Temperature around the Mediterranean Sea on 24 July.

July 2023 may have experienced temperatures last seen in prehistoric times, as climate scientists confirm that once rare heatwaves are now routine events. 

Record heatwaves have been seen this year from the US to India, and according to the latest analysis, this July may be the hottest ever recorded.  

Dr Karsten Haustein, a climate scientist at Leipzig University, says that July’s average global temperature is projected to be 1.3-1.7°C above the average July temperature experienced before humans began warming the planet by burning fossil fuels. This is hotter by 0.2°C than the previous record, set in July 2019.

“Not only will it be the warmest July, but the warmest month ever in terms of absolute global mean temperature. We may have to go back thousands, if not tens of thousands of years, to find similarly warm conditions on our planet,” Haustein said. 

European Union’s Earth Observation Programme, Copernicus, and UN’s World Meteorological Organization have also confirmed that the “first three weeks of July have been the warmest three-week period on record and the month is on track to be the hottest July, and the hottest month on record.”

Scientists attribute the record temperatures to the continued burning of coal, oil, gas and other human activities since the beginning of the industrial era. They are also clear that this is not the new norm: temperatures will continue to rise and extreme weather events will worsen until the world drastically cuts fossil fuel use and reaches net-zero emissions. 

Climate change makes heatwaves routine

Earlier this week an international team of scientists with the World Weather Attribution (WWA) released their analysis of the impact of climate change on this year’s multiple heatwaves spanning the Americas, Europe and Asia. 

Heatwaves hit parts of the US and Mexico, southern Europe and China this July. Both Death Valley in the US and northwest China saw temperatures exceed 50°C. In Europe, too, temperature records were broken in Spain. The analysis was clear: climate change is to blame for once rare heatwaves becoming routine occurrences now. And more is to come.  

The heatwave in China would have been about a one in 250-year event before accelerated heating, while maximum heat like that recorded in July 2023 would have been virtually impossible in the US-Mexico region, as well as in southern Europe, before human-made global heating set in, the WWA analysis found. 

“On the one hand, we really need to stop burning fossil fuels to stop these records from continuing to be broken. But we also need to adapt. We need to adapt because even when we stop burning fossil fuels tomorrow, we will not go back, it will not get cooler,” said Dr Friederike Otto, senior lecturer in Climate Science at Imperial College London.

“We have to live with these and make it possible for people to live with these extreme conditions in summer because they are not rare. And the later we stop burning fossil fuels, the more frequent they become.”

Heat impacts on health set to worsen

Heatwaves are known to be silent killers; in Europe alone, an estimated 62,862 heat-related deaths occurred in 2022, according to a study published in Nature this July.

“Since the inception of the Lancet Countdown eight years ago, we have consistently seen an increase in the health impacts of climate change through our heat-related indicators: heat-related deaths among the elderly are rising; productivity is decreasing globally because of the heat, affecting people’s livelihoods and wellbeing,” said Dr Marina Romanello, who is the executive director of the Lancet Countdown on Climate Change and Health.

This year, news reports in central India linked dozens of deaths to the heatwave but the toll is yet to be confirmed by the government. With most countries lacking high-quality death records, it is easy for deaths linked to heatwaves to be underreported or dismissed.

“These heatwaves and wildfires are another reminder of the urgent need to reduce greenhouse gas emissions and protect the planet on which all life depends,” World Health Organisation Director-General Dr Tedros Adhanom Ghebreyesus said of the ongoing extreme weather events in Europe. He called for immediate climate action. 

All eyes on COP28 negotiations

Later this year, world leaders will meet in Dubai at the annual climate conference, or Conference of the Parties (COP), now in its 28th year. This year’s COP has already come under intense criticism, as the negotiations will be chaired by Sultan al-Jaber, CEO of the Abu Dhabi National Oil Company. 

At a time when fossil fuels need to be phased out, and renewables ramped up at a record pace, the selection of an oil baron to head critical climate talks has evoked dismay among advocacy groups and climate activists. 

Stakeholders remain hopeful that the large-scale acceptance of renewable energy will receive financial support from governments and banks.  

“We are already seeing this exponential build-up of renewable energy happen. 2022 was a banner year for renewables and energy efficiency and we need to see that expanding and going even faster,” said Catherine Abreu, Executive Director of the advocacy group, Destination Zero. 

Image Credits: Copernicus, European Union, Karsten Haustein.

Health workers in Cape Town, South Africa, getting vaccinated against COVID-19 in March 2021. Vaccines only became available for health workers at the end of this study.

A single healthcare worker infected with COVID-19 cost the Kenyan economy over $33,000 – around 18 times the country’s per capita GDP.

This is according to a new report on the economic cost of COVID-19 infections among healthcare workers in Eswatini, Colombia, Kenya and South Africa (the provinces of KwaZulu-Natal and Western Cape) during the first year of the pandemic, which has been compiled by the World Bank and Resolve to Save Lives.

The estimated cost per health worker infection ranged from $10,105 in Colombia to $35,659 in Eswatini, with $34,226 in South Africa’s KwaZulu-Natal province and $33,781 in its Western Cape province.

These figures are based on three calculations: the direct cost of healthcare worker’s infection in terms of their healthcare costs and loss of productivity; the costs of infections transmitted by sick healthcare workers; and the disruptions to essential health services.  

The economic burden was highest in areas with the fewest health workers. In South Africa’s Western Cape, the total cost of health worker infections was equivalent to 8.38% of the total health budget. 

In Kenya, where maternal and child death rates were high before the pandemic, health care worker illness disrupted essential services for these vulnerable populations and caused a substantial increase in deaths. This was the biggest “expense” in that country’s calculations.

“Immunisation, chronic disease management, emergency services, and surgery were also severely disrupted, leading to increased non-Covid deaths,” according to the report.

