“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.

Abdool Ridwan Firaas Ah Seek (centre), flanked by his legal team, challenged the law for being unconstitutional.

The Mauritius Supreme Court ruled on Wednesday that a colonial-era law criminalising consensual sexual relations between men is “unconstitutional” and should be struck from the country’s criminal code with immediate effect.

According to Section 250 of the Mauritian Criminal Code, men convicted of same-sex relations could be jailed for a maximum of five years.

The judges noted that the law, which dates back to 1898, was “not the expression of domestic democratic will but… a course imposed on Mauritius and other colonies by British rule”.

They focussed on citizens’ constitutional right to protection from discrimination. They concluded that Section 250 discriminated against gay men involved in consensual sex in a manner that was not justifiable, and it was thus unconstitutional.

The legal challenge was initiated in 2019 by Abdool Ridwan (Ryan) Firaas Ah Seek, and the LGBTQI rights group, Arc-en-Ciel. Ah Seek presented evidence that the law had a “crippling effect” on his ability to express love and subjected him to psychological and moral harm, making him feel unworthy of recognition and protection by the State. 

The Human Dignity Trust, which supported the legal challenge, said in a statement that it “applauds this decision, as well as the ongoing work of the government to reform wider sexual offence laws to eliminate discrimination and provide proper protection against all sexual violence”.

‘Obsolete colonial law’

United Nations (UN) agencies operating on the small island off the coast of southern Africa welcomed the decision.

“The Supreme Court today overturned an obsolete colonial law and demonstrated its commitment to non-discrimination and leaving no one behind,” said Lisa Singh, UN Resident Coordinator in Mauritius. 

“The UN in Mauritius and internationally welcomes the decision of Mauritius to join the growing list of African countries protecting the human rights of everyone, including LGBTQI+ people.”

“UNAIDS applauds Mauritius for today’s decision which will mean that men who have sex with men will have much easier access to the health and social services they need without fear of arrest or criminalization,” said Anne Githuku-Shongwe of UNAIDS, Director of UNAIDS’ Regional Support Team for Eastern and Southern Africa. 

“Work will need to continue to break down the barriers of stigma and discrimination towards the LGBTQI community, but today’s ruling is a positive step in the right direction. It will save lives.”

Dr Mandeep Dhaliwal, Director of HIV and Health for UNDP, described the decision as “an important victory for human rights, dignity and public health, as there is strong evidence that removing criminal laws on consensual adult homosexual sex results in reduced new HIV infections and increased access to prevention and treatment”. 

Mauritius joins other African countries that have repealed anti-LGBT laws, including Angola, Botswana, Cape Verde, Gabon, Guinea-Bissau, Lesotho, Mozambique, Sao Tome and Principe, Seychelles and South Africa.

However, UNAIDS estimates that 66 countries still have laws which criminalize consensual same-sex relations. 

“In addition to contravening the human rights of LGBTQI people, these laws impede access to health and social services, including HIV services. Such laws fuel stigma and discrimination against LGBTQI people and put them under constant fear of being punished or detained,” according to UNAIDS.

Meanwhile, Uganda has moved in the opposite direction, with its parliament passing a punitive Anti-Homosexuality Act in May. The Parliaments of Kenya and Ghana are also considering similar punitive laws.

Image Credits: Human Dignity Trust.

HIV-positive children can grow up healthy, thanks to the pioneering treatment interventions funded by PEPFAR and partners.

The failure of the US Congress to reauthorise a five-year budget for the world’s largest aid programme for global health, the US President’s Emergency Plan for AIDS Relief (PEPFAR), by its 30 September deadline doesn’t mean that it will automatically end – but without broad bipartisan support, it limps into an uncertain future. 

“In the short term, PEPFAR will be able to continue providing the lifesaving prevention, care, and treatment services in partnership with PEPFAR-supported countries,” said US State Department spokesperson Matthew Miller this week. 

“However, the fact that Congress did not reauthorize the program sends a message to partners around the world, especially in Africa, that we are backing down from our leadership in ending HIV/AIDS as a public health threat.”

Miller added while the Biden administration supported a five-year, “clean” PEPFAR reauthorization, the authorisation of certain programs has expired. 

