TWN Info Service on Health Issues (Feb23/07)
27 February 2023
Third World Network

WHO: Zero Draft of the pandemic instrument creates an “illusion” of equity

27 February, Geneva (Nithin Ramakrishnan and K M Gopakumar) – The Zero Draft of the proposed pandemic instrument to be negotiated at the World Health Organization creates an illusion of equity.

The Bureau of the Intergovernmental Negotiating Body (INB) released the document WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response known as “WHO CA+” on 1 February 2023.

The 3rd Meeting of the INB mandated the Bureau, with support from the WHO Secretariat, to prepare the Zero Draft with legal provisions based on the conceptual zero draft and the inputs received during the said meeting. However, most of the inputs given by the developing countries seem to have been ignored.  

The 4th meeting of INB to be held from 27 February to 3 March will do the first reading of the Zero Draft.

The Zero Draft largely follows the same structure and chapter scheme of the conceptual zero draft.  It contains 38 Articles spread across chapters. These chapters are: (i) Introduction, (ii) Objectives, guiding principles and scope, (iii) Achieving Equity, (iv) Strengthening and Sustaining Capacities, (v) Coordination, Collaboration and Cooperation, (vi) Financing, (vii) Institutional Arrangements, and (viii) Final Provisions.

It includes three additional provisions when compared to the conceptual zero draft on: (i) regulatory strengthening, (ii) protection of human rights, and (iii) a call for a consultative body for the WHO CA+.

This structure neglects two demands from developing countries. First, a different chapter scheme should be used which would reflect the logical order of the pandemic prevention, preparedness, response and recovery processes on the ground. Secondly, the broader phrase of “pandemic prevention, preparedness, response and recovery” should be used instead of “pandemic and recovery of health systems”. Interestingly the Zero Draft continues to be silent on the determination of the pandemic status of a public health event and WHO’s role in determining the same.

Beyond these glaring concerns, there are at least three others emanating from the Zero Draft.

First, the Zero Draft uses soft law language and future promises on the requirements of equity creating the illusion of equity. It either crafts equity provisions in the form of soft law, or in the form of future promises and promotes “business as usual mechanisms” in the future. Neither capacity building, nor transfer of technology and access to health products are guaranteed using legal obligations. This corresponds to the European Commission’s reflection paper explaining their view on a Pandemic Framework Convention.

Second, the Zero Draft skews the understanding of health systems strengthening, aligning with the health security priorities of developed countries, and has the potential to fragment health systems architecture as well as to compromise the implementation of capacity building under the International Health Regulations (IHR) 2005.

Third, the Zero Draft creates no international obligation on developed countries to finance pandemic prevention, preparedness, response and recovery (PPRR) and therefore neglects the principle of common but differentiated responsibilities in real terms.

In effect, the text simply seeks to generate “political will and commitment” on equity, which is not why the new pandemic instrument has been called for in the first place. A “legally binding instrument” was primarily called by many developing country Friends of the Pandemic Treaty to address the absence of concrete legal obligations relating to equity in PPRR. While those concrete provisions are absent, the Zero Draft in contrast responds to the demands of developed country Friends of the Pandemic Treaty and creates legal obligations with regard to sharing of information, pathogens and genetic sequence information, genomic surveillance in line with One Health Approach. 

The Zero Draft therefore creates an illusion on equity without any substantive legal obligations to translate the concept into concrete deliverables such as equitable access to pandemic health products. This necessitates a major revamping of the Zero Draft which is not possible without calling for textual inputs by the Member States.

The illusion of equity

Chapter III of the Zero Draft titled “Achieving Equity in, for and through pandemic prevention, preparedness, response and recovery of health systems” deals with five elements on: (i) WHO global supply chain and logistics network, (ii) access to technology: promoting sustainable and equitably distributed production, transfer of technology and know-how; (iii) regulatory strengthening, (iv) increasing research and development capacities, and (v) WHO Pathogen Access and Benefit-Sharing Systems.

However, the chapter fails to create any real legal obligation on States or other actors to ensure equity in any of these concerns.

