning Infectious Disease Surveillance Program11)—aimed at enhancing cooperation to improve public health preparedness. Elsewhere, nations have come together to form regional disease surveillance networks (eg, the Mekong Basin Disease Surveillance Network [MBDS], the East African Integrated Disease Surveillance Network [EAIDSNet]). These and other efforts have each been devoted to preparing public health leaders in the US and abroad to face critical legal and policy choices during public health emergencies. After all, response can be delayed or inadequate because of ambiguity over authority, liability concerns, and fundamental questions about who is responsible for what.12 Enhancing legal preparedness requires identifying best practices and potential gaps in addressing legal issues and implementing key measures to improve public health capacity, minimize barriers, and encourage effective response. Some of the primary issues that have been the focus of attention in the US include, for example, decisions relating to interjurisdictional legal coordination; authority and ability to enact infection control measures; authority to stockpile, approve, distribute, and mandate medical countermeasures; licensing and credentialing of out-of-state (and out-of-country) healthcare practitioners; managing scarce resources; and addressing liability concerns of public health practitioners and entities during emergencies.13 Globally, attention has been paid to many of the same issues, with a focus on responsibilities for detection and reporting, and the authorities to enact infection control measures. There has been less attention paid to legal issues surrounding the distribution of medical countermeasures or credentialing of healthcare practitioners and ensuring that regulatory agencies are appropriately supported by laws and regulations that prevent them from encumbering effective response. For purposes of this article, law can be defined as a rule of conduct derived from federal, state, or regional constitutions, statutes, local laws, judicial opinions, administrative rules and regulations, international codes, or other pronouncements by entities authorized to prescribe conduct in a legally binding manner.14 Relevant international and national law should be flexible enough to support response to public health emergencies of varying intensity. Although many infectious disease events are localized, low-impact events, response to larger infectious disease outbreaks can be made more difficult by divergent legal responses, especially those authorizing a range of antiquated, inconsistent, and uncoordinated public health interventions.15 Strong national legal frameworks are also fundamental to the receipt of international assistance and increased regional coordination demanded for effective response to disease outbreaks that have crossborder implications or that require international assistance.16 Therefore, national-level legal preparedness efforts must also embrace the global context in which serious threats to public health arise and are handled. Volume 12, Number 5, 2014
The global health community has also recognized national-level legal preparedness as essential to health security. Building legal preparedness is defined by the WHO as a core capacity that nations must develop to implement the International Health Regulations (IHR), and in 2009 the WHO released a toolkit for implementation in national legislation.17 As of 2010, approximately half of states parties had amended legislation to fulfill IHR obligations.18 In addition, the WHO Toolkit for Assessing Health-System Capacity for Crisis Management identifies a legal framework for national multisectoral emergency management as a ‘‘key component’’ critical to comprehensive preparedness for public health emergencies.19
Legal Challenges Presented by the GHSA The following section outlines ways in which law may be integral to accomplishing aspects of each of the 9 objectives of the GHSA (see Figure 1). Of course, the mere enactment of a law or creation of a legal duty does not, by itself, render a nation prepared, and efforts to strengthen legal preparedness should be accompanied by building capacity across the public health system. Further, legal frameworks, and indeed legal capacities, vary among nations, and, as such, application of the following analysis will vary among nations participating in the GHSA.
Prevent Avoidable Epidemics 1. Prevent the emergence and spread of antimicrobial drug resistant organisms and emerging zoonotic diseases, and strengthen international regulatory frameworks governing food safety An effective public health strategy against the development of antimicrobial drug resistance must be informed by legal as well as scientific analysis.20 The perpetuation of antibiotic resistance is accelerated by the excessive use of antibiotics in both humans and animals,21 and informed laws and regulations can serve as an important means of reducing individual and institutional factors that enable such misuse. Law is key to supporting and standardizing necessary efforts to not only improve infection control practices and antibiotic stewardship, but also to creating conditions that help accelerate the discovery and development of new antimicrobials that are essential to slowing the rise of resistance. Effective antibiotic stewardship requires formal and dependable frameworks to overcome barriers to implementation, which tend to include lack of physician participation, ingrained practice in the agricultural sector, absence of formal mechanisms for data collection, variation between jurisdictions, and lack of cooperative strategies.22 Curbing the misuse of antibiotics, both in health care and food 255
256
Figure 1.
encompass a broader set of diseases.
Examine range of legal issues relating to ownership and use of shared viruses, including those relating to Intellectual Property, that motivate decision-making during a health emergency. Nations should establish Memoranda of Understanding to facilitate timely transfer of virus samples. Consider producing an adapted version of the WHO
5. Strengthening the global norm of rapid, transparent reporting and sample sharing in the event of health emergencies of international concern.
Ways in Which Law Can Accomplish Aspects of Each of the 9 Objectives of the GHSA
pathogens.
registered laboratories. Provide frameworks for training scientists.
Regulate of high-risk practice of biology by identifying highrisk pathogens and regulating handling, storage, transport and export of these select pathogens.
2. Promoting national biosafety and biosecurity systems.
Nations should develop legal frameworks for sending and receiving medical countermeasures, public health and medical personnel, and other assistance from and to international partners during emergencies.
9. Improving global access to medical and non-medical countermeasures during health emergencies.
Implement Mutual Aid Agreements to bridge gaps in knowledge and capacity by sharing know-how and personnel before, during, and after an event. Consider legal and regulatory options to temporarily expand professional scopes of practice during a public health emergency to enable certain trained practitioners to help meet personnel needs during response.
National laws should encourage both vaccine production and increased vaccination rates, including by creating a system supporting emergency use of untried vaccines and forming distinct and trusted vaccine injury and compensation models that provides just compensation while maintaining a favorable environment for vaccine production and distribution.
Respond Rapidly and Effectively
lawful authority to properly respond and develop manuals and standard operating procedures to govern response activity.
regulations and policies.
Consider relationship between evidence produced by microbial forensics techniques and standards of legal admissibility. National emergency legislation should delineate the purpose of an Emergency Operations Center and parameters for when it should be activated. Cooperation and data sharing among participating
8. Developing an interconnected global network of Emergency Operations Centers and multi-sectoral response to biological incidents.
7. Training and deploying an effective biosurveillance workforce.
Detect Threats Early
both regulatory and technical - that help speed innovation, improve capacity,, expand distribution and access, and reduce costs.
6. Developing and deploying novel diagnostics and strengthen laboratory systems.
Establish legal duty to report diseases integral to comprehensive biosurveillance. Formalize connections among technical experts across ministries of health and other public health institutions in participating countries to support agreed upon surveillance strategies.
4. Launching, strengthening and linking global networks for real-time biosurveillance.
3. Reducing the number and magnitude of infectious disease outbreaks.
Prevent Avoidable Epidemics
Implement laws and regulations that support and standardize infection control practice and antibiotic stewardship and create conditions that help accelerate the discovery and development of new antimicrobials essential to slowing rise of resistance. Regulate public health risks at the human and animal interface. Strengthen elements of the Codex Alimentarius per recommendations of the 2014-2019 strategic plan.
1. Preventing emergence and spread of antimicrobial drug resistant organisms and emerging zoonotic infectious diseases and strengthening international regulatory frameworks governing food safety.
