INB8: Co-chairs Roland Driece, Precious Matsoso and Dr Tedros

Officially, there are 19 negotiating days left until a pandemic agreement is due to be presented to the World Health Assembly, yet deep divisions remain between World Health Organization (WHO) member states over a number of clauses.

One of the biggest obstacles relates to pathogen access and benefit-sharing (PABS) – or how countries should share information about pathogens with pandemic potential and whether, or how, those sharing the pathogen’s genomic sequencing data and biological material, get rewarded.

From the start of the talks, the European Union and the US have disagreed with the African over PABS, which is addressed in  Article 12 of the draft agreement – so much so, that the Intergovernmental Negotiating Body’s (INB) Bureau has not been able to formulate a new draft text on the article.

New drafts of most other articles were published by Health Policy Watch ahead of the meeting.

Annual ‘PABS subscription’ proposal

Instead of a new draft, however, there is a PABS proposal from the sub-committee that conducted inter-sessional discussions on Article 12 that offers an advance on the previous pandemic agreement draft.

According to the proposal, shared with stakeholders at the start of the INB’s eighth meeting on Monday, commercial manufacturers that are producing vaccines, therapeutic or diagnostic products for “pathogens with pandemic potential” should pay an annual fee (related to their size) “to support the PABS system and strengthen pandemic prevention, preparedness and response capacities in countries”. 

They should also make in-kind contributions such as tech transfer and know how. During a public health emergency with pandemic potential or a pandemic, they should make “real time contributions of relevant diagnostics, therapeutics and/or vaccines”, including a percentage free and not-for-profit prices to be made available upon request by WHO and delivered, through mechanisms set out in Article 13, which deals with a global supply chain.

However, countries will be obliged to immediately share genomic sequencing data (GSD) and biological material of dangerous pathogens with laboratories and biorepositories participating in WHO-Coordinated Lab Networks (CLNs) and on WHO-recommended sequence databases (SDBs). 

“Intellectual property rights may not be sought on biological materials and GSD provided to the CLNs and SDBs,” according to the proposal.

Creating a bureaucracy?

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has long opposed countries being paid to share pathogen information, warning that this will slow down the development of vaccines and medicines.

In addition, should a PABS system be established under the WHO as the first draft proposed, this would create a bureaucracy that would also slow production, IFPMA Director General Thomas Cueni wrote in Health Policy Watch recently.

The EU and US, where most large pharmaceutical manufacturers are based, have generally supported this view.

However, many of the African region’s 47 members feel strongly that they should be compensated for providing information that leads to the development of a vaccine.

At the start of the meeting, WHO Director General Dr Tedros Adhanom Ghebreyesus praised INB members for identifying key challenges, and urged INB members to search for “compromise not competition” – also suggesting that it was time for senior members of countries’ negotiating teams to play more prominent roles in this last stretch.

Solutions emerge when parties “identify the problems as common problems. It’s not the problem of the North. It’s not the problem of the South. It’s our problem”, added Tedros.

He also pointed out that the WHO’s constitution was negotiated in six months so the pandemic agreement is “doable even with the remaining time”.

INB co-chair Precious Matsoso told the meeting that 32 negotiating sessions had been held over the past two years, and that there was the goodwill to reach agreement.

Stakeholders condemn ‘weakened’ text

Ellen ‘t Hoen (left) and Mogha Kamal-Yanni were scathing of parts of the new text.

However, a number of stakeholder organisations given time to address the meeting at the end of the open plenary expressed dismay at the “weakened” agreement.

Most scathing was Ellen ‘t Hoen, head of the Dutch-based Medicines Law and Policy: “Looking back at the previous drafts of your work, we see a steady decline in the forcefulness of many of the provisions,” she noted

“Few hard commitments to action remain. Provisions are increasingly vague, ambiguous or left to voluntary actions. Difficult topics are avoided or have been removed altogether,” she added, referring to the removal of references to “the sharing of vital know-how and trade secrets, the absence of which could block worldwide production of vaccines and other pandemic countermeasures”.

“We have proposed a mechanism to solve this which is possible within the context of the WTO TRIPS agreement. And yet as we look through the developing text, we see mostly watered down attempts and or no attempts at all. 

“The new instrument needs to solve some hard problems to ensure access to vital [intellectual property] know-how, information and products to prevent or combat future pandemics – and that means creating new obligations for WHO Member States, not just reiterating the status quo.”

Nina Schwalbe of Spark Street Advisors addressed the lack of independent monitoring of any pandemic agreement.

