Antimicrobial Resistance
Benchmark 2021
METHODOLOGY

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

ACKNOWLE DG E M E NTS

The Access to Medicine Foundation would like to thank thefollowing people and organisations for their contributions tothis report.
FU N D E RS

UK Foreign, Commonwealth and Development Office
The Dutch Ministry of Health, Welfare and Sport

Antimicrobial Resistance
Benchmark 2021
M ETH ODOLOGY RE PORT 2020
E XPE RT CO M M IT TE E

R ES E ARCH TE AM

Hans Hogerzeil (Chair)

Fatema Rafiqi

Gregory Frank

Ruth Baron

Sudarshan Jain

Dulce Calçada

Joakim Larsson

Guilherme Ferreira

Marc Mendelson

Moska Hellamand

Mirfin Mpundu

Teresa S. Sánchez Pascua

Maria Larsson Ortino
Sarah Paulin (Observer)
AD D ITI O NAL CO NTR I B UTO RS

The Access to Medicine Foundation would liketo thank all of the representatives of the manydifferent stakeholders working to curb antimicrobial resistance who contributed their views to
the development of this methodology.

ACCESS TO M E D I CI N E FO U N DATI O N

The Access to Medicine Foundation is an independent
non-profit organisation based in the Netherlands. It aims toadvance access to medicine in low- and middle-income
countries by stimulating and guiding the pharmaceuticalindustry to play a greater role in improving access.
Naritaweg 227-A
1043 CB, Amsterdam

On the cover is a young boy from
Tanzania, a country where the presence

The Netherlandsof resistant bacteria is widespread as

For more information about this publication, please contact

stewardship, as covered in theFatema Rafiqi, Research Programme Manager frafiqi@accesstomedicinefoundation.org+31 (0) 20 215 35 35
www.amrbenchmark.org

2

are many of the issues in access and

ACCESS TO M E D I CI N E FOU N DATI O N
October 2020

Benchmark. The young boy represents
these underserved populations thatwere the focus during the refinementof the methodology.

3Antimicrobial Resistance Benchmark 2021 – Methodology Report

Table of contents

Access to Medicine Foundation

Halting the next
pandemic
COVID-19 is not the only pandemic that the worldis currently battling. We have seen great progressagainst malaria, HIV/AIDS and TB, and to improve2

Acknowlee
dgm nts

5

Forewordmaternal health, while working to deliver the SDGs.
However, we are also facing warnings of future
pandemics of drug resistant bacterial and fungal

6

SU M MARY

infections. Like COVID-19, antimicrobial resistanceNew framework to track progress on AMR by key pharma players(AMR) poses a significant risk to economies, will
disrupt health systems and endanger our most10

R E VI E WI N G TH E M E TH O D O LO GY

vulnerable populations. Unlike COVID-19, an AMR

How the Benchmark distills the role for pharmaceuticalpandemic can still be stopped if we act now; wecompanies in curbing AMRknow which actions to take and which pathogens
to target. The need to invest in pandemic prepar-

13

WHAT TH E B E N CH MAR K M E A SU R ES

edness and R&D is clear as it is evident that it is14

Company scope

too costly on all accounts to develop a cure at

3rd AMR Benchmark to track progress

16

Disease scope

short notice. By fixing the fundamentals of

Despite these intermediary solutions with cash and17

Product scope

healthcare systems, and by pushing for new

commitments, in the end it lies to each individual

18

Geographic scope

antibiotics and vaccines, we can avert the next big

company to innovate and to sustainably provide

superbug pandemic.

access to the vital antibiotics necessary to prevent

21

HOW THE BENCHMARK MEASURES

22

Analytical framework23

the next pandemic. For pharmaceutical companies,
the role in the global effort against AMR is clear: to

Research & Development

Momentum is building slowly
The key challenges are a sparse R&D pipeline of25

Responsible Manufacturing

new medicines and vaccines, and discouraging

effective; to produce and promote antibiotics

27

Appropriate Access & Stewardship

economic barriers to industry engagement.

responsibly; and to make these available andPharmaceutical companies largely pass over theaccessible to people who need them.

develop new medicines to replace those no longer

33

APPENDICES

antibiotics market due to a comparative lack ofThis refined methodology seeks to not only

34

Appendix I. Priority pathogens included for analysis in R&D

profitability. A viable economic environment isfurther inform and assess the progress of compa-

35

Appendix II. Concepts used in evaluating antimicrobial stewardshipneeded to not only spur R&D, but to ensure anies, but to realistically determine our future state

37

Appendix III. Guidance to Access and Stewardship planningsustainable market that can deliver reliable

as a society if the most important players in the

39

Appendix IV. Definitions

supplies once a product is commercialised. A few

antibiotic market are not advancing and evolving at

42

Appendix V: References

governments are taking steps, with the British andthe pace required.

Swedish governments piloting new economic
incentives to promote R&D and ensure availability.
Several large pharmaceutical companies are also
committing resources, collectively launching the
AMR Action Fund to support development ofnovel antibiotic candidates. But there are still
underserved gaps in the market and insufficientinvestment in commercialisation. Moreover, unless4

action is taken today, those low-income countries

Jayasree K. Iyer

that currently bear the brunt of resistance will

Executive Director

remain overlooked and underserved.

Access to Medicine Foundation

5

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

SUMMARY: TOWARD A 3 RD AMR BENCHMARK

2021 framework will track progress on
AMR by key pharma players

95%
95% of patients
95% of patients
hospitalised
withhospitalised
with
COVID-19
received
COVID-19
received
antibiotics
antibiotics

chains are fragile. Moreover, the efforts to ensure

manufacturing and commercialisation. The impor-equitable access to medicine are reliant on donortance of tackling AMR cannot be over-stated. Lackfunding, with the result being that a few rich coun-of preparation disrupts health systems, economies

tries are benefiting from innovations while low-

and threatens populations. Now is the time to build

and middle-income countries miss out.

on the momentum with new tools, resources, and

The COVID-19 pandemic has underlined the needcollaboration, in order to provide funding, drive

to invest in pandemic preparedness and antibi-robust pipelines, build capacity and supply, andotic R&D, and brought into sharp focus the needensure equitable access.

for many different companies to engage in R&D,

VISI ON FOR TH E PHARMACEUTI CAL I N DUSTRY
Each year, around 5.7 million people die from treat-with Phase III costs at 12 times more than Phase
I.4 Moreover, the costs associated with activi-

To limit antimicrobial resistance, the role for phar-able bacterial diseases due to the lack of accessmaceutical companies is clear: to develop new

biotics by ensuring they are produced in suffi-

to antibiotics, mainly in low- and middle-income

ties beyond R&D, such as manufacturing, supply

medicines to replace ones that are no longer effec-

cient volumes and registered and supplied withincountries (LMICs). More than 700,000 die from
antimicrobial resistance (AMR),1 and the number

chain activities, commercialisation and regulatory

tive, make them available and accessible to thoselow- and middle-income countries.

of drug-resistant bacteria is increasing worldwide.2

survey, 74% of companies indicated they would

While there are signs of increased awareness andincrease investments in AMR if commercial models improve,5 for example through new reimburse-

Each year, 5.7 million
Each year, 5.7 million
momentum to tackle AMR, there is a clear andpeople die due to lack ofpeopledieantibiotics.
due to lackaccess tourgent need for a viable economic environment inof access toantibiotics

Revenue (bn USD)

55.8
589
38.3

447

requirements, are also considerable. In a recent

ment models. The antibacterial market has been

which the companies that develop antibiotics canpredicted to grow to USD 55.8 billion by 2023 (upsurvive and prosper.

who need them, and ensure all antibiotics are procompanies
74% of surveyed
ready to invest
morecompanies
readytoin AMR if commercial
invest more in AMR ifmodels improvecommercial models
improve

nies must engage in responsible sales practices,
including decoupling sales bonuses from sales

common antibiotics, pharmaceutical companies

volumes, or stopping the use of sales teams tomust remain engaged, and ramp up effective

promote antibacterial and antifungal medicines.

from USD 38.3 billion in 2018).6 This is in step withdrug discovery and development operations.

• Companies must implement and audit responsi-

An estimated USD 5 billion is being contrib-

growing demand for generic antibacterials from• With only a few antibiotics in development, andble manufacturing processes that ensure med-

uted by government, philanthropic and industry

emerging markets. Human consumption of anti-

considering the scale of unmet need, companies

icines meet quality standards and minimise thefunders to fund research & development (R&D) for

bacterials is growing primarily in LMICs, wheremust protect new antibiotics at launch, and ena-

risk of antibacterial ingredients being released

replacement antibiotics and vaccines. The domi-

antibacterials are often accessed over-the-counterble access in countries most at risk, by planning

into the environment.

nant funder of AMR-relevant R&D is the pharma-

rather than by prescription.

ahead for access and stewardship.

2018 antibiotics
2023
Global(a consortium of at least 20 pharmaceutical com-

Antimicrobial resistance is being impacted by themarket predicted to
Global antibiotics
growmarket predicted togrowpanies) committed USD 1 billion to shepherd someongoing COVID-19 crisis. Studies indicate that theantibiotics through Phase II and Phase III clini-use of antibiotics to treat COVID-19 could drive

cal trials, aiming to bring 2-4 new antibiotics to

AMR in the wider population. The current treat-patients by 2030. Other pharmaceutical compa-

ment can involve giving antibiotics to prevent sec-

nies are re-engaging in the field through partner-

ondary infections, with 95% of patients admit-

ships and pacts: in early 2020, for example, Rocheand Forge Therapeutics entered a development

ted to hospital being prescribed antibiotics.7
Resistance rates may be positively impacted bypartnership, and Daiichi Sankyo released its chem-

improved infection prevention to control COVID-

ical library to GARDP to enable it to be screened

19 and by the decrease in travel. Conversely, resist-

The next AMR Benchmark will evaluate the eightfor novel compounds. A few national governments

ance rates may be driven up by inappropriate use

large research-based pharmaceutical companies

are stepping up, such as the United Kingdom andof antibiotics linked to suspected COVID-19.

and nine generic medicine manufacturers that

AMR R&D funding
5 bn
across various sources
1.6 bnSweden which are piloting new pull incentive initia-

Antibiotics compaAntibiotics
nies needcompanies
viableneed
viable economic
economic
environment
environment

port AMR surveillance efforts, thereby support-

engage once more. They nevertheless still haveing governments and hospitals in knowing wherea role to play in sharing expertise and intellectual

resistance is developing so they can adapt treat-

property, including compound libraries, contrib-

ment guidelines used to make clinical decisions.

uting manufacturing capacity, securing supply
and addressing affordability.

How the 2021 AMR Benchmark covers pharma companies

were tracked in the previous edition of the AMR

tives that provide fixed compensation in return for

AMR: the next pandemic?

Benchmark (2020). It will analyse small andguaranteed availability of certain medically impor-

Like COVID-19, AMR poses a global risk. Investors

medium-sized enterprises in a standalone report.

tant antibiotics. India, the world’s largest producer

and governments alike have seen the damage ofand consumer of antibiotics, is looking at legisla-a global pandemic. Unlike with COVID-19, there

The 2021 Benchmark covers three areas oftion to set limits on the concentrations of antibac-

is clarity on the path forward and the actions

company activity: Research & Development;

terials found in the waste discharged by companies

required to prevent a full-scale AMR health emer-

Responsible Manufacturing; and Appropriate

into the environment.

gency; the next pandemic could be caused by aAccess & Stewardship.

drug-resistant pathogen. Efforts to curb AMR are
hampered by reliance on just a handful of innova-

Changes to analysis scopes and indicators have

These amounts and initiatives are sizeable. While

tors and on a few geographically spread manufac-

been kept to a minimum in order to enable the

1 bnmost funding targets early research, it is late-turers of active pharmaceutical ingredients (APIs),

longitudinal tracking of company progress,

to AMR Action Fundstage clinical development that is most costly,

which means suppliers are limited and supply

prioritising only essential changes.

(2018)

6• In sharing data and insights, companies can sup-• Companies that are no longer active in R&D canMore funding is available, yet challenges remainfrom pharma industry

over-use of antibiotics and antifungals, compa-• As pathogens become increasingly resistant to

COVID-19 may accelerate AMR

up to 12 times morethan Phase 1• To prevent the overselling and subsequent

duced and promoted responsibly:

ceutical industry, investing USD 1.6 billion in 2018.3
In a new step, in July 2020, the AMR Action Fund

Later stages ofLate-stage clinicalclinical development
developmentcosts
are most costly• Companies should ensure the availability of anti-

Large

Generic

Small andR&D based

Medicinemedium-sizedcompanies

Manufacturers

enterprises

Figure 1

R&D

Responsible
Manufacturing

Appropriate
Access &Stewardship
Progress tracked using
indicator set

Trends explored instandalone report7Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

HOW THE AMR BENCHMARK DRIVES CHANGE

D ISCUSSI O NS & D ECISI O NS

The goal of the AMR Benchmark is to guide and incentivise

a market that has become increasingly fragile over recent

Discussions held during the methodology review covered apharmaceutical companies to play a full role against AMR.

decades. It covers eight large research-based pharmaceu-

wide range of areas and were rich in detail and context. In

This industry cannot afford to overlook the AMR threat. It

tical companies, nine generic medicine manufacturers andmany cases, there was alignment on the behaviours that theputs all areas of healthcare at risk, from oncology, to surgery,a cohort of small and medium-sized enterprises (SMEs)

2021 AMR Benchmark should measure and how. This section

to universal health coverage (UHC). Tracking progress ena-

focused on R&D (SMEs will be studied in a standalone report).

highlights some of the key decisions taken during the meth-bles each company to challenge itself to improve.

