More companies are setting and enforcing limits at their own sites, and are now starting to expand these standards to supplier sites
However, just 5.2% of third-party manufacturing sites are reported as compliant with limits on antibacterial waste disposal
Shionogi and GSK are leading the way in tracking and requiring compliance from suppliers
Pharmaceutical companies are increasingly taking action to limit the release of active pharmaceutical ingredients (APIs) into the environment, by setting and enforcing discharge limits on wastewater from manufacturing sites. While a huge gap remains in ensuring that the same standards apply at manufacturing sites operated by pharma companies’ third-party suppliers, progress by a few companies demonstrates that closing this gap is entirely possible.
Why does this matter?
If waste from the manufacture of antibiotics contains a high concentration of APIs when it is discharged into the environment, there is a serious risk it will contribute towards antimicrobial resistance (AMR). While solid waste is typically sent for incineration or to landfill, liquid waste is discharged into environments such as rivers, where APIs can cause bacteria to gain new and dangerous forms of resistance.
In the short term, the release of APIs into the environment poses the most risk to the health of people living near the manufacturing sites. But in the longer term, resistance inevitably spreads and contributes to the global problem.
What did the Benchmark analysis find?
The 2021 Antimicrobial Resistance Benchmark asked 17 large research-based companies and generic medicine manufacturers to disclose the number of sites they and their suppliers use to manufacture antibacterial APIs and drug products, as well as their environmental practices regarding AMR.
Fifteen companies provided data about their own sites, and 12 also provided information about their suppliers’ sites.
The picture is most positive at the 187 directly-operated sites under analysis, with large research-based companies reporting compliance at over two thirds of their own manufacturing sites, and generic medicine manufacturers reporting compliance at just over one third of their own sites.
While there has historically been little transparency into how and whether companies work with their suppliers to limit the release of antibacterial waste into the environment at suppliers’ sites, clear progress can be identified. The 2018 Benchmark found that only three out of 13 companies required suppliers to set discharge limits, and this has steadily risen, with 10 companies out of 17 now reporting that they set discharge limits.
However, setting limits only works if companies are tracking and reporting on compliance with these limits. According to the data made available, while limits are set at the majority of suppliers’ sites used by those 12 companies (64%), just one fifth of sites measure discharge levels to check for compliance.
Only 45 of the 870 suppliers’ sites (5.2%) were reported to the Benchmark as compliant. It is good news that some pharma companies are now working with their suppliers to improve standards, and that now provides the opportunity to push the remaining 95% of the sites to not only set limits, but to actively monitor and report on compliance.
GSK, for example, reports that antibacterial waste discharges at 37 out 39 of its suppliers’ sites are now compliant with set limits. Shionogi has recently made public which of its own sites and suppliers’ sites are compliant with limits, and Abbott reports having set enforceable contractual provisions related to environmental standards.
Other leaders on environmental risk-management strategies include Novartis, Johnson & Johnson, and Pfizer, all of which report that they quantify discharge levels against set limits at their own sites, and that they ask their suppliers to set limits and report discharge levels.
The drive to cut waste discharge levels is complicated by the fact that there is currently no internationally-agreed regulation on standards on safe concentrations of antibacterials released into the environment. Instead, companies commit to voluntary targets recommended by the AMR Industry Alliance, which means there is a reliance on self-regulation and self-reporting.
What needs to happen next?
There has been clear movement in the right direction over the last few years as pharma companies increasingly report setting and adhering to limits at their own sites.
Pharma companies must now ensure that limits are set on antibacterial wastewater discharge at all of their suppliers’ sites. This is especially important given just how many third party manufacturing sites are involved in the supply chain (comprising 82% of the total sites covered by this analysis).
Pharma companies should continue to set limits, as well as making sure compliance with these limits is assessed at each site. This must be established via supply contracts and quality agreements, and companies should enforce those agreements when limits are exceeded.
In this way, change will be carried all the way through the supply chain from start to finish, and fewer antibacterials will be discharged into the environment – which would be significant progress in the fight against rising antimicrobial resistance.
* No data on any manufacturing sites is available for Alkem and MSD. No data on suppliers’ sites is avaiable for Fresenius Kabi, Hainan Hailing and Sun Pharma.
** In 2018, the following four companies were not in scope: Abbott, Alkem, Hainan Hailing and Otsuka. They have been in scope of the Benchmark since the 2020 report. The other 13 companies which have remained constant since the 2018 Benchmark are GSK, Pfizer, Johnson & Johnson, Shionogi, Novartis, MSD, Sanofi, Sun Pharma, Cipla, Teva, Fresenius Kabi, Aurobindo, and Viatris (formerly Mylan).