World’s leading medicine agencies, including US Food and Drug Agency and European Medicine Agency have gained official WHO recognition as Listed Agencies

WHO has expanded its list of trusted national regulatory authorities from three to 36 agencies – including the United States Food and Drug Adminstration (FDA), the European Medicines Agency (EMA) as well as the European Medicines Regulatory Network (EMRN), composed of the European Commission, and thirty national regulatory agencies.

The WHO Listed Authorities (WLAs) are intended to reflect agencies that follow the highest level of regulatory standards and practices, for reviewing medicines and vaccines quality, safety and efficiency – and therefore can be used as guideposts for other countries to follow.

“With leading regulatory authorities joining our list, we are stronger and more united to improve access to quality, safe and effective medicines and vaccines for millions more people,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General in a press briefing on Tuesday. 

He noted that the approval “covers all regulatory functions, including generics, new medicines, biotherapeutics and vaccines.”

The three previous agencies on the WLA included the Ministry of Food and Drug Safety of the Republic of Korea, the Swiss Agency for Therapeutic Products (Swissmedic) and Singapore’s Health Sciences Authority. The latter received a WHO sign of approval for an “expanded scope” of work “including all regulatory functions” in the recent round – the same level as the other 35 WLAs, Tedros said.

The initiative to create a register of WHO Listed Authorities was launched  in 2021 during the COVID pandemic when time-consuming regulatory reviews slowed some countries’ approvals of critical medicines and vaccines – particularly in low- and middle income countries. Earmarking the WLAs aimed to formalise the process whereby countries with fewer resources could follow the lead of other reputable drug agencies in their deliberations on the approval of new medicines and vaccines . 

The  first agencies – from Switzerland, Korea and Singapore – were granted the WHO WLA designation in late October 2023, as Health Policy Watch reported. 

WLAs Criteria and competences

To attain  the WLA designation, agencies need to apply to  the WHO-Listed Authorities Technical Advisory Group (TAG-WLA).

Applicants must already be listed as a Transitional WHO Listed Authority, reaching a maturity level 3 as per a set of Global Benchmarking Tools and other criteria. Next, the advisory group evaluates the agency’s  qualifications for a more advanced designation.

On the list itself, there is also a hierarchy of status. For instance, Singapore’s Health Sciences Authority (HSA) was designated as a WLA for some regulatory functions in the initial list of October 2023. But in the recent review,  it received WLA designation for an expanded scope of functions, including market surveillance and control. 

“As WLAs, these agencies can be relied on to reassure quality and safety of medicines and vaccines to streamline processes, optimize resources, and expedite access to medicines and vaccines,” Dr Yukiko Nakatani, WHO’s Assistant Director-General stated in a press release.

Attaining the WLA designation also means a commitment to continuous improvement and excellence in regulatory oversight: a quality the working group says EMRN, HSA and US FDA demonstrate, WHO said.

Meanwhile, the list of 36 agencies representing 34 countries may expand further, with several stringent regulatory authorities now pending evaluations, WHO said.

Image Credits: DNDi.

Anti-vaxxers protesting against COVID-19 measures in London in 2022.

Some of the most vocal global right-wing conspiracy theorists and anti-vaxxers are heading to Geneva at the end of this month (May) to agitate against the World Health Organization (WHO) and its pandemic agreement – including a Trump loyalist linked to the 6 January 2021 storming of the US Capitol.

An alliance of right-wing groups, conspiracy theorists and alternative health practitioners calling itself “The Geneva Project” has planned a closed meeting on 31 May, while on 1 June it hosts a 150-minute invitation-only press conference and a public protest to coincide with the end of the World Health Assembly (WHA).

The protest outside the United Nations headquarters aims to “declare independence from global institutions such as the World Health Organization and World Economic Forum while celebrating cultural and individual sovereignty”, according to a press release from the group.

One of their key – and false – claims against the pandemic agreement and the amended International Health Regulations (IHR) is that they will give WHO the power to supersede domestic laws and declare lockdowns and other measures during pandemics and public health emergencies.

Protest speakers include Trump campaigner Dr Kat Lindley, UK anti-vaxxer Dr Aseem Malhotra, biologist and author Bret Weinstein, and Swiss lawyer Philipp Kruse.

Lindley is Texas president of the far-right Association of American Physicians and Surgeons. She was in Washington DC in 2021 during the 6 January assault on the US Capitol, using her Twitter account to call on “patriots” to “answer the call” and “#StopTheSteal”, according to the Fort Worth Star-Telegram.

Malhotra is a cardiologist who has campaigned against COVID-19 vaccines globally, including in South Africa, where he supported a court bid by an anti-vaxx group, the Freedom Alliance of South Africa (FASA), to stop the government from administering the Pfizer vaccine.

Weinstein hosts a podcast in the US that promotes anti-vaxxers and has steadily promoted the animal anti-parasite medicine, Ivermectin, as an effective treatment against COVID-19.

Recently, he was part of perpetuating an astonishing conspiracy linking the attempted assassination of Slovakian Prime Minister Robert Fico with that country’s “courageous rejection of the WHO’s audacious Pandemic Preparedness Treaty and International Health Regulations”.

This conspiracy has been repeated by Republican far-right Member of Congress Marjorie Taylor Greene. Meanwhile, Meryl Nass, a US doctor who had her license suspended for COVID-19 misinformation, intimated in a webinar hosted by Robert F Kennedy’s Children’s Health Defense that WHO Director-General Dr Tedros Adhanom Ghebreyesus was linked to the assassination. 

The Geneva Project mainly consists of far-right groups from the US, including the Brownstone Institute, which claims its “motive force” was policy responses to the COVID-19 pandemic of 2020, and “a willingness on the part of the public and officials to relinquish freedom and fundamental human rights in the name of managing a public health crisis”.

Brownstone president Jeffrey Tucker is also a senior economics columnist for Epoch Times, an international media company founded in the US by supporters of the Chinese dissident group, Falun Gong.

Epoch Times “has become a key media source for COVID-sceptic and anti-vaccine movements in France, Italy and Spain,” according to openDemocracy. It was the major funder of Trump advertisements over six months in 2019 outside of his presidential election campaign, NBC found.

