COVID-19 Diagnostics: The Full Picture

Newsletter Edition #5

Share

Hi,

Our expectations are so low that they exclude a significant part of the world.

At Geneva Health Files, we try to look at the whole picture. That means, questioning if the story is bigger than what it is, or smaller than what we actually see.

Take diagnostics for the pandemic. Millions of rapid antigen tests will be rolled out in poorer countries the world over in the coming months. This is great news. However, they are grossly inadequate given the demand for diagnostic tests especially in countries where COVID-19 shows no signs of slowing down. Access to diagnostics has been traditionally inequitable and the pandemic makes this worse. There was much celebration that the tests will be priced at US $5. That is still way too expensive in many countries. The international poverty line is US $1.90 a day. Millions have been pushed under the poverty line as a result of the pandemic. The global extreme poverty rate could rise to around 9 percent in 2020, according to the World Bank.

To understand what is at stake, we bring you an interview with Professor Brook K Baker, who has witnessed some of these discussions as a civil society representative working on issues around diagnostics, in the ACT Accelerator.

Following our story last week, I received some feedback that the analysis was critical of the good efforts by big organizations. While we appreciate constructive criticism, we also feel responsible for raising questions on the processes, or highlight the efforts of those who do, especially in the midst of a pandemic in the larger public interest. Do get in touch if you disagree, or simply to help us see the full picture. We strive to examine the nuances to make our reporting balanced and credible.

Finally, join me in welcoming Kaitlyn Green, a former paramedic and a student of health financing, who has been committing her time to help make Geneva Health Files sustainable. Consider donating, as we continue to bring you fresh perspectives on the intractable politics and challenges in global health.

Source, share and support us.

Until next week!

Priti

Feel free to write to me: patnaik.reporting@gmail.com


1. Story of the week

I. COVID-19 DIAGNOSTICS [Ag RDTs]: THE FULL PICTURE

The pandemic has revealed the entrenched inequities in the world, and the access to diagnostics for COVID-19 is also illustrative of this. As per latest announcements here in Geneva, 80% of the world’s population - living in low- and middle-income countries - will initially receive only 20% of two kinds of antigen-based rapid diagnostic tests, while the remaining 20% - those in high and upper middle-income countries – can essentially procure 80% of these tests.

Undoubtedly, it is welcome that 120 million tests for the pandemic will be made available to low and middle income countries over a period of six months. However, relative to overall manufacturing capacities, these are very limited and will do far from addressing perceived global health security concerns. Besides, as on date, majority of the funds (US $ 600 million) needed to procure even these 120 million tests are yet to be raised. (The Global Fund said that it has set aside US $50 million to buy at least 10 million of the new rapid tests for LMICs at the guaranteed price, with the first orders expected to be placed this week through the fund’s pooled procurement mechanism.)

Of the US $6 billion estimated to be needed to meet the demand for diagnostics, a woeful $0.3 billion has been pledged, according to documents seen by Geneva Health Files. The immediate need for diagnostics is pegged at $2 billion before 2020 runs out. (This is for 500 million tests – molecular tests and RDTs – in LMICs over the next 12 months, according to FIND). The financing gap stands at US$ 6 billion.

At the weekly WHO press briefing (28.09.20), where the announcement was made, Geneva Health Files raised a question on whether these 120 million tests constituted 20% of the overall rapid antigen tests as agreed with these producers of tests.

Catharina Boehme, the CEO of the Foundation for Innovative New Diagnostics (FIND), acknowledged that this was the case. Here is what she said at the presser:

“Indeed, this reflects 20% of the current manufacturing capacity of these two manufacturers. However, they are rapidly scaling capacity. So, one of the important next steps, is to make sure that we use these increased tests numbers for wider access for low- and middle-income countries. And of course, also work on further price reduction…Indeed it is 20% that are covered under these volume guarantee agreements and 80% remains available for procurement outside of these volume guarantee agreements.”

In a briefing document for member states in July 2020, WHO had said, in general, LMICs were testing at a rate which is 10% of the rate in High-Income Countries (HICs). In low-income countries, the average testing rate is less than 1% compared to HICs.

At the event, Peter Sands, Executive Director of The Global Fund drew attention to this: if LMICs were testing at the rate of HICs right now, 120 million tests would be enough for less than two weeks.

