South African President Cyril Ramaphosa visits Aspen Pharmacare’s manufacturing facility in Gqeberha.

Regional vaccine production features in the draft pandemic accord, but there is still a long road before this becomes a reality

Aspen Pharmacare invested millions of dollars in scaling up its South African production plant to make COVID-19 vaccines – yet it never sold a single vial.

Meanwhile, in a “demoralising blow”, Bangladesh’s government rejected a vaccine developed by Professor Peter Hotez that was being made by a local company because it wasn’t an mRNA vaccine.

While the pandemic accord currently being negotiated is almost certain to support regional vaccine production, setting this up is complex and the COVID-era failures offer a number of sobering and cautionary lessons.

“Unless there is security around domestic or regional procurement, you’re going to be very guarded about getting into this business ever again,” Aspen’s Stavros Nicolaou, head of Strategic Trade, told a recent webinar hosted by Brown University’s Professor Wilmot James.

While Nicolaou’s comment sounds mild, the body blow that his company took would have bankrupted a smaller company.

Three key factors combined to undermine Aspen’s vaccines. First, despite the hype about the need for African-produced vaccines, African governments failed to buy the locally-made vaccines. 

Then Aspen became caught in a political stand-off between Africa and Europe about the fate of African-produced vaccines which delayed production by months. 

When that was eventually resolved, the world had fallen for mRNA vaccines and no longer wanted the viral vector vaccine that Aspen had been licensed to produce by Johnson & Johnson.

Professor Peter Hotez

Hotez, who directs the Texas Children’s Hospital Center For Vaccine Development, assisted to develop a viral vector vaccine concept. The Center then affected a technology transfer to Indian and Indonesian manufacturers that went on to make over 100 million doses, he told the seminar. But Bangladesh had passed over the vaccine, being made locally by a company called Incepta, in favour of the mRNA vaccines.

Scaling up to make vaccines

With the waning of COVID-19, maintaining countries’ and companies’ interest in building regional vaccine manufacturing ability is a challenge – and Aspen’s difficulties should be well noted.

Aside from being Africa’s biggest pharmaceutical company, Aspen is also the leading manufacturer and supplier of general anaesthetics in the world outside of the US.

Aspen’s main production facility, comprising six different manufacturing units, is in Gqeberha, an economically depressed city in one of the poorest regions in South Africa.

Shortly before the pandemic, Aspen had invested around $400 million to expand its sterile capacities and volumes as it planned to relocate the production of some of its general anaesthetics and muscle blockers to Gqeberha.

But when the company saw what was happening with COVID-19, it decided to switch to vaccine production. What followed, said Nicolaou, was “frenzied activity to try and acquire additional capacity” to enable its facility to make vaccines.

In November 2020, Aspen announced that it had reached an agreement to “perform formulation, filling and secondary packaging” for Johnson & Johnson’s COVID-19 vaccine. 

The vaccine only needed one dose, it didn’t need ultra-cold storage and thus seemed to be the most “African-friendly vaccine”, said Nicolaou.

The announcement was a source of national and continental pride, particularly as South Africa’s President Cyril Ramaphosa was chair of the African Union and spearheading the quest to get vaccines for the continent.

But in August 2021, the New York Times exposed that millions of the J&J doses being produced in South Africa were being exported to Europe – at a time when only 7% of South Africans had been vaccinated. 

A political storm erupted. Ramaphosa intervened, appealing to the Europe Commission head Ursula von der Leyen to intervene. By September, European countries had agreed to return the J&J vaccines produced by Aspen for distribution in Africa.

“There was a standoff between Europe and the African Union in terms of where these vaccines would finally land,” explained Nicolaou. “And it took quite significant negotiating and eventually, an agreement was settled between the EU and Africa for some of these vaccines, initially 60% and eventually 90%, to be retained on the African continent.”

Aspen’s Stavros Nicolau

By March 2022, J&J had licensed Aspen to produce and supply the vaccines under their own brand name, Aspenovax. 

Strive Masiyiwa, AU Special Envoy on COVID-19 and Head of the African Vaccine Acquisition Trust (AVAT), described the agreement as “the single biggest win for the African continent in the fight against COVID and future pandemics. It is a timely milestone and an important step in making sure that the gross vaccine inequality we witnessed in the early part of the pandemic is not repeated.”

Aspen had expected to make 400 million vaccines. But the orders never came. Not a single one. By the time the agreement had been secured, Pfizer and Moderna had upped their production, and most African countries had opted for their mRNA vaccines which were being distributed by COVAX.

“That was in November 2021 and demand had dropped off, and not a single Aspen COVID vaccine was produced thereafter. We called our product Aspenovax, and to date, we haven’t sold a single vial of Aspenovax. And that is the problem,” concluded Nicolaou plainly.

After a few months of waiting with no orders materialising, Aspen was forced to close its production line.

Stable and predictable demand

“The first and most important element is we require a stable and predictable demand,” said Nicolaou, adding that there needed to be a proper procurement process through the African Union.

Other important factors are an integrated regulatory system, the transfer of technology and knowledge to local African producers and public-private partnerships.

For Hotez, his Texas Children’s Hospital Center For Vaccine Development disproved the belief that only big pharma companies “have the chops” to make vaccines.

Nonetheless, Hotez says that “too often, those who are in the pharmaceutical space don’t differentiate between the challenges of producing vaccines at scale, compared to small molecule drugs or diagnostics or medical devices”.

“The vaccine space is quite different, mostly because, when you’re talking about far more complicated biologics, the upfront investment is larger. The time horizons are longer and the risk is high as well. So it takes a very special type of biotech or pharma investor to invest in vaccines,” says Hotez.

“People focus a lot on the patents and in my view, that’s in some ways, the least of it. It’s more the capacity building that can take years and years.”

Lora du Moulin, Global Health and Security Lead at the World Economic Forum.

Meanwhile, Lora du Moulin, Global Health and Security Lead at the World Economic Forum (WEF), told the webinar that the WEF was trying to bring together the public and the private sectors through the Regionalized Vaccine Manufacturing Collaborative.

“What we’ve been doing is thinking through what does this ecosystem approach look like? What are the necessary components to ensure vaccine manufacturing is sustained during both peacetime and then able to surge,” said du Moulin. 

“We have identified seven pillars which include business models, market shaping, public-private financing, manufacturing, innovation, tech transfer, workforce supply chain and last but not least, regulatory harmonisation.”

In preparation for the next pandemic, says Hotez: “We need to broaden the ecosystem, broaden the tent and not demonise the pharma companies either. They do a lot of good. They provide a lot of innovation and a lot of important vaccines for the GAVI Alliance.

