Pakistan’s Adeel Khokhar

All World Health Organization (WHO) member states supported the extension of talks on the last outstanding piece of the Pandemic Agreement, the Pathogen Access and Benefit-Sharing (PABS) annex, at the World Health Assembly’s (WHA) Committee A on Monday.

A draft PABS annex was due to have been presented to the WHA for approval, but instead, a report from the World Health Organization (WHO) Director General notes that member states need more time to reach an agreement.

The PABS annex will govern how dangerous pathogens are shared during public health emergencies and how to share any medical products (benefits) produced as a result of manufacturers getting access to this information. 

A draft annex will either be presented at next year’s WHA or at a special WHA if agreement is reached beforehand, according to the report.

Several of the many member states speaking on PABS in Committee A expressed confidence that the annex would be completed by the end of the year.

However, divisions between developed and developing countries remained stark.

Pakistan warned that the PABS negotiations should not be concluded in a way that “preserves the commercial privileges of a handful of manufacturers”.

Pakistan’s representative told the committee: “We are witnessing a sustained effort by some member states to hollow out Article 12 [of the Pandemic Agreement], which clearly establishes the principle of equal footing” between sharing dangerous pathogens and sharing any benefits that manufacturers accrue from such knowledge.

“We will not sign off on a multilateral system success story that serves the interests of industry over the health security of billions,” he added.

‘Conducive to R&D’

Malaysia’s representative in Committee A.

On the other end of the spectrum, the European Union warned that a PABS agreement should not stifle research and development.

“The Pandemic Agreement, as well as the revised IHR [International Health Regulations], contain important provisions that will significantly increase our capacity to confront pandemic emergencies and do so in a more equitable manner,” said the European Union.

“The PABS system has an important role to play in this context, but we need to ensure that the system is also conducive to innovation, and research and development for medical countermeasures, then it can lead to a robust uptake by the private sector.”

African countries, represented by South Africa, explained once again their demands for an equitable PABS system, including that the annex should include legally binding contracts between the WHO and manufacturers.

Impetus for a global PABS system comes from the need to correct the inequities of the COVID-19 pandemic, when developing countries were initially unable to get vaccines – even for healthworkers – as these had all been bought by wealthy countries.

As Namibia reminded the committee: “We negotiated the Pandemic Agreement because the world watched developing countries bury their loved ones due to COVID-19 while vaccines sat unused in warehouses elsewhere. That memory must anchor every line that we now draft.”

“The credibility of this agreement now rests on the PABS annex. If access obligations read ‘shall’ while benefit-sharing obligations read ‘options’, and ‘where available’, we will have written inequity into international laws with our own hands.”

“Benefit-sharing obligations must be legally binding and enforceable,” said Nigeria. “Technology transfer and non-exclusive licensing and local production partnerships must be obligations manufacturers sign onto, not options they select from a menu.”

Malaysia emphasises that annex must clearly spell out the rights and obligations of parties, and be “operationally implementable”.

Referring to the current hantavirus and Ebola outbreaks, Spain urged the completion of the annex so that the Pandemic Agreement could come into force and provide a solid regulatory framework “to prevent, prepare, and respond to health emergencies”. 

After six formal meetings and several informal sessions, the Intergovernmental Working Group (IGWG) will reconvene in July.

WHA president Dr Víctor Atallah (Dominican Republic), Spanish Prime Minister Pedros Sánchez, and WHO Director General Dr Tedros Adhanom Ghebreyesus.

“From conflicts to economic crises to climate change and aid cuts, we live in difficult, dangerous and divisive times,” World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus told the opening plenary of the World Health Assembly (WHA) on Monday.

While geopolitical disagreements have delayed Tedros’s official WHA address until Tuesday morning, the Director General acknowledged in a brief welcome that the WHO “has been through a difficult period as a result of sudden and steep cuts to our funding”.

The organisation’s budget is 90% funded, although some of the funds are pledged rather than in the bank.

Spain’s Prime Minister Pedro Sánchez, a WHA special guest speaker, appealed for solidarity and multilateral support for global health to combat “the pandemic of egotism and selfishness”.

Sánchez said that Spain had increased its official development aid (ODA) by 30%, explaining: “No country can save itself. Protecting others is the best way to protect ourselves.”

Without naming the United States, he added: “The greatest risk for global health is no longer the lack of science, but rather the lack of conscience. In just a few months, the same country that cut $18 billion from global public health and ODA has spent more than $29 billion on war, the humanitarian and geopolitical consequences of which will also be devastating.”

Sánchez, who received a standing ovation, also appealed for countries in the Global South to “have the role that they deserve in decision-making”, and that the reform of global health needed to be focused on strengthening national health centres.

Reforming global health

The WHA is considering how to reform the “global health architecture”. Ghanaian President John Dramani Mahama, also a special guest speaker at the plenary,  appealed for a more inclusive system of multilateralism.

“I’m concerned about whispers I have heard that the draft resolution [on global health reform] seeks to protect existing organisational mandates and prohibit the recommendation of mergers or consolidations,” said Mahama, who is championing Africa’s health sovereignty through the Accra Reset Initiative.

“If we launch a process of reform that is prohibited from recommending actual reform, we are merely performing a ritual. We cannot prioritise institutional comfort over human survival. The WHO’s legitimacy is not served by protecting silos. It is served by a fearless analysis of what works,” Mahama warned.

Barbados’ Prime Minister Mia Mottley also appealed for a more responsive global health system: “Small states are not asking for pity. We’re asking for a system that recognises reality. Vulnerability is not measured by income alone. Fiscal space must be judged alongside climate risk, debt burden, disease burden, and yes, the cost of survival.”

Motley also stressed that emergency funds must move with the speed of an emergency. “The WHO must not be asked to protect eight billion people on Planet Earth on the basis of uncertain contributions and political mood swings,” she said – a reference to the withdrawal from the WHO by the US.

Syrian President Ahmed Hussein al-Sharaa addressing the WHA via a video link.

Syrian President Ahmed Hussein al-Sharaa, who until December of last year was on both the UN and the US list of global terrorists facing sanctions, also addressed the plenary via video.  

Shortly after the opening, the business of the WHA was delayed by several hours by geopolitical disagreements, with some issues going to a vote. 

Member states decided against including Taiwan as an observer, but voted overwhelmingly in favour of a request by the Gulf Cooperation Council to discuss the impact of Iran’s recent attacks later in the week.

Israel’s objection to the tabling of two separate reports on health conditions in the occupied Palestinian territory (OPT) – including one on the immense toll of the recent Gaza war and increasing Israeli military and settler violence affecting West Bank Palestinian communities – also delayed proceedings.

The WHA has a massive agenda, including approving a new tuberculosis strategy and a plan on combating strokes; a global action plan on antimicrobial resistance (AMR) – still outstanding since the AMR UN high-level meeting two years ago; and how to improve emergency care.

 

Annual report finds progress slowing, stalling or reversing across every global health set out in the SDG agenda.

The world is on course to miss every one of the 52 health-related Sustainable Development Goal targets by 2030, the World Health Organization has warned, as ministers from its 194 member states gather in Geneva for an assembly tasked with reversing that trajectory.

With malaria cases rising, maternal deaths still occurring at nearly three times the targeted rate and childhood vaccination coverage plateauing or falling in some regions, progress on global health goals has slowed, stalled or reversed across virtually every measure since 2015, according to the 2026 edition of the WHO’s World Health Statistics report.

“Progress is too slow, too uneven, and increasingly fragile,” Yukiko Nakatani, WHO assistant director-general for health systems, access and data, told a press briefing on Wednesday. “The report is an urgent reminder for member states and all health partners together: we must refocus efforts, safeguard hard-won gains and renew progress.”

WHO Director-General Dr Tedros Adhanom Ghebreyesus said progress toward the health goals was “insufficient, uneven across regions and populations, and increasingly vulnerable to systemic shocks”, with a disproportionate burden falling on low- and middle-income countries, especially those in fragile and conflict-affected settings.

“Progress has stalled on universal health coverage, maternal and child health and reduction in premature mortality due to noncommunicable diseases — which remain the leading causes of mortality globally,” Tedros said.

“These data tell a story of both progress and persistent inequality,” the WHO chief added, “with many people – especially women, children and those in underserved communities – still denied the basic conditions for a healthy life.”

Once achievable health targets out of reach

The UN estimates that around 17% of SDG targets are on track globally.

The SDG health targets are part of a wider agenda adopted by all UN member states in 2015, setting goals on poverty, hunger, education, gender equality, climate and health by 2030.

The third goal — “ensure healthy lives and promote well-being for all at all ages” — sets the dozens of indicators tracked by the annual WHO report, ranging from maternal mortality and HIV incidence to tobacco use and air pollution deaths.

