The spread of bird flu in US cattle prompts concerns about the safety of commercially sold milk products.

Amid the growing avian influenza epidemic in American cattle, the US Food and Drug Administration (FDA) launched new research Tuesday to ensure dairy products available in the market do not contain the virus in its active form.

The research will involve a series of studies to test pasteurised milk samples collected from store shelves. The study aims to determine if, and to what extent, virus contamination may occur in individual as well as pooled milk product samples, as well as in other diary products like cream and cheese.  

The retail survey aims to cover geographic and product gaps in the sampling of 297 products in late April and early May, which found all products tested were H5N1-free.

“As outlined in the FDA’s research agenda released today, the FDA is working on multiple efforts to understand the effectiveness of pasteurization and other inactivation methods,” the FDA advisory stated. So far, pasteurisation proves effective but more research is needed to ensure the virus does not present risk to the food supply.

Farmers reluctant to agree to cattle surveillance

Since March, the highly pathogenic avian flu strain, H5N1, has infected 131 US dairy cow herds in 12 states, according to a separate update from the US Centers for Disease Control and Prevention (CDC). Three human cases of infection following exposure to infected dairy cows have also been reported.

WHO has assessed avian flu risks to public health as low for the general population and low-to-moderate for people working with animals. Yet, as the virus gains ground infecting more species, the risk of human-to-human transmission rises. In the US case, for instance, some 21 cats also have been infected since March. CDC has warned that dogs could become another virus reservoir, increasing risks of transmission to humans, although this scenario remains unlikely for the moment.

H5N1 strain infects a still growing number of species, including many mammals

“CDC monitors disease outbreaks, looking at […] surveillance in wild animals. […] Risk assessments are performed,” said Christine Oshansky of the Biomedical Advanced Research and Development Authority (BARDA) during a National Vaccine Advisory Committee meeting June 13.

Despite the CDC’s and other agencies’ efforts, the US epidemic response has been regarded by many experts as woefully insufficient to date. 

Farmers are reluctant to have themselves or their herds tested – practices that remain voluntary. Farmers also have expressed resistance to using personal protective equipment during milking, when, most likely, infections occur. 

Abiding with CDC and FDA guidelines has perceived downsides, while the positives are not as evident: goggles or respirators, recommended by the CDC, can be cumbersome in the humid and hot milking parlors and reporting just one infected cow marks the whole herd as potentially sick, meaning financial loss for the farm.

The net result has been that only 45 people, so far, have been tested for avian flu symptoms, despite the estimated  million tests distributed across the country. Lack of testing means the real epidemic situation is largely unknown. “We’re flying blind,” assessed Dr. Jennifer Nuzzo, the Director of the Pandemic Center at the Brown University School of Public Health, told KFFHealth News last week.

Stockpiling for emergency

Dedicated vaccines, another element of the epidemic response, are also not yet ready. The FDA has so far approved three H5N1 vaccines: made by Sanofi, a GSK subsidiary, ID Biomedical Corporation of Quebec (IDB), and CSL Seqirus –  all of which take several months to produce.

Other countries, for instance the United Kingdom, are also preparing  stockpiles, while Finland is starting a vaccination programme designated for risk groups, using a vaccine against the H5N8 strain.

Finnish fur animal farming is a potential source of avian flu infections

Seasonal flu vaccines, though only moderately effective in preventing avian influenza infections, can still be helpful, Dr Aspen Hammond, a technical officer at the WHO, said during an Epidemic Information Network seminar on June 6. 

“It has been recommended to use seasonal vaccines, especially in […] healthcare workers, obviously, but also in people that are exposed to potentially infected birds, just to try to minimise them developing symptoms,” he said.

Vaccinating animals also has an important role to play, emphasized Ian Brown, Chairman of the joint World Organisation for Animal Health/Food and Agriculture Organisation network of expertise on animal influenzas, during the seminar:

 “It’s a simple equation: you reduce the infections in domestic birds, you reduce the risk of spillover to wild birds, you reduce the risk of spillover to humans.”

Image Credits: Ashoka Jegroo, USDA, Oikeutta eläimille.

New research shows PFAS, a class of 12,000 man-made chemicals derived from fossil fuels and linked to serious health issues, can be absorbed through human skin.

Human skin can absorb ‘forever chemicals’, University of Birmingham researchers discovered, revealing a new pathway for these toxic substances to enter the body. The finding amplifies health concerns as researchers increasingly detect per- and polyfluoroalkyl substances (PFAS) in people worldwide.

PFAS are man-made chemicals that persist in nature and human bodies for a millennium before breaking down. This class of over 12,000 synthetic compounds derived from fossil fuel by-products is used across industries from textiles to construction and found in everyday items like cosmetics, waterproof clothing and non-stick cookware.

The chemicals have been detected globally in water, soil, and wildlife, even reaching Arctic regions. Scientists link PFAS to serious health issues, including cancer, liver damage, decreased immune response and developmental problems.

Recent studies show PFAS accumulating in testicles, breast milk, and unborn children, raising concerns about reproductive health and infant exposure. The full health impacts on children remain unclear.

In Europe, a leader in toxic chemical regulation, daily PFAS exposure already surpasses safety limits set by the European Food Safety Authority. A 2022 study found that food and dust intake alone push PFAS levels beyond these thresholds for both children and adults.

Now, the skin absorption study adds another layer of concern, suggesting that daily contact with PFAS-containing products could significantly increase overall exposure beyond the already harmful levels.

“This study helps us understand how important exposure to these chemicals via the skin might be,” said Professor Stuart Harrad, a co-author of the study.

‘Safe’ PFAS 

PFAS’s water and oil-resistant properties mean it is commonly found in everyday items such as rain jackets and non-stick pans.

The new research challenges long-held beliefs about PFAS. Scientists previously thought the same properties that make these chemicals repel water and stains would prevent skin penetration. Using advanced 3D human skin models, researchers tested 17 common PFAS compounds; 15 showed significant absorption within 36 hours.

“Our research shows that this theory does not always hold true and that, in fact, uptake through the skin could be a significant source of exposure to these harmful chemicals,” said Oddný Ragnarsdóttir, the study’s lead author.

Contrary to industry claims, shorter-chain PFAS compounds — introduced as ‘safe’ alternatives — were more easily absorbed by the skin. One such compound, commonly found in food packaging and cookware, demonstrated an absorption rate four times higher than longer-chain PFAS.

“We see a shift in industry towards chemicals with shorter chain lengths because these are believed to be less toxic,” Harrad explained. “The trade-off might be that we absorb more of them.”

The findings have significant implications for consumers, who may be unknowingly exposing themselves to PFAS through common products. While experts advise seeking PFAS-free alternatives, the chemicals lurk in countless everyday items, from electronics and carpets to musical instruments, dental floss, and books. Their widespread presence makes complete avoidance nearly impossible, even for the most informed consumers.

