Seven Indian pharmaceutical companies made donations to domestic political parties while they were under investigation for substandard drug production, according to an investigation published in Scroll.

The companies named in the investigation included Hetero Labs and Hetero Healthcare, Torrent Pharma, Zydus Healthcare, Glenmark, Cipla, IPCA Laboratories Limited, and Intas Pharmaceutical. They were under investigation for substandard drugs including the anti-COVID drug, Remdesivir and anti-bacterial and anti-fungal medications.

Overall, some 35 pharmaceutical companies in India contributed nearly Rs 1,000 ($120 million) to political parties competing in the upcoming national elections, which are scheduled in phases through April and May this year.

The donations, originally anonymous, were made through the purchase of “electoral bonds”, system whereby an individual or an institution can fund a political party that was introduced by Prime Minister Narendra Modi’s government in 2017.

India’s Supreme Court recently directed the country’s public sector bank, State Bank of India, to disclose the names of the companies that made donations, and these names have been released by the Election Commission beginning on 14 March.

Punitive actions for failing a drug quality test can range from the suspension of manufacturing to the cancellation of a licence, and the decision lies with the Indian government.

The data released did not, as yet, disclose which political parties were supported, and to what extent. However, with just four weeks to go before the elections, India’s Supreme Court has pressed on for ‘complete disclosure’ of the data in a further order issued 18 March.

The analysis is part of an ongoing series of stories on the electoral bonds by a team of journalists from several independent news organisations including, Newslaundry, Scroll, and The News Minute.

Image Credits: AMR Industry Alliance, Glsun Mall/ Unsplash.

US President Joe Biden on the 20th anniversay of PEPFAR in 2023

Twenty years ago, the sight of women, men and children being carried to hospitals in wheelbarrows as they clung to the fragile threads of life, was heartbreakingly common. 

AIDS was not just a disease. It was a shadow of despair that loomed over our communities, threatening to engulf us in darkness. But then, in a remarkable act of bipartisanship, US President George W Bush and the US Congress introduced the President’s Emergency Plan for AIDS Relief (PEPFAR) and, like the first rays of dawn, it brought hope where there was once only despair.

There was a unanimous call for a five-year reauthorisation of PEPFAR from African Heads of State and government at the African Union Assembly when they met in  February 2023 in Addis-Ababa, Ethiopia. This is a call to action. This crucial extension is not merely a legislative act; it is a covenant with future generations, affirming our shared commitment to ending AIDS by 2030.

The impact of PEPFAR has been nothing short of miraculous. Imagine, 25 million souls given another chance at life, 5.5 million infants cradled in their mothers’ arms, HIV-free, and 20 million individuals now with the medicine that not only sustains their lives but shields others from the virus. 

PEPFAR: 20 years of success

The spectre of AIDS that once snatched infants and young children from this world has been pushed back by a staggering 70%. Villages and cities have witnessed life expectancies surge by over a decade, a testament to the resilience of the human spirit when given a fighting chance.

Through PEPFAR, the very fabric of our societies has been fortified. Our economies, reflected in the GDP per capita, have grown more robust by 2% faster in countries embraced by PEPFAR’s warm reach. 

Seven million children, who might have been orphaned due to AIDS, now find solace and support from their parents. 

Health infrastructure transformed

Our healthcare infrastructure has been transformed with the construction of 70,000 clinics, the establishment of 3,000 laboratories, and the addition of 340,000 dedicated healthcare workers. This strengthened network of care has become our shield and spear, not just against AIDS but against other scourges like COVID-19, Ebola, and more, safeguarding our future from health threats yet unseen.

Amidst our collective stride towards a brighter tomorrow, we find ourselves at a crossroads, confronted by the complex politics surrounding abortion. Let it be clear: in many of our lands, abortion is permitted only under the most stringent of circumstances. 

Our faith-based partners, who have stood valiantly at the forefront of this battle against HIV and AIDS from its inception, would have stepped back if PEPFAR had strayed from its mission to prevent HIV and AIDS. 

Yet, they remain, more committed than ever, a testament to PEPFAR’s unwavering commitment to preserving life. Indeed, 350 African faith leaders have reassured the US Congress, dispelling the misconceptions about PEPFAR’s mission with unequivocal clarity.

PEPFAR mirrors the essence of African values, most notably in our collective resolve to empower and safeguard our adolescent girls and young women.  It embodies the spirit of America’s partnership based on compassion. The DREAMS initiative is more than a program; it is a beacon of hope, offering the education, skills, and support needed to forge paths away from HIV and towards a future filled with promise.

As we look to the horizon, the journey with PEPFAR from emergency response to sustainable progress serves as a shining example of what humanity can achieve when united. 

Yet the road ahead remains long, with millions still in need of treatment and the threat of new infections and deaths looming large. Recent reports forewarn of the catastrophic consequences of halting our march now, with nearly a million more babies at risk of HIV infection and countless lives in the balance by 2030.

As leaders, both in Africa and in the US Congress, grapple with domestic and global challenges, the weight of millions of lives rests in their hands. 

Our heartfelt plea is for a simple, yet profound, continuation of PEPFAR’s mission – a beacon of American leadership, a testament to bipartisan solidarity, and above all, a lifeline for millions. Let us renew our vows, stand united, and march forward together, for the light at the end of the tunnel is within reach, but only if we continue to carry the torch of PEPFAR into the future.