“Remember, COVID-19 is the third major coronavirus epidemic pandemic of the century. We had SARS in 2002, MERS in 2012, and now COVID-19. So the fourth one’s coming. It’s going to happen before the end of this decade and we still haven’t prepared for that.”

mpox

The World Health Organization (WHO) has ended the global health emergency for mpox, marking the end of a 10-month juggling act by the UN health agency as it scrambled to deal with concurrent global pandemics. 

The announcement arrives just days after WHO declared the end of the global health emergency for COVID-19 last Friday, three years and 6.9 million lives after the virus was elevated to a global pandemic in January 2020. 

At a press briefing at WHO’s Geneva headquarters on Thursday, Director-General Dr Tedros Adhanom Ghebreyesus said that despite the change in designation, both viruses still pose “significant health challenges”. 

“While the emergencies of mpox and COVID-19 are both over, the threat of resurgent waves remains for both,” Tedros said. “Both viruses continue to circulate, and both continue to kill. This does not mean the work is over.”

What now?

Tedros’ announcement follows a recommendation by WHO’s emergency committee on mpox hashed out at a prolonged closed-door meeting on Wednesday. The committee assessed that the virus no longer represented a public health emergency of international concern, and recommended an end to the emergency. 

Leaders of the emergency committee stressed that the end of the emergency is not the end of the fight against the virus – but the beginning of a policy shift. 

“Lifting the public health emergency of international concern in no way means that mpox is no longer an infectious disease threat,” said Dr Nicola Low, vice-chair of the mpox committee that issued the recommendation. “[It] means moving towards a strategy that is going to manage the long-term health risks posed by mpox rather than the emergency measures that are inherent in public health emergencies.”

The committee’s recommendations include integrating mpox into national pandemic prevention, preparedness and surveillance programmes, as well as sexual health services already in place for diseases like HIV. 

“It is critically important that we continue the efforts that have been initiated already,” said Dr Rosamund Lewis, technical lead for mpox at WHO’s health emergencies programme. “As long as the virus is given an opportunity to continue to transmit from person to person, it also has the opportunity to evolve.”

Affected communities are key to sustained success

Men queuing for the monkeypox vaccine in the early months of the global outbreak.

Central to the WHO mpox committee’s policy recommendations is an emphasis on continued engagement with affected communities like men who have sex with men. 

Outside of the endemic African countries, men who have sex with men account for nearly all mpox cases, including 99% in the United States. Meanwhile, around half of all mpox infections have been in people living with HIV. 

Immunocompromised patients with HIV are not only at higher risk of severe disease from mpox, but also present an ideal environment for the virus to mutate and evolve to become more transmissible. 

Including mpox as standard in monitoring, detection and prevention programmes for sexually transmitted diseases will allow men who are already connected to sexual health services to be checked for mpox at the same time as other STIs – streamlining surveillance and treatment for both patients and health authorities, experts said. 

“Typically, around half of the cases have been among people who are living with HIV. Gay and bisexual men who have sex with men are the most affected population group here,” said Andy Seale, senior advisor at WHO on global HIV, hepatitis and sexually transmitted infections programmes. “Outbreaks like this start and end in communities and it is these communities that will help us be on top of the surveillance, the intelligence and the dynamics as the outbreak continues to evolve.” 

WHO experts also credited community organisations for their key role in helping to contain the outbreak of the virus through education, awareness, treatment and vaccination campaigns. 

“We now see steady progress in controlling the outbreak based on the lessons of HIV and working closely with the most affected communities,” Tedros said. “The work of community organisations together with public health authorities has been critical.” 

Endemic African countries are another story

mpox
Patient participating in a clinical trial of Tpoxx, an antiviral treatment for the mpox virus, in the Democratic Republic of Congo.

Lost in the shuffle of the celebrations over the end of the mpox emergency is the reality that countries where the disease is endemic – such as the Democratic Republic of Congo and Nigeria – still have a steep hill to climb. 

While a vaccine intended for smallpox made by Danish company Bavarian Nordic was quickly deployed under emergency authorizations in the United States and Europe at the start of the mpox emergency, the manufacturer’s monopoly over the vaccine patent and limited stock prior to the global outbreak made access difficult, even for rich countries. 

“[We] recognize that there has been less than expected or less than desired commitments to vaccine equity and distribution, particularly to Africa,” Lowe said. “But it’s also recognized that we still have insufficient evidence about vaccine effectiveness from randomized control trials.”

Currently, WHO recommends the use of Bavarian Nordic’s vaccine primarily for post-exposure prophylaxis, and only for use in prevention under specific circumstances. Randomised control trials to improve data on the efficacy of the vaccine are being planned in endemic countries, Lowe said. 

Another obstacle to eradicating mpox is the mystery around how the strain of the virus that spread globally evolved to sustain prolonged human-to-human transmission. Until that question can be solved, the road to ridding the world of the virus remains a long one.

“How it went from a possible zoonotic source to the human population with amplification of transmission is something we don’t yet have information on,” Lewis said. “We need to continue to support countries and regions where this research on the origins of the virus that will be instrumental to our understanding going forward is ongoing.

“Countries in Africa were dealing with mpox long before this outbreak began, and will continue to deal with it for some time to come,” Lewis said. 

Nurses working in Neonatal intensive care unit, Yekatit Hospital Medical College, Ethiopia.

Zero gains have been made in any region of the world in reducing premature births in the past decade, a major UN report found. In a perfect storm of flatlining progress in maternal and newborn health, preterm birth has become to the leading cause of child mortality worldwide, responsible for the deaths of over one in five children who die before their fifth birthday. 

The report, which includes the first updated estimates from the UN on preterm births since 2012, estimates 13.4 million babies were born prematurely in 2020, with nearly one million dying from complications related to their premature birth. Since 2010, a total of 152 million babies – one in 10 worldwide – were born too soon.

The consequences of preterm birth, where a baby is born in the first 37 weeks of pregnancy, can be lifelong, leaving millions of children facing serious physical and developmental disabilities and health complications that will shape their lives and that of their families.

“Every two seconds, a baby is born too soon,” the report by the World Health Organization (WHO), UNICEF, and the Partnership for Maternal, Newborn and Child Health (PMNCH) said. “Every 40 seconds, one of those babies dies.” 

Efforts to expand investments in the health of pregnant women, mothers and newborns remain chronically underfunded, the report found, adding that climate change, the cost of living crisis, conflicts and COVID-19 have added to the risks for women and babies around the world.

“Every woman must be able to access quality health services before and during pregnancy to identify and manage risks,” said Dr Anshu Banerjee, WHO’s Director of Maternal, Newborn, Child and Adolescent Health. “Ensuring quality care for these tiniest, most vulnerable babies and their families is absolutely imperative for improving child health and survival.”

