Responsible Manufacturing

Read the results of the 2020 AMR Benchmark analysis into how eight large research-based companies and nine generic medicine manufacturers aim to minimise the risk that antibacterial discharge released from factories contributes to AMR.

Most companies have an environmental strategy to minimise resistance

Thirteen companies have environmental strategy that aims to minimise the impact of their manufacturing processes in promoting resistance. Twelve of the 13 are in the AMR Industry Alliance.

Companies set concentration limits on antibacterial discharge

Almost all companies with an environmental strategy set discharge limits on the levels of antibacterials allowed in manufacturing discharge.

Seven companies assess manufacturing discharge against specific limits

Of the 12 companies that set discharge limits as part of their strategy, seven report having assessed discharge levels against these limits at their own sites. For the five remaining, assessments have either started or are ongoing.

Only half of companies require suppliers to set discharge limits

Six companies report requesting suppliers to set limits for antibacterial discharge. Typically, this is done during supplier audits or via a questionnaire that asks suppliers to provide discharge levels.

No companies assess whether waste-treatment plants meet discharge limits

No companies monitor antibacterial levels discharged by the external privately owned wastewater-treatment plants they use, nor do companies require wastewater-treatment plants to set limits for antibacterial discharge or monitor discharge levels.

Some environmental strategies cover antifungal manufacturing

Of the 15 companies assessed in this area that market antifungals, seven report that they extend their environmental risk-management strategies to also cover these products.

Public reporting on strategy components varies

Five companies publish some components of their overall environmental risk-management strategy, while the 12 that are members of the AMR Industry Alliance additionally publish the discharge limits they have committed to.

No companies publish discharge levels, audit results or suppliers’ identities

No companies publish the levels of antibacterials in wastewaters discharged from their sites or results of audits conducted. Results of audits to suppliers’ sites or the suppliers’ identities are also not published.

Quality systems align with Good Manufacturing Practice

Nearly all companies evaluated report having a quality system consistent with GMP standards at all antibacterial manufacturing sites, including quality monitoring and/or periodic auditing.

​How can manufacturing processes impact drug-resistance?

There are two main ways that antibacterial manufacturing can contribute to antimicrobial resistance (AMR). The first is the most direct: releasing manufacturing waste that includes antibacterial residue directly into the environment. The second route relates to medicine quality: manufacturing antibiotics that contain too little of the active ingredient to successfully treat the infection. Both routes give bacteria opportunities to develop resistance.

Pharmaceutical companies can minimise the risk by ensuring medicines meet quality standards, and by adopting environmental risk-management strategies that aim to limit AMR, setting strict limits for the concentration of antibacterial residue that is permitted in factory discharge. Companies can require suppliers to meet these same environmental standards, as well as the private waste-treatment plants they contract to dispose of their manufacturing waste. The AMR Benchmark looks at which companies are developing and implementing such strategies.

What sets the two company groups apart?

Large R&D-based companies: More likely to extend environmental risk-management strategies to suppliers and adopt discharge limits
The eight large research-based pharmaceutical companies deliver very similar performances in this area. They typically include almost all of the elements of an environmental risk-management strategy that the Benchmark looks for. These include strategies to ensure antibacterial manufacturing waste is dealt with appropriately, as well as audits. Large research-based pharmaceutical companies are more likely than generic medicine manufacturers to assess the risk that discharge exceeds limits designed to cap the concentration of antibacterials in waste that is being released into the environment. They are more likely to have completed at least one round of such risk assessments. Further, many of these companies are extending their strategies and limits to third-party suppliers of APIs and/or drug products, as well as to external private waste-treatment plants. As yet, none of these companies require these plants to limit or monitor the concentration of antibacterials being released.

How the large R&D-based companies compare
Three companies share the lead among the large R&D-based companies: GSK, Johnson & Johnson and Shionogi. They each report a comprehensive strategy to minimise the environmental impact of antibacterial manufacturing, including risk assessments based on discharge limits that address the risk of AMR. Suppliers are expected to meet these same standards.

Generic medicine manufacturers: Environmental risk-management strategies cover own sites, taking steps to implement discharge limits
Performances between the nine generic medicine manufacturers are more varied than among large research-based companies. Two thirds of the generic medicine manufacturers report strategies to ensure antibacterial manufacturing waste is dealt with appropriately, including audits. Most of the generic medicine manufacturers with such strategies also set limits to cap the concentration of antibacterials in waste that is being released into the environment. They are more likely than large research-based companies to still be completing initial risk assessments using these limits at their own sites. These companies report taking initial steps to implement the strategies with suppliers. When it comes to how generic medicine manufacturers audit external private waste-treatment sites, there is generally little information available. As yet, none of the generic medicine manufacturers require these plants to limit or monitor the concentration of antibacterials being released.

How the generic medicine manufacturers compare
Abbott and Cipla lead the generic medicine manufacturers. Both report comprehensive environmental risk-management strategies that include risk assessments based on discharge limits. Abbott also expects its suppliers to follow certain guidelines, while Cipla reports plans for future supplier risk assessments.

In Manufacturing & Production, the AMR Benchmark focuses on antibacterial manufacturing, because its potential impact on resistance is better described and understood than for other areas of antimicrobial manufacturing. The companies are selected based on their global volumes of sales, which indicate that they are prominent players in multiple manufacturing chains with significant influence upon upstream suppliers. The AMR Benchmark evaluates companies on the depth and breadth of their environmental risk-management strategies, how much information they disclose about these strategies, and their mechanisms for maintaining high-quality production. 


Explore the results

Research & Development

Read what the 2020 AMR Benchmark found when it analysed the R&D pipelines of eight large research-based companies and 13 pharmaceutical SMEs. It has mapped their medicine and vaccine projects targeting priority bacterial and fungal pathogens.

Learn more

Responsible Manufacturing

Read the results of the 2020 AMR Benchmark analysis into how eight large research-based companies and nine generic medicine manufacturers aim to minimise the risk that antibacterial discharge released from factories contributes to AMR.

Learn more

Appropriate Access & Stewardship

Read the findings from the 2020 AMR Benchmark on access strategies for antibacterial and antifungal products in LMICs from eight large research-based companies and nine generic medicine manufacturers, as well as stewardship initiatives.

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View our detailed overview of each company’s performance

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