New Details on WHO’s Draft Allocation Framework – A Deep Dive

With more than 13 million cases of COVID19 in mid-July 2020, and rising, WHO has an unenviable and difficult task at hand, to map and decide who gets vaccines and medicines first. As expected, as it works its way on devising an allocation framework (first reported here), it is inevitably having to wrestle with politically contentious decisions in the backdrop of rising vaccine nationalism and countries striking up bilateral deals with drug companies.

It will have to decide, and soon, if it will tackle head on – the elephant in the room in some sense. As it gets into the heart of these difficult negotiations, WHO will have to clearly acknowledge the issues of intellectual property barriers and link it to the sharing of technology for COVID19 health products, in order to ensure greater access. By attempting to free up constraints on manufacturing, it can, to a certain extent address a potential “scarcity situation” where everyone wants to get to the front of the line for vaccines or therapeutics. If WHO and its member states do not come together, many will inevitably get left behind because of where they live or who they are.

It was perhaps not so surprising when Dr Mike Ryan, chief of emergencies at WHO, told journalists at a briefing on July 13th, that it was not realistic to expect that we will magically get a perfect vaccine.

“We can and will develop a vaccine. The question mark is how effective will that vaccine be, and more importantly and more worryingly who will get that vaccine. And will that distribution be fair and equitable?” Dr Mike Ryan, WHO

This is the crux of the challenge in front of WHO and its member states.

While WHO continues its sterling work in responding to the pandemic and other emergencies round the clock, and increasingly exhorting political leaderships world over to do more, it appears, that on some issues it continues to avoid biting the bullet as it were. The foundations of this framework could likely determine the direction of the fight against the pandemic over the coming months and years.

WHO is yet to take a bold stand on the way certain issues are being framed in the discussions on vaccines, for example. As we will see later in this story, it seems WHO has for now accepted Gavi’s two tier approach where some countries may have wider access to vaccines than others.  (Read about Gavi’s Covax Facility here).

This story takes a close look at WHO’s Allocation Framework, now in its first iteration. (Member-states and others are expected to share their feedback to improve the draft). Geneva Health Files, has reviewed a recent version of the framework and also spoke with experts at Third World Network (TWN) to understand the current limitations of the draft allocation framework.

In essence, experts are of the view that WHO should be spelling out in greater detail the implementation of how the allocation framework will help address the pandemic; it should make explicit links between the presence of intellectual property barriers and on ramping up local manufacturing capacities. The framework in its current version is lacking on some of these counts.  (Companies have maintained that intellectual property is not a real barrier for vaccines for example. Reportedly that some WHO officials also share this view. I have not been able to confirm this yet.)

WHO is expected to finalise the framework in the coming weeks. For now, it continues to focus on vaccines. The organization is soon expected to begin work on the allocation framework for therapeutics. It has been pointed out that the allocation mechanism on diagnostics to support low income and middle-income countries is already in place. However, civil society groups believe that access to diagnostic testing remains uneven and are pushing for improving on the allocation framework for diagnostics.

Member states have raised a number of questions on the framework, as reported by TWN earlier, including on whether countries funding the Covax Facility receive preferential allocation of doses; if the framework will apply outside of the Covax Facility (such as for bilateral agreements); whether country funding to Covax will determine the number of doses allocated to them; will those countries who have already have preferential access, also have access to the Covax Facility; what is the financial exposure for countries participating in the Covax Facility, should the vaccines be shown to be inefficacious; will countries be able to define their own public health goals and priorities; among many other concerns.

KEY ELEMENTS OF THE DRAFT ALLOCATION FRAMEWORK AND ITS CRITICISMS

WHO recognizes that “overwhelming demand, scarce manufacturing capacity, high-costs and the lack of a global allocation mechanism,” have in the past, resulted in delays of getting access to drugs and technologies in low- and middle-income countries, relative to wealthier countries. It assumes that access to health products for COVID19 “will most likely be curtailed by the short supply due to insufficient manufacturing capacity coupled with unprecedented demand.” But emphasizes that “a cardinal principle of equity in a pandemic response” means that all countries irrespective of their development or economic status, should have access to a share of these products based on public health need, according to the draft document.

