The Seventy-seventh World Health Assembly (‘WHA-77’) was held in Geneva, Switzerland, on 27 May – 1 June 2024. The theme of WHA-77 has been ‘All for Health, Health for All’, with two main hot topics on the agenda: (1) the revision of the International Health Regulations (IHR) from their 2005 version, based on more than 300 proposals submitted by the WHO Member States and (2) the adoption of the long-awaited International Treaty on Pandemic Prevention, Preparedness and Response (‘Pandemic Treaty’) on the basis of the ‘Proposal for the WHO Pandemic Agreement’ from 22 April 2024. These crucial developments derived from the need to address gaps in the global health governance indicated by the COVID-19 pandemic, such as the insufficient focus of IHR-2005 on the pandemics’ prevention, lack of effective control tools over IHR-2005 enforcement, and the missing provisions on access to medicines, which defined the course of the negotiation process.
The WHO’s work in these two directions took place simultaneously through the Intergovernmental Negotiating Body (INB) and the Working Group on Amendments to the International Health Regulations (WGIHR). The intense INB/WGIHR negotiations in 2022–2024 revolved around such issues as sovereignty, equity, effective implementation, transparency and sustainable financing. However, WHA-77 adopted only the IHR-2005 amendments, while consensus on the provisions of the Pandemic Treaty has not yet been reached. Against this backdrop, this post aims to provide a brief overview of the key amendments to the International Health Regulations in order to shed some light on the perspectives of the adoption of the Pandemic Treaty. The post mainly argues that the adopted IHR-2005 amendments seem to be less far-reaching than the proposed text from the Eighth WGIHR Meeting (April 2024), hence indirectly shifting responsibility to the INB for providing WHO States with an effective legal framework for the prevention and response to global pandemics – in the form of the Pandemic Treaty.
From IHR-2005 to IHR-2024: Key Amendments
The International Health Regulations were initially drafted and later revised mainly from a functional perspective as the technical legal mechanism of the indication and notification of public health emergencies of international concern (PHEICs) – the approach challenged by several previous pandemics (swine flu, polio, Zika, Ebola, COVID-19). Moreover, the WHA-77 hearings seem to reflect the equity discourse, which, to a significant extent, derived from the issues that appeared during and after the COVID-19 crisis. In this regard, one could mention the inadequate dissemination of the coronavirus vaccines and medicines, as well as other pandemic-related health products. The inequitable distribution had a profound negative impact on socioeconomic recovery in low-income and middle-income WHO States. These premises made the WGIHR focus on such main IHR-2005 substantive alterations as the improvement of implementation mechanisms, incorporation of the equity principle, the defining of the ‘pandemic emergency’, and development of the ‘Core Capacities’ to prevent and prepare for PHEICs. The WHA-77 amendments shall enter into force 12 months after their notification by the Director-General to all States Parties (Art. 59 of the IHR).
Determination of Pandemic Emergency
Following these lessons learned from the COVID-19 pandemic, the WHA-77 elaborated on a new category of PHEIC – namely, a pandemic emergency – to favor more effective and well-coordinated responses to events with sufficient potential to become a pandemic. The term ‘pandemic emergency’ refers to a public health emergency of international concern 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 (Art. 1 ‘Definitions’).
Consequently, the WHO Director-General is now under the obligation to conduct further investigation, when the PHEIC is established, to detect the potential pandemic emergency and can declare, when appropriate, a pandemic emergency following the standard procedure for PHEICs (Art. 12 (4 bis)). However, the following factors shall be taken into consideration to make a distinction between ‘ordinary’ PHEICs and pandemic emergencies: the information provided by the States Parties, the advice of the Emergency Committee, scientific principles as well as the available scientific evidence and other relevant information, and an assessment of the risk to human health, of the risk of international spread of disease and the risk of interference with international traffic (Art. 12 (4)).
Importantly, the WHA-77 preferred to skip an important proposed amendment, namely an ‘early action alert’ system incorporation, which was perceived as an issuance of the information and non-binding advice by the WHO Director-General to States Parties on an event which he or she has determined does not constitute a public health emergency of international concern (Arts. 1, 11, 12, 49). Even though this novelty had the potential to increase the effectiveness and the transparency of the IHR-2024 implementation, the vagueness of this term and the wide discretion of the Director-General in this category of cases led to the dropping of this proposed revision.
