A doctor checks an x-ray of the lungs of a hospitalised boy with COVID-19.

What if every household in the world could diagnose coronavirus-triggered pneumonia from their home with a cheap handheld device?

We are not at this stage yet. But the Swiss-made Pneumoscope, an intelligent stethoscope that can diagnose pneumonia in seven minutes, is bringing this dream closer to reality, says Benissa Mohamed-Rida from the Pneumoscope initiative.

The device is one among a series of new portable and low-cost innovations that will be featured at the Geneva Health Forum which opens Monday, 16-18 November.

Why is This Important?

The three-day Forum brings together Swiss and European expertise with that of researchers and practitioners from low- and middle-income countries (LMICs) to explore problems on the cutting edge of global health, as well as innovative solutions.

While an overarching theme of the first-ever virtual of the Forum will naturally be COVID-19, the conference is covering a wide range of other topics – from big picture themes such as climate change and decolonising global health to nuts-and-bolts approaches to tackling cervical cancer or neglected tropical diseases.

The event is co-sponsored by the Geneva University Hospitals and the University of Geneva, in collaboration with Geneva International, WHO, UNAIDs and UNITAR.  It is expected to draw some 1,600 participants from 80 countries worldwide.

In addition, some 120 new health technologies will be showcased at a special GHF Innovation Fair, including the Pneumoscope. People registered to the GHF will be able to visit the online “exhibit” spaces at certain times every day to meet with the innovators and chat with them about their products.

A Pneumonia Diagnosis in Just Seven Minutes

The current Pneumoscope prototype can diagnose in just seven minutes common forms of pneumonia, one of the leading causes of death for children under five in low-income countries.  Although this diagnosis isn’t sufficiently fine-tuned [yet] to identify only COVID-19, it’s a hint at the direction such new technologies are heading.

“In times of a pandemic, public health professionals are on the lookout for cost-effective strategies to promote diagnosis and disease prevention, not only in low-resource settings,” notes Mohamed-Rida, a Paris-based medical doctor who is working with the Swiss-based Pneumoscope Initiative. “If we can be precise in the laterality of pneumonia, there is no need to do an x-ray, so insurance companies will want to pay for the Pneumoscope, even in high-income countries.”

The Pneumoscope Initiative is being led by Geneva University Hospitals and the University of Geneva, in collaboration with the Swiss Ecole Polytechnique Federale Lausanne (EPFL) and Terre des Hommes, a global NGO.

The Smart Scope, an Indian invention that can detect cervical cancer in under 10 minutes.

Among the many other innovations on display will be the Indian-designed Smart Scope, an award-winning portable device that can detect cervical cancer, the second largest killer of women in India after breast cancer.

They are just two examples of the many low-cost health technologies that are emerging out of the “reverse innovation” spirit of entrepreneurs looking to turn resource scarcity into a virtue.

Such devices are potential deal breakers in LMICs, where a lack of more sophisticated x-ray and laboratory infrastructure and trained healthcare workers, means that many preventable diseases, including pneumonia and cervical cancer, slip past our radar.

How Does it Work? Think Shazam

Just like a song that can be recognised through apps like Shazam, respiratory diseases also have their own acoustic “signature”. And they can be recognised by artificial intelligence (AI), with the help of a smartphone or tablet, at a surprisingly high accuracy.

Working from this principle, the Pneumoscope can tease apart a healthy lung from a diseased one at a sensitivity of almost 100%, according to a preliminary case-control study that compared children under 5 years of age with pneumonia to healthy children.

In comparison to commonly used tools to diagnose pneumonia like the WHO/UNICEF case management algorithm, the Pneumoscope is twice as accurate, says Mohammed-Rida. Currently, the algorithm developed by UNICEF/WHO misses every second child with pneumonia, which is ‘simply not good enough’, he adds.

But there’s more. The Pneumoscope can also tease apart viral pneumonia from bacterial pneumonia almost 90% of the time.

That means that it could help address another important issue – unnecessary prescription of antibiotics. In low-income countries, given the scarcity of effective diagnostics, antibiotics are often prescribed when a child is sick with pneumonia – even though they may have a viral infection – and this contributes over time to drug resistance.

In addition, the device can potentially diagnose severe bouts of asthma, the leading chronic disease in children that affects almost 340 million people worldwide. Preliminary results are ‘quite promising’, says Mohammed-Rida, noting that the Pneumoscope picks up asthma’s acoustic signatures 90% of the time, according to preliminary trials that are still unpublished.

The device is currently being field tested in Burkina Faso, Morocco, Brazil, Cameroon and Senegal.

Not a Rolex

The Pneumoscope is designed to withstand a range of extreme conditions, including deserts with scorching temperatures as hot as 50 °C, as well as humid environments and rain.

“The Pneumoscope can’t be a Rolex,” says Mohamed-Rida. “It has to withstand extreme conditions, especially heat and humidity, as well as sand, which clogs up electronics and renders them unusable.”

Although its price remains to be determined, its cost-effectiveness ratio is likely to be “quite interesting”, says Mohammed-Rida. The group is working to manufacture it locally in LMICs through 3D printing.

Reverse Innovation

Because it doesn’t need lots of technical training to use, it’s particularly well-suited for LMICs, where pneumonia is five times more common than in rich countries.

But there may be appetite for the Pneumoscope in high-income countries as well, especially during the pandemic, says Mohammed-Rida. Precisely because such devices save time and money – and may even be more accurate – they often infiltrate upward into more affluent countries – a process some call “reverse innovation.”

Notably, since the Pneumosocope can also detect which side of the lungs is infected, more formally known as the ‘laterality of disease’. it may be able to overcome the need for pricey x-rays.

“This could save overwhelmed healthcare systems tremendous amounts of money,” says Mohammed-Rida.

Image Credits: Keystone / EPA / Emanuele Valeri, Periwinkle Technologies.

Melinda Gates tells Paris Peace Forum that broad global access to COVID-19 vaccines is criticlal to  recovery

A series of new COVID-19 drug and vaccine funding commitments worth just over US$300 million were announced on Thursday by the Gates Foundation, France and the European Commission – amidst a quickening pace of anticipation that at least one, if not two, COVID-19 vaccines may soon become available. 

Appearing at the Paris Peace Forum, Melinda Gates announced a new $US 70 million contribution by the Bill and Melinda Gates Foundation to vaccine research and the ACT Accelerator’s COVAX facility. The WHO co-sponsored ACT Accelerator aims to ensure the worldwide distribution of forthcoming COVID vaccines, along with drugs and tests, to countries that can least afford to purchase them. 

“In this pandemic there is no difference in helping yourself and helping others,” said Gates. “But its not enough to have the right values, we have to put enough money behind our values,” said Gates.

She spoke at the Paris Peace Forum shortly after WHO published an urgent appeal for US $4.579 in immediate financing to the Accelerator’s various arms of support – which aim to cover worldwide procurement of not only vaccines, but also COVID-19 tests, treatments – and required health systems capacity.  Some $US 28 billion will be needed over the course of 2021, WHO warned, in a detailed investment case, published just hours before the Paris Peace Forum event. 

‘Urgent’ finance asks for COVID-19 drugs, diagnostics, vaccines and related health system capacity, published by WHO on 12 November 2020

Gates appeared at the Paris Peace Forum high-level event along with French President Emmanuel Macron, Norwegian Prime Minister Erna Solberg, European Commission President Ursula Von der Leyen, and Dr Tedros Adhanom Ghebreyesus, head of the World Health Organization.  Both the French President and the Von der Leyen also pledged another €100 million Euros each to the Act Accelerator vaccines, tests and treatments initiative. 

Macron also called upon global leaders to adopt an “Act-A Charter” to ensure that “regulatory and policies making COVID-19 products available for all people…if part of the planet is not safe, the entire planet will remain under threat,” he said.

Added von der Leyen, “If we have a COVID19 vaccine, we should have a common approach to give a fair share to everyone so the most vulnerable groups, the frontline workers and the healthcare workers are the ones that get it first.”

Macron’s proposal for a Charter was applauded by WHO’s Dr Tedros who said: “WHO welcomes the ACT-A Charter, which outlines the core principles of equity and fair allocation that align this landmark effort to ensure vaccines, diagnostics and therapeutics are allocated fairly as ‘global public goods’ and not private commodities.”

Meanwhile, however, Norway’s Solberg stressed that, “money talks” and what is needed is $US4.5 billion immediately – as well $US28 billion over the course of 2021 in order to fully fund all four pillars of the Act Accelerator’s activities.

She was referring to the new WHO “investment case” outlining “Urgent Priorities and Financing Requirements” for the ACT Accelerator initiative.  Solberg and other panelists pointed out that the monies, while significant, are small in comparison to the economic costs of a continuing pandemic.  

The Act Accelerator’s $US 28.3 billion ask includes: $US 5.3 billion for COVID tests;  $US 6.1 billion for drugs and other therapeutics; $US 7.8 billion for vaccines; and $US 9.1 billion for upgrading health systems to make it all happen, states the investment case.

Act Accelerator Therapeutics Pillar
ACT Accelerator Vaccine Pillar
Act Accelerator Diagnostics Pillar
Act Accelerator Health Systems Pillar

The Access to COVID-19 (Act) Accelerator is a collaboration  between WHO and the GAVI Vaccine Alliance, the Global Fund, Gates Foundation, The Wellcome Trust, FIND diagnostics, Unitaid and the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI). It is acting on four pillars – that aim to ensure worldwide access to COVID drugs, vaccines, tests and health services.

