After decades of relative obscurity, Ebola viral disease has emerged as a major, global biothreat in 2014. Several hundred cases were previously detected before Ebola’s first appearance in Zaire and Sudan in 1976 to 2013.1 Since its reappearance in Guinea in March 2014, however, thousands—and potentially tens of thousands—of persons have been infected in 5 West African countries (Sierra Leone, Liberia, Guinea, Nigeria, and the Democratic Republic of Congo).2 Approximately 275 million people live in these 5 countries3; 21 million reside in the dense urban environment in Nigeria’s capital, Lagos, alone. With reported mortality rates in affected areas ranging from 30% to 90% (depending on multiple factors including the availability of adequate medical personnel and facilities),Reference Groseth, Marzi and Hoenen4 the impact of Ebola is felt globally. Still, Médecins Sans Frontières (Doctors Without Borders) suggests that global responses are “dangerously inadequate.”Reference Hayden5
For only the third time since reforming its International Health Regulations in 2007, the World Health Organization (WHO) declared a public health emergency of international concern on August 8, 2014.6 While WHO’s declaration lacks the enforceability of emergency powers held by sovereign nations, it sets transnational standards for surveillance and response to the disease. Multiple West African nations have also declared their own states of emergency.Reference Hodge7 President Ellen Johnson-Sirleaf staked “the very survival of our state and…the protection of the lives of our people” on Liberia’s state of emergency.Reference Fofana and MacDougall8 Other countries or regions may follow suit by similarly declaring emergencies as the outbreak spreads.
To date, US national, state, and local governments have not declared formal states of emergency (given a lack of naturally-occurring cases in the country), but legal preparedness efforts are underway. On August 6, 2014, President Obama stated that “Ebola is controllable if you have a strong public health infrastructure in place.”Reference Hodge7 Congress, the State Department, and the Department of Defense are closely assessing the Ebola epidemic and corresponding US policies. The US Agency for International Development has committed millions to global response efforts.9 In addition, multiple federal health agencies have sought to address legal issues centered on public health prevention; the Department of Health and Human Services supports development of the experimental drug ZMapp as a potential treatment10; and the National Institutes of Health is accelerating human clinical trials of Ebola vaccine.Reference Levine11 Meanwhile, the Centers for Disease Control and Prevention (CDC) has advised Americans to avoid nonessential travel to Guinea, Liberia, and Sierra Leone, and strongly discouraged travel to affected regions of Nigeria.12 The agency also disseminated interim guidance on the safe handling of potential Ebola specimens, corpses, and fluids. The Food and Drug Administration (FDA) issued an emergency use authorization on August 5 to allow field use of a rapid Ebola diagnostic test13 and is monitoring the marketplace for fraudulent products purporting to treat Ebola.Reference Borio14
The rise of Ebola necessitates legal responses that promote effective public health responses and respect for the health and human rights of local and global populations. Compulsory public health interventions, administration of experimental drugs, rapid development of vaccines, and allocation of finite resources precipitate difficult choices in law and policy. Crafting decisions in real time via legal triage is neither easy nor predictable, but it is essential to controlling the epidemic and saving lives.
Global and domestic legal responses to Ebola
Law is a critical underpinning and tool of international and domestic public health emergency preparedness and response to Ebola (and other emerging threats). Formal emergency declarations, for example, affect public health and medical responses by instantly altering the legal environment.Reference Hodge and Anderson15 Resulting legal changes vary, depending in part on the choice and type of emergency declared. In the United States, federal and many state (as well as select local) governments may declare states of “emergency,” “disaster,”Reference Anderson and Hodge16 or “public health emergency,”Reference Hodge, Gable and Vernick17 among other classifications. In conjunction with international or inter-jurisdictional declarations, these declarations empower public and private entities to address public health crises in expedited ways. Public health emergency laws (1) offer public and private sectors greater flexibility to act to protect the public’s health through testing, screening, treatment, and vaccination programs; (2) convey or impose social distancing measures designed to control the spread of infectious conditions; (3) allow temporary suspensions of regulations that may impede emergency responses; (4) encourage efforts among volunteer health providers through limits of, or protections from, claims of liabilityReference Hoffman, Goodman and Stier18, Reference Rosenbaum, Harty and Sheer19; (5) facilitate transitions to what the US Institute of Medicine defines as “crisis standards of care”20; and (6) authorize alterations in medical licensing standards and scopes of practice.Reference Hodge, Garcia, Anderson and Kaufman21
Still, invoking states of emergency can be precarious. Ideally, emergency laws should clearly direct preparedness and response efforts. In actuality, they typically do not provide precise legal guidance. Framed in broad (and sometimes vague) statutory or regulatory language, emergency laws offer more of a menu of legal powers and options rather than a definitive guide for action. Providing legal flexibility when clarity is called for may seem counterintuitive, but it does make some sense. Policymakers cannot accurately predict how best to respond to emerging infectious conditions whose origin and epidemiology may be uncertain. Availing multiple legal options is central to controlling emerging infectious diseases just as medical flexibility is to determining and providing adequate treatment.
