Germany’s health minister, Dr Karl Lauterbach and WHO’s Dr Mike Ryan

Amid criticism that the World Health Summit was ‘speed-dating for consultants’, panellists lamented a lack of practical plans to empower local service delivery

A more empowered World Health Organization (WHO), stronger health local systems and better surveillance are some of the weapons that will protect the world against future pandemics, according to panellists at the World Health Summit in Berlin.

“The WHO needs more powers to deal with pandemics. Isn’t there something ridiculous about the fact that the International Atomic Energy Agency can go into a war zone and inspect what’s happening in a nuclear power plant and WHO doesn’t have an absolute right to get visas to go to the site of any outbreak anywhere in the world?” said Helen Clark, the former prime minister of New Zealand and co-chair of the Independent Panel for Pandemic Preparedness and Response. 

She was referring to how China denied WHO-appointed experts access to the outbreak of the pandemic in Wuhan.

“The International Health Regulations need to be made fit for purpose and empowering the WHO on very practical issues like that,” said Clark, who also asserted that “it was not the WHO that failed the world. It is member states that failed the WHO.” 

No one had a plan

Germany’s health minister, Dr Karl Lauterbach, said that when his country assumed leadership of the G7, it was clear that no country had a plan on how to address pandemics. To get a better understanding of the gaps, he convened three informal meetings of scientists.

What emerged, said Lauterbach, were two key consensus points: first, “we are lacking a workforce which is better prepared to recognise a possible pandemic and to avoid that an outbreak becomes a pandemic” and second, a lack of surveillance to identify a pandemic Lauterbach appealed for everything to be geared towards addressing these two crucial needs – and training young people to “get them interested in pandemic control”. 

“We will either spiral upwards or spiral downwards. If we spiral downwards, we will have more climate change, and more pandemics because of climate change. We will have poorer primary health because of climate change and pandemics and we will have more wars because all of this is happening.”

‘Last mile of delivery is first mile of health security’

Dr Mike Ryan, WHO executive director of health emergencies,  agreed that “without data, you’re blind and without a workforce, you have no capacity to act”.

However, he added that “95% of people who survive natural disasters survive because their neighbours and their families dig them out from under a building or pull them out of the water”. 

“That’s exactly the same principle in epidemics. It is local, community-based surveillance, point-of-care diagnostics, the ability to understand there’s a problem in the community and the rapid provision of support to a community before an outbreak becomes a national or global event,” said Ryan.

The “last mile” of health care was also the “first mile of health security” – and often the weakest link.

Describing the health summit as “speed dating for global consultants”, Ryan said that things were very different at the country level where Ministries of Health were “usually underfunded, and the weakest ministry in government”.

“Then we come in with our vertical systems and we start pushing everyone: ‘you must do this and you must do that. We have decided this is best for you’. How paternalistic is that?” Ryan said, appealing for attention to “that principle of service to the people” – and humility.

South Sudan Minster of Health Elizabeth Chuei receiving a COVID-19 vaccine after delivery from COVAX.

‘Little white, northern cabals’

He also took aim at “many unelected individuals around the world who live in their little, white northern cabals who like to sit in rooms and decide what the future of global health is going to be”.

“The reality is 194 ministers of health come together every year in Geneva, and they set out under democratic principles, what are the policies for the world and we need to continue to invest in that,” said Ryan.

“We’re a flawed organisation. But we are radically transparent and we are open. Everything we do is on the table. Everything we do is out there for criticism. I wish it were the same for other entities and institutions.”

He also blamed any failures in the global vaccine delivery platform, COVAX, on “the greed of the north”, “the greed of pharmaceutical industry” and “self-interest in certain member states” that were not prepared to share.

“COVAX went against that trend, and COVAX tried in its best way to represent that need around the world,” said Ryan, adding that he and others often worked “26 hours a day” to address the pandemic and sometimes needed to be “peeled off the wales”.

Principles not plans

Professor Lawrence Gostin from Georgetown University in the US said there was a need for “better governance” of the WHO.

“We need to have more honesty and stewardship, transparency and openness, most important, inclusive participation, effective performance monitoring benchmarks, quality improvement, accountability, and the most important thing is equity,” said Gostin.

German health ministry official Björn Kümmel, who has driven the re-financing of the WHO as co-chair of the Intergovernmental Working Group on Sustainable Financing, said that his country would like to “enable WHO not only financially but also technically, potentially legally through new mechanisms in the IHR and obviously, the pandemic treaty, and politically also vis a vie other global health agencies or other actors who are engaging in global health”. 

However, Kummel conceded that “nobody seems to have a plan”.

Discussion was largely about “principles” – such as “better governance, trust, transparency, acceptance of criticism, [ensuring] the voice of civil society, equity, community intelligence systems.

“All the big words that were mentioned here, I think it’s clear that none of us seems to have the right plan.”

Image Credits: UNICEF.

pollution
Air pollution in Delhi, India.

New evidence that exposure to air pollution can potentially contribute to obesity in women has emerged from a study by the University of Michigan

“Women in their late 40s and early 50s exposed long-term to air pollution—specifically, higher levels of fine particles, nitrogen dioxide and ozone—saw increases in their body size and composition measures,” said Xin Wang, epidemiology research investigator at the University of Michigan School of Public Health and the study’s first author. 

By cross-referencing the residential addresses of the 1,654 US women participating in the study with hybrid air pollutant concentration estimates from 2000 to 2008, the data showed exposure to air pollution was linked with higher body fat, body mass index, and lower lean mass.

But it is not all bad news. The study found that while body fat increased by 4.5%, high levels of physical activity were an effective way to mitigate and offset the effects of air pollution exposure.

Pollution and obesity: a growing link 

With an unprecedented increase in body weight issues worldwide over the last decades, numerous studies have sought to understand the complex and varied causes of obesity – and this is not the first to explore the link to air pollution.