“Our goal is to accelerate the development of COVID vaccines and ensure people in all countries get rapid and equitable access regardless of their ability to pay, said Seth Berkley, CEO of GAVI, also speaking about the Accelerator at the Paris Peace Forum.

Generic Drug Manufacturers Pledge To Collaborate With Medicines Patent Pool 

Meanwhile, a coalition of 18 of the world’s largest generic drug manufacturers pledged to work with the Geneva-based non-profit Medicines Patent Pool (MPP) to expedite delivery of the latest COVID-19 drug solutions, including monoclonal antibodies to low- and middle-income countries.  

“We strongly believe that collaboration is the only way we can make it past this pandemic. Each of us stands ready to contribute to the fight against COVID-19 through our technical expertise and longstanding experience in manufacturing and distribution of quality-assured medicines,” states the pledge, signed by the leading generics manufacturers such as Adcock Ingram, Celltrion, Sun Pharma, Natco and others. 

“This unprecedented cooperation from companies that are typically competitors represents a breakthrough in our efforts to level the playing field for access to drugs that will be crucial to controlling and defeating this pandemic,” said Charles Gore, Executive Director of MPP, in a press release. “These are companies with an excellent track record of working with originators to ensure generic versions of their innovations meet high standards for quality—while answering the need for more affordable, accessible therapies.”

Gore noted that collectively the 18 companies that have so far joined the  “open pledge”  have the capacity to deliver huge amounts of conventional drugs, technically known as “small molecules” in industry parlance.  They also have a growing capacity to produce cutting-edge “biologics,” or drugs based on the chemistry of living, biological compounds. Promising COVID-19 biologics include monoclonal antibodies targeting COVID-19 that are currently in clinical trials, and have shown potential for either treating or prevent viral infections such as COVID-10. However, their cost and manufacturing capacity pose substantial barriers to deploying them globally. 

Gore said he hopes the pledge by such a respected group of generic industry players to produce large volumes of high-quality COVID-19 treatments will encourage firms now developing either new or re-purposed therapies to negotiate agreements allowing rapid access to those in need. This can be either through licensing of their intellectual property, or where licences are not needed, facilitating ways to scale up manufacturing capacity to meet the high demands.

Charles Gore, Executive Director, Medicines Patent Pool

MPP was created in 2010 by the global health initiative Unitaid to negotiate license agreements for the generic manufacture of patented drug products of critical importance to health-care systems in low and middle income countries – vastly easing the process for generic drug manufacturers.  Beginning with HIV and Hepatitis C drugs, MPP’s mandate had recently expanded to include other treatments, most recently COVID-19 therapeutics. 

World Health Assembly Sees Debate on WTO Patent Waiver Proposals – Affirmation by Pharma of “Equitable Access”

In a separate statement, the International Federation of Pharmaceutical Manufacturers and Associations and the International Generic and Biosimilar Medicines Association, declared their “shared commitment to equitable acccess to COVID-19 medicines and vaccines” – adding that the pandemic has also highlighted the “importance of ensuring adequate resources are spent to build stronger, more resilient health systems that can cope with complex health challenges.”

The statement, coincided with this week’s World Health Assembly, which saw a wide-ranging discussion of the COVID-19 pandemic, including fears expressed by low- and middle-income WHO member states that their countries could be left out of the COVID-19 vaccine sweepstakes – as rich countries snap up huge pre-order supplies of those products most likely to come first to market.

To address those concerns, South Africa and India have already jointly proposed an IP “waiver” at the World Trade Organization on patents, copyrights and trade secrets for COVID-related health products – covering not only drugs, tests and vaccines, but also hospital supplies like respirator and protective gear.   The “waiver” proposal has, however, so far failed to make headway against rich countries’ objections. And the proposal was subject to considerable pushback again at this week’s WHA from high-income countries, including the United States and the United Kingdom.

Meanwhile, WHO has tried to promote a “third way” including a C-Tap initiative that would mimic the successful Medicines Patent Pool approach, but for a wider array of COVID-19 products, particularly vaccines.  So far, however, that WHO-led effort does not seem to have gained much ground. That appeared even more evident on Thursday in the news that MPP is now building an alliance with generic drug manufacturers to negotiate patent pooling deals over key COVID drugs – in a format that is more predictable and familiar to industry partners.

Overall, the trends have frustrated medicines access advocates who protest the notion that public monies will be spent to buy pharma products that were also financed, in part, by public “Lofty rhetoric on global public goods and solidarity in the COVID-19 response has not been matched by concrete action on the sharing of know-how and intellectual property rights to facilitate deep technology transfer,” said Knowledge Ecology International’s representative, Thiru Balasubramaniam, during the WHA debate. At the minimum, he said public funders of COVID-19 R&D, such as governments and philanthropies should “use their financial leverage to enable the sharing of know-how, cell lines and rights in data and patents, for COVID-19 related technologies.”

Along with tried-and-true MPP approaches, the mood at the Paris Peace Forum made it clear that European leaders are trying to cut a path forward in the marketplace to ensure universal access to whatever the world needs to recover from COVID-19.

Rather than upending the established legal order at WTO or anywhere else, the approach is to leverage huge loans and donations to buy cutting-edge vaccines, drugs and tests as they come to market – but in coordinated, large scale deals that would at least be more affordable.

And that, may be the other bottom line of the US$28 billion Ask.

 

Image Credits: Paris Peace Forum , WHO , WHO , WHOI , MPP.

WHO Financing by Regional Major Office

Despite nearly two years of internal restructuring, WHO’s budget at its Geneva headquarters is still twice the amount spent in all 54 countries of the Organization’s African Region, said the African bloc of stated at Wednesday’s World Health Assembly. 

Speaking on behalf of the African bloc, Seychelles noted that the most recent WHO financial report highlights the continued trend of disproportionate spending in its Geneva headquarters in comparison to the Organization’s six regional offices and nearly 100 country offices. 

Under a “transformation” plan announced by Director General Tedros Adhanom Ghebreyesus in 2019 WHO Regional and Country offices, which are maintained in the countries of most low- and middle-income WHO member states, are supposed to be assuming a greater leadership role – with more resources allocated to their needs. 

But as of end 2020, more of the $US3.7 million annual budget is still being spent at WHO headquarters than anywhere else — including Africa, where WHO teams desperately need more funds to tackle problems associated with the continent’s high disease burden and systemically weak national health systems. 

“Apportionment of funds to Headquarters remains higher than other regions,” said the Seychelles representative, speaking on behalf of the African bloc during a review of WHO’s 2020-21 biennial budget. “It is twice higher than apportionment to Africa which has weak health systems and burdens. There is the need to shift resources from WHO HQ to where the health issues are, and more can be achieved,” the spokesperson concluded. 

Rich Countries Call for Greater Investment in Primary Health Care and NCDs 

Meanwhile, countries ranging from Japan to China and Norway have enjoined the WHO to commit more resources to the prioritisation of universal health coverage and combating the non-communicable diseases – which are a growing problem in poor as well as rich countries today.

Japan’s delegate noted that efforts should be made towards ensuring that finance and health ministers of member countries are able to collaborate in order to ensure mutual understanding of national and global health financing priorities, especially in countries that are struggling to meet their financial commitments to the WHO.

For the WHO, Japan also urged the global health body to strengthen accountability and enshrine transparency more deeply into its operations. It also called for an independent assessment to ascertain resources were being deployed and used in the most efficient way. 

The delegate for the People’s Republic of China added that funding gaps exist in non-communicable diseases and such gaps will only be closed when member countries of the WHO pay their contributions on time.

LMIC Member States Decry Negative Impact of COVID-19 on their Ability to Contribute to WHO

Although WHO’s leadership has also called upon member states to step up to the bat with larger and more predictable funding, Member States said they are already having a hard time paying the current annual assessments to WHO – as a result of the pandemic’s economic fallout. 

Argentina cited COVID-19 as reason for its delay in paying annual assessed fees to WHO – but pledged to fulfill its commitments. 

“We are making our payment. We’ve made partial contributions for 2019 and we hope to meet pending balances,” the country’s representative said. 

Wars and civil conflicts have also compounded pandemic problems for some countries. Libya’s delegate, for instance, pointed to the suspension of oil extraction activities, the country’s major source of revenue generation. 

“Hostilities have halted oil production but we are working with Tunisia to work out an arrangement. By the end of 2020, we hope to have resumed oil production again and we are asking for global solidarity,” Libya’s representative said. 

Funding Shortfalls Constrain Operations 

Funding for the WHO has been a recurring topic at the World Health Assembly. 

In his opening remarks on Monday, Dr Tedros said that WHO’s member states need to step up to the bat. 

Dr Tedros Adhanom Ghebreyesus, WHO Director General.

Right now, regular  “assessed contributions” comprise only 20% of the organization’s budget, and that is a diminishing proportion. The bulk of the money comes from additional voluntary funding provided by countries and other donors. But ‘earmarking’ of those funds often constrains WHO’s ability to spend money according to its own defined priorities. .   

“Predictable and sustainable funding remains one of the fundamental challenges for the future success of this Organization. For WHO to do its job, we must address the shocking and expanding imbalance between assessed contributions and voluntary, largely earmarked funds,” the DG said.

