Innovation goes hand-in-hand with stewardship and access
CARB-X’s primary focus is accelerating antibacterial innovation. CARB-X also actively supports stewardship and access to ensure that products funded and supported by CARB-X are used responsibly and are made accessible to patients who need them. Stewardship and access principles must exist alongside the research and development of new products, so that these vital products are available to patients who need them, used responsibly, and safeguarded for future generations. This is essential to addressing the global antibiotic-resistant bacteria threat.
Link to announcement March 22, 2021
Stewardship and Access Plan Development Guide provides a new benchmark for product developers around the world
The Stewardship and Access Plan Development Guide, developed and endorsed by cross-sector stakeholders, is the world’s first comprehensive guidance to support developers of therapeutics, diagnostics and preventatives to produce Stewardship and Access Plans. The Guide outlines what is reasonably expected of product developers in relation to stewardship and access. CARB-X-funded product developers are contractually obligated to develop a Stewardship and Access Plan for their funded product, outlining what strategies they will deploy to ensure responsible stewardship and appropriate access in low- and middle-income countries (LMICs). The Plan must be developed within 90 days of their product entering pivotal Phase 3 clinical development, or the equivalent for diagnostics. The Plan would be shared publicly if the product obtains regulatory approval. It is our hope that the contents of this Guide will inspire product developers everywhere, and governments and other organizations, to develop their own plans and to integrate Stewardship and Access principles into their activities.
To view our Stewardship and Access FAQ click here.
To view a 10-minute interview with Kevin Outterson and John Rex, focusing on background to the Guide and practical approaches for product developers, click here.
To view a 50-minute webinar, led by Kevin Outterson and featuring Wellcome’s Tim Jinks, on Stewardship and Access principles and practical approaches for product developers, click here.
“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.”
— Dr. Hanan Balkhy
Assistant Director General on AMR
World Health Organization (WHO)
“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.”
— Tim Jinks
Head of Interventions, Infectious Diseases
Wellcome
”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.”
— Dame Sally Davies
UK Special Envoy on AMR
“To effectively tackle antibiotic-resistant infections, we must ensure sustainable access to lifesaving treatments and their responsible use to limit the further spread of drug resistance. GARDP welcomes and supports CARB-X’s new guide for developing stewardship and access plans. We are working for a world where everyone who needs antibiotics receives effective, appropriate and affordable treatment, no matter where they live.”
— Dr. Manica Balasegaram, Executive Director
Global Antibiotic Research & Development Partnership (GARDP)
“The Access to Medicine Foundation has been working to incentivise pharma companies to develop Stewardship and Access Plans since 2016. We are confident that this new guide will further support companies in making SAPs a priority. We look forward to capturing progress in this important space through our next AMR Benchmark and beyond.”
— Jayasree K. Iyer, Chief Executive Officer
Access to Medicine Foundation
“Addressing AMR requires an innovative and clear approach. The Stewardship and Access Plan Development Guide is the product of global collaboration and public-private partners whose guidance and expertise are helping product developers ensure appropriate use of new antibiotics and blaze a more equitable path toward combating AMR.”