The Global Antibiotic Research and Development Partnership (GARDP) welcomes the re-introduction of the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. As a not-for-profit organization with ambitious goals to develop new treatments for drug-resistant infections that pose the greatest threat to human health, we support novel subscription models that focus on priority health needs, and which can both provide an incentive for the development of new antimicrobials and separate sales revenues from the volume of antibiotic sales. Financial models which integrate the appropriate use and stewardship of antibiotics is a critical goal for preserving the long-term effectiveness of novel antibiotics.
As we have seen with COVID-19, no one is safe until everyone one is safe. High-income countries are greatly affected by AMR – it is estimated that 2.4 million people could die in high-income countries between 2015 and 2050 without a sustained effort to contain AMR. Yet AMR has its highest burden in low- and middle-income countries (LMICs). Even so, these countries are often deprioritized by for-profit companies with respect to prevention and treatment of drug-resistant infections and antimicrobial resistance (AMR). Currently in LMICs, hundreds of thousands of newborns are dying of untreatable sepsis every year, and patients are suffering from multidrug resistant gonorrhea and serious bacterial infections.
Research priorities should consider global health needs. Drug resistance evolves, and drug-resistant infections spread rapidly through international travel, migration, and supply chains. Thus, what may not currently be a threat in the United States (but is a critical threat in another country) may become of public health import in the United States in the near future. Prioritization should also be guided by specific infections of concern and can also be defined according to sub-populations and geographies.
To maximize the Act’s public health impact in the United States and around the world, GARDP recommends the following:
- The Pasteur Act should strengthen registration requirements for successful recipients of either transitional subscription contracts or subscription contracts. While we welcome the recognition that registration is a critical pre-requisite for improving access to antibiotics in LMICs, we believe the legislation could ensure recipients make commitments to register such products in these countries. The Stewardship and Access Plan required of recipients of a contract may not be adequate to move from good intentions to concrete outcomes. We encourage policymakers to include “seeking market authorization in LMICs, either on their own or in partnership with a non-profit entity focused on drug registration and access in LMICs” as a “favored characteristic” in determining contract value. These are necessary in part because very few novel antibiotics today are registered in more than a handful of countries worldwide. Of the novel antibiotics entering the pharmaceutical market between 1999 and 2014, only 12 of the 21 products were registered in more than 10 countries, and those registrations were concentrated in high-income countries (HICs). At the same time, most of the newer antibiotics which have sought approval in HICs have conducted trials in LMICs as a means of collecting data from populations with high incidence of multidrug resistant (MDR) pathogens. Indeed, this should lend itself to ensuring these lifesaving agents are available for patients in LMICs, but unfortunately often does not happen. Finally, companies have typically conducted very little post approval real world studies that are necessary to bridge the gap between small and narrow registrational trials and clinical practice. A wider goal of registering in LMICs could also facilitate more rapid generation of real world data and help all communities.
- The Pasteur Act should encourage the development of combination therapies insofar that such combinations address an unmet public health need. At present, the current language deprioritizes drugs which include an already known active moiety. This will, by design, disincentivize developers from investing in novel combinations that can extend the use of an older antibiotic that could address a critical public health need. We encourage policymakers to reconsider this language to ensure that novel combinations remain of interest to drug developers given the severely limited current pipeline of agents that can tackle highly resistant infections.
- The Pasteur Act should encourage developers to invest in research and development that benefits children under the age of five. Children and newborns face some of the worst consequences of AMR, including a heavy burden of illness and death. At present, research and development of new antimicrobials for children is inadequate. Formulations appropriate for children and the surrounding evidence for their use is lacking, and children suffer from a lack of access to existing antibiotics. The Pasteur Act should include specific legislative provisions to incentivize accelerated development of new antibiotics that address the needs of children, whether novel antimicrobials, formulations, and/or through partnerships and programs.
GARDP applauds Senators Michael Bennet (D-Colo.) and Todd Young (R-Ind.) and Representatives Mike Doyle (D-Pa.) and Drew Ferguson (R-Ga.) for recognizing the threat of antibiotic resistance, the need to address the broken antibiotic market, and the impact of infectious disease on global health. We at GARDP look forward to working with policymakers in the US and globally to ensure that antibiotics are accessible to all who need them.
The Global Antibiotic Research and Development Partnership (GARDP) is a Swiss not-for-profit organization developing new treatments for drug-resistant infections that pose the greatest threat to health. GARDP was created by the World Health Organization (WHO) and the Drugs for Neglected Diseases initiative (DNDi) in 2016 to ensure that everyone who needs antibiotics receives effective and affordable treatment. We aim to develop five new treatments by 2025 to fight drug-resistant infections. focusing on sexually transmitted infections, sepsis in newborn babies and infections in hospitalized adults and children. GARDP is funded by the governments of the United Kingdom, Germany, Japan, Luxembourg, Monaco, Netherlands, South Africa, Switzerland, as well as Médecins Sans Frontières and private foundations.