These were once seen as among the most achievable of the SDGs, given significant progress made under the agenda’s predecessor, the Millennium Development Goals. That hope has not materialised — and the wider SDG agenda is faring no better, with the latest UN figures finding only about a sixth of all targets on course for the 2030 deadline.

“Of the 52 health-related SDG indicators reviewed in this report, more than half have numeric SDG or other global targets,” WHO found. “And none is on track to meet the target at the global level.”

Malaria reversing, TB barely moving

Tuberculosis incidence rates, globally and by WHO region, 2015, 2024 and the 2030 target.

The reversal of progress in eradicating malaria is perhaps the starkest failure on the SDG health agenda. While the world set a target to reduce cases by 90% by 2030, global incidence has instead risen by 8.5%.

The African Region carries nearly the entire global burden, recording an estimated 282 million cases in 2024. Only the South-East Asia Region is on track to meet the 2025 milestone of a 75% reduction.

Tuberculosis is another major failure: of the 80% reduction target set in the WHO End TB Strategy, just 12% has been achieved since 2015.

The European Region cut its TB rate by 39% over the period, while the Region of the Americas went backwards, recording a 13% increase. The African Region, despite still bearing the highest burden, achieved a 28% reduction, more than double the global average.

The HIV picture is brighter, with new infections falling 40% since 2010 to 1.3 million worldwide in 2024. The African Region has cut new infections by 70% — a major achievement — but still accounts for 65% of the 40.8 million people living with HIV worldwide.

Yet HIV incidence cuts remain well short of the 90% SDG target. Hope circulated before 2015 that ending the AIDS epidemic by 2030 was within reach, has faded away.

Maternal and child deaths: progress stalling

Maternal mortality ratio, by WHO region, 2000–2023.

The global maternal mortality ratio has fallen 40% since 2000, but at 197 deaths per 100,000 live births in 2023 it remains nearly three times the 2030 target of fewer than 70 deaths per 100,000 live births.

The annual rate of reduction has slowed to 1.6% since 2015. The world needs that figure to climb to nearly 15% to hit the SDG, a pace more than nine times faster than the world has managed over the past quarter century. Doing so would mean preventing nearly 700,000 maternal deaths by 2030.

Each day, 712 women still die from maternal causes — one every two minutes.

A staggering 80% of those deaths occur in sub-Saharan Africa, where girls face a one-in-40 chance of dying of pregnancy-related complications by age 15. Central and Southern Asia come a distant second, accounting for 17% of the global death toll.

Globally, nearly 95% of all maternal deaths occur in low- and lower middle-income countries. Meanwhile, 73 countries, mostly in Europe, Latin America and the Caribbean, recorded fewer than 20 maternal deaths in 2020.

Vaccination coverage flatlines

Global immunization rates against diphtheria, tetanus and pertussis, measles, pneumococcal infections, and human papillomavirus, 2000–2024.

Routine childhood immunisation has largely flatlined, with global coverage stuck below the levels needed to prevent the outbreaks of vaccine-preventable diseases now resurging in several regions.

Coverage with the third dose of the diphtheria-tetanus-pertussis vaccine has plateaued at around 85%, while second-dose measles vaccination sits at 76% — far below the roughly 95% the WHO says is needed to prevent outbreaks.

The Region of the Americas, once a global leader on routine immunisation, now reports lower coverage for three of four core vaccines than in 2015. The WHO has linked persistent immunity gaps to the rising measles transmission reported across several regions over the past year, including major outbreaks in the United States, Europe and parts of the Eastern Mediterranean.

Coverage of the human papillomavirus vaccine, which protects against cervical cancer, has grown faster than any other core vaccine since 2021 — but from a very low base, reaching just 28% of the target group of 9-14-year-old girls globally in 2024.

A pandemic toll three times larger than officially recorded

Excess death rates (crude and age-standardized), by World Bank income group, 2020–2023.

A key finding buried deep in the report is a new estimate for excess deaths related to the COVID-19 pandemic.

The WHO now estimates 22.1 million deaths above expectation occurred between 2020 and 2023, roughly three times the 7 million COVID-19 deaths officially reported worldwide.

Excess mortality peaked at 10.4 million in 2021, with men experiencing age-standardised excess death rates around 50% higher than women, and people aged 85 and over recording rates ten times those of younger adults, the report found.

The ratio of excess deaths to officially reported COVID-19 deaths rose from roughly 1:1 in 2020 to about 9:1 by 2023, which the WHO attributes increasingly to underreporting as many countries wound down testing and attempted to move past the crisis.

The pandemic erased nearly a decade of gains in life expectancy and healthy life expectancy, the WHO chief said, with only female life expectancy returning to pre-pandemic levels globally by 2023.

“The COVID-19 pandemic inflicted a setback of historic proportions,” Tedros said. “Recovery since 2022 has been uneven, with persistent disparities according to region, age and sex.”

Where there has been progress

Age-standardized prevalence of current tobacco use in people 15 years and older, by sex, globally and by WHO region, 2010 and 2024.

Some indicators are moving in the right direction. Tobacco use has fallen 27% since 2010 — narrowly missing the 30% reduction target — and alcohol consumption is down 13%.

Between 2015 and 2024, 961 million more people gained access to safely managed drinking water, 1.2 billion to safe sanitation, 1.6 billion to basic hygiene services, and 1.4 billion to clean cooking fuels. The number of people requiring interventions for neglected tropical diseases has fallen 36% since 2010.

“These trends reflect too many deaths that could have been avoided,” Nakatani said. “With rising environmental risks, health emergencies, and a worsening health financing crisis, we must act urgently — strengthening primary health care, investing in prevention, and securing sustainable financing to build resilient health systems and get back on track.”

A ‘global health financing emergency’

Density of health professionals, globally and by WHO region.

The WHO warned that the limited gains were now under serious threat from a “global health financing emergency”, as billions of dollars cut by the United States and other wealthy donors, much of it destined to fund progress towards the SDGs, are now gone.

“Official development assistance for health was estimated to be 30-40% less in 2025 than in 2023,” Tedros said. “Many countries face long-standing structural constraints including high debt burdens and insufficient domestic public financing. Sudden aid reductions risk significant disruption of essential health services, reduced access to life-saving essential medicines and vaccines.”

A WHO rapid assessment of 108 low- and lower-middle-income countries earlier this year found that 63% reported job losses, salary suspensions or reductions among health and care workers as a result of the aid cuts. Nearly 70% anticipated future recruitment problems in the health sector.

Alain Labrique, director of WHO’s Department of Data, Digital Health, Analytics and Artificial Intelligence, noted that because the report’s data run only through 2024, the full effect of recent cuts to US foreign aid and other donor retrenchment is not yet visible.

“Should these trends continue, and we don’t see reinvigorated investment in global health, this will have an effect on global health indicators,” he said. “It may continue to cause a reversal in the patterns that we worked so hard to gain.”

Missing data paints a darker picture 

Timeliness of WHO Member States in reporting cause-of-death data, 2025.

Compounding the picture is the fact that the WHO’s own data is incomplete — and likely understates the scale of the problem.

Of an estimated 61 million deaths globally in 2023, only around 21 million were reported to the agency with cause-of-death information. Just 12 million had meaningful coding under the International Classification of Diseases, the global standard used to record what people die from and the foundation of comparable mortality statistics worldwide.

Only 18% of countries reported mortality data within a year. Nearly a third have never submitted cause-of-death data at all.

The shortfalls are concentrated in low- and lower-middle-income countries, where civil registration systems are weakest and where the disease burden is heaviest. Funding cuts have also disrupted disease surveillance, Nakatani said.

“Erosion of data, planning, and surveillance systems undermines reliable measurement, which is essential for progress,” Tedros said. “Too few deaths are recorded with timely, accurate, and meaningful cause-of-death information, limiting the accuracy and relevance of mortality statistics for policy and planning.”

“Data gaps severely limit the ability to monitor real-time health trends, compare outcomes across countries, and design effective public health responses,” Labrique said.

Image Credits: John Cameron, Priscila Oliveira.

Emergency medical supplies and WHO and the Ministry of Health experts rushed to Ituri Province, Democratic Republic of Congo, to confront a threatening new strain of Ebola virus.

As the World Health Assembly opens on Monday in Geneva, it will have to grapple with shrinking global health budgets, new outbreak threats, including a new WHO declaration of a public health emergency in Africa over an Ebola virus strain that lacks any vaccine, and an increasingly fractured geopolitical space with deep disputes over Iran, Ukraine, Gaza and Taiwan spilling into debates. 

