AMR

AMR (antimicrobial resistance) refers to the phenomenon whereby pathogenic microorganisms, such as bacteria, acquire drug resistance to antimicrobials and become immune to them. An increase in AMR has become a major social issue in recent years. The main reason for the increase in AMR is inappropriate use of antimicrobials, including excessive administration. Meanwhile, it is also attributed to release from antimicrobial-manufacturing plants as another factor. Therefore, approaches from various aspects are essential for effective AMR control.

The SHIONOGI Group has provided antimicrobials to society for many years. As a natural responsibility of a company that handles antimicrobials, we strictly control the release of antimicrobials into the environment during the manufacturing process. Since AMR is considered to be a global threat, the SHIONOGI Group believes that it is necessary to manage the release of antimicrobials into the environment not only within the group but throughout the supply chain.

To reduce the environmental impact of antimicrobials during the manufacturing process, the SHIONOGI Group plans to achieve proper management of the release of antimicrobials into the environment throughout the supply chain by 2030 through audits of and feedback from its plants and suppliers. To this end, we aim to maintain and improve the antimicrobial discharge management system at the SHIONOGI Group’s plants and to complete the first AMR audits of all related suppliers by FY2024.

To control and manage the release of antimicrobials into the environment, we will proceed with AMR audits based on the Antibiotic Manufacturing Standard^*1 (“Standard”) stipulated by the AMR Industry Alliance^*2 (“AMRIA”).

*3 AMR Benchmark is the world’s first report in which companies’ AMR control efforts are analyzed and evaluated by the NGO Access to Medicine Foundation, based in the Netherlands.

See this website for details. (External website)

The SHIONOGI Group controls and manages the release of antimicrobials in compliance with the Standard stipulated by AMRIA, and conducts audits of all antimicrobial-manufacturing plants of the SHIONOGI Group as well as all of its suppliers in Japan. Since FY2019, we have conducted audits of our suppliers outside Japan (see tables 1 and 2).

As an antimicrobial release control and management initiative at the Kanegasaki Plant, a SHIONOGI Group flagship plant that manufactures antimicrobials, antimicrobials contained in wastewater are deactivated in each manufacturing building before the wastewater is discharged outside via in-house treatment facilities. According to the Standard, we analyze the concentration of antimicrobials in actual wastewater from the plant to confirm whether the wastewater is harmless when it is discharged into the natural environment. Recently, it has been confirmed that wastewater from the manufacturing process of all five items at the Kanegasaki Plant complies with the discharge limits in the receiving environment.^*5 Solid waste materials, generated from antimicrobial manufacturing at the Kanegasaki Plant, are entirely entrusted to an external service provider (Eco-system Akita Co., Ltd.) for disposal by incineration, with no antimicrobial release into the environment via solid waste materials. At the Tokushima Plant, we also analyze the concentration of antimicrobials in wastewater from the plant for contracted items to confirm that the wastewater complies with the discharge limits in the receiving environment.

As for suppliers, we have confirmed that three of the four drug products, whose manufacture is commissioned to four suppliers in Japan (one drug product per supplier), conform to the discharge limits in the receiving environment. For the remaining drug product for which conformity has not been confirmed, we are currently taking corrective measures. We also commission the manufacture of three drug products to three suppliers outside Japan, and we have confirmed that two of them comply with the discharge limits in the receiving environment. For the remaining supplier for which compliance with the discharge limits in the receiving environment has not been confirmed, we continue to conduct surveillance and take necessary remedial measures. Although there has recently been a delay in the progress of our audit plans as a result of travel restrictions due to the COVID-19 pandemic, we completed the initial audit of our suppliers that we currently have contracts with, both in Japan and overseas, by July 2023. We intend to conduct audits of our suppliers with regard to compliance with the discharge limits in the receiving environment, each year choosing around two to three suppliers within Japan and one to two suppliers outside Japan.

*5 As discharge limits in the receiving environment, the SHIONOGI Group adopts “Predicted No-Effect Concentrations (PNECs)” mentioned in the document published by AMRIA or the limit value of 0.05 μg/L, which is the recommended value for drugs not on the list.

See this website for details. (External website)

Companies F, G, and H: Suppliers outside Japan. 

*6 Although contract manufacturing products are not listed, they conform to the discharge limits in the receiving environment.

*7 Due to the transfer of vancomycin hydrochloride operations in April 2020, the relevant suppliers were excluded from the audits.

〇：Conforming to the criteria of the Common Antibiotic Manufacturing Framework

△：Conforming to the criteria of the Common Antibiotic Manufacturing Framework, except in a small number of aspects; remedial measures being implemented

×：Not fully conforming to the criteria of the Common Antibiotic Manufacturing Framework; remedial measures being implemented