No vaccines for African health workers

At a press conference on Wednesday to launch the report, Dr Keith Cloete, head of health in the Western Cape, South Africa, reminded the audience of the impact of vaccine inequity on health workers.

“Everybody knew that the most important thing was to vaccinate healthcare workers. Our delay in having access to vaccines meant that, in your study period from 1 March 2020 until 28 February 2021, we had vaccines for two weeks,” said Cloete. 

The first South African health worker was vaccinated on 17 February 2021; health workers only got access to vaccines via a clinical trial of Johnson and Johnson vaccines rather than as part of a vaccine rollout for the general population.

In the absence of vaccines, the Western Cape had to try to assuage health workers’ fear by ensuring that they had personal protective equipment (PPE), and by improving its occupational health and safety and employee wellbeing policies, added Cloete.

The province also invested in good data to enable it to predict COVID-19 waves and plan accordingly.

“At the height of the waves is when you have the most healthcare workers in quarantine and in isolation, so you’re going to have the lowest number of available staff. So that’s one of the first predictive models we did, and we then intentionally employed people on contract to cover these waves,” explained Cloete.

The COVID-19 incidence among HCWs was higher than in the general population in all study sites – almost 10 times higher in Kenya and seven to eight times higher in the two provinces of South Africa 

“The economic burden due to SARS-CoV-2 infection among HCWs makes a compelling investment case for pandemic preparedness, particularly the protection of HCWs, and resilient health systems going forward,” argues the report.

Juan Pablo Uribe, the World Bank’s Global Director for Health Nutrition and Population, warned that there was a projected shortage of 10 million health workers by the end of the decade and that health workers from low-income countries were moving to high-income countries, exacerbating shortages in poorer countries.

“Many of our health workers are still very much unsatisfied or frustrated in their workplaces. And more important, they’re facing incredible risks of infection, of disability and injuries and in many places, even of violence,” said Uribe.

Resolve CEO Dr Tom Frieden said that health workers needed to be protected during pandemics by policies, protective equipment, and data systems and information “to hold us all accountable for protecting people who protect and care for us so that they can be safer and healthier, and societies can be safer and healthier”. 

Image Credits: Western Cape government.

As the effects of climate change hit home for people and communities around the world, lawsuits are becoming a central tool in the fight for climate justice.

The number of climate cases taken to court has more than doubled in the last five years, as people and communities turn to the legal system to hold governments and corporations accountable for their inaction on climate change, according to a new Global Climate Litigation Report, published Thursday by the UN Environment Programme (UNEP) and the Sabin Center for Climate Change Law at Columbia University.

The latest data shows that over 2,300 climate-related legal cases have been filed since UNEP began tracking climate litigation in 2017.

“The challenge with climate litigation is that it needs to target each country individually,” said Maria Antonia Tigre, a senior fellow in climate litigation at Columbia’s Sabin Center, at a joint press briefing Tuesday, just ahead of the report’s release. “Lots of cases have to be filed to actually move the needle.”

The new UNEP report collates and analyzes data on some 2180 cases filed to end 2022, with Sabin Center’s online data base recording nearly 200 more cases filed since the start of 2023.

Current trajectory has temperature rising 2.7°C -2.8°C by 2100

That means that lawsuits are now becoming a central tool in the fight for climate justice as the world catapults above the 1.5°C global heating threshold set out by the 2015 Paris Agreement. The current climate emissions trajectory leaves the planet set to exceed pre-industrial temperatures by 2.7°C by 2100, according to a 2021 UN analysis of climate emissions and mitigation commitments.

The weak pledges made ahead of the 2022 COP27 meeting led to even more gloomy projections of a 2.8°C temperature rise by the end of the century.

As governments and corporations fail to adjust course on greenhouse gas emissions that may alter the global climate for generations, people are resorting to litigation to try to claw back control of their future.

“There is a distressingly growing gap between the level of greenhouse gas reductions the world needs to achieve in order to meet its temperature targets, and the actions that governments are actually taking to lower emissions,” said Michael Gerrard, the founder and director of the Sabin Center. “This inevitably will lead more people to resort to the courts.”

The United States continues to dominate global climate change case numbers.

The largest number of climate cases have been filed in the United States, which accounts for around 70% of the global total. Courts in Australia, the United Kingdom, European Union and the United Kingdom round out the top five climate litigators.

Even so, nearly 20% of cases have been filed in developing countries, the report said. For the first time, two developing countries – Mexico and Brazil – are in the top ten countries facing climate litigation.

The report comes a day ahead of the one-year anniversary of the United Nations General Assembly vote to recognize access to a clean, healthy and sustainable environment as a universal human right – a decision viewed as historic for explicitly linking human rights to climate change.

Inger Andersen, Executive Director of UNEP, declared that the resolution sent a message that “nobody can take nature, clean air and water, or a stable climate away from us – at least, not without a fight”.

A year of heatwaves, drought, floods and record temperatures has repeatedly challenged the ambitions set out in the non-binding resolution, pushing people, environments and ecosystems around the world to their limits.

As the current El Niño event develops over the coming months, global-mean air temperature are already expected to rise above pre-industrial levels by more than 1.5°C for extended periods. Average temperatures across the earth’s terrestial areas, which are typically warmer than the seas, have also risen above the threshold already.

“The climate crisis is getting worse, not better,” said Patricia Kameri-Mbote, who leads UNEP’s legal division. “People are increasingly turning to the courts for answers.”

A new field of climate law

The disruptive activities of climate activists around the world are increasingly being met with criminal charges – even as lawsuits over official climate inaction proliferate.

Lawsuits arguing that the right to a healthy and sustainable environment is inherent to existing national constitutional law and international human rights law is the most common category of litigation, the report said.