“We’re still figuring out exactly what that means. There are some appropriations that have continued, so we’re going to work through it.  But the program can continue for now,” Miller told a press briefing.

As long as funds for PEPFAR are appropriated annually by Congress, the programme could continue without formal authorisation, according to Kaiser Family Foundation (KFF).

But this means that grantees would have to submit annual budgets rather than the more sustainable five-year programmes.

“Some requirements would ‘sunset’ if a reauthorisation bill is not passed,” according to KFF, which has identified seven requirements that would end after the 2023 financial year, and one that would end after the 2024 financial year.

A casualty of anti-abortion campaigning

PEPFAR was started by Republican president George W. Bush in 2003 and has enjoyed bipartisan support from both Republicans and Democrats until recently.

But in the past few months, there has been a concerted campaign to link PEPFAR grantees with the promotion and provision of abortion, despite US legislation making it unlawful for PEPFAR to fund or support abortion, and abortion being illegal in most African countries where it operates.

In May, a group of US influential right-wing groups claimed in a letter sent to Senate and Congress leaders that PEPFAR grantees “are using taxpayer funds to promote a radical sexual and reproductive health agenda”. Signatories include the Center for Family and Human Rights (C-FAM), the influential rightwing think-tank Heritage Foundation and the Dr James Dobson Family Institute.

A similar letter was sent on 6 June to the same US politicians by a group of conservative African politicians and religious leaders, mainly Catholics, claiming that PEPFAR “is supporting so-called family planning and reproductive health principles and practices, including abortion, that violate our core beliefs concerning life, family, and religion”.

Amongst the signatories were 10 Kenyan Members of Parliament, but last week the Speaker of Kenya’s Parliament distanced his institution from them, stating that the letter “is not the official position of the National Assembly”.

US Representative Chris Smith, who co-sponsored PEPFAR’s refinancing in 2018, has also joined its critics, claiming that the programme is being used to “promote abortion on demand”. 

Instead of reauthorising PEPFAR for five years, Smith proposed a one-year reauthorization of PEPFAR in the State, Foreign Operations, and Related Programs Appropriations Bill that was narrowly passed by the House of Representatives last Thursday night. 

The Bill adds strict anti-abortion clauses, slashes the foreign aid budget and is unlikely to be passed by the Democrat-dominated Senate.

US Congressional Representative Barbara Lee and PEPFAR head John Nkengasong.

‘Greatest act of humanity’

Dr John Nkengasong, who heads PEPFAR as the US Global AIDS Coordinator in the State Department’s Bureau for Global Health Security and Diplomacy, described PEPFAR as “the greatest act of humanity in the history of infectious diseases that has transformed the ugly face of HIV/ AIDS in Africa from hopelessness and helplessness to hopefulness”.

PEPFAR is estimated to have saved the lives of 25 million people since it was set up 20 years ago. According to UNAIDS, new HIV infections are almost 60% lower than their peak in 1995, while AIDS-related deaths are almost 70% lower since the peak in 2004 – and PEPFAR has played a major role in achieving this.

Around 30 million people now have access to antiretroviral treatment, while nine million still need access. In some African countries, over 90% of people living with HIV depend on PEPFAR funding for their treatment.

Nkengasong has also stated categorically that  “PEPFAR has never, will not ever, use that platform in supporting abortion”.

Dr Uche Ralph-Opara, Deputy Chief Health Officer for Project HOPE, an international organisation addressing global health crises, said that “lives are hanging in the balance”.

“As a public health expert and clinician who has witnessed the transformative power of PEPFAR on the ground, I can attest that without its continued authorization, we risk losing our hard-won gains in the fight against HIV/AIDS,” Ralph-Opara warned.

“From the global health perspective, PEPFAR is not just a program, it’s a lifeline for millions. Its absence would result in increased mortality rates, strained health systems, and certainly a setback in our collective efforts to achieve health for all.”

South African hospice Sister Vicky Sikhosana with a patient with AIDS in South Africa in 2007, before ARVs were available in Africa – a full decade after they were available in Western countries because of high costs.

