Decisive Discussions on Definition, Declaration of a Pandemic; Developed Countries’ Push to Park Access to Countermeasures in the INB? [Update from the Joint Session of INB-WGIHR]
Newsletter Edition #36 [Treaty Talks]
Hi,
Today we bring you a longish update on some very significant discussions that WHO member states have had this week on how to define a pandemic and the way it should be declared.
These fundamental questions will determine the scope and evolution of the on-going negotiations in global health. Countries have to find a way to make these tracks run in a coherent manner. Already, one observes incipient determinations on which issues should be parked where. This is going to get more interesting pretty soon.
Grateful to my reporting team who have brought the voices of countries to you in this story - for they reveal how WHO member states are thinking about these issues.
If you find our work valuable, support us! Accountability journalism is tough and expensive. Help us in raising important questions and bringing closed door negotiations to light in a timely manner. Readers paying for our work helps us meet our costs.
Watch out for our update on the on-going meeting of the WG-IHR in the coming days. Until later!
Best,
Priti
Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva
I. Update from the Joint Session of INB-WGIHR
Decisive Discussions on Definition, Declaration of a Pandemic; Developed Countries’ Push to Park Access to Countermeasures in the INB?
Priti Patnaik with Nishant Sirohi & Tessa Jager
WHO member states came together in recent days in a first substantive joint session that brought together the bureaux of the Intergovernmental Negotiating Body and the Working Group of amendments to the International Health Regulations.
With a mere ten months away from the May 2024 deadline, where both these processes are expected to conclude and culminate in the adoption of new amendments to the IHR and a potentially new pandemic instrument, countries this week grappled with the basics such as what would legally constitute a pandemic, how it would be declared, what kind of actions would it trigger and most importantly, how would these elements sit across the two different, overlapping legal mechanisms. There was also consideration of a few key topics that have featured in both these tracks of negotiations.
While both these two streams of negotiations are evolving differently, some developed countries have already articulated that issues including the access to countermeasures, One Health, among others could be better treated in the INB track. A number of developing countries cautioned against picking and allocating topics at this stage and have pushed for the inclusion of equity in both these tracks.
This will be significant, as we have discussed earlier, since any commitments made under the IHR will come into effect within 12 months of the adoption of the amendments for all 196 state parties, while on the other hand, a Pandemic Accord is subject to ratification by national Parliaments.
This story captures the gist of the suggestions and concerns raised by countries. We also bring to you the context provided by senior WHO officials who presented to member states during the meeting elucidating current practice and indicating what could be possible under current constitutional arrangements with respect to definitions and governance arrangements.
THE JOINT SESSION: July 21 & 24
The joint session of the two processes was held at the conclusion of the sixth meeting of the INB and continued before the commencement of the fourth meeting of the WG-IHR. These sessions were webcast and provided an opportunity to understand member states’ deliberations on the synergies between these two tracks of negotiations.
Countries cautioned against opening up a third front by way of these joint meetings, while acknowledging that such meetings could be useful. In the joint session, countries shared their views on the scope of the instruments, the relationship between them. They also raised questions on ways to define a public health emergency of international concern and a pandemic. In the second part of the session, countries discussed some topics that were relevant for both the IHR and the new instrument. Some countries also expressed their reservations against allocating provisions across the two instruments, and called for coherence and complementarity.
DEFINITION, DECLARATION, DE-ESCALATION OF A PANDEMIC
In their discussion on what constitutes a pandemic, countries wanted to know about the conditions that would merit such a classification including whether human to human transmission, outbreaks by a vector-borne, non-viral, non-respiratory diseases, would determine such a definition. Rapid spread of disease, over a large population have been understood as other conditions.
WHO’s emergencies chief, Mike Ryan spoke to member states on the various decision-making aspects in governing health emergencies not only within the scope of the IHR, but also those events related to emergencies in humanitarian settings. (See at the bottom of this story, how the emergencies flowchart works.)
Ryan recounted the previous challenges in defining what a pandemic meant. He recalled that during the H1N1 pandemic in 2009, there was discussion on simplifying the process to an alert phase, a pandemic phase, and a transition phase. But no specific definition was ever agreed, he said. What was followed was technical advice, risk management guidance to governments. But there was no formal discussion held between Member States, either within the context of IHR or outside the context of IHR as to the definition of what a pandemic is, he said. Historically, he said the discussion around pandemics focused around influenza.