In 2019, researchers at the University of California at Santa Barbara published the first study estimating the causal effect of air pollution on body weight based on data from 13,226 adults in China from 1989-2011. 

This period of study is unique for its historical backdrop. Across the years of the study, China’s economic explosion contributed to a rise in fine particulate matter concentration by 70%. During this time, China’s average BMI increased by 11%, while overweight and obesity rates increased from 8.57% to 32.83% and 0.48% to 4.9% respectively.

“Our study suggests that the cost of air pollution on overweight and obesity is non-trivial,” the authors state. “Although the effect’s magnitude is smaller than studies focused on other economic [and socioeconomic] variables, it is in the same order of scale.”

The International Journal of Obesity also highlighted the potential effects of ambient air pollution on child obesity development but noted evidence is still scarce.

“Early life exposure to air pollution may be associated with a small increase in the risk of developing overweight and obesity in childhood, and this association may be exacerbated in the most deprived areas,” the journal notes. “Even these small associations are of potential global health importance.”

The most striking results came from a study conducted by the Lung Care Foundation and Pulmocare Research and Education in India. The results found that while 39.8% of the children in Dehli, one of the world’s most polluted cities, were obese or overweight, this was true for only 16.4% of children in Kottayam and Mysuru, cities with significantly better air quality.

As studies continue to deepen our understanding of the toxic effects of fine particulate matter (PM2.5) on human health, the silent threat posed by polluted air has revealed itself to be more multifaceted than previously known – and extremely deadly.  

With 99% of the global population breathing air beyond the World Health Organization’s recommended quality limits, an estimated nine million deaths are caused by modern air pollution sources every year. 

New evidence of the adverse effects of air pollution is emerging at a rapid clip, but despite the economic and health implications, progress on the policy front remains slow.

Image Credits: Ella Ivanescu/ Unsplash, Wikimedia Commons: Prami.ap90.

Cancer
More than 1,500 scientists, medical specialists, NGO and civil society representatives, ministers of health, high-level United Nations representatives and people living with, or affected by, cancer are expected this week at the World Cancer Congress 2022.

A lack of expertise in geriatric oncology means that cancer in older adults is often confused with other signs of ageing and diagnosed too late.  Dr Sonali Johnson sets out a blueprint for addressing this barrier – one of the many topics to be discussed at the World Cancer Congress, hosted by the Union for International Cancer Control in Geneva, 18-20 October.

Cancer is a disease for which older adults are particularly at risk as the cells of the body are more likely to turn cancerous as a person ages, primarily as a result of greater exposure to risk factors (though this exposure can be reduced by adopting early a healthy lifestyle). In 2020, over 50% of all cancer cases were among people aged over 65 – nearly 10 million out of a total of 19.3 million – and this proportion will grow further in the coming decades, with the fastest increase occurring in low and middle-income countries (LMICs).

The treatment of cancer is more complex for older adults with co-morbidities, requiring an integrated approach. Yet a lack of expertise in geriatric oncology at different levels of the health system means that cancer in older adults is often diagnosed late as early symptoms are sometimes considered to be signs of ageing. Cancer is more complicated and invasive to treat successfully when it is detected at a more advanced stage.

Age isn’t everything

IUCC
More than half of all people who have cancer are over 65 years old, and this number is predicted to rise as populations age globally. Yet, many health systems are not prepared to address the specific needs of this population.

Older adults are not a uniform group and age alone is a poor predictor of an individual’s health. They can have widely varying physical and mental health at a similar age, with the presence or not of co-morbidities. They may or may not have a strong social support network. They may have considerable or, on the contrary, very limited financial means. Each of these factors will shape if and how an older adult engages with the health system, therefore their preferences and needs should be individually assessed. 

To do so effectively, we need to improve our data on the prevalence of co-morbidities amongst adults aged over 65. Many health policies have been developed and implemented with partial information and in silos, addressing diseases separately. There is an opportunity here for cross-sectoral and multisectoral coordination and integrated approaches that lay the groundwork for patient-centred care.

There is also a need to train health staff in geriatric care to correct the misconceptions that often surround health and ageing – stereotypes, assumptions and prejudices that mask the diverse nature of older populations and the contributions of older adults to society.

Patient-centred care also means removing age limits in clinical trials and the inherent biases in research programmes to make them more inclusive. Currently, doctors and regulators may have little precise knowledge of how older adults react to certain treatments or how cancer medicines may interact with other medications they are taking, since these have not been tested.

Countering misperceptions that older adults themselves may have about clinical trials (e.g. fear of mistreatment, being used as a ‘guinea pig’) is also essential to improve access to services and research. Other limitations also need to be addressed, such as hearing or transportation difficulties.

Only if older adults are proportionately well represented in clinical trials and research can doctors have more insight into the efficiency and side effects of cancer treatments for people over 65.

Caring for older cancer patients is a surmountable challenge

Cancer
Estimated increase in cancer incidence and mortality (2020 data: Globocan / 2030 previsions: AIRC)

The Union for International Cancer Control (UICC) has made cancer and ageing a focus area of its work, supporting the advocacy efforts of UICC member organisations in LMICs working to improve access to cancer services and care for older adults

Initiatives in El Salvador, Guatemala, Kenya, Mongolia and Tajikistan have been set up in partnership with Sanofi, to improve the training of healthcare practitioners in geriatric care; include cancer and ageing strategies in national cancer control plans and universal healthcare packages; ensure cost-free access to cancer medicines for people aged over 65, and increase the availability of palliative care specifically tailored to the needs of older adults.

To improve cancer care for older adults at the international level, the International Society of Geriatric Oncology has developed the Top Priorities Initiative to identify global priorities for progress and development in geriatric oncology and translate these priorities into tangible actions.

