TWN Info Service on Health Issues (Oct21/09)
16 October 2021
Third World Network

WHO: Secretariat’s analysis on benefits and risks of proposed pandemic treaty stands on feet of clay

Kochi/New Delhi, 16 October (Nithin Ramakrishnan and K M Gopakumar) – The WHO Secretariat’s analysis on the benefits, risks and legal implications of a proposed pandemic treaty, and the weaknesses of amending the International Health Regulations (IHR) 2005 stands on feet of clay without the backing of any rigorous reasoning.

The second meeting of the Member States Working Group on Strengthening WHO Preparedness for and Response to Health Emergencies (WGPR) held on 1-3 September requested the Secretariat to prepare an “analysis identifying potential benefits, challenges and risks of a new instrument and the different options for strengthening the effectiveness and implementation of, and compliance with, the IHR (2005), including the benefits, challenges and risks of amending them”.

The Secretariat’s analysis report contains the following 5 sections excluding the introduction:

• Section 2 provides a brief description of the types of instruments available under the WHO Constitution;
• Section 3 addresses legal and structural features relevant to the analysis that follows, including regarding a potential new instrument for pandemic preparedness and response and adjustments to the IHR;
• Section 4 analyses the value of and incentives for (that is, broadly, the benefits of) making adjustments to the IHR to further address pandemic preparedness and response, and related risks;
• Section 5 provides an analysis of the value of and incentives for (that is, broadly, the benefits of) a new WHO instrument in pandemic preparedness and response, and related risks;
• Section 6 provides the conclusion.

Although, Section 5 states that “the evaluation of benefits is an exercise in relativity”, it nevertheless lists the benefits and risks of the proposed new treaty without much comparison with other options such as amendment of the IHR. It presumes that a new instrument would be a treaty adopted under Article 19 of the WHO Constitution as opposed to Article 21 regulations or Article 23 recommendations.

The cited benefits are categorized in four major areas: Governance, Financing, Systems and Tools, and Equity. Three other benefits such as higher confidence, anchoring on key principles, and constituency creation are also mentioned in the analysis. Section 4 recognizes five risks in adopting IHR amendments, although along with some benefits.

This write-up examines and reviews the analysis provided by the WHO Secretariat.

Purported benefits of a new pandemic instrument (A Framework Convention under Article 19 of the WHO Constitution)

Governance: The analysis states that the current complex and fragmented governance structure has not achieved the “desired levels of effective collective action and equitable access to countermeasures, both of which are essential for pandemic preparedness and response”.

The Secretariat believes a legally binding instrument “could establish a global consensus on the governance architecture of pandemic preparedness and response, devoid of the ambiguity that potentially competing voluntary arrangements might create”. However, the analysis is silent on how this instrument will provide such an outcome. It does not provide any reason why such a legally binding instrument should be a framework convention, which hardly provides any clarity on implementation. The analysis is also silent on why an amended IHR cannot provide for larger coherence.

Curiously, the Secretariat along with the co-sponsors of a new pandemic treaty maintain a position that the new treaty will co-exist with and complement the IHR. This actually indicates further fragmentation of the governance mechanisms; one for “public health emergencies of international concern” under the IHR; and the other for pandemics in a separate treaty. On top of that, the framework convention model of the newly proposed treaty will add to the problem of fragmentation since a framework convention works on the basis of numerous instruments negotiated and adopted separately at a later stage. There is no guarantee but only an assumption that all the WHO Member States will become parties to such a convention and its protocols.

Financing: The analysis states that the current financing of emergency preparedness at the global level is virtually non-existent, variable and fragmented. It also records insufficient funding for pandemic preparedness and response at national, regional and global levels. The funding cycles oscillate between panic and neglect, according to the Secretariat.

The Secretariat projects the new treaty as a solution for predictable and sustainable funding. It states: “while voluntary mechanisms have been established, and are being proposed to address these problems, a binding instrument could frame and/or complement such mechanisms and reinforce them, inter alia, through application of the international legal principle of pacta sunt servanda, the obligation to implement undertakings in good faith”.

