Opportunities: next steps for addressing AMR
2021 OPPORTUNITY: Integrate AMR in environmental risk-management strategy and increase public disclosure. Fresenius Kabi reports an environmental risk management strategy that includes auditing processes and recently became a member of the AMR Industry Alliance. The company can integrate AMR in its strategy for its own manufacturing sites, the sites of suppliers and external private waste-treatment plants, based on the guidelines of the AMR Industry Alliance. This includes setting limits and quantifying discharge levels to track compliance. Moreover, Fresenius Kabi can publish information on how it manages environmental risk related to antibacterial manufacturing to curb AMR. The company currently publishes limited information.
2023 UPDATE: Fresenius Kabi publicly reports to be in the process of fully integrating the manufacturing standards of the AMR Industry Alliance into its environmental risk-management strategy. The company requires all its own sites to quantify discharge levels through mass balance calculations, with certain locations also conducting chemical analysis on wastewater samples. Fresenius Kabi reports that approximately one-third of its own manufacturing sites are compliant with discharge limits in the receiving environment. In instances where discharge limits are exceeded, investigation and improvement plans to reach compliance are developed. Additionally, the company publicly reports that, since 2021, it has introduced new methods and systems for treating wastewater, aiming to control discharge levels of antibiotics.
Fresenius Kabi revised its Third-Party Code of Conduct (CoC) to specify that suppliers are expected to make reasonable efforts to meet discharge limits. The company is in the process of evaluating all its suppliers. Currently, approximately half of the company’s assessed supplier sites are reported to be compliant with discharge limits in the receiving environment.
2021 OPPORTUNITY: Expand availability and ensure continuous supply of antibacterial and antifungal medicines to more access countries. Fresenius Kabi expands access through direct selling contracts or tenders and reports a set of cost-containment measures. It also reports to ensure accurate demand planning and data sharing. Fresenius Kabi can ensure equitable access and adequate supply of its antibiotics and antifungals listed on the 2021 WHO EML in more access countries. For example, Fresenius Kabi can build on capacity or mitigate against shortages by working with several API suppliers.
2023 UPDATE: Fresenius Kabi did not report any updates on expanding the availability of antibacterial and antifungal medicines in countries in scope of the Benchmark. The company expanded Active Pharmaceutical Ingredient (API) production capacity at its manufacturing site in Italy. Yet, the extent to which this has increased the availability in countries in scope remains unclear.
Fresenius Kabi reports on several challenges it encounters in ensuring a continuous supply of essential medicines, including economic factors such as rising production costs, increasing environmental standards which require additional resources and European Union’s legal proposals lacking incentives for strengthening the generics industry
2021 OPPORTUNITY: Expand registration of antibacterial and antifungal medicines. Fresenius Kabi reports developing generic IV formulations that are ready to launch directly after the patents of the branded products expire. It can apply this policy in access countries and register its antibiotics and antifungals listed on the 2021 WHO EML, (e.g. daptomycin and caspofungin), in more countries, including in low-income countries with a high burden of disease.
2023 UPDATE: Fresenius Kabi reports it has received approvals for ten antibacterial medicines across seven low- and middle-income countries (LMICs) cumulatively. Among these, two products are listed on the 2023 World Health Organization (WHO) Model List of Essential Medicines (EML).
2021: Performance
Fresenius Kabi performs above average overall in its evaluated Research Areas when compared to the other generic medicine manufacturers in scope.Â
R&D
As a generic medicine manufacturer, Fresenius Kabi is not evaluated in this Research Area.
Responsible Manufacturing
Middle-performing. Reports environmental risk-management strategy for own sites; limited information on whether AMR and discharge limits are taken into account.
Appropriate access
Middle-performing. Files some of its off-patent/generic medicines for registration in access countries. Reports some strategies to expand access and ensure continuous supply of its relevant products.
Stewardship
Performs well. It decouples incentives for sales agents from sales volumes by using tender sales for most sales. It reports broad conflict of interest mitigation for its educational programmes.
