W.H.O. Reform Proposal; Vaccine Prices

Newsletter Edition #2

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Hi,

As promised, here we are, delighted to bring you the second edition of this newsletter from the world of global health Geneva.

This week’s analysis is a close review of the French-German reform proposal for WHO, currently under discussion and what it means for the governance of global health.

Also, Geneva Health Files asked a question to WHO this week on whether it has been able to lead or influence discussions between Gavi and vaccine manufacturers on issues of access and pricing. Read below what Sowmya Swaminathan, Chief Scientist, WHO had to say. We are also told that WHO is setting up an independent expert group to help determine which vaccine candidates to invest in.

As you will see, this newsletter will often have three parts: the story of the week, what we found interesting and what we are watching.

Read on.

Share, source and support Geneva Health Files.

Until next week!

Cheers,

Priti

If you want to write to me, get in touch here: patnaik.reporting@gmail.com


1. Story of the week

GERMAN-FRENCH PROPOSAL FOR WHO COULD SKEW BALANCE OF POWER IN DONORS’ FAVOR

The reform proposal led by Germany and France to strengthen WHO’s emergencies response and bolster global health security, could result in a balance of power tilting in favour of donor countries, diplomatic sources in Geneva say. Questions are being raised on whether the proposal truly seeks to empower WHO, or if it is also an attempt to fill the leadership vacuum caused by the retreat of the U.S. from the multilateral institution.  

The proposal, being perceived in some quarters, as a genuine effort to strengthen multilateralism in global health, may be focusing too much on global health security; and risks exclusion of countries who may not be able to contribute as much as wealthy countries by way of assessed contributions - a key suggestion by Germany and France.

There is no doubt upper middle-income countries and middle-income countries should pay more to make WHO’s financing more flexible, so that all countries become beneficiaries of a strong international organization. However, with the pandemic wreaking havoc in some of these economies, with many projected to have negative GDP growth rates and severely contracted economic conditions, their ability to contribute more to WHO may be affected for years to come, diplomatic sources from developing countries told Geneva Health Files.

Both Germany and France have pledged additional contributions to WHO, in wake of the US decision to leave the UN’s only policy-setting technical agency.  

This reform proposal that is being discussed at WHO, and informally among some member states, suggests three key areas for reform including a wider WHO reform; WHO’s work in emergencies and WHO’s work under the framework of the IHR, according to the document seen by Geneva Health Files. The proposal describes in detail, the vulnerability caused to WHO as a result of uncertainties around financing, and how this impacts its operations from staff recruitment, to fighting emergencies. It also notes weakening of WHO, even as its partner organizations (some of whom are also its donors), continue to be better-funded and often use WHO structures to implement their specific health goals.

I. THE PROPOSAL AND ITS DISCONTENTS

The story so far

The proposal, “Non-Paper on strengthening WHO’s leading and coordinating role in global health – With a specific view on WHO’s work in health emergencies and improving IHR implementation”, being discussed at various levels.

As has been reported earlier, the US had a proposal of its own, but there were enough disagreements for Germany and France to quit these discussions, and come up with their own proposal. Sources said that despite disagreements with the US on the reforms, the European countries continue to engage with the U.S. “There are elements in the proposal, to keep the dialogue on with Washington. Paris and Berlin want to keep the US engaged, till the picture becomes clear”, the source said alluding to US Presidential elections in November this year.

The ministry for Europe and Foreign Affairs, reported earlier this week that Jean-Yves Le Drian, Minister for Europe and Foreign Affairs, discussed the proposal with Tedros Adhanom Ghebreyesus, WHO DG. “Jean-Yves Le Drian and his interlocutor talked about ways for the international community to prepare more effectively for future health crises. With that in mind, the Minister talked about the Franco-German proposals for strengthening the multilateral health architecture, particularly as regards improving the grading of alert levels and implementing the International Health Regulations,” the statement said.

The agenda of global health security

The document recognizes the central role of WHO in addressing global health challenges, including prevention, detection and response to outbreaks. “WHO’s constitution states that it is the mandated leading and coordinating authority in global health,” the document says.

