Africa CDC in Addis Ababa, Ethiopia – gains new clout for medicines manufacturer with a pooled market initiative

The Africa Centres for Disease Control and Prevention (Africa CDC), has announced the creation of a pooled African medicines procurement mechanism at the 37th African Union Summit, which ended yesterday. 

The mechanism aims to spearhead “a new era of predictable demand for African manufacturers, empowering them to plan for the long-term and establish a robust market worth over $50 billion,” said the CDC in a press release on Monday, just after the close of the Summit in Addis Ababa. 

Meanwhile, members of the African Medicines Agency Treaty Alliance (AMATA) urged AU Member States attending the summit to expedite the final set-up of the African Medicines Agency (AMA), which is supposed to help create a more unified regulatory market, essential to pooled procurement. 

AMATA, an alliance representing African patients, academia, civil society, and industry, also called upon the 28 remaining AU states that haven’t yet ratified the AMA treaty to do so rapidly. 

“To date, 27 countries have ratified the treaty, an important achievement that warrants celebration,” AMATA said in a statement. “However, the ratification and deposit of instruments by all 55 Member States is imperative to unify us as one Pan-African Medicines Regulatory Family and to pave the way for the practical implementation of the Agency. We now call on the remaining family of African Union Member States that have yet to ratify and deposit their AMA Treaty instruments to do so urgently,” said AMATA, which took part in a high-level meeting on the AMA, on the margins of the AU summit. 

‘Second independence of Africa’  

With regards to the new African CDC medicines procurement mechanism, Africa CDC Director General Dr. Jean Kaseya said: “The decision means the creation of a robust market for manufacturers and ensures the health security of all Africans.  This will be the second independence of Africa.”

 The African market size for medicines and vaccines is approximately $50 billion USD a year. Africa CDC will be leading the pooled procurement initiative “in collaboration with continental and global partners,” the CDC statement said, without specifying who. ” The move is also designed to ensure that African Union member states can get better deals on price.”

Coinciding with the decision, the African Union also voted to broaden the Africa CDC’s mandate to include the manufacturing of medicines and diagnostics, in addition to its current remit of  vaccines. 

Less than one percent of vaccines are currently manufactured on the continent – a factor that led to the massive inequalities in acccess to COVID-19 vaccines seen on the continent during the pandemic. African leaders have since established a goal that 60% of the vaccines needed by the continent will be manufactured in Africa by 2040, with the CDC positioning itself to play a role leveraging collaborations and deals with the pharma sector. 

AMA critical to boosting African manufacturing 

Rapid establishment of the African Medicines Agency remains critical to “open up more opportunities to boost local manufacturing capacities, promote country participation in clinical research and foster other scientific development activities,” AMATA stressed in its statement. 

Some 37 of the AU’s 55 member states have signed the treaty creating a continental-wide medicines agency, with major countries like Kenya and Ethiopia also moving to ratify the treaty in mid- and late 2023.

But some of Africa’s leading  economic powerhouses like South Africa and Nigeria, remain holdouts – and are not even signatories on the treaty to date.  

Botswana, Zambia. Mozambique and Angola in southern Africa also haven’t signed the treaty either. Nor have conflict-ridden Sudan, South Sudan, Somalia, Eritrea, Libya and the Central African Republic.  

AMA engagement with non-state actors critical 

The AMA also has not yet publicly named a director, prompting calls for the more rapid “operationalization” of its operations among participants in the high-level meeting at the AU summit. 

AMATA also called upon the new AMA Governing Board to establish a framework of engagement with non-state actors drawing upon “all available expertise from academia, research bodies, private sector and community and patient groups to provide technical guidance on specific areas.” 

And it called upon the new AMA Board “to recognise patients as key partners in the management structures and development of the future Agency.”

The African Medicines Agency  is supposed to  streamline regulatory frameworks across the continent – thus enhancing the capacity of governments to approve and monitor vaccines, repurposed and innovative medicines and health technologies in a timely manner. 

The AMA treaty, adopted at the AU Assembly in 2019, came into force on 5 November 2021 following the deposit of the 15th ‎instrument of ratification.

“A strong unified regulatory system will greatly contribute to combating falsified and substandard medicinal products, a serious threat to the African continent,” added AMATA in its statement, adding that. “Coordinated market surveillance, centralised information collection and data sharing between countries will complement and strengthen national efforts to reduce the circulation of falsified products and increase access to safe and innovative products.

“In ratifying and operationalising the African Medicines Agency Treaty, we embrace the opportunity to reaffirm our commitment to the health, prosperity, and unity of societies in Africa, empowering our continent to thrive,” . Let us seize the momentum provided by the 37th AU Summit this week to take this crucial step towards a brighter and healthier future for all Africans,” AMATA said.

 

 

 

Image Credits: Africa CDC .

Drinking water
Contaminants continue to threaten small water supplies

From a community well in east Africa to a standpipe in an urban slum, small water operators furnish vital supplies for billions of people the world over. 

Now, for the first time in nearly 30 years, the World Health Organization (WHO) has published new guidelines for drinking water quality for small water supplies with up-to-date advice on building resilient systems that ensure safe drinking water quality.

With the increased incidence of water-borne diseases such as cholera, “the need remains as acute as ever,” says Bruce Gordon, head of WHO’s Water, Sanitation and Hygiene programme (WASH).

The WHO recorded 40 900 cholera cases and 775 deaths in January alone and estimates that more than 500,000 deaths a year could be prevented through the increased provision of safely managed drinking water.

Infographic: Unsafe Water Kills More People Than Disasters and Conflicts | Statista
A recent infographic from Statista using WHO and UNICEF data on unclean water deaths

“Small water supplies have lacked competence and capacity,” he says, highlighting the dire need for professionalization and resources.  Against that landscape, prioritizing technically simple and affordable water quality solutions is critical, and that is what the WHO guidelines provide. 

New modes of operation are critical, he stresses, to get the world even partially back on track towards attainment of Sustainable Development Goal 6, ensuring the availability and sustainable management of water and sanitation for all by 2030. 

WHO guidelines: the product of a multi-year process 

The new WHO guidelines are the product of a multi-year process of evidence-gathering and evaluation. 