Equity and Solidarity Clauses
Importantly, the amendments were also made to Art. 3, ‘Principles’, in order to underline that the Regulations shall be implemented not only with full respect for the dignity, human rights and fundamental freedoms of persons, but shall also promote equity and solidarity. Note that the amendments do not define the latter terms, possibly delegating this task to the Pandemic Treaty drafters: for instance, the INB Proposal from April 2024 defines ‘equity as a goal and outcome of pandemic prevention, preparedness and response, striving for the absence of unfair, avoidable or remediable differences among and between individuals, communities and countries’. The ‘solidarity with all people and countries in the context of health emergencies’ allows us to pursue ‘the common interest of a more equitable and better prepared world to prevent, respond to and recover from pandemics, recognizing different levels of capacities and capabilities’. Further developments in the INB negotiations process will indicate whether these definitions remain unchanged. At the same time, the general concepts of International Human Rights Law and/or the existing WHO laws could presumably be used to clarify the substance of equity and solidarity for the purposes of IHR-2024 enforcement – at least until the adoption of the Pandemic Treaty.
Institutional Amendments
The abovementioned equity and solidarity clauses are expected to be important in the future for the interpretation of the new States’ obligations under the amended IHR-2024. In particular, one could mention those deriving from the participation in the new States Parties Committee for implementation of the IHR and the establishment of National IHR authorities, which are aimed at complementing the activities of the National IHR Focal Points. Firstly, the States Parties Committee for implementation of the IHR is created to promote and support learning, exchange of best practices, and cooperation among States Parties for the effective implementation of the Regulations, being, however, facilitative and consultative in nature only, and functioning in a non-adversarial, non-punitive, assistive and transparent manner (Art. 54 bis). Secondly, the National IHR authorities shall coordinate the implementation of these Regulations within the jurisdiction of the State Party (Art. 4(1) bis).
It could be argued here that the final text contains significantly less far-reaching clauses than the April WGIHR proposal: for instance, the provisions related to the IHR Implementation and Compliance Committee, which had to (1) promote compliance with the IHR and (2) be responsible for monitoring progress with IHR implementation were revised and shortened significantly. In the adopted version, the States Parties Committee for implementation of the IHR ‘shall be facilitative and consultative in nature only’, aimed at ‘promoting and supporting learning, exchange of best practices, and cooperation among States Parties for the effective implementation [of the Regulations]’. The exclusion of the key enforcement powers seems to reflect the sovereignty discourse surrounding the IHR revision process and was somewhat predictable, given the sensibility of the issue. At the same time, it is unclear whether the Committee, with purely consultative functions (and with no sanctioning mechanisms), can favor effective enforcement of the IHR-2024 in practice.
The Development of Core Capacities
A new obligation to develop ‘Core Capacities’ not only for surveillance and response, but also for prevention and preparedness for PHEICs, comprising pandemic emergencies (Arts. 5, 13), led to the development of the cluster of requirements on local, intermediate and national levels (Annex 1). It could be said that the description of the national obligations seems rather declaratory, possibly because the WHO is expected to publish the guidelines to support States Parties in the development of public health response core capacities later (Art. 13(1)).
For example, the WHA-77 delegates elaborated on new requirements for the local community level and/or primary public health response level, such as the obligation to prepare for the implementation of preliminary control measures; to prepare for the provision of health services necessary for responding to public health risks and events, as well as to engage relevant stakeholders in preparing for and responding to public health risks and events.
The development of Core Capacities on intermediate public health response levels requires that each IHR State Party complies with such new obligations as coordinating with and supporting the local level in prevention and response. In particular, these duties comprise the collaboration in relation to (i) surveillance; (ii) on-site investigations; (iii) laboratory diagnostics; (iv) implementation of control measures; (v) access to health services and health products; (vi) risk communication, including addressing misinformation and disinformation; (vii) logistical assistance.