Over the past decade, Dr Tedros said, the world’s expectations of WHO have grown dramatically, but the organisation’s budget has barely grown at all. Those expectations, he said, will only continue to increase in the wake of the COVID-19 pandemic.

“Our annual budget is equivalent to what the world spends on tobacco products every single day. If the world can send that much money up in smoke every day on products that maim and kill, surely it can find the funds – and the political will – to invest in promoting and protecting the health of the world’s people,” the DG added.

Too Dependent on Handful of Donors 

Tedros also has admitted that WHO is too dependent on a handful of large donors, and there is need to broaden the donor base overall. 

WHO funding by fund type and contributor

 

To that end, he last year announced the creation of the WHO Foundation. The Foundation can draw funds directly from the private sector and individual donors – something that WHO’s strict conflict-of-interest rules generally prevent.   

However less than a year after those moves were put in motion, the COVID-19 pandemic hit – vividly illustrating the shortcomings between expectations and delivery of the WHO’s emergency response in a number of arenas.  

Particularly evident was the slow scientific response to urgent issues like whether the virus was airborne or not, whether masks were useful, and whether or not travel restrictions would help curb the spreading pandemic. 

While some of the delays may have been due to the conservative nature of WHO – which simply re-issued the same kind of travel and public hygiene advice that had been a standard for other epidemics – it was also blamed on a lack of in-house scientific know-how.  

In July, an announcement by the US Administration that it would withdraw its funding – which comprises some 15% of the Organization’s operations, including a significant proportion of resources that go to the African Region and the WHO Health Emergencies Programme. 

The shock has prompted a rethinking among European donors, led by Germany, about how to improve WHO’s budget and make it more sustainable over time. 

Speaking Monday at the resumed 73rd WHA, on behalf of the European Union, German health minister Jens Spahn said the COVID-19 pandemic had highlighted “a gap between WHO‘s 194 member states’ expectations and requests vis-à-vis the organization and its de facto capacities to fulfill them.” 

Jens Spahn, Federal Minister of Health, Germany, speaking at the WHA.
Pockets of Poverty 

While there is a drive to bolster scientific staff and expertise presumably at headquarters in the wake of the pandemic, the underfunded WHO regional and country offices of the low and middle-income countries are also a big donor concern. 

At a WHA debate over the budget, extending over Tuesday and Wednesday, another German WHA delegate  acknowledged the “pockets of poverty” that are often seen in specific programmes or WHO offices. 

Each year, again and again … with a déjà vu we see pockets of poverty — so specific programs that have not received adequate funding,” the official said of the assembly. “Within the last 10 years, many options have been explored in order to change the situation but the financing challenge has not been properly addressed.” 

But another problem, said the delegate, is that information provided by WHO, which informs WHA members’ debate, is “often not adequately grounded on a thorough analysis. We are discussing earmarked versus flexible, predictable versus non-predictable funding. But we never discuss what the consequences and implications are for WHO to perform.”

As a way forward, Germany has now proposed placing an item on sustainable financing on the agenda of the January 2021 WHO Executive Board – the next meeting of WHO’s 33-member governing body. The “ask” from donors is that WHO provide a coherent account here of its  current financial state – and how it affects its capacity to deliver, and what realistic needs it has – as well as alternatives for expanding the overall pool of donors – and money.

 

Image Credits: WHO, WHO.

Hypertension, an NCD that can be prevented through monitoring and early diagnosis

Norway will contribute an additional 133 million USD (1.2 billion NOK) to reduce the burden of non-communicable diseases (NCDs) in low-income countries from 2020 to 2024, the Ministry of International Development announced today. 

The announcement comes in the wake of last year’s path-blazing strategy for how to tackle the growing NCD burden in LMICs, “Better Health, Better Life”. The strategy was the first by an  international donor country to address health risks that are an increasing factor in deaths and disease in poor countries – where poor diets and degraded, unhealthy environments combine with a lack of access to standard NCD prevention and treatments. More than 15 million people under the age of 70 die every year from NCDs, with most of those under-70 deaths in low- and middle-income countries where people have less access to treatment.

Despite the growing burden, most donor assistance to developing countries remains focused on infectious diseases, including vaccine preventable diseases. While those risks can’t be discounted either, too many health programmes are often organized “vertically” so that even basic NCD services, like cervical cancer screening, are ignored. The intricate link between NCDs and infectious diseases has also become more apparent during the COVID-19 pandemic –  where NCD conditions increase the risk of becoming seriously ill or dying from the SARS-CoV-2 virus. 

“Norway is the first donor country with a strategy focusing on NCD-action in developing countries. I hope other donor countries will follow,” said Dag-Inge Ulstein. “There is a huge need for funding. Despite the enormous death burden in low- and middle- income countries, NCD efforts only receive between one and two per cent of all global health-related development aid. The funding gap comes with a consequence, and too often the victims are the most vulnerable.” 

World Health Assembly Discussion on Healthier Lives and Wellbeing 

The announcement coincides with discussions at the World Health Assembly gathering of its member states on a third pillar of the WHO’s strategy that aims to promote – Healthier Lives and Wellbeing. 

However, those discussions covering strategies for healthy ageing, food safety and nutrition… also are at risk of being eclipsed by the highly-politicized debates over the COVID-19 pandemic response and WHO reform.  

“We applaud Norway for prioritising NCD prevention and control within its poverty alleviation and sustainable social development priorities,” says Katie Dain, CEO of the NCD Alliance, in responding to the announcement.

 “Norway is walking the talk on the Sustainable Development Goals and has recognised the urgency for action on the global tsunami of NCDs. It is setting an important precedent for other OECD countries to follow.”  

Nina Renshaw, NCD Alliance Policy and Advocacy Director also adds: “Financing has long been the Achilles heel of the NCD response. The emphasis on ensuring sustainable financing for NCD prevention and control is particularly welcome. 

“We’ve been hearing throughout this week’s World Health Assembly that countries have the will to achieve Universal Health Coverage, (UHC) but need to mobilise the means, in increasingly challenging financial circumstances. That Norway is offering countries support to develop sustainable financing models and calling on other donors to join in to act on NCDs as a major cause of poverty, is a strong signal for others to invest.”

NCDs, including heart disease and hypertension, cancers, lung disease, diabetes, and mental health disorders cause more than 70% of all deaths worldwide. This means that far more people die from non-communicable diseases than from infectious diseases such as malaria, tuberculosis, polio, HIV/AIDS, and Ebola. And in developing countries, NCDs are a large and growing proportion of the disease burden. 

‘Worldwide, 41 million people die each year as a result of respiratory disease, cancer, cardiovascular disease, diabetes, mental disorders and other non-communicable diseases. This cannot continue,” said Ulstein when the Norwegian NCD strategy was first launched a year ago in Oslo.  

A 2019 panel at the launch of Norway’s new NCD-focused development strategy. (left-right) Maria Neira, WHO; Omnia El Omrani, (IFMSA); Mamka Anyona, UNICEF; Tiy Chung, CCA Coalition; Andrea Winkler, Centre for Global Health, the University of Oslo; Katie Dain, NCD Alliance.

“The NCD crisis has been ongoing for several decades. The death toll is rising year by year. NCDs are often chronic diseases, resulting in high health costs for individuals, families and societies. As is often the case, people in vulnerable situations bear the heaviest burden,” said Ulstein. 

And moreover, 86% of “premature” NCD-related deaths occur in low- and middle-income countries, where there is lack of awareness about prevention, and lack of access to diagnosis and treatment. These deaths will cost $7 trillion in economic losses over the next two decades.

Currently about 1-2% of global health-related assistance goes towards combating NCDs, or around $US 611 million. Bilateral donors (national governments or their development agencies) are the dominant source of funding in global health, but have been relatively absent in the field of NCDs until recently. 

Between 2010-2015, non-governmental organizations (NGOs) collectively provided more than twice as much aid for NCDs than bilateral donors, and considerably more than multilateral organizations such as the World Bank and the WHO. 

LMICs have been left to respond to increasing burdens of NCDs with their own scarce resources. Large-scale global efforts have the potential to save millions of lives and contribute to healthier populations and economic growth in LMICs. 

The Norwegian assistance will help fund activities around its three-point strategy: Strengthening primary health care; prevention targeting leading risk factors for NCDs, such as air pollution, tobacco and alcohol consumption, as well as unhealthy diets; and strengthening health information systems and other global public goods for health. 

Strengthening Primary Healthcare Services 

At the primary healthcare level, many NCD interventions can be delivered effectively and affordably, benefiting patients and savings for health systems. This can include checks for hypertension, diabetes, prevention of cervical cancer with HPV vaccination, as well as capacity for prevention and early diagnosis and treatment of mental health disorders in primary health services. Norway will support strengthening health services so that primary health care services are well-equipped to support NCD prevention, early diagnosis, and treatment.

Knowing your blood pressure supports NCD prevention, diagnosis, and early treatment.
Prevention Targeting Risk Factors for NCDs

Norway will support countries requesting assistance to improve taxation and regulation and regulation of products that are harmful to health through its Tax for Development Programme (Skatt for utvikling). These measures can be effectively used to discourage consumption of health-harmful products such as tobacco, alcohol, and sugary drinks. Pollution taxes and regulations can encourage shifts to clean energy and transport. All these are key risk factors that contribute to NCDs. 