Other supporters include a chiropractic practice, a group called Treehouse Living, the Alliance for Natural Health and Freiheitstrychler, the Swiss nationalists who made themselves known during the pandemic for ringing cow bells in protest against COVID-19 laws.

Some of the members of ‘The Geneva Project’.

‘Political opportunism’

Dis- and misinformation exploded during the COVID-19 pandemic, and has gathered momentum as the deadline for negotiating a pandemic agreement at the WHO has approached.

As previously reported by Health Policy Watch, African anti-rights groups and anti-vaxxers met in Uganda earlier this month where there were calls by speakers to reject the pandemic agreement and disinformation that the agreement was a WHO power grab that would undermine member states’ national sovereignty.

Even mainstream media outlets such as the UK’s Daily Telegraph, Newsweek and Sky TV Australia have given prominence to anti-pandemic agreement views in the past few weeks.

Sky News Australia’s recent focus on the WHO pandemic agreement featured a single guest who called on his country to reject the agreement.

Eloise Todd, the executive director and a co-founder of Pandemic Action Network (PAN), says that “some of the recent spikes in disinformation have come about through political opportunism from electioneering politicians”, and that the truth about the pandemic agreement needs more coverage.

“It was national leaders – prime ministers and presidents – of many political stripes that first suggested an international pandemic agreement in late 2020. Even at the height of COVID-19, leaders recognized they needed a roadmap towards better cooperation for future crises,” says Todd.

“Much of the recent disinformation has been around national sovereignty, and yet the wording of the pandemic agreement could not be clearer: ‘Nothing in the WHO Pandemic Agreement’ can be used to ‘direct, order, alter or otherwise prescribe the national and/or domestic laws….such as ban or accept travelers, impose vaccination mandates or therapeutic or diagnostic measures, or implement lockdowns’, ” said Todd, quoting from the draft agreement.

She adds that those responsible for disinformation need to be “held to account: the individuals, those that back them and the companies that enable the spread”. 

Fakes news and disinformation flourished during COVID-19

‘Treat disinformation like organised crime’

Justin Arenstein, CEO of Code for Africa, argues that the best defence against disinformation is to target covert actors and deliberately deceptive behaviour.

“Rather than pumping billions of dollars into endless literacy initiatives that have questionable or partial impacts at best, let’s also put resources behind following the money so that we can better identify covert and criminal behaviour, and the shadowy bad actors who are pulling the strings,” Arenstein told a recent United Nations Information Committee meeting on information integrity.

“What we should instead be doing is treating disinformation and other coordinated info-manipulation for what it is: organised crime. The ‘digital mercenaries’ who offer info-manipulation, surveillance and trolling as a commercial service all operate covertly, and their core service is to mislead and subvert the public. That’s a criminal enterprise,” says Arenstein, who has worked to combat the “infodemic” in Africa for the past few years.

He also calls for positive initiatives to strengthen online trust, such as investing in “the champions who are creating trustworthy, credible content” such as Wikipedia, the Free Encyclopedia, and transparency tools like CrowdTangle that help people to understand who the hidden puppet masters are.

Fake news and disinformation continue to undermine public health and trust in vaccines, with consequences such as outbreaks measles in middle-class areas in the US and Europe where vaccination rates have dropped.

These occurences are likely to become more widespread and harder to manage unless global health organisations and governments take far bolder steps to address the infodemic.

This is the second in our two-part focus on disinformation.

See PART 1: African Anti-rights Groups and Anti-Vaxxers Unite in Global Campaign Against WHO

Image Credits: Sarah le Guen/ Unsplash, Jorge Franganillo/ Unsplash.

Uganda’s First Lady  Janet Museveni (centre), hosts delegates from the African Inter-Parliamentary Conference on Family Values and Sovereignty, including anti-vaxxers Wahome Ngare (front left) and Shabnam Mohamed (front right).

Right-wing African Members of Parliament (MPs), including some of the continent’s most vociferous anti-abortion, anti-LGBTQ lawmakers, united with anti-vaxx conspiracy theorists for the first time at a conference in early May which plotted how to restrict human rights on the continent in the name of “family values”.

Aside from the expected rhetoric against abortion and LGBTQ people, the African Inter-Parliamentary Conference on Family Values and Sovereignty in Entebbe, Uganda, gave a platform to a speaker who claimed that a range of vaccines were unnecessary or designed to reduce African fertility – including the COVID-19, Human Papillomavirus (HPV), malaria and tetanus vaccines.

Others agitated against the World Health Organization’s (WHO) pandemic agreement currently being negotiated to safeguard the world against future pandemics, describing it as a “power grab” aimed at imposing abortion, same-sex marriage and lockdowns on the world.

The anti-vaxx charge was led by Kenyan doctor Wahome Ngare and South African Shabnam Mohamed, who describes herself as a lawyer and journalist. Ngare is chairperson of the African Sovereignty Coalition and a director of the right-wing Kenya Christian Professionals Forum (KCPF).

Mohamed is a leader of the  “Africa chapter” of US presidential candidate Robert F. Kennedy Jr’s Children’s Health Defense, one of the key global sources of vaccine misinformation. She is also part of the World Council on Health, an  alliance of anti-vaxxers, conspiracy theorists and alternative health providers.

Shabnam Mohamed leads the Africa Chapter of Kennedy’s Children’s Health Defense.

Ngare told the conference that SARS-CoV2 was produced in a laboratory and the “endgame of the whole COVID fiasco was to vaccinate everybody” for profit. He also claimed that the tetanus vaccine causes infertility and that vaccines against HPV and malaria (one of the biggest killers of African children) were unnecessary.

“Could the COVID pandemic have been created and designed to facilitate the administration of an injection aimed at reducing one population through sterility and death?” asked Ngare, who also claimed that the WHO had been involved for 20 years in developing a tetanus vaccine that prevents pregnancy.

Vaccines have had a massive impact on African lives, cutting infant deaths in half over the past 50 years, according to a recent Lancet study. The HPV vaccine combats a number of viruses that are the primary cause of cervical cancer, the most pervasive cancer for women on the continent.

Ngare also called on the African MPs to ensure that their governments reject the proposed amendments to the WHO’s International Health Regulations (IHR), which he claimed would turn the WHO “from an advisory organisation into a governing body”, a false claim that is also made repeatedly by Kennedy. 