“Evidence on compliance from other treaties is unequivocal. It must be regular not periodic, and independent monitoring is key,” said Schwalbe.

“Reading Chapter 3 [addressing governance] is like putting together a 1000 piece puzzle without seeing the photo on the box. There are lots of new, complex yet interconnected groups with unclear dependencies:  a Scientific Advisory Committee appointed by the [WHO DG]; an Implementation and Compliance Committee, also appointed by the DG; and a ‘third committee’,” she noted.

Peer review is missing, while proposals for compliance “rely primarily on state self-reporting -which is periodic – not even regular”. 

Latin American NGO Innovarte also attacked Chapter 3 for “lacking a clear mechanism to inform and report on obstacles to implementation without resorting to a dispute settlement mechanism”. 

Retain 20% allocation

Gavi urged INB members to “recognise routine immunisation as a fundamental intervention to reduce pandemic risks that prevents outbreaks before they become pandemics” and also called for the retention of “the 20% suggested pandemic-related products for allocation for lower-income countries as a bare minimum percentage to address equity”. 

This was proposed in the earlier text.

Mogha Kamal-Yanni, representing Oxfam and the People’s Vaccine Alliance, said that “for four years we’ve been watching Europe, the US and others implementing and proposing measures to ensure technology development and transfer and to remove IP barriers in order to enable innovation and access for their population. Yet they object to including the same measures here in the accord.”.

Health Action International expressed “concern that we are heading towards an outcome that would not meet the expectations, needs and hopes entrusted in this process”, and called for “greater transparency and accountability of this negotiating process, particularly regarding undue influence of private actors”.

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.

INB co-chairs Roland Driece and Precious Matsoso

Health Policy Watch has obtained portions of the latest draft of the pandemic agreement that member states will negotiate over at the eighth intergovernmental negotiating body (INB) starting on Monday, 19 February.

At the time of publishing, only member states had access to the draft, although a number of civil society organisations recognised as  stakeholders have requested a draft from the World Health Organization (WHO) Bureau that is overseeing the negotiations for some time.

The tranches of the agreement are grouped according to how they have been negotiated, so are not always sequential.

INB8_Chapter I_

This section deals with terminology, aims and guiding principles. For instance, it defines a pandemic as “the global spread of a pathogen or variant that infects human populations with limited or no immunity through sustained and high transmissibility from person to person, overwhelming health systems with severe morbidity and high mortality and causing social and economic disruptions, all of which requires effective national and global collaboration and coordination for its control”.

INB8 Chapter II 4, 5 and 6

The theme of Chapter 2 is “achieving equity in, for and through pandemic prevention, preparedness and response”.

Article 4 addresses countries’ responsibilities in terms of “pandemic prevention and public health surveillance”, with countries committing to “progressively strengthen” these.

Article 5 sets out a One Health approach, while Article 6 addresses health system preparedness/ readiness, resilience and recovery – but once again dwell on countries’ responsibilities.

INB8_Chapter II_7-8-16-17-18

Article 7 deals with the health and care workforce, and Article 8 with “preparedness monitoring and functional reviews”.

Article 16 addresses international collaboration and cooperation, Article 17 is titled “Whole-of-government and whole-of-society approaches at the national level”, and deals with countries’ responsibilities to ensure pandemic readiness.

Article 18 addresses communication and public awareness, including countries’ obligations to counter “false, misleading, misinformation or disinformation”.

INB8_Chapter II_9

Article 9 deals with research and development (R&D), and includes that countries shall develop policies that “promote equitable access to pandemic-related products in government-funded R&D agreements and in licensing of government-owned technology for such products; and publish relevant terms of government-funded R&D agreements for pandemic-related products”, including prices, licencing and “terms promoting equitable and timely access to such products during a pandemic emergency”.

INB8 Chapter II, 10 11 and 13

This section deals with contested issues.

Article 10.1 addresses “Sustainable and geographically diversified production”,  and includes that member states shall “endeavour” to facilitate the transfer of relevant technology, know-how and licenses pooled

Article 11 is devoted to transfer of technology, but commits member states simply to “collaborate towards” “promoting and otherwise facilitating or incentivizing the transfer of technology and know-how for pandemic-related products on voluntary and mutually-agreed terms”. These include “licensing and collaboration with regional or global technology transfer partnerships and initiatives” (hubs was crossed out), particularly for technologies that have resulted from public funding

Article 13 addresses the establishment of a “global supply chain network” developed and operated by WHO in partnership countries and other stakeholders. This will identify needs during pandemics, aimed at avoiding “competition for resources among international procuring entities, including regional organizations and/or mechanisms”.

