The 2024 Amendments to the International Health Regulations: A Commentary (Part II: Selected Substantive Amendments)

[Dr. Amrei Müller is Assistant Professor/Lecturer (Ad Astra Fellow) at University College Dublin, Sutherland School of Law.

Dr. Silvia Behrendt is the founder and director of the Global Health Responsibility Agency.]

Part I of this contribution elaborated on the procedural irregularities of the adoption of the 2024 IHR amendments. Without any claim to exhaustiveness, Part II focuses on the analysis of some substantive amendments, and open legal and other questions are highlighted and discussed. 

The substantive amendments to the IHR adopted are far-reaching. They extend the material and temporal scope of application of the IHR considerably, both in relation to states’ duties to prevent and prepare for public health emergencies of international concern (PHEICs) and for (newly defined) ‘pandemic emergencies’; and in relation to states’ duties to respond to these events primarily through the production, authorisation, distribution and administration of ‘relevant health products’ recommended by the Director-General to address a PHEIC/pandemic emergency. The powers of the WHO, and in particular its Director-General, are expanded. 

Expanding the Definitions of International Health Emergencies 

Various amendments – in particular to Articles 1 and 12 IHR and to the decision instrument in Annex 2 to the IHR – expand the definition international health emergencies to be declared by the Director-General and the Emergency Committees that s/he can set up in accordance with Articles 12(4)(c) and 49 IHR. Amendments to Articles 1 and 12(1) IHR establish that, in addition to a PHEIC, the Director-General shall be empowered to declare whether an ‘event’ constitutes a ‘pandemic emergency’. A ‘pandemic emergency’ is allegedly a particularly grave PHEIC, as it is defined in amended Article 1 IHR as a PHEIC that 

‘… is caused by a communicable disease and: 

(i) has, or is at high risk of having, wide geographical spread to and within multiple States; and 

(ii) is exceeding, or is at high risk of exceeding, the capacity of health systems to respond in those States; and 

(iii) is causing, or is at high risk of causing, substantial social and/or economic disruption, including disruption to international traffic and trade; and 

(iv) requires rapid, equitable and enhanced coordinated international action, with whole-of-government and whole-of-society approaches.’

At the same time, the decision instrument in Annex 2 to the IHR has been amended together with Article 12(4) IHR. This decision instrument guides both state reporting of health events to the WHO and the Director-General / Emergency Committee in their decision as to whether an event can be classified as a PHEIC or a ‘pandemic emergency’. Whilst no additional guidance has been added to that instrument on how to classify an ‘event’ as a ‘pandemic emergency’, amendments to Annex 2 suggest that the health events activating states’ reporting obligations to the WHO via their National IHR Focal Points (Article 6(1) IHR) are expanded to include ‘clusters of cases of severe acute respiratory disease of unknown or novel cause’ if these events are ‘serious’, ‘unusual and unexpected’, where ‘serious’ may include events representing a ‘significant public health risk even if no or very few human cases have yet been identified’ (Annex 2, examples for the application of the decision instrument).      

Overall, these amendments will extend the types of situations that the Director-General/Emergency Committee can classify as international health emergencies. The current problems – the fact that the 2005 definition of a PHEIC in Article 1(1) IHR as an ‘extraordinary event’ in one state which is determined to ‘(i) constitute a public health risk to other States through the international spread of disease’ and ‘(ii) to potentially require a coordinated international response’ has long been plagued by vagueness – are exacerbated by the amendments. No clear ‘severe’ or ‘life-threatening’ disease benchmarks have been included through the amendments in Article 1 IHR or the decision instrument in Annex 2 to be applied in accordance with the principles of strict necessity and proportionality. This could have ensured that PHEIC or ‘pandemic emergency’ declarations are made only if the world is indeed facing very severe health hazards deserving the highest level of alert that justify the far-reaching global legal, financial, economic and other consequences that such declarations have. Problematic situations of the past – like the declaration of a m-pox-PHEIC by the Director-General after just 5 deaths, against the advice of the m-pox Emergency Committee and with transmission restricted to a very limited demographic in July 2022, as well as the upholding of the Covid-19-PHEIC by the Director-General for more than three years (January 2020 – May 2023) despite the fact that it was clear early on that Covid-19 had a low average infection fatality rate – will likely occur more frequently in the future. 

