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Descriptive review and evaluation of the functioning of the International Health Regulations (IHR) Annex… Anema, Aranka; Druyts, Eric; Hollmeyer, Helge G; Hardiman, Maxwell C; Wilson, Kumanan Jan 10, 2012

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RESEARCH Open AccessDescriptive review and evaluation of thefunctioning of the International HealthRegulations (IHR) Annex 2Aranka Anema1, Eric Druyts2, Helge G Hollmeyer3, Maxwell C Hardiman3 and Kumanan Wilson4*AbstractBackground: The International Health Regulations (IHRs) (2005) was developed with the aim of governinginternational responses to public health risks and emergencies. The document requires all 194 World HealthOrganization (WHO) Member States to detect, assess, notify and report any potential public health emergency ofinternational concern (PHEIC) under specific timelines. Annex 2 of the IHR outlines decision-making criteria forState-appointed National Focal Points (NFP) to report potential PHEICs to the WHO, and is a critical component tothe effective functioning of the IHRs.Methods: The aim of the study was to review and evaluate the functioning of Annex 2 across WHO-reportingStates Parties. Specific objectives were to ascertain NFP awareness and knowledge of Annex 2, practical use ofthe tool, activities taken to implement it, its perceived usefulness and user-friendliness. Qualitative telephoneinterviews, followed by a quantitative online survey, were administered to NFPs between October, 2009 andFebruary, 2010.Results: A total of 29 and 133 NFPs participated in the qualitative and quantitative studies, respectively.Qualitative interviews found most NFPs had a strong working knowledge of Annex 2; perceived the tool to berelevant and useful for guiding decisions; and had institutionalized management, legislation and communicationsystems to support it. NFPs also perceived Annex 2 as human and disease-centric, and emphasized its reducedapplicability to potential PHEICs involving bioterrorist attacks, infectious diseases among animals, radio-nuclearand chemical spills, and water- or food-borne contamination. Among quantitative survey respondents, 88%reported having excellent/good knowledge of Annex 2; 77% reported always/usually using Annex 2 forassessing potential PHEICs; 76% indicated their country had some legal, regulatory or administrative provisionsfor using Annex 2; 95% indicated Annex 2 was always/usually useful for facilitating decisions regardingnotifiability of potential PHEICs.Conclusion: This evaluation, including a large sample of WHO-reporting States Parties, found that the IHR’s Annex2 is perceived as useful for guiding decisions about notifiability of potential PHEICs. There is scope for the WHO toexpand training and guidance on application of the IHR’s Annex 2 to specific contexts. Continued monitoring andevaluation of the functioning of the IHR is imperative to promoting global health security.Keywords: International Health Regulations (IHR), World Health Organization (WHO), Annex 2, public health emer-gency of international concern (PHEIC), evaluation* Correspondence: kwilson@ohri.ca4Department of Medicine, Ottawa Hospital Research Institute, ClinicalEpidemiology Program (1053 Carling Avenue), University of Ottawa, Ottawa(K1Y 4E9), CanadaFull list of author information is available at the end of the articleAnema et al. Globalization and Health 2012, 8:1http://www.globalizationandhealth.com/content/8/1/1© 2012 Anema et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative CommonsAttribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.IntroductionIn 2005 the World Health Assembly approved revisionsto the International Health Regulations(IHR), the pri-mary document governing the international response topublic health risks and emergencies [1,2]. The IHR(2005), which came into force on June 15 2007, requireall States Parties (i.e. countries that have ratified a cove-nant or a convention and are thereby bound to conformto its provisions) to develop and maintain effectivenational capacities to detect, assess, notify and reportevents and to respond to public health risks and emer-gencies [1]. The IHR(2005) represent an important stepin achieving global health security by promoting thepreparation for, and response to, public health risks andemergencies in a manner that does not unnecessarilyimpact cross-border travel and trade [3,4].A major innovation of the IHR(2005) was the shiftaway from disease specific notification to require notifi-cation of any events that may constitute a potential“public health emergency of