Methodology for the 2022 Access to Medicine Index

Access to Medicine
Index 2022
METHODOLOGY1

Methodology for the 2022 Access to Medicine Index

ACKNOWLE DG E M E NTS

The Access to Medicine Foundation would like to thank the following
people and organisations for their contributions to this report.
FU N D E RS
UK Foreign, Commonwealth and Development Office
The Dutch Ministry of Foreign Affairs
Bill & Melinda Gates Foundation
Wellcome Trust
AXA Investment Managers

EXPE RT REVI EW CO M M IT TE E
Hans Hogerzeil (Chair)
Emily Bleimund
Githinji Gitahi
Michela Gregory
Fumie Griego
Martha Gyansa-Lutterodt
Dennis Ross-Degnan
Alan Staple
Fatima Suleman
Klara Tisocki
Prashant Yadav
RESE ARCH TE AM

E D ITO RIAL TE AMJames Hazel

Anna Massey

Kasper Blom

Eleanor Bley Griffiths

Moy Bracken

Rachel Jones

Victorine de Milliano
Myriam Diallo
Sagal Hassan
Camille Romero
Emma Shiffman
AD D ITI O NAL CO NTRI BUTORS
We would like to thank the many other experts who contributed theirviews to the development of this methodology (see page 39).
ACCESS TO M E D ICI N E FOU N DATIO N
The Access to Medicine Foundation is an independent non-profit organisation based in the Netherlands. It aims to advance access to medicine in low- and middle-income countries by stimulating and guiding thepharmaceutical industry to play a greater role in improving access.
Naritaweg 227-A
1043 CB, Amsterdam
The Netherlands
For questions about this report, please contact
James Hazel, Research Programme Manager
jhazel@accesstomedicinefoundation.org+31 (0) 20 215 35 35
www.accesstomedicineindex.org

2

Methodology for the 2022 Access to Medicine Index

Momentum for
improving accessmust not be lost

The Covid-19 pandemic has exposed where the biggest fault-This will be the eighth edition of the Index, which was firstlines are in global access to medicine, and how much more

published in 2008. It has a central role in ensuring that themust be done to fix them. But it has also been a period ofbest of the industry thrives, highlighting best practice andinnovation and partnership, with the pharmaceutical indus-

showing where more can – and should – be done. The Index

try showing just how quickly it can move to address a health-closely examines difficult issues like pricing, supply security,

care crisis. More widely, the pandemic has created a greaterand reaching vulnerable populations. While Covid-19 is cer-awareness of unequal access to healthcare and health prod-

tainly within the scope of our analysis, this Index covers aucts faced by people all over the world. I fear that these

total of 83 diseases and takes an in-depth look at access tochronic issues will never go away if we do not harness thismedicine to provide a clear picture of where we now stand.

momentum – and act now.
Previous indexes have shown worryingly short R&D pipelines
In so many ways, the corporate and public sectors havefor Emerging Infectious Diseases. In addition, not enough was

stepped up since the pandemic began, developing new vac-

being done to ensure affordability and access for the mostcines at unprecedented speeds while also tackling severe

vulnerable populations. So, as we look to the future, I ask: hasstrains to public health services. Yet we have still left thethe pharmaceutical industry truly learned from this pandemic,

poorest populations last in line. Healthcare systems and med-or has Covid-19 won in setting back progress? The Index will

ical supply chains in lower-income countries have faced theilluminate the answers to these questions. The impetus mustbiggest stresses, while the global distribution of vaccines has

not be lost.

been far from equitable. There is much to celebrate, but alsomuch to improve.
Our current Access to Medicine Index came out in January
2021, and my team continues to use the data and the conclusions from the report to facilitate real change within
the pharmaceutical industry. The team has also now begun
work towards the 2022 Access to Medicine Index, and this
Methodology Report – which sets out the framework for the
next Index – is a major milestone along that path.
The 2022 Access to Medicine Index will evaluate the work of

Jayasree K. Iyer

20 of the world’s largest pharmaceutical countries, assess-

Executive Director

ing their efforts in addressing access to medicine in 108 low-

Access to Medicine Foundationand middle-income countries, whose populations have long
endured limited access to new or essential products.

3

Methodology for the 2022 Access to Medicine Index

Table of contents

Acknowledgements

2

APPE N D ICES

38

Foreword

3

I

39

About this report5

IIA Diseases in scope for the 2022

Contributors to this report
Access to Medicine Index

EXECUTIVE SU M MARY406IIB Cancers in scope for the 2022

company practice6

III The good practice standards framework for

TH E 2022 ACCESS TO M E D ICI N E I N D EX

9

IV R&D priorities

Methodology 2021

9

V Ensuring the methodology considers issues

REVI EWI NG TH E M ETHO DO LOGY10VI Definitions

48

VII References

51

A vision for 2030: how this Index will shift pharma

Access to Medicine Index
capacity buildingof sex and gender
How the Index distills access-to-medicine priorities
for pharmaceutical companies

10

ANALY TI CAL FR AM EWO RK

12

42
43
44
47

2022 Index to put greater focus on measuringoutcomes

12

WHAT TH E I N D EX M E ASU RES

18Company Scope

19

Disease Scope

20

Geographic Scope24

Product Type Scope26

HOW TH E I N D EX M E ASU RES

27

A Governance of Access28

B Research & Development

30

C Product Delivery

32

LIST O F FI GU RES
Figure 1

Companies in scope of the 2022 Access to Medicine Index

6

Figure 22021 Methodology Review for the 2022 Access to Medicine Index

10

Figure 3

Analytical Framework for the 2022 Access to Medicine Index

13
19

Figure 4

Companies in scope of the 2022 Access to Medicine Index

Figure 5

Low- and middle-income countries shoulder the bulk of disease burdens

21

Figure 6

Defining the disease scope - screening protocol

22

Table 1

List of diseases, conditions and pathogens included in the 2022 Access to Medicine Index

23

Figure 7

Countries included in the 2022 Access to Medicine Index – 108 Countries

24

Table 2

List of countries included in the 2022 Access to Medicine Index – 108 countries

25

4

Methodology for the 2022 Access to Medicine Index

About this report
This report sets out the methodology for the 2022 AccessTowards 2030

to Medicine Index, including its framework, scopes, prior-

The UN has called for a decade of action in order to achieve

ity topics and indicators. It captures society’s expectations of

the Sustainable Development Goals (SDGs) and universal

pharmaceutical companies regarding access to medicine inhealth coverage (UHC) by 2030, and the clock has alreadylow- and middle-income countries (LMICs). Using this meth-

begun to tick. To reach that milestone, pharmaceutical com-odology, the next Index will assess progress by 20 of thepanies have a central role to play in developing the treat-world’s largest pharmaceutical companies in making medi-

ments needed by the more than 80% of the global popula-cines, vaccines, diagnostics and other health products moretion who live in LMICs, and in improving products’ availability

accessible in LMICs. The Index is published every two years.

across socioeconomic divides. The findings of the 2022 Index
will help illuminate where progress is already being made, andwhere action is still required.
Continuity of framework enables clear trend analysis
Each Access to Medicine Index is the result of a two-year pro-ANALYTICAL FRAMEWORK FOR

cess that begins with a review of the Index methodology.

THE 2022 ACCESS TO MEDICINE INDEXA GOVERNANCE OF ACCESS
2 priority topics, 7 indicators

Ahead of the previous Index, a comprehensive methodology review was carried out in 2019 which resulted in a tighter

15%

analytical framework with a greater focus on the pharmaceutical industry’s core responsibilities on access (such as R&D,

B RESEARCH & DEVELOPMENT 30%
3 priority topics, 7 indicators

affordability, and intellectual property management).
In this cycle, for the upcoming eighth Access to Medicine

C PRODUCT DELIVERY
9 priority topics, 17 indicators

Index, a more targeted approach was taken when it came55%

to reviewing the framework. A variety of experts were consulted to introduce refinements to the methodological framework, only where needed. This continuity within the methodology will facilitate clearer comparisons with data and information from the previous Index, enabling more nuanced trend
analysis.

I N TH IS RE PO RT
Indicator review and stakeholder

Analytical framework geared

14 priority topics, 31 indicators

Four scopes of analysis

consultations The methodology

toward trend analysis This meth-

The 2022 Index will evaluate com-

The 2022 Index will analyse howreview started with internal checks

odology review prioritised conti-

panies in 14 priority topics: areas

20 of the world’s largest pharma-

on indicators, data sets and analyt-

nuity and the capacity for nuancedof behaviour where stakeholders

ceutical companies are addressing

ical approaches, followed by exter-

comparisons, with indicators

agree that pharmaceutical compa-

access to medicine in 108 low- andnal consultations to identify thegrouped into three Technical Areas:

nies have the biggest potential andmiddle-income countries, looking

consensus view on where pharma-

1. Governance of Access

responsibility to make change, suchat 8 product types for 83 diseases,

ceutical companies can take action

2. Research & Development

as product development, licensing

conditions and pathogens.

toward goals for 2030.

3. Product Delivery

Page 9

Methodology for the 2022 Access to Medicine Index

Page 12

Methodology for the 2022 Access to Medicine Index

and pricing.

Page 13

Methodology for the 2022 Access to Medicine Index

Methodology for the 2022 Access to Medicine Index

REVI EWI NG TH E M ETH O DO LOGYANALY TICAL FR AM EWO RKWHAT WE M E ASU RE

How the Index distills access-to-medicine
priorities for pharmaceutical companies

2022 Index to put greater focus on measuringoutcomes

Disease Scope

Page 18

Methodology for the 2022 Access to Medicine Index

Methodology for the 2022 Access to Medicine Index

D ISE ASE SCO PE

FIGURE 5

Low- and middle-income countries shoulder the bulk of

WHAT WE M E ASU RE

disease burdens
These four charts give an indication of how the diseases and conditions in
scope disproportionately affect people living in low- and middle-income
countries. Behind these numbers are millions of people who cannot rely on

Geographic Scopeaccess to affordable, quality medicine.
Communicable diseases, DALYs

23 Communicable Diseases
This category includes the 10 Communicable Diseases (CDs) with the highest DALY burdens in countries in scope, as well as diseases for which product gaps have been identified as priority R&D targets, such as emergent
non-polio enteroviruses and ‘Disease X’, a WHO term to denote a currently

Each Access to Medicine Index is the result of a two-year pro-Primary principles

cess known as the ‘Index cycle’, which begins with a targeted

The primary principles of the 2021 Methodology Review:

review of the Index methodology. The aim is to distil global

1priorities regarding access to medicine and to define howsociety expects pharmaceutical companies to contribute. The

ditions and pathogens confirmed by the Expert Review

pany activity in this area during the period of analysis. For thethat were previously separate under a single term (e.g., “enteric infections”

Committee as critical priorities for improving access to2022 Index, two new diseases (thalassemia and osteosar-

now includes diarrhoeal diseases, typhoid and paratyphoid, and invasive non-access to medicine in order to facilitate broader uptake;range of companies against each other;of ambitious yet achievable expectations for the behaviour ofpractices that, over the past decade, have proven to bepharmaceutical companies in improving access to medicine.

successful, scalable and accepted by governments and othercompany activity on access to medicine over time; andThe Index will follow products emerging from the pipeline(after market approval) and include them in its analyses of

The Methodology for the 2022 Index is based on a tight ana-

stakeholders. This streamlining reflects the global healthgreater access to medicine is needed most. A review of theaccess strategies.

lytical framework of three Technical Areas, and on 14 pri-community’s emphasis on access programmes that can

Methodology for 2022 has set the disease scope for the 2022

ority topics for corporate activity. In each area, the policies
and practices of pharmaceutical companies are measured bySince the last iteration of the Index (2021), its number

indicators that correspond to the core role they can play toof indicators has dropped from 33 to 31. Some have been

5 Ensure the usefulness of the Index’s findings and analyses
for governments, industry, investors, NGOs and other key

I NTE RNAL I N D ICATO R ANALYSES

stakeholders in improving access to medicine.

• Distribution analyses: Assessing the distribution of scores

The 2021 Methodology Review started with a series
Strict standards for developing indicators

EXPE RT REVI EW CO M M IT TE E

Index at 83 diseases, conditions and pathogens. All are inachieve both scale and sustainability.

vious period of analysis, and a review of developments inaccess-to-medicine theory and practice.

Foundation engaged with more than 100 experts and organstructure and sharper analytical capacity.

scope for all three Technical Areas.
Defining the disease scope

tor that a low level of incentive to invest in pharmaceuticalretains epilepsy, bipolar affective disorder and schizophrenia based on con-

R&D will limit the availability of suitable treatment options.

tinuing stakeholder consensus on the critical need for access to treatment. 3,4

Throughout each Methodology Review, strategic guidance is

responsible business practice and appropriate management

per indicator to check the spread of company behaviour inprovided by the Expert Review Committee (ERC), an inde-of access.

pendent body including experts from WHO, governments,a high global disease burden despite the existence of effective

such as data capture, comparison of companies or associatedtreatments, or because they affect poorer populations dispro-(where data is available) will specifically include diseases in

20 Neglected Tropical Diseases

portionately. To identify such diseases, the Foundation usedwhich more than 95% of the global DALY burden is in coun-

As previously, the 2022 Index includes all WHO-classified Neglected Tropicaltries in scope.

panies are fair (large clusters of low scores could indicate

the industry, non-governmental organisations (NGOs), aca-

Analytical focus for 2022

the industry’s role. All indicators for the 2022 Index are listeda screening protocol (see Figure xx). This is based on factors

demia and investors. The ERC met to review proposals for

The analytical framework for 2022 has a tight structure, withfrom page XX onwards.

such as: the prioritisation of the disease by organisations suchfor improvement. Outcomes inform refinements to indica-

the indicators of the 2022 Access to Medicine Index wastors and scoring guidelines.
• Response rate analyses: Assessing company response rates

assessing how far the world’s largest pharmaceutical com-analysis and the potential for companies to improve access.

and quality regarding each data request in the 2021 Index.

panies are meeting society’s expectations. The result is the

The Foundation uses strict standards for deciding when toThis confirms whether questions are clear and whether

methodology for the 2022 Access to Medicine Index.

merge or remove a metric. These include the consensus viewcompanies can feasibly gather data for each question.

on the relevance of the measured behaviour, and the clarity• Correlation analyses: Indicator-level assessments of score
correlations, which help diagnose less relevant indicatorsand degree of consensus regarding the industry’s role.

between related areas of company behaviour.

2021 Methodology Review for the 2022 Access to Medicine Index• Qualitative indicator review: A battery of qualitative assessAccess to
MedicineIndex 2021
26 January
Stakeholder engagement to confirm core role for pharma
JANUARY

2021

tions and role for companies, continuing relevance to access1

Governance of Access

KE Y CHAN G ES I N 2022

(WHO) for improving access to medicine; global and/or coun-exclusively affect women and girls (linked to biological sex).

10 Reproductive, Maternal and Newborn Health2

Research & Development• The Index will modify the weighting of its three Technicaltry-level disease burdens; and the relevance of pharmaceu-

According to a review of data from GBD 2019 and from theConditions

3

Product Delivery

before endorsing the final methodology.

For the 2022 Index, analytical criteria for each indicator haveExpert Review Committee for the 2022 Index

2021

Indicator and data checks

Amsterdam Series
What can we learn fromCOVID-19 to solve chronic issues
in access to health in LMICs?
16 JuneUniversity of Groningen

relate, for example, to the approaches of companies in simi-

U.S. Department of Health andlar country contexts and/or where external market incentives

Human Services(such as pooled procurement mechanisms) resemble each

Githinji Gitahi

Amref Health Africa

other. This change will enable the 2022 Index to make a more

Michela Gregory

Director, ESG Services at NEI

nuanced comparison of access approaches deployed by com-

Investments

panies in different markets and territories.

Fumie GriegoInternational Federation of
Pharmaceutical Manufacturers

Three Technical Areas& Associations

Stakeholders have confirmed three key areas (Technical
Areas) in which pharmaceutical companies have responsibility

Harvard Medical School andThese tests were used to detect and eliminate the risk of

Harvard Pilgrim Health Careand ability to influence access to medicine in low- and middle-

redundant measures, to pinpoint opportunities for enhancing

Institute

income countries (LMICs). The Technical Areas are divided

Areas, decreasing the weighting of Governance oftical intervention. The 2022 Index disease scope has been

Global Cancer Observatory (GLOBOCAN 2020)1,2, endometri-

To recognise the importance of reproductive, maternal and child health,Access to 15% (from 20%) and increasing Research andupdated according to the most recent Global Burden ofosis and ovarian and uterine cancer have comparably higher

the Index has since 2014 included contraceptives and nine Maternal andDevelopment to 30% (from 25%).
focus on indicators that measure outcomes, rather thanthose that measure policies and processes.
• The Index will include two new countries but maintains

Neonatal Health Conditions.1 Additionally the term Maternal and Neonatal

diseases. Including these in 2022 will increase the capacity of

Health conditions has been updated to Reproductive, Maternal and Newborn

the Index to assess the unmet needs of women and girls living

Health Conditions.

population. The WHO defines one DALY as “one lost year ofin LMICs with sex-linked diseases.
12 Priority Pathogens

tion’s ideal health situation, and the actual situation.

As in 2020, the Index covers the 12 pathogens included in the WHO’s
definitive priority pathogens list (2017). These are deemed a priority for
efforts to curb antimicrobial resistance through the development of new
and effective antibacterial agents.6 For tuberculosis, multidrug resistancesemia in its disease scope, based on stakeholder consensus

is a significant issue among patients, making it a critical priority forand the disproportionate burden of these diseases in coun-

pharmaceutical efforts. Because of this, the 2022 Index evaluates it not as

tries in scope.

a pathogen but as a communicable disease.

Alan Staple

The Clinton Health Access Initiative

into 14 priority topics. The Index weights each one according

at the process of technology transfer and put more empha-

University of KwaZulu-Natal

to its perceived importance in improving access to medicine.

sis on this area.

Footnotes on p.24
*At time of ERC meetings

11● Burden in countries in scope

The Access to Medicine Index measures the actions of phar-

1220

D E FI N I NG TH E G EOG R APH I C SCO PE

maceutical companies in places where there is an urgent need
100M

150M
200M
DALY (mn)for better access to medicine. Three criteria have been used

Step 1: Include all countries classified (according to World

to select countries for the 2022 Index (geographic scope): (1)Bank data) as low income or lower-middle income;countries’ level of income (gross national income (GNI) per
capita); (2) level of development, and; (3) scale and scope

Step 2: Include all countries defined (according to the UNDP’sof inequality. Assessments for each country were based on

Human Development Index) as having low or medium humandata from the World Bank, the United Nations Development

development;

Programme (UNDP) and the United Nations Economic andSocial Council (ECOSOC).

