Access to Medicine
Index 2024
METHODOLOGYMethodology for the 2024 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

The UK Foreign, Commonwealth and Development Office
The Dutch Ministry of Foreign Affairs
Bill & Melinda Gates Foundation
The Leona M. and Harry B. Helmsley Charitable Trust
AXA Investment Managers

E XPE RT R E VI E W CO M M IT TE E

R ES E ARCH TE AM

E D ITO R IAL TE AM

Hans Hogerzeil (Chair)

James Hazel

Jana Jacobs

Mojisola Christianah Adeyeye

Moy Bracken

Eleanor Bley Griffiths

Malick Anne

Emma Shiffman

Michela Gregory

Kasper Blom

Fumie Griego

Elisabetta Cesari

Regina Mariam Namata Kamoga

Sjors van Gijzel

Caroline S. Mbindyo

Irene Pirrone

Hema Srinivasan

Marina Plazas Domènech

Fatima SulemanChloë Snowdon

Klara Tisocki
Prashant Yadav
AD D ITI O NAL CO NTR I B UTO RS

We would like to thank the many contributors who have been a part ofthe development of the 2024 Access to Medicine Index Methodology.
Strategic guidance was provided by the Expert Review Committee, apanel of experts from various sectors who ratified the changes made inthis iteration. Recommendations on specific aspects of the Methodology
were provided by a wide range of stakeholders, including frompharmaceutical companies, consulted in the review process (see p. 11-12
for more information).
ACCESS TO M E D I CI N E FO U N DATI O N

The Access to Medicine Foundation is an independent non-profit
organisation that seeks to transform the healthcare ecosystem bymotivating and mobilising companies to expand access to their essential
healthcare products in low- and middle-income countries.
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.accesstomedicinefoundation.org

2

Methodology for the 2024 Access to Medicine Index

Ensuring progressin expanding accessbenefits more people

The publication of our Access to Medicine Index in November

Index will explore the varying approaches taken by companies

2022 came at a critical juncture. With the world slowly

to define, measure and report on the number of people thatemerging from the worst of the COVID-19 pandemic,

have been able to access their products. With this approach,companies could take stock and utilise learnings from thisthe 2024 Index Methodology marks the first step in a

global health crisis to improve and maximise their access-long-term plan to help companies and other global healthto-medicine efforts going forward. Such efforts are vital to

stakeholders identify gaps in access, address disparities,

ensuring that medical progress benefits everyone – no matterand promote accountability for improving health equity andwhere they live.

access to medicine in LMICs.

Encouragingly, the 2022 Index showed how companies are

While the COVID-19 pandemic is now behind many ofincreasingly engaging in strategies to expand access to theirus, the glaring inequities it exposed must come to an end.

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

In many ways, the findings of this upcoming Index will be

Index identified positive examples of equitable pricing models,

important in establishing whether companies have seizedmanufacturing capacity building, and voluntary licensing –opportunities to improve and accelerate progress.

with more companies newly engaged in such agreements

We have seen that by taking action, the industry and theirand technology transfers. Companies are also rethinking

partners can save lives. To close the equity gap we need totheir business models in LMICs and are starting to make bold,reach more people who need access today.

global commitments to expanding access, including promises
to offer entire portfolios of products at not-for-profit prices in
LMICs. However, the real impact of these early-stage efforts
remains to be seen. This Methodology Report, which outlines
the framework that will be used to evaluate companies in
the 2024 Access to Medicine Index, will serve as a valuable
tool for evaluating how well companies live up to thesecommitments.
While the industry has taken an increasingly systematic
approach towards expanding access, progress remains

Jayasree K. Iyer

uneven across LMICs, leaving many people, especially mar-Chief Executive Officer

ginalised populations, without the healthcare they deserve.