international concern”(PHEIC) [5]. Under the IHR(2005), PHEICs are not lim-ited to infectious diseases, but also apply to events stem-ming from biological, radionuclear or chemical agents,from newly discovered or unknown agents or modes oftransmission, and events transmissible via persons, vec-tors, cargo, goods and environmental diffusion [6].While the first and only deceleration of a PHEIC by theDirector General of the World Health Organization(WHO) was the H1N1 outbreak, events such as theexport of melamine contaminated foods detected in2008, the international spread of measles through trave-lers, the meltdown of a Japanese nuclear power plant in2011 and the recent E.Coli outbreak in Europe have allbeen considered potential PHEICs [7,8].In order to assist States Parties in determiningwhether a potential PHEIC should be reported to theWHO, the IHR(2005) requires all States Parties to carryout an assessment of public health events arising intheir territories using a decision instrument contained inAnnex 2 of the Regulations. Under Annex 2, notificationby States Parties to WHO must occur if the response totwo of four criteria is affirmative, or if an event constitu-tes any of the following: poliomyelitis, smallpox, humaninfluenza caused by a new subtype, Severe AcuteRespiratory Syndrome (SARS), cholera, plague, yellowfever, viral hemorrhagic fevers, West Nile virus, or dis-eases of regional concern such as meningococcal diseaseand dengue) (see Additional File 1). States Parties arerequired to notify the WHO of all qualifying eventswithin 24 hours of confirmation [6].Annex 2 is considered a critical component to theeffective functioning of the Regulations, since its goal isto expand the number and scope of events reported tothe WHO by States Parties, thereby strengtheningWHO’s capacity to monitor and pro-actively respond topublic health risks and emergencies. The World HealthAssembly (WHA) mandated the Director-General ofWHO to review and evaluate the functioning of deci-sion-making tool [1]. The University of Ottawa wascommissioned by the WHO to undertake a qualitativestudy and quantitative survey to explore States Partiesawareness, practical use of, usefulness and perceiveduser-friendliness of Annex 2 through an interviewamong a representative sample of States Parties (qualita-tive study) and an online survey involving all States Par-ties (quantitative study).MethodsThis review and evaluation of the functioning of Annex2 was conducted between October 2009 and February2010, and consisted of two consecutive studies: first, aqualitative study based on semi-structured telephoneinterviews, and second, a quantitative online survey. Inboth studies the objectives were to assess the followingamong State Parties: a) awareness of Annex 2; b) com-prehension of the purpose and content of Annex 2; c)use of Annex 2; d) practical implementation of Annex 2;e) usefulness of Annex 2; f) perceived user-friendlinessof Annex 2; g) and challenges and success of Annex 2.Qualitative interviews were used to identify salientthemes, and to fine-tune wording of questions, for thelarger quantitative survey.Study ParticipantsStudy participants for both the qualitative and quantita-tive studies consisted of National IHR Focal Points(NFPs) from WHO-reporting countries. The term“NFP” denotes an institution or office, rather than indi-vidual, that has been designated by its States Party asthe WHO-communication centre for potential PHEICsunder Article 4 of the IHR [9].WHO State Parties are responsible for defining theNFPs specific position and role within their existingstructures. As a consequence, NFPs vary across MemberStates in terms of their professional qualifications, insti-tutional locations (ie. government departments), anddecision-making abilities. The WHO’s National IHRFocal Point Guide describes NFP roles, functions andoperational requirements under the IHR [9]. Accordingto the guide, the NFP must be available and accessibleat all times (7/24/365) for urgent reciprocal communica-tion (via email, telephone and/or fax) with WHO IHRContact Points. The NFP is responsible for consolidatingnational public health event surveillance data from allrelevant sectors of government, for communicating withWHO IHR Contact Points, on behalf of the State PartyAnema et al. Globalization and Health 2012, 8:1http://www.globalizationandhealth.com/content/8/1/1Page 2 of 9concerned and specifically notifying about potentialPHEICs [9].Qualitative StudyA total of 29 States Parties were purposively selected forparticipation in the qualitative study and represented adiversity of geographic regions, size, population