With less than 24 hours before the opening of this year’s World Health Assembly, WHO Director General Dr Tedros Adhanom Ghebreyesus was faced with a new crisis-in-the making – declaring a new Public Health Emergency of International Concern (PHEIC) over an outbreak of a little-known Ebola virus strain in the Democratic Republic of Congo (DRC), which had already killed 87 people. More cases are now surfacing from Kampala in Uganda linked to the DRC outbreak. 

“Unlike for Ebola-Zaire strains, there are currently no approved Bundibugyo virus-specific therapeutics or vaccines. As such, this event is considered extraordinary,” concluded the Director General. 

The outbreak is but one indication of the formidable challenges WHO member states face as they convene on Monday for the 79th session of the WHA – in a world of deepening geopolitical fissures over regional conflicts, shrinking global health budgets, and sharp differences between rich and poor nations over how to even share vaccines and medicines during global health emergencies. 

Pathogen sharing annex to Pandemic Agreement delayed by a year 

The final passengers were evacuated from MV Hondius, the ship affected by a hantavirus outbreak, on Monday.

The new Ebola outbreak, following an outbreak of the deadly hantavirus aboard the Hondius cruise ship as it sailed from Argentina across the Atlantic, has underlined once more the vulnerabilities that the world faces in confronting epidemic and pandemic threats. 

Both dramas began to unfold shortly after WHO member state talks stalled in early May over a critical agreement on pathogen and benefit sharing (PABS), intended as an annex to last year’s WHA Pandemic Agreement, and hailed then as a milestone of global solidarity. 

Given the impasse, PABS negotiators will propose a one-year extension to the talks at this year’s WHA, buying time to reach a critical accord that must be finalised before the overall agreement can begin to be ratified by member states.  

The PABS system aims to ensure that the genetic blueprints for dangerous pathogens are rapidly shared during the most severe, pandemic emergencies – but also the critical medicines and vaccines that lower-income countries need to confront such threats. 

The current deadlock, mainly between developed and developing countries, hinges on how countries with information on emerging pathogens might also benefit from any vaccines, therapeutics or diagnostics developed as a result of their help. Low-income countries aim to establish a baseline for the mandatory sharing of such benefits in standardized contracts between the WHO and pharmaceutical companies. But developed countries argue that compulsory benefit-sharing will stifle R&D for new products at the very time that the world needs it the most.

See related story:

Pandemic Talks Extended – But Colombia Appeals for New ‘Method’ to Settle Differences

Consensus is increasingly difficult at the WHA 

Former WHO Legal Counsel Gian Luca Burci, at a World Health Assembly stage setter on Sunday.

In the last round of PABS talks in early May, some member states led by Colombia appealed for a ‘new method’ for approving the agreement that departs from the traditional “all or nothing” consensus modes of negotiations – including voting in stages over portions of the text where there is general agreement. 

Consensus has become increasingly difficult to reach in a sharply polarized world, said WHO’s former Legal Counsel, Gian Luca Burci, speaking at a high-level WHA preview event convened on Sunday by the Global Health Centre of the Geneva Graduate Institute.  

“Consensus is difficult, and it can create imbalances,” Burci observed, noting that just one or two powerful nations can block agreement by all of the remaining WHA member states. “There are many different views. Is that a good approach, or is it sometimes better to vote? Because consensus gives a veto, and vetoes sometimes are used by big, powerful countries. It’s very difficult for a weak country to stand in the way, and so, in a way, it creates imbalances.”

The increased politicization of global health agendas has also led to more stalemates, stand-offs, and bitter member state confrontations, leading to more voting as well,  Burci noted. This year’s 79th session is likely to continue that trend. 

Political disagreements stall proceedings in a committee of the 78th World Health Assembly – sharp political divides will continue this year.

This session there will likely be the perennial debates over Taiwan’s WHA participation as a WHA  observer, including a draft resolution submitted this year by Belize and about a dozen other countries, primarily Caribbean and Pacific Island states; the health impacts of Russia’s war on Ukraine; and two overlapping reports on health conditions in the occupied Palestinian territory (OPT) – including one more focused on the immense toll of the recent Gaza war and increasing Israeli military and settler violence affecting West Bank Palestinian communities. 

Adding yet another conflict to the fraught list, the Gulf Cooperation Council’s member states last week asked the WHO’s Director General to hold a WHA discussion over the impacts of Iran’s recent attacks on the region’s states. The attacks have threatened vital health and water supplies; global trade in energy, fertilizer and medicines; and temporarily halted the operations of the WHO Hub for Global Health Emergencies Logistics in Dubai, the message stated.

“Disruptions to airspace and transport routes may affect the timely delivery of health assistance to countries in conflict or in need. Taken together, these dynamics may place additional strain on health systems globally, particularly in low- and middle-income countries,” the member states noted. 

A preliminary closed-door member state debate over the inclusion of Iran and Taiwan items, which are not on the formal WHA agenda, is thus set to consume most of Monday morning, on opening day. 

Responding to the US and Argentina withdrawal – and its financial fallout

The United States' withdrawal from the WHO left the organisation with a huge funding gap.
The United States’ withdrawal from the WHO left the organisation with a huge funding gap.

WHO member states will also debate how to respond to the withdrawal of the United States and Argentina from the member state body last year. 

While both countries view their moves as final, other WHA member states could still refuse to recognize Argentina’s departure – insofar as the WHO constitution doesn’t really make provision for member states to leave.

The sole exception to that is the United States, which made the right to leave a condition of joining the WHA in 1948. But due to the non-payment of some $260 million in outstanding dues for 2024-2025, the US hasn’t legally fulfilled its own set of rules, under which it would withdraw from the global body. And that leaves the WHA response in uncharted waters.  

When the WHO Executive Board discussed the issue inconclusively in February, they did so on the basis of a WHO legal review, which was  “a rather forceful document saying that the conditions for withdrawal have not been met either by the United States or by Argentina,” Burci noted.

Even so, he anticipates that this week “a draft decision at the Assembly that basically acknowledges the withdrawal of Argentina.”  But as regards the US with its unpaid dues, “we’ll see what happens. People are exploring various possibilities to avoid antagonizing unnecessarily important countries… but you cannot kick the can down the road.”

One hint of an approach could be buried in another draft decision also before the WHA. This would “suspend”the  US voting privileges if the back dues are not paid by the opening of the next Assembly in May 2027 – in language that ignores the US announced withdrawal altogether. But in this case, the WHO’s largest member state donor would not be singled out alone. The suspension would likewise be imposed on eight other developing countries with unpaid dues, including: Burundi, Djibouti, Equatorial Guinea, Nigeria, Panama, San Tome and Principe, Timor-Leste, and Turkemistan.

WHO’s finances and global architecture reform

WHA members will also hear more about the state of financial play at WHO following the agency’s dramatic budget rollbacks that followed the departure of the US, until then the WHO’s largest member state contributor.    

The good news is that following reductions of nearly a quarter of its workforce, WHO’s $4.2 bilion budget for 2026-27 is now 90% funded, according to a report by the Director General to the member state Planning and Budget Committee (PBAC), which met just ahead of WHA. At the same time, the figure includes $739.8 million in projected resources from commitments that have not yet been definitively secured, the WHA report notes.

Meanwhile, WHO and other global health institutions have yet to respond actively to the challenges posed by the larger global health funding squeeze faced by low-and middle-income countries in an era of sharply declining aid contributions by major donors, including the United Kingdom and Germany, as well as the USA.  

And increasingly, donors as well as developing countries have clamored for reforms in the way global health and aid programmes are organized and managed. Developing nations want to restore national “sovereignty” over health systems – while donor nations, under increased budget strains of their own, want to make programmes more financially self-sustainable over time.

Hanan Balkhy at the WHA stage-setter on Sunday.

 “The language that … I’ve been using in the past two years with my member states, is: How can I help you get rid of us? How can I help you not need us anymore?” said Hanan Balkhy, Regional Director of the Eastern Mediterannean Regional Office, a keynote speaker at the Graduate Institute event. Balkhy has also been mentioned as a potential candidate in the elections of the next WHO Director General in 2027 – and her carefully calibrated remarks, moving from regional to global challenges did not dispel that impression.

“We are living through the most significant reconfiguration of the multilateral system since the inception in 1945 and let’s be honest, if we were designing the global health architecture today, its mandates, financing structures, and governance arrangements, we would build it differently,” said Balkhy, arguing for a kind of back-to-basics approach where global institutions refocus on “norms and standards, surveillance, emergeny preparedness and equitable access to innovation,” while countries regain control over their own national priorities and service delivery.

“The old order is not coming back. We should not mourn it. Nostalgia is not a strategy.”

WHA initiative on global health architecture reform ‘lacking ambition’ 

Proposal for joint WHO-UN reform process of global health architecture before WHA lacks ambition – John Arne Røttingen, CEO Wellcome.