People served by small supplies are more at risk of exposure to waterborne pathogens as well as harmful chemical contaminants, which increases their risk of waterborne illness. 

The guidelines underlines the importance of protecting water quality along with testing water quality and ensuring sustainable financial and data management of small water systems.  

Protective measures can be as simple as ensuring fences are erected around a community water supply to ensure that humans and wild animals don’t encroach and contaminate the area, said Gordon. 

Ensuring that water pumping stations also are protected from flooding, and placed at a safe distance from latrines or other potential contamination sources are other examples of important preventive measures.

Water quality: frequent testing and risk assessments

A public health oriented framework for clean water guidance

The guidelines recommend that small water supplies prioritize the most important water quality parameters. 

“Small supplies need to be even more thoughtful about what kinds of parameters they choose to survey, monitor, and test for,” noted Gordon. Large water companies, for instance, can typically test for upwards of 50 chemical contaminants and even maintain a programme on emerging contaminants, as part of a rigorous water quality regime. 

But with small supplies, their capacity may be limited to testing only once or twice a year for both biological and chemical contaminants.  

The guidelines thus provide a list of the highest priority pollutants that biological and chemical tests need to cover. Top of the list is monitoring for Escherichia coli (E. coli), as an indicator of bacterial contamination, as well as heavy metals like lead and arsenic, in terms of chemicals. 

In resource-constrained settings that add chlorine as a disinfectant to their water supplies, WHO also recommends “free chlorine residual monitoring” between E. coli monitoring, as a proxy indicator of microbial water quality. 

Priority contaminants include E. Coli and heavy metals

When laboratory testing is not available, “regulations should allow the use of field test kits when performance has been validated. Field test kits offer an alternative to analysis in formal laboratory settings, and they often have the advantage of being simpler to use and less expensive than laboratory testing methods.”

When very frequent water quality testing is not feasible, then other sanitary inspection measures to identify and prevent potential sources of contaminant infiltration become even more critical, Gordon stressed.

“For instance, you need to make sure there are no cracks in your wellhead. If you have animals around, or even people, you need to put a fence around your supply. You need to make sure that there is adequate distance between the latrine and the supply, as well as ensuring some point of disinfection at the source or household,” he observes. “So we are really trying to get folks to focus on the basics.” 

Capacity building, financial management and data collection  

Guidance is tailored to different stakeholders, such as household, community or professionally managed supplies. Among those are recommendations for assessment “to inform system strengthening” including capacity-building of a professionalized workforce, rather than reliance only upon a network of volunteers. 

This follows a key theme of the sustainability of clean and safe small water supplies, primarily through building professional workforces, sustainable finance, and water quality data collection. 

The ten principles informing the new WHO guidelines on small water supplies

Each stage of clean water delivery requires an accurate assessment of direct and indirect costs, and consistent financial review and planning, especially for surveillance activities. Costs range from staffing, mobilization, and water quality analysis, to training materials and office and laboratory space. 

“We want to encourage digitization,” noted Gordon. “There’s a lot of interest in the world with digitalization. When people are looking at allocating resources, having a good digital database and a structured and credible way of prioritizing needs is important.

“Water safety is a persistent problem but we have the tools to solve it. We need to finance, build capacity and organize.” 

Image Credits: Jouni Rajala, WHO , WHO Guidelines for drinking-water quality: Small water supplies.

Dr Ricardo Baptista Leite, CEO of Health AI, and Dr Garry Aslanyan, host of the Global Health Matters podcast.
Dr Ricardo Baptista Leite, CEO of Health AI, and Dr Garry Aslanyan, host of the Global Health Matters podcast.

In the most recent episodes of the Global Health Matters podcast, host Dr Garry Aslanyan and his guests reflect on the forces and factors that shape the economic, social, and physical landscape affecting health for all.

“The global policy landscape is changing more rapidly than ever due to the influence of pandemics, regional conflicts and technology,” Aslanyan says during part I of “Geopolitics of Global Health,” on which he hosts Dr Ricardo Baptista Leite, CEO of Health AI.

Health AI, a non-profit foundation headquartered in Geneva, is dedicated to establishing a global regulatory framework. Its mission is to ensure equitable mitigation of risks associated with artificial intelligence while promoting investment and innovation. Through these efforts, it aims to facilitate the adoption of responsible AI to enhance health outcomes worldwide.

“There are social factors that actually ensure that someone is sick or not sick,” Baptista Leite says. “In most places around the world, not to say everywhere, we do not have health systems, we have disease systems. We have models that are broken and that are driving more and more cost and more and more disease.

“All of these health care workers that are burning out, they’re in a rat race, they’re like a hamster on a wheel, just running and running but not going anywhere, or actually taking steps backwards because the system is rigged in a way that it actually gets more and more people sick.”

Global Cooperation & Surveillance

Aslanyan, Baptista Leite and Yodi Alakija, co-chair of the African Union’s African Vaccine Delivery Alliance in part II, ask:

  • What lessons have we learnt during and after the pandemic that could guide us forward?
  • What critical skills and understandings should global health professionals have to understand better and navigate the geopolitical environment impacting their programs or research?
  • Has progress been made to give Global South actors a more influential role at the table, and do current geopolitical tensions help or hinder this process?

Baptista Leite emphasises the critical need for global cooperation in pandemic prevention, stressing the importance of learning from past failures and improving coordination. He highlights initiatives like COVAX and the ACT Accelerator as significant but flawed attempts at equitable vaccine distribution. Still, he says the focus should be on learning from these experiences and implementing better procedures to prevent future pandemics.

He says the key to this effort is agreeing on fundamental concepts and strengthening surveillance mechanisms, with independent oversight to support organisations like the WHO.

“It’s not a question of taking away rights or sovereign leadership from any country; it’s working together,” Baptista Leite says. “We do need some strong surveillance mechanisms, possibly independent mechanisms, that will reinforce the role of organisations like WHO, which are instrumental as the main normative agency for health at the global level.”

Baptista Leite also advocates for an early warning system akin to that for pandemics, but for AI, to detect and address adverse impacts globally. He says Health AI could help certify regulatory bodies so that they can validate AI tools and keep surveillance of their impact in their own communities.

