In an effort to maintain the effectiveness of antimicrobials for humans and animals, and to support the development of new therapeutic and diagnostic tools, the European Commission is working on a proposal for a Council Recommendation on AMR. This initiative is a unique opportunity to step up the collective effort to combat AMR.
The activities of the European Commission and its agencies have led to some progress, but there is little evidence that the health burden of AMR has been reduced. The COVID-19 pandemic has served as a reminder that too little action has been accomplished across Europe and that the collective effort to combat AMR needs to be stepped up in a timely fashion. Actions are needed in several areas. While challenges in the basic science partially explain the crisis in the development of new antibiotics, one critical problem is that the current incentive system, which relies on patents and other intellectual property rights, is not fit for purpose. Mis- and overuse of antimicrobials is also a major cause of AMR that has only been partially addressed. Finally, not all countries have Nation Action Plans (NAPs) or the comprehensive resources to cover all aspects of ‘One Health’ to ensure their successful implementation.
While concrete objectives and activities should be set to strengthen Member States’ action against AMR, these should be complemented, coordinated, and supported by the European Union. EPHA response to this call for evidence focuses on three areas that require particular attention and support: (1) the development of new antimicrobials, (2) preventative measures, and (3) National Action Plans.
EPHA recommends:
- Adopting an end-to-end approach to de-risk the development of novel antibiotics through adequate public funding. Affordability, availability, and accessibility of any final product as well as developer’s accountability must be the conditions embedded to public R&D funding.
- Developing new approaches to delink the costs of investment in R&D from the price and volume of sales. The national authorities and the EU institutions should coordinate joint efforts to develop new antibiotics. The role of public policy coordination in innovation should be strengthened. Incentives models like the milestone prizes, public buyouts of compounds or PDPs (Products Development Partnerships) should be encouraged.
- Avoiding incentives that extend the pharmaceutical monopolies and increase the health products prices like the transferable exclusivity vouchers or similar incentives.
- R&D efforts and investments should be effectively and efficiently coordinated by the EU and its Member States to respond to global unmet health needs.
- Supporting research into the development and assessment of interventions that prevent the development and spread of AMR. The cost of investment in R&D of alternative tools to antibiotics, including vaccines and diagnostic tests, should also be de-linked from sales revenues.
- Provision of educational resources to the public and healthcare professionals to reduce the mis- and overconsumption or prescription of antibiotics. Information asymmetry must be bridged through the delivery of reliable information to the public and the dissemination of clinical pharmaceutical guidelines to support prescribers. Interprofessional training and collaboration must be promoted through stewardship programmes bringing together all health professionals.
- Supporting the development and implementation of National Action Plans (NAPs) to improve the environmental health awareness and encapsulate all areas of “One Health”. While highlighting the importance of the One Health approach to AMR, the EU agencies should continue to provide comprehensive resources to inform, educate, guide and support member States in their individual NAPs development.