These disparities in testing capacities have been long known, it is essential to consider them more closely. Geneva Health Files spoke to those associated with discussions on policy responses on the diagnostics front.

UNWRAPPING THE ANNOUNCEMENT

The Gates Foundation is reported to have “executed separate volume guarantee agreements” with test manufacturers Abbott and SD Biosensor for innovative tests priced at a maximum of US$5 for LMICs. It appears that the Gates Foundation has underwritten these investments, sources told Geneva Health Files.

These two arrangements will make available to LMICs 120 million antigen rapid diagnostic tests (Ag RDTs) – priced at a maximum of US$5 per unit – over a period of six months, FIND said. (The rapid test from SD Biosensor is so far the only one to receive approval under WHO’s Emergency Use Listing procedure. Other tests, including the one from Abbott, are under WHO evaluation, FIND clarified in response to email queries). The organization has reportedly conducted independent evaluations of over 50 tests.

“FIND and WHO are working together to accelerate appropriate use by supporting implementation research that will optimize Ag RDT use in multiple LMICs, in line with WHO guidance. This includes provision of catalytic volumes of tests to understand how Ag RDTs can best fit into health systems,” the statement from FIND said. Also, WHO guidance published on 11 September 2020 highlights the value of these tests in areas where community transmission is widespread, it added. (Here is a list of WHO Emergency Use Listing for In vitro diagnostics (IVDs) Detecting SARS-CoV-2  and WHO’s target product profiles for priority diagnostics for the COVID-19).  

Stijn Deborggraeve, Diagnostics Advisor at MSF Access Campaign told Geneva Health Files, “It is encouraging that WHO has negotiated this volume guarantee for 120 million Abbott and SD Biosensor Ag RDT tests to supply LMICs. These instrument-free rapid tests are crucial for resource limited settings where there is no capacity for PCR testing. Especially in LMICs those tests are highly needed because many LMICs do not have sufficient lab capacity and do not have access to a wealth of testing options as high income countries do.”

Given that allocations of vaccines will be partly based on the state of the epidemic in countries, it is worrisome on multiple levels that what was true of PCR tests is true of Ag RDTs—LMICs continue to receive inadequate and inequitable supplies of tests that are essential to monitoring the state of the epidemic, he added. 

“Unfortunately the volume guarantee to LMICs represents only 20% of the global production capacity while LMICs represent 80% of the global population. As wealthier nations continue to have bilateral deals with the companies for buying COVID-19 medical tools, we are deeply concerned that people in lower and middle income countries will remain deprived of this critical test that can play an essential role in managing this pandemic. We hope that Abbott and SD Biosensor will take the right action to guarantee fair allocation and affordable supply of these tests for all,” according to Deborggraeve at MSF.

WHAT ARE VOLUME GUARANTEES?

How do volume guarantees work? Can they be compared to Advance Market Commitments (AMCs)? In the context of these diagnostics, sources suggested that volume guarantees can be understood as “minimum production capacity reservation”.

Responding to our queries, FIND and The Global Fund clarified, “AMCs generally relate to products that are in still in development, to incentivize R&D expenditure by private companies. A volume guarantee is generally for a product that is already on the market, and enables a company to commit to a certain price/volume commitment knowing that the investment is being underwritten (in this case by the Gates Foundation).”

Boehme of FIND, told The Guardian: they had put in bulk orders for the tests quickly so that low- and middle-income countries would not lose out in the global scramble for rapid tests, as they did when the PCR tests came out. “We see the pressure of supply building rapidly. That’s why we need this volume guarantee. We needed to secure volumes for low- and middle-income countries, before all the other countries place their orders and the poor populations again lose out...”

But how much impact will these volume guarantees have on price?

PRICING OF Ag RDTs

CSO experts who work on the ground, believe that the price of US $5 per unit is still very high. “$5 is high for many LMICs and the Ag RDT prices should drop below $3, including sample collection swabs, in future RDT procurement negotiations especially given the high volumes sold globally,” Deborggraeve at MSF added.

Spokespersons from FIND and The Global Fund, told Geneva Health Files, “At US$5 a test, this is considerably less expensive than the existing molecular tests, which are approximately US$20 per test and until now were the only tests to receive the WHO EUL approval. The cost of the new tests may decrease further if a significant number of tests are procured under the agreement. The initial US$50 million from the Global Fund will be complemented by investments by Unitaid and CHAI to support their introduction up to 20 African countries. Additional investment to support country implementation will be made by FIND and other partners from ACT-Accelerator funds. However, fully utilizing the volume guarantee for 120 million tests will require US$600 million, which we don’t have yet. And even 120 million tests over 6 months, while being a massive increase over what has been available so far, represents a fraction of what is really required.”

