AMR Benchmark Opportunities: progress update

Generic medicine manufacturers

Abbott Laboratories
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?

Request and review discharge levels of all suppliers

In 2021, Abbott introduced AMR provisions within theand increase public disclosure on environmental risk

medicines business’ template contract for its suppliers.

management.

These provisions require suppliers to implement liquid andAbbott can expand its environmental risk management

solid waste management practices, adhere to antimicrobial

requirements to all suppliers by fully implementing its sup-discharge limits, and provide discharge level information

plier contract template which outlines specific provisions forupon request. Abbott publicly reports that the contract isAMR. Abbott currently requests and reviews discharge lev-being implemented with suppliers for its branded genericels for only a subset of its suppliers. Abbott can also publicly

medicines business. In addition, support is provided todisclose more information on how it manages environmen-

suppliers to cohere with the provisions. For example, since

tal risk related to antibacterial manufacturing. It can publish

2022, Abbott offers free wastewater analysis to all sup-information on its progress in implementing the strategy,pliers that exceed discharge limits based on mass balance

the limits it sets, and the results of the audits of own andquantifications. To identify high-risk suppliers for AMR,

suppliers’ sites including antibacterial discharge levels.

Abbott reports the use of a desktop assessment tool since2023. This involves a questionnaire including questions onpharmaceuticals in the environment and AMR. It is unclear
how many supplier sites out of the total are compliant
with discharge limits. In the public domain, Abbott reports
regularly quantifying antibiotic discharge levels against set
discharge limits.

Expand registration and ensure availability ofIn India, Abbott has expanded registration for two Accessantibacterial and antifungal medicines.

antibiotics and two antifungals listed on the 2023 World

Abbott can expand registration of its antibiotics and anti-

Health Organization (WHO) Model List of Essential

fungals listed on the 2021 WHO EML, such as gentamicin,Medicines (EML). Similarly, in the Middle East, Turkey, Africa

itraconazole and tigecycline, to more countries, including

and Pakistan, Abbott has registered four Watch antibiotics

low-income countries, with a high burden of disease.

listed on the same EML. Clarithromycin is the company’s

Further, it can expand equitable access in countries wheremost widely filed antibiotic, with filings spanning 31 low-in-medicines have been registered.

come countries and 55 lower-middle income countries, andmarket presence in the majority of them. Abbott highlightsthat registration expansion for in-licensed products can beconstrained by contractual terms with licensors.
Abbott did not report any developments pertaining toexpanding access to its off-patent/generic antibacterials
and antifungals.

Fully decouple incentives for sales agents from sales

Abbott reports that its sales agents are incentivised forvolumes.

the sales of a basket of medicines that covers different

Abbott ran a pilot in India where it fully decoupled incentives

therapeutic areas and includes antibacterial and antifungal

for sales agents from sales volumes of an anti-infective for

medicines. Sales incentives are partially decoupled fromthree months. It can expand this practice to more countries

sales volumes and, in India, are partially based on qualitative

where it markets antibacterial and/or antifungal medicines

targets, including targets related to AMR risks. However,and to more relevant products.

the specific percentage of variable pay or the level at which
incentives are set is not disclosed.

26

AMR Benchmark Opportunities: progress update

Generic medicine manufacturers

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?

Comprehensively mitigate COI for educational

Abbott continues to organise medical education pro-programmes.

grammes that focus on the responsible use of antimicrobial

Abbott organises medical education programmes for

medicines for healthcare professionals, tailored to the needs

healthcare professionals on responsible use of antimicrobialof healthcare systems and in collaboration with appropriate

medicines. It can ensure that branded materials are notpartners across all regions where its medicines businessused in any educational programmes, as is now the case foroperates. As of 2023, branded materials are no longer usedsome.

in any educational programmes.