Plaintiffs also sued governments for not abiding by emissions targets set out in international agreements like the Paris Accords. They have challenged the construction of new fossil fuel extraction facilities in the courts, and attacked greenwashing in corporate marketing.

The growing number of cases and legal strategies for climate litigation is increasingly defining a new field of law, UN experts said.

“These cases are being seen across the world,” said Andy Raine, head of environmental law at UNEP. “[Precedents] have influence and impact that don’t always just stay within national borders.”

Youth climate activists have been a driving force in climate litigation, filing 34 cases on behalf of children, teens, and young adults.

Legal ‘backlash’ cases proliferate

The report also warned, however, of a growing number of legal “backlash” cases against climate activists and affected communities as corporations try to protect their fossil fuel assets. Criminal and civil cases that target the disruptive actions of climate activists are also increasing, Tigre said.

The legal costs associated with major climate litigation, however, also represent a high bar of entry that prevents many of the world’s most vulnerable from using it as an avenue for climate justice, the report said.

“Many cases are still not brought to the forefront as financial challenges, intimidation, lack of know-how and other barriers remain in place,” the report said. “These barriers are especially harmful for vulnerable groups including Indigenous Peoples, women and those from a lower socioeconomic status, the majority of whom are women.”

International courts yet to weigh in

The International Court of Justice’s advisory opinion on the responsibilities of states to respond to climate change to protect present and future generations is pending.

Climate cases are also working their way through international courts – although the process is slow and painstaking. In March, the UN General Assembly requested an advisory opinion from the International Court of Justice on the obligations of states to respond to climate change. The resolution also invited the court to give an opinion on these obligations with respect to future generations.

“The advantage of the ICJ advisory opinion is that we would hopefully have the highest court in the world clarifying what the legal obligations of states are,” said Tigre. “A big challenge often facing individuals in these systemic cases against governments will be surpassed … domestic courts will likely follow that interpretation.”

“Obviously, you won’t solve any problem in and of itself, because it’s an advisory opinion, but it would help for future litigation and hopefully also lead to certain changes from governments without the need for further litigation, as well,” Tigre added.

Criminal charges have also been sought in international courts. In 2021, a communication was filed with the International Criminal Court (ICC) requesting that former Brazilian President Jair Bolsonaro be investigated for crimes against humanity for his role in deforestation activities in the Amazon rainforest.

The communication argued that Bolsonaro actively promoted and facilitated attacks on the Amazon and the people who depend on it, which constitutes “a clear and extant threat to humanity itself”. If the ICC pursues the case, it would be the first time that environmental and climate harm formed the basis for charges of crimes against humanity.

Image Credits: Markus Spiske/ Unsplash, CC.

High cost has prevented some cancer drugs from being included in the World Health Organization’s (WHO) updated Essential Medicines List (EML) and Essential Medicines for List Children (EMLc) released on Wednesday.

These include “patented, highly-priced” treatments for lung and breast cancer.

“With the cancer medicines, we are facing now an issue where we have a very high burden of disease and very expensive, highly-priced medicines,” said Dr Benedikt Huttner, secretary of the expert committee that advises the WHO on the EML.

“For some of the medicines [cost] was one of the factors leading the expert committee not to recommend them currently,” Huttner told a WHO global press conference.

Among the new recommended EML cancer drugs are a treatment for Kaposi sarcoma and a medicine to stimulate the production of white blood cells to reduce the toxic effect of some cancer medicines on bone marrow, as well as the extension of some children’s cancer treatments to cover three additional cancers.  WHO’s essential medicines lists are widely used by countries in medicines procurement choices and decisions about what drugs to include in government subsidized medicines plans. 

Access to medicines a killer for cancer patients

Access to medicines remains a killer for cancer patients, and the 30% survival rate for children with cancer in low-income countries, in comparison to more than 90% for children in high-income countries, reflects this, said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

“Every year, an estimated 350,000 children are diagnosed with cancer in low and middle-income countries (LMICs). Many of them cannot access the treatment they need,” noted Dr Tedros.

“Only 25% of low-income countries covered childhood cancer medicines in their health benefit packages. This subjects children and families to significant suffering and financial hardship or puts them at risk of receiving substandard and falsified medicines.”

James R Downing, CEO of St Jude Children’s Research Hospital

EML Pricing group still not formed

Despite several WHO mentions of the high cost of drugs excluded from the list, an EML sub-group on pricing, which was recommended by experts in 2021, still hasn’t been been launched.

At Wednesday’s press conference, Huttner reaffirmed it was going to be set up soon – even though it hasn’t begun its work yet.

“There is actually going to be also an advisory group advising WHO on how to deal with the issue of highly-priced medicines,” he stated.  The new working group is supposed to develop more systematic strategies for monitoring medicines prices and for assessing and making high-priced, but essential drugs more affordable, as part of WHO and EML processes.   

‘Where you live in the world’ is a major determinant for children’s cancer survival

A major determinant of survival for children with cancer is “where you live in the world”, James R Downing, CEO of New York City’s St Jude Children’s Research Hospital, told the press conference.

“In developed countries, we have made incredible progress against paediatric cancer with cure rates approaching 90% for many of the more common paediatric cancers. Yet the rest of the world has been left behind,” he added.

In 2021, St Jude Hospital announced that it would contribute $200 million over six years to improve access to cancer drugs for kids via the Global Platform for Access to Childhood Cancer Medicines, an initiative that it is running with the WHO.

The initiative aims to provide an uninterrupted supply of free, quality-assured cancer medicines to low- and middle-income countries – focusing first on six of the most common cancers that cause over half of childhood cancers. The aim is to raise survival rates to at least 60% in these countries by 2030.

Interruptions in medicines access a key factor undermining children’s survival

This followed earlier work between St Jude and the WHO via the Global Initiative for Childhood Cancer, which identified lack of access to medicine and interruptions in supply as key factors undermining the survival of children with cancer.

