Questions about New Amendments to the 2024 IHRs

On June 1, 2024, the World Health Assembly (WHA) adopted a series of new amendments to the International Health Regulations (IHRs). In doing so, the World Health Organization proclaimed that these amendments will “build on lessons learned from several global health emergencies, including the Covid-19 pandemic” by strengthening “global preparedness, surveillance and responses to public health emergencies, including pandemics.” 

Although the IHR amendments were adopted, the decision on the Pandemic Agreement (previously called the Pandemic Treaty) was set back up to 12 months, requiring further negotiations before going to a WHA vote. In response, many advocates of the process quickly sought to highlight that the WHA “had really progressed a lot” while emphasizing that the world still faces significant risk without further agreement on pandemic preparedness. Against this backdrop, the IHRs were quickly seized upon politically as an act of saving face by its champions even though there remained many unresolved questions.

As has become emblematic of the pandemic preparedness and response agenda in general, the passage of the IHR amendments, and continued negotiations on the Pandemic Agreement, remain contentious. The debate surrounding these instruments is often polemic, operating in a political environment that has largely stifled democratic deliberation, wider scientific and political consultation, and ultimately, legitimacy.

This undermining of legitimacy was only reinforced during the WHA, when a series of last-minute additions to the IHR amendments was pushed through. This raises important questions about whether these eleventh-hour additions are based on sound evidentiary rationales and wider public health benefits, or whether they merely allow for a further concentration and potential misuse of power.

Under the Wire

Agreement on the IHR amendments was reached in the final hour and after considerable political arm-twisting. Although the current IHR (2005) stipulates that proposed changes must be finalized four months in advance of a vote (Art 55, Para 2), the text was not available to the delegates of the World Health Assembly until the afternoon of the decision. Furthermore, by pushing through the IHR, and by tabling the Pandemic Agreement for a later vote, the scope and legal status of the IHR have seemingly become less clear, since the last-minute additions to the IHR are notably underspecified and will likely only be concretized with a decision on the Pandemic Agreement. 

For example, the IHR establishes a new financial mechanism without offering any details on its workings, while using similar words as found in Article 20 of the draft Pandemic Agreement. As a result, the putative agreement on the IHR reform has not brought clarity but has only muddied the waters further, and it is not exactly clear how an adopted Pandemic Agreement will impact on the funding requirements within the IHR, or their implementation, monitoring, and evaluation.

Again, this ambiguity has created an ongoing condition ripe for politicization, weaponization, and the abandonment of meaningful and open scientific discourse and policy reflection. Despite these uncertainties, the IHR amendments have been agreed upon and are currently awaiting adoption.

So, What Is Known about the New International Health Regulations?

The IHRs are a set of rules for combating infectious diseases and acute health emergencies that are binding under international law. They were last majorly revised in 2005, extending their scope beyond a previous catalogue of defined diseases such as cholera and yellow fever. Instead, a mechanism for declaring a “public health emergency of international concern” was introduced, which has since been declared seven times, most recently in 2023 for monkeypox.

An initial compilation of reform proposals from December 2022 envisaged that the recommendations issued by the WHO Director-General during such an emergency would effectively become orders that states would have to follow. There was considerable resistance to these plans, especially from critics of the Covid-19 lockdowns recommended by the WHO. In the end, the idea of far-reaching restrictions on national sovereignty did not have majority support among states. In response to this growing resistance, the new IHR reforms appear to be significantly weakened compared to the much-criticized early drafts.

Nevertheless, they still contain some worrying points. For example, there is the introduction of a “pandemic emergency” whose definition is highly unspecific and whose consequences remain unclear, as well as new sections on increasing core competencies for public information control, capacity financing, and equitable access to vaccines. We examine these areas in turn below.

The New Introduction of a “Pandemic Emergency”

Even though the WHO declared SARS-CoV-2 a pandemic on March 11, 2020, the term “pandemic” had not previously been defined in the IHR or definitively in other official WHO documents or international agreements. The new IHR now officially introduces the category of a “pandemic emergency” for the first time. The WHO suggests that this new definition is: 

to trigger more effective international collaboration in response to events that are at risk of becoming, or have become, a pandemic. The pandemic emergency definition represents a higher level of alarm that builds on the existing mechanisms of the IHR, including the determination of public health emergency of international concern.

The criteria for making this declaration include an infectious pathogenic threat with a wide geographical spread or risk of spread, the overload or threat of overloading health systems of affected states, and the onset of significant socio-economic impacts or threats of impact (e.g. on passenger and freight transport).

