AMR Benchmark Opportunities: progress update

Generic medicine manufacturers

Teva Pharmaceuticals Industries Ltd
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?

Ensure compliance with antibacterial discharge limits

Teva has continued its efforts to achieve compliance withat suppliers’ sites by tracking and publicly disclosing

discharge limits for antibiotic waste. It reports that all 33 ofprogress and results specific to antibacterials for all

its own sites were assessed in 2022 and 21 (64%) sites aresites.

compliant with discharge limits in the receiving environment.

Teva can set limits and quantify discharge levels to track

This is an improvement from 2021, when 10 (31%) of its

compliance at all suppliers’ sites, as it does at its own sites,

own sites were reported as compliant. Teva also publicly

and publicly disclose the results. Teva reports the goal todiscloses this information in the public domain.

audit half of all supplier sites by end of 2030. Teva can also

Teva reports it has communicated its expectations to fol-publish information on how it manages environmental risk

low the AMR Industry Alliance standards to 50 of its approx-

related to antibacterial manufacturing. The company cur-imately 140 priority suppliers. In 2023, Teva has rolled out arently publishes limited information.

questionnaire to suppliers to determine the status of theircompliance with discharge limits.

Expand registration of antibacterial and antifungal

Since 2021, Teva reports that it has filed antibacterial andmedicines.

antifungal medicines, listed on the 2023 World Health

Teva can expand registration of its antibiotics and antifun-Organization (WHO) Model List of Essential Medicines

gals listed on the 2021 WHO EML, such as cefalexin, colistin(EML), for registration in five additional low and middle-in-and nystatin, to more countries, including low-income

come countries (LMICs). These include azithromycin,countries.

fosfomycin, fluconazole, caspofungin and terbinafine.
However, the company highlights expanding registration for
in-licensed products can be constrained by contract termswith each licensor.

Ensure continuous supply of antibacterial and antifungal

Teva reports that it supplies antibiotics to 57 markets,medicines.

including 21 LMICs. Almost 80% of the expected antibiotic

Teva mitigates against shortage risks, e.g., by maintaining

sales volume for 2023 is reported to be manufactured

a flexible safety stock management process and keepingin-house.

buffer stocks. It can implement several strategies to miti-Teva reports that it has supplied 438,830 doses ofgate against shortage risks in access countries, e.g., build

antibiotics to address national shortages in South Africa.

local manufacturing capacity and transfer technology into

Additionally, the company reports supplying linezolid andaccess countries.

pyridoxine (a vitamin supplement used in tuberculosis regimens) through tenders to the Stop TB partnership in 2022.
Furthermore, in 2022, Teva reports its donations
exceeded 25 million doses of antibiotics, valued at over
USD 56 million, to various countries around the world, themajority of which are LMICs. Additionally, over 3.2 million
doses of antibiotics were donated to the Ukrainian relief
effort in 2022.

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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?

Expand adaptations to brochures and packaging toTeva reports continuing to insert information leaflets in four

consider more patient needs.

languages in its antibiotic packaging, with aims to extend

In order to support the appropriate use of its antibacterial

this practice to more countries. On packaging of certain

and/or antifungal medicines by patients, Teva adapts

products, Teva includes information on the importance ofbrochures to take account of local languages. It can further

appropriate use of antibiotics. The company also reports

adapt its brochures and packaging to consider literacy

implementing tamper-proof packaging in response to global

levels, paediatric use, environmental conditions and patient

serialisation regulations.

adherence to treatment.

35Antimicrobial Resistance Benchmark 2021

TEVOverall Performance
2020

2021

63% 60%▼Access to Medicine Foundation

Teva Pharmaceutical Industries Ltd
Generic medicine manufacturer
Stock exchange: NYSE • Ticker: TEVA • HQ: Petah Tikva, Israel • Employees: 40,216

TEV
PERFORMANCE

Performance in the Benchmark

Teva performs above average overall in its evaluated Research Areas0%

when compared to the other generic medicine manufacturers in scope.
Responsible Manufacturing: Middle-performing. Reports environmental
risk-management strategy for own sites; tracks compliance with limits atown sites.
Appropriate Access: Middle-performing. Files some of its relevant
products (off-patent generic medicines) for registration in accesscountries. Reports some strategies to expand access and ensure

Points60%

Overall score

24/ 4050%

100%

Performance by Research Area
R&D

Points0%

0/ 060%

Manufacturing

9/ 1547%

Access

7/ 1580%

Stewardship0%

continuous supply of its relevant product.
Stewardship: Performs well. It does not promote antibacterial and/or50%

8/ 10100%

How Teva was evaluatedantifungal medicines to healthcare professionals. It adapts packaging forpatients.