The American Society of Clinical Oncology (ASCO) has issued recommendations for geriatric assessments, a tool to understand an older person’s physiological and socioeconomic situation to inform the most effective and appropriate course of care.

These are being adopted by several health systems, for instance in Chile, where the Arturo Lopez Perez Foundation (FALP) created an oncogeriatric unit to provide a comprehensive geriatric assessment of older adults with cancer.

Caring for older adults is not about prolonging life at all costs – and it is not an insurmountable challenge. Neither does it necessarily involve investing significantly in additional resources or diverting resources from other priorities.

It is, ultimately, about ensuring that the clinical expertise exists to identify the specific needs of older adults and offering them the same opportunities for diagnosis and treatment as other populations enjoy, in line with their wishes and particular situation.

Sonali Johnson is Head of Knowledge and Advocacy at the Union for International Cancer Control (UICC), which is hosting the World Cancer Congress in Geneva, 18-20 October.

Vaccine deliveries by the global COVAX facility.

Midway through last year, the head of the Africa Vaccine Acquisition Task Team, Strive Masiyiwa, angrily accused the global COVID-19 vaccine acquisition platform, COVAX, of misleading African countries about its ability to procure vaccines for them.

Masiyiwa’s bitter remarks came after months of Africans watching Europeans and North Americans being vaccinated against COVID-19 while no vaccines were available for them – even if their governments had the money to pay for them.

By the end of last year, a special meeting of the World Health Assembly had resolved to set up an intergovernmental negotiating body (INB) to negotiate an accord to guide future pandemics, and all member states agreed that it needed to be based on equity. The INB is expected to submit a draft accord to be negotiated at the 77th World Health Assembly in 2024.

This week, an independent evaluation of the Access to COVID-19 Tools Accelerator (ACT-A), COVAX’s parent body concluded that “a different model for pandemic response will be needed in future”.

The review – which combined interviews with over 100 key informants, a survey and a review of documents – comes as the World Health Organization’s (WHO) INB is preparing a “zero draft” to kick off negotiations on the pandemic accord. 

The ACT-A comprised three pillars – diagnostics, therapeutics, vaccines (COVAX) and a fourth cross-cutting pillar, the Health Systems and Response Connector (HSRC), which was viewed as a flop. 

COVAX ‘too ambitious’

Interestingly, the review’s main criticism of COVAX is that its global scope as the key vaccine-purchasing agent for the world was “too ambitious” and that a “more targeted approach” would have been more useful. 

This observation is based on the failure of high-income countries to go through COVAX to buy its vaccines, meaning that COVAX was “unable to play the market shaping role it first envisioned”. 

The crux of any successful pandemic accord will be to ensure that wealthy countries don’t hoard all the available diagnostics, therapeutics and vaccines to fight the next killer pathogen – an almost impossible task.

Instead of expecting wealthy countries to subject their procurement to a global body, it might be more effective for a future pandemic body to “focus on a smaller set of lowest-income countries”, according to the review.

Despite the criticisms, COVAX’s performance in improving access to COVID-19 vaccines in the 92 Advanced Market Commitment (AMC) countries was ranked 7.5 out of 10, the highest survey rating.

By 15 September, it had delivered 1.72 billion doses although massive vaccine inequalities persist. 

Barbados receives 33,600 doses of COVID-19 vaccines, its first shipment through the COVAX facility, in April 2021

Unsuitable operating model

Almost two-thirds of respondents thought that ACT-A’s operating model should not be replicated, citing problems including “insufficient accountability, limited meaningful engagement of low- and middle-income countries (LMIC) and regional bodies, and an insufficient focus on delivery”.

Prioritising speed and using existing global health agencies to respond to the pandemic had “compromised accountability and transparency”, according to the review. 

“Insufficient manufacturing capacity, unhelpful member state responses to COVID-19, and issues around ‘last mile’ implementation were the three factors that had the biggest impact on ACT-A’s ability to deliver on its targets,” according to survey respondents. 

Civil society organisations and academics listed the lack of technology transfers and the management of intellectual property as the most significant challenges. 

“Going forward, a new platform should be established that involves all key R&D partnerships and coordinates R&D across product types and diseases,” the review recommends.

Three-quarters of survey respondents supported joint resource mobilisation instead of uncoordinated fundraising.  ACT-A raised $23.5 billion, two-thirds for COVAX, but fundraising was too slow, and respondents supported a pandemic advance commitment facility with access to credit. 

The World Bank has already heeded this, and last month it set up the Financial Intermediary Fund (FIF) for Pandemic Prevention, Preparedness and Response (PPR) to “provide a dedicated stream of additional, long-term financing to strengthen PPR capabilities in low- and middle-income countries and address critical gaps through investments and technical support at the national, regional, and global levels”. 

The lack of manufacturing capacity, and weak country health systems are key challenges to address before the next pandemic. 

High-level political leadership

Finally, the review advocates for the creation of a high-level political body to keep pandemic preparedness and response high on the global agenda, track overall progress and provide high-level political guidance. 

Previously, the Independent Panel for Pandemic Preparedness and Response (IPPPR) proposed that a council for pandemic preparedness, made up of senior political leaders, be established under the United Nations General Assembly.

Meanwhile, WHO suggested establishing a Global Health Emergency Council and a Committee on Health Emergencies of the World Health Assembly.

ACT-A was guided by a facilitation council chaired by Norway and South Africa, but the co-chairs lacked global clout and spent a lot of energy appealing to world leaders of wealthy countries to share their pandemic products with others.

Image Credits: Gavi , @CEPI , PMO Barbados.

The drought in the Horn of Africa has caused famine in Somalia.

Over 90% of appeals for urgent hunger-related funding made through the United Nations humanitarian system were not fully funded in 2021, according to a report produced by Action Against Hunger.