Nkengasong also warned that PEPFAR’s gains are fragile

 “As a virologist, I will tell you this: if the 30 million people that are receiving [antiretroviral treatment] today stopped, within five weeks the virus will come back and within a couple of years they will start dying,” Nkengasong told the Annual Legislative Conference of the Congressional Black Caucus last week.

“Within a couple of years, [HIV] transmission becomes a global effect,  not just limited to Africa, and we will be all back again to 20 years ago. So the hundreds of billions we’ve invested in HIV goes into the drain and humanity suffers,” he added.

‘Not about abortion’

“PEPFAR is not about abortion but they’re trying to make it about abortion,” House of Representatives member Barbara Lee, the main negotiator for the five-year reauthorisation for the Democrats, told the Congressional Black Caucus conference.

Back in 2002, Lee was part of a group of Congressional Black Caucus members who approached Bush and urged him to address HIV and has been a PEPFAR champion since its inception a year later. 

She admitted that she had almost voted against PEPFAR initially because of some problematic elements including those related to abortion, but that ultimately the Democrats had resolved that they could work with it.

However, Lee said while working to ensure bipartisan support for PEPFAR’s current reauthorisation for another five years, “I have found pushback on the other side [amongst Republicans] big time in terms of, not only the money but also ‘why’ and for me that’s the moral disgrace of where we are right now”. 

She appealed to the faith community to galvanise support for PEPFAR: “We have to get back to some kind of sensible bipartisanship so that we can move forward and end HIV and AIDS by 2030”.

Power: ‘Manufactured controversy’

Meanwhile, USAID Administrator Samantha Power told the conference that “the manufactured controversy is making it difficult to get this clean reauthorization”, quoting a recent article in support of PEPFAR’s reauthorisation written by Bush, saying: “No programme is more pro-life than one that has saved more than 25 million lives”. 

“It’s more rare now to have things happen in a bipartisan way, but to have something stably, bipartisan for 20 years is a signal to all the countries in which we are working, that PEPFAR is here to stay,” Power added. 

She added that USAID staff had been able to go into health ministries of partner countries, confident that “bipartisanship puts [PEPFAR] on such a stable foundation that you can look beyond the next budget cycle.”

PEPFAR has invested some $110 billion in HIV prevention, treatment and care, which has had a huge impact on grantee countries’ health systems, including by increasing disease surveillance capacity, strengthening health services, and improving drug supply management. 

“I’m not sure there’s broad awareness of how much we relied on the PEPFAR infrastructure to tackle COVID-19,” added Power. 

“The PEPFAR tracing and the surveillance systems are ones that are being used for infectious diseases like Ebola and Marburg, or if there is a new COVID variant. The same individuals who transport HIV testing samples are the ones who transported COVID-19 samples. We used some of the same testing machines, some of the same laboratory capacities. When it came to the vaccination drive, it was our PEPFAR platform that was able to rapidly stand up… in getting those shots in arms.”

Goals almost within reach

UNAIDS Director Winnie Byanyima

“In many of the HIV high burden countries, which are in Africa, up to 95% of the funding for putting people on treatment and prevention is paid for by this programme,” according to Winnie Byanyima, head of UNAIDS, the United Nations agency on HIV/AIDS.

“These are countries that are so highly indebted that just the interest on their debt is four to five times as much as they are putting into their whole health systems, let alone for HIV,” Byanyima told a meeting organised by the Clinton Foundation on the sidelines of the UN General Assembly two weeks ago.

“This is not the time to stop PEPFAR. This is the time for the leadership in America to continue doing what it has done right and continue supporting countries to keep their people alive.”

Byanyima said that while the global goal of ending HIV by 2030 was achievable, “we have to have strong political leadership.”.

“It’s failing. We are in a world where the geopolitics have gone crazy and it’s hard to get leaders to stay committed to what they committed to long ago. 

“We need to follow the science to address the real epidemic in each country, not the epidemic they want to think they have, but to follow the scientific evidence,” she added, urging special attention to be paid to eliminating HIV transmission in most at-risk groups in Africa – women and girls, gay men and transgender women.

“Most people in Africa do not understand what we mean by reauthorisation and appropriation,” said Nkengasong. “These people say: ‘Well, it doesn’t mean that you will not get funding’. No, but it sends a signal and weakens our own foreign policy and diplomacy weakens our commitment to humanitarian efforts. Fighting HIV is not just a health issue for Africa. It’s a developmental issue and it’s a security issue.”

