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Politics of Pandemic Agreement- A Beginners Guide


Marking four years since the pandemic was declared and two years into its formation, the World Health Organization’s (WHO) Inter-Governmental Negotiating Bureau (INB) for the Pandemic Agreement unveiled the Negotiating Text on March 7th, 2024. This text will be discussed during the ninth and penultimate session of the INB, to be held from March 18th to 28th in Geneva. Subsequently, it will undergo deliberation for formal adoption at the 77th World Health Assembly, set to convene at the end of May 2024.Top of Form

The scope of this article is to present a brief and accessible introduction to one of the most important global health policy developments of our time. One in which global geopolitics is inextricably linked with public health concerns. Although an analysis of the lines introduced and removed throughout the preceding eight negotiation sessions of the INB would be interesting, our current focus is solely on the penultimate text presented to the global community. Our aim is to highlight where the battle lines are drawn and why. (For an in-depth exploration of the draft’s development, Geneva Health Files provides an excellent resource. While it may require payment to access, it is certainly worthwhile. Also see, Kerry Cullinan, New Pandemic Agreement Draft Lands &Text-Based Negotiations Can Begin, Health Policy Watch, Pandemic Agreement 11/03/2024 • Kerry Cullinan ).

Alongside the INB’s efforts, discussions on amendments to the International Health Regulations (IHR, 2005) are ongoing. The IHR serves as the key international legal framework for addressing pandemics and Public Health Emergencies of International Concern. It’s crucial to view the amendments to the IHR 2005 and the text of the Pandemic Agreement as interconnected entities.

Section I: About the “Negotiating Text”

We start by introducing the Negotiating Text of the Pandemic Agreement, dated March 7th, 2024. Originally named the Pandemic Treaty, it’s now titled the WHO Pandemic Agreement. Unlike declarations, agreements are binding on Member States that ratify them.

The 31-page text is divided into three chapters. Chapter I sets out the definitions, objectives, and principles. Chapter II covers the main actions required for Pandemic Prevention, Preparedness and Response (PPPR) and Chapter III (article 21 to 36) deals with Institutions, Governance, and legal provisions.

The definitions are useful to any public health scholar, for they will have the legitimacy of a signed international agreement. The objective is a one-line statement: “The objective of the WHO Pandemic Agreement, guided by equity, and the principles and approaches set forth herein, is to prevent, prepare for and respond to pandemics.” There are some big wins for developing countries in the six principles set forth in article 3. Each of these six principles represent the main areas of contention between the developing world and the industrialized nations: These six are:

  1. Full respect for the dignity, human rights and fundamental freedoms of all persons, and the enjoyment of the highest attainable standard of health of every human being.
  2. the sovereign right of States to adopt, legislate and implement legislation, within their jurisdiction, in accordance with the Charter of the United Nations and the general principles of international law, and their sovereign rights over their biological resources.
  3. equity as the goal and outcome of pandemic prevention, preparedness and response, ensuring the absence of unfair, avoidable or remediable differences among groups of people.
  4. common but differentiated responsibilities and respective capabilities in pandemic prevention, preparedness, response, and recovery of health systems.
  5. Solidarity, transparency, and accountability to achieve the common interest of a more equitable and better prepared world to prevent, respond to and recover from pandemics; and
  6. the best available science and evidence as the basis for public health decisions for

The sovereignty principle was stated explicitly to respond to the fear raised that a pandemic agreement would give powers to the global health body or other newly created global health institution to impose their choice of strategy. In particular this related to the fear of imposed global or regional lockdowns. While the principles have been welcomed, concerns have been raised as to whether these principles are supported by substantive commitments in the main text.

Articles 4 to 8: Strengthening health systems for PPPR.

Article 4 of the text covers social determinants of pandemic prevention and the necessity for a comprehensive microbiological surveillance system. This entails countries ensuring clean water, sanitation, infection prevention, and control in healthcare settings. It highlights the importance of vector control, zoonotic disease identification and control, laboratory biosafety, and antimicrobial resistance(AMR) management. It also stresses coordinated microbiological surveillance, including entomological and zoonotic aspects, with timely feedback to the WHO.

