The World Health Organization (WHO) and its 194 Member States have been engaged for over two years in the development of two “instruments” or agreements with the intent of radically changing the way pandemics and other health emergencies are managed.
Historical Perspective
These aim to increase the centralization of decision-making within the WHO as the “directing and coordinating authority.” This terminology comes from the WHO’s 1946 Constitution, developed in the aftermath of the Second World War as the world faced the outcomes of European fascism and the similar approaches widely imposed through colonialist regimes. The WHO would support emerging countries, with rapidly expanding and poorly resourced populations struggling under high disease burdens, and coordinate some areas of international support as these sovereign countries requested it. The emphasis of action was on coordinating rather than directing.
With the evolution of the WHO in recent decades from a core funding model (countries give money, the WHO decides under the WHA guidance how to spend it) to a model based on specified funding (funders, both public and increasingly private, instruct the WHO on how to spend it), the WHO has inevitably changed to become a public-private partnership required to serve the interests of funders rather than populations.
Why May 2024?
The WHO, together with the World Bank, G20, and other institutions have been emphasizing the urgency of putting the new pandemic instruments in place earnestly, before the “next pandemic.” This is based on claims that the world was unprepared for COVID-19, and that the economic and health harm would be somehow avoidable if we had these agreements in place.The urgency for May 2024 is clearly therefore inadequately supported, firstly because neither the WHO nor others have demonstrated how the harms accrued through COVID-19 would be reduced through the measures proposed, and secondly because the burden and risk is misrepresented. In this context, the state of the Agreement is clearly not where it should be as a draft international legally binding agreement intended to impose considerable financial and other obligations on States and populations.
Based on the DG’s claims, they are essentially redundant, and what new non-mandatory clauses they contain, as set out below, are certainly not urgent. Clauses that are mandatory (Member States “shall”) must be considered within national decision-making contexts and appear against the WHO’s stated intent.
The COVID-19 response resulted in an unprecedented transfer of wealth from those of lower income to the very wealthy few, completely contrary to the way in which the WHO was intended to affect human society. A considerable portion of these pandemic profits went to current sponsors of the WHO, and these same corporate entities and investors are set to further benefit from the new pandemic agreements. As written, the Pandemic Agreement risks entrenching such centralization and profit-taking, and the accompanying unprecedented restrictions on human rights and freedoms, as a public health norm.
To continue with a clearly flawed agreement simply because of a previously set deadline, when no clear population benefit is articulated and no true urgency demonstrated, would therefore be a major step backward in international public health. Basic principles of proportionality, human agency, and community empowerment, essential for health and human rights outcomes, are missing or paid lip-service. The WHO clearly wishes to increase its funding and show it is “doing something,” but must first articulate why the voluntary provisions of the current IHR are insufficient. It is hoped that by systematically reviewing some key clauses of the agreement here, it will become clear why a rethink of the whole approach is necessary. The full text is found below.
The commentary below concentrates on selected draft provisions of the latest publicly available version of the draft agreement that seem to be unclear or potentially problematic. Much of the remaining text is essentially pointless as it reiterates vague intentions to be found in other documents or activities which countries normally undertake in the course of running health services, and have no place in a focused legally-binding international agreement.
“Recognizing that the World Health Organization ... is the directing and coordinating authority on international health work.”
“Recalling the constitution of the World Health Organization ... highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”
“Deeply concerned by the gross inequities at national and international levels that hindered timely and equitable access to medical and other Covid-19 pandemic-related products, and the serious shortcomings in pandemic preparedness.”
“Reiterating the need to work towards ... an equitable approach to mitigate the risk that pandemics exacerbate existing inequities in access to health services, ...”
As above—in the past century, the issue of inequity has been most pronounced in pandemic response, rather than the impact of the virus itself (excluding the physiological variation in risk). Most recorded deaths from acute pandemics, since the Spanish flu, were during COVID-19, in which the virus hit mainly sick elderly, but response impacted working-age adults and children heavily and will continue to have effect, due to increased poverty and debt; reduced education and child marriage, in future generations.
“(i) ‘pathogen with pandemic potential’ means any pathogen that has been identified to infect a human and that is: novel (not yet characterized) or known (including a variant of a known pathogen), potentially highly transmissible and/or highly virulent with the potential to cause a public health emergency of international concern.”