This week the Asssembly is due to review and approve a joint UN-WHO process to support review and reforms in the “global health architecture” .  It represents the first formal WHO foray into the much-hyped ‘global health architecture’ arena – one which has already spawned its own new acronym – GHA.  

But the WHO initiative lacks ambition in terms of actually taking a hard look at the institutional mandates and how they could be streamlined, said Wellcome’s CEO, John-Arne Røttingen, also speaking at the GHC event. He noted that the WHA mandate doesn’t extend to any serious examination of the oft-competing roles and responsibilities of the UN’s global health institutions. These institutions include not only the WHO, but also UNAIDS, UNICEF, UNDP, UN Women, and the UN Population Fund (UNFPA).  

“I am concerned about the risk being that we are not bold enough, really, and that we become incremental instead of going for bolder reforms,” Røttingen observed. “I’m really concerned about the current drafted mandate for the joint WHO process, because it’s really, from an architecture point of view, about changing the wallpaper and the colors of the painting.

“It’s clearly said that the process should not look at roles and responsibilities for the individual organizations, it should not propose any institutional change across organizations. In a way that takes out all of the ambition of the process,” he said, then issuing a challenge to: “member states in the room, you still have five days to fix that – go ahead.”

Reforms also need to go far beyond the UN and the global health sector 

Reforms to foster ‘health sovereignty’ need to go beyond the health sector, said Magda Roballo (right), co-chair of the UHC 2030 Steering Committee.

At the same time, reforms need to go far beyond making global health institutions more efficient. They need to ensure that national health systems regain “sovereignty” over their health services in terms of both financing and programmatic control, pointed out Magda Roballo, co-chair of the UHC 2030 Steering Committee, also speaking at the GHC event. 

And that can only happen through bigger changes in trade, debt structures, and employment.  

“The health ecosystem depends on structures that have been built over eighty years,” she noted, “and they all have a major influence on health. If we don’t look into the bigger picture, that’s a very high risk to health reform,” she said. 

“It is true that as health agents we don’t have the power to change what is going to happen in the fiscal and the financial space, but we need to interact with the reforms in the global financial architecture and the UN 80 initiative, if we are going to change what is the landscape for the future of the health sector.”

Speaking later to Health Policy Watch, Roballo cited the dominance of informal labor systems in Africa and other LMICs, and related to that, outflows of untaxed revenues and capital from industries and commerce as key issues. These, in turn, are closely tied to global trade and tax policies and norms, as well as financing frameworks. 

“There is no way we can generate domestic resources and break the cycle of dependency if we are not able to reform the financial system,” she said. 

”There is more money that goes out of our continent than what comes in as ODA, which means there is money,” she said.  “We just need to find better ways of using that money, generating more money, fresh money, not just recycling, in order to invest in our health systems,” she said. 

“You’re talking about intellectual property, about market forces that don’t make it easy for Africa to build its own industries, and then be able to generate not only employment but locally produced goods, rather than spending money importing things that we can produce locally.

“It’s a matter of Health sitting in [meetings of] Foreign Affairs because they understand that health is an important foreign relations topic, … and in finance, security and other platforms.” 

Health sovereignty, yes, but we can’t really do it alone? 

While health ‘sovereignty’ is a popular slogan, countries remain interdependent – Suerie Moon, GHC Director.

More profoundly, both rich and poor nations still have to come to terms with the fact that while health ‘sovereignty’ is an increasingly popular slogan today in many nations, countries remain deeply interdependent in terms of the health security everyone craves, added GHC Director Suerie Moon, at the event. 

And this requires cooperation on almost every front – from the financing of health systems to the health products nations produce and consume, the capacity to conduct surveillance, research, and collaborations that protect everyone better from disease threats. 

“COVID kick-started this move towards “health sovereignty,” and recent events have made some hit the accelerator,” she said. “However, the desire for health sovereignty is bumping up against the hard reality of health interdependence. No country can fully protect the health of its people on its own. 

“Just two recent examples illustrate how. The closure of the Strait of Hormuz is disrupting supply chains for lifesaving pharmaceuticals and humanitarian assistance. It also means fertilizers will not reach many farmers during planting season, creating acute food insecurity for 45 million people. A war taking place in one region is posing new challenges for health worldwide.

“As a second example, passengers and crew of the MV Hondius where the hantavirus outbreak occurred, were of 23 different nationalities. Efforts to repatriate them and contain the outbreak have involved around 30 [countries]. Within a short timespan, this outbreak on a single ship directly affected the Americas, Africa, Europe, and Asia.

“Both of these examples remind us that countries cannot address health threats without relying somewhat on others. The paradox is that health sovereignty can only be achieved by strengthening how we govern health at the international level.”

–Updated 18 May.

Image Credits: @WHO African Region, BBC, Diana Jalea, GHC , Anonymous/HPW, Health Policy Watch .

The outbreak of Ebola in the Democratic Republic of Congo (DRC) may be “a much larger outbreak than what is currently being detected and reported, with significant local and regional risk of spread”, the World Health Organization (WHO) warned on Sunday. 

The WHO declared the outbreak a public health emergency of international concern (PHEIC) on Saturday, confirming that it involves the Ebola species, Bundibugyo virus disease (BVD). There is no vaccine or treatment for BVD, and a high case fatality rate of 30-50%.

By Saturday, there were 336 suspected cases and 87 deaths, 13 of which had been confirmed as BVD, according to the Africa Centres for Disease Control and Prevention.

Very high risk of spread in DRC

Africa CDC warned that the risk of spread within the DRC was “very high” as a “four-week detection delay” had enabled “extensive uncontrolled community transmission”.

It also said the risk for East Africa is “high”. The outbreak is likely to have originated in the Mongbwalu health zone of DRC’s Ituri province, a high-traffic mining area on the borders of South Sudan and Uganda, which “increases the risk of regional exportation and cross-border transmission”, according to the WHO.

Two laboratory-confirmed cases (including one death) with no apparent link to each other were reported in Kampala in Uganda, late last week, involving two people travelling from the DRC.

Meanwhile, insecurity and conflict in the DRC are “restricting surveillance and rapid response operations”, Africa CDC noted.

While there are no approved vaccines or therapeutics, Africa CDC said its research team is studying the candidate vaccine, Ervebo, and potential treatments including “DP134, Remdesivir, Opaldesivir (oral form), and monoclonal antibodies”.

It also warned that while national and regional stocks of personal protective equipment (PPE) are “sufficient to cover existing demand patterns”, if transmission increases, countries will need to import new PPE and the lead time for this is six to eight weeks.

Why ‘public health emergency’?

“Response measures include deployment of rapid response teams, delivery of medical supplies, strengthened surveillance, laboratory confirmation, infection prevention and control assessments, the set-up of safe treatment centres, and community engagement,” the WHO said in a statement issued on Sunday.

WHO Director-General Dr Tedros Adhanom Ghebreyesus said that the outbreak meets the criteria of the definition of PHEIC in terms of the International Health Regulations as it is “extraordinary”, constitutes a public health risk to other countries and “requires international coordination and cooperation to understand the extent of the outbreak, to coordinate surveillance, prevention and response efforts, to scale up and strengthen operations and ensure ability to implement control measures.”

The “extraordinary” nature of the outbreak includes “unusual clusters of community deaths with symptoms compatible BVD”, and the high positivity rate of the initial samples collected (eight positive out of 13 samples).

The WHO is in the process of convening an emergency committee under the provisions of the IHR, “as soon as possible” to advise affected countries on how to respond to the outbreak.

The final passengers were evacuated on Monday from the MV Hondius, the cruise ship affected by a hantavirus outbreak while it crossed the South Atlantic.

The World Health Organization said Friday it is embarking on a plan to coordinate studies in more than 20 countries to “better understand the natural history of the disease” following an outbreak of the Andes strain of the hantavirus linked to the cruise ship MV Hondius. 

While stressing that the risks to the public remain low, officials also warned that more infections could still emerge during a six-week long incubation period.

Speaking at a press briefing, WHO Director-General Tedros Adhanom Ghebreyesus said the agency’s “current priorities are to continue to better understand the epidemiology of the Andes virus, including how this outbreak began and spread,” adding that WHO is “working with more than 20 countries to coordinate studies to better understand the natural history of the disease.”

More needs to be understood about potential human-to-human modes of transmission of this particular species of hantavirus, he and other WHO officials at the briefing acknowledged. While hantavirus is usually transmitted by rodents, the Andes species can be transmitted between people. But key questions remain regarding modes of virus transmission and the length of time that an infected person could remain infectious to others, even after testing negative for the virus. 

So far, the outbreak aboard the ship that emerged as it traveled to Antartica and then across the Atlantic, seems to have been contained, Tedros said, noting that “The response to the Hantavirus outbreak is a recent prime example of what can happen when the world comes together to confront a disease threat.”