Global Health Security Agenda Objectives - Select Legal Elements
LEGAL AND REGULATORY CAPACITY TO SUPPORT GHSA
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science
MORHARD AND KATZ
production, may also require a regulatory strategy that monitors the use of antibiotics and limits when antibiotics are authorized, perhaps by adjusting labeling requirements or altering public subsidies for antibiotics.20 Practitioners must also be equipped with legal authority to detain or isolate people infected with highly resistant pathogens in order to properly control infection and to prevent the spread of resistant organisms. The paucity of new antibiotics being developed makes the task of addressing increasing resistance all the more challenging. The pace of new drugs being developed is slower than the rate of rise of antibiotic resistance.23 The development pipeline for new antimicrobial drugs is bleak, driven by a marked decrease in industry research and development and government inaction.24 The cause of slowing development is multifactorial, although, fundamentally, each factor relates to return on investment.25 Therefore, in addition to protecting against overuse, innovative legal solutions may also be required to provide sufficient market incentives for companies to invest in development of antimicrobials. For example, nations might consider adopting laws and regulations that uncouple return on investment from sales volume and price; simplify applicable regulatory frameworks for the development of antimicrobials, both shortening time to approval and reducing costs of clinical trials; and/or extend patent periods to allow successful developers to benefit from longlasting market exclusivity.26 The GHSA also aims to build capacity to prevent emergence and spread of zoonotic infectious diseases, which are linked to over 60% of all new diseases.27 Toward this goal, GHSA efforts should support countries as they develop legal and regulatory frameworks that encourage the intersectoral collaboration required to manage public health risks at the human and animal interface.28 Although most emerging infectious diseases occur in wildlife, countries should be encouraged to implement enforceable risk reduction measures, including those supporting case/outbreak transparency and notification measures, and associated compensation mechanisms, biosecurity in farms and marketplaces, and control of animal movement.29 Given that recent significant, high-profile food contamination events in China,30 the United States,31 and Europe,32 for example, have raised awareness of the public health challenges posed by foodborne disease and the increasingly global nature of the food supply chain,33 it is appropriate that strengthening international regulatory frameworks governing food safety is an objective of the GHSA. This objective is also synergistic with the Codex Alimentarius strategic plan for 2014-2019.34 2. Promote national biosafety and biosecurity systems Enhancing biosafety and biosecurity protects populations, makes researchers safer from disease, and makes dangerous pathogens more secure and difficult to obtain by those interested in misuse. Under objective 2, the GHSA seeks to build national and regional capacities to manage biological Volume 12, Number 5, 2014
material and advance frameworks to promote safe and responsible conduct. A prime approach for addressing these challenges is through the adoption and implementation of country-specific biosecurity legislation. Such legislation should support comprehensive regulation of the potentially high-risk practice of life science research and diagnostic laboratories by: identifying and specifying select dangerous pathogens; regulating the transportation of these select biological agents; regulating the handling, storage, and use of these agents; requiring the development and implementation of biosafety and security plans at laboratories; creating a process for certifying and registering laboratories; providing frameworks for training scientists in dual-use research of concern; creating mechanisms for facility inspections; and creating systems for notification of theft, loss, or release of dangerous pathogens.35 However, although legal authority must back any effective oversight system, precise legal or regulatory measures are not typically well suited to accommodating the rapid pace of scientific advances and associated potential risks, and effective regulation should not unduly hamper scientific research.36 Regional biosecurity and biosafety associations have been actively engaged in setting norms and providing frameworks for national consideration of biosecurity programs. Some countries, such as Kenya, have put great effort into devising not only policy frameworks for biosecurity, but also working to pass updated and relevant legislation.37 To successfully meet GHSA objective 2, more countries will need to make explicit efforts to update and implement biosecurity regulations and legislation. Likewise, although many nations have passed national legislation to support domestic compliance with the Biological Weapons Convention, all States Parties should fulfill their commitment to do so.38
3. Reduce the number and magnitude of infectious disease outbreaks through vaccination against epidemicprone diseases Vaccination law is an essential part of any nation’s preparedness for infectious disease emergencies and will be key to accomplishing the GHSA’s objective of establishing effective national programs for vaccination against epidemic-prone diseases. National laws should both encourage vaccine production and increase vaccination rates among at-risk populations, including healthcare workers,39 as well as the population generally.40 Further, during a public health emergency, national governments may decide to authorize the administration of an untried vaccine, which could result in adverse events. Therefore, given the unique nature of the market for medical countermeasures and the compelling government interest in developing and using the vaccine, distinct and trusted vaccine injury and compensation models should be in place to compensate those who may be harmed in the course of vaccine administration in a manner that does not prevent countermeasure manufacturers from supplying vital vaccines.41 257
LEGAL AND REGULATORY CAPACITY TO SUPPORT GHSA
Detect Threats Early 4. Launch, strengthen, and link global networks for realtime biosurveillance Strong surveillance systems enabling prompt identification of infectious disease threats are integral to health security. At the national level, law offers a means to require and regulate disease reporting, which is an essential part of any biosurveillance system. For example, in the US each state has laws mandating that certain providers report cases of defined diseases to local health departments, which then report to the state level. These data provide the direction and scope of many state and local health department activities—from detecting individual cases and controlling outbreaks to implementing prevention and intervention activities.42 Across the globe, regional networks have been created to standardize and regulate disease surveillance activities. In Africa, for example, 47 nations participate in the WHO Integrated Disease Surveillance Programme, which provides policy and technical support to enhance surveillance capacity, standardizes case definitions and reportable diseases, facilitates information sharing, and assists in implementation of the revised IHR.43 The GHSA prompts nations to establish interoperable and networked monitoring systems that can predict and identify infectious disease threats. In addition to establishing a legal duty to report information, proper laws must also address tensions that may arise between individual privacy rights and the community’s interest in minimizing spread of infectious disease.20 Different systems of law deal with privacy concerns differently, which can be an obstacle to establishing regional and global surveillance networks, another goal of the GHSA. The first step in forming regional and global disease detection networks is making and formalizing connections among technical experts across the ministries of health and other public health institutions in participating countries to support agreed upon strategies. Bilateral and multilateral agreements, including those articulating institutional agreements, arrangements, and definitions, are important to effectively integrating and coordinating local, national, and regional level health officials in support of a regional network.
and the development of diagnostic tools. Lack of adequate sharing during the MERS outbreak reflects a concern on the part of the WHO, which has alleged that sample sharing has been stymied by intellectual property concerns, prompting sharing agreements to be limited to bilateral agreements between laboratories rather than sharing multilaterally using established WHO frameworks.45 There are other reasons that countries may be hesitant to share samples, including uncertain benefits for their populations and claims of ownership of biological materials originating within borders.46 The IHRs do not specifically address the sharing of samples or benefits produced from research involving shared samples, and, although WHO’s PIP Framework has provisions governing sharing of virus samples, it is nonbinding and applies only to influenza virus. Any efforts to improve international sample sharing will likely require better understanding of the legal issues relating to ownership and use of shared viruses that motivate decision making during a health emergency. Accomplishing the GHSA objective of strengthening the global norm of rapid sample sharing may require an entirely new legal framework, but it may also be achieved through memoranda of understanding or an adapted version of the PIP to encompass a broader set of diseases.
5. Strengthen the global norm of rapid, transparent reporting and sample sharing Despite the notable fact that all nations shared flu strains internationally during the H1N1 pandemic, in part because of the newly agreed upon WHO Pandemic Influenza Preparedness (PIP) Framework,15 the ongoing MERS outbreak has led to a global legal controversy over ownership and sharing of dangerous viruses.44 The controversy has underscored the fact that there are inadequate international rules on sharing samples of dangerous pathogens and the benefits produced by the research on them.44 Sharing of virus samples (eg, purified virus, virus sequences, patient serum samples, etc) by international public health laboratories is relied on to develop seed stocks that enable the manufacture of vaccines against a spreading disease
6. Develop and deploy novel diagnostics and strengthen laboratory systems Diagnostic tests are critical for diagnosing diseases to support domestic and international early disease detection and biosurveillance and for improving global health. Specifically, point-of-care diagnostics offer a number of possible advantages over other diagnostic approaches, including the potential to expedite clinical decision making, to reduce patient loss to follow up while waiting for test results, and to facilitate the delivery of care outside traditional healthcare settings, particularly in lower cost environments.47 The GHSA aims to develop and deploy these new point-of-care diagnostics to support global health security. There are no currently available point-of-care diagnostic tests for the low-incidence, but high-consequence diseases, including biothreat agents, which are especially pertinent to global health security.47 Further, it has become apparent that market forces alone are not sufficient to prompt the development of these tests at this time. The Bill & Melinda Gates Foundation is leading the most prominent efforts to accelerate development by hosting the Point-of-Care Diagnostics Initiative, which has the goal of creating new diagnostic platforms that enable high-quality, low-cost diagnosis of disease and also facilitate sustainable markets for diagnostic products.48 Central to this effort is defining standards for point-ofcare diagnostics, to help speed innovation, improve capacity, expand distribution and access, and reduce costs.49 In addition to more technical standards, which may be supported by law, regulatory standards may help increase the supply of qualityassured diagnostic products by normalizing (though not necessarily harmonizing) the global regulatory environment, thus reducing the need to have devices approved by multiple
258
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science
MORHARD AND KATZ
national regulatory authorities and mitigating concern that regulatory controls in some areas of the world are too lax.47 Standards may come about organically, resulting from natural market forces, but formal standard setting typically requires a recognized consensus process that generally addresses intellectual property and regulatory issues. For example, to create standards applicable to development and deployment of point-of-care diagnostics, participating developers will have to identify applicable patents, examine their impact on general innovation, and consider whether patent protection should be relaxed or licensing agreements should be entered into to strengthen global health security. Additionally, given that effective standards aim to lower entry barriers and draw diverse developers, voluntary regulatory standards and reputation systems are likely to supplement formal regulation, which may raise concerns regarding security and quality control, particularly in nations with advanced regulatory systems for medical devices.49 If successfully implemented at an appropriate time, standards may go a long way toward accomplishing the GHSA objective of advancing diagnostic capacity at the point of care.
tions center should be able to stand up on short order and serve as a central command and control center to facilitate and coordinate government response to an infectious disease outbreak. During an incident, an emergency operations center can house real-time monitoring of suspected-case alerts and response by integrating data sources from laboratories, clinical hubs, and transportation and communication networks.53 The nature of such a facility, its purpose, and parameters for when it should be activated (eg, following a declaration of emergency) should be delineated in national emergency legislation. Cooperation and data sharing among participating government entities should be defined and supported by regulations and policies. Professionals staffing the operations center must have lawful authority to properly respond to an outbreak. Response activity should be codified in manuals and standard operating procedures pertaining to response to specific incidents. Additionally, the development of frameworks to guide communication, both across government, between governments, with the media, and with the public, will strengthen situational awareness and incident command.