“We are continuously surrounded by consumer products that intentionally or unintentionally have things that we probably shouldn’t be using,” Graham Peaslee, a Notre Dame physicist specializing in identifying PFAS in consumer goods, told the Washington Post. “We are coating ourselves in this stuff every day.”

Regulators behind the ball

The European Union is emerging as a global leader in PFAS regulation, with its chemical safety agency considering a ban on this class of chemicals.

The mounting scientific evidence concerning the environmental and health dangers of PFAS is pushing regulators to take notice.

In the European Union, some PFAS are already restricted under existing laws and the bloc has set limits for PFAS in drinking water and certain consumer products. The European Chemicals Agency is considering a ban on PFAS, proposed by five member states in 2023.

The United States recently announced a review of the Environmental Protection Agency’s proposed rules to regulate PFAS dumping by industrial facilities involved in metal finishing, meat and poultry, textiles, and steam electric power generation. This marks a first step towards nationwide regulation of these chemicals.

As global regulators move slowly toward action on PFAS, experts worry the genie may already be out of the bottle. True to their moniker, “forever chemicals” take centuries to break down, persisting in the environment and human bodies.

The World Health Organization (WHO) recognizes PFAS as chemicals of concern. In 2022, WHO released guidelines on PFAS in drinking water, recommending combined limits for certain compounds.

PFAS are also addressed under WHO’s work on the Strategic Approach to International Chemicals Management (SAICM), a policy framework led by the UN Environment Programme and WHO that aims to achieve the sound management of chemicals throughout their life cycle to minimize adverse impacts on human health and the environment.

Industry hobbles efforts at international regulation

Research shows that humanity produces around 460 million metric tonnes of plastic a year, and without urgent action, this will triple by 2060. Much of that plastic is lined with PFAS.

The fossil fuel, plastics, and chemical industries are deeply interconnected, with giants like ExxonMobil, Saudi Aramco, and Chevron dominating all three sectors. As with climate change, these companies knew about PFAS environmental and health risks decades before the public, according to recent research.

A 2023 study published in the National Library of Medicine found industry documents showing companies knew PFAS were “highly toxic when inhaled and moderately toxic when ingested” by 1970, 40 years before the public health community. The study alleges that companies employed tactics similar to those used by tobacco and pharmaceutical industries to influence science and regulation, including suppressing unfavourable research and distorting public discourse.

Today, industry interests continue to resist international regulation efforts. At Basel Convention talks this week, Russia opposed World Health Organization involvement in a Science Policy Panel on chemicals and waste. The proposed panel, similar to the IPCC’s role in climate change, would provide scientific evidence to treaty parties, potentially leading to tougher, binding rules.

Sources close to the talks say Russia, a major fossil fuel producer, opposes WHO involvement to limit scientific evidence on health impacts. This move could weaken future chemical regulations under the Basel Convention, the legally binding treaty governing transboundary movements of hazardous waste.

Fossil fuel and chemical producers have also stalled progress on a global plastic pollution treaty since talks began in 2022. Major plastics powers led by the United States, Saudi Arabia, China and Russia are blocking efforts to include production caps in the agreement, which would be legally binding if passed. These countries manufacture most of the world’s 380 million tonnes of annual plastic output.

While PFAS and plastics are distinct chemical families, both derive from petroleum products. PFAS often coat plastic products, such as grease-resistant food containers, but aren’t part of the plastic’s chemical structure. This shared origin in fossil fuels links these industries, complicating efforts to regulate either product independently.

PFAS are not the direct focus of the plastics treaty, but environmental experts, the UN Environment Programme, and a coalition of 66 ‘high ambition’ countries led by Norway and Rwanda are pushing for a broader scope. They advocate for a legally binding instrument that could include harmful additives like PFAS and cap plastic production. Major fossil fuel-producing nations oppose these measures.

The negotiations, conducted under UNEP, require consensus, giving significant leverage to those opposing production limits. The next session is scheduled for late 2024.

With 4.4 million tonnes of PFAS released between 1950 and 2015 and production still rising, the health threat posed by these toxic compounds continues to mount. The fossil fuel industry increasingly sees plastics and related chemicals as crucial revenue sources amid pressure to reduce oil and gas production for energy use.

Image Credits: Artur Voznenko, CC, Thijs ter Haar, Florian Fussstetter/ UNEP.

UNAIDS has welcomed the recent ruling by Namibia’s High Court that its laws prohibiting same-sex acts between men are unconstitutional as they unfairly discriminate against gay men.

Namibian citizen Friedel Dausab, supported by the Human Dignity Trust, sought to have laws prohibiting sodomy and “unnatural sex acts” and sections of the Immigration Control Act and the Defence Act that criminalised homosexuality declared invalid.

He brought the case against the Ministers of Justice, Home Affairs and Defence, the Prosecutor General and the Attorney General. 

Judges Nate Ndauendapo, Shafimana Ueitele and Claudia Claasen ruled in Dausab’s favour, noting that these laws discriminated as they treated gay men differently from women who have sex with men, and heterosexual men who have sex with women.

Dausab told Reuters after the ruling that he was “just happy” after the court’s decision as “it won’t be a crime to love any more.”

“The enforcement of private moral views of a section of the community (even if they form the majority of this community), which are based to a large extent on nothing more than prejudice, cannot qualify as such as a legitimate government purpose,” noted the judgement.

Anne Githuku-Shongwe, UNAIDS regional director for East and Southern Africa, described the court’s decision as ” a powerful step towards a more inclusive Namibia”.

“The colonial-era common law that criminalised same-sex sexual relations perpetuated an environment of discrimination and fear, often hindering access to essential healthcare services for LGBTQ+ individuals. To protect everyone’s health, we need to protect everyone’s human rights,” she said.

 In sub-Saharan Africa, men who have sex with men in countries where they are criminalised are five times more likely to be living with HIV than in countries that do not criminalise this, according to UNAIDS.

Globally, in 2022, men who have sex with men were 23 times more likely to acquire HIV, and transgender women 20 times more likely to acquire HIV than other adults aged 15–49.

Project HOPE, which also works to combat HIV in Africa, said that “dismantling discriminatory laws is a crucial step toward ensuring everyone can safely access health care, including HIV testing and treatment”.

“While much progress has been made toward mitigating HIV and AIDS, we cannot hope to end the epidemic in Africa unless we fully embrace human rights and provide stigma-free services for all, including LGBTQIA+ communities. Access to evidence-based HIV services are quite literally a matter of life and death,” said Steven Neri, Project HOPE’s Africa director.

Iraq outlaws ‘effeminacy’

Namibia’s ruling is similar to that of Botswana’s High Court in 2019, which declared that Section 164 of Botswana’s Penal Code was unconstitutional as it discriminated against LGBTQ people’s right to liberty and privacy.