“Where babies are born determines if they survive” 

Preterm birth by gestational age and region in 2020. Source: UNICEF, WHO.

Most preterm deaths and disabilities are preventable, but inequalities in access to quality and timely care can create staggering differences in a preterm baby’s odds of survival. In analysing the new data set out in the report, its authors are blunt: “Where babies are born determines if they survive.”

Fewer than one in 10 babies born before the 28-week mark survive in low-income countries, compared to nine out of 10 in high-income countries. Sub-Saharan Africa and South Asia have the highest premature birth rates and highest mortality risk. Together, they account for over 65% of preterm births globally. Overall, almost half of all preterm babies born in 2020 were from just five countries: China, India, Nigeria, Ethiopia and Pakistan.

“The single biggest gap that we see around the world is the chance of survival for a preterm baby,” Joy Lawn, a professor at the London School of Hygiene and Tropical Medicine and co-author of the report told BBC Africa. “So this is the loudest cry in this report, that these babies should have an equal chance.” 

Sister Munaye Esmael holds her four-day-old son Umar Abdul Shafri at the UNICEF-supported Neonatal Intensive Care Unit in Ethiopia.

A broader crisis in maternal health

But premature births are just one part of the larger story of maternal health inequalities. 

In 2020, nearly 95% of maternal deaths occurred in low- and lower-middle-income countries. Over 200,000 of those deaths – 70% – took place in sub-Saharan Africa, where girls who reach the age of 15 face a one in 40 chance of dying from pregnancy-related causes. 

Meanwhile, an estimated 2.3 million newborns died within their first 28 days of life in 2022. Of the 6400 infants dying every day, 98% were in low- and middle-income countries, and 78% were in sub-Saharan Africa and Asia.

“Pregnant women and newborns continue to die at unacceptably high rates worldwide, and the Covid-19 pandemic has created further setbacks to providing them with the healthcare they need,” Banerjee said. “More and smarter investments in primary healthcare are needed now so that every woman and baby – no matter where they live – has the best chance of health and survival.” 

More staff, more equipment, more support

As premature births claim the top spot on the ladder of causes of child mortality, less than a third of countries report having enough care units to treat vulnerable newborns, a new UN report launched at a major maternal and newborn health conference in Cape Town, South Africa, this week found. 

Around two-thirds of emergency childbirth facilities in sub-Saharan Africa are not fully functional due to a lack of vital resources like water, electricity, medicines, equipment, or staff for round-the-clock care, the report added. 

Miriam Asembo, a nurse and mother of two premature babies, shared her experience of what it is like to be on both sides of an underfunded maternal care system in her home country of Kenya. 

“There is a lack of incubators per number of premature babies born, we find babies sharing incubators in public hospitals, which is ridiculous,” she said, adding that sharing incubators can increase infant mortality due to infection risks. “It boils down to access to oxygen cylinders and medical air, which is something that we should not be talking about in 2023.” 

There is also a chronic lack of trained midwives, nurses and hospital staff. In 2022, nearly a third of women did not receive even half of the WHO’s recommended antenatal checkups during the pregnancy or have access to any postnatal care.

“We need to address the human resource shortages and training of personnel in these low-income countries, right from the traditional midwives to the nurses to the doctors,” Asembo said.

“The saddest bit is as much as [people] give birth to babies prematurely, nobody follows up with you to find out what you are doing to keep the child alive,” she said of her experience after the birth of her two children, Sifa and Teko.

Lost years, lost potential 

Estimated national preterm birth rates and numbers in 2020. Source: UNICEF, WHO.

Poor neonatal conditions have been the leading cause of lost disability-adjusted life years (DALYs) since 1990. This high burden of DALYs – each representing the loss of one full year of health compared to life expectancy –  is due to how early babies who lose their lives to preterm-related complications die, effectively leaving their entire lives, and economic potential, ahead of them. 

“Investment in the right care during this sensitive period can unlock more human capital than at any other time in the life-course, bolstering the case for investing now to gain significant human and economic returns,” the report said. 

Lawn, who has worked in neonatal care across Africa for her entire career, echoed the report’s findings, highlighting the role Africa’s youthful demographics are already playing in the continent’s growth, and can play in its future. 

“We continue to accept that more than one million newborns die every year in Africa, more than on any other continent,” she said. “This is really critical for Africa … Those newborns, they don’t have a voice. Often the women who it happened to don’t have a voice. And politicians are not rising up and saying that this is not just charity, it is investing in the future of your country.

“You want your newborns not just to survive, but to thrive,” Joy concluded. “The investment may not be small, but the return is huge for the next generation.”

Image Credits: UNICEF.

HIV activists want the US government to appeal Tuesday’s court ruling that pharmaceutical company Gilead did not infringe on patents held by the Centers for Disease Control and Prevention (CDC) related to two anti-retroviral (ARV) drugs.

The US government had claimed $1 billion in patent violations in relation to the use of Gilead’s Truvada and Descovy for HIV prevention – called pre-exposure prophylaxis (PrEP).

The case is the conclusion of a lawsuit filed by the Trump administration in 2019, in which the federal government argued that Gilead had violated its collaboration with the CDC and patents the CDC had secured while the two bodies were working together.

Gilead had provided the CDC with its drugs for a trial to see whether they could be used to prevent, not just treat, HIV. The CDC had paid for the trials on macaque monkeys and acquired patents related to this research.

The CDC had then offered Gilead licenses on the patents in exchange for royalties on two drugs if they were marketed for PrEP.

However, Gilead refused and went on to market its drugs for PrEP, initially charging patients around $20,000 for a year’s supply of Truvada.

In addition, Gilead had counter-sued the federal government in 2020 for violating the terms of their PrEP collaboration, arguing that the CDC had sought the patents without notifying the company of its intention, as required by their agreement, and that these patents – on Gilead’s drugs – were thus invalid.

Gilead won that case last year, which undermined the federal government’s case.

However, the advocacy organization PrEP4All, said that, “if the jury’s verdict stands, it will not only perpetuate harm to the American people but also threaten to set a dangerous precedent, encouraging other drug companies to privatize and profit from publicly developed technology with impunity”.

“Taxpayers paid for CDC and NIH’s invention and development of HIV PrEP. CDC scientists patented their work. The government attempted, for years, to negotiate with Gilead a reasonable license to these patents.”

However, Gilead said in a statement that the court decision “confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it”.

The UN multi-stakeholder meeting on pandemic prevention, preparedness and response.

The global response to COVID-19 failed people in developing countries, women and health workers and must never be repeated, non-state actors told a meeting hosted by the United Nations (UN) in New York on Tuesday.

The UN convened the four-hour multi-stakeholder meeting on pandemic prevention, preparedness and response (PPPR) in preparation for a High-Level Meeting (HLM) on the issue in September, which will adopt a political declaration.