Article 5 calls for a One Health approach, the document defines One Health quite adequately “as an integrated, unifying approach that aims to sustainably balance and optimize the health of people, animals and ecosystems. It recognizes that the health of humans, domestic and wild animals, plants and the wider environment (including ecosystems) is closely linked and interdependent.”  The action points are restricted to establishing of laboratories and enhanced surveillance, placing a burden on developing countries that lack these resources. At the same time, they fail to offer specific tools or strategies that can be operationalized in the developing countries to prevent damage to the ecosystem.   Top of Form

Article 6 is a call for a commitment from countries to develop, strengthen and maintain its health system, including primary health care, with equity and resilience, with a view to the progressive realization of Universal Health Coverage (UHC). UHC has been clearly defined and this article further reiterate the importance of ensuring access to routine essential services during the pandemic. It also calls for post-pandemic recovery strategies, strengthened health information systems, better risk communication and community engagement.

Article 7 complements article 6 and is a very clear and powerful expression of the need for a large public health workforce, with adequate skills and good terms of employment and provisions for worker safety and social security as a necessary condition.

Article 8 leaves it to the countries to monitor and report on progress.

All of this is well said, but can developing countries do all that is required in the above articles? Most countries are far away from UHC.  The text does call on “Parties commit to cooperate, within means and resources at their disposal, and with the support of the WHO secretariat and other relevant organizations, in order to provide or facilitate financial, technical and technological support, assistance, capacity-strengthening and cooperation, in particular in respect of developing countries.”

The article notes that the national capacities differ, and that there is a need for cooperation to close funding and technical gaps so that countries can catch up to the public health standards in each of these areas and achieve an adequate preventive capacity. But who sets these standards and what if the means and resources at the disposal are not adequate. Who does the term “other Parties” refer to and how binding is it on them to respond. If “other parties” refers to multi-stakeholder participation or donor investments, they encounter challenges of constrained agendas, restricted timelines and lack comprehensive plans for system or institutional strengthening, transition, and sustainability. These aspects are crucial considerations particularly for low resource settings.

Articles 9 to 15: Access to Scientific Knowledge and Essential Technologies:

These articles are potentially a big step forward to one of the central concerns of the agreement- ensuring universal access to scientific knowledge and technologies required for preventing and responding to a pandemic.

Article 9 is a call for further investment in research and development It calls for research on 1) epidemiology of emerging diseases, and pandemics, on 2)  public health and social interventions used to control pandemics and the burden imposed by these measures on society and on 3) relevant health products, with the aim of promoting equitable access, including their timely availability, affordability and quality.

One positive gain in this treaty is its endorsement of the need for transparent and publicly shared research inputs and outputs stemming from government-funded research and development of pandemic-related products. This includes scientific publications with securely shared and stored data.

Such provisions may include: (i) licensing and/or sublicensing, preferably on a non-exclusive basis; (ii) affordable pricing policies; (iii) technology transfer on voluntary terms; (iv) publication of relevant information on research inputs and outputs; and/or (v) adherence to product  allocation frameworks adopted by WHO; and (b) publish relevant terms of government-funded research and development agreements promoting equitable and timely access to such products during a pandemic emergency.

Article 10 is a call for promoting public and private sector investments aimed at creating or expanding manufacturing facilities for pandemic-related products, especially regional manufacturers based in developing countries.

Article 11 calls for developed nations to transfer the technologies required for such distributed manufacture of essential medicines, vaccines and devices. There’s a strong focus on building capacity in developing countries for manufacture of both pandemic related and routine health products especially where public financing has contributed to product innovation and development. It calls for timeliness and transparency in sharing relevant licenses and agreements, and a commitment to share licenses of government owned products. It specifically urges countries to fully utilize the flexibilities granted by the TRIPS Agreement, as emphasized in the Doha Declaration on the TRIPS Agreement and Public Health of 2001. The Doha declaration prioritizes public health concerns over intellectual property rights.