“Some 40-60% of children being treated for cancer will have disruptions in their access to chemotherapy, and that decreases their chance of cure,” said Downing. 

“In other countries, the quality of the drugs is not up to standards, and so they’re getting inferior drugs that are leading to inferior treatment.”

The platform is being piloted in six countries initially, with UNICEF as a collaborating partner.

“The idea is that we will set up a secretariat at the WHO that will manage this, and that we will have a procurement agency that will produce those drugs with generic drug producers,” Downing explained.

“We will know the market size because of the analytics that we have developed and then we will be able to ship those drugs into those countries. And we know their capacity to use those drugs effectively to treat children with cancer because they’re part of the St Jude Global Alliance and we have spent energy and time training them and putting forward to them the exact protocols they should be using to treat those children.”

Another challenge is the lack of diagnostic tools to diagnose cancer in LMICs, and St Jude is also working on a platform to develop and distribute cheaper diagnostics.

Children undergoing chemotherapy

Multiple sclerosis drugs included on EML for first time

In other new EML additions, medicines for the treatment of multiple sclerosis (MS) have been included on the essential medicines list for the first time ever, along with new treatments for cardiovascular conditions and infectious diseases.

Three medicines that can slow MS – cladribine, glatiramer acetate and rituximab – have been added. Multiple sclerosis is a chronic, debilitating disease of the nervous system affecting approximately 2.8 million people worldwide. 

Fixed-dose combinations of multiple medicines (commonly called ‘polypills’) for the prevention of diseases of the heart and blood vessels, have also been added to the EML for the first time.

“The list is an important tool for achieving universal health coverage, providing guidance to governments, health facilities and procurers on which medicines are the best value in terms of benefits for individuals and communities. The EML includes medicines only on the basis of solid evidence for safety and efficacy. Approved indications within national jurisdictions or the availability of on-label alternatives is not a decision criterion,” said Huttner. 

Other medicines for infectious diseases that have been listed in the new EML include:

  • ceftolozane + tazobactam, effective against multi-drug resistant bacteria, including difficult-to-treat infections caused by carbapenem-resistant Pseudomonas aeruginosa; the drug is a ‘reserve’ group antibiotic, under WHO’s three-tiered  “AWaRe” system for judicious antibiotic use, meaning it should only be used when other treatments have failed.
  • pretomanid to treat multidrug-resistant or rifampicin-resistant tuberculosis;
  • ravidasvir (to be used in combination with sofosbuvir) for the treatment of chronic hepatitis C virus infection in adults;
  • monoclonal antibodies for Ebola.

Altogether, the recommended changes bring the number of medicines on the WHO essential medicines list, which is updated every two years, to 502 drugs for adults and to 361 for the essential medicines list for children. 

But the WHO warned that “rising prices and supply chain disruptions mean that all countries now face increasing problems in ensuring consistent and equitable access to many quality-assured essential medicines”.

Image Credits: National Cancer Institute, National Cancer Institute, USA.

WHO's New Leadership TeamThe cases of drug-resistant gonorrhoea, a sexually transmitted disease, are on the rise in many parts of the world, the World Health Organization (WHO) has warned. 

The agency added that it considers Neisseria gonorrhoea a “priority microorganism” to be monitored for antimicrobial resistance. 

The new WHO guidance on sexually transmitted infections (STIs) requires countries to work towards improving access to better testing and diagnostic services. 

“Early testing and diagnosis are key in stopping the spread of STIs,” Dr Teodora Wi, the lead for sexually transmitted infections of the WHO’s Global HIV, Hepatitis and STIs programmes, said. “When left untreated, certain STIs can lead to long-term irreversible outcomes and some can be potentially fatal.”

Countries like Australia, Austria, Canada, Denmark, France, Ireland, the United Kingdom, and several countries in Asia including China, Japan, Singapore and Vietnam, have reported cases of Neisseria gonorrhoea, a pathogen that is highly resistant to the antibiotic medication ceftriaxone.

“The enhanced gonorrhoea AMR surveillance (EGASP) suggests high rates of resistance in gonorrhoea to current treatment options such as ceftriaxone, cefixime and azithromycin in Cambodia, for instance,” the WHO said in a press release. 

Eighty two million new cases of N.gonorrhoea are being reported around the world every year in people between the ages of 15 and 49. 

“In addition, antimicrobial resistance (AMR) in N. gonorrhoea is particularly problematic. With resistance to both cephalosporins, including third-generation extended-spectrum cephalosporins, and fluoroquinolones, N. gonorrhoea is a multidrug-resistant pathogen,” the WHO indicated, adding that the resistance observed in the pathogen outpaces the new antibiotics being developed for it. 

“WHO considers N. gonorrhoea to be a priority microorganism for AMR monitoring in the Global Antimicrobial Surveillance System and for drug development in the context of AMR.” 

The new guidance is also expected to help make STI testing more accessible and affordable to the masses, which will lead to better data collection, the WHO added. 

Image Credits: Flickr – Guilhem Vellut, Guilhem Vellut.

pandemic
Investment in strong health systems is key to pandemic-proofing the world.

Thirty-seven countries have received grants worth $338 million from the Pandemic Fund to boost their resilience to pandemics in the first round of the fund’s disbursements.

Three disbursements involve multi-country grants: to 12 Caribbean countries to strengthen their early warning surveillance, build laboratory systems and workforce development; to seven Latin American countries to engage communities and territories​ in pandemic response, and to five Central Asian countries to bolster their One Health response.

Single-country recipients include Burkino Faso, Ethiopia, Kazakhstan​, West Bank and Gaza, Yemen and Zambia.

The fund, which was launched at the G20 meeting in November 2022 to help low- and middle-income countries prepare for future pandemics, received 179 applications from 133 countries. 

