BACK TO MAIN  |  ONLINE BOOKSTORE  |  HOW TO ORDER

TWN Info Service on Health Issues (Jan23/05)
27 January 2023
Third World Network

WHO: Will the Zero Draft of pandemic legal instrument incorporate calls for equity?

Kochi, 27 January (Nithin Ramakrishnan) – With the imminent release of the zero draft of the WHO’s new pandemic instrument, a looming question is how far the Bureau of the Intergovernmental Negotiating Body (INB) will incorporate the call for the inclusion of equity provisions.

During the third INB meeting held on 5 to 7 December 2022, many developing country Member States at the WHO demanded the INB Bureau to develop a Zero Draft of the new International Instrument for pandemic with “equity” incorporated in every chapter of the new instrument.

That meeting agreed that “the INB Bureau – with support from the WHO Secretariat – will prepare the zero draft, based on the conceptual zero draft and input received during the third meeting of the INB (INB3), with legal provisions, for consideration by the INB at its next meeting, and as a proposed basis for commencing negotiations at the fourth meeting of the INB (INB4)”.

An advanced English version of the zero draft is expected by 1 February 2023, and the translated version – in all other WHO official languages – by 10 February.

The conceptual zero draft (CZD), which was tabled for discussion in INB3, approached equity as one of the several components and had confined “equity” to only Chapter III. This approach insulates other chapters of the pandemic instrument from equity. However, developing countries view equity not only as one of the major objectives, but as “the central element” of the new instrument.

The CZD was developed around 35 Articles distributed across 8 chapters: (i) Introduction, (ii) Objectives, principles and scope, (iii) Achieving Equity, (iv) Strengthening and Sustaining Capacities for PPRR (pandemic prevention, preparedness, response and recovery), (v) PPRR coordination, collaboration and cooperation, (vi) Financing, (vii) Institutional Arrangements, and (viii) Final Provision. These chapters were discussed briefly during the INB3. The CZD however did not include a title of the instrument as the scope of the instrument is yet to be decided. Developing countries want the new instrument to not only address prevention, preparedness and response, but also “recovery”.

Developing countries highlighted certain missing elements in the CZD and called on the INB Bureau to include them in the Zero Draft. Also, in most of the chapters several demands have been reiterated by developing countries to ensure the pandemic treaty will not fall short of the obligations on equity.

Missing elements in the CZD

  1. Definition of a pandemic: The most important concept which could help bring clarity in the negotiation of the new pandemic instrument is the definition of “pandemic”. This is currently not included in the CZD. Delaying even a working definition puts countries into a difficult situation since they are forced to negotiate without prior understanding of what a pandemic is. Countries including Bangladesh and Brazil, and even the United Kingdom and Singapore, have called for definitions.
  2. Determination of status of outbreak as a pandemic: Unlike the International Health Regulations (IHR) 2005, which provide clarity on the authority and the process by which a disease outbreak is characterised as a “public health emergency of international concern” (PHEIC), the CZD draft provides no explanation or place holder provision for the determination or declaration of a disease outbreak or health concern as a “pandemic”.
  3. Obligations of WHO: Almost 20 out of the current 35 Articles in the CZD speak about what States Parties must do in the context of pandemic prevention, preparedness, response and recovery (pandemic PPRR). However, none speaks about what actions will be undertaken by WHO for pandemic PPRR. This omission is extremely dangerous, because without a proper role and distinguishable functions for WHO, there will be no framework to monitor or review the WHO’s actions during a pandemic. The current language will not help hold WHO accountable for a coordinated international public health response to a pandemic. This is important since WHO is the central actor in the pandemic PPRR regime.  It is understood that there are a few developing countries who have called for the inclusion of “obligations of WHO” in the CZD in their submissions to INB2 and written submissions thereafter. The Africa Group of 47 Member States clearly demanded that the zero draft’s language must reflect the obligations of WHO and other stakeholders, not just that of the Member States. Countries like Indonesia, Botswana, Bangladesh, Malaysia, Uruguay, and Costa Rica have called for describing the obligations WHO, one or other way.
  4. Expansion of Recovery: The developers of the CZD have been parsimonious when it comes to the recovery from pandemics. The background note says the CZD has incorporated recovery to the extent it relates to recovery of health systems after a pandemic. However, developing countries in the previous INB meetings called for inclusion of recovery in a more general manner, which may include recovery of economic or social sectors which get affected by the pandemic outbreak and spread. The WHO Secretariat who was explaining the inclusion of “recovery of health systems” in the CZD, during the INB3 meeting, maintained that recovery is included “purely” from a health systems perspective.