Article 12, The focus is on pathogen access and benefit-sharing (PABS), involving the establishment of “the WHO Pathogen Access and Benefit-Sharing System (PABS system)- a multilateral system for access and benefit sharing for pathogens with pandemic potential”. Its goal is to enable timely access to biological materials and genetic sequences of potential pandemic pathogens to facilitate product development for their control. These materials will be shared through WHO-coordinated laboratories. In exchange for sharing, countries must provide access to benefits from medical products developed. The WHO will sign binding contracts with manufacturers to ensure this. Manufacturers will make annual financial contributions to support the PABS system and commit to providing a portion of products at not-for-profit prices during emergencies.

Article 13 provides for establishing a Global Supply Chain and Logistics Network the details of which would be worked out by the conference of Parties. It also provides for government procurement of commodities and some of the principles regarding stocking, distribution, and allocation. It calls for transparency regarding purchase agreements.

Article 14 is on the regulatory mechanisms to approve new products and for quality assurance and article 15 is on liability and compensation mechanisms.

Articles On Coordination, Financing and Governance.

Articles 16 and 17 are on coordination across nations and within nations and 19 focusses on support to developing nations. Article 18 is on communication and awareness and calls for promoting the use of scientific medicine and addressing the problems of misinformation. Article 20 deals with financing.  It calls for strengthening domestic financing, promotes the use of debt relief to cope with and respond to pandemics. It also proposes the establishment of a “Coordinating Financial Mechanism” to support the implementation of the pandemic agreement and the International Health Regulations (IHR).

In Chapter III, all articles from 21 to 37 deal with different aspects of institutional design and governance for the Pandemic Agreement.

Section II The Big Political Issues:

1. Pathogen Access and Benefit Sharing (PABS):

During the COVID-19 pandemic, scientists began to design vaccine candidates only a few hours after the first SARS-CoV-2 genome sequence was shared. By the end of 2020, mass vaccination had begun in the United States and Europe. High-income countries promised to share vaccines through the voluntary WHO COVID-19 Vaccines Global Access (COVAX), they failed to meet this commitment. Today, nearly one-third of the world’s population has still not received a single dose, and the death toll resulting from vaccine nationalism continues to grow. Over 100 countries led by South Africa and India appealed to WTO for an emergency waiver of intellectual property rights related to Covid vaccines, but these proposals were blocked. It’s estimated that the death toll could have been less by a million if this had been granted and domestic manufacture had been started up 1.

Till the 1993 Convention on Biological Diversity recognized parties’ sovereign rights to their ‘genetic resources’, scientists in the industrialized countries frequently took samples from the global south without permission or collaboration and used these to make products that yielded huge profits. But they did not consider it necessary to share these benefits with the countries from which the samples were taken. Under the Nagoya Protocol on Access and Benefit-sharing of 2014, countries developed laws to ensure benefits- which could be financial or technology or collaboration. This was provoked by the Indonesian government in refusing to share the 2009 H1N1 avian flu virus samples.

In the pandemic treaty negotiations, representatives of developed countries are arguing against such sharing on grounds that a PABS clause would block progress towards open Science. But a group of 290 scientists have written in arguing for such a clause. Now though the clause is agreed, the division is on whether the access to information on pathogens should be bartered with ensuring the sharing of benefits on account of providing such information. Developed countries oppose a “transactional mechanism” and seek to make access compliance independent or stronger than commitments to benefit-sharing. Developing countries view this as crucial to ensure equitable and fair access to essential countermeasures, and for addressing concerns about sovereignty and agency.

