Taking Collective Action to Address AMR and Promote the Development of New Antimicrobials (Guest Blog)
25.04.18
Unlike Zika virus or SARS, antimicrobial resistance (AMR) is a predictable phenomenon. We have known since the first antibacterials were introduced that drug resistance inevitably follows. Put simply, when we use them, sooner or later, we lose them. Though we enjoyed a false sense of security over the past few decades as the development of new and ever more powerful antimicrobials outpaced the emergence of resistance, we now have to face a stark reality: bacteria develop new modes of resistance much faster than we can develop new drugs to defeat them.
The number of companies actively pursuing antimicrobial and antifungal discovery and development has precipitously declined in the past two decades. Just this past month, one of the few remaining large pharmaceutical companies investing in antibiotics decided to discontinue its efforts. There are less than 50 investigational antibiotics in the pipeline, compared to over 800 oncology and vaccine candidates. At the same time, global antibiotic consumption continues to increase. A recent Proceedings of the National Academy of Sciences publication reported that antibiotic use in 76 countries increased by 65 percent between 2000-2015, with most of this increase in middle-income countries. These ominous trends are punctuated by reports of drug-resistant pathogen outbreaks - most recently a highly resistant outbreak of Salmonella typhi in Pakistan.
Immediate action is imperative! We must speed up antimicrobial discovery and development, and slow down the emergence of drug resistance when new medicines do become available. These are very hard challenges, but certainly not unsolvable ones.
Preserving the efficacy of the drugs we do have requires a coordinated global “ecosystem” effort across human, animal, and ecologic domains. The highest priority is to prevent infections in the first place, through better sanitation, hygiene, human and animal vaccines, and less-invasive medical care. We also need to rapidly and accurately diagnose infections and antimicrobial susceptibility to ensure that both human and animal infections are treated with the right drug at the right time for the right duration. And last but not least, we must all collaborate to foster responsible antimicrobial stewardship - using antimicrobials only when necessary and reserving those effective against highly resistant pathogens to special situations where they alone are effective.
Speeding up antimicrobial development is a more formidable challenge. Two main barriers to industry engagement have to be overcome: scientific challenges in identifying new targets and classes of drug candidates, and uncertain market rewards for innovation. The outlook for the former has probably never been brighter, given the revolution in bioscience capabilities we are enjoying. However, the latter challenge is proving to be much more difficult, and we can only succeed in justifying capital allocation to the quest for novel, safe and effective antimicrobials if there are appropriate incentives to drive innovation.
The current model fails to provide a sufficient economic return to spur the level of investment that society needs. Even when new and effective antimicrobials are approved, the return on investment for the developer is generally lower and slower compared to medicines in other therapeutic areas. The imperative to restrict use of pharmaceuticals that target resistant bacteria limits their market size, and current pricing models do not offset these volume limitations. In short, because healthcare systems, insurers, and governments currently do not provide an adequate return for novel antibiotics, there is little financial incentive to invest in their development.
In order to restock our medicine chest with effective antimicrobials, novel incentive mechanisms are needed. Policymakers, both at the EU and national level, must take action to create an economic environment that will support sustained investment in and, ultimately, delivery of a pipeline of products to ensure more patients do not succumb to infections caused by resistant bacteria. The European Commission’s Action Plan on AMR is a good starting point, but there is still much more to do.
In the context of the current preparation of the next Multi-Financial Framework and the future Framework Programme 9, the European Commission should consider putting in place novel incentives at the EU level, such as an EU market entry reward. This is one of the key recommendations of IMI’s DRIVE-AB, as these rewards could play an important role in enhancing the economic feasibility of antibiotic development. In parallel, at the member state level, countries should examine how their health technology assessment and reimbursement systems can be reformed to expand appropriate access to novel antibiotics. Adoption of a suite of incentives by the EU and by national governments would enable a more predictable and sustainable return on investment for successful innovation to combat AMR and meaningfully impact investment decisions.
Together, we must work to translate the current crisis into concrete action that will deliver solutions to address this growing global health threat. As one of the few large pharmaceutical companies that has sustained a focus in antimicrobial discovery and development, MSD is fully committed to continuing to collaborate with EU decision-makers, governments and other key stakeholders to ensure that these live-saving medicines are available for generations to come.