(i)                 WHO Global Pandemic Supply Chain and Logistics Network

Article 6 seeks to establish a WHO Global Pandemic Supply Chain and Logistics Network (the Network) and requires Parties to WHO CA+ to support its development and operationalization. While paragraph 2 of the proposed Article 6 seeks to establish the Network alongside the entry into force of the new instrument, paragraph 6 then goes on to state that “the Parties, working through the Governing Body for the WHO CA+, shall take all appropriate measures to establish and start functioning of the Network no later than XX”. This means the real operationalization of the Network will be delayed by a further unspecified period after the entry into force of the new instrument.

It is important to note that the proposed Network does not include production and mainly focuses on upstream supply chain, i.e. supply of raw materials to manufacturers of health products. This could lead to further concentration of the production and supply of health products unless the text is explicit about the need for diversification of production across all tregions.   

Paragraph 3 of Article 6 solicits support in the development and operationalization of the supply chain network thorough (a) determining types and size of products needed for “robust” pandemic PPRR; (b) assessing anticipated demand for and mapping sources for such products, as well as “existing” delivery and distribution options; (c) identifying the “most efficient”, “multilateral”, “regional” purchasing mechanisms as well as in  “promoting” transparency in cost and pricing of all elements along the supply chain; (d) developing a mechanism to ensure fair and equitable allocation of the products; (e) establishing and operationalizing, “as appropriate”, international consolidation hubs and regional staging area; and finally in (f) developing dashboards relating to supply capacity and availability.

Paragraph 4 requires Parties to “commit not to” impose restrictions that “unduly” interfere with the trade in, or of, pharmaceutical “raw materials”, and “ingredients”.  Paragraph 5 takes support from humanitarian principles to further seek a “legally binding” commitment from Parties to WHO CA+ to facilitate “unimpeded” access to humanitarian staff and cargo.

However, the Zero Draft makes no call for any type of “legally binding commitment”, to ensure unhindered, universal and equitable access to medicines and other health products required for pandemic PPRR. Since the outbreak of COVID-19 many WHO Member States, who are facing various economic sanctions have expressed the need for unhindered access to health products. Yet paragraph 4 which calls against undue interference with the supply chain is limited to only pharmaceutical raw materials and ingredients. Further, paragraph 5 uses the phrase “legally binding” explicitly for qualifying the commitment sought towards access to humanitarian staff and cargo. This means other commitments or mechanisms under Article 6 are not legally binding.

Moreover, the Zero Draft fails to explain what the Network is, what its components are, who the members are, whether it is intergovernmental or not and how the decisions are made in the Network. The use of certain phrases like “working with relevant stakeholders and experts” gives the impression that WHO CA+ is envisaging the Network to be a multi-stakeholder entity that cannot subject Member States to legal obligations. Such a Network will clearly lack legitimacy as well as ability to develop a legally binding allocation mechanism for medicines and other health products required for pandemic PPRR.

(ii)              Access to Technology

Article 7 deals with access to technology promoting sustainable and equitably distributed production and transfer of technology and know-how. Paragraph 1 of this Article recognises the need to address the inequitable access to health products by increasing manufacturing capacity, which is distributed equitably, geographically and strategically. However, the subsequent paragraphs on operationalising this does not contain any clear direction or legally binding provisions to do so. They envisage mechanisms for technology transfer but postpone their creation to a future date after the entry into the force of the new instrument.

For instance, paragraph 2 of the Article requires Parties “working through the Governing Body for the WHO CA+” to strengthen and develop innovative multilateral mechanisms that promote and incentivize relevant transfer of technology and know-how for production of pandemic-related products, on mutually agreed terms, to capable manufacturers. The provision does not further explain what those incentives are or the nature of these mechanisms, whether they will be legally binding or not.