demo-graphics, economic development, and epidemiologicalprofiles. The sample was weighted to low- and middle-income States Parties to ensure that their unique per-spectives were adequately captured. NFPs from theseselected States Parties were invited to voluntarily partici-pate in a 1.5 hour interview by email, and offered inter-preters to conduct the interview in the language of theirchoice. The study team, with input from the IHR Coordi-nation Department of WHO, developed an interview pro-tocol focused on the study objectives and consisting ofopen-ended questions. During interviews, the study teamtested the reliability of NFP responses by means of trian-gulation, a process which cross-examines emergingthemes and considers them valid only once two of threequestions produce similar answers. Oral and signed con-sent were obtained from each participant. Telephoneinterviews were digitally audio-recorded, and transcribedverbatim [10]. Data analysis was facilitated with the useof a qualitative research software, NVivo (version 8.0)(QSR International Pty Ltd., 2008, Melbourne, Australia)to code and sort the collected qualitative data. Tworesearchers analyzed data in duplicate to ensure that par-ticipants’ viewpoints were adequately interpreted [11].Quantitative StudySubsequent to the qualitative interviews, all 193 StatesParties were invited to participate in the quantitativesurvey, with the goal of obtaining an exhaustive sample.Contact details were supplied by the IHR CoordinationDepartment. Participants were invited to voluntarily par-ticipate in the study via email. The survey containing anembedded participant consent form, was administeredto States Parties via a secure internet-based web portalhttp://www.QuestionPro.com, and was available in allsix official languages of the World Health Assembly.Only one answer was allowed for each State Party. Keyvariables were measured through dichotomousresponses and Likert-type scales. PASW Statistics (ver-sion 18.0) (SPSS, Inc., 2009, Chicago, USA) was used toclean the dataset and to generate descriptive statistics.Participation in both studies was on a voluntary basis.EthicsThe qualitative and quantitative study methodologyunderwent ethical review at the University of Ottawaand was exempted from review by the WHO ResearchEthics Review Committee.ResultsResponse RateAmong the 193 States Parties eligible to participate, atotal of 29(15.0%) NFPs participated in qualitative tele-phone interviews, and 133(68.9%) completed the quanti-tative online survey. Response rates for the studiesvaried by WHO region (Figure 1).Country Surveillance CapacityIn the quantitative survey, the majority of NFPs reportedhaving either excellent (30[22.9%]) or good (58[44.2%])ability to assess potential PHEICs under the IHR’sAnnex 2. NFPs indicated that they received surveillancedata from government agencies, to which they applyAnnex 2, in the following proportions: Health 127(95.5%), Agriculture 77(57.9%); Environment 45(33.8%);National Security 22(16.5%); Transportation 17(12.8%);and Energy 8(6.0%). NFPs’ access to surveillance infor-mation was reportedly higher for events involving infec-tious diseases (Table 1).Awareness and knowledge of Annex 2NFPs participating in qualitative interviews were unan-imously aware of Annex 2, and had varying in-depthknowledge about the tool, depending on their priorexposure to WHO guidance and trainings. Some con-fusion persisted among NFPs that had not accessedany training regarding operational and communicationprocedures for notifying WHO about potentialPHEICs. In the quantitative survey, 112(88.2%) NFPsindicated they had ‘excellent’ or ‘good’ knowledge ofAnnex 2, and 108(82.1%) had accessed some form ofWHO training about Annex 2. When we explored thestatistical association between NFPs knowledge ofAnnex 2 and access to training, we found that NFPswho had accessed WHO training were significantlymore likely to report having ‘excellent ’ or ‘good ’knowledge of Annex 2, compared to those that hadnot accessed any training (p = 0.03).Qualitative interviews with NFPs also revealed thatmany States Parties were expanding awareness and useof Annex 2 beyond the national/federal level, to stateand municipal public health officials and even front-line clinicians. In the quantitative survey, 37(29.8%)NFPs rated the overall awareness of Annex 2 at thenational/federal government level as ‘excellent ’ or‘good’, compared to only 19(16.1%) at the provincial/state/canton and 13(10.1%) at municipal/local levels. Atotal of 93(70.5%) of NFPs reported ‘excellent ’ or‘good’ awareness of Annex 2 in Health agencies, com-pared to 32(24.8%) in