Dr Joanne Liu, representing the Independent Panel for PPR, told the meeting that Ebola would not have been defeated without high-level political leadership, and the same was necessary to address future pandemics.

“We need the highest level of political attention on pandemic threats because they are overwhelming, complex and have a multi-sectoral impact,” said Liu. “A leader-led Global Health Threat Council is essential to sustain global pandemic readiness.”

Lui added that “it is certain that new pandemic threats will emerge, but full-blown pandemics are a political choice.

“This September, the UN General Assembly has the historical opportunity to choose to make COVID-19 the last pandemic of such devastation.”

Health threats council?

In a recorded message, World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus supported “the proposal for a health threats council as a forum for high-level political leadership”. 

However, he warned that such a council had to be “grounded in WHO constitutional mandate and complement and strengthen existing governance structures, including the World Health Assembly and the Standing Committee on Health Emergency Prevention, Preparedness and Response, which the WHO’s executive board established last year”. 

Otherwise “we face the risk of establishing multiple disconnected initiatives that drive further fragmentation”, he added.

But Nina Schwalbe, representing the UN University’s International Institute of Global Health, advocated for a high-level council to hold member states accountable for their commitments to PPR that was independent of the WHO.

“As has been evidenced by other sectors, including human rights, chemical weapons, climate and atomic energy, signing a treaty is not enough,” she noted. 

“Compliance requires independent monitoring. Reporting to the highest level of government, a high-level political council made up of heads of state and their representatives can drive cross-national, multisectoral accountability and monitor member states compliance with the pandemic accord,” she added.

Meanwhile, the Pandemic Action Network called for “a robust set of monitoring and accountability mechanisms in the high-level declaration, starting with a progress review within 12 months of the summit”. 

Nurses from the primary care team at the Gonçal Calvo Health Centre in Spain test for COVID-19.

Addressing inequity

“The primary manifestation of inequality was the inequitable distribution of vaccines,” said Dr Carlos Correa of the South Centre. “The COVAX mechanism failed to achieve equitable distribution of vaccines not only due to financial reasons but because the governance of the system was not multilateral in nature.”

Amnesty International noted that 28% of COVID-19 deaths were in Latin America and the Caribbean, yet it is home to only 8.4% of the world’s population.

“Our societies suffer a rampant inequality that excludes entire populations from health systems, especially women and indigenous peoples,” it noted.

The Medicines Patent Pool (MPP) said it was possible to include equitable access conditions in funding agreements to help “address questions of affordable access long before the product comes to market”. 

“This is especially important in the context of PPPR. Public, multilateral and charitable financing of r&d can be conditioned on funded entities taking sufficient measures by voluntary licencing or otherwise, to ensure that every medical technology is available and affordable to all,” said the MPP.

Meanwhile, the People’s Vaccine Alliance wants any political declaration to “enable local production to ensure a sustained supply of countermeasures”. 

“That means a commitment to sharing technology, removing intellectual property barriers, investing in r&d in the south, and investing in actual manufacturing,” said the alliance’s Mohga Kamal-Yanni.

Protecting healthworkers 

“The pandemic exacted a huge toll on the physical and mental health of health workers around the world, infecting millions and causing the deaths of more than 180,000,” said Pamela Cyriano from the International Council of Nurses.

“Excessive” burnout and the ageing of the workforce are exacerbating the already existing shortage of six million nurses, half of which are in our African nations. 

“Healthcare workers stepped up for COVID and put their lives on the line. But we have to ask, will they be there the next time,” she said, calling for the investment in fair and decent pay and in the training new nurses,” sakis Cyriano.

David Bryden, director of the Frontline Healthworkers Coalition, also pointed out that “migration of health workers, in particular nurses, from low and middle-income countries to high-income countries has increased dramatically in recent years, putting pandemic response capacity at risk in their countries of origin”.

More parliamentary involvement

Ricardo Baptista Leite, president of UNITE Parliamentarians’ Network for Global Health

Ricardo Baptista Leite, president of UNITE Parliamentarians’ Network for Global Health, urged more involvement of Members of Parliament in negotiations on a pandemic accord, currently coordinated by the WHO.

“I was in a meeting of 300 MPs recently and asked who had heard of the pandemic accord and no one put up their hand,” said Leite, pointing out that MPs pass the budgets of countries and are thus essential in securing finances for pandemic preparedness.

Leite also urged more action against the deluge of misinformation that is undermining public trust in medicines and vaccines.

Angela Kane, Senior Advisor to the Nuclear Threat Initiative.

Angela Kane, former UN Undersecretary General and Senior Advisor to the Nuclear Threat Initiative, said that there were “significant gaps” in international mechanisms to help figure out the source of biological events.

The WHO “is well positioned to assess outbreaks of natural origin, so-called spillover from animals to humans”, said Kane, adding that it is “still deciding how far it will go to assess an outbreak origin once signs begin to emerge that it may have resulted from a lab accident or deliberate bioweapons attack”. 

“This is an important decision because WHO needs to maintain the trust and openness of its member states to carry out its public health mission and engaging in security-related issues could make that difficult,” said Kane.

On the other end of the spectrum the UN Secretary-General has the authority to investigate allegations of deliberate bioweapons use –  but only when there were brought to it by member states and this had never happened.

“There is no mechanism in the UN system to assess events of unknown origin that fall between the scope of these two mandates,” said Kane. “Are we doing enough to rapidly identify cases where there’s ambiguity about a source of an outbreak?

“The challenges of discerning COVID-19 origins have highlighted the need to fill this gap for determining the origins of a disease outbreak in a form that is scientifically based.”

The multi-stakeholder meeting was one of a trio – the others dealing with tuberculosis and universal health coverage – held this week in preparation for the UN HLMs on these three issues over three consecutive days from 20-22 September.

Image Credits: Consorcio Sanitario del Maresme, Spain.

Registered nurses Fatmata Bamorie Turay (left) and Elizabeth Tumoe, look after newborns at the Princess Christian Maternity Hospital, in Freetown, Sierra Leone.

As the United Nations multi-stakeholder meeting on universal health coverage (UHC) convenes on Tuesday afternoon in New York,  we urge that women health workers are properly recognized and rewarded

The global health workforce crisis is no longer a looming possibility. It is a reality. Pre-pandemic the World Health Organization (WHO) projected a global shortage of 10 million health workers by 2030 and since then the situation has significantly deteriorated. Staff shortages are reported ever more frequently, health workers strike more often and high-income countries increase their incentives for nurses to move from low-income countries.