Access to Medicine Foundation

Among a few key enhancements identified through extensive
stakeholder dialogue, the ratified framework will now place agreater emphasis on monitoring whether more patients arereceiving essential healthcare products. To begin with, the3Methodology for the 2024 Access to Medicine Index

Table of contents

5		

Executive summary9		

The 2024 Access to Medicine Index Methodology

10		

Reviewing the Methodology		
How the Foundation defines actions companies can take toexpand access13 		

What the Index measures

14 		

Company scope

15 		

Disease scope

19

Geographic scope21 		

Product type scope22		

How the Index measures23 		

Governance of Access27 		

Research and Development

31		

Product Delivery

39		

Appendices40		IA 	Diseases in scope of the 2024 Access to Medicine Index

43

IB Cancers in scope of the 2024 Access to Medicine Index

44

II 	The Good Practice Standards framework for capacity building

45		

III 	R&D priorities

48		

IV 	Ensuring the Methodology considers issues of sex and gender49		

V 	Definitions

53 		VI References

FIGURE LIST
5

Table 1 	The 20 companies in scope of the 2024 Access to Medicine Index

6

Figure 1 	Scopes of the 2024 Access to Medicine Index

8

Figure 2 	Analytical framework for the 2024 Access to Medicine Index

11

Figure 3 	Methodology review for the 2024 Access to Medicine Index

12

Figure 4 	Stakeholders consulted during the 2024 Index Methodology review

14

Figure 5 	Companies in scope of the 2024 Access to Medicine Index

16

Figure 6	Defining the disease scope

17

Figure 7 	Low- and middle-income countries have a disproportionate share of global disease burdens

18

Figure 8 	List of diseases, conditions and pathogens included in the 2024 Access to Medicine Index

19

Figure 9 	113 countries are included in the 2024 Access to Medicine Index

20

Table 2 	List of countries included in the 2024 Access to Medicine Index

4

Methodology for the 2024 Access to Medicine Index

Executive Summary

Every two years, the Access to Medicine Foundation publishes the Access to
Medicine Index, which evaluates and compares 20 of the world’s largest research-

TABLE 1 The 20 companies in scope of thebased pharmaceutical companies according to their efforts to improve access to2024 Access to Medicine Index

their products in low- and middle-income countries (LMICs).
This report sets out the 2024 Index Methodology, clearly defining the scopes andCompany Name

HQ

analytical framework – including priority topics and indicators – that will be used in

AbbVie IncUSA

the 2024 Access to Medicine Index.

Astellas Pharma Inc

JPN

AstraZeneca plc

GBR

Bayer AG

DEU

Boehringer Ingelheim GmbH

DEU

Bristol Meyers Squibb Co

USA

Daiichi Sankyo Co, Ltd

JPN

Eisai Co, Ltd

JPN

Eli Lilly & Co

USA

Gilead Sciences Inc

USA

GSK plc

GBR

Johnson & Johnson

USA

Merck & Co, Inc (MSD)

USA

Merck KGaA (Merck)

DEU

Novartis AG

CHE

Novo Nordisk A/S

DNK

Pfizer IncUSA

the best practices identified through our research. By actively engaging with all

Roche Holding AG

CHEstakeholders, the Foundation facilitates the wider application of best practices andSanofiFRA

the development of new approaches to long-standing access challenges. Beyond

Takeda Pharmaceutical Co, Ltd

JPN

How the Index drives change
The Index evaluates pharmaceutical companies in areas where they have thegreatest potential and responsibility to make change, identifying best practice,tracking progress, and highlighting where critical action is needed to expand
access to medicine. By ranking companies every two years, the Index shows which
companies are leading the way and spurs them to be competitive and collaborate
with local partners on priority access-to-medicine topics.
While the Index directly evaluates the actions of 20 companies, it also serves
as a valuable self-assessment tool and provides a set of best practices that canempower a diverse range of entities in expanding access to medicine. The carefully
constructed Index Methodology can, for example, be utilised by other innovative
research-based firms and biotechnology companies to benchmark their actions. By
analysing what is working where, and why, the Index also provides clear blueprints
for expanding best practice.
Key to the Foundation’s changemaking work is linking opportunities with

the Index Report, the Foundation engages in learning and evaluation sessions withcompanies to improve access to medicine. Investor briefings and topic-specificroundtables also form an integral part of our ongoing commitment to guide andincentivise companies on improving access to medicine for people living in LMICs.
Building stakeholder consensus
With over 15 years of methodological development, the Index framework andindicators have evolved through ongoing practical experience and extensive
dialogue and consensus building between stakeholders. Through this process, theFoundation ensures the analytical framework, and its metrics, are aligned withsocietal expectations as to how pharmaceutical companies can make their products
available, accessible, affordable, and of good quality to people living in LMICs.
For the 2024 Index, the Foundation interviewed over 100 global health stakeholders, including pharmaceutical companies, to refine the Methodology and reachconsensus on enhancing and/or updating metrics.
Enhanced focus on patient reach
The previous Index aimed to encourage companies to widen the scale and scopeof access, including increasing the number of products in their portfolios andtargeting a wider range of LMICs to reach more patients. In line with this approach,5

