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

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Goal 1

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.

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Goal 2

SECURE—accelerating access to essential new and generic antibiotics to prepare countries for the silent pandemic of drug-resistant bacterial infections

Goal 3

Improve conditions surrounding access, including 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 newly developed or co-developed antibiotic treatments for newborns, children and adults are accessible for appropriate use in patients around the world, with a special focus on low- and middle-income countries. In this pursuit, GARDP embeds access initiatives into its agreements to develop and co-develop antibiotics, for example with Venatorx Pharmaceuticals and Entasis Therapeutics, now an affiliate of Innoviva Specialty Therapeutics (see milestones below).

To carry out this work, GARDP analyses the entire product-to-patient pathway to identify and, with partners, address access barriers. GARDP also prioritizes the development of evidence across populations and age groups so that medical professionals can better understand how and when to use these newly available antibiotics appropriately.

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.

Exploratory and policy projects

Through exploratory and policy projects, GARDP works to fill critical innovation and knowledge gaps to support data-driven policies and advocate for adequate funding for equitable access to antibiotics. These projects include an antibiotic shortages assessment undertaken by GARDP with Imperial College, UK, and the Postgraduate Institute of Medical Education and Research (PGIMER), India. The assessment will identify the root causes of antibiotic shortages and the impact thereof in India, South Africa and the UK. It will also include recommendations to address those shortages, which can guide future policy decisions.

Our vision for access

Figure Access Vision 2023

Read Access Strategy

Key milestones

2017: SIGNED collaboration agreement with Entasis Therapeutics, an affiliate of Innoviva Specialty Therapeutics, which gives GARDP the ability to make accessible a new antibiotic for drug-resistance gonorrhoea (zoliflodacin), upon approval, in all low- and middle-income countries
2020: SIGNED collaboration and license agreement with Venatorx Pharmaceuticals that grants GARDP exclusive license to make accessible a new antibiotic combination, cefepime-taniborbactam, in 67 low- and lower middle-income countries, as well as in the public markets in India and South Africa
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
2022: SIGNED license agreement with Shionogi and collaboration agreement with Shionogi and CHAI to expand access to an antibiotic (cefiderocol) in nearly 70% of countries worldwide
2023: SIGNED manufacturing sublicense agreement for cefiderocol with Orchid Pharma

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

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
Viewpoint: A Nonprofit Drug Development Model is Part of the Antimicrobial Resistance Solution (2021)