Step 3: Include all high-development countries with a highThe 2022 Index has a geographic scope that covers 108

inequality-adjusted HDI ratio (HiHDI) as defined by the UN

countries. Two new countries have been added for the 2022

Inequality-Adjusted Human Development Index (this enables

Index (Algeria and Venezuela). The rest have been in scope

the Index to track higher-income countries with significant

since 2018. With its two previous iterations covering the samelevels of inequality); and106 countries, the Index can draw on the benefits of consistency and capacity in tracking the progress of pharmaceutical

Step 4: Include all Least Developed Countries (LDCs) as

companies and their impacts in countries that face develop-

defined by ECOSOC.

ment and inequality-related constraints in access to medicine.
050M● Burden in rest of world

100M

150M
200M
DALY (mn)

FIGURE 7Countries included in the 2022 Access to Medicine Index – 108 Countries

Neglected tropical diseases, DALYs
Scabies and other ectoparasites
DengueSoil-transmitted helminthiasis
Foodborne trematodiases
Taeniasis/cysticercosis
Schistosomiasis
Lymphatic filariasis
Onchocerciasis
Leishmaniasis
RabiesTrachoma
Chagas disease
Echinococcosis
Human African trypanosomiasis
Leprosy
Dracunculiasis● Burden in countries in scope

02M
4M● Burden in rest of world

6M

8M
10M
DALY (mn)Maternal & neonatal health conditions, mortality

World Health Organization (WHO)INSEAD and Center for Global
Development

10

Ischaemic heart disease
StrokeCOPD
Diabetes mellitus
Migraine
Unipolar depressive disorders
Kidney diseases
Alzheimer's disease
Anxiety disorders
AsthmaHypertensive heart disease
Epilepsy
Schizophrenia
Bipolar affective disorder
Endometriosis
Sickle cell disorders
Thalassemia• In assessing supply chains, the Index will look more closely

Fatima Suleman
Klara Tisocki

incidence rates and/or DALY burdens than other sex-linked

data on disability-adjusted life years (DALYs). This measure is commonly used to measure the burden of disease in ahealthy life” to account for the gap between a given popula-longstanding consistency in its geographic scope. This
reflects the recent economic shifts and inequality issues
which can hinder access in such countries.
• The 2022 Index newly includes osteosarcoma and thalas-

data and to identify where scoring guidelines could be tight-

Prashant Yadav

Disease Study (GBD 2019), which also provides country-level• A shifting of weight between Technical Areas puts greater

ened. During the indicator review, topics were identified for
discussion during the next phase of stakeholder dialogue.

Expert Review
Comittee Meeting
23 Junebeen refined to ensure like-for-like comparison. This could

Hans Hogerzeil (Chair)
Emily Bleimund

to medicine, potential for longitudinal comparisons and the‘change-making’ potential of each indicator.
Dennis Ross-Degnan
SEPTEMBER

The 2022 Index also brings into scope three diseases thatIndex, making recommendations where the consensus view isments of each indicator including clarity of the expecta-

Methodology
for the2022 Index

Final methodology adjustments
following ERC endorsement

as Policy Cures Research and the World Health Organization

Diseases (NTDs).5 Five of these are especially prevalent in poorer regions(particularly rural areas) of low-income countries.

unclear or where uncertainty exists in areas of measurement,

and can reveal or confirm positive or negative relationships
FIGURE 2

31 indicators grouped into three Technical Areas:

the scope, structure and analytical approach of the 2022

In 2022, the Index retains its focus on these diseases andanalyses. In addition, indicators may have been merged or
removed in accordance with their relevance to access and/orthat expectations may be too high) and the extent of room

reviewed through quantitative and qualitative analyses fortionate incidences.2 Cancers in scope now include osteosarcoma, for which
treatments are included on the WHO’s Essential Medicines List. The Index

Some diseases are in scope of the Index because they impose

In 2021, the research team carried out a targeted review

robustness, response quality, the potential for longitudinal

includes thalassemia.1 It also includes cancer types with high or dispropor-

that mostly affect people in low- and middle-income countries (LMICs). The Index considers this to be a strong indica-refined, either to tailor a metric more closely to stakeholders’of the analytical framework, scopes and indicators. Each of

ate role for pharmaceutical companies in improving access to

Non-communicable diseases, DALYs

expectations of company behaviour, or to improve elements

approaches. This was followed by an external review to reaf-

medicine in low- and middle-income countries (LMICs). The● Burden in countries in scopeThis category includes the 10 Non-Communicable Diseases (NCDs) withimprove access. As previously, this role centres on the crea-

the 2021 Index. This indicates whether expectations of com-

0
50M
● Burden in rest of world

typhoidal salmonella).

the highest DALY burdens in countries in scope. For the first time, this list

Previous iterations of the Index have focused on diseases

Lower respiratory infections
Enteric disease*
HIV/AIDS
Malaria
Tuberculosis
Viral hepatitis (B and C)
Meningitis
Sexually transmitted infections (STIs)**
Measles
Pertussis
Tetanus18 Non-Communicable Diseases

tion and equitable delivery of health products while ensuring

firm the consensus view among stakeholders on the appropri-

resulting consensus was translated into a set of metrics forcoma) have been brought into scope for all Technical Areas.

data about disease burdens and incidence, together withindependent prioritisations, to pinpoint those for whichof alternative viewpoints and technical expertise. Topics wereprioritised through internal analyses of data and indicators,
independent reviews of the Index research during the pre-4 Preserve the capacity of the Index to track pharmaceutical

medicine. To define this priority list, the Foundation used

the identification and confirmation of best practices andmedicine. Consultations have been carried out with global
health technical experts, to take account of a diverse range

isations. This led to an analytical framework with a tightenedof internal checks on indicators, data sets and analyticalextensive dialogue between stakeholders. The result is a set

we can expect from pharmaceutical companies on access toaccess needs in LMICs, thus incentivising change;

Development Goals, informed by the impacts of the COVID19 pandemic and building on the extensive strategic review

unknown pathogen that could cause a serious international epidemic (asseen for COVID-19). The 2022 Index combines some prioritised diseases

31 indicators
The Index’s methodological framework for 2022 streamlines

3 Ensure all metrics are robust and can fairly compare aof the Index methodology carried out in 2019, when the

The full disease scope applies to all Technical Areas. COVID19 remains in scope and the Index will continue to track com-

With more than 10 years of methodological development,
the Index has evolved its framework and indicators through2 Enable the identification of best practice in all aspects of

For this latest review, the Foundation continued to lookahead to the 2030 deadline for achieving the Sustainable

The Access to Medicine Index assesses the actions of pharmaceutical companies in relation to the set of diseases, con-

TO M E D ICI N E I N D EX
The Foundation has built stakeholder consensus on whatin access to medicine, and are responsive to the emerging

emphasis is on defining ambitious, but achievable, actions forcompanies to take.

STAKE HO LD E R OUTRE ACH FO R TH E 2022 ACCESS

Ensure that the framework and indicator set clearly reflect
the core role for R&D-based pharmaceutical companies

Preterm labour and birth complications
Birth asphyxia and trauma
Other neontal conditions
Neonatal sepsis and infections
Maternal haemorrhage
Hypertensive disorders of pregnancy
Maternal sepsis
Abortion and miscarriage
Obstructed labour● Burden in countries in scope

0
200k
400k
● Burden in rest of world

Legend: Basis for inclusion*● World Bank income classification● UN Human Development Index● UN Inequality-Adjusted Human
Development Index● ECOSOC LDC List
● New inclusion*Classification at the time of the 2018 Access to Medicine
Index period of analysis. Updated country income anddevelopment classifications are available through theWorld Bank and UNDP data.
Due to scaling, countries may not be visible on the map(e.g., Tuvalu)

600k

800k
1M
21
DALY (mn)2455

Methodology for the 2022 Access to Medicine Index

EXECUTIVE SU M MARY

A vision for 2030: how this Index will shift
pharma company practiceThis report sets out the analytical framework for the next

lies. Millions more children have gone without timely vaccina-

Access to Medicine Index, the longest-running assessment oftions since the pandemic began. The shortages of medicines

pharmaceutical industry action to improve access to medi-caused by disruptions to supply chains also affect those living

cine. It builds on the previous Index methodology, which waswith non-communicable diseases, including diabetes andpublished in March 2020 when the world was waking up tocancer. These groups are especially dependent on receiving a

the threat of COVID-19.

steady supply of treatment.

Governments, philanthropic foundations and multi-lateralThe pandemic has also reduced access to medicine in moreagencies pivoted quickly to devote funding and resources toindirect ways. With the closure of health facilities and restric-

the pandemic. The private sector also responded vigorously,

tions on travel, many pregnant women have lost access to theramping up programmes to develop new vaccines, diagnostics

obstetric and/or neonatal treatments they may require. Thisand treatments, while working to minimise disruption to sup-puts them at grave risk, and jeopardises gains made over theply chains. The COVID-19 pandemic has provided a case study

past decade in maternal and infant mortality rates.

for the role played by the pharmaceutical industry in developing and delivering health products, and exposed the vast andcomplex network of supply chains and logistics that factories,
clinics and pharmacies depend upon.
The UN has called for a decade of action to achieve its
Sustainable Development Goals (SDGs) and universal healthcoverage (UHC) by 2030. The pandemic is demonstrating in real time how access to medicine can be achieved – orblocked. Even though vaccines now exist that could end the

FIG 1 Companies in scope of the 2022 Access to Medicine Index

pandemic, price, patents, and national stockpiling are among

Company NameCountry

Market cap 2020
(bn USD)the factors that influence which populations are served first.

AbbVie IncUSA

186,681Astellas Pharma Inc

JPN

31,067wake-up call for changing the way healthcare is delivered. Yet

AstraZeneca plc

GBR

135,160

there is a clear risk that the world could soon return to ‘busi-

Bayer AGDEU

63,404

ness as usual’ when it comes to delivering access to medicine.

Boehringer Ingelheim GmbH

DEU

n/a

Bristol Myers Squibb Co

USA

136,580

Fall-out continues from the pandemic

Daiichi Sankyo Co, Ltd

JPN

60,019Furthermore, the COVID-19 pandemic is not over; action

Eisai Co, Ltd

JPN

20,849is still required to curb this pandemic and prepare for the

Eli Lilly & CoUSA

195,068

future by building strong and responsive health systems. The

Gilead Sciences Inc

USA

80,940COVID-19 pandemic has triggered far-reaching consequences

GlaxoSmithKline plc

GBR

86,525for global health, disrupting a vast range of programmes

Johnson & Johnson

USA433,237

designed to increase access to medicine. Screening andMerck & Co, IncUSA

190,309

treatment for tuberculosis, malaria and HIV/AIDS have been

Merck KGaA

DEU73,652interrupted; so have programmes and activities that target

Novartis AG

CHE

201,943

neglected tropical diseases (NTDs) and sexual and reproduc-

Novo Nordisk A/S

DNK

172,363

tive health. Such disruptions can have a ripple effect on devel-

Pfizer Inc

USA

192,793

opment gains: for example, by putting women and girls at risk

Roche Holding AG

CHE

292,984of unwanted pregnancies and impacting their ability to attend

Sanofi

FRA

118,723school, join the workforce and help provide for their fami-

Takeda Pharmaceutical Co, Ltd

JPN

55,422The tough lessons from the pandemic should provide a6

Methodology for the 2022 Access to Medicine Index

A vision for 2030

What changes are we working to achieve?

To achieve the SDGs and UHC by 2030 despite the impact

To achieve the SDGs and UHC by 2030 despite the impact ofof COVID-19, the pharmaceutical industry must complete

COVID-19, the pharmaceutical industry must complete a shifta shift in how it addresses access to medicine. Namely, itin how it addresses access to medicine:must approach access to medicine systematically and at
scale, ensuring that healthcare products are delivered to theGovernance of Access by 2030

right people via initiatives tailored to local needs and health• Access-to-medicine is fully integrated into commercial

systems.
This has been confirmed in 2021 by the Access to Medicine
Foundation through its stakeholder dialogue, which it holds
every two years to verify the consensus view on pharma’s
core role in improving access to medicine. A key step in thestrategy, including oversight, incentives and accountability
from HQ to in-country operations.
• Results of access initiatives are monitored and sharedpublicly.
• Business is conducted in an ethical and responsible manner.

methodology review for the next Access to Medicine Index,
this latest dialogue builds on the extensive strategic review

Research & Development by 2030

carried out in 2019, when the Foundation engaged with more

• Pharmaceutical R&D responds to the needs of people inthan 100 experts and organisations. This led to an analyticalframework with a tightened structure and sharper analytical
capacity.
Each Access to Medicine Index assesses 20 of the world’s

low- and middle-income countries.
• Companies’ access plans for registration, supply andaffordability are systematically developed during R&D, fromat least Phase II of clinical development.

largest R&D-based pharmaceutical companies on theiractions to improve access to medicine for people living in the

Product Delivery by 2030

low- and middle-income countries measured by the Index,• Access is prioritised for products viewed as essen-which are home to more than 80% of all people alive today. It

tial to public health, particularly where there are few

examines companies on their policies and practices in strat-

manufacturers.

egy, compliance, R&D, pricing and product delivery. The 20
companies in scope account for more than half of global
pharmaceutical revenue. Considering their pipelines, portfolios, resources and global reach, these companies have aunique capacity to develop the health products that people in
LMICs need, and to improve the availability of these products
across socioeconomic divides.

• New products are quickly and widely registered in low-andmiddle-income countries.
• LMICs can rely on a steady and sufficient supply of quality
products.
• Payers and patients can afford the health products theyneed, including people at the base of the income pyramid.
• Alternative manufacturers are enabled to supply quality products, competing on price, to countries where patent-holding companies do not plan to supply directly.
• Health systems are supported through partnerships including local stakeholders and in line with local needs.

7Methodology for the 2022 Access to Medicine Index

How the Index drives change
As a tool to drive change, the Index identifies best practice,

The next Index will be published in 2022. It will cover:tracks progress and shows where critical action is needed to• 20 of the world’s largest pharmaceutical companies;

improve access to medicine. It evaluates companies in areas• 31 metrics covering the core role for pharma on access towhere they have the biggest potential and responsibility to

medicine in strategy, compliance, R&D, pricing and productmake change, and identifies what is working where and why,in order to provide blueprints to expand good practice. By
ranking companies every two years, it spurs them to compete and collaborate on priority access-to-medicine topics. It
shows which companies are leading the way, as better per-delivery;• 108 low- and middle-income countries (LMICs) where better access to medicine is most urgently needed; and• 83 diseases, conditions and pathogens that disproportionately impact people in LMICs.

formers rise in the ranking.

KE Y ANALY TI CAL TH E M ES FO R 2022
• Progress toward the SDGs and UHC. The methodology review introduced discrete refinements to the analytical framework while maintaining consistency with previous analytical approaches. Indicators have been modified
to ensure like-for-like comparisons are more precise. As aresult, the 2022 Index will continue to track progress, while

ANALYTICAL FRAMEWORK FOR THE 2022 ACCESS TO MEDICINE INDEX

making more sensitive comparisons of how pharmaceuticalcompanies use their access approaches in different markets
and territories around the world.

3 TECHNICAL AREAS

14 PRIORITY TOPICS

Indicators
per topic

Responsible business practices

4

Governance and strategy

3

Access planning

3

Product development

3

Building R&D capacity

1

Equitable access strategies

3Intellectual property strategy

3

Quality and supply

3

nies are putting in place to respond to urgent need, includ-

Licensing quality

2

ing through partnerships and/or by sharing technology with

Product donations

2

Registration

1

Inclusive business models

1

Local manufacturing

1

Health systems strengthening

1

A GOVERNANCE OF ACCESS 15%• Pandemic preparedness and response. The previous Index,
published in January 2021, found that most pathogens posing pandemic concerns were unaddressed by R&D. In 2022,

B RESEARCH & DEVELOPMENT 30%

the Index will assess whether this has changed, as part of abroader assessment of the industry’s level of pandemic preparedness. Importantly, it will also examine companies’ agility in ramping up manufacturing and deployment to make
COVID-19 products available to all countries, and particularly, assessing pricing and supply commitments, identifying best practices and exploring where and how the industry fell short.
• Continuous supply. Pharmaceutical companies are newly
conscious of how quickly demand for new products can

C PRODUCT DELIVERY 55%

surge. The 2022 Index will assess the measures compa-

smaller companies, generic medicine manufacturers andresearch institutes. It will also assess the measures companies took to ensure the supply of existing health products
and protect pre-existing access commitments.

8

Methodology for the 2022 Access to Medicine Index

The 2022 Access to
Medicine Index
Methodology 2021

The Access to Medicine Index is the product of a two-year
cycle known as the Index cycle, which starts with a reviewof the Index methodology. The aim of the review is to distill
global priorities regarding access to medicine and define howsociety expects pharmaceutical companies to contribute.
In this section:
REVI EWI NG TH E M ETHO DO LOGY
The 2022 Methodology Review started with a series of internal checks on indicators, data sets and analytical approaches.
This was followed by an external review to confirm the consensus view among stakeholders on where pharmaceuticalcompanies should take action in the coming decade.
STAKE HO LD E R CO NSE NSUS
To achieve the SDGs and UHC by 2030 despite the impact
of COVID-19, the pharmaceutical industry must complete ashift in how it addresses access to medicine. Namely, it must
approach access to medicine systematically and at scale,ensuring that healthcare products are delivered to the rightpeople via initiatives tailored to local needs and health systems. This has been confirmed in 2021 by the Access to
Medicine Foundation through its stakeholder dialogue, which
it holds every two years to verify the consensus view on pharma’s core role in improving access to medicine.
ANALY TICAL FR AM EWO RK
The 2022 Access to Medicine Index is based on a refined analytical framework of three Technical Areas, and 14 priority
topics for corporate activity.
The analytical framework comprises 31 indicators grouped
into three Technical Areas:
1. Governance of Access
2. Research & Development
3. Product Delivery

99

Methodology for the 2022 Access to Medicine Index

REVI EWI NG TH E M ETHODOLOGY

How the Index distills access-to-medicine
priorities for pharmaceutical companies

Each Access to Medicine Index is the result of a two-year pro-Primary principles

cess known as the ‘Index cycle’, which begins with a targeted

The primary principles of the 2021 Methodology Review:

review of the Index methodology. The aim is to distil global

1

Ensure that the framework and indicator set clearly reflect

priorities regarding access to medicine and to define how

the core role for R&D-based pharmaceutical companies

society expects pharmaceutical companies to contribute. The

in access to medicine, and are responsive to the emerging

emphasis is on defining ambitious, but achievable, actions forcompanies to take.

access needs in LMICs, thus incentivising change;
2 Enable the identification of best practice in all aspects of

For this latest review, the Foundation continued to lookahead to the 2030 deadline for achieving the Sustainable

access to medicine in order to facilitate broader uptake;
3 Ensure all metrics are robust and can fairly compare a

Development Goals, informed by the impacts of the COVID19 pandemic and building on the extensive strategic review

range of companies against each other;
4 Preserve the capacity of the Index to track pharmaceuticalof the Index methodology carried out in 2019, when thecompany activity on access to medicine over time; andFoundation engaged with more than 100 experts and organ-

5 Ensure the usefulness of the Index’s findings and analyses

isations. This led to an analytical framework with a tightenedfor governments, industry, investors, NGOs and other key

structure and sharper analytical capacity.

stakeholders in improving access to medicine.

