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TWN Info Service on Health Issues (Jul20/02)
6 July 2020
Third World Network


COVID-19: Questions over WHO’s Global Equitable Allocation Framework & its workings

6 July (Sangeeta Shashikant and K.M. Gopakumar) – Member States have raised questions on the outline of the World Health Organization’s (WHO) proposal for “A Global Framework to Ensure Equitable and Fair Allocation of COVID-19 Products” (Allocation Framework).

Of particular concern is the link to, and implications of, the Gavi COVID-19 Vaccines Global Access (Covax) Facility and rich countries seeking priority access through advance purchase agreements with vaccines manufacturers.

[Gavi, the Vaccine Alliance is a public-private partnership and one of the leads of the Vaccine Pillar of the Access to COVID-19 Tools (ACT) Accelerator launched on 24 April 2020, at an event co-hosted by the Director-General of WHO, the President of France, the President of the European Commission, and the Bill & Melinda Gates Foundation.]

The WHO Secretariat organised two briefings for Member States to present the framework outline on 18th June and 2nd July. A working draft of the Allocation Framework and Vaccine Allocation Mechanism is expected to be available on 6th July with the aim to finalise it by the end of July.

The 73rd World Health Assembly held in May 2020 provided the mandate for the creation of an Allocation Framework.

Resolution WHA73.1 calls on the Director-General to “rapidly” and “in consultation with Member States with inputs from relevant international organizations, civil society, and the private sector, to identify and provide options that respect the provisions of relevant international treaties [….] to be used in scaling up development, manufacturing and distribution capacities needed for transparent equitable and timely access to quality, safe, affordable and efficacious diagnostics, therapeutics, medicines, and vaccines for the COVID-19 response, taking into account existing mechanisms, tools, and initiatives, such as the Access to COVID-19 Tools (ACT) Accelerator, and relevant pledging appeals, such as the Coronavirus Global Response pledging campaign, to be submitted for the consideration of the governing bodies” [emphasis added].

The prioritized populations identified by WHO for “[s]trategic allocation of scarce products” to maximise the health impact are the healthcare system workers ( ~1% share of global population); adults >65 years old (~8% share of the global population) and other high risk adults (with comorbidities) (~15% share of global population).

Based on this data and on the assumption of 2 doses per person, WHO presents approximate estimates of doses required for vaccination i.e. 115 million doses for healthcare workers; 1115 million doses for adults >65 years old; and 2650 doses for other high risk adults with comorbidities.

In the latest briefing, the WHO Secretariat identified the goal of the vaccine Allocation Mechanism as to “[p]rotect public health and minimize societal and economic impact by reducing COVID-19 mortality”.

It proposed the following allocation priority: health and social care workers (all countries to receive doses to cover 3% of their population); high-risk adults (all countries to receive additional doses to cover 20% of the population) and further priority groups (country would receive doses to cover more than 20% of their population based on country need, vulnerability and COVID-19 threat).

The briefing however did not reveal how WHO intends to address the disconnect with Gavi’s Covax Facility. Draft documents on the design of the Covax Facility propose unequal access giving self-financing participating countries preferential access (guaranteeing supply of doses sufficient to cover 20% of the population) over low and middle income countries that will be subject to WHO’s Allocation Framework to mainly vaccinate “their highest priority populations”.

In other words, as per the proposed Covax facility documents, WHO’s Allocation Framework would only be applicable to low income countries (LIC) and low and middle income countries (LMIC), thus compromising fair and equitable access and allocation of vaccines.

Equally concerning is the suggestion in Gavi’s proposal that upper middle income developing countries are considered as “self-financing”, and required to make upfront financial payments, even though the efficacy of vaccines in development is an unknown. Non-participating countries may also not get access to supply of vaccines, under the proposed design.

[See also “COVID-19: Global Concern that Gavi’s Vaccine Initiative Promotes Inequitable Access” available at
https://twn.my/title2/intellectual_property/info.service/2020/ip200605.htm]

The WHO briefings also did not explain how the organization will meet the allocation targets if rich countries such as the European Union and the United States enter into advance purchase agreements with manufacturers, capturing the limited supply of vaccines.

In the past week, several news outlets reported that the global supply of remdesivir, a therapeutic medicine, has been bought up by the US. A similar scenario appears to be emerging for vaccines.