This provides a very wide scope to alter provisions. Any pathogen that can infect humans and is potentially highly transmissible or virulent, though yet uncharacterized means virtually any coronavirus, influenza virus, or a plethora of other relatively common pathogen groups. The IHR Amendments intend that the DG alone can make this call, over the advice of others, as occurred with monkeypox in 2022.
“(j) ‘persons in vulnerable situations’ means individuals, groups or communities with a disproportionate increased risk of infection, severity, disease or mortality.
“This is a good definition—in Covid-19 context, would mean the sick elderly, and so is relevant to targeting a response.
“‘Universal health coverage’ means that all people have access to the full range of quality health services they need, when and where they need them, without financial hardship.”
While the general UHC concept is good, it is time a sensible (rather than patently silly) definition was adopted. Society cannot afford the full range of possible interventions and remedies for all, and clearly there is a scale of cost vs benefit that prioritizes certain ones over others. Sensible definitions make action more likely, and inaction harder to justify. One could argue that none should have the full range until all have good basic care, but clearly the earth will not support “the full range” for 8 billion people.
This Agreement is specifically for pandemics (a poorly defined term but essentially a pathogen that spreads rapidly across national borders). In contrast, the IHR amendments accompanying it are broader in scope—for any public health emergencies of international concern.
“2. the sovereign right of States to adopt, legislate and implement legislation”
The amendments to the IHR require States to undertake to follow WHO instructions ahead of time, before such instruction and context are known. These two documents must be understood, as noted later in the Agreement draft, as complementary.
“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.”
This definition of equity here needs clarification. In the pandemic context, the WHO emphasized commodity (vaccine) equity during the COVID-19 response. Elimination of differences implied equal access to COVID-19 vaccines in countries with large aging, obese highly vulnerable populations (e.g. the USA or Italy), and those with young populations at minimal risk and with far more pressing health priorities (e.g. Niger or Uganda).
Alternatively, but equally damaging, equal access to different age groups within a country when the risk-benefit ratio is clearly greatly different. This promotes worse health outcomes by diverting resources from where they are most useful, as it ignores heterogeneity of risk. Again, an adult approach is required in international agreements, rather than feel-good sentences, if they are going to have a positive impact.
“5. ... a more equitable and better prepared world to prevent, respond to and recover from pandemics”
As with “3” above, this raises a fundamental problem: What if health equity demands that some populations divert resources to childhood nutrition and endemic diseases rather than the latest pandemic, as these are likely of far higher burden to many younger but lower-income populations? This would not be equity in the definition implied here, but would clearly lead to better and more equal health outcomes.
The WHO must decide whether it is about uniform action, or minimizing poor health, as these are clearly very different. They are the difference between the WHO’s commodity equity, and true health equity.
Equity in health should imply a reasonably equal chance of overcoming or avoiding preventable sickness. The vast majority of sickness and death is due to either non-communicable diseases often related to lifestyle, such as obesity and type 2 diabetes mellitus, undernutrition in childhood, and endemic infectious diseases such as tuberculosis, malaria, and HIV/AIDS. Achieving health equity would primarily mean addressing these.
In this chapter of the draft Pandemic Agreement, equity is used to imply equal access to specific health commodities, particularly vaccines, for intermittent health emergencies, although these exert a small fraction of the burden of other diseases. It is, specifically, commodity-equity, and not geared to equalizing overall health burden but to enabling centrally-coordinated homogenous responses to unusual events.
“2. The Parties shall undertake to cooperate:
“(b) in support of ... initiatives aimed at preventing pandemics, in particular those that improve surveillance, early warning and risk assessment; ... and identify settings and activities presenting a risk of emergence and re-emergence of pathogens with pandemic potential.
“(c-h) [Paragraphs on water and sanitation, infection control, strengthening of biosafety, surveillance and prevention of vector-born diseases, and addressing antimicrobial resistance.]”
The provisions under this long article mostly cover general health stuff that countries try to do anyway. The difference will be that countries will be assessed on progress. Assessment can be fine if in context, less fine if it consists of entitled “experts” from wealthy countries with little local knowledge or context. Perhaps such compliance is best left to national authorities, who are more in use with local needs and priorities. The justification for the international bureaucracy being built to support this, while fun for those involved, is unclear and will divert resources from actual health work.
“6. The Conference of the Parties may adopt, as necessary, guidelines, recommendations and standards, including in relation to pandemic prevention capacities, to support the implementation of this Article.”