Dr Jean Kaseya is the Director General of Africa Centre for Disease Control and Prevention.

 

 

 

Image Credits: PEPFAR, Africa CDC.

Delhi, India, where toxic smog blocks out the sun.

Bangladesh is the world’s most polluted country and Delhi is the most polluted capital. But India also has the most air quality monitors in South Asia – while some wealthy petro-nations have virtually none.

The air quality global ranking of cities for 2023 has been released by a Swiss firm, IQAir, which has been reporting this annually for over six years now. 

Never before has one country dominated the top spots for the worst air quality to the extent that India does, but the report also exposes massive gaps in monitoring pollution in the global south which stem from a lack of funds, political will or both. Air pollution is linked to over eight million deaths annually, or almost 16 per minute, and is considered a major health risk.

Nine of the top 10 most polluted cities are in India, up from six the previous year. Meanwhile, 42 cities in the top 50 are in India, up from 39; and an astounding 83 cities in the top 100 are Indian (up from 63 and 65 in the previous two years).

Delhi is back to being the most polluted capital of the world, the fifth time in the last six years. Its PM 2.5 level has averaged over 102 micrograms per cubic metre, up 10 units from the previous year. WHO’s safe guideline is just 5 micrograms. 

The report by IQAir summarises PM2.5 air quality data from 7,812 cities spanning 134 countries, regions, and territories. It sourced the data from 30,000 air quality monitoring stations operated by research institutions, governmental bodies, universities and educational facilities, non-profit organizations, private companies, and citizen scientists. 

World Air Quality Report 2023

Report exposes gaps in air quality monitoring

The data, however, cuts two ways. While it shows how dire the crisis is in India, it also exposes major gaps in monitoring. Take South Asia for starters. The world’s top three most polluted nations are all here: Bangladesh, Pakistan, and India in that order. But in Bangladesh, only two places monitor air quality, while Pakistan has 10 sites. India monitors 256 cities . 

“In Southeast Asia as a whole, 74% of the cities in the region are in India. This increase in monitoring shows the Indian government’s awareness of the country’s pollution problem, and the way to begin addressing it is to have a robust monitoring network, which India is actively doing,” a spokesperson from IQAir told Health Policy Watch. 

The lack of monitoring in other regions is stark. In Africa and South America, it raises questions of inequity and funding. The report only has data from 79 places in Africa and 219 in all of Latin America and the Caribbean. In sharp contrast, the United Kingdom alone has 219 monitoring sites, Europe 2,004, and the US has 3,242. 

In West Asia, where some countries have among the highest per capita income and GHG emissions globally, the absence of more widespread monitoring may raise questions of political will or priorities. Iraq for example has only two places with data, Saudi Arabia has three, and the UAE, a federation of seven member states, also only has three.

How the data is collected

Although some countries may have more monitors than reflected in the report, IQAir says it only uses data that meets its threshold. Chad, for instance, was the most polluted country in 2022, but it did not meet their data inclusion standards for the latest report, neither did cities like Hotan in China and Peshawar in Pakistan which are still polluted but are not included in the top 10 most polluted cities this year.

Over the years, the report has come to be extensively quoted – last year it was cited some 4,000 times according to the spokesperson. 

The report endorses a rising trend of the use of a major change in monitoring tech and that is low-cost sensors. In India, for example, the official, regulatory grade while very accurate may cost about 10 times more than the low-cost ones.

Authorities are now rolling these out by the hundreds in some of the heavily polluted regions including in Bihar, home to the world’s #1 most polluted place. Of the roughly 30,000 monitors used for the 2023 World Air Quality Report, most (61%) are low-cost monitors. The margin of error is approximately 10%, a spokesperson said.

World’s worst polluted city, and country

The world’s most polluted city is Begusarai in the east Indian state of Bihar. Its pollution level averaged 118.9 micrograms/cubic meter, 24 times the WHO’s safe limit. The most polluted country is Bangladesh which, at 79.9 micrograms, is more than 15 times higher than the safe limit. The two are hundreds of kilometres apart but air pollution connects them. 

“Due to its geographical location, Begusarai experiences a stream of pollution from various parts of India. This also explains why Bangladesh is the most polluted country in the world. Pollution from northern and southern India is funneled in by winds and affects the entirety of eastern India and Bangladesh. This is known as transboundary pollution.”

The Begusarai-Bangladesh link starkly illustrates the one big hope of tackling air pollution and that is for creating partnerships between governments and authorities. Transboundary pollution or the concept of a common air mass – creating an airshed – across political or administrative boundaries is seen as a cost-effective and most impactful option for reducing pollution. 

Climate change, pollution, and pollen allergies 

Significantly, the report warns that climate change could be exacerbating air pollution. Fossil fuel emissions account for 65% of global CO2 emissions and are also the primary cause of the majority of PM2.5-related deaths, it says, highlighting the interconnected relationship between air quality and climate change.

With extreme heat events becoming more severe and frequent, in many regions, intense pollution events may coincide with extreme heat, where weak winds hinder ground-level ventilation thereby allowing pollutants to accumulate. The frequency of such events is expected to increase. 

