Guidance on Stewardship and Access for developers published
Led by Wellcome Trust, a group of AMR funders has published the first guidance on strategies and activities to support Stewardship and Access for companies bringing new antibacterial products to market.
The Stewardship and Access Plan Development Guide provides companies with a framework to develop plans so that their product will be used responsibly, minimizing the spread of antibiotic-resistant bacteria while helping patients get access to life-saving products. The guide gives a technical deep-dive into the key components that companies can include in their plans to ensure maximum impact and outlines concrete examples of the strategies that could be adopted.
The Guide sets a new benchmark for the responsible use of antibiotics, other therapeutics, preventatives including vaccines, and diagnostics to address antibiotic-resistant bacterial infections. Overuse and misuse of antibiotics around the world are major contributors to the global drug-resistant bacteria crisis. The World Health Organization (WHO) estimates that 700,000 people die each year from infections caused by bacteria that have developed resistance to antibiotics.
“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,” said Kevin Outterson, Executive Director of CARB-X, which is led by Boston University and is investing $480 million in 2016-22 to accelerate the early development of innovative antibacterial products including antibiotics, vaccines and rapid diagnostics. “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.”
Companies funded by CARB-X, a global non-profit partnership that supports the world’s largest early development pipeline of new products, are required to develop a Stewardship and Access Plan for their CARB-X-funded project, when it reaches clinical trials. The plan outlines what strategies will be deployed to help ensure responsible stewardship globally and access in low- and middle-income countries.
It is hoped that the Guide will also serve to inspire product developers everywhere, and governments and other organizations involved in antimicrobial resistance (AMR), to be more proactive in integrating Stewardship and Access principles into their activities.
A new benchmark for developers of innovative antibacterial products
“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. 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,” said Tim Jinks, Head of Drug-Resistant Infections Program at Wellcome Trust, which led the development of the Guide.
World AMR leaders welcome the guide as a step forward
Dame Sally Davies, UK Special Envoy on AMR, said: “Sound Stewardship and Access Plans are key to the success of new products in the AMR space, because they ensure global accessibility to new treatments while also preventing inappropriate antimicrobial use in healthcare settings and beyond. But what does a good plan look like? This Guide will be made available to all developers, to help them articulate and formulate their own activities when they bring much-needed products to market, enabling us to achieve that goal of “access, not excess” to these essential medicines.”
Dr. Hanan Balkhy, Assistant Director General on AMR at the WHO, said: “Public and private funded innovation to tackle antimicrobial resistance becomes meaningless if it does not benefit all patients wherever they live, and if products are not used responsibly. WHO welcomes CARB-X’s initiative to integrate the principles of stewardship and access into the funding of antibacterial R&D, and to do so early in the R&D process with transparency and purpose.”
The Guide was developed by a cross-sector working group led by Wellcome Trust, one of CARB-X’s major funders. It included several other CARB-X funders – the United States Department of Health and Human Services (HHS) Office of Global Affairs (OGA) and Biomedical Advanced Research and Development Authority (BARDA), the UK Department of Health and Social Care (DHSC) Global AMR Innovation Fund (GAMRIF), and the Bill & Melinda Gates Foundation (BMGF) – as well the Global Antibiotic Research and Development Partnership (GARDP), the Access to Medicine Foundation (ATMF), and the Biotechnology Innovation Organization (BIO).