Agriculture, 21(16.4%) in Envir-onment, 20(15.6%) in National Security, 13(10.2%) inTransportation, 12(9.4%) in Justice, and 7(5.6%) inEnergy.Anema et al. Globalization and Health 2012, 8:1http://www.globalizationandhealth.com/content/8/1/1Page 3 of 9Practical Use of Annex 2Frequency of UseThe qualitative interviews revealed that NFPs are usingAnnex 2 with varying levels of frequency. While somehave instituted a routine practice of applying Annex 2to all public health events that emerge in their nationalsurveillance system, others reserve the tool for eventsthey suspect may qualify for notification under Annex2’s criteria. The quantitative survey revealed that 59(46.8%) respondents indicating they ‘always’ use Annex2 and 38(30.2%) indicating they ‘usually’ use the tool forthe notification assessment of potential PHEICs.TrainingThe qualitative interviews revealed that many NFPs areleading trainings about Annex 2 within their countriesthrough a range of mechanisms. Some NFPs indicatedthey had conducted informal trainings about Annex 2,while others had developed elaborate training curriculaand ‘trainers of trainers’ for the purpose of increasingknowledge, institutional memory and succession plan-ning regarding Annex 2. In the quantitative survey, 84(67.2%) NFPs indicated they had facilitated trainingsabout Annex 2, which were conducted largely withingovernment health agencies (Table 2).Legal, Regulatory or Administrative InstrumentsDuring the qualitative interviews, many NFPs explainedthat their country had some form of legislation pertainingto Annex 2 in place, usually regarding infectious diseases.In the quantitative survey, 94(76.4%) NFPs responded thattheir country had some form of legal, regulatory or Africa Americas Eastern Mediterranean Europe South-East Asia Western Pacific Overall Qualitative Survey  7/46 (15%) 6/35 (17%) 7/21 (33%) 3/53 (6%) 3/11 (27%) 3/27 (11%) 29/193 (15%)  Quantitative Survey 30/46 (65%) 28/35 (80%) 9/21 (43%) 41/53 (77%) 6/11 (55%) 19/27 (70%) 133/193 (69%)  Figure 1 Participant response rate for qualitative and quantitative surveys, disaggregated by World Health Organization (WHO)region.Anema et al. Globalization and Health 2012, 8:1http://www.globalizationandhealth.com/content/8/1/1Page 4 of 9administrative provisions for assessing and notifying publichealth events in accordance with Annex 2, either in placeor under development. Of these States Parties, 33(35.9%)had guidelines to facilitate interpretation of this federal/national legislation regarding Annex 2. Consistent withqualitative findings, 91(68.4%) NFPs indicated they hadlegislation concerning the four diseases requiring notifica-tion in all circumstances under the IHR (2005)’s Annex 2:91(68.4%) human influenza caused by a new subtype; 82(61.7%) for wild-type poliomyelitis; 85(63.9%) for SARS;and 75(56.4%) for smallpox.Standard Operating Procedures (SOPs)Qualitative interviews with NFPs revealed that severalStates Parties had Standard Operating Procedures (SOPs)that provided guidance on the deployment of human/financial resources, inter/intra-agency and public commu-nication, and other operation-based activities pertaining tothe assessment and notification of potential PHEICs underAnnex 2. Several countries indicated they had SOPs forspecific locations within their territory and for certain sce-narios. In the quantitative survey, 68(54.4%) NFPs indi-cated that they had a formal SOP for the implementationof Annex 2 either in place or in development. Amongthese State Parties 39(29.2%) had SOPs to guide assess-ment and notification of potential PHEICS for points ofentry, 28(21.1%) for ships, 28(21.1%) for front-line publichealth settings (e.g. clinics, hospitals), 16(12.0%) for animalfarms, 11(8.3%) for food processing plants, 9(6.8%) forwater treatment plants, 8(6.0%) for international popula-tion gatherings, and 7(5.3%) for industrial plants.Communication SystemsDuring the qualitative interviews, several NFPs explainedthey had domestic communication plans in place to ensuretimely detection, assessment and monitoring of potentialPHEICs within their country. Many NFPs expressed adesire to improve their communication with internationalstakeholders including WHO, but had varying levels ofcomfort regarding early communication about surveillancedata with WHO officials and NFPs from neighboring coun-tries. Predominant concerns regarding early communica-tion with WHO officials and NFPs from neighboringcountries included the fear that it may raise unnecessaryalarm in WHO and neighboring governments, may causeexcessive media attention and may lead to unnecessary tra-vel or trade