Countering Biological Threats: Challenges for the Department of Defense's Nonproliferation Program Beyond the Former Soviet Union (2009)

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Appendix H International Health Regulations 1. Purpose, scope, and principles The International Health Regulations (2005), hereafter referred to as “IHR (2005)” or “the regulations,” are a legally binding agreement among World Health Organization (WHO) member states and other states that have agreed to be bound by them (states parties). The IHR (2005) define their “purpose and scope” as “to prevent, protect against, control, and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks and which avoid unnecessary interfer- ence with international traffic and trade.” 2. Concepts and approaches The IHR (2005) are purposely broad and inclusive in respect of the public health event to which they have application in order to maximize the probabil- ity that all such events that could have serious international consequences are identified early and promptly reported by states parties to WHO for assessment. The regulations aim to provide a legal framework for the prevention, detection, and containment of public health risks at the source, before they spread across borders, through the collaborative actions of states parties and WHO. Notification is required under IHR (2005) for all “events that may consti- tute a public health emergency of international concern.” In this regard, the broad new definitions of “event,” “disease,” and “public health risk” in the IHR (2005) are the building blocks of the surveillance obligations for states 1This material was excerpted from the Web page of the World Health Organization entitled “Ten Things You Need to Know about the IHR (2005).” Available online at www.who.int/csr/ihr/ howtheywork/10things/en/index.html. 167 

168 APPENDIX H parties and WHO. Disease means “an illness or medical condition, irrespec- tive of origin or source, which presents or could present significant harm to humans.” The term event is broadly defined as “a manifestation of disease or an occurrence that creates a potential for disease.” Public health risk refers to “a likelihood of an event that may affect adversely the health of human popula- tions, with an emphasis on one which may spread internationally or may pres- ent a serious and direct danger.” A public health emergency of international concern (PHEIC) is defined as “an extraordinary event which is determined to constitute a public health risk to other states through the international spread of disease and to potentially require a coordinated international response.” Consequently, events of potential international concern, which require states parties to notify WHO, can extend beyond communicable diseases and arise from any origin or source. 3. Shared realities require a move towards collective defenses The IHR (2005) introduce a legal framework to support existing and innovative approaches in the global detection of events and response to public health risks and emergencies. Although the IHR (2005) were built in part on the foundations of their predecessor, the IHR (1969), they are primarily based on the recent experiences of WHO and its member states in national surveillance systems, epidemic intelligence, verification, risk assessment, outbreak alert, and coordination of international response, all of which are part of WHO’s decade- long work to enhance international public health security. The IHR (2005) have a broad scope, provide for the use of a wide range of information, and emphasize collaborative actions between states parties and WHO in the identification and assessment of events and response to public health risks and emergencies. In WHO’s coordination of the international response to public health emergencies of international concern, maximum mea- sures are replaced by formally recommended and context-specific temporary health measures, tailored to the actual threat faced. 4. Rejections and reservations The IHR (2005) are legally binding following their entry into force on June 15, 2007, for all WHO member states that neither rejected them nor filed reservations thereto by the deadline of December 15, 2006. In fact, no member state notified a rejection, and only two member states notified reservations to the director-general of WHO. 

APPENDIX H 169 5. Notification and other reporting requirements The IHR (2005) describe key elements of the procedures to be followed by states parties and WHO in sharing information about notified events. Official event-related communications under the IHR (2005) are carried out between the national IHR focal point and the WHO IHR contact point, both of which are officially designated and required to be available 24 hours a day, 7 days a week. The IHR (2005) specify the following three ways in which states parties can initiate event-related communications with WHO: 1. Notification: The IHR (2005) provide new notification requirements for states parties. These provisions move away from the automatic notification and publication by WHO of cases of specific diseases to the notification to WHO of all events that are assessed as possibly constituting a PHEIC, taking into account the context in which an event occurs. These notifications must occur within 24 hours of assessment by the country. There are four criteria that states parties must follow in their assessment of events within their territories and their decision as to whether an event is notifiable to WHO: 1. Is the public health impact of the event serious? 2. Is the event unusual or unexpected? 3. Is there a significant risk of international spread? 4. Is there a significant risk of international restriction(s) to travel and trade? Notifications must be followed by ongoing communication of detailed public health information on the event, including, where possible, case definition, laboratory results, source and type of risk, number of cases and deaths, condi- tions affecting the spread of the disease, and the health measures employed. Figure H-1 illustrates the notification process. 2. Consultation: In cases where a state party is unable to complete a definitive assessment with the decision instrument in Annex 2, states parties have an explicit option of initiating confidential consultations with WHO and seeking advice on evaluation, assessment, and appropriate health measures to be taken. 3. Other Reports: States parties must inform WHO through the national IHR focal point within 24 hours of receipt of evidence of a public health risk identified outside their territory that may cause international disease spread, as manifested by imported or exported human cases, vectors that carry infection or contamination, or by contaminated goods. 