Rich countries that have already secured preferential access are also encouraged by Gavi to participate in the Covax facility for the supply of vaccines as “an insurance policy” meaning that some rich countries may enjoy a bigger piece of the pie.

[See also “COVID-19 vaccines: EU prioritises preferential access, paying lip-service to global solidarity”
https://twn.my/title2/intellectual_property/info.service/2020/ip200603.htm]

Given the extensive public funding that is subsidizing vaccine development and production, another notably absent issue in the briefings is the determination of the vaccine prices. This is very relevant in the context of both allocation and procurement, and how intellectual property barriers and technology transfer will be addressed, so that manufacturing of effective vaccines may be scaled up massively by engaging vaccine manufacturers globally.

[The Covax facility documents reveal acceptance of tiered pricing reflecting countries’ varying ability to pay and the commercial opportunity especially in the long run. This goes against the simple “at-cost” price advocated by many civil society organisations and the call for making Covid-19 vaccines a global public good.]

Further, 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.

Some diplomatic sources and civil society groups have also raised concerns over the lack of “meaningful consultations” on the Allocation Framework and various mechanisms being developed despite the mandate to consult as contained in the World Health Assembly resolution WHA73.1. Thus far the WHO Secretariat has only organised briefing sessions with Member States with power point presentations, without any consultation document for inputs from Member States.

WHO’s Global Allocation Framework

During the 18th June briefing, the WHO Secretariat presented “major elements” of its proposal to “illustrate the potential use of this framework to allocate vaccines”.

The Allocation Framework “builds on the Access Principles” and “informs Allocation Mechanisms” tailored for each intervention (beginning with vaccines). The five principles to ensure equitable access to health products in the context of Covid-19 identified by WHO are:

  • transparency is ensured to improve efficiency and accountability;
  • health products are carefully selected and allocated to address the public health need;
  • flexible regulatory and procurement approaches are incorporated to improve access;
  • collaboration with relevant global and national stakeholders is enhanced to accelerate and scale-up the response; and
  • ethical values are used to inform allocation strategies.

According to the Secretariat, these principles will ensure “[f]air allocation of limited resources by following a set of principles which are pre-agreed and have the highest political commitment with mutual accountability; [a]ffordability for countries and funders to maximize allocation of financial resources necessary to procure goods; [s]ustainability for health systems and manufacturers; [f]ocus on specific populations with attention to essential, high-risk and the most vulnerable; [t]ailored response to national capacities”.

WHO in its presentation acknowledged that “[n]ew products will initially be supply-constrained, requiring a sequential allocation as supply increases to achieve the best public health impact”.

“Several constraints and uncertainties must be managed at the same time: the disease’s epidemiology and pathophysiology; the characteristics of new products and timing of their availability and the settings in which they will need to be used,” the presentation adds.

The initial goal of the Allocation Framework is “[r]educing COVID-19 mortality & protecting health systems” to “significantly improve the well-being of populations and reduce the impact on societies and economies” and which “can be achieved by prioritizing specific populations for vaccination”.

The prioritized populations identified by WHO for “[s]trategic allocation of scarce products” to maximise the health impact are the healthcare system workers ( ~1% share of global population); adults >65 years old (~8% share of the global population) and other high risk adults (with comorbidities) (~15% share of global population).

Based on this data and on the assumption of 2 doses per person, WHO presents approximate estimates of doses required for vaccination i.e. 115 million doses for healthcare workers; 1115 million doses for adults >65 years old; and 2650 doses for other high risk adults with comorbidities.

The presentation stresses that “Given the ubiquitous nature of COVID-19, all countries should receive an initial allocation as products become available” adding that “[e]ventually, prioritisation of geography and timing would be based on a risk assessment of countries’ vulnerability and COVID-19 threat”.

Key considerations listed by WHO for the Allocation Framework are:

  • “Flexibility” – “for adapting to the nature of each new product and the evolving epidemiology and risk”
  • “Transparent criteria” – “will drive allocation as doses become available”
  • “Increasing volumes” – “allocated to participating countries as more products become available, allowing for immunization of additional groups”
  • “[P]roduct-specific information” as it becomes available, “WHO will issue policy recommendations to inform optimal use of scarce resources”.

Allocation will also consider product specific factors (e.g. quantities, characteristics and logistics) and country-specific factors, though recognizing “[c]urrent limitations in country capacities should not limit allocation and deployment”.