Risk to public remains low, says Dr Tedros Adhanom Ghebreyesus at the WHO briefing Friday on hantavirus.

Ten cases to date – but more could emerge during six-week incubation

As of Friday, a total of 10 cases, including three deaths, have been reported to WHO,  including “eight people who were laboratory-confirmed for Ande’s virus infection, and two probable,” the Director Genera reported

The operation to repatriate the ship’s remaining passengers who disembarked Monday at the port of Tenerife, in the Canary Islands, has been completed, with “more than 120 people now being cared for – all in their home countries or quarantined in host countries en route to their final destination.” 

Route of the infected cruise ship Hondius across the Atlantic.

Some 26 crew members and captain are still on board, but “there are no symptomatic persons on board as of today” Tedros observed. The ship is sailing to the Netherlands where the crew is due to disembark on Monday. 

More cases may be still reported in coming days as passengers are quarantined and tested in specialized facilities or at home, Tedros warned, but he added, “This does not mean the outbreak is expanding. It shows that the control measures are working, that laboratory testing is ongoing, and that people are being cared for with support from their governments.”

He and other WHO officials at the briefing stressed that the risk from this outbreak to the global population is low, even as investigations continue into possible human-to-human transmission aboard the vessel as well as prior to its early April departure from the port of Ushuaia, Argentina, on what was supposed to be a routine a sightseeing cruise hopping from Antartic glaciers to a string of tropical islands off the coast of West Africa.

Outbreak likely began with infection before the ship left Argentinian port

Maria Van Kerkhove, Director Epidemic and Pandemic Management

Maria Van Kerkhove, WHO Director for Epidemic and Pandemic Management, said there was “some evidence” of human-to-human transmission in the closed confines of the ship  “particularly between a husband and wife, between the ship’s doctor and a patient.”

She said WHO’s “working hypothesis is that the outbreak began with infection prior to the disembarkment of the ship.”

Van Kerkhove said all passengers and crew were being treated as “high risk” contacts because “we simply don’t have all of the answers yet.” WHO has recommended 42-day quarantines for everyone aboard the ship because “people could be infected and not know it.”

She also confirmed that the third death linked to the outbreak was “an older woman who did die on board on the second of May,” and that testing in the Netherlands later confirmed she was positive for the virus.

Genome sequences of the virus from infected patients have been analyzed in labs in South Africa, Institut Pasteur in Dakar, Senegal and at the Geneva University Hospital, Van Kerkhove said, adding that the United States Centres for Disease Control and Transmission (CDC) has also been involved. None have identified significant mutations in the virus of the sort that occurred in the SARS virus, kicking off the COVID pandemic: 

“I am not a virologist, but what they are telling me is, and what they have said is, that they haven’t identified any changes to suggest a change in the virus to make it more transmissible, more severe, or anything like that,” Van Kerkhove said.

“But what we do hope, actually, is to have more samples coming from rodents, so that we can look at the sequences within the rodents themselves, and do a deeper analysis understanding the circulation of this virus, particularly in South America, disentangle  how circulation happens, and how we can prevent spillover and outbreaks from happening in the future.” 

No WHO hantavirus emergency committee so far

To date, there is no need to convene a WHO emergency committee on the outbreak: Abdirahman Mahamud, Director Health Emergency Response Operations.

Since the outbreak has so far been contained, and no dangerous virus mutation has been identified, WHO has not called for an emergency meeting of hantavirus experts, said Abdirahman Mahamud, Director Health Emergency Response Operations. Convening an emergency committee would be a required step to any WHO declaration of a global public health emergency, 

“We will do regular updates and risk assessments, should something change, should the DG need to trigger the mechanisms that he has to convene an emergency committee,” Van Kerkhove added. 

Even so, two noted global experts, Ellen Johnson Sirleaf and Helen Clark, co-chairs of The Independent Panel for Pandemic Preparedness and Response, which in 2021 evaluated the global response to COVID-19, last week called for review of how the outbreak had been handled in its preliminary stages aboard the ship.

“A review should determine whether a more precautionary approach could have been applied pursuant to the guidelines in the WHO Handbook for Managing Public Health Events on Board Ships,” said the two women in a statement, adding that the hantavirus outbreak has “tested the international system” demonstrating both its strengths and gaps. 

New Ebola virus outbreak in the Democratic Republic of Congo

Separately, Tedros announced a new Ebola outbreak in the northeastern Ituri province of Democratic Republic of the Congo, with 13 confirmed cases so far. It is the country’s 17th recorded Ebola outbreak since 1976.

Tedros said WHO had released $500,000 from WHO contingency fund for emergencies to immediately support the response,” including “risk communication and community engagement, strengthening disease surveillance, active case finding and contact tracing.”

WHO Africa Regional Director Mohamed Yakub Janabi said the outbreak area was “a very densely populated area” with “population movement linked to mining and cross-border trade,” which “naturally increases the transmission rate.”

WHO officials said they were still awaiting confirmation of the Ebola strain but noted that vaccine protocols and emergency response systems were already being prepared.

See related hantavirus coverage here:

https://healthpolicy-watch.news/review-of-global-outbreak-response-as-all-passengers-leave-hantavirus-hit-ship/

Image Credits: Franklin Braeckman/Oceanwide Expeditions , BBC, El Pais/OpenStreetMap.

Despite sharply rising levels of diabetes, access to diagnosis and basic treatment tools remains sharply limited in developing countries.

On the five-year anniversary of the Global Diabetes Compact, WHO has issued a call to manufacturers to submit requests for “prequalification” of generic versions of the GLP-1 drug semaglutide for diabetes management – the drug that initially became famous for weight-loss – as well as fast-acting insulin analogues that have gained popularity over human insulin in recent decades. The call is part of a broader initiative to accelerate access to life-saving diagnosis and treatment which remains out of reach for most people living with diabetes in low-and middle-income countries.  

It was only when Selasi Hormenoo was hospitalized in Accra Ghana’s Regional Hospital in a coma in 2021 that doctors finally diagnosed her Type 1 diabetes – just in time to save her life. 

The university student had been in and out of clinics and smaller hospitals for a variety of infectious diseases as well as chronic conditions. Following a mistaken diagnosis with Type 2 diabetes, she was put on insulin for a while. But when the medication ran out, she didn’t try to get it refilled. Astonishingly, no one had even explained to her that diabetes is a lifelong condition. 

Selasi Hormenoo, Ghana diabetes activist.

“The diagnosis, in a way, was a blessing,” says the young woman, now 25 and a peer mentor for others living with the condition. I no longer have to be consistently in the hospital for any minor issue.”

But until last year, when Ghana included soluble human insulin into the National Health Insurance Scheme basket of free medicines, she was spending about $200 a month for insulin drugs appropriate to her type 1 condition. And even now, she can only access newer, rapid-acting insulin analogue products, which she finds more convenient to use, through donations – when they are available. 

Milestone moves to expand access to diabetes treatment   

This week, in milestone moves, WHO published a call to generic manufacturers of both rapid-acting insulin analogues and the  GLP-1 diabetes control drug semaglutide,  to submit their products for “WHO Prequalification” – a global standard of quality control. Although the drug has gained fame as an obesity and weight loss medication under the brand name Ozempic®, the WHO call is specifically for the prequalification of formulations to support diabetes management. 

WHO “Prequalification” of products by manufacturers aims to help pave the way for mass procurement of generic versions of the treatments in low- and middle countries, signalling quality assurance of the manufactured product to global and national procurement agencies.    

And those moves aim to help dramatically expand access to improved diabetes treatment across low- and middle-income countries (LMICs). 

“The burden of diabetes falls disproportionately on people with the least access to diagnosis and treatment. Increasing the number of quality-assured manufacturers can help reduce barriers to access and support more equitable diabetes care globally,” said WHO’s Alarcos Cieza, who heads the WHO unit on Management of Noncommunicable Diseases (NCDs).  

The moves coincide with the five year anniversary of the Global Diabetes Compact agreed upon by the World Health Assembly (WHA) in 2021.

The Compact’s targets, subsequently endorsed by WHA in 2022, aim to achieve by 2030 80% coverage for diabetes diagnosis, glycaemic and blood pressure control – along with 60% use of statins to reduce the risks of cardiovascular disease from high cholesterol.  And 100% of people living with type 1 diabetes, the most life-threatening form, should have access to affordable insulin and self-monitoring tools. 

World far from reaching diabetes diagnosis and treatment goals

Adults living with diabetes – most of those lacking access to diagnosis and treatment are in developing countries.