The Benchmark focuses on antibiotics and antifungals, asodology review.

The Benchmark is published every two years. It provides

bacteria represent the greatest proportion and widest geo-

the consensus view on where companies can and should begraphic spread of resistant pathogens. It will evaluate compa-

responding to AMR and tracks how a cross-section of thenies’ actions to improve access to products and ensure their

Third Benchmark will provide accountability and independ-

Refined approach to data gathering

industry is making progress against this expectation.

good stewardship. This part of its assessment will focus on

ent insight into progress

The Benchmark has established a new standard for industry

In 2021, as in previous iterations, the Benchmark will focus

102 resource-limited countries with high burdens of disease.

The stakeholder dialogue held in 2020 confirmed the needtransparency in the AMR space, and looks to public and part-on companies with a major stake in the antibiotics space,

By giving pharmaceutical companies public recognition forfor a third Benchmark to continue tracking the pace ofner data sources for verification, as well as inviting companies

their actions on AMR, the Benchmark provides accountabil-change. The first AMR Benchmark, published in 2018, pro-to engage. As companies have differing capacities and com-ity as well as a guide and an incentive for them to do more.

vided a baseline analysis of pharmaceutical company action

mitments to data-sharing, the Benchmark team minimises theCompanies in scope for the 2021 Antimicrobial Resistance

The Benchmark identifies good practices being implemented

against AMR in relation to all infectious diseases, to capture

impact of this difference by collecting publicly available data,

Benchmarkas templates for other companies to make further progress.

a full range of companies’ policies and practices. The sec-

stimulating companies to publish specific information, andStakeholders such as investors and governments use theond report provided an update, two years on. It found signs

engaging directly with companies to clarify, verify and expand

Benchmark to inform strategies for influencing the industry

of progress, but not at the scale or pace required. The third

the data collected.

and securing their engagement in this vital sector. Its findings

Benchmark will provide accountability, act as a guide andTable 2
L ARG E R ES E ARCH - BA S E D PHAR MACE UTI C AL CO M PAN I ES
Revenue
CompanyCountry HQ (bn USD)*

inform policy on incentives for industry and others to engage

incentive for companies to expand their activities, and inform1

GlaxoSmithKline plc

GBR

44.8

in infectious diseases, and identifies areas where greater

policy-making on market shaping and industry engagement.

2

Johnson & Johnson

USA

82.1

investment, engagement and political weight is needed.

Changes to analysis scopes and indicators have been kept

3

Merck & Co, Inc

USA

46.8

4

Novartis AG

CHE

47.4

to a minimum in order to enable the longitudinal tracking ofcompany progress, prioritising only essential changes.
MAKI NG TH E B E NCH MARK M ETHO DO LOGY

5

Otsuka Pharmaceutical Co, Ltd**

JPN

12.8

6

Pfizer Inc

USA

51.8

7

Sanofi

FRA

40.6

The Benchmark is developed independently by the Access toStandalone investigation into small- and medium-sized

Evaluation of unique access strategies for medicines and for8

Shionogi & Co, Ltd

JPN

3.1

Medicine Foundation. It translates the consensus view on how

enterprises (SMEs)

vaccines

pharmaceutical companies need to act on AMR into a set of

The 2021 Benchmark will publish its findings in two reports.

The 2021 Benchmark will examine access strategies for medi-

ambitious but achievable expectations for action. This meth-

One will track the progress of large research-based phar-cines separately to those for vaccines. When it comes to anti-

G E N E R I C M E D I CI N E MAN U FAC TU R E RS

odology has been refined through a targeted review of themaceutical companies and generic medicine manufacturers

bacterials and antifungals, vaccines are typically more profit-

CompanyCountry HQ (bn USD)*

previous methodological framework. This review aimed tosince 2020. The other will examine the actions and role ofable than medicines, have greater international demand and1

Abbott Laboratories

USA

31.9

ensure that the Benchmark, as a tool to evaluate

SMEs. SMEs play a unique role in antibacterial and antifungal

global support mechanisms and infrastructure that facilitate

2

Alkem Laboratories Ltd

IND

1.1

pharmaceutical company activities, remains rigorous and canresearch and development, leading in novel projects, and gen-availability. Vaccines also tend to be registered more widely3

Aurobindo Pharma Ltd

IND

3.1

be extended for trend analysis between reports.

erally have few products on the market. They are often dedi-

across LMICs than medicines. As a result of these differences,4

Cipla Ltd

IND

2.3

cated to a small number of R&D projects. When compared tothe pharma companies that control these products have dif-5

Fresenius Kabi AG

DEU

7.8

analytical approaches. This was followed by an externallarge research-based pharmaceutical companies, SMEs havefering roles and responsibilities for improving access. To bet-

6

Hainan Hailing Chemipharma Corp Ltd***

CHN

0.7

review with expert stakeholders, including individuals fromlimited capacity to run large clinical trials, or to produce andter assess current best practice, stakeholders and experts

7

Mylan NV†

GBR

11.5

international organisations, governments, industry, NGOs,

distribute on-market products. The SME report will provide

agreed that the Benchmark can best examine registration,

8

Sun Pharmaceutical Industries Ltd

IND

4.4

research centres and other relevant groups and initiatives. It

an in-depth analysis of the unique challenges, successes, andaccess and affordability strategies separately in three catego-

9

Teva Pharmaceutical Industries Ltd

ISR

16.9

sought a consensus on specific AMR topics and the appropri-

prospects relevant to this category of companies

ries: on-patent medicines, off-patent medicines and on-pat-

Revenue

The review included checks of indicators, data sets andate role for pharmaceutical companies, and analytical scopes.
S MALL AN D M E D I U M -S I Z E D E NTE R PR I S ES

ent vaccines.

Methodology proposals were reviewed and ratified by theExpert Committee of 10 independent experts, including fromThe 2021 Benchmark will also capture, in a separate report, the activities ofWHO, top-level academic centres and public sector entities,

clinical-stage biopharmaceutical companies that focus on antibacterial and/as well as investors and industry representatives.

or antifungal R&D (termed small and medium-sized enterprises, or SMEs).
* Revenue from latest fiscal year data
available (exchange rates from www.xrates.com, the exchange rate of the last
day of the fiscal year was used).
** Financial information (Revenue) is for
Otsuka Holdings, the parent company ofOtsuka Pharmaceutical Co, Ltd.

8*** Financial information (Revenue) is for
Changjiang Runfa Health Industry Co, Ltd,the parent company of Hainan Hailing
Chemipharma Corp Ltd.
† Mylan is to be renamed Viatris, following
closing of merger with Upjohn, a divisionof Pfizer, expected Q4 2020.

9

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

REVIEWING THE METHODOLOGY

respective Research Areas; (2) capacity to stimulate action

OUTCOME: REFINED SCOPES AND INDICATOR SET

and create change and impact; (3) clarity about the expecta-

How the Benchmark distills the role forpharmaceutical companies in curbing AMR

tions and roles set for companies; (4) assessment of the dis-

The Access to Medicine Foundation has now finalised thetribution of scores per indicator to evaluate overall company

methodology for the next (2021) AMR Benchmark. The key

behaviour; (5) availability of data and resources; (6) meas-changes are summarised here and set out in more detail on

urability, including the quality of responses received to date,

the following page:and data collected for assessment; (7) potential for additional• The actions of SMEs will be explored in a standalone report,

reporting, including longitudinal comparisons both indus-

planned for publication in Q2 of 2021. Further, SMEs will

try-wide and company-specific; and (8) expert and stake-not be scored in the 2021 iteration of the AMR Benchmark,holder feedback.

reflecting the unique role that they play in antimicrobial
R&D, and their limited role in improving the appropriate

External review and consensus building

accessibility and stewardship of on-market products.

Over a period of five months, aspects of the methodology• As companies have differing capacities and commitments

The Antimicrobial Resistance (AMR) Benchmark is an evalu-(2) that all metrics are relevant and actionable in terms of thewere discussed and evaluated by individuals from a range

to data-sharing, the Benchmark team will take steps toation of how pharmaceutical companies are ensuring appro-

appropriate role of the different types of companies that areof international organisations, governments, NGOs, lead-

reduce the impact of these differences in 2021. It will place

priate access to antimicrobial products while at the sametackling AMR, and that they stimulate change; (3) that all met-

ing research centres and other relevant groups and initia-emphasis on collecting publicly available data, while con-time playing their part to curb the rise of AMR. The goal ofrics are robust, allowing for the efficient and feasible collec-

tives addressing AMR. Our research team also gathered feed-sistently pushing companies to publish more information,

the AMR Benchmark is to guide pharmaceutical companies totion of data; and (4) that each metric helps to identify bestback from companies evaluated in the 2020 Benchmark, andand continuing to engage directly with companies to clarify,

take effective action to tackle the problem of drug resistance.

practices for companies to emulate and use to make progress.

from industry organisations and alliances including the AMR

By giving pharmaceutical companies public recognition for

Industry Alliance, Biotechnology Innovation Organization

verify and expand the data collected.
• Raising the bar for companies, the 2021 Benchmark will

their actions on AMR, the Benchmark provides accountability

Internal and external reviews(BIO), Indian Pharmaceutical Alliance (IPA) and Association

bring back into scope assessment relating to public waste-

as well as an incentive for them to expand their activities.

The review included internal checks of indicators, data sets

for Accessible Medicines. The team then used feedback andand wastewater-treatment plants, covered in the area of

The Benchmark is developed independently by the Accessand analytical approaches. This was followed by an external

insights gathered via this process to inform its proposals for

to Medicine Foundation, and translates the consensus view

review that drew on the views of a range of expert stakehold-modifying the methodology.

about how companies need to tackle AMR into a set of ambi-

ers, and sought to establish a consensus on specific AMR top-

tious but achievable expectations for action.

ics and the appropriate role for pharmaceutical companies.

The methodology framework for the next Benchmark has

Responsible Manufacturing.
• In general, vaccines are more profitable than medicines forcompanies: there is greater international demand than for

The Expert Committee

antimicrobial medicines, and agencies such as UNICEF and

Proposals from the research team formed the basis for dis-Gavi, the Vaccine Alliance give global support to facilitate

been the focus of a targeted review of the methodology used

Testing the analytical framework, scopes and indicators

cussion with our Expert Committee (EC). The EC comprises

registration and marketing. To capture this difference, thefor the last iteration. This review aimed to confirm global

The framework for the methodology has been reviewed and

10 independent experts from organisations including WHO,Benchmark will separately assess access strategies relating

health priorities regarding AMR and to define pharmaceuti-

updated with each iteration to ensure that the Benchmark (astop-level academic centres and public sector entities, as well

to vaccines from those relating to medicines.

cal companies’ role in halting its rise. It drew on the Accessa tool to evaluate pharmaceutical activities) remains rigor-

as investors and pharmaceutical industry representatives.

to Medicine Foundation’s experience in building consensus

ous and can be extended for trend analysis between reports.

The EC’s recommendations and strategic guidance clarified aabout where companies can take action, and how this can

As part of this, the Access to Medicine Foundation’s research

pathway, especially in areas in which it was hard to reach con-be translated into robust metrics. In turn, the Foundationteam began by conducting a targeted internal review of thesensus (for example, the exact role of the industry and theuses the methodology review to affirm the robustness of theanalytical framework, looking at scopes and indicators todetails of what good practice looks like). Using recommenda-

A R ES E ARCH & D E VE LO PM E NT

Benchmark analysis and to maintain its capacity for trend

evaluate robustness, quality of response, and the potential fortions from the EC, the research team adjusted its proposed

This Research Area maps companies’ R&D activities that tar-analysis between reports.

companies to improve performance.

methodology framework. The EC then ratified the refined

get priority bacterial and fungal pathogens posing significant

The primary principles of the methodology review are: (1)The team used the following criteria during this review: (1)framework, confirming the new methodology for a new itera-

threats due to AMR.

that the Benchmark is responsive to access and AMR needs;

continued relevance for AMR and ability to add value withintion of the AMR Benchmark.

The three Research Areas

B R ES PO N S I B LE MAN U FAC TU R I N G

Methodology Review for the 2021 Antimicrobial Resistance Benchmark
Figure 4
Expert Committee Meeting
July 2020

AMR Benchmark 2020
Jan 2020

Analytical
Framework, Scopes,
Indicators

2020

10

INTERNAL
REVIEWS

Company andstakeholder views on
2020 Benchmark

2021 Benchmark
scopes and metrics
discussions

EXTERNAL REVIEWS & CONSENSUS BUILDING

Methodology
2021 AMR
BenchmarkOct 2020

Final adjustments following
ratification
FINALISATIONThe Expert Committee members

This Research Area compares companies’ strategies forHans Hogerzeil (Chair), University of Groningen

upholding manufacturing quality standards and limiting theGregory Frank, Biotechnology Innovation Organization (BIO)

environmental impact of antibacterial manufacturing on

Sudarshan Jain, Indian Pharmaceutical Alliance (IPA)

resistance.