While global funding has increased by 233% over the past decade, overall humanitarian needs are up 500%. 

“This means that 42% fewer UN appeals are being fulfilled,” the report stated.

In an analysis of the response to ‘crisis’ levels of hunger experienced in 2020 in 13 countries, less than 8% of food security appeals were fully funded while none of the appeals for support of water, sanitation, and hygiene (WASH) programs were fully funded.

Moreover, more than six out of ten of hunger-related appeals were not even funded to the halfway point while countries that experienced the greatest hunger crises received less hunger funding (by percentage of appeals filled) than countries with half the rate of hunger.

Michelle Brown, Action Against Hunger USA’s advocacy director, described the findings as alarming and called on the global community for more funding to combat hunger, especially in places where the crises are severe.

“While donors have increased their funding, they haven’t increased their funding to the necessary level to actually meet all of those needs,” Brown told Health Policy Watch. “As needs continue to go up, humanitarian funding continues to go up as well but not at the same level. We’re seeing a really significant gap between what the needs are and what the funding levels are.” 

Moreover, she said the report did not take into account the impact of the Ukraine crisis on food prices and the humanitarian response: “What we’re going to see are even greater levels of need, and for similar funding levels that aren’t able to meet those needs.”

It is still possible to end hunger in our lifetimes

In spite of the burgeoning hunger-related crisis and the worsening risks posed by conflicts and climate change, the report notes that it is still possible to end hunger “in our lifetimes”. This, it said, is based on a number of factors including progress made so far. 

Currently, about 828 million people (one in ten worldwide) are undernourished and 50 million people in 45 countries are on the verge of famine, yet between 2005 and 2014, the number of undernourished people dropped from 806 million to 572 million. This represents a reduction of nearly 30% within the period alone. 

The report also noted that the world has enough food and funding to meet the UN Global Goal of Zero Hunger by 2030. But it warned that this goal cannot be achieved without closing the hunger funding gap.

“We have the ability and we have the compassion that’s needed to finally solve hunger. Right now, especially when you look at what’s happening in East Africa, the needs are enormous and we have an opportunity to save lives. We’ve seen in the past that humanitarian assistance can save lives, it can prevent a famine and…this time around, [we need] to ensure that we don’t find ourselves in a famine situation,” Brown told Health Policy Watch.

Image Credits: UN-Water/Twitter .

AMA Treaty approved by South Africa
South African Health Minister Mathume Joe Phaahla affirms support for the AMA at a February 2022 visit of WHO Director General Dr Tedros Adhanom Ghebreyesus.

In a major step forward for the new regulatory alliance, Africa’s third-largest economy, South Africa is now moving to join the African Medicines Agency. 

South Africa’s Cabinet has approved the signing of the African Union treaty establishing the African Medicines Agency (AMA) and submitted it to Parliament for ratification, according to a government statement on 23 September. 

“Cabinet approved the signing of the Treaty for the Establishment of the AMA and its submission to Parliament for ratification,” the statement reported.

“This will give effect to the treaty that was adopted by the African Union Assembly in 2019. The treaty formally establishes the AMA for the continent. The agency will regulate medical products and improve the safety and efficacy of the medical products for the continent.

“The signing and ratifying of this treaty will advance South Africa’s global and continental commitment toward strengthening the continental regulatory system on its health products,” the statement added.

If the South African Parliament ratifies the treaty, South Africa will be the 34th country to swing behind the AMA since the treaty took force in November 2021 with the ratification of the first 15 African countries to get behind the initiative. 

AMA Countdown – status as of 11 October 2022

Public health officials welcome South African move

Zimbabwean public health specialist Dr Nokuthula Kitikiti, who is of South African origins, described the development as “great news”.  She noted that South Africa’s move holds special relevance since its national regulatory agency is one of the few in Africa that has achieved the milestone of being designated as “maturity level 3” (ML3) by WHO. 

“Smaller and less developed agencies can benefit from their participation in the AMA by building capacity through joint reviews and understanding the process at the South African Health Products Regulatory Authority (SAHPRA) and other ML3 agencies,” she told Health Policy Watch.

As a key regional manufacturing centre for vaccines and the site of the World Health Organization’s (WHO) mRNA vaccine hub, Kitikiti said it is is vital for South Africa to be involved in AMA as Africa builds its vaccine manufacturing capabilities. 

“South Africa also has a vibrant patient and civil society community that I am sure will enrich the continent-wide discussions on how to involve the public and patients in a more meaningful way in health products regulations as the AMA takes shape. We are still very nascent in this compared to other regions. After all, we are all doing this to make medicines safer and more accessible for patients,” she added.

Key country in operationalizing AMA 

South Africa has been one of the big country holdouts on treaty ratification – along with Nigeria in West Africa and Kenya in East Africa. 

 

This is despite pledges from South Africa’s political leadership that it supported the AMA dating back as far as 2017 when the AMA’s first stakeholder consultative meeting was held at the South African historical city of Johannesburg.

Senior South African government officials have repeatedly stated that they had no hesitation regarding being a part of the AMA. In February 2022, South Africa’s Health Minister, Dr Joe Phaahla affirmed the country’s support for the continental-wide medicines regulatory authority, and said the government would sign the treaty.  

“There is no, in principle, hesitation. It’s more operational in terms of making sure that we do sign the treaty on the AMA,” the minister said, during a tour by WHO’s Director General of Cape Town’s new mRNA vaccine R&D hub.

Treaty ratification by parliament remains critical next step for South Africa – also for Kenya  

The front page of the AMA Treaty

Even so, ratification of the AMA treaty by the South African parliament remains a critical step before the deal is sealed. Following that, the treaty ratification then needs to be formally deposited with the African Union. 

Kenya’s parliament has remained stalled on the treaty ratification already for the past five months ever since the cabinet signalled its approval of the treaty in May. 