Methodology for the 2024 Access to Medicine Index

and based on stakeholder consensus, the 2024 Index will now also place greater
emphasis on the concept of ‘patient reach’, which refers to the number of people
that have managed to access a company’s products. The aim is to evaluate andguide companies to more transparently define, measure, and report on their impact
in reaching patients living in LMICs. Not only will this enable the assessment of
successful strategies, but it can help companies to identify gaps in access, address
disparities, and better allocate resources to improve health equity and the lives ofunderserved populations.
With this strengthened approach, the Foundation aims to promote accountability
within the industry, and to encourage the development and improvement of
inclusive business models aimed at LMICs. Additionally, assessing patient reachcan help stakeholders – including governments, non-governmental organisations,and investors – make informed decisions regarding partnerships, policies andinvestments.
As set out below, this increased focus on patient reach is reflected in many ofthe enhancements and updates to the 2024 Index Methodology, particularly in the
Governance of Access Technical Area.
What the Index will measure
Following analysis of company pipelines, portfolios, market capitalisations andrevenue, the 2024 Index will assess the same 20 pharmaceutical companies as in
the 2022 Index (see Table 1 on p. 5).
As summarised in Figure 1, companies will be analysed based on a fixed set of
diseases and product types across a specific geographic scope, with some changes
made since the 2022 Index.

FIGURE 1 Scopes of the 2024 Access to Medicine Index
CO M PAN Y SCO PE

G EO G R APH I C SCO PE

D I S E A S E SCO PE

PRO D U C T T Y PE SCO PE

20 research-based

113 low- and middle-income

81 diseases, conditions and

8 product types

pharmaceutical companies

countries (LMICs)

pathogensThis scope is deliberately broad in

Companies are selected based

Company actions are measured in

The diseases, conditions and path-order to capture the wide-ranging

on their market capitalisation

countries where better access toogens in scope disproportionately

product types available to supportand revenue, and the relevance

medicine is most urgently needed.

impact people living in LMICs:

the prevention, diagnosis and•		23 communicable diseases

treatment of relevant conditionsof their product portfolios andpipelines for the diseases andAll countries that were included in•		16 non-communicable diseases

and diseases in countries covered

countries in scope of the Index.

the 2022 Index will continue to be•		20 neglected tropical diseases

by the Index:

part of the scope.

•		10 maternal and newborn•		Medicines

health conditions
Five countries have been added•		12 priority pathogens•		Microbicides•		Preventative vaccines

since the 2022 Index:•		Therapeutic vaccines•		Jamaica•		Vector control products•		Jordan•		Platform technologies•		Lebanon•		Diagnostics•		Marshall Islands•		Contraceptive methods and•		Saint Lucia