So why is it that recent international documents on global health, including the G7 foreign ministers’ communique on 18 April, fail to acknowledge the crucial role of health workers in the achievement of universal health coverage (UHC)? Why don’t health ministers and heads of state address the real reasons for the emptying rosters, the rock-bottom morale and the sky-high burnout?

Women make up a significant majority of the health workforce, comprising 70% of overall health and care workers and 90% of frontline staff. They lead the delivery of health to five  billion people and contribute an estimated $3 trillion annually to global health, half in the form of unpaid work. They are the backbone of our health systems.

Underpaid, excluded from leadership

But this is how we reward them. They are paid 24% less on average than their male counterparts – if they are paid at all. There are plenty, in fact six million of them estimated to be grossly underpaid or unpaid. As Samantha Power, Administrator of USAID, rightly acknowledged recently, there should be no such thing as working for free when you are providing lifesaving care.

Three-quarters of all leadership roles in health go to men who benefit from a male bonus syndrome of more opportunities for promotion, higher salaries and lower expectations at home for family care.  

Workplaces are increasingly unsafe, with reports of increased gender-based violence in health rising. There are issues with sexual abuse, exploitation and harassment.  

During the pandemic, women have suffered from a lack of infection control equipment or if it was available, trying to adjust personal protective equipment purchased in men’s sizes, increasing the risk they faced. They were the ones on the front lines, trying to explain why services like sexual and reproductive health care had been deprioritised and there was no support available. 

Women HCWs experience sexual harassment at workplace.
Two women healthcare workers caring for an infant.

Opportunity for a reset

This year is an opportunity for a reset. Heads of state will travel to the UN on 21 September and release a new global commitment to Universal Health Coverage.  

In advance of this, on 8-9 May, they have invited civil society to give suggestions for what to include in their negotiations.

While diplomats might be overwhelmed with a long list of asks, we want to remind them that health does not deliver itself.  Vaccines, drugs and technology are no good sitting in storage.  Hospitals and health centers are just buildings and beds without nurses or doctors. There is no early warning system for disease, no maternal care and no programs for primary health care unless staff are trained, retained and on shift.

So, for the governments who are preparing the negotiations, here is our prescription for prevention:

  • Fully deliver on all commitments to gender equality and the rights of women and girls in UHC, made at HLM 2019
  • Guarantee gender equality in health systems leadership and  decision-making at all levels, including use of quotas and targets for women in leadership and all-women shortlists for selection until gender parity is achieved. Give particular attention to geographical diversity
  • Close the gender pay  gap, and value and appropriately remunerate unpaid and underpaid health and care workers, including community health workers
  • Design, properly resource and deliver health systems based on gender-responsive policies and health services and the elimination of gender inequality and discrimination
  • Resource and deliver universal access to sexual and reproductive health services as essential services, and mainstream them in national health policy frameworks
  • Monitor and evaluate progress towards universal health coverage in data and analyses disaggregated by sex, gender identity and other relevant stratifiers

 Women health and care workers have faced systemic bias and traumatizing work conditions. If the world wants operating health systems, governments have an opportunity to check the lists and triage women health workers to the top.

Dr Roopa Dhatt is Co-Founder and Executive Director, of Women in Global Health.

Sharan Burrow is the former General Secretary of the International Trade Union Confederation

Image Credits: World Bank/Flickr, Photo by Mufid Majnun on Unsplash.

TB activists attend a community assembly in New York’s Battery Park to call for more investment in TB vaccines and treatments.

The United Nations (UN) is hosting three multi-stakeholder meetings in New York on Monday and Tuesday on tuberculosis, pandemic prevention, preparedness and response (PPPR) and universal health coverage (UHC).

They are aimed at getting the views of non-state actors in preparation for UN High-Level meetings in September, starting with pandemic preparedness on 20 September, followed by UHC, then TB on consecutive days.

On Sunday, a community assembly was held in New York’s Battery Park to call for more investment in TB, the second-biggest infectious disease killer after COVID-19. It included the public reading of the TB vaccine R&D investment open letter signed by almost 1200 individuals and organisations around the world.

“We have seen before that investing in averting TB deaths can bring significant economic benefits! Every dollar invested in this effort returns an average of $43 dollars, making it a smart and impactful investment for communities and economies alike,” said Kate O’Brien from We are TB USA.

“We need new TB vaccines to end TB, mitigate the impact of COVID-19 on the global TB response, and control the spread of drug-resistant TB, a key driver of antimicrobial resistance. Yet, the only available TB vaccine is the century-old Bacillus Calmette-Guérin (BCG) which is largely ineffective in adolescents and adults,” said Keyuri Bhanushali, a TB survivor and activist from Mumbai, India.

“Let’s invest in TB vaccine R&D to finally put an end to this devastating pandemic.”

Lack of consultation over pandemic and UHC meetings

However, some civil society participants told Health Policy Watch that there had been little consultation about participation, particularly in relation to the pandemic and UHC meetings, including over speakers on the panels and the procedures to be followed.

Many organisations had invested in bringing affected people from other parts of the world to the UN meetings yet they were unsure of whether they would be able to speak from the floor. In addition, they questioned why organisations’ statements would be loaded onto the website of the World Health Organization (WHO), not that of the UN.

In response, Paulina Kubiak, spokesperson for the President of the General Assembly (PGA), told Health Policy Watch that there had been “an open registration process on the UN Indico website for stakeholders to participate in the multi-stakeholder hearings”, with registration open from 2 March to 7 April. 

“The panellists were selected in accordance with the relevant resolutions of the General Assembly which require the PGA to organize the multi-stakeholder hearings with the support of the WHO and other relevant partners (Stop TB Partnership in the case of TB and UHC2030 in case of UHC),” said Kubiak.

“Written statements can be submitted by participants until May 15 and will be available on the WHO website in due course (pending the volume of submissions).”

The meetings are being broadcast live on the UN webTV:

Image Credits: UN Photo/Manuel Elias.

TibuHealth allows Kenyans to book medical appointments and tests online

Barriers to inclusive health are spurring African innovators into action. But to build an inclusive health system the continent needs to address structural inequalities – political, social and economic – and this will require that private and public partners alike embrace radical collaboration to support inclusive innovation.

When public health graduate student, Jason Carmichael, arrived in Kenya in 2013, he noticed numerous gaps in the healthcare system that troubled him. There were not enough hospitals. Doctors were not always working full-time or at full capacity, and patients were not getting the care they needed. Then he met Kenyan tech whizzkid, Peter Gicharu. They pooled their expertise and started testing models aimed at connecting the dots between healthcare providers and patients.

Fast forward to 2018, and the launch of TibuHealth, a social enterprise that delivers health services directly to those who need them. Born of the curiosity of two people about how to do things better, the system allows patients to request medical consultations, sample collections and vaccinations in their home or other chosen location using an app, website, customer support line or email.