The 2021 Methodology Review started with a series
of internal checks on indicators, data sets and analytical

Strict standards for developing indicators

approaches. This was followed by an external review to reaf-

In 2021, the research team carried out a targeted review

firm the consensus view among stakeholders on the appropri-of the analytical framework, scopes and indicators. Each of

ate role for pharmaceutical companies in improving access tothe indicators of the 2022 Access to Medicine Index was

medicine in low- and middle-income countries (LMICs). The

reviewed through quantitative and qualitative analyses forresulting consensus was translated into a set of metrics forrobustness, response quality, the potential for longitudinalassessing how far the world’s largest pharmaceutical com-analysis and the potential for companies to improve access.

panies are meeting society’s expectations. The result is the

The Foundation uses strict standards for deciding when tomethodology for the 2022 Access to Medicine Index.

merge or remove a metric. These include the consensus viewon the relevance of the measured behaviour, and the clarityand degree of consensus regarding the industry’s role.

FIGURE 22021 Methodology Review for the 2022 Access to Medicine Index
Access to
MedicineIndex 2021
26 January

Methodology
for the2022 Index

Stakeholder engagement to confirm core role for pharma

Final methodology adjustments
following ERC endorsement

JANUARY

2021

SEPTEMBER

2021

Indicator and data checks

Amsterdam Series
What can we learn fromCOVID-19 to solve chronic issues
in access to health in LMICs?
16 JuneExpert Review
Comittee Meeting
23 June*At time of ERC meetings

10Methodology for the 2022 Access to Medicine Index

STAKE HO LD E R OUTRE ACH FO R TH E 2022 ACCESSTO M E D ICI N E I N D EX
The Foundation has built stakeholder consensus on what
we can expect from pharmaceutical companies on accessto medicine. As in previous years, consultations have been
carried out with global health technical experts to ensure adiverse range of viewpoints and technical expertise are incorporated. This included global health donors, internationalorganisations, investors, low- and middle-income country
governments and regulators, NGOs, pharmaceutical industry organisations, product development partnerships (PDPs)
and research and academic institutions. The Foundation also
engaged with companies evaluated in the Index.
I NTE RNAL I N D I CATO R ANALYSES

EXPE RT REVI EW CO M M IT TE E

• Distribution analyses: Assessing the distribution of scores

Throughout each Methodology Review, strategic guidance isper indicator to check the spread of company behaviour inprovided by the Expert Review Committee (ERC), an inde-

the 2021 Index. This indicates whether expectations of com-pendent body including experts from WHO, governments,

panies are fair (large clusters of low scores could indicate

the industry, non-governmental organisations (NGOs), aca-that expectations may be too high) and the extent of room

demia and investors. The ERC met to review proposals forfor improvement. Outcomes inform refinements to indica-

the scope, structure and analytical approach of the 2022

tors and scoring guidelines.

Index, making recommendations where the consensus view is• Response rate analyses: Assessing company response rates
and quality regarding each data request in the 2021 Index.

unclear or where uncertainty exists in areas of measurement,
before endorsing the final methodology.

This confirms whether questions are clear and whether
companies can feasibly gather data for each question.
• Correlation analyses: Indicator-level assessments of score

Expert Review Committee for the 2022 Index
Hans Hogerzeil (Chair)

University of Groningencorrelations, which help diagnose less relevant indicators

Emily Bleimund

U.S. Department of Health andand can reveal or confirm positive or negative relationships

		

Human Services

between related areas of company behaviour.

Githinji Gitahi

Amref Health Africa

Michela Gregory

Director, ESG Services at NEI

ments of each indicator including clarity of the expecta-		

Investments

tions and role for companies, continuing relevance to accessFumie GriegoInternational Federation of

to medicine, potential for longitudinal comparisons and the		Pharmaceutical Manufacturers‘change-making’ potential of each indicator.

		& Associations

Martha Gyansa-Lutterodt

Ministry of Health, Ghana

These tests were used to detect and eliminate the risk ofDennis Ross-Degnan

Harvard Medical School andredundant measures, to pinpoint opportunities for enhancing

			Harvard Pilgrim Health Caredata and to identify where scoring guidelines could be tight-

			Instituteened. During the indicator review, topics were identified forAlan Staple

The Clinton Health Access Initiative

discussion during the next phase of stakeholder dialogue.

Fatima Suleman

University of KwaZulu-Natal

Klara Tisocki

World Health Organization (WHO)Prashant Yadav

INSEAD and Center for Global		Development• Qualitative indicator review: A battery of qualitative assess-11

Methodology for the 2022 Access to Medicine Index

ANALY TI CAL FR AM EWO RK

2022 Index to put greater focus on measuringoutcomes

With more than 10 years of methodological development,

31 indicators					the Index has evolved its framework and indicators throughThe Index’s methodological framework for 2022 streamlines

extensive dialogue between stakeholders. The result is a set

the identification and confirmation of best practices andof ambitious yet achievable expectations for the behaviour ofpractices that, over the past decade, have proven to bepharmaceutical companies in improving access to medicine.

successful, scalable and accepted by governments and other

The Methodology for the 2022 Index is based on a tight ana-

stakeholders. This streamlining reflects the global healthlytical framework of three Technical Areas, and on 14 pri-community’s emphasis on access programmes that canority topics for corporate activity. In each area, the policies

achieve both scale and sustainability.

and practices of pharmaceutical companies are measured bySince the last iteration of the Index (2021), its number

indicators that correspond to the core role they can play toof indicators has dropped from 33 to 31. Some have been

improve access. As previously, this role centres on the crea-

refined, either to tailor a metric more closely to stakeholders’tion and equitable delivery of health products while ensuring

expectations of company behaviour, or to improve elements

responsible business practice and appropriate management

such as data capture, comparison of companies or associatedof access.

analyses. In addition, indicators may have been merged or
removed in accordance with their relevance to access and/or

Analytical focus for 2022

the industry’s role. All indicators for the 2022 Index are listed

The analytical framework for 2022 has a tight structure, withfrom page 28 onwards.		

31 indicators grouped into three Technical Areas:
1

Governance of Access

KE Y CHAN G ES I N 2022

2

Research & Development• The Index will modify the weighting of its three Technical3

Product Delivery

Areas, decreasing the weighting of Governance of Access

For the 2022 Index, analytical criteria for each indicator haveto 15% (from 20%) and increasing Research & Development

been refined to ensure like-for-like comparison. This could

to 30% (from 25%).

relate, for example, to the approaches of companies in simi-• A shifting of weight between Technical Areas puts greaterlar country contexts and/or where external market incentives

focus on indicators that measure outcomes, rather than(such as pooled procurement mechanisms) resemble eachthose that measure policies and processes.

other. This change will enable the 2022 Index to make a more

• The Index will include two new countries but maintains

nuanced comparison of access approaches deployed by com-

longstanding consistency in its geographic scope. This

panies in different markets and territories.

reflects the recent economic shifts and inequality issues
which can hinder access in such countries.

Three Technical Areas• The 2022 Index newly includes osteosarcoma and thalas-

Stakeholders have confirmed three key areas (Technicalsemia in its disease scope, based on stakeholder consensus

Areas) in which pharmaceutical companies have responsibility

and the disproportionate burden of these diseases in coun-and ability to influence access to medicine in low- and middle-

tries in scope.

income countries (LMICs). The Technical Areas are divided• In assessing supply chains, the Index will look more closely

into 14 priority topics. The Index weights each one according

at the process of technology transfer and put more empha-

to its perceived importance in improving access to medicine.

sis on this area.

12Methodology for the 2022 Access to Medicine Index

FIGURE 3

Analytical Framework for the 2022 Access to Medicine Index

The 2022 Access to Medicine Index analyses company behaviour using a framework of 31 indicators organised in three Technical Areas. In line with previous Index methodology reviews, theemphasis
has increased
on R&D and FOR
productdeliverysuchpricing and INDEX
licensing.
ANALYTICALFRAMEWORKTHE
2022strategies
ACCESS
TOasMEDICINE

3 TECHNICAL AREAS
A GOVERNANCE OF ACCESS 15%

B RESEARCH & DEVELOPMENT 30%

C PRODUCT DELIVERY 55%

14 PRIORITY TOPICS

Indicators
per topic

Responsible business practices

4

Governance and strategy

3

Access planning

3

Product development

3

Building R&D capacity

1

Equitable access strategies

3Intellectual property strategy

3

Quality and supply

3

Licensing quality

2

Product donations

2

Registration

1

Inclusive business models

1

Local manufacturing

1

Health systems strengthening

1

13

Methodology for the 2022 Access to Medicine Index

GOVE RNANCE O F ACCESS			

15%

To improve access to medicine both tangibly and sustaina-

Changes in 2022

bly, pharmaceutical companies must implement clear access• The 2022 Index looks at access-related governance struc-strategies that focus on the long term. By enforcing rigor-

tures including monitoring and incentives for top-level staff.

ous standards of behaviour across their operations (including• It assesses whether a company’s strategies cover all thera-with third-party contractors), companies can mitigate the risk

peutic areas, which may yield a wider range of access initia-

of practices that cause harm and undermine their efforts toimprove access from occurring.

tives for consideration.
• It examines companies’ limit-setting policies around trans-

This Technical Area looks at how companies plan, govern

fers of value likely to influence the behaviour of health-and manage the achievement of their objectives for increas-care professionals (HCPs) in countries in scope (e.g., pay-ing access to medicine, and at how they apply processes toments to attend and/or speak at events, to continue

minimise the occurrence and risks of non-compliant and/or corrupt behaviour. It evaluates companies’ strategies for

medical education and other non-monetary benefits).
• It looks at how companies monitor risks around non-com-

access, considering whether these align with corporate strat-

pliance at the national level with laws and standards on eth-egies. It also looks at how companies measure and incentivise

ical marketing, anti-corruption and clinical trial governance.

progress towards their objectives for access.

PRIO RIT Y TO PI CS AN D EXPECTATIONS FOR CO M PANY B E HAVIOU R
Governance & strategy

Indicator(s)To ensure that they implement access strategies successfully, pharmaceutical companies must establish struc-

GA1, GA2, GA3tures for governance and management. By assigning responsibility and offering incentives at the highest level, companies can increase the likelihood of prioritising, maintaining and achieving access-related objectives. Companies
are expected to develop and implement a clear, long-term strategy to improve access to medicine. Such a strategy should not remain isolated from the main business of the company; it should seek to align with commercial concerns. Companies should share publicly their progress towards strategic goals. Considerations around access to
medicine should not be limited to a few areas but incorporated systematically into all R&D projects and all commercialisation/market-access strategies, specifically in relation to LMICs.

Responsible business practices
Corrupt behaviour and unethical marketing can have direct consequences for access to medicine, such as the misdi-

GA4, GA5, GA6, GA7

rection of national health budgets and promotion of the irrational use of medicines. Pharmaceutical companies canlimit misconduct by enforcing stringent compliance processes across their operations and with third parties, and bymodifying how they incentivise sales agents and disclosing publicly how they engage with healthcare professionals.
They can also implement policies to ensure they interact ethically with healthcare professionals, for example by setting limits on transfers of value (e.g., with fair market value assessments). The Index expects companies to have inplace controls to mitigate the risk of non-compliance for their operations in LMICs; these should include monitoring and auditing processes. Companies should also be able to regulate the activities of contracted third parties. To
assess the effectiveness of controls, the Index checks for negative rulings and/or settlements with regards to unethical marketing, corruption, anti-competitive behaviour (whether or not related to intellectual property) and clinical
trial misconduct in LMICs. In accordance with their public standing, companies are expected to have IP policies thatare conducive to the international consensus on public health.

For indicators and their full rationales, see p.28-29

14

Methodology for the 2022 Access to Medicine Index

RESE ARCH & D EVE LO PM E NT			

30%

Large research-based pharmaceutical companies play a

Changes in 2022

significant role not only in developing new medicines and• The Index will no longer use a standalone indicator toother life-saving products, but also in bringing them toassess how companies consider post-trial access to inves-

market. Advance planning is needed to make new prod-

tigational products. Instead, it will incorporate this assess-ucts rapidly available to people who need them, wherever

ment when considering R&D access planning as a whole.

they live. This Technical Area analyses in-house and collaborative R&D activity that aims to develop or adapt products for diseases, conditions and pathogens in scope of
the Index, and in response to the needs of people living inlow- and middle-income countries (LMICs). It also examines whether companies plan sufficiently during the development of their products to make sure those that are successful become swiftly accessible in LMICs.

PRIO RIT Y TO PI CS AN D EXPECTATIONS FOR CO M PANY B E HAVIOU R
Product development

Indicator(s)Pharmaceutical companies have the capacity and expertise to develop and adapt products to address unmet public

RD1a, RD1b, RD4

health needs in LMICs, where products are suitable for those populations. Companies can do this either in-houseor in partnership. The Index maps companies’ R&D activity against defined and published R&D priorities outlining
where new, effective products are needed urgently: for example, for pathogens flagged as a priority due to antimicrobial resistance, or for neglected tropical diseases. R&D priorities include ‘Disease X’, a term used by the WHO torefer to currently unknown pathogens that could cause a serious international epidemic or pandemic. Regarding diseases for which R&D priorities have not yet been independently assessed (such as non-communicable diseases), theIndex examines whether companies’ projects take account of particular needs of people living in LMICs. Companies
are also expected to disaggregate and disclose the resources they dedicate to such R&D.

Planning for access
Planning for access helps pharmaceutical companies to ensure they take account of public health needs duringRD2, RD3a, RD3b

product development. Such planning can help those in LMICs to gain access to products more rapidly and affordably
following their market entry. When companies establish a structured process to develop access plans, this can help
such planning become standard. Companies are expected to have in place plans for pipeline projects from (at least)
Phase II clinical trials. These plans need to prioritise access planning for R&D projects that target defined R&D priorities, or which demonstrate clear value for patients in LMICs.

Building R&D capacity
Pharmaceutical companies have the expertise and ability to support the development of skilled R&D sectors in

RD6

LMICs. Companies can engage in relevant activities, such as technology transfers, to build local R&D capacity andsupport the development of research skills. In turn, this can enable local researchers to address relevant healthneeds and priorities.

For indicators and their full rationales, see p.30-31

15

Methodology for the 2022 Access to Medicine Index

PRO DUCT D E LIVE RY			

55%

The choices pharmaceutical companies make in delivering

Changes in 2022

their products are a critical factor for countries striving to• The indicators and analytical approaches in this Technicalachieve universal health coverage.
As a first step, companies must register their products forsale where they are needed, so that these can be madeArea have been held largely constant, to facilitate trend
analysis.
• This Technical Area covers registration, pricing, IP strate-

swiftly available to populations in need. Companies can thengies, licensing, product donations, quality and supply, local

deploy three main access strategies considered to have theaspects of manufacturing and strengthening of health sys-

biggest potential for impact on the supply and affordability oftems. Combining these reflects a consensus view that these

medicine: equitable pricing, responsible IP (intellectual property) management and product donations.
This Technical Area assesses how companies design their

are interdependent aspects of product delivery.
• Three categories are used to assess how companies tailor access strategies to their products: (a) supranationallystrategies and tailor their tools to boost access. Further,procured products such as vaccines; (b) healthcare prac-

it captures how companies leverage their expertise andtitioner-administered products and; (c) self-administeredresources to address significant local barriers to access. Suchproducts.

barriers might include gaps in local healthcare infrastructure,• Indicator PP1: Access Strategies: Coverage will no longer

poorly functioning supply chains, weak quality assurance sys-

be assessed by the Index, as it was not feasible to system-

tems and/or lack of skills.

atically estimate the number of patients reached and makefair comparisons between different products used for different indications.

PRIO RIT Y TO PI CS AN D EXPECTATIONS FOR CO M PANY B E HAVIOU R
Registration

Indicator(s)Registration is a key first step for products to become available to populations in need. The Index continues to lookPR1

at how widely pharmaceutical companies file to register their newest products in countries in scope and make themavailable for patients’ use in these countries. Companies are expected to prioritise registration in countries with highdisease burden, and to aim for registration in LMICs within 12 months of first registration with either the EMA, FDA
or JPMDA.

Equitable access strategies
Equitable access means no one is left behind, with everyone in LMICs – including those at the base of the income pyr-PP3, PP4, PP5

amid – enabled to benefit from products. Companies are expected to apply access strategies to key products acrossLMICs, maximising the availability of these products to those with less income. Such strategies include pricing, non-exclusive licensing, product donations and technology transfer. When setting pricing strategies, companies are expected
to aim for affordability, and to integrate into their pricing approach a payer’s ability to pay for the product.

Intellectual property (IP) strategy
Responsible, transparent management of intellectual property can stimulate research and development (R&D) by

PPL1, PPL2, PPL3

third-party researchers. Companies that choose not to develop their IP assets further can license these out to external researchers on access-oriented terms. For LMICs, responsible IP management can also facilitate the affordable supply of medicines and other health products by supporting the entry of generic pharmaceutical manufacturers into new markets and the decision-making of international procurers. Companies are expected to publish patentstatuses and implement patent filing/enforcement policies to mitigate the risk that patent protections will limit R&D
and product availability and affordability.

Licensing quality
Non-exclusive voluntary licensing supports the market entry of alternative manufacturers of patented products, in

PPL4, PPL5

turn supporting more secure supply and enhancing affordability through stimulation of competition. Pharmaceuticalcompanies are expected to engage in quality non-exclusive licensing (acting to quickly license newly registered products,
or those still in development, on terms that promote access) and to ensure they disclose these agreements publicly.

