Amended WHO International Health Regulations for better global pandemic governance?

Abstract

Recent amendments to the International Health Regulations (IHR), adopted at the 77th World Health Assembly in May 2024, represent an important conceptual development in the field of global pandemic governance. The regulations now include the notion of a pandemic emergency, a heightened subcategory of the public health emergency of international concern, which necessitates rapid, equitable, and enhanced coordinated international action to counteract global pandemics. In addition, changes to the guiding principles expressly require that the implementation process ‘shall promote equity and solidarity’. This is further crystallised in concrete commitments to enable equitable access to health products and provide for the mobilisation of financial resources for developing countries. Taking lessons from the COVID-19 pandemic, these changes make the IHR a more effective tool against global pandemics and represent significant steps towards achieving global health justice.

Introduction

The past decade exposed the world to numerous global health threats. The spread of infectious diseases, such as Ebola and COVID-19, the continuing growth of non-communicable diseases combined with the diminishing role of international organisations, and the lack of necessary funding and poor international cooperation show that the world has failed to manage a multifaceted and dynamic landscape of global health. ¹ This led some experts to emphasise that a ‘global health crisis is not primarily one of disease, but of governance’. ²

The challenge of effectively governing the global health landscape, particularly the spread of infectious diseases, falls to the World Health Organization (WHO) and its International Health Regulations (IHR). ³ When the IHR was revised in 2005, it represented an innovative contribution to pandemic governance in that it intertwined the regulation of infectious diseases with State interests in security and trade, integrated human rights principles in the new governance regime, and built into it a role for hybrid actors, such as the global surveillance network. ⁴ This made the IHR the most important global health treaty, placing the WHO at the centre of global pandemic governance. ⁵

However, pandemic crises, such as the outbreaks of Ebola in West Africa in 2014, the DRC Congo in 2019, and COVID-19 in 2020, uncovered serious deficiencies in the practical implementation of the IHR. In these cases, the WHO unreasonably delayed declarations of a public health emergency of international concern (PHEIC) as political considerations prevailed over epidemiological reasons. ⁶ After the devastating COVID-19 pandemic, ⁷ calls emerged that the international community should strengthen the IHR, and in May 2024, the World Health Assembly (WHA) adopted a package of amendments to the IHR. ⁸

This commentary aims to analyse these amendments and their role in enhancing global pandemic governance through the lens of global governance for health. The latter is understood as a collection of norms, institutions, and processes framed by the principle of equity and guided by rules of good governance that shape the health of the world’s population. ⁹ First, the article analyses the concept of a pandemic emergency by looking at the changes to the concept of a PHEIC and the complex nature of pandemic emergencies that make their management more demanding. Considering the management of previous PHEICs by the WHO, the article then scrutinises the PHEIC procedure from the perspective of good governance, particularly from the viewpoints of effectiveness, transparency, and accountability.

Second, the commentary looks at equity and solidarity, two (new) principles governing the IHR, and their relevance in global health discourse and practice. To do so, we review the academic discourse on equity, paying particular attention to the concept of distributive justice. It then proceeds to an article-by-article analysis of equity in the IHR to show the IHR’s take on equity and its meaning for global pandemic governance. The article concludes that legal improvements to the IHR framework could lead to a more efficient global pandemic governance, provided that the IHR regime abides by the rules of good governance and implements the principle of equity in practice.

Expansion of a PHEIC with a pandemic emergency

The declaration of a PHEIC is a ‘crucial governance activity’ ¹⁰ and a ‘cornerstone of the IHR’ ¹¹ . The WHO Director-General can declare it when an extraordinary health situation constitutes a public health risk to other States through the international spread of disease, and it potentially requires a coordinated international response. ¹² The amended Article 1 introduces a pandemic emergency as a subcategory of a PHEIC. A pandemic emergency means a PHEIC that is caused by a communicable disease and consists of four elements: (1) it has, or is at high risk of having, ¹³ wide geographical spread to and within multiple states; (2) it is exceeding, or is at high risk of exceeding, the capacity of health systems to respond in those States; (3) it is causing, or is at high risk of causing, substantial social and/or economic disruption, including in international traffic and trade; and (4) it requires rapid, equitable, and enhanced coordinated international action, with whole-of-government and whole-of-society approaches. ¹⁴ A pandemic emergency thus ‘represents a higher level of alarm that builds on the existing mechanisms of the IHR’. ¹⁵