devices6

Methodology for the 2024 Access to Medicine Index

How the Index will measure
The Methodology for the 2024 Index is based on a robust analytical framework that
corresponds to the core role pharmaceutical companies can play to improve accessto medicine. As in the previous Index, this role centres on the creation of equitabledelivery of health products while ensuring responsible practice and appropriate
management of access.
For the 2024 Index, the period for which data will be analysed covers company
activities between 1 June 2022 and 31 May 2024.
3 Technical Areas
Stakeholders have again confirmed three Technical Areas in which pharmaceuticalcompanies have responsibility and ability to influence access to medicine in LMICs.
The Technical Areas are divided into 15 priority topics (see Figure 2 on p. 8). EachTechnical Area is weighted differently, as indicated in brackets below.
1. Governance of Access (15%): Assesses company strategies, goals and incentive
structures related to access to medicine. It also looks at how companies apply
processes to minimise the risk and occurrence of non-compliant and/or corrupt
behaviour, and the remedial actions companies take when such breaches occur.
Additionally, this Technical Area will newly assess how companies measure andreport on patient reach.
2. Research & Development (30%): Assesses in-house and collaborative researchand development (R&D) activity aimed at developing or adapting products fordiseases, conditions and pathogens in scope of the Index, and in response to
the needs of people living in LMICs. It also examines whether companies plansufficiently during the development of their products to make sure those that
progress through the pipeline become swiftly accessible in LMICs.
3. Product Delivery (55%): Assesses how companies improve access to theirproducts through a variety of mechanisms, including registration, pricing
strategies, responsible intellectual property management, inclusive businessmodels and product donations. It also examines how companies design andmeasure outcomes of their access strategies and tailor their tools to boost
access. Further, it captures how companies leverage their expertise andresources to address significant local barriers to access. Such barriers might
include gaps in local healthcare infrastructure, poorly functioning supply chains,weak quality assurance systems and/or gaps in skills.
32 indicators
The 2024 Index will assess companies using an analytical framework consistingof 32 indicators of company performance (one more than in 2022) to provide aholistic view of companies’ efforts to increase access to medicine in LMICs.
Several indicators have been either added, modified or merged to continue totailor the analytical framework closely to evolving stakeholder expectations ofcompany behaviour, or to improve elements of data collection and analysis.
All indicators that will be used in the 2024 Index, including descriptions andrationales for changes, are listed in this report, with a summary of key changes set
out on page 8.

7

Methodology for the 2024 Access to Medicine Index
KE Y CHAN G ES I N TH E 2024 I N D E X
G OVE R NAN CE O F ACCESSR ES E ARCH AN D D E VE LO PM E NT

PRO D U C T D E LIVE RYThis Technical Area has been signifi-

This Technical Area has been updated

The main shift in this Technical Area

cantly updated for the 2024 Index withto capture access plans for all R&D

is a complementary and expanded

a merging of overlapping indicators,

projects in Phase II or beyond targeting

focus on how companies are improving

and updates to the remaining indicators

diseases in scope of the Index, inthe number of patients reached in

to better capture the most important

addition to projects that are deemed

LMICs for specific products. This has aelements of Governance of Access.

priority R&D. The Technical Area

bearing on access strategy indicators.

Notably, a new priority topic onalso newly includes a requirement

Registration and ensuring continuous

measuring and reporting patient reachthat a company publicly discloses

supply indicators have been updated

has been introduced, which will look at

its overarching R&D access planningto capture additional information on

the success of companies’ strategies

commitments for patients living incollaborative registration proceduresin ensuring their essential healthcare

LMICs on its website or in its reporting.

and local manufacturing, respectively.

products reach patients living in LMICs.

To focus and streamline analysis,

This includes a standalone patientother modifications to indicators werereach indicator, which will evaluate how

made, including merging indicators andcompanies define, measure and report

the addition of inclusion criteria, oron patient reach.

clarifying language where needed.

FIGURE 2 Analytical framework for the 2024 Access to Medicine Index
The 2024 Access to Medicine Index will analyse company behaviour using ananalytical framework of 32 indicators organised in three Technical Areas thatare divided into 15 priority topics.
3 Technical Areas

