The WHO Allocation Framework; Q&A with Achal Prabhala
WHO’s efforts to put in place a plan to divvy up COVID-19 health products equitably across the world is now being hashed out, even as member-states and companies strike up bilateral deals in the hope of getting preferential access, particularly to vaccines, when they become available.
It is not clear whether WHO will be able to prevail on countries to implement what it hopes will be a global allocation mechanism to ensure equitable allocation. In fact it is not even clear whether WHO will be able to ensure that Gavi’s COVAX Facility will follow up on its plans.
As Geneva Health Files reported earlier, Gavi’s Covax Facility seeks to follow WHO’s allocation framework only for low income and lower middle income countries. WHO sees Gavi very much as a partner, but it is not clear if it intends to “challenge” Gavi’s approaches to vaccine supply. Some experts believe that WHO has the legal backing of its constitution and the COVID-19 resolution adopted in May 2020, but it is not clear whether it will tackle head-on the politically sensitive dynamics in the allocation of health products. To be sure, there have been calls at the highest levels for solidarity and vaccines as global public goods, but what this will mean in practice is anyone’s guess. One believes that many of these dynamics can be shaped by individual personalities with the authority to make a difference, but a number of other factors must align to make this a reality.
WHO’s framework for equitable and fair allocation of COVID-19 products, dated June 18, 2020, is still in the works, and is expected to be finalised by the end of August 2020. These discussions for now seem to be focused on vaccines, but the framework will guide the broader health products landscape. WHO says that strategies and allocations for all product types are interdependent.
In response to a question raised by Geneva Health Files at WHO’s regular press briefings, Dr Mariangela Simao, Assistant Director General for Access to Medicines, Vaccines and Pharmaceuticals, WHO, explained that the allocation framework on COVID-19 health products will determine allocation within and between countries based on epidemiological and other country specific contexts. (The high priority group people over 65 will have different meanings in Japan as compared to a country in Africa, for example, she added.)
What the framework says:
In a briefing document to member states, WHO said that “the Global Allocation Framework builds on the Global Access Principles and informs Allocation mechanism.” It aims to have “a Fair and equitable Allocation Mechanisms Tailored for each intervention (beginning with vaccines)”.
WHO believes that the Allocation Framework is a key component of an overall approach for achieving fair and equitable access to COVID-19 products.
It also acknowledges not only the importance of public health and social measures to address the pandemic, but the reality of supply constraints of new products. It suggests a “sequential allocation” as supplies increase, as a way out. How this “sequence” will work has not yet been made public.
The various constraints and uncertainties include disease epidemiology and pathophysiology; the characteristics of new products and timing of their availability; the settings in which they will need to be used, according to WHO.
The framework is circumscribed by elements including priority populations, the way specific products should be allocated based on their characteristics and the pace at which countries will have access to the products taking into account health systems and population factors, and the dynamic nature of the threat.
WHO says that “Reducing COVID-19 mortality & protecting health systems will significantly improve the well being of populations and reduce the impact on societies and economies. These public health goals can be achieved by prioritizing specific populations for vaccination. Achieving these goals will be a key milestone in the pandemic response, even though it will not eliminate the disease altogether.”
It believes that strategic allocation of scarce products will maximise the health impact – for this a priority population must be defined with the goal of reducing mortality and protecting health systems. The priority population includes healthcare system workers constituting 1% of global population; adults who are older than 65 years accounting for 8% of the population and other high risk adults (with comorbidities) constituting 15% of the population. (These estimates are based on WHO data on medical doctors, community health workers, nurses and midwives; and data on adults between 30 and 70 suffering from cardiovascular disease, cancer, diabetes, obesity or chronic respiratory disease.)
The goal of reducing mortality and protecting healthcare systems leads to prioritization of these population groups. These priority groups would be used to calculate how much product should be allocated to each country, and may inform how countries use those doses. This approach will be finetuned based on product characteristics, according to WHO. Given the ubiquitous nature of COVID-19, all countries should receive an initial allocation as products become available, WHO believes.
Further, the Framework in its current version, maps the numbers needed for “initial vaccination”. This translates into 115 million doses for nearly 50 million health workers, 1,500 million doses for nearly 650 million adults above 65 years of age, and more than 2,650 million doses for nearly 1,150 million people who are classified as high risks adults with co-morbidities. (These estimates assumes 2 doses per person and a 15% wastage rate.)
These determinations on prioritisation of geography and timing would be based on a risk assessment of countries’ vulnerability and COVID-19 threat, WHO says. “The potential impact of COVID-19 on countries will be assessed using epidemiological data and the allocation of products would be adapted to the vulnerability of countries’ health systems and population factors,” WHO reasons.