For indicators and their full rationales, see p.32-37

16

Methodology for the 2022 Access to Medicine Index

PRO DUCT D E LIVE RY			

55%

Product donations

Indicator(s)Product donations continue to play an important role in eliminating, eradicating and/or controlling some diseases

PP2a, PP2bthat affect populations living in LMICs. For people living in poverty, donations may represent the only chance to get
access to the treatment they need. Pharmaceutical companies supplying such products are expected to publicly
commit to staying engaged until elimination, eradication and control goals are reached, and to expanding coverageof programmes where these can facilitate goal achievement. Companies also need to be able to respond rapidly toemergencies by making ad hoc product donations.

Inclusive business models
To achieve universal health coverage, people in the lowest income brackets must also gain access to medicine.

PBM1

Inclusive business models are an important way to extend market-based access strategies to populations with limited ability to pay (people on the lower tiers of the income pyramid). Successful outcomes are more likely for inclusive business models which address capacity constraints, and for those with a long-term vision and goals, financial
commitments and clear objectives.

Quality and supply
Inefficiencies and weaknesses in supply chains (whether in procurement processes, delivery logistics, storage or at

PQ1, PQ2, PCB2

other stages) can have a huge impact on the accessibility, availability and quality of medicines. To identify bottlenecks and improve capacity for good supply chain management into LMICs, pharmaceutical companies are expected
to engage with relevant local partners. Substandard and falsified (SF) medicines represent a significant threat to
public health. To mitigate this, companies are expected to report SF cases to national authorities and/or WHO Rapid
Alert in a timely manner.

Local manufacturing
Making medicines locally can help to reduce costs and improve supply, but quality must be guaranteed. When phar-

PCB1

maceutical companies work with third-party manufacturers in LMICs, they can take steps to ensure local staff havethe skills and technology necessary to meet the requirements of good manufacturing practices (GMP). By engaging
more widely with other manufacturers and organisations such as universities, companies can bring broader value interms of quality manufacturing to build local capacity beyond that needed for their own products and portfolios.

Health system strengthening
Robust health systems must be in place for products to be deployed, prescribed and administered safely and effec-

PCB3

tively. Such systems may include infrastructure, trained health professionals, diagnostic capacity, data management andthe means to reduce stigma. For pharmaceutical companies these activities are not a central responsibility, but companies have both the expertise and the capacity to help strengthen local health systems. Initiatives need to be carried out
with appropriate partners (aligning with local needs) and must manage conflicts of interest and monitor outcomes.

For indicators and their full rationales, see p.32-37

17

Methodology for the 2022 Access to Medicine Index

What the Index
measures

The Access to Medicine Index assesses pharmaceutical company policies and behaviour regarding specific diseases andproduct types across a specific geographic scope. The following pages set out the rationale for these analytical scopes andhow they have been defined.
In this section:
CO M PANY SCO PE
20 companies• Selected based on a combination of market capitalisation and relevance of pipeline and portfolio for access to
medicine
D ISE ASE SCO PE
83 diseases, conditions and pathogens• 23 Communicable Diseases• 18 Non-Communicable Diseases• 20 Neglected Tropical Diseases• 10 Maternal & Neonatal Health Conditions• 12 Priority Pathogens
G EOG R APH IC SCO PE
108 low- and middle-income countries
PRO DUCT T YPE SCO PE
Medicines, microbicides, preventive vaccines, therapeutic vaccines, vector control products, platform technologies, diagnostics, contraceptive methods and devices

18 18

Methodology for the 2022 Access to Medicine Index

WHAT WE M E ASU RE

Company Scope

The Access to Medicine Index assesses 20 of the world’s

The largest R&D-based companies were identified throughlargest R&D-based pharmaceutical companies on their poli-a company market capitalisation and revenue analysis,cies and practices to improve access to medicine for people

which also took mergers, acquisitions and divestments into

living in low- and middle-income countries. Considering

account. Their pipelines and portfolios were then mapped

their pipelines, portfolios, resources and global reach, theseagainst diseases in the scope of the Index and the R&D needs

companies have clear opportunities and a responsibility toof people living in countries in scope. Companies that quali-

address access.

fied for analysis based on size could be disqualified for having

Companies are selected based on their market capitali-

fewer relevant products and R&D projects than companies

sation and revenue, and the relevance of their product port-of similar size. Companies that exclusively produce generic

folios and pipelines for the diseases and countries covered

medicines are not eligible for inclusion as they have a dis-by the Index. Following a review of these criteria, the 2022

tinctly different role to play in improving access to medicine.

Index will evaluate the same 20 companies as in 2022, facilitating trend analysis.

FIGURE 4

Companies in scope of the 2022 Access to Medicine Index

Company Name

Stock Exchange

Revenue,

Market2020 (bncap** (bn

USD)*

USD)***Country

Ticker186,681
31,067

AbbVie Inc

New York

USA

AbbVie Inc 45,804
ABBV

Astellas Pharma Inc

Tokyo

JPN

Astellas Pharma
4503
11,338Inc

AstraZeneca plc

London

GBR

plc
AZNAstraZeneca
26,617135,160

Bayer AG

Xetra Germany

DEU

Bayer AG 50,849
BAYN

63,404

Boehringer Ingelheim GmbH

n/a

DEU

Ingelheim GmbHn/a Boehringer24,032
n/aBristol Myers Squibb Co

New York

USA

Squibb Co 136,580
BMYBristol Myers
42,518

Daiichi Sankyo Co, Ltd

Tokyo

JPN

Daiichi Sankyo
Co, Ltd
4568
8,734

60,019Eisai Co, Ltd

Tokyo

JPN

Eisai Co, Ltd
4523
5,861

20,849

Eli Lilly & Co

New YorkUSA

LLY Eli Lilly & Co
24,540

195,068

Gilead Sciences Inc

NASDAQUSAInc
GILDGilead Sciences
24,64280,940GlaxoSmithKline plc

London

GBR

plc
GSKGlaxoSmithKline
46,29786,525

Johnson & Johnson

New York

USA

JohnsonJNJJohnson &82,584

433,237

Merck & Co, Inc

New York

USA

Inc
MRKMerck & Co,
47,994

190,309

Merck KGaA

Xetra Germany

DEU

MRKMerck KGaA
21,53673,652

Novartis AG

Swiss Exchange

CHE

Novartis AG
NOVN48,659201,943

Novo Nordisk A/S

Copenhagen

DNK

Novo
A/S
NOVO
B Nordisk
20,955

172,363

Pfizer Inc

New York

USA

PFEPfizer Inc 41,908

192,793

Roche Holding AG

Swiss Exchange

CHE

AG
ROGRoche Holding
66,049292,984
118,723

SanofiEuronext Paris

FRA

SANSanofi

Takeda Pharmaceutical Co, Ltd

Tokyo

JPN

Takeda Pharmaceutical
Co,55,422
Ltd
4502
29,016* Exchange rates on 31 December 2020, from oanda.com. For Yen, exchange rate is as of 31 March 2021.
** Market cap on 18 February 2021, from Bloomberg terminal*** Exchange rates on 18 February 2021, from oanda.com

44,267

0

100

200

● Market cap 2020
● Revenue 2020

300

400

500
bn USD

19

Methodology for the 2022 Access to Medicine Index

WHAT WE M E ASU RE

Disease Scope

The Access to Medicine Index assesses the actions of phar-

The full disease scope applies to all Technical Areas. COVID-

maceutical companies in relation to the set of diseases, con-19 remains in scope and the Index will continue to track com-ditions and pathogens confirmed by the Expert Review

pany activity in this area during the period of analysis. For theCommittee as critical priorities for improving access to2022 Index, two new diseases (thalassemia and osteosar-

medicine. To define this priority list, the Foundation usedcoma) have been brought into scope for all Technical Areas.

data about disease burdens and incidence, together withThe Index will follow products emerging from the pipeline

independent prioritisations, to pinpoint those for which(after market approval) and include them in its analyses ofgreater access to medicine is needed most. A review of theaccess strategies.

Methodology for 2022 has set the disease scope for the 2022
Index at 83 diseases, conditions and pathogens. All are inPrevious iterations of the Index have focused on diseases

scope for all three Technical Areas.

that mostly affect people in low- and middle-income countries (LMICs). The Index considers this to be a strong indica-

Defining the disease scope

tor that a low level of incentive to invest in pharmaceuticalSome diseases are in scope of the Index because they impose

R&D will limit the availability of suitable treatment options.

a high global disease burden despite the existence of effective

In 2022, the Index retains its focus on these diseases andtreatments, or because they affect poorer populations dispro-(where data is available) will specifically include diseases in

portionately. To identify such diseases, the Foundation usedwhich more than 95% of the global DALY burden is in coun-a screening protocol (see Table 1). This is based on factors

tries in scope.1

such as: the prioritisation of the disease by organisations suchas Policy Cures Research and the World Health Organization

Three diseases that exclusively affect women and girls(WHO) for improving access to medicine; global and/or coun-(linked to biological sex) remain in scope for the 2022 Index.

try-level disease burdens; and the relevance of pharmaceu-

According to a review of data from GBD 2019 and from thetical intervention. The 2022 Index disease scope has been

Global Cancer Observatory (GLOBOCAN 2020),1,2 endometri-

updated according to the most recent Global Burden ofosis and ovarian and uterine cancer have comparably higher

Disease Study (GBD 2019)1, which also provides country-level

incidence rates and/or DALY burdens than other sex-linked

data on disability-adjusted life years (DALYs). This meas-diseases. Their inclusion in the disease scope increases theure is commonly used to measure the burden of disease in acapacity of the Index to assess the unmet needs of women

population. The WHO defines one DALY as “one lost year ofand girls living in LMICs with sex-linked diseases.

healthy life” to account for the gap between a given population’s ideal health situation, and the actual situation.

20

Methodology for the 2022 Access to Medicine Index

D ISE ASE SCO PE

FIGURE 5

Low- and middle-income countries shoulder the bulk of
disease burdens

These four charts give an indication of how the diseases and conditions in
scope disproportionately affect people living in low- and middle-income
countries. Behind these numbers are millions of people who cannot rely on
access to affordable, quality medicine.
Communicable diseases, DALYs

23 Communicable Diseases
This category includes the 10 Communicable Diseases (CDs) with the highest DALY burdens in countries in scope¹, as well as diseases for which product gaps have been identified as priority R&D targets, such as emergent
non-polio enteroviruses and ‘Disease X’, a WHO term to denote a currently
unknown pathogen that could cause a serious international epidemic (asseen for COVID-19). The 2022 Index combines some prioritised diseases
that were previously separate under a single term (e.g., “enteric infections”
now includes diarrhoeal diseases, typhoid and paratyphoid, and invasive non-Lower respiratory infections
Enteric disease*
HIV/AIDS
Malaria
Tuberculosis
Viral hepatitis (B and C)
Meningitis
Sexually transmitted infections (STIs)**
Measles
Pertussis
Tetanus050● Burden in rest of world

typhoidal salmonella).

● Burden in countries in scope

18 Non-Communicable Diseases

Non-communicable diseases, DALYs

This category includes the 10 Non-Communicable Diseases (NCDs) withthe highest DALY burdens in countries in scope. For the first time, this list
includes thalassemia.1 It also includes cancer types with high or disproportionate incidences.2 Cancers in scope now include osteosarcoma, for which
treatments are included on the WHO’s Essential Medicines List. The Index
retains epilepsy, bipolar affective disorder and schizophrenia based on continuing stakeholder consensus on the critical need for access to treatment. 3,4

20 Neglected Tropical Diseases
As previously, the 2022 Index includes all WHO-classified Neglected Tropical
Diseases (NTDs).5 Five of these are especially prevalent in poorer regions(particularly rural areas) of low-income countries.

10 Reproductive, Maternal and Newborn HealthIschaemic heart disease
StrokeCOPD
Diabetes mellitus
Migraine
Unipolar depressive disorders
Kidney diseases
Alzheimer's disease
Anxiety disorders
AsthmaHypertensive heart disease
Epilepsy
Schizophrenia
Bipolar affective disorder
Endometriosis
Sickle cell disorders
Thalassemia● Burden in countries in scope

050● Burden in rest of world

100

150
200
DALY (mn)

100

150
200
DALY (mn)Conditions
To recognise the importance of reproductive, maternal and child health,the Index has since 2014 included contraceptives and nine Maternal andNeonatal Health Conditions. Additionally the term Maternal and Neonatal
Health conditions has been updated to Reproductive, Maternal and Newborn
Health Conditions.

12 Priority Pathogens
As in 2020, the Index covers the 12 pathogens included in the WHO’s
definitive priority pathogens list (2017). These are deemed a priority for
efforts to curb antimicrobial resistance through the development of new
and effective antibacterial agents.6 For tuberculosis, multidrug resistanceis a significant issue among patients, making it a critical priority forpharmaceutical efforts. Because of this, the 2022 Index evaluates it not asa pathogen but as a communicable disease.

Neglected tropical diseases, DALYs
Scabies and other ectoparasites
DengueSoil-transmitted helminthiasis
Foodborne trematodiases
Taeniasis/cysticercosis
Schistosomiasis
Lymphatic filariasis
Onchocerciasis
Leishmaniasis
RabiesTrachoma
Chagas disease
Echinococcosis
Human African trypanosomiasis
Leprosy
Dracunculiasis● Burden in countries in scope0
1
2● Burden in rest of world

3

4
5
DALY (mn)Maternal & neonatal health conditions, mortality
Preterm labour and birth complications
Birth asphyxia and trauma
Other neontal conditions
Neonatal sepsis and infections
Maternal haemorrhage
Hypertensive disorders of pregnancy
Maternal sepsis
Abortion and miscarriage
Obstructed labour● Burden in countries in scope
Footnotes on p.24

0
200
400
600
800
● Burden in rest of world Mortality (1000s)

21

Methodology for the 2022 Access to Medicine Index
FIGURE 6

Defining the disease scope - screening protocol

The Access to Medicine Index analyses company practice in relation to adefined set of diseases, conditions and pathogens. These are identified aspriorities for improving access to medicine using the protocol shown here.

Which diseases qualify for inclusion?
Is the disease or condition suitablefor pharmaceutical intervention?

no

Disease excluded

yes
Is the disease classified as a
yes
Neglected Tropical Disease by WHO?

Disease includedno
Was the disease previously included in yes
WHO GHO data as a maternal orneonatal health condition?*noIs the disease a cancer type?

Disease included
Cancer inclusion criteria
The cancer types included in the 2020 Access to

yesMedicine Index remain in scope as well as any newcancer types that belong to:
1 The ten cancer types with the highest global inci-noComparing DALY burdens in countries
in scope, is the disease one of the tencommunicable diseases or ten
non-communicable diseases with theyeshighest burden?

dence rates.
2 The ten cancer types with the highest incidence incountries in scope.

Disease includednoIs the disease one for which countries
in scope carry a disproportionately
high (≥95%) proportion of the global
yes
DALY burden?

3 The five cancer types with the highest percentage ofglobal incidence in countries in scope”

Disease includednoIs the disease an R&D priority
identified in at least one of six key
R&D priority lists?**

yes

Disease included

noDisease excluded
Exceptions: Bipolar affective disorder, epilepsy, hypertensive heart disease, schizophrenia and alzheimer’s disease were in scope for the 2021
Index and have been retained due to, e.g., the continuing need for better
access to treatment. Endometriosis and ovarian and uterine cancer havealso been retained to reflect a greater focus on sex-linked barriers to access.
Furthermore osteosarcoma has been included as it is the most common primary malignant bone tumor in children and young adults ( ref 1.)* As listed in the WHO methods and data sources for global burden of disease estimates 2000-2019** R&D priority lists: Policy Cures Research G-FINDER neglected disease,
emerging infectious diseases and reproductive health areas; WHO R&D
Blueprint; WHO Initiative for Vaccine Research; WHO priority pathogen list.
		

22

Methodology for the 2022 Access to Medicine Index
TABLE 1

List of diseases, conditions and pathogens included in the 2022 Access to Medicine Index
Rationale for inclusion

R&D priority*
●

●

●

●

●

●

●

●

Bunyaviral diseases●

Dengue and Chikungunya

Coronaviral diseases●

Dracunculiasis●

Echinococcosis●●●

Disease X***●

Emergent non-polio
enteroviruses●

Filoviral diseases●

Henipaviral diseases
HIV/AIDS●●●

Leptospirosis
Lower respiratory infections●

Malaria●●

Measles●●

Meningitis●●

Pertussis●●

Rheumatic fever
Sexually transmitted infections(STIs)†●

Tetanus●●

Viral hepatitis (B and C)●

Yellow fever

Diabetes mellitus●

Endometriosis

●

●

●

●
●

●

●

●

Schistosomiasis

●

●

●

Snakebite envenoming

●

●

●

Soil-transmitted helminthiasis

●

●

●

●

●
●

Taeniasis/cysticercosis●

Trachoma

●

●

Yaws

●

●

Reproductive, Maternal and Newborn Health Conditions●

Birth asphyxia and birth trauma●

Contraceptive methods●●

Epilepsy●

Scabies and other ectoparasites●●●

Lymphatic filariasis●●

Chronic obstructive pulmonary
disease (COPD)●●

Bipolar disorder
Cancer‡

●

●

●
●

●

Leprosy●

Alzheimer’s disease
Asthma●●Non-Communicable Diseases●●●

Rabies●Anxiety disorders●

Leishmaniasis

Onchocerciasis

●

Zika

●

●

●
●

●

Human African Trypanosomiasis●●

Tuberculosis

●

●

●
●

●

Food-borne trematodiases

Mycetoma, chromoblastomycosis
and other deep mycoses●

Stakeholder consensus**

WHO-identified NTD or MNH
condition●

Chagas disease●

Diphtheria≥95% disease burden in countries in scope

Buruli ulcer

Neglected Tropical Diseases

Arenaviral haemorrhagic fevers(Lassa fever)Enteric diseases

Top ten DALY burden in countries in scope

Stakeholder consensus**

R&D priority*

WHO-identified NTD or MNH
condition≥95% disease burden in countries in scope

Top 10 DALY burden in countries
in scope

Communicable Diseases

Rationale for inclusion

●
●

●
●

Hypertensive disorders ofpregnancy●●

Abortion and miscarriage§●●

Maternal haemorrhage●●

Maternal sepsis●●

Neonatal sepsis and infections●●

Obstructed labour●●

Other neonatal conditions●●

Preterm birth complications

●

●

●

Priority pathogens||●

Acinetobacter baumannii (carbapenem-resistant)●Campylobacter spp. (fluoroquinolone-resistant)Hypertensive heart disease●

Ischaemic heart disease●

Enterobacteriaceae (carbapenem-resistant, 3rd generation

Kidney diseases●

cephalosporin-resistant)Migraine●

Enterococcus faecium (vancomycin-resistant)

Schizophrenia
Thalassemia●

Sickle cell disease●●

Haemophilus influenzae (ampicillin-resistant)●

Helicobacter pylori (clarithromycin-resistant)
Neisseria gonorrhoeae (3rd generation cephalosporin-resistant,

Stroke●fluoroquinolone-resistant)

Unipolar depressive disorders●

Pseudomonas aeruginosa (carbapenem-resistant)
Salmonella spp. (fluoroquinolone-resistant)
Shigella spp. (fluoroquinolone-resistant)

Green text = newly in scope for the 2022 Index

Staphylococcus aureus (methicillin-resistant, vancomycin-inter-

Exclusions: none in 2021

Streptococcus pneumoniae (penicillin-non-susceptible)* Diseases, conditions and pathogens
indicated as R&D priorities on identified lists published by Policy Cures
Research and WHO.
** These diseases have been retained or
added due to specific access barriers,
amongst other reasons, as identified instakeholder engagement.

mediate and vancomycin-resistant)*** Disease X is defined by WHO as apathogen currently unknown to cause
human disease that could cause a serious international epidemic.
† Excludes HIV/AIDS.
‡ Includes 18 cancer types. See Cancer
Inclusion Appendix for more details.