restrictions (Table 3). In the quantitative sur-vey, 99(74.4%) of NFPs responded that they had a domesticcommunications plan in place or in development to facili-tate intra-country communication about public healthevents of potential international concern.Usefulness of Annex 2In the qualitative interviews, most NFPs expressed thatthey found Annex 2 to be very useful for deciding uponTable 1 National IHR Focal Point (NFP) reported access to specific types of public health event data for assessmentunder the International Health Regulations (IHR)(2005)Types of public health event data Number (%) NFPs with access to specific types ofpublic health event data (n = 133)Human influenza caused by new sub-type 126 (94.7%)Wild-type poliomyelitis 98 (73.7%)Severe Acute Respiratory Syndrome 79 (59.4%)Smallpox 60 (45.1%)Other communicable diseases 94 (70.7%)Contaminated food (i.e. substance and microbial contamination) 93 (69.9%)Contaminated water 76 (57.1%)Radionuclear spill 38 (28.6%)Chemical contamination of products or the environment 52 (39.1%)Other toxic release 33 (24.8%)Bioterrorist attack 45 (33.8%)Pharmaceutical product (contamination, adverse event, failure) 64 (48.1%)Communicable diseases among animals 81 (60.9%)Table 2 Number of National IHR Focal Points (NFPs) thatreported facilitating trainings about Annex 2 ofInternational Health Regulations (IHR) in specificgovernment agenciesType of government agency Number (%) trainings facilitatedby NFPs (n = 133)Health 83 (62.4%)Agriculture 49 (36.8%)National Security 33 (24.8%)Environment 33 (24.8%)Transportation 30 (22.6%)Justice 10 (7.5%)Energy 7 (5.3%)Anema et al. Globalization and Health 2012, 8:1http://www.globalizationandhealth.com/content/8/1/1Page 5 of 9the need to notify WHO of a potential PHEIC, particu-larly for those PHEICs deemed automatically notifiableunder Annex 2 (see Additional File 1). However, someraised concerns that, in the absence of any accepted, evi-dence-based hierarchy of pathogens and toxins, Annex 2was difficult to apply to certain events such as humaninfluenza caused by a new subtype, food- and water-borne events, and chemical spills. Several NFPsdescribed Annex 2 as overly human-centric, limiting itsapplication to potential PHEICs consisting of commu-nicable diseases among animals. In the quantitative sur-vey, 116(95%) NFPs indicated that Annex 2 was ‘always’or ‘usually’ useful in facilitating decisions regardingwhether a public health event has to be notified toWHO. NFPs found Annex 2 ‘fully relevant’ for infec-tious diseases, such as smallpox (114[87.7%]), SARS (110[84.0%]), and human influenza cause by a new subtype(110[84.0%]), and less relevant for communicable dis-eases among animals 35[27.1%]), chemical contamina-tion of products or the environment (57[44.5%]), andcontaminated water (52[40.6%]) or foods (5[41.4%]).User-friendliness of Annex 2During the qualitative interviews most NFPs indicatedthat the 24-hour timeline for notification of a potentialPHEIC to WHO was reasonable, but delays were inevi-table due to the need to obtain clearance from seniorgovernment officials. In the survey, 113(89.0%) NFPsreported that the 24-hour timeline for notification wasreasonable. However, 51(40.2%) NFPs require clearancefrom 2-3 individuals/offices prior to notification toWHO, contributing to delays in notification.Interviews revealed that the majority of NFPs felt thatthe four decision instrument criteria of Annex 2 wereclear but could benefit from refinements in the algo-rithm and checklist in order to prevent difficulties ininterpretation. In the quantitative survey, NFPs indicatedthat the user-friendliness of Annex 2 could be improvedif NFPs had access to disease-specific incidence thresh-old values to facilitate assessment of each criterion (67[50.4%]), guidance on how to interpret surveillance datain the specific national context (63[47.4%]), and morecase scenarios for training (90[67.7%]). Just over half ofall NFPs additionally suggested that the development ofa centralized online communication platform would beuseful in order to expand notification options, improvecommunication between NFPs from neighboring coun-tries and contribute to training in the use of Annex 2(68[56.7%]).DiscussionOverall, our findings suggest that there is overwhelmingsupport for Annex 2 among NFPs. Although States Par-ties appear to have varied capacities in event-based sur-veillance, we found that the vast majority of NFPs had astrong awareness and knowledge of Annex 2, particu-larly those within government health agencies. Annex 2was deemed useful for assessing communicable diseases,and less helpful for discerning