“If something goes wrong, if there’s an adverse effect, if there’s an unintended impact of artificial intelligence in one country, we want everyone to get a red flag immediately,” Baptista Leite says. “We are living in a time of algorithmic colonisation, or some call it digital colonisation, in the sense that many Global North organisations are basically deploying their AI-driven or AI-generated technologies into low- and middle-income countries; they’re extracting data with no oversight. In some countries, governments are paying these companies to do this, and they’re basically taking away this goldmine from the countries.

“So it is a new form of colonisation that I think will end up leading to social unrest if we do not address it quickly, particularly in the sensitive field of health and health data,” he continues. “The studies are showing that if we have a symbiotic relationship between machines and humans, we can leverage the health outcomes in ways that we’ve never done before, towards that vision of health and well-being for communities, including those that today live in low resources settings.”

Dr Garry Aslanyan, host of the Global Health Matters podcast (left), with Yodi Alakija, co-chair of the African Union’s African Vaccine Delivery Alliance.
Dr Garry Aslanyan, host of the Global Health Matters podcast (left), with Yodi Alakija, co-chair of the African Union’s African Vaccine Delivery Alliance.

Geopolitical Literacy

For her part, African Union’s Alakija is a staunch advocate championing women’s equity and African voices in decision-making. She and Aslanyan touch on three critical points related to the geopolitics of health: The importance of investing in building alliances and shared understanding, that even alliances born out of adversity can build global health unity, and that the “decolonisation” rhetoric should be reframed as efforts to rebalance power.

Alakija stresses that everyone in the health sector must also have a basic understanding and training in geopolitics.

“We need to speak more practically about the aspects required to implement policies, and many of these often involve complex political considerations,” Alakija says. “This understanding is essential, really, for effectively advocating for and implementing health interventions, education development in good dimensions, in different geopolitical contexts.

“We also need to understand that the geopolitical landscape is constantly changing, and so global health professionals ourselves must be adaptable and flexible,” she continues. “We have to be prepared to modify our voice and our strategies and our approaches in response to shifting political dynamics.”

Listen to previous episodes of Dialogues on Health Policy Watch.

Image Credits: Global Health Matters Podcast.

India has pushed back over provisions in trade deals with the European Free Trade Association (EFTA) that could affect access to generic drugs.

PUNE, INDIA – Commerce minister Sunil Barthwal has clarified that India will not sign a new trade agreement with the European Free Trade Association (EFTA) that would limit access by the country’s thriving generic medicine industry to new drug formulations for critical diseases.

India is currently negotiating a new trade deal with the EFTA, which includes Iceland, Liechtenstein, Norway, and Switzerland. And leaked excerpts of the draft agreement had raised concerns among patients and advocates due to provisions limiting access and use by generic manufacturers of clinical trial data from originators’ drug trials, for a period of “up to six years.”

Such data exclusivity provisions means that generic manufacturers either need to wait out the exclusivity period or repeat expensive clinical trials, something that can impede the approval of generic brands in countries that cannot afford original, patented drug versions.

In cases where the patent for a new medicine has also been registered in a developing country, such as India, data exclusivity provisions also could slow or block government issuance of  ‘compulsory licenses’ to generic manufacturers to produce a medicine at a lower price.

Barthwal ‘we rejected their demand’

“They want that there should be data exclusivity, we rejected their demand. We are with our generic industry,” Indian media reports quoted Barthwal as saying of the EFTA pressures, which reportedly were led by Switzerland, home to several major pharma companies, including Novartis and Roche.

India’s clarification came as a relief to medicines access groups.

“We welcome the Indian Commerce Ministry’s strong stand against the inclusion of data exclusivity in its trade talks with EFTA that benefits patients across the world,” Dr Farhat Mantoo, Executive Director of Médecins Sans Frontières (MSF) South Asia said in a statement.

In a press briefing Wednesday, MSF, Public Eye, and Delhi Network of Positive People had raised concerns about the precedent that India’s agreement to a data exclusivity clause could trigger a cascade of impacts on access to affordable medicines.

India is the world’s largest producer of generic drugs 

Loon Gangte, founder of Delhi Network of Positive People has lived with HIV for nearly two decades, and relied on cheap generic medicines produced by the Indian companies to maintain his health. India is the world’s largest producer and exporter of generic medicines.

The absence of data exclusivity provisions in the country’s patent laws, until now, has been a key factor enabling the affordable entry of new drugs for HIV, tuberculosis (TB) and viral hepatitis, he said in Wednesday’s press briefing.

Gangte, who has been living with Hepatitis C and TB, as well as HIV, noted that in the past two decades his medications changed several times. “The drugs which we took five years ago, we are not taking today because we have developed resistance or because of the side effects. It keeps on changing,” he said.

It is the development of generic formulations that have allowed him to keep up and have continued access to effective drugs.

Loon Gangte, founder, Delhi Network of Positive People

Switzerland led pressures for exclusivity clause inclusion 

The World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights or TRIPS agreement gives member countries freedom to formulate their own national patent laws while setting some ground rules on intellectual agreements. India’s patent laws has so far allowed for generic competition to flourish and that has also benefited patients in many other countries, notably in Africa as well as Asia.

India has traditionally resisted the incorporation of such intellectual property restraints in almost all of the free trade agreements it negotiates, Leena Menghaney, MSF’s South Asia head said, despite being under immense pressure for years.

In the case of the new EFTA agreement, Switzerland has been the country leading the push for the new data exclusivity provisions, Meghaney said in the briefing.

Although India represents less than 1% of the total Swiss pharmaceutical product exports, it is home to pharmaceutical giants like Novartis and Roche – which increasingly have their eyes on the Indian domestic market as emerging markets elsewhere – where Indian generic exports may dominate, said Patrick Durisch of the Swiss-based medicines advocacy group Public Eye.

A decade ago, Novartis fought and lost a case over a patent for its cancer drug Glivec in India’s Supreme Court. Roche, meanwhile, failed to win patent protection for its lung cancer drug, Tarceva.

India represents a huge and untapped market

India, with the world’s largest population, thus represents a huge and untapped drug market for innovative pharmaceutical companies, even though currently, the market continues to be dominated by cheaper generic drugs.