While over half of Africa’s 54 countries prohibit consensual same-sex relations, since 2019, Botswana, Gabon, Angola, and Mauritius have repealed laws that criminalised LGBTQ+ people.

Further afield decriminalisation has also happened in Bhutan, Antigua and Barbuda, Barbados, Singapore, Saint Kitts and Nevis, Cook Islands, and Dominica.

Namibia’s High Court decision also bucks the trend set by Uganda and Ghana, which have made their colonial anti-LGBTQ laws even more harsh in the past 18 months.

Earlier this year, Iraq introduced anti-LGBTQ legislation that imposes a prison sentence of up to 15 years for same-sex sexual relations. Transgender people face up to three years in prison for receiving gender affirmation care, while the “intentional practice of effeminacy” is outlawed, and people who “promote homosexuality” face up to seven years in prison. 

UNAIDS urged all countries to follow Namibia’s lead, remove punitive laws, and tackle prejudices against LGBTQI people.

“Criminalising consensual same-sex relationships and gender expression not only violates fundamental human rights but also undermines efforts to end AIDS by driving marginalised populations underground and away from essential health services, including life-saving HIV prevention, treatment and care services,” according to UNAIDS.

“Stigma, discrimination and criminalisation can be lethal,” said Winnie Byanyima, executive director of UNAIDS.

“In the response to HIV, we have learnt that a human rights-based approach is critical in responding to a health crisis and leaving no one behind. Countries must remove these discriminatory criminal laws and introduce legislation which protects rights if we are to end AIDS as a public health threat for everyone.”

Image Credits: UNAIDS.

People running
The World Health Organization sees physical activity as a “missed opportunity” in combatting noncommunicable diseases.

Physical inactivity levels have jumped to 31%, meaning that around 1.8 billion people did not meet the recommended levels of physical activity in 2022 , according to a new report from the World Health Organization (WHO). 

This is an increase of 10% since 2000, mostly driven by data from lower-middle income countries. Lack of physical activity increases the risk of a host of non-communicable diseases (NCDs)  like heart disease and diabetes, poor physical and cognitive function, weight gain, and mental ill-health. 

Map of global physical inactivity
Global physical inactivity has risen by 10% in the past two decades. Much of the world’s inactivity is concentrated in lower-middle income countries.

The WHO recommends at least 150 minutes of moderate-intensity activity, 75 minutes of vigorous-intensity activity, or an equivalent combination per week. Yet much of the global adult population fails to meet the recommendation.

The study, published in The Lancet Global Health Journal, is the first global estimate since 2016, and uses data from over 500 population-based surveys covering 5.7 million participants in 197 countries and territories. 

The WHO’s physical activity global target aims to reduce the prevalence of insufficient physical activity by 15% from 2018 to 2030. However global trends indicate physical inactivity will instead rise to 35% by 2030.

This poses a “silent threat” to global health and drives the burden of chronic diseases, as Dr Rüdiger Krech, WHO director of Health Promotion, noted in a press release. 

“We need to find innovative ways to motivate people to be more active, considering factors like age, environment, and cultural background. By making physical activity accessible, affordable, and enjoyable for all, we can significantly reduce the risk of noncommunicable diseases and create a population that is healthier and more productive,” said Krech.

High levels of inactivity in Asia Pacific and South Asia

Japan, the Republic of Korea, and Singapore, considered high-income Asia Pacific countries, had the highest prevalence of insufficient physical activity at 48% in 2022. 

Second to this region is South Asia, with a 2022 prevalence of 45%. These numbers are especially worrying as those who are physically inactive have 20-30% increased risk of death compared with those who are physically active. Physical inactivity is linked specifically to heart disease, diabetes, stroke, colon and rectal cancer, and breast cancer. 

However, lower-middle income countries face the highest levels of physical inactivity at 38% in 2022 compared to low (17%), upper-middle (27%), and high income (33%) countries. 

Gender disparities persist 

Map of physical inactivity for women
Prevalence of insufficient physical activity among women.

Beyond geographic variations, the study warns of widening gender disparities. Globally, 34% of women are physically inactive, compared to 29% of men. In some countries, this difference is as much as 20 percentage points, according to a press release. 

The gender physical activity gap stems from many complex barriers limiting women’s physical activity: less leisure time, stereotypes, body image insecurities, and the constraints of cultural acceptability. Women and girls’ sports also receive less investment, according to a recent Lancet editorial on the issue.

Map of physical activity in men
Prevalence of insufficient physical activity in men.

These disparities widen as women age, with women over 60 having the highest relative levels of physical inactivity across all regions.

Physical inactivity increases as women age across all regions.

“These new findings highlight a lost opportunity to reduce cancer, heart disease and improve mental well-being through increased physical activity,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General in a press statement. “We must renew our commitments to increasing levels of physical activity and prioritize bold action, including strengthened policies and increased funding, to reverse this worrying trend.” 

Hopes for a more active world

The authors note that, although their physical inactivity estimates exceed the WHO targets for many countries, several countries are on track to increase physical activity by 2030. For example, at least six countries in Oceania have seen marked reductions in physical inactivity since 2000, from 23% to 14% in 2022. 

The WHO recommends at least 150 minutes of moderate-intensity activity, 75 minutes of vigorous-intensity activity, or an equivalent combination per week.

An additional 16 countries are on track to reach the global target of reducing inactivity by 15% by 2030 if their trend continues at the same pace.

The WHO has called on countries to strengthen their policy implementation to promote and enable physical activity. Listing community sports, active recreation, and better active transport as ways to promote physical activity, the WHO aims to promote its 2030 targets through country-level policies. 

“Promoting physical activity goes beyond promoting individual lifestyle choice – it will require a whole-of-society approach and creating environments that make it easier and safer for everyone to be more active in ways they enjoy to reap the many health benefits of regular physical activity,” said Dr Fiona Bull, Head of the WHO Unit for Physical Activity in a press statement.

 

Image Credits: Gabin Vallet, The Lancet Global Health, WHO.

The MSF’s leadership wants its medicine advocacy to focus on products its field offices need for humanitarian efforts.

The leadership of Médecins sans Frontières (MSF) is under significant global pressure to reverse its decision to close its Access Campaign, with indications that the issue may be raised at the organisation’s general assembly that begins in Geneva on Thursday (27th).

The decision has been described as a triumph for technocrats within MSF, who want the organisation to be more narrowly focused on humanitarian efforts and less on the wider political issues hampering patients’ access to medicines.

Over 100 civil society organisations and 250 individuals have signed a letter addressed to MSF’s leadership and board, urging them to reverse the decision to close the iconic unit, which they say will “cause catastrophic and irreparable damage to access to health technologies for communities served by MSF projects and beyond”.