§ Listed as ‘Abortion’ in previous Indices.
|| Collectively, these will be referred toas communicable diseases in the 2021
Access to Medicine Index as ‘Other
prioritised antibacterial-resistantinfections’.

23

Methodology for the 2022 Access to Medicine Index

WHAT WE M E ASU RE

Geographic Scope

The Access to Medicine Index measures the actions of phar-

D E FI N I NG TH E G EOG R APH I C SCO PE

maceutical companies in places where there is an urgent needfor better access to medicine. Three criteria have been used

Step 1: Include all countries classified (according to World

to select countries for the 2022 Index (geographic scope): (1)Bank data) as low income or lower-middle income;7countries’ level of income (gross national income (GNI) per
capita); (2) level of development, and; (3) scale and scope

Step 2: Include all countries defined (according to the UNDP’sof inequality. Assessments for each country were based on

Human Development Index) as having low or medium humandata from the World Bank, the United Nations Development

development;8Programme (UNDP) and the United Nations Economic andSocial Council (ECOSOC).
The 2022 Index has a geographic scope that covers 108

Step 3: Include all high-development countries with a highinequality-adjusted HDI ratio (HiHDI) as defined by the UN

countries. Two new countries have been added for the 2022

Inequality-Adjusted Human Development Index8 (this enables

Index (Algeria and Venezuela). The rest have been in scope

the Index to track higher-income countries with significant

since 2018. With its two previous iterations covering the samelevels of inequality); and106 countries, the Index can draw on the benefits of consistency and capacity in tracking the progress of pharmaceutical

Step 4: Include all Least Developed Countries (LDCs) as

companies and their impacts in countries that face develop-

defined by ECOSOC.9

ment and inequality-related constraints in access to medicine.

FIGURE 7Countries included in the 2022 Access to Medicine Index – 108 Countries

Legend: Basis for inclusion*● World Bank income classification● UN Human Development Index● UN Inequality-Adjusted Human
Development Index● ECOSOC LDC List
● New inclusion*T he latest country income and developmentclassifications are available through the World Bank and
UNDP data.
Due to scaling, countries may not be visible on the map(e.g., Tuvalu)

24

Methodology for the 2022 Access to Medicine Index

TABLE 2

List of countries included in the 2022 Access to Medicine Index – 108 countries*

East Asia & PacificMiddle East & North Africa

Malawi

LIC

Cambodia

LMIC

Algeria

LMIC

Mali

LIC

China

HiHDI

Djibouti

LMIC

Mauritania

LMIC

Indonesia

LMIC

Egypt, Arab Rep.

LMIC

Mozambique

LIC

Kiribati

LMIC

Iran

HiHDI

Namibia

MHDC

Korea, Dem. People’s Rep.

LIC

Iraq

MHDC

Niger

LIC

Lao PDR

LMIC

MoroccoLMIC

Nigeria

LMIC

Micronesia, Fed. Sts.

LMIC

Palestine, State of/

RwandaLIC

Mongolia

LMIC

West Bank Gaza

LMICSão Tomé and Principe

LMIC

Myanmar

LMIC

Syrian Arab Republic

LMIC

Senegal

LIC

Papua New Guinea

LMIC

Tunisia

LMIC

Sierra Leone

LIC

Philippines

LMIC

Yemen, Rep.

LMIC

Somalia

LIC

Samoa

LMIC

South Africa

MHDC

Solomon Islands

LMIC

South Asia

South Sudan

LIC

Thailand

HiHDI

Afghanistan

LIC

Sudan

LMIC

Timor-Leste

LMIC

Bangladesh

LMIC

Swaziland/Eswatini

LMIC

Tonga

LMIC

BhutanLMIC

Tanzania

LIC

Tuvalu

LDC

India

LMIC

Togo

LIC

Vanuatu

LMIC

Maldives

HiHDI

UgandaLIC

Vietnam

LMIC

Nepal

LIC

ZambiaLMIC

Pakistan

LMIC

Zimbabwe

LIC

Sri Lanka

LMIC

Europe & Central Asia
Armenia

LMIC

KosovoLMIC

Sub-Saharan Africa

Kyrgyz Republic

LMIC

Angola

LHDC

Moldova

LMIC

Benin

LIC

LIC		

Low income country

Tajikistan

LMIC

Botswana

MHDC

		World Bank income classifications

Turkmenistan

MHDC

Burkina Faso

LIC

LMIC

Lower-middle income country

UkraineLMIC

BurundiLIC

		World Bank income classifications

Uzbekistan

LMIC

Cabo Verde

LMIC

LDC

Least Developed Country

CameroonLMIC		ECOSOC LDC List

Central African Republic

LIC

LHDC

Low Human Development Country

Latin America & Caribbean
Belize

HiHDI

Chad

LIC

		

UN Human Development Index

Bolivia

LMIC

Comoros

LIC

MHDC

Medium Human Development Country

BrazilHiHDICongo, Dem. Rep.

LIC

		

UN Human Development Index

Colombia

HiHDI

Congo, Rep.

LMIC

HiHDI

High Human Development Country

Dominican Republic

HiHDI

Côte d’Ivoire

LMIC

		

with high inequality

Ecuador

HiHDI

Equatorial Guinea

MHDC

		

UN Inequality-Adjusted Human

El Salvador

LMIC

Eritrea

LIC

		Development Index

Guatemala

LMIC

Ethiopia

LIC

Guyana

MHDC

Gabon

MHDC

Haiti

LIC

Gambia, The

LIC

Honduras

LMIC

Ghana

LMIC

MexicoHiHDI

GuineaLIC

Nicaragua

LMIC

Guinea-Bissau

LIC

Paraguay

MHDC

Kenya

LMIC

Peru

HiHDI

Lesotho

LMIC

Suriname

HiHDI

Liberia

LIC

Venezuela

HiHDI

Madagascar

LIC* These include 106 countries assessed in the 2021
Access to Medicine Index, with two new countries
in scope, that are Algeria and Venezuela. The latest
country income and development classifications areavailable through the World Bank and UNDP data.

25

Methodology for the 2022 Access to Medicine Index

WHAT WE M E ASU RE

Product Type Scope

To capture the wide-ranging product types available to sup-Vector Control Products

port the prevention, diagnosis and treatment of relevant condi-

These include pesticides, biological control compounds andtions and diseases in countries covered by the Index, this scope

vaccines targeting animal reservoirs. Only chemical pesticides

is deliberately broad. In 2022, as in four previous iterations,

intended for global public health use and which specifically aim

the Index continues to include the same eight product types in

to inhibit and kill vectors that transmit diseases relevant to thescope, as described below.

Index are included. Likewise, only biological control interventions that specifically aim to kill or control vectors associatedMedicines

with transmitting Index-relevant diseases are included. Only vet-

All innovative and adaptive medicines, branded generics anderinary vaccines specifically designed to prevent animal-to-hu-

generic medicines used to directly treat the target pathogen

man transmission of diseases covered by the Index are included.

or disease process, regardless of formulation, are included.
Medicines used only for symptomatic relief are not included.

Contraceptive Methods & Devices
This covers instruments, apparatuses, appliances, implants andMicrobicides

other similar or related articles intended to be used to control

These include topical microbicides specifically intended to pre-contraception (e.g., condoms or diaphragms). It also includes

vent HIV.

combination products that deliver medicines (e.g., hormone-delivery contraceptive rings).

Therapeutic Vaccines
This covers vaccines intended to treat infection.

Platform Technologies
Only products that are specifically directed at meeting thePreventive Vaccines
This covers vaccines intended to prevent infection.

needs of people living in the countries covered by the Index are
included. These comprise, for example, general diagnostic platforms, adjuvants, immunomodulators and delivery technologies

Diagnostics

and devices. Implants and platform technologies for reproduc-This covers diagnostic tests designed for use in resource-limited

tive health are also included in this category.

settings (i.e., designed to be cheaper, faster, more reliable, easier
to use in the field).

Platform technologies that have utility for accelerating thedevelopment of health products for ‘Disease X’, a term used by
WHO to refer to currently unknown pathogens that could cause
a serious international epidemic, are also included. These platform technologies have led to the rapid development of potential COVID-19 vaccine candidates.

26

Methodology for the 2022 Access to Medicine Index

How the Index
measures

The 2022 Access to Medicine Index assesses company behaviour using an analytical framework of 31 indicators organised in three Technical Areas. The following pages set out
what each Technical Area measures and the rationale for eachindicator.
In this section:
I N D ICATO RS• Indicators per Technical Area
• Changes since 2021
• Indicator rationale

27 27

Methodology for the 2022 Access to Medicine Index

I N D I CATO RSAGOVE RNANCE O F ACCESS			

15%

2022
Indicator

Change since 2021 (new/code

2022 Indicatorretained/ modified)

GA1

Governance structures and incentives

Retained

The company has a governance system that includes

No change

Indicator rationale

Assigning responsibility for access to medicine indirect board-level responsibility and accountability forlow- and middle- income countries at the high-its access-to-medicine initiatives. To facilitate effective

est level of a company increases the chance that

implementation of the strategy, senior management

access-related objectives are given attention,(that is, CEO and/or senior executives) and in-country

remain on track and are achieved. Access-related

operational managers have access-to-medicine objec-

objectives and incentives encourage the CEO,tives and incentives to reward the effective delivery ofsenior management and in-country/regional man-initiatives that improve access to medicine in countries

agers to perform towards achieving access goals.

and for diseases within the Index scope.
GA2

Access-to-medicine strategy

Retained

The company has an access-to-medicine strategy and

The indicator covers how

An access-to-medicine strategy integrated in thedemonstrates that it is integrated within its corporate

the company applies

overall corporate strategy indicates that a com-

strategy. Well-integrated strategies extend across the‘access thinking’ across its

pany considers access to medicine in LMICs to becompany’s portfolio and pipeline, for diseases within

products and therapeu-

relevant for its long-term growth, creating more

Index scope.

tic areas.

sustainability for access to medicine. The strategy
should cover all products in the company’s portfolio
and all projects, particularly those deemed to be ofsignificant public health importance.

GA3

Public disclosure of access-to-medicine outcomes

Retained

The company has time-bound, measurable goals The

No change

Public reporting of such information informs exter-

company has time-bound, measurable goals and objec-

nal stakeholders about companies’ activities andtives for access to medicine. It publicly shares progress

progress, and facilitates accountability.

toward such goals and objectives (outcomes*).
* Results achieved by a company’s access-related activities.
These can be short-term (such as an increased proportion ofpeople with more knowledge about diseases, symptoms ortreatments) and/or medium- to long-term (such as number ofpatients retained in care; number of patients diagnosed after
community awareness and linkage to care programmes; and/or
availability of medicines at outlets). Outcomes can also relate toa country’s health system (such as the number of healthcare professionals trained).

GA4

Responsible promotional practices

Retained

The company incentivises responsible sales practices

Decoupling sales agents’ financial rewards from the(for example, by taking steps to decouple bonuses forvolume of medicine they sell removes the incen-

sales agents* from sales volume targets only). Further,

tive to oversell. This is not only important to stem

it has a policy limiting transfers of value** to health-

the rise of antimicrobial resistance, but also to pre-care professionals (HCPs) in countries in Index scopevent scarce resources being diverted from healthor volunteers to publicly disclose information about

budgets.

such transfers in countries in scope. The company also
follows local disclosure requirements and has a clear

Public disclosure of transfers of value provides(public) policy to ensure ethical interactions with suchaccountability regarding interactions between com-HCPs.

panies and healthcare professionals. Such disclosure can, for example, help to curb inappropri-*Including sales representative employees and third parties.

ate incentives that can lead to irrational prescrib-**Transfers could include payments for attending and/or speak-ing. Research shows that HCPs report often using

ing at events, continuing medical education, promotional activi-

promotion as a source of information about new

ties, or other non-monetary benefits directed at HCPs.

drugs. It is important to foster responsible promotional practices to ensure appropriate and quality
access to medicine.

28

Methodology for the 2022 Access to Medicine Index

GA5

Compliance controls

Retained

The company demonstrates it has controls* (such as

The indicator assesses

Corruption can detract from access to medicine,internal controls, risk-based country audits and formal

those compliance controls

so it is essential for companies to implement com-

processes applying to third parties) to mitigate the risk

which correspond to thepliance controls to reduce this risk. Such controlsof non-compliance in its operations in LMICs; for exam-

specific needs of LMICs.

aim to prevent non-compliant activities, whichple, in areas such as ethical marketing, anti-corruption

can negatively affect access by undermining con-and clinical trials.

fidence in the pharmaceutical sector, diverting
scarce resources from health budgets, impacting* The Index looks for compliance controls such as the follow-

prices and limiting the availability of medicines in

ing: fraud-specific risk assessment; auditing and review mecha-

the public sector.

nisms; live/continuous monitoring system for compliance; country risk-based assessments; and processes to ensure third party
compliance.

GA6

Incidence of breaches

Retained

The company has not been found to be the subject of

No change

Breaches of codes/regulations/laws can undermine

negative legal rulings or settled cases for unethical mar-confidence in the pharmaceutical sector, divert

keting practices/corrupt practices/anti-competitive

scarce resources from health budgets, impact

practices/misconduct in clinical trials in countries within

prices and limit the availability of medicines in thescope of the Index during the past two years.

public sector. Such civil, criminal and regulatory
infractions provide information about the qualityof a company’s compliance systems and responses
to unethical or illegal behaviour. These cases taketime to prosecute and settle, and therefore, though
they might be historical in nature, they may reachsettlement during the Index’s period of analysis.

GA7

Policies related to competition

Modified

There is evidence the company employs an intellec-

IP-related anti-compet-

Where a company applies an IP strategy whichtual property (IP) strategy conducive to creating accessitive behaviour* will bedoes not operate in accordance with the inter-to medicine. This is in accordance with the rights ofassessed alongside a com-national consensus on IP standards (through, fornational governments to deploy IP systems flexibly, aspany’s publicly disclosed

example, exerting pressure on governments not todefined by the international framework on IP (i.e., thestance on the international incorporate TRIPS flexibilities within national legis-

Doha Declaration on the TRIPS Agreement and Public

framework on IP. The

lation), there can be a knock-on negative impact for

Health).

Index no longer assesses

access to medicine in those countries. The Index

whether companies havelooks for an absence of such incidents over two

a policy to dissent fromyears.

industry association positions on IP.
* For example, patenting products in Least Developed
Countries, challenging patent
waivers, adopting evergreening practices, lobbying against
the usage of TRIPS flexibilities
by governments of countries inIndex scope (including throughindustry trade associations),
and lobbying for strengtheningof IP standards beyond TRIPS
in countries in Index scope.

29

Methodology for the 2022 Access to Medicine Index

I N D I CATO RS
B

RESE ARCH & D EVE LO PM E NT			

30%

2022
Indicator

Change since 2021 (new/code

2022 Indicatorretained/ modified)

RD1a

R&D pipeline: Prioritised diseases

Retained

The company engages in the development of products

No change

Indicator rationale

Large research-based companies have the capacitythat target priority product gaps identified by global

through R&D to help address public health needs

health research organisations.* This includes innova-

in low- and middle-income countries (LMICs) fortive and adaptive R&D and in-house and collaborative

identified priorities. They are well positioned to

R&D.

ensure that these products progress through thepipeline, even if there is little commercial incentive.

*Currently, the Index categorises R&D priorities using lists fromthe WHO and Policy Cures Research.

RD1b

R&D pipeline: Other diseases

Retained

The company engages in the development of prod-

No change

Where the global health community has not for-ucts that clearly address a public health need in LMICs

mally identified gaps that should be prioritised

beyond the R&D priorities identified by global health(there is no priority list for NCDs, for example),research organisations.* This includes innovative andcompanies can consider independently the devel-

adaptive R&D that, for example, addresses heat stabil-

opment of innovative and adaptive products. These

ity issues or ease of administration, or targets popula-should clearly address a public health need intions for which further studies/specific formulations

LMICs based on considerations including heat sta-

are needed (such as for children, pregnant/lactating

bility, use in special populations (such as among

women, etc).

children and pregnant women) and the participation of patients from these countries in clinical trials.

*Currently, the Index categorises R&D priorities using lists fromthe WHO and Policy Cures Research.

RD2

Planning for access: Framework

Retained

The company ensures it plans equitable access for all

No change

By establishing a structured framework andproducts it develops successfully (both in-house andapproach to develop access plans for all productcollaboratively) for people in LMICs, and demonstrates

candidates (both in-house and collaborative R&D),

a systematic approach to access for all R&D projects,

a company increases the likelihood of developing

which is applied from Phase II study onward.

long-term access plans as early in the process as
possible.

RD3aPlanning for access: Project-specific plans for priori-

Retained

tised diseases
The company ensures that all R&D projects for diseases No change

Advance access planning is particularly critical forprioritised by the WHO and Policy Cures Research are

R&D projects developed to address key productsupported by detailed commitments and strategies

gaps relevant to patients in LMICs. Companies canto improve access to products in countries within theensure these products quickly reach the people

scope of the Index.

who need them by planning for access during
clinical development (starting from Phase II). To
strengthen the potential for impacts on publichealth, the company’s access plans should go
beyond addressing registration to consider affordability and aspects such as supply.