While enumerating the vast scope of the mandate of WHO from its normative work, to shaping the research agenda, addressing outbreaks and providing technical support, the document says, “…it has become clear that the WHO partly lacks the abilities to fulfil this mandate. The international community’s expectations regarding WHO’s capacities outweigh by far its given financial, structural and legal abilities.”

The document refers to the COVID-19 response resolution and the commitments for the evaluation of the lessons-learned during this period. “The lessons-learned process following this global health crisis will have to focus in particular on the strengthening of global health security structures including the WHO’s Emergency Programme (WHE) and potential updates to the International Health Regulations (IHR),” it says. This seems to be central to the reform proposal.

How financing uncertainties affect WHO operations

The proposal makes a strong case to improve funding for WHO. “It is clear that Member States’ (MS) expectations vis-à-vis WHO have by far outgrown their willingness to provide funding to the organisation.”

It lays out a dire picture, that has been much discussed over the last few months: WHO’s budget over a two-year period is about US$5 billion. Only 20% of its programme budget – US$ 1 billion over two years, is in the form of assessed contributions. The rest are not only voluntary, tied contributions – half of that amount come from non-Member States actors. It adds that only assessed contributions are somewhat predictable, and for the remaining 80% of its budget WHO has to deal with uncertainty and raise funds, while being susceptible to donor interests all along.

The proposal recognizes that the top 15 donors contribute to more than 80 % of all voluntary contributions.

It goes on to note that “The current overall funding level of WHO is way below the funding level of partner global health organizations, with limited global and subject-wise scope. Some of these partner global health actors belong to WHO’s top donors, as they are using WHO’s global structures to implement their specific health goals.” (Geneva Health Files is of the view that this is particularly striking in the context of the ACT Accelerator launched as a one-stop shop multi-stakeholder solution to the COVID-19 response.)

Staff operations affected

The proposal points out that this vulnerability in financing has also contributed to the way WHO conducts its operations. As a result of uncertainties in assured funding, WHO is apparently not able to recruit staff in a predictable manner. Consequently, many areas of work are increasingly being outsourced to external consultants, the proposal suggests. (Whether financing crunch is the only reason WHO outsources work to external consultants, is debatable given its reliance on big consulting firms over the years.)

At a time as critical as the current pandemic – these shortages come home to roost. “Key functions such as pandemic preparedness call for a sustainable, highly skilled and adequately sized workforce.” All major HR reforms in the past years could not be implemented to the full extent as the current funding mix sets clear limitations,” the proposal notes.

Germany and France propose a series of actions including suggesting a general increase of assessed contributions and of core voluntary contributions to cover WHO’s core business (base programme); strengthen WHO’s normative role and strengthening the Chief Scientist Office.

They also suggest supporting the development of the WHO Academy in order to strengthen WHO capacity to elaborate and disseminate its guidance, including through training of WHO staff, health personnel and countries’ officials, in particular IHR National Focal Points. This Academy was established by France in Lyon.

In addition, the proposal calls for making more use of technical expertise of WHO collaborating centres around the world, expert networks such as technical advisory bodies and public health institutions. (Some experts believe that this web of collaborating centres already has a big influence on WHO’s technical work, and have called for greater geographical diversity in the engagement of such collaborating centres.)

The crunch in emergency operations

While noting the reforms brought in after the 2014-2015 Ebola outbreak in Africa that resulted in the creation of the WHO’s Emergency Programme (WHE) and the Contingency Fund for Emergencies (CFE), the proposal says “systematic structural deficits still remain as they have not been adequately followed up by the global community during the lessons-learned process after the West-Africa Ebola outbreak,” emphasizing the chronic underfunding of these streams of work.

“Only 11 key donors currently contribute to almost 80% of the available funding for WHO’s work in health emergencies,” it warns. Continued underfunding and without being steered by countries, could “lead to further fragmentation in particular in global health security structures,” the proposal adds. (According to WHO’s website, only 37% of its emergencies pillar under the General Programme of Work has bene funded in 2020-21. And its emergency operations and appeals remain half-funded.)

