Norway’s Ambassador for Global Health, Dr John-Arne Røttingen, is the incoming CEO of Wellcome.

Norway’s Ambassador for Global Health, Dr John-Arne Røttingen, has been appointed CEO of the charitable foundation Wellcome, one of the world’s largest funders of science aimed at solving urgent health issues, the body announced on Wednesday.

Røttingen, who will assume the position in January 2024, has had a versatile and varied career. He started out as a medical scientist, and then trained as a medical doctor before moving into the fields of infectious disease epidemiology and global health.

He received his MD and PhD from the University of Oslo, an MSc from Oxford University and an MPA from Harvard University. 

He has already had a long association with Wellcome. He was the founding CEO of the Coalition for Epidemic Preparedness Innovation (CEPI), which Wellcome helped to launch in 2017.

He was also CEO of the Research Council of Norway, where he worked with Wellcome and European funders to accelerate open access to research publishing. His current position is in Norway’s Ministry of Foreign Affairs.

Røttingen has also led the steering groups for the Ebola vaccine trial in Guinea and the COVID-19 WHO Solidarity Trial, as well as the Lancet Series on access and sustainable effectiveness of antimicrobials. He has worked in academia and co-authored more than 150 peer-reviewed publications.

He is currently on the boards of Gavi, the vaccine alliance, PATH, the Global Antibiotic Research and Development Partnership (GARDP) and the Medicines Patent Pool (MPP). 

“Wellcome believes in the power of science to build a healthier future for everyone, and that science delivers the greatest change through collaborative action across society,” said Wellcome board chairperson Julia Gillard.

“John-Arne’s career and experience exemplify these beliefs. He has built a reputation as one of the world’s most effective and respected figures at the interface between science and advocacy at the highest global levels.”

Røttingen said that he had long admired Wellcome’s  “inspiring work to bring the potential of science and discovery to society to build a healthier future”. 

“Philanthropy has a critical role to play in catalysing and complementing public and private research spend to improve health globally. I know well from my own experience the power of the support Wellcome gives science and scientists, backing basic research and ensuring transformative research achieves impact in the world,” he added.

Wellcome has committed to spending £16 billion on science until 2032, supporting discovery research into life, health and wellbeing, and focusing on three key health challenges: mental health, infectious disease and climate and health.

Wellcome is self-funded through returns from its investment portfolio, which has grown significantly in recent years to £38bn. 

Incoming EMRO director Dr Hanan Balkhy being congratulated by current regional director Dr Ahmed Al-Mandhari

Dr  Hanan Balkhy has been elected as the World Health Organization’s (WHO) Regional Director for the Eastern Mediterranean Region (EMRO), becoming the first woman ever to have been chosen for the challenging position in the world’s most conflict-ridden region.

A Saudi national, Balkhy will assume the position on 1 February 2024 for a period of five years, serving a population of 745 million people. 

This was after the region’s 22 member states chose Balkhy on Tuesday at their 70th session. Her nomination will be presented to the WHO Executive Board in January for formal ratification. 

Balkhy has an expertise of more than a decade in public health, children’s health, and infectious diseases. 

She has been Assistant Director-General for Antimicrobial Resistance at the WHO headquarters in Geneva since 2019. Prior to this, Balkhy was the first Executive Director for Infection Prevention and Control at the Saudi Arabian Ministry of National Guard. 

Socio-economic gaps

The EMRO region stretches out across Morrocco to the Gulf and West Asia to Pakistan, the new regional director has to explore and identify strategies to improve the region’s healthcare capabilities by addressing the glaring socio-economic gaps. 

The region comprises some of the world’s richest countries – Qatar, the United Arab Emirates (UAE), Saudi Arabia, Bahrain, Kuwait and Oman – and the poorest – Afghanistan, Yemen, Sudan and Somalia.  Iran, Iraq, Afghanistan and Pakistan are all part of the region

There are massive discrepancies between the countries in terms of health indicators. For example, the life expectancy in Qatar is 80 years but in Somalia, it is only 55.4 years. 

In terms of maternal mortality, 620 Afghan women die for every 100,000 live births, in comparison with 70 Kuwaiti women  per 100,000 births.

While Israel opted to be part of the WHO European region, Balkhy will have to address the health fallout of the intense conflict between Israel and the Occupied Palestine Territory, which is also part of her region.

A mother and her newborn baby at the Maternal & Child Health Training Institute in Dhaka, Bangladesh.

Excessive bleeding is the main cause of women dying in childbirth, yet the global guidelines to tackle postpartum haemorrhage (PPH) are inadequate and outdated.

To rectify this, the World Health Organization (WHO) and its partners have developed the world’s first PPH roadmap, and aim to have new global guidelines by the first quarter of 2025.

“Severe bleeding in childbirth is one of the most common causes of maternal mortality, yet it is highly preventable and treatable,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “This new roadmap charts a path forward to a world in which more women have a safe birth and a healthy future with their families.”

The roadmap focuses on four strategic areas – research, norms and standards, implementation and advocacy.