On the national level, each State Party shall now develop, strengthen and maintain the core capacities related to surveillance; deploying specialized staff; developing and/or disseminating guidance for clinical case management and infection prevention and control; access to health services and health products needed for the response; and risk communication, including addressing misinformation and disinformation. In addition, the IHR States shall coordinate activities nationally and support local and intermediate levels, where applicable, in preventing, preparing for and responding to public health risks and events.
The INB Mandate Extended: What to Expect from the Pandemic Treaty Negotiations?
Because the Pandemic Treaty – despite the initial INB timeframe – was not adopted during WHA-77, the mandate of the INB was extended to develop the final version of the text within a year. Hence, the agreement is likely to be adopted either by the 78th World Health Assembly (May 2025) or, if feasible, earlier at a special session of the Assembly (December 2024). The WHA-77 ‘modest’ approach to the IHR-2005 amendments may possibly indicate both the sensitivity of the issues discussed and the intention to leave a wider margin for maneuver in drafting the Pandemic Treaty.
The proposal for the Pandemic Treaty is still being developed on the basis of Art. 19 of the WHO Constitution – that is, as a legally binding convention or agreement that would be submitted to ratification by Member States, which, however, does not exclude the inclusion of the non-legally binding elements. Given the lack of a common vision of the main components of the final text by the WHO States Parties indicated by WHA-77, the INB must overcome important substantive issues related to the definition of the so-called One Health approach, which is to be formalized in the Treaty text, as well as the basic rules for the formation of the global WHO’s Pathogen Access and Benefit-sharing Systems.
Another (procedural) point of concern of the INB members is the complementarity and coherence between the proposal for the WHO’s Pandemic Agreement and the amended version of the IHR-2024. Strategies for solving possible conflicts between these legal instruments were already offered during the recent INB session (September 2024): (1) prioritizing the Pandemic Treaty (lex posterior derogat priori), (2) prioritizing the more specialized instrument in different situations (lex specialis derogat generali), and/or (3) drafting international instruments for mutual supportiveness (either in the form of the Treaty clause(-s) or Protocols) – but only the next WHA will indicate if and how these premises affect the course of the INB negotiations, and hence the WHO’s Pandemic Treaty final version.
The 77th World Health Assembly: Modest Amendments to the IHR-2005… More Expectations of the WHO’s ‘Pandemic Treaty’?
Written by Nasiya Daminova and Shisong JiangThe Seventy-seventh World Health Assembly (‘WHA-77’) was held in Geneva, Switzerland, on 27 May – 1 June 2024. The theme of WHA-77 has been ‘All for Health, Health for All’, with two main hot topics on the agenda: (1) the revision of the International Health Regulations (IHR) from their 2005 version, based on more than 300 proposals submitted by the WHO Member States and (2) the adoption of the long-awaited International Treaty on Pandemic Prevention, Preparedness and Response (‘Pandemic Treaty’) on the basis of the ‘Proposal for the WHO Pandemic Agreement’ from 22 April 2024. These crucial developments derived from the need to address gaps in the global health governance indicated by the COVID-19 pandemic, such as the insufficient focus of IHR-2005 on the pandemics’ prevention, lack of effective control tools over IHR-2005 enforcement, and the missing provisions on access to medicines, which defined the course of the negotiation process.
The WHO’s work in these two directions took place simultaneously through the Intergovernmental Negotiating Body (INB) and the Working Group on Amendments to the International Health Regulations (WGIHR). The intense INB/WGIHR negotiations in 2022–2024 revolved around such issues as sovereignty, equity, effective implementation, transparency and sustainable financing. However, WHA-77 adopted only the IHR-2005 amendments, while consensus on the provisions of the Pandemic Treaty has not yet been reached. Against this backdrop, this post aims to provide a brief overview of the key amendments to the International Health Regulations in order to shed some light on the perspectives of the adoption of the Pandemic Treaty. The post mainly argues that the adopted IHR-2005 amendments seem to be less far-reaching than the proposed text from the Eighth WGIHR Meeting (April 2024), hence indirectly shifting responsibility to the INB for providing WHO States with an effective legal framework for the prevention and response to global pandemics – in the form of the Pandemic Treaty.