Highlighting the challenges in arriving at a definition for pandemics, Ryan said:
‘’So there have been issues with the word pandemic and we've had this right away through the DG declared a public health emergency of international concern at the end of January 2020. And the issues that were raised, were those ‘does this constitute a pandemic?’ And I even see in the definition that’s in the CAA+, the definition looks great. But then you recognise that much of the determination is post-factual. We have to remember, in a rapidly developing event, is we don't know after the extent to spread, we don't often have diagnostics, we don't understand the severity that's changing in different places. And the severity may be different. The intensity may be different. So, you're dealing with a moving object. The determination of a public health emergency is supposed to say: ‘’ the emergency exists, we must act collectively, we must act now, we must respond.’’ The characterization of such an event as a pandemic, is a characterization of the event. Pandemos means pan-demos, coming from the Greek ‘’everybody’’. And the assumption of the pandemic is that a pandemic will affect every human on the planet, because people have no previous immunity, and the determinants of the scientific factors associated with the virus or the bacterium, with a pathogen or such, that the virus will become a pandemic. So, the question is, are you defining a pandemic that will occur or are you defining a pandemic that has occurred? And when you still have a fighting chance of containing a disease, when you believe that there's still an opportunity to significantly shut down, contain or transmit the disease, or the transmission of a disease. The question is: does the pandemic definition assist or not assist in that process? So, in that sense, all pandemics in the sense, are public health emergencies of international concern, but not all public health emergencies of international concern are pandemics.
So, we have a public health emergency of international concern associated with Mpox or with polio, but they were never declared as pandemics. You could argue the polio was a pandemic. It was never declared as a pandemic. You could also argue that Mpox was a pandemic, because it affected people all over the world, but it affected a particular population segment all over the world. So, you can get yourself into a lot of twisted discussions. The primary determination is the determination that an emergency exists, and that that emergency requires the collective response of the Member States. What you then characterize that emergency to be, pandemic or not a pandemic, becomes…it is not academic because it has major implications for things like countermeasures and everything else - but I do think one sits on top of the other.
I think it will be difficult in future to have two different instruments that have different pathways to defining both things. And that could be challenging. So, at the very minimum, the two instruments will need to be very aligned on the definitions they use. The worst outcome would be two instruments that actually have any contradictions built in. It is difficult enough at the moment to manage one instrument and pay due respect to that. But there is no question that the IHR itself is not adequate to deal with a pandemic. The question is, where is the pandemic defined? And I think that's been the question going back and forth between the two groups.’’
He also dwelled on the difficulties in qualifying the alerts around emergencies and pandemics considering the implications for actions.
“The binary nature of the PHEIC is sometimes difficult to deal with. Because at one level, you either have a PHEIC or you don't. It's an emergency or it's not. It's a global emergency, or it's not an emergency at all. So, the challenge is: by saying it's not a public health emergency of international concern, then are you actually saying: ‘’it's not a problem.’’ By saying it's a public health emergency of international concern, are you triggering global responses where they may not be needed?
So, there is this issue, and the review committee of COVID-19 had suggested to use a kind of a world alert response. Something as a formal announcement, some kind of intermediate level. We are not here as the Secretariat to define that, but you know, …we kind of have a ready goal. We don't have the set-part. We don't have the part that says we're very worried. We're very concerned. It's not yet a PHEIC, but you know…we could put that out in disease outbreak news, and we can say at press conferences. But there isn't a formal way for the World Health Organization secretariat, or for the Director-General, to say that we're in an intermediate stage or that there's some level in between. And that could be helpful in terms of day-to-day public health management. There is, as I said before, this issue of pandemic definition and the word declaration here, our characterization. Do you declare a pandemic? Or do you characterize a particular PHEIC as being a pandemic? And that's a discussion I think member states need to have.”
Ryan also alerted that the current CAA+ definition while being useful, would not help make a decision on the declaration of a pandemic without relevant data at the time of such a declaration.
“In a sense, a pandemic is almost a prediction of the future. It's to say a pandemic condition exists. The nature of the virus or the nature of the pathogen is such that it will generate a pandemic. Because we want to respond to the pandemic, you have to start before, de facto, every country is infected. You have to trigger the responses early. So, whether or not within your deliberations, a definition of pandemic comes into the IHR or whether it's defined within the INB process, it's really important that those two definitions are the same and then we don't end up with a competing process. Or, quite frankly, it would be, we end up with two parallel decision-making processes to trigger that - I think that would not be helpful.”
