Access to Antibiotics

Barriers to antibiotic access

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.