30

Methodology for the 2022 Access to Medicine Index

RD3b

Planning for access: Project-specific plans for other

Retaindiseases
The company ensures that its R&D projects that

No change

To ensure successful products can be made avail-address a public health need in LMICs beyond the R&D

able swiftly and widely, R&D projects that target

priorities identified by WHO and Policy Cures Researchhigh-burden diseases in LMICs and address theare supported by detailed plans to improve access toneeds of their populations require solid advance

products in countries within the scope of the Index.

access planning. Companies can ensure theseproducts are quick to reach the people who needthem by planning for access during clinical development (starting from Phase II). To strengthen thepotential for impacts on public health, the company’s access plans should go beyond addressing registration to consider affordability and aspects suchas supply.

RD4

Disclosure of resources dedicated to R&D

RetainThe company publicly discloses the resources dedi-

No change

Public disclosure of R&D investments can be usedcated to its R&D activities conducted in-house and/to identify and prioritise areas of limited financial

or in collaboration for diseases within the scope of theinvestment for which a greater level of investment

Index and suitable for countries relevant to the Index.

from public and private sectors may be needed.
Such disclosure can contribute to build understanding about levels of investment needed tobring to market particular types of products fromdifferent therapeutic areas.

RD5

Clinical trial conduct: Post-trial access

DeletedThe company publicly commits to ensuring equita-

This indicator has been

Commitment to this principle helps ensure thatble post-trial access to investigative treatments tested

deleted: registration andaccess to investigational products can con-in countries within the scope of the Index for treat-affordability commitments

tinue once the trial has ended (post-trial access)ment-eligible clinical trial participants living in thesefollowing clinical trials arefor trial participants and for the general popula-countries.

captured in indicators RD2tion in which the trial was held. Public disclosure

and RD3a/b.

of this commitment enables accountability andunderstanding of a company’s intended approach.
Stakeholders agree that post-trial access is oneof the key responsibilities of companies related toclinical trials, and they increasingly call for consideration of access in ways that extend beyond registration commitments.

RD6

Capacity building in R&D

Retained

The company increases local capacity for healthNo change

For the development of medicines that can treat

research (including clinical trial capacity) and productlocal diseases, meet local needs, and correspond todevelopment by undertaking R&D capacity-building ini-disease patterns in countries in scope, it is impor-tiatives in partnership with local universities and publictant to support local R&D. Companies need to be

sector research organisations that meet standards of

incentivised to take action for building local R&D

good practice* in countries in Index scope.

capacity that goes beyond their own interests/
portfolio. They have expertise in R&D that they can*Such practice addresses local needs, priorities and/or skills

share locally.

gaps; is carried out in partnership with a local university or publicresearch institution; has good governance structures in place forthe partnership; supports or aligns its initiative goals with institutional goals; measures outcomes; and works toward long-term
aims/sustainability.

31

Methodology for the 2022 Access to Medicine Index

I N D I CATO RSC

PRO DUCT D E LIVE RY			

55%

2022
Indicator

Change since 2021 (new/code

2022 Indicatorretained/ modified)

PR1

Registration

Retained

Indicator rationale

The company files to register its most recently launched

Filing to register new products rapidly in low-

products that target diseases in scope of the Index

and middle-income countries is a critical step tobroadly, while taking the countries with the highest dis-enable more widespread access in those coun-ease burdens into account.

tries. Recently launched products should ideally be
filed for registration in countries in need within 12
months of the first global filing.

PP2aAccess strategies: Ad hoc donations

Retained

The company has public policies and supply processes

Donation programmes are a route to access toin place to ensure ad hoc donations* are carried out rap-

medicine for the poorest populations. When dona-

idly in response to expressed need.

tions are made ad hoc in humanitarian situations(e.g., conflict, natural disasters, etc.), they should bemade rapidly in response to expressed need.

*A gift of products for which there is no clear, defined long-term
strategy to control, eliminate or eradicate a disease. This may
include a company donating a range of medicines based on explicit
needs of a country. Donations made during emergency situations,such as conflicts and natural disasters, are also included here.

PP2b

Access strategies: Long-term donation programmes

Retained

The company engages in long-term, sustainable productDonation programmes can be a route to access todonation programmes whose goals of elimination, erad-

medicine for the poorest populations. They play

ication and control are possible and realistic. It publicly

a special role where there is very limited ability tocommits to the achievement of such goals.

pay and where a commitment is made to stay in the
programme until elimination, eradication and control goals are achieved. Public disclosure of such acommitment is an important indicator of this will toremain active until goals are achieved.

32

Methodology for the 2022 Access to Medicine Index

PP3Supranationally procured products:

Retained

Access strategies
The company applies access strategies to its suprana-

For relevant products, this indicator evaluates

tionally procured products* and extends those strate-

whether or not companies engage with mar-gies not only to countries graduating from these pro-ket-shaping and/or pooled procurement organisa-

curement agreements, but also to countries and popu-

tions such as UNICEF, Gavi, and the Global Fund.

lations which do not qualify for them.

Importantly, it also assesses the extent to which
companies consider comparative access to prod-*Products for which international pooled procurement, advanceucts for countries which do not qualify for suchmarket commitments, market-shaping facilities and significant

support.

public funding and donor support exist. These products include
vaccines and products indicated for the treatment of HIV, tuberculosis, malaria and neglected tropical diseases. Companies which do
not market these products will not have this indicator applied.

PP4

Healthcare practitioner-administered products: Access Retained
strategies
The company takes into consideration the ability ofCompanies have an important role of supportinga country’s reimbursement authority to pay and thegovernments in achieving universal health cover-demographic* characteristics of a country, in order toage by improving the reach of products across thedetermine the ability to pay of different segments ofincome pyramid.

the country’s population, aiming to increase reach fortheir healthcare practitioner-administered products**

Companies should carefully determine ability toacross the income pyramid.

pay, taking into account socioeconomic factors
which may determine different payers’ abilities.

This is evidenced by:

Products which need the oversight of a healthcare(a) an approach which demonstrates how pricing strat-

practitioner for administration are likely to be moreegies incorporate factors which determine payer’s abil-complex and require more sophisticated health

ity to pay for different segments of the population (e.g.,systems for administration and ongoing care.

patients paying out of pocket) and how non-pricing ini-Companies may therefore choose to also partner

tiatives (i.e., patient assistance programmes, donations,with public sector organisations to boost healthvoluntary licensing) complement those pricing strate-

system strength.

gies to maximise reach, and(b) evidence of how the approach has increased theCompanies can choose to use a mix of strate-patient number since the product was introduced, andgies to maximise reach of their access approach:(c) plans to increase patient numbers for the follow-

intra-country segmentation, licensing and dona-

ing X years.

tions.

* The characteristics of a population such as age, sex, income level,

Successful strategies should be evidenced by aneducation level, employment, etc.

increase in patient numbers both to date and pro-**Products that often require either hospital administration of thejected into the future.

product or the attention of a skilled healthcare professional duringadministration. Companies which do not market these products
will not have this indicator applied to them.

33

Methodology for the 2022 Access to Medicine Index

2022
Indicator

Change since 2021(new/code

2022 Indicatorretained/ modified)

PP5

Self-administered products: Access strategies

Retained

Indicator rationale

The company takes into consideration the ability ofCompanies have an important role of supportinga country’s reimbursement authority to pay and thegovernments in achieving universal health cover-demographic* characteristics of a country, in order toage by improving the reach of products across thedetermine the ability to pay of different segments ofincome pyramid.

the country’s population, aiming to increase reach fortheir self-administered products** across the income

Companies should carefully determine ability to

pyramid.

pay, taking into account socioeconomic factors
which may determine different payers’ abilities.

This is evidenced by:(a) an approach which demonstrates how pricing strat-

Companies can choose to use a mix of strate-egies incorporate factors which determine payer’s abil-gies to maximise reach of their access approach:ity to pay for different segments of the population (e.g.,

intra-country segmentation, licensing and dona-patients paying out of pocket) and how non-pricing ini-tions.

tiatives (i.e., patient assistance programmes, donations,
voluntary licensing) complement those pricing strate-

Successful strategies should be evidenced by angies to maximise reach, andincrease in patient numbers both to date and pro-(b) evidence of how the approach has increased thejected into the future.

patient number since the product was introduced, and(c) plans to increase patient numbers for the following X years.
* The characteristics of a population such as age, sex, income level,
education level, employment, etc.
**Self-administered products are defined as those products which
are easier to administer by the individual patient, and that are notnecessarily prioritised by governments or by the global healthcommunity (typically treatments for other non-communicable diseases, such as diabetes, stroke, hypertension and heart disease).
Companies who do not market these products will not have thisindicator applied.

PPL1

PPL2

Patent filing & enforcement

Retained

The company publicly commits to not filing for (orClarity about where patents are to be filed or will

enforcing) patents relating to diseases in scope in

be enforced gives greater certainty to international

least developed countries, low-income countries anddrug procurers and generic medicine manufactur-in a subset of lower-middle income countries anders when planning the manufacture and/or supply

upper-middle income countries.

of generic products.

Patent status disclosure

Retained

The company publicly discloses the patent status of its

Transparency is part of the social contract that

products for diseases relevant to the Index, in countries

underlies the patent system. When transparency is

within the Index scope.

standard, this supports procurement agencies tomake important decisions about which products
to supply. Companies should deploy a transparent approach for all relevant therapeutic areas andproduct types.

PPL3

IP sharing

Retained

The company provides evidence of sharing its intellec-

When a company shares its intellectual property

tual capital (such as molecule libraries, patented com-on terms conducive to increasing access, this canpounds, processes and technologies) with researchaccelerate research and development efforts andinstitutions and neglected disease drug discovery ini-

help to make new products available to popula-tiatives (such as WIPO Re:Search, Conserved Domains

tions in need in LMICs. Such potential for access is

Database and Open Source Drug Discovery) which are

optimised when companies share their more valua-developing products for diseases and countries in scope

ble assets, such as those more likely to accelerate aof the Index.

product/s onto the market.

34

Methodology for the 2022 Access to Medicine Index

PPL4

Licensing: Access-oriented terms

Retained

The company agrees access-oriented, transparent,

Access-oriented terms provide generic medicine

non-exclusive voluntary licences which include clauses

manufacturers with additional flexibility (in manu-

that facilitate the affordability and supply of quality

facturing and/or distribution processes, for exam-

products.

ple) supporting them to optimise affordability andsupply.

PPL5

Licensing: Geographic scope

Retained

The company includes a broad range of countries within

Including more countries in a licence will increase

the geographic scope of its licences, including mid-

the potential for that licence to make an impact on

dle-income countries outside of sub-Saharan Africa

public health. Often, the terms of voluntary licenceswith high burdens of disease

exclude entire populations of middle-income countries. To increase access to medicine and potential
benefits for public health, voluntary licences should
include those populations with proven need.

PQ1

Ensuring continuous supply

Modified

The company has mechanisms in place to improveThis indicator has been

Ensuring continuous supply and preventing the

supply chain efficiency and takes informed action tomade to better capturerisk of stock-outs means patients who need essen-

ensure uninterrupted supply and to make products

actions taken by compa-

tial medicines can continue to access high-quality

available in sufficient quantities in a timely manner. Such nies to ensure unintermechanisms and actions are as follows:

products.

rupted supply.

(a) The company has a system in place and works with
relevant stakeholders (e.g. Government agencies, distributors, hospitals, warehouses, wholesalers or otherrelevant networks) to inform on issues that may affectthe supply chain.
​(b) The company manages a buffer stock of relevant
products and works with several API suppliers in place
and/or produces in-house APIs to prevent shortages. ​​(c) The company works to enhance local supply capacities and strengthen supply chains.*​​(d) The company transfers technology to regional manufacturers to improve manufacturing capacity andavailability.* ​*Analysis is based on submission in PCB1 and PCB2.

35

Methodology for the 2022 Access to Medicine Index

PQ2

Reporting substandard and falsified (SF) medicines

Retained

The company has a policy/procedure for reporting con-

From a public health point of view, reporting to therelevant authority confirmed cases of SF medicines

firmed cases of substandard and falsified (SF) med-in a timely manner is important, as it allows author-

icines in countries in scope to relevant stakeholders

ities to quickly withdraw these from the market. SF(national regulatory authorities and WHO Rapid Alert)*

medicines cause harm and death. Pharmaceuticalin a timely manner.** This prioritises the minimisation ofcompanies have a responsibility to mitigate the riskharm to public health.

of harm by sharing information with health authori-.

ties as rapidly as possible.

*Reporting to local regulatory authorities should take place regardless of whether local regulations require it. Reporting to WHO
Rapid Alert is encouraged in all cases, particularly when local regulatory systems are weak and/or compromised.
**The company provides evidence of a policy or approach toreport confirmed cases of SF medicines as soon as possible andwithin 10 working days to local regulatory authorities and WHO
Rapid Alert, when visual inspection (confirmation of mislabeling,
confirmation of fake packaging) is sufficient to establish that product packaging is falsified. In cases where laboratory analysis isrequired for confirmation, the policy should require reporting ofcases as soon as possible (and within 10 working days, once confirmation has taken place) to local regulatory authorities (and WHO
Rapid Alert)

PCB1

Capacity building in manufacturing

Retained

The company undertakes manufacturing capacity build-

Companies have a role in supporting local manufac-

ing initiatives with local manufacturers aimed at achiev-

ture outside of their own plants, contributing to theing international Good Manufacturing Practice (GMP).

quality manufacture of other products locally. Local

These initiatives meet good practice standards* in

manufacturing can bring medicines more quickly tocountries within the scope of the Index.

low- and middle-income country markets and simplify supply chains.

*Addresses local needs, priorities and/or skills gaps; builds capacityof third-party or unaffiliated manufacturers, or works with external
parties; guided by clear, measurable goals or objectives; measuresoutcomes; has long term aims/aims for sustainability

PCB2

Capacity building in supply chain management

Retained

The company undertakes supply chain capacity build-

An inefficient supply chain can significantly impact

ing initiatives in countries within the scope of the Index

access to medicine. It can increase the risk ofin partnership with local stakeholders (e.g., ministries of

low quality, counterfeit medicines and stockouts.

health and public procurement, logistics and distribu-

Companies have a role in supporting strong, resil-tion agencies) that meet good practice standards* withient supply chains which also benefit products

the aim of improving the affordability, accessibility andbeyond their own portfolios.

quality of products, including products outside of its
own portfolio.
*Addresses local needs, priorities and/or skills gaps; is carried out
in partnership with relevant stakeholders; is guided by clear, measurable goals or objectives; measures outcomes; has long term
aims/aims for sustainability

36

Methodology for the 2022 Access to Medicine Index

PCB3

Health system strengthening

Retained

Where no conflicts of interest exist, the company inWhile health systems are the primary responsibility

partnership with local stakeholders undertakes healthof governments, companies can provide support.

system strengthening initiatives that meet good prac-

Well-functioning health systems promote better

tice standards* in countries in scope of the Index. Such

diagnosis, pharmacovigilance, disease surveillance

initiatives work in a coordinated way with other parties,

and overall treatment. They are critical for sustain-

complementing the local health system, with outcomesable access to medicine.

clearly monitored.
*Addresses local needs, priorities and/or skills gaps; is carried out
in partnership with relevant stakeholders; has good governancestructures in place; has processes in place to mitigate or prevent
conflict of interest; is guided by clear, measurable goals or objectives; measures outcomes; publicly discloses outcomes; has longterm aims/achieves integration within the system

PBM1

Inclusive business models

Retained

The company develops and implements scalable inclu-

The Index covers models

Inclusive business models aim to identify accesssive business models with long-term horizons that aim

which address accessconstraints and remedy market inefficiencies within

to meet the access needs of populations at the baseissues for the lowest

LMICs. They can create opportunities for businessof the pyramid* and/or of vulnerable populations** inincome tiers of popula-and populations at the base of the income pyra-countries in scope of the Index.

tions (which may include

mid. These models need a long-term horizon withother vulnerable popula-

the ultimate aim of being adopted by a country’s

tions); are implemented

people who live on USD $1-5 per day.

national health system. Such models also provide
in-country, within the Index value in targeting vulnerable populations who may
scope; are done in partner- not receive adequate attention from health sys-

*Sometimes referred to as the bottom level of the income pyramid or ‘working poor’, a term that designates roughly four billion**Vulnerable populations can include (but are not limited to) chil-

ship (with support of local

dren, girls and women, LGBTQI+ people, people living with HIV andactors); present benefits

people living with mental health conditions.

for business and patientstems.

alike; demonstrate evidence of financial sustainability; (plan to) measureoutcomes.

37

Methodology for the 2022 Access to Medicine Index

Appendices
I

Contributors to this report

IIA Diseases in scope for the 2021 Access to Medicine
Index
IIB Cancers in scope for the 2021 Access to
Medicine Index
III

The good practice standards framework for		
capacity buildingIV

R&D priorities

V

Ensuring the Index methodology is sensitive togender and sex

VIDefinitions

VII References

38 38

Methodology for the 2022 Access to Medicine Index

APPE N D IX I

CO NTRI BUTO RS TO TH IS RE PO RT

Throughout the 2021 Methodology Review, many contribu-

Medicine Index with multiple viewpoints. Other stakeholder

tors have supported the Index Research Team. Strategic guid-groups and individuals who are part of the Index engagement

ance was provided by the Expert Review Committee (ERC), a

streams (companies, investors, and governments) have notpanel of independent experts from the WHO, governments,

been named, but have engaged through different ways. The

the industry, NGOs, academia and investors, among oth-Access to Medicine Foundation engaged with all 20 compa-

ers. Recommendations on specific topics of the Index were

nies evaluated in the 2021 Index, and companies’ staff fromprovided by a wide range of specialists in different aspects

across their organisations provided feedback. We grate-of access to medicine. Experts from a variety of organisa-

fully acknowledge all contributions. The following individuals

tions (academic, non-governmental, multilateral) supported

agreed for their names to be publicly acknowledged:

the development of the Methodology for the 2022 Access to

EXPE RT REVI EW CO M M IT TE E
Hans Hogerzeil – Chair

University of Groningen

Martha Gyansa-Lutterodt

Ministry of Health, Ghana

Emily Bleimund

U.S. Department of Health and Human Services

Dennis Ross-Degnan

Harvard Medical School and Harvard Pilgrim

			(HHS) Office of Global Affairs			

Health Care Institute

Githinji Gitahi

Amref Health Africa

Alan Staple		

The Clinton Health Access Initiative (CHAI)

Michela Gregory

Director, ESG Services at NEI Investments

Fatima Suleman

University of KwaZulu-Natal

Fumie GriegoInternational Federation of Pharmaceutical

Klara Tisocki		World Health Organization (WHO)			Manufacturers & Associations (IFPMA)

Prashant Yadav

INSEAD and Center for Global Development

Janet Byaruhanga

NEPAD

Ken Shadlen		

London School of Economics

Nick Chapman

Policy Cures Research

Rob Terry		WHO

Laurent Fraisse

Drugs for Neglected Diseases initiative (DNDi)

Taryn Vian		

University of San Francisco

Greg S. Garrett

Drugs for Neglected Diseases initiative (DNDi)

Veronika Wirtz

Boston University School of Public Health

Katy M. Graef

BIO Ventures for Global Health (BVGH)

Shalini Jayasekar Zürn

Union for International Cancer Control (UICC)

Metin Gülmezoglu

The Concept Foundation

Sonali Johnson

Union for International Cancer Control (UICC)

Fabienne Jouberton

MSF

Jillian Kohler		

University of Toronto, WHO Collaborating			Centre for Governance, Transparency and			Accountability in the Pharmaceutical Sector

Amina Maillard

Medicines Patent Pool

Rohit Malpani

Independent consultant

Serge Oga		

University Félix Houphouët-Boigny of Abidjan

Acknowledgment in this report is not intended to imply endorsement of

Cristina Parsons Perez

NCD Alliance

the Access to Medicine Index, its final methodology, the analysis or theDavid Pritchard

Imperial Logistics

results. Final decisions regarding the content of the Technical Areas andJudit Rius Sanjuan

UNDP

indicators are ultimately made by the Access to Medicine Foundation.

