Almost all large research-based pharmaceutical companies require suppliers to set discharge limits
For the first time, the Benchmark can report that three generic medicine companies now require their suppliers to set discharge limits
Antibiotic manufacturing chains are sprawling and complex, with many different suppliers delivering active pharmaceutical ingredients (APIs) and drug products to downstream partners.
Pharmaceutical companies, including both large-research based companies and generic medicine manufacturers, occupy dominant positions in these supply chains as the suppliers’ major customers, and are therefore uniquely placed to influence the standards and practices of those upstream suppliers.
The Benchmark firstly examines whether pharmaceutical companies implement ambitious AMR risk-management strategies and standards at their own sites, and then examines whether they require their suppliers and waste treatment plants to also meet the same standards.
Limits are set out in companies’ environmental risk-management strategies, and indicate the highest acceptable level of antibacterial residue which should be present in antibacterial manufacturing waste when released into the environment.
Progress in requiring suppliers to set limits
Companies generally perform the best at setting and monitoring specific AMR-related standards at their own manufacturing sites, as can be seen in the table below.
However, there is progress in requiring suppliers’ manufacturing sites to also meet specific standards around limits on the levels of antibacterial residue in wastewater.
All assessed large research-based companies now report that they require suppliers to set discharge limits, except for Otsuka. Since the 2020 Benchmark, Sanofi newly reports requiring its suppliers to set limits.
In the previous two iterations of the Benchmark, no generic medicine manufacturers reported that they required suppliers to set limits. Now, for the first time, the Benchmark can report that three generic medicine manufacturers require suppliers to set limits, namely Abbott, Cipla and Viatris.
Abbott, for example, introduced a new contract template for suppliers in 2021, with clauses that specifically require implementation of AMR standards. If corresponding audit results are not satisfactory, Abbott can enforce contractual provisions.
Looking at the other generic medicine manufacturers, Teva has future plans in place to assess suppliers and require them to set limits. Fresenius Kabi encourages suppliers to set limits – but formal mechanisms such as audit requirements or specific terms in supplier contracts, are not in place.
What are companies doing in practice?
Sanofi implemented a Health Safety and Environment management system (HSE) and Pharmaceuticals In the Environment (PIE) programme. These include environmental requirements intended to minimise the impact of the discharge of antibacterials on the environment.
Zero liquid discharge (ZLD) technology is a treatment process in which the site does not discharge any water into the environment as this will be reused and recycled, while solid residue is incinerated or sent to landfill after treatment. Of the five companies which currently implement ZLD, Viatris is the only company to report that it has taken the extra step of analysing the recycled water to check for the presence of APIs, which was found to be at zero.
Shionogi’s sole directly-operated manufacturing site is located in Kanegasaki, Japan, and this is where it manufactures five out of its eight antibacterial products. The three remaining medicines are produced by third-party suppliers. For Shionogi’s products, five of its APIs have an established science-based PNEC. For those APIs without a specific PNEC, Shionogi applies a default value of 0.01 ug/L. Shionogi has set the expectation that its suppliers must also follow these limits.