In order for member states to have a better grip on WHO emergencies’ work, Germany and France, suggest constituting a sub-committee under the Executive Board that could provide countries to have adequate oversight and guidance to WHO’s work in health emergencies and pandemic preparedness and response activities. “This sub-committee shall be able to follow crises and emergencies, when necessary, on a daily basis, hold meetings with the emergency committee and provide guidance to the DG,” the proposal says.

The countries also suggest sustainable financing of WHO’s work in health emergencies by all 194 member states through an increase of assessed and core voluntary contributions. This, they say, will enable WHO to act in crisis without immediate need for shoring up funding.

IHR reforms

The proposal also focuses on the limitations of the International Health Regulations (currently under review) including uneven level of implementation of the IHR core capacities. It also refers to other globally legally binding instruments that include incentivizing implementation and reporting mechanisms and other legal frameworks with more “concrete procedures” allowing the relevant international organization the right to intervene. It laments that WHO’s abilities under the IHR remain limited and largely dependent on the relevant countries’ willingness to cooperate.

Similar to the American proposal, these countries suggest, reforming the mechanism to declare a Public Health Emergency of International Concern (PHEIC). They call for a gradual PHEIC declaration and a stepped level of alerts. This could be done by establishing a traffic light system to foster transparency on measures and communication about present public health threats, the proposal says.

In addition, the proposal also suggests that WHO’ mandated international experts should be enabled to independently investigate and assess (potential) outbreaks as early as possible. “Based on the results of the evaluation of the WHO-coordinated international health response to COVID-19, this could consist in strengthening WHO’s network and teams to immediately perform outbreak investigation and allowing WHO-led multinational teams to access territories of States Parties to investigate any potential outbreak or health emergency at any time,” the proposal says. This would allow the WHO to alert the world about a potential global emergency sooner, it argues.

This, sources say can be deeply problematic and may not fly at all with member states cautious about potential implications for sovereignty. “Those countries that suggest that they can go into any country and look for ‘potential’ outbreaks, even if as a part of a multi-national WHO-led team, may not be willing to open up for investigations, themselves” the diplomatic source from a developing country added. Entering foreign territory without consent, or alleging that a country is responsible for an outbreak, can reflect a colonial mindset, the source was of the view.

II. IMPLICATIONS FOR GOVERNANCE

While the overwhelming emphasis on emergencies work is understandable, given that the world is very much in the midst of the COVID-19 pandemic, some fear that it may create an imbalance in WHO’s overall functions. “Some of the other vital areas of WHO’s normative work, and issues such as non-communicable diseases, for example, traditionally under-funded, could suffer even more in the long-term due to this emphasis on emergencies,” the source who did not want to be identified told Geneva Health Files, while discussing the reform proposal.

Increasing assessed contributions is key to give flexibility to WHO in the way it prioritizes funding, however if only rich countries are able to beef up their assessed contributions, relative to others, they will end up have a greater influence in the decision-making within WHO, the source pointed out.

The proposal itself does not shy away from articulating the writing on the wall in some sense, in describing the diminishing of WHO’s role in the multilateral setting, something both civil society organizations and member states have long fought against.

Given the changes in global health governance and the fragmentation of the global health architecture with numerous global health actors and unclear mandates, it says that the WHO should be in a position to play a leading and coordinating role.

“However, the budgets of WHO’s partner organizations have outgrown WHO’s budget by far with the consequence that it is questionable whether WHO really is on an equal level playing field, able to defend its leading and coordinating role vis-à-vis these financially far more powerful actors.”

In the broader context of global health governance and the legitimacy of the WHO, sources also raised the question of the ACT Accelerator, funded by the European Commission, where WHO is effectively in a coordinating role. “I hope the ACT Accelerator delivers on the promises it has made. If the ACT Accelerator, does indeed help meet the response to COVID19, does it mean that the countries who funded it, will revert to funding WHO again? Or will it be further entrenchment of structures such as the ACT Accelerator – that essentially has put WHO on the sidelines,” a diplomatic source suggested.