“We are very pleased that the Pandemic Fund has been able to move forward so quickly to allocate funding to projects that represent a good balance across geographical regions, country income groups, and participating Implementing Entities,” said Pandemic Fund Board co-Chairs, Dr Chatib Basri, former Indonesian finance minister, and Dr Sabin Nsanzimana, Rwanda’s health minister.

Independent evaluation

“All proposals were independently reviewed and evaluated by the Technical Advisory Panel (TAP)and we are confident that the portfolio of projects selected by the board for funding will increase pandemic prevention, preparedness, and response (PPR) capacity and respond to the inequalities that COVID-19 further revealed to the world.”

The WHO’s head of health emergencies, Dr Mike Ryan, currently chairs the TAP, while the fund is hosted by the World Bank.

“In keeping with the Pandemic Fund’s mission to catalyse funding and promote coordination, the $338 million of grants awarded will mobilize over $2 billion in additional resources, adding $6 for each $1 coming from the Fund,” according to a media release from the Fund.

 Priya Basu, executive head of fund’s secretariat, said that the response to the first call was “eight times oversubscribed”. 

“This first round of funding was a learning exercise and we are committed to drawing lessons that will be reflected in how we do business in the future. We are excited to see the results and impact of our funding,” added Basu.

The fund’s second call for proposals is expected towards the end of 2023.

It has raised $2 billion in seed capital from 25 sovereign and philanthropic contributors but needs an estimated $10-billion a year for the next five years to pandemic-proof the world.

Image Credits: Tehran Heart Centre .

United Nations Headquarters, New York

The final reading of the Political Declaration for the United Nations High-Level Meeting on Pandemic Prevention, Preparedness and Response (PPPR) is scheduled for Tuesday in New York – and while the revised text has a few more practical clauses than the bland zero-draft, it remains more aspirational than actionable.

The draft Political Declaration, which has been shared with Health Policy Watch, puts “equitable, people-centered and community-based” primary health care at the centre of countries’ pandemic mitigation.

There are five sections to the “call to action”: equity, global governance, leadership and accountability, health, and financing and investment.

In terms of equity, the declaration commits to strengthening “research and development capacity in developing countries” funded by “greater official development assistance”, surge financing and other “innovative financing”.

Strongest language for medical supply

The strongest language in the declaration calls on member states to “ensure the supply and distribution of sustainable, fair, equitable, effective, efficient, quality, safe, affordable and essential medicines, including generics, vaccines, diagnostics and other health technologies and innovation”.

Some of the “how” to achieve this involves the transfer of technology and know-how “within the framework of relevant multilateral agreements”; voluntary licensing – although confined to cases where public funding has been invested in research and development;  and strengthening “local and regional capacities for the manufacturing, regulation and procurement”.

Emergency trade measures designed to tackle pandemics should be “targeted, proportionate, transparent, temporary”. In addition, they should not “create barriers to trade or disrupt global and regional supply chains”. 

India’s decision to refuse to allow locally manufactured generic COVID-19 vaccines to leave its borders at the height of the pandemic – effectively stopping the only vaccine supply COVID-19 vaccine access platform COVAX had lined up for developing countries – would be antithetical to these clauses.

Manufacturing capacities should be “diversified” across regions and ‘facilitate the movement of medical and public health goods, especially during pandemics and other health emergencies among and within countries”.

The declaration also stresses the need to address the current global pandemics of HIV, tuberculosis and malaria, as well as tackling antimicrobial resistance – a potential pandemic source.  

One contentious clause 

The declaration will be adopted at the High-Level Meeting on 20 September which is aimed at “political mobilisation” for PPPR, but the draft is being finalised in two days of informal consultations on Monday and Tuesday. After Tuesday, the declaration goes into “silence procedure” – that is no more discussion – under the HLM. 

By Monday, the one clause that was still contentious called for “the importance of refraining from promulgating and applying any unilateral economic, financial or trade measures not in accordance with international law and the Charter of the United Nations that impede the full achievement of universal health coverage, particularly in developing countries”.

China, Russia, Pakistan, Cuba and others support this clause but the US, European Union and others want it removed.

The HLM will be “aligned and informed” by the ongoing World Health Organization (WHO) negotiations on the pandemic accord and the changes to the International Health Regulations (IHR), according to the declaration.

Another pandemic HLM will be convened in 2026 “to undertake a comprehensive review of the implementation of the present declaration” – a far cry from the establishment of an international oversight body proposed by the Independent Panel.

Meanwhile, Monday saw the conclusion of the joint plenary meeting of the WHO Intergovernmental Negotiating Body (INB) negotiating a pandemic accord, and the Working Group on the International Health Regulations (WGIHR), which is amending the globally binding regulations relating to public health emergencies.

The WGIHR continues meeting for the remainder of the week, as the two negotiation processes accelerate ahead of the looking summer vacation in the northern hemisphere.

Image Credits: UN Photo/Manuel Elias.

Dr Mike Ryan, WHO head of health emergencies.

The worst outcome of the two World Health Organization (WHO) pandemic negotiations currently underway would be the adoption of contradictory definitions and processes, warned Dr Mike Ryan, the head of health emergencies at the World Health Organization (WHO) on Friday.

“At the very minimum, the two instruments will need to be very aligned on the definitions they use,” stressed Ryan at a joint meeting of the Intergovernmental Negotiating Body (INB) negotiating a pandemic accord, and the Working Group on the International Health Regulations (WGIHR), which is amending the globally binding regulations relating to public health emergencies.

Twisted road from emergency to pandemic

The primary determination of the IHR is whether a  public health emergency of international concern (PHEIC) exists that requires the collective response of the member states, Ryan explained at Friday’s meeting.

“The binary nature of the PHEIC is sometimes difficult to deal with because, at one level you either have a PHEIC or you don’t, [but] the events don’t sit that easily,” said Ryan. 

