The Unseen Epidemic: Why Antimicrobial Resistance Demands Immediate Attention

If we were to create a hierarchy of global threats, sitting at the top alongside the climate crisis and food security would be a quiet yet deadly scourge of humanity: antimicrobial resistance. Also known as AMR, this describes the process by which bacterial infections grow unresponsive to the existing suite of antimicrobial drugs like antibiotics – often with fatal results. One of the most significant public health challenges of our time, it is also one that, until recently, drew astonishingly little interest from the public or politicians alike.

This is a mistake.

Antimicrobials are to medicine what fertilizers and crop protection are to agriculture: take them away without offering a viable alternative, and the system no longer functions.

It is no exaggeration to state that modern medicine – and by extension, public health and individual wellbeing – is almost entirely dependent on the efficacy of antimicrobials, most notably in the form of antibiotics.

The looming threat of AMR is not caused by scientists failing to create the right medicines. Rather, it is caused by a failure among governments and health bodies across the world to create the market conditions needed for the survival of medicine as we know it.

Combating antimicrobial resistance requires a concerted effort from governments, healthcare providers, farmers, and the public if we are to reach Sustainable Development Goal 3 (ensure healthy lives for all) and safeguard the continued effectiveness of vital medicines for future generations. Alongside reducing antibiotic use, I will argue in this article that the key to keeping AMR at bay is ensuring that biotech companies can afford to dedicate the necessary resources to developing new antimicrobials.

Without access to effective antimicrobials, a century of medical progress is lost

Antibiotics are a class of drug that has been used in wound healing since ancient Egyptian times , but whose true potency was only truly discovered a century ago. In 1928, biochemist Alexander Fleming made one of the most significant medical breakthroughs of the 20th century when he (accidentally) discovered penicillin, triggering the process that would, over the next two decades, result in the development of mass-produced antibiotics, a foundational pillar of modern medicine.

Since Fleming’s discovery, antibiotics (and the wider antimicrobial family to which they belong) have saved countless lives. They have transformed wound treatment, childbirth and surgery. Without access to enough effective antimicrobials, many common surgical procedures – including caesarean sections and hip replacements – would be so high-risk as to be unthinkable in all but the most desperate cases. Maternal and neonatal deaths would surge. Organ transplants would be impossible, as would chemotherapy for many cancer patients. Food security would be jeopardized as farmers would struggle to treat sick livestock. People living with cystic fibrosis or other immune system conditions would be yet more vulnerable to infection. We could even return to an age where something as trivial as an insect bite or a small cut to the skin could kill.

The more antimicrobials are used, the less effective they become

This sounds like a dystopia – but scientists warn that it is all but inevitable unless we take swift and decisive action on a global level.

Because while antimicrobials (particularly antibiotics) are truly a wonder drug, the more they are used, the less effective they become.

Even if antibiotics were used sparingly, over time bacteria would still develop resistance to them, and we would need to develop a completely new generation of the medicine every twenty to thirty years.

And we do not use antibiotics sparingly – we use them with a dizzying degree of carelessness.

A huge proportion of antibiotics are unnecessarily or wrongly prescribed (often due to a lack of diagnostic capacities), or purchased without a valid prescription and used in a clinically inappropriate manner. In the US, nearly a third of the antibiotics prescribed in doctor's offices and emergency departments are medically unnecessary. Globally, a study in 2017 found that nearly three-quarters of all antimicrobials sold were given to animals raised for food – often in order to accelerate growth or to mitigate the consequences of unhygienic living conditions, rather than to treat existing infections.

The overuse of antimicrobials has accelerated the inevitable decline of these critical medicines, with already tangible effects.

For instance, the majority of urinary tract infections are now resistant to one or more antibiotics. In India, where antibiotics can be purchased without a valid prescription and with no medical guidance , AMR kills 60,000 newborn babies every year, and doctors believe that 6 out of 10 patients in some ICU wards have antimicrobial-resistant infections. Worldwide, in 2019, antimicrobial resistance was directly responsible for an estimated 1.27 million deaths and linked to nearly 5 million in total. According to US figures, rates of carbapenem-resistant Acinetobacter, one of the highest priority pathogens for the WHO and CDC, jumped 78% from 2019 to 2020 alone.

Compounding the crisis is the fact that, while AMR is accelerating, R&D in antimicrobials is stagnating.