7. Train and deploy an effective disease surveillance workforce The GHSA calls for nations to put in place a trained and functioning biosurveillance workforce. Not surprisingly, there is no legal mechanism that can substitute for a trained workforce of physicians, veterinarians, biostatisticians, laboratory scientists, and epidemiologists. However, as nations aim to increase their capacity in this respect, mutual aid agreements may serve to bridge gaps by sharing know-how and, if necessary, personnel before and during an infectious disease outbreak.50 Such agreements can form the basis for formal exchanges of best practices, training courses, technical data, operating strategy, and surveillance tools and strategies. For example, Connecting Organizations for Regional Disease Surveillance (CORDS) facilitates arrangements whereby an expert from one disease surveillance network is detailed to another network to work for a period of time to improve capacity and exchange knowledge.51 Similar agreements, whether they are bilateral or multilateral, may be helpful in accomplishing this GHSA objective. Additionally, nations might consider exploring legal and regulatory options to temporarily expand professional scopes of practice during a public health emergency to enable certain trained practitioners to help meet personnel needs during an outbreak response, freeing up other officials to perform more sophisticated surveillance work.52
9. Improve global access to medical and nonmedical countermeasures during health emergencies The GHSA seeks to encourage nations to build capacity to produce or procure personal protective equipment, medications, vaccines, and technical expertise. Specifically, the US aims to support nations as they develop national frameworks for sending and receiving medical countermeasures and public health and medical personnel from and to international partners during public health emergencies.54 As a general matter, transferring vaccines between nations during a public health emergency can have obvious benefits. However, such transfers must be properly managed in order to avoid potential risks, particularly with respect to donation of medical countermeasures, which may be an important component of improving global access.55 The WHO Vaccine Donation Guidelines attempt to address these risks by requiring, for example, that vaccines donated in support of national routine vaccination programs are donated in a manner and at a level that does not threaten the sustainability of the program and that the donated vaccine is subject to licensing standards in both the recipient government and the producing country.56 Although the WHO makes exceptions to these guidelines for vaccines donated for emergency, epidemic, or pandemic situations when it may not be possible to apply typical specifications, additional legal challenges may emerge in such circumstances. For example, in the US, the Public Readiness and Emergency Preparedness Act (PREP Act) provides manufacturers, distributors, program planners, and other officials with very broad immunity against claims of liability associated with harms resulting from medical countermeasures administered in the course of a declared public health emergency.57 These protections apply to a range of medical countermeasures, including those that are donated and those licensed under
Respond Rapidly and Effectively 8. Develop an interconnected global network of emergency operations centers and multisectoral response to biological incidents The GHSA also calls for nations to establish emergency operations centers (EOCs). A national emergency operaVolume 12, Number 5, 2014
259
LEGAL AND REGULATORY CAPACITY TO SUPPORT GHSA
emergency use authorization authorities. However, immunity protections are applicable only in US courts, and no protection is offered under the PREP Act for claims filed under foreign law in courts outside the US (although protections may be available in US courts against claims based on events that took place outside the US).58 Further, liability protections vary depending on whether the donations are made via the US government, the WHO, or directly.59 Liability concerns may slow donation of vaccines that could be crucial to increasing global coverage during a pandemic, and trying to unravel the web of domestic licensing and legal liability surrounding vaccine donation during a pandemic is not ideal. Accordingly, realizing this objective may require a proactive, international effort to explore these issues and begin addressing any concerns in advance of the next pandemic.
Conclusion The Global Health Security Agenda should spur nations around the world to commit to building the capacities necessary to prevent, detect, and respond to public health emergencies. Nations should remember the importance of building complementary legal and regulatory frameworks that will enable progress, ensure success, and allow for sustainability of capacity-building efforts.
References 1. The Global Health Security Agenda. US Department of Health and Human Services website. http://www.globalhealth. gov/global-health-topics/global-health-security/ghsagenda. html. Accessed April 28, 2014. 2. Public Health Security and Bioterrorism Response Act of 2002. Pub. L. No. 107-188; 116 Stat 594. 2002. 3. Public Readiness and Emergency Preparedness Act. US Department of Health and Human Services website. Reviewed March 5, 2014. https://www.phe.gov/Preparedness/ legal/prepact/Pages/default.aspx. Accessed July 23, 2014. 4. Pandemic and All-Hazards Preparedness Act. Pub. L. No. 109-417; 120 Stat. 2831. 2006. 5. The Model State Emergency Health Powers Act (MSEHPA). Centers for Law and the Public’s Health website. Updated January 27, 2010. http://www.publichealthlaw.net/ModelLaws/ MSEHPA.php. Accessed April 26, 2014. 6. World Health Organization. International Health Regulations (2005). 2d ed. http://whqlibdoc.who.int/publications/2008/ 9789241580410_eng.pdf?ua = 1. Accessed April 26, 2014. 7. World Health Organization. Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. 2011. http://www.who.int/ influenza/resources/pip_framework/en/. Accessed April 26, 2014. 8. World Health Organization. WHO Framework Convention on Tobacco Control. 2003. http://www.who.int/fctc/text_ download/en/. Accessed April 26, 2014.
260
9. GHSI background. Global Health Security Initiative website. http://www.ghsi.ca/english/background.asp. Accessed April 26, 2014. 10. NAPAPI: North American countries join forces to prepare for pandemics [news release]. World Health Organization website. April 2, 2012. http://www.who.int/influenza_vaccines_ plan/news/napapi_2_april_2012/en/. Accessed June 18, 2014. 11. HHS announces early warning infectious disease surveillance project with Me´xico [news release]. US Department of Health and Human Services. March 9, 2006. http:// www.globalhealth.gov/news-and-events/archive-news/2006/ 20060309-hhs.html. Accessed April 26, 2014. 12. Hoffman S. Responders’ responsibility: liability and immunity in public health emergencies. Georgetown LJ 2007;96:1913. 13. Hodge JG Jr, Anderson ED. Principles and practice of legal triage during public health emergencies. NYU Ann Surv Am L 2008;64:249. 14. Kamoie B, Pestronk RM, Baldridge P, et al. Assessing laws and legal authorities for public health emergency legal preparedness. J Law Med Ethics 2008;36(Suppl 1):23-27. 15. Hodge JG Jr. Global legal triage in response to the 2009 H1N1 outbreak. Minn JL Sci & Tech 2010;11:599. 16. Identifying and addressing barriers to the emergency sharing of international public health and medical assistance. Submitted by the United States of America. Biological Weapons Convention Meeting of Experts. August 12-16, 2013. http:// unog.ch/__80256ee600585943.nsf/(httpPages)/eed3e63397 c2144bc1257bf80054fe12?OpenDocument&ExpandSection = 1#_Section1. Accessed April 26. 2014. 17. World Health Organization. International Health Regulations (2005). Toolkit for implementation in national legislation. January 2009. http://www.who.int/ihr/Toolkit_Legislative_ Implementation.pdf. Accessed April 26, 2014. 18. Katz R, Kornblet S. Comparative analysis of national legislation in support of the revised International Health Regulations: potential models for implementation in the United States. Am J Public Health 2010;100(12):2347-2353. 19. World Health Organization. Toolkit for Assessing HealthSystem Capacity for Crisis Management. http://www.euro.who. int/__data/assets/pdf_file/0008/157886/e96187.pdf. Accessed April 26, 2014. 20. Fidler DP. Legal issues associated with antimicrobial drug resistance. Emerg Infect Dis 1998;4(2):169-177. http:// wwwnc.cdc.gov/eid/article/4/2/98-0204.htm. Accessed April 26, 2014. 21. Davies J, Davies D. Origins and evolution of antibiotic resistance. Microbiol Mol Biol Rev 2010;74(3):417-433. 22. Bal AM, Gould IM. Antibiotic stewardship: overcoming implementation barriers. Curr Opin Infect Dis 2011;24(4): 357-362. 23. Despite superbug crisis, progress in antibiotic development ‘alarmingly elusive’ [news release]. Infectious Diseases Society of America website. April 18, 2013. http://www.idsociety.org/ 2013_antibiotic_development/. Accessed April 26, 2014. 24. Bad Bugs, No Drugs. As Antibiotic Discovery Stagnates.A Public Health Crisis Brews. Infectious Diseases Society of America; July 2004. http://www.idsociety.org/uploadedfiles/idsa/policy_ and_advocacy/current_topics_and_issues/antimicrobial_ resistance/10x20/images/bad%20bugs%20no%20drugs.pdf. Accessed April 26, 2014.
