It sounds like something out of a science fiction novel, but this question is not so far removed from our modern-day reality. Antimicrobial resistance (AMR) has the potential to change the way we can rely on modern medicine. Everything from tooth extraction to chemotherapy can start carrying undesirable risks.  

AMR is a natural process where pathogens such as bacteria grow a resistance to the medicines, namely antimicrobials, which are our only defence to fight them. This process can create what we often refer to as superbugs. An OECD study showed that AMR proportions have been increasing across the EU/EEA between 2005 and 2015, close to one in five infections in the EU/EEA is due to antibiotic-resistant bacteria. In some countries, like Romania and Greece, about 40% of infections are due to antibiotic-resistant bacteria.1 

The creation of these superbugs has caused the WHO to rank AMR among the top 10 threats to global health. If no action is taken, AMR could cause 10 million deaths worldwide each year by 2050. To put this into a context that’s an annual death toll higher than both cancer and diabetes combined.  

Antimicrobials take at least 10- 15 years to develop. However, since the 1990s there has been a 30-year void in discovering new classes of antibiotics. Why is this the case? Well, the answer is simple, new antimicrobials need to be invented with the intention to just sit on a shelf until it is necessary to use them. Unfortunately, although this makes them very precious, they are not valued accordingly, generating low revenues compared to investments. Hence the creation of a failure in the market where R&D costs are higher than the potential return on investment. This has meant most of the larger players in the pharmaceutical sector have decided not to continue investing in antimicrobial research. The void so far has been filled by small and medium-sized enterprises (SMEs) who end up being the main innovators in new preventive, diagnostic and therapeutic solutions to fight AMR. Indeed, SMEs are involved in the development of more than 80% of the 360 antibacterial assets portfolio worldwide.  

The BEAM Alliance represents more than 60 European SMEs striving to develop the solutions to fight AMR and has gathered three recommendations for new policies and instruments to better address the threat:  

  1. Accessible funding mechanisms for SMEs in the form of grants or loans. Currently, only 20% of public funding is currently reaching SMEs to drive the innovation engine.  
  1. Incentive mechanisms rewarding SME-driven innovation could take the form of partially delinked incentives offering a revenue source independent of product sales or interim incentives can give the opportunity to recoup investments made across the whole discovery and development value chain.  
  1. Protect the true value of antimicrobials through Health Technology Assessment approaches that are refined to include adequate criteria that recognize the true of new antimicrobials that can fight a patient’s infection and save a life.  

Linking this to what is on the table on the EU legislative agenda, the Health Emergency Preparedness and Response Authority (HERA), in parallel with the extended mandates of the European Centre for Disease Prevention and Control and of the European Medicines Agency, has the potential to promote the coordinated development of new medical countermeasures for optimal responses to crises; so that the next public health threat is identified and prepared for in time to mitigate the havoc wreaked throughout the past 18 or so months.  

The review of the general pharmaceutical legislation will aim to modernize the regulatory framework to dedicate sufficient attention to unmet medical needs and bolster resilience through diversified supply chains. The EU is learning from the recent past as it turns its gaze to the future, where the threat of antimicrobial resistance is recognized as a looming challenge.  

November 18th marks the start of World Antimicrobial Awareness Week organized by the WHO. This worldwide awareness campaign exists because we are getting close to a critical stage where we won’t be able to treat a growing number of infections, jeopardizing the advances of modern medicine and as exemplified through the covid experience, our daily lives. Therefore, it is imperative that we get this right- incentivizing our innovators and finding answers today to address the next big health threat tomorrow. 

whois: Andy White Freelance WordPress Developer London