South Africa, on the behalf of the Africa Region said that the pandemic has shown the need to reinforce funding at the national level to be able to counteract the pandemic at different stages. It supported the inclusion of recovery in the instrument. However, it went on to say that “in the current CZD, recovery is very limited and limited to health systems, although we know the interrelatedness of health systems with other systems. Therefore, it looks like other sectors may not benefit from the support for recovery. For the health to implement one health approach for instance, they would require all systems involved from other sectors to be equally functional and that may also need support for recovery.”

  1. Concrete actions and descriptions of legal measures: The CZD failed to explain the concrete actions which the State Parties and WHO will undertake in the context of pandemic PPRR, perhaps owing to the placeholder nature of CZD. This has led to calls, especially by countries from the South-East Asia Region (SEAR) and from the Africa Group, for clearer language and clarity on the obligations of Member States, and other actors.

Malaysia said that the CZD uses the word “measure”’ several times without details on what those measures are in particular, and it requested further improvement and clarity on the CZD. India on behalf of SEAR stated that “Member States are of the view that for the negotiations to begin earnestly at INB4, the bureau should provide legal language instead of the imprecise language of the CZD”.

  1. Equity as a component in decision making: Even though the entire call for new instruments began with the shocking realisation that lack of equity was at centre of the breakdown of the COVID-19 response, whenever it comes to decision-making several provisions in the CZD use the phrase “science and evidence-based”, for example in Articles 13(2)(b) and 15(2)(b). This gives the impression that equity considerations have no place in the decision-making process.

It must be kept in mind that countries like Bangladesh had repeatedly pressed for a change in this style of language in previous meetings of the INB and in the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR). The country has persistently asked for using the phrase “science, evidence and equity-based decision making”, instead. Bangladesh re-emphasised the same in INB3. The need for socialisation of science and technology would be reflected in this model of decision making. The Africa Group has been very vocal about three aspects of equity in previous INB and WGPR meetings, i.e. goal, principle and outcome.  This means every decision in the context of pandemic PPRR, whether at the national level or at the WHO, should be made only after mainstreaming equity considerations.

Equity as the “bedrock” for the Zero Draft development

Many Member States, not only developing countries but also some developed countries, agree that equity should be at the heart of the new instrument. Equity has been reiterated several times in different ways, for example equity has been pressed to be included in the new instrument as “objective”, “principle”, “outcome”, “goal”, “central elemental”, “core element” etc.

The Africa Region lead in this call. According to one delegate, “This will not be a reality until we embed equity in every chapter and every provision of this new instrument”. South Africa on behalf of the Africa Region stated that “equity should remain at the centre, objective principle and an outcome. We welcome that equity is a standalone [in] chapter III, but we stress the need to have equity issues threading in all chapters across all elements.”

India on behalf of SEAR observed that “ensuring equity has been one of the abiding challenges during this (COVID-19) pandemic. Equity is the bedrock of this instrument and each chapter of this instrument should be informed by and strive for achieving it.”

Fiji, in particular, called for specific monitoring of the measures relating to equity. Several other developing countries such as Nigeria and Pakistan argued that language on equity provisions should be modified such that equity should be ensured at every stage, i.e. prevention, preparedness, response and recovery, and also in access to products and technologies used at each of these stages. Some others highlighted that in the current CZD draft equitable access is limited to “pandemic response products”.

Bangladesh very keenly observed that equity provisions should be triggered at the PHEIC stage itself, only then the international community can ensure a PHEIC does not evolve to become a pandemic. Further, Brazil and Saudi Arabia called for equity considerations to be integrated in the One Health Approach.

Access and Benefit Sharing – “two sides of the same coin”

Article 9 of CZD speaks about access to pathogens with pandemic potential and genetic sequence data and fair and equitable sharing of benefit arising therefrom (ABS). However, in its second paragraph, the first clause calls for benefit sharing, the second clause calls for measures to recognize ABS as a specialised system, and then the third clause discusses sharing of pathogens and genetic sequence data measures.

The second paragraph calls for engaging with stakeholders in the design and development of the system which violates the principles of the Framework for Engagement with Non-State Actors (FENSA).

In this way the CZD is creating confusion to the concept of ABS and the processes involved in the mechanism. ABS processes begin with provision of access to genetic resources such as pathogens and their genetic sequence information, and end with the fair and equitable sharing of benefits arising from the utilisation of such genetic resources. The text of Article 9 however impairs the concept by reversing the order of sharing. This helps the developed countries like the U.S. which seeks to undermine ABS by delinking “access to pathogens” and “fair and equitable benefit sharing”. They argue, both within INB and outside, that the existing ABS model is transactional and creates delay in health response to emergencies.