The world remains far from those goals – while reaching the undiagnosed a huge challenge. An estimated 830 million adults over the age of 18 were living with diabetes in 2022, up from 200 million in 1990, according to a joint study by WHO, Imperial College and the NCD Risk Factor Collaboration (NCD-RisC), published last year in The Lancet. Using different methods of assessment, the International Diabetes Federation estimated that some 589 million adults aged 20-79 years, were living with the condition in 2024 – one out of every nine adults. Roughly 43% of those adults were undiagnosed with 90% of the undiagnosed living in low- and middle-income countries, according to the IDF analysis.

And while diabetes prevalence was once higher in wealthier nations, it is now rising most rapidly in low- and middle-income countries, The Lancet study found. Obesity, a leading risk factor for diabetes, also is accelerating in developing countries, even while it has plateaued in high-income countries, according to another study published this week in Nature. 

Yet in those same countries, insulin products remain unaffordable if available at all. Comparatively newer GLP-1s, such as semaglutide, which help reduce obesity and other health risks for people living with type 2 diabetes, are even harder to come by in Ghana, notes Hormenoo, who works as a peer mentor with Diabetes Youth Care, a Ghana-based non-profit.

While GLP-1s are not usually recommended for type 1 diabetes – those people Hormenoo knows who are living with type 2 find the products “extremely inaccessible.” 

Just one semaglutide pen costs around $500 in Accra, meaning that monthly costs for the weekly injections can amount to $2000 or more. 

“GLP-1s are almost unknown – the knowledge that people do have is more around celebrities using it for weight loss,” she concludes.

Explosion in generic manufacture may lead to change

Nature NCD Risk Factor Collaboration (NCD-RisC): Obesity incidence is now growing more rapidly in low- and middle-income countries, while it has plateaued in many higher-income countries.

But the recent expiration of the core patent for the weight-loss drug Semaglutide in India, China and Brazil in March may signal a big change for Africa as well. Domestically, the patent expiration has already led to expanded generic production in countries that are drug manufacturing as well as export powerhouses. And therein lies the role of the WHO prequalification of that and other products, to ensure that the products purchased and sold are quality-controlled. 

“WHO Prequalification does not re-evaluate whether semaglutide works or is safe –  that has already been established through clinical trials, subsequent approvals by stringent national regulatory authorities and confirmed by its inclusion on the WHO Essential Medicines List,” said WHO’s Bianca Hemmingsen, technical lead for diabetes.

“What WHO Prequalification assesses is whether a specific [generic] manufacturer can produce semaglutide at the required quality standard. The WHO invitation to manufacturers opens a pathway to apply for prequalification of GLP-1 receptor agonists, specifically semaglutide, for the first time.”

Semaglutide was added to the WHO Essential Medicines List in 2025 

The new generation of obesity drugs reached sky-high popularity – and prices. Now, with the opening of generic competition, that is changing.

Semaglutide was originally developed by Novo Nordisk under the brand name of Ozempic®, and approved for diabetes management about 20 years ago, says Hemmingsen. Last year, it was added to WHO’s Essential Medicines List for diabetes management, in recognition of the drug’s documented benefits.  

The medication, part of a family of glucagon-like peptide-1 receptor agonists (GLP-1 RA) drugs, mimics the natural incretin hormone GLP-1, lowering blood sugar, slowing stomach emptying to increase satiety, and reducing appetite.  While the drug and similar formulations have recently gained fame for weight loss, the medication improves glucose control and thus diabetes management; related cardiovascular health and blood pressure conditions; and is being studied for neuroprotective effects.

“It’s a very welcome step, we believe it will allow more access to more markets than the generic manufacturers had until now, presuming they meet the technical qualifications and standards,” said Dr Nikhil Tandon, professor and head of the Department of Endocrinology and Metabolism at the All India Institute of Medical Sciences in New Delhi, of the WHO moves.  

“Generic manufacture of GLP-1 has already dramatically brought down the price in India,” by as much as 80%, said Tandon. Indian manufacturers were “ready to launch” generic versions of the drug in late March, the day after the patent expired. 

Nikhil Tandon, All India Institute of Medical Sciences

Now, the WHO prequalification process should provide a gateway for manufacturers to export more easily to other low- and middle-income countries –  where national regulatory processes may be weaker and slower to take up new products.  Recent research has meanwhile projected a worldwide price drop as a result of the shift to generics. 

Although generic sales in developing countries may soon begin to boom, secondary patents for the drugs will continue to protect the brand-name drugs from generic competition in the United States and Europe until around 2031-2032.

WHO process may also expand access to rapid-acting insulin analogues 

Insulin supplementation traditionally administered through a vial and syringe. Newer products in ready made cartridges with pens can make use easier.

While semaglutide may be headline-grabbing, Tandon is also hopeful that the global manufacture of insulin will also increase through the expanded WHO Prequalification insulin track, which now includes rapid-acting analogues in both vial and cartridge forms. 

Just three large pharma firms, Novo Nordisk, Eli Lilly and Sanofi still produce more than 90% of the world’s insulin. 

Smaller manufacturers based in China, India and elsewhere are gradually scaling up production, including of popular insulin analogues which have now been off patent for some time. But breaking into new export markets remains difficult, something that makes the WHO prequalification call timely, observes Tandon, who sits on a WHO Technical Advisory Group for Diabetes.  

“In India, a drug price control order already makes insulin much cheaper than products sold in many other parts of the world,” Tandon.  But in many low-income countries, conventional human insulin remains difficult to access – while analogues can be almost impossible.  

“If the products of manufacturers are based in lower income countries are prequalified by the WHO, this will allow many countries to access insulin at much cheaper rates than those sold by other manufacturers,” Tandon said. “With WHO prequalification, it helps cut through some of the steps of the [country’s] regulatory process.” 

While Tandon still regards human insulin as largely equivalent in terms of clinical benefits for the type 1 diabetes patients who need it the most, newer analogues also offer some “nuanced” benefits in the case of risks of night-time or severe hypoglycemia, he said.  

Notably, users tend to find them “more convenient” because they can be taken just a few minutes before meals, as compared to human insulin, which requires more advance planning. 

In the updated WHO call, it is these rapid-acting insulin analogues that are a new addition; the rest of the analogues were already listed for WHO prequalification. 

But Tandon is hopeful that this new addition of these very popular, rapid-acting formulations could make a difference, stimulating more manufacturing interest and leveling the playing field “with good and sound technical targets. With the number of players available, I think access to markets will perhaps increase and it will bring prices down.”

Marketing surveys show growth of manufacturing capacity 

Benefits of using insulin pens instead of syringe and vial. But such pens, as well as fast-acting analogue insulin, remains harder to access in LMICS.

Not only in India, but worldwide, the number of companies manufacturing generic versions of semaglutide appears to be expanding rapidly, while the manufacture of insulin products may finally be on the upswing too.  

A survey of manufacturers of semaglutide conducted earlier this year by WHO in collaboration with the University of Geneva, identified more than 80 companies  marketing or registering new generic GLP-1 formulations across 11 countries including: Argentina, Bangladesh, Brazil, Canada, China, India, Indonesia, Laos, Pakistan, Paraguay, and Russia. The bulk of production, particularly for injectable formulations (such as prefilled pens and syringes) as well as oral forms, is concentrated in India and China.

In February, WHO convened an insulin manufacturers’ dialogue.  Some  28 insulin manufacturers joined the meeting – more than even the WHO team had heard about previously.  

Collaborative Registration Procedure another gateway to increasing access

The WHO Collaborative Registation Procedure is complementary to the Prequalification process in terms of expanding product access.

As production and export of new diabetes products expands to more low- and middle-income countries national regulatory authorities still face challenges in reviewing and approving the drugs and devices – even if their producers have been approved by the WHO prequalification channel.

“This is due to the often limited capacity to assess complex biological medicines. And there are additional complexities for those delivered in delivery systems like injection pens, which require evaluation of both the product and the device,” Hemmingsen notes. 

So along with the prequalification process, which can single out quality-approved manufacturers, WHO is also encouraging low- and middle-income countries to take advantage of another tool, called the Collaborative Registration Procedure (CRP), which can support more rapid national regulatory evaluation and approval. 

“The goal is to avoid duplication of effort,” stressed Hemmingsen.  “If a product has already been rigorously assessed, countries should not need to start from scratch. This is particularly important for LMICs where regulatory capacity often is limited.”  

This process can work through two complementary pathways, she explains: 

  • If the product of a particular manufacturer has been “prequalified” by WHO, countries can reliably use that assessment as the basis for expedited national registration via the CRP. 
  • If a product has been approved by another stringent national regulatory authority – that  recognized as such as a “WHO Listed Authority”, other countries can rely upon that country’s regulatory approval to fast-track their own.   

Current WHO-listed Authorities that participate in the WHO CRP process include the European Medicines Agency, SwissMedic, the United Kingdom’s MHRA, TGA Australia and, most recently, Health Canada. 

