Implementation of the International Health Regulations (2005): Recent Developments at the World Health Organization

Introduction

The world is more interconnected than ever before. In 2017, more than 4 billion people travelled by plane, a figure that the global airline industry expects to nearly double by 2035.[1] This interconnectedness has benefited states and their citizens in many ways. However, it has also aided pathogens, which can now travel more easily. The 2014–2016 Ebola outbreak in West Africa claimed over 11,000 lives and, according to 2014 projections from the World Bank, cost approximately USD 2.2 billion in GDP in the mostly affected countries Guinea, Liberia, and Sierra Leone.[2] The international community is prioritizing efforts to address current and future risks of international spread of diseases, including at the recently concluded seventy-first session of the World Health Assembly (WHA). The WHA is the supreme governing body of the World Health Organization. At this year`s annual session it considered a five-year global strategic plan (2018–2023) to improve public health preparedness and response on the international spread of disease, following its annual debate on the implementation of the International Health Regulations (2005) (IHR (2005)).[3] The plan and its implementation are going to be key elements in the achievement of WHO`s strategic priority, reflected in WHO's Thirteenth General Programme of Work. It aims to better protect one billion people from health emergencies by 2023 and, together with the implementation of other relevant instruments negotiated under UN auspices, work towards achieving Sustainable Development Goal Three ("Ensure healthy lives and promote well-being for all at all ages").

The International Health Regulations (2005)

The IHR (2005) are the latest manifestation of an effort in international health law-making that began in the second half of the nineteenth century. Adopted by the fifty-eighth session of the World Health Assembly in 2005 in a thoroughly revised form compared with the previous version initially adopted in 1951, they are legally binding under Articles 21 and 22 of the WHO's Constitution on WHO`s 194 member states. Two states not members of WHO (the Holy See and Liechtenstein) have also acceded to the Regulations. Shortly after their entry into force for the whole WHO membership in 2007, the IHR (2005) were described as "the result of experience gained, and lessons learned during the past 30 years."[4] The Regulations do, indeed, embody paradigmatic shifts on several aspects as compared to their predecessors, especially:

• from a narrow list of only three diseases to a broad all-hazards approach, based on risk assessment and "event"-based surveillance, which was designed to ensure consistency with other international legal regimes such as those on trade and human rights; 
• from an exclusively state-based reporting and notification system to the use by the WHO Secretariat of non-governmental sources for surveillance and detection (Articles 9 and 10), in addition to state-based reporting and notification;
• from a passive to an active and structured mandate for the WHO Director-General to alert the world to "public health emergencies of international concerns" and to issue "Temporary Recommendations" (PHEICs – Articles 1, 15, 17) in response; 
• from a rigid system of maximum measures that states may deploy to prevent and control outbreaks to a more flexible system based on an assessment of the overall context. The Regulations acknowledge the prerogative of states to take health measures that may exceed WHO's Temporary Recommendations (see previous bullet) or even breach a number of IHR (2005) obligations, provided that such measures meet defined requirements (such as the provision of a public health rationale and relevant scientific information for measures in excess that significantly interfere with international traffic, compare Article 43);
• from the non-existence of provisions regarding the internal capacity of states to prepare for and respond to outbreaks (e.g. laboratory capacity, referral and reporting mechanisms, effective logistical assistance) to legal obligations on states parties to establish so-called "core capacities" in the areas of disease surveillance and response (see Articles 5 and 11, and Annex 1).

In terms of compliance, the IHR (2005) rely, like other international instruments, largely on a horizontal compliance mechanism, in which states parties can review each other's level of compliance on the basis of reports provided annually to the Health Assembly (Article 54.1).[5]   This is the only explicitly provided for mechanism of overall review and assessment of compliance in the Regulations. 

Review of the IHR (2005) Following the Ebola Outbreak in West Africa in 2014–2016

The IHR (2005), which are implemented with the assistance of dedicated staff in the WHO Secretariat, grants states parties a deadline of five years from the entry into force of the Regulations for establishing and maintaining core capacities. By 2012, only 42 of 194 states parties declared that they had met their core capacity requirements.[6] Insufficient implementation of the IHR (2005) became painfully visible in the Ebola outbreak in West Africa between 2014 and 2016. In the words of the Review Committee on the Role of the IHR (2005) in the Ebola Outbreak and Response (IHR-Ebola Review Committee), the outbreak "stretched national and global response capacities far beyond their limits" and "shone a bright light on just how ill-prepared and vulnerable the global community" remained when confronted by international outbreaks of highly pathogenic infectious diseases.[7] WHO`s initial response to the outbreak as well as the effectiveness of the IHR (2005) was subject to some strong criticism and consequently, together with other aspects of the global Ebola outbreak response,[8] they became the object of several independent reviews,[9] including by the IHR-Ebola Review Committee that met from 2015 to 2016.[10] Following its review of the functioning of the IHR (2005) in relation to the Ebola outbreak, the Committee recommended, inter alia, the following:[11]

• Rather than amending the IHR (2005), a Global Strategic Plan to improve public health preparedness and response should be developed to ensure their implementation, especially regarding the monitoring of core capacities required under the Regulations;
• Self-assessment by each state party, complemented by voluntary external assessment of IHR (2005) core capacities, should be recognized best-practices to monitor and strengthen the implementation of the IHR (2005);
• WHO should establish a standing advisory committee, which would have the primary purpose of regularly reviewing WHO's risk assessment and risk communication; WHO should also create an intermediate level of alert (an "International Public Health Alert") that would be lower than a PHEIC, which requires specific follow-up;
• WHO should champion the open sharing of information on public health risks, including sharing biological samples of pathogens and gene sequence data during public health emergencies. WHO and states parties should ensure that sharing of samples and sequence data is balanced with benefit-sharing on an equal footing.