Around 70,000 women die every year as a result of this excessive bleeding, with over 85% of these deaths in sub-Saharan Africa and South Asia. 

Risk factors include anaemia, placental abnormalities, and other complications in pregnancy such as infections and pre-eclampsia. 

Yet the current guidelines are largely silent on how to prevent PPH. Anaemia, or severe iron deficiency, affects 37% of pregnant women around the world – and in some places in South Asia, is as high as 80%. This could be rectified by giving vulnerable pregnant women high-quality prenatal vitamins that include iron.

Lack of trained health workers and medicines

Many countries lack the medicines and trained health workers to stem the excessive bleeding.

Research conducted in four African countries by Dr Hadiza Galadanci, a Nigerian obstetrician, found that many healthcare workers struggled to recognise how much blood loss is too much – and over half the women who experienced PPH were never diagnosed.

“If bleeding starts, it needs to be detected and treated extremely quickly,” according to the WHO. “Too often, however, health facilities lack necessary healthcare workers or resources, including lifesaving commodities such as oxytocin, tranexamic acid or blood for transfusions.”

To address the frequent stock-outs of PPH medicines, the WHO and global partners involved in pooled procurement – such as the Global Financing Facility (GFF), Reproductive Health Supplies Coalition and UNFPA – will conduct a scoping exercise by the end of the year to work out how to “nudge procurement of PPH commodities towards higher quality products and to increase international financing for these commodities”. 

Extending the scope of midwives

One of the measures that the WHO is working on to address the lack of trained health workers is for the scope of practice of midwives to be extended. The International Federation of Gynecology and Obstetrics (FIGO), International Confederation of Midwives (ICM), and ministries of health and national professional societies are assisting with this.

The ICM recently published a scope of practice and competencies for midwives that includes providing intravenous medication, for example.

“Addressing postpartum haemorrhage needs a multi-pronged approach focusing on both prevention and response – preventing risk factors and providing immediate access to treatments when needed – alongside broader efforts to strengthen women’s rights,” said Dr Pascale Allotey, WHO Director for Sexual and Reproductive Health. 

“Every woman, no matter where she lives, should have access to timely, high-quality maternity care, with trained health workers, essential equipment and shelves stocked with appropriate and effective commodities – this is crucial for treating postpartum bleeding and reducing maternal deaths.”

The Bill and Melinda Gates Foundation (BMGF) recently released a report advocating for a simple package of care to be adopted by countries to stem PPH.

Five treatments are conventionally used to stop the bleeding – uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, and genital tract examination. 

“But those interventions were being delivered sequentially – and far too slowly,” according to the report, which advocates for them all to be applied at the same time.

Image Credits: UN Photo/Kibae Park/Flickr.

Lab technicians at South African at vaccine manufacturer Afrigen.

The Bill and Melinda Gates Foundation (BMGF) announced on Monday that it would invest $40 million to advance the development of mRNA innovation and production in low- and middle-income countries (LMICs) to help them produce low-cost and high-quality vaccines at large scale.

In an address to the more than 1,400 scientists, policymakers, and donors attending the foundation’s Grand Challenges annual meeting in Senegal, BMGF co-chair Bill Gates, called for the world to spend at least $3 billion more every year on global health research and development (R&D) to close the critical gaps in funding for neglected diseases.

“New health technologies have the potential to save millions of lives, but R&D funding is going in the wrong direction,” Gates told delegates. “Donors need to step up their commitments to ensure health innovations reach other who need them more quickly, so more lives can be saved”. 

Although overall health R&D funding is growing, only about 2% is directed at diseases that affect the world’s poorest population. 

The Gates Foundation acknowledges the potentially critical role of mRNA technology in developing vaccines against infectious diseases commonly found in the global south, including tuberculosis and  malaria. 

The new grant of $40 million is to improve the access of African research institutes with vaccine manufacturing experiences to access to Quantoom Biosciences’ affordable mRNA research and manufacturing platform. 

Quantoom Biosciences will get $20 million to facilitate access to the next-generation mRNA health tools, while the Institut Pasteur de Dakar in Senegal and South Africa’s Biovac, will each receive $5 million to improve their capacity to develop vaccines to fight local diseases. A further $10 million will be allocated to other LMIC vaccine developers that have yet to be identified. 

“Putting innovative mRNA technology in the hands of researchers and manufacturers in Africa and around the world will help ensure more people benefit from next-generation vaccines,” said Dr Muhammad Ali Pate, Nigeria’s Minister of health and social welfare and a global expert on vaccines. 

“This collaboration is an encouraging step that will increase access to critical health technologies and help African countries develop vaccines that meet the needs of their people.”

The cost of producing a vaccine with Quantoom’s platform could drop to nearly half the cost of vaccines produced with traditional mRNA methods. 

“Innovation can be transformative, but only if it reaches the people who need it most,” said Morena Makhoana, CEO of Biovac. 