The proposed agreement text is aimed to ensure that their scientists share lifesaving data openly and rapidly. Scientists will still be able to share their data freely outside of PABS platforms, and WHO could also establish its own repository or clearinghouse for genetic sequence data and samples, which would potentially provide scientists with more transparent management of these resources and the guarantee of continued access. The current clause provides for 10% of the products to be provided back to this pool at controlled prices and 10% would be free, but others argue that this is far too little.  These are important gains, but not enough. The global South would want binding commitments on benefits in terms of both products and transfer of technology.  They would also not want to leave contracting of manufacturers for PABS with WHO secretariat and would seek developing countries concerned to be involved. The global north on the other hand will want to weaken commitments on benefit sharing while strengthening compliance rules for sharing access.

Even on access a new area of concern has emerged.  Many countries, both developed and developing require transparency considerations in the kind of information shared, how data flows, who owns the data, how is it stored. This is particularly important for developing countries like India, China and other BRICS nations since they have the capacity to make their own medical counter-measures if they have the access to the biologic material and genome sequences.

The battlelines are clear.

2. The Intellectual Property Rights (IPR) Issues:

The Covid 19 pandemic saw a very few companies being able to develop a vaccine and then stock-piling these far in excess of their capacity, while most countries, languished for want of even minimal doses. These led to a large number of avoidable deaths. It led to huge inefficiencies as stocks expired in the stockpiles of the industrial nations. It also led to super-profits for a few corporate. It also saw a huge rise in tax based public health expenditures, meaning that this enrichment of the corporates was at the cost of the public.

The corporate companies and the countries that depend on IPR to maintain their dominance in global manufacturing and trade, defend the current IPR Regime on the basis that such profits are essential to offset the costs and risks of innovation and product development. They argue that without such profits, Big Pharma cannot undertake the expensive research that is required to innovate new products and bring them to the market. It is not only the profits, these companies also have the monopoly over production, making it impossible to scale up production. They argue that LMICs do not have the capacity to undertake quality production, and these countries are better off buying from these corporates.

These arguments are rejected by developing countries, by the academic community and civil society. They point out that there is little evidence that these profits are ploughed into innovation of products of public health importance. Further these costs of innovation can be estimated, and can be paid to them, while de-linking it from market prices. Market prices need to be based only on the costs of manufacture. There is much justice in this demand since most of the investment in research is through tax based public financing- and allowing corporates to include the costs of innovation into prices is asking the public to pay twice for the same product. Quite often these companies do not do the basic research that is required, contenting themselves with buying up patents that are promising and using it to wield monopoly powers.

For these reasons the statements in articles 9 to 15 on building a regime of innovation and development are most welcome—but they clearly do not elaborate far enough. For example, there are no binding commitments on corporates to share the technology developed, especially when it is based on public financing. While it talks of implementing the TRIPS flexibilities these are quite difficult to implement, especially during an emergency. What the world requires is an agreement that the declaration of a public health emergency of international concern should automatically trigger the waiver of all patents that are required to manufacture all the required diagnostics, vaccines and medicines. There is also no mention of a dedicated “Technology Access Pool.” that was proposed during the pandemic, and which could reduce the dependence on developed countries and would facilitate development of production facilities in the LMICs   It is unlikely that having resisted so far, the developed world would concede this in the next round of negotiations. LMICs could walk out of the agreement, for without these clauses they would have little to gain from an agreement. However, most of them are so dependent politically and economically on the developed countries that they are unlikely to do so.

One question is why governments of the west are so stubborn.  After all the European Union is conceding the need for such measures within the region. President Biden has been accused  of showing double standards- standing up to Big Pharma when it comes to domestic health security and letting go when it is the interests of the rest of the world.