On de-escalation, Ryan said:
“De-escalation or termination of a PHEIC is not specified in the IHR 2005…. The secretariat is continuing to try and to find ways that we can continue to keep recommendations out there [in the context of COVID-19 and MPox]. But it's a rather laborious, and it's a bit clunky. And then there are some issues regarding potential regulatory implications and termination of PHEIC. Because so many contractual and regulatory issues at national level are linked to the PHEIC-existence and non-existence of a PHEIC. That it's something that must be taken into consideration.”
THE LEGAL IMPLICATIONS FOR DEFINITION AND GOVERNANCE
During the joint session, countries also had the opportunity to collectively look at the underlying legal questions of both these tracks of negotiations.
Steven Solomon, WHO’s Principal Legal Officer, presented a comparison on the mandates, scope, purpose of both instruments, to member states at the meeting. The relationship between the two processes, and the underlying provisions and considerations in the WHO constitution that have implications for these instruments was also discussed.
Solomon laid out the underlying mandates of both negotiations: the INB was established by the Health Assembly at its second-ever Special session (Dec 2021) (decision SSA2(5)]; the WGIHR was established by the Health Assembly at its Seventy fifth meeting (May 2022) [decision WHA75(9)].
He also pointed out that the IHR language suggests a proportionality approach, taking into account both public health risk and impact on international traffic and trade. The draft language for the INB invokes the principle of equity, the right to health and the principles that are also found in Article three of the Bureau's text.
He also discussed the current language in the Bureau’s text, and existing provisions in the IHR (Article 57) - these suggest the need to interpret relevant international instruments so as to be complementary and compatible. Article 57 of the IHR also anticipates the possibility of concluding treaties to facilitate the application of the IHR.)
While a convention or an agreement is under Article 19 such as the WHO Framework Convention on Tobacco Control [opt-in instrument], the IHR have been incorporated under Article 21 of the WHO Constitution [opt-out instrument].
He also highlighted constitutional mechanisms to promote coherence between the two legal instruments. One option would be to bring a resolution by the Health Assembly in order to adopt both of the instruments and previous instances where this has been done was also cited. Establishing related structures and cross-referencing instruments are other ways to ensure coherence, he said.
A resolution of the Health Assembly can be used to both bridge gaps, and establish coherence among and between different normative products of the Health Assembly, he added.
In response to questions for countries on governance and potential conflicts between the two instruments, Solomon said:
“One of the rationales for the proposal for a third main committee of the health assembly to deal with emergency related items is it could be a forum for consideration of not only the IHR, CAA+, PIP framework, and the initiatives Secretariat…is that we continue to serve those normative instruments as well as WHE operations. But it could [provide for] decision-making accorded to the constituency, the membership of each of those bodies…But clearly with the IHR having 196 parties, anything agreed in that context by consensus would presumably meet the requirements of a CAA+, whose parties would be coextensive with it. So potential issues could be resolved through a common forum….There are other ways to do this through complementary conference of the parties and WHA meetings.”
During the meeting INB Co-Chair pointed out that while the INB would report to the World Health Assembly, the IHR processes report to the WHO Executive Board. These differing reporting lines could have significant implications, she pointed out.
CROSS REFERENCING DEFINITIONS
Solomon also emphasized how definitions can be cross-referenced across both the instruments and cited examples where this has been done.
“One example is the Nagoya protocol which has in its Article 2 use of terms, the chapeau simply states, “The terms defined in the convention shall apply to the protocol”. And this kind of a cross reference can occur not only between parent instrument and the protocol, but it can apply to two instruments that operate in any relationship.
In Article, 1 definitions of the IHR, you will see the chapeau which says for the purposes of the IHR, these are their terms. This could simply be amended to say for the purposes of the IHR and the WHO CAA+ unless otherwise provided here in these terms, mean these things.. So, it's there isn't a problem with defining pandemic and doing that through an amendment of Article 1 definitions of the IHR. For the purposes of clarity, if this is the wish member states, a cross-reference going both ways would make the most sense.
With respect to the question of including the term PHEIC in a definition of a pandemic. This is also possible……you can see this member states have done this with definitions in a range of areas where they have defined a term and then use the understanding for that defined term in other defined terms. It's a building block approach to language and it is helpful both from an implementation perspective and an interpretation perspective.”
LIST OF ISSUES ACROSS TWO TRACKS
A list of issues that feature in both these processes has also been drawn up including on equity, CBDR, ABS, surveillance, financing and capacity building among others.