The actual aim of the IHR amendments is to ensure there is a clear process for responding to “public health emergencies of international concern (PHEIC)” to ensure that the world is better prepared for disease outbreaks that have the potential to become pandemics.

Shabnam Mohamed (centre) and Wahome Ngare (right) prepare to address the inter-partliamentary conference on family values in Entebbe, Uganda.

Disinformation shopping list

The pandemic agreement currently being negotiated at the WHO aims to ensure that its 194 member states are better equipped to prevent, prepare for, and respond to, future pandemics – including how to ensure more equitable access to vaccines and medicines in future pandemics.

Yet Mohamed provided a shopping list of disinformation about the pandemic agreement, which is currently in draft form. She took particular exception to the proposed pathogen access and benefit-sharing (PABS) system.

This aims to set up a global system where countries can share biological and genomic information about pathogens with the potential to cause pandemics, and derive benefits for doing so, such as getting access to medicines and vaccines. Under the current draft, the WHO will get 20% of any health-related pandemic products – including vaccines and medicine – to distribute to countries and groups most in need to avoid vaccine hoarding.

However, Mohammed, erroneously claims that the proposed PABS system will encourage “biological weapon research” and “dangerous experimentation”.

She also claimed that “South Africa” has drawn up a Bill to withdraw from the WHO. However, she and MPs from the  right-wing African Christian Democratic Party (ACDP), a tiny party with three seats in South Africa’s 400-seat National Assembly, are behind a “Bill”, which has not even been tabled in that country’s Parliament. 

The ACDP is expressly opposed to COVID-19 vaccines and stated its supports for the animal parasite medicine, Ivermectin, as a COVID treatment in its election manifesto in the run-up to the country’s national elections on 29 May.

During Mohamed’s presentation , she claimed that the WHO’s pandemic agreement is a “global power grab”.

‘Kill the gays’ politicians in attendance

Ngare and Mohammed received a warm welcome at the conference, which was addressed by some of the most right-wing politicians on the continent, including Ugandan Cabinet Minister David Bahati, responsible for his country’s 2009 “Kill the Gays” Bill that advocated for the death penalty for same-sex relations in certain situations. Although Uganda’s Constitutional Court nullified that Bill in 2014, the country passed a similar Bill in 2023, which Bahati helped to champion, and this recently survived a court challenge.

Dr Seyoum Teklemariam Antonios, Africa director of the US anti-rights group, Family Watch International, told the conference that the pandemic agreement and “transgender healthcare guidelines” pose serious threats to Africa’s growth and development and requested Uganda’s leaders to prevent its representatives at the upcoming World Health Assembly (WHA) from signing these treaties. No transgender healthcare guidelines are on the agenda at the WHA.

Antonios is well known for his extreme views, and has declared homosexuality the “pinnacle of immorality”, claiming that his country,  Ethiopia, “shall be the graveyard for homosexuality”. He has had close ties to US anti-rights organisations for at least two decades.

Family Watch International, has been designated as a “hate group” by the Southern Poverty Law Center.  It is one of the most active anti-LGBTQ groups on the continent and at the United Nations (UN). Amongst its many activities, it hosts annual training sessions for African politicians at its Arizona base on how to mobilise against LGBTQ rights and sex education in schools.

Uganda’s Minister of Mineral Development Sarah Opendi,  chaired the conference. Attendees included Egyptian MP Amira Saber, Eswatini MP and son of King Mswati, Prince Lindaninkosi Dlamini, and Fabakary Tombong Jatta, Speaker of The Gambia’s National Assembly.

After the Entebbe conference, a small group of delegates, including Ngare and Mohamed, joined Opendi at the State House to meet with Ugandan First Lady Janet Museveni, who is also Minister of Education and Sport.

Post-pandemic global realignment of conservatives

Anti-science dis- and misinformation has become a global movement since the COVID-19 pandemic. During the pandemic, a disparate range of organisations and individuals, particularly in the US, spread various conspiracy theories, including that the pandemic was intentionally created as part of a plan by secretive elites to control the world population through lockdowns and quarantines, and that China was also involved in the spread of a “lab-created” virus.

These groups included the far-right conspiracy theory movement QAnon, America’s Frontline Doctors and Kennedy’s Children’s Health Defense.

The Center for Countering Digital Hate (CCDH) found that 12 people were responsible for two-thirds of anti-vaxx information on Facebook and Twitter in the US at the height of the pandemic in 2021.

Nine of the “disinformation dozen” derived their livelihoods from the “alternative health” sector. Top spreader Joseph Mercola “peddles dietary supplements and false cures as alternatives to vaccines”, while Ty and Charlene Bollinger, the third-biggest spreaders of misinformation, are “anti-vax entrepreneurs who run a network of accounts that market books and DVDs about vaccines, cancer and COVID-19”, according to the CCDH.

Kennedy was the second biggest misinformation spreader. 

CCDH’s ‘disinformation dozen’, the top spreaders of COVID disinformatiin in the US.

Post-pandemic, these groups and some of their views have found resonance with US right-wing political organisations opposed to abortion and LGBTQI rights, as well as with nationalists, and anti-China groups.

These seemingly unrelated views have coalesced around opposition to the WHO, particularly the pandemic agreement that is being negotiated at present.

In January, some of the foremost right-wing groups in the US sent a letter to the WHO Executive Board urging it to reject awarding official relations status to the Center for Reproductive Health – and based their argument on misinformation.

“Giving special status to the Center for Reproductive Rights will further fuel the culture wars undermining the WHO’s mission to tackle health issues. It confirms fears that WHO’s new accord on pandemic preparedness will be used to undermine national laws related to abortion,” claims the letter.

Signatories included the Heritage Foundation, Family Watch International, C-Fam, Family Research Council, Susan B. Anthony Pro-Life America, International Organization for the Family, ACLJ Action and Human Life International.

However, this is a distortion as every draft of the pandemic agreement has explicitly recognised countries’ sovereignty, noting that the WHO has no power to “direct, order, alter or otherwise prescribe the national and/or domestic laws”.