“This collaboration will help close critical gaps in access to promising mRNA vaccines against diseases that disproportionately affect the world’s poorest. It will also assist us in our mission to establish end-to-end vaccine manufacturing capability at scale in Africa for global supply”.

During the COVID-19 pandemic, Africa was sidelined in the rush for vaccines. In reaction, the African Union adopted a New Public Health Order in September 2022 which sets a bold target of meeting up to 60% of the continent’s vaccine demand through regional manufacturing by 2040. At present, the continent only produces 1% of vaccines used in Africa.

Image Credits: Rodger Bosch/ MPP & WHO.

One billion people were classified as migrants in 2020, including 26.4 million refugees and 4.1 million asylum seekers – many driven from their homes by political conflict and climate crises.

But migrants and refugees seldom get access to mental health services, despite being amongst the most at-risk people. 

On World Mental Health Day on Tuesday, the World Health Organization (WHO) released a new report outlining the latest global evidence on factors influencing the mental health of refugees and migrants and their access to care. 

“Refugees and migrants face many unique stressors and challenges. This report sets out the urgent need for robust policies and legislation, rooted within stronger health systems, to meet the mental health care needs of refugees and migrants,” said Dévora Kestel, WHO Director for Mental Health and Substance Use. 

Common mental disorders such as depression, anxiety and post-traumatic stress disorder (PTSD) tend to be higher among migrants and refugees, particularly girls and women, according to the WHO.

The report summarises different risk factors and barriers refugee and migrant groups experience and outlines five key themes to be addressed in order to improve their access to mental health care.

The first is community support. Evidence shows that being part of a community with a shared background and attending school are associated with better mental health for children. Policies that promote social integration and strengthen family bonds and community networks may benefit refugees and migrants of all ages.

The second theme focuses on basic needs and security, characterising risk factors for mental health conditions such as insecure income, unemployment, and a lack of housing, food and legal status. 

“Deportation, imprisonment and resettlement are realities for many migrants without legal status and for asylum seekers. Therefore, guaranteeing the basic needs (food security and nutrition, protection, accommodation and general subsistence) of these populations should be the first level of intervention,” according to the report.

The third theme covers stigma and cultural barriers to mental health services. 

“Experiences of racism and discrimination are consistently associated with adverse mental health outcomes,” according to the WHO.

“Locating mental health services outside the health system (e.g. in community centres, women’s groups and schools), matching therapists or other helpers to clients (e.g. based on gender, language or cultural background), mobilising communities to support themselves (e.g. training lay workers and peer supporters) and offering a variety of individual, group and tele-mental health care supports could help to improve the acceptability of services and reduce stigma-related barriers,” the report suggests.

Theme four addresses exposure to adversity and trauma, including detention for refugees.

“Human rights-based policies and criminal justice measures are needed to protect refugees and migrants from adversities and potentially traumatic events, including by providing safe migration channels, limiting the use of detention (especially for vulnerable groups), ensuring that detention is used only as a last resort, and improving the health of detained refugees, migrants and asylum seekers,” according to the report.

The fifth theme addresses access to services, including those for mental health. Barriers raised include those of language, lack of access to online information and refugees and migrants’ lack of knowledge about their entitlements. 

The report suggests services that offer translators, practical support with immigration and registration documents and language and digital literacy programmes.“Good mental health and well-being is a right for all, including for refugees and migrants,” said Dr Santino Severoni, Director of the WHO’s Department of Health and Migration.

“This report will support and strengthen health systems’ responses to the mental health needs of refugees and migrants so that they can receive quality mental health care and support in ways they find accessible, acceptable, and affordable.”

Image Credits: Maria Teneva/ Unsplash.

The inaugural Health Day at COP28, the upcoming UN climate summit in Dubai, will launch the one-year progress report of the Sharm el-Sheikh Adaptation Agenda, a key outcome of last year’s summit in Egypt.

The agenda, which was agreed at COP27, includes a number of commitments to increase finance and investment in climate change adaptation, protect people from the health threats posed by urban heat, improve health surveillance systems, and invest in resilient health systems.

It also lays out a total of 30 global adaptation outcome targets by 2030, which are “urgently needed to increase the resilience of 4 billion people to accelerate transformation across five impact systems: food and agriculture, water and nature, coastal and oceans, human settlements, and infrastructure, and including enabling solutions for planning and finance.”

Mariam Allam, co-chair of the UNFCCC Adaptation Committee and lead negotiator for the Sharm el-Sheikh Adaptation Agenda, said the stocktake would be an important moment to assess progress on increasing adaptation and resilience for public health and health systems.

“This agenda is global in nature, but immediately prioritizes the 4 billion vulnerable people by 2030,” she said. “This is really what we know from the best available science from the IPCC is that there are roughly 3.6 billion people who live in formability hot spots because of the escalating impacts and risks associated with climate change.”

“It’s an important moment because we will be including a narrative on where we stand on increasing adaptation and resilience for public health, but also the resilience of the health system itself,” Allam added.