“Both pathways reduce the regulatory burden on under-resourced national authorities and accelerate the journey from manufacturer approval to patient access,” observed Hemmingsen. 

Together, the combined processes should help expedite access of quality-controlled products to more markets than generic manufacturers have had until now, leading to eventual price reductions and more access – along the lines of the 2030 goals. 

For Hormenoo, the young woman living with diabetes in Ghana, her diagnosis and regular access to insulin has been nothing short of transformational. From being chronically ill, and in and out of hospitals, she has completed university, national service, and is now hunting for a job.  

“It’s still hellish walking in the sun and I can’t go to the beach at all,” Hormenoo notes, referring to the nerve damage she suffered before she began regular insulin treatment.  “But the diagnosis has really helped with my quality of life – having uninterrupted education and being able to work, has been a major upgrade for me. I can confidently go out into the corporate space.”

And as Tandon puts it: “Every single person with type 1 diabetes should have access to insulin and monitoring equipment. It’s critical, because there is no other way of putting it politely, people who have Type 1 diabetes and who don’t have access to insulin will die.”

Image Credits: isensusa/Unsplash, Nature , Chemist4u, WHO, MSF, WHO Special Access Programme, Regulation and Safety Unit.

WHO experts Dr Ranti Fayokun and Dr Vinayak Prasad demand strict global nicotine pouch regulations.
WHO experts Dr Ranti Fayokun and Dr Vinayak Prasad demand strict global nicotine pouch regulations at a press conference.

The World Health Organization (WHO) has called on governments to strictly regulate nicotine pouches to prevent an imminent epidemic among vulnerable adolescents. These highly addictive products threaten to dismantle decades of global progress in tobacco control if left completely unchecked, health officials warn.

Faced with declining cigarette sales, tobacco companies continuously release new product lines, expanding their portfolios to include vaping products, heated tobacco, and nicotine pouches. While the industry promotes these pouches as tools to help adults quit smoking, public health experts argue that companies deliberately target children to draw in young generations.

According to the WHO’s first-ever report on nicotine pouches, published Friday, retail sales volumes skyrocketed past 23 billion units in 2024, reflecting a 50% increase from the previous year. The global market valuation subsequently approached $7 billion by 2025. Sales are largely driven by North American consumption, with a revenue share of almost 80%. Sweden leads the per person use globally.

Aggressive marketing of nicotine pouches

A global regulatory void leaves 160 states without specific frameworks to govern nicotine pouch sales.
A global regulatory void leaves 160 states without specific frameworks to govern nicotine pouch sales.

Only 32 countries and territories, including Canada and Colombia, actively regulate nicotine pouches, while 16 more have banned their sale. Conversely, roughly 160 states currently lack specific regulatory frameworks.

This legislative void enables manufacturers to deploy aggressive marketing tactics with sleek packaging, vast social media influencer campaigns, and candy-inspired flavours without restriction. Digital algorithms promote these deceptive products across platforms heavily frequented by teenagers.

“With nicotine pouches, tobacco companies have added a new item to their menu of addiction,” explained Jorge Alday, director of STOP at Vital Strategies, in a statement to Health Policy Watch, commenting on the report.

‘Harms are well documented’

Varied nicotine concentrations across major tobacco brands highlight the wide range of potency in pouches.
Varied nicotine concentrations across major tobacco brands highlight the wide range of potency in pouches.

Sustained nicotine exposure significantly increases cardiovascular risks by stimulating the sympathetic nervous system, explained Ranti Fayokun, author and coordinator of the WHO report, presenting the report on marketing of nicotine pouches. This chemical reaction releases adrenaline, which subsequently elevates heart rates and constricts blood vessels. Crucially, early nicotine exposure damages adolescent brains that are still actively developing.

While a study of various nicotine pouches found a median content of 9.48 milligrams per pouch, toxicological testing reveals extreme chemical concentrations in certain brands, with some tiers reaching up to 150 milligrams of nicotine. If a young child were to ingest these packages, the acute dose could easily prove lethal.

“The harms of nicotine are very well documented,” underscored Vinayak Prasad, unit head of the WHO’s Tobacco Free Initiative.

WHO urges strict regulation and tax increases

WHO’s recommended regulatory pillars: flavor bans, advertising restrictions, tax increases, and closing legislative loopholes.
WHO’s recommended regulatory pillars: flavour bans, advertising restrictions, tax increases, and closing legislative loopholes.

To mitigate risks and reduce addiction among adolescents, the WHO insists that policymakers establish strict flavour bans that specifically target youth-oriented options, such as bubble gum and alcohol-inspired varieties like Mojito, Cosmo, and Gin & Tonic. Furthermore, comprehensive advertising restrictions must explicitly prohibit the use of social media influencers and sports sponsorships.

The agency also calls for prominent health warnings and plain packaging to counter the sleek, deceptive designs currently dominating the market, and taxation must increase substantially to reduce overall market affordability, the experts demand. To mitigate the risk of severe dependence, regulators must implement strict caps on the maximum allowable nicotine content per pouch.

States with regulations and prohibitions in place should strictly enforce their existing mandates. Legislative loopholes must be closed that allow synthetic nicotine, as manufacturers increasingly use lab-made nicotine and analogues to evade existing laws.

Health officials emphasise that “nicotine is nicotine”, noting that synthetic variants carry the same addictive properties and must be regulated uniformly alongside tobacco-derived products. “These products are engineered for addiction, and there is a strong need to protect our youth from industry manipulation,” underscored Etienne Krug, director of the Department of Health Determinants, Promotion and Prevention at the WHO.

Global Anti-Tobacco Summit Targets Youth Nicotine Addiction ‘Epidemic’ and Environmental Harms

Image Credits: WHO, Felix Sassmannshausen/HPW.

Protests against fossil fuel lobbyists at COP30 in Bélem, Brazil, likening them to having the tobacco industry at a health conference.

Just as health leaders reframed tobacco from a consumer product to a public health threat, they can now help shift the narrative on fossil fuels.

In the coming days, the annual World Health Assembly will convene in Geneva. Following the recent Santa Marta Conference on Transitioning Away from Fossil Fuels, national health ministers and global health leaders have both an opportunity and responsibility to address the root cause of the climate-induced health crisis: fossil fuels.

The Santa Marta conference addressed the need to transition away from fossil fuels, the root cause of climate change. Fifty-seven countries, representing one-third of the global economy, committed to developing roadmaps to end fossil fuel use, marking an important step toward protecting public health and the climate.

Santa Marta demonstrated growing momentum beyond traditional climate negotiations. While the UN climate COP process remains essential, countries increasingly recognize that progress has been too slow given the escalating impacts of climate change and health. The next Santa Marta conference, hosted by Tuvalu and Ireland in 2027, will provide a key opportunity to strengthen international cooperation on phasing out fossil fuels.

Fossil fuel combustion constitutes the biggest public health emergency of our time

Heavy-Duty trucks and buses spew out soot, including climate-changing black carbon and health harmful PM2.5 on a highway.

Climate change is not only an environmental issue; it is a public health emergency. Fossil fuels are not just an energy source; they are harmful to health. Despite this, health was largely overlooked – the final Santa Marta conference text had no mention of health. The health community must raise a clamour to ensure that future climate negotiations take our health into consideration.

Fossil fuels harm human health throughout their lifecycle, from extraction and refining to transport, combustion, and petrochemical production. They pollute air, water, and soil; drive extreme heat and food insecurity; worsen respiratory and cardiovascular diseases; and contribute to millions of premature deaths each year. Frontline communities near extraction sites, refineries, highways, ports, and petrochemical facilities face disproportionate risks of toxic exposure, cancer, displacement, and economic disruption.

The world is already experiencing the consequences of the fossil-fuel-driven climate crisis. Last month, temperatures in parts of South and Southeast Asia reached 45 to 46°C, making outdoor work unsafe and pushing the limits of human survivability. Floods, wildfires, storms, crop failures, and infectious disease outbreaks are increasingly overwhelming health systems worldwide.

Subsidizing the sale of products that harm human health 

Ending fossil fuel subsidies would be one of the most effective global public health interventions ever, also averting 1.2 deaths a year from air pollution.

Yet governments continue to subsidize the very products causing this harm. In 2024 alone, fossil fuels received an estimated US$725 billion in public subsidies, even as air pollution, much of it from fossil fuels, costs the global economy about US$8.1 trillion annually in healthcare expenses, lost productivity, and premature deaths. From a public health perspective, this contradiction is stark: governments are using public funds to subsidize disease, death, climate disruption, and increased pressure on already overburdened health systems.