“It identifies a non-exhaustive list of issues/topics that are being addressed both in the INB and WGIHR processes. It does not purport to propose the allocation of issues or topics to either process,” the document from WHO says.
The country statements below, indicate the preferences of member states on their approaches to deal with common topics across the two tracks of negotiations. In general, many countries were of the view that it is premature at this stage to carve out issues between these instruments. Countries including Australia, Switzerland, the UK, the US among others suggested that while surveillance and other “traditional” IHR topics should continue to be dealt within the IHR, issues including One Health and access to medical countermeasures should be addressed in the INB track.
COUNTRY STATEMENTS
We present excerpts from country statements:
India
“In our view, the definition consideration on the term pandemic is critical to the relationship between the two instruments…
The challenges is this: the fundamental purpose of the IHR is to provide maximum possible protection against international spread of disease while causing minimum interference in trade and travel. This is the delicate balance the IHR strikes. This balance is critical in demonstrating the need for governments to be able to report disease outbreaks promptly without the fear of unduly damaging economic repercussions. We understand it to be the proportionality approach in the IHR.
Article 2 of the IHR, purpose and scope capture this by containing the phrase which avoid unnecessary interference with international traffic and trade. We also note that no amendments to this phrase have been proposed by any Member State… We have heard this morning.. that no matter how a pandemic is defined, it will have to take cognizance of significant economic, trade and travel disruptions, preferably when these disruptions are imminent and have not already manifested as there will be limited value in declaring a pandemic when it is already too late for global action to be galvanized with urgency. This would have to involve a precautionary approach.
Given the nature and character of a pandemic, it can be said that the IHR purpose and scope render, the IHR unfit to contain an effective definition of pandemic. A pandemic will operate under a significant burden of economic disruption and may even need to cause it. The definition and process of declaration of a pandemic by the Director General will have to render the issue of interference with travel and trade as a non-priority. This conflict in the nature of the IHR and a pandemic has the potential to disrupt the balance and the proportionality approach in the IHR. It is also our view that regardless of where the term pandemic is defined, its process of declaration should be contained only in one instrument to give the Director General clear legal authority from a single article of the WHO Constitution…”
European Union
“… When it comes to scope from a legal point of view, the proposals made for both the Pandemic Agreement and the International Health Regulation fall within the constitutional mandate of the WHO as set out in Article 19 and 21 A, respectively. However, we do not see any specific constitutional requirement that would clearly indicate the choice of the Pandemic Agreement or the IHR for any particular issue.
Such a choice may be influenced by other policy consideration, such as the differences between the two instruments in terms of ratification, enter into force or participation. It may, in particular be of relevance when deciding on the allocation of issues under the two instrument to reply to the following question. How important the universality of certain obligation in their rapid entry into force are perceived to be for the effective implementation of the instrument?
We note that the conceptual and operational model of the IHR is widely and universally accepted and appreciated by the WHO membership and that's been integrated in the health security policies and practices of many or most Member States. Taking these considerations into account we consider that amendments the IHR should first and foremost aim at clarifying and strengthening existing IHR provision and increasing their effective implementation. On the other hand, the Pandemic Agreement should clearly, at least address upstream prevention for instant prevention of zoonotic spill overs and downstream issues such as access to countermeasures in pandemic situation and other structure preparedness tools, including science research, cooperation, or support for regional manufacturing of countermeasures, and more.”
On the relationship between the two instruments:
“… in order to resolve or prevent conflicts between provision of the two legal instruments will need to be finalized later in the negotiation when the content of the substantive provision is clear. Essentially, this will be achieved through one or more conflict clauses intended to regulate the relationship between the Pandemic Agreement and other agreements in order to resolve or prevent conflict between provisions stemming from different legal instruments.”
On definition and declaration:
“We believe that in as far as the definition and declaration of a pandemic situation are concerned, it is important to agree on a single and not too stringent definition that would then significantly limit the scope of operation of the relevant provisions. We were put forward a proposal within the package a suggestion we made in the in the context of the Pandemic Agreement and that is contained in the compilation document at page 22.
But if we think that the same definition would definitely need to apply to both instruments..
So, the definition that we suggest, would read as follows: “pandemic situation means a manifestation of a disease, irrespective of origin or source that is spreading, or is likely to spread over a wide geographical area, often worldwide, that is affecting or is likely to affect a large number of person and is creating or is likely to create a severe social disruption and economic loss”.