27

Antimicrobial Resistance Benchmark 2021

ABTOverall Performance
2020

2021

53% 69%▲Access to Medicine Foundation

Abbott Laboratories
Generic medicine manufacturer
Stock exchange: NYSE • Ticker: ABT • HQ: Chicago, IL, US • Employees: 109,000

ABTPERFORMANCE
Abbott performs well overall in its evaluated Research Areas compared

Performance in the Benchmark

0%

to the other generic medicine manufacturers in scope.
Responsible Manufacturing: Performs well. Reports comprehensive
environmental risk-management strategy for own sites and suppliers;
quantifies discharge levels at all own sites.
Appropriate Access: Middle-performing. Files some of its off-patent/
generic medicines for registration in access countries. Reports somestrategies to expand access and ensure continuous supply of its relevant

incentives for sales agents from sales volumes for an anti-infective,

R&D

programmes. It adapts packaging for patients.

50%

100%

Points0%

0/ 073%

Manufacturing

11/ 1553%

Access

8/ 1580%

Stewardship
0%50%

12/ 15100%

How Abbott was evaluatedhowever it does not decouple such incentives for its other products.
It reports broad conflict of interest mitigation for its educational

31/ 45

Performance by Research Area

product.
Stewardship: Performs well. It ran a pilot where it fully decoupled

Points69%

Overall score

A R&D

12.1 2.2 2.3 2.43●

●

●

●

123B Manufacturing ●

●

●

●

●

1.1

1.2 1.3 2.1 2.2 2.3

3C Access

●

●

●

4

5

6

7C Stewardship

●

●

●

●

●

●

●

●

● ● ● Scored●

Not scored

OPPORTUNITIES FOR ABBOTTCHANGES SINCE 2020

Request and review discharge levels of all suppliers and increase public disclosure on environ-• In 2021, Abbott introduced a new contract

mental risk management. Abbott can expand its environmental risk management requirements totemplate for suppliers of APIs and drug prod-

all suppliers by fully implementing its supplier contract templete which outlines specific provisions

ucts with clauses that specifically requirefor AMR. Abbott currently requests and reviews discharge levels for only a subset of its suppliers.

implementation of AMR standards.

Abbott can also publicly disclose more information on how it manages environmental risk related to• In response to an opportunity from the 2020

antibacterial manufacturing. It can publish information on its progress in implementing the strategy,

AMR Benchmark, Abbott ran a new pilot in

the limits it sets, and the results of the audits of own and suppliers’ sites including antibacterial dis-which it fully decoupled incentives for sales

charge levels.

agents from sales volumes of an anti-infective

Expand registration and ensure availability of antibacterial and antifungal medicines. Abbott can
expand registration of its antibiotics and antifungals listed on the 2021 WHO EML, such as gen-in India for three months.
• Abbott is funder and member of the con-tamicin, itraconazole and tigecycline, to more countries, including low-income countries, with a highsortium VALUE-Dx. VALUE-Dx is the firstburden of disease. Further, it can expand equitable access in countries where medicines have been

Innovative Medicines Initiative project initiatedregistered.

by six in vitro diagnostic companies who work

Fully decouple incentives for sales agents from sales volumes. Abbott ran a pilot in India where itwith 20 non-industry partners to combat AMR

fully decoupled incentives for sales agents from sales volumes of an anti-infective for three months.
It can expand this practice to more countries where it markets antibacterial and/or antifungal medi-

and improve patient outcomes.
• Since 2020, Abbott has adapted packaging ofcines and to more relevant products.

eight of its antibacterial medicines, including

Comprehensively mitigate COI for educational programmes. Abbott organises medical educa-

amoxicillin and azithromycin, to take accounttion programmes for healthcare professionals on responsible use of antimicrobial medicines. It canof adherence to treatment, literacy and pae-ensure that branded materials are not used in any educational programmes, as is now the case fordiatric use to facilitate the appropriate use ofsome.

such medicines by patients.