The true cost of fossil fuels remains obscured because health harms are treated as “externalities.” But asthma, strokes, heat deaths, cancers, pregnancy complications, and polluted drinking water are not externalities; they are direct and devastating impacts. When these costs are fully accounted for, fossil fuels are no longer economically rational. They are a dangerous and outdated relic.

Following the example of Tobacco

Six out of ten smokers, or 750 million people globally want to quit tobacco use.

For decades already, the health community has carried the weight of responding to the symptoms of the climate-induced health crisis while often avoiding its primary cause. This must change.

And yet, the health community has both the moral authority and institutional capacity to speak to the impacts of fossil fuels directly. Just as health leaders reframed tobacco from a consumer product to a public health threat, they can now help shift the narrative on fossil fuels.

There is already a clear precedent: the World Health Organization Framework Convention on Tobacco Control (FCTC), the first global treaty negotiated under WHO leadership. The FCTC recognized that protecting health requires more than treating disease; it requires regulating the industry responsible for the harm. We can apply this same approach to fossil fuels.

Tobacco control showed that effective public health action requires conflict-of-interest protections, restrictions on advertising and sponsorship, public education, fiscal measures, warning labels, litigation support, and international cooperation to reduce demand for harmful products. Fossil fuels require a similarly comprehensive response.

Health ministries and the WHO have a critical role in advancing this agenda.

The 78th session of the World Health Assembly in May 2025 – member states passed a Global Action Plan for climate and health.  Ending fossil fuel subsidies would put teeth into that decision.

The World Health Assembly is the world’s highest decision-making forum on health. Resolutions passed in Geneva shape national health priorities, influence financing, guide public health norms, and determine how governments respond to emerging threats.

WHA can guide the WHO Secretariat in advocating for stronger conflict-of-interest protections to limit the influence of the fossil fuel industry in health policymaking and other multilateral processes. They can document the full lifecycle health harms of fossil fuels, plan protective health measures, promote health impact assessments for fossil fuel projects and infrastructure, and support air pollution standards based on current science. They can also champion subsidy reform as a public health intervention and help redirect public finance toward clean energy, resilient health systems, and social protection.

The health community can also help revoke the social license of the fossil fuel industry by clearly communicating that these products are fundamentally incompatible with health protection. This is especially urgent as fossil fuel companies continue to use disinformation, greenwashing, and political influence to delay action, tactics long recognized by the public health community from efforts against other health-harming industries.

At WHA78 last year, countries made progress through the WHO Global Action Plan on Climate Change and Health and commitments to reduce air pollution deaths. However, these efforts will remain incomplete unless governments address the primary driver of both climate change and air pollution: fossil fuels. WHA member states must recognise that fossil fuels are health-harming products, and their phase-out is a public health imperative.

The science is clear, the health evidence is overwhelming, and solutions exist. The question now is whether the global health community is prepared to address the cause of the crisis, not just its consequences.

On May 19th, the Global Climate and Health Alliance and the Office of the United Nations High Commissioner for Human Rights (OHCHR) will co-host Fossil Fuels, Health, and Human Rights – Centering Health and Human Rights in the Global Transition Away from Fossil Fuels where the issue will be discussed. It would be open to attend in person in Geneva and via Zoom.


Dr Jeni Miller is Executive Director of the Global Climate and Health Alliance, a consortium of more than 250 health professional and health civil society organisations and networks from around the world addressing climate change.

Image Credits: Mike Muzurakis IISD/ENB , UNEP, Galen Crout , Sarah Johnson.

Climate change, rising food insecurity and overwhelmed health systems have created a perfect storm for child undernutrition in parts of sub-Saharan Africa.

Philanthropy can help make every dollar deliver more impact.

I often think about a boy I met in Kajiado County, Kenya. He was the same age as my son, but half his weight. A World Health Organization (WHO) colleague measured the circumference of his arm to confirm what was already painfully clear: he was severely malnourished and needed urgent medical care.

He and his mother had walked to a clinic not far from fields of dead animals, victims of prolonged drought linked to climate change. It was one point in a chain of dominoes – failed rains, lost livestock, rising food insecurity, overwhelmed health systems – that would determine whether this child would have the chance to realize his full potential.

As governments reduce aid budgets and global health institutions confront growing financial pressure, it is imperative that we ground ourselves in how our decisions affect lives such as his.

Imperative to turn resources into sustained impact

The current crisis in global health is often described as a crisis of insufficient funding. That is true. But it is also something deeper: a growing imperative to turn resources into sustained impact more effectively.

In the past twenty-five years, global health financing has driven extraordinary progress against infectious diseases. Investments through organizations such as Gavi and the Global Fund cut child mortality in half and saved nearly 100 million lives. Those investments built systems that benefit everyone, from rapid vaccine development during COVID to catch-up immunization campaigns reaching millions of children.

Testing for hypertension. The burden of non-communicable diseases (NCDs) is growing globally, including in low- and middle-income countries.

Over that same period, the global health landscape has changed. Many countries are transitioning from low- to middle-income status and rightly want greater ownership of their own health priorities and systems. The burden of disease is increasingly shifting toward noncommunicable diseases (NCDs) and mental health conditions, whose prevention and treatment depend on strong regional and national health systems.

Identifying, scaling and sustaining what works

In this new environment, the WHO’s role becomes even more important.

WHO’s greatest value is not that it delivers services directly. Its value lies in helping countries identify, scale, and sustain what works: setting evidence-based norms and guidelines, coordinating surveillance and emergency response, convening governments around shared priorities, and supporting countries to adapt global knowledge into effective national action.

In the last year alone, the WHO helped additional countries eliminate neglected tropical diseases; prequalified the first malaria treatment for newborns and infants; and negotiated concrete global targets to control NCDs and promote mental health. In a more fragmented world, this work underscores why trusted global institutions are becoming more – not less – important.

This is also where philanthropy can play a transformative role. Not because philanthropy can replace governments; it cannot. Public financing will remain the foundation of global health. But philanthropy can help improve how all financing is mobilized and used.

Globally, charitable giving represents an enormous source of social investment – roughly $2 trillion annually. (For perspective, that is roughly 100 times larger than government aid for global health.) Yet only a small fraction supports global health, and an even smaller share strengthens the systems required to deliver health interventions at scale.

Some of the most compelling examples of WHO’s role are not always the most visible

Zambia started to roll out the malaria vaccine in December 2025. This baby is being vaccinated at the Lumezi Urban Clinic.

In my experience, mobilizing philanthropic capital requires clear theories of change, measurable outcomes, accountability for results, and the ability to adapt based on evidence. It requires organizations to explain not only what they will do, but why it matters, how progress will be measured, and how local institutions and communities will ultimately sustain impact.

Those disciplines improve the effectiveness not only of philanthropic dollars, but of all dollars invested in global health.

In its first five years, the WHO Foundation raised $214 million from charitable sources, including support from 84 new donors to the WHO, generating $4.40 in commitments for every dollar invested in fundraising. Our experience reinforces a simple lesson: philanthropy responds not only to need, but to clarity, trusted partnerships, measurable outcomes, and the confidence that institutions can deliver meaningful impact at scale.

Some of the most compelling examples are not the most visible.

WHO-supported measles surveillance networks, spanning hundreds of laboratories across more than 190 nations, help countries detect outbreaks early and sustain routine immunization. WHO’s Basic Emergency Care program has trained frontline health workers in low-resource settings to reduce mortality from trauma, sepsis, and shock. WHO’s work on mental health is helping countries integrate care into primary health systems, expanding access where services have historically been absent altogether.

Philanthropy can help accelerate the impact of global health investments

None of these efforts depend on philanthropy alone. But philanthropy can help accelerate them, strengthen accountability around them, drive new evidence, and demonstrate models that governments and national systems can sustain and scale over time.

The closing Plenary session of the 78th World Health Assembly at the Palais des Nations in Geneva, Switzerland, on 27 May 2025.

As global health leaders gather in Geneva for this year’s World Health Assembly, the conversation cannot simply be about how much money has been lost. It must also be about how effectively we use the money that remains – and how we build institutions capable of turning resources into measurable, equitable, and sustainable impact.

I think again of the boy and his mother in Kajiado County.

They do not care whether help comes from governments or philanthropies. They care whether systems work. Whether medicines and vaccines are available. Whether a health worker shows up before it is too late.

Yes, global health needs more money. But it also needs the discipline, partnerships, and institutions capable of turning resources into lives saved — consistently and at scale. In a period of shrinking aid budgets, that may matter as much as the funding itself.

 

Anil Soni is CEO of the WHO Foundation and a global health leader and innovator with nearly 30 years of experience expanding access to healthcare across the public, private, and nonprofit sectors.

Image Credits: Christine Olson/Flickr, WHO Global Report on Hypertension/Natalie Naccache, Temwanani Mtonga/ Gavi, WHO .