It must be noted that there is no guarantee that a new treaty could facilitate such funding. Moreover, the analysis is silent on the ways or mechanisms to achieve predictable, transparent, broad-based, sustainable and flexible funding.

While the function of the Secretariat may not require huge funding and could be financed through the WHO’s assessed contributions scale, the implementation of the treaty provisions at three levels require huge financing, which demands more financial commitments from developed countries. Many developed countries have already opposed the enhancement of assessed contribution to WHO. The current deliberations within the Working Group on Sustainable Financing of WHO once again show the lack of interest in increasing the assessed contributions. The co-existence of a pandemic treaty with the IHR and the WHO programme on health emergency would result in the further draining of scarce financial resources.

Systems and Tools: Regarding systems and tools to deal with pandemics, the Secretariat assumes that there are at least 8 significant areas to be addressed. However, none of these is outside the scope of the IHR while framework principles regarding these areas are already available within the IHR. They are as follows:

No.	Systems and Tools for Pandemic Response	Linkages to IHR 2005
1	Enhancing the global early warning, alert and emergency response system	Already included in Article 5 of IHR 2005; better standards may be prescribed or better technology may be put into use looking at the extent of information dissemination in the public sphere.
2	Ensuring a global health emergency end-to-end supply chain and logistics system	A duty to cooperate is innate and inherent in the IHR 2005. The regulations can only be put into use such that there is no unnecessary interference with trade and traffic (Article 2). Article 43 provides for a review of additional health measures taken up by Member States over and above the WHO recommendations. There are dedicated chapters on international movement of people and goods in IHR 2005. There are also provisions like Article 44 of IHR 2005 which require positive collaboration and assistance in logistical support. An implementation scheme may be prepared and appended to IHR 2005 through an amendment.
3	Mobilizing a global health emergency workforce that is rapidly deployable nationally, regionally and internationally, to detect and respond to health emergencies	Deployment of Medical teams or Health emergency workforce should be subjected to the understanding of sovereign interests of affected states. Local Capacity enhancement must be preferred over this. Presently WHO is under a mandate to maintain adequate resources, material, financial and human for deployment in Member States upon request: Article 44(2) read with Article 5(3) and Article 13(4)-(5).
4	Accelerating research and innovation for health emergencies around a transparent and coordinated global process to pursue research and innovation priorities for collective action	A Global R&D blueprint has been in discussion for nearly a decade in WHO. Research collaboration also comes under the obligation to provide technical collaboration and assistance under Article 44. Many mechanisms are already put into use. The agenda to carve out R&D only for pandemic preparedness is against the sustainable health governance principles such as Universal Health Care and One Health approach.
5	Enhancing and expanding networks, mechanisms and incentives for the sharing of pathogens and biological samples, genomic data to facilitate and accelerate the development of diagnostic tests and evaluation for diseases of epidemic potential.	Biological substances are natural resources over which Member States have sovereignty. Sharing the same with the global community should abide by existing national and international laws on the subject. The same can be discerned from Article 46. However, model agreements like Standard Material Transfer Agreements in the Pandemic Influenza Preparedness Framework can be incorporated in IHR as well.
6	Establishing an access and benefit sharing mechanism to ensure the timely, predictable, fair and equitable access to products arising from the use of such pathogens, biological samples and genomic data.	As mentioned earlier, current international law itself provides for this. A normative advancement is desired in terms of developing detailed benefit sharing clauses and mandatory usage of the same in material transfer agreements under IHR. During a public health emergency of international concern, the benefits must not only be shared with the pathogen provider, but to all populations.
7	Managing misinformation and disinformation needs a coordinated response to manage the infodemic phenomenon that has escalated during the COVID-19 pandemic.	Technical Guidelines are the most appropriate form of instrument in this regard. More than legal obligations, the issue at hand demands more technological know-how and handling of mass and social media outlets.
8	Coordinating a global platform to foster the safe development and implementation of innovative pandemic tools, mindful of the need for international collaboration to accelerate innovation while ensuring the maximum benefit of all such new tools.	This is too generalist in its explanation and IHR 2005 read with other relevant international law provisions can provide an effective basis and working principles for such global platforms. Provisions such as Articles 14, 44, 46 can be put into use as well.