Declaring a pandemic emergency can immediately trigger emergency mechanisms available to the WHO, countries, and other global health actors to combat a global pandemic. These mechanisms may include mobilising the health workforce, releasing financial resources from contingency funds, announcing emergency financial appeals, and developing and/or distributing adequate medical products (e.g. vaccines and medical equipment) and other necessary measures. ¹⁶

Pandemic emergency as a complex phenomenon

Global governance for health emphasises that the complex nature of challenges makes the process of governance more demanding. ¹⁷ Infectious diseases, which make an important part of global health challenges, ‘involve a complex interplay of factors that determine the development, transmission, and control of these diseases’. ¹⁸ Such a dynamic makes a pandemic emergency a complex one: an infectious disease is unusual or unexpected, and the emergency is multi-layered because there is a presence of a multitude of actors, a lack of humanitarian access, and the existence of high-security risks to staff and so on. ¹⁹

In managing a pandemic emergency, the following variables play an essential role: a communicable disease may develop at a different pace in various regions; the pathology of the disease (new strains) may evolve differently across the world; there might be significant differences in the adoption of health response measures by countries; the level of success in containing the disease may vary from country to country; other health emergencies or diseases may develop parallel to the evolution of the infectious disease; a communicable disease response requires effective coordination of various global, regional, governmental, and societal actors; a substantial health workforce should be mobilised to contain the outbreak and so on.

Good governance in the PHEIC framework

While the procedure to declare a PHEIC, including a pandemic emergency, was not amended, it nonetheless merits a fresh look from the perspective of good governance. The WHO Director-General has a leading role in managing the complex situation of a PHEIC, which now includes a pandemic emergency. ²⁰ They have the prerogative to declare a PHEIC, including a pandemic emergency, and adopt temporary recommendations for stopping an infectious disease outbreak. When making decisions, the Director-General must take into account all available information and applicable scientific principles and evidence; make an assessment of risks to health, international spread, and human traffic; and take into consideration the advice of the Emergency Committee. ²¹ The latter is an independent, advisory body of health experts that is convened ad hoc for each health emergency. Apart from providing advice concerning the determination of a PHEIC, including a pandemic emergency, the Emergency Committee also provides views on adopting appropriate temporary recommendations. ²²

However, a simple overview of the legal context does not convey the whole picture of the performance of the WHO in managing global health emergencies. Several PHEICs – the H1 N1 pandemic, two Ebola crises, and COVID-19 – exposed serious deficiencies in terms of good governance. From the perspective of global governance for health, applying good governance to a pandemic emergency requires compliance with rules of accountability, transparency, and effectiveness. ²³

Effectiveness

Looking at the past declarations of PHEICs, it is worrying that the practice of decision-making, particularly in the context of two PHEICs related to the spread of Ebola, favoured political and economic considerations over scientific and legal categories in assessing the risk for human health, disease spread, and international traffic, ²⁴ which resulted in delays in declaring a PHEIC and numerous fatalities that could have been prevented. ²⁵ Furthermore, there has been a lack of a rapid decision-making and proactive approach to emergencies. ²⁶ This deficiency led to delays between the first serious reports about the disease and subsequent declarations of a PHEIC. ²⁷ Therefore, the Ebola example shows that IHR bodies should rely on clear interpretations of scientific and legal elements entrenched in the definition of a pandemic emergency to avoid delays in the decision-making process. Also, given that the classification of a pandemic emergency may involve assessing a number of high risks, the Director-General and the Emergency Committee should adopt the practice of regular use of probabilistic decision-making methods. ²⁸ The probabilistic decision-making concerning health emergencies can be fraught with tensions between the quantitative and qualitative approaches. In the early stages, when there is a lack of reliable data, the qualitative approach usually gets the upper hand. In later stages, when the data flow is abundant, the quantitative approach prevails. ²⁹ As neither extreme is preferable, methodological models should synthesise both approaches whenever possible. ³⁰ Probabilistic methods should make regular use of newly available technologies, such as artificial intelligence tools, to assess relevant risks. ³¹