170 APPENDIX H FIGURE H-1 WHO public health event notification process. 6. International event detection, R01457 joint assessment, and response Figure H-1 The IHR (2005) underpin WHO’s mandate to manage the international bitmapped fixed image response to acute public health events and risks, including public health emer- gencies of international concern. The regulations also recognize WHO’s gen- eral surveillance obligations and set out specific procedures for concerned 

APPENDIX H 171 states parties and WHO to collaborate in the assessment and control of public health events and risks, even before such events have been officially notified to WHO. 7. PHEIC determination and temporary recommendations If immediate global action is needed to provide a public health response to prevent or control the international spread of disease, the IHR (2005) give the director-general of WHO the authority to determine that the event constitutes a PHEIC. On such occasions, an IHR emergency committee will provide its views to the director-general on temporary recommendations on the most appropriate and necessary public health measures to respond to the emergency. In cases where the state party concerned may not agree that a PHEIC is occurring, the emergency committee will also provide advice. The temporary recommendations issued by the director-general are for affected and nonaf- fected states parties to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic. 8. National surveillance and response capacities Another fundamental innovation in the IHR (2005) is the obligation for all states parties to develop, strengthen, and maintain core public health capacities for surveillance and response. To be able to detect, assess, notify, and report events and respond to public health risks and emergencies of international con- cern, states parties must meet the requirements described in Annex 1A of the IHR (2005). Annex 1A outlines these core capacities at the local (community), intermediate, and national levels, including, at the national level, the assessment of all reports of urgent events within 48 hours and the immediate reporting to WHO through the national IHR focal point, when required. The IHR (2005) require each state party, with the support of WHO, to meet the core surveillance and response capacity requirements “as soon as possible,” but not later than 5 years after the date of entry into force for that country. The IHR (2005) set out a two-phase process to assist states parties in planning for implementation of their public health capacity obligations. In the first phase, from June 15, 2007, to June 15, 2009, states parties must assess the ability of their existing national structures and resources to meet the core surveillance and response capacity requirements. This assessment must lead to the development and implementation of national plans of action. In the second phase, from June 15, 2009, to June 15, 2012, the national action plans are expected to be implemented by each state party to ensure that core capacities are present and functioning throughout the country and its rel- 

172 APPENDIX H evant territories. States parties that experience difficulties in implementing their plans may request an additional 2-year period until June 15, 2014. 9. Public health security in international travel and transport International points of entry, whether by land, sea, or air, provide an oppor- tunity to apply health measures to prevent international spread of disease. For this reason, several new provisions have been included. When applying IHR- related health measures to international travelers, for example, it is required that they be treated with courtesy and respect, taking into consideration their gender, sociocultural, ethnic, and religious concerns. They must be supplied with appropriate food, water, accommodation, and medical treatment if quar- antined, isolated, or otherwise subject to medical or public health measures under the IHR (2005). States parties are required to designate the international airports, ports, and any ground crossings that will develop specific capacities in applying public health measures required to manage a variety of public health risks. These capacities include access to appropriate medical services (with diagnostic facilities); services for the transport of ill persons; trained personnel to inspect ships, aircraft, and other conveyances; maintenance of a healthy environment; and establishment of plans and facilities to apply emergency measures such as quarantine. 10. New and updated health documents The IHR (2005) require immediate implementation of a range of new or revised health documents at points of entry, including the following: • Model Maritime Declaration of Health • Model International Certificate of Vaccination • Health Part of the Aircraft General Declaration