INB8_Chapter II_19-20_clean  

Article 19 addresses implementation capacities and support. Article 20 deals with financing, and proposes the establishment of a “Coordinating Financial Mechanism” to support the implementation of the  pandemic agreement, including “cooperating parties, in particular in developing country Parties”, as well as the agreement’s secretariat. The money will come from state and non-state actors.

It will consist of “a pooled fund to provide targeted, supplementary financing to support strengthen and expand capacities for pandemic prevention, preparedness and response, and as necessary for day zero surge response” in countries who do not have access to resources from existing financing entities.

INB8_Chapter III

This deals with institutional arrangements, dispute settlement, and final provisions. It establishes a governing body to review the implementation of the agreement, which will be run by a secretariat. It makes no provision for independent oversight of the pandemic agreement.

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.

Over 1 million displaced Gazans crowded into makeshift camps in Rafah near the Egyptian border.

The World Health Organization says it is making contingency preparations for a possible Israeli incursion into the Gazan city of Rafah. The city hugging the Egyptian border remains under the control of the militant Palestinian Hamas government, nearly four months after Israel’s devastating invasion that followed a Hamas assault October 7 on some 22 Israeli border communities.  

But with over 1.5 million displaced Palestinians crowded into makeshift shelters in the Rafah area, a full-blown Israeli military entry into the area would be an “unfathomable catastrophe, further expanding the humanitarian disaster beyond all imagination,” said Dr Rick Peeperkorn, Director of WHO’s Office of the Occupied Palestinian Territories (OPT), on Wednesday.   

Peeperkorn was speaking in a WHO press briefing from Rafah, where WHO responders already are struggling to cope with a broken health system, an unending flood of wounded Palestinians, and barriers to resupply of health facilities further north with needed medical supplies.  More than 28,000 Palestinians have been reportedly killed in the fighting. Some 1200 Israelis were killed in the 7 October Hamas raids, while about 100 of the 240 Israelis taken hostage then continue to be held captive in Gaza. 

Rick Peeperkorn, WHO Representative for the “Occupied Palestinian Territory” (OPT), speaking from Gaza.

Heavy fighting was seen in Rafah early Monday morning, when Israeli commandos staged a rescue operation to free two elderly Israeli-Argentinian hostages held in an apartment in the city;  Palestinian authorities said that the operation, accompanied by fierce gun battles and Israeli airstrikes, led to the deaths of 74 Palestinians.  But that may only be a prelude to what could follow, WHO officials fear.  

“All eyes are on Rafah,” declared Peeperkorn, describing the tensions in the city, whose fate may be decided by the success or failure of Egyptian, US and Qatari-mediated negotiations over a possible ceasefire deal, including  Hamas release of remaining Israeli hostages alongside the release of Palestinian prisoners jailed by Israel.  

“We all watch the news and we all get the stories about this possible incursion,” Peeperkorn said, “and military activities are getting closer.”  

And while WHO is making plans in the event of a mass evacuation order of the area by Israel, “This should not happen,” Peeperkorn insisted, saying: “There is no place for people to go.  This is a desperate plea. Yes, contingency plans are being made, but they would be completely insufficient,” he added.

Meanwhile, getting supplies into northern Gaza remains a risk challenge with only about 40% of missions approved by Israel since November when Israel’s military operations in Gaza City commenced.

“Since January, that figure is much, much lower, and the missions have been denied, impeded or postponed,” Peeperkorn said.  “Approximately 45% of the mission requests for the south are facilitated,” he added, adding, “That’s absurd – even when there is no ceasefire a humanitarian corridor should exist.”

Nasser Hospital in eye of the battle in Khan Younis

WHO health supplies delivered to Al Nasser Medical complex in Khan Younis on 23 October, 2023.  The hospital is now encircled by Israeli troops amidst heavy fighting in the area.

Peeperkorn also called upon Israel to allow WHO access to Al Nasser Hospital in Khan Younis, a city just north of Rafah.  Nasser Hospital serves as the leading medical facility serving Gazans in the southern part of the 364 square kilometer enclave. 

The hospital has been encircled by Israeli troops for over a week with WHO unable to access the site, he said, adding: “We know that 10 or more civilians have been killed outside and inside the compound,” he said, adding that there were also unconfirmed reports that the a main gate to the hospital compound as well as two medical supply warehouses had been destroyed. 