As a response, Indonesia stated that, “We are pleased to see that ABS are already included in CZD, but we would like to suggest ABS as a standalone section. On this, we would like to underline sharing of pathogen samples and benefits derived thereof, should not be seen as something transactional. These issues should be seen as two sides of the same coin, one cannot be accessed without the other one. Our past failure to concretely address ABS, why we are still in a pandemic and why some countries are lagging behind in vaccinations.”

The WHO already has an ABS mechanism in the context of Pandemic Influenza Preparedness (PIP) Framework and Member States have clearly agreed that they have “commitment to share on equal footing the H5N1 and other influenza viruses of human pandemic potential and the benefits…” The framework also recognizes “these as equally important parts of the collective action for global public health”.

[COVID-19 response has benefited enormously from the PIP Framework, even though it was not characterised as influenza. Over 90 percent of the laboratories that benefit from the Framework worked during COVID-19.  50,000 specimens were tested through these facilities each week. More than 50 countries shared their COVID-19 data through an established influenza platform. Over 94 percent of the countries supported by PIP authorised COVID-19 vaccines within a 2-week period.

More than five million people have enrolled in the COVID-19 courses through a PIP-supported open WHO platform. 40 countries supported by PIP developed COVID-19 response plans early on. All this was made possible with very limited income generated through the PIP Framework through annual partnership contributions made by pharmaceutical manufacturers, which does not even amount to 1 percent of the profits they make.]

Linking the ABS with access to technology and diversification of the production of medicines and vaccines, Nigeria’s statement reads as follows: “Given that technology transfer is not predictable and sustainable at the moment, the obligatory role of WHO in facilitating these must be set out in the document of providing process for implementing technology transfer for production of … medical products and vaccines in a pandemic. There is also the necessity to clearly state ABS provisions in the document and where necessary situate the operational mechanism to include availing WHO of requisite technology and know-how for inevitable diversification of production of all medical necessities during pandemics in designated production facilities across the global community.”

Namibia further stated: “… on chapter 3 particularly on the question on achieving equity through the development of a fair and equitable benefit sharing mechanism. An agreement on access and benefit sharing is one of the major equity issues to be resolved by this INB, as we seek to find an agreement of ABS for purposes of this instrument, we must not lose sight of the IHR amendment process where proposals for expeditious access to genetic sequence material including genetic sequence data had been put forward without corresponding proposals of benefit sharing. In other words, we must guard against final outcomes whether through the IHR amendment process or the INB process, where access to pathogens and genetic sequence data is prioritised without a clear and comprehensive benefit sharing mechanism. We remain hopeful that the proposed meetings between the bureaus of INB and IHR amendment process will ensure that necessary guidance is provided to prevent unequal outcomes… We do not want Article 9 in the conceptual Zero draft to be interpreted as an aspirational ABS to be achieved in the distant future. We would support having a standalone chapter as suggested by Indonesia or alternatively having an annex to the instrument of ABS…”

While countries such as Brazil, India, Bangladesh, Botswana and others also supported the calls for ABS mechanisms, Uganda notably invited attention to another aspect of the ABS regimes. It stated: “We already know that over 80 laboratories handle highly contagious and infectious pathogens for research purposes. There are no global surveillance mechanisms to ensure that these laboratories are sharing their biomarkers, biobanks and about their research activities. This is something we need to add to the treaty.”

Common But Differentiated Responsibilities (CBDR) as key to equity

The principle of “Common but Differentiated Responsibilities” (CBDR) recognises the different levels of socio, economic and scientific development among the community of nations. Countries including India, Namibia, Pakistan, Paraguay, Brazil, Botswana, Iran, Indonesia, Nigeria and Bangladesh stressed on incorporating this principle to the new pandemic instrument. It must be noted that India has proposed an amendment to incorporate the same principle in the IHR 2005 as well.

Pakistan not only emphasised the principle’s suitability for adaptation, but linked CBDR with the realisation of equity. “We would first like to join others welcoming the focus that has been put on equity in Chapter III, and also that the principle of CBDR and respective capabilities should be reflected here… this principle holds a great amount of significance in terms of equity as well.”  In its opening statement as well, Pakistan stressed the centrality of anchoring the principle of CBDR and respective capabilities in the draft text and said that it is important that burden sharing is done in line with national capacities and circumstances.

Paraguay, recalling Fiji’s statement, stated further, “We do not have the same capacities. Even though the pillar of equity is enforced in this treaty, it is probable that there are asymmetries that continue when it comes to dealing with future pandemic. Therefore, we consider that we should analyse how we can include shared (as translated by Spanish interpreters) and differentiated responsibilities. This should be included in the framework of the pandemic treaty.”