Image Credits: The Global Alliance to end AIDS in children, Kerry Cullinan.

Dr Hala Khudari, WHO Libya representative

The World Health Organization’s (WHO) Eastern Mediterranean region (EMRO) is struggling to address “an unprecedented number of health emergencies” driven by state fragility and conflict, climate-change-related extreme weather events, mass displacement and economic disparities”, regional director Dr Ahmed Al-Mandhari told a media briefing on Wednesday.

The most pressing immediate problems involve assisting Libya after its recent floods and addressing the humanitarian needs of people caught in the armed conflict in Sudan.

Dr Hala Khudari, an official from WHO’s Libya office, reported that 4,333 deaths had been recorded but that about 8,500 persons were still unaccounted for. Meanwhile, 101 health workers had died, including 25 specialists.

“The corpses are found in many places. Even yesterday and two days ago, there were corpses found about 250 kilometres off the beach, which shows the magnitude of this disaster,” said Khudari.

Even before Storm Daniel struck the country, a decade of conflict had taken its toll on Libya’s health system, with acute shortages of staff, medicines, equipment and medical technologies, according to the WHO.

Al-Mandhari said that “protracted armed conflicts have ravaged nine of the region’s 22 countries and territories, resulting in increased trauma, displacement and attacks on health care”, and 55% of world’s refugee population lived in the region.

“Nearly six months after the outbreak of war in Sudan, 70% of the country’s hospitals are not functional and malnutrition levels are soaring,” he added.

Next week, the EMRO region holds its regional conference where it will discuss the multiple crises and elect new leaders. 

Six candidates have made themselves available for election. Iraq has nominated pharmacologist Najim Abbas Jabir Al-Awwadi and Morocco has proposed former health minister Anass Doukkali. Pakistan has suggested health systems expert Abdul Ghaffar and Iran has put forward health policy professor Ali Akbari Sari.

Sudan has nominated its goodwill health ambassador Ahmed Farah Shadoul and Saudi Arabia has proposed the sole woman, clinical and public health specialist Hanan Hassan Balkhy.  If elected, she would be EMRO’s first-ever female regional director.

WGIHR co-chairs New Zealand’s Dr Ashley Bloomfield and Saudi Arabia’s Dr Abdullah M Assiri.

It’s likely to be a mad sprint to submit amendments to the International Health Regulations (IHR) by the World Health Assembly (WHA) next May, according to the working group overseeing this process, which is meeting for the fifth time this week.

Meanwhile, the Intergovernmental Negotiating Body (INB) is expected to release a new draft of the pandemic accord within the next few weeks following a flurry of meetings in September.  The new draft will be sent to member states ahead of the seventh meeting of the INB, which is set for 6-10 November, and resuming on 4-6 December 2023.

“When the 2005 International Health Regulations were negotiated and agreed, the final meeting finished on the weekend before the WHA started – at 4 am on a Saturday morning,” Dr Ashley Bloomfield, co-chair of the WGIHR, told the meeting on Monday.

While he hastened to add that the working group was “not intending to do that”, Bloomfield assured member states that they did not have to finish deliberations by January as they were not obliged to report to the World Health Organization’s (WHO) executive committee.

This followed an assurance by the WHO’s Principal Legal Officer, Steven Solomon, that there were no legal impediments to the WGIHR continuing negotiations up until the eve of the WHA, despite December being their last scheduled meeting.

The WGIHR could simply give the WHO DG a progress report by January, while a final text was still being negotiated, added Solomon.

Prioritise equity, Africa urges

The IHR are the only global rules that set down compulsory actions for countries once the WHO Director-General has declared that a disease outbreak is a “public health emergency of international concern (PHEIC)” – particularly in terms of reporting, surveillance and the domestic implementation of the IHR’s procedures.

However, the IHR failed to contain COVID-19, according to a damning report from the Independent Panel on Pandemic Preparedness and Response, which found that the IHR’s alert system “does not operate with sufficient speed when faced with a fast-moving respiratory pathogen” and the regulations are “a conservative instrument as currently constructed and serve to constrain rather than facilitate rapid action”.