However, it is important to note that none of these conditions must exist or be demonstrable at the time of declaration. Rather, it is sufficient that there is a perceived risk of their occurrence. This gives the WHO Director-General considerable scope for interpretation and is a reminder of how extensive restrictions on fundamental human rights were justified for over two years in many countries during the Covid-19 response, pursued due to an abstract threat of imminent overloading of health systems, even at times of minimal transmission.

A fourth criterion for declaring a pandemic emergency allows even more freedom of interpretation. The health emergency in question “requires rapid, equitable and enhanced coordinated international action, with whole-of-government and whole-of-society approaches.” Thus, the design of the response determines the status of the actual triggering event.

In a recent BMJ editorial, “the new ‘pandemic emergency’ is a higher level of alert than a public health emergency of international concern (PHEIC)”, with Helen Clark further suggesting in another interview that “these amended international health regulations, if fully implemented, can result in a system that can better detect health threats and stop them before they become international emergencies.” 

What one must imagine by such an approach is left to our imagination, but it brings back unpleasant memories. After all, in its report from Wuhan in February 2020, the WHO did not once use the word lockdown, but praised the actions of the Chinese authorities as an “all-of-government and all-of-society approach.”

It is interesting that in the new IHR, the declaration of a pandemic emergency does not have any specified consequences. After its definition, the term is only used in the context of the existing mechanism to declare a PHEIC, after whose mention the words “including a pandemic emergency” are inserted. Of course, what the declaration of a pandemic emergency entails may be defined later during implementation discussions between WHA signatories.

As a “higher level of alert,” the category of pandemic emergency may function more as a kind of agenda placemark within the IHR, rather than a clear trigger for mandatory action. The introduction of the term “pandemic emergency” may also anticipate the planned Pandemic Agreement, where greater detail may be attached to the term. For example, the Agreement could stipulate that the declaration of a pandemic emergency automatically triggers certain actions or the release of funds. 

Currently the scope of the new term “pandemic emergency” is too underspecified to make a full determination. As a result, its “potency” remains something to watch and will largely depend on its practical implementation. For example, like many IHR it could simply be ignored by States, as witnessed at times during Covid-19. Alternatively, the term could trigger or provide an excuse for a host of measures like those seen during Covid-19, including immediate travel and trade restrictions, screening, accelerated vaccine development, non-pharmaceutical interventions such as mask mandates and lockdowns.

Given the last-minute inclusion of the phrase and the lack of deliberation about its necessity, it is currently impossible to know exactly whether it acts as an extra procedural threshold to assure the presence of a serious threat (with a higher level of scrutiny beyond the PHEIC before raising the alarm), or whether it is now just another linguistic device to circumvent procedures to rapidly invoke emergency powers and actions. Given that many policy responses to Covid-19 were ad hoc, knee-jerk, and at times arbitrarily implemented in the face of opposing evidence, it is justified to be concerned about the latter.

Expanding Core Capacities for Information Control

The current IHR already requires member states to develop “core competencies” on which they must report annually to the WHO. The focus here is on the ability to quickly identify and report exceptional disease outbreaks. However, the existing core competencies also extend to epidemic response. For example, states must maintain capacities for quarantining sick people entering the country and to coordinate border closures.

In addition, the new IHR defines new core competencies. These include access to health products and services, but also to dealing with misinformation and disinformation. Public information control is thus defined internationally for the first time as an expected component of health policy. Although these competencies now remain ambiguous, it is nonetheless important to monitor and reflect upon how new expectations of States to monitor, manage, and/or restrict public discourse concerning “infodemics” are made more concrete.

The benchmarks, which were already updated in December 2023 and which the implementation of the IHR is to be based on, provide a foretaste. The new benchmark for “infodemic management” emphasizes a fact-based approach to misinformation and respect for freedom of expression, but also formulates the expectation that States should take measures to reduce the spread of misinformation.

This is reminiscent of agreements made between US officials and social media operators during the coronavirus pandemic. Emails published by Facebook as part of a court case reveal that the platform informed White House employees that it had inhibited the spread of posts claiming that natural immunity from infection was stronger than immunity from vaccination, even though this is very much an open question.

As a result, there are at least three obvious concerns related to the requirement that States must have the capacity to manage “infodemics.”