other types of potentialPHEICs. NFPs cited numerous initiatives to support theTable 3 National IHR Focal Points (NFPs) concerns about early communication with World Health Organization (WHO)and with NFPs from neighboring countries regarding a potential public health emergency of international concern(PHEIC)NFP concerns regarding early communication Communication with WHO countryand regional offices(n = 133)Communication with NFPs fromneighboring States Parties(n = 133)Yes (%) Yes (%)Early communication may unnecessarily raise alarm in WHO 31 (23.3%) 15 (11.3%)Early communication may unnecessarily raise alarm in mygovernment33 (24.8%) 20 (15.0%)Early communication may unnecessarily raise alarm in thegovernment of a neighboring country21 (15.8%) 41 (30.8%)Early communication may create unnecessary mediaattention37 (27.8%) 33 (24.8%)Early communication may result in unnecessary trade/travelrestrictions24 (18.0%) 29 (21.8%)Early communication may overburden country and regionaloffices and NFPs14 (10.5%) 15 (11.3%)Early communication utilizes our limited telephonecommunications budget6 (4.5%) 4 (3.0%)None of the above 56 (42.1%) 60 (45.1%)Other 8 (6.0%) 6 (4.5%)Anema et al. Globalization and Health 2012, 8:1http://www.globalizationandhealth.com/content/8/1/1Page 6 of 9practical use of the tool and provided several sugges-tions on how to improve its user-friendliness.Our results indicate that States Parties’ ability todetect potential PHEICs was strongest in governmenthealth agencies, and lowest in agencies of nationalsecurity, transportation and energy. Results from thisstudy suggest that many States Parties may be strugglingto establish core capacities in event-based surveillance[12]. The IHR (2005) calls upon State Parties to enhancetheir surveillance and response infrastructure and neces-sary logistical and human resource capacity across allgovernments sectors by 2012 [13]. However, for manylow resource countries, the development of an epidemicintelligence framework across multiple sectors, as hasbeen done in the European Union for example [14],poses a serious financial challenge [15] and may explainthe significant variation between States Parties’ reportedsurveillance capacity [16-19]. These findings suggestthere is scope for the WHO to further support StatesParties in enhancing their national surveillance, poten-tially by leveraging existing bilateral partnershipsfocused on capacity building [20].We also found that the majority of NFPs regularlyused Annex 2 for the assessment of public health events,and had taken active steps towards institutionalizing itsuse in their national, regional and municipal surveillancesystems. The majority of NFPs had facilitated trainingsabout Annex 2 in their country, many had developedgeneral SOPs and systems to facilitate rapid communi-cation of public health events from municipal tonational levels of government. Of note, the vast majorityof States Parties had some form of legal, regulatory oradministrative provisions supporting the use of Annex 2and many had guidelines to facilitate its interpretation.These findings suggest that most States Parties aremeeting their IHR core capacity requirements for theestablishment of national legislation and policy [12], andthat many federations, where public health regulatorypower resides in local or regional governments, may becentralizing and harmonizing their public health policiesand practices, allowing them to better comply with theIHR(2005) [21-23]. The fact that most States Partiesindicated they had legislation specific to the four dis-eases requiring automatic under the IHRs Annex 2, andhad SOPs to guide use of Annex 2 in diverse settings,suggests that cross-national management systems are inplace to effectively notify WHO of potential PHEICs.Our findings also suggest that NFPs generally per-ceived Annex 2 to be very user-friendly. NFPs cited thetimeline for notification of a potential PHEIC as reason-able and that the algorithm and checklists represented asubstantial improvement over the previous IHR diseaselist. Overall, NFPs felt that Annex 2 was simple to readand clear, particularly when applied to communicablediseases. However, NFPs described having difficulties ingauging the severity of certain types of public healthevents, given the absence of evidence-based thresholds(e.g. contamination of food and water, infectious dis-eases among animals and chemical contamination ofproducts or the environment). These findings are con-sistent with a published reported from one State Partyin sub-Saharan Africa that indicated the country lackedsurveillance guidelines and case definitions for