Here and later, the COP is invoked as a vehicle to decide on what will actually be done. The rules are explained later (Articles 21-23). While allowing more time is sensible, it begs the question of why it is not better to wait and discuss what is needed in the current INB process, before committing to a legally-binding agreement. This current article says nothing not already covered by the IHR2005 or other ongoing programs.
Nothing specific or new in this article. It seems redundant (it is advocating a holistic approach mentioned elsewhere) and so presumably is just to get the term “One Health” into the agreement. (One could ask, why bother?)
“2. Each Party commits ... [to] :
“(a) routine and essential health services during pandemics with a focus on primary health care, routine immunization and mental health care, and with particular attention to persons in vulnerable situations
“(b) developing, strengthening and maintaining health infrastructure
“(c) developing post-pandemic health system recovery strategies
“(d) developing, strengthening and maintaining: health information systems”
“(e) promoting the use of social and behavioural sciences, risk communication and community engagement for pandemic prevention, preparedness and response.”
This long Article discusses health workforce, training, retention, non-discrimination, stigma, bias, adequate remuneration, and other standard provisions for workplaces. It is unclear why it is included in a legally binding pandemic agreement, except for:
“4. [The Parties] ... shall invest in establishing, sustaining, coordinating and mobilizing a skilled and trained multidisciplinary global public health emergency workforce .... Parties having established emergency health teams should inform WHO thereof and make best efforts to respond to requests for deployment ...”
Emergency health teams established (within capacity etc.)—are something countries already do, when they have capacity. There is no reason to have this as a legally-binding instrument, and clearly no urgency to do so.
“1. The Parties shall, building on existing and relevant tools, develop and implement an inclusive, transparent, effective and efficient pandemic prevention, preparedness and response monitoring and evaluation system.
“2. Each Party shall assess, every five years, with technical support from the WHO Secretariat upon request, the functioning and readiness of, and gaps in, its pandemic prevention, preparedness and response capacity, based on the relevant tools and guidelines developed by WHO in partnership with relevant organizations at international, regional and sub-regional levels.”
Note that this is being required of countries that are already struggling to implement monitoring systems for major endemic diseases, including tuberculosis, malaria, HIV, and nutritional deficiencies. They will be legally bound to divert resources to pandemic prevention. While there is some overlap, it will inevitably divert resources from currently underfunded programs for diseases of far higher local burdens, and so (not theoretically, but inevitably) raise mortality. Poor countries are being required to put resources into problems deemed significant by richer countries.
Various general provisions about undertaking background research that countries are generally doing anyway, but with an “emerging disease” slant. Again, the INB fails to justify why this diversion of resources from researching greater disease burdens should occur in all countries (why not just those with excess resources?).
Mostly non-binding but suggested cooperation on making pandemic-related products available, including support for manufacturing in “inter-pandemic times” (a fascinating rendering of “normal”), when they would only be viable through subsidies. Much of this is probably unimplementable, as it would not be practical to maintain facilities in most or all countries on stand-by for rare events, at cost of resources otherwise useful for other priorities. The desire to increase production in “developing” countries will face major barriers and costs in terms of maintaining quality of production, particularly as many products will have limited use outside of rare outbreak situations.
This article, always problematic for large pharmaceutical corporations sponsoring much WHO outbreak activities, is now watered down to weak requirements to “consider,” “promote,” “provide,” within capabilities etc.
This Article is intended to establish the WHO Pathogen Access and Benefit-Sharing System (PABS System). PABS is intended to “ensure rapid, systematic and timely access to biological materials of pathogens with pandemic potential and the genetic sequence data.” This system is of potential high relevance and needs to be interpreted in the context that SARS-CoV-2, the pathogen causing the recent COVID-19 outbreak, was highly likely to have escaped from a laboratory. PABS is intended to expand the laboratory storage, transport, and handling of such viruses, under the oversight of the WHO, an organization outside of national jurisdiction with no significant direct experience in handling biological materials.
“3. When a Party has access to a pathogen [it shall]:
“(a) share with WHO any pathogen sequence information as soon as it is available to the Party;
“(b) as soon as biological materials are available to the Party, provide the materials to one or more laboratories and/or biorepositories participating in WHO-coordinated laboratory networks (CLNs), ...”
Subsequent clauses state that benefits will be shared, and seek to prevent recipient laboratories from patenting materials received from other countries. This has been a major concern of low-and middle-income countries previously, who perceive that institutions in wealthy countries patent and benefit from materials derived from less-wealthy populations. It remains to be seen whether provisions here will be sufficient to address this.