This kind of scheduling capacity means that there is burden-shifting from the public sector to the private sector, lightening the load felt by public sector institutions. Tibu’s services cost Ksh 1,850 (US$15.80) while a typical GP charges Ksh 1,800 – 3,000. 

TibuHealth is one of the hundreds of social enterprises in sub-Saharan Africa doing extraordinary work solving healthcare challenges in innovative and often very practical ways. 

Innovating to overcome barriers 

Social enterprises are emerging as critical actors in African healthcare systems, rising to prominence during the COVID-19 pandemic where they played a key role in bolstering government responses across the region.

Where others see challenges, social innovators like Gicharu and Carmichael see opportunities. Typically, these innovative actors harness community-centred approaches and inclusive solutions to close the gaps in healthcare delivery. By their nature, they are willing to take risks to create change. They also have the local insight and business sense to turn their ideas into reality.

 According to a new White Paper published by the World Economic Forum on Innovation towards health equity in Africa, there are 10 common barriers to inclusive healthcare that social innovators across the continent are working to dismantle. The analysis included an AI scan of 450,000 pieces of content across 48 African countries and eight languages, in addition to 35 interviews and three verification workshops in 2022. 

It found that the majority of healthcare innovations (about 65%) were seeking to address issues such as weak healthcare capacity and infrastructure, the lack of access and affordability of quality healthcare and medicine, the economic impact of COVID-19, and inequality related to COVID-19 – particularly the low COVID-19 vaccination rate, due, partly to vaccine hoarding by wealthier countries. 

Other major themes included stigmatization, health literacy, digitalization and the inaccessibility of data, gender inequality, malnutrition and food insecurity, access to basic needs, and supply chain disruptions and logistic challenges.

Fundamental shift needed

But while the solutions these innovators are coming up with are ingenious and many of them are making a huge impact, on their own they won’t be enough to build a more equitable health system in Africa. As health inequality is a systems problem, it will require a systemic response.

The WEF White Paper makes the point that, to fully realise the potential of social health entrepreneurs, a fundamental shift needs to take place towards a broader health equity agenda. There needs to be a recognition that social, political and economic factors are all integral to developing fairer health systems and this will require an all-out collaboration across all sectors to create an environment that enables innovation for equity.

To build such an enabling ecosystem, attention would need to be paid to formal elements, such as public policies, governance structures, regulatory frameworks and investment programmes, and informal elements such as cultural, social and economic norms and practices.

Key principles to build equity

We believe that four key principles are necessary to underpin this work.

First, social innovators and their corporate and government partners need to build for the long haul. This means that, rather than rushing to develop a competitive solution, they need to take the time to develop their business model and authentically engage with their customers and partners to create an interconnecting web of reciprocal relationships which will help to lay solid foundations for the enterprise.

Second, they would need to be prepared for the reality that in complex systems progress is not linear. As Margaret Wheatley, the systems theorist, wrote: “We live in a world of complex systems whose very existence means they are inherently uncontrollable”. To put this another way, we need to make friends with the reality that setbacks in this line of work are common.

Building for the long haul and being clear-eyed about the nature of progress and success are key traits that encourage entrepreneurial resilience, the third key principle of an inclusive health system. If the COVID-19 pandemic showed us one thing it was that resilience – the ability to withstand and overcome adversity – is not necessarily an inherent trait but a muscle that must be exercised as individuals, teams, and organisations. 

Healthcare innovators and their partners then must take care to put in place practices to build their resilience muscle. This could include developing robust feedback loops that allow for open communication, real-time change and strong bonds between stakeholders. The ability to learn and adapt is a key factor in resilience.

Lastly, to build inclusive healthcare systems it will be necessary to embrace radical partnerships and opportunities for collaboration between different disciplines, institutions, businesses, multilaterals and government departments. 

Health equity is everyone’s business. Every actor in the ecosystem needs to do what they can to support the innovation and resilience of social entrepreneurs and innovators at ground level and they need to work together to go further.

Unlocking such partnerships will require greater levels of trust and mutual understanding between government business and societal actors, and this will take hard work to build. But build it we must because, without it, it is unlikely that we will get close to achieving true health equity in Africa. And sick and vulnerable people across the continent will continue to be excluded from life-saving care.

 

Katusha de Villiers is Health Systems Innovation Lead for the Bertha Centre for Social Innovation and Entrepreneurship at the University of Cape Town.

Gillian Moodley is a Project Manager at the Bertha Centre for Social Innovation and Entrepreneurship at the University of Cape Town. 

Both contributed to the new white paper on Innovation towards health equity in Africa, published by the World Economic Forum.

 

WHO Director General Dr Tedros Adhanom Ghebreyesus declares an end to the COVID-19 global public health emergency – but warns disease remains a threat.

The COVID global health emergency is over, said WHO Director General Dr Tedros Adhanom Ghebreyessus at a press conference on Friday.  His declaration came more than 39 months after WHO first declared a public health emergency of international concern (PHEIC) on 30 January 2020 over a mysterious respiratory virus that emerged in Wuhan, China but quickly overcame countries around the world.

Speaking at a media briefing, the WHO DG warned that the disease remains a threat along with multiple other stressors threatening global health and security – from climate change to weak health systems. Taken together, these could soon lead to yet another pandemic if not forcefully addressed.

He called upon political leaders to move quickly to finalise the terms of a new Pandemic Accord being negotiated by WHO member states, as well as agreeing to revisions in WHO’s existing International Health Regulations so as to “transform that suffering” of COVID 19 into “meaningful and lasting change” with a “commitment to future generations that we will not go back to the old cycle of panic and neglect that left our world vulnerable.”

He noted that “COVID-19 turned our world upside down” with a reported death toll of seven million deaths but a likely actual death toll of close to 20 million.

And “the virus is here to stay” he stressed, warning countries not to let down their guard.

Litany of damage

Coronavirus lockdown in a Roma community in Romania in May 2021. Poverty made social distancing and basic hygiene rules difficult, if not impossible, for billions.

In the warm-up to his announcement, the WHO DG reviewed the litter of global damage wrought by the virus that ripped like a hurricane through societies worldwide in early 2020:

“COVID has been so much more than a health crisis,” Tedros observed.  “it has caused severe economic upheaval, shaving trillions from GDP, disrupting travel and trade, shattering businesses and throwing millions into poverty.

“It caused severe social upheaval, with borders closed, movements restricted and schools shut, and millions of people experiencing loneliness, isolation, anxiety, and depression.

“COVID-19 has exposed and exacerbated political lines within and between nations.|

“It has eroded trust between people, governments and institutions, fueled by a torrent of myths and misinformation. And it has laid bare the searing inequalities of our world – with the poorest and most vulnerable communities the hardest [hit] and the last to receive vaccines and other tools.”