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science
MORHARD AND KATZ 25. Spellberg B, Guidos R, Gilbert D, et al. The epidemic of antibiotic-resistant infections: a call to action for the medical community from the Infectious Diseases Society of America. Clin Infect Dis 2008;46(2):155-164. 26. Outterson K. New business models for sustainable antibiotics. Working Group Paper. Chatham House website. January 2014. http://www.chathamhouse.org/publications/ papers/view/197446. Accessed April 26, 2014. 27. Jones KE, Patel NG, Levy MA, et al. Global trends in emerging infectious diseases. Nature 2008;451(7181):990993. 28. Managing zoonotic public health risks at the human-animalecosystem interface. World Health Organization website. http://www.who.int/foodsafety/about/flyer_zoonoses.pdf?ua = 1. Accessed April 26, 2014. 29. Zoonotic Diseases: A Guide to Establishing Collaboration between Animal and Human Health Sectors at the Country Level. World Health Organization; 2008. http://www.oie.int/doc/ ged/D12060.PDF. Accessed April 26, 2014. 30. Huang Y. China’s worsening food safety crisis. The Atlantic August 28, 2012. http://www.theatlantic.com/international/ archive/2012/08/chinas-worsening-food-safety-crisis/261656/. Accessed April 26, 2014. 31. Outbreak Investigations – Recent Outbreaks. Food and Drug Administration. February 21, 2014. http://www.fda.gov/ Food/RecallsOutbreaksEmergencies/Outbreaks/ucm272351. htm#outbreaks. Accessed April 26, 2014. 32. Flynn D. Germany’s E. coli outbreak most costly in history. Food Safety News June 16, 2011. http://www.foodsafetynews. com/2011/06/europes-o104-outbreak-most-costly-in-history/#. U9ACeqHD_cs. Accessed April 26, 2014. 33. Your food is global. Complex supply chains permeate even local products. Global Food Security website. http://www. foodsecurity.ac.uk/food/food-global.html. Accessed April 26, 2014. 34. Codex Alimentarius Commission. Strategic Plan 2014-19. Food and Agriculture Organization of the United Nations. ftp://ftp.fao.org/codex/Publications/StrategicFrame/Strategic_ plan_2014_2019_EN.pdf. Accessed April 26, 2014. 35. Sutton V. Biosecurity Law and Policy. Lubbock, TX: Vargas Publishing; 2014. 36. Committee on Education on Dual Use Issues in the Life Sciences; National Research Council. Challenges and Opportunities for Education about Dual Use Issues in the Life Sciences. Washington, DC: National Academies Press; 2010. 37. Aluoch A, Macharia J. Kenya—Towards Health Security. Presentation. https://www.unog.ch/80256EDD006B8954/ (httpAssets)/91C3C75079C7A7C6C1257926002CD7B7/ $file/BACAC + - + Kenya + presentation.pdf. Accessed April 26, 2014. 38. The Biological and Toxin Weapons Convention website. National implementation. http://www.opbw.org. Accessed June 24, 2014. 39. Griffin MR. Influenza vaccination of healthcare workers: making the grade for action. Clin Infect Dis 2014;58(1):58-60. 40. Parmet WE. Pandemic vaccines—the legal landscape. N Engl J Med 2010;362(21):1949-1952. 41. Gostin LO. Medical countermeasures for pandemic influenza: ethics and the law. JAMA 2006;295(5): 554-556.
Volume 12, Number 5, 2014
42. National Notifiable Diseases Surveillance System: monitoring the occurrence and spread of diseases. Centers for Disease Control and Prevention website. http://wwwn.cdc.gov/nndss/ document/DNDHI_NNDSS_12_232372_L_remediated_ 11_5_2013.pdf. Accessed April 28, 2014. 43. Integrated Disease Surveillance. Objectives/functions. World Health Organization Africa website. http://www.afro. who.int/en/clusters-a-programmes/dpc/integrated-diseasesurveillance/overview/objectivesfunctions.html. Accessed April 26, 2014. 44. Fidler D. Who owns MERS? The intellectual property controversy surrounding the latest pandemic. Foreign Affairs June 7, 2013. http://www.foreignaffairs.com/articles/139443/davidp-fidler/who-owns-mers. Accessed March 30, 2014. 45. Garrett L. The Middle East plague goes global. Foreign Policy June 28, 2013. http://www.foreignpolicy.com/articles/2013/ 06/28/the_middle_east_plague_goes_global. Accessed April 26, 2014. 46. About the Nagoya Protocol. Convention on Biological Diversity website. http://www.cbd.int/abs/about/. Accessed April 28, 2014. 47. Nuzzo JB, Rambhia K, Morhard RC, et al. Diagnosing Infection at the Point of Care. UPMC Center for Health Security website. http://www.upmchealthsecurity.org/ourwork/publications/diagnosing-infection-at-the-point-of-care. Accessed April 26, 2014. 48. Gates Foundation and Grand Challenges Canada announce over $31 million for point-of-care diagnostics in the developing world [news release]. Grand Challenges in Global Health website. December 15, 2011. http://www.grandchallenges.org/ about/Newsroom/Pages/POC_DxGrants.aspx. Accessed April 28, 2014. 49. Masum H, Lackman R, Bartleson K. Developing global health technology standards: what can other industries teach us? Global Health 2013;9(1):49. 50. Stier DD, Goodman RA. Mutual aid agreements: essential legal tools for public health preparedness and response. Am J Public Health 2007;97(Suppl1):S62-S68. 51. CORDS: Connecting Organizations for Regional Disease Surveillance. Strategic Plan. April 22, 2011. http://www.nti.org/ media/pdfs/CORDS-strategic-plan_confirmed-final_DL_629.pdf?_ = 1322498985. Accessed April 28, 2014. 52. Courtney B, Morhard R, Bouri N, Cicero A. Expanding practitioner scopes of practice during public health emergencies: experiences from the 2009 H1N1 pandemic vaccination efforts. Biosecur Bioterror 2010;8(3):223-231. 53. Borchert JN, Tappero JW, Downing R, et al. Rapidly building global health security capacity—Uganda demonstration project, 2013. MMWR Morb Mortal Wkly Rep 2014; 63(4):73-76. 54. Global Health Security—Vision and Overarching Target. http://www.cdc.gov/globalhealth/security/pdf/ghs_overarching_ target.pdf. Accessed April 26, 2014. 55. Vaccine donation policy. GAVI Alliance website. http:// www.gavialliance.org/about/governance/programme-policies/ vaccine-donation/. Accessed April 28, 2014. 56. Vaccine donations. WHO-UNICEF Joint Statement. August 7, 2010. http://whqlibdoc.who.int/hq/2010/WHO_IVB_ 10.09_eng.pdf. Accessed April 28, 2014.
261
LEGAL AND REGULATORY CAPACITY TO SUPPORT GHSA 57. PREP Act Q&As. US Department of Health and Human Services website. March 5, 2014. https://www.phe.gov/ Preparedness/legal/prepact/Pages/prepqa.aspx. Accessed April 26, 2014. 58. Recent developments in FDA’s emergency authority for medical countermeasures. Public Health Law Webinar Series. March 15, 2012. https://www.networkforphl.org/_asset/ msj92r/WebinarQsAsFINAL.pdf. Accessed April 28, 2014. 59. WHO Coordination Efforts to Make Pandemic (H1N1) Vaccines Available Globally. GHSAG MCM Meeting; Washington, DC; 4 November 2009. https://www.blsmeetings.net/2009 ghsimeetingsmcm/presentations/Plenary/Roth-WHO-H1N1. pdf. Accessed April 28, 2014.
Manuscript received April 29, 2014; accepted for publication June 25, 2014.
262
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science
Address correspondence to: Rebecca Katz, PhD, MPH Associate Professor, Health Policy, Global Health and Emergency Medicine Milken Institute School of Public Health George Washington University 950 New Hampshire Ave., NW, 6th Floor Washington, DC 20052 E-mail: [email protected]
Legal and Regulatory Capacity to Support the Global Health Security Agenda Ryan Morhard and Rebecca Katz
On February 13, 2014, 27 nations, along with 3 international organizations, launched the Global Health Security Agenda (GHSA). The intent of GHSA is to accelerate progress in enabling countries around the world to prevent, detect, and respond to public health emergencies—capacities to be achieved through 9 core objectives. Building national, regional, and international capacity includes creating strong legal and regulatory regimes to support national and international capacities to prevent, detect, and respond to public health emergencies. Accordingly, establishing and reinforcing international and national-level legal preparedness is central to advancing elements of each of the 9 objectives of the GHSA.
O
n February 13, 2014, 27 nations, along with 3 international organizations, launched the Global Health Security Agenda (GHSA).1 The intent of GHSA is to accelerate progress in enabling countries around the world to prevent, detect, and respond to public health emergencies— capacities to be achieved through 9 core objectives. Building national, regional, and international capacity includes creating strong legal and regulatory regimes to support national and international capacities to prevent, detect, and respond to public health emergencies. These legal and regulatory frameworks may not always be the first step taken by nations, nor the highest priority, but all other capacities rely on a strong legal and regulatory foundation to ensure long-term functionality and sustainability as new capacities become engrained into national and international systems. This article describes the ways in which law may be integral to accomplishing elements of each of the 9 objectives of the GHSA.