Some 402 patients and staff remain inside the hospital, he added, including 35 people on dialysis and 80 in the intensive care unit, including three neonates. 

Israel charges that Hamas military forces are operating from Nasser Hospital

In a message posted on X,  early Wednesday morning, Israel’s military claimed that Hamas military forces are operating from the Nasser hospital compound.  Israel demanded the “immediate cessation of all military activity in the area of the hospital and the immediate departure of military operatives from it.

 “The terrorist organization, Hamas, continues to conduct military activities within Nasser hospital complex, and moreover that the place was used to hold hostages,” said Israel’s military coordinator for Palestinian civilian affairs in the occupied territories, COGAT.

The post further said that the IDF had “conveyed this message to a senior official in the Palestinian Health Authority in Gaza and via him to senior officials in the Palestinian Health Ministry” warning that “if Hamas does not stop this terrorist activity, the IDF reserves its right to act against these actions according to international law.” 

Peeperkorn again denies Israeli allegations of  WHO “collusion” with Hamas 

Teresa Zakaria, WHO health emergencies official in Geneva at Wednesday’s briefing.

Last month, Israel also charged that WHO had ‘colluded’ with Gazan health authorities, by ignoring the evidence Israel had provided of Hamas military activities within and under hospitals – including hospital video footage as well as testimonies from former Hamas hostages freed in late November.

Those charges have been forcefully denied by WHO Director General Dr Tedros Adhanom Ghebreyesus, and were so again by Peeperkorn in Wednesday briefing on the situation in the Nasser complex: 

“Hospitals should never be militarized. That would be wrong. But we have received no evidence of military misuse of hospitals,” Peeperkorn asserted.

Added Teresa Zakaria, a WHO emergency officer in WHO’s Geneva headquarters: “Hospitals must be safeguarded and should not never be militarized; this constitutes, in itself, an attack on health facilities,” she said, comparing it to shootings or bombardment.

But she added that WHO lacks capacity to investigate such allegations as part of its Surveillance System for Attacks on Health Care (SSA) reporting. 

”We are not in a position to investigate any [other] activities taking place in hospitals or underneath hospitals. We focus on the delivery of services, we are not in a capacity to look beyond the delivery of services,” Zakaria said.   

WHO platform reporting on attacks on health facilities in the Occupied Palestinian Territory, including Gaza, the West Bank and East Jerusalem, since 7 October. WHO does not publicly name the health facility or designate who undertook the attack.

Israel’s unusual message to the Palestinian Authority over Nasser hospital

The very public message by Israel to the “Palestinian Health Authorities in Gaza” over the Nasser hospital situation is unusual in the context of war-time communications to date.  

Israel’s hard-line government has generally rejected suggestions by the United States and other allies that governance arrangements in Gaza, post-war, should involve the Palestinian Authority (PA), which is the internationally-recognized representative of Palestine. 

The PA, largely aligned with the Palestinian Fatah movement, was violently ejected from Gaza by Hamas in 2007, after a short period of Fatah-Hamas coalition rule. That followed Israel’s 2005 military withdrawal and Gazan elections  in which Hamas won the majority of votes – but not an outright majority. 

While the PA still holds a foothold in Gaza’s civic administration, its political echelon has been at odds with Hamas leadership ever since the group’s seizure of power – although Palestinian Authority officials have publicly expressed outrage with Israel’s invasion of Gaza as well as solidarity with the plight of Palestinians beseiged there.    

Image Credits: WHO .

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 .

Intergovernmental Negotiating Body meeting over a new pandemic accord in November 2023

A wide array of stakeholders are looking toward the upcoming World Health Assembly this May to conclude negotiations on a new pandemic accord that seeks to make the world more prepared for the next pandemic.

And most would agree that the primary task of the Intergovernmental Negotiating Body (INB), established by the World Health Assembly (WHA) in December 2021 to negotiate the draft agreement, is to address the inequities observed in the distribution of COVID-19 vaccines, medicines, diagnostics and other  countermeasures to low- and middle income Countries (LMICs).

In this respect our collective response failed, in particular to Africans, and this should never be allowed to happen again. With this in mind, the biopharmaceutical industry, represented by IFPMA, tabled the Berlin Declaration in July 2022, committing to early and equitable access by reserving an allocation of real-time production of vaccines, treatments, and diagnostics for priority populations in lower-income countries, as well as taking measures to make them available and affordable.