It only means Parties are to work through the governing body of the WHO CA+ to further strengthen or develop them as the case may require, after the entry into force of the new instrument. Thus, it is an empty promise without any legally binding obligations to diversify manufacturing capacity.  Further, such transfer is to be based on “mutually agreed terms” to “capable manufacturers”. This means only those limited existing manufacturers, who can satisfy standards like the WHO Prequalification, will be able to benefit from such mechanisms. Even then, it would be if they succeed in negotiating “mutually agreed terms” – a contract. It is a matter of common knowledge that “mutually agreed terms” means a voluntary licensing mechanism that to date does not transfer technology and know-how in the way and scale that is needed.

Paragraphs 3 deals with the functioning of the above-mentioned mechanisms during inter-pandemic periods. These functions are:  

(a)   facilitate and incentivize manufacturers to transfer technology and know-how, on mutually agreed terms, to capable manufacturers including through technology transfer hubs and development partnerships and to address the needs of development of new pandemic related products in short span of time;  

(b)   strengthen coordination with other international organisations on issues related to public health, intellectual property and trade, including matching of supply to demand and mapping manufacturing capacities and demands;

(c)   encourage entities within their respective national jurisdictions and in particular those that receive significant public financing for research and development, to grant on mutually agreed terms licences to capable manufacturers, notably from developing countries for using their intellectual properties and other protected substances in the process of pandemic response product research, development and production, in particular of pre-pandemic and pandemic-related products;

(d)   collaborate to ensure equitable and affordable access to health technologies.

None of the above actions create any legal obligations and can be termed as best endeavour clauses. So violation, neglect or underperformance of these functions does not create any serious legal consequences because the action verbs used in the clauses (a) to (d) such as “facilitate”, “incentivize”, “strengthen”, “encourage” and “collaborate” are ambiguous in nature. They give multiple ways of interpretation and are not outcome oriented. For instance, any type of facilitating action or encouraging action on the side of the States Party (a corresponding exemption from export duty) would discharge the Parties from the obligations under clause (a) or (c) respectively. It does not matter whether the patent holder or the entity having the technology transferred the technology or know-how to the developing country or not.

Paragraph 4(a) states that Parties, during a pandemic, “will” take appropriate measures to support time-bound waivers of intellectual property rights that can accelerate or scale-up manufacturing of products-related products during the pandemic to the extent necessary to increase availability and adequacy of the products. Similarly, Paragraph 5(a) says Parties “will” apply the full use of the flexibilities provided under the TRIPS agreement including those recognized under the Doha Declaration on the TRIPS Agreement and Public Health of 2001 and in Articles 27, 30, 31 and 31bis of the TRIPS Agreement;

Interestingly the verb “will”, used instead of “shall” in clause (a) and (b) compromises the obligatory nature of the clauses. Further paragraph 4 (c) and (d) stipulates that partis shall:

·         encourage all holders of patents related to the production of pandemic-related products to waive or manage as appropriate, payment of royalties by developing country manufacturers to use during pandemic and to require those received public financing for development of products covered by such patents; and  

·         encourage all research and development institutes, including manufacturers, in particular those receive public funding to waive or manage as appropriate the royalties on continued use of their technology in the production of pandemic related products.

The only obligation under paragraph 4 (c) and (d) is to encourage non-state actors to act, “as appropriate”, and do not create any legal obligations on State Parties.  In short, technology transfer or know-how sharing are subject to interpretation and negotiation as to what is “appropriate” in each of these actions on a case-by-case basis during pandemics, and during inter-pandemic periods it is subjected to “mutually agreed terms”, which again is a subject of negotiation on a case-by-case scenario. As long as relevant entities do not arrive at consensus, on what these agreed terms are or what is appropriate in a given scenario there will be no real transfer of technology or sharing of know-how. This is nothing but transactionalising the pandemic PPRR regime.

(iii)            Increasing research and development (R&D) capacity

Article 9 aims at the increase of R&D capacities and institutions for pandemic-related products particularly in developing countries. However, no clear direction is provided in subsequent paragraphs on how R&D capacity building could happen in developing countries and the role of developed countries and WHO in this regard.

Paragraph 1 adopts an open science with regard to sharing of scientific information, findings and results.  