In an open letter 2 coordinated by the People’s Vaccine Alliance, organizations such as Oxfam, the African Alliance, Innovarte, and Public Citizen have called on EU and US leaders to back measures in the pandemic agreement that ensure equity in access to new technologies. These measures include facilitating lower-income countries’  to overcome intellectual property barriers, making public funding of R&D contingent upon sharing pharmaceutical technology with Global South nations, and ensuring transparency in global health by publishing all government contracts with involved companies

Understanding these double standards leads us to fundamental lessons in geopolitics. The advanced, industrialized economies, once colonial powers, amassed wealth through unequal trade terms they imposed. In today’s neo-colonial phase, maintaining economic and political dominance still relies on these unequal trade terms. While manufacturing is cheaper in LMICs, intellectual property rights (IPR) regimes enable Western nations to locate production in their settings and reap profits; or even better manufacture in developing countries and make the profits flow back to the west. The substantial profits in pharmaceuticals benefit not only corporations but also drive economic growth and high returns on investment in shares and stocks for a significant portion of the population in these nations.

These terms of trade will change only if developing countries make major steps in domestic manufacture and innovation- and this is one area where the negotiators of the South have been hard at work. But even here there is a push-back from the developed world.

It’s challenging to gauge the winners in these negotiations. While positive clauses are added, others seem to be amended in the opposite direction, making it hard to track changes across articles 9 to 15. One way to assess progress is by considering whether the combined clauses of the IHR amendments and the Pandemic Agreement place the world in a better position for responding to future pandemics, at least as regards enabling timely and widespread countermeasures. In the COVID-19 pandemic, only China and India among low- and middle-income countries (LMICs) managed to launch such measures, with India having only one manufacturer for each of its two vaccines, one on voluntary licensing and another indigenously developed, and both made super-profits. While the agreement acknowledges the issues at stake, at this has to be welcomed, the answer to whether the world is better prepared is NO. Negotiators from the Global South must gain much more traction in the last rounds of negotiations to achieve the necessary health equity, security, and sovereignty.

3. Universal Health Coverage & Pandemic Preparedness/Response

This is another area of divergence between what LMICs require in an agreement and what is conceded to them by the Western powers. Articles 4, 6, 7 & 8 are welcome in that these express the importance of strengthening health systems and achieving universal health coverage.

A simple axiom would be that if a nation is unable to provide healthcare and social security in normal times, it is unlikely to be able to provide it in times of a pandemic. The reality is that many countries are very far from achievement of universal health coverage, built on the foundations of primary healthcare. Most developing nations do not have the financial resources that achievement of universal health care requires. This reflects on the stage of development they have achieved after throwing off the yoke of colonialism, but also on poor governance and the impact of continuing wars and conflicts, displacement and migration. Indebtedness to the global north consequent to structural adjustment policies is also a huge problem.

The other reason for the poor status of health systems in the developing world are the structural adjustment policies enforced by global financial institutions. In the earlier period the emphasis was on restricting public provision of care to very minimalist selective packages and leaving the rest to private markets. This undermined public health systems and increased inequities in access and outcomes and greatly increased the costs of care. In the past decade health sector reforms promoted by global institutions have taken the form of shifting the role of governments from provider of services to purchasing care from private sector service providers often in the form of publicly funded insurance programmes. But this did not work for pandemic response. We learnt this lesson in the covid pandemic.  Most of the contracted private providers did not rise to the occasion. It was the public health services that had to be relied on. Yet the whole agreement is silent on this aspect and has no warnings against such enforced policies of privatization.

The IHR 2005 also deals with health systems strengthening under its articles that relate to the building of core capacity. Reforms in these articles could also provide scope for a clear acknowledgment of the structural barriers to health systems strengthening and what needs to be done to address this [i] .

Clearly there must be a global commitment to finance health systems strengthening which is based on publicly administered systems operating outside a market framework.  And health systems strengthening has to be on terms where healthcare is provided as if it is a public good- and unrelated to peoples ability to pay for it.  In addition, developing countries call for debt relief or debt swaps, so that the current payments to repay loans are legally permitted to be diverted to strengthening health systems. Africa in particular lobbied hard for this, and one of its leading negotiators from Angola, made a convincing cases for a financial package to least developed countries for health systems strengthen to enable them to fulfil the surveillance obligations being imposed on them. Journalists report that some developed countries were influential enough to persuade Angola to change this troublesome negotiator 3.