Unhealthy, unregulated food is one risk factor for NCDs

Strengthening Health Systems 

The aim is to aid countries in developing better health information systems to improve access to health data critical for early stage NCD diagnosis treatment, supporting NCD-related health norms and standards, and will improve access to medical equipment and medication, especially in areas hit by crises and conflict. 

Together, these three points support the WHO Sustainable Development Goals (SDG) of reducing premature deaths from NCDs (SDG 3.4) by one-third by 2030 and Universal Health Coverage (SDG 3.8), and includes targets of reducing deaths from air pollution, strengthening tobacco control, and preventing harmful use of alcohol. 

Image Credits: icd 10/Flickr, Stine Loe Jenssen, John Campbell/Flickr, Sven Petersen/Flickr.

A map tracking rates of breast feeding globally, following the WHA discussion on breast milk substitutes
Global scorecard tracks rates of infants under 6 months who are exclusively breastfed, by country, with red as the lowest rate and green reflecting countries with 60% or more exclusive breast-feeding for under 6 infants. Grey indicates no information available.

Breast milk substitutes, long decried by global health specialists, are making new inroads into the markets of poor countries during the COVID-19 pandemic – including through new and more effective modes of digital marketing.

Guidelines for distributing and donating such substitutes to households facing hunger and malnourishment due to the economic fallout of COVID-19 lockdowns, are urgently needed, a number of member states told members of the World Health Assembly (WHA) meeting in a virtual session on maternal and child nutrition on Tuesday.

Nearly a dozen countries, including Kenya, Zambia and the United States, drew attention to the need for WHO and other global health organizations to address the marketing, distribution and recommendations for breast milk substitutes in a more uniform manner.

“Inappropriate promotional foods for infants and young children has been a big challenge in the fight against malnutrition in countries such as Zambia, particularly with the many advances in marketing strategies using various technologies,” said the country’s representative to the WHA.

Digital marketing makes it difficult for countries to ensure that mothers are not unduly targeted by ads promoting substitutes, further complicating authorities’ ability to control the reach of manufacturers.

“Zambia, for instance, despite recording a decline in most childhood forms of malnutrition has experienced a decline in infants exclusively breastfed in their first six months from 73% in 2013, to 17% in 2018.

“At the same time, the country has seen an increase in nutrition-related non-communicable diseases, which could in part, be attributable to inappropriate feeding of infants and young children as a result of advertising.”

Breastfeeding outcome in Zambia according to WHO
The rate of breastfeeding in Zambia, compared to the region and globally.

The Zambian representative said that clear guidelines are needed on how to address donations of breast milk supplements during the COVID-19 pandemic.

WHO says countries should monitor the marketing of such substitutes, which often undermine breastfeeding and normalise artificial feeding, more strictly.

The recommendation is part of a draft WHO report on the comprehensive implementation plan on maternal, infant and young child nutrition.

The draft report states: “The widespread use of digital marketing strategies for the promotion of breastmilk substitutes is a cause of growing concern.

“Modern marketing methods that were still unknown when the International Code for Marketing Breastmilk Substitutes was first adopted, are now used regularly to reach young women and their families with messages that normalize artificial feeding and undermine breastfeeding.”

It also said: “Tactics such as industry-sponsored online social groups, individually-targeted Facebook advertisements, paid blogs and vlogs, online magazines, and discounted Internet sales are used increasingly.”

Missing the WHO Targets

The report finds that an estimated 41% of infants aged under 6 months were exclusively breastfed, based on the latest survey estimates for 2013-2018. The World Health Assembly has set a target to increase this global rate to at least 50% of nursing infants by 2025.

The US representative at the WHA spoke on the issues of breast milk substitute marketing.

48 countries have exclusive breastfeeding rates higher than 50%, while 51 countries have rates below it. Of 73 countries with sufficient data to estimate current trends, 34 are on track to reach the proposed target by 2025. 16 countries present insufficient progress, while 23 either present no improvement or are worsening.

The draft report also said: “WHO Guidance on ending the inappropriate promotion of foods for infants and young children recommends that companies marketing foods … should not sponsor meetings for health professionals. Despite that guidance, 38% of national paediatric associations continue to receive funding for their conferences from the manufacturers of breastmilk substitutes.”

A US representative asked the WHO Secretariat to provide clarity on its data collection, however. She said that transparency is important in preparing a comprehensive report to understand the scope and impact of digital marketing strategies which may not be in accordance with the International Code for marketing of breast milk substitutes.

“In the interest of good governance, it is important to ensure that the Secretariat clearly defines the scope and resources necessary to provide a comprehensive report and member state guidelines,” the representative stated.

Global Perception Versus Local Reality

While stressing their support for WHO’s Comprehensive Implementation Plan on Maternal, Infant and Young Child Nutrition: Biennial Report, a sharp contrast existed between the issues raised by developing countries compared with their developed counterparts. While developed countries suggested that their local laws have provisions to deal with the various issues mentioned in the report, developing countries stressed the need for WHO to further increase its support for member countries.

In its submission, Israel described the issue of maternal, infant and young child nutrition as crucial to global health. It then pledged its support to WHO which it also commended the various policy documents and guidelines that the global health authority had put forward regarding the COVID-19 pandemic.

The moderator at the session.

Kenya – one of two African countries that commented – localised the burdens of nutrition especially for their citizens. Kenya’s representative said the country has been making “difficult progress” in promoting maternal infant and young child nutrition. While describing the country’s breast milk substitute act of 2012, the country’s spokesperson said the government has been able to secure legislative provisions for breastfeeding-friendliness at the workplace in Kenya.

“There is also the development of national guidelines for healthy diets and physical activity. In addition, we have integrated food and nutrition content in our current school curriculum,” the spokesperson stated.

But in spite of the progress made, several challenges remain and they have been exacerbated by the COVID-19 pandemic in Kenya, disproportionately affecting young children and older persons.

“We therefore invite WHO to support member states to monitor and document the impact of COVID-19 on food security, nutrition status and to develop measures to mitigate the negative impact on nutrition,” the representative said.

“We also note with concern the findings that in the absence of a substantial scaleup, it is likely that the 2025 targets will not be met,” the UK said. “This is now even more of a challenge. Given the direct, indirect impacts of COVID-19, the Japan 2021 Nutritions for Growth Summit will come at a critical time.”

The United Kingdom urged the WHO Secretariat to promote engagement between WHO country offices and member state governments to support them to use published commitment guidelines to develop concrete policy and financial commitments that can catalyze progress towards the global nutrition targets.

Image Credits: WHO, WHO / UNICEF Global Breastfeeding Collective, WHO / UNICEF Global Breastfeeding Collective, WHO.

Air pollution above India
Smoke covering Punjab, Delhi, Uttar Pradesh and Madhya Pradesh, as captured by Nasa’s Visible Infrared Imaging Radiometer Suite.

DELHI, India – As north India reels under ‘severe’ levels of air pollution for the fourth day in a row, the government has appointed a former Petroleum Ministry bureaucrat to chair a new national Commission For Air Quality – hastily set up by a presidential decree just 10 days ago.

Dr M.M. Kutty, former head of India’s Ministry of Petroleum and Natural Gas, took over as chair of the new Commission on Friday, a day when official monitors reported PM2.5 levels in Delhi as high as 953, almost 100 times more polluted than WHO’s guidelines for 24-hour particulate pollution levels.

Delhi and adjoining areas are now regularly seeing PM2.5 cross 500 micrograms per cubic metre – more than 50 times the WHO-recommended 24-hour standards – as seasonal crop stubble fires continue to burn in neighboring rural states of Punjab, Haryana, Rajasthan and Uttar Pradesh.

NASA researcher Dr Pawan Gupta tweeted on Monday that there have been more fires in Punjab in the last two months, than any other September and October in 9 years, with the exception of 2016.

Adding to the pollution mix are seasonal weather conditions -falling temperature and stagnant winds – and open wood or biomass-burning fires to heat homes. Things could get even worse in coming days and weeks if Delhi’s residents also begin setting off firecrackers that are a traditional part of the late autumn festival of lights, Diwali.

New Ordinance For An Old Problem?

The new commission actually does something significant in terms of Indian law. It replaces the 22-year-old Supreme Court-empowered Environment Pollution (Prevention and Control) Authority (EPCA), with a formal government body responsible to the central government of Prime Minister Narendra Modi.

As such, it represents the most explicit action yet by Modi to address the threat of India’s air pollution to public health – even though the Prime Minister continues to avoid the issue in his public statements.

India’s Prime Minister Narendra Modi

Although air quality experts have welcomed the creation of the new Commission, they said that the notable lack of government urgency to act in the face of another mounting air pollution crisis remains disappointing.

“A new commission, with full-time members, representation from the Centre and states, and dedicated staff is a step in the right direction,” Shibani Ghosh, public interest lawyer and Fellow at the Centre of Policy Research, told Health Policy Watch. “It could address concerns of intermittent focus on air quality, institutional capacity constraints and lack of bureaucratic coordination.”

“What the ordinance has done is replace the EPCA and the multiple other task forces with a single new commission with full-time staff, representatives from the central and state governments and significant powers,” explained Dr Santosh Harish, who specialises in energy and environment policy and air quality governance. “This could help address some of the issues in bureaucratic coordination across agencies in this region.

“However, all the major actions needed for improved air quality – tackling industrial or power plant emissions more effectively, finding a long-term solution to stubble burning, improving waste management – involve increased political willingness to impose costs on polluters. Neither the ordinance or the commission seem to solve that problem,” he added.