Without affirmative legal direction, however, some public and private actors may perform well outside of legal boundaries in contravention of human rights principles or individual freedoms. Alternatively, they may fail to respond because of erroneous legal advice, liability fears, or other perceived negative legal ramifications. Allegations that medical workers in Sierra Leone are abandoning Ebola patients are particularly troubling.22 Illegal or unethical responses, or failures to respond, are equally unacceptable.
Through legal triage, global and national actors must prioritize legal issues and generate solutions in real time to facilitate legitimate public health efforts to limit the spread of Ebola in balance with communal and individual interests. Making sage legal choices is complex when epidemiologic facts are sketchy, resources are scarce, and communal well-being in affected jurisdictions is in jeopardy. Legal debates related to the administration of experimental drugs to Ebola patients are illustrative. Some call for rapid approval or facilitation of such drugs through emergency use authorizations by FDA.Reference Steenhuysen23 Absent a cure or even definitive medical intervention for Ebola, they argue that any drug is better than none. However, questions over the safety, availability, and efficacy of these drugs make manufacturers and medical personnel vulnerable to potential liability if unrelated harms arise in patients taking these drugs.Reference Morin24 Unleashing a harmful experimental drug (or vaccine) on populations facing the threat of Ebola may result in a legal and ethical firestorm, even if such harms were unperceived or unintended.
Potential for international and national infringements of human rights and freedoms
Other law and policy controversies extend from the use of public health powers and authorities to control the spread of Ebola through social distancing measures. Use of isolation, quarantine, cordon sanitaire, curfews, closures, travel restrictions, and other techniques in response to emerging infectious conditions are historically and often legally prescribed.Reference Hodge25 Concerning a condition such as Ebola, which can infect and kill over half its victims in relatively short periods, limiting the movement of those infected, exposed, or merely in the area may arguably be imposed as a last-ditch effort to control its spread. When such measures are used overzealously or applied too extensively, however, they may unjustifiably infringe on human rights and freedoms.
Examples and images of potential human rights violations stemming from Ebola are wide-ranging. On August 7, 2014, it was reported that the army in Sierra Leone blockaded rural areas of the country in which Ebola had spread, constraining populations’ rights to travel, whether they are infected or not.Reference Fofana and MacDougall8 On August 18, after a medical ward was looted 2 days before, Liberian armed forces were ordered to shoot on sight anyone unlawfully entering the country from Sierra Leone under the cover of darkness.26 Liberia also implemented a nightly curfewReference Paye-Layleh27on August 19 and barricaded a slum of 50 000 persons with razor wire and patrols to prevent departures.Reference Hildebrandt28 Broad-sweeping attempts to cordon populations not only lack efficacy to prevent the disease from spreading, they also can negatively impact communal health by denying people access to food, medicine, and other essential, life-sustaining services. Continued stigmatization of Ebola patients and survivors is patently discriminatory and a threat to their livelihood.29 On August 21, 2014, South Africa banned entry of all non-citizens from Sierra Leone, Liberia, and Guinea,Reference Stevis30 in spite of the explicit rejection of blanket travel bans by WHO.31 National restrictions on flights and other travel to affected regions not only limit passage of unaffected persons, but also prevent the transport of essential supplies and personnel.32
Refining global legal approaches to counter Ebola
While at WHO, the late physician and advocate Jonathan Mann is credited for advancing the ideal that protecting the public’s health and respecting human rights are synergistic not incompatible.Reference Gostin and Lazzarini33 Mann’s observation arose largely from international debates over appropriate treatment of persons with HIV/AIDS in the 1980s, but his message applies equally in modern outbreaks such as Ebola. To the extent that public health emergency laws and policies offer options for action, those options should be exercised consistent with basic human rights.Reference Gostin34 Many of these rights are sufficiently flexible to allow for expedited uses of public health powers that have been empirically shown to control emerging threats. Conversely, governmental actions driven more by fear and stigmatization than efficacy are unacceptable. On international and domestic fronts, legal actions related to Ebola must (1) be grounded in public health science; (2) seek to protect patients, their families, and health care workers; and (3) respect human rights. Only then may Ebola be conquered successfully.
Disclaimer
This commentary is supported by the Robert Wood Johnson Foundation through a grant awarded to the Sandra Day O’Connor College of Law, Arizona State University. Any opinions, finding, conclusions or recommendations expressed in this publication are those of the author and do not represent the policy or position of the Robert Wood Johnson Foundation.