Paragraph 2 requires Parties, while funding research and development for pandemic PPRR, to do the following, taking into account the extent of public funding:

(a)   “Promote” the free, public dissemination of results of research,

(b)   “endeavour” to include terms and conditions for prices, allocation, data sharing and technology transfer, as appropriate, and publication of contract terms,

(c)   Ensure promoters of research “assume” appropriate level of risk,

(d)   “Promote and incentivize” technology co-creation and joint ventures,

(e)   Establish “appropriate” conditions including on distributed manufacturing, licensing, technology transfer and pricing policies.

Again, the language used in the above clauses are nothing but “best endeavour” clauses and are not outcome oriented. Similarly with Paragraph 3 that proposes to enhance transparency in the publicly funded research including on the prices and contractual terms of public procurement. However, mere pricing disclosures or information about public procurement terms are not enough to scrutinise the actions and pricing policies of manufacturers and whether they are justified or serve equity during pandemics.

A few more ideas such as “global compensation mechanism” for injuries resulting from pandemic vaccines and the need for taking individual and collective steps to build “clinical research ecosystem” are further articulated in paragraphs 5 and 10 respectively. However, Paragraph 6 suggests that pending establishment of a global compensation mechanism Parties “shall endeavour” to exclude buyer/recipient indemnity clauses of indefinite or excessive duration”.

The most significant problem here is that there is no provision to mandate the WHO Global Observatory on Health Research and Development to focus on pandemics. Another important gap is the absence of an institutional mechanism for accessing science related to pandemics. Such a body could do the horizon scanning for emergency technologies and tools, conduct the health technology assessment, prioritize research and development priorities after the assessing the scientific knowledge associated with pandemics. At the same time the Zero Draft promotes the regulatory harmonization as an equity element, in line with the U.S. non-paper submitted to the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies. Harmonization may unnecessarily end up in high compliance costs for developing country pharmaceutical manufacturers as well as small scale and medium scale manufacturers.

Access and Benefit Sharing

Article 10 stipulates that a WHO Pathogen Access and Benefit Sharing System (PABS) for accessing pathogens and genomic sequence and sharing of benefits arising therefrom will be established within a time to be specified by the Parties, Thus PABS is also a system to be established in the future.  

Interestingly, paragraph 2 states that the PABS will cover “all pathogens of pandemic potential, including their genomic sequences” as well as “access” to benefits arising therefrom. Paragraph 3 of Article 10 obligates States to “provide” pandemic potential pathogens and sub-variants to laboratories recognized as part of WHO’s coordinated laboratory network and to upload the genomic sequence of such pathogens to one or more publicly available databases.

In the PABS system envisaged under WHO, access to pathogens is accorded to various recipients by the laboratories that are part of the WHO coordinated network which receives pathogens from parties subject to conclusion of a Standard Material Transfer Agreement (SMTA). It is not clear who is going to develop this SMTA and when. The only stipulation in the Zero Draft is that the SMTA shall provide certain options to recipients/entities accessing pathogens and these are basically (i) real-time access for WHO to 20% (10% donation and 10% at affordable prices) of production of safe, efficacious, and effective pandemic-related products including diagnostics, vaccines, personal protective equipment and therapeutics, and (ii) commitment by the countries where manufacturing facilities are located that they will facilitate the shipment to WHO according to schedules to be agreed by the WHO and manufacturers.

This stipulation is further limited only to benefits arising from pathogens, inconsistent with paragraph 1 of Article 10 which recognizes the need for sharing of benefits arising from genomic sequences shared. It is also strange that a commitment from countries to facilitate shipment is considered as a benefit sharing option. There are several other types and forms of benefit sharing in the Nagoya Protocol on Access and Benefit Sharing; however, they find very limited space in the text proposed for PABS. Sharing of monetary benefits is completely ignored by Article 10.

