On antibacterial manufacturing, transparency from companies inches forward
Independent evaluation of manufacturing practices of antibacterials is still limited due to lack of transparency on audit results, discharge levels and supply chains.
- Despite more companies publicly commit to discharge limits for antibacterial waste, publicly available information stays opaque
- Shionogi offers hope as leading example of disclosure on environmental impact
Data on compliance with environmental standards at manufacturing sites can often only be reported by the Benchmark in an aggregate manner due to requests for confidentiality.
Very few companies publicly report any level of detail on either the number of manufacturing sites audited, or on how many of these sites report compliance with safe levels. No company publicly reports on the actual levels of antibacterial residue entering local soil and water, and no company publishes its audit results.
The AMR Industry Alliance has a central role in setting strategy and deciding on public disclosure across the industry. But of the 12 members in scope, two companies (Fresenius Kabi and Otsuka) have not yet set limits at their own sites, and five companies (Aurobindo, Fresenius Kabi, Otsuka and Teva) have not yet formally required their suppliers to set limits. Cipla and Abbott report following the AMR Industry Alliance’s guidelines, despite not being a member.
Two companies, GSK and Shionogi, stand out by reporting on whether the levels of antibacterial discharge found at their manufacturing sites (both directly-operated and suppliers’ sites) comply with the limits set. This information is available in their annual or environmental reports. Novartis also reports on whether its own sites are compliant with pharmaceutical limits, though the company’s data is not specific to sites producing antibacterials.
Of the 12 companies that report setting limits, nine also publish their commitment to these limits via their websites or annual reports. The three that do not are Abbott, Aurobindo and Cipla. Publicly committing to set limits is important so companies can be held accountable when not living up to their own words.
The benefits of transparency
Without this information, it is difficult for independent third parties, including academic experts and government institutions, to critically assess if there is any progress and impact in making sure that antibacterial discharge levels are safe.
A lack of transparency also hinders evaluation of the accuracy of mass balance estimations compared to sampling, and what dilution factors are applied.
The publication of both a) the methods used by the companies, and b) the resulting data, would permit deeper understanding of the current situation, opportunities for optimisation, and the dissemination of good practice. It would allow procurers to examine AMR-associated risks of a company’s manufacturing practices in their procurement processes.1
Shionogi leads the way when it comes to public disclosure, by publishing many aspects of its environmental risk-management strategy in its environmental report. The company shares which antibacterials it has in its portfolio, and maps the manufacturing of these products to the company’s own sites and suppliers’ sites, reporting which are compliant with discharge limits. Furthermore, the location of suppliers and the name of its only external waste-treatment plant are also disclosed. Altogether, Shionogi serves as a positive example of a company that provides clarity about its antibacterial manufacturing supply chain.
1. Larsson DGJ, Fick J. Transparency throughout the production chain—a way to reduce pollution from the manufacturing of pharmaceuticals? Regul Toxicol Pharmacol. 2009;53(3):161-163.doi:10.1016/j.yrtph.2009.01.008