Swine Flu: Legal Obligations and Consequences When the World Health Organization Declares a “Public Health Emergency of International Concern”
a human-to-human spread of the virus with community level infection in at least two countries
in one WHO region.
World Health Organization (WHO) Director-General Dr. Margaret Chan today raised the influenza pandemic alert to Phase 5, indicating that a pandemic is imminent. She advised all countries to “immediately activate their pandemic preparedness plans.”
WHO uses six phases of alert to communicate the seriousness of infectious threats and to warn countries of the need to prepare and respond to outbreaks. Phase 6, the pandemic phase, requires an additional “community level outbreaks in at least one other country in a different WHO region.” Phase 6 would indicate a global pandemic.
On Saturday, the World Health Organization (WHO) declared the swine influenza A (H1N1) outbreak in Mexico and the United States to constitute a “public health emergency of international concern” under the International Health Regulations, a legally binding international instrument on disease prevention, surveillance, control, and response adopted by 194 countries. Countries with confirmed cases of swine flu are asked to report all probable and confirmed cases and deaths to WHO on a daily basis. WHO Director-General Dr. Margaret Chan also called upon all countries to intensify their surveillance and detection of unusual influenza-like outbreaks and cases of severe pneumonia.
At the time of the meeting by WHO’s Emergency Committee this past weekend, the Government of Mexico reported 18 confirmed cases, with additional suspected cases in 19 of the country’s 32 states. Press reports cited 1,300 cases and 81 deaths, but WHO noted that these are “cases of respiratory illness” that have not been laboratory confirmed as swine flu. The U.S. government reported 20 cases with no deaths in 5 of the country’s 50 states. As of today, 27 April 2009 at 1 p.m., the U.S. Centers for Disease Control and Prevention (CDC) reported 40 confirmed cases, with the majority in New York City. The CDC activated its Emergency Operations Center, and the Department of Health and Human Service yesterday declared a nationwide a nationwide public health emergency in response to the swine flu, allowing emergency use of certain antivirals.
Because swine flu is being found in additional countries and has pandemic potential, WHO today increased the severity of the warning from Phase 3 to Phase 4 based on data from Canada, Mexico, and the United States showing human-to-human transmission and the ability of the virus to cause community-level outbreaks. Phase 3 is when an animal or human-animal influenza virus has caused “sporadic cases or small clusters of disease in people, but has not resulted in human-to-human transmission sufficient to sustain community-level outbreaks.” Phase 4 indicates “a significant increase in risk of a pandemic but does not necessarily mean that a pandemic is a forgone conclusion.” At this time, WHO has not recommended any travel or trade restrictions or border closings.
This discussion explores the International Health Regulations, its provisions for infectious disease containment, what constitutes a public health emergency of international concern, and the scope of enforcement authority to thwart a global pandemic.
Background
What are the International Health Regulations?
The World Health Organization (WHO) represents the sole health agency under the auspices of the United Nations. The WHO Constitution, adopted in 1946, empowers the agency to adopt binding obligations and procedures to prevent infectious disease spread internationally. The International Health Regulations (IHR), originally adopted in 1969 as a replacement to the International Sanitary Regulations and updated in 2005, represent a legally binding international instrument on disease prevention, surveillance, control, and response. See WHO, Revision of the International Health Regulations, WHA Res. 58.3, World Health Assembly, 58th Ass. (May 23, 2005). The IHR entered into force on 15 June 2007.
What are the legal duties of states imposed by the International Health Regulations?
Adopted by 194 states, the Regulations essentially impose a universal duty on all states to prevent the spread of disease domestically and internationally and to respond to infectious outbreaks. Specifically, the Regulations require states to monitor disease outbreaks, to notify WHO under specified conditions, to provide verification of reported events, to strengthen their domestic capacities for surveillance and response, and to develop a national public health emergency response plan. Further, states must maintain health facilities and provide health services at international airports, ports, and ground crossings to reduce the risk of international disease spread.
Public Health Emergency of International Concern
What is a “Public Health Emergency of International Concern”?
States have a legal duty under the International Health Regulations to respond promptly to a “public health emergency of international concern.” A PHEIC threat must represent an extraordinary public health event, pose a public health risk to other states through the international spread of the disease, and potentially require a coordinated international response.
“public health emergency of international concern” means an extraordinary event which is
determined, as provided in these Regulations:
(i) to constitute a public health risk to other States through the international spread of disease
and
(ii) to potentially require a coordinated international response
Under Article 6, states must report a potential PHEIC threat within 24 hours of identifying a potential threat.
1. Each State Party shall assess events occurring within its territory by using the decision
instrument in Annex 2. Each State Party shall notify WHO, by the most efficient means of
communication available, by way of the National IHR Focal Point, and within 24 hours of assessment of public health information, of all events which may constitute a public health emergency of international concern within its territory in accordance with the decision instrument, as well as any health measure implemented in response to those events. If the notification received by WHO involves the competency of the International Atomic Energy Agency (IAEA), WHO shall immediately notify
the IAEA.