From IHR-2005 to IHR-2024: Key Amendments
The International Health Regulations were initially drafted and later revised mainly from a functional perspective as the technical legal mechanism of the indication and notification of public health emergencies of international concern (PHEICs) – the approach challenged by several previous pandemics (swine flu, polio, Zika, Ebola, COVID-19). Moreover, the WHA-77 hearings seem to reflect the equity discourse, which, to a significant extent, derived from the issues that appeared during and after the COVID-19 crisis. In this regard, one could mention the inadequate dissemination of the coronavirus vaccines and medicines, as well as other pandemic-related health products. The inequitable distribution had a profound negative impact on socioeconomic recovery in low-income and middle-income WHO States. These premises made the WGIHR focus on such main IHR-2005 substantive alterations as the improvement of implementation mechanisms, incorporation of the equity principle, the defining of the ‘pandemic emergency’, and development of the ‘Core Capacities’ to prevent and prepare for PHEICs. The WHA-77 amendments shall enter into force 12 months after their notification by the Director-General to all States Parties (Art. 59 of the IHR).
Determination of Pandemic Emergency
Following these lessons learned from the COVID-19 pandemic, the WHA-77 elaborated on a new category of PHEIC – namely, a pandemic emergency – to favor more effective and well-coordinated responses to events with sufficient potential to become a pandemic. The term ‘pandemic emergency’ refers to a public health emergency of international concern 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 (Art. 1 ‘Definitions’).
Consequently, the WHO Director-General is now under the obligation to conduct further investigation, when the PHEIC is established, to detect the potential pandemic emergency and can declare, when appropriate, a pandemic emergency following the standard procedure for PHEICs (Art. 12 (4 bis)). However, the following factors shall be taken into consideration to make a distinction between ‘ordinary’ PHEICs and pandemic emergencies: the information provided by the States Parties, the advice of the Emergency Committee, scientific principles as well as the available scientific evidence and other relevant information, and an assessment of the risk to human health, of the risk of international spread of disease and the risk of interference with international traffic (Art. 12 (4)).
Importantly, the WHA-77 preferred to skip an important proposed amendment, namely an ‘early action alert’ system incorporation, which was perceived as an issuance of the information and non-binding advice by the WHO Director-General to States Parties on an event which he or she has determined does not constitute a public health emergency of international concern (Arts. 1, 11, 12, 49). Even though this novelty had the potential to increase the effectiveness and the transparency of the IHR-2024 implementation, the vagueness of this term and the wide discretion of the Director-General in this category of cases led to the dropping of this proposed revision.
Equity and Solidarity Clauses
Importantly, the amendments were also made to Art. 3, ‘Principles’, in order to underline that the Regulations shall be implemented not only with full respect for the dignity, human rights and fundamental freedoms of persons, but shall also promote equity and solidarity. Note that the amendments do not define the latter terms, possibly delegating this task to the Pandemic Treaty drafters: for instance, the INB Proposal from April 2024 defines ‘equity as a goal and outcome of pandemic prevention, preparedness and response, striving for the absence of unfair, avoidable or remediable differences among and between individuals, communities and countries’. The ‘solidarity with all people and countries in the context of health emergencies’ allows us to pursue ‘the common interest of a more equitable and better prepared world to prevent, respond to and recover from pandemics, recognizing different levels of capacities and capabilities’. Further developments in the INB negotiations process will indicate whether these definitions remain unchanged. At the same time, the general concepts of International Human Rights Law and/or the existing WHO laws could presumably be used to clarify the substance of equity and solidarity for the purposes of IHR-2024 enforcement – at least until the adoption of the Pandemic Treaty.
Institutional Amendments
The abovementioned equity and solidarity clauses are expected to be important in the future for the interpretation of the new States’ obligations under the amended IHR-2024. In particular, one could mention those deriving from the participation in the new States Parties Committee for implementation of the IHR and the establishment of National IHR authorities, which are aimed at complementing the activities of the National IHR Focal Points. Firstly, the States Parties Committee for implementation of the IHR is created to promote and support learning, exchange of best practices, and cooperation among States Parties for the effective implementation of the Regulations, being, however, facilitative and consultative in nature only, and functioning in a non-adversarial, non-punitive, assistive and transparent manner (Art. 54 bis). Secondly, the National IHR authorities shall coordinate the implementation of these Regulations within the jurisdiction of the State Party (Art. 4(1) bis).