2021: Pipeline and Portfolio
Looking at bacterial and fungal pathogens
The AMR Benchmark evaluates pharmaceutical companies on the size and relevance of their R&D pipelines and on the actions they are taking to ensure their products on the market are accessible and being used responsibly.Â
Portfolio
Products on the market
Mid-sized portfolio: At least 51 products: 48 antibacterial medicines; 3 antifungal medicines
Off-patent/generic medicines: 10 of 51 were selected for analysis** (aztreonam [R], caspofungin [F], clindamycin [A], daptomycin [R], fluconazole [F], isoniazid [T], linezolid [T], meropenem [W], metronidazole [A], piperacillin/tazobactam [W])
AWaRe medicines***: 16 Access group; 22 Watch group; 5 Reserve groupÂ
Anti-TB medicines***: 3
Pipeline
As a generic medicine manufacturer, Fresenius Kabi is not evaluated in this Research Area.
2021: Sales & Operations
Scope, scale and focus of the business
Therapeutic areas: Anaesthesia, Critical illness, Fluid management, Liver insufficiency, Maldigestion / malabsorption, Oncology, Paediatrics, Transfusion medicine.
Business segments: Fresenius Kabi
Product categories: Biosimilars, Generic medicines, Medical devices
M&A since 2020: None in the antibacterial and/or antifungal sectors
Sales by business segment
Sales by region
2021: Performance breakdown
Explore Fresenius Kabi's performance in detail, including the drivers behind any movement and the main areas where it scores well or poorly compared to peers.
Research & Development
As a generic medicine manufacturer, Fresenius Kabi is not evaluated in this Research Area.
Responsible Manufacturing
Middle-performing. Reports environmental risk-management strategy for own sites; limited information on whether AMR and discharge limits are taken into account.
Environmental risk-management for own sites; questionnaire-based assessments of all suppliers
Publicly discloses some information on environmental risk management
System in place to maintain production quality for own and suppliers’ sites; no requests for official corrective actionÂ
Evaluated: antibacterials manufacturing (APIs and drug products)
B.1 Environmental risk-management for own sites; questionnaire-based assessments of all suppliers
Fresenius Kabi reports a strategy to minimise the environmental impact of wastewaters and solid waste from antibacterial manufacturing at its sites, including audits every 1-4 years. It became a member of the AMR Industry Alliance in 2020 and plans to set discharge limits and quantify levels at its sites in the near future.Â
There is limited information on the requirements that Fresenius Kabi makes of third-party suppliers of antibacterials with respect to AMR. It reports conducting a questionnaire-based CSR assessment of all suppliers which includes questions on how antibacterial waste is processed by suppliers. It does not report requiring suppliers to set discharge limits or quantify discharge levels.
There is also limited information on the requirements Fresenius Kabi makes of external private and public waste-treatment plants, in terms of environmental strategy, audits and antibacterial discharge limits and levels. It reports external waste disposal companies are regularly audited but exact audit parameters are defined locally by each site.
B.2 Publicly discloses some information on environmental risk management
Fresenius Kabi publishes some components of its environmental risk-management strategy, without specific references to AMR. It does publicly disclose that non-recyclable hazardous waste including antibiotics is mainly incinerated. Since 2020, it is a member of the AMR Industry Alliance, which publishes a list of recommended antibacterial discharge targets. Fresenius Kabi does not publish: (1) the results of environmental audits, whether conducted at its own sites, the sites of suppliers or external private and public waste-treatment plants; (2) a list of these suppliers and plants; or (3) the levels of antibacterial discharge from its own or suppliers’ sites.
B.3 System in place to maintain production quality for own and suppliers’ sites; no requests for official corrective actionÂ
Fresenius Kabi reports own sites and suppliers have a system to maintain high-quality antibacterial production consistent with international GMP standards. This includes periodic risk-based audits and tracking of corrective and preventive actions. It also reviews, as part of its external audit process, the results of audits that suppliers conducted with their own suppliers. The Benchmark found no requests for official corrective action from the FDA or EMA related to non-conformities with cGMP at Fresenius Kabi’s own sites or any subsidiaries that manufacture antibacterials.