This is all the more the case as the country develops economically and the burden of non-communicable diseases rise across low- and middle-income countries with consequent new demands for drugs.

Against that landscape, however, Switzerland’s persistent demands for restrictive intellectual property provisions would “strengthen the monopoly rights of its pharmaceutical industry at the expense of patients in India and beyond – even though India’s patent law is TRIPS-compliant,” Durisch said.

“This is a blatant example of Switzerland putting corporate profits over public health and human rights – and it underlines the urgent need for a sustainable Swiss foreign economic policy,” he added.

Swiss government officials, asked by Health Policy Watch for comment, did not respond as of publication.

India is, meanwhile, set to hold national elections in May, in which Prime Minister Narendra Modi is vying for another five-year term – after ten years already in office.

The government has been keen to wrap up the trade negotiations before that. Meanwhile, pharma industry pressures on the national government have increased.

The Indian pharma manufacturers that forged new collaborations with large pharma firms abroad, during and post-COVID, are leveraging more influence. Organizations like the OPPI which represents big pharma have been lobbying hard in New Delhi.

But apparently, that has not been enough to tip the barrel against generics manufacturers and the public that they represent.

Data exclusivity and access

From the innovative pharma industry point of view, restricting access to clinical trial data protects the huge investments that need to be made into new drugs – thus supporting new drug investments and innovation.

“Data exclusivity provisions make sure other companies are not able to rely on this original data to submit a copy of this medicine for approval without permission, within a limited period of time,” Guilherme Cintra, Innovation Policy Director of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) told Health Policy Watch. “Such measures are critical in making sure that the right incentives are in place for companies to invest in the development of new medicines and vaccines.”

Critics, however, argue that current evidence around data exclusivity is not encouraging from the perspective of access.

“Contrary to industry’s arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry’s appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free‐riding’ encounters some important problems: Neither legitimize excluding all others,” concluded a 2016 article by a team of researchers at the University of Ghent, Belgium.

In Jordan where data exclusivity was introduced as part of the US-Jordanian Free Trade Agreement, a study found that of 103 medicines registered and launched between 2002 to 2006 that had no patent protection in Jordan, 79% had no competition from a generic equivalent because of data exclusivity.

For patients like Gangte, it is ultimately affordability that is important, and what generics make possible, saying: “We are not against big pharma or we are not pro-generics. If big pharma company gives us a medicine cheaper than the Indians generics, we will buy your medicine.”

Image Credits: Unsplash.

pandemic
Health workers don personal protective equipment before attending to patients with COVID-19.

After months of protesting about the lack of space for civil society in the World Health Organization’s (WHO) pandemic agreement negotiations, the Pandemic Action Network (PAN) is hosting two community meetings next week – and it expects member states to show up and listen.

The meetings take place next Wednesday and Thursday (21 and 22 February), in the midst of a two-week meeting of the Intergovernmental Negotiating Body (INB).

“Groups from across civil society have worked hard to create opportunities for civil society organisations’ (CSO) voices to be heard by the INB negotiators to the pandemic agreement, including for next week – what we need is a cast-iron guarantee from member states that they will show up, listen and consider incorporating civil society asks into the agreement,” says Eloise Todd, PAN’s executive director and co-founder.

“The future agreement will be more effective if it builds on civil society and community lived experience and learnings from the vast inequities of the COVID-19 pandemic and other pandemics. 

“We call on CSOs around the world and based in Geneva to join us for these sessions, and our message to member states is clear: we hope and expect to see you there,” adds Todd.

INB co-chairs Precious Matsoso and Roland Driece will attend both meetings, which will take place during the INB’s lunch breaks from 12:45 to 13:45pm (CET) on both days in a WHO meeting room near the negotiations in Geneva.

The first meeting will include a focus on “access and benefit sharing”, while the second will include “accountability and institutional arrangements”.

 

PAN has invited both civil society organisations and member states to register for the meetings either virtually or to attend in-person. The deadline for in-person registration is close-of-business on Monday 19 February.

“To help ensure the world is equipped to prevent, prepare, and rapidly respond to the next

pandemic, the INB process must result in a meaningful, ambitious, and accountable agreement that goes beyond business as usual,” says PAN.

“To do so, civil society expertise, support, and engagement are critical. These meetings will provide an opportunity for civil society to share feedback and recommendations on the evolving text.”

The eighth INB meeting begins on Monday as negotiators knuckle down for the final stretch before their May deadline.

PAN and its over 70 partners have asked member states to  “cement equity, accountability, financing, prevention, and gender in the final agreement”.

Tedros hits out at ‘lies’

Meanwhile, WHO Director General Dr Tedros Adhanom Ghebreyesus hit out at the “litany of lies and conspiracy theories” aimed at undermining the pandemic agreement in an address to the World Governments Summit in Dubai on Monday.

“We cannot allow this historic agreement, this milestone in global health, to be sabotaged by those who spread lies, either deliberately or unknowingly,” said Tedros.

“Let me be clear: WHO did not impose anything on anyone during the COVID-19 pandemic. Not lockdowns, not mask mandates, not vaccine mandates. We don’t have the power to do that, we don’t want it, and we’re not trying to get it.

“Our job is to support governments with evidence-based guidance, advice and, when needed, supplies, to help them protect their people. But the decisions are theirs. And so is the pandemic agreement. It has been written by countries, for countries, and will be implemented in countries in accordance with their own national laws,” he added.

“Far from ceding sovereignty, the agreement actually affirms national sovereignty and national responsibility in its foundational principles.”

Image Credits: U.S. Army National Guard/Edwin L. Wriston, Tehran Heart Centre .

Bacteria
Close to 5 million deaths are associated with antimicrobial resistance (AMR) globally in 2019

The WHO has released a first-ever list of 21 antimicrobials earmarked as “authorized for use in humans only” – a first for the organization in its efforts to protect overuse and abuse of critical first-line drugs that need to be protected by overuse in animal and plant health sectors – and consequent antimicrobial resistance (AMR). 

Significantly, most of the 21 antimicrobials earmarked by  WHO as “authorized for use in humans only” include mostly novel compounds developed and authorized over the past six years. 