Joakim Larsson, University of Gothenburg
Marc Mendelson, University of Cape Town

C APPRO PR IATE ACCESS & STE WAR DS H I P

Mirfin Mpundu, ReAct Africa

This Research Area assesses companies’ access strategies forMaria Larsson Ortino, Legal & General Investment

antibacterial and antifungal medicines and vaccines for 102

Management

countries where greater access is most needed, alongside

Sarah Paulin, World Health Organization (Observer)

their global stewardship initiatives.

2020

11

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

What the Benchmark
measures

The AMR Benchmark assesses company action regarding specific diseases and product types and within a specific geographic scope, depending on the Research Area in question.
The following pages set out the rationale for these analyticalscopes and how they have been defined.
Table 2. Analysis scopes for the AMR Benchmark
Company scope

8 large research-based pharmaceutical companies
9 generic medicine manufacturers
Cohort of small- and medium-sized enterprises (instandalone report)

Disease scope

Bacterial and fungal infections

Product scope

Antibacterial and antifungal medicines and vaccines

Geographic scope

Global, with access indicators focusing on 102
countries where greater access is needed

1213Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

WHAT WE M E ASU RE

Company scope

Generic medicine manufacturers: those that rank in the top

SMEs: those with antibacterial and/or antifungal pipelines

five for volume and/or value of sales of antibacterials, basedthat are novel and/or target priority pathogens (as identified

on 2017 IQVIA data; and/or market leaders that are large ven-by The Pew Charitable Trusts and/or by the World Healthdors of active pharmaceutical ingredients (APIs).10

Organization).

Companies in scope for the 2021 Antimicrobial Resistance Benchmark
Table 4
L ARG E R ES E ARCH - BA S E D PHAR MACE UTI C AL CO M PAN I ES

The AMR Benchmark examines how a cross-section of

Key changes for 2021

the pharmaceutical industry is responding to the threat of

The Benchmark research programme will publish its findings

drug-resistant infections. In 2021, as in previous iterations,in two reports. One will track the progress of large research-

its focus is on companies with a major stake in the antibiot-

based pharmaceutical companies and generic medicine man-ics space, a market that has become increasingly fragile overufacturers since 2020, and is planned for release in Q4 ofrecent decades. These companies remain major actors and2021. To preserve capacity for tracking progress, the com-can play a key role in shaping the market. The Benchmark

panies in scope in these groups are unchanged since 2020.

considers the steps they are taking to address AMR throughThirteen of the companies in these groups in 2021 have been

the antibacterial and antifungal medicines and vaccines toevaluated continuously by the Benchmark research pro-

improve human health they develop and bring to market.

gramme since 2018.

Pharmaceutical companies that develop and market such

The other report will examine the actions and role of SMEs,

products can be grouped into three broad categories: (1)and is planned for release in Q2 of 2021. SMEs play a uniquelarge research-based pharmaceutical companies; (2) genericrole in antibacterial and antifungal research and development,

medicine manufacturers; and (3) clinical-stage biopharma-leading in novel projects, and generally have few products

ceutical companies (referred to by the Benchmark as small

on the market. They have limited capacity, specifically whenand medium-sized enterprises or SMEs) that focus on R&D.

compared to large research-based pharmaceutical compa-

Companies from all three categories are in the scope of thenies, in planning and facilitating appropriate access and stew-

2021 Benchmark research programme.

ardship of products on the market. The SME report will high-

The Benchmark assesses eight large research-based phar-light the ways in which these companies arrange finance,

maceutical companies and nine generic medicine manu-

develop medicines, and navigate a market that is often uncer-

facturers, all of which were evaluated in the previous itera-tain and volatile. Moreover, it aims to foreground examples oftion of the Benchmark. By volume and value of sales, theseSMEs that, despite challenging market conditions, are striving

are today’s largest players in the global market for antibacte-

to bring their innovations to lower- and middle-income coun-rial medicines. The Benchmark also looks at SMEs with clini-

tries (LMICs), where access to new and effective medicines is

cal-stage pipelines that contain relevant and mature projects.

less widespread. SMEs will not be scored in the 2021 iteration

Companies are evaluated in those areas in which they possessof the AMR Benchmark.

CompanyCountry HQ

Ticker

Stock Exchange

Revenue (bn USD)*

1

GlaxoSmithKline plc

GBR

GSK

London44.8

2

Johnson & Johnson

USA

JNJ

New York

82.1

3

Merck & Co, Inc

USA

MRK

New York

46.8

4

Novartis AG

CHE

NOVN

Six Swiss Exchange

47.4

5

Otsuka Pharmaceutical Co, Ltd **

JPN

4578

Tokyo

12.8

6

Pfizer Inc

USA

PFE

New York

51.8

7

SanofiFRA

SANEuronext Paris

40.6

8

Shionogi & Co, Ltd

JPN

4507

Tokyo

3.1

CompanyCountry HQ

Ticker

Stock Exchange

Revenue (bn USD)*

1

Abbott Laboratories

USA

ABT

New York

31.9

2

Alkem Laboratories Ltd

IND

ALKEM

NSE

1.1

3

Aurobindo Pharma Ltd

IND

AUROPHARMA

NSE

3.1

4

Cipla Ltd

IND

CIPLA

NSE

2.3

5

Fresenius Kabi AG

DEU

FRE***

Frankfurt

7.8

6

Hainan Hailing Chemipharma Corp Ltd †CHN

002435

Shenzhen

0.7

7

Mylan NV ‡

GBR

MYL

NASDAQ

11.5

8

Sun Pharmaceutical Industries Ltd

IND

SUNPHARMA

NSE

4.4

9

Teva Pharmaceutical Industries Ltd

ISR

TEVA

New York/Tel Aviv

16.9

G E N E R I C M E D I CI N E MAN U FAC TU R E RS

the greatest potential and responsibility to limit antimicrobial
Defining the scope

resistance (see table 3).

The company scope was held constant with the 2020 com-

S MALL AN D M E D I U M -S I Z E D E NTE R PR I S ESpany scope, mergers and bankruptcies permitting, in orderCompanies assessed per Research Area

to track progress. Below, the specific criteria originally used

The 2021 AMR Benchmark will also report on the activities of clinical-stage biopharmaceutical companies (referred to by

to select the companies, based on their antibacterial mar-the Benchmark as small and medium-sized enterprises or SMEs) that focus on R&D. It will look at those SMEs withA R ES E ARCH & D E VE LO PM E NT

ket presence and pipelines,* are outlined. Table 4 lists theantibacterial and/or antifungal pipelines that are novel and/or target priority pathogens (as identified by The Pew• Large R&D-based pharmaceutical companies

companies.

Charitable Trusts and/or by the World Health Organization). Their actions will be explored in a standalone report. SMEs

Table 3• Small & medium-sized enterprises (in standalone report)

will not be scored in the 2021 iteration of the AMR Benchmark.

Large research-based pharmaceutical companies: thoseB R ES PO N S I B LE MAN U FAC TU R I N Gthat rank in the top five for either the volume or value of their• Large R&D-based pharmaceutical companies

sales of antibacterials, as identified using IQVIA Midas intel-• Generic medicine manufacturers

ligence data on consumption of antibiotics globally** (2017);
and/or those that are active in this market and that have anti-

C APPRO PR IATE ACCESS & STE WAR DS H I P

bacterial pipelines with at least one antibacterial drug or vac-

• Large R&D-based pharmaceutical companies

cine candidate*** targeting a priority pathogen in scope, as
identified by the Pew Charitable Trusts8 or WHO.9• Generic medicine manufacturers

14*The selection of large research-based pharmaceutical companies andgeneric medicine manufacturers was done with reference to antibacterials as bacteria represent the greatest proportion and widest geographic spread of resistant pathogens. These companies will also be analysed, where appropriate, on the vaccines and antifungals they develop
and market.

**Refers to aggregate sales in 75 countries.
***Candidates had to be in Phase II or more advanced stages of clinicaldevelopment at the time of selection (July 2018).

Data sources:* 		 Revenue from latest fiscal year data available (exchange rates from www.x-rates.com,
the exchange rate of the last day of the fiscal year was used).
**		 Financial information (Ticker, Stock exchange, Revenue) is for Otsuka Holdings, theparent company of Otsuka Pharmaceutical Co, Ltd.
***		 Ticker and Stock exchange information is for Fresenius SE & Co. KGaA, the parent
company of Fresenius Kabi AG.

† 		 Financial information (Ticker, Stock exchange, Revenue) is for Changjiang Runfa
Health Industry Co, Ltd, the parent company of Hainan Hailing Chemipharma Corp
Ltd.
‡ 		 Mylan is to be renamed Viatris, following closing of merger with Upjohn, a division of
Pfizer, expected Q4 2020.

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Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

WHAT WE M E ASU RE

WHAT WE M E ASU RE

Disease scope

Product scope

The 2021 AMR Benchmark evaluates the actions and commit-

A Research & Development

The 2021 AMR Benchmark covers antimicrobial medicines

ments made by pharmaceutical companies to limit the impact

In this Research Area, the Benchmark focuses its assess-and vaccines that target bacterial and fungal infections inof AMR from bacterial and fungal pathogens.

ment on priority pathogens (bacteria and fungi) that posehumans, as follows:

All bacterial and fungal infections are in scope for thethe greatest threat to human health. The pathogens in scope• Medicines: all innovative and adaptive medicines, branded

Benchmark’s Appropriate Access & Stewardship Research

are limited to those included in the priority lists published bygenerics and generic medicines (regardless of formulation)

Area. For R&D and Responsible Manufacturing, thethe CDC and WHO (see appendix I). The Benchmark researchused for direct treatment against bacterial and fungal path-

Benchmark examines a narrower range, reflecting scientificteam will take account of any relevant updates, including

ogens, or disease processes (but not products used only forevidence and stakeholder recommendations that prioritise

the upcoming publication of a WHO priority list for fungal

symptomatic relief); andspecific pathogens or products for these areas (see table 4).

infections.

• Vaccines: both preventive and therapeutic vaccines that tar-

Antimicrobial resistance to treatments for other pathogens,

get bacteria or fungi.

particularly HIV/AIDS and malaria, also constitutes a seri-

B Responsible Manufacturing

ous global threat. However, these diseases have R&D require-This Research Area will maintain its focus on antibacterial

Each of the Benchmark’s Research Areas has its own tailoredments and market structures that differ in important ways

products, as in 2020. The companies in scope include someproduct scope, as shown in table 5.

from those for bacterial and fungal diseases. Therefore, theseof the largest global players in terms of antibacterial productdiseases remain out of scope of the Benchmark researchsales, and their actions to minimise the release of active anti-

Key changes for 2021

programme.

bacterial ingredients into the environment are expected to

For the 2021 AMR Benchmark the product scope will remainmake a sizeable impact when it comes to limiting resistance.

the same as in the 2020 AMR Benchmark.

Key changes for 2021

In contrast, it is not possible to achieve a comparable level of

Before analysis begins in 2021, the AMR Benchmark willcertainty regarding the management of antifungal discharge.

review the application of its disease scope to reflect any

As this is an emerging area of concern, the Benchmark willchanges in the published lists of priority pathogens, such as

seek to identify and highlight best practices in environmental

the anticipated WHO priority list for fungal pathogens.

risk management, practices that also take account of antifungal discharge.

Products assessed per Research Area
Table 6A R ES E ARCH & D E VE LO PM E NT
• Antibacterial medicines and vaccines that target priority pathogens (seeC Appropriate Access & Stewardshipappendix I) in discovery, pre-clinical and clinical phases I-III, or which are

It is important to ensure that people have appropriate accessapproved; andto antibacterials and antifungals. The disease scope of thisResearch Area includes all bacterial and fungal infections.

• Antifungal medicines and vaccines that target priority pathogens (seeappendix I) in discovery, pre-clinical and clinical phases I-III, or which areapproved.
B R ES PO N S I B LE MAN U FAC TU R I N G

Diseases and pathogens assessed per Research Area

• Manufactured and/or marketed antibacterial medicines; andTable 5A R ES E ARCH & D E VE LO PM E NT

• Manufactured and/or marketed antibacterial active pharmaceuticalingredients (APIs).

• Priority bacteria as defined by CDC and WHO (see appendix I)• Priority fungi as defined by CDC and WHO (see appendix I)

C APPRO PR IATE ACCESS & STE WAR DS H I P
Appropriate Access

B R ES PO N S I B LE MAN U FAC TU R I N G• All bacteria• Marketed on-patent antibacterial and antifungal medicines and vaccines;
and• Marketed off-patent/generic antibacterial and antifungal medicines,

C APPRO PR IATE ACCESS & STE WAR DS H I P

including products from the WHO’s Essential Medicines List.

• All bacteria

Stewardship• All fungi• All marketed antibacterial and antifungal medicines.