Solutions being proposed by the INB negotiators must undeniably put equity front and centre. However, in doing so, we should not jeopardize the elements of the COVID-19 response that worked well, notably, the rapid development and scale up of medical countermeasures and the unprecedented public-private partnerships that helped end the pandemic by May 2023.  Without these successful elements, there will be life-threatening delays in developing the medical countermeasures that will be needed to fend off the next pandemic.

Pathogen Access Benefit Sharing (PABS) System proposal is deeply flawed

The genetic map to the SARS CoV2 virus was shared within days, ensuring rapid development of countermeasures.

As INB negotiators discuss a Pathogen Access Benefit-Sharing (PABS) System as part of an overall Pandemic Agreement, it is critical to preserve the innovation system and research incentives that were so successful in the fight against COVID19 and supported the rapid development of vaccines, treatments and tests at record speed and unprecedented scale. Failing to do so will mean we do not effectively tackle the biggest shortcoming of the COVID-19 pandemic – the inequitable rollout of medical countermeasures.

It is essential that provisions of the pandemic accord regarding access to pathogens and genetic sequences provide a decoupled solution, with no strings attached.  During the COVID-19 pandemic, access to pathogens and genetic data was swift and unconditional. Thankfully, no country tried to impose national legislation, related to the Nagoya ABS Protocol, to such sharing – something that could have considerably slowed rapid scientific response.

 WHO/INB pandemic accord negotiating document of October 2023

Unimpeded sharing of SARS-CoV-2 pathogen data enabled the development of a safe and effective COVID-19 vaccine within a record 326 days from the release of the virus’ genetic sequence. Without this principle, private sector engagement will be disincentivized and the measures will prove counterproductive.

Creating a “closed system” that centralizes pathogen access under one organization’s control, as some parties have proposed, would introduce considerable bureaucratic hurdles and could require years, if not decades, to implement.

This centralized approach offers no evident benefits whereas a more realistic approach involves bolstering collaboration among established networks such as European Virus Archive Global (EVA-G), American Type Culture Collection (ATCC), or the German Collection of Microorganisms and Cell Cultures (DSMZ).

Stringent requirements for sharing or accessing pathogen data would also severely hinder responses to future pandemics and basic research and development (R&D). Conditions, uncertainties, and negotiations surrounding pathogen access will cause delays in the developing medical countermeasures, leading to significant public health consequences, including loss of lives and unnecessary economic pressures. In the COVID-19 pandemic context, even a one-month delay could have meant an extra 400,000 lives lost.

Four key criteria for a PABS System

R&D for COVID-19 vaccine candidates proceeded at an unprecedented pace.

To prevent future delays in critical R&D of countermeasures, the WHO Pandemic Accord must include four key criteria:

  • Enable a flexible, decentralized pathogen sharing system leveraging existing networks and databases,
  • Establish a legally enforceable obligation for all countries to promptly share pathogen samples and sequence data,
  • Implement a legally binding presumption of consent for accessing pathogens,
  • Legally recognize the Accord as a Specialized International Instrument under Article 4, Paragraph 4 of the Nagoya Protocol. This would avoid any delay that could otherwise be created from national ABS laws, which are designed to protect claims by countries to their indigenous biological resources – not dangerous pathogens.

Moreover, pathogens or their genetic sequences aren’t “owned” by any single country; they quickly traverse borders. The idea of incentivizing or paying royalties to countries for spreading dangerous pathogens is outright absurd.

In instances where the Nagoya Protocol was applied, the results have been negative, as demonstrated in a 2023 report by the consultancy firm Covington, which reviewed the application of the Nagoya Protocol, for example in the case of the outbreak of Zika virus in 2015 and seasonal influenza in 2021.

Governance and implementation

Standing ovation at November 2021 special World Health Assembly session that voted to negotiate a new pandemic accord during the height of the COVID pandemic.

Effective governance and implementation are also important.  This means involving all of those parties which will contribute to the success of any Pandemic Accord, including through consensus-based decision making. Conversely, top-down decision making, without clear criteria, would undermine the trust that is necessary for the system to function. Excluding manufacturers from serious discussions about the PABS viability during the ongoing negotiations, especially given that most public health emergencies of international concern (PHEIC) are of no commercial interest, is simply wrong.

The private sector must be involved, and we must avoid overlaps, whereby manufacturers willing to sign up to the public-private partnerships created by the Pandemic Accord would be exposed to benefit sharing obligations and to national Nagoya ABS provisions.