Ryan suggested that member states could introduce a third category to indicate an “intermediate stage” that would enable WHO to say: “We’re very worried, but it’s not yet a PHEIC”. 

Surprisingly, the International Health Regulations (IHR) do not include a definition of a pandemic, whereas the INB has a draft definition in its compilation draft of a pandemic accord.

The textbook definition of a pandemic is “a public health emergency that represents a fully global threat that we expect to affect everyone in the population”, according to Ryan.

But declaring a pandemic is tricky as it usually had to be made before all countries have been affected and often when there isn’t yet enough data to determine the trajectory of a disease outbreak.

“So the question is, are you defining a pandemic that will occur are you defining a pandemic that has occurred? And when you still have a fighting chance of containing a disease, does a pandemic definition assist or not assist in that process?” he asked.

“You could argue that polio was a pandemic although it was never declared as a pandemic. You could also argue that Mpox was a pandemic because it affected people all over the world, but it affected a particular population segment all over the world. So you can get yourself into a lot of twisted discussions,” he warned.

“Do the member states want to introduce the concept of ‘pandemic’ formally into the process, or do you want to have that characterization built in as part of the declaration of PHEIC? They’re not exactly the same thing.”

 

Already, the process of getting as far as identifying a potential health risk is detailed and complicated.

“There is a very complex intelligence workflow, and this is going on 24 hours a day, 365 days a year, and being carried out by all of our regional and country offices with yourselves,” Ryan told member states.

“Around 60,000 different pieces of information are scanned a month, and at least 1000 signals of relevance are detected,” he added. Around 35 new health threats were considered for a formal rapid risk assessment by the Secretariat each month, with around five requiring assessment.

Country responses

The representative from Brunei.

In response to the challenges Ryan posed, the US suggested: “a tiered alert system under the IHR to better define stages of public health threats, enable better reporting incentives and to prevent local or regional outbreaks from becoming large-scale global health emergencies, including pandemic emergencies”. 

The US said that it viewed the “current PHEIC or binary approach as insufficient to trigger international coordinated action at earlier stages of outbreaks”. This was needed to “mobilise resources, facilitate early assistance and allow countries and regions to ramp up response measures in a more tailored and timely way”.

“Our proposal under the IHR also includes the pandemic emergency declaration within this tiered alert system to maintain consistency with the well-established framework to evaluate risks and to galvanise a coordinated global response to declared emergencies,” added the US representative.

“This IHR pandemic emergency declaration would be linked to the pandemic accord because of its ability to trigger activation of emergency response provisions within the accord.”

Brunei proposed “a simple definition of a pandemic as a PHEIC resulting from an emerging infectious disease with potential to overwhelm health systems”, and said its declaration should lie within the provisions of the IHR.

“While the IHR has its emphasis on the early spread of disease, it doesn’t say very much about what happens when the global spread is already well established. It is in this gap that we see a pandemic accord can be of most value by providing for a multilateral system for ensuring global health security in the event of sustained and prolonged disease spread,” added Brunei. 

The Brunei representative made a rather neat distinction between the two instruments, characterising the IHR as “emphasising the obligations of member states to the WHO, particularly in terms of reporting, surveillance and domestic implementation of standing recommendations of the Director General”, and the pandemic accord, which “could serve as an instrument that outlines the obligation of member states to each other”. 

Australia also supported strengthening the process to declare a PHEIC and new IHR provisions “to introduce criteria for declaration of a pandemic or pandemic emergency”.

“The criteria must be unambiguous and meaningfully differentiate between a pandemic and a PHEIC, and the definition of a pandemic should avoid restrictive criteria that might delay effective public health responses,” it stressed.

The joint WGIHR and INB meeting continues on Monday.

INB informal meetings to continue

Meanwhile, the public report back at the end of the sixth INB meeting on Friday yielded very little information other than that there will be more informal meetings to assist with its negotiations on the controversial Chapter Two on equity. 

The informal meetings will continue on research and development (Article 9), on access and benefit sharing (Article 12) and supply chain logistics (Article 13).

Three new informal meeting processes have been added to the already overloaded agenda. Informal meetings on the “co-development and transfer of technology and know-how” (Article 11) will be co-facilitated by Colombia, the Philippines and Saudi Arabia.

India, Tanzania, and the United Kingdom will co-facilitate informal talks on pandemic prevention and public health surveillance (Article 4) and “Strengthening pandemic prevention and preparedness through a One Health approach” (Article 5).

Pandemic accord
A COVAX vaccine delivery to Africa in April 2021

With the fate and nature of the pandemic accord currently being negotiated by World Health Organization (WHO) member states still uncertain, global health experts are calling for “realistic” backup plans to protect the world against the next pandemic.

“We need an ambitious but implementable pandemic accord – that is the Holy Grail,” Javier Guzman, Director of Global Health at the Center for Development (CDG) told a CDG panel on Thursday convened to discuss the lessons of the pandemic, particularly in relation to the global COVID-19 vaccine access platform, COVAX.

“Now, will it materialize? Will it be enforceable? Would it be ambitious enough? Will it be ratified? I’m not very optimistic, based on what I’ve seen,” said Guzman. “So if that doesn’t happen – or if that happens, but it’s not enforceable, or it’s not what we all need as the globe – then we need to move to the second best option, which is realistic options.”

Guzman said that two such options include building regional vaccine manufacturing capacity and ensuring vulnerable countries have quick access to financing. He cited the regional level, particularly in Africa, as the place to seek solutions to the problems of equitable access to vaccines, which were predominantly felt at a regional rather than global level.

Regional manufacturing efforts are underway

Around 30 investment initiatives across 14 African countries for vaccine manufacturing on the continent have been announced since COVID-19. / Image: PAVM, Gavi, AVMI, Africa CDC, Lion’s Head Research, WHO.