Given the various uncertainties around vaccines, WHO asserts that “a global access mechanism that meets the needs of all countries is the preferred option” over “national access mechanism where countries negotiate deals with manufacturers to meet national needs and “Grouped access mechanism” where countries form regional groups or blocks to negotiate supply agreements.

Without providing much details, WHO highlights that the mechanism will provide an “[o]pportunity to have fair access and allocation across countries”; “[a]ccess to a large number of manufacturers, offering ‘risk-pooling’ (e.g., less risk of having no supply if certain vaccine candidates fail, or do not cover all populations)”.

Concerns with Outline of Proposed Framework

Several concerns with WHO’s proposed Allocation Framework have been raised by some Member States including:

  • will countries funding the Covax Facility receive preferential allocation of doses?
  • will this framework apply outside of the Covax Facility (e.g., for bilateral-agreements)?
  • will the funding that countries provide to Covax be linked to how many doses they are allocated?
  • how and when will the framework be adapted/extended to apply to other COVID-19 products?
  • will countries be able to define their own public health goals and priorities?
  • will consideration be given to other priority groups? (e.g., those with risk of exposure and transmission, essential workforces, potential risk factors of gender and ethnicity)
  • concern that prioritising populations initially (of healthcare system workers; adults >65 years and other adults with co-morbidities) could lead to lower allocation to low income countries and lower middle income countries
  • what will be done for countries with younger populations (e.g., with fewer adults over 65)?
  • how will data reporting limitations affecting the threat and vulnerability assessment be dealt with?
  • how will the assessment account for interdependencies between the perceived COVID-19 threat and countries’ public health strategies testing capabilities etc?
  • prioritization based on threat could be sensitive given interdependencies with countries’ public health strategies testing etc.
  •  what will be done to ensure that limitations in country capacities do not influence allocation?
  • what is the time frame this Allocation Framework to apply to (e.g., once supply meets demand)
  • Member States should retain decision making authority on how to use doses within their own countries;
  • consideration should be given to vulnerable populations within countries, small island states etc.

During the 2nd July briefing, the WHO lead on Access and Allocation, Assistant Director-General Dr. Mariângela Simao provided a bit more detail on the proposed Allocation Framework with the goal to “Protect public health and minimize societal and economic impact by reducing COVID-19 mortality”.

Dr. Simao presented two phases of the allocation. In the first phase, initially “[a]ll countries receive doses to cover 3% of their population”, “enough to cover all workers involved in health and social care work”.

As vaccine supply increases “[a]ll countries receive additional doses to cover a total of 20% of their population” which “could include the elderly, adults with comorbidities or others depending on locally relevant risk factors”. Countries are to receive doses proportionally to their total population.

At the second phase WHO will consider “further priority groups” where based on country need, vulnerability and COVID-19 threat, countries receive doses to cover more than 20% of their population to cover additional priority populations.

In addition, “A buffer will also be set aside for emergency deployment based on immediate needs”.

Dr. Simao stressed that the “fundamental principle” is that “all countries receive doses at the same time”.

On concerns with respect to Gavi’s Covax facility, Dr. Simao stated that the work that the WHO is doing “is very much integrated” with Gavi and the Coalition for Epidemic Preparedness Innovations (CEPI), and regular meetings are being held to “converge the allocation mechanism with the design and characteristics of the Covax facility”. CEPI is another lead entity of the Vaccine Pillar of the ACT Accelerator.

However, no details were provided on how the divergences would be addressed. Instead, Dr. Simao did confirm that Gavi will have two tiers of countries, one tier will be self-financing while the second tier will be for low and middle income countries supported by Gavi’s advance market commitments.

Dr. Simao added that “We are working to make sure that Covax facility is oriented with the allocation framework” which is expected to be finalised by the end of July.

In response to a question by Ecuador about allocation criteria for therapeutics and diagnostics, Dr. Simao responded that work on an allocation framework for therapeutics will begin next week, adding that for diagnostics, an allocation framework to support low income and middle income countries is already in place, and hence no further work would be undertaken on that.

On 6th July the Secretariat is expected to share a working draft of the Global Allocation Framework and Vaccine Allocation Mechanism. This draft may provide some more information on the issues raised above.+

 


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