COP28 Health Day focus on adaptation raises concerns

COP27
COP27 in Egypt saw a record number of fossil fuel lobbyists attend the talks.

The preliminary agenda for Health Day at COP28 places a heavy emphasis on adaptation to the health impacts of climate change, rather than mitigation of carbon emissions. 

While many global health experts have welcomed the inclusion of a health day in the COP28 summit, some have criticized the focus on adaptation, arguing that it ignores the need to cut greenhouse gas emissions, which is the root cause of the problem.

Allam, the UNFCCC Adaptation Committee co-chair, defended the focus on adaptation, arguing that adaptation measures are essential to protecting people from the effects of climate change that are already threatening the health of millions around the world. 

“Mitigation is the starting point of the solution, but at the same time, impacts are happening [now],” said Allam. “Adaptation action has been seen as a distraction from the primary purpose [since] decades ago, but now we’re seeing the impacts happen faster than we would have anticipated at only 1.1C degrees.”

 “I think the starting point being mitigation is an important exercise,” she added. “That needs to be done, but it’s not enough.”

Critics also argue that the focus on adaptation at COP28 is a way for oil-producing countries like the United Arab Emirates, which is hosting the talks, to avoid addressing the need to cut emissions. They also worry that the UAE’s status as a member of the oil cartel OPEC has already clouded the agenda in favour of adaptation measures, rather than mitigation.

“There’s absolutely no way we can adapt our way out of this crisis,” said Diarmid Campbell-Lendrum, head of the World Health Organization’s Climate Change and Health Unit. “There are limits to adaptation… in some places we are already passing the limits of adaptation.”

“We do need to cut carbon emissions, and if we do that, we can in fact get great health benefits,” said Campbell-Lendrum, citing examples like reduced deaths from cleaner air.

Oil Giants Seek to Rebrand as Climate Leaders Ahead of COP28

COP28 President Sultan al-Jaber meets with Kenyan President William Ruto at the inaugural Africa Climate Summit in Nairobi.

The world’s biggest oil producers, including the United Arab Emirates, are seeking to rebrand themselves as champions of the fight against climate change as the COP28 summit approaches.

This week, the UAE hosted the International Petroleum Exhibition and Conference (Adipec), which brings together the most powerful players in the oil and gas industry every year. At the conference, Sultan al-Jaber, the president of COP28 and chief of the Emirati’s state oil giant ENOC, told the audience that the oil industry is central to the solution to climate change.

“This is your opportunity to show the world that, in fact, you are central to the solution,” Jaber said.

The conference hosted just two months ahead of the critical climate summit in the same city, chose the slogan: “Decarbonize. Faster. Together.”

But demand for fossil fuels is still going up, and OPEC is increasing production – and profits – to match. Last week, OPEC agreed to raise its medium- and long-term outlook for oil demand, according to Reuters. OPEC is expected to make an official announcement reflecting the revised demand estimates on Monday.

COP27, which took place in Egypt last year, saw over 600 fossil fuel lobbyists attend the summit. Only one country – the UAE – had a larger delegation than the fossil fuel lobby.

Jaber told the petroleum conference that the science of the IPCC – whose recent report concluded that the world must cut carbon emissions by 43% by 2030 to hit the 1.5C warming target – must be respected.

“That is our north star. It is our destination,” he said. “It is simply respecting the science.” 

Can the UAE lead the climate fight?

A Dubai-based company led by a member of the United Arab Emirates royal family has invested $1.5 billion in carbon offset projects in Zimbabwe, a deal that could influence the climate agenda as the UAE considers its role as an oil producer.

The deal, announced last week, is one of the largest carbon offset deals ever signed. It involves almost a fifth of Zimbabwe’s total landmass and will focus on rainforest protection and rehabilitation.

Carbon offset schemes like this one are controversial, with some critics arguing that they allow polluters to continue emitting greenhouse gases without actually reducing their emissions. Others have referred to the practice as “carbon colonialism”.

Voluntary carbon offsets, such as those in the deal between Zimbabwe and the UAE-based company, have achieved “zero mitigation”, Robert Mendelhson, a professor of forest policy and economics at Yale told Carbon Brief last week. 

“They have not changed behaviour and so they have not led to any reduction of carbon in the atmosphere,” he said. 

The focus on carbon credits and offsets during the first Africa Climate Summit in September was also roundly criticized. Over 500 civil society groups signed an open letter to Kenyan President William Ruto, who presided over the summit, accusing him of allowing “the position and interest of the West, namely, carbon markets, carbon sequestration, and ‘climate positive’ approaches” to dominate the proceedings. 

“These concepts and false solutions are … being marketed as African priorities,” the letter said.

“I was held down, tied up, forcibly medicated and placed in a seclusion cell,” Jarrod Clyne of the International Disability Alliance told the international launch of a guide on mental health and human rights on Monday.

This had happened in New Zealand “on the basis of a diagnosis of bipolar disorder, during a manic episode”, Clyne told the launch of the guide, which has been developed by the World Health Organization (WHO) and the Office of the High Commissioner on Human Rights (OHCHR).

