New report sets out clear steps pharma cos to curb AMR risk in antibiotic production

A new report from the Access to Medicine Foundation, an independent non-profit organisation, zeroes in on responsible manufacturing, setting out three clear areas pharma companies can focus on to ensure they limit AMR risk when manufacturing their antibiotics.  

Since the first AMR Benchmark in 2018, the Foundation has been assessing how some of the world’s leading producers of antibiotics perform on limiting AMR risk from manufacturing. Despite progress, significant gaps remain. This new report analyses responsible manufacturing more closely, identifying clear examples from companies that are developing practices to limit AMR risk from manufacturing more effectively. 

The report analyses selected companies of varying sizes that manufacture and market antibiotics – including research-based pharma companies, generic medicine manufacturers and business-to-business providers. The report specifically mentions Abbott; Aurobindo; Centrient;* Fresenius Kabi; GSK; Pfizer; Novartis and its generics division, Sandoz;** Shionogi; Teva; and Viatris.  

Pharma companies like these, which hold market authorisations for antibiotics, are uniquely positioned to drive change across the antibiotic supply chain, and can help transform the industry. Not only can they prioritise responsible manufacturing at the manufacturing sites they own and operate, but they have the ability to influence the standards and practices of the various third-party suppliers they contract in the production of their lifesaving medicines.   

“The role of the pharma industry in tackling AMR has never been more critical. Responsible manufacturing is among the ways in which they can help prevent drug resistance from becoming uncontrollable – and can ensure that the production of their lifesaving antibiotics does not cause unintended harm to human health or the environment. We have seen that progress is possible, but we now need more companies to seize the opportunities we have identified to accelerate industry-wide change,” said Jayasree K Iyer, CEO, Access to Medicine Foundation. 

To support and enable progress, this report identifies three specific areas that companies need to focus on to strengthen their responsible manufacturing practices and limit AMR risk more effectively. 

• Companies need to prioritise effective wastewater management methods to establish, quantify and monitor discharge limits for ensuring wastewater safety at their own manufacturing sites.  
• By utilising their unique positions in the supply chain, companies can transform the industry. 
• Ensuring transparency and accountability across the antibiotic supply chain is crucial. 

The report finds beyond curbing AMR, engaging in responsible manufacturing practices will also be critical to ensuring business continuity within the context of the wider global health landscape.  

“Stakeholders – including procurers, investors and regulators – are already looking to pharma companies that demonstrate their commitment to limiting their impact on AMR and the environment. This report offers practical examples that both large and small players can follow to ensure they meet these expectations. By investing in responsible manufacturing, companies can help curb rising drug resistance while positioning themselves favourably in the market,” said Marijn Verhoef, Director of Operations and Research, Access to Medicine Foundation. 

Procurers, for example, who can consider criteria related to the environment and sustainability when making purchasng decisions, are increasingly expecting companies to demonstrate comprehensive and effective practices to keep antibiotic waste within limits. 

Notably, three companies in scope of the report – Fresenius Kabi, Sandoz and Viatris – were awarded with tenders as part of the Norwegian Hospital Procurement Agency’s 2019 sustainable pilot procurement programme. The companies won the tenders partly by achieving the highest score on environmental criteria, which specifically considered whether companies had environmentally friendly production in place to reduce the risk of AMR.  

More investors also now view AMR as a systemic risk that needs to be considered within environmental, social and governance (ESG) standard-setting and reporting frameworks. There are also signs that regulation aimed at reducing AMR risk from manufacturing, which is currently lacking, may be introduced, or strengthened, in several countries.  

FOOTNOTES:  

*Centrient is a business-to-business provider of antibiotics and antifungals and has not been assessed in any of the three iterations of the AMR Benchmark.  

**Novartis has announced that it will separate its generic division, Sandoz, into a standalone company by way of a 100% spin-off, planned for Q4 2023.