Quality Of Commission Members Will Be Decisive

In the absence of greater leadership from the prime minister, what will be critical to the effectiveness of this 18-member commission is the dynamism and accountability of its appointed members.

Alongside Kutty, other members are a mix of retired and serving bureaucrats and non-profits, with few technocrats or scientific experts on the new panel. This leads environmentalists to worry that the new commission may end up as yet another body of file-pushing officials.

Young people in Delhi demand action against air pollution
A long-standing issue: young protesters from the Democratic Youth Federation Of India, Delhi state, demand action against air pollution.

Those named so far include: Arvind Nautiyal, a mid-level Joint Secretary in the Ministry of Environment; Dr K J Ramesh, former head of the Indian Meteorological Department; Professor Mukesh Khare of Indian Institute of Technology-Delhi; Dr Ajay Mathur of The Energy Research Institute and Ashish Dhawan of the Air Pollution Action Group as NGO representatives.

The new commission also includes representatives from Punjab, Haryana, Uttar Pradesh and Rajasthan – which contribute to the seasonal air pollution with their crop-burning practices.

But other key stakeholders, like the Health Ministry, the Agriculture Ministry, the Rural Development Ministry and the Labour Ministry all seem to have been left out, at least for the moment.

It remains to be seen how the new commission might set measurable, time-bound goals and outcomes that could make a difference in the air pollution emissions – as well as being accountable to such targets.

If tackled systematically, these would include urban and rural measures, from shifting energy and transport policies to cleaner modes and sources to weaning farmers off of rice subsidies that leave crop residues which are easiest burned – to other, more nutritious indigenous grains and legumes that could be composted or managed more sustainably.

“A lot depends on how this commission will get constituted and the rules that are issued to enable its function,” Ghosh commented. She added: “Unless competing interests are heard and decided in a deliberative manner and the Commission is held accountable to ambitious but achievable targets for improved air quality, not much will change on the ground.”

Supreme Court Declares: No Smog in Delhi – Easier Said Than Done

Modi’s announcement of the new air quality commission followed weeks of Supreme Court pressures on his government in September and October. His government promulgated an Ordinance (which acts as law when Parliament is not in session) that brought this commission into existence via a gazette notification.

A view of Humayun's Tomb in New Delhi at various points during the air pollution season
A view of Humayun’s Tomb in New Delhi at various points during the ‘pollution season’.

The gazette notification – all five chapters and 26 sections of it – is fairly detailed and was likely in the works for some time.

The move to act, observers say, could have been prompted by any number of factors besides the Supreme Court. Those may have included US President Donald Trump’s denunciation of India’s “filthy air” in a pre-election debate, or growing public awareness of the health impacts of poor air quality, particularly during the pandemic. The gazette itself acknowledges that the number of petitions and litigations on environmental issues is skyrocketing across India’s judicial system.

On Friday, the country’s Supreme Court continued to be active on the issue. It directed the federal government to ensure that there is no smog in Delhi and neighboring areas following heightened alarm over the health hazard it poses during the coronavirus crisis, Bar and Bench reported.

The judges were responding to senior advocate Vikas Singh, representing one of the petitioners in court, who said the condition in Delhi was akin to a “public health emergency” and that “drastic measures need to be taken” to tackle the air pollution.

Environment Pollution Control Authority Dissolved by New Law

The Supreme-Court EPCA, which operated for 22 years, has meanwhile been dissolved with the publication of the new law.

The Government’s legal notification creating the new commission stated: “It is now considered necessary to have a statutory authority with appropriate powers and charged with the duty of taking comprehensive measures to tackle air pollution on a war footing and powers to coordinate with relevant states and the central government.

“The quality of air remains a cause of concern on account of the absence of a statutory mechanism for vigorous implementation of measures put in place.”

The government notice said the new body represents a “self-regulated, democratically monitored mechanism for tackling air pollution” that will lead to better “coordination, research, identification and resolution of problems surrounding the air quality index”. It is hoped this will do away with “limited and ad hoc measures.”

The commission will be empowered to direct orders to control air pollution and take cognizance of complaints. It will also have the authority to set new parameters for curbing emissions, as well as levying fines to violators. Pollution offences can invite a jail term of up to 5 years and penalties of up to $135,000, Section 14 of the new notification states.

Law Conceived Hastily – Commission Lacks Statutory Powers

Other questions revolve around why the new ordinance was so hurriedly issued by government fiat, rather than as a bill to be voted on by both houses when Parliament was in session.

“The haste in setting up this commission without any scope for public comment does not bode well for the professed objectives of increased public participation mentioned multiple times in the preambular text in the ordinance,” Harish said. “This is a missed opportunity at thinking through how to operationalise airshed level management.”

Delhi’s skyline, chronically obscured in late winter by heavy air pollution.

Experts are also annoyed at the way air pollution is being treated as a problem only in Delhi and its surrounding areas. Ritwick Dutta, an environmental lawyer, said:

“Unless the Central Government sets up similar committees in other polluted regions of the Country, it violates the right to equality under Article 14 of the Constitution and discriminates against those who are not in the NCR. Clearly, there are equally if not more polluted regions which are beyond the NCR.”

“There is disproportionate representation from agencies and ministries which are responsible for the problem,” Dutta said. “As it is currently constituted, the new Commission is neither a representative nor independent body to deal with the issue of air pollution.”

Dutta added: “The Commission has been given power similar to the one conferred on EPCA. EPCA in its 22 years rarely exercised its statutory powers and had become an advisory body to the Supreme Court. The same situation is likely to take place with regard to the new Commission.”

Still Missing – Accountability to Measurable Goals

What happens if air quality remains at the current hazardous levels in the Indo-Gangetic Plains by next winter, or even the year after?

“We certainly don’t want to be stuck with another EPCA-like authority for the next 22 years which will be as ineffective in bringing down pollution on the public payroll,” said Anita Bhargava, co-founder of Care for Air, a clean air non-profit.

In short, while on paper it might seem as if the Commission is empowered with legal and financial resources – its real power and its own accountability to measurable goals remains to be seen.

Bhargava added: “Any responsible government should already have been at work to find some real solutions to this gigantic problem that is causing more disease, disability and death than war, terror and several communicable and non-communicable diseases put together.”

There are solutions. The problem of massive stubble burning can be solved by zero-till farming. There are new rapid composting technologies, like the Pusa decomposer. Farmers should be discouraged from growing the wrong crop in the wrong state at the wrong time of the year – like water-intensive rice in water-scarce northern states such as Punjab.

But in light of the legacy so far, environmentalists fear that the commision may lack the real authority to act, and could still end up becoming yet another body adding to an already long list: “Between the Supreme Court, EPCA, National Green Tribunal (NGT), Central Pollution Control Board (CPCB) and State Pollution Control Board (SPCB) no one is clear as to what needs to be done,” Ritwick Dutta said.

Until the creation of this Commission, only the Indian judiciary has made any significant attempt at tackling the problem of pollution, whether through banning fireworks or crop-stubble burning, or the well-intentioned but misdirected order to install smog towers, a clear case of judicial overreach. But it isn’t really the job of judges to make public policy and enforce laws. It is the job of legislators and the executive.

“We still need to see measurable goals set, and timebound, real outcomes from this Commission. And of course, transparency and accountability,” Bhargav summarised.

Jyoti Pande Lavakare is the author of “Breathing Here is Injurious to your Health: The Human Cost of Air Pollution” published by Hachette and available on pre-order.

Image Credits: Pawan Gupta, Mike Bloomberg, DYFI Delhi Twitter, Chetan Bhattacharji / Care for Air, Wikimedia Commons: Prami.ap90.

Virtual World Health Assembly nerve center at WHO’s Geneva headquarters, with only a skeletal staff around the table, due to the pandemic.

The World Health Assembly on Tuesday approved a resolution calling to strengthen WHO and global preparedness for health emergencies – with few new teeth but lots of symbolism attached.

The resolution makes a sweeping, but still largely ceremonial, call to countries and the WHO to reinvigorate systems of emergency preparedness, vulnerability assessment,  alert, response, compliance and investments, in line with the 2005 International Health Regulations (IHR), which are a binding legal framework. 

The new resolution’s major novelty is a mandate to WHO to come up with proposals by next year’s WHA for “possible complementary mechanisms to be used by the Director General to alert the global community about the severity and/or magnitude of a public health emergency, in order to mobilize necessary support and facilitate international coordination.” 

In plain language, member states have discussed adding a possible “amber alert” – like an orange traffic signal – to the current IHR system by which WHO could signal that a public health emergency is developing – even before it becomes a full blown “public health emergency of international concern”. 

Geopolitical Divide Between Reformists & Backers of the Status Quo

Tuesday’s debate between member states over the measure seemed largely to be a warm-up for the more far-reaching reform proposals that may be in the offing next year, following the completion of multiple reviews over pandemic response now underway. Those reviews are looking at countries’ and WHO’s pandemic performance; WHO’s health emergencies programme, and the IHR system itself. 

And overall, member state remarks were framed by the same geopolitical divides that plague multilateral efforts more generally – leaving questions about what kind of truly far-reaching reforms could really be achieved that might help head off a future pandemic.  

Speeches by the United States, Japan, European and other western allies, on the one hand pressded for more speed in data sharing, transparency and measures to compel member state compliance with early alert rules.  Russia, Pakistan and China, on the other hand, suggested no such changes in the IHR system are needed; and such reforms could even encroach on countries’ sovereignty.