outbreakresponse to food, chemical and radio-nuclear hazards[18]. In developing countries, effective detection of foodand water-borne diseases requires significant improve-ments in laboratory infrastructure and expertise [24].Meanwhile, the surveillance and reporting of chemical,nuclear and radiological threats have been described aspersistent challenges by several States Parties in bothdeveloping and developed countries [25], complicatingplanning for major incidents [26]. Further guidancewhere possible, on global standardization of rare typesof public health events were deemed necessary by NFPs.Our findings regarding NFP awareness, knowledge andefforts to integrate Annex 2 into national legislation,organizational procedures and communication systemsappears to be in direct contrast with results from therecent WHO Database Study which found that notifica-tion of public health events by NFPs has remained quitelimited [27]. A potential explanation for this discordanceis that Annex 2 was designed and written in such a wayas to be intentionally non-specific. It has been assumedthat this intentional ambiguity would broaden the typeand numbers of notifiable events under the IHR (2005)and lead to an over-reporting of public health events byNational IHR Focal Points to WHO. However, thatintentional ambiguity may actually be having the oppo-site effect. Lack of detail in Annex 2 may in fact haveallowed more discretion in reporting which in turncould have resulted in more conservative notificationpractices.Implications of FindingsThere are several steps WHO and States Parties cantake to further improve the use of Annex 2 (AdditionalFile 2). Since having a thorough and confident under-standing of Annex 2 was associated with havingaccessed WHO guidance and training on the tool, thereis a need to ensure that all NFPs access some form oftraining regarding Annex 2, and especially the WHO’sGuidance for the Use of Annex 2 of the IHR(2005) [28].A mechanism to prevent the non-specificity of Annex 2as a reason to err on the side of not reporting and tosupport NFPs in any internal disputes over notification,would be to provide more specific examples of whatclasses of conditions would require reporting throughan increased number of case scenarios. If a case study ofAnema et al. Globalization and Health 2012, 8:1http://www.globalizationandhealth.com/content/8/1/1Page 7 of 9an analogous event suggested that reporting is requiredit could reduce discretion resulting in the decision tonot report. NFPs unanimously found the case scenarioscontained within WHO’s Interim Guidance for the Useof Annex 2 of the IHR(2005)[6] to be helpful for obtain-ing a strong working knowledge of the tool.Several States Parties have demonstrated a tremendousamount of innovation with regard to activities they havetaken to support Annex 2. In some circumstances, theseactivities to support Annex 2 may constitute ‘best prac-tices’ that other States Parties can learn from and warrantcloser attention. There is equally a need for WHO todevelop parameters for the appropriation/modification ofAnnex 2 by States Parties. Furthermore, while the inten-tion and one of the great strengths of Annex 2 is torequire an interpretation of public health events takinginto account the context in which they occur, there isscope for WHO to support NFPs in their notificationassessment by developing thresholds for the seriousnessand risk of spread for specific events and circumstances.The majority of NFPs supported the use of a centra-lized, web-based platform to simultaneously strengthentraining in the use of Annex 2, information sharing withNFPs from neighboring States Parties, and notification ofpotential PHEICs to WHO, Internet-based reporting hasbeen associated with increased timeliness of outbreakdetection and public communication [29], and is becom-ing increasingly feasible in developing countries due togrowing Internet access, IT user-friendliness and reducedcosts [30]. Automated syndromic surveillance systemcould complement existing laboratory and public healthsurveillance programs, and be maintained with minimalinvestment into technological or human resources [30].Study LimitationsWhen considering the findings of our study it is impor-tant to recognize the limitations of the methodology.First, our evaluation sampled NFPs. These individualswould be expected to be amongst the most supportiveand knowledgeable individuals of the IHR (2005) withina State Party. Similar enthusiasm and knowledge for theIHR cannot necessarily be expected to exist in otherparts of the public health surveillance and response sys-tem and could reflect on