AMR Benchmark Opportunities: progress update

Generic medicine manufacturers

Fresenius Kabi AG
This table is part of a November 2023 report that looks at what actions each company in scope of the Antimicrobial
Resistance (AMR) Benchmark has taken with regards to each of the Opportunities set out in its 2021 AMR Benchmark
Report Card. The full 2021 Report Card is also included in this PDF.

2021 O PPO RTU N IT Y

2023 U PDATE

What was the Opportunity shared in the AMR Benchmark?

What progress has been made on this Opportunity?

Integrate AMR in environmental risk-management

Fresenius Kabi publicly reports to be in the process ofstrategy and increase public disclosure.

fully integrating the manufacturing standards of the AMR

Fresenius Kabi reports an environmental risk management

Industry Alliance into its environmental risk-management

strategy that includes auditing processes and recentlystrategy. The company requires all its own sites to quantify

became a member of the AMR Industry Alliance. The

discharge levels through mass balance calculations, withcompany can integrate AMR in its strategy for its own man-certain locations also conducting chemical analysis on

ufacturing sites, the sites of suppliers and external private

wastewater samples. Fresenius Kabi reports that approxi-

waste-treatment plants, based on the guidelines of the AMR

mately one-third of its own manufacturing sites are com-

Industry Alliance. This includes setting limits and quantifying

pliant with discharge limits in the receiving environment. In

discharge levels to track compliance. Moreover, Fresenius

instances where discharge limits are exceeded, investigation

Kabi can publish information on how it manages environ-and improvement plans to reach compliance are developed.

mental risk related to antibacterial manufacturing to curb

Additionally, the company publicly reports that, since 2021,AMR. The company currently publishes limited information.

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 makereasonable 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 thereceiving environment.

Expand availability and ensure continuous supply ofFresenius Kabi did not report any updates on expanding theantibacterial and antifungal medicines to more accessavailability of antibacterial and antifungal medicines in coun-countries.

tries in scope of the Benchmark. The company expanded

Fresenius Kabi expands access through direct selling con-

Active Pharmaceutical Ingredient (API) production capacity

tracts or tenders and reports a set of cost-containment

at its manufacturing site in Italy. Yet, the extent to whichmeasures. It also reports to ensure accurate demand plan-

this has increased the availability in countries in scopening and data sharing. Fresenius Kabi can ensure equitableremains unclear.

access and adequate supply of its antibiotics and antifungals

Fresenius Kabi reports on several challenges it encoun-

listed on the 2021 WHO EML in more access countries. For

ters in ensuring a continuous supply of essential medicines,

example, Fresenius Kabi can build on capacity or mitigate

including economic factors such as rising production costs,

against shortages by working with several API suppliers.

increasing environmental standards which require additional
resources and European Union’s legal proposals lacking
incentives for strengthening the generics industry.

Expand registration of antibacterial and antifungal

Fresenius Kabi reports it has received approvals for ten anti-medicines.

bacterial medicines across seven low- and middle-income

Fresenius Kabi reports developing generic IV formulations

countries (LMICs) cumulatively. Among these, two productsthat are ready to launch directly after the patents of theare listed on the 2023 World Health Organization (WHO)branded products expire. It can apply this policy in access

Model List of Essential Medicines (EML).

countries and register its antibiotics and antifungals listedon the 2021 WHO EML, (e.g. daptomycin and caspofungin),in more countries, including in low-income countries with ahigh burden of disease.

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Antimicrobial Resistance Benchmark 2021

FRK

Overall Performance
2020

2021

55% 63%▲

Access to Medicine Foundation

Fresenius Kabi AG
Generic medicine manufacturer
Stock exchange: XFRA • Ticker: FRE (Fresenius SE & Co KGaA)* • HQ: Bad Homburg, Germany • Employees: 40,519

FRK
PERFORMANCE
Fresenius Kabi performs above average overall in its evaluated ResearchPerformance in the Benchmark

0%

Areas when compared to the other generic medicine manufacturers inscope.
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

Stewardship: Performs well. It decouples incentives for sales agents

R&D

50%

100%

Points0%

0/ 060%

Manufacturing

9/ 1553%

Access

8/ 1580%

Stewardship
0%50%

8/ 10100%

How Fresenius Kabi was evaluatedfrom sales volumes by using tender sales for most sales. It reports broad
conflict of interest mitigation for its educational programmes.

25/ 40

Performance by Research Area

strategies to expand access and ensure continuous supply of its relevant
products.