A R&D

12.1 2.2 2.3 2.43●

●

●

●

123

B Manufacturing ●

●

●

●

●

1.1

1.2 1.3 2.1 2.2 2.3

3C Access

●

●

●

4

56

7

C Stewardship●

●

●

●

●

●

●

●

● ● ● Scored●

Not scored

OPPORTUNITIES FOR TEVACHANGES SINCE 2020

Ensure compliance with antibacterial discharge limits at suppliers sites by tracking and publicly• In its 2020 Environmental, Social anddisclosing progress and results specific to antibacterials for all sites. Teva can set limits and quan-

Governance (ESG) Progress Report, Teva pub-tify discharge levels to track compliance at all suppliers’s sites, as it does at its own sites, and pub-

licly commits to meet existing AMR Industry

licly disclose the results. Teva reports the goal to audit half of all supplier sites by end of 2030. Teva

Alliance commitments to minimise antimicro-

can also publish information on how it manages environmental risk related to antibacterial manu-bial discharges from its own operations andfacturing. The company currently publishes limited information.
Expand registration of antibacterial and antifungal medicines. Teva can expand registration of its
antibiotics and antifungals listed on the 2021 WHO EML, such as cefalexin, colistin and nystatin, tosupply chain by 2030.
• Teva pledged an unknown amount to the AMR
Action Fund

more countries, including low-income countries.
Ensure continuous supply of antibacterial and antifungal medicines. Teva mitigates against shortage risks, e.g., by maintaining a flexible safety stock management process and keeping buffer stocks.
It can implement several strategies to mitigate against shortage risks in access countries, e.g., build
local manufacturing capacity and transfer technology into access countries.
Expand adaptations to brochures and packaging to consider more patient needs. In order to support the appropriate use of its antibacterial and/or antifungal medicines by patients, Teva adapts
brochures to take account of local languages. It can further adapt its brochures and packaging to consider literacy levels, paediatric use, environmental conditions and patient adherence totreatment.

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Antimicrobial Resistance Benchmark 2021Access to Medicine Foundation

SALES AND OPERATIONSTEVNet revenues by business segment

Therapeutic areas: Migraine/headache/pain, Neurodegenerative condi-

2019

tions and movement disorders, Oncology, Respiratory

2020

Business segments: North America, Europe, International Markets

8,447
0

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

8,542

2,246

4,757

2,154

10,000

North America

Europe20,000mn USDInternational Markets

TEV
Net revenues by region
2019

8,542

4,795

2,2462020

8,447

4,757

2,1540
North America

5,00010,000EuropeInternational markets

PORTFOLIO for pathogens in scope

TEV
Products on the market

Comparatively large portfolio: At least 137 products: 115 antibacterial med-0icines; 22 antifungal medicines

4,7950115
50

100

22150

15,00020,000mn USD● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine

Off-patent/generic medicines: 10 of 137 were selected for analysis*(amoxicillin [A], azithromycin [W], cefalexin [A], ciprofloxacin [W], clotrimazole [F], colistin [R], daptomycin [R], ethambutol [T], isoniazid [T],nystatin [F])AWaRe medicines**: 21 Access group; 43 Watch group; 5 Reserve groupAnti-TB medicines**: 4

PERFORMANCE BY RESEARCH AREAA

RESEARCH & DEVELOPMENT

As a generic medicine manufacturer, Teva is notevaluated in this Research Area.

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

B.1

Environmental risk-management for own

charge levels.

sites and plans implementation at sup-lished. Teva also does not publish: (1) the results

Teva expects external public and privateof environmental audits, whether conducted at

waste treatment plants to comply with its gen-its own sites, the sites of suppliers or external

Teva reports a strategy to minimise the environ-eral environmental standards. There is limited

private and public waste-treatment plants; or (2)mental impact of wastewaters and solid waste

information on the requirements Teva makes

a list of these suppliers and plants.

from antibacterial manufacturing at its sites,of external private and public waste-treatment

including audits every three years. It reports set-plants, in terms of audits and antibacterial dis-ting discharge limits in the receiving environ-charge limits and levels.

plier sites

B.3

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

ment for all antibacterials manufactured at its
Publicly discloses some information on