Expanding the situations that the Director-General can declare to constitute international health emergencies will also extend the legal and other global consequences that such declarations have. Surprisingly, the amendments leave it entirely open as to whether the declaration of a ‘pandemic emergency’ has any legal consequences additional to those of a PHEIC, prompting the question about the legal reasoning behind the adoption of the amendment introducing ‘pandemic emergencies’ into the IHR. It can be speculated that this has something to do with the scope of application of the new Pandemic Treaty that the WHO hopes to adopt in the near future, given that this treaty shall regulate global pandemic preparedness and response activities in even more detail. However, adopted amendments to Articles 1, 15, 16 and 17 IHR expand the Director-General’s/Emergency Committee’s competences to issue temporary and standing recommendations to states to adopt medical and non-medical countermeasures to address the PHEIC/pandemic emergency once they have made use of their enlarged powers to declare such.    

‘Relevant Health Products’ as the Alpha and Omega of Preventing and Responding to Infectious Disease Outbreaks 

These amendments concern new powers to issue temporary and standing recommendations on ‘relevant health products’ in particular. The Director-General/Emergency Committees shall no longer only make such recommendations ‘regarding persons, baggage, cargo, containers, conveyances, goods’ but also regarding ‘relevant health products’ to ‘prevent or reduce the international spread of disease’ (amendments to Article 15(2) and 16(1) IHR). ‘Relevant health products’ are defined in an amendment to Article 1 IHR as 

‘health products needed to respond to public health emergencies of international concern, including pandemic emergencies, which may include medicines, vaccines, diagnostics, medical devices, vector control products, personal protective equipment, decontamination products, assistive products, antidotes, cell- and gene-based therapies, and other health technologies;’   

Thus, the Director-General/Emergency Committees can directly recommend the global use and administration of specific health products that they deem ‘needed’ to address an infectious disease outbreak that they classified as a PHEIC/pandemic emergency. The Director-General and the Covid-19 Emergency Committee have done this already during the Covid-19-PHEIC, recommending (e.g. here, here, here, here and here) states to successively vaccinate an increasing percentage of their populations with emergency-listed cell- and gene-based therapies (regularly referred to as ‘vaccines against Covid-19’). 

Additional amendments to Article 13(8) (as well as to Article 44(2)) IHR enable the WHO to ‘facilitate, and work to remove barriers, to timely and equitable access by States Parties to relevant health products’ inter alia by empowering the Director-General to promote the global production, allocation, distribution and research and development of ‘relevant health products’. In particular, the Director-General shall  

(a) conduct, and periodically review and update, assessments of the public health needs, as well as of the availability and accessibility including affordability of relevant health products for the public health response; publish such assessments; and consider the available assessments while issuing, modifying, extending or terminating recommendations pursuant to Articles 15, 16, 17, 18, and 49 of these Regulations; 

(b) make use of WHO-coordinated mechanisms, or facilitate, in consultation with States Parties, their establishment as needed, and coordinate, as appropriate, with other allocation and distribution mechanisms and networks that facilitate timely and equitable access to relevant health products based on public health needs; 

(c) support States Parties, upon their request, in scaling up and geographically diversifying the production of relevant health products, as appropriate, through relevant WHO-coordinated and other networks and mechanisms, subject to Article 2 of these Regulations, and in accordance with relevant international law; 

(d) share with a State Party, upon its request, the product dossier related to a specific relevant health product, as provided to WHO by the manufacturer for approval and where the manufacturer has consented, within 30 days of receiving such request, for the purpose of facilitating regulatory evaluation and authorization by the State Party; and 

(e) support States Parties, upon their request, and, as appropriate, through relevant WHO-coordinated and other networks and mechanisms, pursuant to subparagraph 8(c) of this Article, to promote research and development and strengthen local production of quality, safe and effective relevant health products, and facilitate other measures relevant for the full implementation of this provision. 