The article then becomes yet more concerning:
“6. WHO shall conclude legally binding standard PABS contracts with manufacturers to provide the following, taking into account the size, nature and capacities of the manufacturer:
“(a) annual monetary contributions to support the PABS System and relevant capacities in countries; the determination of the annual amount, use, and approach for monitoring and accountability, shall be finalized by the Parties;
“(b) real-time contributions of relevant diagnostics, therapeutics or vaccines produced by the manufacturer, 10 percent free of charge and 10 percent at not-for-profit prices during public health emergencies of international concern or pandemics, ...”
It is clearly intended that the WHO becomes directly involved in setting up legally binding manufacturing contracts, despite the WHO being outside of national jurisdictional oversight, within the territories of Member States. The PABS system, and therefore its staff and dependent entities, are also to be supported in part by funds from the manufacturers whom they are supposed to be managing. The income of the organization will be dependent on maintaining positive relationships with these private entities in a similar way in which many national regulatory agencies are dependent upon funds from pharmaceutical companies whom their staff ostensibly regulate. In this case, the regulator will be even further removed from public oversight.
The clause on 10 percent (why 10?) products being free of charge, and similar at cost, while ensuring lower-priced commodities irrespective of actual need (the outbreak may be confined to wealthy countries). The same entity, the WHO, will determine whether the triggering emergency exists, determine the response, and manage the contracts to provide the commodities, without direct jurisdictional oversight regarding the potential for corruption or conflict of interest. It is a remarkable system to suggest, irrespective of political or regulatory environment.
“8. The Parties shall cooperate ... public financing of research and development, prepurchase agreements, or regulatory procedures, to encourage and facilitate as many manufacturers as possible to enter into standard PABS contracts as early as possible.”
The article envisions that public funding will be used to build the process, ensuring essentially no-risk private profit.
“10. To support operationalization of the PABS System, WHO shall…make such contracts public, while respecting commercial confidentiality.”
The public may know whom contracts are made with, but not all details of the contracts. There will therefore be no independent oversight of the clauses agreed between the WHO, a body outside of national jurisdiction and dependent of commercial companies for funding some of its work and salaries, and these same companies, on ‘needs’ that the WHO itself will have sole authority, under the proposed amendments to the IHR, to determine.
The Article further states that the WHO shall use its own product regulatory system (prequalification) and Emergency Use Listing Procedure to open and stimulate markets for the manufacturers of these products.
It is doubtful that any national government could make such an overall agreement, yet in May 2024 they will be voting to provide this to what is essentially a foreign, and partly privately financed, entity.
The WHO will become convenor of a “Global Supply Chain and Logistics Network” for commercially-produced products, to be supplied under WHO contracts when and where the WHO determines, whilst also having the role of ensuring safety of such products.
Having mutual support coordinated between countries is good. Having this run by an organization that is significantly funded directly by those gaining from the sale of these same commodities seems reckless and counterintuitive. Few countries would allow this (or at least plan for it).
For this to occur safely, the WHO would logically have to forgo all private investment, and greatly restrict national specified funding contributions. Otherwise, the conflicts of interest involved would destroy confidence in the system. There is no suggestion of such divestment from the WHO, but rather, as in Article 12, private sector dependency, directly tied to contracts, will increase.
While suffering the same (perhaps unavoidable) issues regarding commercial confidentiality, this alternate Article 13 seems far more appropriate, keeping commercial issues under national jurisdiction and avoiding the obvious conflict of interests that underpin funding for WHO activities and staffing.
This entire Article reflects initiatives and programs already in place. Nothing here appears likely to add to current effort.
“1. Each Party shall consider developing, as necessary and in accordance with applicable law, national strategies for managing liability in its territory related to pandemic vaccines ... no-fault compensation mechanisms ...
“2. The Parties ... shall develop recommendations for the establishment and implementation of national, regional and/or global no-fault compensation mechanisms and strategies for managing liability during pandemic emergencies, including with regard to individuals that are in a humanitarian setting or vulnerable situations.”
Together with an earlier provision on public funding of research and manufacturing readiness, and the removal of former wording requiring intellectual property sharing in Article 11, this ensures vaccine manufacturers and their investors make profit in effective absence of risk.