In Kenya, the National Assembly officially received a memorandum proposing ratification of the AMA in June 2022 but nearly four months later, parliamentarians are yet to vote on the treaty. 

According to the memorandum that presented the treaty to the parliament, the signing and ratification of the treaty by Kenya will “demonstrate Kenya’s commitment to the continent’s collective action to the improved regulation of medicines, medical products and technologies… Ratification will bring about positive consequences both to the country and States Members.”

However, Kenya held national elections in August, leading to a Supreme Court challenge of the election of President William Ruto, whose election was ultimately upheld. The ensuing political uproar, however, likely also delayed the parliamentary move. 

East African countries urged to sign the treaty 

The treaty has long been a topic of discussion in regional African political forums, including at events such as the Commonwealth Speakers and Presiding Officers’ Conference held in November 2021 in Rwanda and attended by both Kenya and South Africa. 

South Africa approves AMA Treaty.
(On right) Amos Masondo, head of the South African delegation to the Commonwealth Parliamentary Conference in Rwanda in November 2021.

At that conference, the leader of South Africa’s delegation Amos Masondo, urged parliamentarians across the continent to “accelerate the ratification” of the treaty.

“Establishment of an AMA [will] help regulate products; help invest more in research and development, [and help countries] to build their own vaccine production while fighting to address vaccine nationalism that disadvantages the African continent,” Masondo said.

Nigeria another holdout – could be a costly delay  

In West Africa, meanwhile, Nigerian global health equity advocate Ifeanyi Nsofor told Health Policy Watch the continual delay in the treaty’s ratification and full implementation could create confusion in the pharmaceutical landscape on the continent as countries that have already signed and submitted the treaty may have a different policy direction from those that haven’t. 

He added that the delay could also have impacts on plans to scale up vaccine manufacturing on the continent.

“Of importance is the way it could delay plans to manufacture vaccines in Africa. Infectious diseases do not care about politics. Ultimately, Africans would suffer from this reluctance. It’s a matter of life and death,” Nsofor told Health Policy Watch.

Lesotho and Mozambique the latest formal AMA entries

In spite of holdouts, the number of countries in Africa that have swung behind the treaty has continued to grow – and now constitutes a two-thirds majority of the African Union’s member states.  

On 1 September, the Kingdom of Lesotho became the latest Member State to ratify and deposit the AMA Treaty instrument.

Prior to that, the Republic of Mozambique also signed the treaty on 8 August but it has yet to ratify the treaty and deposit the ratified instrument with the African Union as per the formal required procedure. 

Regarding the holdouts, the official AU line continues to be “countries have different ratification processes at the national level … However, the AU Commission continues with advocacy efforts to encourage more member states to ratify the Treaty.”

At the same time, AU Special Envoy to the AMA, Michel Sidibé, and the AMA Treaty Alliance (AMATA) are also engaging patient groups, industry, academia and civil society to support the AMA treaty and its operationalization. 

Sidibé, who also is the former Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS), described the success of this approach as reliant on “partnerships with stakeholders across the health ecosystem”.

“It is very important to not lose momentum…We don’t have another way to do it except making sure that we maintain and sustain our advocacy — and we mobilize political leaders,” said Sidibé in one recent Health Policy Watch interview. 

AMA will be enlisted in African Union’s battle against drug resistant microbes 

AMA advocates have continuously underlined the knock-on benefits the new regulatory agency would have in terms of not only harmonising the approval of new medicines – but also thereby ensuring more access to affordable quality medicines. 

This, in turn, can help fight worrisome trends like antimicrobial resistance (AMR) – which the continent has little capacity to track or tackle right now, according to one recent study of 14 countries.

According to a new African Union Framework for AMR Control, the nascent AMA will promote a common scheme for prohibiting the sale of non-standard antimicrobials, whose use can foster drug resistance, backed by post-marketing surveillance. 

In the context of the framework, the AMA will contribute to strengthening laboratories for drug quality control and promote the education of pharmacists in identifying sub-standard or falsified drugs, using innovative tests to measure drug quality, while also encouraging policies that promote the availability of genuine, safe and effective products at competitive prices.

The Framework also promotes collaboration with governmental and non-governmental partners (including community groups) to increase awareness amongst not only clinicians and pharmacists but also veterinarians and animal and crop producers about substandard and falsified antimicrobials.

For full coverage on the development of the African Medicines Agency, see our AMA Countdown Page here: 

African Medicines Agency Countdown

-Kerry Cullinan contributed to the reporting on this story.

Image Credits: @elmimuller, Kenyan Parliament website, South African Parliament.

Panellists Chioma Nwakuchwu, Hyunsook Kim, moderator Gian Luca Burci and Martin Friede at the Global Health Centre at the Geneva Graduate Institute.

If sustainability of vaccine production is the question, then mRNA technology is the answer, Martin Friede, co-ordinator for vaccine research at the World Health Organization (WHO), told a panel convened by the Global Health Centre at the Geneva Graduate Institute on Monday.

“The big advantage of mRNA is that, in theory, you can make many vaccines with that technology – you can make flu vaccines, possibly chicken pox vaccines, herpes zoster vaccines, TB vaccines, possibly even HIV vaccine,” Friede told the panel on the long-term sustainability of local vaccine production, convened in partnership with the Republic of Korea’s (ROK) permanent mission in Geneva.

In addition, he said, you can produce enough bulk mRNA for about 100 million annual vaccines in a small facility that cost about $10-11 million to set up.

This contrasts with WHO attempts some years back to encourage the decentralised manufacture of influenza vaccines, which needed capital investment of around $200 million per facility. That vaccine production method – based on eggs – could not be adapted to make other vaccines, he added.

Two big buts

Martin Friede, co-ordinator for vaccine research at the World Health Organization (WHO).