Changing climate patterns are also stretching out pollen seasons and making these more intense with increased levels of grass and tree pollen emissions due to changing climate patterns. 

Tackling climate change and air pollution jointly is inevitable for policymakers. The question is, can they deliver quickly enough?

Image Credits: Wikipedia, Sumitmpsd , IQAir.

‘You can’t chicken out now,” warned INB co-chair Precious Matsoso.

World Health Organization (WHO) member states abandoned careful diplomatic language at the start of the final round of negotiations for a pandemic agreement on Monday (18 March), exposing deep divisions between countries from the global North and South.

An unprecedented 11 African countries spoke during the two-hour opening session, largely expressing support for the latest pandemic agreement draft as a “good start” for text-based negotiations.

But the opposite was so for developed countries. Switzerland, which is home to numerous pharmaceutical companies, said that it “does not accept the text in its current state”. 

Switzerland does not accept the draft text.

The US and UK said it was a “step backwards” – as did the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) commenting during the later stakeholder session.

Africa stands firm on PABS

Ethiopia, on behalf of the African region’s 47 member states and Egypt, wants “concrete outcomes” on key priorities, including “a pathogen access and benefit-sharing system (PABS) that establishes on an equal footing footing a multilateral system with binding terms and conditions for access and legal certainty or for sharing of both monetary and non-monetary benefit”.

PABS is one of the most contentious clauses of the draft text. Article 12 proposes a WHO PABS system whereby countries share biological materials and genetic sequence data (GSD) of pathogens with pandemic potential with a “WHO-coordinated laboratory networks (CLNs) and sequence databases (SDBs)”.

If manufacturers want access to these, they will need to conclude legally binding contracts with WHO, pay annual contributions, and reserve 10% of pandemic products produced as a result to be distributed for free and 10% at not-for-profit prices during pandemics and outbreaks of international concern.

South Africa at INB 9

South Africa stated further terms related to PABS: “We highlight the sovereign right of member states to control access over their genetic resources. We emphasise that such multilateral PABS system must be on an equal footing with binding terms and conditions for access and legal certainty for sharing of both monetary and non monetary benefits.”

Bangladesh, representing a diverse group of 31 countries known as the Equity Group, wants “access to pathogens and benefit sharing on equal footing”.

Lack of legal certainty

Bangladesh also called for an action-oriented agreement with clear deliverables that addresses the lack of “legal certainty” for timely, equitable access to health products.

“To operationalize equity, we need to clearly delineate obligations with responsibilities on various parties, including mentioning developed countries vis a vis developing countries, which is missing in the current negotiating text,” said India for the WHO South East Asia Region (SEARO). 

“We are not supportive of any parallel or breakaway sessions or processes where small delegations will possibly be left out,” it added – something that developed countries support but smaller delegations say they cannot manage.

“Be frank,” urged Australia at INB 9

Australia, speaking for Canada, New Zealand, Norway and the United Kingdom, called for “significant pragmatism and a fundamental change in the way that we are working” to get to an agreement. 

“The proposed text, in addition to not being streamlined into clear legal commitments, does not fully capitalise on the progress made through the subgroups. It includes concerning elements that do not bring us closer but rather contribute to polarisation and significant aspects that are neither practical nor implementable,” added Australia.

“We have to be ready to be frank with one another. Listen carefully and find common ground and we need working modalities that enable us to do that.” 

‘Red lines’ included

“At this late stage, it is not productive to reintroduce challenging concepts such as CBDR [common but differentiated responsibility], intellectual property waivers and new funding vehicles that do not have a chance of achieving consensus,” said the US.

“We have stated very clearly on multiple occasions that these are red lines,” it added. “We have run out of time to be revisiting provisions that are not implementable, not feasible or contrary to national law.”

The European Union (EU) lamented the “significant dilution” of pandemic prevention and preparedness. It also claimed that the text “could have been an opportunity to find an agreement in key areas such as technology transfer and intellectual property, financing, and PABS at the time where stakeholders have never been more ready to make a decisive contribution to benefit sharing” – but did not elaborate on what such an opportunity could look like. 

For Germany, the revised text “still contains some elements that have been clearly identified as non-consensual” as well as “still lacking crucial elements, for example, to improve prevention preparedness in order to make sure that we are not hit by a pandemic like COVID again”.

The European Union at INB 9

‘You can’t chicken out now’

“You can’t chicken out now. You’ve already agreed. So because this is now in a legal text, perhaps what you need to do is to determine which of those elements should be obligatory,” cajoled Precious Matsoso, co-chair of the intergovernmental negotiating body (INB) which has been steering the negotiations.

“One hundred percent said equity was important, finance was important, capacity building and strengthening of countries was important. Surely that can change now when you’re supposed to start the negotiations.”

But the INB Bureau was also criticised for not including in the text agreements reached in the four sub-groups that facilitated earlier negotiations and for dispensing with small group discussions.

Areas of agreement

Pointing to “critical areas” that still need to be agreed, WHO Director General Dr Tedros Adhanom Gebreyesus focused on what has been agreed: “Importantly, you agree on what you’re trying to achieve. You agree on the need for predictable and sustainable financing for pandemic preparedness and response. You agree on the need for an equitable system for access and benefits. You agree on the need to engage the private sector. 