Signatories include past MSF leaders Dr Unni Karunakara (former international president), Kris Torgeson (former international secretary general), Gorik Ooms (former general director) and Dr Tido von Schoen-Angerer (former executive director of the Access Campaign).

Dr Mariângela Simão, former World Health Organization (WHO) Assistant Director-General for Access to Medicines and former New Zealand Prime Minister Helen Clark also joined civil society organisations and health experts in their appeal to MSF.

“The planned dismantling of the Access Campaign’s core structure, capacities, expertise, and networks will reverberate across the access to medicines movement and beyond,” they write.

“It will be yet another setback to the already-shrinking patient activist and civil society space critical to holding pharmaceutical companies and governments accountable so that medicines are never a luxury.”

‘Longstanding power struggle’

Von Schoen-Angerer, who headed the Access Campaign from 2006 to 2012, told Health Policy Watch that the closure was the outcome of “a longstanding power struggle” between MSF’s international office and its five powerful operational centres – Paris, Amsterdam, Brussels, Geneva and Barcelona – and the strong global and somewhat independent Access Campaign.

“It’s also a clear move from some people in MSF who want to depoliticise [the organisation], with a stronger focus on a technocratic approach; on products alone, shying away from some of the underlying political issues that determine access,” he added. 

“They are no longer willing to take up the political battle to really fight these access battles for better prices, more research and development, greater equity. 

“We’re looking at a more inward, more technocratic MSF that wants to get health products for their patients alone, and is no longer wanting to fight the bigger political battles that need to be fought.”

However, an MSF spokesperson told Health Policy Watch that the letter’s concerns were based on “the misleading notion that MSF is halting or reducing its work on access to products for healthcare. 

“This is 100% wrong. MSF is redoubling its efforts to deliver tangible improvements in access to products for healthcare driven by our new collective vision to expand our efforts to improve access to products for healthcare.”

Access Campaign victories

MSF’s ‘Europe! Hands Off Our Medicine’ campaign demands removal of harmful provisions from the EU-India trade agreement, which threatens the supply of affordable medicines made in India.

The Access Campaign has advocated for lower prices and better access to a range of medicines for over 25 years and won some major victories – particularly for HIV and TB patients. 

It was launched in 1999, first campaigning for Thai drug companies to be able to produce affordable generic versions of Pfizer’s costly fluconazole, used to treat infections in people with HIV. Its latest triumph was earlier this year when it helped to secure affordable access to bedaquiline for people with multi-drug-resistant TB.

In 2003, it helped to launch the Drugs for Neglected Diseases initiative (DNDi), an independent, non-profit drug development organisation focused on developing new treatments for some of the world’s most neglected diseases.

The Access Campaign is unique as it has both a global view of issues blocking access to medicines –  such as Free Trade Agreements that prevent generic competition – and local knowledge of communities’ needs from MSF’s field offices. 

But the unit is the victim of a costly two-year restructuring exercise aimed at redirecting resources from global issues to MSF’s work on the ground, according to sources.

These sources told Health Policy Watch that around 50 staff are to be cut to 19 and housed in a new unit called “Access to Products for Healthcare”. Current staff will have to compete with one another for the posts. The new unit will advocate for access to specific products needed by MSF’s humanitarian efforts.

At present, there is no strategic plan for the new unit, and staff are to be dispersed between five regional offices – Kuala Lumpur in Malaysia; Nairobi, Kenya; Dakar, Senegal; Rio de Janeiro, Brazil; and Brussels, Belgium.

Von Schoen-Angerer described as “arrogant” the restructuring process which cost “hundreds of thousands (of Euros)” yet involved “MSF talking entirely to itself, completely ignoring the hundreds of allies in terms of organisations in the Global South, but also the North – the academics, the governments that the Access Campaign has worked with.”

“That’s why they have come out with this letter because they’ve never been consulted,” he added.

In 2015, MSF’s “A Fair Shot” campaign called on Pfizer and GSK to reduce the price of the pneumonia vaccine – the most expensive standard childhood vaccine – to $5 per child. In 2016, a price of $9 per child is offered to humanitarian organisations like MSF, but only for use in emergencies.

MSF International stands its ground

An MSF spokesperson told Health Policy Watch on Wednesday that they were not aware of the issue being on the agenda of the general assembly, MSF’s highest decision-making body, or when it would be discussed by the MSF board.

Asked what the motivation was for closing the Access Campaign, the spokesperson said that “the new structure will be closer to our medical humanitarian operations, to better support the needs of the communities we assist. Five regional offices will work together with our operational teams and patients as well as with our partners and networks.”  

They added that populations’ access to healthcare were being affected by new developments including “technological breakthroughs, new political players, and new legal and commercial realities and regulations”. 

“For our patients and also our networks, we have a duty to ensure that we remain optimally organised to leverage our unique positions for improving access to products for healthcare for those deprived of them.”

MSF’s International Office said in statement  this week that the organsation’s “focus is on directly addressing the problems our patients and our operational teams face.

“We will also continue to work globally to address systemic barriers causing or amplifying these problems. This includes advocating for changes to policies and practices that determine who can or cannot access lifesaving health care products in many of the more than 70 countries around the world where we work.” 

MSF’s Alexandre Michel boarding a UN Air Service helicopter bound for Les Cayes in southern Haiti following an earthquake.

Loss of global advocacy?

Many access activists fears that MSF will no longer advocate around HIV, neglected tropical diseases, intellectual property, research and development, trade agreements, transparency, and other cross-cutting access issues

However, when asked directly whether MSF would cease its global work on issues such as the pandemic agreement negotiations and global trade agreements, the spokesperson simply responded: “In 2025, MSF’s new structure dedicated to our work with improving access to products for healthcare will continue the work of the Access Campaign that aligns with our new collective access to products for healthcare priorities, including dossiers on vaccines, diabetes, [anti-microbial resistance], TB, and diagnostic tools. Next year will also be dedicated to dedicated to finalising the new structure’s longer-term strategic plan.”

The spokesperson added that “around 35 staff are contracted to the Access Campaign” as well as “a number of others with temporary contracts”.  

“At least 19 of them have the immediate opportunity to work for the new structure. Others may also be absorbed (due to their expertise) by other MSF sections, operational directorates or projects.”

But Von Schoen-Angerer expressed concern that there is no strategy in place for the new unit “beyond vague priorities” and  it will take at least a year to develop a strategic plan.

Loss of unique skills

“They are firing all the fantastic staff or humiliating them by making them reapply if they want to be part of the new structure. Allies will be lost, battles will be lost and it will take years before this will become effective.” he added.

Fatima Hassan, director of the South African Health Justice Initiative (HJI), described the skills of Access Campaign staff as “unique, unprecedented, and multi-disciplinary.”

“There are no other groups right now in the world that can replicate its work or fill its large shoes,” said Hassan, urging MSF not to “dilute” it.