To be practicable, the partnership should reach a critical mass to come into force – the idea of coercing companies to engage is unrealistic. Considering the free movement of pathogens and the potential refusal of major jurisdictions to join the PABS framework, this would create an uneven playing field for manufacturers based on their origin.

PABS cannot be built like the Influenza Preparedness System

Another issue is that the current draft text introduces very problematic clauses on mandatory contributions to finance the PABS, likely conflicting with several national constitutions.

National tax regimes are a matter beyond the constitutional jurisdiction of WHO, and any concept of “annual monetary contributions based on size and nature of the manufacturer” essentially amounts to a corporate tax.

While some may argue this mirrors the Pandemic Influenza Preparedness (PIP) system, which is designed to with “voluntary” contributions, this model is not suitable for pathogens in general and will not work.

Unlike the seasonal influenza market, where WHO and its Global Influenza Surveillance and Response System (GISRS) are basically the sole repository of biological influenza samples and the small number of companies involved in the seasonal influenza market rely on access to the WHO-owned samples, the landscape for known or unknown pathogens, let alone genetic sequence data, is vastly different.

The fact that the SARS-CoV2 Omicron variant was rapidly sequenced in parallel in South Africa, Botswana, and Hong Kong, is a prime example.  Restricting access to such data would hamper public health objectives by undermining the fast development of medical countermeasures (MCM). While companies do support surveillance and health systems strengthening, their contribution must remain voluntary.

Ensuring a more equitable rollout

The PABS system shoudl provide a credible solution to more equitable rollout of medical countermeasures.

Moreover, the PABS system should provide a credible solution to ensure a more equitable rollout of medical countermeasures, which the current proposal before the INB would fail to achieve. Achieving equitable access to vaccines, drugs, diagnostics and other tools demands a comprehensive approach, free from linking access to pathogen samples and sequence data to benefit-sharing obligations.

Through the Berlin Declaration, the industry has already expressed its commitment to early and equitable access by reserving an allocation of real-time production of vaccine, treatments, and diagnostics for priority populations in lower-income countries and to take measures to make them available and affordable. Such commitments should not hinge on the conditionalities of access to pathogens.

The Pandemic Accord should seek to engage companies and solidify the commitments made in the Berlin Declaration – not disincentivize them.

Proposals that include unrealistic conditionalities for pathogen access, and that disregard the ubiquity of pathogens that travel across borders, would fail to achieve a fairer distribution of medical countermeasures and risk significant delays to any pandemic response.

Towards equitable access

An effective agreement would follow a fundamental principle ingrained in medical practice: do no harm. It is essential to preserve successful elements from the fight against COVID-19 – such as fast, unhindered access to pathogens, a robust innovation ecosystem and unprecedented public-private partnerships – and focus on how to address the inequitable rollout of medical countermeasures. Conversely, an Accord that creates multiple barriers to pandemic preparedness and response, would do more harm than good.

Industry supports a comprehensive partnership involving GAVI, CEPI, the Global Fund, the WHO, and the private sector to enhance equity. The private sector is integral in the co-creation of solutions, and therefore must be consulted in a meaningful way – particularly given the role the sector will play in responding to future pandemics.

Companies have been stating for over a year that they are prepared to commit to pre- and during- pandemic measures including: improving surveillance; research on pathogens of pandemic potential; voluntary licensing and technology transfer based on mutually agreed terms to improve geographic diversity of manufacturing’; and real-time allocation of part of production, and equity-based tiered pricing.

For the Accord to succeed, constructive strategies to enhance pandemic prevention and preparedness through health systems strengthening, improved surveillance, and a decoupled approach to accessing pathogens and genetic sequences are critical.  Additionally, we need joint commitments from countries to procure additional medical countermeasures for the Accord partnership. Similar commitments from the industry should be accompanied by regulatory convergence and removal of trade barriers.  Furthermore, decentralized governance and implementation of the Accord through a partnership approach that includes the private sector are other crucial elements.

It’s not too late. An effective pandemic agreement will require the contribution of all stakeholders, acting in cooperation. Industry is keen to provide evidence and experience to the negotiators and we are eager to take our responsibility and make a positive contribution to a practical agreement. The world cannot afford to miss this opportunity.

Thomas Cueni is the Director General of the International Federation of Pharmaceutical Manufacturers and Associations. 

Image Credits: NIAID-RML , Pfizer, NPHCDA.

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 .