16

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Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

WHAT WE M E ASU RE

Geographic scope

Antibacterial and antifungal resistance is emerging andIndex (IHDI) value lower than or equal to the median value

spreading across the globe. To address this, efforts to cre-of 0.583 (UNDP, 2018); andate and produce new medicines and vaccines (and estab-Countries in scope for access metrics in the 2021 Antimicrobial Resistance Benchmark - 102 countries
Figure 3• Countries with a high** burden of bacterial and fungallish responsible manufacturing practices) must be priori-

infectious diseases, as measured in disability-adjusted life

tised globally. Wherever effective antibacterial and antifun-

years (DALYs) by IHME in its “Global Burden of Diseasegal products are marketed, efforts are needed to improve

Study 2017” (2018).

their rational use. For these reasons, the geographic scope ofthe 2021 Antimicrobial Resistance Benchmark remains global,

Where countries had missing values for HDI or IHDI in UNDP’s

comprising 218 countries and/or territories.*2018 report, the Benchmark took into account past reports

Challenges around availability of products, and appropriate(to 2013).

access, remain significantly higher in some countries, generally resource-limited countries with high burdens of disease.
A group of Benchmark indicators (referred to as ‘access metrics’) is thus dedicated to measuring how companies plan foraccess to antibacterial and antifungal medicines and vaccines

Geographic scope assessed per Research Area

in such countries (referred to as ‘access countries’); and/or

Table 7

how they are already addressing these challenges there. The
access metrics are indicators A.3, C.1.1-C.1.3, C.2.1-C.2.3 andA R ES E ARCH & D E VE LO PM E NT

C.3.

• R&D Pipeline: Global• Stewardship Plans: Global

Key changes for 2021

• Access Plans: 102 countries where better access is needed

To enable progress to be measured, the 2021 Benchmark
maintains the same subset of 102 ‘access countries’ in scope

B R ES PO N S I B LE MAN U FAC TU R I N G

as in 2020.

• GlobalDefining the scope for access metrics

C APPRO PR IATE ACCESS & STE WAR DS H I P

The 102 ‘access countries’ were identified through: (1) their• Appropriate Access: 102 countries where better access is needed

level of income (gross national income [GNI] per capita); (2)• Stewardship: Global

Basis for inclusion in scope for access metrics		
● World Bank list of economies (June 2018): Income group● ECOSOC (2018): LDC List / UNDP Human Development Indices andIndicators (2018): HDI● UNDP Human Development Indices and Indicators (2018): IHDI● IHME Global Burden of Disease Study 2017 ResultsA(2018): bacterial
and
Not in scope
fungal infections● Not in scope for access metrics

D

E

C

Due to scaling, countries may not be visible on the map e.g., Tuvalu.

their levels of development; (3) their scope and scale of inequality; and (4) their infectious disease burden. Assessmentsof these levels drew on data published in 2018 by theWorld Bank,11 United Nations Economic and Social Council(ECOSOC),12 United Nations Development Programme(UNDP),13 and Institute for Health Metrics and Evaluation(IHME),14 specifically:• Countries classified as low income or lower middle-income,according to World Bank data (June 2018);• Countries classified as Least Developed Countries (LDCs)
by ECOSOC’s Committee for Development Policy (2018);• Countries classified as low or medium human development
in UNDP’s Human Development Index (HDI), based on data
published in September 2018;• Countries with an Inequality-adjusted Human Development

18*The Benchmark considers all countries or territories listed in the WorldBank Country and Lending Groups (June 2018). The World Bank warns
that the term “country” (used interchangeably with “economy”), does not
imply political independence but refers to any territory for which authorities report separate social or economic statistics.

** Calculated as the sum of the burden of disease for 24 infectious diseases included in IHME’s 2017 Global Burden of Disease Study (2018). All
countries above the third quartile of the data distribution were included,
unless a country was classified by the World Bank as having high income
or by the UNDP as having a “Very high” HDI or being above the third quartile of the IHDI distribution.

19

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

List of countries covered by access metrics for the 2021 Antimicrobial Resistance Benchmark – 102 countries
Table 8

East Asia & Pacific

How the Benchmark
measures

MoroccoLMIC

Nigeria

LMIC

Cambodia

LMIC

Syrian Arab Republic

LIC

Rwanda

LIC

China

HIDBC

Tunisia

LMIC

São Tomé and Príncipe

LMIC

Indonesia

LMIC

Palestine, State /SenegalLIC

Kiribati

LMIC

West Bank and Gaza

LMIC

Sierra Leone

LIC

Korea, Dem. People’s Rep.

LIC

Yemen, Rep.

LIC

SomaliaLIC

Lao PDR

LMIC

South Africa

MHDC

Micronesia, Fed. Sts.

LMIC

South Asia

South Sudan

LIC

Mongolia

LMIC

Afghanistan

LIC

Sudan

LMIC

Myanmar

LMIC

Bangladesh

LMIC

Tanzania

LIC

The AMR Benchmark will map how a cross-section of the

Papua New Guinea

LMIC

Bhutan

LMIC

Togo

LIC

pharmaceutical industry is responding to the rise of antimi-

Philippines

LMIC

India

LMIC

UgandaLIC

crobial resistance (AMR). It will assess their policies and prac-

Solomon Islands

LMIC

Maldives

HIHDC

ZambiaLMIC

tices for slowing drug resistance and for improving appro-

Thailand

HIDBC

Nepal

LIC

Zimbabwe

LIC

priate access to medicines and vaccines for people living inTimor-Leste

LMIC

Pakistan

LMIC

countries where greater access is needed. The Benchmark

TuvaluLDC

Sri Lanka

LMIC

will compare companies’ approaches, where relevant andVanuatu

LMIC

Vietnam

LMIC

Europe & Central Asia

appropriate, with reference to their pipelines and portfolios.
Sub-Saharan Africa
AngolaLMIC

The analytical framework is structured along three
Research Areas:

Benin

LIC

LMIC

Botswana

HIHDC

KosovoLMIC

Burkina Faso

LIC

A Research & Development

Kyrgyz Republic

LMIC

BurundiLIC

B Responsible Manufacturing

Moldova

LMIC

Cabo VerdeLMICC Appropriate Access & StewardshipTajikistan

LIC

Cameroon

LMIC

Turkmenistan

HIHDC

Central African Republic

LIC

Ukraine

LMIC

Chad

LIC

Uzbekistan

LMIC

Comoros

LIC

Congo, Dem. Rep.

LIC

Georgia

Latin America & Caribbean

Country classification is based on 2018 data.

LIC

Low-income country

Congo, Rep.

LMIC

BelizeHIHDC

Côte d’Ivoire

LMIC

Bolivia, Plurinat. StateLMIC

Equatorial Guinea

MHDC

Brazil

HIHDC

Eritrea

LIC

Colombia

HIHDC

Eswatini

LMIC

Dominican Republic

HIHDC

Ethiopia

LIC

El Salvador

LMIC

Gabon

HIHDC

Guatemala

MHDC

Gambia, The

LIC

Guyana

MHDC

Ghana

LMIC

Haiti

LIC

GuineaLIC

Honduras

LMIC

Guinea-Bissau

LIC

Mexico

HIDBC

Kenya

LMIC

Nicaragua

LMIC

Lesotho

LMIC

Paraguay

HIHDC

Liberia

LIC

Peru

HIDBC

Madagascar

LIC

Country

Suriname

HIHDC

Malawi

LIC

UNDP Human Development Indices and

Mali

LIC

Mauritania

LMIC

Middle East & North Africa

World Bank income classifications 		
(June 2018)
LMIC

Lower middle-income country
World Bank income classifications 		
(June 2018)

LDC

Least Developed Country
UN ECOSOC LDC list (March 2018)

LHDC

Low Human Development Country
UNDP Human Development Indices andIndicators (September 2018)

MHDC

Medium Human Development Country
UNDP Human Development Indices andIndicators (September 2018)

HIHDC

High Inequality in Human Development

Indicators (September 2018)
HIDBC

High Infectious Disease Burden

Djibouti

LMIC

Mozambique

LIC

Country

Egypt, Arab Rep.

LMIC

Namibia

MHDC

IHME Global Burden of Disease Study

Iraq

MHDC

Niger

LIC

2017 Results (2018)20

21

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

RESE ARCH ARE AS

HOW WE M E ASU RE

A

Analytical framework

Research & Development

Company scope: Large R&D-based companies; SMEs (separate report) • Diseases: Bacterial, fungal infections • Products: Medicines, vaccines • Geographic scope: Global/Other

As antimicrobial resistance erodes the effectiveness of theing how companies share their intellectual capital (formerly

world’s current arsenal of antibacterial and antifungal med-

the A.3 indicator), due to the inadequate quality of data

icines, the need to develop new ones – to replace those los-available for analysis. Collaboration and sharing of intellec-

ing their effectiveness – becomes ever more pressing. New

tual property remain strong tools to stimulate R&D, and thevaccines also play a key role in slowing the emergence andAccess to Medicine Index will continue to credit relevant com-

The 2021 AMR Benchmark will evaluate company action using

marketed product portfolio. For example, large research-spread of resistance, by preventing the transmission of dis-panies that are developing compelling initiatives in this area.

an analytical framework of three Research Areas: Researchbased pharmaceutical companies will be assessed acrossease and averting inappropriate use of antimicrobial med-

& Development, Responsible Manufacturing and Appropriate

all Research Areas if they have vaccines and medicines. If

icines. The pharmaceutical industry must commit and takeAccess & Stewardship. The three Research Areas have been

they have only medicines, they will not be scored in the vac-action to develop new medicines and vaccines for thoseconfirmed by stakeholders as those areas where pharma-cine specific indicators (A2.3, C.1.3, C.2.3). Generic medi-

bacteria and fungi that pose the gravest of threats to human

R&D investments

ceutical companies have core responsibilities to limit AMR.

cine manufacturers will be assessed only in the Responsible

health because of their widespread resistance against exist-

The Benchmark will capture the financial resources that

In each Research Area, companies’ policies and practices are

Manufacturing and Appropriate Access and Stewardshiping standard of care (see appendix I).

each company dedicates to R&D for antibacterial and anti-measured by indicators that correspond to priority actions forareas. Following stakeholder consensus, the unique role ofpharmaceutical companies.

small and medium-sized enterprises (SMEs) in antimicrobial

This research area maps and captures R&D investments

the amounts of resources available to companies in scope,

R&D will be explored in a standalone report.

and pipelines, highlighting focal points and current gaps. It

the Benchmark will focus on the proportion of total revenue

also explores how companies plan ahead to ensure newly

derived from pharmaceuticals that each company invests in
R&D for its projects in scope.

20 indicators

WHICH ACTIVITIES WILL BE ANALYSED?

fungal medicines and vaccines. To balance out differences in

The framework for the 2021 AMR Benchmark comprises 20

Where the data comes fromapproved products are swiftly made available globally andindicators; two are new additions and one has been removed.

The Benchmark has established a new standard for indus-

equitably (through advance planning for access) in low- andTwo new indicators were developed to examine access to

try transparency in the AMR space, and looks increasingly at

middle-income countries (LMICs), and that new medicines are

R&D pipelines

on-patent vaccines separate from on-patent medicines. Thispublic and partner data sources, as well as inviting companies

used appropriately, in ways that minimise the risk of resist-

The Benchmark uses a mix of quantitative and qualitative

split applies to both the Registration and Expanding Accessto engage. While it is evident that companies have differing

ance emerging and spreading (through advance planning

metrics to examine the clinical and preclinical pipelines of theand Affordability indicators (C.1.3 and C.2.3). Moreover, thecapacities and commitments to data sharing, it is an objective

for stewardship). The Benchmark encourages pharmaceuti-companies in scope. The R&D research area focuses on anti-

Benchmark will no longer be assessing how companies shareof the Benchmark to stimulate companies towards greatercal companies to commit resources and engage with relevantbacterial and antifungal medicines and vaccines that address

their intellectual capital (formerly the A.3 indicator) due totransparency and to put more data in the public domain. The

partners to facilitate such advance planning.

priority pathogens: namely those identified by the World

the inadequate data available for analysis. Other indicators

next iteration of the Benchmark will continue the emphasis

In this research area, the Benchmark assesses a number

Health Organization (WHO) and Centers for Disease Control

have been modified or refined, to tailor the metrics or toon collecting data primarily from the public domain as well asof large research-based pharmaceutical companies that are(CDC) as posing the greatest threat to public health and for

improve data capture, to enhance comparison between com-

directly engaging with companies to clarify, verify and expand

engaged in: (a) R&D for new antibacterial and antifungal med-

which there is an urgent need to develop new medicines andpanies, or to conduct additional analyses.

on the data collected. Public sources will include the US Foodicines and vaccines in preclinical and clinical stages of devel-

vaccines (see appendix I). The Benchmark will report on theand Drug Administration (FDA), the European Medicines

opment; as well as (b) R&D to adapt existing medicines andnature and number of projects targeting these priority patho-

Analysing companies only where relevant

Agency (EMA), ClinicalTrials.gov, annual filings and reports

vaccines. The Benchmark research programme also evaluates

gens that each company has in its R&D pipeline, including new

Whethera company is assessed ina certain Research
Area
AB
Framework showing

fromCcompanies, among others.

the R&D activities of clinical-stage biopharmaceutical com-and adaptive medicines and vaccines (A.2.1) (referring to R&D

panies (referred to as small and medium-sized enterprises, orto create new formulations or label extensions).