No new classes of antibiotics have been discovered since the 1980s , meaning that all antibiotics that have been brought to market in the past three decades are variations of drugs that have been discovered before. And the situation currently shows little sign of improving: between 2010 and 2022, the United States Food and Drug Administration (US FDA) approved just 17 new antimicrobials (to draw a comparison, the body approved 16 new antimicrobials in just 4 years between 1983 and 1987).?

This situation has arisen largely because pharmaceutical and biotech companies face an untenable level of risk when developing new antimicrobials. Currently, reimbursement models for antimicrobials continue to be based on volume of use – but simultaneously, governments and health bodies strive to keep volumes small to prevent resistance from developing, which severely limits future revenues.

As Juergen Eckhardt , my colleague who heads our venture capital arm, Leaps by Bayer, explains : “Given the reality that antibiotics can cost more than US$1 billion to develop, it’s clear that developers face a difficult path to making their investment back.” Even if a company develops a new “wonder drug” antimicrobial, the product will not be purchased in the volumes that would be needed to recuperate the costs of innovation. Companies that have sought to work for the greater good against this backdrop have paid a heavy price, as Juergen elaborates: “Of the last nine antibiotics approved for use in the U.S., the companies behind seven have gone bankrupt or experienced significant financial headwinds.” A prime example is Achaogen, which declared bankruptcy less than 10 months after the US Food and Drug Administration approved its new antibiotic plazomicin, which took 15 years and US$1 billion to develop.

Controversial measures are needed to bring use of antibiotics down

Such figures are starting to trigger unease, and, finally, action. But this action needs to accelerate – globally and across industry and regulators.

The first piece of the solution is reducing worldwide demand for antimicrobials (mostly antibiotics).

Here, the onus is partly on national governments to implement measures like expanding public education campaigns to decrease unnecessary demand, or further improving hygiene cultures in hospitals and healthcare centres to reduce the risk of infection and curb antibiotic needs among inpatients. They must also introduce measures that will likely be controversial among industry and consumers: imposing more stringent controls on distribution of antibiotics to humans and animals, and lowering the intake of antibiotics among livestock either by reducing meat consumption or by mandating stricter animal welfare standards.

National and international health bodies have a role to play, too. They must invest in vaccination programmes to better prevent diseases and infections that create (medically necessary) demand for antibiotics. And industry can help improve diagnostics to reduce cases of unnecessary prescriptions, and, in cases of bacterial infection, better pinpoint which antimicrobials will be effective so as to ensure broad-spectrum antibiotics are used when their application is smart and/or necessary.

To a certain extent, national or regional initiatives can help boost global engagement on AMR. We have seen this in the field of livestock farming: after the EU banned the use of antibiotics to make animals grow faster, the US finally followed in 2017. However, unnecessary use of antibiotics in meat production is still widespread elsewhere, suggesting an urgent need for international cooperation to ensure action is triggered across borders. Because, as the Covid pandemic showed, national efforts can only go so far when it comes to a public health crisis.

There are promising signs that the topic is gaining in momentum at multilateral level: the UN General Assembly will convene a High-Level Meeting on AMR for the second time during its General Assembly in New York in September, providing an opportunity for world leaders to collectively address the threat. I am optimistic that financing innovation will be high on the agenda, after it was a prominent topic at the preparatory session in May . The EU has committed to step up its actions as well, although at this stage its proposals (including incentives for development, targets for antibiotics reduction, and mandatory prescriptions for antimicrobials) remain non-binding for member states.

The presence of antibiotics and resistant bacteria in the environment needs to be contained

The second piece of the AMR puzzle is reducing the environmental factors that accelerate the crisis.

Recent evidence suggests that water pollution from microplastics and heavy metals facilitates horizontal gene transfer and thus speeds up the spread of AMR – as do the effects of climate change (increased temperatures, increased incidence of flooding). This gives extra urgency to climate change mitigation and adaption efforts, particularly those relating to flooding protection – as well as highlighting the need for governments and companies to invest in wastewater and filtering technologies.

The final part in the fight against AMR is also the most complex: incentivizing innovation in the field of antimicrobials – that is to say, incentivizing the development of new groups of antimicrobials (or alternatives to antimicrobials) that are effective against infection.