What is articulated in the current text is just an appeal to the Parties to close the gaps , “within means and resources at their disposal,” and with “the support of the WHO secretariat and other relevant organizations, in order to provide or facilitate financial, technical and technological support, assistance, capacity-strengthening and cooperation, in particular in respect of developing countries .”  This is really a status quo position. There are no binding commitments linked to road-maps and financing arrangements on how this would be achieved. If the only gain is nominal global recognition of the need to support member countries in health systems strengthening, developing countries are conceding too difficult to achieve obligations in disease surveillance which would alter priorities and allocation adversely. Moreover, the pressures of compliance on data sharing comes without effective mechanisms of data governance. Moreover, they commit to achieving standards and guidelines set by global institutions, and these could potentially become legal obligations.

Doubt has also been raised in civil society circles that the term Parties, though usually used for denoting the member- countries, could be extended to global institutions who could then be financed to take over certain national functions.

[i] Lisa Forman et al, Reforms to the International Health regulations must Advance Human Rights Newsletter #70, Geneva Health Files, March 8th, 2024.

4. Asymmetry in Pandemic Response:

There are many equity related issues in the pandemic treaty [i]. One major equity-related overarching issue with pandemic response in the agreements, particularly in the IHR amendments, is that while countries’ obligations to provide information from strengthened disease surveillance are becoming stricter, the global community’s commitment to assisting developing countries in responding to pandemics remains weak and uncertain.

In colonial times healthcare provision in the colonies was usually directed to protecting the health of the elite living in colonial enclaves from the diseases raging in the population. outside. This same pattern could be seen to be repeating on a global scale with the west strengthening protective measures across its borders, but otherwise leaving the majority in developing nations to fend for themselves.

[i] KM Gopakumar, On the brink of legitimizing Inequity; Negotiations at WHO for a Pandemic Instrument and Amending the IHR, Geneva Health Files, Newsletter Edition #67, 27th February 2024

5. The One Health Issue:

There have been some concerns regarding how feasible it is for developing countries to implement obligations as set out on OneHealth. Article 6, addressing OneHealth, appears to outline a series of desirable principles. In practical terms, its call for countries struggling to establish clinical laboratories to fulfil obligations to establish animal health institutions and environmental laboratories with international standards is very far bridge to cross. Most of these nations have not yet established adequate surveillance for human diseases.

Further all this only helps with surveillance and early reports. What the Agreement does not acknowledge is that the damage to ecosystems occurs from the terms of industrialization, commercialization in food production and intensified extraction of natural resources, largely due to corporate control, and any attempt to address this requires a complete re-think of the development agenda. But developing countries also need development. What are the alternative paths of development that respect harmony with nature and desist from depletion and degradation of natural resources?  Would that not require different terms of international cooperation and terms of trade and restraints on corporate power? All of these are not part of the discussion. Perhaps they are ruled out of the scope of the agreement. But what remains is very onerous obligations on surveillance that includes animal health and potential spillover viruses, and data sharing on the same. These can hardly be achieved without serious compromise on finances for strengthening public services.

6. Human Rights and Social Restrictions:

The other big concern is regarding the imposition of social and economic restrictions considered as necessary for the control of the pandemic. In many countries the costs and consequences of such restrictions was more than that caused by the pandemic itself. This could be seen by the popular response to lock-downs.

In high income countries lock-downs were initially welcomed by most political and working organizations that represented the interests of working people. Social protection measures protected them, at least partially from the closure of work places and public transport. Of course even here some sections like school children were largely adversely impacted. It were the corporates  and governments who were worried because of the loss of wages and the payouts due to social security. On the other hand in low income countries, where there are almost no social security measures for the largely unorganized workforce, lock-downs were a catastrophe. Though some elements of restriction would have been necessary at times of peak spread to “flatten the curve” at most times the risks of the disease were less than the risks of disruption of economic and social life. The most clear examples of this was the massive distress migration that India witnessed as migrant labour left stranded in the cities trekked back hundreds of miles with families due to closure of both work places and public transport without any warning whatsoever. Further in almost all LMICs, the call for social restrictions led to the management of a public health emergency as a law and order issue with militarization of the state response and wide-spread abuse of human rights.