The US conservatives’ ‘Project 2025’

In April 2023, the Heritage Foundation, a far-right US think-tank, launched Project 2025: The Presidential Transition Project, consisting of policy proposals and a recruitment strategy to ensure the takeover of all government offices and entities should Donald Trump be re-elected.

The proposals are contained in a 920-page book, and include the demand that vaccines  “tested on aborted fetal cells” should be removed from US supplies – including those that vaccinate children against chickenpox, and the three-in-one MMR vaccine that protects children against measles, mumps and rubella. 

An extract from Project 2025’s Mandate for Leadership.

 

In addition, Project 2025 calls for the promotion of  “the unsurpassed effectiveness of modern fertility awareness–based methods (FABMs) of family planning”, which is a “natural” method to control pregnancy without contraceptives.

The conservative blueprint mentions the WHO a handful of times – all negatively. It refers to the “manifest failure and corruption” of the WHO during the pandemic, describing it as “willing to support the suppression of basic human rights, partially because of its close relationship with human rights abusers like the [People’s Republic of China]”.

The next US Administration must “return to treating international organizations as vehicles for promoting American interests – or take steps to extract itself from those organizations”, it adds.

Former US president Donald Trump famously froze US payments to the WHO in April 2020, accusing the global body of “severely mismanaging and covering up” the COVID-19 pandemic.

Since the pandemic, nationalist rhetoric from right-wing Make America Great Again (MAGA) Republicans against the WHO has grown, based partly on their rejection of lockdowns and masks and partly on their belief that the WHO is engaged in a campaign to undermine countries’ autonomy.

Danger of smearing WHO in ‘culture war’

Globally, the frenzied dis- and misinformation about the WHO’s pandemic agreement reached a crescendo this month – apparently to coincide with the supposed deadline of the pandemic agreement negotiations.

While much of the tone and messaging of the anti-WHO groups is similar to the pandemic-era anti-vaxxers, the chorus is bigger, louder and much more systematic, and the organisations involved are more diverse.

But making the WHO a target in the “culture war” has serious implications for global health, as well as solidarity and human rights. WHO spokesperson Paul Garwood said that the global body is “concerned about the impact of dis- and misinformation of people’s well-being and health choices”.

“We will continue to share clear, evidence-based helpful information to our member states and the broader public at large,” added Garwood.

Tian Johnson, a strategist for the African Alliance, a Pan-African health justice organisation, described the positive impact of the WHO on health on the continent.

“The WHO’s leadership in public health, technical expertise, and support in disease prevention have significantly advanced health equity and accessibility, fostering global solidarity during times of crisis,” said Johnson.

“The coordinated campaign to undermine the WHO’s global and African work demands a robust response. We must actively resist, advocate for, and confront the far-right groups seeking to propagate hatred, division, and violence on our continent.

“These overseas groups, who benefit from local support and leadership, thrive on exacerbating discord by vilifying our differences and deflecting attention from their own failures to serve their communities. They understand that a unified Africa, one that embraces our commonalities over divisions, poses a direct challenge to their agenda of white supremacy and colonialism,” added Johnson.

He urged African organisations to “strengthening our local institutions, rallying behind the WHO’s global and regional efforts, and championing science”.

READ Part 2 – Disinformation: Anti-WHO Convoy Heads to Geneva for World Health Assembly

 

The INB in session during negotiations in June 2023.

Members of the Intergovernmental Negotiating Body (INB) face another sleep-deprived week as talks on the World Health Organization’s (WHO) pandemic agreement resumed on Monday and run until Friday.

There are many outstanding articles and little prospect that the agreement will be completed in time for the World Health Assembly (WHA) next week, but participants hope that the broad outlines of the agreement and the way forward will have been reached by Friday.

Whatever agreement is reached needs to be tabled at the WHA, which will decide on the way forward.

There is already a proposal on the table for two key and complex aspects of the pandemic agreement –  One Health and a pathogen access and benefit-sharing (PABS) system – to be decided on by 2026.

INB co-chairs told reporters after what was supposed to be the last meeting on 10 May that member states were finally entering into the give-and-take spirit of talks after two years of little compromise.

“The closer you get to the endpoint, the more willingness there is to move. We worked very hard and deep into the night, but there’s just so much so many issues that we need to agree upon and which are sometimes very technical or political,” said INB co-chair Roland Driece.

“I think this is the last mile,” added co-chair Precious Matsoso, who said that One Health, PABS, intellectual property and human resources had preoccupied delegates.

This week’s agenda (see below) is focused on the key articles on which there is not yet agreement:

Common definitions

At least part of Monday’s talks, on definitions, will be helped by the agreements reached by the Working Group on amendments to the International Health Regulations (WGIHR). The IHR and the pandemic agreement will use the same definitions.

The WGIHR worked until the early hours of Saturday morning, agreeing “in principle on a large, ground-breaking package of amendments” to the IHR, according a media statement from  WHO.

“These amendments build on over 300 proposals made by countries in the wake of the COVID-19 pandemic. They set out to improve the ability of countries to prepare for, detect and respond to Public Health Emergencies of International Concern (PHEICs), and will be part of a package to be put forward to the World Health Assembly (WHA),” 

WGIHR members are due to meet again this week to “wrap up their work on the few remaining issues that need to be finalised”, according to WHO.

A few disagreements on technology transfer and finances prevented the end of the process, according to sources.

WGIHR co-chair Ashley Bloomfield still hopes to reach an agreement on what to present to WHA, but it’s hard to imagine when his committee will have much time as many are also on the INB.

‘Robust’ IHR amendments

“Amending the International Health Regulations reflects the critical need to bolster our collective defences against current and future public health risks, all whilst firmly adhering to the principle of national sovereignty and respecting equity,” said WGIHR co-chair, Dr Abdullah Assiri.

“We have coalesced around a robust set of amendments which will make international cooperation more effective and easier to implement.”

The IHR were first adopted by the World Health Assembly in 1969 and last revised in 2005, to manage public health outbreaks and emergencies. All 194 WHO Member States plus Liechtenstein and the Holy See are party to the IHR. 

“The International Health Regulations have served the world well for nearly 20 years but our collective experience in using this vital tool for the management of multiple public health emergencies, including the COVID-19 pandemic, has demonstrated important areas in which they could be strengthened for the benefit of all 196 State Parties,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. 