At least three questions arise concerning these amendments: First, the amendments do neither define any criteria as to how the Director-General/Emergency Committees shall assess which ‘relevant health products’ are indeed ‘needed’, and how and by whom it is ensured that they are safe and effective. In other words, there are no explanations as to how the effectiveness of these products to address the infectious disease that triggered the PHEIC is to be ensured, nor are there criteria and mechanisms as to how their safety shall be guaranteed. 

It can, however, be reasonably assumed that these ‘relevant health products’ shall be products that have either received an Emergency Use Listing (EUL) by the WHO and/or an emergency use authorisation (or equivalent) by influential domestic or regional health authorities like the US’ Food and Drug Administration or the European Medical Agency. That is, they will be experimental products that are emergency ‘listed’ or emergency ‘authorised’ for use on a ‘time limited [preliminary] basis while further data is being gathered and evaluated’ (p.7) during a PHEIC/pandemic emergency. The common justification for this is that in such situations of a PHEIC/pandemic emergency, it is expected that, in the words of the WHO, ‘the community/public health authorities may be willing to tolerate less certainty about the efficacy and safety of products, given the morbidity and/or mortality of the disease and the lack or paucity of treatment, diagnosis/detection or prevention options’ (p.6). This assumption of the authors is based on three points: 

1. the history of the WHO’s Covid-19 response relying primarily on recommendations to conduct global mass vaccinations with unlicenced modRNA- and DNA-based products (cell- and gene-based therapies) to address the Covid-19-PHEIC, a recommendation upheld until this day via a standing recommendation (section D); 
2. the existing WHO programmes for the preventive research and development on pathogens with pandemic potential (R&D Blueprint) allowing for ‘the rapid activation of research and development activities during epidemics [or rather: PHEICs]’ aiming to ‘fast-track the availability of effective tests, vaccines and medicines that can be used to save lives and avert large scale crisis,’ and to thus ‘reduce the time between the declaration of a PHEIC and the availability of effective tests, vaccines and medicines’ (p.11) potentially to just 100 days; and 
3. the EUL procedure itself, through which WHO issues de facto global emergency authorisations (‘listings’) for unlicensed medicinal products to address a PHEIC once it declared such a PHEIC. EULs inter alia enable procurement and global distribution of unlicensed medical products by the WHO’s public-private partnerships like Gavi and UN agencies like UNICEF.   

Questions concerning the systematic monitoring of adverse events as well as questions of liability for adverse events caused by WHO-recommended ‘relevant health products’ are not addressed by the amendments. Questions concerning the duties of states and responsibilities of the WHO to secure the human right to health including access to safe and effective medical products (paras. 12(c) and (d)) and the prohibition to subject individuals to medical treatment or medical experimentation without their free and informed consent (more on this here) remain unaddressed. These questions arise in particular with regard to ‘cell- and gene-based therapies’ that the Director-General/Emergency Committees are now directly authorised to recommend (and ‘emergency-list’) for global use, legally entrenching the practice that was established by the Director-General and the Covid-19 Emergency Committee, and that is further promoted by the WHO Science Council established in 2020. A growing body of scientific literature (e.g. here, here, here, here, here, here, here, here, here, here, here, here and here) raise questions about the effectiveness and safety of the ‘cell- and gene-based therapies’ that came in the form of vaccines against Covid-19, that received EULs from the WHO during the Covid-19-PHEIC and were subsequently recommended by WHO for global administration, and distributed via Covax. For adverse events caused by these products WHO, however, excluded and excludes any (future) liability through disclaimers (see Annex 8, pp.64-65) and with reference to the privileges and immunities of the organisation and its staff (p.17). Such questions should arguably be discussed thoroughly before such cell- and gene-based therapies are recommended by the WHO to address PHEICs/pandemic emergencies on a routine basis, empowered by the amendments. 