But in light of the steady downward trend in COVID-related mortality, brought about by a weakening virus, growing population immunity and increased vaccination rates, WHO’s COVID-19 Emergency Committee “recommended to me that I declare an end to the Public Health Emergency of International Concern (PHEIC), ” he said.  He was referring to the emergency provisions of WHO’s International Health Regulations (IHR) that legally obligate WHO members states to act on public health threats.

The Emergency Committee made its recommendation following a meeting Thursday in Geneva – the 15th such gathering since the SARS-CoV2 virus was first reported in Wuhan in early January 2020.

COVID is over as a global health emergency – but not as a global health threat

An Italian border guard checks the temperature of an arriving airline passenger in April 2020, as the first wave of the COVID pandemic crested.

“It’s therefore with great hope that I declare COVID-19 over as a global health emergency. However, that does not mean COVID-19 is over as a global health threat,” Tedros cautioned.

“Last week COVID-19 claimed one life every three minutes – and that’s just those that we know.  As we speak thousands of people around the world are fighting for their lives in intensive care units. And millions more continue to live with the debilitating effects of post COVID-19 conditions.

“This virus is here to stay. It’s still killing. And it’s still changing; the risk remains of new variants emerging that cause new surges in cases. So the worst thing any country could do now is to use this news as a reason to dismantle the systems it has built or to send the message to its people that COVID-19 is nothing to worry about.”

“This is not a signal for us to lower our guard”: Didier Houssin, head of the WHO COVID Emergency Committee

“This is not a signal for us to lower our guard,” added Didier Houssin, head of the WHO COVID Emergency Committee that had met Thursday and issued its recommendation to WHO for the COVID state of emergency to finally be lifted.

What the announcement does reflect, however, is that “it’s time for countries to transition from emergency mode to managing COVID-19 alongside other infectious diseases,” Tedros said.

With that in mind, he said that he would deploy a “never used” provision in the WHO International Health Regulations, to establish a standing COVID Review committee to make and update recommendations to countries about management of the virus on an on-going basis.

Declaration was not unexpected

A WHO declaration on the end of the global health emergency had been anticipated for sometime, Tedros and other WHO officials speaking at the Friday briefing admitted.

“I emphasize that this is not a snap decision,” Tedros said. “It’s a decision that has been considered carefully for some time, planned for, and made on the basis of careful analysis of the data.”

WHO’s release Wednesday of an updated COVID-19 Global Strategic Preparedness, Readiness and Response Plan (SPRP) 2023-2025” had fueled speculation among seasoned WHO-watchers that an announcement was imminent.

Is the COVID Pandemic Over?

The document was billed as a guide for managing COVID “in the transition from an emergency phase to a longer-term, sustained response”.

Alongside reducing circulation of the SARS-CoV-2 virus and diagnosing and treating COVID-19, a third objective of the plan is to “to support countries as they transition from an emergency response to longer-term sustained COVID-19 disease prevention, control and management”, the WHO DG stated in a foreword.

Worldwide, countries have also gone back to near normal – with lockdowns and social distancing giving way to packed cafes and theatres.  Masking remains visible in some venues like airports and subways – but at a voluntary bare minimum.  And government travel and emergency decrees have now been lifted in even the most COVID-wary nations, like Japan and China – the latter of which saw a big wave of cases in late 2022 after intense public protests led to the removal of most domestic restrictions.

Coincidentally or not, the United States is also set to announce an end to its national COVID emergency next week, on 11 May.  That will see the lifting of most federal COVID vaccine mandates for groups like health workers – even though the virus still remained the fourth leading cause of death in the US in 2022.

Transform the suffering into meaningful and lasting change

But even as so-called ‘normalcy’ returns, Tedros urged global health leaders to rapidly conclude negotiations on a strong Pandemic Accord, as well agreeing to amendments in the existing WHO International Health Regulations (IHR), to avoid repeating the mistakes of the COVID pandemic once more.

“One of the greatest tragedies of COVID-19 is that it didn’t have to be this way,” Tedros said. “We have the tools and technologies to prepare for pandemics better, to detect them and then to respond to them faster and to mitigate their impact.  But globally, a lack of coordination, a lack of equity, and the lack of solidarity meant that those tools were not used as effectively as they could have been.  Lives were lost that should have been.

“We must promise ourselves, and our children and grandchildren that we will never make those mistakes again,” he said describing the draft treaty and IHR revisions as representing a “commitment to future generations that we will not go back to the old cycle of panic and neglect that left our world vulnerable.

“… If we all go back to the way things were before COVID-19, we will have failed to learn our lessons.”

Huge strides made should not be lost

Mike Ryan, WHO Executive Director, Health Emergencies

WHO’s Health Emergencies Executive Director Mike Ryan, echoed those sentiments noting how the COVID pandemic saw huge strides made in the expansion of national disease surveillance systems, laboratory testing, clinical care, and access to life-saving tools from new vaccines to oxygen.

“The challenge is really how to we keep up this momentum,” he observed, “because it’s not only important for COVID, it’s important for other diseases that are in circulation.

“We need the world to get into a preparedness mode,” he added.  “We can’t just keep responding and responding and responding.  We have to get the inequities out of our system.  We saw people in this pandemic literally bargaining for oxygen cannisters on the streets of major cities. This is the 21st century.  Is this what we want to witness in the next pandemic?

A COVID patient breathes in life-saving oxygen outside an overcrowded New Delhi hospital at the height of India’s COVID surge in 2021.

“We saw family members physically fighting to get their loved ones into a hospital bed.  We saw people die before they got to the emergency room. That’s the reality of our preparedness.  We talk about technology but we can’t just use technology to get out of the mess we’re in.  We have to address our systems. We have to address how we govern.  We have to address how we finance.”

Negotiating teams have just a year to reach broad consensus

Wholesale markets in Asia and Africa may often sell wild animals captured or bred for food consumption; SARS-CoV2 may have emerged from such a Wuhan market.

Within WHO, there are two member state groups leading negotiations on a draft pandemic accord and revisions in existing WHO health emergency (IHR) rules. The two bodies, the Intergovernmental Negotiating Body (INB) and the IHR Working Group have just one more year to complete their work in line with a mandate to bring draft agreements to the World Health Assembly by May 2024.  They are planning a joint meeting soon in an effort to sort out what topics, among the multiple issues facing negotiators, would better be handled in one instrument as compared to the other.

Together, they face a formidable task in reaching WHO member state consensus over a raft of issues – from measures to ensure stricter monitoring and reporting by countries of emerging threats to more sustainable financing of developing country health systems and more equitable distributions of vaccines, medicines and other vital health tools.