There are two big buts related to mRNA, however, according to Friede. The first is that few people know how to make mRNA vaccines and most of them work for big pharma companies BioNtech or Moderna.

The second is that, unless a facility makes more than one vaccine, staff will get bored and move on.

To address the first obstacle, the WHO set up an mRNA development hub in South Africa to develop mRNA technology for low and middle-income. Big pharma demurred to share their COVID-19 vaccine recipe and know-how, so the WHO enlisted the help of academics that had been involved in the discovery of mRNA. This hub has made a Moderna-like vaccine that it is in the process of starting animal trials on.

To address the challenge of under-utilised staff, Friede suggests that mRNA capacity can be added to a facility that is producing other products – such as biotherapeutics, monoclonal antibodies, or even veterinary or agricultural products.

“So sustainability really comes down to the cost of keeping the facility going and the cost of keeping your staff occupied with other stuff when they are not making mRNA vaccines,” he advises. 

Gavi’s ‘market-shaping’

Meanwhile, Chioma Nwakuchwu, senior manager for public policy engagement at Gavi, spoke of the “delicate balance of market shaping” that the global vaccine platform has been involved in over the past two decades to broaden the vaccine manufacturing base.

“When we first started in 2001, there were only five suppliers from five different countries. But as you’ll see, over the past 20 years or so, we had 18 manufacturers from 12 countries,” said Nwakuchwu.

However, she acknowledged that there had been an inadequate supply of vaccines during the earlier part of the COVID-19 pandemic, and Gavi was looking into how to add more manufacturers to its database – not just for pandemics but to produce routine immunisations.

“We see this as an opportunity to expand our market shaping as well as a healthy market framework in line with the vision of the organisation which is truly about equitable access.”

In response to Friede asking whether Gavi was considering “favouring a regional procurement for regional use, or at least some mechanism around this”, Nwakuchwu confirmed that Gavi was exploring this with the Africa Centres for Disease Control – for non-COVID products.

“Initially, the focus was on COVID-19, and we’re really encouraging and speaking with the Africa CDC because they are spearheading this initiative for Africa to say, ‘let’s look at the disease landscape for Africa. Let’s prioritise non-COVID vaccines because this could be where, in terms of your investment, it makes more sense’. 

“The challenge has to be around the coordination because this is a continental ambition. They’ve set out about 22 antigens that they want to procure,” she said.

She affirmed that Gavi supported increased manufacturing capability in Africa to “right-side” delays that prevent equitable access to medical products, but added that the organisation was in the process of developing a white paper looking at how to accommodate new manufacturers while ensuring that there was “ a stable and healthy global supplier base”.

Republic of Korea’s bio-hub

Ambassador Jung Sung Park, deputy representative from the ROK permanent mission in Geneva

The WHO opened a second hub, this time on bio-manufacturing, in the Republic of Korea (ROK) in February to train people from low- and middle-income countries in how to produce biologicals, such as vaccines, insulin, monoclonal antibodies and cancer treatments.

“My country is determined to support low and middle-income countries in strengthening their bio-manufacturing capacities so that we can pave the way towards a safer and more secure world when encountering health crisis,” Ambassador Jung Sung Park, deputy representative from the ROK permanent mission in Geneva, told the panel.

Hyunsook Kim, the director of the hub which falls under the ROK health ministry, says that the hub has already run four training sessions this year – but that practicals are essential for the learning process, otherwise it’s like “watching on YouTube how to make a cake without baking one yourself”.

“Producing biopharmaceuticals is very different from producing chemical drugs,” said Kim.

“If we want to make chemical drugs, you just mix them together and that’s it. But if you want to produce biopharmaceuticals, you have to provide the nutrients to cells to make 1000s of millions of cells. It’s called formulation. And then you have to extract the substance from the cells, which means purification. And then you have to make the appropriate formulation liquid or powder and then you have to inject the liquid or powder into a syringe or vial.”

She added that next year, more hands-on training would be provided and that the hub was speaking to donors to get more investment, as well as expanding the premises to establish a “global bio-campus”.

Soumya Swaminathan, WHO Chief Scientist, at a press briefing at the height of the COVID pandemic in September 2020.

World Health Organization Chief Scientist Dr Soumya Swaminathan, a respected voice in WHO’s senior leadership is expected to resign within the next month – in the first major leadership shuffle by Director General Dr Tedros Adhanom Ghebreyesus since the COVID-19 pandemic began, Health Policy Watch has learned.  

Conversely, Dr Mike Ryan, executive director of WHO’s Health Emergencies Programme, who had earlier been expected to leave the organization, appears set to remain, several WHO insiders with knowledge of the pending reshuffle confirmed.

Sources said that Swaminathan, who at age 63 is still two years short of WHO’s mandatory age of retirement, had wanted to remain for one more year in the office which she has built from scratch.  

However, Tedros is reportedly keen to make changes in his leadership, senior staff perform at the director general’s will – and there have also been hints  that Swaminathan’s style was too independent for the director-general. 

Another source close to the chief scientist, however, said that she was leaving voluntarily after five years in senior WHO leadership to reunite with her her husband and elderly parents – who have remained in her hometown of Chennai, India while she served in Geneva.

The upcoming reshuffle is also likely to include the departure of WHO Deputy Director Dr Zsuzsanna Jakab, sources told Health Policy Watch.  

Jakab, a Hungarian health professional born in 1951, is already well over the WHO mandatory retirement age of 65 – which can be exceptionally extended only by three years. She previously served as the Regional Director for WHO’s European office.

From left to right: WHO’s Mike Ryan, Tedros Adhanom Ghebreyesus and Sylvie Briand in in a February 2020 COVID press briefing – just after WHO’s declaration of an international public health emergency.

 Ryan, who appears set to remain for the moment, is highly regarded in emergency circles. However, he is also someone who has remained consistently deferential to Tedros’ own political authority and direction throughout more than two withering years of WHO’s COVID pandemic response.  