Mariana Roldão Santos

WHO

Contributors engaged in a personal capacity, and their views may not nec-

Windégoudi C. Sawadogo

National Pharmaceutical Regulation Agency,

essarily reflect the views of all members of the stakeholder groups or the(ANRP) Burkina Fasoorganisations they represent.

			
TECH N I C AL E XPE RTS		39Methodology for the 2022 Access to Medicine Index

APPE N D IX I IA

D ISE ASES I N SCO PE FO R TH E 2022 ACCESS TO M E D ICI N E I N D EX

Diseases are included based on their burden of disability-ad-mortality data was collected from the Institute for Healthjusted life years (DALYs) in countries in scope, WHO classi-

Metrics and Evaluation’s 2019 Global Burden of Disease study

fications and the relevance of pharmaceutical interventions.

(GBD 2019) and are presented as totals for countries in scope

The disease scope for the 2022 Index has expanded from 82

and disaggregated by sex where possible. Incidence data forto 83 diseases, conditions and pathogens. DALY burden andcancer types was collected from GLOBOCAN 2020.

TABLE 3

Diseases, conditions and pathogens in scope of the 2022 Access to Medicine Index
Total DALYs% DALYs% DALYsN O N - CO M M U N I C AB LE D I S E A S ES (17)(Countries in scope)(female)(male)

Alzheimer’s disease

14091001

60

40

Anxiety disorders

21036967

61

39

Asthma172052535050

Bipolar affective disorder5719253

51

49

Cancer*DALY not applicable

N/A

N/A

Chronic obstructive pulmonary disease (COPD)

59324781

43

57

Diabetes mellitus

53331082

49

51

Endometriosis

1817717100

0

Epilepsy10894638

45

55

Hypertensive heart disease

1696865852

48

Ischaemic heart disease

135566680

39

61

Kidney diseases

33377377

47

53

Migraine

32046243

62

38

Schizophrenia

11253865

46

54

Sickle cell disease335391050

50Stroke115249723

45

55

Thalassemia

74024347

53

Unipolar depressive disorders

35449935

61

39

Total incidence% incidence% incidence

C AN CE R T Y PES I N SCO PE (18)*(countries in scope)(female)(male)

Bladder

20640524

76

Brain, nervous system

188564

45

55

Breast1205094

100

0Cervical

492901100

0Colorectal

95224544

56

Gallbladder

79290

65

35

Head and neck62606925

75

Kaposi sarcoma

25498

33

67

Leukaemia

260989

57

43

Liver

674563

29

71

Lung

1200632

33

67

Non-Hodgkin lymphoma

266902

43

57

Oesophageal

48741633

67

Osteosarcoma

Incidence not available in GLOBOCAN 2020 N/A

N/A

Ovarian

192618100

0Prostate

4881570100

Stomach72020633

67

Thyroid

367564

76

24

Uterine181414100

0CO M M U N I C AB LE D I S E A S ES

Total DALYs% DALYs% DALYs(23 + 12 priority pathogens**)(Countries in scope)(female)(male)

Arenaviral haemorrhagic fevers (Lassa fever)DALY not available in GBD 2017

N/A

N/A

40

Methodology for the 2022 Access to Medicine Index
Bunyaviral diseases

DALY not available in GBD 2019

N/A

N/A

Coronaviral diseases

DALY not available in GBD 2019

N/A

N/A

Disease X

N/A

N/A

N/A

Enteric diseases

94517532

48

52

Diarrhoeal diseases

36562248

52

Diphtheria

DALY not available in GBD 2019

N/A

N/A

Emergent non-polio enteroviruses

195394

54

46

Filoviral diseases***

DALY not available in GBD 2019

N/A

N/A

Henipaviral diseases

45381627

52

48

HIV/AIDSDALY not available in GBD 2019

N/A

N/A

Leptospirosis88246796

48

52

Lower respiratory infections

46424214

49

51

Malaria

6992861

49

51

Measles16003241

45

55

Meningitis

N/A

N/A

N/A

Other prioritised antibacterial-resistant infections

10119037

54

46

Pertussis

DALY not available in GBD 2019

N/A

N/A

Rheumatic fever

8333009

49

51

Sexually transmitted infections (STIs)

2308625

45

55

Tetanus46042666

37

63

Tuberculosis

21105821

28

72

Viral hepatitis (B and C)

28711028

72

Yellow fever

257

45

55

Zika

1,700

48

52

% DALYs% DALYsN EG LEC TE D TRO PI C AL D I S E A S ES (20)Total DALYs (Countries in scope)(female)(male)

Buruli ulcer

DALY not available in GBD 2017

N/A

N/A

Chagas disease

24555941

59

Dengue and chikungunya†2348991

47

53

Dracunculiasis

1

54

46

Echinococcosis

98181

51

49

Foodborne trematodiases

74728239

61

Human African trypanosomiasis

82612

48

52

Leishmaniasis

69270942

58

Leprosy

28672

36

64

Lymphatic filariasis

1613533

19

81

Mycetoma, chromoblastomycosis and other deep mycoses

DALY not available in GBD 2017

N/A

N/A

Onchocerciasis

1230270

47

53

Rabies

7801203070Scabies and other ectoparasites

4633065

49

51

Schistosomiasis

1614876

52

48

Snakebite envenoming

DALY not available in GBD 2017

N/A

N/A

Soil-transmitted helminthiasis

1945708

58

42

Taeniasis/cysticercosis‡

1150180

54

46

Trachoma

180125

52

48

Yaws

DALY not available in GBD 2017

N/A

N/A

R E PRO D U C TIVE , MATE R NAL AN D
N E WBO R N H E ALTH (10)Total mortality (countries in scope)

Birth asphyxia and birth trauma

558039Contraceptive methods

Mortality not applicable

Hypertensive disorders of pregnancy

27429

Abortion and miscarriage

19365

Maternal haemorrhage

46117

Maternal sepsis

16699

Neonatal sepsis and infections

221229

Obstructed labour

10454

Other neonatal conditions

363225Preterm birth complications

638178* The 18 cancer types are collectively
counted as one non-communicabledisease.
** Collectively, these will be referred toas communicable diseases in the 2021
Access to Medicine Index as ‘Other
prioritised antibacterial-resistantinfections’.

***Includes DALY burden for Ebola only.
† Includes DALY burden for dengue only.
‡ Includes DALY burden for cysticercosis
only.

41

Methodology for the 2022 Access to Medicine Index

APPE N D IX I I B CANCE RS I N SCO PE FO R TH E 2022 ACCESS TO M E D I CI N E I N D EX

Cancer remains in scope for the 2022 Index, and the cancer

Osteosarcoma is newly in scope. Ovarian and uterine can-types included are in scope for all Technical Areas. The 18

cer remain in scope as they have comparably higher inci-

cancer types in scope for the 2018 Index have been retained

dences compared to other sex-linked cancer types. As in theand supplemented with new cancer types based on high inci-

methodologies for the 2018 and 2021 Indices, products fordence both globally and in countries in the scope of the Index,

the management of pain and supportive treatments (for e.g.,using data from GLOBOCAN 2020.

antiemetics) will not be included.

There are 19 cancer types in scope for the 2022 Index,
including 15 which were originally in scope for the R&D
Technical Area of the 2018 Index based on high incidence.
Head and neck cancers are combined as a single cancer type.

TABLE 4

Cancer types in scope and basis for inclusion

Three main criteria were used to include cancer types in the previous Index
for the R&D Technical Area. These cancer types were retained and supplemented with additional cancer types that met an updated set of criteria, or
which had a comparably high incidence amongst sex-linked cancer types.
The resulting 18 cancer types are in scope for all Technical Areas in 2022.
Five cancer types
Ten cancer types

where countries in

Included in

IncludedTen cancer types

with highest

scope account for2022 Accessfollowing sex-

with highest global

incidence inhighest % of global

to Medicine

linked cancer

incidence rates

countries in scope

incidence

Index

analysis

Breast22614191205094

Cervical

604127492901

Colorectal

1931590952245931931626069Cancer types in scope (19)
BladderBrain, nervous system

81%

Gallbladder
Head and neck*
Kaposi sarcoma

87%**
74%

Leukaemia
Liver905677674563Lung

22067711200632

604100487416

81%

Non-Hodgkin lymphoma
Oesophageal
Osteosarcoma

80%●

Ovarian●

Prostate

1414259488157

Stomach1089103720206Thyroid

586202367564

Uterine●* Includes all head and neck cancers defined by GLOBOCAN 2018.
** This percentage reflects the proportion of nasopharynx cancer cases in countries in scope.

42

Methodology for the 2022 Access to Medicine Index

APPE N D IX I I I

TH E GOO D PR ACTICE STAN DARDS FR AM EWO RK FO R CAPACIT Y BU I LD I NG

This framework has been developed to convey stakehold-

There are three basic criteria that all initiatives must meet:ers’ expectations for good practice in capacity building. The

1) be active during the period of analysis, 2) take place inframework is tailored for four subthemes of capacity build-a country/countries in scope of the Index and 3) address a

ing included in the Index and is comprised of six standards. All

clearly defined local need. Initiatives in all subthemes arecompany initiatives are measured against this framework.

expected to be done in partnership, save in manufacturing
where there may be a direct engagement with contracted

Good practice standards for initiatives:

third-party manufacturers. Health system strengthening initi-

1

Addresses local needs, priorities and/or skills gaps

atives must also have processes in place to prevent conflict of

2 Carried out in partnership with relevant stakeholders

interest; have clearly defined, measurable goals and/or objec-

3 Has good governance structures in place (including fortives; and measure outcomes in order to be eligible. Initiatives

mitigating or preventing conflicts of interest)

are excluded if they do not meet all inclusion criteria, with

4 Guided by clear, measurable goals or objectives

excluded initiatives not being considered for scoring or fur-

5 Includes regular monitoring, evaluation and public sharing

ther analysis. Initiatives that meet all inclusion criteria areof approaches, progress and learnings

assessed against the remaining good practice standards.

6 Has long term aims or achieves integration within thehealth system
TABLE 5

Capacity building initiative flowchart

The chart provides a guide to the criteria by which submitted company

based on the nature of the activities which typically fall within that area. Thisinitiatives are included for analysis in the Index and the criteria by which they

chart was developed as a tool for companies to guide them in selection ofare analysed. The chart is broken down by subtheme/area of capacity

their five initiatives per area during the data collection process.

building. The expectations from stakeholders vary slightly for each area

Start

Is the initiative active during theperiod of analysis?
Yes

Does the initiative take place in a

Inclusion criteria

country/countries in the scope of
the Index?

Good practice standards
used for analysis

Exclude from
AnalysisNo

Yes

Does the initiative address
local needs?
Yes

Which subtheme?

R&D

Manufacturing

Partnership with local
university or publicresearch institution?

No

Yes

Must build capacity ofthird-party or
unaffiliated manufacturers or work withexternal parties (i.e.
local universities);
in-house capacity
building excludedNo

Supply Chain

Health System Strengthening

Initiative done inpartnership?
No
The initiative should
build capacity beyond
company’s own supply
chain

Initiative done in partnership?*
Yes
Initiative has processes in place to mitigate
or prevent conflict of interest

Initiative has clearly defined, measurable
goals and/or objectives

Partnership has good
governance structures in
place

No

Yes

Yes

Yes

No

No

Yes
Initiative measures outcomes

No

Yes
Goals align with or
support institutional goals

Initiative has clearly
defined, measurable goals
and/or objectives

Initiative has clearly
defined, measurable goals
and/or objectives

Initiative publicly
discloses outcomes

Initiative measuresoutcomes

Initiative measuresoutcomes

Initiative measuresoutcomes

Partnership has good governancestructures in place

Initiative has long term
aims/
aims for sustainability

Initiative has long term
aims/
aims for sustainability

Initiative has longterm aims/
aims for sustainability

Initiative has long term aims/achieves
integration within the system

DS2* Done with appropriate, relevant partners,
including local partners

43

Methodology for the 2022 Access to Medicine Index

APPE N D IX IVTABLE 6

R&D PRIO RITI ES

Priority diseases, conditions and pathogens

●

●

●

●

Rift Valley fever

●

●

●

Severe fever with thrombocytopenia syndrome (SFTS)●●

Other bunyaviral diseases

●

●

●

●

Buruli ulcer
Cancer

HPV-related cervical cancer

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

Chagas disease

●

●

●

●

Contraceptive methods

●

●

●

●

●

●

●

●

●

Coronaviral diseases

Dengue and Chikungunya

Enteric diseases

Middle East respiratory
syndrome coronavirus(MERS-CoV)

HIV/AIDS

●

●
●

●

●

●

●

●

●

●

●

Coronavirus disease 2019
(COVID-19)

●

●

●

●

●

●

●

Other highly pathogenic coronaviral diseases

●

●

●

●

Chikungunya

●

●

●

●

●

Dengue

●

●

●

●

●

Cholera

●

●

●

●

●

Cryptosporidiosis

●

●

●

●

●

●
●
●

Enterotoxigenic E. coli (ETEC)
infections

●

●

●

Enteroaggregative E. coli
(EAEC) infections

●

●

●

●

●

●

●

●

Shigellosis

●

●

●

●

●

Typhoid and paratyphoid fever(S. typhi, S. paratyphi A)

●

●

●

●

●

Non-typhoidal S. enterica
(NTS)

●

●

●

●

●

●

●

●

●

Ebola

●

●

●

●

●

●

●

Marburg

●

●

●

●

●

●

●

Other filoviral diseases

●

●

●

●

●

●

Nipah

●

●

●

●

●

●

●

Other henipaviral diseases

●

●

●

●

●

●

●

●

●

●

●

Emergent non-polio enteroviruses (including EV71,
D68)

Henipaviral diseases●●

Rotaviral gastroenteritis

Filoviral diseases●

Severe acute respiratory syndrome (SARS)Giardiasis (lambliasis)

WHO Priority Pathogen
List

Crimean-Congo haemorrhagic
fever

●

WHO Initiative for
Vaccine Research

Bunyaviral diseases

WHO R&D Blueprint●

Policy Cures Research
G-FINDER emerging
infectious diseases
Policy Cures Research
G-FINDER sexual & reproductive health
Policy Cures Research
G-FINDER neglecteddiseases

Diagnostics●

Devices (for reproductive
health only)

Vaccines (Therapeutic)●

Vector Control Products

Vaccines (Preventive)●

Specific disease target

Arenaviral haemorrhagic
fevers (Lassa fever)Microbicides

Medicines

ATMI Disease

●

●

●

●

44

Methodology for the 2022 Access to Medicine Index

Human African
trypanosomiasis
Hypertensive disorders ofpregnancy●
Pre-eclampsia

●

●

●

●

●

●

●

●
●

Leishmaniasis

●

●

●

●

●

Leprosy

●

●

●

●

●

●

●

●

●

Leptospirosis
Lower respiratory
infections

S. pneumoniae●

Influenza●●

Respiratory syncytial virus
(RSV)

●

●

Lymphatic filariasis
Malaria●
P. falciparum●●

P. vivax●●

Maternal haemorrhage

Postpartum haemorrhage●

Meningitis

N. meningitidis

Mycetoma, chromoblastomycosis and other deep
mycoses

Mycetoma

Neonatal sepsis andinfections

Group B Streptococcus

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●
●

●

●
●

●
●
●
Chlamydia●●

Scabies
Schistosomiasis●●●

Rheumatic fever

●

●

●
●

●

●

●

●

●

●

●

●

●

●

●
●

Gonorrhoea

●

●

●

●

●

HSV-2

●

●

●

●

●

HTLV-1

●

●

●

●

●

Syphilis

●

●

●

●

●

●

●

●

Other STIs●●

Hookworm diseases●●

Strongyloidiasis●●

Trichuriasis●●

Ascariasis●●

Snakebite envenoming●

Taeniasis/cysticercosis●

Trachoma

●
●

●

●

●

Hepatitis B●

Hepatitis C

●

●

●

●

Zika

●

●

●

●
●

Tuberculosis
Viral hepatitis (B and C)●●

Onchocerciasis

Soil transmitted
helminthiasis●●

Cryptococcal meningitis

Sexually transmitted
infections (STIs)

●

●

●

●

●

●

●

●

●

●

●

●
●

●

●

●

●

Disease X*

●

●

●

●

Green text = priority R&D product● Gap identified● Specific gap

gap newly in scope for the 2020

Definition: Product gap identified

Definition: Specific R&D need orIndex

for the disease, condition or patho-

product gap identified, e.g., for a

gen on one or more of the R&D pri-

new route of administration to beority lists

developed or specific serotypes to● Included on priority R&D list

be targeted* Disease X is defined by WHO as a pathogen currently unknown to cause human disease that could cause a serious international epidemic. Priority R&D for this diseaseis restricted to platform technologies that enable cross-cutting R&D preparedness
that is also relevant for an unknown Disease X.

45

Methodology for the 2022 Access to Medicine Index

TABLE 7

Priority pathogens

12 antibacterial-resistant pathogens remain in scope for the 2022 Access to Medicine Index. Pathogens
on the WHO priority pathogen list are deemed by WHO as priority R&D targets for new and effective
antibacterials active against the pathogens themselves and the diseases they cause. This WHO priority
pathogen list does not define specific products needed.