Jarrod Clyn (right) from the International Disability Alliance experienced abuse in a mental institution.

Human rights abuses and coercive practices in mental health care, including involuntary hospitalisation and treatment, are still “far too common”, according to the WHO in a statement.

“An estimated one in eight people globally live with a mental health condition. And yet, most of them lack access to the health services they need. People with mental health conditions often face human rights violations, including stigma and discrimination as well as coercion, abuse or neglect in care,” WHO Director-General Dr Tedros Adhanom Ghebreyessus told the launch, on the eve of World Mental Health Day on Tuesday.

“The guidance we’re launching today serves as a roadmap for countries to develop, implement, and evaluate laws that protect and promote mental health and human rights,” added Tedros. “It can catalyse legislation reform, opening doors to care and services that are person-centred, rights-based and recovery-oriented.”

Volker Turk, UN Human Rights Commissioner

Volker Türk, the United Nations (UN) High Commissioner for Human Rights, said the COVID-19 pandemic had both exacerbated many people’s mental health problems and exposed how mental health laws in every region are often based on “the coercive and institutionalised approach”.

“Our new joint guidance is intended as a long overdue course correct,” said Volker.”Our ambition must be to transform mental health services, not just in their reach, but in their underlying values, so that they are truly responsive to the needs and dignity of the individual, that they are enabling people to participate fully in their own recovery.”

Orientation away from psychiatric hospitals

Devora Kestel, WHO Director of Mental Health and Substance Abuse, pointed out that low and middle-income countries (LMICs) spent over 70% of their mental health budgets on mental hospitals or institutions, while high-income countries spent around 35% of their budgets on institutions.

“Overall, these hospitals account for $2 out of every $3 spent globally by governments on mental health where they should instead be invested in community-based services,” said Kestel.

Devora Kestel, WHO Director of Mental Health and Substance Abuse.

“And we know from many reports that those institutions are associated with extensive abuses. Institutionalisation is an example of one issue that this guidance is tackling by promoting the closure of institutions while supporting the development of alternative community-based health service,” she added.

“Stigma, discrimination, as well as the disempowering messages that many people receive within the mental health system is also a huge challenge to overcome,” added Michelle Funk, WHO’s head of Policy, Law and Human Rights in the Department of Mental Health.

“For example, in many cases, when people receive a diagnosis, they’re often treated as being unable to actively participate and contribute to society, leading to further marginalisation and exclusion,” said Funk.

“Another pressing issue is that services have placed too much emphasis on diagnosis and the use of medication in order to manage symptoms, rather than taking a holistic person-centred, rights-based approach to treatment and care.”

An extract from Michelle Funk’s presentation on the guidance.

The guidance sets out what needs to be done to accelerate deinstitutionalization and establish a rights-based community approach to mental health care. This includes adopting laws to gradually replace psychiatric institutions with “inclusive community support systems and mainstream services, such as income support, housing assistance and peer support networks”.

People with mental conditions taking charge 

Caroline Mazel Carlton, a US mental health activist, has been hearing voices since she was a child and initially took heavy medication to quieten them.

“When I met the biomedical model, I learned that the world was afraid of me. They were afraid of me because people thought I was psychotic and dangerous and that was really lonely,” sais Mazel Carleton.

“The doctors did prescribe a lot of pills, and I think that me being given pills made other people feel better, like less afraid of me. But taking the pills did not solve my problems. Basically, they just slowed my mind and body down. I gained a lot of weight and I also ended up sleeping 16 hours a day.”

And the voices didn’t go away: “My voices sounded like they were underwater; like they were drowning, and it was scary.”

After a number of turbulent years, Mazel Carton quit her medication and now works for Wildflower Alliance, helping those with auditory and visual hallucinations. They have developed a number of coping strategies, including using the voice recording function on mobile phones to help discern whether the voices they hear are internal or external.

Nigerian mental health activist Hauwa Ojeifo.

Nigerian mental health activist Hauwa Ojeifo has been belittled and discounted by psychiatrists treating her for bipolar disorder and post-traumatic stress.

“I’m a person who refused to stay in the shadows of a system that’s riddled with abuse and allows my lived experience to be reduced to nothing,” said Ojeifo. “But guess what, according to how the mental health system works, I have no rights to be anything other than a patient.”

“It has been daunting to be diminished because I am not a health professional. But I do still maintain that no one knows about my condition more than I do.”

Ojeifo has formed an organisation, She Writes Woman, to assist people who have mental health issues.

“I have seen the life-threatening effect of the lack of informed consent and involuntary detention on people with mental health conditions,” Ojeifo told the launch.

“The simple claim that people with mental health conditions have full and equal rights and can be active participants and co-creators in their own mental health journeys is perhaps the most threatening ideology to the biomedical model of mental health,” she added.

“When we are urging a movement beyond the biomedical model, the key word here is ‘beyond’. It’s not leaving medication completely behind; it’s not preaching against medication. It is an attempt to get people to reorient themselves away from the dominance of that model.”