15 Priority Topics

32 Indicators

G OVE R NAN CE O F ACCESS

Responsible business practices●●●●

Governance and strategy●●

Measuring and reporting patient reach●

Access planning●●●

Product development●●●

Building R&D capacity●

Equitable access strategies and outcomes●●●●●Intellectual property strategy●●●

Quality and supply●●●

Product donations●●

Health system strengthening●

Inclusive business models●

Licencing quality●

Local manufacturing●

Registration●

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

PRO D U C T D E LIVE RY

8Methodology for the 2024 Access to Medicine Index

The 2024 Access to Medicine
Index Methodology
The Access to Medicine Index is the product of a two-year
cycle, which starts with a review of the previous Index
Methodology aimed at ensuring the Index remains a rigorous
tool for assessing companies’ activities and is an effective
guide for incentivising change.
In the following sections, the report outlines the 2024
Access to Medicine Index Methodology, including the review
process and the analytical framework on which the 2024
Index will be based.
REVI EWI NG TH E I N D EX M ETHO DO LGY
The 2024 Index Methodology Review started with a series
of internal checks on indicators, data sets and analytical
approaches. This was followed by an external review toconfirm the consensus view among stakeholders on wherecompanies should take action to make their products
available, accessible, affordable, and of good quality to people
living in low- and middle-income countries (LMICs).
ANALY TICAL FR AM EWO RK• What the Index measures
This section sets outs the rationale for the analytical scopesof the 2024 Access to Medicine Index, and how they havebeen defined.
• How the Index measures
This section explains how company actions will bemeasured across three Technical Areas and 15 priority
topics in the 2024 Access to Medicine Index.
The analysis of company performance comprises 32
indicators grouped into three Technical Areas:
1. Governance of Access
2. Research and Development
3. Product Delivery

9

Methodology for the 2024 Access to Medicine Index

REVI EWI NG TH E M ETHODOLOGY

How the Foundation defines actions
companies can take to expand access
The publication of each Access to Medicine Index is the culmination of a two-year
process known as the ‘Index cycle’, which starts with an extensive review of theIndex Methodology. Through this review, the Foundation ensures the Index captures
the priority areas that research-based pharmaceutical companies can focus on to
make their products available, accessible, affordable, and of good quality to people
living in low- and middle-income countries (LMICs).
The 2024 Methodology review commenced in 2023, with the Index teamcarrying out a targeted internal review of the analytical framework, scopes,
and indicators used in the 2022 Index. This was followed by an external review
to reaffirm the consensus view among stakeholders on the appropriate role ofpharmaceutical companies in improving access to medicine in LMICs. The resulting
consensus has been translated into a refined set of metrics for assessing how far
the world’s largest pharmaceutical companies are going in fulfilling their roles andmeeting society’s expectations.
Primary principles of the 2024 Methodology review
1. Ensure that the framework and indicator set clearly reflect the core role of large
research-based pharmaceutical companies in access to medicine, are responsive
to the emerging access needs in LMICs, and incentivise change.
2. Enable the identification of best practice in all aspects of access to medicine inorder to facilitate broader uptake.
3. Ensure all metrics are robust and can be used to fairly compare a range ofcompanies against each other.
4. Preserve the capacity of the Index to track pharmaceutical company activity on
access to medicine over time.
5. Ensure the usefulness of the Index’s findings and analyses for governments,
companies, investors, non-governmental organisations (NGOs) and other key
stakeholders in improving access to medicine.
How the Foundation develops and updates metrics
The Foundation uses strict standards for deciding when to merge or remove a
metric within the analytical framework. These include the consensus view on therelevance of the measured behaviour, and the clarity and degree of consensus
regarding the industry’s role. As part of the Foundation’s internal review of the
Methodology, each of the indicators in the 2022 Access to Medicine Index wasquantitively and qualitatively analysed for robustness, response quality, the potential for longitudinal analysis and the ability to drive change among companies.
Further details of the review process are laid out below:• Distribution analyses: Assessing the distribution of scores per indicator to checkthe spread of company behaviour in the 2022 Index. This indicates whether
expectations of companies are fair (e.g., a cluster of high scores could indicate
an area where expectations for company performance should be raised) and theextent of room for improvement. Outcomes inform refinements to indicators andscoring guidelines.

10Methodology for the 2024 Access to Medicine Index• Response rate analyses: Assessing company response rates and the quality ofdata provided for each data request in the 2022 Index. This establishes whether
questions are clear and whether companies can feasibly gather data for eachquestion.
• Correlation analyses: Indicator-level assessments of score correlations, which
help diagnose less relevant indicators and can reveal or confirm positive or
negative relationships between related areas of company behaviour.
• Qualitative indicator review: A battery of qualitative assessments of eachindicator including clarity of the expectations and role for companies, continuing
relevance to access to medicine, potential for longitudinal comparisons and the‘change-making’ potential of each indicator.
These tests were used to detect and eliminate the risk of redundant measures, topinpoint opportunities for enhancing data and to identify where scoring guidelines
could be tightened. During the indicator review, topics were identified for discussion during external consultations with experts and stakeholders.