Experts at TWN told Geneva Health Files that “short supply due to insufficient manufacturing capacity” can be addressed by having mechanisms for sharing intellectual property and technology transfer.

As described in an earlier post on the allocation framework, WHO has outlined three areas that will help achieve fair and equitable access for health products to fight the pandemic: a set of cross-cutting principles for access to and allocation of health products; a global framework to ensure equitable and fair access and allocation of COVID-19 products; and fair and equitable allocation mechanisms tailored to each product. 

Some of the cross-cutting principles are meant to address issues of transparency, ethics, collaboration, regulatory and procurement approaches among others. In addition, WHO also highlights “issues linked to prices and affordability so that costs do not pose a barrier to access, while safeguarding sustainability of both health systems and manufacturers.”

Civil society groups, such as TWN, want WHO to recognise the importance of principle of diversified supply in order to accelerate scaling-up of key products. Experts said that, in its framework, WHO must emphasize on “price transparency including prices charged in different countries, transparency about public funding received, and the cost of R&D”.

It is welcome to note the framework referring to a recent policy guidance from WHO Working Group on Ethics and COVID-19, to use ethical principles to guide prioritization. “Critical judgements need to be made in connection to the stage of pandemic, the type of product and other considerations…  This is expected to imply a prioritization of  certain populations over others and treating similar populations the same way,” the document notes.

DURATION OF THE FRAMEWORK

As per the draft framework, it seems that WHO seems to somewhat limit the application of the framework to “initial phases”. This is puzzling, given that on multiple occasions, top officials of the organization have said that the pandemic could continue for several years. “The global allocation framework aims to promote equitable access of vaccines, therapeutics and diagnostics in short supply for the initial phases until production increases and supply becomes sufficient to cover global demand,” it says.

And adds that:

“Efforts to ensure availability and affordability of medical products for all countries are beyond the scope of this framework, however WHO supports these efforts through other various partnerships and programs such as the ACT accelerator and COVAX facility … the framework and enabling mechanisms are designed to be time-limited, potentially covering the period of supply constraints.”

WHO Draft allocation framework

As pointed out earlier, initiatives such as ACT Accelerator and Gavi’s Covax are not endorsed by all the member-states represented by WHO. Civil society groups have raised multiple concerns on Gavi’s Covax will work – from financing to issues around intellectual property, most of all, to what extent and how will the allocation framework shape the outcomes from the ACT Accelerator and the Covax Facility.

This kind of formulation suggests that ensuring availability and affordability of drugs, after the “initial phases” of the pandemic, is beyond the scope of the framework. This leaves it open to interpretation that WHO does not want to address issues such as implications of preferential agreements on the availability of drugs beyond the “initial phases”, and on the larger questions on governance. TWN experts want WHO to explicitly link issues of availability and affordability of drugs to the allocation framework.

Understandably, member states have to come together to ensure equitable access. WHO calls for “solidarity and political commitment and mutual accountability of global stakeholders..” But the framework devised by WHO will be fundamental to shape “equitable access” – that has become somewhat of a buzzword in the wake of the pandemic.

WHO believes that the allocation process should be driven by the overall goal to public health minimize societal and economic impact. For the allocation of vaccines, “the initial focus is on reducing mortality and protecting the health system to maximize public health impact,” it says.  

“In order to ensure stewardship of scarce resources for COVID-19, WHO proposes to focus initially on using the vaccine to reduce mortality and protect the health system. It is important to note that this is the current working assumption, but a definite goal should be defined once specific products become available and SAGE is able to provide direct policy guidance,” the draft document says.

DETERMINATION OF PRIORITY POPULATIONS AND TARGET GROUPS

The selection of target groups will be based on policy and strategy, according to the document. By way of illustration, WHO says “if the goal is to reduce mortality, those at the highest risk of dying should be prioritized for immunization, and therapeutics may be reserved for potentially severe cases.” It will also be a function of product-type.

“The framework will then help define the volumes that each country should receive and at what pace they will receive them in order to cover the targeted groups. If the products are in short supply compared to the estimated volumes for each country, the allocation should proceed in a progressive manner as more quantities become available,” WHO envisions.

