A framework has been released so that treatments targeting antibiotic-resistant bacteria are used responsibly and that the spread of antibiotic-resistant bacteria is minimised when new products are launched onto the market.
Antibiotics
The Stewardship and Access Plan Development Guide has been developed by international collaborators working across industry, government and philanthropic efforts.
The document provides companies with guidance on strategies and activities that help support stewardship and access for developers bringing new antibacterial products to market. The framework sets a new benchmark for the responsible use of antibiotics and other therapeutics such as vaccines and diagnostics that target antibiotic-resistant bacterial infections.
The World Health Organisation (WHO) has highlighted drug-resistant bacteria as one of the top global health threats. It’s estimated that 700,000 people die every year from infections caused by antibiotic resistant infections.
“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, health security and economic perspective, it is the right approach.”
Companies that receive funding by CARB-X will need to develop a Stewardship and Access Plan for when their product reaches clinical trials. This will outline what strategies will be deployed to ensure responsible stewardship and access in low-and middle-income countries.
It’s hoped that the guide will also make governments and product developers be more proactive in integrating stewardship and access principles into their activities.
“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.
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.”