It is not clear when and how the proposal will be brought under formal discussions between member states at WHO. Some suggest, it could be taken up at the WHO Executive Board meeting to be held in October this year.  Queries sent to the German and French missions here in Geneva seeking information on the status of the proposal, were not answered by the time this story went to print.

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2. What we found interesting this week:

WHO on vaccine prices

Geneva Health Files asked a question to WHO this week on whether it has been able to lead or influence discussions between Gavi and vaccine manufacturers on issues of access and pricing.

This is what Sowmya Swaminathan, Chief Scientist, WHO said:

Gavi’s Covax Facility was basically set up to have that leverage, because of the volumes that will be procured through that Facility. Covax is a pooling mechanism that will buy vaccines from manufacturers and supply them to countries. Both countries – high income countries that will pay for their vaccines, as well the countries that normally get Gavi support. There are 92 countries which are low income or low middle income, or some of the very small countries, they will be supported though development aid. There are at least 79 countries that have expressed an interest - upper middle income, and high-income countries that will buy vaccines. Once we have these commitments from countries, we can make advance purchase commitments to companies. That helps them to plan and also helps them then to scale the number of doses and also reduce the price accordingly. The more the volume you are buying, the better the price could be.

The facility will obviously enter into a lot of negotiations. Currently what we are hearing from our manufacturers is that, they either want to supply at a not-for-profit basis, or just the cost-price plus a little bit to cover their expenses. There are some manufacturers who have proposed a tiered pricing, a lower price for the lower income countries, high and higher for middle- and high-income countries.

The type of vaccine also makes a difference. There are some vaccines currently that could be in the range of couple of dollars per dose, up to vaccines that are being priced between $20-$30 a dose. And this is dynamic and it will change, as more vaccine candidates become available, the pricing is going to change. We have to plan right from the beginning when they are limited candidates and limited choice.

So, on the one hand, you have the push funding that CEPI is doing, funding being invested into the Research & Development of the vaccine candidates. And on the other hand, you have the Gavi Covax Facility which is providing the pull funding, providing the market commitments, the advance purchase commitments. Between these two, it should be able to bring vaccines to people at an affordable price.

And most countries are thinking about how they will provide vaccines to their own citizens at a no-cost or low-cost basis or a cost-sharing basis. There are country by country discussions also happening.

WHO on a new independent advisory group for vaccines investment:

In response to a question on how many candidates in the Facility and if WHO is coordinating the vaccine trials, Dr Swaminathan said:

Let me explain the difference between the Covax portfolio and the Facility. The portfolio is made up of vaccine candidates supported by CEPI (we talked about the push funding), there are about 9 candidates, or 9 companies that are being supported by CEPI. Another 20 or so that are being considered for funding support. That is on the investment side of things.

Then the Covax Facility itself which is going to be this big pooling mechanism for vaccines. There, basically the Facility is open to vaccines from all over the world. There is no restriction on who funded it, or who developed it. The vaccines need to prove it is efficacious, safe and that it meets the benchmark set by WHO and the regulatory agencies (FDA, EMA etc). WHO has a big role here, because obviously we will be asked to provide an opinion on whether a vaccine is ready for use, whether it can be prequalified, or whether it can receive an emergency use authorisation. So, we are preparing ourselves for the assessment for all of these vaccines that are going to start coming through once there are results.

There is an independent expert group that is being set up – an independent product group - that will advise Gavi and advise the Facility on which vaccine candidates to invest in….based on many criteria including the scientific data of the vaccine, but also what is going to be the potential price, how easy is it to scale up. Some technologies are much easier to make in bulk than others, that could be a criterion. Storage conditions that may be simpler for use in many countries… and so on.

Initially there may be limited choice. As time goes on, there will more choice, to choose certain candidates for certain countries, for certain age groups. At the moment it will be based on a clear set of criteria, it will be decided by independent, international expert advisory group.

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3. We are also watching:

  • The Facilitation Council that will advise on the work of the Access to COVID-19 Tools Accelerator.

  • What the pause in the AstraZeneca trial, will mean for the gold rush for vaccines?

  • The approaching deadline of September 18, for countries to sign up to Gavi’s Covax Facility.

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