Ellen ‘t Hoen, director of Medicines Law & Policy and former policy and research director of the  Access Campaign, has also expressed her alarm at the move, describing the campaign as “a pillar of global access to medicines work”.

“Access issues have never been more front and centre in global health, as the recent lack of progress in the negotiations of the WHO pandemic accord – and the desperate scramble to access COVID-19 countermeasures that preceded the launching of the accord process – have underlined,” noted ‘t Hoen’s Medicines Law & Policy this week.

“If MSF proceeds with this decision, it will leave a significant void in the access movement. Particularly, groups in low and middle-income countries will bear the brunt of this loss. There are no apparent players who can take over the role of the MSF Campaign because most lack the multidisciplinary expertise and resources MSF has.”

This week, Unitaid’s executive director, Philippe Duneton, also added his voice to appeals for MSF to continue its access work in an open letter to MSF’s president, Dr Christos Christou.

“MSF’s voice and work in access remains more needed than ever, addressing the grassroots causes of inequities whether in HIV or global health emergencies, neglected diseases, and neglected populations that the market keeps failing,” noted Duneton, whose organisation works to ensure low- and middle-income countries have access to treatment and tools to combat major health challenges.

Image Credits: MSF, MSF Access Campaign.

Delegates during the launch of a WHO visceral leishmaniasis elimination framework

WHO framework to eliminate visceral leishmaniasis (VL), a deadly disease most prominent in East Africa, was launched Thursday.

It can play an important role in eliminating VL as a public health problem by 2030: a goal key countries of the East African region committed to in last year’s Nairobi Declaration.

“The VL elimination framework will offer important direction to countries in the region and provide momentum to reach the finish line of elimination,” said Dr Dereje Duguma, the Health Minister of Ethiopia, a co-host of the launch.

“The Government of Ethiopia remains committed to working with partners to develop programs at all levels, from national to community, to expand access to healthcare and achieve the targets of elimination by 2030.”

Visceral leishmaniasis, or kala-azar, is a deadly parasitic disease causing fever, weight loss, spleen and liver enlargement, transmitted by the bite of infected female sandflies. Lethal if left untreated, the disease is endemic in 80 countries worldwide, with 73% of the estimated 50,000 to 90,000 cases annually occurring in the Eastern African region in 2022, according to the WHO. Children under 15 account for half of the infections.

Malnutrition, but also poor sanitary and housing conditions increase the risk of leishmaniasis infection. Sandflies, which transmit the disease, often live next to crowded buildings or spaces with open sewages or bad waste management. VL outbreaks are also frequent when many people without immunity to the parasite migrate to areas where it is endemic or with environmental changes, such as deforestation, building of dams, but also climate change.

Successful elimination thanks to framework

A good implementation of a regional Strategic Framework for VL led to a total elimination of the disease in Bangladesh in 2023 – becoming the first country worldwide to achieve the status – and a significant reduction of cases in the region. Eastern Africa wants to follow a similar path.

 

A 2014 plan to eliminating VL in Bangladesh, India and Nepal brought a massive decline in case numbers

Between 2004 and 2008, Bangladesh, India and Nepal accounted for 70% of global visceral leishmaniasis cases. The regional framework adopted in 2005, paired with sustained stakeholder support and a political will for an accelerated program implementation contributed to a successful case reduction.

The combined number of cases for the three countries decreased almost forty times, from 39,809 in 2005 to only 1,074 in 2022, according to WHO data.

Nairobi Declaration commitments

Representatives of eight East African countries pledged to follow the path to VL elimination, signing the Nairobi Declaration in 2023. The ministries of health of Chad, Eritrea, Ethiopia, Kenya, Somalia, South Sudan, Sudan, and Uganda, along with key stakeholders in the region set the goal of significantly curbing VL cases by 2030. Djibouti has also signed the declaration and co-hosted the WHO elimination framework launch last Thursday.

The framework, developed in partnership with the Drugs for Neglected Diseases initiative (DNDi) and Ministries of Health across the region, outlines five main strategies for VL elimination: early diagnosis and treatment, vector management, surveillance, social mobilisation, and operational research.

It also features a step-by-step guide through elimination phases as well as sets regional and country targets, such as a 90% reduction in VL burden in Eastern Africa by 2030, decreasing the number of cases to 1,500 annually.

“By providing countries with tailored tools and strategies, we are laying a strong foundation for sustained progress in the fight against this neglected tropical disease,” said Dr Saurabh Jain, WHO’s Focal Point for VL.

Image Credits: WHO.

The WHO stresses that there is no safe level of alcohol consumption.

Romania, Georgia and Czechia have the highest alcohol consumption rates in the world while, in the best-case scenario, only 14% of those who abuse alcohol have access to treatment.

These are some of the insights from the World Health Organization’s (WHO) global status report on alcohol and substance use disorders, based on 2019 data from 154 countries. 


Around 400 million people lived with alcohol and drug use disorders, with 209 million of these being people with alcohol dependence.

Those living in the vast WHO European region, which includes Russia, consumed the most alcohol – 9.2 litres of pure alcohol per person annually. The Region of the Americas, which includes North and South America and the Caribbean, followed with 7.5 litres.

In Romania, the average daily pure alcohol consumption per capita was a staggering 36.9 grammes, the highest in the world. Georgia (31.1g), Czechia (28.8) and Latvia (28.4) – all in the European region – were not far behind.

Despite Australia’s hard-drinking image, its drinkers averaged 21.9 g per capita per day, the third highest in the West Pacific region after Laos (25) and the Cook Islands (22.9). 

In the region of the Americas, Canada (21.5) and the USA (20.8) topped the list. In Africa, South Africa (19) had the highest alcohol consumption, while Thailand (17) was the highest in the South East Asia region. Alcohol consumption was low in the Muslim-dominated Eastern Mediterranean region, topped by the United Arab Emirates (5).

Severe harms; ‘No safe level’

“Substance use severely harms individual health, increasing the risk of chronic diseases, mental health conditions, and tragically resulting in millions of preventable deaths every year. It places a heavy burden on families and communities, increasing exposure to accidents, injuries, and violence,” wrote WHO Director-General Dr Tedros Adhanom Ghebreyesus in the report’s foreword. 

Dr Vladimir Pozniak, WHO’s head of alcohol, drugs and addictive behaviours

“The level of alcohol consumption per capita among drinkers amounts to an average of 27 grammes of pure alcohol per day, which is roughly equivalent to two glasses of wine, two bottles of beer or two servings of spirits,” Dr Vladimir Pozniak, WHO’s head of alcohol, drugs and addictive behaviours, told a media briefing this week.

Of all deaths attributable to alcohol in 2019, an estimated 1.6 million deaths were from non-communicable diseases (NCDs), including 474,000 deaths from cardiovascular diseases and 401,000 from cancer.

Some 724 000 deaths were due to injuries, such as those from traffic crashes, self-harm and interpersonal violence. 