Teva reports that its own sites and suppliers

mended by the AMR Industry Alliance. Discharge

environmental risk management andhave a system to maintain high-quality antibac-

levels are quantified using a mass balance

quantifying discharge levels at own sitesterial production consistent with internationalsites, based on PNECs to limit AMR, as recom-B.2

approach. It reports 22 of 32 sites have quanti-

Teva publishes some components of its envi-

GMP standards. This includes periodic risk-

fied discharge levels and 10, or 31%, are compli-

ronmental risk-management strategy. It is abased audits and tracking of corrective and pre-ant with discharge limits.

member of the AMR Industry Alliance, which

ventive actions. There is limited information on

publishes a list of recommended antibacte-

whether Teva requires its suppliers to audit theirers of antibacterials to follow similar standards.

rial discharge targets. Teva publicly commits toown suppliers. In January 2020, an FDA drug

It reports a goal to audit 50% of all >250 suppli-quantifying discharge levels at 20 of its 34 own

quality inspection identified non-conformities

ers by the end of 2030.*** It does not yet requiresites that manufacture antimicrobials by the end

with cGMP at one Actavis site (a Teva subsidiary

suppliers to set discharge limits or quantify dis-of 2020.† The levels themselves are not pub-in Davie, FL, USA) producing antibacterial drug

Teva started requiring third-party suppli-* See Appendix VII for information about
eligibility criteria for products.
** Listed on the 2019 WHO EML.
***After period of analysis, Teva reported
that the number of suppliers is updated

to ~150.
†Discrepancy with number of sites in B.1 isexplained by Teva’s submission data for
the Benchmark being more up to datethan publicly available data.

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Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

products, resulting in an official request for corrective action. Teva reports that the oral antibacterial products manufactured at this site were
not impacted by the observations and that thesite is taking corrective actions.

CAPPROPRIATE ACCESS & STEWARDSHIP – ACCESS

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries‡
Teva is not eligible for indicators: C.1.1, C.1.3, C.2.1

access in access countries through donations

Planning (ERP) system. It reports keeping buffer

and C.2.3. For more information, see Appendix

and tenders. In 2020, Teva, together with itsstocks. Teva does not report capacity build-VII.

partners, reports having donated more than 17ing and technology transfer initiatives. To mit-mn units of antibiotics and antifungals to accessigate against substandard and falsified prod-countries. In Malawi, Teva is partnering withucts, Teva directly donates its medicines to cer-

Global HOPE and Direct Relief, to donate anti-

tified partners and uses security features such as

Teva has an average performance, filing three ofbiotics for pediatric immunosuppressed cancerserialisation.

its 10 relevant off-patent/generic medicines forpatients. The initiative aims to treat 4,000 new

registration in three access countries on aver-patients in Malawi over the next five years. Teva

age. Its most widely filed relevant product isparticipates to the GDF and IDA Foundation

the antibacterial azithromycin, filed in 19 accessglobal tenders for tuberculosis, to provide line-countries. Two of its relevant products are filed

zolid to all GDF eligible countries.

C.1.2 Filed to register off-patent/generic medicines in 3 access countries on averagein less than ten access countries. One of its relevant product (azithromycin) is filed for registra-C.3

Some strategies to ensure continuous
supplytion in seven LICs.

Teva has an average performance, with stratC.2.2 Some strategies to expand access toegies reported in three of four areas assessed.

off-patent/generic medicines

Teva mitigates against shortage risks by main-

Teva has an average performance, with accesstaining a certain volume of products ready tostrategies reported for three of its ten relevant

donate. Teva has a flexible safety stock man-off-patent/generic medicines. It aims to expand

agement process within its Enterprise ResourceC

APPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

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

Educational Stewardship Activities

C.6

Makes one type of brochure and/orpackaging adaptation to facilitate appro-

There is no information regarding Teva’s involve-

priate use by patientsment in AMR-related educational programmes
aimed at healthcare professionals and it isTeva adapts packaging to facilitate the appro-

therefore not eligible for this indicator as there ispriate use of azithromycin, linezolid and pyri-no conflict of interest mitigation to be assessed.

doxine by patients. Teva is middle-performing inthis measure, taking account of language. TheC.5

Does not promote its antibacterial and/packaging contains information translated intoor antifungal medicines

English, Spanish, French and/or Portuguese.

Teva performs strongly in sales practices. It does
not deploy any sales agents to promote its anti-C.7

bacterial and/or antifungal medicines to health-As a generic medicine manufacturer, Teva is notAMR Surveillancecare professionals. Since Teva does not develop

assessed in this indicator nor does it report any

or use marketing materials for antibacterial and/involvement in AMR surveillance activities.

or antifungal medicines to promote such medicines to healthcare professionals, the company is not eligible to be assessed on marketing materials.

‡ 102 low- and middle-income countries
where better access to medicine is mostneeded.

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