Ryan was appointed as executive director of health emergencies in 2019 following Tedros decision to sideline the noted Australian epidemiologist Dr Peter Salama.  Salama had held the post since 2016 – when he was appointed on the tail end of the West African Ebola epidemic that caught WHO off guard and prompted a major reorganization of the agency’s emergencies team. 

But in Tedros’ first big internal reorganization, the director general nimbly moved Salama from Health Emergencies into a newly-created position as the Executive Director of “Universal Health Coverage”. 

Salama accepted the new role with grace.  But internally the shuffle was seen as a figurehead role and a kind of demotion by Tedros, who reportedly habored a grudge against Salama, one former WHO official told Health Policy Watch.  That dated back Salama’s reported criticism of Ethiopia’s mishandling of a series of cholera outbreaks in the period when Tedros was the country’s health minister from 2005-2012. A mismanagement scandal that rocked the WHO Emergencies team, led by Salama in 2018-19, had nonetheless created the political opportunity for Tedros to act. 

In January 2020, shortly after Salama took on his new role on UHC, he died of a heart attack.  

Tedros’ Centralised leadership style  

Tedros at a WHO press briefing in January 2022.

The question is now who will replace the outgoing Jakab and Swaminathan – both known as strong, experienced leaders – along with other, lesser-known names who may also be swept aside in the pending shuffle.  

Tedros’ tenure at WHO has been marked by a centralized leadership style, as a Lancet editorial observed in late August. And that has left less space for senior staff to express themselves independently, than they typically did under past director-generals – a concern for a science-based organization. 

“Power has been increasingly centralised around the Director-General’s office under Tedros’ leadership. This strategy might be advantageous in a crisis that demands a commander-in-control. But a lack of depth in wider leadership leaves shortcomings in the organisation, stated The Lancet, in an August editorial marking the start of Tedros Adhanom Ghebreyesus’ second term in office.

“It’s a very sort of lonely, authoritarian way of power – that’s clear,” one diplomatic source, who has known and admired Tedros since his days as Minister of Health in Ethiopia (2005-2012), told Health Policy Watch.

Expresses herself publicly on sensitive topics – including COVID treatments   

Swaminathan has been one of the few senior WHO staff to express herself publicly and independently on oft-controversial issues. During the COVID crisis she appeared very frequently not only at WHO global media briefings, but on international and Indian TV.  

She distinguished herself, in particular, by her willingness to speak out about the emerging evidence around new COVID treatments – in cases where WHO went against the trends of politically popular but scientifically unfounded therapies – including remdesivir, Ivermectin and hydroxychloroquine. 

On remdesivir, in particular, WHO recommended against using the drug in November 2020, bucking a US Food and Drug Administration approval of the drug developed by the pharmaceutical company Gilead.

At the time, Swaminathan bluntly told journalists in a WHO global briefing that the FDA had ignored evidence submitted by WHO from in a multi-country “Solidarity Trial” to the effect that the drug failed to reduce mortality or yield other measurable benefits.  The fact that she dared to reveal such information on the powerful FDA so frankly was an unusual move for a WHO official.  

Independent voice in Indian science circles

Swaminathan’s statements also have bucked politically popular positions in India. Her statements on the lack of evidence for Ivermectin as a COVID treatment, earned her the wrath of the Indian Bar Association – which went so far as to file legal complaints against some of her comments in 2021.  

The IBA, Indian insiders told Health Policy Watch, tends to parrot positions of the government of Prime Minister Narendra Modi,   

Swaminathan’s comments on ivermectim, however, lined up squarely with the fact-based guidance of not only WHO but also India’s own Ministry of Health and Family Welfare – which in spring 2021 dropped ivermectin from its own list of recommended COVID treatments. Swaminathan welcomed that move saying that the revised national guidelines were  “simple, rational, and clear guidance for physicians. 

When Tedros first was elected as WHO Director General, in 2017, he appointed Swaminathan as his deputy director general.  However, in a 2019 reshuffle, he then moved her from the DDG’s post into the newly-formed chief scientists’ office.  It was something some WHO insiders also interpreted as a kind of political sidelining by Tedros – although Swaminathan was eminently well-suited for her new role that placed her in charge of WHO’s evidence base.  

WHO observers will now be watching closely to see if Tedros appoints a new chief scientist with the stature to speak out as Swaminathan did.  A noted India pediatrician and researcher in tuberculosis, she previously served as the director of the Indian National Institute for Research in Tuberculosis in Chennai and from 2015-2017, as director general of the Indian Council of Medical Research.  

From 2009-2011 Swaminathan also was coordinator at TDR, the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, based in Geneva. 

Anticipation mounting 

Anticipation of the pending senior WHO staff reshuffle, was mounting this week as Tedros formally announced several new director’s level appointments in WHO, as well as 11 new country representatives, in an internal WHO staff message distributed on Friday.  

The new appointments include Gaya Gamhewage, a Sri Lankan physician as  Director, Prevention and Response to Sexual Exploitation, Abuse and Harassment. 

Gamhewage has already been acting in that critical position, where she is leading much of the WHO programmatic response to the sexual exploitation and harassment scandal that erupted in the Democratic Republic of Congo in September 2020. The allegations raised in DRC are the focus of a still-ongoing internal investigation.

Tedros also announced the appointment of Dr Alian Labrique, a Belgium researcher as director in the relatively new WHO entity of Digital Health Intelligence.  Labrique is a former Professor and Associate Chair for Research at Johns Hopkins University. 

At the same time, Tedros announced a new WHO country representative to the Democratic Republic of Congo, Dr Boureima Hama Sambo, as well as new heads of office in Mauritius,  Barbados, Panama, Qatar, Romania, Albania, Belarus, Solomon Islands, DPR Korea (north Korea) and Myanmar. 

