Are You Ready for a Pandemic? The International Health Regulations Put to the Test of Their ‘Core Capacity Requirements’

Legal analyses of the Covid-19 pandemic have mainly addressed measures adopted in response to this event. However, institutional agendas related to disasters, such as the Sendai Framework for Disaster Risk Reduction 2015-2030, reaffirm that similar attention should be paid to prevention and preparedness measures that can positively impact potentially affected communities, also in economic terms (for health emergencies see the 2019 report of the Global Preparedness Monitoring Board, co-convened by WHO and the World Bank Group). Measures addressing risk reduction also have international legal implications (Samuel, Aronsson-Storrier & Bookmiller and here) and indeed the International Health Regulations themselves encapsulate this perspective, particularly through their Articles 5 and 13, and Annex 1. However, the implementation of such obligations has suffered from various shortcomings and has not been supported by a substantial monitoring system. The recent focus on such issues by WHO and Member States has resulted in some new initiatives, but ultimately constituted too little and too late.

Articles 5 and 13 of the IHR

The IHR include a series of obligations related to structural and capacity-building measures, sometimes referred to as ‘protracted obligations’ (Villarreal), which are expected to contribute to its overall goal ‘to prevent, protect against, control and provide a public health response to the international spread of disease’ (Article 2 IHR).

Article 5 IHR provides that ‘(e)ach State Party shall develop, strengthen and maintain … the capacity to detect, assess, notify and report events in accordance with these Regulations, as specified in Annex 1’, while Article 13 IHR requires ‘the capacity to respond promptly and effectively to public health risks and public health emergencies of international concern as set out in Annex 1’, also providing that ‘WHO shall publish, in consultation with Member States, guidelines to support States Parties in the development of public health response capacities’.

The IHR have also established deadlines. Both provisions require States to act ‘as soon as possible but no later than five years from the entry into force’ of the IHR (namely 15/6/2007), while admitting the possibility to request a 2-year extension in the case of ‘justified needs’ and, subsequently, a further 2-year postponement due to ‘exceptional circumstances’. Such options have been used extensively by States when approaching the deadlines: in 2012, 118 States requested an extension, while 38 actually failed to report; in 2014, 81 States asked for a further postponement, while 48 avoided any communication (here). The extensions nonetheless came to an end in 2016: at the time the WHO Director-General recognized that “(p)rogress has been made, but these capacities have not been established in many countries” (WHA A/69/20, para. 16), without naming and shaming non-compliant States.

The ‘Core Capacity Requirements’ Provided in Annex 1

IHR Annex 1, referred to in Articles 5 and 13 IHR, further details the measures States are expected to adopt. Its section B, devoted to ‘Core Capacity Requirements for Designated Airports, Ports and Ground Crossings’, is in line with approaches already present in early sanitary conventions requiring States to maintain public health capabilities at points of disease entry and exit.

Conversely section A, devoted to ‘Core Capacity Requirements for Surveillance and Response’, was one of the novelties introduced by the 2005 IHR (Negri, 274). It lists a series of public health capacities qualified as ‘minimum requirements’, focusing on the capacity to detect and assess potential health threats relevant to the IHR and to guarantee a public health response. In this latter regard preparedness measures might include, for example, the need: ‘to establish, operate and maintain a national public health emergency response plan’; ‘to provide support through specialized staff, laboratory analysis of samples…and logistical assistance (e.g. equipment, supplies and transport)’; ‘to determine rapidly the control measures required to prevent domestic and international spread’, etc.

Annex 1 thus broadly identifies areas of intervention, although lacking clear quantitative and qualitative parameters and without detailing potential sub-sets of measures functional to fulfilling minimum requirements. Subsequent WHO documents have nonetheless provided further guidance, such as the 2013 Checklist and indicators for monitoring progress in the development of IHR core capacities in States Parties. This latter non-binding document details the operational meaning of eight capacities functional to fulfilling the goals identified by Articles 5 and 13, such as Core Capacities 3 (Surveillance), 4 (Response), 7 (Human Resources), 8 (Laboratory), while providing for further content. For instance, Core Capacity 5 (Preparedness) mentions not only elements already listed in Annex 1, such as ‘public health emergency response plans’, but also refers to further instrumental measures. For instance reference is made to the ‘surge capacity’, i.e. ‘the ability of the health system to expand beyond normal operations to meet a sudden increased demand’ regarding beds, personnel and equipment, or to measures functional to the identification of ‘available resources, the development of appropriate national stockpiles of resources and the capacity to support operations’, thus emphasizing the potentially far-reaching character of relevant measures. Nonetheless, doubts could still be raised regarding the effective thresholds to be fulfilled by States in order to comply with the ‘minimum requirements’ referred to in Articles 5, 13 IHR and in Annex 1, as their effective content can hardly be qualified as crystal clear to some extent.