With respect to the declaration of a pandemic, it is important to keep the same approach which applies to declaration of a PHEIC which is already a well-known process and which is based on a delegation of authority to the WHO Director General.”
Bangladesh
“On relationships between the two instruments, as soon as a pandemic situation is declared closer cooperation among the countries will be required, whether they are party to the pandemic instrument or not. So, wouldn't it be expedient to create a provision that brings all the countries under a common platform. This would help achieve discipline among multiple process and avoid fragmentation in governance and architecture of global health systems. If governance related matters are correlated between the two instruments, it will help attain better coordination as well as make the best use of both financial and human resources…”
“We do believe that the current IHR is functional, surveillance measures are able to detect pandemic potential events. Therefore, we would request the Secretariat to develop a decision instrument based on their experience and existing information to determine the pandemic status of a given outbreak and submit it for consideration of the Member States in INB and WGIHR on relationship, in our understanding the pandemic treaty is adopted as a specialist instrument under IHR in conjunction with WHO constitution agreed provision, the world can achieve much more than that of having a standalone instrument.”
ON FINANCING
“It is better to establish a WHO financial mechanism under IHR 2005 and link it to WHO CA+ because membership of IHR is near universal and larger bulk of capacity building and core list of capacities are mentioned in IHR 2005. And our financial mechanism without any prejudice to its application to WHO CA+. We see its relevance to make a room in IHR.”
The U.S.
“We would like to provide some feedback on the list of topics. We believe that some of the items listed should remain in both texts but may capture different elements. For example, we would not describe equity as being a singular topic, but rather an underlying concept of both of our negotiation tracks and something that should be accomplished through both instruments. As another example, provisions on the oversight for the IHR and the Pandemic Accord will need to be similar but also appear in each agreement….
…. we are interested in the possibility of assigning substantive discussions on topics with overlap to one or the other negotiation track on the understanding that it's temporary placement would be without prejudice to its ultimate location. It could result in ultimately the topic ending up in one negotiation or the other or the one provision on a topic would end up in the IHR and another provision of the same topic in the Accord, or that the same provision could end up in both instruments and complementary ways.
This approach would be especially useful for topics in which the same or similar intent is sought in both instruments, for example, related to access to health products.
We would propose for example, that the topic access to health products be assigned to the INB negotiations were multiple articles linked to this topic and where many experts from Member States have been closely engaged. Any relevant or interested colleagues who participate in the WGIHR could be invited to these discussions.
For the topic of early warning, however, we would recommend that the discussions be held in the WGIHR negotiations and that any interested INB participants be invited to those discussions, since Member States experts have been active in the WGIHR on this topic.
….We feel that an amended IHR and the new Pandemic Accord should be seen as an important package that together will significantly strengthen the global health architecture. To accomplish this, we need to ensure complementarity to both legally to avoid conflicting obligations, but also operationally so implementers around the world can understand expectations and obligations and work together expeditiously to face public health and pandemic risks and challenges. Member States must think through how best to achieve this to avoid unintended consequences that could obstruct rather than support global efforts to prevent, detect and respond we recognize this is challenging, and we welcome not only this discussion, but also future joint work as appropriate to consider substantive areas of overlap and how best to address them to protect people and save lives.
…. in the interest of focusing on substance first, we would like to suggest assigning specific topics to a specific negotiating track, being clear that doing so would not prejudice any outcomes in the other track. We could then invite Members of the other negotiation track to participate as appropriate, facilitating fuller and more efficient negotiations while reducing the overall burden on our delegations….”
Kenya
“We recognize there will be and should be overlaps of certain topics in both instruments which we consider necessary duplication. Kenya further agrees with the list of issues and topics prepared by the Bureau that are being addressed both in the INB and WGIHR processes but believe this list is not exhaustive, since the discussions on the content of the Pandemic Treaty still evolving. We concur with the African group that any discussions on allocation of issues or topics to either of the processes may be premature at this stage, given the differences in the nature and maturity of the two instruments, as well as the scope and the universality of the application. At this point, Kenya is of the view that discussions should focus on unpacking the list of identified issues to provide more granularity in order to bring clarity and improve common understanding as we move towards coherence and complementarity between the two processes.
Japan
“The IHR in our view should focus on presenting norms related to required capacities for each country from a technical perspective. On the other hand, it is appropriate for the CA+ to encompass elements of international collaboration and preparedness, including strengthening of health system, which is important for pandemic prevention and strengthening cooperation or capacity building, particularly in developing countries.”