Background Law, and the duties, relationships, frameworks, regulations, and policies it engenders, is a cornerstone of strengthening
national, regional, and global ability to prevent, detect, and respond to infectious disease threats. Deficiencies in law can undermine effective response to public health emergencies. Accordingly, establishing and reinforcing international and national-level legal preparedness is central to advancing elements of each of the 9 objectives of the GHSA. Legal preparedness describes the legislation, regulations, and policies that support a public health system’s ability to prevent, detect, and respond to an emergency. In the United States, attention to this distinct aspect of preparedness heightened following 9/11 and the anthrax terror attacks, when an array of legislation governing public health response to infectious disease was enacted at the federal (eg, Public Health Security and Bioterrorism Preparedness Response Act,2 Public Readiness and Emergency Preparedness [PREP] Act,3 Pandemic and All-Hazards Preparedness Act4) and state (eg, Model State Emergency Health Powers Act5) levels. Likewise, globally, the past decade has seen revisions of the International Health Regulations,6 enactment of the Pandemic Influenza Preparedness (PIP) Framework,7 and other international treaties, such as the World Health Organization (WHO) Framework Convention on Tobacco Control.8 The United States participates in a host of formal partnerships—multilateral (eg,
At the time this article was written, Ryan Morhard, JD, was an Associate at the UPMC Center for Health Security, Baltimore, Maryland. Rebecca Katz, PhD, MPH, is an Associate Professor in the Milken Institute School of Public Health, George Washington University, Washington, DC. 254
MORHARD AND KATZ
Global Health Security Initiative9), trilateral (North American Plan for Animal and Pandemic Influenza10), and bilateral (eg, US-Mexico Early Warning Infectious Disease Surveillance Program11)—aimed at enhancing cooperation to improve public health preparedness. Elsewhere, nations have come together to form regional disease surveillance networks (eg, the Mekong Basin Disease Surveillance Network [MBDS], the East African Integrated Disease Surveillance Network [EAIDSNet]). These and other efforts have each been devoted to preparing public health leaders in the US and abroad to face critical legal and policy choices during public health emergencies. After all, response can be delayed or inadequate because of ambiguity over authority, liability concerns, and fundamental questions about who is responsible for what.12 Enhancing legal preparedness requires identifying best practices and potential gaps in addressing legal issues and implementing key measures to improve public health capacity, minimize barriers, and encourage effective response. Some of the primary issues that have been the focus of attention in the US include, for example, decisions relating to interjurisdictional legal coordination; authority and ability to enact infection control measures; authority to stockpile, approve, distribute, and mandate medical countermeasures; licensing and credentialing of out-of-state (and out-of-country) healthcare practitioners; managing scarce resources; and addressing liability concerns of public health practitioners and entities during emergencies.13 Globally, attention has been paid to many of the same issues, with a focus on responsibilities for detection and reporting, and the authorities to enact infection control measures. There has been less attention paid to legal issues surrounding the distribution of medical countermeasures or credentialing of healthcare practitioners and ensuring that regulatory agencies are appropriately supported by laws and regulations that prevent them from encumbering effective response. For purposes of this article, law can be defined as a rule of conduct derived from federal, state, or regional constitutions, statutes, local laws, judicial opinions, administrative rules and regulations, international codes, or other pronouncements by entities authorized to prescribe conduct in a legally binding manner.14 Relevant international and national law should be flexible enough to support response to public health emergencies of varying intensity. Although many infectious disease events are localized, low-impact events, response to larger infectious disease outbreaks can be made more difficult by divergent legal responses, especially those authorizing a range of antiquated, inconsistent, and uncoordinated public health interventions.15 Strong national legal frameworks are also fundamental to the receipt of international assistance and increased regional coordination demanded for effective response to disease outbreaks that have crossborder implications or that require international assistance.16 Therefore, national-level legal preparedness efforts must also embrace the global context in which serious threats to public health arise and are handled. Volume 12, Number 5, 2014
The global health community has also recognized national-level legal preparedness as essential to health security. Building legal preparedness is defined by the WHO as a core capacity that nations must develop to implement the International Health Regulations (IHR), and in 2009 the WHO released a toolkit for implementation in national legislation.17 As of 2010, approximately half of states parties had amended legislation to fulfill IHR obligations.18 In addition, the WHO Toolkit for Assessing Health-System Capacity for Crisis Management identifies a legal framework for national multisectoral emergency management as a ‘‘key component’’ critical to comprehensive preparedness for public health emergencies.19
Legal Challenges Presented by the GHSA The following section outlines ways in which law may be integral to accomplishing aspects of each of the 9 objectives of the GHSA (see Figure 1). Of course, the mere enactment of a law or creation of a legal duty does not, by itself, render a nation prepared, and efforts to strengthen legal preparedness should be accompanied by building capacity across the public health system. Further, legal frameworks, and indeed legal capacities, vary among nations, and, as such, application of the following analysis will vary among nations participating in the GHSA.
Prevent Avoidable Epidemics 1. Prevent the emergence and spread of antimicrobial drug resistant organisms and emerging zoonotic diseases, and strengthen international regulatory frameworks governing food safety An effective public health strategy against the development of antimicrobial drug resistance must be informed by legal as well as scientific analysis.20 The perpetuation of antibiotic resistance is accelerated by the excessive use of antibiotics in both humans and animals,21 and informed laws and regulations can serve as an important means of reducing individual and institutional factors that enable such misuse. Law is key to supporting and standardizing necessary efforts to not only improve infection control practices and antibiotic stewardship, but also to creating conditions that help accelerate the discovery and development of new antimicrobials that are essential to slowing the rise of resistance. Effective antibiotic stewardship requires formal and dependable frameworks to overcome barriers to implementation, which tend to include lack of physician participation, ingrained practice in the agricultural sector, absence of formal mechanisms for data collection, variation between jurisdictions, and lack of cooperative strategies.22 Curbing the misuse of antibiotics, both in health care and food 255
256
Figure 1.
encompass a broader set of diseases.
Examine range of legal issues relating to ownership and use of shared viruses, including those relating to Intellectual Property, that motivate decision-making during a health emergency. Nations should establish Memoranda of Understanding to facilitate timely transfer of virus samples. Consider producing an adapted version of the WHO
5. Strengthening the global norm of rapid, transparent reporting and sample sharing in the event of health emergencies of international concern.
Ways in Which Law Can Accomplish Aspects of Each of the 9 Objectives of the GHSA
pathogens.
registered laboratories. Provide frameworks for training scientists.
Regulate of high-risk practice of biology by identifying highrisk pathogens and regulating handling, storage, transport and export of these select pathogens.
2. Promoting national biosafety and biosecurity systems.
Nations should develop legal frameworks for sending and receiving medical countermeasures, public health and medical personnel, and other assistance from and to international partners during emergencies.
9. Improving global access to medical and non-medical countermeasures during health emergencies.
Implement Mutual Aid Agreements to bridge gaps in knowledge and capacity by sharing know-how and personnel before, during, and after an event. Consider legal and regulatory options to temporarily expand professional scopes of practice during a public health emergency to enable certain trained practitioners to help meet personnel needs during response.
National laws should encourage both vaccine production and increased vaccination rates, including by creating a system supporting emergency use of untried vaccines and forming distinct and trusted vaccine injury and compensation models that provides just compensation while maintaining a favorable environment for vaccine production and distribution.
Respond Rapidly and Effectively
lawful authority to properly respond and develop manuals and standard operating procedures to govern response activity.
regulations and policies.
Consider relationship between evidence produced by microbial forensics techniques and standards of legal admissibility. National emergency legislation should delineate the purpose of an Emergency Operations Center and parameters for when it should be activated. Cooperation and data sharing among participating
8. Developing an interconnected global network of Emergency Operations Centers and multi-sectoral response to biological incidents.
7. Training and deploying an effective biosurveillance workforce.
Detect Threats Early
both regulatory and technical - that help speed innovation, improve capacity,, expand distribution and access, and reduce costs.
6. Developing and deploying novel diagnostics and strengthen laboratory systems.
Establish legal duty to report diseases integral to comprehensive biosurveillance. Formalize connections among technical experts across ministries of health and other public health institutions in participating countries to support agreed upon surveillance strategies.
4. Launching, strengthening and linking global networks for real-time biosurveillance.
3. Reducing the number and magnitude of infectious disease outbreaks.
Prevent Avoidable Epidemics
Implement laws and regulations that support and standardize infection control practice and antibiotic stewardship and create conditions that help accelerate the discovery and development of new antimicrobials essential to slowing rise of resistance. Regulate public health risks at the human and animal interface. Strengthen elements of the Codex Alimentarius per recommendations of the 2014-2019 strategic plan.
1. Preventing emergence and spread of antimicrobial drug resistant organisms and emerging zoonotic infectious diseases and strengthening international regulatory frameworks governing food safety.