A popular internet ditty attributed to a Damien Barr during the covid 19 lockdowns was: “The We are all in the same storm: but not in the same boat, some are on super-yachts  and some have just one oar.” The biomedical features of a pandemic may be the same across countries but the balance of risks and consequences of measures to contain the spread could be vastly different.

There in nothing in this agreement to respond to this experience. There are some important articulations. One is a reassurance against encroachment of sovereignty with special reference to lock-downs. Article 24 declares that “ Nothing in the WHO Pandemic Agreement shall be interpreted as providing the Secretariat of the World Health Organization, including the WHO Director-General, any authority to direct, order, alter or otherwise prescribe the domestic laws or policies of any Party, or to mandate or otherwise impose any requirements that Parties take specific actions, such as ban or accept travellers, impose vaccination mandates or therapeutic or diagnostic measures, or implement lockdowns.”

The second of these is the use of the phrase “common but differentiated responsibilities and respective capabilities”.  Derived from climate change negotiations, the incorporation of this principle in the text marks significant progress, achieved through rigorous negotiation efforts. This principle has effectively supported arguments for access to medical products, though even here substantive commitments are weak. However, there is no correlation established between this principle and the necessity to ensure that future social restrictions are proportionate to the risk, considering that the balance of risks will fluctuate with social conditions.

While both these declarations are welcome neither the developed countries nor the developing countries, felt it necessary to ensure that lockdowns will be evidence based, limited in duration and scope and sub-groups covered, proportionate to risk, and with adequate support and compensation for those most affected. In many countries authoritarian rulers, elected or otherwise, found the pandemic a convenient excuse to deepen repression, and this is not acknowledged, let alone addressed.

One must note that article 3 of the IHR calls for preventing civil and political rights in the response to a pandemic. But this has no teeth and further does not extend to the social and economic rights. It could not even address the disruption of routine health services, often shut down by governments. The greater the degree of marginalization, the more such populations got affected. Amendments to the IHR should be used to address this. IHR is currently inadequate to mandate building robust health systems or ensure social security arrangements that can kick in during an emergency.

A closely related issue is vaccine mandates. Article 36 of IHR article prohibits countries from requiring health documents including certificates of vaccination except where the WHO has issued such recommendations. During the COVID-19 pandemic many countries made vaccination a requirement for entry and exit, and moreover often specified that vaccines approved in their countries would be considered. This was illegal and discriminatory against the majority of the worlds’ population who had either no access to any vaccine or only to a vaccine developed in their countries.

7. Governance and Accountability:

The main mechanisms of governance for the agreement that are proposed is a Conference of the Parties (COP) as is usual for most agreements. In the Conference of Parties each country will have one vote. The WHO will act as its secretariat. That could help in coordination with the existing IHR. There are contestations of whether a COP is required, and whether the WHO should be the secretariat, but if this is an Agreement adopted under Article 19 of the WHO constitution, that more or less follows.

However, one of the major issues of contestation is whether this whole text should be adopted under article 19 of the WHO constitution, in which case it would be known as a Pandemic Agreement, or Treaty or Covenant. Or should it be adopted under Article 21 of the WHO constitution in which case it would be known as Pandemic Regulations. The official mandate is to develop the Agreement under article 19 but a space was kept open to revert to article 21.

For a detailed discussion refer to Priti Patnaik, Pandemic regulations or Pandemic Agreement Growing Affinity for Article 21 over Article 19, Geneva Health Files, Newsletter #66, February 24th, 2024 [i] So far, the proposal has been to adopt it under article 19, in which case the Parliament of each country has to ratify the agreement for them to be included. Choosing to opt-in involves an active process. Therefore, Article 19 entails a stronger binding of countries to the commitment, but it also poses the risk that many countries, including the USA, might dilute provisions unfavourable to corporate interests during negotiations and ultimately walk out without ratifying it, as they have done previously. Additionally, it will likely take considerable time for enough countries to sign on.