The Zero Draft also recognizes PABS as a specialised international access and benefit sharing instrument within the meaning of Nagoya Protocol and requires Parties to take measures to give effect to such recognition domestically as well as internationally. Such a recognition can only be accorded if the conditions stated in Article 4 of the Nagoya Protocol are satisfied. The present text creating an obligation to share genetic materials clearly cannot be considered a specialised instrument, as it violates the principle of sovereign rights recognized under the Convention on Biological Diversity and its Nagoya Protocol, and does not provide for adequate legal certainty on the fair and equitable sharing of monetary and non-monetary benefits.

Most unfortunately the provision which envisages access to health products to WHO as a benefit, fails to make it obligatory for the States Parties hosting the recipients of pathogens and genetic sequence information to ensure benefits arising therefrom are shared with WHO. This is currently considered as an optional benefit under clause (h) of paragraph 4.

In short Article 10 seeks to “ensure” transfer of pathogens and genomic sequence to WHO and to recipients by creating a concrete legal obligation to share pathogens and genomic sequence within WHO CA+. At the same time, the Zero Draft relegates the sharing of benefits to “future negotiations” between the WHO, recipients and countries where the manufacturing takes place.

It must be noted that this is not much different from the language of the provisions on strengthening the logistics network, access to technology, or research and development capacities. The Zero Draft therefore effectively reduces the calls for equity into a subject matter that is left open to the negotiating capacities of countries vis-a-vis technology patent holders and product manufacturers. It creates no legal obligation to ensure the relevant capacities are built in the developing countries or the relevant technologies and products are transferred as a matter of fact and equity for pandemic PPRR.

Fragmenting health systems architecture

Chapter IV, titled “Strengthening and sustaining capacities for pandemic prevention, preparedness, response and recovery of health systems” is the corresponding part of Zero Draft that deals with Health Systems Capacities. It contains four Articles. Article 11 claims to deal with health systems preparedness and resilience. Article 12 speaks about strengthening and sustaining the health workforce and Article 13 about preparedness monitoring and universal peer review. Finally, Article 14 deals with protection of human rights during public health emergencies.

The chapter obligates States to strengthen and sustain health systems capacities but provides no concrete obligations on international cooperation and assistance in this regard. Additionally, it assumes achievement of universal health coverage could suffice for health systems strengthening and focuses less on capacity building. It is a known fact that universal health coverage is an insurance package, often driving public money into private sector health care providers and does not contribute to building strong public health infrastructure and universal health care.

Capacity building, even in those provisions where it is included, focuses on emergency capacities, and there again on surveillance capacities and laboratory networks including genomic surveillance systems and One Health approach. Response capacities are out of sight and health systems recovery are mentioned without any clarity as to the actions and policies needed for recovery. Very vaguely it seeks to strengthen public health functions, but resilience is only paid lip service. There are no obligations to determine resilience standards for primary health and hospital care systems and to build up capacities alignment with such standards. There is also no future focus or call for horizon scanning for health technologies and periodic upgradation of health systems capacities.

Thus, Chapter IV repeats the mistakes of IHR 2005, by fragmenting the health systems architecture and prioritizing surveillance. Overemphasis on sophisticated and complex concepts are used to develop ambiguous language with no layer of details on the obligations to be performed by States and the WHO. It is interesting that the preparedness monitoring, and peer reviews prescribed in Article 13, provides nothing for monitoring and measurement of international cooperation and assistance in this health system's preparedness and capacity strengthening.

Further, for instance, while Paragraph 4(c) of Article 11 calls on States to provide for strengthening surveillance, none of the other clauses call on States to strengthen capacities for production and distribution of medicines or health products or increasing the hospital care facilities which are important response capacities. Unfortunately, this disproportionate emphasis on surveillance capacities will continue to hamper the implementation of IHR Annex 1. This is because chapter IV in prioritising once again surveillance capacities will skew international aid further towards surveillance. 

The interlinkage between the new instrument and IHR is very well clear in paragraph 4 of Article 11. It reads thus: “Each Party shall, in accordance with national law, adopt policies and strategies, supported by implementation plans, across the public and private sectors and relevant agencies, consistent with relevant tools, including, but not limited to, the International Health Regulations, and strengthen and reinforce public health functions…”.