“We would have a much bigger problem if you did not agree on the fundamental objectives of the agreement. But you do now you need to agree on how to achieve these objectives. I have every confidence that you can and will.”

Text-based negotiations are proceeding in plenary from now until the end of this ninth INB meeting on 28 March, the eve of Easter. Evening sessions will not go beyond 6.30pm to accommodate Muslim delegates observing Ramadan. However, a Saturday session has been added to give the process extra time.

A vaccinator marks the little finger of a child who has been vaccinated, Sudan, November 2020.

Sudan will resume immunising children against polio after detecting circulating vaccine-derived poliovirus type 2 (cVDPV2) in its waster water, as six other African countries have reported either cases or positive environmental samples over the past two weeks.

Mali and Nigeria reported one case each, Yemen reported three cases and Angola, Côte d’Ivoire and Sierra Leone reported positive environmental samples.

Sudan’s Federal Ministry of Health (FMOH) announced that it will launch a polio vaccination campaign next month after cVDPV2 was detected in six wastewater samples between last September and January.

The states of Red Sea, Kassala, Gedaref, River Nile, Northern, White Nile, Blue Nile and Sennar are being targeted.

War, heatwave undermine health services

War between two opposing military forces in Sudan has halted the country’s immunisation drive for an entire year. To make matters worse, the country is in the grips of a debilitating heatwave with temperatures exceeding 40ºC. Schools were closed from Monday and are expected to remain closed for at least two weeks.

Looting and attacks on health facilities have also affected services, with over a million polio vaccines destroyed as a result.

The breakdown in health services, including routine vaccination, significantly increases the risk of spread of communicable diseases amid outbreaks of cholera, dengue, malaria and measles reported from numerous states.

Sudan reported the emergence of variant poliovirus type 2 in January 2024. It was detected in six wastewater samples collected from September 2023 to January 2024 in the Port Sudan locality, Red Sea State.

The FMOH, with support from the World Health Organization (WHO), has completed field investigations and a risk assessment to determine the extent of the virus circulation. 

This new detection comes 14 months after Sudan declared an outbreak of variant poliovirus type 2, from an unrelated emergence of the virus, which was detected in a 4-year-old child in West Darfur in October 2022. 

In response to that outbreak, the FMOH, in collaboration with the United Nations Children’s Fund (UNICEF) and WHO, delivered and distributed 10.3 million doses of oral polio vaccine in a nationwide polio vaccination campaign in March 2023, reaching around 8.7 million children aged under 5 years (98% of all children of this age group in Sudan).

Wastewater detection

“While no vaccination campaign has taken place since April 2023 due to the ongoing conflict, surveillance for poliovirus in children – conducted by searching intensely for acute flaccid paralysis (AFP), the most common indicator of polio infection – and in wastewater has been strengthened to swiftly detect any presence of the virus,” according to the WHO.

While the FMOH has not found any children paralysed due to the new emergence, the detection of poliovirus in wastewater samples means that children across the country are at high risk. 

“The new detection has only redoubled our commitment to safeguarding our children’s future. In collaboration with partners, we are mobilising an outbreak response campaign to ensure that every child under five years in accessible areas receives the polio vaccine, and special plans will follow for hard-to-reach areas,” said Dr Dalya Eltayeb, Director-General of Primary Health Care in Sudan’s FMOH.

There is no cure for polio, a highly infectious viral disease that mainly affects children aged under five years, but it can be prevented through vaccination. Caregivers must ensure that during upcoming vaccination campaigns, all children aged under 5 years receive oral polio vaccine drops every time they are offered. They should also receive routine vaccinations according to their age.

“The ongoing war is undoing the enormous gains the country has registered on childhood vaccinations,” said Dr Tedla Damte, Chief of Health and Nutrition at UNICEF Sudan.

“Millions of displaced children on the move cannot be protected against life-threatening diseases, like polio, yet these can be prevented through vaccination. Health systems are overstretched, subsequently impacting the delivery of health services including vaccinations. UNICEF remains committed to supporting vaccination campaigns to protect children, no matter what,” he emphasised.  

Image Credits: WHO Sudan.

Members of the drafting group of the intergovernmental negotiating body (INB).

Two final – and likely sleepless – weeks of negotiation on the pandemic agreement begin on Monday, and negotiators have been urged to bring in their principals to ensure speed up decision-making.

The negotiations may well be extended but, for now, this ninth meeting of the World Health Organization (WHO) intergovernmental negotiating body (INB) is set to end on the eve of the Easter weekend on 28 March and includes a weekend session.

“Since we have now a few weeks left, I think the engagement of the highest level of leaders will be important to give you more space for compromise because it’s through compromise and collaboration that we can get to the finish line,” WHO Director General Dr Tedros Adhanom Ghebreyesus told negotiators at the last INB meeting.

Tedros also appealed to the leaders of the G20 to assist with the negotiations when he addressed them this week.

“Your leadership is now needed more than ever, with the deadline approaching for the pandemic agreement and amendments to the International Health Regulations,” Tedros told the leaders who were meeting in Brazil.

Lack of consensus on critical areas

Noting that the World Health Assembly is less than 10 weeks away, Tedros told the G20 that the was a lack of consensus at the INB on “critical areas”.

