Superbug pandemic threatens to undo medical progress

DISCLAIMER: All opinions in this column reflect the views of the author(s), not of EURACTIV Media network.

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Time to rethink innovation incentives to combat antimicrobial resistance (AMR). [Shutterstock]

It’s never easy to focus on more than one crisis at a time. But, as vaccines begin to point the way out of the COVID-19 pandemic, there is another global health threat lurking in the background which needs our attention: antimicrobial resistance (AMR).

Nathalie Moll is the Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Its impact on our health systems, our social lives and our economies could be just as profound as the COVID-19 crisis from which we are slowly emerging.

The scale of the AMR challenge is so great that it can be hard to take in. A world without antibiotics is one in which everything from tooth extraction and prostate surgery to Caesarean sections and chemotherapy carry unpalatable risks. In short, it would represent an unprecedented leap backwards.

According to the World Bank, an estimated 10 million people could die annually by 2050 if solutions – new antimicrobials – are not found. For context, this is more than twice the estimated number of deaths from COVID-19 in 2020 and 2021 to date.

Of course, AMR was a significant threat long before any of us had heard of SARS-CoV-2. It was simmering in the background and we are gradually losing an arms race against bacterial and fungal infections capable of evolving to evade our arsenal of antibacterial weapons. So, while COVID-19 may have taken the world by surprise, the potential impact of AMR can be foreseen. We need to take action before it is too late.

A market like no other

The comparisons with COVID-19 must not be lost on us. The battle between vaccines and coronavirus variants should increase our collective understanding of how new bacterial strains can evolve to evade antimicrobial medicines. There is one important difference: increasing vaccination will reduce opportunities for new COVID-19 variants to emerge. In contrast, inappropriate use of antibiotics contributes to antimicrobial resistance – the more of any antibiotic that is used, the greater the risk of resistance.

This takes us to the nub of the problem. Antibiotic stewardship – the cautious use of the antibiotics we have today – is an important piece of the puzzle in our shared fight against AMR. However, it leaves us with a paradox that makes the antibiotic market like no other: any new antimicrobial medicine will be held in reserve, so that superbugs do not develop resistance to that newest line of defence.  From a medical perspective, this makes sense and is well understood by research-based pharmaceutical companies. However, from a commercial perspective it poses problems. Developing new medicines is costly and, for investors, success is far from certain.

If new antibiotics are approved by regulators, they are used sparingly to preserve effectiveness. In recent years, a number of antibiotic-focused biotechnology companies have declared bankruptcy or exited this space due to the lack of commercial sustainability. The consequence is a huge public health need for new antibiotics but a lack of funding available for antibiotic R&D, particularly in the later stages of clinical research.

In addition, this essential area of research is scientifically complex. As bacteria are constantly evolving, they are a moving target for researchers developing new treatments. Furthermore, resistance to antimicrobials can be difficult to predict and clinical trials are complex.

Wanted: innovative incentives

Industry is committed to working with others to overcome these challenges. The task now is to create a sustainable innovation ecosystem for antimicrobial R&D and commercialisation.

The AMR Action Fund, an initiative from over 20 leading biopharmaceutical companies, developed in cooperation with the World Health Organization, the European Investment Bank, and the Wellcome Trust has committed over $1 billion to strengthen and accelerate antibiotic development, and ensure there is a sustainable pipeline of new antibiotics to fight the highest priority bacterial threats. Its goal is to harness the investment, expertise and political will needed to bring between two and four new antibiotics to patients by 2030.

Even if the Action Fund successfully delivers novel antibiotics, it will be wasted unless the economics are fixed by policy-makers. At the heart of this fix will be adapted market-based policy changes, including reimbursement reforms and new ‘pull’ incentives needed to create a sustainable R&D environment. The successful development of antimicrobials should be rewarded for the insurance value they hold for society, thus attracting investment to this vital cause without encouraging the use of precious new products.

There may not be a single simple solution to the threat of AMR. However, by working together, stakeholders can agree a suite of measures that would support investment in antimicrobial R&D.

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