Another 284 000 deaths were linked to communicable diseases. For example, alcohol consumption has been shown to increase the risk of HIV/AIDS as people are more likely to have unprotected sex, and increase tuberculosis and lower respiratory infections by suppressing a wide range of immune responses.

The highest proportion (13%) of alcohol-attributable deaths in 2019 were young people aged 20-39 years.

Globally, almost a quarter (23.5%) of all 15 to 19 year olds were current drinkers, with the highest rates in the European region (45.9%) followed by the Americas (43.9%).

Pozniak stressed that “there is no risk free levels of alcohol consumption”.

“The WHO has not produced guidelines [on safe alcohol consumption] because the diversity of countries, the diversity of populations, their exposure to alcohol, are so different, that to come up with universal levels of risks would be an unmanageable task,” said Pozniak.

“It’s advisable to consult with a health professionals on the risks associated with level or pattern of consumption, taking into consideration the individual characteristics of a person [such as] pre-existing disorders or current health conditions because the risks varies substantially, depending on all these factors.”

Lack of treatment options

The total alcohol per capita consumption decreased slightly from 5.7 litres in 2010 to 5.5 litres in 2019. But the world is far from reaching the Sustainable Development Goal (SDG) target 3.5 by 2030 of reducing alcohol and drug consumption and improving access to quality treatment for substance use disorders.

Although effective treatment options for substance use disorders exists, treatment coverage is incredibly low. 

The proportion of people in contact with substance use treatment services ranged from less than 1% to a maximum of 35% in 2019. This was even lower for alcohol-related treatment, with up to 14% of people who needed it, accessing treatment.

 “Most of the 145 countries that reported data did not have a specific budget line or data on governmental expenditures for treatment of substance use disorders. Although mutual help and peer support groups are useful resources for people with substance use disorders, almost half of responding countries reported that they do not offer such support groups for substance use disorders,” according to the WHO.

“Stigma, discrimination and misconceptions about the efficacy of treatment contribute to these critical gaps in treatment provision, as well as the continued low prioritisation of substance use disorders by health and development agencies.”

A significant number of countries reported interference from the alcohol industry in their efforts to develop effective alcohol policies, according to the report. Industry interference was highest in countries that were effectively increasing the price of alcohol.

“Industry interference was most frequently reported in the African Region (62.1%). However, across all income groups, between 42% and 50% of countries pointed to this interference as a barrier to move forward,” it notes.

Actions for progress

To accelerate progress towards achievement of SDG target 3.5 and reduce the health and social burden attributable to substance use, the WHO recommends action in eight areas.

These include increased awareness through a coordinated global advocacy campaign, and the re-commitment to implement the Global Alcohol Action Plan 2022-2030 with a focus on the SAFER package.

It also calls for increased capacity of health and social care systems to deal with substance abuse, more training of health professionals, better monitoring and research and more engagement with civil society organisations, professional associations and people with lived experience.

Image Credits: Stanislav Ivanitskiy/ Unsplash.

Breast cancer screening in Nigeria
Breast cancer is among the many non-communicable diseases growing in lower-and-middle-income countries, where funding for prevention is often diverted to other health concerns.

When Felicia Knaul met Tonya Rosa, a Mexican woman undergoing chemotherapy for breast cancer, “she was there with a big smile on her face…even though her cancer had recurred.” 

But Rosa told Knaul that her first round of treatment had impoverished her family, “they had to sell their business, their home, their assets to be able to pay for her care.”

But now, she had a card that gives her access to Mexico’s public insurance to cover her treatments.

Rosa’s story was one of many shared at a two-day international financing dialogue for NCDs and mental health hosted by the World Health Organization (WHO) and the World Bank in Washington, DC. The meeting convened as part of the preparation for the United Nations High-Level on these issues in 2025.  

For Knaul, a global health economist, cancer researcher and advocate, providing care for NCDs and mental health patients requires “a health system that could deal with the whole gamut of issues that go through, from primary prevention all the way through to end-of-life care.”

Representatives from over 30 countries reiterated this call for strengthened, affordable health coverage as the means to address NCDs and bolster mental health. 

Adriana Alfonso, Director of Health Surveillance with Uruguay’s Ministry of Health, credits the country’s recent mental health successes to its decree in making psychiatric care obligatory in an affordable and universal manner at health centers. These interventions were only possible through concerted government cooperation and willpower. 

Primary care financing as a sustainable solution

Graphic on NCD financing
Health and finance leaders from over 30 countries met to discuss a path forward to sustainable NCDs and mental health financing.

“In the past, when we prepared annual budgets, we didn’t really take into account the mental health issues. In the case of Uruguay, we have a yearly budget that is discussed at the parliament level, and we needed to make sure that we had a mental health budget that was sustainable,” Alfonso noted. 

Providing dedicated funds for mental health has translated into co-payment reductions and increases in beds in mental health facilities and halfway homes. 

Lester Tan, director of Health Policy, Development, and Planning at the Department of Health in the Philippines, echoed this sentiment in describing the economics of mental health in the Philippines. 

In 2021, mental health conditions cost the Philippine economy an estimated $1.37 billion dollars, equivalent to 0.4% of GDP.  Yet, investing in more treatment of epilepsy and depression would have an incredibly high return on investment – 6.6 and 5.3 times respectively. 

“This evidence, together with the implementation of a mental health law passed in 2018 have contributed to the scaling up of mental health services in the country. There are now 362 mental health access sites nationwide, which have served 124,000 users in 2022,” said Tan.

These mental health successes hinge on expanded financing of primary health care, the “how” of NCDs and mental health care, as a panelist noted.

Tan notes that the Philippines benefitted from expanding the number of health professionals trained in mental health at the primary care level. “This capacity building prioritized depression, epilepsy, self harm and psychosis.”

A multi-sectoral approach to overcome ‘fragmentation’

School girls with caption on primary health care and mental health
Increased primary health care investment has the potential to reduce the global burden of NCDs through prevention, treatment, and care.

Other panelists noted the urgency for multisectoral approaches to financing NCDs and mental health care – working across government institutions and ministries. An NCD expert from the Tunisia Ministry of Health, noted that her ministry recruited the help of the Ministry of Youth, Sport, and Heritage to organize a national day of exercise. 

“During this National Day, everybody was invited to exercise, and we talked about the importance of physical activity. The Ministry of Health decided to do screenings for hypertension and diabetes on this day, and we, of course, had a very large media campaign and awareness raising campaign in the entirety of the country,” she said. 

Beyond the more straightforward partnerships between adjacent ministries, the health sector must work more closely with ministries of finance, noted Aleksandra Altievska, head of fund budgets at North Macedonia’s Ministry of Finance. “I recommend that every Ministry of Health always keep in mind that the Minister of Finance has other priorities.”