34

Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONS

ABTNet sales by business segment

Therapeutic areas: Cardiovascular, Diabetes care, Gastro intestinal/immu-

2019 4,486

nity health, Infectious disease (Diagnostic, Covid-19), Metabolic disorders,

2020 4,303

7,647

10,805010,000

20,000

Pain/central nervous system, Respiratory, Women’s health.
Business segments: Established pharmaceutical products, Nutritional
Product categories: Diagnostics, Generic medicines, Medical devices,
M&A since 2020: None in the antibacterial and/or antifungal sectors

7,713

12,23957

11,78766

30,000Established Pharmaceutical Products
Nutritional Products
Diagnostic Products

products, Diagnostic products, Medical devices
Vaccines

7,409

40,00050,000mn USD

40,00050,000mn USD

Medical Devices
OtherABTNet sales by region
11,3982019

11,534

13,022

2020
012,580

10,000

United States
JapanThe Netherlands

20,00030,000GermanyIndia
All other countries

China
Switzerland

PORTFOLIO for pathogens in scope
Comparatively large portfolio: At least 85 products: 75 antibacterial medi-ABT
Products on the marketcines; 3 antibacterial vaccines; 7 antifungal medicines
Off-patent/generic medicines: 10 of 85 were selected for analysis* (amoxicillin/clavulanic acid [A], amphotericin b [F], cefixime [W], clarithromycin

3075 720406080100120● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine[W], clofazimine [T], colistin [R], gentamicin [A], itraconazole [F], linezolid[T], tigecycline [R])AWaRe medicines**: 16 Access group; 20 Watch group; 3 Reserve groupAnti-TB medicines**: 10PERFORMANCE BY RESEARCH AREAA

RESEARCH & DEVELOPMENT

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

B

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

B.1

Comprehensive environmental risk-man-Abbott expects external private waste-treat-agement for own sites and suppliers;

ment plants to comply with its general environ-tracks compliance with limits at own

mental standards. It audits these plants at leastsites

every five years (based on risk) which includes

and levels of antibacterial discharge from its
own or suppliers’ sites.
B.3

System in place to maintain production
quality for own and suppliers’ sites; noAbbott reports a comprehensive strategy tochecking the suitability of technologies used

minimise the environmental impact of waste-

for processing waste and protocols for prevent-requests for official corrective action

waters and solid waste from antibacterial man-ing contamination. It also employs conservative

Abbott reports own sites and suppliers have aufacturing at its sites, including audits every

measures for effluents sent to external private

system to maintain high-quality antibacterial

three years. It reports setting discharge limits

and public wastewater treatment plants.

production consistent with international GMP

in the receiving environment for all antibacteri-standards. This includes periodic risk-based
Limited publicly available information on

audits and tracking of corrective and preven-limit AMR, as recommended the AMR Industry

environmental risk management

tive actions. Abbott also requires its suppliers toAlliance. Discharge levels are quantified using

Abbott publishes some components of its envi-audit their own suppliers. The Benchmark founda mass balance approach, verified by chemicalronmental risk-management strategy, with-no requests for official corrective action fromanalysis if applicable. It reports tracking compli-

out specific references to AMR. It does publish

the FDA or EMA related to non-conformities

ance with discharge limits of own sites.

having a programme in place to assess and min-with cGMP at Abbott’s own sites or any subsidi-

imise the impact of discharges, from own andaries that manufacture antibacterials.

als manufactured at its sites, based on PNECs toAbbott requires third-party suppliers of anti-B.2

bacterials to follow the same standards, includ-suppliers’ sites manufacturing APIs, on the envi-

ing limits based on PNECs. It reports conductingronment. Abbott does not publish: (1) the results

on-site audits every 3-5 years. It requests andof environmental audits, conducted at its own

reviews the discharge levels of its suppliers. Asites, the sites of suppliers and/or external pri-

subset of its suppliers’ sites report to have quan-vate and public waste-treatment plants; (2) a listtified discharge levels.

of these suppliers and plants; or (3) the limits* 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***Abbott is not eligible for indicators: C1.1, C1.3,

Abbott reports two simplified treatment regi-

C.2.1 and C.2.3. For more information, seemens examples in Bolivia, India, and Peru. It esti-Appendix VII.

mates its simplified treatment regimen containing clarithromycin to reach 5,000 cumulative

C.1.2 Filed to register 8 of 10 relevant off-pat-patients per year in Peru and Bolivia.

ent/generic medicines in 8 access countries on average

C.3

Several strategies to ensure continuous
supplyAbbott has an average performance, filing eightof its ten relevant off-patent/generic medi-