DISCONTENT IN THE DECISION-MAKING PROCESS

In the course of reporting this story, sources suggested that major policy decisions within the ACT Accelerator, including the ones on diagnostics, appear to be made with some “donor” countries at the table. Many developing countries were not aware of these discussions and agreements.

The process is very much “top-down”. The donors sit at the table, but implementing countries do not, a person familiar with the matter told Geneva Health Files on the condition of anonymity.

Given the pace at which these decisions are being made, regular consultative practices involving member states of WHO, as is the norm in multilateral processes in global health, appear to be done away in the interest of time and speed. Even middle income countries that Geneva Health Files reached out to, were not aware of these announcements. 

In addition, what might be puzzling is that there is a perception that developing countries have failed to engage enough and effectively negotiate on issues of concern to them. Without an official, streamlined multilateral process of engagement, this might be difficult to accomplish to begin with, sources pointed out.

These were precisely the concerns that were raised when the ACT Accelerator came into being – much of the decision-making processes are now allegedly being shaped away from the consideration of WHO member states.

To be sure, the diagnostics pillar of the ACT Accelerator has benefited from deep engagement with civil society groups. “Unlike the vaccines pillar, there is greater transparency in the discussions around diagnostics,” one source familiar with processes within the ACT Accelerator said. The ACT-Accelerator Diagnostics Pillar is governed by FIND and the Global Fund, in addition to WHO and over 30 global health expert partners. Work streams include research and development, market readiness, procurement, and country preparedness.

EQUITABLE ACCESS?

If enough number of developing countries are not even at the table, how can equitable access be ensured, notwithstanding that current allocation for diagnostics promise 20% of (Ag RDTs) tests for 80% of the world?

Also, it is not entirely clear to what extent intellectual property is a barrier to the access to diagnostics. Some experts say that trade secrets and monopolies are greater barriers as far as diagnostics are concerned.

“The first step towards ensuring equitable allocation of these new Ag RDTs is securing significant volume for LMICs, which is what the volume guarantees set out to achieve. Then it’s a question of ensuring that there is adequate funding for the procurement of these tests, even for the poorest countries…”the co-conveners of the diagnostics operations of the ACT Accelerator said.

“We also need to make sure the introduction of new tests is supported by policy (the role of WHO) and implementation research and support, which is what FIND, Unitaid, Africa CDC, and other partners are working on. By far the biggest barrier to achieving rapid and equitable deployment of these tests is likely to be money,” they added.

Read on, to see what our expert of the week has to share:

Q&A: BROOK K BAKER, INTERIM CIVIL SOCIETY REPRESENTATIVE, DIAGNOSTICS PILLAR, ACT ACCELERATOR

BROOK K BAKER [Image Credit: Northeastern University]

Brook K. Baker: Professor of Law, Northeastern University, School of Law. He is also Honorary Research Fellow, University of KwaZulu Natal; Senior Policy Analyst for Health GAP (Global Access Project).

He has been one of the interim civil society representative in the diagnostics pillar, of the ACT Accelerator. He is also a part permanent civil society representative in the Therapeutics Pillar.

[GHF]1. Do you believe that not enough attention has been given to diagnostics during this pandemic? There seems to be a lot of attention on vaccines instead.

I do believe that diagnostics have been greatly underemphasized, though partners working in the ACT-A Diagnostics Pillar have been working long and hard to reverse this neglect. Fast, affordable, easy-to-use, and accurate tests for active coronavirus SARS-2 infections are critically important to connecting people who are infected to care and to contact-tracing and testing for those who have been exposed. However, as we are increasingly seeing in rich countries, testing is also essential to reopening economies and expanding social activities in schools, workplaces, government facilities, transportation centers, etc.

People in low-income countries have had abysmal access to molecular/PCR tests that are expensive and require scarce reagents, skilled workers, and expensive lab equipment.

Because of scarce supplies and hoarding by rich countries, low-income countries have 1% of the PCR testing rate of rich countries and middle-income countries have only 10%.