WHO Priority Pathogen
List

WHO Initiative for
Vaccine Research gaps

WHO R&D Blueprint

Acinetobacter baumannii

Policy Cures Research
G-FINDER emerging
infectious diseases

Policy Cures Research
G-FINDER sexual &reproductive health

Policy Cures Research
G-FINDER neglecteddiseases

Other prioritised antibacterial-resistant infections●(carbapenem-resistant)Campylobacter spp.

●

(fluoroquinolone-resistant)Enterobacteriaceae (carbapenem-resistant, 3rd generation●●

cephalosporin-resistant)Enterococcus faecium●(vancomycin-resistant)
Haemophilus influenzae●(ampicillin-resistant)
Helicobacter pylori●(clarithromycin-resistant)
Neisseria gonorrhoeae (3rd generation cephalosporin-resistant,●●fluoroquinolone-resistant)Pseudomonas aeruginosa●(carbapenem-resistant)
Salmonella spp.
(fluoroquinolone-resistant)
Shigella spp.
(fluoroquinolone-resistant)

●

●

●

●

Staphylococcus aureus(methicillin-resistant, van-●comycin-intermediate andvancomycin-resistant)
Streptococcus pneumoniae(penicillin-non-susceptible)●●● Included on priority R&D list

46

Methodology for the 2022 Access to Medicine Index

APPE N D IX V

E NSU RI NG TH E M ETHO DO LOGY CO NSI D E RS ISSU ES O F SEX AN D G E N D E R

To be effective in creating access tothat it fully considers those accessviously led the Index to include uter-medicine and health products, compa-

challenges that pertain to sex andine and ovarian cancer, as these appear

nies must recognise and address in theirgender. Experts emphasise the need

far more frequently than other sex-

approaches those barriers to accessto approach methodological matters inlinked cancers (such as testicular, vulval,that lie beyond affordability, supply anda manner that is neither gender-blind

penile and vaginal). For 2022, the Index

health system strength. Barriers may(for example, aggregating burden with-keeps these two cancer types in scope.7

relate to differences in socioeconomicout considering disproportionate gen-

Breast, cervical and prostate cancer

status and to the prevalence of dis-der-based burden or discrimination)

types remain included in the disease

eases in certain geographic locations,nor gender-unequal (that is, considering

scope on the basis of other criteria (seebut some barriers are rooted in the sex

needs that apply only to one gender).

page 23).

and gender of patients. Among cisgen-

The effects of the COVID-19 pandemic

der women and girls, for example, one

have brought such issues into sharper

panies address access barriers thatreport found that up to 58% of those

focus: disrupted access to modern con-relate to stigma, the 2022 Index eval-in low- and middle-income countries

traceptive methods, for example, isuates inclusive business models that

(LMICs) cannot access or use the medi-

affecting females disproportionately

target populations at the base of thecine they need. Fear of side effects andand differently in certain settings.6

income pyramid. These may include vul-

other health concerns may be factors,

Furthermore, to examine how com-

According to the consensus view

nerable populations such as cisgen-but so may the preferences of theirof the role pharmaceutical compa-

der women and girls, and those who

male partners.1
Sex and gender are important in how

nies should play in addressing theseare part of LGBTQI+ communities. For

issues, it is vital that companies ensure

all R&D projects the Index examines, itdiseases present and how disease bur-adequate representation and con-considers whether companies includedens are distributed. Females in coun-sideration of sex and gender in clini-

vulnerable populations in clinical trials.

tries included in scope of the Index

cal trial cohorts and product develop-

carry approximately 60% of the DALY

ment. Such consideration might lead to(disability-adjusted life year) burden(a) greater representation of female,for anxiety and depressive disorders2transgender and vulnerable popula-(although males are less likely to dis-

tions in clinical trials, and thereby toclose mental health problems to pri-more suitable products for those popu-

mary care providers, with correspond-

lations; (b) greater focus on the safety

ing underreporting and undertreat-and efficacy of medicines in pregnant

ment).3 Males carry approximatelyor lactating women; (c) a focus during

60% of the DALY burden for stroke

product development of sex- or gen-and heart disease.2 Certain vulnerable

der-linked comorbidities relating to the

populations have higher rates of HIV

disease/condition in question; and/or

infections and experience considera-(d) information about the presence or

ble stigma: these include transgenderabsence of drug-drug interactions withwomen, female sex workers and cisgen-contraceptives.

der men who have sex with men.4,5Social and cultural stigmas present

Foundation has examined sex-disag-

enormous barriers for people to accessgregated DALY burden data to con-the medicines they need. While gov-

sider the inclusion of additional dis-ernments and local organisations famil-eases or conditions. Most for which theiar with cultural and social norms must

burden is disproportionately (more thanaddress these barriers, pharmaceutical70%) high for either males or females,

companies can play a key role in part-such as maternal health conditions, arenerships to support the development

already included in the disease scope.

and integration of inclusive business

Some, such as road injuries and sexualmodels. These need to be set up with aviolence, are not suitable as candidates

long-term outlook, one that appreciates

for specific pharmaceutical interven-

the varying vulnerabilities of a range oftion. However, assessment of the inci-

patient groups.

dence of sex-linked cancer types (bothIn 2022, the Index aims to ensure

Reflecting on these points, theR E FE R E N CES
1. Wulifan JK, Brenner S, Jahn A, De Allegri M. A scoping
review on determinants of unmet need for familyplanning among women of reproductive age in low
and middle income countries. BMC Womens Health.
2016;16(1):2. doi:10.1186/s12905-015-0281-3
2. GBD Results Tool | GHDx. http://ghdx.healthdata.org/
gbd-results-tool. Accessed July 23, 2021.
3. WHO Department of Mental Health and Substance
Dependence. Gender Disparities in Mental Health.;
2013.
4. Poteat T, Ackerman B, Diouf D, et al. HIV prevalenceand behavioral and psychosocial factors among transgender women and cisgender men who have sex
with men in 8 African countries: A cross-sectional
analysis. PLoS Med. 2017;14(11). doi:10.1371/journal.
pmed.1002422
5. Human Rights Campaign. Transgender People and HIV:
What We Know | Human Rights Campaign. Human
Rights Campaign. https://www.hrc.org/resources/
transgender-people-and-hiv-what-we-know. Published2017. Accessed January 22, 2020.
6. United Nations. The Impact of COVID-19 on Women,
9 April 2020, The Year 2020, Marking the TwentyFifth Anniversary of the Beijing Platform For .; 2020.
https://www.un.org/development/desa/dpad/.
Accessed July 27, 2021.
7. Global Cancer Observatory. Cancer Today. https://gco.
iarc.fr/today/online-analysis-table. Accessed June 22,2021.

globally and in countries in scope) pre-47

Methodology for the 2022 Access to Medicine Index

APPE N D IX VI

D E FI N ITIO NS

Access plansincludes all the typical elements ofBase of the income pyramidWorking definition, used for analysis

a strategy (a clear rationale, targets,

The base of the income pyramid, also

Plans to ensure that public health needs

objectives and expected outcomes).

referred to sometimes as the working

are taken into consideration during

In low- and middle-income countries

poor, designates the four billion people

R&D. Access plans can be developed

where the company operates, the strat-

living on an average of USD 1-5 per day.

in-house or in collaboration and include

egy may apply to a defined set of dis-commitments and strategies as welleases, products or therapeutic areas, orCompliance controls

as more concrete access provisions:to the whole pipeline and portfolio.

Compliance controls evaluated in theagreed-upon measures typically devel-

Index are processes and structures

oped in partnership to enforce account-

Ad hoc donation programmes

aimed at minimising the risk of occur-ability. These plans facilitate availabil-Working definition, used for analysis

rence of non-compliant activities and/or

ity, accessibility and affordability for

A gift of products for which there isbehaviour of the company’s employees

patients in countries within the scope

no clear, defined long-term strategy toand, if applicable, the third parties theof the Index (e.g., registration commit-

control, eliminate or eradicate a disease.

company formally engages with acrossments, equitable pricing strategies, suf-

This may include a company donating a

its operations in low- and middle-in-

ficient supply commitments, non-ex-

range of medicines based on the explicit

come countries.

clusivity in specified territories, waiv-

needs of a country. Donations made

These processes include:

ing patent rights, royalty-free provisions

during emergency situations, such as• Fraud-specific risk assessment toand applying for WHO prequalification).

conflicts and natural disasters, are also

pro-actively identify vulnerabilities forincluded here.

fraud and actual cases;

Access initiatives• Auditing and review mechanisms con-Working definition, used for analysis

Adaptive product R&D

ducted by external, independent spe-

An access initiative - within the con-Working definition, used for analysis

cialists, applying to third parties in all

text of the Access to Medicine Index -The adaptation of existing/registeredcountries the company is operating;is an initiative a company is involved in

New Chemical Entities (NCEs), New• A live/continuous monitoring system

which seeks to address access to med-

Biological Entities (NBEs) or other rel-for compliance, other than finan-

icine constraints in low- and middle-in-

evant medicines, therapeutic and pre-cial auditing, to continuously monitor

come countries. This may or may notventative vaccines, diagnostics, vector

activities to detect discrepancies;

be in partnership with others, and may

control products, microbicides or other• Country risk-based assessments toor may not involve improving accesshealth products that may address anidentify vulnerabilities for non-compli-

to specific pharmaceutical products.

unmet need in countries in scope,

ant or corrupt activities in countries in

Where access initiatives relate to prod-e.g., new demographic segments (e.g.,

scope where the company is operat-

ucts, it may be either an equitable pric-

infants/children, pregnant women),ing strategy, a non-exclusive voluntary

environmental conditions (e.g., heat-re-• Processes to ensure third party com-licensing approach, technology trans-

sistant formulations) or new formula-pliance (including e.g., contractual

fer or structured donation programme.

tions (e.g., oral formulations).

agreements, training on codes of

Examples of access initiatives which doing; and

conduct).

not involve products include, for e.g.,

Affordability

awareness-raising activities in healthWorking definition, used for analysis

Budget impact

system strengthening. Where products

A measure of the payer’s ability to pay

Working definition, used for analysis

are involved in an access initiative, thisfor a product (whether or not theyAn estimated measure of the cost ofwill be clearly identified within the text

are the end user). The Index takes

treatment with a given therapy for aof the Access to Medicine Index report.

this into account when assessing pric-

given number of patients in a specificing strategies for relevant products.

population.

Access-to-medicine strategy

Pharmaceutical companies use many

Working definition, used for analysis

different criteria to assess affordability.

A strategy specifically intended to
improve access to medicine, that48

Methodology for the 2022 Access to Medicine Index

Conflict of interest

larly conveyed to all concerned; and 3)

Non-pricing initiatives

A conflict of interest is the conflict thatthe transparency and accountability for

Working definition, used for analysis

arises when the commercial interests ofprocesses, decisions and outcomes of

Actions taken to increase the number of

a company are potentially at odds withinitiatives.

patients reached through access meth-the interests of the partnership, theods other than price. Non-pricing ini-

partner (i.e., local stakeholders), or theGood practice standards

tiatives applied may include, but are

health and well-being of the population

A set of six standards that encompass

not limited to, non-exclusive voluntary

the partnership intends to help.

good practice in capacity building initi-

licensing, donations partnering with

atives. These standards form a frame-

governments, patient assistance pro-

Demographic factors

work used for the assessment of com-grammes and non-assert declarations.

Working definition, used for analysis

pany capacity building initiatives. The

Characteristics of a population such as

standards include: working in partner-

Outcomes

age, sex, income level, education level,

ship, having good governance structures

Working definition, used for analysis

employment, etc.

in place, addressing local needs, having

Outcomes are the results achieved by aclear goals and objectives, measuring

company’s access-related activities.

Equitable pricing strategy

outcomes and having long-term aims or

These can include short-term (e.g., an

Working definition, used for analysis

achieving integration in the system.

increased proportion of people with

A targeted pricing strategy which aims

more knowledge on diseases, symp-

at improving access to medicine for

Healthcare practitioner-administeredtoms or treatments) and/or medium-those in need by taking the abilities to

products

to long-term outcomes (e.g., patients

pay of individuals and healthcare sys-

Working definition, used for analysis

retained in care; number of patientstems into account in a manner that is

Products that typically require either

diagnosed after community aware-

locally appropriate.

hospital administration of the productness and linkage to care programmes;or the continued attention of a skilledavailability of medicines at outlets).

Ethical marketing

healthcare professional for administra-

Outcomes can also reflect on the coun-

Promotional activities that are aimedtion, such as an intravenously adminis-try health system (e.g., number ofat the general public, patients, health-tered oncology medicine.

healthcare professionals trained).

leaders in such a way that transparency,

Innovative product R&D

Patient Assistance Programmes

integrity, accuracy, clarity and complete-

Working definition, used for analysis

Working definition, used for analysis

ness of information can be ensured.

The development of New Chemical

Patient assistance programmes are

Entities (NCEs), New Biological Entities

defined as programmes initiated by

Fair market value assessment(NBEs) or other medicines, therapeu-

pharmaceutical companies which pro-Working definition, used for analysis

tic and preventive vaccines, diagnos-

vide financial assistance or free-of-

Fair market value assessments define

tics, vector control products and micro-

charge medicines for a defined patient

the appropriateness of payments madebicides which have not previously been

population with limited ability to pay.

to healthcare professionals. These pro-approved for use.

care professionals/students and opinion

vide structure to ensure ethical inter-

Period of analysis

actions between the pharmaceutical

National reimbursement authority

For the 2022 Index, the time period forindustry and HCPs they engaged with.

Working definition, used for analysis

which data will be analysed covers com-

Governmental bodies with the author-pany activities which must be ongoing

Falsified medicine

ity to control, approve and determine

between 1 June 2020 and 31 May 2022,

Medical products that deliberately/

pricing and reimbursement of medicinalas this is the cycle of the Index. Projects

fraudulently misrepresent their identity,

products in a country.

that have ended before 1 June 2020 arecomposition or source. [Definition from
WHO, 2017]not included.
Non-exclusive voluntary licences
Working definition, used for analysis

Post-trial accessGood governance structures

Non-exclusive voluntary licences are

The continued provision of treatment

Working definition, used for analysis

defined as the licences which enable -to clinical trial participants who still

Good governance structures include

on a non-exclusive basis, and according

require an intervention following thethree components: 1) the structures

to the terms of the licence agreed - theclose of the clinical trials in which they

put in place which establish clear roles,

manufacture and supply of generic ver-participated.

responsibilities and decision making

sions of patented medicines by otherstructures; 2) the systems of commu-

manufacturers.

nications whereby information is regu-

49Methodology for the 2022 Access to Medicine Index

Priority R&D

Supranationally procured productsWorking definition, used for analysis

Working definition, used for analysis

R&D that addresses product gaps that

Products for which international pooled

are needed by people living in low- andprocurement, advance market commit-

middle-income countries due to inef-

ments, market-shaping facilities andfective, maladaptive or non-existentsignificant public funding and donor

products for certain diseases, condi-

support exist. These products include

tions and pathogens in the scope of thevaccines and products indicated for theIndex. These product gaps are definedtreatment of HIV, tuberculosis, malaria

as being those listed in a series of six

and neglected tropical diseases.

priority lists developed by WHO and
Policy Cures Research, an independent

Structured donation programmes

research group.

Working definition, used for analysis
A gift of products for which a defined

Private sector

strategy exists as to the type, volume

Working definition, used for analysis

and destination of donated products.

Private sector refers to payer types

Structured donation programmes are

such as private insurance and patientslong-term, targeted donation pro-paying out of pocket.

grammes based on country needs, usually targeted to control, eliminate or

Self-administered products

eradicate a disease.

Working definition, used for analysis
Self-administered products are defined

Vulnerable populations

as those products which patients canWorking definition, used for analysis

typically take or administer to them-

Vulnerable populations represent

selves without needing a skilled health-people at greater risk of facing stigma

care worker for regular usage. Theseand additional barriers to access due

products may or may not be priori-

to social, economic or health consider-

tised by governments or by the global

ations. These can include, but are nothealth community (e.g., treatments forlimited to, children, girls and women,

non-communicable diseases such as

members of the LGBTQI+ community,

diabetes, stroke and heart disease).

people living with HIV, etc.

Substandard medical products
Also called ‘out of specification’,these are authorized medical products that fail to meet either their quality standards or specifications, or both.
[Definition from WHO, 2017]50

Methodology for the 2022 Access to Medicine Index

APPE N D IX VI I RE FE RE NCES

1

Global Burden of Disease Collaborative

6 WHO Publishes List of Bacteria for Which

Network. GBD Results Tool | GHDx. http://ghdx.

New Antibiotics Are Urgently Needed. Saudi Med

healthdata.org/gbd-results-tool. Accessed July

J. 2017;38(4):444. https://www.who.int/news/

23, 2021.

item/27-02-2017-who-publishes-list-of-bacteriafor-which-new-antibiotics-are-urgently-needed.

2 Global Cancer Observatory. Cancer Today.

Accessed July 23, 2021.

https://gco.iarc.fr/today/online-analysis-table.
Accessed June 22, 2021.

7 Bank W. World Bank Country and Lending
Groups – World Bank Data Help Desk. World

3 World Health Organization. Epilepsy. https://

Bank. 2020:1-8. https://datahelpdesk.worldbank.

www.who.int/news-room/fact-sheets/detail/epi-

org/knowledgebase/articles/906519-world-

lepsy. Published 2019. Accessed June 22, 2021.

bank-country-and-lending-groups. Accessed
September 15, 2021.

4 World Health Organization. WHO |Comprehensive Mental Health Action Plan 2013–

8 UNDP. Human Development Report 2020:

2020. World Health Organization; 2013. http://

The Next Frontier Human Development and thewww.who.int/mental_health/action_plan_2013/

Anthropocene. UNDP New York, NY, USA. 2020:1-

en/. Accessed June 22, 2021.

7. http://hdr.undp.org. Accessed September 15,
2021.

5 World Health Organization. Control of
Neglected Tropical Diseases. https://www.who.

9 UN. LDCs at a Glance | Department of

int/data/gho/data/themes/neglected-tropi-

Economic and Social Affairs. United Nations

cal-diseases. Accessed June 22, 2021.

Department of Economic and Social Affairs.
https://www.un.org/development/desa/
dpad/least-developed-country-category/ldcsat-a-glance.html. Published 2018. Accessed
September 15, 2021.

51

Methodology for the 2022 Access to Medicine Index

Report Design
Klaas van der Veen
Marloes van Dijken
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