Support for African manufacturing is already progressing. Next month, Gavi, the global vaccine alliance, the African Union (AU) and the African Centre for Disease Control and Prevention (Africa CDC) are convening a regional vaccine manufacturing forum to bolster the least-resourced continent.

The aim of the forum is for African leaders, African manufacturers and Gavi to “strategize around sustainable manufacturing”, said Gavi’s Aurélia Nguyen. Gavi and the AU have already signed a memorandum of understanding in this regard.

“Investing in our routine systems is the backbone of investment in pandemic preparedness and response if we’re able to make more systemic changes,” added Nguyen, COVAX’s former CEO and Gavi’s Chief Program Strategy Officer.

Akhona Tshangela, programme coordinator for the Partnerships for African Vaccine Manufacturing (PAVM) at the Africa CDC, said that the continent “is working towards building a vaccine manufacturing capacity that promotes tech transfer and strengthens the regional framework”.

The PAVM has been formed to address the limited production of vaccines, diagnostics and therapeutics on the continent, said Tshangela, adding that the AU’s memorandum of understanding with Gavi will “help support our manufacturers on the continent to gain entry into the markets”.

“In addition to vaccine manufacturing, we’re also focusing on ensuring that we develop regional regulatory harmonisation frameworks so that whatever products come out of the African continent are seen as good quality and safe for use not just globally,” Tshangela added.

While there is a lot of appetite and political will for diversified vaccine manufacturing, and the benefits for the resilience of the global vaccine supply chain are clear, the costs must also be placed squarely on the negotiating table, said Guzman. 

“Clearly, we need to understand that there is a trade-off,” he said. “If you want to have diversified vaccine manufacturing, you sacrifice some economies of scale, you sacrifice price, affordability.”

Access to financing

L-R: (top)Janeen Madan Keller (moderator), Matt Cooper, Javier Guzman,(bottom) Aurelia Nguyen, Akhona Tshangela, Saul Walker.

Nguyen highlighted five key lessons from COVAX for future pandemics: having financing from day zero; clear communication with stakeholders, particularly about risk; equitable access, particularly for the most vulnerable; legal and regulatory challenges to access, and trade-related barriers in a pandemic setting. 

Whether the world has learnt Nguyen’s first lesson of the COVID-19 pandemic – that financing must be available from day zero – remains uncertain.

Financing for pandemic preparedness

A pandemic fund to bolster global investment in prevention, preparedness and response ahead of the next pandemic was launched at a G20 meeting last year, but the fund has mobilized far less than the estimated minimum of $10 billion a year needed to equip countries to combat future pandemics.

“How we can maximise the investments by the pandemic fund to support pandemic preparedness? And now what is the conversation about surge financing?” asked Guzman. 

“We’ve got new heads of the World Bank and the Inter-American Development Bank – but how can we, either regionally or globally, agree on a framework to provide swift access to funds in response to a pandemic? That could be relaxed rules on country borrowing or it could be automatic access for pre-qualified countries,” he said. 

Saul Walker, Director of Public Partnerships at the Coalition for Epidemic Preparedness Innovations (CEPI), also spoke about the need for quick access to finances in the face of a pandemic.

Although CEPI made some “initial investments” in mRNA vaccine research and development (R&D) in February 2020, it was simply unable to compete with the vast R&D funding coming in from high-income countries and other funders in later rounds. 

If CEPI had been able to compete with this funding, it might have enabled more equitable access to the mRNA vaccines that were later developed.

Matt Cooper, an independent consultant for Itad who took part in an independent evaluation of COVAX completed in May, argued that the global pandemic preparedness and response strategy must find a way to “facilitate, incentivize, perhaps even compel, vaccine manufacturers to engage in tech transfer agreements such that vaccine suppliers can be scaled up as rapidly as possible”.

“Countries are serving their own populations first and companies are pursuing their commercial interests,” warned Cooper. “Let’s be under no illusion that those behaviours will be replicated in the future.”

Ducks in a row

On 24 February 2021, a plane carrying the first shipment of COVID-19 vaccines distributed by the COVAX Facility landed at Kotoka International Airport in Accra.

Responding to COVID-19 was like “flying a plane while we were building the plane, and then trying to work out where to land it,” said Walker.

CEPI was only three years old when the pandemic started and had to work out a multitude of things on the fly. This was also true for the many organisations, countries and structures working together as the pandemic unfolded. 

Stakeholders in the pandemic response had to hash out  “roles and responsibilities, handoffs, how information flows up and down a value chain, how much delegation boards are given to be able to move fast, what the risk tolerances of different organisations are,” said Walker.

“And actually as you move along, roles and responsibilities change,” he said.

For Nguyen: “At the end of the day, it really is the strength of the health system that determines the strength of the pandemic response.”

And for Guzman, the current period of preparation must not be wasted as the next pandemic looms: “It’s about timing. It’s about having everything ready to go.”

Image Credits: WHO, UNICEF/Kokoroko.

Raquel da Silva, who lives in Manaus in Brazil’s Amazonas State, had malaria five times in five consecutive months.

Brazil is the first country in the world to introduce tafenoquine, the first new single-dose treatment for P. vivax malaria developed in 70 years, in its public health system.

Raquel da Silva has lived in Manaus in Brazil’s Amazonas State since her childhood. Today she shares her home on the banks of the Rio Negro with her husband Camilo, their three children, her mother-in-law and her grandmother-in-law. 

On the weekends, she works in a restaurant. As a mother of three, Raquel needs her energy to keep up with her children, but living in one of the most malaria-affected areas in the country, she has lost track of how many times she has contracted malaria. 

“My family and I had malaria five times for five consecutive months last year,” Da Silva told Medicines for Malaria Venture (MMV) when she first met them in 2020.