Working with ministries of finance to fund NCDs and mental health interventions is critical because, as Joanna Ralston of the World Obesity Federation explained, NCDs are challenges that “can’t be targeted by one sector.”

“We have a global health system that really was built around single vector diseases, just to oversimplify, and yet, now we’re coming in with something that has these commercial elements, [environmental] elements, all these factors, this great level of complexity that that has to be respected,” Ralston said. 

Obesity, as just one example, continues to impact nations across all age levels, because of the fragmentation of the response, said Ralston. “The increase of obesity is around 100% in the past couple of years, when the goal was a 0% increase.” Fragmented, under-resourced responses undermine progress on NCDs and mental health – something that advocates hope can be overcome by renewed multi-sectorial frameworks and partnerships. 

Leveraging patient experiences 

NCD finance conference in Washington, DC June 2024
Several panelists shared their own experiences living with an NCD at the Washington, D.C conference.

Knaul, who founded the Mexico-based breast cancer advocacy organization Cancer de mama: Tomatelo a Pecho, notes that the numbers alone won’t sway policymakers – bringing in patient narratives is paramount to the future of non-communicable disease prevention, treatment, and care. “Health systems repeatedly fail patients with cancer and other NCDs,” she said.

Engaging people with lived experiences of NCDs or mental health challenges bolsters local and international support, argued Charity Muturi, an NCDs and mental health policy advocate in Kenya. 

“When a national task force on mental health was formed, we felt that, as patients, our voices needed to be on the table,” said Muturi, who discussed her own challenges navigating mental health care in Kenya. 

Ralston summed up the struggle with communicating the burden of NCDs and mental health. “Evidence and narrative are what are needed to be successful. We need to be rooted in evidence, but we need to have a way of communicating that story to decision makers, policy makers, and the wider public. And that has been a challenge with NCDs.”

Image Credits: Roche, WHO.

Dr Mamy Andrianirina Rakotondratsara (centre) distributing antimalarials in rural Madagascar.

Malaria has long been at the heart of public health efforts in Africa. As a preventable but potentially fatal disease, it is caused by a parasite transmitted by mosquitoes. In 2022, the WHO African Region accounted for about 94% of cases globally. WHO says 78% of deaths in the region are among children under 5 years of age.

That’s why Dr Mamy Andrianirina Rakotondratsara, a medical doctor and research technician for Madagascar’s National Institute of Public and Community Health (INSPC), wanted to dedicate his TDR-supported studies for a Masters in Public Health to malaria research.

Originally from an endemic region in eastern Madagascar, Rakotondratsara has been personally affected by malaria as he lost his older brother to the disease. 

“I lost someone close and beloved to me from this disease,” he told Health Policy Watch in an interview. That reinforced his determination to address the disease in the course of his studies. 

Dr Mamy Andrianirina Rakotondratsara lost his brother to malaria and is passionate about addressing the disease.

In 2021, during the course of his Masters studies at the Cheikh Anta Diop University of Dakar (UCAD), Rakotondratsara  also completed TDR’s Massive Open Online Course (MOOC) on implementation research. 

As part of this course, he designed a study around the relationship between the frequency of malaria episodes and mosquito bed net coverage, working with other researchers and doctors that specialize in malaria. This research is still ongoing and specifically targets the rural population of Madagascar’s Anosibe An’Ala district. 

Although results are still pending, designing such a study has laid the foundations for Rakotondratsara to put the research findings into practice in his home region and disease context, complementing his prior work on malnutrition. 

Sub-regional training centre for Francophone Africa

Students engaged in a field training in participatory epidemiology organised by the  National Institute of Public and Community Health Madagascar.

Rakotondratsara was able to undertake this research thanks to TDR’s global postgraduate training scheme – which focuses on building students’ skills to do interdisciplinary forms of research that look at barriers and opportunities for better uptake of available preventative and treatment methods.

For physicians, researchers and other professionals interested in local public health, the fellowships supported by TDR – the global research programme on diseases of poverty co-sponsored by UNICEF, UNDP, WHO and the World Bank – provides essential skills for health programme management and implementation. It is particularly important for addressing infectious diseases affecting vulnerable and underserved populations and promoting engagement in research from the local to global levels.

UCAD is one of the two universities in French-speaking West Africa to collaborate with TDR in the programme. It has been hosting students since 2021, to conduct research into how to control infectious diseases found across the region. In 2022, University of Sciences, Techniques and Technologies in Bamako, Mali, joined the programme with the support of Germany’s Deutsche Gesellschaft für Technische Zusammenarbeit.

“The TDR training allowed us to have a new vision of the health system,” Rakotondratsara  observes.  It changed my way of asking questions when faced with poor health indicators. Regarding my Master’s thesis, it gave me an idea of issues to be explored in the mosquito net distribution process, starting with the quantification of needs to end point use.”

He strives to integrate such lessons learnt into his current role with the INSPC. And he is also planning to pursue a PhD with a specialization in implementation research.  

“The INSPC is a public health training and research institution attached to the Ministry of Public Health,” he explains. “Given that it is a research institution, in collaboration with funding bodies, we are often called upon to carry out expert appraisals on their behalf. As a research technician, I accompany this research and bring my contributions to it,” he says.

“Based on my experience, it’s my intention to ensure that implementation research finds an important place both in the research and the teaching context.” 

Towards better management of Schistosomiasis

Although less well known, schistosomiasis, also known as bilharzia, is the second most prevalent disease after malaria both in Senegal and much of the rest of sub-Saharan Africa.

Its most common form – urogenital schistosomiasis – can result in damage to the bladder, urethra, and kidneys. It is a parasitic disease that occurs in tropical and subtropical regions where there is limited access to clean water, particularly in the Senegal River Basin, a hyper-endemic region for several species of the parasite that causes the disease. 

The different variants of the disease are classified by WHO according to the NTD principles for which a greater global response is needed, making it an important research target in the TDR program.

Oumy Kaltome Boh, a physician originally from Dakar, has been interested in the burden of NTDs in Senegal since her formative years, and hopes to see their eradication by 2030.

Dr Oumy Kaltome Boh

“Faced with the impact of these diseases on the health of the population,” she says, her main objective is to contribute to their management “through the implementation of innovative interventions.” 

This is what led Boh to undertake a Masters degree in management of health programmes at UCAD, as well as an International Inter-University Diploma in emerging infections.  

Benefiting from a TDR grant in December 2020, Boh was able to conduct a study examining the day-to-day lifestyle practices and environmental factors that make schistosomiasis transmission more likely in endemic areas of her home country.

As part of this study, done in collaboration with Senegal’s national bilharziasis programme, she also aimed to verify the effectiveness of schistosomiasis treatment with praziquantel, the only available treatment option currently. A total of 287 children were followed over the course of three weeks, with ‘Day Zero’ representing the date of administration of a single praziquantel dose. Between days 14 and 21, both the effects of the drug on disease progression were assessed and a favourable efficacy profile was found, with a 98% reduction in parasite eggs by day 21.

