The European Health Union has declared AMR one of its top three priority health threats in the EU requiring urgent attention and action. Within the context of the revision of the Pharmaceutical Legislation and the planned European Council Recommendations on AMR taking place in Q4 2022, the event brought together high-level European policymakers to discuss the innovation framework for the development of new antibiotics based on concrete examples of initiatives conducted by national health authorities to fight AMR. The event also explored collaborative and governance models to achieve better implementation of actions and best practices for a holistic AMR approach.

 

“The meeting was crucial to increase awareness of Antimicrobial Resistance and the need for new innovations to address unmet needs. I’m calling on patient organisations, industry, the European Commission, academia, and healthcare professionals to work together to drive policy change and put in place a common response to this increasing societal challenge,” said MEP Aldo Patriciello.

 

"The inclusion of the AMR within the work programme of the incoming Sweden Presidency of the Council of the EU and the prioritisation of the topic by the European Health Emergency Preparedness and Response Authority (HERA) give the opportunity to advance policy action to improve stewardship, surveillance of resistance patterns across Europe and incentivise innovation. These actions should be fully integrated into One Health Strategies providing solutions for human, animal and environmental health. The involvement of civic society and patient advocacy groups is also crucial in the development and implementation of AMR National Plans" commented Mariano Votta, Director of Active Citizenship Network, the EU branch of the Italian NGO Cittadinanzattiva.

 

MEP Fabio Massimo Castaldo also affirmed the importance of developing a predictable regulatory environment to incentivise private investments in new antibiotics, in addition to setting up rapid procurement and purchase mechanisms for crisis-relevant medical countermeasures to respond to emerging threats and better prepare European health systems. He stated that “with the adoption of the Global Health Strategy and Pharmaceutical Legislation Review, the time to act is now, and as Members of the European Parliament, we will thoroughly review these proposals to ensure it meets the objective and ambition that are needed.”

 

In 2019, bacterial AMR was directly responsible for 1.27 million deaths and associated with nearly 5 million deaths.2 Future projections for the impact of unresolved AMR are as high as 10 million deaths per year by 2050.3 Antibiotics are crucial for every aspect of modern-day healthcare, from common surgeries to chemotherapy and organ transplants. Unless urgent action is taken, we could face a future in which a lack of effective antibiotics could make routine medical procedures dangerous, make more complex interventions and procedures impossible, and reduce our ability to respond to outbreaks of infectious diseases. Tedros Adhanom Ghebreyesus, Director General at the World Health Organization (WHO) has called it a ‘slow tsunami that threatens to undo a century of medical progress’. 

 

“We know that incentivising innovation is critical in order to stimulate antimicrobial R&D and a pipeline of new and effective antibiotics, and this is necessary at both a European and local country level. We have seen specific examples of successful models which have been implemented in European countries and urge other EU member states to follow suit and consider similar incentives to help address the challenges faced in bringing novel antibiotics to market,” commented Mark Hill, Senior Vice President, Global Head of Value and Access, Shionogi.

 

While developing antibiotics is a long, costly and uncertain process, commercialisation can also be challenging. Once launched, understandably, there is often a low frequency of use driven by the need for stewardship to prevent resistance development. Low use leads to limited revenues, which in turn restricts continued commercialisation and new product research. As a result of these economic challenges, many large pharmaceutical companies are no longer active in the development and commercialisation of antibiotics, and several smaller biotech companies have filed for bankruptcy. Shionogi strongly supports the introduction of new incentives, funding and value assessment models for reimbursement to restore a viable commercial market to address the economic challenge faced in bringing novel antibiotics to market, whilst promoting stewardship.

 

Shionogi is committed to maintaining the momentum and leveraging collaborations with civil society, policymakers, industry, academia, and healthcare professionals to champion innovation to collectively turn the tide in the fight against AMR.