Efforts to increase access to coronavirus testing is disproportionately underfunded within the ACT-Accelerator. Vaccines are, of course, underfunded, but diagnostics even more so. The recent announcement that the ACT-Accelerator has secured commitments to manufacture 120 million new antigen test for LMICs from two manufacturers, SD Biosensor and Abbott, is important and a significant accomplishment for ACT-A that needs to now be fully funded, but this will meet only a fraction of the need in LMICs and will mainly permit testing of health workers.

[GHF]2. Has the lack of adequate attention to diagnostics impacted policy response?

The relative scientific neglect of diagnostics has led to constrained funding and limited diagnostics R&D, especially for tests well suited for use and affordability in LMICs, though this is changing somewhat. There has also been insufficient attention on mechanisms for scaling up manufacturing of new, more accurate rapid Ag tests and diversifying the manufacturing base in LMICs so that they are less dependent on the limited number of suppliers that preferentially serve domestic and rich country markets. There should be a much greater focus on opportunities for technology sharing/transfer and scale-up of LMIC diagnostic manufacturing capacity.

[GHF]3. It appears that according to recent proposals negotiated in Geneva, LMICs may end up getting only 20% of Rapid Antigen Diagnostics Tests as secured by FIND/WHO under the ACT Accelerator. (120 million tests - 20% of manufacturers' capacities for "volume guarantees", as declared)

Low- and middle-income countries with 80% of the global population are getting 20% of the rapid Ag tests produced by two companies, SD Biosensor and Abbott, and rich countries with 20% of the global population are getting 80%.

SD Biosensor and Abbott are only two of dozens of testing companies that are developing and marketing rapid Ag tests. Thus, it’s not as if rich countries will not also be buying up many other Ag tests above the 80% from these two supplies.

Are we supposed to feel gratitude that diagnostic industry maintain control over global public goods and make minor concessions to global access? This “rationing” of tests for LMICs portends a very limited use-case focused primarily on health workers, leaving many others untested. Although we could celebrate this partial capacity reservation for 120 million tests, the overall picture is yet another exemplar of grotesque nationalism and market fundamentalism, like that which occurred for PCR molecular tests. Diagnostic nationalism marches hand-in-hand with vaccine and therapeutics nationalism.

Not only is nationalistic hoarding by the rich a problem, but there is a yawning resource gap not just for the purchase of the current 120 million tests (test cost $600 million), but for the other 380 million tests ACT-A intends to deliver by end of 2021. The total cost would be $3 billion even if all the purchases were for the lower-cost Ag tests, and the ACT-Accelerator only has a tiny fraction of this sum.

Like this story? Consider a donation.

Support Geneva Health Files


2. What we found interesting this week:

I. GATES FOUNDATION JOINT COMMUNIQUE WITH PHARMA COS.

The role of the Gates Foundation in this pandemic has been expansive and gets more interesting in the context of global health governance, with every passing week.

On the eve of the U.N.G.A. event, a joint communique was issued by the Foundation and 16 pharmaceutical companies: Life Science Companies and the Bill & Melinda Gates Foundation: Commitments to Expanded Global Access for COVID-19 Diagnostics, Therapeutics, and Vaccines.

  • There are a number of issues of note here. But this was significant, given discussions in the EU on liability provisions in vaccine deals.

    “Advance fit-for-purpose regulatory and liability processes for all stakeholders involved, which prioritize safety while not slowing down access to critical new tools.”

II. TAKING STOCK: COVID-19 TECHNOLOGY ACCESS POOL

Do have a look at this recent discussion on "Appraising Progress of WHO’s COVID-19 Technology Access Pool (C-TAP)" organized by Knowledge Ecology International (KEI).

Experts spoke about why the C-TAP has not taken off and why it should. (Can COVAX and C-TAP work together, for example?)

Also check out Oxfam’s recent work, cited in this discussion, estimating that rich countries with 13 percent of the world’s population “have already cornered more than half of the promised doses of leading COVID-19 vaccine candidates”.

Finally, a few organizations including KEI, recently sent this letter to WHO, pushing for a greater role of the WHO Global Observatory on Health R&D in the COVID-19 response.

Share Geneva Health Files


3. We are also watching:

Leave a comment


Support this independent global health journalism initiative. Regular donations are crucial in order to sustain the production of Geneva Health Files.

Support Geneva Health Files