Points63%

Overall score

A R&D

12.1 2.2 2.3 2.4

3

●

●

●

●

123

B Manufacturing ●

●

●

●

●

1.11.2 1.3 2.1 2.2 2.3

3C Access●●●4567C Stewardship

●

●●

●●

●

●

●

● ● ● Scored●

Not scored

OPPORTUNITIES FOR FRESENIUS KABICHANGES SINCE 2020

Integrate AMR in environmental risk-management strategy and increase public disclosure.

• Fresenius Kabi increased the number of regis-Fresenius Kabi reports an environmental risk management strategy that includes auditing processes

tration filings in access countries for eight out

and recently became a member of the AMR Industry Alliance. The company can integrate AMR inof 10 of its relevant off-patent/generic anti-

its strategy for its own manufacturing sites, the sites of suppliers and external private waste-treat-bacterial and antifungal medicines, compared

ment plants, based on the guidelines of the AMR Industry Alliance. This includes setting limits andto four out of 10 in 2020, meeting the oppor-

quantifying discharge levels to track compliance. Moreover, Fresenius Kabi can publish informa-tunity provided in the 2020 Benchmark. Theytion on how it manages environmental risk related to antibacterial manufacturing to curb AMR. The

also increased registration to seven accesscompany currently publishes limited information.

countries on average from four on average

Expand availability and ensure continuous supply of antibacterial and antifungal medicines tosince 2020.

more access countries. Fresenius Kabi expands access through direct selling contracts or tenders• In 2020, Fresenius Kabi became a member ofand reports a set of cost-containment measures. It also reports to ensure accurate demand plan-

the AMR Industry Alliance stating a commit-ning and data sharing. Fresenius Kabi can ensure equitable access and adequate supply of its antibi-ment to apply its corresponding guidelines forotics and antifungals listed on the 2021 WHO EML in more access countries. For example, Fresenius

manufacturing going forward.

Kabi can build on capacity or mitigate against shortages by working with several API suppliers.
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 listedon the 2021 WHO EML, (e.g. daptomycin and caspofungin), in more countries, including in low-income countries with a high burden of disease.

* Fresenius Kabi AG is a business segmentof Fresenius SE & Co. KGaA

46

Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONSFRKSales by business segment

Therapeutic areas: Anaesthesia, Critical illness, Fluid management,

2019

Liver insufficiency, Maldigestion / malabsorption, Oncology, Paediatrics,

2020

Transfusion medicine.

6,919
6,9760Business segments: Fresenius Kabi

2,000

4,000

6,000

8,000

10,000mn EUR

8,00010,000
mn EUR

Fresenius Kabi

Product categories: Biosimilars, Generic medicines, Medical devices
M&A since 2020: None in the antibacterial and/or antifungal sectors

PORTFOLIO for pathogens in scope

FRK
Sales by region (Fresenius Kabi)
2019

2,313

2,424

2020

2,458

2,376

02,000EuropeNorth America

2,182
2,142

4,000

6,000

Emerging markets

FRK
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** (azt-0048 3204060● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine

reonam [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 groupAnti-TB medicines***: 3

PERFORMANCE BY RESEARCH AREAARESEARCH & DEVELOPMENT

As a generic medicine manufacturer, Fresenius
Kabi is not evaluated in this Research Area.

BRESPONSIBLE MANUFACTURING Evaluated: antibacterials manufacturing (APIs and drug products)

B.1

Environmental risk-management for own

nal private and public waste-treatment plants, inpliers and plants; or (3) the levels of antibacterialsites; questionnaire-based assessments

terms of environmental strategy, audits and anti-

discharge from its own or suppliers’ sites.

of all suppliers

bacterial discharge limits and levels. It reports

Fresenius Kabi reports a strategy to minimise

external waste disposal companies are regularly

the environmental impact of wastewaters andaudited but exact audit parameters are definedsolid waste from antibacterial manufacturinglocally by each site.

at its sites, including audits every 1-4 years. It

B.3

System in place to maintain production
quality for own and suppliers’ sites; norequests for official corrective action

Fresenius Kabi reports own sites and suppliers
Publicly discloses some information on

have a system to maintain high-quality antibac-in 2020 and plans to set discharge limits andenvironmental risk management

terial production consistent with international

quantify levels at its sites in the near future.

