Disclosure of environmental risk-management
Shionogi is the first company to report publicly on how it manages the environmental risk of its antibacterial waste, disclosing detailed information
Japan and India
During pharmaceutical manufacturing, antibacterial residue is released into the environment through factory wastewaters. The environment, composed of water and soil, naturally contains bacteria, but when exposed to antibacterial waste that is released by the manufacturing sites, this can trigger the emergence and/or selection of resistance genes and contribute to AMR development.
Currently there are no specific regulations governing discharge of antibacterial waste, so it is important for companies to disclose publicly how they manage this. As stakeholders, such as governments, academic experts and procurers, depend on self-reporting, this increases companies’ responsibility to be transparent. When companies publish details and outcomes of strategies to manage the environmental risks associated with discharge, independent third parties can analyse processes and performance, and assess progress for keeping emissions at safe levels. The publication of methods and data also allows procurers a path to ensure they can leverage responsible environmental practices of company’s manufacturing in its sustainable procurement policies.
Of the 17 companies in scope, only three provide some information publicly about which sites comply with guidance on safe levels. The extent to which manufacturing practices of other companies pose a risk for AMR is not yet clear.
Why does Shionogi stand out?
As the first company to publish extensive detail, Shionogi leads the field. In 2020 it published an environmental report disclosing information on audit results covering wastewater management, solid-waste management and discharge limits. Its disclosure covers all antibacterial APIs and/or drug products the company makes at its site in Kanegasaki, Japan, and those made at nine supplier sites. Information is presented clearly and concisely, is broadly accessible and includes a table of antibacterials, as well as their connection to Shionogi sites and suppliers, and compliance with discharge limits per site.
At its own site, Shionogi complies with limits for all APIs and all five of its drug products. It names the locations of five out of nine supplier sites (four in Japan, one in India) and the products they supply. These quantify their discharge levels, and three of them (making flomoxef, doripenem and sulfamethoxazole/trimethoprim) comply with limits. Shionogi also names its only external private waste-treatment plant, used for disposal by incineration, in scope.
Shionogi belongs to the AMR Industry Alliance, which publishes recommended discharge limits, and it makes AMR central to its contribution to global sustainability. By self-regulating and sharing information proactively (so far, only 33% of its supplier sites fully comply with guidance), the company sets a precedent for transparency. It demonstrates best practice by providing details specific to products, sites, and suppliers, which allows third parties to assess product-specific risks on an ongoing basis. Shionogi reveals whether sites discharge beneath safe levels, discloses results clearly and supports ethical procurement.
GSK and Novartis are the only other companies to publicly disclose some information on compliance, though a lack of detail makes it hard to assess which of their sites and products might pose a risk for AMR. GSK discloses that all 20 of its own sites and 32 of 45 supplier sites comply with discharge limits. Novartis reports that 80% of its own sites comply with pharmaceutical limits, though the company’s data is not specific to antibacterials.
Shionogi says it will consider making publicly available the details of how it performs mass balance calculations to show the quantities of product discharged during production. It also commits to disclosing to the Benchmark actual details of audit results. To progress further, it could name other supplier locations on a city level to increase understanding of its supply chain and associated AMR risks.
Other companies should follow Shionogi’s lead and take steps to disclose locations of suppliers, how many sites have safe levels of discharge, and compliance on a per-product basis. Since AMR-related risk also arises downstream, the Benchmark looks for companies to disclose details of external wastewater treatment plants, helping to ensure use of appropriate technologies and protocols can minimise the spread of resistance.