Equity: The analysis states: “A new instrument could address the topic of equity in pandemic preparedness and response, which could include ensuring economic and social protection and advancing respect for human rights, providing for equitable access to healthcare services and medical countermeasures, including vaccines, and ensuring equitable representation and participation (including considering gender, geographic and socioeconomic status) in global pandemic preparedness and response activities and work conducted pursuant to the instrument”.

The analysis argues that a non-binding instrument makes the commitments related to equity “skew towards the aspirational, rather than operational”. Further, it also recognises that such a risk, i.e., couching equity-related provisions in non-binding language, exists even in the proposed new instrument. Yet the Secretariat hopes that “the increased visibility of negotiations on legally-binding terms and conditions could drive expectations, ambitions and results for concrete and operational steps”. This hope is misplaced especially in the light of IHR Article 44, which has already created a legal obligation to cooperate, and has failed to translate into reality. It is not clear how a new treaty would be different.

The other three purported benefits of the treaty mentioned in the analysis are more rhetorical and wishful thinking without any backing of evidence.

Firstly, the analysis assumes that the parties will implement the provisions in good faith when legally binding commitments are established.

This assertion ignores the fact the IHR is also legally binding instrument including a dispute resolving mechanism and yet the implementation is below the required levels.

Secondly, a legally binding instrument under Article 19 of the WHO Constitution “would be grounded in the equitable and human rights principles set out in the Constitution’s preamble”.

This gives an impression that IHR is not grounded on these principles which is misleading. Article 3 of IHR sets out 4 key principles of implementation and two of which directly deals with human rights and equity. It states that the implementation of these Regulations shall be with full respect for dignity, human rights and fundamental freedoms of persons. It shall be guided by the Charter of the United Nations and the Constitution of the World Health Organization.

Thirdly, the analysis hopes that the governing structure under a legally binding instrument will create public attention and non-binding instruments do not create such attention. It cites the example of the WHO Framework Convention on Tobacco Control (FCTC).

Here again, the analysis promotes a new treaty without taking into account the existence of the IHR. While public attention is important in the implementation of international legal instruments, that cannot be a reason for creating a new treaty. Besides, the FCTC is well-known because of the continuous vibrant advocacy and campaigning undertaken by health professionals and civil society activists. The same could replicated for any other type of instrument.

Risks involved in the proposed new treaty

The Secretariat analysis lists the following risks in pursuing the new treaty proposal:

1) Delay in the conclusion of the treaty resulting in delays or non-action on pandemic preparedness;
2) The negotiation on a new treaty requires time and resources which may result in the diversion of resources meant for COVID-19 response;
3) WHO may not be the appropriate forum to deal with cross-cutting issues like trade and intellectual property;
4) The new instrument may result in too rigid or too broad provisions, which may fail to meet expectations; and
5) Varying obligations may come in conflict with the new instrument and existing instruments, and between Member States

The analysis projects the idea of a framework convention as a solution to address the risk of an overly rigid agreement. It states: “an overly “rigid” legal instrument might not be able to appropriately address the multi-faceted and dynamic nature of pandemic preparedness and response. These risks can be mitigated by the instrument choice itself; in particular, the use of a framework convention instrument could enable the over-arching framework to be established, and subsequent negotiations and instruments (for example protocols) on specific subsequent areas”.

The idea of a framework convention, however, itself bears the risk of varying obligations among the parties of the framework convention. The process of adopting protocols is virtually opening up a permanent negotiating forum and protracted negotiations. The risk on varying obligations between instruments and Member States enhances both fragmentation of norms, and of governance and finance. The analysis is silent on the fragmentation of governance and finance and makes only a passing reference to the risk of fragmentation of norms. A pandemic, which requires coordinated action among Member States requires obligations across the WHO membership. This has not been factored in.

Purported risks in amending IHR 2005

The analysis along with four benefits of amending IHR 2005 sets out five risks. They are:

• Indiscriminate treatment of all public health emergencies of international concern;
• Complex Structure involving internal and external cross references;
• Limited Scope of Article 21 of the Constitution of WHO;
• Limited Scope of IHR owing to Article 2; and
• Challenges in creating an IHR compliance mechanism.