Namibia
“…It is in fact Namibia's considered opinion that distribution of elements between the two instruments might lead to fragmentation. The two instruments should be vertically aligned and not horizontally separated.
Esteemed Co-Chairs, we need to incorporate equity in both instruments, because we also need to ensure equity for health emergencies that are not pandemics in nature. Containing PHEICs before they become pandemic is of utmost importance. We should therefore continue to discuss equity considerations include in common but differentiated responsibilities and access to health products and technologies under both work streams.
….it is premature at this stage to schedule joint meetings on these issues.
Co-Chair, allow me to address this argument about the universality of the IHR. So much talk about the universal application of the IHR and that CBDR will undermine IHR universal application. This argument does not hold … . We fail to reconcile this argument was affected there is a possibility of filing reservation reservations under the IHR. Some of the current reservations actually qualify the reporting obligations of some Member States under the International Health Regulations and it seems to us that this argument about universality is a mere fallacy.
Co-Chairs, we regret to note that some Member States continue to insist on pushing equity proposals out of the IHR negotiations, notwithstanding the clear legal mandate from the World Health Assembly and the Executive Board to incorporate equity under both works work streams. And we have noted that some are proposing alternative indirect methods which will lead to the same negative result of distributing elements between the two instruments.
Co-Chair, the importance of incorporating equity under both instruments also lies in the fact that it might take longer for some Member States to ratify the envisaged pandemic treaty. While some of them might not even ratify the treaty, we are very much alive to this possibility.”
Switzerland
“…The group, the working group, needs to focus on targeted amendments that focus on clear issues that have been clearly identified. The scope of the regulations defined under Article 2 gives a clear parameter for work on our work needs to keep that in mind. Therefore, Switzerland believes that all new mechanisms are project that goes beyond IHR has to be addressed within the INB which is a key place to develop new ideas.”
…we believe that the working group on IHR needs to approach the following issues surveillance, review of implementation of IHR capacity building, as well as cooperation and collaboration. The following subjects need to be addressed in INB, discussions related to equity, reviews and reports especially the universal review on preparedness UHPR, access to medical products access and shared benefit sharing, funding and financing of response to pandemics, capacity building, as well as collaboration and cooperation, preparation and resilience of health systems.”
Brazil
“In our view, the relationship between the revised International Health Regulations and future Pandemic Accord is complex, and it is important to allow enough time for discussing common issues as they arise in both processes. Therefore, we believe that in the future, we might need other editions of this joint session.
We believe it is crucial to ensure that both instruments are coherent, complementary, mutually reinforcing, and guided by equity in order to address the gaps identified during the COVID 19 pandemic, and another public health emergency of international concern. More perspective, some elements should remain within the IHR, such as surveillance, notification of potential PHEICs, health documents or recommendations on public health measures related to persons and including points of entry. Many member states have also proposed amendments that enhance and make the IHR fit for purpose….
Beyond that, we believe that the determination and the criteria for the determination of the pandemic should be included in the revised IHR building upon the mechanism we already have for the determination of a PHEIC. Our understanding is that any pandemic will necessarily constitute a prior failure and we should have agreed upon criteria or definition for raising the emergency to pandemic level. Determination of a pandemic should be made by the DG taking into consideration the same elements for the PHEIC including advice of the Emergency Committee should also consider some kind of future coordination among the governing bodies of both the IHR and the Pandemic Instrument, once these topics are dealt with properly…Finally, let me stress that each instrument has its own specificity and scope. However, equity is a key concept and should be present both in the future Pandemic Instrument and the IHR. The same is true for access to health products and technologies, implementation support measures, resources and international cooperation. We should distinguish those situations where a country fails to fulfil its obligation because it is unable to, than those that isn’t willing to…”
Australia
“Viewing prevention, preparedness and response as a continuum, the IHR largely focuses on the middle of that continuum, addressing detection, assessment and initial response to disease events. In our view, the pandemic agreement should focus on aspects of the continuum, beyond the scope of the IHR at one end prevention measures to reduce the risk of dangerous pathogens emerging or re-emerging and at the other cooperation and coordination for sustained and effective public health response and recovery, while also reinforcing preparedness commitments under the IHR.
Equity is fundamental across the entire continuum.