Second, there are no safeguards included to ensure that recommendations concerning the global administration of ‘relevant health products’ are made without undue influence and pressure exerted by pharmaceutical companies that have a considerable commercial interest to have their products recommended for global use by the WHO – an ‘authoritative’ expert organisation – in response to a PHEIC/pandemic emergency. Given the considerable dependence of the WHO on private entities including the pharmaceutical industry, inter alia through its ever-increasing reliance on public-private partnerships and funding provided by (philanthropic) foundations like the Wellcome Trust and the Bill and Melinda Gates Foundations (which themselves have extensive relations to the pharmaceutical industry) and investment rounds, this concern shall not be disregarded lightly. As WHO is also empowered by the amendments to facilitate the global (pre-emptive) research & development, production, allocation, distribution and administration of ‘relevant health products’ it recommends for addressing a PHEIC/pandemic emergency, the amendments can be seen as a considerable win for the pharmaceutical industry. 

Third, questions can be asked as to whether the amendments’ general focus on the reliance on ‘relevant health products’ to address outbreaks of infectious diseases – their global development, production, distribution and administration – constitutes good public health policy and reasonable use of scarce health budgets, especially in low-income countries. Amendments to Article 44(2bis) IHR oblige states to ‘maintain or increase domestic funding, as necessary […] to strengthen sustainable financing to support the implementation’ of the IHR, and amendments to Annex 1 require states to considerably expand their domestic prevention, surveillance, reporting, notification, verification, preparedness, response and collaboration ‘core capacities’ in relation to PHEICs/pandemic emergencies. Moreover, amendments to Article 44bis IHR establish a Coordinating Financial Mechanism with the mandate to secure sustainable financing of the implementation of the IHR. This would include the financing of activities concerning ‘relevant health products’ discussed above. Little discussion has been had as to whether such investments will indeed bring any health improvements for individuals worldwide. Seen from the perspective of global disease burden, infectious disease outbreaks like Covid-19 are minimal, especially in low-income countries with young populations, and questions can be asked as to whether such massive investments are proportionate to the health risks faced. The WHO has, in addition, never explained why it moved away from much more holistic, time-tested approaches to responding to infectious disease outbreaks that were commonplace before the appearance of SARS-CoV-2. 

New Core Capacities: Risk Communication

One of the new core capacities that states shall build in accordance with the adopted amendments to Annex 1 to the IHR shall be highlighted here: the core capacity for ‘risk communication, including addressing misinformation and disinformation’ (see amendments to Annex I, section A(2)(c)(vii) and A(3)(i)). This, once more, gives a legal basis to what has been done during the Covid-19-PHEIC by the WHO and its member states: the systematic ‘pre-bunking’, ‘de-bunking’ and censorship of information and commentary that criticise, question or just discuss the WHO-recommended medical and non-medical countermeasures against a PHEIC under the WHO’s Infodemic Management Programme. ‘Pre-bunking’ aims to ‘immunise’ and regularly ‘boost’ the population against possible future mis- or disinformation by providing targeted advance information, explaining the alleged strategies and techniques employed by those who allegedly spread mis- or disinformation, or by pre-classifying certain sources pre-emptively as unreliable and untrustworthy. ‘De-bunking’ implies adding disclaimers and corrections to articles and social media posts, often through fact-checks, or by re-directing to allegedly trustworthy sources like the WHO’s website or the social media accounts of ‘Dr Tedros’ (the current WHO Director-General) or by downranking (i.e. reducing the reach by suspending algorithmic amplification) of certain accounts or pieces of alleged misinformation. Removing misinformation involves outright censorship and de-platforming of social media accounts.

Amendments to the IHR do not, however, clarify who determines what qualifies as ‘mis- and disinformation’, for how long, and in accordance with what criteria. Nor is there any recognition that these amendments can come in conflict with both states’ human rights duties under the human rights to freedom of expression, opinion and information and the right to science, and WHO’s responsibilities for these same rights. During the Covid-19-PHEIC, numerous scientists, doctors and individuals faced widespread interference with their  academic and other publications as well as social media posts. This, among other things, has prevented an open, thorough and independent investigation and evaluation of the WHO-led response to the Covid-19-PHEIC to this day, including the highly likely laboratory origins of SARS-CoV-2.    