After decades of relative obscurity, Ebola viral disease has emerged as a major, global biothreat in 2014. Several hundred cases were previously detected before Ebola’s first appearance in Zaire and Sudan in 1976 to 2013.1 Since its reappearance in Guinea in March 2014, however, thousands—and potentially tens of thousands—of persons have been infected in 5 West African countries (Sierra Leone, Liberia, Guinea, Nigeria, and the Democratic Republic of Congo).2 Approximately 275 million people live in these 5 countries3; 21 million reside in the dense urban environment in Nigeria’s capital, Lagos, alone. With reported mortality rates in affected areas ranging from 30% to 90% (depending on multiple factors including the availability of adequate medical personnel and facilities),Reference Groseth, Marzi and Hoenen4 the impact of Ebola is felt globally. Still, Médecins Sans Frontières (Doctors Without Borders) suggests that global responses are “dangerously inadequate.”Reference Hayden5
For only the third time since reforming its International Health Regulations in 2007, the World Health Organization (WHO) declared a public health emergency of international concern on August 8, 2014.6 While WHO’s declaration lacks the enforceability of emergency powers held by sovereign nations, it sets transnational standards for surveillance and response to the disease. Multiple West African nations have also declared their own states of emergency.Reference Hodge7 President Ellen Johnson-Sirleaf staked “the very survival of our state and…the protection of the lives of our people” on Liberia’s state of emergency.Reference Fofana and MacDougall8 Other countries or regions may follow suit by similarly declaring emergencies as the outbreak spreads.
To date, US national, state, and local governments have not declared formal states of emergency (given a lack of naturally-occurring cases in the country), but legal preparedness efforts are underway. On August 6, 2014, President Obama stated that “Ebola is controllable if you have a strong public health infrastructure in place.”Reference Hodge7 Congress, the State Department, and the Department of Defense are closely assessing the Ebola epidemic and corresponding US policies. The US Agency for International Development has committed millions to global response efforts.9 In addition, multiple federal health agencies have sought to address legal issues centered on public health prevention; the Department of Health and Human Services supports development of the experimental drug ZMapp as a potential treatment10; and the National Institutes of Health is accelerating human clinical trials of Ebola vaccine.Reference Levine11 Meanwhile, the Centers for Disease Control and Prevention (CDC) has advised Americans to avoid nonessential travel to Guinea, Liberia, and Sierra Leone, and strongly discouraged travel to affected regions of Nigeria.12 The agency also disseminated interim guidance on the safe handling of potential Ebola specimens, corpses, and fluids. The Food and Drug Administration (FDA) issued an emergency use authorization on August 5 to allow field use of a rapid Ebola diagnostic test13 and is monitoring the marketplace for fraudulent products purporting to treat Ebola.Reference Borio14
The rise of Ebola necessitates legal responses that promote effective public health responses and respect for the health and human rights of local and global populations. Compulsory public health interventions, administration of experimental drugs, rapid development of vaccines, and allocation of finite resources precipitate difficult choices in law and policy. Crafting decisions in real time via legal triage is neither easy nor predictable, but it is essential to controlling the epidemic and saving lives.
Global and domestic legal responses to Ebola
Law is a critical underpinning and tool of international and domestic public health emergency preparedness and response to Ebola (and other emerging threats). Formal emergency declarations, for example, affect public health and medical responses by instantly altering the legal environment.Reference Hodge and Anderson15 Resulting legal changes vary, depending in part on the choice and type of emergency declared. In the United States, federal and many state (as well as select local) governments may declare states of “emergency,” “disaster,”Reference Anderson and Hodge16 or “public health emergency,”Reference Hodge, Gable and Vernick17 among other classifications. In conjunction with international or inter-jurisdictional declarations, these declarations empower public and private entities to address public health crises in expedited ways. Public health emergency laws (1) offer public and private sectors greater flexibility to act to protect the public’s health through testing, screening, treatment, and vaccination programs; (2) convey or impose social distancing measures designed to control the spread of infectious conditions; (3) allow temporary suspensions of regulations that may impede emergency responses; (4) encourage efforts among volunteer health providers through limits of, or protections from, claims of liabilityReference Hoffman, Goodman and Stier18, Reference Rosenbaum, Harty and Sheer19; (5) facilitate transitions to what the US Institute of Medicine defines as “crisis standards of care”20; and (6) authorize alterations in medical licensing standards and scopes of practice.Reference Hodge, Garcia, Anderson and Kaufman21
Still, invoking states of emergency can be precarious. Ideally, emergency laws should clearly direct preparedness and response efforts. In actuality, they typically do not provide precise legal guidance. Framed in broad (and sometimes vague) statutory or regulatory language, emergency laws offer more of a menu of legal powers and options rather than a definitive guide for action. Providing legal flexibility when clarity is called for may seem counterintuitive, but it does make some sense. Policymakers cannot accurately predict how best to respond to emerging infectious conditions whose origin and epidemiology may be uncertain. Availing multiple legal options is central to controlling emerging infectious diseases just as medical flexibility is to determining and providing adequate treatment.