We need to be pragmatic on areas of overlap to ensure clarity and avoid duplicating efforts that might complicate or delay critical activities to prevent prepare for and respond to health emergencies. That's why we see it as essential that the Bureau continue to work closely together, facilitating the two negotiation processes working collectively and collaboratively to address weaknesses in the current legal framework for health emergency prevention, preparedness and response. And it's critical that definitions of terms used in both instruments are consistent and clear for effective implementation.
The definitions of a public health emergency of international concern and pandemic are key to triggering major obligations in the respective instruments. Australia support strengthening of the process to declare a PHEIC and the incorporation of new provisions in the IHR to introduce criteria for declaration of a pandemic or pandemic emergency. The criteria must be unambiguous and meaningfully differentiate between a pandemic and a PHEIC. And the definition of a pandemic should avoid restrictive criteria that might delay effective public health responses….
Moving forward on this using the structure and processes we already have in the IHR will allow us to progress on defining other terms proposed for the Pandemic Agreement, including pandemic related products and pathogens with pandemic potential.”
The U.K.
“On the objective scope and relationship between these instruments, the UK believes the objective of the Accord is clear to ensure more effective global prevention, preparedness for and response pandemics. The issues that INB must address include among others, ensuring more equitable access to pandemic response products, driving fast and open sharing of information, building more equitable capacities for research and development, embedding one health approach to pandemic PPR, and sustaining high level political buying and accountability to tackle pandemic.
In parallel, this IHR scope and purpose are clearly stated in Article 2. We believe the purpose and scope of the IHR as the technical framework for a broader range of public health events remain valid and should not be expanded. These regulations are broadly fit for purpose and its strength is in setting out required course valence and response capacities for State Parties. We believe that implementation, especially related to surveillance and information sharing are the primary issues that must be addressed through targeted amendments.”
The Philippines
“There should be an expected and acceptable threshold for conversions in the two instruments. We must emphasize that any redundancy at this point is purely hypothetical. We must resist the urge to compartmentalize prematurely or we risk losing useful proposals together when we have greater certainty over the form that each instrumental take, we can begin to identify where duplication serves to reinforce and where they create conflict and confusion that need to be resolved.”
China
“First, equity should be fully discussed and fully reflected in both documents and instruments. Second, we should reduce duplication, especially in the institutional arrangements including evaluation and reporting should be an arrangement that does not create a dual track that burdens member states compliance and implementation.
Third, regarding the definition of the pandemic with think that it needs to be defined as soon as possible, this is the basis of our next step of work…under the IHR and INB.”
The WTO
“The list of issues that appear in the Bureau's text and the compilation of proposed amendments includes several topics with trade related elements are placed prominently on WTO agenda. This includes topic five, on access to health products, and the allocation of vaccines, therapeutics and diagnostics embedded within topic six on access and benefit sharing. These topics were subject of two pandemic related outcomes of the 12th WTO Ministerial Conference held last June and they continue to be actively considered in various detail bodies. Technology Transfer, for example, has been at the centre of recent submissions by developing and developed country members and we expect that work in this area will be intensified in the run up to 13th WTO Ministerial Conference to be held in February 2024.”
NEXT STEPS
At the open plenary session earlier this week, Co-Chair of the WG-IHR, Ashley Bloomfield said that the WG-IHR bureau will work with the secretariat towards a white paper to address questions on definitions, declaration of the pandemic, the actions such a declaration may trigger, and ways to tackle de-escalation of a pandemic. Future joint sessions with the two bureaux will also likely be planned. Countries including China and the U.S., among others, suggested the need for such joint sessions.
Coming weeks will also see member states discuss how matters such as the access to countermeasures, access and benefits sharing will relate both to the IHR and the Pandemic Accord. Questions on governance, compliance and financing will also need to be resolved across these two tracks.
Sources close to the discussions already indicate the reluctance and difficulties in substantially expanding the scope of the IHR to include such new measures. But ultimately, member states will steer these negotiations in line with their priorities.
Also see from the Geneva Graduate Institute: Averting a collision course?: beyond the pandemic instrument and the international health regulations
HOW EMERGENCIES ARE DETECTED & DECLARED:
Excerpts from the presentation of Mike Ryan at the joint session:
“The main changes in 2005 were the expansion of the scope of IHR. Previous to IHR (2005), [they] were focused on three specific diseases cholera plague and yellow fever. And it moved to an all hazards approach and event-based approach. So the current IHR requires countries to notify WHO of any public health event including biological but also chemical and radiological and nuclear events based on a risk assessment as provided in decision instruments in annex two of the IHR . And that in itself was a big step forward to provide a single instrument to allow countries to determine whether they should be reporting an event at the international level. The IHR also require countries to establish core capacities for surveillance and response and to respond to WHO’s requests for verification. WHO through the IHR was also obliged to share information with states parties and to take into account reports from other sources other than the notification, the official notification of the events.