Global Health Security Agenda Objectives - Select Legal Elements
LEGAL AND REGULATORY CAPACITY TO SUPPORT GHSA
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science
MORHARD AND KATZ
production, may also require a regulatory strategy that monitors the use of antibiotics and limits when antibiotics are authorized, perhaps by adjusting labeling requirements or altering public subsidies for antibiotics.20 Practitioners must also be equipped with legal authority to detain or isolate people infected with highly resistant pathogens in order to properly control infection and to prevent the spread of resistant organisms. The paucity of new antibiotics being developed makes the task of addressing increasing resistance all the more challenging. The pace of new drugs being developed is slower than the rate of rise of antibiotic resistance.23 The development pipeline for new antimicrobial drugs is bleak, driven by a marked decrease in industry research and development and government inaction.24 The cause of slowing development is multifactorial, although, fundamentally, each factor relates to return on investment.25 Therefore, in addition to protecting against overuse, innovative legal solutions may also be required to provide sufficient market incentives for companies to invest in development of antimicrobials. For example, nations might consider adopting laws and regulations that uncouple return on investment from sales volume and price; simplify applicable regulatory frameworks for the development of antimicrobials, both shortening time to approval and reducing costs of clinical trials; and/or extend patent periods to allow successful developers to benefit from longlasting market exclusivity.26 The GHSA also aims to build capacity to prevent emergence and spread of zoonotic infectious diseases, which are linked to over 60% of all new diseases.27 Toward this goal, GHSA efforts should support countries as they develop legal and regulatory frameworks that encourage the intersectoral collaboration required to manage public health risks at the human and animal interface.28 Although most emerging infectious diseases occur in wildlife, countries should be encouraged to implement enforceable risk reduction measures, including those supporting case/outbreak transparency and notification measures, and associated compensation mechanisms, biosecurity in farms and marketplaces, and control of animal movement.29 Given that recent significant, high-profile food contamination events in China,30 the United States,31 and Europe,32 for example, have raised awareness of the public health challenges posed by foodborne disease and the increasingly global nature of the food supply chain,33 it is appropriate that strengthening international regulatory frameworks governing food safety is an objective of the GHSA. This objective is also synergistic with the Codex Alimentarius strategic plan for 2014-2019.34 2. Promote national biosafety and biosecurity systems Enhancing biosafety and biosecurity protects populations, makes researchers safer from disease, and makes dangerous pathogens more secure and difficult to obtain by those interested in misuse. Under objective 2, the GHSA seeks to build national and regional capacities to manage biological Volume 12, Number 5, 2014
material and advance frameworks to promote safe and responsible conduct. A prime approach for addressing these challenges is through the adoption and implementation of country-specific biosecurity legislation. Such legislation should support comprehensive regulation of the potentially high-risk practice of life science research and diagnostic laboratories by: identifying and specifying select dangerous pathogens; regulating the transportation of these select biological agents; regulating the handling, storage, and use of these agents; requiring the development and implementation of biosafety and security plans at laboratories; creating a process for certifying and registering laboratories; providing frameworks for training scientists in dual-use research of concern; creating mechanisms for facility inspections; and creating systems for notification of theft, loss, or release of dangerous pathogens.35 However, although legal authority must back any effective oversight system, precise legal or regulatory measures are not typically well suited to accommodating the rapid pace of scientific advances and associated potential risks, and effective regulation should not unduly hamper scientific research.36 Regional biosecurity and biosafety associations have been actively engaged in setting norms and providing frameworks for national consideration of biosecurity programs. Some countries, such as Kenya, have put great effort into devising not only policy frameworks for biosecurity, but also working to pass updated and relevant legislation.37 To successfully meet GHSA objective 2, more countries will need to make explicit efforts to update and implement biosecurity regulations and legislation. Likewise, although many nations have passed national legislation to support domestic compliance with the Biological Weapons Convention, all States Parties should fulfill their commitment to do so.38
3. Reduce the number and magnitude of infectious disease outbreaks through vaccination against epidemicprone diseases Vaccination law is an essential part of any nation’s preparedness for infectious disease emergencies and will be key to accomplishing the GHSA’s objective of establishing effective national programs for vaccination against epidemic-prone diseases. National laws should both encourage vaccine production and increase vaccination rates among at-risk populations, including healthcare workers,39 as well as the population generally.40 Further, during a public health emergency, national governments may decide to authorize the administration of an untried vaccine, which could result in adverse events. Therefore, given the unique nature of the market for medical countermeasures and the compelling government interest in developing and using the vaccine, distinct and trusted vaccine injury and compensation models should be in place to compensate those who may be harmed in the course of vaccine administration in a manner that does not prevent countermeasure manufacturers from supplying vital vaccines.41 257
LEGAL AND REGULATORY CAPACITY TO SUPPORT GHSA
Detect Threats Early 4. Launch, strengthen, and link global networks for realtime biosurveillance Strong surveillance systems enabling prompt identification of infectious disease threats are integral to health security. At the national level, law offers a means to require and regulate disease reporting, which is an essential part of any biosurveillance system. For example, in the US each state has laws mandating that certain providers report cases of defined diseases to local health departments, which then report to the state level. These data provide the direction and scope of many state and local health department activities—from detecting individual cases and controlling outbreaks to implementing prevention and intervention activities.42 Across the globe, regional networks have been created to standardize and regulate disease surveillance activities. In Africa, for example, 47 nations participate in the WHO Integrated Disease Surveillance Programme, which provides policy and technical support to enhance surveillance capacity, standardizes case definitions and reportable diseases, facilitates information sharing, and assists in implementation of the revised IHR.43 The GHSA prompts nations to establish interoperable and networked monitoring systems that can predict and identify infectious disease threats. In addition to establishing a legal duty to report information, proper laws must also address tensions that may arise between individual privacy rights and the community’s interest in minimizing spread of infectious disease.20 Different systems of law deal with privacy concerns differently, which can be an obstacle to establishing regional and global surveillance networks, another goal of the GHSA. The first step in forming regional and global disease detection networks is making and formalizing connections among technical experts across the ministries of health and other public health institutions in participating countries to support agreed upon strategies. Bilateral and multilateral agreements, including those articulating institutional agreements, arrangements, and definitions, are important to effectively integrating and coordinating local, national, and regional level health officials in support of a regional network.
and the development of diagnostic tools. Lack of adequate sharing during the MERS outbreak reflects a concern on the part of the WHO, which has alleged that sample sharing has been stymied by intellectual property concerns, prompting sharing agreements to be limited to bilateral agreements between laboratories rather than sharing multilaterally using established WHO frameworks.45 There are other reasons that countries may be hesitant to share samples, including uncertain benefits for their populations and claims of ownership of biological materials originating within borders.46 The IHRs do not specifically address the sharing of samples or benefits produced from research involving shared samples, and, although WHO’s PIP Framework has provisions governing sharing of virus samples, it is nonbinding and applies only to influenza virus. Any efforts to improve international sample sharing will likely require better understanding of the legal issues relating to ownership and use of shared viruses that motivate decision making during a health emergency. Accomplishing the GHSA objective of strengthening the global norm of rapid sample sharing may require an entirely new legal framework, but it may also be achieved through memoranda of understanding or an adapted version of the PIP to encompass a broader set of diseases.
5. Strengthen the global norm of rapid, transparent reporting and sample sharing Despite the notable fact that all nations shared flu strains internationally during the H1N1 pandemic, in part because of the newly agreed upon WHO Pandemic Influenza Preparedness (PIP) Framework,15 the ongoing MERS outbreak has led to a global legal controversy over ownership and sharing of dangerous viruses.44 The controversy has underscored the fact that there are inadequate international rules on sharing samples of dangerous pathogens and the benefits produced by the research on them.44 Sharing of virus samples (eg, purified virus, virus sequences, patient serum samples, etc) by international public health laboratories is relied on to develop seed stocks that enable the manufacture of vaccines against a spreading disease
6. Develop and deploy novel diagnostics and strengthen laboratory systems Diagnostic tests are critical for diagnosing diseases to support domestic and international early disease detection and biosurveillance and for improving global health. Specifically, point-of-care diagnostics offer a number of possible advantages over other diagnostic approaches, including the potential to expedite clinical decision making, to reduce patient loss to follow up while waiting for test results, and to facilitate the delivery of care outside traditional healthcare settings, particularly in lower cost environments.47 The GHSA aims to develop and deploy these new point-of-care diagnostics to support global health security. There are no currently available point-of-care diagnostic tests for the low-incidence, but high-consequence diseases, including biothreat agents, which are especially pertinent to global health security.47 Further, it has become apparent that market forces alone are not sufficient to prompt the development of these tests at this time. The Bill & Melinda Gates Foundation is leading the most prominent efforts to accelerate development by hosting the Point-of-Care Diagnostics Initiative, which has the goal of creating new diagnostic platforms that enable high-quality, low-cost diagnosis of disease and also facilitate sustainable markets for diagnostic products.48 Central to this effort is defining standards for point-ofcare diagnostics, to help speed innovation, improve capacity, expand distribution and access, and reduce costs.49 In addition to more technical standards, which may be supported by law, regulatory standards may help increase the supply of qualityassured diagnostic products by normalizing (though not necessarily harmonizing) the global regulatory environment, thus reducing the need to have devices approved by multiple
258
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science
MORHARD AND KATZ
national regulatory authorities and mitigating concern that regulatory controls in some areas of the world are too lax.47 Standards may come about organically, resulting from natural market forces, but formal standard setting typically requires a recognized consensus process that generally addresses intellectual property and regulatory issues. For example, to create standards applicable to development and deployment of point-of-care diagnostics, participating developers will have to identify applicable patents, examine their impact on general innovation, and consider whether patent protection should be relaxed or licensing agreements should be entered into to strengthen global health security. Additionally, given that effective standards aim to lower entry barriers and draw diverse developers, voluntary regulatory standards and reputation systems are likely to supplement formal regulation, which may raise concerns regarding security and quality control, particularly in nations with advanced regulatory systems for medical devices.49 If successfully implemented at an appropriate time, standards may go a long way toward accomplishing the GHSA objective of advancing diagnostic capacity at the point of care.