RESEARCHRESPONSIBLE
indicators
attainabledepends
onand
thesize and nature of
its R&D pipeline andscores& DEVELOPMENT
30 points

MANUFACTURING
15 points

ACCESS& STEWARDSHIP

SMEs), with the findings being published in a separate stan-

35 points

dalone report (see below for more information).

Large R&D companies
Analytical Framework
for the 2021 AMR Benchmark

The Benchmark will also evaluate the degree to which
products in clinical development are of value for public health(indicator A.2.2); the number of vaccines in pipelines (A.2.3);

The AMR Benchmark covers three Research Areas. Large research-based pharmaceutical companies and generic medicine
Generic manufacturers
manufacturers are evaluated using 20 indicators. Whether a company is scored depends on its pipeline and portfolio. The role and

KEY CHANGES FOR 2021

actions of SMEs
R&D will be covered in a standalone report. SMEs will not be assigned scores.
Small in& antimicrobial
medium enterprises

In a change from previous iterations of the Benchmark, SMEs

(A.2.4). It will draw on assessments published by WHO andwill be addressed in a standalone publication. As SMEs play a

The Pew Charitable Trusts of existing antimicrobial pipelines

unique role in antibacterial and antifungal R&D, this separate(including considerations for non-traditional products). As inreport will enable a deeper exploration of the particular chal-

previous iterations, the 2021 AMR Benchmark will highlightlenges they face in developing medicines, acquiring financing,projects that have clear clinical value beyond WHO’s criteria

navigating the market and surviving. It aims to highlight exam-

for innovation.

Figure 4A
RESEARCH& DEVELOPMENT

Large research-based pharmaceuticalcompanies

1 2.1 2.2 2.3 2.4 3

B
RESPONSIBLE
MANUFACTURING

1

2

3

C
APPROPRIATE ACCESS& STEWARDSHIP

1.1 1.2 1.3 2.1 2.2 2.3 3

4

5

Indicator number
6

7

22

pathogens as defined by the CDC and WHO, respectively

ples of SMEs that, despite challenging market conditions, con-

Generic medicine manufacturers
Small and medium-sized enterprises

the number of projects that target “urgent” and “critical”

Actions will be analysed, not scored, and covered in dedicated report

ScoredNot scoredtinue to strive to bring innovations to LMICs, where access to

Access and stewardship planning

new and effective medicines is less widespread. These com-

Planning ahead for access helps to ensure companies takepanies will not be scored using the indicators presented here.

account of public health needs during product development.

In a separate change, the Benchmark will no longer be assess-

Such planning, conducted early on, can help to create more

23

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

rapid access to new medicines and vaccines at more afforda-

Benchmark assesses the extent to which companies create

ble prices following their entry to markets. Access plans canand disclose plans to make new products swiftly accessible

include equitable pricing strategies, widespread registration

upon market entry, and ensure they are used appropriately

strategies and non-exclusive voluntary licensing agreements.

thereafter. A list of strategies that companies can use to start

For new antimicrobial medicines, these access plans must beplanning for access and stewardship ahead of commercialisa-

coupled with stewardship plans to ensure that, upon com-tion can be found in Appendix III.

RESE ARCH ARE AS

B

Responsible Manufacturing

Company scope: Large R&D-based companies, generic medicine manufacturers • Disease scope: Bacterial infections • Product scope: Medicines • Geographic scope: Global

mercialisation, new products can be used appropriately andremain effective over time. Companies are expected to haveplans in place for pipeline projects in Phase II and beyond. The

Indicator

A.1

A.2.1

Rationale

Change since 2020

R&D investments
R&D investments (including in-kind) dedicated to the development of

To characterise the overall financial resources

antibacterial and antifungal medicines and vaccines targeting prior-dedicated to R&D for antibacterial and anti-

ity pathogens in the fiscal year 2019 and 2020, developed in-house or

fungal medicines and vaccines focusing spe-through collaborations (as long as the assessed company investmentcifically on priority pathogens as defined byrepresents 50% or more of the project costs).

WHO and the CDC.

No change

Pipeline size
The size of a company’s R&D pipeline targeting priority pathogens,

To characterise the degree to which a com-

including antibacterial and antifungal medicines and vaccines (newpany focuses on antibacterial and antifungal

chemical/biological entities and adaptations) developed in-house or

R&D, in addition to financial information.

No change

treatment plants were excluded as, given national and/or

the impact of antibacterial manufacturing upon antimicro-

regional regulations, companies reported having little powerbial resistance (AMR). During pharmaceutical manufac-

to negotiate contractual terms with these plants, in particu-

turing, antibacterial residue can be released into the envi-

lar wastewater treatment plants. Nonetheless, public and pri-ronment in factory wastewaters. This can contribute to
the development of AMR, as bacteria naturally present invate plants can play an important role in minimising the riskof AMR development.19 In 2021, the Benchmark will consider

water and soil are exposed to antibacterial ingredients thata wider set of actions that companies can take to minimise

can trigger the emergence and/or selection of resistancegenes.15-17 Manufacturing practices and management sys-

AMR risk related to waste streams sent from their production

tems that give rise to poor-quality products can also con-stringent actions such as contractual terms requiring private

tribute to the development of AMR, since bacteria are more

plants to monitor discharge limits, but will also newly cover

likely to become resistant when medicines containing a low-other preventative or ad hoc measures adopted, e.g., in col-er-than-optimal amount of the active ingredient are used tolaboration with public or private plants.
WHICH ACTIVITIES WILL BE ANALYSED?

There are three main routes through which companies can

A.2.2 Novelty of pipeline
The novelty of new investigational clinical antibacterial and antifun-

To encourage companies to invest in innova-

gal medicines targeting priority pathogens that the company is devel-

tive therapeutic approaches that reduce theoping (in-house or through collaborations). A new product candidate

risk of (cross-) resistance, thus increasing thein development is defined as containing at least one new component

useful life of the molecule.

No change(entity) not previously approved.

A.2.3 Vaccines in the pipeline
The number of new vaccines that the company is developing for prior-

Vaccination against priority pathogens canity pathogens in scope (in-house or through collaborations).

have a positive impact in minimising AMR by

No change

reducing transmission of infection and use of
antimicrobials, which helps to lower the riskof new resistance genes developing or resistant strains being selected for.

A.2.4 Projects targeting critical priorities

minimise the risk that their manufacturing operations will

Environmental risk-management strategy

contribute to the development of AMR. These routes are

During pharmaceutical manufacturing, products with anti-

addressed in each of the three indicators in this Researchbacterial activity are often released into the environment via

Area, and are as follows: (1) adoption of a clear and thor-

wastewaters or solid waste (such as sludge). This releaseough environmental risk-management strategy that applies

increases the risk that resistant bacteria will develop andto a company’s own manufacturing sites, to the sites of its

resistance genes will spread in the environment. Companies

third-party suppliers of active pharmaceutical ingredients

can minimise that risk by adopting a robust environmental(APIs) and/or drug products, and to external waste-treat-risk-management strategy. The Benchmark will assess how

ment plants*; (2) publication of information on the risk-man-companies manage and dispose of their antibacterial waste,agement processes implemented and their outcomes, includ-

including how they limit levels of antibacterial residue ining antibacterial discharge levels, and; (3) adoption of spe-

wastewaters. It will also look at how they apply relevant pol-cific policies and actions to uphold high-quality manufacturing

icies and/or practices to third-party suppliers and external

standards for antibacterial medicines, accepted by recognised

waste-treatment plants.

authorities.

The number of projects that target a ‘critical’ pathogen (as defined

To measure a company’s commitment toby WHO) and/or ‘urgent’ pathogen (as defined by the CDC). These

global health priorities through its focus onpathogens include carbapenem-resistant (CR) Acinetobacter

developing antibacterial and antifungal medi-

spp., Candida auris, Clostridioides difficile, CR or ESBL-producing

cines and vaccines against those microorgan-

Enterobacteriaceae, drug-resistant Neisseria gonorrhoeae and CR

isms identified as posing the most critical and

Pseudomonas aeruginosa.

urgent threats to public health.

No change

Access and stewardship planning
The proportion of late-stage antibacterial and antifungal R&D projects

To describe efforts to ensure that, upon com-targeting priority pathogens, for which the company provides infor-

mercialisation, successful antibacterial andmation about having plans in place for 1) access in countries in scope

antifungal medicine and vaccine candidates

and where burden of disease is higher; and 2) stewardship on a global

targeting priority pathogens are made avail-base. This indicator applies to late-stage R&D projects in Phase II andable rapidly and affordably and can be used

III of clinical development (developed in-house or through collabora-

appropriately.

No change

In this Research Area, the Benchmark assesses large

Disclosure on environmental risk management

research-based pharmaceutical companies and generic med-

The Benchmark examines whether companies implement

icine manufacturers in scope. The antibacterial sales vol-specific strategies to manage environmental AMR risks asso-

umes or values for these companies demonstrate that theyciated with antibacterial manufacturing discharge, as well as

are prominent players in multiple manufacturing chains, withwhether they publish certain elements of these strategies,

significant influence over their upstream suppliers. Some ofand their outcomes. Publishing such details allows independ-these companies are also prominent producers of antibac-

ent third parties to analyse and compare the processes andterial APIs. The Benchmark does not directly assess otherperformances of different companies, and promotes the dis-large API producers that have less prominent sales of finishedsemination of good practice. Publication can also give pro-products, but the activities of some are covered indirectly as

curers of antibacterial medicines (such as governments andsuppliers of the companies in scope.

other public institutions) the information necessary to iden-

KEY CHANGES FOR 2021

tify companies that manufacture responsibly.20,21
The Benchmark will look at how much information acompany publishes about its strategies and audit results.

tions) and recently approved products.

24

sites to both public and private plants. These will still include

treat infections.18

through collaborations.

A.3

This Research Area compares company strategies to limit

In its evaluation of companies’ environmental strategies (B.1)

Stakeholders are asking for companies to publish amounts ofand transparency (B.2), the 2021 Benchmark will bring backantibacterials discharged from their own and suppliers’ manu-

into scope assessment relating to public waste- and waste-

facturing sites (as quantified by chemical analysis or mass bal-water-treatment plants. For the 2020 Benchmark, publicance estimation). The publication of less detailed information*Including any waste treatment or disposal
contractor, e.g., wastewater treatment plants,
incineration plants and landfills.

25

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

RESE ARCH ARE AS

may also be taken into account by the Benchmark in its eval-rial ingredients, below the amount required for therapeuticuation, provided the information is useful to third parties.

effect) will reach patients. The Benchmark will assess mech-This is now explicitly referenced in the indicator. Even lim-

anisms that companies have put in place at their own (andited transparency can support companies and stakeholders inthird-party) manufacturing sites to maintain high-quality pro-

mapping out a path towards fuller disclosure.

duction of antibacterial medicines. It will focus on the ways

Access Company scope: Large R&D companies, generic manufacturers • Diseases: Bacterial, fungal infections • Products: Medicines, vaccines • Geographic scope: 102 Countries

companies engage with suppliers to increase accountability

Stewardship Company scope: Large R&D companies, generic manufacturers • Disease scope: Bacterial, fungal infections • Product scope: Medicines • Geographic scope: Global

Manufacturing high-quality antibacterials

and minimise risks, particularly in areas where suppliers find it

To help curb the development of antibacterial resistance,difficult to meet quality standards.

C

Appropriate Access & Stewardshipcompanies can uphold high standards in antibacterial man-This Research Area looks at how companies are working toor how they are already addressing these challenges there.

ufacturing. This can minimise the likelihood that poor-qual-

increase access to their antibacterial and antifungal med-

Regarding stewardship, companies can take action in a range

ity medicines (those with subtherapeutic doses of antibacte-icines and vaccines, while also ensuring these will be usedof areas including surveillance and implementing strategies toappropriately (stewardship). The two issues are closely

ensure that sales and marketing practices counter the risks ofinterlinked and need to be considered jointly. In Appropriate

inappropriate use.

Indicator

B.1

Rationale

Change since 2020

Environmental risk-management strategy
The company has an environmental risk-management (ERM) strat-

To assess the comprehensiveness of a com-egy to minimise the environmental impact of manufacturing discharge

pany’s strategy to minimise the impacts ofof antibacterials. This applies to: (a) its owned and/or operated manu-

antibacterial production on resistance andfacturing sites; (b) third-party suppliers of antibacterial active pharma-

the degree to which the strategy is extended

ceutical ingredients (APIs) and drug products; and (c) external waste

to the company’s suppliers and providers oftreatment plants. The strategy includes, for (a), (b) and (c), the follow-

waste treatment/disposal services.