Furthermore, it is self-evident that the actual capacity to meet such goals is also dependent upon the overall public health capacities of the States concerned. However, while the ‘surveillance and response capacity obligations in the new IHR are more demanding than those found in the ICESCR’s right to health’ (Fidler, 373), due to a fixed deadline rather than a progressive approach and a lack of specific attention to the structural deficiencies among Member States, ‘(t)he IHR lack detailed strategies for capacity building’ (Gostin, 188). Indeed Article 44 IHR, dealing with collaboration and assistance by States and WHO, has been qualified as a ‘weak obligation on financial and technical assistance’ (Fidler, 374), also considering that nearly 80% of WHO’s budget is voluntary and highly earmarked, thus ‘precluding holistic preparedness efforts and hindering WHO’s ability to provide a global safety net’ (2019 Annual report on global preparedness for health emergencies, 33). These features have unfortunately implied a ‘limited international solidarity to support the weakest countries in building capacities’, as recognized by the 2015 Report of the IHR Review Committee regarding the second extension of the IHR deadline (para. 17).

Such elements appear to have played a role in the very soft monitoring mechanism put in place to assess implementation of the IHR and in the limited results achieved by States regarding their preparedness for health emergencies, as detailed below.

The Monitoring System of the IHR: Light and Shadows

In accordance with Article 54 IHR, ‘States Parties and the Director-General shall report to the Health Assembly on the implementation of these Regulations as decided by the Health Assembly’, thus grounding the monitoring system on mandatory reports to be provided annually (World Health Assembly Resolution 61(2), 2008).

Current reports are based on the 2018 SPAR (State Party Self-Assessment Reporting) tool, consisting of 24 indicators for 13 IHR capacities related to the detection, assessment, notification/reporting of and response to public health risks. These capacities might refer to issues such as human resources and laboratories or the legal and financial framework, regarding which States conduct self-assessment based on five possible levels of performance, by simply ticking the appropriate box. Furthermore, this self-evaluation largely relies on formal aspects, with limited benchmarks. For example, indicator C8.3 on ‘Emergency Resource Mobilization’, addressing issues such as ‘human (experts), financial, logistics (medical countermeasures, stockpiles), and health facilities (beds, equipment, etc.)’, attributes the maximum score to States which self-assess that ‘resource mapping and mobilization mechanisms are regularly tested and updated’. It is thus hard to maintain that these reports provide an effective indication of the functionality of national systems and of the real capacities required to manage health emergencies (Gostin/Katz, 278)

Furthermore, even if reports are made public in order to satisfy minimal transparency requirements, they are not subjected to any potential review mechanism common to other areas of international law. No individual or collective follow-up/debate on reports, on-site visits or direct engagement with States is provided for, and no adverse effects ensue if reports are submitted late, incomplete or not presented at all. This non-confrontational approach, coupled with substantial structural deficiencies, has probably contributed to the fact that the fulfillment of such requirements is not treated as a top priority, ultimately resulting in serious shortcomings. Based on the reports submitted in 2018 and their own evaluations, about two thirds of States have poor or modest levels of preparedness, with overall scores ranging from levels 1 to 3 out of 5 (here).

Nonetheless, in recent years growing attention to such issues can be registered. This could be linked to different elements: a) the end of the grace period provided by the IHR; b) reports by the IHR Review Committees on the H1N1 and Ebola outbreaks, which underlined structural deficiencies as critical factors (here and here); c) assessments regarding the inadequate levels of preparedness made by external actors, such as the 2016 UN High-Level Panel on the Global Response to Health Crises and the Global Health Crises Task Force or authoritative commissions of experts (here and here), which have also contributed to the emergence of concurring approaches addressing such issues, such as the Global Health Security Agenda (Meier et al.; Katz et al.)

Recent Initiatives related to Preparedness for Pandemics

On this basis, some recent attempts have been made to shift WHO’s approach, finally resulting in some (modest) results.