On the other hand, if approved under article 21, it is applicable to all countries unless they opt out. Opting-out is the active process. But whereas article 19 is a treaty or agreement applicable to all concerns of WHO, article 21 are regulations more restricted to preventing the international spread of disease. For background it is useful to note that WHO has two treaties under its governance. The Framework Convention on Tobacco Control is under Article 19, and the International Health Regulations are under Article 21.

Article 21 is a narrower mandate, the obligations are more focussed, its quicker to implement, and it does not require a separate governance mechanism. If the negotiations bring about a text that is suited to the developed world, the preference for article 21 would grow. Article 19 on the other hand has a wider scope and the developing world needs that wider scope to put health systems in place, and develop alternatives to the current regimes of innovation, manufacture and access to technologies.

It is difficult to state which option is better. A lot could depend on the position that the BRICS nations and within that the position India would take.

[i] Priti Patnaik, Pandemic regulations or Pandemic Agreement Growing Affinity for Article 21 over Article 19, Geneva Health Files, Newsletter #66, February 24th, 2024.

In conclusion:

There can be no confusion about what are the requirements of the majority of the world from the Pandemic Agreement and the amendments of the International Health Regulations. If the countries are united and the emerging economies within the developing world, which are represented in the BRICS+ alliance take a leadership position, not only in defence of their national interests but also on behalf the developing world, much can be achieved. To date India and most emerging economies have acted with considerable clarity and purpose in these negotiations defending their own interests and pushing for changes especially with regard to access to medicines.  However global health diplomacy in an unequal and unfair world is unpredictable and often countries compromise on their health interests in return for bargains to be made in other sectors like trade, security or political endorsement and alliances.

It needs an alert public health community to monitor and shape the public discourse on what countries need from these treaties for achieving health equity and health security. While access to technologies or medical countermeasures remains the central focus of the negotiations, we also need to bring the attention of policy makers on the requirement of progress towards Health for All and the need to ensure that we never again have to experience the social, economic, health and human rights catastrophe that we have just been through during the Covid 19 pandemic.


    1. Shalini Singh for detailed edits and comments
    2. Source of information and discussion of issues
      1. Geneva Health Files
      2. PHM’s WHO Tracker:
      3. Third World Network


  1. Carlson C, Becker D, Happi C, et al. Save lives in the next pandemic: ensure vaccine equity now. Nature. 2024;626(8001):952-953. doi:10.1038/d41586-024-00545-3
  2. Civil-Society-Open Letter on People’s Vaccine -to-Presidents-Biden-and-von-der-Leyen March-11 2024.pdf.

3. Patnaik P. EXCLUSIVE: Did Some Developed Countries Oust Africa Group’s Key Negotiator, a Forceful Voice on Equity Provisions in INB-IHR Negotiations? Geneva Health Files. Published December 1, 2023. Accessed March 17, 2024.

Other Key Readings:

i). Lisa Forman et al, Reforms to the International Health regulations must Advance Human Rights Newsletter #70, Geneva Health Files, March 8th, 2024.
ii). KM Gopakumar, On the brink of legitimizing Inequity; Negotiations at WHO for a Pandemic Instrument and Amending the IHR, Geneva Health Files, Newsletter Edition #67, 27th February 2024

iii).  Priti Patnaik, Pandemic regulations or Pandemic Agreement Growing Affinity for Article 21 over Article 19, Geneva Health Files, Newsletter #66, February 24th, 2024.

This article is posted at the website For more background resources on this issue you could visit conversation Health Policy in the same website.

Comments (2)

Excellent work

The six contradictions between developed and developing nations makes it clear that we should achieve all these demands. But in the present system one side we should for these rights and secondly we should fight for implementation of these rights.

I fully endorse the position. The PHM has to take its movement to leaps and bounds

With regards
S. Sukumar

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