“Countries have come together around improved international mechanisms to protect every person in the world and future generations from the impact of epidemics and pandemics, with a commitment to equity and solidarity.”

Amending the IHR and developing a pandemic agreement are complementary processes.

“The IHR focuses on building countries’ capacities to detect and respond to public health events which could take on international dimensions, whilst the draft pandemic accord focuses on a coordinated international response to pandemics, with equitable access to vaccines, therapeutics and diagnostics at the centre,” according to the WHO.

Image Credits: WHO.

Testing bacteria for resistance to antibiotics at the Liverpool School of Tropical Medicine

The World Health Organization (WHO) has updated its list of antibiotic-resistant bacteria that pose the greatest threat to human health, ranking the 15 families of bacteria that feature as “critical”, “high” and “medium” threats. 

The Bacterial Priority Pathogens List (BPPL) 2024’s “critical” list features bacteria that are high burden, can resist treatment and spread resistance to other bacteria.

A new entrant on the “critical” list is a third-generation cephalosporin-resistant Enterobacterales. It joins tuberculosis resistant to rifampicin, and gram-negative bacteria resistant to last-resort antibiotics.

Gram-negative bacteria have built-in abilities to find new ways to resist treatment and can pass along genetic material that allows other bacteria to become drug resistant as well.

“The list provides guidance on the development of new and necessary treatments to stop the spread of antimicrobial resistance (AMR),” according to the WHO

AMR occurs when bacteria, viruses, fungi, and parasites no longer respond to medicines. It is driven largely by the misuse and overuse of antimicrobials.

High priority bacteria include fluoroquinolone-resistant salmonella and shigella; gonorrhoeae that is resistant to third-generation cephalosporin and/or fluoroquinolone, and Staphylococcus aureus that is methicillin-resistant

“Antimicrobial resistance jeopardises our ability to effectively treat high-burden infections, such as tuberculosis, leading to severe illness and increased mortality rates,” said Dr Jérôme Salomon, WHO’s Assistant Director-General for Universal Health Coverage.

Not enough support for new drugs

But there is not enough support for the development of new antibiotics, according to a new report released this week by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

The report reviews the antibiotic pipeline data against bacterial pathogens identified by the WHO and other public health agencies as of the greatest concern. 

Only 10 new antibiotics or combinations were approved by stringent regulatory authorities between 2017 and 2023, and only two of these are defined as innovative by the WHO. None constitute a new class of antibiotics. 

There is currently just one antibiotic candidate in Phase III clinical trials across the four bacterial pathogens defined as a critical priority by WHO. Only two of the seven high-priority pathogens have innovative candidate antibiotics in development, with five having three or fewer candidates at any stage of clinical development.

James Anderson, IFPMA’s Executive Director of Global Health acalled for “urgent action” to reinforce the pipeline of antibiotics and protect the world from rising drug resistance. 

“Robust pull incentives are crucial in encouraging the research and development investment needed, and by demonstrating the impact that these can have, this report underscores the economic and health imperative for governments to act boldly in a year when the UN is focused on combatting AMR,” said Anderson.

Using predictive health intelligence and data analytics experts from Airfinity, the report found that, if no new incentives are introduced that could encourage investment into antibiotic R&D, the pipeline will continue to decline, delivering only eight approvals by 2033. Under this scenario, in 10 years’ time, the pipeline is expected to contain 26 treatments, of which only 6 are in late stages of development.

However, if “effective incentives” are introduced by 2025, 19 new antibiotics could be approved and a pipeline of 72 treatments in 2033.

Some of the examples the IFPMA cites as promising incentives include a novel subscription model being rolled out in the UK. This involves paying companies a fixed annual fee for antimicrobials based primarily on their value to the National Health Service (NHS), as opposed to the volumes used. 

Last year, Japan announced that it will pilot a revenue guarantee model to help subsidies companies that work to address AMR.

 

However, the IFPMA wants a global model to reward the successful development of new antibiotics. 

“There needs to be a level of global coordination and enough countries involved to make sure that the total economic package is sufficient to attract the necessary R&D investment,” according to the IFPMA.

Image Credits: DFID/ Will Crowne, IFPMA.

Processed foods are a major drive for excess salt consumption.

More than one in three adults in WHO’s European Region aged 30-79 has hypertension, or high blood pressure – and a key factor is excess consumption of salt, according to a new WHO report published this week.

The report “Action on Salt and Hypertension,” calls on governments to take “mandatory” measures to reduce the public’s salt intake, including much tougher limits on the salt content of processed foods.

“From the food industry’s perspective, high-salt foods tend to yield the most profit,” states the WHO press release accompanying the report. “But the fact is that these foods put customers’ health at risk. Population-level salt reduction through mandatory reformulation produces rapid results, is feasible, is cost-saving and ultimately saves lives.”

Cardiovascular disease, including hypertension, ischaemic heart disease and related ailments, currently kill some 10,000 people a day in WHO’s European Region, which includes some 53 member states from Great Britain to central Asia.

According to the new report, produced by WHO’s European Regional Office, men are almost 2.5 times more likely to die from cardiovascular diseases (CVDs) than women.  And the probability of premature death (30-69) from CVDs is almost five times higher in eastern Europe and central Asia as compared to Western Europe.

And 52 out of 53 countries in the European Region have an average daily salt intake above the WHO recommended maximum level of 5 grams (around one teaspoon) per day. The highest levels of salt consumption are in central Asia, the Russian Federation and eastern Europe. Tiny Malta is the sole country meeting the WHO guidelines.

Malta is the sole country in the 53 member European Region that meets WHO guidelines for salt intake.

“CVDs and hypertension are largely preventable – and controllable,” said Hans Kluge, WHO Regional Director for Europe. “Four million, a staggering figure, is the number of deaths caused by cardiovascular diseases every single year – primarily in men, particularly in the eastern part of our WHO region.

“These are the facts, but this is something we can change….. Implementing targeted policies to reduce salt intake by 25% could save an estimated 900 000 lives from CVDs by 2030.”

‘Opposing fundamental interests’

Street food and processed foods are amongst the leading culprits of excess salt consumption, the WHO report concludes. And therefore “regulating the amount of salt in processed foods has the potential to have a positive impact on people’s health.”