The guidance proposes new approaches, including “person-centred and community-based services” that are developed with “the engagement and participation of those with lived experience, including experience of intergenerational trauma”.

“This collaborative approach is essential to create a mental health system that respects human rights, prioritises care and support over control, and supports individuals in achieving their full potential.”

The launch was also addressed by government officials from Portugal, Brazil, Israel and the Philippines who reported on progress they are making to take a more human rights approach to mental health.

Extract from Funk’s presentation on the guidance.

Image Credits: Joice Kelly/ Unsplash.

Dr Ashley Bloomfield, WGIHR co-chair

Negotiations at the World Health Organisation (WHO) about how to amend the International Health Regulations (IHR) to make them fit to tackle the next pandemic will be extended until as far as May 2024.

This was resolved at the Working Group on the IHR amendments, which ended on Friday following a week-long meeting with a long list of undecided clauses and agenda items. 

Co-chair Dr Ashley Bloomfield of New Zealand praised the “very strong spirit of cooperation”, “focus on delivering on our mandate” and “very effective communication” at the closing plenary last Friday.

Meanwhile, co-chair Dr Abdullah Assiri of Saudi Arabia said that the WGIHR is “confident that we will be able to deliver on our mandate by the [May] 77th World Health Assembly. The will is there”.

However, a multitude of clauses and issues remain unresolved after the fifth negotiating meeting to amend the only legally binding global health laws, which set out countries’ obligations to disease outbreaks with risk of international spread. 

Bloomfield stressed that the WGIHR have a shared and clear understanding of its twofold mandate, which he explained as: “First, to come up with a set of targeted amendments, but secondly, and these are interlinked, to reorient the International Health Regulations towards equity”.

“We have made progress this week on that topic, definitely not as much as we intended to, but we have intersessional plans to keep progress going on both parts of our mandate – both the technical amendments but also the reorientation towards equity, and that remains a very strong focus for our work here and will continue,” added Bloomfield.

Intersessional meetings

The working group has resorted to intersessional meetings on sticky issues between the formal negotiations to enable parties to get a better understanding of each other’s positions.

The intersessional meetings decided on before the next formal negotiations in early December include sessions on financing for public health emergencies, IHR implementation, and the process of declaring a Public Health Emergency of International Concern (PHEIC).

This will include the “pandemic continuum, including definitions, criteria and the process for determining each”, according to the WHO in a media release.

However, the WHO said that the working group discussed eight proposed amendments including the Definitions, Purpose and Scope, Principles and Responsible Authorities (Article 4), the composition of the Emergency Committee (Articles 48 and 49) and the Decision Instrument for The Assessment and Notification of Events (Annex 2).

Dr Ricardo Leite at the launch of Health AI in Geneva

GENEVA – At the 1853 World Fair, the inventor of a new safety brake technology for elevators, Elisha Otis, demonstrated his innovation by posing an elevator right over the heads of a crowd of visitors and then cutting the cables. The new security brake kicked in.

His gimmick helped build trust in an innovation that led to the development of modern cities the world over. 

“From New York to Johannesburg, to Geneva to Lisbon, this would have been impossible without the simple elevator that we get into probably every day without even thinking about it,” observed Dr Ricardo Leite, a Portuguese physician.

“It had to start somewhere, to build trust in a new technology that could change the world.” 

Leite was speaking at the launch of Health AI, the Global Agency for Responsible AI in Health at a recent closed-door Geneva event that included leading members of Geneva’s international agencies and diplomatic corps.   

Leite is the CEO of the newly reformed artificial intelligence (AI) initiative, which was first launched in 2019 at the Geneva Graduate Institute as I-DAIR, the International Digital Health and Artificial Intelligence Research Network, and headed by Amandeep Singh Gill, the UN Secretary General’s Tech Envoy.  

Following a year-long strategy rethink, and having gained the status of a WHO implementing partner, Health AI has big ambitions to support not only research but AI rollout through the development and uptake of coherent regulatory policies nationally and worldwide.  

The aim is for validated AI methods and devices to earn trust in health systems, just like the elevator did over a century ago.  

AI outpacing the capacity of medicine agencies 

Post-pandemic, new technologies for the diagnosis and treatment of diseases are growing by leaps and bounds. And with it, the pace of change in digital health technologies using AI is snowballing. 

National and regional health systems face a huge challenge in meeting the fast-changing world of AI-powered medical devices – with evidence-based standards for review and approval that can help good or great innovations win acceptance.

“The world is a very different place [than what we knew] in 2019,” observed Leite. “We are in the middle of a scientific and technological revolution, not only because of machine learning and super-intelligence but because of the links between what’s happening in artificial intelligence with other sectors of the scientific revolution – from quantum computing to biotechnology to gene editing.”

He said that, in rethinking the strategy, the organisation went through an in-depth process with stakeholders and market analysis. 