Four INB subgroups have been working to find solutions on four key issues, One Health; sustainable production, technology transfer and supply chains; pathogen access and benefit sharing; and implementation support and financing, he added.

“The subgroups have each submitted their reports to the INB bureau, which has integrated their recommendations into the revised text of the agreement, which was circulated to member states last week. Starting on Monday next week, the INB will meet for the final time, and I sincerely hope that member states will begin to converge on these key issues,” Tedros urged.

“If we miss the opportunity to put in place a pandemic agreement and a stronger IHR, we risk losing momentum. More importantly, we risk leaving the world exposed to the same shortcomings that hampered the global response to COVID-19: a lack of coordination, a lack of sharing information, and a lack of equity.”

Civil society concerns

The Pandemic Action Network (PAN) has highlighted “the agreement’s unclear legal status, intellectual property questions, and pandemic prevention, preparedness, and response financing strategy” as  “top concerns”. 

PAN and others have developed a civil society version of the pandemic agreement that they aim to present to negotiators – also civil society organisations are not allowed to be in the room during the negotiations.

Meanwhile, in a laudable sign of transparency, the Europe Union has published its text-based proposals.

However, anything can happen in the next two weeks of negotiations as negotiators are fond of stressing: “nothing is decided until everything is decided”.

Practical questions left to COP?

Many practical questions about how the pandemic agreement will be implemented – including how to finance countries’ pandemic prevention, preparedness and response (PPPR) – seem likely to be left to the proposed Conference of Parties (COP).

For example, according to the latest pandemic agreement draft, a “Coordinating Financial Mechanism” will support the implementation of the pandemic agreement and the International Health Regulations (IHR) (see Article 20).

But Professor Garrett Wallace Brown, chair of Global Health Policy at the University of Leeds, told a Geneva Global Health Hub (G2H2) media briefing on Tuesday that “final decisions about the details of the coordinating mechanism are being offloaded to the Conference of the Parties (COP), which I think is a wise decision given the circumstances”. 

“There are only nine negotiating days left and there are lots of details to work through. But I think it’s only wise if the COP is representative, inclusive, proportional to risk and deliberative, meaning a move away from business as usual,” said Wallace Bown.

He added that in his conversations with INB negotiators, “what they want to do is make the wording strong enough to show that there’s a commitment to a coordinating mechanism and a commitment to financing those”.

Africa holding out for equity

Dr Jean Kaseya

Africa Centre for Disease Control and Prevention Director General Dr Jean Kaseya told Health Policy Watch recently that he had travelled to Geneva to discussion the pandemic agreement negotiations with African ambassadors.

“The African Union Assembly approved the common African position. That is the tool that is leading that is facilitating the discussion for the pandemic treaty,” said Kaseya.

“But let me tell you there are only two words for me summarising this pandemic treaty. The first one is equity. The second one is respect. These are the two words that are really driving Africans who are negotiating. You have got everything around these two words. When we are talking about financing, when we talk about pathogen access and benefit sharing, everything is around respect and equity.”

The Africa Group of 47 member states plus Egypt have been pushing hard for countries that share the genetic and biological information of pathogens with pandemic potential to derive benefits in return from manufacturers who make products from this information.

Preserve ‘innovative ecosystem’, urges pharma 

However, the head of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has described the latest draft as “a step backwards rather than forwards”.

IFPMA Director-General Thomas Cueni, appealed for the agreement to both “take steps to ensure equity in access to medicines and vaccines in future pandemics” while also “preserving the innovation ecosystem that delivered a vaccine just 326 days after the SARS-CoV2 genome sequence was first sequenced”.

Article 12 of the current draft proposes that manufacturers pay an annual subscription fee to a yet-to-be-formed World Health Organization (WHO) Pathogen Access and Benefit-Sharing (PABS) System in exchange for “rapid, systematic and timely access to biological materials of pathogens with pandemic potential and the genetic sequence data (GSD) for such pathogens”.

The article also proposes that manufacturers provide “real-time contributions of relevant diagnostics, therapeutics or vaccines” with 10% free and 10% at not-for-profit prices during public health emergencies of international concern.

But Cueni believes that “conditions, uncertainties, and negotiations surrounding pathogen access will cause delays in the developing medical countermeasures, leading to significant public health consequences, including loss of lives and unnecessary economic pressures”.

‘Compromise and collaboration, not competition’

Meanwhile, Tedros said that although time is tight, “if there is political commitment to have a deal we will have the agreement by May 2024”,

“Instead of really competing on issues, we have to focus on constructive problem-solving. It is not the problem of the North. It is not the problem of the South. It’s our problem. This is about preparing the world to fight a common enemy. So compromise and collaboration will be the way forward rather than competition.” 

He told the G20 that “there is no reason negotiations on the pandemic agreement and the IHR cannot be finalised in the next 10 weeks”, but that this will require “courage and compromise” – and leadership.

“The leadership of G20 countries in the next nine weeks, and especially in the next two weeks, is vital. We cannot – we must not – miss this generational opportunity.”

HIV medicine dolutegravir.

The World Health Organization (WHO) recently reported drug resistance to the world’s gold-standard antiretroviral medicine, dolutegravir  “exceeding levels observed in clinical trials” – with resistance ranging from 3.9% to 19.6%.