Appropriate Access
Middle-performing. Files some of its off-patent/generic medicines for registration in access countries. Reports some strategies to expand access and ensure continuous supply of its relevant products.
Filed to register off-patent/generic medicines in 7 access countries on average
Some strategies to expand access to off-patent/generic medicines
Some strategies to ensure continuous supplyÂ
Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countriesâ€
Fresenius Kabi is not eligible for indicators: C.1.1, C.1.3, C.2.1 and C.2.3. For more information, see Appendix VII in the 2021 AMR Benchmark report.
C.1.2 Filed to register off-patent/generic medicines in 7 access countries on average
Fresenius Kabi has an average performance, filing eight of its 10 relevant off-patent/generic medicines for registration in seven access countries on average. Its most widely filed relevant product is the antifungal metronidazole filed in 21 access countries. Seven of its relevant products are filed in less than ten access countries. Two of its relevant products are filed for registration in at least one LIC.
C.2.2 Some strategies to expand access to off-patent/generic medicines
Fresenius Kabi has an average performance. It expands access to its off-patent/generic medicines in access countries through direct sales contracts or tenders. Fresenius Kabi reports a set of cost-containment measures applied on its generic medicines, leading to lower prices. It provides some evidence of patient reach. Details were provided under the basis of confidentiality.
C.3 Some strategies to ensure continuous supplyÂ
Fresenius Kabi has an average performance, with strategies reported in all four areas assessed. It ensures accurate demand planning and data sharing and mitigates against shortages risks. Details were provided under the basis of confidentiality. It conducts internal or external audits of its suppliers, ensures compliance to the ISO and GMP standards, evaluates its supply performance through KPIs and has a Supplier Code of Conduct. Fresenius Kabi reports, subject to confidentiality, where it produces antibiotics in low- and middle-income countries. To mitigate against substandard and falsified products, Fresenius Kabi has implemented a Global Serialisation Program.
Stewardship
Performs well. It decouples incentives for sales agents from sales volumes by using tender sales for most sales. It reports broad conflict of interest mitigation for its educational programmes.
Broad COI mitigation strategies in place for its educational programmes
Engages in sales and marketing practices to address appropriate use
Evaluated: stewardship activities relating to antibacterial & antifungal medicines globallyÂ
C.4 Broad COI mitigation strategies in place for its educational programmes
Fresenius Kabi performs well in conflict of interest (COI) mitigation for the five AMR-related educational programmes for HCPs assessed by the Benchmark. Four programmes have all three COI mitigation strategies looked for by the Benchmark: (1) content is developed independently from its marketing department; (2) a pledge not to provide financial or material incentives to participants; and (3) a policy of not using branded materials. The remaining programme has two COI mitigation strategies: the content is developed by Fresenius Kabi’s marketing department.
C.5 Engages in sales and marketing practices to address appropriate use
Fresenius Kabi performs above average in sales practices. It reports that it sells most of its antibacterial and/or antifungal medicines through hospital tenders and does not have sales incentives linked to the sales volume of these tenders.
Fresenius Kabi engages in marketing practices that aim to address the appropriate use of its antibacterial and/or antifungal medicines. Its marketing materials include emerging resistance trends and/or include treatment guidelines for healthcare professionals: for a range of its intravenous antibacterial medicines used in intensive care units.
C.6 Stewardship-Oriented Adaptations for Patients
Fresenius Kabi is not eligible for this indicator as its medicines are administered by healthcare professionals in the hospital setting so there is no need to adapt brochures and/or packaging to facilitate the appropriate use of its antibacterial and/or antifungal medicines by patients.
C.7 AMR Surveillance
As a generic medicine manufacturer, Fresenius Kabi is not assessed in this indicator nor does it report any involvement in AMR surveillance activities.