FIGURE 3 Methodology review for the 2024 Access to Medicine Index
Access to
MedicineIndex 2022
15 November

2024 Access to
Medicine Index
METHODOLOGY

Stakeholder
consultations

Methodology
for the2024 Index
10 October

Access to
MedicineIndex 2024
November

Data collection
and analysis

2023
Company roundtables:
Defining and measuring
patient reach
8 and 10 May

2024 Access to
Medicine Index

2024
Expert Review
Committee
Meeting
20 July

2025

Methodology
training forcompanies
24 - 26 October

Stakeholder outreach for the 2024 Access to Medicine Index
A key step in the Index Methodology review process is building stakeholder consensus on what is expected from companies in advancing access to medicine. As inprevious years, consultations were carried out with global health experts to ensure
a diverse range of viewpoints and technical expertise were incorporated. For the2024 Index Methodology, this included consultations with over 100 stakeholders
from varying sectors, including all 20 pharmaceutical companies evaluated in the2022 Index (see Figure 4 on p.12).
Importantly, in May 2023 the Foundation also held two roundtables on the
topic of ‘patient reach’. These sessions facilitated discussions with pharmaceuticalcompanies about how they define and quantify patient reach. In combination withinsights from experts on the topic, company feedback has been used to inform themodification and creation of indicators for the 2024 Index to measure patient reach,while fairly assessing company performance.
The Foundation continues to strive for diversity in consensus building withrespect to factors like gender and ensuring the inclusion of individuals with relevant
expertise and/or first-hand experience with access to medicine issues in LMICs.
In the 2024 Index Methodology consultations, stakeholders representing LMICs
increased, and gender parity was achieved.

11

Methodology for the 2024 Access to Medicine Index

FIGURE 4: Stakeholders consulted during the 2024 Index Methodology review
Public private
partnerships
Investors
Funders
Research
and academic
institutions
Governments
Private sector

7
9
10

7 2

Stakeholders(%)
10

Pharmaceuticalindustry

21

18

15

Internationalorganisations
Non-governmentalorganisations

Expert Review Committee
The endpoint for the Methodology review is the meeting of the Expert Review
Committee (ERC), who provide strategic guidance in ensuring the Methodology
reflects expectations of pharmaceutical companies. The ERC is an independent
body and comprises a diverse range of international experts on access to medicine – including from the World Health Organization (WHO), governments, thepharmaceutical industry, NGOs, academia, and investors. The ERC met in July 2023
to review proposals for the scope, structure, and analytical approach of the 2024
Index. This involved making recommendations where the consensus view was
unclear or where uncertainty existed in areas of measurement, before endorsing
the final Methodology.
Expert Review Committee for the 2024 Index• Chair of the Committee: Hans Hogerzeil, Emeritus Professor of Global Health at
the University of Groningen (Netherlands) and co-chair of the Lancet
Commission on Essential Medicines Policies• Mojisola Christianah Adeyeye, Director General at the National Agency for Foodand Drug Administration and Control (NAFDAC) and Professor Emeritus at
Roosevelt University (Chicago, USA)
• Malick Anne, Bureau Chief of non-communicable diseases (NCDs) at Senegal’s
Ministry of Health and Social Action• Michela Gregory, Director, Responsible Investing & Environmental, Social andGovernance (ESG) Services, at NEI Investments• Fumie Griego*, Deputy Director General and Chief Operating Officer at theInternational Federation of Pharmaceutical Manufacturers and Associations(IFPMA)• Regina Mariam Namata Kamoga, Executive Director of the Community Healthand Information Network (CHAIN) in Uganda and Founding Director of the World
Patient Alliance• Caroline S. Mbindyo, CEO of Amref Health Innovations for Amref Health Africa• Hema Srinivasan, Chief Access Officer at MedAccess• Fatima Suleman, Professor in the School of Health Sciences, Universityof KwaZulu-Natal (South Africa) and Director of Collaborating Centre for
Pharmaceutical Policy and Evidence Based Practice at WHO• Klara Tisocki, Team Lead (Pricing and Affordability) and Regional Advisor,
Essential Medicines (South East Asia Regional Office) at WHO• Prashant Yadav, Senior Fellow at the Center for Global Development andAffiliate Professor of Technology and Operations at Institut Européend’Administration des Affaires (INSEAD)*Designation at the time of the Expert
Review Committee meeting. At thetime of publishing the 2024 Index
Methodology, this member had left her
respective organisation.