Pharmaceutical R&D is a famously expensive and protracted process, and antimicrobials are no different. Certain components must be manufactured in dedicated facilities, and while technologies like AI may incrementally help make parts of the development process more efficient, phases like clinical trials will always be long and resource-intensive. And as noted above, drugmakers seeking to develop new antimicrobials have no hope of being able to recoup the costs of R&D, let alone make a return on investment.

The only way of addressing this burgeoning crisis is to provide long-term financial security for the biotech firms investing in antimicrobial R&D.

One entity aiming to achieve precisely this is the AMR Action Fund , the largest collaborative venture ever created to address AMR. The US$1 billion Action Fund is primarily financed by companies, including Bayer. While we have shifted our R&D focus in public health to neglected tropical diseases and oncology, we recognize the grave danger posed by AMR, and in line with our mission “Health for all, hunger for none” are contributing to efforts to fight it.

The AMR Action Fund leads to promising innovation, but is just a stopgap

The Action Fund aims to have two to four new antimicrobials approved in the coming decade, by investing in biotech companies that are developing new antimicrobials for the most threatening drug-resistant pathogens. This gives a short-term lifeline to the companies on the frontline of AMR, who otherwise have little hope of attracting investment.

The Fund has already seen promising results, with one of its portfolio companies having recently received FDA approval for an antibiotic designed to treat uncomplicated Urinary Tract Infections. This is a major milestone and we are thrilled to continue supporting the Fund’s work as it delivers more new products – and helps keep AMR at bay.

Then, in parallel to its financing work, the Fund advocates with national governments for market conditions that should, in the long-term, transform the antimicrobials segment into a sound investment for drugmakers. According to its CEO, Henry Skinner, the Fund was designed to “buy time for policymakers to fix the market and provide the necessary incentives in order to bring private investment back to this critical field of medicine”.

New reimbursement models should incentivize R&D

So what does fixing the market look like, exactly? The Action Fund believes – and I agree – that antimicrobial reimbursement must be reshaped into a “subscription”-based model. Henry Skinner describes this as “a gold standard that draws on the power of the markets to create success and efficiency. A subscription model for antimicrobials guarantees financial returns for companies that are investing in AMR R&D and are successful at innovating urgently needed therapies while also ensuring that patients have access to the medicines they need, thus creating significant societal benefits for generations to come.” Under this model (think “Netflix for antibiotics”), the purchaser pays a fixed sum based on access to the particular class of antimicrobial, rather than paying per dose of medicine purchased. The model would thus reward manufacturers in line with the intrinsic value of antimicrobials to public health, rather than basing reimbursement on the volumes consumed.

Some governments are beginning to adopt this model. Demonstrating exemplary AMR leadership, the UK launched “the world’s first ‘subscription-style’ payment model for antibiotics ” in 2022, under which the government will pay pharmaceutical companies upfront for access to their antibiotic products. The pilot for this has just been extended – a promising step forward, although the GBP20 million cap on annual payments may inhibit the industry’s ability to devote considerable resources to the topic. The US Congress, too, has been mulling a similar model for several years now, but the bill that would underpin it – the PASTEUR Act – has not progressed beyond draft stage, despite enjoying bipartisan support. Were the bill to pass, it would provide a powerful example of a shift from a per-volume reimbursement model to one that fosters access for working antibiotics.

Yet some of the biggest players in the G20, most notably China and India, have not yet engaged seriously with AMR at an international level. Both could play a real leadership role given their size, relevance to the pharmaceutical market, and the fact that they are two of the countries currently struggling most with the effects of AMR. A shift in priorities and mindset is urgently needed – and it looks like this must first take place in G7 countries, and ultimately throughout the G20.

Governments and societies at large need to act

None of these solutions require radically new science, or more research. We know the scientific methods and have the tools to produce new classes of antibiotics; there is ongoing research into promising alternatives like bacteriophage viruses .

Fighting AMR needs governments to focus on better market conditions, not just on better science.

I hope that as awareness of AMR grows, action correspondingly accelerates. This is a topic that transcends party lines in many countries – including the US, where famously few topics see bipartisan consensus – and I believe the leadership shown by countries such as the UK can help spur larger measures in others. But this must happen quickly.

Henry Skinner perfectly captures the problem when he describes it thus: “We inherited a well-stocked medicine cabinet, and we owe the same to future generations.” By rethinking reimbursement, governments can empower industry to safeguard a century of medical progress.