Governments must report the number of cases and deaths to WHO and provide updates to WHO on the disease containment and response measures being used.
2. Following a notification, a State Party shall continue to communicate to WHO timely, accurate and sufficiently detailed public health information available to it on the notified event, where possible including case definitions, laboratory results, source and type of the risk, number of cases and deaths, conditions affecting the spread of the disease and the health measures employed; and report, when necessary, the difficulties faced and support needed in responding to the potential public health emergency of international concern.
The affirmative notification obligation of states applies to deliberate uses of infectious bioweapons within a sovereign state, as well as to naturally occurring, accidental, or suspicious infectious outbreaks, provided that the disease outbreak could constitute a potential public health emergency of international concern.
If a State Party has evidence of an unexpected or unusual public health event within its territory, irrespective of origin or source, which may constitute a public health emergency of international concern, it shall provide to WHO all relevant public health information. In such a case, the provisions of Article 6 shall apply in full.
Which authority determines the existence of a public health emergency of international concern?
The WHO Director-General ultimately makes the decision to declare a PHEIC. The decision is informed, among other factors, by the findings of the Emergency Committee, established under Article 48. The Emergency Committee met for the first time since its establishment in 2007 on Saturday, 25 April 2009 to consider the swine flu outbreak in Mexico ()and the United States (20 reported cases). The Director-General may also consider information provided by states, the decision instrument, scientific information, the risks of international disease spread, and economic impacts.
WHO must confirm the existence of the threat before publicly announcing or sharing information with third parties about the existence of a public health emergency of international concern.
In determining whether an event constitutes a public health emergency of international concern, the Director-General shall consider:
(a) information provided by the State Party;
(b) the decision instrument contained in Annex 2;
(c) the advice of the Emergency Committee;
(d) scientific principles as well as the available scientific evidence and other relevant
information; and
(e) an assessment of the risk to human health, of the risk of international spread of disease and of the risk of interference with international traffic.
To assist countries with a timely classification of a domestic versus international health emergency, Annex 2 of the Regulations provides a decision instrument to clarify four major factors of consideration for the threshold of “international concern.”
At least two of the four criteria must be present before a state is obligated to report its findings to WHO:
(2) the unusual or unexpected nature of the event;
(3) the potential for the event to spread internationally; and/or
(4) the risk that restrictions to travel or trade may result because of the event.
Non-binding examples are also given to assist in the interpretation of the decision instrument. Examples include:
- Event caused by a pathogen with high potential to cause epidemic (infectiousness of the
agent, high case fatality, multiple transmission routes or healthy carrier). - Cases reported among health staff.
- Occurrence of the event itself unusual for the area, season or population.
- Where there is evidence of local spread, a case linked to participation in an international gathering, such as pilgrimage, sports event, conference, etc.
- Is the source suspected or known to be a food product, water or any other goods that
might be contaminated that has been exported/imported to/from other States? - Has the event caused requests for more information by foreign officials or international
media?
Enforcement Authority to Stop a Disease Outbreak or Possible Pandemic
What is WHO’s enforcement authority with respect to a public health emergency of international concern?
The International Health Regulations remain grounded in a state-centric model for disease containment based on voluntary cooperation by countries. The Regulations presume a primary responsibility of each country to prevent and respond to infectious outbreaks. Significantly, the Regulations lack a provision on enforcement authority or any penalties for noncompliance. WHO publicly acknowledges that it relies on “peer pressure” and “public knowledge” as the primary incentives for voluntary compliance with international obligations.
What is the scope of WHO’s authority in the absence of state cooperation or consent?
The Regulations provide three powers to WHO with respect to international disease control regardless of state cooperation or consent.
- Obtaining information from private sources without government consent
The Regulations allow WHO to receive information about infectious outbreaks from private sources, including non-governmental organizations and individuals inside the country, without consent from domestic government authorities. - Sharing information without government consent
WHO may share information about the infectious threat with other parties when the affected country rejects international assistance. - Unilaterally declaring a public health emergency of international concern
WHO may declare unilaterally a public health emergency of international concern if a country fails to cooperate. The theory is that a public declaration allows other countries to take protective action and, at the same time, creates political pressure on the uncooperative country to remedy its noncompliance. WHO’s declaration, however, does not authorize coercive intervention inside the country concerned.
Can the international community intervene inside a country with an outbreak?
What would happen if the outbreak occurs in a country unwilling to voluntarily take action in response to a swine flu outbreak within its boundaries? Currently, the legal authority of the international community to intervene coercively, even in extraordinary circumstances, in response to a serious infectious outbreak when a country is unable or unwilling to respond remains uncertain and untested.