But the framework also makes allowances for exceptional situations. Depending on the product and “stages in the allocation process”, “countries may need to be prioritized according to clear, objective and transparent criteria that may include the threat that COVID-19 poses to them and the vulnerability of their health system, according to WHO.

For those countries exposed to a higher threat and vulnerability, there should be more volumes allocated in the initial rounds, however all countries should receive at least a portion of the volumes in each round, the document says.   

Basically, the framework suggests two phases:

The first phase involves all countries receiving doses to cover 3% of their population that ostensibly caters to health and social care workers. Later, as vaccines supply increases, the access will expand to include 20% of the population for all countries that will cover elderly, adults with comorbidities or others depending on locally relevant risk factors. The idea rests on countries receiving doses in proportion to their population.

The second phase involves additional priority groups based on need, vulnerability and COVID-19 threat.

In addition, “to attend and manage outbreaks, deployments and other emergency related situations, a number of doses should be reserved early on as part of an emergency buffer. This dynamic stockpile should be managed by WHO and made available to implementing partners, humanitarian organizations and other relevant organizations,” the document says.

As per WHO plans as described in the draft document, “priority populations and target groups should be grouped into tiers that have progressive access to the vaccine based on descending priority, as long as the product supply remains limited.” Tiers are expected to be “composed of different target groups that are considered of similar priority”. Eventually all population groups that could benefit from vaccination will be included in subsequent tiers, WHO explains in the document.

Tier 1 could potentially include workers in health and social care settings, people over the age of 65, and those with underlying conditions putting them at a higher mortality risk. (Civil society groups want the inclusion of vulnerable populations who may be marginalised based on race, ethnicity, income.)

A recent WHO estimation of these groups yielded the following numbers: 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 assume 2 doses per person and a 15% wastage rate.)

“For most countries, a phase 1 allocation equal to 20% of the population would cover most of the population comprising these groups. By initially prioritizing these groups, a vaccination program may achieve an enormous impact on the course of the pandemic even under conditions of supply-constraints,” the document explains.

For a lay observer, it is not clear how the estimate of 20% of the population was arrived at by WHO and whether this would make sense to apply to all countries. (Recall that Gavi’s preliminary design on its Covax initiative shows similar estimates. “The Facility will work to secure enough vaccine doses to enable all countries in this group to vaccinate e.g. 20% of their populations, to ensure that every country can immunise their highest priority populations,” Gavi’s document had suggested.)

(Elsewhere in the document WHO explains that, “this fixed percentage ensures predictability for all participating countries and allow for flexibility in the use of these doses according to national needs and context.”) 

Experts at TWN have pressed for more information on the data and evidence on which WHO has decided to prioritize Tier 1 and decided to allocate up to 20% of vaccine to each country. “What is the impact on mortality and recovery from pandemic if more is allocated? What if less than 20% can be made available, what will be the impact?” one expert pointed out.

TWN contests some of these assumptions on this target population on several counts. First, whether market forces will determine vaccine allocation and prices in the long-term once the initial 20% of the population is vaccinated. Second, more fundamentally, why does WHO assume supply-constraints only in the short-term?

Demand will be a function of the kind of vaccine, its efficacy. Given the scale of the pandemic, demand for vaccines will continue and as a result, supply constraints are likely to continue for a long time, experts at TWN said. Even for existing known medicines and vaccines, despite years of being in market, there are supply constraints, they point out. WHO must clarify whether manufacturers would end up charging monopoly prices after the initial phase in the “short-term”.

To address supply constraints, experts suggest that WHO must refer to the COVID-19 Technology Access Pool (C-Tap) in its allocation framework that will facilitate technology sharing and transfer.

ALLOCATION BETWEEN COUNTRIES

After the identification of target populations and priority tiers, countries will be prioritised for allocation in two phases as per WHO’s existing plans. While phase 1 will see an initial allocation of doses proportionally to all participating countries, during phase 2, countries will be allocated additional doses at a pace as determined by the risks they face.

PHASE 1:

So, the first objective will be to try and make available doses to cater to 20% of the population of each country covering those most at risk. This it defines as the Tier 1 population.