Along with the resignations of Swaminathan and the retirement of Jakab, Tedros is expected to announce the retirement or removal several other senior staff, who currently hold positions as Assistant Director General, in charge of WHO’s major disease and thematic clusters.

Image Credits: WHO, Fletcher/HPW .

Health workers in full protective gear to treat Ebola patients,.

Four health workers have already died in the Ebola outbreak in Uganda and, while rapid tests are still not available, authorities have managed to cut the testing turnaround time from 24 to six hours, according to the World Health Organization (WHO) Africa region and Africa Centres for Disease Control.

Meanwhile, the US is routing all citizens who have been in Uganda in the 21 days before their arrival to five US airports – New York, Newark, Atlanta, Chicago or Washington – for “enhanced screening”, the US Embassy in Uganda announced on Thursday.

At separate briefings on Thursday, the WHO AFRO and Africa CDC attributed the shortened testing time to the establishment of a new test facility at the epicenter of the outbreak that is capable of conducting real-time polymerase chain reaction (RT-PCR), as well as the availability of more testing reagents.

However, the genomic sequencing data available at present has not yet enabled health authorities to identify origin of the disease or Patient Zero.

The outbreak was declared on 20 September, but public health experts suspect that it started in early September, several weeks before the first confirmed case was seen at a government health facility. 

As of 5 October, the WHO reported 63 probable cases and 29 deaths. Ten health workers are confirmed infected, for of whom have died.

Dr Yonas Tegegn Woldemariam, WHO Representative in Uganda,  reported that about 77% of the listed contacts have been reached.

“I believe we are proceeding fast in responding to this disease outbreak. We started with three districts but it has now gotten to two additional districts but we relate these new district cases to the original districts where either a health worker or a positive case have had contact with original cases,” said Woldemariam.

Initially, samples were being sent to the Uganda Virus Research Institute (UVRI) which is 160km from the epicenter of the outbreak, but the new on-site laboratory facility.

“I am positive that we could control this in reasonably good time,” he said. 

Uncertainties remain

At the WHO AFRO press briefing on Thursday, Professor Pontiano Kaleebu, director of the Medical Research Council at UVRI, said that the current strain “is the nearest to the Ebola virus we had here in Luweero (an agro-pastoralist district in central Uganda) in May 2011. It is very close to that strain but there are few mutations in the virus.”. 

While the virus was first identified in Sudan, it has since spread and Uganda has had at least two previous outbreaks. 

Kaleebu admitted that the sequencing data was not sufficient to convincingly identify the index case or the origin of infection.

“Doing that will require an extensive multidisciplinary approach that involves everyone including ecologists. This is already underway and we will be looking at the whole picture to identify connections. But we need to also be aware that if the index patient has died and was not tested, we may not be able to specifically pinpoint that case,” Kaleebu told Health Policy Watch.

Meanwhile, a range of organisations is assisting Uganda to respond to the outbreak, including Medicins sand Frontieres, which has set up an isolation facility in the Mubende district.

 

Image Credits: Naomi Nolte IFRC emergency communication coordinator.

The second iteration of the Self-Care Readiness Index (SCRI) will be released later this month during the Global Self-Care Federation World Congress 2022.

Self-Care Readiness Index 2.0
Self-Care Readiness Index 2.0

The congress takes place on the 19th and 20th of October 2022, in Cape Town, South Africa. The Self-Care Readiness Index 2.0 builds on the 2021 report, analysing another 10 countries to provide an even more in-depth understanding of the state of healthcare and self-care around the world.

The Congress will touch on a wide variety of self-care and healthcare related topics and will be joinable both in person and remotely.

The Index will be presented alongside a discussion on Redefining the Global Self-Care Agenda, featuring remarks from Judy Stenmark, Director General of the Global Self-Care Federation (GSCF), Manoj Raghunandanan, Global President of Self-Care and Consumer Experience at J&J, Sarah Onyango, Secretariat Director at Self-Care Trailblazer Group and Mario Ottiglio, Managing Director of High-Lantern Group, and will feature contributions from key global actors in the health arena. The discussion will be chaired by Dr Skhumbuzo Ngozwana, Chief Executive Officer of Kiara Health, South Africa, and Alain Main, former Chairperson of the Global Self-Care Federation (GSCF).

Opening remarks will be given by Dr Princess Nothemba (Nono) Simelela, Assistant Director-General for Family, Women, Children and Adolescents at WHO.

Healthcare professionals, policymakers, health economists, regulators, academia, media and other parties interested in discourse around self-care and reforming the healthcare system are invited to attend the event on the 19th of October at 8:30am SAST, which will include a moderated panel discussion and questions and answers from the audience.

“The SCRI shows us that self-care is practiced differently and is included in healthcare systems a variety of ways around the world,” Stenmark said. “But despite these differences, similarities abound – notably around the fundamental benefits brought to individuals, providers, and wider healthcare systems. Self-care cannot be ignored any longer – it is a hugely beneficial part of healthcare for all actors.”

The Index serves as a research and policymaking tool that explores key enablers of self-care in support of designing a better model for healthcare systems overall. The creation of the Index is spearheaded by the Global Self-Care Federation but is also supported by the WHO as part of a broader three year collaboration.

Self-care remains an emerging topic amongst healthcare discourse – in both national and international conversations. The Index helps to close the current knowledge and practice gap, as well as reinforcing the overall need to adopt self-care globally to facilitate the achievement of Universal Health Coverage and greater health of the world’s population.

“No matter how we see it included, the benefits remain clear,” Stenmark added. “Self-care needs to be an integrated part of every healthcare system.”

The SCRI 2.0 launch event will be livestreamed via GSCF’s YouTube channel and open for all global attendees to join.

Image Credits: Global Self-Care Federation .