“A strong request from practically every stakeholder in the field was to address the lack of governance and regulatory frameworks for AI as it is applied to health, particularly with regards to safety issues, which is leading to distrust.  

“But they also voiced concerns that we are not harnessing the potential that AI can provide, leading to better health.” 

In response, the research network is now reinventing itself as a global agency to support countries – particularly low-and middle-income countries (LMICs) – to develop and roll out coherent AI policies and regulations for health and medical technologies.  

“It’s a major shift from where I-DAIR started,” observes Leite. “We are moving away from the research collaborative that we are, to becoming an agency. 

“We’ve become an implementing partner of the WHO. We are part of the management team of the Global Initiative on AI for Health, which is a partnership between WHO, the International Telecommunication Union (ITU) and the World Intellectual Property Organization (WIPO),” he said.

AI technologies are already in health 

Some AI technologies are already being widely used in healthcare settings. For instance, AI is now almost ubiquitous in the modern analysis of CT and MRI images to identify tumours and other physiological abnormalities.  

“Most modern equipment is already using artificial intelligence, looking at millions of images to automatically interpret the image that comes out from a certain patient, providing a proposed interpretation,” said Leite in an interview with Health Policy Watch. “The final report is always validated by a human, by the radiologist. But this is a very practical example of what is already working and health systems around the world.”  

But trust in new technologies also is a challenge. But new health interventions – from the earliest interventions such as clean water and sanitation to halt the spread of cholera to the COVID-19 vaccine – have often been met with wide public distrust that hindered their rollout and use.  

“The lack of effective governance…is increasing the risk and also the distrust and hindering the adoption of responsible AI solutions towards better health outcomes” said Leite, speaking at the Geneva event at the lakeside residence of the Swiss Ambassador to the UN.

“So the question is when computers deal with your health, who really deals with the computer?” 

“And if every country is regulating [AI] differently, this is a nightmare for anyone developing technology.  It just hinders the pace of innovation and hinders the pace at which people will actually have access to technology that can lead to better health outcomes.” 

Leite knows about such governance challenges first-hand. As a Portuguese Member of Parliament and later the head of UNITE, Parliamentarians Network for Global Health, he was involved in developing and promoting strategies for better global health governance on topics ranging from infectious diseases to climate change – in countries around the world. 

Even Europe, which has one of the strongest regulatory frameworks for medicines in the world, is the “wild west” when it comes to AI technologies, said Leite.  

“There is really no firm oversight. There are a lot of attempts to address this, but we do not have a systemic global approach.” 

Co-creating global standards with WHO  

While WHO would naturally lead the development of global guidelines on the use of AI in health, in collaboration with partners in ITU and WIPO, Leite expects that Health AI will become the “bridge” between the normative standards set by the international agencies and their real-life uptake and use by countries.  

“The idea is to co-create [with WHO] these new standards. We anticipate that this will take one or two years. But we need to do this fast, because the trillions that are being invested will be translated into thousands of AI-driven tools that will flood the market”

Health AI also intends to build capacity at the regional level, training teams of people who are “capable of validating AI tools for health, to have access to their own markets and ensuring that they are complying with these responsible AI standards, similar to what is done today for medicines and medical devices”, says Leite. 

He foresees that regulatory review of AI health innovations will be vested with national and regional medicines agencies that already exist – from the US Food and Drug Administration (FDA), to the European Medicines Agency (EMA) and the newly-formulated African Medicines Agency.

At the same time, he anticipates that sharing knowledge about evidence-based AI technologies between countries can accelerate their global uptake – much as national approvals for new vaccines today is often linked to regulatory reviews by agencies in other regions or countries. 

“That’s why we believe in creating this network model across the world –  to use that collective intelligence to address the volume issue,” he said. 

Artificial Intelligence is developing at such a pace that it is leaving regulators behind, creating a digital ‘wild West’.

He notes that the US FDA, one of the first national regulatory authorities to leap into AI regulation, has already become overwhelmed by the pace of innovation. 

“New AI tools are increasing from a few dozen to 200 to 300 a year. And that is only the beginning, as trillions of dollars are invested into AI. So even richer countries need to understand this and to step up their game,” Leite said. 

“With the rise of the number of technologies coming out,  many countries won’t have the capacity to deal with the amount of volume of requests. The network will reduce costs and lead to savings. So if Finland approves a technology, Kenya and Germany can potentially approve it, without having to go through the whole process.   

“Having that network will allow us to create a global repository where all of the tools as they are approved, can be posted. 

“And that network is also going to be critical, because that way if something goes wrong with a piece of technology somewhere in the world, we can have an early warning system shared around the world so that all regulatory agencies can act accordingly.” 

Once regulations for health AI are firmly in place, private sector inventors will have to submit their innovations for regulatory approval and pay application fees for regulatory review, just as medicines are processed today. That will yield income that can fund the regulatory agencies’ expansion to this new and largely unfamiliar AI frontier. 

“This means the AI review can become self-sustaining and a source of revenue for regulatory agencies. As validation AI teams start working in countries, we as health AI will provide annual certification to these teams, making sure that they meet the global standards, as well as connecting them to global networks. 