Fresenius Kabi publishes some components

GMP standards. This includes periodic risk-basedof its environmental risk-management strat-audits and tracking of corrective and preven-ments that Fresenius Kabi makes of third-party

egy, without specific references to AMR. It does

tive actions. It also reviews, as part of its exter-

suppliers of antibacterials with respect to AMR.

publicly disclose that non-recyclable hazardous

nal audit process, the results of audits that sup-It reports conducting a questionnaire-based CSR

waste including antibiotics is mainly incinerated.

pliers conducted with their own suppliers. The

assessment of all suppliers which includes ques-Since 2020, it is a member of the AMR Industry

Benchmark found no requests for official cor-

tions on how antibacterial waste is processed

Alliance, which publishes a list of recommended

rective action from the FDA or EMA related toby suppliers. It does not report requiring suppli-

antibacterial discharge targets. Fresenius Kabi

non-conformities with cGMP at Fresenius Kabi’sers to set discharge limits or quantify discharge

does not publish: (1) the results of environmental

own sites or any subsidiaries that manufacturelevels.

audits, whether conducted at its own sites, theantibacterials.

became a member of the AMR Industry Alliance

There is limited information on the require-

B.2

There is also limited information on thesites of suppliers or external private and public

requirements Fresenius Kabi makes of exter-

waste-treatment plants; (2) a list of these sup-** See Appendix VII for information about
eligibility criteria for products.
*** Listed on the 2019 WHO EML.

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Antimicrobial Resistance Benchmark 2021

CAccess to Medicine Foundation

APPROPRIATE ACCESS & STEWARDSHIP – ACCESS

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries†
Fresenius Kabi is not eligible for indicators: C.1.1,C.2.2 Some strategies to expand access toDetails were provided under the basis of confi-C.1.3, C.2.1 and C.2.3. For more information, see

off-patent/generic medicines

dentiality. It conducts internal or external audits

Fresenius Kabi has an average performance. Itof its suppliers, ensures compliance to the ISO

expands access to its off-patent/generic med-and GMP standards, evaluates its supply perfor-icines in access countries through direct sales

mance through KPIs and has a Supplier Codecontracts or tenders. Fresenius Kabi reports aof Conduct. Fresenius Kabi reports, subject toFresenius Kabi has an average performance,

set of cost-containment measures applied on

confidentiality, where it produces antibiotics

filing eight of its 10 relevant off-patent/genericits generic medicines, leading to lower prices. It

in low- and middle-income countries. To mit-medicines for registration in seven access coun-provides some evidence of patient reach. Details

igate against substandard and falsified prod-

tries on average. Its most widely filed relevant

were provided under the basis of confidentiality.

ucts, Fresenius Kabi has implemented a Global

Appendix VII.
C.1.2 Filed to register off-patent/generic medicines in 7 access countries on average

product is the antifungal metronidazole filed in
21 access countries. Seven of its relevant prod-Serialization Program.
C.3

Some strategies to ensure continuous
supplyucts are filed in less than ten access countries.
Two of its relevant products are filed for regis-Fresenius Kabi has an average performance, withtration in at least one LIC.

strategies reported in all four areas assessed.
It ensures accurate demand planning and data
sharing and mitigates against shortages risks.

CAPPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally
C.4

Broad COI mitigation strategies in placetices that aim to address the appropriate use offor its educational programmes

its antibacterial and/or antifungal medicines. Its

Fresenius Kabi performs well in conflict of inter-marketing materials include emerging resistanceest (COI) mitigation for the five AMR-related

trends and/or include treatment guidelines foreducational programmes for HCPs assessed

healthcare professionals: for a range of its intra-by the Benchmark. Four programmes have all

venous antibacterial medicines used in intensive

three COI mitigation strategies looked for bycare units.

the Benchmark: (1) content is developed independently from its marketing department; (2) aC.6

pledge not to provide financial or material incen-

Stewardship-Oriented Adaptations forPatients

tives to participants; and (3) a policy of not using

Fresenius Kabi is not eligible for this indicator

branded materials. The remaining programme

as its medicines are administered by healthcare

has two COI mitigation strategies: the con-professionals in the hospital setting so there istent is developed by Fresenius Kabi’s marketing

no need to adapt brochures and/or packaging todepartment.

facilitate the appropriate use of its antibacterial
and/or antifungal medicines by patients.

C.5

Engages in sales and marketing practices
to address appropriate use

C.7

AMR SurveillanceFresenius Kabi performs above average in sales

As a generic medicine manufacturer, Fresenius

practices. It reports that it sells most of its anti-Kabi is not assessed in this indicator nor does

bacterial and/or antifungal medicines throughit report any involvement in AMR surveillance

hospital tenders and does not have sales incen-activities.

tives linked to the sales volume of these tenders.
Fresenius Kabi engages in marketing prac-† 102 low- and middle-income countries
where better access to medicine is mostneeded.

48