“We need a more independent and authoritative World Health Organization with strengthened IHR implementation, including robust monitoring and evaluation,” said Australia, speaking on behalf of the reformers. “We look forward to an assessment of whether the WHO powers are sufficient to properly investigate and prevent future outbreaks.”  

A representative from Japan speaks at the resumed 73rd WHA, November 2020.

Said Japan: “IHR reform calls for clearly defined responsibilities and requirements for countries to improve their communications capacities and processes.”  

The United States, meanwhile, said there was “overwhelming agreement” between the G7 (Group of 7 most industrialized nations), “that WHO and IHR state parties must improve preparedness and response, including a ‘traffic light approach’ for declaring a public health emergency of international concern, universal review mechanisms for IHR compliance, and revising travel and trade restrictions in systematic and evidence-based way.

“The US along with its G7 partners initiated discussions on WHO strengthening and reform in early 2020,” said Garrett Grigsby, Director of Global Affairs for the US Department of Health and Human Services. “Several member states have since put forward proposals “that reflect our shared values,” he said, noting that the US had put forward a “roadmap” for reform, also being supported by Brazil. 

On the other side of the divide, Russia stated grand revisions legal mandates should be avoided:  “We need to use the experience accumulated in combating  the pandemic to strengthen existing multilateral instruments of cooperation in combating epidemics including the International Health Regulations, but not to revise them.” 

China, stepping gingerly, added, “We firmly support WHO’s leadership role and the framework of the IHR, adding only that “all parties should “effectively implement the requirements of the IHR &…work together to maintain global health security.”

China’s reprsentative speaks at the WHA73

Pakistan, which also has said that too much IHR reform could impinge on countries’ sovereignty, stressed the need for stepping up technical assistance to low-income countries and addressing fundamental drivers of pandemics, like population growth and climate change. 

“The pandemic has highlighted the need for developing IHR core capacities,” said Pakistan’s WHA representative. “The discourse on  the IHR must embed a focus on technical assistance, financing and capacity building, & trends outside the health sector, like climate change, need particular attention,” the representative said. “That there will be another pandemic is not a question of IF, but of When, in light of climate change, population growth and other global trends.”

Low- and Middle Income Countries: Investments & Technical Assistance Most Important 

Other low and middle-income countries also tended to stress the importance of gaining greater access to investments, equipment and other know-how – as compared to reforming the legal rules of the emergencies system.

Reforms in the IHR and other emergency response systems should “build on existing mechanisms to avoid running up costs,” said Kenya’s WHA representative.

Bangladesh talked about the importance of “more predictable and stable core funding” for WHO as key to improving the Organization’s emergency capacity – and thus its support to countries. 

Ghana called for a “more meaningful engagement between the International Health Regulations review and member states – particularly low- and middle income countries and small island states – to reflect all experiences.”

Investigating the Sources of the Virus 

Left-right: Bjorn Inge Larsen, Norway; Helen Johnson Sirleaf;  and Helen Clark at the virtual WHA

The member state debate followed presentations of two reviews of the pandemic response. These included reviews of WHO’s Health Emergencies programme by an Independent Oversight and Advisory Committee (IOAC), and a report by the Independent Panel for Pandemic Preparedness and Response (IPPR), just getting underway. The IPPR review is intended to take a more step-back approach, evaluating pandemic response by countries as well as by WHO.  

“It’ll be important to establish a “chronology” about what happened in the emergence and spread of the SARSCoV-2,” said Helen Clark, former New prime minister of New Zealand, in a diplomatic remark heavy with meaning. She is serving as the co-chair of the IPPR committee along with Helen Johnson Sirleaf, former prime minister of Liberia. 

Member states would also like to see yet another, new WHO committee dig more deeply in the murky history surrounding the original source of the SARS-CoV2 virus, and its origins. 

There is wide agreement among experts that those sources is a natural, animal reservoir, like bats, which are known to harbor coronaviruses in the wild. But the route by which this novel coronavirus first reached humans remains entirely unclear.  Bats found to be harboring a virus  nearly identical to SARS-CoV2 have been reported by Chinese researchers in one or two published studies, but at sites hundreds of miles away from Wuhan, China, where the first major infection cluster was reported.  

Whether the virus reached the city of 10 million people via people traveling to the city from rural China, or via another wild animal source, such as pangolins, sold in the city’s open markets there, or yet by other means [more conspiratorial theories have it escaping from a laboratory], remains a mystery.  And in light of the strict limits imposed  more generally by the Chinese government on research and information exchange, the landscape for investigating such a question is forbidding.   

A new WHO terms of reference for the virus investigation, drafted in July but only published recently states: 

 “As the information is scarce, there are limited hypotheses about how the outbreak might have started in Wuhan. It may have started from an infected individual contaminated elsewhere, from contact with an infected animal, or less likely through contact with contaminated products. The early cases in Wuhan are thought to have occurred in early December, and preliminary information from surveillance data of severe pneumonia suggest no unusual cluster or departure from trends in the weeks and months preceding the first reported case in Wuhan. 

“The search for the virus’s origins is a study in the compromises the WHO has made,” observed the New York Times in a damming 3 November report of how the Organization may have hindered such work, more than it  has helped.

Seafood and fresh food market in Wuhan, Hubei, China. Some early cases of SARS-CoV-2 were traced back to Wuhan’s Wholesale Seafood Market, but not all – adding to the mystery of where it first emerged.

Countries Also Say Investigation of Virus Origins Should Move Faster 

Only recently has WHO formulated the committee of international experts to probe the issue more systematically, which was mandated by the WHA in May – and only after the names were approved by Beijing. Moreover, the first, critical, elements of inquiry, to probe who were in fact the first people to become infected in China and the role of the Wuhan wild animal market, will be led by Chinese scientists.

At Tuesday’s WHA session, a number of countries expressed impatience that the quest for the virus origins needs to move ahead more aggressively. 

“The  investigation into the sources of the virus should be prioritized,” said the United Kingdom at the debate, striking a chord that the United States and other European allies also echoed.  

Underlying the comments are palpable fears that the committee’s mission could be watered down and lost at sea in the same geopolitical gulf that divides China’s controlled information regime from European and western allies. 

“The terms of reference for investigating the SARS-CoV-2 virus origins was not negotiated in a transparent way with member states,” charged the US, at Tuesday’s WHA session. 

“Member states only received TOR terms a few days ago. And it seems to be inconsistent with the mandate provided by the WHA’s member states,”  it added, referring to the  WHA resolution mandating the virus quest, which was approved by member states already in May. 

At the close of Tuesday’s WHA session, WHO Director General Dr Tedros Adhanom Ghebreyesus attempted to reassure jittery member states that the experts appointed would be serious and impartial, saying:  “The review team on SARS-CoV2 origins will be coming from the United States, Russia, Australia, Sudan, Denmark, The Netherlands, Germany, Japan, Vietnam and the United Kingdom.  

“And the TOR is now online,” he added, saying that WHO would make updates on the investigation “transparent so you can see how study of the virus origins progresses.”

Even so, sentiment that more light needs to shine on such processes also appears to be widely shared in Europe hard-hit by the pandemic – including the most progressive and pro-WHO member states. 

After lauding WHO for its “significant improvement” in handling the COVID-19 pandemic, as compared to the 2014-16 Ebola outbreak that paralyzed West Africa, Norway’s representative added, diplomatically, the following caveat:  

Norway “would have liked to have seen more WHO leadership in the early phases, including earlier WHO access to the source of the outbreak.” 

Image Credits: @ThiruGeneva, Arend Kuester/Flickr.

Jens Spahn, Federal Minister of Health, Germany, speaking at the WHA.

World Health Assembly members set aside the contentious issue of restoring Taiwan’s observer status at the member state forum – to focus on the challenges posed by the COVID-19 pandemic, and linked to that WHO reform. 

That was despite a growing push by the United States, backed by Europe and their western Pacific allies for a stronger role for Taipei in WHO fora – an elected government representing some 23 million people which has managed to keep its COVID-19 cases to less than 600.  

The Taiwan issue was dealt with at a two-hour closed door WHA meeting, then followed by public, declaratory remarks by two countries, Honduras and Marshall Islands, in support of Taiwan’s re-admission, and two opponents, China and Pakistan, and concluding with no action for the moment. Left to unravel, a full-fledged public debate would have consumed a day of speeches, leaving bitter deadlock among member states pro and con, observers said.

WHO Reform Agenda

But meanwhile, political consensus appeared to be shaping up around initiatives being advanced by both European countries, the United States and other G-7 allies, to strengthen the hand of the WHO signficantly – in terms of its emergencies powers to get data and take action – as well as its technical capacity and created channels for more sustainable financing. 

“A key lesson of the COVID-19 pandemic is that there is a gap between WHO’s 194 member state expectations, … and its de- facto capacities to fulfill them,” said Jens Spahn, German Federal Minister of Health, speaking on behalf of the European Union, on Monday, the first day of the week-long WHA session, which picks up from a two-day WHA emergency event in May. 

Referring to a recent report on WHO’s health emergencies operations by an Independent Oversight Advisory Committee, Spahn said that the EU had already launched informal discussions among its member states in October to define a WHO reform agenda. That process will resume soon after the WHA sessions, he said.

Virtual World Health Assembly nerve center at WHO’s Geneva headquarters, with only a skeletal staff around the table, due to the pandemic.

