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Antimicrobial resistance (AMR) is a severe global health threat. In the EU alone, there were an estimated 58,300 fatalities directly attributed to AMR in 2019, with a further 196,600 deaths associated with resistance (Cassini et. al. 2019). This means that AMR-associated deaths in the EU outnumbered deaths from HIV/AIDS, tuberculosis, diarrheal diseases, breast cancer, and diabetes in 2019 (IHME 2020).
In order to combat the rising rate of drug-resistant infections, we must ensure that we have a continuous pipeline of novel antimicrobials coming to market to replace those which are no longer effective. Unfortunately, due to a combination of scientific challenges, stewardship practices which limit sales volumes, high-risk profiles, and low prices which fail to reflect the societal value novel antimicrobials provide, market incentives have failed to stimulate the needed innovation (BCG 2022).
To address these challenges, the Council of the EU has published recommendations for the acceleration of EU actions to combat AMR. This included a commitment from the EU Commission to develop pan-EU pull incentives to stimulate research and development of new antimicrobials (Council of the European Union 2023). Additionally, the European Commission's Health Emergency Preparedness and Response Authority (HERA) is working to pilot a pan-EU pull incentive program designed to improve access to antimicrobials (HERA 2023).
However, despite the actions being taken at the EU-level, the implementation of a successful pull incentive program will require significant commitment and coordination from individual member states (Anderson, Micheal, et al). Because each member state has mandate over their own health care systems, the EU Commission can’t implement a pull incentive without their consent (Mossialos et al.). Furthermore, one of the most prominent suggestions for a pan-EU pull incentive mechanism is an annual revenue guarantee as suggested by DRIVE-AB. This mechanism would have the European Medicines Agency (EMA) select eligible antimicrobials and individual member states decide whether or not to opt-in to the joint tender. Each member state would be responsible for paying the difference between the revenue pharmaceutical companies generate from sales and the minimum revenue guarantee amount based on their "fair share" (Årdal et al. 2023).
For such a mechanism to succeed, enough member states would need to participate in the joint tender. This presents a challenge for policymakers designing and advocating for such policies because there is still significant uncertainty around how much individual member states will prioritize AMR within their national budgets. Without enough commitment from member states, the mechanism wouldn’t be able to operate and is liable to the free rider problem (Anderson, Micheal, et al).
Given this, before the EU can implement a coordinated pull incentive mechanism, they need to ensure that it will have high-levels of member state participation. National Action Plans (NAPs) for AMR offer a unique vessel for member states to signal this commitment. NAPs are critical frameworks that outline the strategies and commitments of countries in tackling AMR, making them an excellent tool to coordinate AMR action, since they make countries’ intentions transparent and allow others to hold them accountable. A pan-EU pull incentive scheme could begin with EU nations indicating their willingness to commit to funding pull incentives in their NAPs.
While several countries, including Latvia and Ireland, have signaled their intention to explore new economic mechanisms for funding AMR innovation, many NAPs do not mention the need to fund the research and development of novel antimicrobials or consider where this funding might come from, as shown in the map below:
A map of all EU nations with available AMR NAPs in the WHO database by the language in their NAP. one point was awarded for each of the following: mentioning research and development, mentioning funding for research and development, mentioning research and development on novel antimicrobials, and mentioning or describing pull incentives.
Right now, many AMR plans are near expiration or have already expired, making now an excellent moment to improve subsequent NAPs. We suggest that all EU member states include wording about pull incentives or innovative financial mechanisms in their next AMR NAPs as a coordinated effort to include this language would demonstrate that members of the EU are truly interested in exploring new avenues for funding AMR research.
Nations by AMR NAP expiration date. Nations colored red have plans that have already expired.
The language of the NAPs should recognize three objectives:
Recognition of the Issue and Broad Commitment to Incentivise Development: EU member states should commit to incentivizing the development of new antimicrobial therapeutics, diagnostics, and vaccines.
Exploration of Innovative Financing Mechanisms: Within the broad commitment to incentivise development, include a specific commitment to explore delinked “pull incentives” and / or other “innovative financing mechanisms”
Coordination with International Partners: EU countries should commit to collaborate with international partners and EU institutions to develop a coordinated system for incentivizing antimicrobial development, ensuring alignment with global efforts.
Ideally, these commitments should demonstrate member states willingness to participate in an EU coordinated pull incentive scheme while also allowing for flexibility at the national level where required. Overall, the potential for a pan-EU pull incentive mechanism offers a promising path forward in the fight against antimicrobial resistance. By including commitments to pull incentives and innovative financing mechanisms in their National Action Plans, EU member states can demonstrate a unified commitment to addressing this critical issue.
Sources
Cassini et. al., Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modeling analysis. Lancet Infect Dis. 2019 Jan;19(1):56-66. doi: 10.1016/S1473-3099(18)30605-4. Epub 2018 Nov 5.
Anderson, Micheal, et al. “Implementing an EU pull incentive for antimicrobial innovation and access: blueprint for action.” The Lancet, 2024, https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(24)00109-5/fulltext#secsectitle0020. Accessed 30th July 2024.
Global Burden of Disease Collaborative Network. Global Burden of Disease Study 2019 (GBD 2019). Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2020.
Council of the European Union. “Council Recommendation on stepping up EU actions to combat antimicrobial resistance in a one health approach.” https://data.consilium.europa.eu/doc/document/ST-9581-2023-INIT/en/pdf Accessed August 14, 2024
Boluarte and Schulze (2022). The Case for a Subscription Model to Tackle Antimicrobial Resistance. Boston Consulting Group. Accessed online 3 May 2024.
"Library of AMR national action plans". WHO. Accessed online 3 May 2024.
Mossialos E Permanand G Baeten R Hervey TK Health systems governance in Europe: the role of European Union law and policy. 1st edition. Cambridge University Press, New York, NY2010
Adapted, with permission. B. Polek, R. Blankart, S. Mühlebach, W. Fürst. The Round Table on Antibiotics, a multi-disciplinary Swiss initiative to foster the development and availability of antibiotics (n.d) https://roundtableantibiotics.ch/download/86/RTA_poster_Swiss_Pharma_Science_Day_2023.pdf?inline=true
Årdal et al. DRIVE-AB. Policy brief on a Pan-EU-EEA Pull Incentive for Antimicrobial Innovation and Access. Accessed online 14 August 2024.
European Commission. HERA 2024 Work Plan (2023). https://health.ec.europa.eu/publications/hera-2024-work-plan_en Date accessed: August 14, 2024