However, even this is not assured. It seeks to devise a method of “gradual allocation” while aiming for equitable distribution. “In phase 1, all countries should gradually receive tranches to cover a subset of Tier 1 target groups before other Tier 1 target groups are considered in the allocation. Thus, an initial tranche of doses representing at least 3% of the population should be made available to all countries,” the draft says. This 3% benchmark, WHO hopes, will enable immunization of the workers in health and social care settings. Further, “Additional tranches would follow gradually as more supply becomes available till 20% of the national population is covered in all countries,” the current version of the framework says.

It believes that this kind of a proportional allocation scheme will offer predictability and visibility for both manufacturers and countries. What is not clear is whether countries with additional access (those with preferential access or assured bilateral deals) will also follow this mechanism.

So ideally, “all countries will receive enough doses to cover the initial tranches and/or tier (20% allocation in phase 1) before other countries may receive doses towards their next tranche and/or tier,” WHO explains. But is also seeks to build, flexibilities or exceptions. One, is that countries can be allowed to receive doses for their next tranche and/or tier, if there is an availability of stock which cannot be absorbed at that time by other countries. Second, exception on quantity per allocation round, can be made for small states where it may be cost-effective to ship in one shipment more that the percentage of the tranche and/or tier under consideration, the draft says.

Civil society seeks transparent criteria on which grounds can such exceptions be made since these could end up as opportunities for political influences.

PHASE 2:

A weighted-allocation scheme will determine the distribution of doses during the second phase, according to WHO.  “The prioritisation and quantification of products for each allocation round should be based on a risk assessment through the evaluation of:  the threat – the impact of COVID-19 on countries, assessed using epidemiological data; and the vulnerability – the vulnerability of countries’ health systems and population factors,” the draft says. WHO has furnished detailed annexes to discuss the parameters to define threat and vulnerability.  (To assess the level of threat, it seeks to take into account the effective reproductive number and its trend; the co-circulation of influenza virus. Similarly, to assess vulnerability, the framework will take into account, the health system capacity according to the UHC index and occupancy of hospital beds.)

The framework also discusses “boundary conditions” where the allocation of vaccines take into account product supply and country context.

Civil society advocates believe that such a weighted allocation may penalise those countries which has addressed the pandemic more successfully than others.

The current version of the document does not adequately explain in detail how such a framework will be governed. The draft says “The success of a global access and allocation framework and corresponding mechanism require accountability amongst all participating countries and organizations…”  A specific governance structure and functions are expected to be developed in the coming weeks.  

In general, there is a sense amongst certain stakeholders that there has been a lack of meaningful consultations around the framework and associated mechanisms. The pandemic has also affected greater engagement from the capitals, one diplomatic source said.

IN CONCLUSION

For the allocation framework to be truly effective it must address concerns on intellectual property barriers. It is not clear why the allocation framework does not refer to the voluntary pooling mechanism C-TAP, which has the potential to address supply constraints of health products. WHO must own the initiative and countries must sign up to it as the European Parliament recently suggested.

TWN, is of the view that WHO is looking at supply issues within a very limiting frame. There is not enough clarity or detail yet, on how nascent initiatives such as ACT Accelerator and Gavi’s plans will streamline supply and availability of health products – based on which the allocation will be decided. Experts at TWN said, “The allocation framework is extremely short-sighted. It is focused on specific structures providing limited supplies that will be allocated to countries. But the issue of supply constraint is a longer-term problem that requires a more sustainable solution including strategies on scaling-up manufacturing by all competent manufacturers globally. And this will mean addressing IP barriers.”

In a recent analyses on the allocation framework, COVID-19: Questions over WHO’s Global Equitable Allocation Framework & its workings, TWN said:

“…the Allocation Framework bears the danger of legitimising the practice of advanced purchase agreements as the purported way forward to ensure fair and equitable access, without addressing the issue of concentration of production and intellectual property monopoly.”

(Image source: Draft Allocation Framework – Towards Equitable Access and Fair Allocation of COVID-19 Health Products)

(Geneva Health Files looked closely at Gavi’s Covax Facility, read here, and analysed an initial version of the Allocation Framework)

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