He said the the EU Council was already supporting a number of concrete measures “to strengthen WHO’s role – without prejudice to the ongoing reviews and evaluations.”

Spahn referred to a laundry list of actions needed to strengthen WHO’s mandate in the framework of existing, binding International Health Regulations, “including with regards to travel and trade restrictions, independent epidemiological onsite assessments, reporting by state parties, monitoring and evaluation, and through revision of the PHEIC [Public Health Emergency of International Concern] declaration alert system,” he said. 

Other tasks, he noted, include “include strengthening WHO’s role in preparedness response, its standard-setting functions, it’s work on zoonotic diseases.”

COVID Needs to Be Game Changer- Member States Need to Put Their Money On The Table 

But equally important to a stronger mandate to act in emergencies, is the degree of funding needed to execute, Spahn said. And for that, member state contributions need to match the size of WHO’s mandate. 

“Currently there is a major discrepancy in between how we all praise the importance of a well functioning and effective WHO, and our common will to finance WHO, through our membership fees. Let us open our eyes:  are US$ 490 million US dollars in [combined global] membership fees per year, adequate to fulfill WHO’s mandated role? Hardly.  Germany is ready to explore all possible options to make who stronger. But in the end, this will only be possible. If the 194 members of this organization, take on more financial responsibility. 

“From Germany’s point of view, the COVID-19 pandemic must be understood as a game changer. None of us was adequately prepared. We will have to change the way we are doing business… Preparing costs billions, responding costs trillions.”

Two draft reform plans are already circulating, one as a European Union ‘non-paper‘, and a “WHO Roadmap” published by the United States Department of Health and Human Services, which focuses more narrowly on ways to improve WHO’s emergency response mandate and systems, obliging member states to greater transparency.  But diplomatic sources say that there are many points of synergy and convergence between the two.

Said one source close to the discussions, both initiatives in fact evolved out of the same conversations among the (G-7) Group of 7 most industrialized countries, and there had been “fairly good consensus on direction and elements”. Even if two concept notes have emerged now, “much of it is the same and includes elements that had been talked about in the broader group.”

In a parallel discussion on the WHO budget, Belgium’s WHA representative said that WHO needs to provide more precise and ‘updated reporting’ on its financial status and any shortfalls caused by the pandemic- calling for a longer discussion at the next Executive Board meeting in the context of proposed reform moves.

“It would be helpful if the Secretariat could provide us with a short update on how WHO is managing financially during COVID-19, and how gaps caused by retracting donors can be dealt with or not,” the representative said. “Predictable, flexible and sustainable financing is one of the core issues to strengthen WHO and to allow it to act independently,”  added Belgium. “We believe that the Secretariat should develop, together with the independent review panel, proposals on the amount and type of funding, especially core funding, that WHO needs in order to be able to fulfill its mission.”

Taiwan Set Aside – For Now

As for Taiwan, a procedural move by 13 WHA member states to restore its observer status, led by Belize and backed by the United States, Canada and other European and Western Pacific allies was discussed largely behind closed doors, in an early afternoon WHA session. The move was hotly opposed by Beijing as a threat to its sovereignty – even though Taiwan had served as an observer to the WHA until 2017. Following a terse agreement two countries from each side of the divide presented their arguments publicly.

Speaking on behalf of Taiwan’s inclusion, Honduras and The Marshall Islands, referred to the Island’s exemplary record in controlling the virus and the technical expertise that it has to share in pandemic control, saying that the Assembly “has continued to exclude Taiwan for political reasons.  They are prioritizing poilitical considerations over health considerations here.

China, meanwhile, said that including Taiwan as an observer to the Assembly would violate the agreed-upon UN “One China principle … that both sides of the straits belong to China.”

 

Meanwhile US Ambassador Andrew Bremberg issued a video coinciding with the debate, describing Taiwan as “a democratic role model, generous donor and a force for good. Taiwan is an exemplary partner in addressing the world’s most serious challenges- especially during this global pandemic.

“We believe Taiwan’s inclusion would benefit the world and the WHO.  Taiwan’s model COVID19 response has proteted the health and safety of the 23 miliion people living on the island. Taiwan’s generous efforts to share scientific and technical expertise, and its donations of tens of millions of masks and hundreds of thousands of medical supplies, have saved countless lives.

“In preventing Taiwan’s participation, the WHO is allowing some to politicize public health, and allowing its core mission to suffer. The solution is simple, the Director General should invite Taiwan to participate as an observer. This was the status quo from 2009 until 2016.  Nothing has changed since them, except the democratically elected leadership of Taiwan, which is not an acceptable reason to block Taiwan’s participation”.

Bremberg also said that going forward, the WHO should include “substantively, without limitations, Taiwan health experts with expertise in the COVID-19 pandemic response, including in technical meetings and full accesss to all relevant facilities and virtual spaces. This is a desire shared by a growing number of countries within this body, who respect Taiwan as a responsible and generous actor, with world-class health expertise.”

Although WHO has officially stated, throughout the pandemic, that Taiwanese experts do have access to WHO technical consultations, other insiders familiar with the Organization say that any meetings with experts had to first go through WHO’s legal department, technical barriers were placed on virtual consultations, and experts with any government title or ranking had to be screened by Beijing – placing the bar impossibly high.

Until 2017, Taiwan had access to the WHA as an observer, upon the personal invitation of the Director General. But following the Taiwanese election of a new government dominated by the more nationalistic, the Democratic Progressive Party, relations with Beijing soured – and the invitations ceased. WHO’s current Director General, Dr Tedros Adhanom Ghebreyesus has been reluctant to buck the pressures from Beijing.

We Are Family – Hit Featured In Lighter Moments Of WHA

 

While the bitter Taiwan dispute remained as vivid reminder of the limits of WHO calls for global “solidarity”, the Assembly was marked by lighter moments. Those included the release of a new cover for the classic “We Are Family” hit by Singer Kim Sledge – featuring health workers from around the world singing the classic pop song – and a performance by the Tonga Nurse Choir, in honor of WHO’s Year of The Nurse and Midwife.

Director General Proposes ‘Peer Review’ of Countries’ Emergency Preparedness

Meanwhile, in his opening remarks Dr Tedros also called upon WHO member states to “address the shocking and expanding imbalance between assessed contributions and voluntary, largely earmarked funds,” observing that WHO’s annual budget is equivalent to what the world spends on tobacco products in a single day.

And he proposed a new system of “peer review” for emergency preparedness. The Universal Health & Preparednesss Review – would bring countries together for transparent review of each other’s response capacities.  He invited Cameroon, the Central African Republic, France and Germany to test the concept in a pilot phase.

WHO Director General Dr Tedros speaking at the 73rd World Health Assembly

The WHO Director General also warned that “a vaccine cannot address the global under-investment in essential public health functions and resilient health systems, nor the urgent need for a “One Health” approach that encompasses the health of humans, animals and the planet we share.”

No Vaccine for Climate Change

“It’s time for the world to heal – from the ravages of this pandemic, and the geopolitical divisions that only drive us further into the chasm of an unhealthier, un-safer and unfairer future” he said.

Drawing linkages between the current pandemic and the inter-related crises of unsustainable development, he added:  “We cannot afford to see health merely as a byproduct of development or a commodity that only the rich can afford.

“There is no vaccine for climate change. The world has reached a fork in the road. We cannot afford to pump carbon dioxide into the atmosphere at the same rate, and still breathe clean air, we must chose.”

Number of COVID-19 cases against number of deaths reported to WHO as of 8 November 2020.

Meanwhile, Michael Ryan, Executive Director, WHO Health Emergencies Programme (WHE), gave an update on the COVID-19 pandemic, noting that the world had reached “the grim milestone” of 50 million cases globally. Sharp increases in cases are being seen right now in Europe, the Americas and the Eastern Mediterranean Region – while cases in Africa, Southeast Asia and the Western Pacific are more stable or even declining.

On a brighter note, a senior WHO advisor, Bruce Aylward, briefed Member States on the progress made in organizing global procurement systems for COVID-19 drug treatments, tests and forthcoming vaccines  the Access to COVID-19 Tools (ACT) Accelerator. The Accelerator’s multi-pronged strategy aims to create systems for more equitable distribution of life-saving COVID-19 rapid tests, treatments, and future vaccines through a new “COVAX Facility” which over 180 WHO member states have now joined.

The Accelerator has raised over US$15 billion in finance already, although billions of dollars still need to be raised, Aylward said.  Seehere our Health Policy Watch story on the new drive to build and procure a global toolkit of COVID-19 drugs worth $US 6 billion.

As the WHA proceedings were unfolding, more good news came that Pfizer’s COVID19 vaccine candidate had achieved 90% efficacy in its interim clinical trial results.

 

Image Credits: WHO.

COVID-19 mRNA vaccine candidate developed by Pfizer and BioNTech.

A COVID-19 vaccine candidate developed by Pfizer and BioNTech has far exceeded expectations, showing a 90% efficacy rate so far among the tens of thousands of volunteers who were immunized in a clinical trial, the company said on Monday.

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Albert Bourla, CEO of Pfizer, in a press release. 

Albert Bourla, CEO of Pfizer.

In another statement Bourla added: “We are one step closer to potentially providing people around the world with a much-needed breakthrough to help bring an end to this global pandemic.”