The category “mainly contains newer antimicrobials that are very important in treating serious multidrug-resistant infections in humans,” WHO explains in its guidance. So the new WHO label is effectively a warning sign to the farm industry that they should not be used in animals or plants in the future. 

Among the antimicrobials authorized “for use in humans only” are: plazomicin, aminomethylcycline, anti-pseudomonal penicillins with and without β-lactamase inhibitors, carbapenems with or without inhibitors, third- and fourth-generation cephalosporins with β-lactamase inhibitors, sulfones, as well as drugs critical to treating tuberculosis and other mycobacterial diseases.

Some of the older ones on the WHO list, e.g. carbapenems, are not licensed for use in animals in the United States, but are sometimes used in companion animals. 

The report aims to provide guidance for authorities in the public health and animal health sectors, veterinarians, prescribers of antimicrobials, and agricultural professionals, as well as classify antimicrobial categories by importance to human use, WHO said.   

Reducing risks to human health 

Antibiotics are commonly overused in animals—often without the input of veterinarians—to boost their growth and keep them from picking up infections.

A second category of medically important antimicrobials refers to drugs “authorized for use in both humans and animals.” 

But this is further broken down into “highest priority critically important antimicrobials (HPCIA),” “critically important antimicrobials (CIA),” “highly important antimicrobials,” and “important antimicrobials.” 

Widespread animal use of leading antibiotics has become a major driver of growing ‘superbug’ resistance to common drug treatments, or AMR. In 2019 AMR was associated with the deaths of close to 5 million people globally. 

To address these risks, the use of critical antimicrobials needs to be rationalized more systematically in both animal as well as human health. WHO’s drug classifications create an order of priority for doing this, notes an analysis from the University of Minnesota-based Center for Infectious Disease Research and Policy (CIDRAP.) 

“The risk to human health is greatest if the antimicrobials listed as ‘authorized for use in humans only’ are used in non-human sectors,” noted the CIDRAP analysis. “Those risks and impacts decline progressively with the use of agents from the other categories.”

“For instance, the criteria for inclusion in the first two medically important antimicrobial categories is whether the antimicrobial class is one of the limited available therapies or the sole available therapy to treat serious bacterial infections and if it’s used to treat bacterial infections possibly transmitted from non-human sources (such as Salmonella and Escherichia coli).

“Among the classes categorized as HPCIA are third- and fourth-generation cephalosporins, quinolones, and polymyxins. The CIA category includes aminoglycosides and macrolides,” CIDRAP noted. 

Antimicrobial risk scale

Scale of prioritization of medically important antimicrobials (MIA)

One Health and AMR

A One Health approach

The non-human use of antimicrobials in fact includes a broad range of species, beyond the historical focus on food-producing animals. These include aquaculture, companion animals, and fur-bearing animals. Reducing antimicrobial use in the non-human sector remains vital for preserving the efficacy of these substances, WHO said. 

Antimicrobial resistance (AMR) occurs when pathogens like bacteria, viruses, fungi, and parasites no longer respond to antimicrobial medicines, making infections harder to treat while increasing the risk of disease spread, severe illness, and death. Infections typically treated with routine medicines thus become life threatening. 

“Because AMR develops and transfers within and among all sectors, minimizing the risk of emergence and transmission of AMR  calls for a One Health approach,” WHO explained in the new guidance.

“To improve the responsible and prudent use of antimicrobial agents—and in particular medically important antimicrobial agents—it is thus essential to decrease their inappropriate use across sectors.”

Additionally, the report advocates for the more systematic inclusion of medically important antimicrobials in AMR monitoring and surveillance programs – which continue to be patchy and incomplete in most countries of the world.

New WHO category ‘for use in animals only’

In addition to the existing “highly important antimicrobials” (HIA) and “important antimicrobials” (IA) classifications, the WHO now includes an “authorized for use in animals only.” This group was added to “ensure that all antimicrobials used in animals come under scrutiny as part of the standard evaluation approach, so that they would not be placed in a low priority category by default, without proper assessment of the potential risk of AMR in humans.”

Image Credits: Photo by Myriam Zilles on Unsplash, Commons Wikimedia, WHO , WHO .

Closure of the Tenth FCTC COP: Head of the WHO FCTC Secretariat Dr Adriana Blanco Marquizo and COP10 President Zandile Dhlamini (Eswatini)

The Tenth Conference of Parties (COP10) of the WHO Framework Convention on Tobacco Control (WHO FCTC) sidestepped a controversial debate on e-cigarettes and heated tobacco products – effectively kicking the can on any decisions related to regulation of that swelling market to the next meeting in two years time.

However, the parties at the conference, the first face-to-face meeting in six years, agreed on a milestone decision strengthening language around Article 18, and “protection of the environment and the health of persons in respect of tobacco cultivation and manufacture.”

The parties also agreed to strengthen Article 19, which nations can use to hold the tobacco industry liable for its devastating impact on people’s health and the planet. The civil society group Corporate Accountability welcomed that measure as a “historic step forward to make Big Tobacco pay.”  And the COP adopted a “Panama Declaration” reaffirming the “fundamental and irreconcilable conflict” between the tobacco industry and public health.

Article 18 – historic moves on environmental protection

Dr Adriana Blanco Marquizo, Head of the WHO FCTC Secretariat, also described the new decision on Article 18 as “historic” – insofar as it expands and details the measures that countries should take to limit tobacco’s environmental harms.   

“The decision urges Parties to take account of the environmental impacts from the cultivation, manufacture, consumption and waste disposal of tobacco products, and to strengthen the implementation of this article, including through national policies related to tobacco and protection of the environment,” Blanco Marquizo said at a Saturday press conference concluding the week-long meeting.

“Globally, some 200 000 hectares of land are cleared every year for tobacco cultivation, accounting for up to 20% of the annual increase in greenhouse gasses (GHGs),” added WHO in a press release released on Sunday, just after the close of the week-long conference, although it failed to explain the source for the GHG estimate.

The new decision also addresses the issue of cigarette filters. An estimated 4.5 trillion cigarette butts are thrown away annually worldwide, representing 1.69 billion pounds of toxic trash- containing plastics. 