As a result, the 2022 WHA resolved that the IHR should be amended. This resulted in a flood of over 300 proposed amendments from member states, which the WGIHR has been picking through, and has drawn up a compilation text.  Bloomfield, former Director General of Health in New Zealand, highlighted that equity, financing the response to health emergencies, and pathogen benefit-sharing are the most challenging areas.

Since the last WGIHR meeting in July, there have been briefings on the alert system for declaring a PHEIC, as well as pandemic financing together with INB members.

Kenya urges progress on equity clauses.

Kenya, on behalf of the 47 members of WHO’s Africa region, urged the working group to ensure “tangible progress on equity-related amendment proposals put forward by state parties to prevent escalation of PHEICs to pandemics by building the necessary capacities in countries”.

However, the Kenyan delegate noted that it appeared from the recent briefing on the system of declaring a PHEIC that “while the current alert system has been functioning well under the IHR, what was problematic during COVID-19 was the response, in particular actions related to equitable access to the health products and supplies.

“The PHEIC determination does not currently trigger a mechanism for the development, procurement and distribution of risk response measures such as diagnostics, medicines or vaccines.”

Meanwhile, South Africa called for equity clauses to be discussed first – while Saudi Arabia urged that clauses where there was agreement to be dealt with rapidly first.

Taking stock of progress

The meeting will take stock of progress on IHR articles previously considered. In the past week, the co-chairs have sent out new text proposals on Articles 4 (responsible authorities), 5 (surveillance), 9 (other reports), 10 (verification) and 48 and 49 (the Emergency Committee).

It will also consider Annex 2, which covers the “decision instrument for the assessment and notification of events”. Meanwhile,  informal consultations on Article 8 (consultation) and Article 11 (exchange of information) will also be considered in the WGIHR closed drafting session, which ends on Friday.

Meanwhile, the new draft of the pandemic accord comes following a series of informal meetings of the INB’s drafting group in September. These focused on some of the more contentious articles in the current Bureau text, namely  Articles 4 (pandemic prevention and public health surveillance),  5 (One Health), 9 (research and development), 11 (technology transfer) 12 (access and benefit-sharing) and 13 (supply chain and logistics). 

WHO Director Dr Tedros Adhanom Ghebreyesus announces the approval of a second malaria vaccine Monday.

The WHO has officially recommended a second malaria vaccine for children, the R21/Matrix-M, co-developed by researchers at Oxford University and the Serum Institute of India. Global rollout could greatly improve access to immnization against a disease that kills over 600,000 people a year, 96% in Africa.  But experts stress that vaccines can complement — but not replace — other malaria control strategies.

Nearly two years after the World Health Organisation (WHO) officially recommended the RTS,S malaria vaccine, the global health body on Monday approved a second vaccine, the R21/Matrix-M – whose clinical trial results have shown a high degree of efficacy in preventing serious malaria cases and deaths amongst children at risk. 

The WHO decision paves the way for a global rollout of a vaccine that could make a significant dent in the burden of malaria today – which mostly kills African children under the age of 5.

“The R21/Matrix-M malaria vaccine is an easily deployable vaccine that can be manufactured at mass scale and modest cost, enabling as many as hundreds of millions of doses to be supplied to countries which are suffering a significant malaria burden,” said the University of Oxford in press release. The Serum Institute of India has “already established production capacity for 100 million doses per annum, which will be doubled over the next two years.”

Speaking at a WHO press briefing, Dr Tedros Adhanom Ghebreyesus, WHO Director-General, noted that just as COVID-19 vaccines played important roles in getting the pandemic under control, RTS,S and R21/Matrix-M vaccines — which he described as safe and effective — are also giving the world new hope of bringing malaria, which is one of the oldest diseases known to humanity, under control.

The global health organisation’s recommendation was based on advice from two expert groups — the Strategic Advisory Group of Experts on immunisation (SAGE) and the Malaria Policy Advisory Group.

Phase III clinical trials of the R21 vaccination involved some 4,800 children in Burkina Faso, Kenya, Mali and Tanzania.