Transparency

The documentation underpinning decisions of the Director-General and Emergency Committees usually remains classified. However, information, minutes and votes, findings of rapid risk assessment, and technical documentation should be available to States Parties and, as much as possible, to the public. ³² The same goes for keeping the identity of the Emergency Committee members and their declarations of the conflict of interest confidential, which was a problem during the H1 N1 outbreak. ³³ In addition, any future declarations of a PHEIC, including a pandemic emergency, by the WHO Director-General should observe the precautionary principle and adhere to clear, objective, and published criteria. ³⁴ The precautionary principle guides decision-makers to take action to protect and avoid damage to public health when there is scientific uncertainty. ³⁵ Even if the scientific data are inconclusive while the risk of an international pandemic spread is high, the WHO should declare a PHEIC, including a pandemic emergency, to prevent severe and irreversible damage to public health. ³⁶ Fears over public criticism for creating panic because of premature declarations should not hamper a responsible decision-making process. ³⁷

One of the major criticisms of the WHO during PHIECs has been that its decision-making processes were functioning in a black-box fashion, which questioned its trustworthiness in handling global health challenges. ³⁸ The WHO, as an international organisation, suffers from the problem of a ‘democratic deficit’ in the sense that people cannot exert a direct influence on the conduct of global health affairs. ³⁹ Yet, this is in stark contrast with their legitimate personal interest to have access to timely, comprehensive, and credible information about global health measures aimed at the protection of their health and lives. Lessons learned from the COVID-19 pandemic point to a need for a good communication strategy with the public and an ability to translate science into clear and succinct messages to the audience. ⁴⁰ A range of practical measures providing a steady and reliable flow of information to those concerned would significantly enhance transparency and legitimacy of the work of WHO bodies in situations of great health volatility. ⁴¹

Accountability

So far, the Emergency Committee members followed the WHO culture of seeking consensus on critical issues and discouraging open debate about sensitive issues such as emergency declarations. ⁴² Therefore, a shift in mind-set should be encouraged to express divergent views when necessary. ⁴³ The Practice of the Director-General to conferring with only a subset of the Emergency Committee rather than a whole before making final decisions should not be acceptable. ⁴⁴

In some cases, political leadership at the highest level, including the Director-General, was absent when there should have been governance through assertive leadership. ⁴⁵ The Director-General and the Emergency Committee members should assume responsibility for adopting decisions in cases of pandemic emergencies whenever a situation requires swift response. Thus, there should also be a clear differentiation between deliberations of the Emergency Committee and the Director-General to avoid amalgamation of views.

On the one hand, the Director-General convenes the session of the Emergency Committee, frequently attends it in part or in whole, and in this way, sets the tone of the meeting. ⁴⁶ On the other hand, the Director-General has, up until now, always ‘rubber-stamped’ decisions of the Emergency Committee, thus relegating the decision-making power to the advisory body. ⁴⁷ However, decision-making by both bodies should be disjointed to allow for an autonomous assessment in each phase, first during the deliberations by the Emergency Committee, followed by the final consideration of the Director-General. Undoubtedly, the views of the Emergency Committee carry the authority of an expert body and must be taken seriously. However, the Committee is an ad hoc advisory body convened for a particular PHEIC. The Director-General, as the ‘chief technical and administrative officer’ ⁴⁸ of the WHO, enjoys full legitimacy to exert leadership in this regard and has, as we have seen, legal prerogatives to make final decisions regarding pandemic emergency issues.