A somewhat pointless article. It suggests that countries cooperate with each other and the WHO to implement the other agreements in the Agreement.
However, the “community ownership” wording is interesting (“empower and enable community ownership of, and contribution to, community readiness for and resilience [for PPPR]”), as this directly contradicts much of the rest of the Agreement, including the centralization of control under the Conference of Parties, requirements for countries to allocate resources to pandemic preparedness over other community priorities, and the idea of inspecting and assessing adherence to the centralized requirements of the Agreement. Either much of the rest of the Agreement is redundant, or this wording is purely for appearance and not to be followed (and therefore should be removed).
“1. Each Party shall promote timely access to credible and evidence-based information ... with the aim of countering and addressing misinformation or disinformation ...
“2. The Parties shall, as appropriate, promote and/or conduct research and inform policies on factors that hinder or strengthen adherence to public health and social measures in a pandemic, as well as trust in science and public health institutions and agencies.”
The key word is as appropriate, given that many agencies, including the WHO, have overseen or aided policies during the COVID-19 response that have greatly increased poverty, child marriage, teenage pregnancy, and education loss.
“3. The WHO Secretariat ... organize the technical and financial assistance necessary to address such gaps and needs in implementing the commitments agreed upon under the Pandemic Agreement and the International Health Regulations (2005).”
As the WHO is dependent on donor support, its ability to address gaps in funding within Member States is clearly not something it can guarantee. The purpose of this article is unclear, repeating in paragraphs 1 and 2 the earlier intent for countries to generally support each other.
“1. The Parties commit to working together…In this regard, each Party, within the means and resources at its disposal, shall:
“(a) prioritize and maintain or increase, as necessary, domestic funding for pandemic prevention, preparedness and response, without undermining other domestic public health priorities including for: (i) strengthening and sustaining capacities for the prevention, preparedness and response to health emergencies and pandemics, in particular the core capacities of the International Health Regulations (2005); ...”
This is silly wording, as countries obviously have to prioritize within budgets, so that moving funds to one area means removing from another. The essence of public health policy is weighing and making such decisions; this reality seems to be ignored here through wishful thinking. (a) is clearly redundant, as the IHR (2005) already exists and countries have agreed to support it.
“3. A Coordinating Financial Mechanism (the ‘Mechanism’) is hereby established to support the implementation of both the WHO Pandemic Agreement and the International Health Regulations (2005)”
This will be in parallel to the Pandemic Fund recently commenced by the World Bank—an issue not lost on INB delegates and so likely to change here in the final version. It will also be additive to the Global Fund to fight AIDS, tuberculosis, and malaria, and other health financing mechanisms, and so require another parallel international bureaucracy, presumably based in Geneva.
It is intended to have its own capacity to “conduct relevant analyses on needs and gaps, in addition to tracking cooperation efforts,” so it will not be a small undertaking.
“1. A Conference of the Parties is hereby established.
“2. The Conference of the Parties shall keep under regular review, every three years, the implementation of the WHO Pandemic Agreement and take the decisions necessary to promote its effective implementation.”
This sets up the governing body to oversee this Agreement (another body requiring a secretariat and support). It is intended to meet within a year of the Agreement coming into force, and then set its own rules on meeting thereafter. It is likely that many provisions outlined in this draft of the Agreement will be deferred to the COP for further discussion.
These articles cover the functioning of the Conference of Parties (COP) and various administrative issues.
Of note, “block votes” will be allowed from regional bodies (e.g., the EU).
The WHO will provide the secretariat.
Under Article 24 is noted:
“3. 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.”
These provisions are explicitly stated in the proposed amendments to the IHR, to be considered alongside this agreement. Article 26 notes that the IHR is to be interpreted as compatible, thereby confirming that the IHR provisions including border closures and limits on freedom of movement, mandated vaccination, and other lockdown measures are not negated by this statement.
As Article 26 states: “The Parties recognize that the WHO Pandemic Agreement and the International Health Regulations should be interpreted so as to be compatible.”
Some would consider this subterfuge—The Director-General recently labeled as liars those who claimed the Agreement included these powers, whilst failing to acknowledge the accompanying IHR amendments. The WHO could do better in avoiding misleading messaging, especially when this involves denigration of the public.
Article 32 (Withdrawal) requires that, once adopted, Parties cannot withdraw for a total of 3 years (giving notice after a minimum of 2 years). Financial obligations undertaken under the agreement continue beyond that time.