Abbott has an average performance, with strat-cines for registration in eight access countries

egies reported in all four areas assessed. It

on average. Its most widely filed relevant prod-ensures accurate demand planning and data

uct is the antibiotic clarithromycin filed in 58

sharing by having a monthly rolling forecast

access countries. Seven of its relevant productswith a 24-months horizon. Abbott mitigatesare filed in less than ten access countries. One ofagainst shortage risks by keeping a buffer stock

its relevant products is filed for registration in atfor critical APIs and finished products. It has

least one LIC.

a dual-sourcing strategy for its strategic APIs.
Abbott reports one technology transfer initiative

C.2.2 Limited information on strategies toof its drug product unit operations to a third-

expand access to off-patent/genericparty drug manufacturer. To mitigate against

medicines

substandard and falsified products, Abbott uses

Abbott has an average performance as it reports

packaging features, conducts employee’s train-

limited information on how it expands access toings, and tests potential falsified products in a

its ten relevant off-patent/generic medicines.

dedicated laboratory.

CAPPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

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

Broad COI mitigation strategies in placevent the inappropriate use of its antibacterialon the packaging of eight antibacterial paediat-for its educational programmes

and/or antifungal medicines.

ric suspensions that directs to a video explaining

Abbott performs well in conflict of interest

Abbott engages in marketing practices that

how to use them appropriately.

(COI) mitigation for the five AMR-related edu-aim to address the appropriate use of its anti-

cational programmes for HCPs assessed bybacterial and/or antifungal medicines. Its mar-C.7

the Benchmark. To mitigate COI for three pro-keting materials reflect emerging resistance

As a generic medicine manufacturer, Abbott isgrammes, it provides financial resources totrends and/or include treatment guidelines for

not assessed in this indicator but its activities inindependent third parties (APUA, Medscape,healthcare professionals: for clarithromycin.

AMR surveillance are reported. The Benchmark

BSAC and the University of Dundee) to develop

AMR Surveillancenotes that Abbott is active in two AMR surveilMakes three types of brochure and/lance programmes. It runs the national ARISE

COI mitigation strategies looked for by theor packaging adaptations to facilitate

programme, which is focused on regional sen-Benchmark: (1) content is developed inde-appropriate use by patients

sitivity indices at a state level on hospital- andthe programme. One programme has all three

C.6

pendently from its marketing department;

Abbott adapts packaging to facilitate the appro-

community-acquired infections in India since(2) a pledge not to provide financial or mate-

priate use of its antibacterial medicines byJanuary 2019. Abbott only shares the data col-rial incentives to participants; and (3) it does

patients. Abbott performs strongly in this meas-

lected in this programme through a data plat-

not use branded materials. The remaining pro-ure, taking account of adherence to treatment,

form in a restricted manner. Moreover, thegramme has two of three COI mitigation strat-literacy and paediatric use. It adapts the package

CANWARD programme is a national programmeegies looked for by the Benchmark: it is unclear

size of clarithromycin in eight countries to a fullmanaged by the Canadian Antimicrobial

whether branded materials are being used.

treatment course of either a 7-, 10-, or 14-day

Resistance Alliance with support from Abbott,treatment. Moreover, Abbott has dose marking

among others. Only the aggregated results

Engages in sales and marketing practices

on the packaging of cefixime in India to improve

are shared through an open-access data plat-to address appropriate use

patient adherence to treatment. Further, itform, as well as through peer-reviewed journal

Abbott performs above average in sales prac-

includes a QR code on the packaging of amoxi-

articles.

tices. It ran a pilot in 2021 where it fully decou-

cillin that directs patients to information on thepled incentives for sales agents from sales vol-appropriate use and the course of treatment toumes of an anti-infective in India for three

improve adherence to treatment. Additionally,months. However, outside of this pilot Abbott

Abbott adapts packaging for antibacterial medi-

does not report whether it decouples incentives

cines in India by including pictograms to support

for sales agents from sales volumes to help pre-literacy challenges. Finally, it includes a QR code

C.5*** 102 low- and middle-income countries where better access to medicine ismost needed.

36