Modified

Access & Stewardship, the Benchmark assesses companies’
strategies to expand access to these medicines and vac-

KEY CHANGES FOR 2021

cines in the 102 countries identified as most in need of bet-

To assess how companies make their on-patent products avail-ter access to such products (see Geographic Scope). It alsoable and affordable, in 2021, the Benchmark will make separate

considers their stewardship initiatives for these products

examinations of on-patent medicines and on-patent vaccines.

globally.

This is because companies have different roles and opportunities for expanding access to vaccines than for antibacterial andAntibacterial and antifungal medicines and vaccines are

antifungal medicines. In general, vaccines are more profitableing elements: (i) implementation of waste treatment/management

essential tools in treating infectious disease worldwide. Yet

than medicines: there is greater international demand than forpractices for both liquid and solid antibacterial-containing wastes,

millions of people live without reliable access to these med-

antimicrobial medicines, and agencies such as UNICEF and Gavi

icines, or lack information to use them appropriately. Issues

the Vaccine Alliance give global support to facilitate registra-of access and stewardship are especially relevant in coun-tion and marketing.

taking AMR risk into account; (ii) on-site auditing of compliance withthe strategy; (iii) setting of antibacterial discharge limits based on predicted no-effect concentrations (PNECs) for resistance selection; andtries where healthcare systems have limited resources, andFurther, the Benchmark has updated its assessment crite-waters (by chemical analysis or mass balance estimation) to assess

for whom the burden of infectious diseases is high. Limited

ria to enable a more detailed assessment of how companies

and minimise the risk that limits are surpassed.

resources, for example, can reduce capacity to prevent andensure the quality and uninterrupted supply of their products.

manage such diseases, particularly resistant infections.
Limitations in access to quality-assured antibacterial andPricing indicators are adjusted to examine how companies

Disclosure on environmental risk management

antifungal medicines and vaccines arise for a variety of rea-

strategies they use to increase affordability and expand access.

sons. These include low availability (such as when new and

A selection of “forgotten antibiotics” – older products that are

on-patent medicines are not registered for sale in countries

effective but no longer widely marketed – will be highlighted asin need); lack of affordability of on- and off-patent/genericpart of the registration and affordability analyses.

(iv) quantification of the levels of antibacterials discharged in waste-

22

B.2

The company publishes the following elements of its ERM strat-

To assess how much information a company

egy, which should be easily accessible on the main company website

makes available publicly to allow independentand dated: (i) the specific waste treatment/management practices

third parties to analyse and compare compa-

adopted to minimise environmental impact of wastewaters and solidnies’ environmental risk-management pro-

waste from antibacterial manufacturing; (ii) results of strategy audits,

cesses and performances.

Modifiedproducts; disruptions in the supply chain; and issues thatdetailed or with some level of aggregation and/or anonymisation, conducted at the company’s manufacturing sites, third-party sites that

result from less mature regulatory systems. Such restric-

WHICH ACTIVITIES WILL BE ANALYSED?

manufacture antibacterial APIs and drug products for the company

tions may lead to patients purchasing or being prescribed▶ACCESS

medicines that do not meet either their medical need or theRegistration

quality standards needed for treatment, which can increase
the risk of resistance.23,24 Stewardship programmes are also

To make their products available in different countries, com-

own sites, third-party supplier sites and/or external wastewater treat-

important to delay the emergence and spread of resistance.

local regulatory authorities. It is important that filing is done

ment plants, along with the methodology used for quantification; andIn this Research Area, the Benchmark assesses large

as widely and rapidly as possible after a product is approved,

research-based pharmaceutical companies and generic med-particularly if that product is innovative or superior to thoseicine manufacturers. The companies in scope have antibac-

already on the market. The Benchmark will look for evidence

and/or external waste-treatment plants; (iii) limits set for antibacterial discharge from own sites, third-party supplier sites and/or external
wastewater treatment plants, along with methodological and evidential bases; (iv) levels (concentrations) of antibacterial discharge from(v) names and/or locations, including with some level of aggregation,of third parties manufacturing individual antibacterial APIs and drug
products and/or of external waste-treatment plants.

terial and/or antifungal products on the market, and play anthat companies are filing their on- and off-patent antibacte-

important role in expanding access and ensuring stewardshiprial and antifungal medicines and vaccines for registration ingate/anonymised ones.

for these products.

countries with the lowest levels of income, and with the high-

Manufacturing high-quality antibacterials

est levels of inequality and public health need.

ing to product registration, accessibility, affordability and

The Benchmark will assess all the on-patent antibacte-

improving supply chains. Challenges around appropriate

rial and antifungal medicines and vaccines that each com-

access to products remain significantly higher in some coun-pany produces. It will also assess each company’s off-pat-tries, resource-limited countries with high burdens of dis-

ent/generic products, prioritising those on the World Healthease, referred to by the Benchmark as ‘access countries’. The

Organization’s current Model List of Essential Medicines

Appropriate Access indicators are dedicated to measuring(EML). This lists products that the WHO considers effective,

WHO. Non-conformities reported by such authorities may be taken

how companies plan for access to antibacterial and antifun-

safe and cost-effective, and which it deems essential for every

into account in the Benchmark’s assessment.

gal medicines and vaccines in these particular countries; and/health system. In particular, the Benchmark will pay special

The company reports systems in place to ensure, maintain and/To assess the risks that a company will pro-or improve the production of high-quality antibacterial APIs andduce antibacterial medicines with subther-drug products at its own and third-party manufacturing sites, in aapeutic dose levels (and/or of sub-optimal

manner consistent with the international standards on current Good

quality), which can contribute to the develop-

Manufacturing Practice (cGMP) developed and accepted by recog-

ment and spread of antibacterial resistance.

nised national and international authorities, such as the FDA, EU and26

panies must first file their products for registration with the

The Benchmark values detailed disclosures more highly than aggre-

To expand access, they can implement strategies relatB.3

determine the greatest needs and gaps in accessibility, and the

No change27

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation
Indicator

Rationale

attention to anti-tuberculosis and antifungal medicines on the▶S T E WA R DSH I P

EML, and to antibacterial medicines the WHO categorises as
Access, Watch and Reserve.25 The Access category includes

Educational stewardship activities
Companies often organise activities for healthcare profes-

antibacterials with wide indications and lower resistancesionals (HCPs) to educate them about the usage of products

medicines

potential than medicines in the other two categories. The

they make. Through these activities, companies can help to

The company files to register its on-patent antibacterial and antifungal med-

When a company files to register its new anti-

Watch category includes products with high resistance poten-

raise awareness of antimicrobial resistance and inform pre-icines in the countries with the lowest levels of income, highest levels of ine-

bacterial and antifungal medicines in low- andtial – these are the main targets of stewardship programmes.

scription practices to encourage appropriate use. While there

quality and highest public health need.

middle- income countries where disease burden

Finally, the antibacterials classified as Reserve are to be used

is no clear consensus as to whether companies should engage

only as a last resort to treat multi-drug-resistant infections.

in such activities, when companies do choose to engage, theThe Benchmark will also assess and report on the registra-consensus view is that they must take steps to mitigate thetion of relevant forgotten antibiotics in the WHO’s 2019 EML.

risk of conflict of interest. In this regard, the Benchmark will

These older antibiotics, no longer widely marketed, are still

examine, for example whether companies use non-branded

considered safe and effective for treating infections from sus-materials in their educational activities for HCPs, issue unre-

ceptible and resistant bacteria.26

stricted grants to independent third parties to develop edu-

Change since
2020

C.1.1

Registration of on-patent antibacterial and antifungal
Modified

and inequality are higher, this demonstrates acommitment to enter markets in need, and toprovide access to products in these markets.
Registration is a key step to ensure these products will be available where needed.

cational activities, and/or pledge not to provide financial or
Expanding access and affordability

material incentives to participants.

C.1.2

Registration of off-patent/generic antibacterial and antifungal medicines

The lack and/or inadequate use of antibacterial and antiand mortality, so it is essential for products to be made bothResponsible promotional practices
One of the strategic pillars of the global effort to address

accessible and affordable. For these medicines and vaccines,

AMR is to ensure antimicrobial medicines are used appropri-

the Benchmark will consider companies’ efforts to identify

ately and only when needed. This requires companies to avoid

the greatest needs for their products and any gaps in acces-

incentivising sales agents to, for example, mis-sell or over-sibility. Companies will be assessed on how they set prices,

sell products. Companies can lower the risk of sales agents

both at country level and for different populations within eachbehaving in unethical ways by minimising focus on sales vol-country. In addition to assessing pricing strategies such as

umes in their incentive schemes. The Benchmark will look attiered pricing, as well as donations, the Benchmark will con-the style and nature of incentives offered to companies’ sales

vaccines

sider other strategies to expand the accessibility of products.

agents, and at whether these reward high volumes of sales.

The company files to register its on-patent antibacterial vaccines in countries

When a company files to register its new anti-

Examples include decisions to license patented medicines to

By adopting incentive targets that are based on quality of ser-with the lowest levels of income, highest levels of inequality and highest public

bacterial vaccines in low- and middle-income

promote generic competition, and collaborations with organ-

vice, behaviour and other competencies, for example, compa-

health need.

countries where disease burden and inequality

isations that procure medicines on a global or regional basisnies can fully or partially decouple incentives from sales.

fungal medicines and vaccines creates substantial morbidity

The company files to register its off-patent and generic antibacterial and anti-

When a company files to register off-patent/

fungal medicines in countries with the lowest levels of income, highest levels

generic products in low- and middle-incomeof inequality and highest public health need.

countries where disease burden and inequality
are higher, this demonstrates a commitment toenter markets in need, and to provide access to
its products. Registration is a key step to ensure
these products will be available where needed.

C.1.3

Registration of on-patent antibacterial and antifungal

enter markets in need, and to provide access to
products in these markets. Registration is a key

Revolving Fund). The Benchmark will assess the geographic

Stewardship-oriented adaptations for patients
When medicines are prescribed or bought over the coun-reach of such efforts to ensure affordability and accessibil-

ter, the quality of information provided with them canity, and will consider evidence for commitments made by

improve the likelihood that they will be used appropri-

companies to expand access to more people including thoseately. The Benchmark will assess whether companies havemedicines

in underserved and vulnerable populations in low- and mid-adapted their brochures and packaging in ways that encour-

The company makes efforts to expand access to and ensure affordability ofWhen a company addresses the accessibility

age patients to use antibacterial and antifungal medicines

on-patent antibacterial and antifungal medicines in an appropriate manner toand affordability of its most innovative antibac-

underserved populations in countries in scope. Company demonstrates theterial and antifungal medicines, this can help

following:

low- and middle-income countries to reduce

dle-income countries.

appropriately. For example, companies can provide brochures
Ensuring continuous supply

in local languages or offer pictograms to help populations in

When supply chains are fragile or demand increases unex-

which illiteracy is an issue.

pectedly, this can lead to shortages in medicines and vaccines.

step to ensure these products will be available
where needed.

C.2.1

Expanding access to on-patent antibacterial and antifungal
Modified• Evidence of efforts to assess need and gaps in access for populations living in their burdens of infectious diseases, including
access countriaes

resistant infections.

• Evidence of efforts to close this gap (alone or in partnership) via methods

cially in resource-limited settings. The Benchmark will exam-

AMR surveillance
Surveillance systems play a critical role in helping companies

ine upstream and downstream mechanisms used by com-and others to monitor, control and ultimately prevent the rise

panies to ensure an uninterrupted supply of quality prod-

and spread of infectious diseases and antimicrobial resist-

ucts, and to prevent “stockouts” (situations in which stock isance. The Benchmark examines whether companies haveused up). It will assess the supply of APIs, holdings of buffer

their own AMR surveillance systems; are involved in building

stock, how companies share data with external stakeholders

capacity for new surveillance activities; and support or con-

to anticipate demand, capacity-building initiatives, and strat-

tribute to existing local, national and global systems. Further,egies to mitigate the circulation of substandard and/or falsi-

it assesses whether companies share raw surveillance data

fied medicines.

publicly through open-access data platforms: for example, on

In turn, this can have a profound impact on access, espe-Neware higher, this demonstrates a commitment to(such as Gavi, the Vaccine Alliance; Global Drug Facility; theGlobal Fund; and the Pan American Health Organization’s

No changethat address patients’ ability to pay across the whole income pyramid, via voluntary licensing, equitable pricing, donations and other means (e.g. by collaborating with regulatory authorities, public health organizations and genericcompanies to expand access of their products)• Evidence showing the number of patients that benefitted has increased andis sustained over time (long term access)• Plans to ensure the continued expansion of access to underserved populations in access countries

the AMR Register established by the Wellcome Trust and theOpen Data Institute.