It could be argued here that the final text contains significantly less far-reaching clauses than the April WGIHR proposal: for instance, the provisions related to the IHR Implementation and Compliance Committee, which had to (1) promote compliance with the IHR and (2) be responsible for monitoring progress with IHR implementation were revised and shortened significantly. In the adopted version, the States Parties Committee for implementation of the IHR ‘shall be facilitative and consultative in nature only’, aimed at ‘promoting and supporting learning, exchange of best practices, and cooperation among States Parties for the effective implementation [of the Regulations]’. The exclusion of the key enforcement powers seems to reflect the sovereignty discourse surrounding the IHR revision process and was somewhat predictable, given the sensibility of the issue. At the same time, it is unclear whether the Committee, with purely consultative functions (and with no sanctioning mechanisms), can favor effective enforcement of the IHR-2024 in practice.
The Development of Core Capacities
A new obligation to develop ‘Core Capacities’ not only for surveillance and response, but also for prevention and preparedness for PHEICs, comprising pandemic emergencies (Arts. 5, 13), led to the development of the cluster of requirements on local, intermediate and national levels (Annex 1). It could be said that the description of the national obligations seems rather declaratory, possibly because the WHO is expected to publish the guidelines to support States Parties in the development of public health response core capacities later (Art. 13(1)).
For example, the WHA-77 delegates elaborated on new requirements for the local community level and/or primary public health response level, such as the obligation to prepare for the implementation of preliminary control measures; to prepare for the provision of health services necessary for responding to public health risks and events, as well as to engage relevant stakeholders in preparing for and responding to public health risks and events.
The development of Core Capacities on intermediate public health response levels requires that each IHR State Party complies with such new obligations as coordinating with and supporting the local level in prevention and response. In particular, these duties comprise the collaboration in relation to (i) surveillance; (ii) on-site investigations; (iii) laboratory diagnostics; (iv) implementation of control measures; (v) access to health services and health products; (vi) risk communication, including addressing misinformation and disinformation; (vii) logistical assistance.
On the national level, each State Party shall now develop, strengthen and maintain the core capacities related to surveillance; deploying specialized staff; developing and/or disseminating guidance for clinical case management and infection prevention and control; access to health services and health products needed for the response; and risk communication, including addressing misinformation and disinformation. In addition, the IHR States shall coordinate activities nationally and support local and intermediate levels, where applicable, in preventing, preparing for and responding to public health risks and events.
The INB Mandate Extended: What to Expect from the Pandemic Treaty Negotiations?
Because the Pandemic Treaty – despite the initial INB timeframe – was not adopted during WHA-77, the mandate of the INB was extended to develop the final version of the text within a year. Hence, the agreement is likely to be adopted either by the 78th World Health Assembly (May 2025) or, if feasible, earlier at a special session of the Assembly (December 2024). The WHA-77 ‘modest’ approach to the IHR-2005 amendments may possibly indicate both the sensitivity of the issues discussed and the intention to leave a wider margin for maneuver in drafting the Pandemic Treaty.
The proposal for the Pandemic Treaty is still being developed on the basis of Art. 19 of the WHO Constitution – that is, as a legally binding convention or agreement that would be submitted to ratification by Member States, which, however, does not exclude the inclusion of the non-legally binding elements. Given the lack of a common vision of the main components of the final text by the WHO States Parties indicated by WHA-77, the INB must overcome important substantive issues related to the definition of the so-called One Health approach, which is to be formalized in the Treaty text, as well as the basic rules for the formation of the global WHO’s Pathogen Access and Benefit-sharing Systems.
Another (procedural) point of concern of the INB members is the complementarity and coherence between the proposal for the WHO’s Pandemic Agreement and the amended version of the IHR-2024. Strategies for solving possible conflicts between these legal instruments were already offered during the recent INB session (September 2024): (1) prioritizing the Pandemic Treaty (lex posterior derogat priori), (2) prioritizing the more specialized instrument in different situations (lex specialis derogat generali), and/or (3) drafting international instruments for mutual supportiveness (either in the form of the Treaty clause(-s) or Protocols) – but only the next WHA will indicate if and how these premises affect the course of the INB negotiations, and hence the WHO’s Pandemic Treaty final version.
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