New Institutions 

Amendments establish a number of new institutions. First, at the domestic level, in accordance with amendments to Articles 1 and 4 IHR, all state shall establish a ‘National IHR Authority’, that is an ‘entity designated or established by the State Party at the national level to coordinate the implementation’ of the IHR ‘within the jurisdiction of the State Party’. It is not clear, however, how these new National IHR Authorities shall relate to and/or cooperate with existing National IHR Focal Points responsible for the implementation of the IHR and of WHO-recommended countermeasure during a PHEIC/pandemic emergency.  

Second, amendments to Article 54bis establish a States Parties Committee for the Implementation of the International Health Regulations. The Committee shall have the task to ‘promot[e…] and support[…] learning, exchange of best practices, and cooperation among State Parties for the effective implementation’ of the IHR. The Committee shall also establish a Subcommittee with the task ‘to provide technical advice’. The Committee shall be comprised of all State Parties to the IHR and shall adopt its own working methods at its first meeting. It is unclear how the work of this new Committee shall relate to the already existing Review Committee that the Director-General has set up in accordance with his obligations under Articles 50 and 54(2) IHR. Given the severe resource constraints WHO operates under, questions can be asked about the added value that the establishment of a new institutional element shall offer.   

Third, as already indicated, Article 44bis(1) establishes a Coordinating Financial Mechanism with a mandate to provide ‘timely, predictable, and sustainable financing for the implementation’ of the IHR, to ‘seek to maximise the availability of financing for the implementation needs and priorities of State parties, in particular developing countries’ and to ‘mobilise new and additional financial resources […]’ for the effective implementation of the IHR. Moreover, the Financial Mechanism shall ‘promote harmonization, coherence and coordination with existing financing instruments’ (amended Article 44bis(2)(c)), without, however, giving any detail as to how this should work given that the new Financial Mechanism will not have competence to direct or otherwise interfere with the workings of such existing mechanisms. Amended Article 44bis(3) indicates that the Mechanism shall function ‘under the authority and guidance of the WHA’, whilst amendments to Article 54bis(4) further specify that the above-mentioned State Parties Committee for the Implementation of the International Health Regulations shall adopt the terms of reference for the Financial Mechanism as well as modalities for its operationalisation and governance.        

Concluding Remarks 

As highlighted in Part I, the 2024 far-reaching amendments to the IHR have been adopted in violation of Article 55(2) IHR. They entrench the almost exclusive focus on the global production, distribution and administration of emergency ‘listed’ (by WHO) or emergency authorised (by domestic regulatory agencies) experimental health products to address infectious disease outbreaks that was followed by the WHO Director-General, the Covid-19 Emergency Committee and WHO member states to address the Covid-19-PHEIC. This is an approach much favoured by the pharmaceutical industry, that will also warmly welcome the considerable increase in product-oriented funding in pandemic preparedness and response activities that the amendments will trigger. Amendments make it easier for the Director-General/Emergency Committees to declare a PHEIC/pandemic emergency and directly empower the same Director-General/Executive Committees to recommend ‘relevant health products’ for global mass use as medical countermeasures to address these PHEICs/pandemic emergencies. Other amendments offer a firm legal basis for conducting ‘risk communication’ programmes in all WHO member states, involving the fight against alleged medical mis- and disinformation. 

Given that the WHO has never conducted a thorough, independent and comprehensive investigation into the effectiveness and far-reaching negative economic, financial, social and health consequences of its product-based response to the Covid-19-PHEIC, state parties to the IHR may be well-advised to use the 10 months period which Article 59 IHR affords them to carefully examine whether it is in their interest and the interest of the populations they represent to opt out of some or all adopted amendments to the IHR. They may, in addition, pay particular attention to their duty to ensure that any new obligations under international law that they take on do not undermine their ability to comply with their existing duties under regional and international human rights law.