28

29

Antimicrobial Resistance Benchmark 2021 – Methodology Report
Indicator

Access to Medicine Foundation
Rationale

Change since

Indicator

Rationale2020

C.2.2 Expanding access to off-patent/generic products antibacte-

2020

C.4

rial and antifungal medicines
The company makes efforts to expand access to and ensure affordability ofWhen a company addresses the accessibility

off-patent antibacterial and antifungal medicines in an appropriate manner toand affordability of its off-patent/ generic anti-

underserved populations in countries in scope. Company demonstrates thebacterial and antifungal medicines, this can help

following:

low- and middle-income countries to reduce• Evidence of efforts to assess need and gaps in access for populations living

their burdens of infectious diseases, includingin access countries

Modified

Educational stewardship activities
The company has a clear strategy to ensure that any conflict of interest (COI)

Companies organise educational activities, suchis mitigated in its (support of) antibacterial and antifungal stewardship educa-

as Continuing Medical Education, that can influ-

tional activities directed at healthcare professionals. To mitigate COI, the com-ence and/or change the behaviour of prescrib-pany provides an unrestricted grant to an independent third party to develop

ers and potentially affect access to appropriate

the educational activity, or if it is developed in-house, the company ensurestreatment as well as the use of antibacterials

third party such as an accreditation body.

resistant infections.

stewardship must put in place robust safeguarding strategies, policies, and procedures to mit-

equitable pricing, donations and other means (e.g. by collaborating withigate any conflicts of interest in educational

regulatory authorities, public health organisations and other companies toactivities directed at healthcare professionals.

expand access of their products).*• Evidence showing the number of patients that benefitted has increased andC.5

is sustained over time (long term access)• Plans to ensure the continued expansion of access to underserved populations in access countries

C.2.3 Expanding access to on-patent antibacterial and antifungal
vaccines
When a company addresses the accessibil-

Responsible promotional practices
Responsible promotional practices when engaging with healthcare profession-

Promotional practices used to sell antibacte-

als include sales practices that aim to avoid overselling of antibacterials andrial and antifungal medicines can lead to bias

antifungals by either not promoting such products or by decoupling incen-

in prescribers’ practices, and could mean prod-

tives for sales agents from sales volumes. In addition, the company adapts

ucts are prescribed inappropriately. To limit pre-its marketing materials to include AMR trends and guidelines for healthcare

scriber bias and reduce the risk of inappropri-

professionals.

ate prescription, companies need to implement

on-patent antibacterial vaccines in an appropriate manner to underserved pop- ity and affordability of its innovative vaccines,

ing sales incentives to prevent overselling or

ulations in countries in scope. Company demonstrates the following:

mis-selling.

this can help low- and middle-income countries

C.6

including resistant infections.

• Evidence of efforts to close this gap (alone or in partnership) via methods
that address patients’ ability to pay across the whole income pyramid, via voluntary licensing, equitable pricing, donations and other means (e.g. by collaborating with regulatory authorities, public health organizations and othercompanies to expand access of their products)• Evidence showing the number of patients that benefitted has increased andC.7

tions in access countries

Ensuring continuous supply
The company applies multiple strategies both upstream and downstream to

Accessibility relies on companies having strat-

ensure the uninterrupted supply of quality products. These include the follow-

egies to ensure a continuous supply of on- anding components:

off-patent antibacterial and antifungal medi-• Evidence to ensure sufficient supply of APIscines and vaccines. To ensure an uninterrupted• Bilateral data-sharing with countries or regions for demand planning.

supply of good quality products, companies• Buffer stock for key antibacterial and antifungal medicines(including duration need to prepare for stockouts by ensuring theand reporting of shortages)
come countries

Stewardship-oriented adaptations for patients
The company adapts its brochures and/or its packaging to facilitate the appro-

To encourage appropriate use of medicines andpriate use of antibacterial and antifungal products by patients. The company

limit the emergence of antimicrobial resistance,

considers the needs of the patient population, including language, literacy, andcompanies may need to adapt brochures andpaediatric use (if relevant). In addition, the company aims to improve adher-

packaging to guide patients about how to use

ence to treatment and considers local environmental conditions to preserve

products. For example, brochures can be writ-

the effectiveness.

ten in a native language, or include pictograms

No change

instead of text.

is sustained over time (long term access)• Plans to ensure the continued expansion of access to underserved popula-• Capacity building initiatives to strengthen supply chain in low- and middle-in-

No change

responsible promotional practices by alter-New• Evidence of efforts to assess need and gaps in access for populations living in to reduce their burdens of infectious diseases,

C.3

ent in this area, so companies need to limit theirrole accordingly. Those involved in educationalthat address patients’ ability to pay across the whole income pyramid, viaaccess countries

No change

COI is mitigated through an independent review of the educational activity by a and antifungals. Conflicts of interest are inher-• Evidence of efforts to close this gap (alone or in partnership) via methods

The company makes efforts to expand access to and ensure affordability of

Change since

Modified

AMR surveillance
The company has, supports, and/or contributes to antibacterial and antifun-

By publicly sharing data on the surveillance ofgal surveillance programmes to track resistance to pathogens, and shares such

resistance, companies can assist in the effort

data publicly.

to monitor the rise of resistance to antibacte-

Modifiedrial and antifungal medicines. Such data is an
essential tool for governments and researchers to measure burdens of resistant infections.
Sharing data also helps in forecasting and prioritising objectives for the design of stewardship policies.

supply of APIs, keeping sufficient buffer stock,
and aligning with external stakeholders on
supply and demand. When people are assured• Mitigation of the circulation of substandard and falsified medicines (including of a continuous supply, this decreases the
how the company verifies the credentials of suppliers and customers down-

chance they will resort to obtaining substandard

stream, and to whom it reports encounters of falsified medicines)

or falsified medicines, which can increase therisk of AMR emerging and spreading30*On publication, this list incorrectly included voluntary licensing due to a proof-reading error.

31

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

Appendices32

33

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

APPE N D IX I . PRI O RIT Y PATHOG E NS I NCLU D E D FO R ANALYSIS I N R&D

APPE N D IX I I . CO NCE PTS USE D I N EVALUATI NG ANTI M ICRO B IAL STEWARDSH I P

In the Research & Development Research Area, theupdates to these priority lists, including the upcoming publi-

This appendix gives an overview of activities relevant to

Benchmark will assess the size and public health value of acation of a WHO priority list for fungal infections (in discus-

the Stewardship indicators within the Appropriate Accesscompany’s pipeline of investigational antibacterial and anti-sion at the time of publication of this report)***.

& Stewardship research area. It describes in detail what thefungal medicines and vaccines. The disease scope for the

Indicator A.2.4 of the Benchmark will assess companies’

2021 AMR Benchmark includes the pathogens, with their spe-

projects targeting the most critical priorities in these lists, i.e.

cific resistance profiles, from the priority pathogens lists pub-targeting the pathogens classified by the CDC and WHO as

lished by World Health Organization (WHO)* and the Centers“Urgent” or “Critical”, respectively.

for Disease Control and Prevention (CDC)** (see full list

expectations are of the companies assessed in the 2021 AMR
Benchmark.
The next table describes for each Stewardship indicator:(a) the type of activity that is evaluated in the indicator; and(b) which group the activity is directed at.

below). Modifications to the disease scope will be consideredby the Benchmark Research Team according to any relevant
Stewardship activities relating to healthcare professionals or
patients
Pathogen

WHO Priority

Resistance profile

List*

CDC Biggest

Resistance profile

Threats**

CriticalCarbapenem

Bordetella pertussis
Campylobacter spp.

High

Fluoroquinolones

Clostridioides difficile
Enterobacteriaceae

Educational activities (such as CME*)

Healthcare professionals

C.4 Educational Stewardship Activities

Promotional activities + materials

Healthcare professionals

C.5 Responsible Promotional Practices

Watch

Drug-resistant

Product packaging

Patients

C.6 Stewardship-oriented Adaptations for Patients

Serious

Drug-resistant

AMR surveillance

Public health authorities; research-

C.7 AMR Surveillanceers; public

UrgentCriticalCarbapenem

UrgentCarbapenem

Extended-Spectrum ß-Lactamase

Serious

Extended-Spectrum ß-Lactamase

High

Haemophilus infuenzae type b (Hib)

Medium

Ampicillin

Helicobacter pylori

High

Clarithromycin

Mycobacterium tuberculosis

R&D priority

Mycoplasma genitalium
High(ESBL)

Vancomycin (VRE)Enterococcus spp.

Neisseria gonorrhoeae

Relevant in indicator

Carbapenem(ESBL)
Enterococcus faecium

Directed at

Urgent

BACTERIA
Acinetobacter spp.

Stewardship activity

Cephalosporins

Serious

Vancomycin (VRE)

Serious

Drug-resistant

Watch

Drug-resistantUrgentDrug-resistantFluoroquinolones
Pseudomonas aeruginosa

CriticalCarbapenem

Salmonella spp.

High

Fluoroquinolones

Salmonella non-typhoidal & serotype

Serious
SeriousMultidrug-resistant (MDR)
Drug-resistanttyphi*CME: Continuing Medical Education

The table below describes examples of sales practices that are considered best practice, as well as current practices from the 2020 AMR
Benchmark.
Current vs. best sales practices
Best sales practices

Current sales practices

No promotion of (selected) antibacterial and/or antifun-

Promotion of antibacterial and/or antifungal medicines

gal medicines

directed at healthcare professionals

Full decoupling of incentives for sales agents from sales

Partial decoupling of incentives for sales agents fromvolumessales volumes (e.g. 25% variable pay)

NB: Variable pay may be linked to sales volumes.

Shigella spp.

MediumFluoroquinolones

Serious

Drug-resistant

Staphylococcus aureus

High

Methicillin

Serious

Methicillin (MRSA)

Streptococcus (group A)

Concerning

Erythromycin

Streptococcus (group B)

Concerning

Clindamycin

Serious

Drug-resistant

Aspergillus fumigatus

Watch

Azole-resistantCandida auris

UrgentStewardship-oriented adaptations for patients

Candida spp.

Serious

Drug-resistantType of material

Vancomycin-intermediate andresistant

Streptococcus pneumoniae

MediumPenicillin-non-susceptible

This table gives an overview of materials relevant in indicator C.6
Stewardship-oriented adaptations for patients and gives examples ofeach type of material from the 2020 AMR Benchmark.

FUNGI

Product-specific or

Goal

Example of adaptation

At a minimum adheres to

Johnson & Johnson: Packaging a six-month treat-

local regulations

ment regimen (188 tablets) in a single bottle togeneral
Packaging

Product-specificenable patients to follow a full course of treatment
without needing to make multiple visits to a pharR E FE R E N CE S
* WHO. (2017). Global priority list of antibiotic-resistant bacteria to
guide research, discovery, and development of new antibiotics.
** U.S. Centers for Disease Control and Prevention (CDC). (December,2019). Antibiotic resistance threats in the United States, 2019.
*** WHO. (2020). First meeting of the WHO Antifungal Expert Groupon Identifying Priority Fungal Pathogens: meeting report.

34

macy or clinic.
Brochures (package insert)

Product-specific

At a minimum adheres to

GSK: Developing a graphics-based smartphone

local regulations

application to educate patients in low-literacy
environments.

Leaflets

General

To educate patients on

Cipla: General patient education leaflets at the phar-

AMR

macy or clinic on what antifungal resistance is andhow to prevent it.

35

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

APPE N D IX I I I . GU I DANCE TO ACCESS AN D STEWARDSH I P PL AN N I NG

This is an overview of the most common types of data thatcan be generated in AMR surveillance programmes. Its benefits and examples of data platforms containing such data areThis appendix provides a list of strategies for access andpresented in the table below.

stewardship accompanying late-stage R&D projects, determined as phases II and III of clinical development and recently
approved products.