First, it is often the case that governments will seek justification for emergency powers or extrajudicial actions, whether these are for legitimate public safety concerns or to promote ulterior political motives whilst stifling freedom of speech. Given that an “infodemic” can relate to communication associated with any health emergency, there should be concern about the potential for “mission creep” in the use of management measures or emergency actions to promote, demote, or censor information about a particular health risk. In other words, there are legitimate questions about what, when, and how information management should be used and whether such management promotes a balanced and proportionate approach.

Second, and relatedly, the stipulation to strengthen capacities to manage infodemics says nothing about what should count as “information” and what should count as “misinformation.” Currently, the WHO suggests that “an infodemic is too much information including false or misleading information in digital and physical environments during a health emergency.” Here, the issue is that there is simply too much information available, some of which will be inaccurate.

This definition could be used to promote single and easily digestible narratives regarding a complex emergency while also removing good information that does not fit this narrative. This not only raises concerns about what constitutes good scientific method, practice, and evidence creation but would support diminished public reason-giving by officials while restricting collective decision-making. 

Third, the determination of what constitutes misinformation and thus a threat to society will require a political body and/or political processes. The alternative would be placing decisions over the lives and health of others in unelected bureaucratic hands, which would raise significant concerns regarding the democratic process and conformity with the spirit of post-World War Two human rights norms.

Expanding Core Capacities for Financing the IHR

The revised IHR establishes a new financial mechanism to encourage further investment in pandemic prevention, preparedness, and response without providing any further details about its mode of operation. Ambiguity is compounded by the fact that it remains unclear how the new Coordinating Financing Mechanism for the IHRs is meant to correspond to the proposed Coordinating Financial Mechanism for pandemic preparedness, as outlined in Article 20 of the draft Pandemic Agreement.

Although the wording is very similar, it is not clear whether the IHR and Agreement will share this Mechanism, or whether there will be two mechanisms to channel finance, perhaps even three if both are independent of the already existing Pandemic Fund at the World Bank. This is not merely a case of semantics, since the financing requirement for pandemic preparedness, which also includes associated health emergencies, is currently estimated to be over $30 billion annually. In the context of global health, this represents an enormous expenditure with significant opportunity costs. As a result, however, this new Mechanism is designed, it will have wide-ranging knock-on effects that will starve other health priorities of needed resources.

The active assumption is that the IHR Coordinating Financing Mechanism will cover both the IHRs and the Pandemic Agreement, since there has been a strong push from donor countries to limit fragmentation within the pandemic preparedness agenda and to “streamline” its governance and financing. That said, it remains open to negotiation, and it is still undecided whether the new Coordination Mechanism will be hosted by the World Bank, the WHO, or by a new external organization or external Secretariat under a World Bank Financial Intermediary Fund (FIF). In addition, it remains unclear how both pandemic preparedness and the IHRs will mobilize financing, given the exceptionally large price tag and the fact that donors have shown a reduced appetite for providing more development assistance.

Thus, a public health concern emerges where lower-resource states will still be “on the hook” to deliver on the new IHR capacities themselves, subject to penalties for non-compliance. As suggested above, given that the estimated price tag for low-and-middle-income countries for pandemic preparedness is $26.4 billion a year, not to mention additional costs for complimentary IHR, this represents a major opportunity cost with very serious public health implications. 

Expanding Core Capacities for Vaccine Equity

Popular commentaries on the new IHR argue that “equity is at their heart,” including the claim that the new Coordinating Financing Mechanism will “identify and access financing to fairly address the needs and priorities of developing countries” and that they reflect a renewed commitment to “vaccine equity.” In the case of the latter, the normative weight behind claims for vaccine equity stemmed from the fact that many poorer states, particularly in Africa, were denied access to Covid-19 vaccines due to advance purchasing agreements between Western countries and the pharmaceutical industry.

In addition, many Western states stockpiled Covid-19 vaccines despite already having large surpluses, which was quickly labelled as a form of “vaccine nationalism,” and which many argued occurred at the expense of poorer countries. As a result, much of the debate within the IHR working group, and what ultimately delayed the Pandemic Agreement, involved positions taken by African and Latin American countries that demanded greater support from the (pharmaceutical) industrial nations regarding access to vaccines, therapeutics, and other health technologies.

In the emerging pandemic preparedness agenda, the WHO is to meet requirements for equity primarily by playing a more active role in ensuring access to “health products.” The WHO subsumes a wide variety of goods under this role, such as vaccines, tests, protective equipment, and genetic therapeutics. Among other things, poorer states are to be supported in increasing and diversifying the local production of health products.