The report recommends that governments therefore introduce mandatory policies to reduce salt intake – including tougher limits on the amount of salt permitted in common processed and manufactured foods; on foods prepared and sold to the public in canteens and food outlets; as well as better labelling of foods sold to consumers in groceries.

“Reducing salt at population level highlights the opposing fundamental interests of public health and the food industry,” the report states.”From a food industry perspective focused on profit, salt contributes to food safety by increasing shelf-life and is a cheap way to make food more palatable.

“In addition, the body gets used to the taste of salt and craves food with a higher salt content. It is these high-salt foods that tend to yield the most profit. In contrast, the public health perspective is focused on the significant health and economic costs to society caused by high salt intake.

“The food industry can lobby for limiting reductions in salt, sugar and fat content of food, as well as influence the private health sector which may have less interest in prevention if payment is based on treatments provided. When facing industry opposition, it is important that policy-makers remember that population-level salt reduction through reformulation produces rapid results, is feasible, is cost-saving and ultimately saves lives.”

Image Credits: WHO/S. Volkiv, WHO/Action on Salt and Hypertension.

Delegates at a WHO intergovernmental negotiating body meeting.

The latest draft of the World Health Organization’s (WHO) pandemic agreement, which was sent out to member states on Wednesday (15 May), shows just how far the talks still have to go.

Health Policy Watch obtained a copy of the draft agreement, which we are sharing on our paywall-free site:

READ: Latest Pandemic Agreement Draft, reflecting progress up to 10 May

Around a third of the text is still white, indicating either that it has not been agreed on or not even discussed. According to a stakeholder briefing, there were some 300 paragraphs to negotiate on at the last meeting of the Intergovernmental Negotiating Body (INB).

However, some of the most significant articles are awash with yellow and green highlights, indicating progress.

Yellow means the text has been agreed to in a working group. Green means it has been agreed to in the plenary of the Intergovernmental Negotiating Body (INB).

Chapter 1 (Articles 1-3), dealing with aims and definitions, is largely white text but unlikely to take much time to reach agreement on.

Chapter 2 (Articles 4-20) is operation room of the agreement, dealing with equity throughout the chain of pandemic prevention, preparedness and response

One Health (Article 5) is mostly yellow.

Article 11 (technology transfer and know how) is also largely yellow, but there are a number of brackets around phrases such as “voluntary”.

The controversial Article 12 on pathogen access and benefit-sharing (PABS) is a mass of yellow and green.

A new addition to the PABS Article, which is neither yellow or green, is the proposal that, during a “public health emergency of international concern (PHEIC) or pandemic emergency”, manufacturers party to the PABS system “grant to WHO royalty free, non-exclusive manufacturing licences, that can be sub-licensed to manufacturers in developing countries for the production of vaccine therapeutics and/or diagnostics”.

Articles 7, 14, 18, 19 and even 20, on sustainable finance, seem close to agreement.

Chapter 3 (Articles 21-27) on institutional arrangements and final provisions, is largely agreed on.

The INB Bureau has also decided on a timetable for the final talks, with virtual meetings set to be held from 20-24 May, ending two days before the start of the World Health Assembly (WHA) on 27 May:

If there is no agreement by the WHA, the INB will simply present the latest version of the agreement.

When the negotiations ended on 10 May, INB co-chairs Roland Driece and Precious Matsoso said the negotiations had finally started to make progress in the past two weeks.

“The closer you get to the endpoint, the more willingness there is to move. We worked very hard and deep into the night, but there’s just so much so many issues that we need to agree upon and which are sometimes very technical or political,” said Driece.

“I think this is the last mile,” said Matsoso, adding that One Health, PABS, intellectual property and human resources had preoccupied delegates.

But at this stage, it is unclear just how long this “last mile” will be – whether INB delegates will be able to get something together before this World Health Assembly, starting on 27 May, or whether it will need to be stretched to another date months or even a year down the line.

Image Credits: WHO.

Tanzania’s President Samia Suluhu Hassan and Norway’s Prime Minister Jonas Gahr Støre (centre) co-chaired the summit.

In a ground-breaking move, global leaders on Tuesday made an unprecedented financial pledge to tackle the dirty cooking fuels crisis, which silently claims millions of lives across Africa. 

The Summit on Clean Cooking in Africa, chaired jointly by the leaders of Tanzania and Norway, alongside the African Development Bank, secured financial commitments from governments, development institutions and companies. 

The summit was co-hosted in Paris by the Clean Cooking Alliance (CCA) and the International Energy Agency (IEA). 

This was the largest amount of money to be pledged to clean cooking energy at a single gathering, and earmarked for a continent where four in five people still cook on open fires. As such, the summit was billed as a potential turning point for Africa, and particularly African women who shoulder much of the health burden from cookstove pollution.

Lack of access to clean cooking affects over two billion people globally, with over half living in Africa, often reliant on open fires and rudimentary stoves, fuelled by charcoal, wood, agricultural wastes and animal dung. 

In Africa, more than 850 million people still depend on wood and charcoal for cooking, the leading cause of indoor air pollution, with devastating effects on health. 

In fact, toxic indoor smoke is the second biggest cause of premature death in Africa, predominantly affecting women and children. Household air pollution causes nearly half of pneumonia deaths among children under five years of age.

Impact on women

“Successfully advancing the clean cooking agenda would contribute toward protecting the environment, climate, health, and ensuring gender equality,” Tanzanian President Samia Suluhu Hassan told the summit in Paris.

Hassan has called for the generous replenishment of the African Development Fund, which  includes $12 billion for clean cooking with the goal of ensuring clean cooking for all by 2030.

“Insufficient funding and a lack of awareness about the economic opportunities within the clean cooking industry hamper efforts to scale interventions,” she said.

Hassan cited three major challenges facing clean cooking in Africa, including the lack of access to adequate, affordable and sustainable solutions, lack of global attention to the problem and the absence of smart partnerships to ensure clean cooking access for all.

“Amidst these challenges, central to Tanzania’s own commitment is delivering on or recently-launched 10-year Clean Cooking National strategy, which aims to ensure 80% of Tanzanians use clean cooking solutions by 2034,” she said.

