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 working to accelerate access to antibiotics for appropriate use around the world.
Imagine this scenario. A person is hospitalized with bacterial pneumonia. The doctor starts the patient on an antibiotic, and takes a sample for lab testing. Over the next two days, the patient’s breathing becomes laboured, and high fever sets in. The lab results come back: the patient is infected with a bacteria that shows resistance to multiple classes of antibiotics. Only a few, hard-to-get antibiotics are likely to be safe and effective. If treatment is delayed, the infection will grow, making recovery even more difficult, if not impossible.
To beat this infection, the doctor needs access to the right antibiotic to treat the patient as soon as possible.
But getting the right antibiotic from the research lab to a patient in need is a complex process that is influenced by technical, legal, regulatory, economic, and social factors. Recently approved (“novel”) antibiotics rarely reach patients outside a limited number of countries. The obstacles range from limited high-quality evidence for developing guidelines on optimal use to broken markets to incomplete introduction plans.
Barriers to antibiotic access
Lack of access to novel antibiotics is a global problem. 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 10 of the 25 new antibiotics that entered the market between 1999 and 2014 were registered in more than ten countries.
In addition, delays in paediatric development of novel antibiotics often compromise access and limit treatment options for newborns and children. Although many countries with National Action Plans for antibiotic resistance mention access to novel antibiotics as an important objective, most of these plans remain grossly underfunded, and many are not implemented.
GARDP is working to overcome barriers so that antibiotics are accessible to people in need of all ages, wherever they live. Accessible antibiotics are:
- Affordable in all settings, including those with limited resources
- Available at the right time in the right place
- Developed for use in children and adults
- Used appropriately to minimize resistance
Expanding antibiotic access in a responsible way will require a concerted effort by a variety of actors across the public, private and non-profit sectors. GARDP is working with medical professionals, policymakers, antibiotic developers, non-profit groups and others to carry out this important work.
Goal 1: Advancing access to antibiotics in GARDP’s portfolio, both in development and after regulatory approval, including novel and generic antibiotics
GARDP aims to ensure its innovative product development is linked with post-approval access. GARDP analyzes the entire product-to-patient pathway to identify and, with partners, address access barriers. GARDP 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.
GARDP has signed a first-of-its-kind license agreement with Shionogi and a collaboration agreement with Shionogi and CHAI to provide access to cefiderocol, an antibiotic with activity against a number of drug-resistant bacteria on the WHO Priority Pathogen List, including Enterobacterales and Pseudomonas aeruginosa. 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 not been available in low- and middle-income countries, which are hardest hit by the highly drug-resistant infections for which cefiderocol was designed.
Under the agreement with Shionogi, GARDP will be able to manufacture and commercialize cefiderocol through sub-licensees in a large range of countries that 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 (135 countries total). To deliver on this agreement, GARDP and Shionogi have teamed up with CHAI in a three-way collaboration agreement. See more here.
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.
Goal 2: Securing access to a portfolio of novel and generic antibiotics
SECURE, a future “antibiotic facility,” is a collaborative initiative developed by the WHO and GARDP, with support from UNICEF and the Clinton Health Access Initiative. SECURE seeks to accelerate access to a portfolio of essential antibiotics, including generic antibiotics that have long been in use, as well as novel antibiotics that have recently been approved by a stringent regulatory authority (SRA). These antibiotics have been chosen in light of their ability to treat bacterial infections and to contain a pandemic of drug-resistant bacterial infections.
Taking a collaborative and global approach, SECURE is the first dedicated mechanism to expand access to essential antibiotics which goes beyond access to single products. It has a number of features that are innovative in the context of efforts to expand access to antibiotics and to address antibiotic resistance:
- A comprehensive vision of a sustainable and stable global antibiotics market.
- An antibiotic procurement platform that optimizes production and supply planning (through activities like market shaping, central contracting, the use of regional procurement platforms, price negotiation and pooled procurement).
- A focus on accelerating evidence generation on the proper use of antibiotics. This information can be used to develop new guidelines for optimal use and to support antimicrobial stewardship programmes.
- Support for wider registration for newly approved and generic antibiotics where they are needed.
- An innovative financing mechanism for the procurement of antibiotics, including an assessment of the possibility of a payment model that de-links cost from volume and accounts for the needs of low- and middle-income countries.
- An opportunity to expand the use of new products in new geographical markets by providing better forecasting and predictable demand to facilitate production planning.
Goal 3: Improving the policy environment for access
GARDP takes a leadership role in advocating for funding and in developing policies that aim to accelerate global access to antibiotics. In this role, GARDP works to fill critical innovation and knowledge gaps to support data-driven policies for equitable access to antibiotics. Currently, GARDP is partnering with Imperial College, UK, and the Postgraduate Institute of Medical Education and Research (PGIMER), India, to complete an assessment of 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.
Key milestones of GARDP’s work on access:
- 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
- SIGNED collaboration 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
- SIGNED partnership agreement with Entasis Therapeutics, which gives GARDP the ability to make accessible a new antibiotic for gonorrhoea (zoliflodacin), upon approval, in all low- and middle-income countries.
- SIGNED Memorandum of understanding with Dr Reddy’s Laboratories and Aurigene Pharmaceutical Services Limited (APSL) in India, as well as with the Thailand Ministry of Public Health, to work toward improving access to the antibiotic zoliflodacin.
- Overview of license agreement with Shionogi (see also full license agreement)
- Collaboration overview with Venatorx Pharmaceuticals
- Partnership overview Entasis and GARDP
- Memorandum of understanding with Dr Reddy’s Laboratories and Aurigene Pharmaceutical Services Limited (APSL) in India
- Memorandum of understanding with Thailand Ministry of Public Health
- Viewpoint: A Nonprofit Drug Development Model is Part of the Antimicrobial Resistance Solution
- GARDP report on Sustainable Access Workshop (2019)
- GARDP India Access Report 2022