Along with that, climate change, ecosystem destruction, and poorly regulated wildlife markets and trade are constantly increasing the risks of zoonotic spillover of new and resurgent diseases from animals to humans. And these are problems that the health sector cannot effectively address without the active consent and collaboration of economic and environment sectors.

Appeals to UN General Assembly to show leadership

Ellen Johnson Sirleaf, former Liberian president and former co-chair of the Independent Panel.

The problems go beyond what WHO alone can handle, some leading advocates have asserted, calling for the UN General Assembly to play a more active role going forward. The UN General Assembly is scheduled to hold a high level meeting on pandemic preparedness, prevention and response on 20 September – with a civil society stakeholder meeting set for next week.

Among the voices calling for more UN-wide leadership are Helen Clark and Ellen Johnson Sirleaf, former co-chairs of the Independent Panel on Pandemic Preparedness and Response, which issued a scathing report to WHO in May 2021. On Thursday the two former co-chairs issued a new “Road Map”  calling for more assertive action by the UNGA alongside WHO.

“Bold political choices to protect the world” are needed, the report states, including UN-wide agreement on stronger international pandemic rules, equitable countermeasures and an independent monitoring body working alongside an “authoritative WHO”.

In terms of finance, at least US$10.5 billion annually is needed to support low- and middle-income countries to bring health systems preparedness up to par.  So far, only about 10% of that has been committed to a new World Bank-hosted Pandemic Fund. Debt relief for overstretched developing nations and innovative forms of climate and sustainable development finance also are critical to pandemic prevention, the report states, referring to the “Bridgetown Agenda” championed by Mia Mottley, prime minister of Barbados.

“At a time of difficult geopolitical divide, the UN General Assembly High-Level Meeting presents an historic opportunity to demonstrate the power of multilateralism and political leadership, and choose human collaboration to overcome the threat of pathogens that could materialise anywhere, anytime,” said Helen Clark, former Prime Minister of New Zealand.

“We will face new pandemic threats. The UNGA must draw on the hard lessons from COVID-19 and honour the memory of the many millions of people who have died, to commit to comprehensive reforms that leave no gaps in the system this time,” said Johnson Sirleaf, former president of Liberia.

Image Credits: Thomas Hackl/Flickr, Flickr, Peter Griffin/Public Domain Pictures.

INB co-chair Precious Matsoso

Equity and intellectual property (IP) rights are – unsurprisingly – the most important and trickiest issues facing countries negotiating the terms on which the next global pandemic will be addressed.

This emerged at a World Health Organization (WHO) briefing on Thursday addressed by Precious Matsoso, co-chair of the Intergovernmental Negotiating Body (INB) crafting a pandemic accord, and Dr Ashley Bloomfield, co-chair of the working group on amendments to the International Health Regulations (IHR).

Matsoso said that IP was being raised in discussions about how to “stimulate innovation” and “facilitate access” to pandemic-related products, including vaccines and medicines.

Meanwhile, Bloomfield said that a key discussion in the IHR working group was how to “effectively put equity into operation through the regulations”, particularly aiming at improving member states’ capacity to address future pandemics. 

“[The discussions] are around the funding for that, and they are around access and benefit sharing and, in particular, access to the technologies that are derived from the sharing of viral samples – in particular vaccines, but also treatments,” said Bloomfield, adding that these were also issues being discussed by the INB.

Combined processes

There is only a year left for both to complete negotiations on both a pandemic accord and changes to the IHR, the only globally binding rules to guide international disease outbreaks. Both the draft accord and proposed amendments are due to be presented to the 2024 World Health Assembly.

As there is significant overlap in the work of the INB and the IHR working group, they are currently planning a joint meeting, said Matsoso.

“Member states in a number of meetings have raised this issue of the overlaps and duplications, and they’ve called on us to bring these processes closer and ensure that we can delineate those areas that belong to different parts,” said Matsoso.

“We see this as a continuum because, you can imagine, if you’re in a country, and you’re hit with a pandemic and you have to refer to both these instruments once they’re adopted, there must be a systematic way in which they are followed,” said Matsoso.

“Our task is both bureaus (technical leads for the two processes)  is to help member states to organise this in such a way that there’s coherence and the synergy, but also a continuum so that they don’t see [the two instruments] as separate processes.”

Dr Ashley Bloomfield, co-chair of the IHR working group.

Bloomfield added that the bureaus “have met several times already together, virtually, and our last meeting most recent meeting was just a couple of days ago”.

At that meeting, bureau members had started to “shape up this request that we’ve got from both processes from the member states to hold a joint session to start to address these issues that we have in common”. 

For some member states, the same representatives are negotiating in both the INB and the IHR working group. Meetings have thus usually been organised “adjacent and back to back” to help these representatives, primarily from African countries and small island states.

Pandemic oversight

One of the weaknesses of the IHR is that there is insufficient monitoring, oversight and compliance with the regulations.

The US, Africa region and the European Union have all made proposals to address this gap, said Bloomfield.

“There’s quite a lot of similarity between those proposals so there’s work underway to see if we can get a single convergent proposal,” he said. 

“The tenor of the discussion we have had is very much of the flavour that we should be looking to how we can incentivize and support countries to implement the IHR in full and to comply with their obligations, rather than sanction,” he added.

Matsoso said that, within the INB, proposals had been made about peer review mechanisms, adding that “punitive measures have not been shown to work anywhere… But there must be some accountability mechanisms”.

National sovereignty

Panellists expressed surprise at the ongoing mis-and disinformation about how the pandemic negotiations would result in member states losing their national sovereignty to the WHO.

WHO Principal Legal Officer Steven Solomon described the two processes as “some of the most transparent in the history of WHO’s work on global health instruments”. 

WHO Principal Legal Officer Steven Solomon

“Member state-driven means that member states decide and, in the context of preparing instruments like this it means specifically that member states, countries, make the proposals,” said Solomon.

“Countries do the drafting country, do the negotiating, the work and finding consensus. Countries make the decision on what is to be agreed and then, under the Constitution, countries adopt whatever the outcome might be in the World Health Assembly,” he added. 

“Even at that point, this does not mean acceptance by a country after adoption in the Health Assembly, which is a formal act. Then countries individually must consider and decide whether they accept what was adopted in the Health Assembly. So there’s nothing automatic that happens in terms of the entry into force of whatever will be adopted at the Health Assembly.  Countries themselves will decide to accept or not the outcomes of that process of the assembly.”

Bloomfield also stressed that, despite the “myths and disinformation”, “member states are in the driving seat and they are the decision-makers”.

“It’s not really an issue that is troubling the discussions we’re having in the working group because all those people are fully aware of the mandate they have from their governments.”