AMR surveillance data
Type of AMR surveil-

Benefits

Examples of data platforms

Peer-reviewed journal articles and graph-Peer-reviewed journal articles; Results

ics-based databases on the results of surveil-

databaselance data
Resultsning commonly expected to be developed and arranged whilea product is still in development, via commitments, explicit
plans and contracts between company and governments

lance data can be helpful in providing insightand distributors, NGOs, and local stakeholders. This is not an

into where resistance to specific medicines is

exhaustive list as many ways to expand access and ensure

occurring.
Raw data

The following are examples of access and stewardship plan-

By using and combining the raw data fromThe AMR Register (https://amr.theodi.org/)companies’ surveillance programmes, third-

proper stewardship can be developed. Companies applying one or more of these plans will be credited in the AMR
Benchmark.

party researchers can explore the potential
for further research, beyond the specific questions asked by the companies themselves.
Clinical trial data

Clinical trial data that contains surveillancedata includes more patient-specific information such as the age, outcomes and comor-

The YODA project (https://yoda.yale.edu/)

ACCESS STR ATEG I ES

DetailRegistration

Prioritise filing in countries, including LMICs, with high disease burden
and high resistancebidities. This is valuable as it gives more detail

Prioritise fast registration within 6-12 months or concurrently with

about the proportion of resistant infections
and the impact on fatality.

launching in US/EU
WHO Prequalification of Medicines

Facilitate eligibility of products for UN procurement and accelerated

Programme

registration; relevant for access to countries with less mature national
regulatory authorities

WHO Collaborative Procedure forAccelerated registration mechanism

Accelerated Registration
EMA Article 58

Facilitate access to essential medicines in LMICs

Responsible IP and Licensing

Waiver patent rights and/or non-enforcement of rights in selectArrangements

geographies
Plan for voluntary licensing arrangements to expand access

Managed Access Programmes

Implement programmes in high-burden countries, LMICs
Compassionate Use, Special Access Schemes/Programmes

Product Donation Programmes

Identify populations in need with no capacity to pay and plan to donate
as appropriate, working with local partners

Special Importation Waivers

Expand access for specific populations where there is an expressed
need

Sustainable Manufacturing and Supply

Plan shortage mitigation strategies
Forge and maintain local manufacturing commitments to keep costs
low and shorten supply chains

Equitable pricing

Price-caps to ensure limits on mark-ups by third parties
Price-volume agreements
Tailored strategies for expanding access in LMICs, such as assessments
to determine the appropriate strategies needed to consider disease
burden, public health value, income, ability to pay, and local healthcare
structure

STE WAR DS H I P STR ATEG I ES

DetailSurveillance

Plan for adequate monitoring of resistance emergence and trends
Share data through open data platforms

Responsible Promotion

Do not promote developed antibiotics

Availability of Companion Diagnostics

Plan for adequate availability of diagnostics, as applicable
Plan for susceptibility testing of pathogens, as applicable3637Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

APPE N D IX IV. D E FI N ITI O NS
Access plan

Antibacterial medicine

Antimicrobial stewardship[Working definition, used for analysis][Working definition, used for analysis]

A systematic and comprehensive process that

An access plan is a plan set up to ensure that

Antimicrobial medicine used to treat bacterial

aims to ensure that all aspects of prescribing,public health needs are taken into considera-

infections by directly targeting the bacteria that(e.g., drug, dose, duration), dispensing, and thetion during R&D. These plans may be developed

cause the infection or the disease process (asuse of antimicrobial medicines are consistentin-house or through collaborations and include

opposed to targeting the symptoms of the infec-

with the available evidence on how to minimise

commitments, strategies, concrete provisionstion). See also Antibiotic medicine.

the emergence of antimicrobial resistance.

developed in partnership) to enforce accounta-

Antibacterial resistanceAppropriate promotional practices

bility. Access plans facilitate availability, acces-

Antimicrobial resistance occurring specifically in[Working definition, used for analysis]

sibility and affordability for patients in countries

bacteria. This resistance renders the medicines

Promotional activities targeting the general

within the scope of the Benchmark (e.g., regis-

normally used to treat bacterial infections (e.g.,

public, patients and healthcare professionals in

tration commitments, equitable pricing strate-

urinary tract infections, pneumonia, bloodstreamsuch a way that transparency, integrity, accuracy,

gies, sufficient supply commitments, non-exclu-

infections) ineffective. Sometimes also referredclarity and completeness of information can besivity in specified territories, waiving of patent

to as antibiotic resistance. See also antimicro-

ensured.

rights, royalty-free provisions and applying forbial resistance.

and other agreed-upon measures (typically

Appropriate use of antimicrobials

WHO prequalification).
Antibiotic medicine

The cost-effective use of antimicrobials, which

Active pharmaceutical ingredient (API)[Working definition, used for analysis]

maximises clinical therapeutic effect while mini-

The active pharmaceutical ingredient (API) is

Equivalent to Antibacterial medicine. The term

mising both drug-related toxicity and the devel-

the active pharmaceutical component of a med-“antibiotic” is used inconsistently in the liter-

opment of antimicrobial resistance [WHO Global

icine that carries out its intended effects. Some

ature to denote either a drug that targets any

Strategy for Containment of Antimicrobial

medicines, such as combination therapies, havetype of microorganism in the body or, alterna-

Resistance, 2001].

multiple active ingredients that target multiple

tively, a drug that targets bacteria specifically.

disease pathways and/or symptoms. The inac-

Given the ambiguity, the Benchmark prefera-

Clinical-stage drug development

tive ingredients of a medicine are referred to as

bly avoids use of this term, referring to the more[Working definition, used for analysis]

excipients.

general category as “antimicrobial” and to theClinical-stage drug development comprises

more specific one as “antibacterial”.

phases I through III of clinical development.
Products approved (or awaiting approval)

Adaptive R&D[Working definition, used for analysis]

Antifungal medicine

between 22 June 2019 (end of the period

R&D adaptations to existing medicines and/or[Working definition, used for analysis]of analysis for the previous edition of thevaccines. This includes new formulations, new

Antimicrobial medicine used to treat fungal

Benchmark) and 30 April 2021 are also catego-

fixed-dose combinations of existing chemical or

infections by directly targeting the fungi thatrised as late-stage.

biological entities, a new target demographic, or

cause the infection or the disease process (asthe repurposing of an existing product for addi-

opposed to targeting the symptoms of the

Conflict of interest

tional indications.

infection).

[Working definition, used for analysis]

Affordability

Antimicrobial medicine

nies’ engagement in public health-oriented ini-

[Working definition, used for analysis][Working definition, used for analysis]

tiatives, a conflict of interest potentially arises

The measure of a payer’s ability to pay for a

A medicine used to treat an infectious disease bywhen the commercial interests of the company

product (whether or not they are the end user).

directly targeting the bacteria, fungi, helminths,

conflict with the primary interest of protecting

The Benchmark takes this into account when

protozoa or viruses that cause the infection or

and promoting public health.

assessing pharmaceutical companies’ pricing

the disease process (as opposed to targeting thestrategies.

symptoms of the infection).

AMR surveillance

Antimicrobial resistance

oped to a usually effective antimicrobial medi-[Working definition, used for analysis]

Antimicrobial resistance is the ability ofcine through exposure to a similarly acting sub-

The continuous and systematic collection, anal-

microbes such as bacteria, viruses, fungi andstance. Cross-resistance can occur amongysis and interpretation of antimicrobial infection

parasites (protozoa or helminths) to grow in thehuman antimicrobials and is also observed

and resistance-trend data needed for the plan-

presence of an antimicrobial substance (e.g., a

between human antimicrobials and products

ning, implementation, and evaluation of antimi-

medicine) that would normally kill them or limit

used in animal health or agriculture (e.g., pesti-

crobial stewardship activities.

their growth. Resistance is a consequence ofcides, herbicides or fungicides).

Within the context of pharmaceutical compa-

Cross-resistance
Cross-resistance refers to the resistance devel-

evolution via natural or artificial selection.

38

39

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation
or both. [based on WHO, 2017]

Disability-Adjusted Life Year (DALY)

such as unexpected contamination, incorrect

has received exclusivity rights, allowing the

The disability-adjusted life year (DALY) is alabelling or incorrect dose of the active ingre-

patent holder to prevent or stop others from

Product Development Partnershipmeasure of disease burden that combines dis-dient. GMP covers all aspects of pharmaceuti-

making, using, selling or importing the medicine[Working definition, used for analysis]

ease-associated mortality and morbidity. It is thecal production (e.g., starting materials, prem-within the country that granted the patent.

Product Development Partnerships (PDPs) takesum of the number of years of life lost (YLLs)

ises, equipment, training and personal hygiene of

The Benchmark determines patent status for its

the form of centralised non-profit organisations

and years lived with disability (YLDs). DALYs

staff) and includes processes that provide docu-

products in scope through a process that com-that facilitate financial risk-sharing across theallow comparison of disease burden across dif-mented proof that correct procedures are con-bines data from selected regulatory authority

public and private sectors by pooling and sharing

ferent populations and health conditions acrosssistently followed at each step of the manufac-

websites (e.g. FDA) and participating companies.

resources, both tangible and intangible, for thetime. One DALY equals one lost year of healthyturing process. GMP guidelines are establishedlife.

and overseen by regulatory agencies in individual

Originator medicine

countries or regions, as well as the WHO.

The medicine that was first authorised world-

Drug productdevelopment of medicines, vaccines and other
health tools.

wide for marketing, normally as a patented prod-

Public-private partnership

The finished dosage form of a medicine

Healthcare Professional

uct, on the basis of its documented efficacy,[Working definition, used for analysis]

obtained at the end of the manufacturing pro-

Any specialised worker in any branch of health-safety and quality, according to requirements at

A public-private partnership (PPP) is a partner-

cess, (e.g., the tablet, capsule, or solution con-care that provides preventive, curative or reha-

the time of authorisation. The originator med-ship between one or more public organisations

taining the active pharmaceutical ingredient(s),bilitative services to the community.

icine always has a brand name; this name may,and the private sector for providing a public

however, vary among countries.

asset or service, in which the private party bears

generally, but not necessarily, in association withsignificant risk and management responsibil-

one or more other ingredients). Also referred toIntellectual capital

as a finished drug product, finished product or[Working definition, used for analysis]

Over-the-counter medicine

ity, and remuneration is linked to performance.

formulation.

Intellectual capital is the intangible value of aA medicine that can be purchased without pre-The Benchmark also considers a partnershipcompany, covering its employees (human capi-

scription from a healthcare professional.

between a non-profit organisation and the private sector to be a PPP.

Environmental risk management (ERM)tal), its relationships (relational capital) and the[Working definition, used for analysis]

infrastructure (e.g. hardware, software, data-

Period of analysis

In the context of antibacterial product manufac-

bases, processes, patents) that supports the[Working definition, used for analysis]

Pull incentive

turing, environmental risk management (ERM)

work of its employees (structural capital). A

The 2020 AMR Benchmark report will assess

Pull incentives, in the form of extended exclu-

seeks to determine and manage environmen-

company’s intellectual capital gives it a competi-company activities taking place during a period

sivity periods, higher reimbursement or market

tal risks resulting from the production of anti-

tive advantage. In the context of the Benchmark,of analysis going from 21 June 2019 and 30 April

entry rewards, reward companies for bringing

bacterials, such as the emergence of antibacte-

the intellectual capital of a pharmaceutical com-

2021. For the R&D research area, projects need

new drugs to the market through lowering the

rial resistance, to protect human health and thepany may comprise of, for example, molecule

to be ongoing, approved or awaiting approval by

uncertainty for return on investment.

environment.

libraries, patented compounds, processes andthe end of the period of analysis.
Push incentive

technologies or unpublished data on pharmacoFalsified medicine

logical characteristics of compounds.

A medicine which is deliberately and fraudu-

Pre-clinical-stage drug development

Push incentives, in the form of grants, partner-[Working definition, used for analysis]

ships or tax credits, are employed to lower thelently mislabelled with respect to identity and/Late-stage drug development

Pre-clinical-stage drug development comprises

cost of and de-risk research and development ofor source. Falsified medicines may contain no[Working definition, used for analysis]

the discovery and pre-clinical phases of drug

a new medicine.

active ingredient, the wrong active ingredi-

In the context of the pharmaceuti-

development.

ent or the wrong amount of the correct active

cal R&D pipeline, medicine and vaccine

ingredient.

candidates in Clinical phase II or ClinicalPredicted no-effect concentration (PNEC)[Working definition, used for analysis]

phase III are considered to be in late-In the context of environmental risk assessment,

A stewardship plan is a plan set up to ensure

Finished productstage clinical development. Products

the predicted no-effect concentration (PNEC)

that AMR-relevant public health needs are taken

See Drug product.

approved (or awaiting approval)

is the concentration of a substance in any envi-

into consideration during R&D. These plans may

between 21 June 2019 (end of theronment below which adverse effects will mostbe developed in-house or through collabora-

Generic medicine

period of analysis for the previous edi-

likely not occur. The PNEC can be based ontions and include commitments, strategies, con-A medicine that is created to be the same as ation of the Benchmark) and 30 April

acute (short-term) or chronic (long-term) toxic-

crete provisions and other agreed-upon meas-

known marketed brand-name drug (the origina-

2021 are also categorised as late-stage

ity data and usually takes account of the uncer-

ures (typically developed in partnership) to

tor medicine) in dosage form, strength, route ofby the Benchmark.

tainty in extrapolating from collected/available

enforce accountability. Stewardship plans facil-

data to the entire ecosystem.

itate the appropriate use of antimicrobial med-

administration, quality and performance charac-

Stewardship planicines and reduce the emergence of resistance.

teristics, and intended use. See also Originator

Off-patent medicine

medicine.

[Working definition, used for analysis]

Priority pathogen

Examples include (but are not limited to) appro-

A medicine whose granted patent protection has[Working definition, used for analysis]

priate promotional practices and conducting sur-

Good Manufacturing Practices

expired. Patent protection typically lasts for 20

Priority pathogens are pathogens for which newveillance studies.

Good manufacturing practice (GMP) is a system

years and is specific to each country.

medicines and vaccines are highly needed. The
Benchmark identified this set of priority path-

Substandard medicine

ently produced and controlled according toOn-patent/patented medicine

ogens based on the WHO priority pathogens

Also referred to as “out of specification”, theseappropriate quality standards. Within pharma-[Working definition, used for analysis]

list as of 25 February 2017 and the CDC’s US

are market-authorised medicines that fail toceutical production this serves to minimise risks

A patented or on-patent medicine is one which

Biggest Threats list as of December 2019.

meet either quality standards or specifications,employed to ensure that products are consist-40

41

Antimicrobial Resistance Benchmark 2021 – Methodology Report

Access to Medicine Foundation

APPE N D IX V: RE FE RE NCES

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42

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Antimicrobial Resistance Benchmark 2021 – Methodology Report

Report Design
Explanation Design
Editorial teamAnna Massey
Rachel Jones
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