Decision WHA71(15) and the Five-Year Strategic Plan

The report of the IHR-Ebola Review Committee was provided to the sixty-ninth session of the World Health Assembly in May 2016. It became clear, during the consideration of the report, that member states held different views on some of the recommendations of the Committee, especially those relating to the introduction of an intermediate level of alert and to the external evaluation of core capacities. When the matter returned to the WHO Executive Board in January 2018, following a two-year consultation process facilitated and supported by the IHR (2005) Secretariat, the Executive Board recommended to the World Health Assembly to adopt a draft decision to "endorse" the draft strategic plan. The Health Assembly considered the recommendations of the Executive Board at its seventy-first session in May 2018.

At the end of an intense debate, the Health Assembly adopted decision WHA71(15) on May 26, 2018. Four aspects draw particular attention when comparing the final versions of decision WHA71(15) and the five-year plan with their draft versions and with the recommendations made by the IHR-Ebola Review Committee and other external reviews.

First, the plan does not specifically address the recommendation from the IHR-Ebola Review Committee that the WHO should champion the open and equitable sharing of information on public health risks, including the sharing of biological samples and gene sequence data during public health emergencies. This is an issue of urgent importance for the timely development of medicines, vaccines, and diagnostics in light of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization. This treaty, a Protocol to the Convention on Biological Diversity, creates a global framework on "access- and benefit-sharing" for genetic resources and traditional knowledge associated with genetic resources. Under the Protocol, users who wish to access genetic resources must obtain the prior informed consent (PIC) of the provider country and negotiate and agree on the terms and conditions of access and utilization of this resource through the establishment of mutually agreed terms (MAT). Notably, the WHO has addressed the question of sharing biological samples of pathogens and the resulting benefits, with specific regard to pandemic influenza, in the Pandemic Influenza Preparedness Framework, adopted by the Health Assembly in 2011 as a framework under Article 23 of the Constitution.[12]

Second, decision WHA71(15) differs in several ways from the draft decision recommended by WHO`s Executive Board. In contrast, the five-year plan itself did not change as compared to the version that the Board recommended to the Health Assembly for endorsement. This may be explained by the difficulty of renegotiating in an open-ended intergovernmental meeting a lengthy technical document emerging from a long consultative process and the attempt to resolve differences of views through the decision acting on that plan.

Third, the change in the operative verb used in paragraph 1(a) of decision WHA71(15) is a significant development. Rather than endorse the plan, the Health Assembly chose to "welcome" the plan "with appreciation." Since such operative verbs are reflective of the intentions of member states, and nuances in their choice are perceived as important, their negotiation is often arduous, and the result may not always be immediately understandable to an external observer. Similar to other governing bodies in the UN system like the General Assembly, the World Health Assembly uses a wide variety of verbs to express the level of political support and the implications of the actions to be taken under resolutions and decisions, from "endorses" to "notes," to "notes with appreciation" and "welcomes with appreciation." It is clear that those verbs have different meanings and are not synonymous with the term "approves." The importance that member states attribute to the use of the operative verb "welcome with appreciation" in decision WHA71(15) is underlined by the specific mention in the decision that such action does not create "any legally binding obligations for Member States."

The last notable change appears in operative paragraph (2)(c) of decision WHA71(15). In it, the Health Assembly chose to delete a controversial reference to external evaluations of states parties` internal "core capacities." Rather than referencing "the voluntary monitoring and evaluation instruments developed by the Secretariat to assess the core capacities (including joint external evaluation, simulation exercises and after-action review)" in an operative paragraph the Health Assembly recalled, in the preamble to decision WHA71(15), that member states may use "any voluntary monitoring and evaluation instruments, including those referenced in the five-year global strategic plan." It thus underscored that member states, while required to report annually on their implementation of the IHR (2005), can choose whether or not to go through a process of external evaluation of their core capacities, and whether to conduct simulation exercises and after-action reviews to assess their own compliance with the IHR (2005). The IHR (2005) thus continue to differ from many international instruments, for example in the area of international environmental law, which often rely on more centralized compliance mechanisms anchored in hard law.

Outlook

Decision WHA71(15) signals a renewed commitment by WHO member states to improve public health preparedness and response through implementation of the IHR (2005). The five-year strategic plan and its implementation are going to be key elements in the achievement of WHO`s strategic priority, reflected in WHO's Thirteenth General Programme of Work, to better protect one billion people from health emergencies by 2023.[13] Further implementation of the IHR (2005) and the five-year plan is also going to be a key element in the achievement of Sustainable Development Goal Three, which addresses the strengthening "of the capacity of all countries, in particular developing countries, for early warning, risk reduction and management of national and global health risks" as a target, and "International Health Regulations (IHR) capacity and health emergency preparedness" as an indicator. Not all recommendations made by the IHR-Ebola Review Committee and other external reviews found their way into the five-year plan and the decision taken by the World Health Assembly. There is an "unfinished plate" of recommendations, ranging from the creation of an intermediate level of alert (short of a Public Health Emergency of International Concern) to a better financing of WHO`s emergency response capacity, that member states individually, the UN and WHO can work towards further implementation.[14]