The Africa Region, India and Bangladesh have proposed amendments to IHR 2005 Annex 1 to enable a more coherent health systems approach to emergencies.

No Obligation on Provide Equitable Financing

Chapter VI on “financing for pandemic prevention, preparedness, response and recovery of health systems” fixes the primary responsibility on national governments in promoting and protecting public health of their populations. The responsibility of the international community, especially that of the developed countries has been effectively ignored. The Zero Draft calls for financing specifically for pandemic prevention, preparedness, response and recovery of health systems. It is doubtful whether such a provision can effectively address financing for health systems strengthening.

It may be argued that it is legitimate to limit the focus of the provision to pandemic PPRR because of the purpose of the new instrument. However, unless prioritization is given to health systems strengthening and resilience then the provision will defeat the stated purpose of pandemic PPRR. This is because focusing on pandemic PPRR capacities may concentrate resources and investments in emergency capacities, and the general lack of capacities in health systems may once again go neglected.

In a way, the current provision neglects the historical responsibilities of the developed countries and international financial institutions which they control in creating health inequities and other deficiencies in the health systems of the developing countries. These countries therefore have differentiated obligations to provide for more financial and technological resources to developing countries.

Article 19 is therefore, one of the most important provisions of the Zero Draft in which the principle of common but differentiated responsibilities (CBDR) should have been reflected. However, there is not even a mention of this principle within this chapter. Developing countries, both during INB3 and before INB3, have called for financial mechanisms to be established within the new instrument or IHR 2005, which would be accountable to the World Health Assembly. Developing countries have also called for prioritising health system strengthening through enhancement of primary health and hospital care systems in international finance and aid. Nevertheless, none of these demands are reflected in Chapter VI.

On the other hand, the Zero draft calls to avoid the duplication of financial mechanisms, silently pointing towards a World Bank Fund where WHO’s involvement in governance, proposal and result evaluations are limited. It is in the interests of the developed countries to finance pandemic PPRR through this World Bank fund, which does not obligate the donors/developed countries to provide finance and at the same time, give them undue control over the financing policies and conditionalities. 

An empty consolation text has been provided in paragraph 5 of Article 19 to reflect developing countries’ interests: “The Parties represented in relevant regional and international intergovernmental organisations and financial and development institutions shall encourage these entities to provide financial assistance for developing country Parties to support them in meeting their obligations under the WHO CA+, without limiting their participation in or membership of these organisations.”

Need for Member State Proposals

The above analysis shows that the Zero Draft requires drastic improvement to reflect the call for an equitable mechanism to address various pandemic preparedness and response needs. This requires textual proposals from the Member States since the legal texts developed by the Secretariat and the INB Bureau, with regard to equity, kicks the can further down the road.

A current modalities document which is circulated among Member States, however, seeks to avoid this step. It does not invite Member States to submit text proposals for any of the provisions before the meetings of the INB. There will be no compilation of Member State proposals as in the case of the Working Group on Amendments to IHR 2005. It seeks to mandate the INB Bureau once again, along with support of the Secretariat to develop a first draft of the WHO CA+ after the deliberations of INB4 and INB5.

Suggestions on the Zero Draft from Member States can only be raised first orally in the drafting committee meetings of INB4 and INB5, which are closed meetings away from public scrutiny. These suggestions may be made in writing by Member States within one week of each meeting. All these are not only against the true spirit of international negotiations but also efficiency of the negotiations. It permits the entire Zero Draft to be changed into a First Draft through a process handled by the WHO Secretariat without allowing the world outside the WHO to know about the Member States’ arguments and positions on the text of the drafts of WHO CA+.

It must be noted that these arguments and positions belong to category of travaux preparatoires (negotiation history) for the new instrument in the making. The travaux is a very vital instrument for interpreting the provisions of the new WHO CA+ in the implementation stage.  The absence of detailed travaux has already caused several problems in the interpretation of the IHR 2005 and its implementation. It would be unfortunate if the WHO Secretariat is all set to commit the same mistake by closely involving itself with the Bureau and Member States in drafting behind closed doors. +