‘’The decision instrument is fairly complex, we can go into it, but it effectively means that events like smallpox, SARS, wild type polio virus, human influenza caused by a new subtype, always notifiable under the IHR. Any event of potential international public health concern that met two of the criteria listed below. And essentially, that's all managed through an algorithm that countries are able to use.’’
We are using all types of different systems to be able to pick up signals of events around the world. We engage verification through our regional offices and country offices, technical teams, ministries of health. In terms of verification, we carry out standardized risk assessment on a subset of events requiring that risk assessment. And obviously we report rapid risk assessments and events through the GIS platform to member states on disease outbreak news on the World Wide Web, and we coordinate response to such events at an international level.’’
“There is a very complex intelligence workflow, and this is going on 24 hours a day 365 days a year, and is being carried out by all of our regional and country offices…60,000 different pieces of information scanned a month, at least 1000 signals of relevance…[or defective] this leads to 35 new events being detected. Those events are taken through a process to determine whether or not they require formal rapid risk assessment by the Secretary have an average of five of them require those assessments. And as part of that process, we are updating EIS (Events Information Sites) bulletins for events that are ongoing and new events at all times, and putting information of disease outbreak news. This is like a funnel of information that allows us to deal with formal and informal notifications and eventually reach a point where we can carry out risk assessments.’’
“This process can lead to one of two and they are not mutually exclusive processes. One is significant events are always put through our who Emergency Response Framework, which allows us to grade an event. The grading on an event is mainly focused on determining what level of response WHO as an organisation needs to carry out, it gets WHO ready to respond, and it determines the resources, the allocation reallocation of staff and resources needed. So, a grade three event will require an organisation response, grade two events, less. Some events are referred through the DG can determine whether or not he wishes to convene an emergency committee if he believes the Public Health Emergency of International Concern is potentially occurring. The reason why we have these two approaches is much of our emergency response work is occurring in humanitarian settings. And situations like that which don't in themselves require an IHR related process, but the organisation still needs to be able to respond. So these aren't completely parallel processes one feeds into the other. But it is the Director General that will determine whether or not an emergency committee is to be called next.
EMERGENCY COMMITTEE
‘’The mandate of an emergency committee is to advise the DG, if the events represent a public health emergency of international concern or not. It is also to advise the DG of the termination of such public health emergency and to advise the DG on issuance of temporary recommendations….The process of bringing that Committee together, adheres to the regulations on expert advisory bodies, which is part of the WHO basic documents…. Members are selected from a roster of experts and other expert advisory panels of WHO and experts dominated by the affected state party as well. There are rules of procedure [around] confidentiality and conflict of interest measures. The effective state party or parties are always invited to provide information and attend the sessions and the EC reports with the views of ECs provided to the Director General.’’
‘’The WHO Director General has convened an emergency committee under the IHR for 10 events of which seven were determined to constitute public health emergencies of international concern. The definition of a Public Health Emergency of International Concern or PHIEC is the event must be extraordinary, in the sense of being unusual and unexpected, must constitute a public health risk to other states, to the international spread of disease. And it must require coordinated international response. The declaration of a public health emergency leads to the Director General issuing temporary recommendations to the member states and these are defined as non-binding advice for the application for limited time. Risk specific measures to prevent or reduce the international spread of disease meant to minimising interference with international traffic. These are reviewed every three months and the Emergency Committee continues to meet every three months until the PHEIC is terminated.’’
‘’The pathway on termination is not as clear and it's not as defined as such within the IHR. Once a public health emergency of international concern is terminated the DG can issue temporary recommendations for maximum of three months.
The DG can conceive can at the present time, the DG can also issue standing recommendations, but that requires the convening of a review committee and the establishment of standing recommendations associated with that. We are going through that process at the moment for both impacts M-Pox and COVID-19. It represents a rather cumbersome process. But this is the requirements of the IHR. So, we are trying to stick to the letter of the IHR principles here. And then ensuring that there are recommendations that remain. The COVID-19 PHEIC may have been terminated, but the disease is not gone. And countries need to maintain diagnostics, treatment and other and other measures.’’
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