A Stewardship and Access Plan Development Guide for countering the spread of antibiotic-resistant superbugs was developed and released this week by CARB-X, some of its leading funders and major antibacterial researchers.
The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced the release was directed at pharmaceutical companies worldwide as a framework to guide the development and use of their products. Overuse and misuse have been common fuel to the spread of the problematic new bacteria as they adapt to existing threats.
“Antibacterial innovation must go hand-in-hand with responsible use and access. Otherwise, innovative drugs that are meant to help patients risk contributing to the global burden of antibiotic resistance,” Kevin Outterson, Executive Director of CARB-X, said. “We all must do our part to see that antibacterials are used responsibly and that patients who need them have access to them. From a public health, a health security and economic perspective, it is the right approach.”
The guide is a first of its kind, at a time when the World Health Organization estimates 700,000 people are dying each year from antibiotic-resistant bacteria. That number is only expected to grow with time, left unchecked. As a result, this plan outlines strategies for developers to pursue to guarantee responsible care globally and guarantee access in low and middle-income countries.
CARB-X alone is in the process of investing $480 million between 2016-22 to accelerate the early development of innovative antibacterial products, including antibiotics, vaccines, and rapid diagnostics. The global non-profit partnership is one of the largest supporters of the early development pipeline of new products. Companies funded by it must create a Stewardship and Access Plan for their projects once they reach clinical trials.
“Responsible stewardship and equitable access to antibiotics is critical so that these vital products are available to patients who need them and safeguarded for future generations,” Tim Jinks, Head of Drug-Resistant Infections Program at Wellcome Trust, which led development of the Guide, said. “The Guide represents a new benchmark for what can be expected from companies preparing to market innovative antibiotics, as they should proactively develop robust plans enabling worldwide stewardship and equitable access alongside market entry plans. We are delighted to see the publication of the guide and hope that these insights inform the wider pharmaceutical, scientific, and global health community, as well as CARB-X awardees.”
Other contributors and endorsers included The Access to Medicine Foundation, UK Government, The Bill & Melinda Gates Foundation (BMGF), U.S. Department of Health and Human Services Office of Global Affairs and Biomedical Advanced Research and Development Authority, and The Global Antibiotic Research & Development Partnership.