12

Methodology for the 2024 Access to Medicine Index

What the Index measures
The Access to Medicine Index assesses pharmaceuticalcompanies’ policies and behaviour regarding specific diseases
and product types across a specific geographic scope. The
following pages set out the rationale for these analyticalscopes and how they have been defined.
In this section:
CO M PANY SCO PE
20 companies
D ISE ASE SCO PE
81 diseases, conditions and pathogens• 23 communicable diseases• 16 non-communicable diseases• 20 neglected tropical diseases• 10 maternal and newborn health conditions• 12 priority pathogens
G EOG R APH IC SCO PE
113 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.

13

Methodology for the 2024 Access to Medicine Index

WHAT WE M E ASU RE

Company Scope
The Access to Medicine Index assesses 20 of the world’s largest research-based
pharmaceutical companies on their policies and practices to improve access to
medicine for people living in low- and middle-income countries. Considering theirpipelines, portfolios, resources, and global reach, these companies have clear
opportunities and a responsibility to address access.
Companies are selected for inclusion based on their market capitalisation andrevenue, and the relevance of their product portfolios and pipelines for the diseases
and countries in scope of the Index. The largest research-based companies in
the world were identified through a company market capitalisation and revenue
analysis, which also took mergers, acquisitions, and divestments into account. Theirpipelines and portfolios were then mapped against diseases in scope of the Index
and the research and development (R&D) needs of people living in countries inscope. Companies that qualified for analysis based on size could be disqualified forhaving fewer relevant products and R&D projects than companies of similar size.
Following this review, the 2024 Index will evaluate the same 20 companies as in
2022, facilitating trend analysis.
Companies that exclusively produce generic medicines are not eligible for inclusion as they have a distinctly different role to play in improving access to medicine.
These companies are assessed in the Access to Medicine Foundation’s Generic andBiosimilar Medicines Programme.

FIGURE 5 Companies in scope of the 2024 Access to Medicine Index
Revenue 2022*

Market cap*** 2023

Company

Stock exchangeCountry

Ticker(USD bn)**(USD bn)**

AbbVie Inc

NYSE

USA

ABBV

58.054 AbbVie Inc

271.166

Astellas PharmaInc
27.449Astellas Pharma Inc

TSE

JPN

4503

9.457

AstraZeneca plc

LSE

GBR

AZN

44.351 AstraZeneca plc239.227

Bayer AG

XFRA

DEU

BAYN

55.773 Bayer AG

62.073

Boehringer Ingelheim

Privately held

DEU

N/A

30.133 Boehringer Ingelheim
N/A

Bristol Myers Squibb

NYSC

USA

BMY

46.159 Bristol Myers Squibb
143.698

Daiichi Sankyo Co, Ltd

TSE

JPN

4568

7.624

Daiichi Sankyo Co,
Ltd
64.893Eisai Co, Ltd

TSE

JPN

ESALY

5.518

Eisai Co, Ltd

Eli Lilly & Co

NYSE

USA

LLY

28.541 Eli Lilly & Co

Gilead Sciences

NASDAQ

USA

GILD

27.281 Gilead Sciences101.612

GSK plc

LSE

GBR

GSK

36.724 GSK plc

Johnson & Johnson

NYSE

USA

JNJ

94.943 Johnson & Johnson
510.406

Merck & Co, Inc (MSD)

NYSE

USA

MRK

59.283 Merck & Co, Inc295.235

Merck KGaA (Merck)

XFRA

DEU

MRK

24.438 Merck KGaA

77.040Novartis AG†

SWX

CHE

NOVN

50.545 Novartis AG

218.128

Novo Nordisk A/S

Nasdaq Copenhagen

DNK

NOVO-B

26.095 Novo Nordisk A/S
332.395

Pfizer Inc

NYSE

USA

PFE

100.330 Pfizer Inc

Roche Holding AG

SIX

CHE

ROG.SWAG
70.723 Roche Holding 255.783

Sanofi

EPA

FRA

SAN

47.263 Sanofi

TAK

26.040 Takeda Pharmaceutical
52.147 Co, Ltd

Takeda Pharmaceutical Co, Ltd

TSE

JPN

16.665385.22473.763221.317134.6040*All revenues are taken from companies’
2022 annual reports. For the Japanheadquartered companies, this represents
revenue from April 2021 to March 2022.
For remaining companies, this represents
revenue from January 2022 to December
2022.