When exposed to sunlight and moisture cigarette filters break down into smaller plastic pieces, eventually leaching out some of the 7000 chemicals contained in a single cigarette. Many of those chemicals are environmentally toxic. “The decision on Article 18 is very timely given the ongoing intergovernmental negotiation committees working to develop an international legally binding instrument on plastic pollution, including in the marine environment,” stated WHO.

Delayed action on e-cigarettes and heated tobacco products

On the down side, action on new tobacco products that was expected to be one of the main conference outcomes was delayed – apparently under significant industry pressure.

Instead of a final agreement on a decision around e-cigarettes and heated tobacco products, the delegates agreed to create a working group to continue reviewing and revising the advice that would be produced until COP 11 in two years time. Industry has been pressing very hard on vapes as a way of reducing smoking harms.

Even though no common stance was agreed upon, countries can already take action based on existing FCTC resources and guidance, asserted Nuntavarn Vichit-Vadakan of Thailand, chair of a COP10 working committee addressing the issue. 

Those include ”Partial guidelines for implementing articles 9 and 10; an “information note on new and emerging tobacco products”; and a July 2023 report by the WHO FCTC Secretariat on the challenges posted by novel and emerging tobacco products. 

“The partial guidelines are ready for implementation by parties, only a few points are left unfinished,” Vichit-Vadakan said. But she expressed hope that the working group created at COP10 would make more progress on the regulation of new tobacco products over the coming two years, saying, “Each time we have decisions, we make one step forward to protecting the population.” 

Heated tobacco and e-cigarettes are soaring in popularity, especially among the young, even as the proportion of consumers of more traditional tobacco products like cigarettes has declined, from 33% of adults at the beginning of the century to 22% in 2023.

Big tobacco firms such as Philip Morris International, British American Tobacco and others have invested heavily in fighting regulation of the new products, promoting a narrative that frames them as a safer, cleaner alternative to traditional cigarettes, which support “tobacco harm reduction”. 

At the COP, a number of countries, led by Guatemala and including the Philippines, China, Russia, Antigua and Barbuda, echoed industry talking points that attempt to frame heated tobacco products and vapes as less risky than cigarettes, calling for more debate and research on the topic. This, critics say, will also delay implementation of lifesaving protections.

Member states at closing session of the Tenth Framework Convention Tobacco Control (COP10)

Panama declaration, against industry interference

Tobacco-aligned interest groups also organized a series of parallel events to the COP, attacking the Conference for an alleged lack of transparency and exclusion, ignoring the internal rules of the international treaty and its meetings, which establish safeguards to protect the conference of vested interests.

Industry representatives were also present during a daily debriefing organised by the Brazilian delegation, lobbying in favour of tobacco trade, reported the Global Alliance for Tobacco Control.

Despite those moves, the conference, saw far less interference than last December’s UN Climate Conference in Dubai (COP28), civil society advocates observed. 

“The talks were not inundated with corporate lobbyists like the most recent U.N. climate summit. The FCTC provides a strong example for how the UNFCCC and other international bodies can protect policy from corporate profit-seeking,” said Corporate Accountability.

Against that background, the adoption of the “Panama Declaration” was also a symbolic gesture of defiance. 

The Declaration refers to the “fundamental and irreconcilable conflict between the tobacco industry’s interests and public health policy interests,” Blanco Marquizo said, describing big tobacco as an “industry that profits from suffering and death.”

Meeting of Parties on illicit tobacco products

A smaller, four day Meeting of the Parties (MOP3) of February 12 to 15 follows the concluded conference. The 62 participating parties will look at progress in implementing the Protocol to Eliminate Illicit Trade in Tobacco Products.

FCTC’s implementation report found that since the last meeting of the MOP, over a half of the parties reported progress in tracking and tracing tobacco products (Article 8 of the Protocol), which makes smuggling more difficult.

Less has been achieved in terms of international collaboration, with respect to measures such as mutual legal, training and technical assistance or extradition of suspects of illegal trade in tobacco products.

Tobacco burden

Illegal or not, smoking is a major public health burden, killing over eight million people worldwide every year, according to the WHO. 

WHO Director General Dr Tedros Adhanom Ghebreyesus called tobacco “the biggest public health threats the world has ever faced” in his opening address at COP10.

“More than 20 years since it was adopted by the World Health Assembly, the WHO Framework Convention on Tobacco Control remains one of the world’s most powerful tools for health,” asserted Tedros. One study from Nature Medicine presented during the conference confirmed, for instance, that taxing tobacco products significantly reduces the number of people who become addicted.

“We are proud of the progress made by Parties during the tenth global tobacco treaty talks in the areas of liability against the tobacco industry and protecting the environment and human rights,” said Daniel Dorado, Corporate Accountability’s Campaign Director. “Now, we urge Parties to implement these measures at home to advance justice and make Big Tobacco pay for its harms to people and the planet in the next two years before Parties meet again in 2026.”

Image Credits: WHO/FCTC/Octoma.

Ethiopia, on behalf of the Africa group,  welcomed the special meeting to consider equity at the WGIHR

The working group negotiating amendments to the World Health Organization’s (WHO) International Health Regulations (WGIHR) has extended its seventh meeting, which was supposed to end last Friday, to include a special session on equity.

The resumed WGIHR 7 will be held within the first two weeks of March, finally acceding to member state’s requests – including from the Africa Group and the large alliance of countries known as the Equity Group – to give adequate attention to equity.

Unequal access to vaccines and other medical products during the COVID-19 pandemic was one of the triggers for the reform of the IHR, which are the rules setting out countries’ roles and responsibilities, and those of the WHO, during public health emergencies of international concern.

The resumed meeting will pay special attention to a new Article 13A, which addresses the availability and affordability of health products, technologies and know-how, according to a  year-old summary of the IHR negotiation text, which is the most recent public version of the negotiating text.

Article 44, dealing with collaboration and assistance, is another equity-related section that deals with building capacity to identify emerging public health threats, including through surveillance, research and development cooperation, and technological and information sharing.

The final key equity-related section is Annex 1, which relates to the core capacities needed by countries to improve their disease detection, surveillance and emergency response, including the assistance that developed countries can offer to developing countries to improve their capacity.

Ethiopia on behalf of the Africa group expressed its support for the equity-focused dedicated sessions to Articles 13 A and 44 A, describing it as “critical and important”.