It is, therefore, paramount that the decision-making process during a pandemic emergency, which can quickly transform into a complex emergency, abides by the principles of good governance to reduce and neutralise the impact of a pandemic. The concept of global governance for health accentuates the importance of effectiveness, transparency, and accountability for the process of good and responsible management and decision-making in the PHEIC framework while simultaneously highlighting the need for health equity. ⁴⁹

Equity and solidarity in the IHR

While many evoke the concept of equity when discussing global health, there is a lack of understanding of its practical implications. This might be partially due to the lack of consensus on what equity is. Some think of equity in the context of pandemics as an overarching principle, going beyond the meaning of fairness and justice, which are defined as fundamental values fostering trust and cooperation. ⁵⁰ Others equate achieving health equity with achieving justice in global health ⁵¹ or take a pragmatic approach of juxtaposing equity with the principle of formal equality by noting that equity requires equal things to be treated equally and unequal things be treated unequally, while equality demands that everyone be treated the same no matter their differences. ⁵² If there is any consensus, it is that there is no consensus on the matter. ⁵³

It needs to be noted, however, that the prevalent (academic) discourse on equity in global health focuses on the value-based normative nature of equity. Under this approach, equity in health can be defined as ‘the absence of systematic disparities in health (or in the major social determinants of health) between groups with different levels of underlying social advantage/disadvantage – that is, wealth, power, or prestige’. ⁵⁴ Ensuring health equity, therefore, requires what Gostin calls global health with justice, that is, ‘achieving the highest attainable standard of physical and mental health, fairly distributed’, ⁵⁵ which effectively equates equity (in health) with the concept of distributive justice. The latter requires just distribution of societal burdens and resources. ⁵⁶

Although contrasting theoretical perspectives on equity might foster a rich debate in academic circles, the lack of shared understanding of equity has real-world repercussions in the international community, where, for equity to have any effect, actors have to agree on its meaning to be then able to proceed to its practical implementation. This is one of the reasons why the inclusion of the principle of equity in the IHR is so important. Equity is not only a general principle framing the agreement in Article 3 but is also explicitly included in Articles 13 and 44, which provide insights into the meaning and content of equity and its implementation in the context of global health. ⁵⁷

Equity and solidarity as guiding principles of the IHR

Equity is enshrined in Article 3, which establishes the principles of the IHR, that is, dignity, human rights and fundamental freedoms of persons, equity, and solidarity. ⁵⁸ This provision serves as an implementation framework for all stipulations of the IHR, meaning that States Parties will have to take all these principles into account when implementing measures outlined in the treaty. By incorporating the principles of equity and solidarity, the IHR recognises that these principles are, in fact, key values that need to be respected by the WHO and States Parties, as well as instruments that need to be operationalised for the IHR to function successfully. ⁵⁹

Equitable coordinated international action during a pandemic emergency

Equity is also referred to in the definition of a pandemic emergency in Article 1, which, among other already discussed criteria, states that a pandemic emergency necessitates equitable, coordinated international action. ⁶⁰ The inclusion of equity in the definition of a pandemic emergency highlights the importance of the concept in managing global health threats. This definition, however, is not without its challenges. While criteria for pandemic emergency outlined in paragraphs (i) to (iii), that is, geographical spread, health system capacity, and social and/or economic disruption, can be easily measured and quantified, the same cannot be said for the provision in paragraph (iv) on coordinated international action which specifically includes equity. The Director-General and advisory bodies will, therefore, have to determine how to assess the need for equitable, coordinated international action when declaring a pandemic emergency. This is a rather difficult task, especially taking into consideration the elusive nature of the concept.

