Case Study


Company Sandoz AG
Sub category of Industry Generics
Category of commitment Access

Initiative’s description

Retarpen, or benzathine benzylpenicillin G (BPG), is a WHO-approved essential medicine. It is the only recommended treatment to prevent mother-to-child transmission of syphilis, and it is a first line medication for rheumatic heart disease. A single dose of low-cost BPG ends the syphilis infection risk in adults with no documented risk of antibiotic resistance. Globally, more women who are pregnant suffer from syphilis than from HIV, resulting in over 500,000 adverse pregnancy outcomes annually.

However, a study carried out by WHO a few years ago showed that this commonly prescribed essential antibiotic, which has a typical average cost of just below US2 per vial, was unavailable in 39 out of 114 countries,[i] potentially putting millions of lives at risk. Global supplies of the API for this critical medicine are limited to a handful of suppliers, all based in China.

Sandoz, which has been supplying BPG to many markets worldwide for the past 30 years, faced severe quality issues with its existing API supplier, resulting in repeated stock-outs. Despite high levels of investment required to remediate the situation, and an economically poor business case, Sandoz recognized the high medical need for this critical product and committed to remediating its Retarpen supply situation by 2020. The remediation work is currently proceeding according to plan. While it is difficult to make exact impact forecasts, WHO prequalification should help to ensure that the Sandoz “relaunch” drives global access to this essential medicine.