However, this blanket requirement for equity requires some unravelling because health equity and commodity equity, although certainly linked, are not always synonymous. For example, there is little doubt that there exist vast health inequities between countries and that these disparities often fall along economic lines. If human health matters, then the promotion of health equity is important, since it focuses on adjusting resource distribution to create more fair and equal opportunities for the disadvantaged and those facing the greatest disease burden. This of course will include access to certain “health products.” 

Yet, the objective of health equity should be to promote better health outcomes by identifying and then targeting interventions and resources that can do the greatest good for the most people in a particular community or region. This is particularly important under conditions of scarcity or limited financial capacities. Again, this has relevance for claims of vaccine equity, since in the case of Covid-19 vaccines, it is not at all clear that mass vaccination was necessary or appropriate in most of Africa given its minimal-risk demographics, the limited and waning protection from vaccines, and the high level of natural immunity existing in Sub-Saharan Africa at the time of vaccine rollout. 

The cost of mass vaccination policies is high in financial and human resources. When coupled with the limited potential that mass vaccination would have on African public health, this particular vaccine expenditure represents an example of significant opportunity cost in relation to other notable endemic disease burdens, thus becoming a potential driver of health inequity.

This again raises questions about the best use of resources. For instance, should resources be devoted to mitigating zoonotic outbreaks in Africa to shield the Global North from theoretical pandemic risk, or should resources be used to provide low-cost screening to address the over 100,000 African women dying from preventable cervical cancer each year, which is ten times the mortality rate of women in the Global North?

In many ways, it could be argued that the focus on “vaccine nationalism” and its counter-narrative of “vaccine equity” is more a symbolic bulwark for much wider problems in global health, where historical disparities, including access to affordable medicines and TRIPS restrictions (Agreement on Trade-Related Aspects of Intellectual Property Rights), have affected health outcomes.

Existing inequities become even more insidious in cases where there are known, effective, and relatively cheap interventions, but where structures become prohibitive. As a result, the announced expansion of the production of health products in developing countries is probably sensible because, as Covid demonstrated, no one expects that scarce medicines will be donated to poorer nations in a real emergency. However, if this is to be done sensibly, it must be concentrated on products of local public health priority and not products offering limited benefits.

It remains to be seen whether commitments to equal access to health products are more than lip service or a lobbying success for the pharmaceutical industry, which clearly understands the market opportunities conferred by the emerging pandemic preparedness agenda. A more cynical view would suggest that the pharmaceutical industry sees vaccine equity as a profitable entry mechanism to serve the markets of less solvent countries at the expense of European and North American taxpayers (whether or not such a countermeasure makes sense in a future context). 

However, healthy skepticism of the commercial interests of Big Pharma should not lead critics to overlook the fact that access to health products is in fact significantly restricted in many places, leading to a lower standard of medical care. This drives further poverty, but poverty – itself a crucial determinant of health – cannot be overcome by supplying vaccines alone. No commitment to equity will solve the fundamental problem of a global wealth gap, which has become even more extreme since the 2020 Covid-19 response, and is an underlying cause of most inequity in health. 

Power Abhors Proper Deliberation

The World Health Assembly did show that fundamental criticism of emerging pandemic preparedness instruments has transcended the realm of civil society activism and the few scientists who publicly questioned their validity. Various states look to exercise their right not to implement the changes to the IHRs in whole or in part. Slovakia has already announced this, and other states such as Argentina and Iran have expressed similar reservations. All States now have under ten months to review the regulations and, if necessary, make use of this “opt-out” option. Otherwise, they will come into force for these States despite remaining questions and ambiguities.

The additions to the IHR raise many unanswered questions. Although both pundits and detractors of the IHR amendments and Pandemic Agreement had hoped for a more definitive conclusion to be reached on June 1, 2024, we now face a protracted and nebulous process. While Member States decide whether to accept or opt out of the amendments, the International Negotiating Body (INB) for the Pandemic Agreement has just started to lay out its next steps.

During these processes specificity must be found regarding the new category of “pandemic emergency” and the new financing and equity architecture. Only then will citizens and decision-makers be able to evaluate a more “complete package” of pandemic preparedness, understand its wider implications, and make evidence-based decisions.

In response, REPPARE continues to build upon its ongoing work to assess pandemic risk, the relative disease burden of pandemics, and the assumed costs and financing of the pandemic preparedness agenda. In the next phase of research, REPPARE will map and examine the emerging institutional and policy landscape of pandemic prevention, preparedness, and response. This should help identify its political drivers and help determine its suitability as a global health agenda.