In the trial of over 43,000 participants across six countries, there have been 94 cases of COVID-19 in people not previously infected; but fewer than 9 of those cases were in participants who received both shots of the vaccine – leading to the estimate of 90% efficacy for interim trial results, just disclosed.

The trial will continue until 164 cases of COVID-19 are recorded among trial and control arm participants, so as to confirm the efficacy rate. 

Plans are on track for Pfizer and BioNTech to apply to the US Food and Drug Administration (FDA) for an emergency use authorization in the third week of November, Bourla said. 

That will be the milestone moment when a required two months of safety data has been collected for all of those who participated in the trial. No serious safety concerns have been raised so far, the press statements said -although no breakdown by age group has been provided either. Some 42% of participants were from diverse ethnic and racial backgrounds.

The FDA previously said that a COVID-19 vaccine trial should be at least 50 percent effective, which the Pfizer and BioNTech vaccine candidate has far exceeded. 

“The big news is that we have a #SARSCoV2 vaccine with a strong signal of efficacy,” said Eric Topol, founder and director of the Scripps Research Translational Institute, on Twitter. “We’ll have at least one vaccine into Phase 1a rollout before year end, which is a stunning achievement – from virus sequence to vaccination in < 12 months.” 

“This is a victory for innovation, science and a global collaborative effort,” said Ugur Sahin, BioNTech CEO. “Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.” 

Avoiding the Election

Pfizer’s announcement narrowly missed the US presidential elections last week  – fulfilling the previous commitment  that the company would not be ready earlier to apply for the authorization. 

Despite the victory of Democratic contender Joe Biden, who has now been recognized as the new President-elect,  US President Donald Trump immediately took to Twitter to trumpet the vaccine breakthrough, saying: 

“STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!”

President-elect Joe Biden took a much more cautious approach, welcoming the progress as “excellent news” giving Ameicans “cause for hope” – but warning that a vaccine would only become widely available later next year. 

“Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year. Today’s news is great news, but it doesn’t change that fact,” Biden said. 

There had been concern that timing an announcement to coincide with the election might negatively influence public confidence in a vaccine, with Pfizer CEO Albert Bourla criticising President Donald Trump for politicising the vaccine timeline.

Will the Vaccine be Administered Equitably?

Although the results, should they be confirmed, are encouraging news for fighting the pandemic, the Pfizer vaccine, in particular, will pose huge challenges for distribution in low- and middle-income countries because it requires a cold storage temperature in extremes of -70°C. 

Vaccine storage containers being loaded into air cargo. Establishing temperature controlled conditions is essential to respect cold chain requirements.

In addition, there is the question of vaccine supply and distribution. Pfizer and BioNTech estimate that some 50 million vaccine doses could be manufactured by the end of 2020, enough to immunize 25 million people, and 1.3 doses in 2021. They have also said that they are positioned to manufacture more than 1 billion doses during 2021. 

Global health leaders have warned for months that initial vaccine supplies will likely be limited and need to be reserved for healthcare workers and high risk individuals around the world.  

However, Operation Warp Speed, a US government programme aiming to rush a COVID-19 vaccine to market, already signed a $1.95 billion deal with Pfizer for 100 million doses of the vaccine in July. Pfizer also has reached supply agreements with the EU for 200 million doses, covering 100 million people, as well as with the United Kingdom, Canada and Japan. 

If Pfizer’s vaccine is indeed the first to make it to market, the big question that the world will be watching is this: will the company would be obliged to begin distributing all of its initial batches in the USA and other high-income countries where it has already signed procurement deals – with remaining middle- and low-income countries served much later, and after appropriate cold-chain infrastructure is established?   

On the more positive side, the Pfizer vaccine candidate is only one among 10 other vaccine candidates in late-stage clinical trials worldwide. Moderna, a pharma company developing a COVID-19 vaccine with similar technology as Pfizer, has also announced their plans to release their interim clinical results and apply for an FDA Emergency Use Authorization by the end of November. It requires a more moderate – 20°C temperature for shipping and long-term storage.

Science of mRNA Vaccines
Description of Pfizer’s use of mRNA technology to develop COVID-19 vaccines.

Pfizer and BioNTech’s drug is an RNA vaccine. This treatment is based on a part of the virus’ genetic code – messenger RNA (mRNA) – that contains the genetic information needed to produce the coronavirus’ receptors.

If a synthetic mRNA is successfully administered to a person, their cells are then able to build proteins that mimic the receptors, triggering the immune system without causing illness.

The 90% efficacy rate was achieved 7 days after the second dose of the vaccine, which is taken three weeks after the first, totalling 28 days. It has also been shown to block nearly 20 mutated versions of the virus strain, the company said. However the duration of protection obtained remains undetermined. 

Image Credits: Pfizer, World Economic Forum, Flickr – CDC Global, Pfizer.

COVID-19 drug development
Employees at Roche, one of the companies developing monoclonal antibodies for the scheme.

A WHO co-sponsored partnership is laying the groundwork for a worldwide distribution plan of $US 6 billion worth of the most effective COVID-19 drugs, including cutting-edge monoclonal antibodies treatments if proven effective – so as to ensure that high-income countries do not snap up all available new therapies as they arrive on the market.

The proposed basket of medicines would be procured under the auspices of the World Health Organisation’s (WHO) co-sponsored ACT Accelerator: a collaboration with seven other UN and global health agencies and philanthropies, including Unitaid and The Wellcome Trust, to provide equitable access to COVID-19 drugs.

The scheme requires more than US$6 billion – $750 million of which is required by February 2021, according to the plan. Due to be released in the coming week, it is currently under review by the ACT Accelerator’s Facilitation Council, co-chaired by Norway and South Africa, represeneting both donor countries and as well as low- and middle-income countries (LMICs) that would benefit from reduced prices and drug reserves.

The new procurement scheme is being supported by Bill and Melinda Gates Foundation and Mastercard Impact Fund – which banded together with Wellcome in a COVID-19 Therapeutics Accelerator to provide funding and support for the drug procurement effort.

Partners of the WHO co-sponsored Act Accelerator.
Procurement Plan Includes Monoclonal Antibodies, but Excludes Remdesivir – Due To Lack of Proven Benefit

More than half of this investment would go to procuring and distributing monoclonal antibodies, as part of what is referred to as the Therapeutics Pillar – 1 of 4 pillars of the Accelerator scheme, alongside vaccines, diagnostics and health systems.

Monoclonal antibodies appear to be a promising treatment: these artificial antibodies are manufactured copies of those created by the body to fight invading viruses. The emerging  treatment would join key approved treatments – like the steroid dexamethasone – in the medicine basket.

A Unitaid spokesperson, speaking on behalf of the ACT-A Therapeutics pillar, told Health Policy Watch that the procurement plan is being developed as part of the “investment case” for the ACT-Accelerator therapeutics pillar – which will then be shared with donors to recruit the needed $US billion in funding.

“What this investment case is doing is preparing the ground so that when a certain drug is proven to be effective and when it gets the go-ahead from the WHO, we are ready to go.”

The spokesperson added: “The ACT-Accelerator Therapeutics Pillar (co-convened by Unitaid and Wellcome) analysed the treatment pipeline to identify promising treatments with strong clinical safety and efficacy data that could be scaled up. Following this analysis, monoclonal antibodies (mAbs) and proven repurposed therapeutics like corticosteroids (dexamethasone and hydrocortisone) are the most promising options so far. The pillar is preparing different pathways to support access to mAbs as well as monitoring the pipeline and maintaining flexibility to invest in and support other promising therapeutics.”

She stressed that the plan would only be executed with drugs that are actually approved by regulators and the WHO. “Everything is evidence-based and the fundamental principle is to ensure that LMICs don’t lose out.”

Roche Also Confirms Contact With Act Acccelerator

Drugmakers Novartis and Roche are both developing monoclonal antibody treatments; Roche has collaborated with Regeneron to develop and manufacture an antibody treatment known as REGN-COV2.

A spokesperson for Roche told Health Policy Watch: “As part of our commitment to addressing the pandemic, we’ve had preliminary discussions with partners of the ACT-Accelerator about the access plan for REGN-COV2 antibodies.

“These discussions were in the context of development and production of COVID-19 therapeutics, which could eventually inform planning of the ACT-A Therapeutics Partnership,” the spokesperson added. “It is too early to speculate on future decisions, but we will continue working with them and other groups regarding REGN-COV2.”

On the other hand, Remdesivir, a drug approved by the United States Food and Drug Association (FDA), will not be included following a WHO study that found almost no evidence for reduced mortality. WHO announced it was issuing guidance on using remedesivir, but this information is yet to be published.

Cheaper Drugs for LMICs; Equitable Distribution Could Prevent 60% of Deaths

The aim is to ensure that LMICs receive access to these drugs, preventing pre-orders for supplies being locked-up by rich countries.

A recent model, created by researchers at the Northeastern University MOBS Lab, Massachusetts, found that distributing vaccines equitably based on population size could prevent up to 60% of deaths, highlighting the benefits of a scheme like the ACT Accelerator.

The scheme is intended to keep a consistent flow from research and development, to distribution and the administration of the vaccine. Drugmakers Novartis and Roche, both developing monoclonal antibodies, are confirmed to have had contact with WHO regarding the scheme.

Roche has collaborated with Regeneron to develop and manufacture REGN-COV2. A spokesperson from Roche told Health Policy Watch that approximately 2 million doses were projected to be supplied within the first half of 2021.

 

Image Credits: Roche.