tions center should be able to stand up on short order and serve as a central command and control center to facilitate and coordinate government response to an infectious disease outbreak. During an incident, an emergency operations center can house real-time monitoring of suspected-case alerts and response by integrating data sources from laboratories, clinical hubs, and transportation and communication networks.53 The nature of such a facility, its purpose, and parameters for when it should be activated (eg, following a declaration of emergency) should be delineated in national emergency legislation. Cooperation and data sharing among participating government entities should be defined and supported by regulations and policies. Professionals staffing the operations center must have lawful authority to properly respond to an outbreak. Response activity should be codified in manuals and standard operating procedures pertaining to response to specific incidents. Additionally, the development of frameworks to guide communication, both across government, between governments, with the media, and with the public, will strengthen situational awareness and incident command.
7. Train and deploy an effective disease surveillance workforce The GHSA calls for nations to put in place a trained and functioning biosurveillance workforce. Not surprisingly, there is no legal mechanism that can substitute for a trained workforce of physicians, veterinarians, biostatisticians, laboratory scientists, and epidemiologists. However, as nations aim to increase their capacity in this respect, mutual aid agreements may serve to bridge gaps by sharing know-how and, if necessary, personnel before and during an infectious disease outbreak.50 Such agreements can form the basis for formal exchanges of best practices, training courses, technical data, operating strategy, and surveillance tools and strategies. For example, Connecting Organizations for Regional Disease Surveillance (CORDS) facilitates arrangements whereby an expert from one disease surveillance network is detailed to another network to work for a period of time to improve capacity and exchange knowledge.51 Similar agreements, whether they are bilateral or multilateral, may be helpful in accomplishing this GHSA objective. Additionally, nations might consider exploring legal and regulatory options to temporarily expand professional scopes of practice during a public health emergency to enable certain trained practitioners to help meet personnel needs during an outbreak response, freeing up other officials to perform more sophisticated surveillance work.52
9. Improve global access to medical and nonmedical countermeasures during health emergencies The GHSA seeks to encourage nations to build capacity to produce or procure personal protective equipment, medications, vaccines, and technical expertise. Specifically, the US aims to support nations as they develop national frameworks for sending and receiving medical countermeasures and public health and medical personnel from and to international partners during public health emergencies.54 As a general matter, transferring vaccines between nations during a public health emergency can have obvious benefits. However, such transfers must be properly managed in order to avoid potential risks, particularly with respect to donation of medical countermeasures, which may be an important component of improving global access.55 The WHO Vaccine Donation Guidelines attempt to address these risks by requiring, for example, that vaccines donated in support of national routine vaccination programs are donated in a manner and at a level that does not threaten the sustainability of the program and that the donated vaccine is subject to licensing standards in both the recipient government and the producing country.56 Although the WHO makes exceptions to these guidelines for vaccines donated for emergency, epidemic, or pandemic situations when it may not be possible to apply typical specifications, additional legal challenges may emerge in such circumstances. For example, in the US, the Public Readiness and Emergency Preparedness Act (PREP Act) provides manufacturers, distributors, program planners, and other officials with very broad immunity against claims of liability associated with harms resulting from medical countermeasures administered in the course of a declared public health emergency.57 These protections apply to a range of medical countermeasures, including those that are donated and those licensed under
Respond Rapidly and Effectively 8. Develop an interconnected global network of emergency operations centers and multisectoral response to biological incidents The GHSA also calls for nations to establish emergency operations centers (EOCs). A national emergency operaVolume 12, Number 5, 2014
259
LEGAL AND REGULATORY CAPACITY TO SUPPORT GHSA
emergency use authorization authorities. However, immunity protections are applicable only in US courts, and no protection is offered under the PREP Act for claims filed under foreign law in courts outside the US (although protections may be available in US courts against claims based on events that took place outside the US).58 Further, liability protections vary depending on whether the donations are made via the US government, the WHO, or directly.59 Liability concerns may slow donation of vaccines that could be crucial to increasing global coverage during a pandemic, and trying to unravel the web of domestic licensing and legal liability surrounding vaccine donation during a pandemic is not ideal. Accordingly, realizing this objective may require a proactive, international effort to explore these issues and begin addressing any concerns in advance of the next pandemic.
Conclusion The Global Health Security Agenda should spur nations around the world to commit to building the capacities necessary to prevent, detect, and respond to public health emergencies. Nations should remember the importance of building complementary legal and regulatory frameworks that will enable progress, ensure success, and allow for sustainability of capacity-building efforts.
References 1. The Global Health Security Agenda. US Department of Health and Human Services website. http://www.globalhealth. gov/global-health-topics/global-health-security/ghsagenda. html. Accessed April 28, 2014. 2. Public Health Security and Bioterrorism Response Act of 2002. Pub. L. No. 107-188; 116 Stat 594. 2002. 3. Public Readiness and Emergency Preparedness Act. US Department of Health and Human Services website. Reviewed March 5, 2014. https://www.phe.gov/Preparedness/ legal/prepact/Pages/default.aspx. Accessed July 23, 2014. 4. Pandemic and All-Hazards Preparedness Act. Pub. L. No. 109-417; 120 Stat. 2831. 2006. 5. The Model State Emergency Health Powers Act (MSEHPA). Centers for Law and the Public’s Health website. Updated January 27, 2010. http://www.publichealthlaw.net/ModelLaws/ MSEHPA.php. Accessed April 26, 2014. 6. World Health Organization. International Health Regulations (2005). 2d ed. http://whqlibdoc.who.int/publications/2008/ 9789241580410_eng.pdf?ua = 1. Accessed April 26, 2014. 7. World Health Organization. Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. 2011. http://www.who.int/ influenza/resources/pip_framework/en/. Accessed April 26, 2014. 8. World Health Organization. WHO Framework Convention on Tobacco Control. 2003. http://www.who.int/fctc/text_ download/en/. Accessed April 26, 2014.
260
9. GHSI background. Global Health Security Initiative website. http://www.ghsi.ca/english/background.asp. Accessed April 26, 2014. 10. NAPAPI: North American countries join forces to prepare for pandemics [news release]. World Health Organization website. April 2, 2012. http://www.who.int/influenza_vaccines_ plan/news/napapi_2_april_2012/en/. Accessed June 18, 2014. 11. HHS announces early warning infectious disease surveillance project with Me´xico [news release]. US Department of Health and Human Services. March 9, 2006. http:// www.globalhealth.gov/news-and-events/archive-news/2006/ 20060309-hhs.html. Accessed April 26, 2014. 12. Hoffman S. Responders’ responsibility: liability and immunity in public health emergencies. Georgetown LJ 2007;96:1913. 13. Hodge JG Jr, Anderson ED. Principles and practice of legal triage during public health emergencies. NYU Ann Surv Am L 2008;64:249. 14. Kamoie B, Pestronk RM, Baldridge P, et al. Assessing laws and legal authorities for public health emergency legal preparedness. J Law Med Ethics 2008;36(Suppl 1):23-27. 15. Hodge JG Jr. Global legal triage in response to the 2009 H1N1 outbreak. Minn JL Sci & Tech 2010;11:599. 16. Identifying and addressing barriers to the emergency sharing of international public health and medical assistance. Submitted by the United States of America. Biological Weapons Convention Meeting of Experts. August 12-16, 2013. http:// unog.ch/__80256ee600585943.nsf/(httpPages)/eed3e63397 c2144bc1257bf80054fe12?OpenDocument&ExpandSection = 1#_Section1. Accessed April 26. 2014. 17. World Health Organization. International Health Regulations (2005). Toolkit for implementation in national legislation. January 2009. http://www.who.int/ihr/Toolkit_Legislative_ Implementation.pdf. Accessed April 26, 2014. 18. Katz R, Kornblet S. Comparative analysis of national legislation in support of the revised International Health Regulations: potential models for implementation in the United States. Am J Public Health 2010;100(12):2347-2353. 19. World Health Organization. Toolkit for Assessing HealthSystem Capacity for Crisis Management. http://www.euro.who. int/__data/assets/pdf_file/0008/157886/e96187.pdf. Accessed April 26, 2014. 20. Fidler DP. Legal issues associated with antimicrobial drug resistance. Emerg Infect Dis 1998;4(2):169-177. http:// wwwnc.cdc.gov/eid/article/4/2/98-0204.htm. Accessed April 26, 2014. 21. Davies J, Davies D. Origins and evolution of antibiotic resistance. Microbiol Mol Biol Rev 2010;74(3):417-433. 22. Bal AM, Gould IM. Antibiotic stewardship: overcoming implementation barriers. Curr Opin Infect Dis 2011;24(4): 357-362. 23. Despite superbug crisis, progress in antibiotic development ‘alarmingly elusive’ [news release]. Infectious Diseases Society of America website. April 18, 2013. http://www.idsociety.org/ 2013_antibiotic_development/. Accessed April 26, 2014. 24. Bad Bugs, No Drugs. As Antibiotic Discovery Stagnates.A Public Health Crisis Brews. Infectious Diseases Society of America; July 2004. http://www.idsociety.org/uploadedfiles/idsa/policy_ and_advocacy/current_topics_and_issues/antimicrobial_ resistance/10x20/images/bad%20bugs%20no%20drugs.pdf. Accessed April 26, 2014.