This was potentially very bad news as dolutegravir has been the recommended first- and second-line HIV treatment for all population groups since 2018 – but the WHO told Health Policy Watch this week that the drug resistance was largely related to patients not adhering to treatment properly rather than growing resistance to the medicine.

Dolutegravir is “more effective, easier to take, and has fewer side effects than other drugs currently in use” with “a high genetic barrier to developing drug resistance”, according to the WHO.

It is used in antiretroviral therapy (ART) in combination with tenofovir and lamivudine, and its use has led to “very high levels of viral load suppression at the population level, often in excess of 90% or even 95%”, according to WHO. 

Country reports on resistance

The reports on resistance come from country surveys in Uganda, Ukraine, Malawi and Mozambique, WHO told Health Policy Watch.

In Uganda, Ukraine and Malawi, the levels of resistance to dolutegravir ranged from 3.9% to 8.6% in adults, ranging from those who had never taken ART to those with some exposure to the drugs.

But in Mozambique, the survey involved people experienced with treatment who had transitioned to a dolutegravir-containing regimen while having high HIV viral loads. And in this instance, resistance reached 19.6%. 

“Overwhelmingly, data suggest that non-adherence to treatment is the primary reason for viral non-suppression in people taking dolutegrivar, not drug resistance,” said the WHO spokesperson.

“Levels of HIV drug resistance observed to the integrase inhibitor dolutegravir are much lower than resistance levels observed in populations failing non-nucleoside reverse transcriptase inhibitors (NNRTIs)-based antiretroviral therapy,” added WHO.

NNRTIs refer to a class of ARVs that block an HIV enzyme called reverse transcriptase, which prevents the virus from replicating. Efavirenz, the previous WHO-recommended first-line HIV treatment regimen, was an NNRTI.

“In populations not achieving viral suppression on NNRTI-based ART, we saw levels of resistance from 70-90%. The combination of higher levels of viral load suppression and the much lower levels of acquired drug resistance affirm the global guidelines’ change from NNRTI- to dolutegravir-based treatment,” the WHO added.

The WHO official noted that there was still “much to learn about dolutegravir resistance”, with “very early and limited data” suggesting that “very large proportions of people not achieving viral suppression” on the dolutegravir would do so with “enhanced adherence support”. 

Dolutegravir and TB medication 

Meanwhile, a new clinical trial has found that people newly diagnosed with HIV fared well when given preventative treatment for tuberculosis at the same time as dolutegravir.

These results were released at the recent Conference on Retroviruses and Opportunistic Infections in Denver, Colorado.

“Each year, there are an estimated 670,000 new TB cases among people living with HIV and an estimated 167,000 deaths from TB-related HIV,” according to a media release from the Aurum Institute, one of the research partners in the trial.

The trial – called DOLPHIN-TOO – focused on whether the efficacy of dolutegravir in people living with HIV who had never previously been treated with ARVs was affected by prophylactic TB treatment – either the standard isoniazid (6H) or the newer regimen comprising of a weekly dose of isoniazid and rifapentine for three months referred to as 3HP.

The results showed that, while people in the 3HP group did have lower levels of dolutegravir in their bloodstream than people in the 6H group, they were able to achieve an undetectable level of HIV virus in blood by eight weeks and maintain this for the length of the six-month study. 

Minimal side effects were seen, none were severe, and the majority were resolved with continuation of therapy. 

Previous research released at the Union World Conference on Lung Health in November of 2023, had provided information on the safety and efficacy of the use of 3HP and dolutegravir  together, but without data on the drug levels in the blood.

“This study points to the use of short course TB preventive treatment in people who are newly diagnosed with HIV and are at highest risk of active TB disease,” according to a media release from Aurum.  

Medication-related harm accounts for a half of preventable harm in medical care

As many as one in 20 patients experience avoidable side effects from medication that they use, with this figure rising to 7% in developing countries. 

The causes range from taking the medication at the wrong time, which could result in minor side effects, to taking an  inappropriate drug, which might result in unpredicted harm as serious as yet another disease or even death.

Such errors are not that scarce, concludes Dr Maria Panagioti, senior lecturer in primary care and Health Services Research at the University of Manchester and one of the authors of a new World Health Organization (WHO) systematic review “Global burden of preventable medication-related harm”. 

The global cost associated with administering unsafe care is estimated at $ 40 billion each year, WHO says.

“Without measurement, action to drive improvements are not possible, regardless of context,” said Dr Neelam Dhingra, head of  WHO’s Patient Safety Unit, during a webinar on the new guidance. 

While developing new treatments and better policies is important, much progress in healthcare can be achieved as a result of simply “doing no harm,” she said.

Errors occur, reduction targets are scarce

Only 18% of WHO member countries have a national target for reducing medication-related harm.

Seven years ago, WHO established a Medication Without Harm challenge in which it setting the goal of reducing harm by incorrect medication by half in five years. This was followed by a Global Patient Safety Action Plan, approved by the World Health Assembly in 2019. But much remains to be done.

“Assessing the burden of patient harm and also medication-related harm is a critical part of measuring patient safety,” Dhingra highlighted. “However, this truly remains a challenging agenda still.”

According to the new systematic review, half of all avoidable harm in medical care is related to medication, and a quarter of mediciation’s preventable harm can have severe or even life-threatening consequences.