Equitable access to health products

The operationalisation of equity first occurs in Article 13, in which the IHR defines a public health response, which now includes equitable access to relevant health products. The provision requires States Parties to develop, strengthen, and maintain core capacities to prevent, prepare for, and respond to public health risks and PHEICs, including pandemic emergencies. This article was substantially amended to include the WHO and States Parties’ obligations to ensure equitable access to relevant health products. ⁶¹ In terms of the obligations of the WHO, the IHR now states that its role is to support States Parties and coordinate international response activities after the determination of a PHEIC, including a pandemic emergency. ⁶² The WHO is also to facilitate and work to remove barriers to timely and equitable access by States Parties to relevant health products after the determination of and during a PHEIC, including a pandemic emergency, based on public health risks and needs. ⁶³ This is in line with the objective of the WHO, that is, the attainment of the highest possible level of health by all peoples, which requires the WHO to act as the directing and coordinating authority on international health work. ⁶⁴ Taking into consideration the predatory behaviour of countries during the COVID-19 crisis, this is certainly a step in the right direction, especially when reviewing the role and tasks of the Director-General.

The role of the Director-General is two-fold. First, the Director-General is entrusted with conducting assessments of public health needs, including availability, accessibility, and affordability of relevant health products, publishing such assessments, and taking these assessments into consideration when exercising powers regarding temporary or standing recommendations. ⁶⁵ This is important since it will presumably not only address the obvious issues of (in)equitable access to health products but also alleviate some of the previously mentioned issues with transparency that have been plaguing the WHO. ⁶⁶ Having a clear process of assessment, with the results being available to countries as well as to the public, should help build trust in recommendations issued by the Director-General, while simultaneously serving the cause of equity.

Second, Article 13 establishes a facilitating role of the Director-General when working with WHO-coordinated and other allocation and distribution mechanisms and networks or manufacturers. ⁶⁷ In this vein, the Director-General is to make use of and coordinate with such mechanisms and networks to facilitate timely and equitable access to relevant health products, support States Parties in scaling up and geographically diversifying the production of relevant health products, share with States Parties product dossiers for the purpose of their subsequent regulatory evaluation and authorisation, and support States Parties in promoting research and development and strengthening local production of relevant health products. Recognising the fact that global health encompasses numerous actors, ⁶⁸ there is very much a need for a coordinating authority if the global health system is to operate under principles of good governance for health. The WHO, with its central position in the global health architecture, is well-placed to take on such a role. However, to undertake all these complex roles successfully, the WHO will presumably need a substantial increase in financing and human resources for this provision to have any meaningful effect.

The revised IHR also establishes State Parties’ responsibilities. Countries are required (subject to applicable law and available resources) to collaborate, offer each other assistance, and support the WHO coordinating role in implementing actions related to public health response. This can be achieved by engaging with relevant stakeholders to facilitate equitable access to relevant health products and by making available relevant terms of their research and development agreements for relevant health products related to promoting equitable access to such products. ⁶⁹

Overall, amendments to Article 13 reflect the lessons learned during the COVID-19 pandemic, when countries failed to deliver a coherent global health response at the expense of developing countries. ⁷⁰ While the IHR makes concrete steps towards ensuring equitable access to health products, it is important to emphasise that under international law, countries already have a duty of international cooperation and assistance to ensure universal, equitable access to vaccines and treatment wherever needed and thus ensure the realisation of the right to health. ⁷¹ Even more, the Committee on Economic, Social and Cultural Rights (CESCR) ⁷² has repeatedly reminded the international community that not only countries but also business entities, including pharmaceutical companies, should respect rights in the International Covenant on Economic Social and Cultural Rights. ⁷³ The CESCR emphasised that they should refrain from invoking intellectual property rights in a manner that is inconsistent with the right of every person to have access to a safe and effective vaccine and treatment for COVID-19 and with the obligation of States to guarantee, as expeditiously as possible, universal and equitable access to such a vaccine. ⁷⁴

While the language of the IHR is less potent than that of the CESCR’s statement, it still reflects the obligations of the international community, particularly countries, to collaborate with each other while simultaneously managing global health threats within their own community to ensure global solidarity and equitable distribution of vaccines and treatment. It is also important to note that Article 13, although not immediately obvious, reflects the fact that the implementation of the IHR is based on respect for human rights and fundamental freedoms (Article 3), which includes a universally recognised right to health.