Bangladesh also stressed the importance of altering the provisions on international collaboration and cooperation in the CZD on the basis of the CBDR principle.

Botswana highlighted that though the CBDR principle is mentioned in the CZD as a principle to be applied, the same has not been translated into differentiated responsibilities in the rest of the parts of the CZD.

Call to make One health Approach equitable

Regarding the idea of a One Health Approach, the CZD is not clear as to how the new instrument will address this. The measures which need to be considered under this approach within a pandemic instrument must be enumerated. Only then can the impact on the implication of this new approach be studied. It must be noted that a One Health Approach has been a scientific concept so far and incorporating it into a legally binding text such as the new pandemic instrument must be done very cautiously, not only by understanding the scope of the concept and its application, but also by negotiating a legal definition for the approach.

On the other hand, the CZD focusses on building a gigantic surveillance infrastructure, without adequate reflection of commensurate benefits for the developing countries that could be reaped from this approach. Left open-ended and unclear, a One Health Approach would run directly counter to a crucial rationale for a new pandemic instrument, i.e. to overcome the inequities experienced in COVID-19.

Against this background, Brazil has underpinned the importance of principles of sustainability, equity and CBDR for One Health Approach as well as the promotion in a balanced and cohesive manner of the three pillars of sustainable development (economic, social, environmental). According to Brazil, the measures of infectious diseases are a complex and multi-causal phenomenon, which makes it inappropriate to identify very narrow drivers of pandemics. Each country and region face their own specific one-health challenges and therefore there cannot be one-size fits all. Brazil further remarked that the concept needs to be more matured in the instrument.

Countries such as Saudi Arabia, South Africa and Indonesia also called for expanding equity to One Health provisions.

Argentina also remarked that a One Health Approach should be based on scientific principles which do not discriminate between countries and should not be used inter alia as a trade restriction. Even certain developed countries like Japan called for more clarity.

The INB Co-chair clearly recognized the divergence over the scope and manner in which the approach will be applied. Meanwhile Bangladesh expressed reservation against using pandemic treaty provisions for effectuating the non-negotiated One Health Joint Plan of Action developed by the quadripartite consisting of WHO, FAO, OIE and UNEP.

New and existing financial resources

While several developing countries called for financial assistance and sustainable financing, Paraguay made it very specific that the instrument should be clear about the existing financing resources and the new resources. It pointed towards the emphasis in the CZD on increasing the funding at the national level for building capacities and stated that the instrument needs to be a “treaty of international cooperation and solidarity”.

According to Paraguay, international cooperation and solidarity is fundamental in the strengthening of national capacities and the zero draft should reiterate this. It stated further that “we also mentioned mechanisms of financing that are new and existing ones to build capacities at national and regional level. Regarding this, it would be interesting to include the types of mechanisms already being used and mechanisms that should be used to avoid ambiguities and to make sure that we have a clear landscape of the measures that the parties will have at their disposal.”

In this regard, Namibia also observed that, “… it’s either we establish new international financial measures or we rely on already existing established international mechanisms. As per our submission yesterday, our preference is the former. If we are to entertain the idea of relying on an already existing international mechanism, we need more clarity. What are these already existing international mechanisms? What is the governing structure of these mechanisms? Who holds these mechanisms accountable? Was WHO membership involved in the creation of these international mechanisms?” and is there any role for the WHO Members or all developing countries, to the extent necessary for access funding for pandemic preparedness, prevention, response and recovery, irrespective of their classification of low, middle or upper middle-income? We also ask ourselves whether these already established funds would be able to provide pandemic preparedness and response finance to countries under unilateral coercive measures? Or donor countries influence decision making to block the provision of finance to some countries?”

Uganda questioned the chapter on financing in the CZD and categorically stated that Chapter VI on Financing is incomplete. It then set out 4 types of measures to be included in this regard: (i) measures to initiate debt relief mechanisms in developing countries with active disease outbreaks; (2) measures to restrict  payments for existing national debts for a time-bound period for countries with active epidemic events; (3) measures to ensure commercial banks have mechanisms to relieve or restructure debts payments for citizens for a time-bound period during active pandemic or epidemic; (4) measures to maintain annual contingency funds for employees in the address disruption of health and well-being during pandemic event.

Bangladesh wanted the financial mechanism to be able to fund implementation of both IHR and the pandemic instrument obligations and to be managed by the WHO. This according to Bangladesh would not fragment the resources available for WHO for health emergency purposes.+

 


BACK TO MAIN  |  ONLINE BOOKSTORE  |  HOW TO ORDER