Medication error is often avoidable. Yet, it is experienced by 5% of all patients.

Many mistakes occur in specific contexts, such as when patients are already taking many different kinds of medication (polypharmacy) that interact with one another, or patients who transition between caretakers, or in situations where high risk drugs are used.

Areas of improvement

The new WHO policy brief proposes key areas for addressing the risks including better communication and engagement of patients and patient organisations. With good public awareness of medication effects, it is easier for patients themselves to identify errors, such as the prescription of the wrong drug by a pharmacist.

Four domains and three key areas outlined in the WHO’s Global Patient Safety Action Plan

Healthcare workers should also receive training on medication harm, the brief notes. Better health worker conditions also reduce the risk of errors from factors such as fatigue and multi-tasking.

Identification of high risk drugs and additional care in their management is also critical. 

There is a “huge burden of preventable harm due to unsafe medication practices and medication errors,” Dhingra noted. ”Action is required at all levels, […] and we need to implement safe systems and practices for medic medications.”

Image Credits: WHO/Quinn Mattingly, WHO, WHO.

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

A leading Geneva-based global health organization has decried the lack of tests available for mpox in the Democratic Republic of the Congo (DRC) – where an outbreak declared in 2023 continues unchecked – saying that children are the main victims. 

“The mpox situation in the DRC is deeply alarming and the lack of tests for both mpox and HIV means it’s unclear just how bad the mpox situation is and what the underlying comorbidities are,” said Dr Ayoade Alakija, Chair of the Board at FIND in a press release.

According to FIND, a global non-profit dedicated to accelerating access to diagnostics, only 16% of suspected mpox cases in DRC undergo a PCR test. Among suspected cases that are tested, six out of ten test results are positive, underlining the degree of under-estimation of confirmed mpox cases.

“Testing capacity for mpox and HIV in the DRC is severely limited, meaning that many likely cases of mpox in the country are treated as suspected cases only,” Dr Sergio Carmona, FIND CEO and chief medical officer said.

Left unchecked – virus risks further spread abroad

Alakija compared the current mpox outbreak in the DRC with the situation during the COVID-19 pandemic, when many African countries were left behind in terms of tests and treatments and vaccines.

Left unchecked, the deadly Clade I form of the mpox virus now circulating in the DRC risks spreading further in Africa and beyond, she warned. 

“The people that are being prioritized for tests, treatment and vaccination are not in the outbreak countries in Africa,” she noted, referring to the rollout of measures in high- and middle-income countries over the past two years to counter the much milder, Clade I, form of the mpox virus that exploded in 2022. 

“We can either mobilize resources and fight the deadly mpox outbreak now in the DRC, or we can let the virus continue to spread and fight it when it is imported into other countries,” Alakija  said.

DRC outbreak is the largest ever recorded

According to the US Centers for Disease Control (US CDC) the current DRC mpox outbreak is the largest ever recorded, with cases reported in 22 out of the DRCs 26 provinces. Some 12,569 suspected cases and 581 deaths have been reported since 1 January 2023.  

From the start of 2022 to January 2024, the DRC reported 21,630 suspected MPXV cases and 1,003 deaths. Around 85% of deaths in this period were children under 15 years of age, according to WHO data.  

Epidemic curve shown by month for cases reported to WHO from the African region. Recent cases mostly in DRC.

Potentially ‘distinct’ Clade I strain and new patterns of transmission 

Mpox is a viral infection, which belongs to the same virus family as smallpox. It was traditionally confined to remote, rural areas of central and western Africa, where transmission was sporadic and occurred primarily through human contact with rodents and other small mammals. 

The virus burst onto the global arena in 2022 when WHO declared a global health emergency after the milder, Clade II form of mpox, began to spread through dozens of countries worldwide, infecting thousands of people, mainly through sexual transmission, and particularly men having sex with men. 

The global health emergency was declared over in 2023 following the scale up of diagnostics and vaccination in middle- and high-income countries, aimed at high-risk groups. 

Over the past year, however, global health authorities have expressed rising alarm over the increased circulation of the more deadly Clade 1 of mpox throughout central and east Africa – including through patterns of sexual transmission, including heterosexual transmission, not previously seen. 

In the case of the eastern DRC, female sex workers found to be among the leading groups transmitting the disease, along with transmission through close familial or community contacts, according to a study published Tuesday on the pre-print health sciences platform, MedRxiv. The study looked at transmission patterns in the city of Kamituga, in DRC’s south Kivu province.  

The sustained community-level transmission of mpox now seen in Kamituga “is….  being driven by a distinct Clade I mpox strain, possibly a novel subgroup, as confirmed with qPCR,” the researchers from over a dozen countries found. 

Mpox has similar symptoms as smallpox, including painful blisters and rash, fever, chills and fatigue. In the case of the milder, Clade II form of the virus, most patients recover after a few weeks of supportive care, WHO says.

Image Credits: WHO.

COVID-19 screening in Bangkok, Thailand: Financing future pandemic preparedness and response is unclear.

Many practical questions about how the pandemic agreement will be implemented – including how to finance countries’ pandemic prevention, preparedness and response (PPPR) – seem likely to be ceded to the Conference of Parties (COP).