the ability of a States Party toutilize Annex 2. Furthermore NFPs may not necessarilyplay the key role in the risk assessment of an eventoccurring within the territory of a given State Party.This process may involve decision makers based outsidethe respective NFP. While the studies were addressed toNFPs, the only national stakeholder clearly identifiableand accessible by WHO, no restrictions were imposedon NFPs regarding consultation with other relevantdecision makers. However, because of the anonymousnature of the survey we do not know whether theanswers that we received from NFPs represent the viewsof individual risk assessors within the NFP, the entireNFP team, or a group of collaborators includingnational experts outside of the NFP. Additionally, ourfindings are susceptible to responder bias. NFPs that didparticipate may have been systematically different fromthose that did not. In particular we noted a differentialresponse per WHO Region, with comparatively lessresponses from the Eastern Mediterranean and SouthEast Asia, and more responses from the Americas andEurope. Non-response from certain States Parties maybe explained by individual circumstances (e.g. workload),cultural norms, or participant exhaustion (from otherrecent WHO evaluation [31]). Future evaluations shouldseek to verify whether observations from the presentstudy are representative of those regions. Also, for thoseNFPs we obtained responses from, there is the risk ofsocial desirability bias. It is possible, for example, thatparticipants modified their responses (e.g. regardingawareness, knowledge, usefulness of Annex 2) in orderto satisfy WHO headquarters representatives associatedwith the study. Finally, descriptive results from thisstudy should be interpreted as baseline data for subse-quent in depth analysis and longitudinal investigation.ConclusionOur findings suggest that there is overwhelming supportfor Annex 2 among States Parties. Many States Partieshad taken active steps towards institutionalizing theIHR’s Annex 2 in their national, regional and municipalsurveillance systems, suggesting State commitment tothe development of IHR core capacities. States Parties’ability to detect potential PHEICs was strongest in gov-ernment health agencies, and lowest in agencies ofnational security, transportation and energy, pointingtowards areas for possible expansion of WHO-supportedcapacity building efforts. The IHR’s Annex 2 wasdeemed highly useful for assessing notification of infec-tious diseases, but less helpful for evaluating other typespotential PHEICs, suggesting scope for the WHO toexpand and refine its guidance documents.Additional materialAdditional file 1: Annex 2 of the International Health Regulations(IHRs): Decision instrument for the assessment and notification ofevents that may constitute a public health emergency ofinternational concern. Jpeg figure.Additional file 2: World Health Organizations (WHO)recommendations to strengthen the functioning the InternationalHealth Regulations (IHR) Annex 2. Recommendations listed from 1 to15.Anema et al. Globalization and Health 2012, 8:1http://www.globalizationandhealth.com/content/8/1/1Page 8 of 9List of abbreviationsIHR: International Health Regulations; NEP: National IHR Focal Point; PHEIC:public health emergency of international concern; WHO: World HealthOrganization.AcknowledgementsWe would like to thank all participating NFPs for their time and interest inthis study. We are grateful to WHO staff at the Regional and Country Officesfor their invaluable support in the implementation of the qualitative studyand the survey. Finally, we would like to acknowledge all colleagues at WHOHeadquarters collaborators who assisted us in the development andimplementation of the study, and who funded the study.Author details1Experimental Medicine Program, Department of Medicine, Faculty ofMedicine (2775 Laurel Street), University of British Columbia, Vancouver (V5Z1M9), Canada. 2Faculty of Health Sciences (2016-451 Smyth Road), Universityof Ottawa, Ottawa (K1H 8M5), Canada. 3Global Capacities Alert andResponse, World Health Organization, (20 Avenue Appia, CH 1121) Geneva27, Switzerland. 4Department of Medicine, Ottawa Hospital ResearchInstitute, Clinical Epidemiology Program (1053 Carling Avenue), University ofOttawa, Ottawa (K1Y 4E9), Canada.Authors’ contributionsAA and KW led and implemented the independent program evaluation,which involved developing qualitative and quantitative study designs andsurvey tools; leading participant interviews; analyzing study results. AA andKW wrote the manuscript. 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