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science
MORHARD AND KATZ 25. Spellberg B, Guidos R, Gilbert D, et al. The epidemic of antibiotic-resistant infections: a call to action for the medical community from the Infectious Diseases Society of America. Clin Infect Dis 2008;46(2):155-164. 26. Outterson K. New business models for sustainable antibiotics. Working Group Paper. Chatham House website. January 2014. http://www.chathamhouse.org/publications/ papers/view/197446. Accessed April 26, 2014. 27. Jones KE, Patel NG, Levy MA, et al. Global trends in emerging infectious diseases. Nature 2008;451(7181):990993. 28. Managing zoonotic public health risks at the human-animalecosystem interface. World Health Organization website. http://www.who.int/foodsafety/about/flyer_zoonoses.pdf?ua = 1. Accessed April 26, 2014. 29. Zoonotic Diseases: A Guide to Establishing Collaboration between Animal and Human Health Sectors at the Country Level. World Health Organization; 2008. http://www.oie.int/doc/ ged/D12060.PDF. Accessed April 26, 2014. 30. Huang Y. China’s worsening food safety crisis. The Atlantic August 28, 2012. http://www.theatlantic.com/international/ archive/2012/08/chinas-worsening-food-safety-crisis/261656/. Accessed April 26, 2014. 31. Outbreak Investigations – Recent Outbreaks. Food and Drug Administration. February 21, 2014. http://www.fda.gov/ Food/RecallsOutbreaksEmergencies/Outbreaks/ucm272351. htm#outbreaks. Accessed April 26, 2014. 32. Flynn D. Germany’s E. coli outbreak most costly in history. Food Safety News June 16, 2011. http://www.foodsafetynews. com/2011/06/europes-o104-outbreak-most-costly-in-history/#. U9ACeqHD_cs. Accessed April 26, 2014. 33. Your food is global. Complex supply chains permeate even local products. Global Food Security website. http://www. foodsecurity.ac.uk/food/food-global.html. Accessed April 26, 2014. 34. Codex Alimentarius Commission. Strategic Plan 2014-19. Food and Agriculture Organization of the United Nations. ftp://ftp.fao.org/codex/Publications/StrategicFrame/Strategic_ plan_2014_2019_EN.pdf. Accessed April 26, 2014. 35. Sutton V. Biosecurity Law and Policy. Lubbock, TX: Vargas Publishing; 2014. 36. Committee on Education on Dual Use Issues in the Life Sciences; National Research Council. Challenges and Opportunities for Education about Dual Use Issues in the Life Sciences. Washington, DC: National Academies Press; 2010. 37. Aluoch A, Macharia J. Kenya—Towards Health Security. Presentation. https://www.unog.ch/80256EDD006B8954/ (httpAssets)/91C3C75079C7A7C6C1257926002CD7B7/ $file/BACAC + - + Kenya + presentation.pdf. Accessed April 26, 2014. 38. The Biological and Toxin Weapons Convention website. National implementation. http://www.opbw.org. Accessed June 24, 2014. 39. Griffin MR. Influenza vaccination of healthcare workers: making the grade for action. Clin Infect Dis 2014;58(1):58-60. 40. Parmet WE. Pandemic vaccines—the legal landscape. N Engl J Med 2010;362(21):1949-1952. 41. Gostin LO. Medical countermeasures for pandemic influenza: ethics and the law. JAMA 2006;295(5): 554-556.
Volume 12, Number 5, 2014
42. National Notifiable Diseases Surveillance System: monitoring the occurrence and spread of diseases. Centers for Disease Control and Prevention website. http://wwwn.cdc.gov/nndss/ document/DNDHI_NNDSS_12_232372_L_remediated_ 11_5_2013.pdf. Accessed April 28, 2014. 43. Integrated Disease Surveillance. Objectives/functions. World Health Organization Africa website. http://www.afro. who.int/en/clusters-a-programmes/dpc/integrated-diseasesurveillance/overview/objectivesfunctions.html. Accessed April 26, 2014. 44. Fidler D. Who owns MERS? The intellectual property controversy surrounding the latest pandemic. Foreign Affairs June 7, 2013. http://www.foreignaffairs.com/articles/139443/davidp-fidler/who-owns-mers. Accessed March 30, 2014. 45. Garrett L. The Middle East plague goes global. Foreign Policy June 28, 2013. http://www.foreignpolicy.com/articles/2013/ 06/28/the_middle_east_plague_goes_global. Accessed April 26, 2014. 46. About the Nagoya Protocol. Convention on Biological Diversity website. http://www.cbd.int/abs/about/. Accessed April 28, 2014. 47. Nuzzo JB, Rambhia K, Morhard RC, et al. Diagnosing Infection at the Point of Care. UPMC Center for Health Security website. http://www.upmchealthsecurity.org/ourwork/publications/diagnosing-infection-at-the-point-of-care. Accessed April 26, 2014. 48. Gates Foundation and Grand Challenges Canada announce over $31 million for point-of-care diagnostics in the developing world [news release]. Grand Challenges in Global Health website. December 15, 2011. http://www.grandchallenges.org/ about/Newsroom/Pages/POC_DxGrants.aspx. Accessed April 28, 2014. 49. Masum H, Lackman R, Bartleson K. Developing global health technology standards: what can other industries teach us? Global Health 2013;9(1):49. 50. Stier DD, Goodman RA. Mutual aid agreements: essential legal tools for public health preparedness and response. Am J Public Health 2007;97(Suppl1):S62-S68. 51. CORDS: Connecting Organizations for Regional Disease Surveillance. Strategic Plan. April 22, 2011. http://www.nti.org/ media/pdfs/CORDS-strategic-plan_confirmed-final_DL_629.pdf?_ = 1322498985. Accessed April 28, 2014. 52. Courtney B, Morhard R, Bouri N, Cicero A. Expanding practitioner scopes of practice during public health emergencies: experiences from the 2009 H1N1 pandemic vaccination efforts. Biosecur Bioterror 2010;8(3):223-231. 53. Borchert JN, Tappero JW, Downing R, et al. Rapidly building global health security capacity—Uganda demonstration project, 2013. MMWR Morb Mortal Wkly Rep 2014; 63(4):73-76. 54. Global Health Security—Vision and Overarching Target. http://www.cdc.gov/globalhealth/security/pdf/ghs_overarching_ target.pdf. Accessed April 26, 2014. 55. Vaccine donation policy. GAVI Alliance website. http:// www.gavialliance.org/about/governance/programme-policies/ vaccine-donation/. Accessed April 28, 2014. 56. Vaccine donations. WHO-UNICEF Joint Statement. August 7, 2010. http://whqlibdoc.who.int/hq/2010/WHO_IVB_ 10.09_eng.pdf. Accessed April 28, 2014.
261
LEGAL AND REGULATORY CAPACITY TO SUPPORT GHSA 57. PREP Act Q&As. US Department of Health and Human Services website. March 5, 2014. https://www.phe.gov/ Preparedness/legal/prepact/Pages/prepqa.aspx. Accessed April 26, 2014. 58. Recent developments in FDA’s emergency authority for medical countermeasures. Public Health Law Webinar Series. March 15, 2012. https://www.networkforphl.org/_asset/ msj92r/WebinarQsAsFINAL.pdf. Accessed April 28, 2014. 59. WHO Coordination Efforts to Make Pandemic (H1N1) Vaccines Available Globally. GHSAG MCM Meeting; Washington, DC; 4 November 2009. https://www.blsmeetings.net/2009 ghsimeetingsmcm/presentations/Plenary/Roth-WHO-H1N1. pdf. Accessed April 28, 2014.
Manuscript received April 29, 2014; accepted for publication June 25, 2014.
262
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science
Address correspondence to: Rebecca Katz, PhD, MPH Associate Professor, Health Policy, Global Health and Emergency Medicine Milken Institute School of Public Health George Washington University 950 New Hampshire Ave., NW, 6th Floor Washington, DC 20052 E-mail: [email protected]