Norwegian Prime Minister Jonas Gahr Støre said his country will invest approximately $50 million to support clean cooking energy.

“Improving access to clean cooking is about improving health outcomes, reducing emissions, and creating opportunities for economic growth,” he said.

Respiratory and cardiovascular diseases

The global clean cooking energy campaign received a boost at the United Nations Climate Change Conference in the United Arab Emirates (UAE) in November last year with the launch of the African Women Clean Cooking Support Programme(AWCCSP) which aims to provide clean cooking technologies to women and girls in Africa to reduce the use of firewood and charcoal.   

Dirty cooking causes respiratory and cardiovascular diseases, increases planet-heating emissions, and robs women’s of their time, experts said at the conference.

IEA Executive Director Fatih Birol emphasized the significance of the Summit’s outcome. “This summit had delivered an emphatic commitment to an issue that has been ignored for too long” Biro states, underscoring the potential of the $2.2 billion commitment to support  fundamental rights such as health, gender equality and education, while also mitigating emissions and restoring forests.

Akinwumi Adesina, President of the African Development Bank Group, announced plans to increase financing for clean cooking to $200 million annually over the next decade, while also scaling up the provision of blended finance for clean cooking through Sustainable Energy Fund for Africa(SEFA).

“We are delighted to play a leading role… to definitively tackle lack of access to clean cooking, that affect a billion people in Africa,” he said.

Mary Robinson, former president of Ireland, arrives at the summit.

Following the Summit, the IEA announced plans to employ a “double-lock system” to ensure sustained momentum behind clean cooking efforts.

This system entails effective tracking methods to ensure pledges and commitments are fulfilled, alongside continued efforts to engage more partners and generate additional funds to meet the $4 billion annual capital investments required until 2030 to achieve universal access to clean cooking in sub-Saharan Africa.

More than 100 countries, international institutions, companies, and civil society organizations signed The Clean Cooking Declaration, reaffirming their commitment to prioritizing the issue and enhancing efforts toward achieving universal access for all.

Nearly one in three people globally still use open fires or basic stoves for cooking thus causing untold health damage, lower living standards and widening gender inequality, according to IEA report titled, A Vision for Clean Cooking Access for All.

 Women suffer the worst impacts from the lack of clean cooking. The burden of fuel collection and making meals typically falls on women and takes on average 5 hours a day.  

 “Clean cooking is a topic that rarely hits the headlines or makes it onto the political agenda,” said Birol. “And yet, it’s a cornerstone of global efforts to improve energy access, gender equity, economic development and human dignity,”

Former President of Ireland, Mary Robinson, cautioned against unfulfilled promises.

 “We need to know what kind of new money is coming in and how it will be spent. We have to test everything these days, as so many promises are made and not fulfilled,” she said.

“The fact that 900 million women in Africa still cook on dirty stoves should not be tolerated in the 21st century,” Robinson asserted.  “And to hear it only requires $4 billion, with $300 million being allocated each year for the next few years. Isn’t that very doable?”

Test tube rack stocked with electronic cigarettes.

A $3-million “educational” deal between tobacco giant Philip Morris International (PMI) and Medscape, a medical education provider for healthcare professionals, has been abandoned after the BMJ and The Examination exposed it last month.

The deal involved a PMI grant to Medscape to fund continuing medical education (CME) accredited courses on smoking cessation for doctors and other healthcare providers. 

With waning tobacco sales, PMI has moved into selling smokeless tobacco products and e-cigarettes alongside cigarettes.

However, Medscape has “bowed to pressure and agreed to permanently remove a series of accredited medical education courses on smoking cessation funded by the tobacco industry giant Philip Morris International (PMI)”, according to The BMJ.

“Medscape has acknowledged its ‘misjudgment’ in a letter to complainants and says that it will not accept funding from any organisation affiliated with the tobacco industry in the future,” the journal added.

When the exposé was first published, Professor Anna Gilmore, director of the Tobacco Control Research Group at the University of Bath, UK, said that Medscape had “now lost all credibility and has some serious questions to answer. PMI lost all credibility decades ago, despite its ceaseless and highly misleading attempts to rehabilitate its image. It has now sunk to a new low.”

A few years back, PMI established the Foundation for a Smoke-Free World headed by former World Health Organization (WHO) official Derek Yach to promote its tobacco-free products. 

The intention of the Medscape course appears to be to downplay the negative health effects of non-cigarette nicotine products.

“Medscape had planned to deliver 13 programmes under the deal—called the PMI Curriculum, according to the internal document. It had also planned podcasts and a ‘TV-like series’,” The BMJ revealed.

Medscape describes itself as “the leading online global destination for physicians and healthcare professionals worldwide, offering the latest medical news and expert perspectives; essential point-of-care drug and disease information; and relevant professional education and CME”.

The tobacco industry has a long history of sponsoring academics and research aimed at downplaying the negative impact of tobacco and smoking.

In its response to The BMJ, a PMI spokesperson said: “Health agencies around the world have recognised the beneficial role that smoke-free products can play to improve public health.

“We are concerned that known special interest groups are actively blocking medical education that the [US] Food and Drug Administration and medical community have determined are needed. These actions stand to prolong use and possibly increase consumption of combustible cigarettes – the most harmful form of nicotine use.”

But Professor Tim McAfee, former director of the US Centers for Disease Control and Prevention’s Office on Smoking and Health, ctold The BMJ that PMI’s partnership with Medscape “the ultimate example of the fox not only signing up to guard the hen house but offering to sit on the eggs.” 

“It is a perversion of ethics surrounding continuing medical education to allow the very companies that caused and profit from the continuing epidemic of tobacco-related death and disease to be involved in any way,” added McAfee, who is based at the Department of Social and Behavioral Sciences at the University of California in San Francisco.

Image Credits: Unsplash.

NCDs
A nurse vaccinates a baby at a clinic in Accra, Ghana. Investments in nursing can have a ten-fold economic benefit in LMICs.

More than 4.5 billion people lack access to essential health services, while globally 60 million lives are lost due to failures of health care systems, translating into a 15% loss of global GDP.

Yet the consequences in terms of poor health and economies are preventable through increased investments in nurses who deliver upwards of 80% of hands-on care, according to a new report from the International Council of Nurses (ICN). 