“You all recall that this has been tabled prior for several months and we believe that these [articles] are at the heart of dealing with equity-related issues, which are part of the mandate of the IHR discussion,” said Ethiopia. 

Joint session planned with INB

During the reportback, WGIHR Co-chair Dr Ashley Bloomfield said that there would be a joint session between his group and the Intergovernmental Negotiating Body (INB), which is drawing up the pandemic accord, on 23 February.

That date is also the deadline for member states to provide written comment on the new text provided by the bureau during the meeting.

Bloomfield also pointed out that the resumed seventh meeting would take place after a two-week negotiating INB session, which begins on 19 February, and was likely to benefit from equity-related discussions during the INB.

“Our relationship with the INB process is strong and essential,” stressed Bloomfield.

The European Union’s representative stressed that the work of the WGIHR and the INB needed to be aligned.

“It is not that we are going to do this to do the same discussion or to address the same issues,one here and one there. This is not going to be possible nor efficient. There should be an understanding that there are a number of issues – sharing countermeasures, access to countermeasures, the financial issues writ large, some governance issues – that are entirely connected, and they cannot be addressed in isolation, otherwise, we will never solve them,” he stressed.

There was across-the-board appreciation for the role of the Bureau in facilitating the negotiations, particularly providing text in real time during the meeting for member states to consider.

Reality-check for negotiators

Dr Mike Ryan gives negotiators a reality check.

Dr Mike Ryan, the WHO’s executive director of health emergencies, gave negotiators a reality check at the end of the meeting.

“While you’ve been doing this, this week in the interest of the future health and workability of amended IHR, the elves have been in the basement processing 37,000 signals of potential epidemics, triaging 80 of those signals for follow-up member states, confirming 14 events around the world -circulating vaccine-derived polio, measles, Avian flu, Nipah, Chikungunya, [extensively drug-resistant] TB, diphtheria, swine flu, Orbivirus, Rift Valley Fever, Western Equine Encephalitis, yellow fever, SARS COV2 and the Lassa fever outbreak all happening in real time,” said Ryan.

The WHO has also carried out systematic rapid risk assessments under IHR, and published various alerts and disease outbreak news. 

“That’s the core of IHR. That’s what IHR is about, is working with our member states to increase that capability for the world to work together to detect, confirm, to share real time information about emerging events and ensure those events get collective response,” stressed Ryan.

“It’s a very precious process that has taken decades to develop,” he added. “What you’re discussing here may sometimes seem like word-smithing or not having necessarily an immediate impact on the world. It will because it will define the next 10 years of global surveillance and of collective security when it comes to health emergencies and particularly high impact epidemics. 

“This is a collective process. It provides a safety net, it provides protection for all our communities. You’ve treated this process with tremendous care and professionalism. I just would urge you again as the Director General has: get this done by May and give us back the IHR in better shape than it’s ever been and we will be forever grateful.”

Girls and women in Pakistan receiving hepatitis prevention education – more outreach and action in communities is needed.

Approximately 10 million Pakistanis are living with hepatitis C (HCV) with three people dying of HCV- related causes every minute – and this in the case of a disease that is now largely curable with treatment. 

Hepatitis B Virus (HBV) also poses major public health burden on the country’s health system with an estimated 4 million active infections in the population. Transmission is largely driven by infections acquired from healthcare settings, which puts the wider population at risk.

Altogether, it’s estimated that more than 20,000 people a year die in Pakistan from hepatitis-related causes. 

WHO’s strategy for Elimination of Hepatitis refers to a 90% reduction in new HBV infections and a 75% reduction in new HCV infections by 2030 over the 2020 baseline, and a 65% reduction in overall mortality.  The Sustainable Development Goals (Target 3.3) meanwhile, call for “combating hepatitis” by 2030.

Great strides could be made towards these WHO and SDG goals with the uptake of new  strategies for bringing hepatitis diagnosis and treatment to the primary and district care levels. This also would save families the heavy  burden, and public hospitals the high-costs, of later stage treatment. 

Heptatis C prevalence in Pakistan

Hepatitis isn’t treated as a priority disease 

Pakistan, a range of health systems challenges have contributed to sluggish progress towards disease elimination to date. 

First and foremost, due to lack of effective and strategic advocacy, hepatitis does not get much attention from policy and decision makers. This is reflected in the resources being directed towards the programs of competing priorities. The primary diseases of public health focus remain dengue, polio and tuberculosis – which in fact account for far fewer deaths when compared to hepatitis B and C.

As a result, there is little incentive to expand public health hepatitis services, leading to disparity in demand and supply of hepatitis screening, vaccination, and treatment services – treatment that can lead to cure for those living with HCV. Additionally, private treatment remains expensive and out of reach for the majority of the country’s population.

Lack of access to diagnosis and care services 



Provincial hepatitis control programs exist but there is a large variability in successful program implementation across Pakistan’s provinces. 

The infrastructure of provincial hepatitis programs is centralized and mostly limited to hepatitis clinics that are located at tertiary healthcare facilities, i.e. hospitals. 

The access to preventive, diagnostic and treatment services for impoverished and marginalized communities that are at the highest risk is more difficult. Even for those who manage to access the central healthcare system, the pathway from screening to treatment acquisition is hard to navigate and time consuming.

Notably, a PCR assessment of viral load remains the standard for a confirmed diagnosis, and this only available through a limited number of labs. Provincial hepatitis programmes must bear the cost of transportation and quality management of samples, along with testing people with suspected cases. For a patient, the process from tet to results can take days and sometimes weeks. This system consumes the resources in ineffective way.

Public hospitals saddled with high costs of acute disease treatment

The shortcomings of the hepatitis control programs are reflected in the consequently  high burden of liver disease and costs associated with treating ‘decompensated liver disease’, where acute symptoms develop, as well as liver failure and liver cancer, in tertiary care hospitals.

This requires resources to be spent on specialized gastroenterology and hepatology healthcare. In addition, the patients must bear out-of-pocket costs for expensive CT scans, tests of  tumor markers, etc..  This imposes a significant financial toll on families, who therefore are likely to end up in government hospitals due to lack of affordability.