Key considerations for the Global Allocation Framework, include: “flexibility to adapt to the nature of each new product and the evolving epidemiology and risk; transparent criteria to drive allocation as doses become available; increasing volumes could be allocated to participating countries as more products become available, allowing for immunization of additional groups; and policy recommendations to inform optimal use of scarce resources as product-specific information becomes available.”
While allocation will consider product and country-specific factors, WHO underscores that “current limitations in country capacities should not limit allocation and deployment” and that support will be provided for this.
Image Source: WHO
Most importantly, WHO suggests a global access mechanism as a preferred option that meets the needs of all countries, because it gives an opportunity to have fair access and allocation across countries. This option also gives access to a large number of manufacturers, offering ‘riskpooling’ meaning “less risk of having no supply if certain vaccine candidates fail, or do not cover all populations”.
“Due to these uncertainties, a global access mechanism that meets the needs of all countries is the preferred option,” WHO says in its document on the Allocation Framework.
It lists three options:
National access mechanism: Countries negotiate deals with manufacturers individually (e.g., lock into supply agreements locally)
Grouped access mechanism: Countries form regional groups or blocks to negotiate supply agreements
Global access mechanism: Countries participate in a global mechanism to procure and access products
Image Source: WHO
Q&A with Achal Prabhala
To understand the importance of the framework and the limitations WHO potentially faces in following up on this goal, Geneva Health Files spoke with Achal Prabhala, an expert on access to medicines issues for his incisive views on this.
Prabhala is the coordinator of the AccessIBSA project, which campaigns for access to medicines in India, Brazil and South Africa. See his recent opinion on vaccines for the poorest people, in The Guardian here.
Q. What are some of your views on the WHO Framework? The current version does not seem to have too many details on how the allocation mechanism will work. I understand WHO is also awaiting feedback from countries.
I think that having guidance from an authority like the WHO on how to allocate vaccines in a fair and equitable manner is absolutely necessary; other than the practical necessity, there is immense value in having solutions articulated by a credible global authority. The initial documents I have seen outline a rational and useful approach.
But, I’m interested in how the WHO develops them into guidelines not just within countries but between countries, which is to say, what is the fairest way to roll out these vaccines globally? Given supply constraints, much of which could be avoided (Gavi is working with a far smaller set of suppliers than it needs to because of vaccine monopolies) it seems unlikely that we will have enough supply to meet the full, simultaneous global demand for vaccines, possibly even for the highest priority groups. I do think that evolving supply horizons will drive an equitable global allocation framework, and in this respect, having the WHO consider supply as an ethical imperative becomes crucial. Which leads me to ask what it thinks of the Gavi Covax AMC for instance, and how much it can influence Gavi? And how it evaluates the IP-driven monopoly constraints at Gavi, vs the WHO’s own C-TAP?
If supply is a constraint, then – from both the moral and epidemiological perspectives – how does one allocate existing vaccines between countries? The moral and the epidemiological mostly coincide, of course, but there might be situations where they do not.
For instance, it seems like a fairly straightforward thing to say that countries who have purchased vaccines should not get priority over countries who have had them subsidised or donated – and yet, Gavi’s current plans seem to tilt in favour of richer countries making decisions on their own as to how much supply they need. But there might also be some really hard epidemiological issues to deal with as well: from a medical perspective, how does one evaluate need between countries that appear to have done a better job containing the spread of the coronavirus, like Germany for example, and countries that have not, like Brazil, for example?
Q. It is not clear how WHO will be able to operationalise the goal of vaccines as Global Public Goods. I understand, that the process is political and contentious. The DG is reportedly trying to work at the political level, but as we have seen major EU countries do not seem to be in favor of vaccines as a global public good, in practice.
A quandary is how the WHO – or anyone else for that matter – can square off global allotments from a mechanism like Gavi, with the concurrent supply from bilateral, national deals like the US & EU have entered into with vaccine manufacturers. Other countries, even poorer countries, might do the same in the future. With lots of criss-crossing supply streams, how do we reconcile the sovereign right to protect people within a country with the real possibility that some countries might start hoarding more than they need?
The WHO has the authority to draft a global allocation framework, of course, but enforcing it, or operationalising it, is another thing altogether.
I think there may be lessons to be learnt from other systems of global cooperation, where collaboratively produced norms are enforced by default, not because they have to be, but because they make the most sense. In that respect, the operations of the WHO’s Global Influenza Surveillance and Response System (GISRS) may offer a useful model. Twice a year, the GISRS puts out the recommended strains to be included in the flu vaccine we all get. Its collaborator network of laboratories in 110 countries helps them produce their recommendations, and once they’re out, no one is forced to use them, but everyone does.
COVID-19 vaccines: EU prioritises preferential access, paying lip-service to global solidarity
Order without Intellectual Property Law : Open Science in Influenza – Cornell Law Review 2017
Open letter to Gavi Board Members: Urgent changes to COVAX Facility design required to ensure access to COVID-19 vaccines for all
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