Investments in the health workforce in low and middle-income countries (LMICs), and particularly nurses, would result in a massive return on investment at a ratio of 10:1, the report finds.

The economic burden of inadequate health systems is at the forefront of the report, whose release coincides with Sunday’s observance of International Nurses Day. This year’s theme on “the economic power of care” echoes the outsized contributions nurses make to global economic growth, and identifies critical areas for strategic investments in the face of increasing healthcare demands and burnout.

“What governments must recognise is that such investment in nursing is not a cost: investing in health care saves money, and our experts say having a healthy population could boost global GDP by $12 trillion or 8%,” remarked ICN President Pamela Cirpriano. 

The report finds that countries need to increase the size of their nursing workforces so that they have 70 nurse for every 10,000 population, in order to reach key Universal Health Coverage (UHC) benchmarks by 2030. And that means at least 30.6 million more nurses need to be educated and employed around the world. 

In countries where there are more nurses per capita, UHC coverage is also higher.

The report cites WHO data from 2023 to the effect that effective Universal Health Coverage (UHC) could save 60 million lives by 2030, and increase global life expectancy by 3.7 years.

“But achieving it requires a massive increase of investment in the nursing workforce,” Cirpriano stressed, noting that, “nurses are the drivers of Primary Health Care (PHC) which has been recognized by the United Nations as the catalyst for reaching the UHC 2030 goals.”

Costs of underinvestment of nursing
The ICN report identified the numerous costs of underinvestment in nursing

Cost-cutting measures will backfire

Although nurses make up 50% of the healthcare workforce, national investments in nurses education, salary and conditions have been eroded, rather than bolstered, in the post-COVID era.  

“Faced with the global shortage of nurses instead of investing in the current nursing workforce we are seeing too many governments choosing short-term and cost reduction driven policies, such as international recruitment, creating new non-registered nurse roles and looking to reduce the length of nurse education,” said ICN Chief Executive Officer Howard Catton.

“These are the wrong choices, taking us in the wrong direction, and seriously risk putting people off joining the profession and seeing more of our experienced nurses quit or leave earlier than they would have done. 

Even in high income countries such as the United States see “nurses frequently grapple with insufficient staffing levels, heavy workloads, and resource constraints, all of which can detrimentally affect their job satisfaction and retention,” said Lisa Kitko, RN & PhD, dean of the University of Rochester School of Nursing, speaking to Health Policy Watch. 

“It’s essential to recognize the economic value that nurses bring to health care organizations through their expertise, skills, and contributions to patient outcomes,” she said. “As the largest health care profession, and most trusted, nurses are uniquely positioned to improve lives and strengthen communities. They consider the future of health care more systemically, integrating the physical, social, and mental well-being of patients.”

A 1:10 return on investment ratio for nursing

The report notes that every $1 invested in health systems generally brings a return of $2-$4. “Stronger health systems equal better health, and healthier populations bring significant returns on investment.” 

But the economic returns are even greater for lower-and-middle-income countries (LMICs). Investment in the LMIC health workforce, particularly nurses, would result in a massive return on investment at a ratio of 1:10.

“We know investments in nursing will create improvements in health care delivery, be a catalyst for economic development, and will advance peace and social well-being,” said Cipriano. 

“What we do has an impact far beyond the visible care we deliver in hospitals, homes, communities, and crisis settings.”

The report notes the cascading benefits of investments in the nursing workforce include not only better direct job creation but better health overall, leading to productive gains in other sectors.

An opportunity for increased gender equality

Benefits of investments in nursing
The benefits of investments in the nursing sector range from empowering women to fostering peace

Investing in nursing and the broader care economy also “is crucial for closing gender gaps,” the report streses. Improving pay, working conditions, and career advancement opportunities in nursing empowers women and stimulates the rest of the economy, especially in the context where approximately 90% of nurses worldwide are women.

For the same reasons, investing in the nursing workforce also can help alleviate poverty, especially for women and girls.

Such investments also require more economic focus and renumeration for roles that are now unpaid care work. Some 76% of unpaid care work is performed by women, and  when care work is paid, it is characterized by low wages. The report sees the economic opportunity in improving pathways to better paid care work. “Better care systems and recognizing and redistributing unpaid care work can significantly contribute to closing gender gaps in labor markets,” notes the report.

Furthermore, the report highlights how investments in nursing have cascading economic benefits, including globally. One prominent example is the more than $50 billion that nurses educated in the global south and working in the global north send home in remittances each year.  At the same time, LMICs have also suffered a significant nursing “brain drain” as affluent countries rely increasingly on importing nurses from abroad, rather than investing in a stronger domestic healthcare work force.  

“What is important now is to make sure that we reinforce to the world that nurses no longer want to be hidden,” said Cipriano at a recent webinar. ICN CEO Howard Hatton added that “for too long, people have dismissed the economic value of caring as being irrelevant or of having no value, that is plainly wrong.” 

“Social cohesion, peace, and prosperity”

While much of the report identifies the economic implications of nursing, it also makes an argument for the connections between the work nurses do and peace. The report notes that “through their work, nurses address the root causes of ill health and the risk factors that lead to conflict.

As frontline workers and primary care providers, nurses “see the connections to other issues, such as political conflicts, family breakdowns, loss of jobs, poverty and mental health crises,” the report states.

“With their trusted position within communities, nurses can play a critical role in bringing people together, building bridges and the wider partnerships and relationships that are the foundations of peace and community cohesion.”  

Kitko, who is also a vice president of the University of Rochester Medical Center, said that she’s “observed a growing acknowledgement from health care leadership of the need to invest in nursing education, training, and professional development. Today, nurses have unprecedented opportunities to shape policy, conduct research, deliver high-quality care, and spearhead transformative changes aimed at strengthening the well-being and resilience of our nursing workforce.”

At the same time, many societies and governments continue to undervalue nursing, she notes, warning that “people often overlook the advanced education, specialized skills, and leadership roles that many nurses hold.

“We must continue to promote the image of nursing, highlighting nurses’ expertise, compassion, and impact on patient care.”

Image Credits: Kate Holt/USAID, International Council of Nurses , International Council of Nurses.