Today, Boh holds the position of deputy chief medical officer in the health district of Saint-Louis, Senegal, and is mainly involved in care and prevention activities for people living with HIV or tuberculosis.

Recruited into this position by the Ministry of Health, she stresses that it was through the support of the TDR postgraduate training scheme that she acquired the skills she needed to manage the public health challenges in this district. In particular, learning about community-based approaches allowed her to better “understand the specific needs and problems” of the districts. 

New research and management approaches

As a key aspect of disease control, students supported by TDR can learn to apply new health research and management approaches previously unknown in Senegal, Boh says.

Among these is the One Health approach, which aims to assess how diseases emerge from a holistic and ecosystem-oriented perspective, taking into account the reciprocal role of humans, animals, plants, and microorganisms such as the aforementioned pests.

By combining scientific, strategic, and rigorous implementation training, the TDR grants offered through UCAD enable their recipients to evaluate and propose improvements to health interventions against poverty-related infectious diseases. 

These opportunities are game-changers for both UCAD students and the future of implementation research in French-speaking Africa. With the help of TDR grants, Boh emphasises, students can gain exposure to critical health programmes and “pool their skills in order to end the neglect of poverty-related diseases and to achieve the Sustainable Development Goals.”

This is the second article in a series on TDR’s research capacity strengthening programme – building skills of public health researchers, implementers, health practitioners and policy-makers in the fast-developing field of implementation research for improving uptake of effective health interventions.

None of the over 2,000 young women and girls injected twice a year with a new drug, lenacapavir, contracted HIV in one of the most important advances in HIV prevention.

Gilead Sciences announced these results last Friday, reporting that its Phase 3 PURPOSE 1 trial, conducted in South Africa and Uganda involving 2,134 women and girls aged 16-25, had been so successful that it was terminating early.

Its announcement has been widely hailed as a huge breakthrough in the HIV sector where a vaccine has been elusive, and a range of groups urged Gilead to priorise early access to lenacapavir.

The injectable was compared with Truvada and Descovy, two pills taken daily that have proven successful as pre-exposure HIV prophylaxis (PrEP). 

Sixteen of the 1,068 women in the Truvada group and 39 of the 2,136 women in the Descovy group contracted HIV during the trial. 

During a scheduled review of results, the trial’s independent data and safety monitoring board (DSMB) found the lenacapavir regimen was safe and highly effective. The trial, expected to run until September, was terminated early based on its success. Results of the trial have not been peer-reviewed yet.

The age group targeted by the trial is the worst affected by HIV in southern Africa. In 2022, over three-quarters of infections in 15 to 24-year-olds in the region were girls and women, according to UNAIDS.

“Every week, 4,000 adolescent girls and young women aged 15–24 years became infected with HIV globally in 2022, and 3,100 of these infections occurred in sub-Saharan Africa,” added UNAIDS.

One of the ‘most important results’

“This is one of the most important results we’ve seen to date in an HIV prevention study,” said Mitchell Warren, executive director of AVAC, a non-profit HIV prevention advocacy organisation.

“Adding additional HIV prevention options means more people may find an option that is right for them. Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most – from an easier-to-follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit.” 

Professor Linda-Gail Bekker, director of the Desmond Tutu HIV Centre in South Africa, said that the twice-a-year injectable could provide a “critical new choice” to prevent HIV.

“While we know traditional HIV prevention options are highly effective when taken as prescribed, twice-yearly lenacapavir for PrEP could help address the stigma and discrimination some people may face when taking or storing oral PrEP pills, as well as potentially help increase PrEP adherence and persistence given its twice-yearly dosing schedule,” added Bekker.

Gilead expects results by early 2025 from the programme’s other trial, PURPOSE 2, which is assessing twice-yearly lenacapavir for PrEP in men who have sex with men, transgender and non-binary people, currently underway in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the US. 

Access to lenacapavir, marketed as Sunlenca in the US, still needs to be worked out once it is approved by regulatory authorities.

Cost of access?

Lenacapavir (marketed as Sunlenca) was approved in the US in 2022  for “heavily treatment-experienced adults with multi-drug resistant  HIV-1 infection and for treatment of people living with HIV who have been on other HIV treatment regimes which are currently failing”.

However, Gilead charges $40,000 per patient per year in the US, reports aidsmap. 

When announcing the PURPOSE 2 results, Gilead acknowledged  the “importance of helping to enable access in order for twice-yearly lenacapavir for PrEP, if approved by regulatory authorities, to achieve the broadest impact”. 

“In light of today’s milestone and the company’s ongoing commitment to communities affected by HIV, Gilead intends to brief community partners and provide a public statement regarding its planned access approach for high-incidence, resource-limited countries, which are primarily low- and lower-middle-income countries,” said the company.

Gilead’s statement was welcomed by African HIV medicines access group AfroCAB in an open letter to its CEO, Daniel O’Day.

“Replacing 365 pills of oral PrEP with just two injections is a life-changing transition and urgently needed option, as millions of our brothers and sisters, friends, and neighbours face challenges of stigma, pill burden, and adherence, leaving them unprotected against HIV acquisition,” said AfroCAB.

“To forge a new pathway forward for [lenacapavir], we call on stakeholders to act now. After thousands of our community members have taken part in clinical trials for LEN and other injectable PrEP products, it is time that pharmaceutical companies, governments, and donors play their part in driving access among the communities that supported the science.”

“We expect to see a timeline that takes into account a full analysis of PURPOSE 1 data and the coming data from PURPOSE 2 from Gilead as soon as possible, and we urge regulatory agencies to prepare to fast track regulatory review,” Warren added.

“We also call on [the World Health Organization] to be prepared to quickly include lenacapavir, if approved by regulatory agencies, in HIV prevention guidelines. There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact and expand the toolbox of HIV prevention choices.”

Meanwhile, Unitaid urged Gilead to make access to lenacapavir a priority, calling for “the terms of their access strategies – including any voluntary licensing agreements – [to be] transparent, global health-oriented, and equitable”.

“Lack of prompt and broad action would jeopardise translating the clinical trial results into real-life impact,” said Unitaid, which offered to work with Gilead to enable access, including “quality-assured, low-cost generics”.

“Unitaid is dedicated to leveraging its recent investment through the Wits Reproductive Health and HIV Institute to facilitate market shaping interventions on long-acting PrEP options (in partnership with the Clinton Health Access Initiative), as well as its continued support to enabling elements such as the key work of WHO and the WHO Prequalification program, the Medicines Patent Pool and other intellectual property grants, to ensure access to this life-saving product is as broad as possible,” the organisation said in a statement last week.

Image Credits: Gilead, Diana Polekhina/ Unsplash.