AMR: new business model for antibiotics development urgently needed

EU policymakers and stakeholders warned that the Coronavirus crisis may be a foretaste of what to expect from a world without effective antibiotics.
Bacteriophage viruses attacking an E. coli cell | Photo credit: Eye of Science/Science Photo Library

By Brian Johnson

18 Jun 2020

Can the EU put aside past intransigence and take urgent and effective action to tackle the threat of Antimicrobial Resistance? That was a key question raised during a recent webinar on the need for a new business model for the development, production and sale of new antibiotics, organised by the Parliament Magazine and the PA International Foundation.

Opening the online discussion on 4 June, German S&D group MEP Tiemo Wölken warned participants that the COVID-19 crisis was “only a foretaste of what we could expect in a world where antimicrobials were no longer effective.” As the name suggests, antimicrobial resistance (AMR) refers to bacterial infections that are now resistant to existing antibiotics – often referred to as ‘superbugs’. In part this has been caused by antibiotics overuse in both agriculture and in human healthcare.

Wölken, vice-chair of the MEP Interest Group on Antimicrobial Resistance warned that a global AMR crisis could be far worse than what we are currently confronting. “Let’s be clear, AMR is a global public health threat with the potential to kill millions of people. Already, each year, AMR kills at least 33,000 Europeans. According to the UN, this could increase to 10 million worldwide deaths a year by 2050.”


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He said that “very little” was being done to reduce the threat of AMR, warning that, “There is an obvious market failure in investing in research and development of new antibiotics. The current system is designed to generate profit for pharmaceutical companies and so the industry is failing to deliver on new health technologies for treatments that simply do not and cannot promise high returns of investment.”

Renowned economist Lord Jim O’Neill - who chaired the UK Government’s recent review on AMR - said the chaos caused by the COVID-19 outbreak had helped end what he called “the artificial separation” between health, economics and finance. “Many people in finance and those responsible for running economic policies haven’t seen AMR as a priority policy. The COVID-19 outbreak, horrific as it has been, can only be helpful. Health and economics are now - rightly – seen as one issue.”

"People are dying in hospitals every day because antibiotics aren’t working. This problem will continue unless we find a new solution, which is why it’s vital to develop innovative new models for bringing solutions to market" Peter Liese MEP

He said the situation had deteriorated sharply in the four years since he presented the UK review, with more major pharmaceuticals companies exiting the market. Without urgent action to restrict the inappropriate use of current antibiotics and develop new treatments and new diagnostics, “we are going to be in an even bigger mess in the future than we are currently with COVID-19”.

Irene Norstedt, Acting Director for health within the European Commission’s Research and Innovation directorate, said, “Antibiotics are a cornerstone of our health system. We need to boost our investment in antibiotics development and work in partnership with industry”. Citing €1bn worth of EU investment since the mid-1990s, she said she hoped to see further investment in antibiotics R&D within the Horizon Europe programme.

Webinar co-host, German EPP deputy Peter Liese, told participants that it was now time to look at regulating human antibiotics use at EU level, as was already the case for veterinary use. “Politically it’s difficult, but perhaps in the current climate, a European level effort is required here.” Liese, a medical doctor by profession, added that, “People are dying in hospitals every day because antibiotics aren’t working. This problem will continue unless we find a new solution, which is why it’s vital to develop innovative new models for bringing solutions to the market.”

The Lygature Foundation’s Dr Jon de Vlieger explained how the European Lead Factory (ELF) is driving investment in pre-competitive drug discovery research. With Europe becoming increasingly dependent on third countries, particularly Asia, for vaccines, antibiotics and active pharmaceutical ingredients (APIs), ELF has been substantially EU funded and is now being touted as a platform to establish a European ‘Silicon Valley for drug discovery and development’. “It’s clear that we are facing a major challenge. AMR will hit us hard, in terms of health and also economically. However, as a broad drug discovery platform, ELF is uniquely positioned to help address topics such as AMR.”

Dr Marc Gitzinger, vice-President of BEAM, an alliance of 55 drug development and diagnostic SMEs working on AMR drug development and discovery, said, “SMEs are virtually the only companies currently developing AMR drugs. Out of 41 antibiotics presently in clinical development, only one is being developed by a large pharmaceutical company”. He explained that the traditional economic model for AMR drugs was broken. “All these SMEs rely on external funding. But the usual venture capital and private equity companies have all left the field of antimicrobial drug development.” He warned that unless SMEs could access new funding and market entry rewards, there will be no new antibiotics.

"So far, the Commission has only provided guidelines; unless we prepare ourselves for the next outbreak or AMR crisis, we will all suffer greatly. It is time for legislation with mandatory action" Tiemo Wölken MEP

Dr Jean-Paul Pirnay highlighted the potential of bacteriophages in the fight against AMR. Pirnay, Research Director at Queen Astrid Military Hospital in Brussels said, “These harmless and naturally produced, virus-based bacteriophages have been controlling bacteria since the beginning of life on Earth. Unlike antibiotics, bacteriophages - or simply ‘phages’ - can evolve to overcome bacterial resistance.” Pirnay said phages could work well as part of an AMR mix, alongside antibiotics. However, because of the European Commission’s regulatory approach on phage use, there was little funding available and their use in saving lives was minimal. He argued for a new EU phage regulation and called on policymakers to follow Belgium’s lead and mirror the country’s Magistral Phage Medicine Framework allowing the development and use of phages as a pan-European solution.

In closing, Liese and Wölken both agreed that it was now time for the European Commission to propose new legislation to combat AMR. “So far, the Commission has only provided guidelines; unless we prepare ourselves for the next outbreak or AMR crisis, we will all suffer greatly. It is time for legislation with mandatory action.” After the webinar DG SANTE responded on the AMR dialogue in writing.

Check out the emerging multistakeholder debate at www.stopAMR.eu

 

Click here to download all of the presentations.

In case you missed it, here's the full webinar video:

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