Equity and solidarity in collaboration, assistance, and financing

The need for international cooperation and solidarity to ensure equity is also reflected in the amendments to Article 44, which establishes various approaches to collaboration, assistance, and importantly, financing. ⁷⁵ States Parties are to collaborate in the mobilisation of financial resources to facilitate the implementation of their obligations, particularly in addressing the needs of developing countries. ⁷⁶ They are also required, subject to applicable law and available resources, to maintain or increase domestic funding and collaborate, including through international cooperation and assistance, to strengthen sustainable financing to support the implementation of the IHR. ⁷⁷ Furthermore, States Parties are required to collaborate to ensure financing needed to equitably address the needs and priorities of developing countries by encouraging governance and operating models of existing financing entities and funding mechanisms is to be regionally representative and responsive to those needs and by identifying and enabling access to financial resources. ⁷⁸ The main (equity) implementation instrument of the IHR for financial support is the Coordinating Financial Mechanism as set out in a new IHR Article 44 bis. This mechanism is important as it is considered ‘a concrete measure to mobilise funding for low-income and middle-income countries to support IHR implementation’. ⁷⁹ The focus on the needs of developing countries and international assistance can be seen as an expression of the principle of solidarity, which is, with the exception of Article 3, never used verbatim in the IHR and is crucial to realising the principle of equity.

The importance of Article 44 is also highlighted in Article 54 bis, which establishes the States Parties Committee for the Implementation of the IHR; in particular, Articles 44 and 44 bis. This Committee is to be guided by equity, solidarity, and other principles set out in Article 3. ⁸⁰ While the mention of Article 3 principles in this context is commendable, it is also important to note that the Committee does not hold much power. ⁸¹ It is primarily a consultative body that aims to promote and support cooperation among States Parties. ⁸² The WHO has no explicit role in this respect, which might make coordination among the countries more difficult.

Equity in the context of the IHR is therefore seen as equity of access (to relevant health products), as well as equity of assistance, which somewhat clarifies the meaning of equity in the context of global health and should help the WHO bodies to apply this principle while governing global health threats. It will be important, however, for the WHO and other members of the global health community to interpret equity not only in the context of the IHR but also to consider the broader discourse on equity, particularly the notion that achieving equity in health is synonymous with achieving distributive justice in health. While the IHR may stop short of enshrining distributive justice per se, it can be built upon by good and equitable governance framed by the notion of solidarity, a prerequisite to ensuring equity on a global level since that is unachievable without global collaboration and cooperation.

Conclusion

At present, it seems that there is a dissonance between the IHR legal regime and an intricate web of internal WHO mechanisms, procedures, and practices. This, coupled with a large number of global health actors, sovereigntist tendencies, and the complexity of infectious diseases, makes governing global health threats difficult, especially during a PHEIC.

Therefore, strengthening the IHR is not only a step in the right direction but a necessary stride forward. The inclusion of a pandemic emergency opens the way for a more rapid and comprehensive international health response to pandemics. However, the legal framework of a pandemic emergency should be enhanced by complying with the rules of good governance, such as the effectiveness, transparency, and accountability of the IHR bodies, notably the Director-General and the Emergency Committees. In order to achieve competent management of pandemic emergencies, the legal framework should match the reality and vice versa.

As global governance for health demands not only effective, transparent, and accountable management of global health threats but also health equity, its inclusion (and the inclusion of the principle of solidarity) in the IHR is commendable and is expected to contribute to providing better health outcomes for the entire world population during pandemic emergencies. Ensuring access and assistance during such times is crucial to achieving equity, in particular, with regard to countries whose health systems are weak and who experience shortages of medical products. Equity and solidarity thus serve as a mobilising force for protecting global health. IHR norms, therefore, have the potential to improve global pandemic governance if they go hand in hand with the rules of good governance aimed at ensuring global health equity.