I wrote an article last year on the legal authority of the international community to intervene in response to an outbreak inside an uncooperative state. I explored the legal justification under the Chapter VII powers of the UN Charter and under the doctrine of humanitarian intervention. The full text is available online on SSRN: Emergency Preparedness for a Pandemic Under International Law (2008).
Can WHO impose restrictions to travel and trade?
When considering responses to global infectious threats, WHO is sensitive to the possible economic impacts to countries and the global economy created by unilateral or coercive sanctions and travel restrictions, such as requiring countries to provide health screenings at ports of entry or mass-scale quarantines to minimize disease spread. If WHO believes that trade and travel restrictions are necessary, it can recommend those measures to countries for implementation.
WHO also is sensitive to the potentially disproportionate burdens on weaker countries and the realistic limits of international funds to compensate countries for economic losses arising from international public health emergency responses. WHO, however, has not explicitly endorsed or demonstrated that it favors the least harmful alternative for the affected country when analyzing and deciding the balance between public health measures and international trade.
The Regulations do not preclude countries from implementing enhanced travel and trade restrictions under domestic law provided that they achieve the same level of protection as WHO-recommended measures and are not explicitly prohibited by the Regulations or international human rights law.
Can a country violate international human rights law to implement disease control measures?
The goals of protecting societal health during an infectious disease emergency may require the curtailment of civil liberties and infringement on individual human rights, particularly as the result of disease control mechanisms. The most vivid examples include potentially mandatory drug treatments or vaccinations and compulsory quarantines. Notably, the International Health Regulations and international human rights law are consistent with the imposition of isolation and quarantine by governments as coercive disease control mechanisms, as well as the use of police or military action to enforce them. These coercive methods of disease control may constrain individual interests, even where proportional means are used, but generally represent permissible derogations from human rights obligations during an emergency to safeguard the societal goal of public health. Which specific individual interests are implicated by compulsory public health powers is still an open discussion with scholars disagreeing on whether disease control measures impinge solely on civil liberties or also on human rights.
Article 32 of the Regulations requires states to respect the “dignity, human rights and fundamental freedoms” of individuals. The scope of this provision is limited to “travellers.” A “traveller” is defined under Article 1 as “a natural person undertaking an international voyage.” Thus, domestic citizens who are not crossing borders are exempted from the application of Article 32. Domestic citizens, therefore, would need to rely on international human rights law and any domestic laws.
In implementing health measures under these Regulations, States Parties shall treat travellers
with respect for their dignity, human rights and fundamental freedoms and minimize any discomfort or distress associated with such measures, including by:
(a) treating all travellers with courtesy and respect;
(b) taking into consideration the gender, sociocultural, ethnic or religious concerns of
travellers; and
(c) providing or arranging for adequate food and water, appropriate accommodation and
clothing, protection for baggage and other possessions, appropriate medical treatment, means of necessary communication if possible in a language that they can understand and other
appropriate assistance for travellers who are quarantined, isolated or subject to medical
examinations or other procedures for public health purposes.
Pursuant to international human rights law, any disease control measures that impact civil liberties, such as restrictions on freedom of movement, must: (1) be prescribed by law, (2) be nondiscriminatory, (3) relate to a compelling societal interest, (4) have a reasonable chance of success, and (5) favor the least restrictive alternative needed to achieve the purpose. The lack of clarity in international instruments on domestic procedural safeguards for individuals during an infectious outbreak could lead to an abuse of power or unintended consequences for civil liberties and human rights.
Resources on Inside Justice
International and Regional Organizations – Swine Flu Resources
- World Health Organization (WHO) Swine Flu
- Global Outbreak Alert and Response Network (GOARN)
- EUROPA – Threats to Health
- European Centre for Disease Prevention and Control (ECDC)
- European Public Health Alliance, Directorate General for Health and Consumer Affairs (DG SANCO)
- Pan American Health Organization (PAHO)
Country-Specific Swine Flu Resources
International Organizations – Infectious Outbreaks
- Food and Agriculture Organization (FAO) (overseeing agreements related to food safety and transboundary animal and plant disease control)
- United Nations Environment Programme (UNEP) (supporting the reduction of environmental threats to human health)
- World Intellectual Property Organization (WIPO) (overseeing international agreements relevant to licensing rights of pharmaceuticals)
- World Health Organization (WHO) (“WHO is the directing and coordinating authority for health within the United Nations system.”)
- World Tourism Organization (UNWTO) (supporting states in emergency crisis management and planning related to infectious outbreaks)
- SOS Travel (a website provided the UNWTO to assist travellers and the industry in case of an infectious emergency)
- World Trade Organization (WTO) (WTO agreements with implications for public health include: Sanitary and Phytosanitary Measures, Trade in Services, and Technical Barriers to Trade)