“When I got malaria, my baby was six months old, so I didn’t manage to take the full treatment regimen for seven days. I took just enough so my symptoms would improve, so it always relapsed. My husband works so he had to leave the house and I didn’t have energy to do anything. It was hard.”

Malaria disproportionately impacts the poorest and most vulnerable in society, perpetuating a cycle of poverty. P. falciparum, which is more deadly and prevalent in Africa, has long received the most attention in the malaria world, but P. vivax, known for its frequent relapses, also requires focus if more malaria-endemic countries are to join the 41 nations that have already been declared malaria-free.

Approval of tafenoquine for national rollout

On 5 June, Brazil took an important step in that direction, becoming the first country in the world to approve the new single dose P. vivax treatment, tafenoquine, for nationwide rollout in the public health system.

P. vivax malaria is the most geographically widespread of the two parasites and is the predominant species in most countries in Asia-Pacific and Latin America as well as in other areas on the cusp of malaria elimination.

Transmission is driven by the parasite’s ability to cause relapses – patients suffer recurrent malaria episodes from just one infectious mosquito bite, and human-to-human transmission occurs when a mosquito feeds on the blood of an infected person and transmits the parasite to family members, friends, and neighbours. 

To stop the relapses, both the blood- and liver-stages of the P. vivax infection must be treated, providing what is known as ‘radical cure’.

Until now, this involved blood-stage treatment with chloroquine for three days and liver-stage treatment with primaquine for seven or 14 days. But there are huge issues with treatment adherence. Most patients will not complete the full 7-14 day treatment course, and so risk suffering relapses which in turn fuel further P. vivax malaria transmission.

Turbocharging Brazil’s efforts to eliminate malaria

In Brazil, where over 80% of reported malaria cases in 2021 were caused by P. vivax, the Ministry of Health (MoH) and the country’s malaria research community have been searching for better tools to tackle P. vivax malaria for a long time. 

Between 2014 and 2016, researchers in Manaus and Porto Velho played a pivotal role in the clinical development programme for tafenoquine, the single-dose treatment developed by GSK and MMV.

The same researchers also conducted critical clinical and operational studies on a new point of care test, developed by SD Biosensor and PATH  that could identify a hereditary condition, glucose-6-phosphate-dehydrogenase (G6PD) deficiency, which can cause haemolytic anaemia in those who take either primaquine or tafenoquine. In Brazil around 5% of the population is presumed to be G6PD deficient.

The new G6PD test opened up new opportunities to rapidly diagnose the condition and adapt treatment accordingly. Tracking the development of the diagnostic and treatment in tandem, Brazil’s Ministry of Health recognised their potential to supercharge the country’s malaria elimination efforts.

By the time tafenoquine had been approved as a treatment and registered in Brazil in 2019, plans were already underway to study the drug’s real-world application in Manaus and Porto Velho. The MoH wanted to know whether it would be feasible for health workers, at different levels of the vast network of malaria services within the public system, to perform the quantitative point-of-care G6PD test and provide tafenoquine or primaquine based on the test results.

First real-world study launched with impressive results

Fast forward, past COVID-related delays, to September 2021 when the first real-world study, TRuST, was launched, sponsored by the MoH and MMV. The MoH in coordination with the Municipal and State level health authorities rolled out tafenoquine and G6PD testing in 43 health facilities throughout Manaus and Porto Velho. 

They trained 370 healthcare professionals, and more than 6,000 patients consented to have their data anonymized and collected for analysis by the TRuST study team.

The results were impressive. The level of compliance with the new treatment protocol was above 99%, consistent across all healthcare facilities, showing that routine testing for G6PD activity before providing appropriate radical cure was feasible throughout the Brazilian health system. 

Following the end of patient recruitment into the study in August 2022, a comprehensive dossier was submitted to CONITEC, the country’s health technology assessment body, in December of that year. The dossier included the first and second interim analyses of TRuST; a qualitative research study looking at patient and health worker perceptions; a cost-effectiveness analysis; and a budget impact analysis. 

On reviewing this, CONITEC recommended that the new tools be incorporated into the public health system. On 5 June, the government of Brazil issued a decree on adoption, making it the first malaria-endemic country to introduce single-dose tafenoquine and quantitative point-of-care G6PD testing throughout the health system.

As one of the patients treated with the new shorter treatment during the study, Raquel is optimistic about the new possibilities that the drug provides. She says that, although she also takes preventive measures such as using bed nets, the drug provides a sense of security in case she or her family members do fall ill again.

Regional impact

What does this mean beyond Brazil? Countries in the region are already seeking to learn from Brazil’s experience. A similar tafenoquine and G6PD testing feasibility study, funded by Unitaid, is about to start in Peru with support from MMV and the University of Peru Cayetano Heredia (UPCH). 

The team there received training from the TRuST team in December 2022, enabling them to move more quickly, based on the Brazilian experience. The Ministry of Public Health in Thailand is conducting a similar study with support from MMV, examining routine use of tafenoquine and point-of-care G6PD testing in hospitals and malaria clinics. 

Recruitment in that study is set to conclude in August, providing real-world evidence from a different context. Unitaid is supporting two additional real-world feasibility studies on the use of tafenoquine and G6PD testing in Vietnam and Ethiopia, with support from the international global health non-profit PATH and local research partners. Together this emerging evidence may inform WHO guidelines and support national malaria programmes as they seek to optimise tools for the control and elimination of P. vivax.

Marcus Lacerda was one of the Principal Investigators on both the Tafenoquine Rollout STudy (TRuST) and the Tafenoquine Phase III studies.

Elodie Jambert is senior director at Medicines for Malaria Venture (MMV), the product development partnership that co-developed tafenoquine with GSK and co-sponsored TRuST with the Brazilian Ministry of Health.

Image Credits: Nathalie Brasil, Instagram: @_nathaliebl.