It may seem impossible to imagine a future where a minor injury and routine surgery is life-threatening, or cancer treatments are too risky to carry out at all. But with antimicrobial resistance (AMR) on the rise and, unless there is urgent collective action, this could soon be our reality.
As we still recover from one pandemic, we need to prevent a second; one that has the potential to be even more catastrophic.
AMR is a major health burden that claimed nearly 1.3 million lives in 2019[1] alone. The future outlook is even bleaker — AMR is predicted to kill 10 million people every year by 2050, a figure that surpasses the number of deaths currently caused by cancer, with projected economic losses of up to $100 trillion, if no action is taken.[2]
As we still recover from one pandemic, we need to prevent a second; one that has the potential to be even more catastrophic. That’s why an EU Parliament event was held earlier this month to address the growing threat of AMR ahead of World Antimicrobial Awareness Week. Hosted by Shionogi, in partnership with Active Citizenship Network and endorsed by the MEPs Interest Group on European Patients’ Rights & Cross-Border Healthcare, the event discussed actionable solutions and policy changes needed to counter this critical global health threat.
A broken market for antimicrobials
AMR occurs when bacteria, viruses, fungi and parasites evolve until they no longer respond to antimicrobials (medicines such as antibiotics). As a result, infections become more difficult to treat and the risk of disease spreading, severe illness and death is heightened.[3]
New antibiotics are powerful weapons to help combat AMR. As pathogens continually evolve their response to antimicrobials, new and innovative treatments are needed to outpace the development of resistance. However, the traditional economic model for drug discovery is failing when it comes to antibiotic development. New antibiotics should be used sparingly or as a final resort in order to preserve their effectiveness. For this reason, there is no viable market for new antibiotics: investment is lacking, and many pharmaceutical companies are abandoning antibiotic research and development (R&D) altogether, or indeed claiming bankruptcy, as a result.
As pathogens continually evolve their response to antimicrobials, new and innovative treatments are needed to outpace the development of resistance.
While several global and European initiatives — including the Global Action Plan by the World Health Organization (WHO)[3] and the One Health Action Plan by the European Commission[4] — have raised awareness and prioritized AMR, more pragmatic and collaborative action is required at a country level.
AMR: a second pandemic in the wake of COVID-19?
There are fears that the COVID-19 pandemic may have exacerbated the situation. This is due to an initial lack of understanding of treating the virus, leading to widespread inappropriate use of antibiotics.[5]
Nonetheless, AMR has been somewhat overshadowed by the pandemic,[6] and if we’ve learnt anything from COVID-19, it’s that a global health threat which appears distant can suddenly creep up — devastating lives, health care systems and economies in its wake.
Today, we still face ramifications of the pandemic. And, as we reflect on the past three years, we realize just how truly vulnerable our health care systems are to infections when we have limited or no standard treatments available to combat them. This becomes a significant concern with multidrug-resistant infections emerging.[7]
Advocating for urgent policy change at EU Parliament
So, collectively, how can we address the threat of AMR and encourage the development of new antimicrobials?
An important starting point is new economic incentives, such as pull incentives, which help to incentivize antibiotic R&D and support innovation. Pull incentives, like new reimbursement models, partially or fully delink the revenue of new antibiotics from sales volume, thereby rewarding companies for making effective antibiotics available. This helps create a more predictable and sustainable market that encourages development of new antimicrobials.
Mark Hill, senior vice president, global head of value and access, at Shionogi said: “We know that incentivizing 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.”
The meeting was crucial to increase awareness of antimicrobial resistance and the need for new innovations to address unmet needs.
The importance of these incentives was affirmed at the EU Parliament event. Considering the upcoming revision of the EU pharmaceutical legislation and the upcoming Council recommendations on AMR, the event brought together high-level European policymakers to discuss concrete examples of innovative frameworks conducted by national health authorities to fight against AMR.
“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 organizations, industry, the European Commission, academia and health care professionals to work together to drive policy change and put in place a common response to this increasing societal challenge,” said MEP Aldo Patriciello.
MEP Fabio Massimo Castaldo also affirmed the importance of developing a predictable regulatory environment to incentivize 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 they meet the objective and ambition that are needed”.
“We hope that the tangible recommendations from this event can be leveraged by member states,” added MEP István Ujhelyi. “At the end of the day, we need to turn policies into practice, and for this to become reality, member states have a critical role in acknowledging the challenge that AMR poses to society and health care systems and implementing actions, plans and best practices.”
Mariano Votta, director of Active Citizenship Network, the EU branch of Italian nongovernmental organization Cittadinanzattiva, said: “The inclusion of the AMR within the work program of the incoming Sweden Presidency of the Council of the EU and the prioritization of the topic by the European Health Emergency Preparedness and Response Authority give the opportunity to advance policy action to improve stewardship, surveillance of resistance patterns across Europe and incentivize 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.”
As a company that has been researching and developing medicines in infectious disease since 1878, Shionogi recognizes that implementing policy change requires time, stakeholder engagement and political goodwill, but we can make significant progress if industry works closely with governments and policy stakeholders to coordinate our actions at regional and local country level. Shionogi is committed to ensuring that individual patients and society as a whole will continue to benefit from effective antimicrobials, and we are calling for collaborative partners to join us in the fight against AMR.
[1] Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet, 399:629–655 (2022).
[2] O’Neill J et al. (2016) Review on antimicrobial resistance. Tackling drug-resistant infections globally: final report and recommendations, https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf
[3] WHO (2016) Global action plan on antimicrobial resistance, https://www.who.int/publications/i/item/9789241509763
[4] European Commission (2017) A European One Health Action Plan against Antimicrobial Resistance (AMR), https://health.ec.europa.eu/system/files/2020-01/amr_2017_action-plan_0.pdf
[5] Cherry W et al. A rapid review of the overuse of antibiotics during the COVID-19 pandemic: lessons learned and recommendations for the future. AMRC Open Research. 3:17 (2021).
[6] Cameron, et al. Antimicrobial Resistance as a Global Health Threat: The Need to Learn Lessons from the COVID-19 Pandemic. Available at: https://onlinelibrary.wiley.com/doi/10.1111/1758-5899.13049
[7] Adebisi YA et al. COVID-19 and Antimicrobial Resistance: A Review. Infectious Diseases, 14 (2021).
