Access to Antibiotics
The right antibiotic at the right dose and the right time can mean the difference between life and death for a patient with a serious bacterial infection. Unfortunately, even in the face of growing antibiotic resistance, many health systems—particularly in low- and middle-income countries—do not have reliable access to effective antibiotics. GARDP is taking action during late-stage antibiotic development and after approval so that new and existing antibiotics are accessible to people in need of all ages, wherever they live.
Programme goals
Advancing access to antibiotics in GARDP’s portfolio, both in development and after regulatory approval, including novel and generic antibiotics. Innovative product development is linked with post-approval access.
SECURE—accelerating access to essential new and generic antibiotics to prepare countries for the silent pandemic of drug-resistant bacterial infections
Improve market conditions, implementation and policy
“The products that are coming out of the antibiotic development pipeline are not making it to patients around the world. This is especially true of patients in low- and middle-income countries, who are most affected by antibiotic resistance. We are working to improve access to the antibiotics that are desperately needed.”
– Jennifer Cohn, Global Access Director, GARDP
Current projects
Cefiderocol access project
On the basis of a first-of-its-kind license agreement with Shionogi, a collaboration agreement with Shionogi and CHAI, and a sublicense agreement with Orchid Pharma, GARDP and partners aim to provide access to cefiderocol, an antibiotic with activity against a number of drug-resistant bacteria on the World Health Organization (WHO) priority pathogen list, including Enterobacterales and Pseudomonas aeruginosa (read the full agreement). Cefiderocol has been approved by the US Food and Drug Administration and by the European Medicines Agency, and it is included on the WHO Model List of Essential Medicines. Until now, this antibiotic has been available in only a few high-income countries, and it has not been available at all in low- and middle-income countries (LMICs).
Under the agreement with Shionogi, GARDP will be able to manufacture and commercialize cefiderocol through sub-licensees in almost 70% of countries worldwide (135 countries), most of which tend to have delayed access (if any) to novel antibiotics. The license territory includes all low-income countries, most lower middle- and upper middle-income countries, and select high-income countries.
In September 2023, GARDP and Orchid Pharma Ltd (Orchid) signed a sublicense agreement to manufacture cefiderocol. The agreement has important access, environmental, & stewardship provisions, including cost-plus pricing, with a commitment to lower the costs based on volumes to help keep the product affordable for patients and health systems in low-resource settings.
Through this project, GARDP aims to forge new pathways and build sustainable networks so that cefiderocol—and, in the future, other antibiotics like it—can reach people in need.
Access initiatives for antibiotic treatments in development
GARDP aims to ensure that its co-developed antibiotic treatments for newborns, children and adults are accessible for appropriate use in patients around the world. With this goal in mind, GARDP provides technical and financial support to antibiotic developers for products that align with public health needs in exchange for manufacturing and commercialization rights, and it embeds access considerations into the R&D process. GARDP has also signed a partnership agreement with the Global Drug Facility (GDF), part of the Stop TB Partnership hosted by UNOPS, to pool procurement of antibiotics in the GARDP portfolio. Such pooling is expected to accelerate delivery, lower wastage, and lower costs for the benefit of patients and health systems.
SECURE: The Antibiotic Facility prepares countries for a pandemic of drug-resistant bacterial infections
SECURE, a collaborative initiative by WHO and GARDP, seeks to accelerate access to a portfolio of essential antibiotics, including generic antibiotics that are in short supply or not widely available, as well as newly approved “reserve” antibiotics for resistant bacterial infections.
SECURE is the first dedicated mechanism to expand access in LMICs to essential antibiotics, which goes beyond access to single products. Visit secureantibiotics.org.
Implementers networks and other activities
A number of barriers hinder new antibiotics from being available for the right patient at the right time, especially in low- and middle-income countries. To overcome these barriers, GARDP is facilitating the development of implementer networks in Kenya and South Africa (where they are known as “PREACTs”), as well as in India. It is similarly engaging stakeholders in the Latin American and the Caribbean region, with an initial focus on Brazil.
These implementer networks bring together members of national Ministries of Health, academic centres and major public and private healthcare providers among others to help identify which new antibiotic treatments are most important for their region. They may act as early adopters of these treatments and share data and best practices to introduce these treatments appropriately across the country or region. Although GARDP currently has a coordinating role of these networks, they may become self-managed and self-funded in the future.
Alongside these networks, GARDP carries out a number of market shaping and policy-related activities to foster antibiotic access, including generating data to offer insight on product demand and appropriate use, and recommending policies that enable reliable and affordable antibiotic supply.
Our vision for access
Key milestones
- 2017-2022: SIGNED collaboration and license agreements with: Entasis Therapeutics, an affiliate of Innoviva Specialty Therapeutics, for zoliflodacin (2017); Venatorx Pharmaceuticals for cefepime-taniborbactam (2020); Shionogi & Co., Ltd, and CHAI for cefiderocol (2022)
- 2021: PARTNERED with InfectoPharm, which donated supplies to support the development of new treatment for neonatal sepsis
- 2021: SIGNED memorandum of understanding with the Thailand Ministry of Public Health to work toward ensuring access to the antibiotic zoliflodacin
- 2024: SIGNED collaboration agreement with the Global Drug Facility to pool procurement of antibiotics in GARDP portfolio
About access to antibiotics
About access to antibiotics
Lack of access to novel antibiotics is a global problem that acutely affects whole countries and regions as well as certain population groups. A recent study found that the majority of the 18 new antibacterials approved and launched between 2010-2020 were accessible in only 3 out of 14 high-income countries (Sweden, UK and US). In low- and middle-income countries, the problem is even worse. Only 12 of the 25 new antibiotics that entered the market between 1999 and 2014 were registered in more than ten countries. Moreover, the evaluation of new treatments for use in children is regularly delayed for years, if undertaken at all.
Impediments to antibiotic access range from lack of high-quality evidence for usage guidelines to incomplete introduction plans. Efforts to overcome these barriers—including access objectives in National Action Plans on antibiotic resistance—remain underfunded and largely unimplemented.
Inaccessible antibiotics can’t be used to treat patients with bacterial infections. GARDP is working to overcome barriers to access so patients of all ages can receive appropriate treatments wherever they live.
Learn more
Learn more
- Poster on antibiotic implementor networks in South Africa and Kenya (PREACTs)
- Assessment of Antimicrobial Resistance Diagnostic Capacity and Antibiotic Use in 10 Counties in Kenya
- Access Strategy and Priorities (Updated Nov. 2023)
- Cefiderocol access project: Overview of license agreement with Shionogi (see also full license agreement) (2022)
- GARDP Report: Access to Essential Antibiotics for India: Challenges and Opportunities