“Both groups reviewed evidence from the trials of the R21/Matrix-M vaccine, which showed that in areas with seasonal transmission, it reduced intermittent cases of malaria by 75% in the 12 months following a three-dose series of the vaccine; a fourth dose given a year after the third was shown to maintain protection,” the WHO Director General said.

When used in real-life settings in peak malaria season, both R21/Matrix-M and the RTS,S appear to perform similarly, he added, saying “It’s comparable with other recommended malaria interventions.”

While the Phase 3 clinical trials have shown the vaccine to be safe, safety monitoring will continue as the vaccine is rolled out on a wider said.

At a cost of between two and four US dollars a dose, the cost of the new vaccine is similar to that of the RTS,S. 

Reshaping the fight against malaria

R21 malaria vaccination clinical trial site in Kiwangwa, Tanzania – one of four African countries which hosted Phase 3 trials.

Welcoming the development, Gavi, The Vaccine Alliance said the vaccine can help reshape the fight against malaria, a disease that killed 619,000 people globally in 2021 with 96% of those deaths being in the Africa region, thus making the disease one of Africa’s biggest killers.

David Marlow, CEO of Gavi, described the announcement as another major step towards our goal of creating a malaria-free life for every child. The vaccine, along with the existing RTS,S vaccine, “will be an effective complement to existing malaria interventions.

The vaccine can “play a key role in meeting the high demand we are seeing in endemic countries,” Marlow added. 

Since 2000, malaria deaths have fallen by more than half, and the disease has been successfully eliminated from many parts of the world. But globally, progress has stalled with nearly half the world’s population remaining at risk of malaria. In 2021, there were an estimated 247 million cases of malaria, and 619,000 deaths with 95% of cases and deaths being in Africa — and mostly among children under five. 

Demand for the RTS,S vaccine far exceeds supply thus making the R21/Matrix-M vaccine a particularly important additional tool to protect more children faster, and to bring the world closer to the WHO’s vision of a “malaria-free world”, noted Tedros at the press briefing. 

Already being licensed in West Africa

Pre-immunisation interview for R21 malaria vaccine clinical trial candidate

The R21/Matrix-M malaria vaccine has already been licensed for use in Ghana, Nigeria and Burkina Faso – which opted to go ahead with deployment even before the formal WHO greenlight based on previously reported clinical trial results. 

“The R21/Matrix-M malaria vaccine has been shown to be safe and highly effective across multiple clinical studies and is now approved as WHO policy for widespread use. The vaccine is easily deployable, cost effective and affordable, ready for distribution in areas where it is needed most, with the potential to save hundreds of thousands of lives a year,” said Sir Adrian Hill, Director of Oxford’s Jenner Institute, where the vaccine was developed.

According to the institute, the vaccine recently reached the primary one-year endpoint in a pivotal large-scale Phase III clinical trial that included 4,800 children across Burkina Faso, Kenya, Mali and Tanzania. 

“The Phase III trial results are under peer review before publication,” the institute stated in its press release coinciding with the WHO announcement.

While the vaccine had a 75% efficacy when given just before high transmission season, WHO said, it had some waning of efficacy over the first year of follow-up at both seasonal and perennial transmission sites. But a booster dose restored efficacy at the seasonal sites with a vaccine efficacy over 18 months of 74%. 

An earlier Phase IIb clinical trial conducted in Burkina Faso also reported two-year efficacy and showed that a booster dose of the vaccine maintained high efficacy against malaria, meeting WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy.

There has been some speculation over whether the new Oxford vaccine could ultimately be more effective than its predecessor.  However WHO said that experience to date shows similar performance in settings with high seasonal malaria transmission:

“The two WHO-recommended vaccines, R21 and RTS,S, have not been tested in a head-to-head trial,” WHO notedin a press release.  “There is no evidence to date showing one vaccine performs better than the other. The choice of product to be used in a country should be based on programmatic characteristics, vaccine supply, and vaccine affordability.”

Closing the gap between supply and demand

Dr Hanna Nohynek, Chair of SAGE

Speaking at the briefing, Dr Hanna Nohynek, Chair of SAGE, said malaria vaccines introduced widely have the potential to save tens of thousands of young lives each year. She added that the introduction of the vaccine should be done in the context of comprehensive malaria control efforts, and the vaccine can be used following a seasonal or age-based schedule as already described for RTS,S. 