In particular the 2015 Report of the IHR Review Committee regarding the second extension concluded in its Recommendation No. 7 that ‘(i)mplementation of the IHR should now advance beyond simple “implementation checklists”’, suggesting that the Secretariat develop ‘options to move from exclusive self-evaluation to approaches that combine self-evaluation, peer review and voluntary external evaluations involving a combination of domestic and independent experts’. This suggestion was endorsed  in World Health Assembly Resolution 68.5 (2015) and the consultation processes with Member States concerning potential options (here) led the Director-General to present, in 2016 (A/69/20, Annex), some new voluntary technical tools to complement the annual report, finally resulting in the current ‘IHR Monitoring and Evaluation Framework’.

Within the latter the only mandatory component, namely annual reports, has not been significantly affected, hence confirming the shortcomings emphasized above. Conversely, three new voluntary tools have been developed to facilitate evaluations aimed at identifying the most critical domestic challenges. Two of these can be autonomously managed by States, even if external involvement is encouraged: simulation exercises for public health emergencies (128 exercises conducted so far) and the Guidance for after Reaction Review (64 reviews so far). Finally, the Joint External Evaluation provides for independent assessments of progress made toward achieving the targets under Annex 1 IHR, focusing on 19 technical areas. The mechanism is still based on a cooperative approach with the country concerned: for instance, the State’s approval is required for the selection of experts and regarding the methodology to be adopted and, similarly, it must agree to the publication of findings and recommendations on the WHO website. Apparently only 96 reports are publicly available (here), out of 112 on-site missions (here). Still, external evaluations have had an impact on the self-assessments conducted by States. In recent years some overall decreases recorded in reported performance (here) should be linked to the possibility of having more reliable data at States’ disposal.

Support for such tools was reiterated in the World Health Assembly Decision 71(15), which adopted the Five-year Global Strategic Plan to Improve Public Health Preparedness and Response, 2018–2023 and reaffirmed the technical support provided by WHO to States in making use of such tools. Nonetheless, as highlighted by Burci and Quirin, the final version of Decision 71(15) softened references to external review mechanisms: a sign for the continuing preference for self-assessment. Furthermore, this plan was less ambitious than proposals made by the 2016 IHR Review Committee on the Ebola Crisis, where recommendations 2-3 requested a Global Strategic Plan to improve public health preparedness and response, asking for clear performance indicators, national core capacity development and maintenance plans, independent external assessments on a 5-year cyclical basis and technical and financial support, expected to be contingent on countries undertaking such reviews and reaching pre-determined milestones.

The growing relevance of these issues re-emerged in the resolution proposed in February 2020 by the Executive Board to the 73^rd session of the World Health Assembly, devoted to ‘Strengthening preparedness for health emergencies: implementation of the International Health Regulations (2005)’. The resolution would have advocated States ‘to take actions to implement the unmet obligations’ or to prioritize the improvement of health emergency preparedness, confirming their support for the abovementioned ‘IHR Monitoring and Evaluation Framework’ and calling upon multiple stakeholders for political, financial and technical support. However, the lack of specific targets, deadlines, and a desire to continue “business as usual” in terms of the reporting procedure might prompt doubts about the potential effectiveness of this resolution. Ironically, the Covid-19 crisis, which has dramatically tested States’ preparedness, also implied a postponement of the debate on this resolution, as the first set of the 73^rd session of the World Health Assembly, held virtually, was devoted to few challenging issues (Villarreal).

Conclusions

While innovative in introducing obligations regarding certain structural measures, the IHR have faced a series of difficulties in guaranteeing implementation of the ‘core capacities’ required of States. Limits related to the legal architecture and an institutional agenda which has not prioritized such issues has implied that States are not effectively pushed to fulfil such obligations. Such elements are furthermore coupled with more substantial obstacles: the largely under-emphasized financial implications of such measures which contributes to the critical deficiencies in several public health systems and which requires difficult choices in the allocation of resources, and the lack of domestic and international agendas aimed at prioritizing such future-oriented activities in the face of  apparently more compelling issues. Even recent attempts within WHO to refocus attention on such aspects appear to have been too little and, unfortunately, too late.

Whether or not the Covid-19 crisis prompts further reflection within WHO on the IHR, the opportunity to address these aspects should not be missed, and more substantial approaches to favoring the implementation of such obligations must be sought if we aim to finally improve States’ preparedness for the next pandemic.