“Through the investment model we are proposing, high-income countries will get paid back in two years, while in low- and middle-income countries we will be able to see a payback in year four.”

Addressing inequalities in national uptake of AI for health 

Another issue that Health AI aims to address is the persistent, yawning gap between high and low-income countries in access to new health technologies of any kind, let alone AI-based ones.   

“This whole pandemic really demonstrated the fragility of our health systems and the tremendous inequalities around the world,” Leite stressed.  

Ensuring IP agreements and arrangements with the private sector don’t lock out LMICs will also be critical to ensure wide access to essential new AI technologies – which could also prove critical in warding off the next pandemic.  

“We need to counteract ‘digital colonisation’ and narrow the digital divide between countries, creating opportunities.” 

Ensuring that promising AI innovations also receive R&D support from the public sector can help ensure that they may become “global public goods” accessible to all, added José Barroso, board chair of the Vaccine Alliance, Gavi, another featured speaker at the Geneva event. 

“Let’s call it the decoupling of serious risk, when it comes to global public goods,” added Barroso, a former president of the European Commission (2004-2014) and former Prime Minister of Portugal (2002-2004). 

Leite envisions that Health AI can also help to assess a “fair price” for new technologies that have been validated, as well as strategies for reimbursement of costs for use through national health systems. 

At the same time, it is important to ensure that AI remains in the service of mankind – and not the other way around – as some dystopian visions of the future have forewarned. 

“It is commonplace to say that great opportunity, [brings] great challenges,” concluded Barroso. “Opportunities, because it can bring enormous benefits in terms of health. Some artificial intelligence is able to solve problems that we cannot solve. As for the challenges, these are obvious… namely issues of privacy, issues of political control, inequity and these are very serious.

Concluded Leite: “The first thing we learnt at medical school is first do no harm. It doesn’t mean avoiding all risks. It means ensuring that the benefits override the risks to a point that can lead to better health outcomes for most of the population.”

Dolutegravir, the HIV medicine recommended by WHO.

Colombia’s Minister of Health has asked the country’s patent office to issue a compulsory licence for an antiretroviral drug, dolutegravir, which is still protected by a patent issued to ViiV Healthcare.

Minister of Health and Social Protection Guillermo Alfonso Jaramillo issued a Declaration of Public Interest on Wednesday indicating that he was taking this step to enable the country to import cheaper generic versions of the HIV medicine.

According to the minister, people living with HIV pay $100 a month for the drug, which is 50 times more expensive than the generic version available through the Pan American Health Organisation. 

The Colombian government estimates that it will be able to put 28 people on generic dolutegravir for the same cost as one person currently on the patented drug. 

HIV cases have increased by 31% over the past year in the country, with some 18,410 people now living with HIV. In addition, the country has experienced an influx of people from Venezuela seeking HIV treatment.

Compulsory licensing allows national authorities to license a third party to produce a generic version of a patented product before the drug’s patent expires. 

According to the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of  Intellectual Property Rights (TRIPS Agreement), governments are allowed to issue compulsory licenses in when it is in the public interest to do so.

Could set a precedent for the region

The health ministry’s move comes after more than 120 civil society organisations and prominent individuals petitioned Jaramillo to issue a compulsory license.

Dolutegravir is the preferred treatment for people living with HIV, according to the WHO. Generic dolutegravir is available to other countries through voluntary licenses with the Medicines Patent Pool (MPP). 

“In its voluntary license signed with MPP, ViiV excluded Colombia and many populous middle-income countries, maintaining its monopoly and its ability to charge high prices in the country,” according to Médecins Sans Frontières. 

“Colombia’s declaration helps open pathways to neighbouring countries like Brazil following suit to access more affordable generics. Colombia’s patent office is expected to issue a compulsory license under the declaration.”

Francisco Viegas, MSF Access Campaign’s medical innovation policy advisor, said that  Colombia’s declaration “puts forward convincing reasons to issue a compulsory license, and requests the Colombian Patent Office to do so to enable access to more affordable generic versions of dolutegravir”.

“This fully legitimate action by the Colombian government is the first of its kind from Colombia and is a significant act of leadership that clearly puts people and public health over corporations’ profits,” added Viegas.

“We also urge other countries that struggle to supply dolutegravir to follow suit, like Brazil, where even though national production capacity of dolutegravir exists, it was halted because a patent was granted. A compulsory license by Brazil to allow access to more affordable generic versions of this drug could substantially change the lives of people with HIV.”

“This decision represents a milestone for public health in Colombia,” said Andrea Boccardi Vidarte, UNAIDS Director for the Andean Countries in a statement. 

“Through our local, regional and global offices, UNAIDS will continue supporting the government on the implementation of this landmark decision.”

ViiV Healthcare is a joint venture of GlaxoSmithKline, Pfizer and Shionogi that specializes in the treatment of HIV.

Image Credits: UNAIDS.