Without affirmative legal direction, however, some public and private actors may perform well outside of legal boundaries in contravention of human rights principles or individual freedoms. Alternatively, they may fail to respond because of erroneous legal advice, liability fears, or other perceived negative legal ramifications. Allegations that medical workers in Sierra Leone are abandoning Ebola patients are particularly troubling.22 Illegal or unethical responses, or failures to respond, are equally unacceptable.
Through legal triage, global and national actors must prioritize legal issues and generate solutions in real time to facilitate legitimate public health efforts to limit the spread of Ebola in balance with communal and individual interests. Making sage legal choices is complex when epidemiologic facts are sketchy, resources are scarce, and communal well-being in affected jurisdictions is in jeopardy. Legal debates related to the administration of experimental drugs to Ebola patients are illustrative. Some call for rapid approval or facilitation of such drugs through emergency use authorizations by FDA.Reference Steenhuysen23 Absent a cure or even definitive medical intervention for Ebola, they argue that any drug is better than none. However, questions over the safety, availability, and efficacy of these drugs make manufacturers and medical personnel vulnerable to potential liability if unrelated harms arise in patients taking these drugs.Reference Morin24 Unleashing a harmful experimental drug (or vaccine) on populations facing the threat of Ebola may result in a legal and ethical firestorm, even if such harms were unperceived or unintended.
Potential for international and national infringements of human rights and freedoms
Other law and policy controversies extend from the use of public health powers and authorities to control the spread of Ebola through social distancing measures. Use of isolation, quarantine, cordon sanitaire, curfews, closures, travel restrictions, and other techniques in response to emerging infectious conditions are historically and often legally prescribed.Reference Hodge25 Concerning a condition such as Ebola, which can infect and kill over half its victims in relatively short periods, limiting the movement of those infected, exposed, or merely in the area may arguably be imposed as a last-ditch effort to control its spread. When such measures are used overzealously or applied too extensively, however, they may unjustifiably infringe on human rights and freedoms.
Examples and images of potential human rights violations stemming from Ebola are wide-ranging. On August 7, 2014, it was reported that the army in Sierra Leone blockaded rural areas of the country in which Ebola had spread, constraining populations’ rights to travel, whether they are infected or not.Reference Fofana and MacDougall8 On August 18, after a medical ward was looted 2 days before, Liberian armed forces were ordered to shoot on sight anyone unlawfully entering the country from Sierra Leone under the cover of darkness.26 Liberia also implemented a nightly curfewReference Paye-Layleh27on August 19 and barricaded a slum of 50 000 persons with razor wire and patrols to prevent departures.Reference Hildebrandt28 Broad-sweeping attempts to cordon populations not only lack efficacy to prevent the disease from spreading, they also can negatively impact communal health by denying people access to food, medicine, and other essential, life-sustaining services. Continued stigmatization of Ebola patients and survivors is patently discriminatory and a threat to their livelihood.29 On August 21, 2014, South Africa banned entry of all non-citizens from Sierra Leone, Liberia, and Guinea,Reference Stevis30 in spite of the explicit rejection of blanket travel bans by WHO.31 National restrictions on flights and other travel to affected regions not only limit passage of unaffected persons, but also prevent the transport of essential supplies and personnel.32
Refining global legal approaches to counter Ebola
While at WHO, the late physician and advocate Jonathan Mann is credited for advancing the ideal that protecting the public’s health and respecting human rights are synergistic not incompatible.Reference Gostin and Lazzarini33 Mann’s observation arose largely from international debates over appropriate treatment of persons with HIV/AIDS in the 1980s, but his message applies equally in modern outbreaks such as Ebola. To the extent that public health emergency laws and policies offer options for action, those options should be exercised consistent with basic human rights.Reference Gostin34 Many of these rights are sufficiently flexible to allow for expedited uses of public health powers that have been empirically shown to control emerging threats. Conversely, governmental actions driven more by fear and stigmatization than efficacy are unacceptable. On international and domestic fronts, legal actions related to Ebola must (1) be grounded in public health science; (2) seek to protect patients, their families, and health care workers; and (3) respect human rights. Only then may Ebola be conquered successfully.
Disclaimer
This commentary is supported by the Robert Wood Johnson Foundation through a grant awarded to the Sandra Day O’Connor College of Law, Arizona State University. Any opinions, finding, conclusions or recommendations expressed in this publication are those of the author and do not represent the policy or position of the Robert Wood Johnson Foundation.
Acknowledgments
Asha Agrawal, Gregory Measer, Alicia Corbett, Rose Meltzer, and Matt Saria provided research, editing, and formatting assistance with this manuscript.