However, these risks are unfounded. The first alleged risk of not having a separate definition and regime for a pandemic is a merit, not a risk. An attempt to define “pandemic” will carve out obligations of the IHR and will create a specific scheme of law for pandemics. It will lead to verticalization of health sector development. This is not desirable because obligations under IHR are resource intensive and cannot be effectively discharged until “functioning health systems” are established and maintained at required levels in the territories of Member States. Preparing and working towards capacities only for health emergency itself is a deviation from the “functioning health systems” approach, and there again preparing specifically for pandemics is further narrowing down of the scope of the health development agenda.

According to the Secretariat, the second risk is associated with complexity of the IHR law and is two-fold. First, provisions of the IHR cross-refer to multiple provisions within, and external to, the IHR, thereby creating complexity in interpretation of provisions. Secondly, the Secretariat also perceives adding another layer of alert during the proposed IHR amendments – such as a pandemic alert – and believes that it would increase the complexity.

Both are unwarranted fears. The 2021 IHR review committee has concluded that an intermediary alert is not useful. Having a pandemic treaty will also create another alert mechanism, although outside the IHR. It shall also create a confusion within WHO, regarding which law is to be triggered and when. Moreover, the complexity of having several cross references is the nature of health law, due to the presence of a number of interlinked legal provisions pertaining to health in international law. In fact, health laws are one of the illustrated examples of cross-fertilization of international legal regimes.

To wish this complexity away will in turn require a complex text and interpretation tools to deal with cross referencing. For instance, if a provision of law is made about pathogen and benefit sharing without referring to the Nagoya Protocol on Access and Benefit Sharing, a bare minimum “notwithstanding” clause has to be inserted. Such a clause will affect not only obligations under the Nagoya Protocol, but also under the Convention on Biological Diversity and Article 46 of the IHR. Therefore, the new provision will still require complex interpretation in order to be useful for any practical application. With varying state membership in each of these treaties, the situation is more complex than it appears. There is no doubt that a framework treaty and its subsequent protocols would not resolve, but increase this complexity.

The third risk identified by the Secretariat is the limited scope of Article 21 of the WHO Constitution. However, the scope of Article 21 is actually not so limited; both the text and the subsequent practice indicate broad areas. The scope is enhanced by both practice and interpretation. Two sets of the IHR, one adopted in 1969 and the revised one in 2005 have already stretched the interpretation of the text of Article 21(a) which says “other procedures designed to prevent” international spread of disease”.

Provisions such as Article 21(c) and 21(d) of the WHO Constitution also enhance the scope of regulations. The former provides for standard setting in diagnostics, and the latter provides for regulations to be made relating to the safety, purity and potency of biological, pharmaceutical and similar products moving in international commerce.

The Secretariat further identifies Article 2 of the IHR, which restrains the implementation of the IHR to methods or ways that do not compromise international traffic and trade, as the fourth risk. The Secretariat feels this leads the Emergency Committee and WHO Director-General away from taking a precautionary approach towards public health events. The right approach to reduce such a risk is to bring in more transparency in the decision-making process and make it more evidence-based. A precautionary approach without evidence can lead to several negative consequences on developing countries dependent on tourism and like sectors.

Finally, according to the Secretariat, “Revising the IHR may not appropriately ensure appropriate global pandemic preparedness and response, if States Parties do not comply with the revised instrument. A criticism expressed of the IHR is that the compliance of States Parties with the Regulations is not robust, including, importantly, in the context of a public health emergency of international concern, including in the recent COVID-19 context”.

However, furthering such a misconception or taking the next steps based on this, without attempting to clarify the true legal and obligatory nature of the IHR, is to tacitly accept the proposition that the WHO’s regulatory capacity is not effective. It disregards the compliance mechanisms legally available under the IHR and WHO Constitution. Reporting and reviewing mechanisms under Article 54 of the IHR and Article 62 of WHO Constitution, as well as the dispute settlement mechanisms under Article 55 of the IHR are not used promptly and properly even after almost 15 years of adoption of the IHR 2005. Thus, implementation is the issue, not lack of a legal regime.