Needed – large scale decentralization and door-to-door models 

Pakistan’s Punjab province had undertaken a model of decentralised care for hepatitis.

To combat hepatitis in Pakistan, a program overhaul is therefore needed – so as to bridge the existing gap between public health and clinical medicine. This involves drafting a comprehensive national action plan that holistically addresses all components of the disease epidemiology, as well as harnessing available resources, and implementation science more effectively.

The action plan must provide for the large-scale decentralization of hepatitis care alongside a pattern of ‘differentiated’ service delivery.  This means establishing structures allowing people to be treated in community primary facilities and district-level secondary facilities at earlier stages of infection and disease – with more  complicated cases referred to hospitals for more complex tertiary care.

For communities with a high burden of infection, small scale micro-elimination programs using a door-to-door elimination model can be implemented. This also requires agreement to an effective, ‘needs-based’ utilization of resources,  with some sharing of commodities and human resources, from other successfully running programs at district level.

Combating under-diagnosis

Punjab province, Pakistan

Along with that, establishing a strong, hierarchal surveillance system for HBV and HCV infections is the need of the hour. 

Underdiagnosis of hepatitis is a barrier to elimination. But this can be addressed with the use of new and innovative surveillance tools and technologies to generate quality data and support  evidence-based decision making.

Strategic advocacy and communication must be included in the action plan to improve risk perception and community health literacy about bloodborne infections.

And most important of all, end user involvement in drafting the national plan is a must with the feedback from primary care providers and frontline health workers to tailor the program based on community needs.

On World Hepatitis Day 2019,  the national government announced a PKR 35 billion ($125 million) investment in hepatitis control, launching a National Hepatitis Elimination initiative.   The plan aims to screen up to 140 million people and expand treatment to those infected.  

It’s still far too little to cure the millions living with hepatitis. But it remains a beginning, showing high-level political commitment. But pledges alone are not sufficient. The dire need is to make hepatitis elimination a national priority with a strategic shift in governance and policy and ensuring the intelligent expenditure of resources.

Dr. Nida Ali

Dr Nida Ali is a fellow with the Coalition for Global Hepatitis Elimination, a program of the Task Force for Global Health. The Coalition pursues worldwide elimination of viral hepatitis by strengthening local capacity and bringing together global partners to share knowledge and experiences related to prevention, testing, and care and treatment. 

 

Image Credits: The Hepatitis Fund, Indus Health Network , End Hepatitis, End Hepatitis , Nida Ali.

Dozens of white tents stand outside Türkiye’s Gaziantep train station housing Turks and Syrian refugees, shortly after the February 6 2023 earthquake.

One year after a 7.8 magnitude earthquake wracked Türkiye and Syria, some 690,000 people  remain displaced in southern Türkiye, out of the 3 million people that initially lost their homes  when the natural disaster hit in the early morning of 6 February 2023.   

Another 40,000 Syrians remain internally displaced mainly in the northern region of the country.  

At the same time, the number of Syrians requiring humanitarian assistance has increased from 15.3 to 16.7 million people as the challenges of internal displacement related to years of civil war, food insecurity, and economic crises compound disaster recovery. 

“Thousands are still homeless and vulnerable,” said Shabina Mantoo, a spokesperson for the United Nations High Commission on Refugees (UNHCR). And 40,000 [Syrians] still reside in temporary facilities,” she said, speaking at a Geneva press conference earlier this week where UN agencies renewed their appeals for donors to support earthquake reconstruction.  

The earthquake that struck southern Türkiye and northwestern Syria, killed 59,000 people as well as causing widespread damage to infrastructure. A series of aftershocks as well as freezing temperatures further complicated rescue efforts for the tens of thousands injured. 

The disaster was one the region’s deadliest in recent times, with years of civil war and conflict compounding Syria’s efforts to recover.  Turkiye, meanwhile, continues to host 3.7 million Syrian refugees from years of civil war, compounding its own efforts to recover as well, said Mantoo.  

A family from Lattakia in northwestern Syria, stands near their destroyed house shortly after a devastating earthquake hit their city on Feb. 6, 2023

Aid to Syria dwindles

In the weeks immediately following the disaster, United Nations agencies raised some $387 million in pledges for basic humanitarian and health supplies, as well as reconstruction of some 48 damaged healthcare facilities in northwestern Syria. 

But in the months that have since followed, global attention and funding has shifted to other conflict zones and areas, such as the civil war raging in Sudan and Israel’s war with Hamas in Gaza.  

While Türkiye’s government has undertaken programs of national reconstruction, recently unveiling rebuilt homes and medical buildings in the earthquake’s epicenter of Kahramanmaraş province, much of Syria’s displaced population continues to reside in temporary camps, supported by international aid agencies and donors.

“We don’t have funding to even think of going into larger scale rehabilitation and reconstruction,” said Mads Brinch Hansen, head of the International Federation of the Red Cross delegation to Syria, speaking at the Geneva press conference. 

United Nations High Commissioner for Refugees spokesperson Shabina Mantoo at a UN press conference in Geneva on the one-year anniversary of the earthquake.

WHO appeal for emergency funding

Last month, WHO issued a flash appeal for another $1.5 billion in aid to nearly a dozen Grade 3 humanitarian emergencies raging in the Eastern Mediterranean Region and Africa, including for $80 million for Syria. 

On Tuesday, the global health agency warned that funding shortages could threaten WHO’s work in northwest Syria, potentially disrupting direct health aid to two million people. 

“On 6 February, it will be one year since a series of devastating earthquakes hit southern Türkiye and northern Syria, killing 50 000 people in Türkiye and 5900 in Syria. Tens of thousands more people were injured, and thousands of homes and public buildings, including hospitals, were damaged or destroyed.  This was one of the biggest disasters in the region in recent times,” the agency noted. 

“In Syria, the earthquakes hit communities that had already been deeply affected during the 13-year long conflict-driven crisis.” 

WHO underlined the role the agency is still playing in supporting Syria’s recovery, including: delivery of health supplies; strengthening disease surveillance and outbreak response; and addressing the mental health and psychosocial needs of the affected populations. 

Image Credits: Abdulsalam Jarroud/TNH, @UNICEF/UN0779766/Belal.