“The availability of a second malaria vaccine is expected to close the gap between supply and demand, enabling broader and possibly unconstrained access,” the chair said.

Meanwhile, Serum Institute of India  said its doses are ready for wider roll-out almost immediately, with an expected production capacity of over 180 million doses per year. SII also confirmed it is collaborating with DEK Vaccines in Ghana to develop capacity to undertake fill-finish manufacturing in the country.

“The WHO recommendation and approval of the R21/Matrix-M vaccine marks a huge milestone on our journey to combat this life-threatening disease, showing what exactly can be achieved when the public and private sector, scientists and researchers, all work together towards a shared goal,” said Adar Poonawalla, CEO of the Serum Institute of India.

No silver bullet to end malaria

While commending the addition of the new vaccine to available malaria-control tools, there is no silver bullet to end the disease, Dr Michael Charles, CEO of the Roll Back Malaria Partnership noted.

“While this announcement is a step in the right direction, there are still major hurdles to overcome,” he said. “In the face of significant funding shortfalls and the growing threats of insecticide and drug resistance, and climate change – further investment must be urgently mobilised to scale-up, manufacture and roll-out malaria vaccines to ensure they are readily accessible to countries that decide to use them.” .

With countries facing different challenges, health ministries will need to determine how the two vaccines can complement their existing malaria control strategies. 

“This new vaccine will be highly effective to fight malaria, but must be used in tandem with other tools such as insecticide-treated nets, indoor residual spraying and preventive medicines to have the greatest impact,” Charles added.

Image Credits: Tom Wilkinson,/Oxford University, University of Oxford/Tom Wilkinson.

WHO is rushing emergency health supplies to refugees from Nagorno-Karabakh who have fled over the border to Armenia

WHO said it is racing emergency health supplies to Armenia, struggling to cope with over 100,000 refugees who have poured over the border from the ethnic Armenian enclave of Nagorno-Karabakh over the past 10 days. 

The enclave, controlled by an ethnic Armenian separatist group since 1994, was retaken by Azerbaijan in a lightning-style military campaign that began on 19 September and lasted about 24 hours.  

The Armenian government said Monday that 100,514 of the region’s estimated 120,000 residents have crossed into Armenia. Eyewitnesses said that the regions capital city, Stepanakert, was virtually deserted. 

In a press release, WHO said that it was rushing emergency health supplies to the Armenian Ministry of Health – to cope with the refugees’ arrival. It is the second such mass exodus event to be witnessed in Europe recently, following Russia’s invasion of Ukraine in February 2022. 

“WHO had already pre-positioned trauma supplies to Armenia,” said WHO’s Regional Director for Europe, Hans Kluge.  

“Following the dramatic explosion of a fuel depot along the route taken by those entering Armenia, WHO is dispatching burns kits to support the advanced care needed for severe burns patients,” Kluge said. He was referring to the massive fuel depot explosion on September 25 amid the exodus. The blast killed at least 170 people and injured 200 more.

“We’ve activated our emergency systems and will be sending experts to the country across a range of disciplines including mental health, burns management, essential health services, and emergency coordination following a full assessment of the needs. 

“To support the general health needs of the displaced population, WHO is also sending medicines for non-communicable diseases, that will cover 3 months of treatments for up to 50,000 persons,” Kluge added, saying “The challenges are truly enormous, and we’re there to do all we can.”

A WHO special envoy, Robb Butler, has also been dispatched to Armenia to assess more long term needs. 

“At the first major town the refugees are fleeing to, I saw an immense outpouring of solidarity from the local Armenian community and volunteers, who are doing all they can to provide food, water and shelter,” said Butler.

“But you see the despair on many of the faces of the displaced. They have left everything behind, their homes, their belongings, the graves of their loved ones. There are children, the elderly, women and girls with specific sexual and reproductive health needs. It’s clear that the mental and emotional scars the refugees carry will take time to heal. But it’s also obvious that the staggering speed with which this crisis is unfolding requires all hands on-deck – WHO, our UN partners, civil society organizations – to complement and support the government’s efforts. 

Image Credits: WHO/Nazik Armenakyan .