According to the latest pandemic agreement draft, a “Coordinating Financial Mechanism” will support the implementation of the pandemic agreement and the International Health Regulations (IHR) (see Article 20).

“There’s a key debate with Article 20 within the negotiations about whether the coordinating mechanism should be hosted by the Pandemic Fund, the World Health Organization (WHO), or whether a new entity should be created,” Professor Garrett Wallace Brown, chair of Global Health Policy at the University of Leeds, told a Geneva Global Health Hub (G2H2) media briefing on Tuesday.

“There’s seemingly little appetite for a new institution, and there is a strong narrative being promoted for the Pandemic Fund in order to decrease fragmentation,” added Wallace Brown, who is director-designate of new WHO Collaboration Centre for Health Systems and Health Security.

The Pandemic Fund’s Priya Basu has made a strong bid for her entity to become this mechanism, telling Devex this week that a new fund to support PPPR would mean “duplication”.

Professor Garrett Wallace Brown, chair of Global Health Policy at the University of Leeds

But Wallace Brown said that “final decisions about the details of the coordinating mechanism are being offloaded to the Conference of the Parties (COP), which I think is a wise decision given the circumstances”. 

“There are only nine negotiating days left and there are lots of details to work through. But I think it’s only wise if the COP is representative, inclusive, proportional to risk and deliberative, meaning a move away from business as usual.”

In conversation with delegates involved in the Intergovernmental Negotiating Body (INB) thrashing out the pandemic agreement, Wallace Brown said that “what they want to do is make the wording strong enough to show that there’s a commitment to a coordinating mechanism and a commitment to financing those”.

In addition, they were “being somewhat more clear about what types of financing and what types of mechanisms would be housed underneath that, but offshoring those details for 12 months – I’m suggesting 24 months – to try to work out exactly how that is done”. 

Domestic funds?

According to the draft, the financing mechanism would include a pooled fund for PPPR, and may include “contributions received as part of operations of the [Pathogen Access and Benefit-Sharing System], voluntary funds from both states and non-state actors and other contributions to be agreed upon by the Conference of the Parties”.

G2H2 co-chair Nicoletta Dentico

However, G2H2 co-chair Nicoletta Dentico warned that poorer countries were mired in debt and debt cancellation should be a consideration to help these countries.

“Fifty four low-income countries with severe debt problems had to spend more money on debt servicing than on the COVID disease in 2020,” said Dentico, who heads the global health justice program at Society for International Development (SID).

“Contrary to the WHO Framework Convention on Tobacco Control, the [pandemic agreement] text opened for the final negotiations stubbornly ignores the repeated calls for legal safeguards that are indispensable to immunise the treaty implementation and financing from vested corporate interests,” added Dentico.

Mariska Meurs from the Dutch health NGO WEMOS, warned that “domestic funding for pandemic prevention preparedness and response must not undermine other domestic public health priorities”. 

“The draft pandemic treaty text worryingly includes ‘innovative financing mechanisms’, which often means using public funds not for heath, but to attract private-for-profit investors. Instead, the pandemic treaty should embrace the most obvious and fair avenues for funding pandemic prevention, preparedness and response: global tax justice and debt cancellation”.

“But undermining other domestic public health priorities is exactly what we’ve seen happening under COVID-19. We’ve witnessed the shifts in global and domestic funding and how funding for basic health care has gone down,” warned Meurs.

“The text, as it lies before us now, does not acknowledge or try to remedy this.”

Mariska Meurs from the Dutch health NGO WEMOS

“The draft pandemic treaty text worryingly includes ‘innovative financing mechanisms’, which often means using public funds not for heath, but to attract private-for-profit investors. Instead, the pandemic treaty should embrace the most obvious and fair avenues for funding pandemic prevention, preparedness and response: global tax justice and debt cancellation,” said Meurs.

Pandemic Fund ‘black box’

Low and middle-income countries are more in favour of the pandemic financing mechanism being housed in the WHO “because they see it as being more representative” than the Pandemic Fund, said Wallace Brown.

But donors “are less keen because they see it as a mechanism that would give them less control of how funds are spent”.

However, for the Pandemic Fund to become the PPPR mechanism would require “radical changes” not “minor tweaks as we’re currently being told”. 

Some of the problems with the fund, are that it only focuses on three elements of PPPR and this “creates vertical silos”, and there is no explicit guidance in the fund’s governance framework on “how equity will be addressed in either the fund process or with reference to prioritise beneficiaries of programmes”, according to Wallace Brown.

In addition, the first round of funding was eight times over-subscribed but the selection process “was not clear”.

“Applications that met the scorecard threshold for funding had to be rejected, and it remains unclear exactly how the governing board made their final decisions,” he added.

Describing his personal view on the way forward as “agnostic”, Wallace Brown said he had been studying the Pandemic Fund for a while and “think it’s a bit of a black box”. 

However, the WHO would need capacity building to become the mechanism 

“They do handle funds, they have the contingency fund for emergencies. They are able to make funding available to people and have processes for that, but they don’t have it at the same scale as a World Bank,” he said.

“Or there could even be a third entity. So at the moment, I’m remaining agnostic. I think there needs to be better analysis, better evidence to decide what works and what doesn’t work” – and these kinds of details “won’t be decided in nine days”.

Image Credits: Prachatai/Flickr.