**Exchange rates on 2 May 2023 fromoanda.com***Market cap on 2 May 2023 fromfinance.yahoo.com†Novartis will spin off Sandoz, its genericpharmaceutical and biosimilar division, onor around October 4 2023, just prior to
the publication of this Methodology.

100 200 300 400 500 600● Market cap 2023
● Revenue 2022

14

Methodology for the 2024 Access to Medicine Index

WHAT WE M E ASU RE

Disease scope
The Access to Medicine Index evaluates pharmaceutical companies’ actions inaddressing access to medicine for diseases, conditions and pathogens that the
global health community considers most critical to address in low- and middleincome countries (LMICs). This scope is defined by consulting epidemiological
data and independent priority lists. In the development of each new Index
Methodology, this analysis is conducted, and its results are ratified by the Expert
Review Committee. Following this review, the disease scope for the 2024 Access to
Medicine Index has been set at 81 diseases, conditions and pathogens.
Defining the disease scope
Some diseases are in scope of the Index because they impose a high global disease
burden despite the existence of effective treatments, or because they affect poorer
populations disproportionately. To identify such diseases, the Foundation useda screening protocol (see Figure 6 on p. 16). This is based on factors such as: theprioritisation of the disease by organisations such as Policy Cures Research and theWorld Health Organization (WHO) for improving access to medicine; global and/or
country-level disease burdens; and the relevance of pharmaceutical intervention.
The 2024 Index disease scope has been updated according to the most recent
Global Burden of Disease Study (GBD 2019),1 which also provides country-level
data on disability-adjusted life years (DALYs). This measure is commonly used tomeasure the burden of disease in a population. The WHO defines one DALY as “onelost year of ‘healthy’ life” to account for the gap between a given population’s ideal
health situation, and the actual situation.
• All cardiovascular diseases are now included. All diseases, conditions andpathogens that were included in the 2022 Access to Medicine Index scope willremain in scope for the 2024 Index. However, stroke, ischaemic heart disease
and hypertensive heart diseases have been grouped into the umbrella categoryof cardiovascular diseases, reducing the total number of diseases, conditions andpathogens in the disease scope from 83 to 81.
• Previous iterations of the Index have focused on diseases that mostly affectpeople in LMICs. The Index considers this to be a strong indicator that a low levelof incentive to invest in pharmaceutical research and development (R&D) will
limit the availability of suitable treatment options. In 2024, the Index will retain
its focus on these diseases and (where data is available) will specifically include
diseases in which more than 95% of the global DALY burden is faced by countries
in scope of the Index.1• Three diseases that exclusively affect women and girls (linked to biological sex)
remain in scope for the 2024 Index. According to a review of data from GBD
2019 and from the Global Cancer Observatory (GLOBOCAN 2020), endometriosis, ovarian and uterine cancers have comparably higher incidence rates and/or DALY burdens than other sex-linked diseases.1,2 Their inclusion in the disease
scope increases the capacity of the Index to assess the unmet needs of womenand girls with sex-linked diseases living in LMICs.

15

Methodology for the 2024 Access to Medicine Index

D I S E A S E SCO PE

23 communicable diseases

incidence in LMICs.2 For the 2024

10 reproductive, maternal andThis category includes the 10

Access to Medicine Index, hypertensive

newborn health conditions

communicable diseases with theheart disease, ischaemic heart disease

To recognise the importance of

highest DALY burdens in countries inand stroke are combined into cardio-

reproductive, maternal and childscope of the Index, as well as diseases

vascular diseases. Sickle cell disease

health, the Index has since 2014

for which product gaps have been

and thalassemia remain in scope due

included contraceptives and nine

identified as priority R&D targets, suchto a disproportionate disease burden inmaternal and newborn healthas emergent non-polio enteroviruses

countries in scope of the Index. Bipolar

conditions.

and ‘Disease X’, a WHO term to denoteaffective disorder, epilepsy and schiz-a currently unknown pathogen that

ophrenia are retained based on con-

12 priority pathogens

could cause a serious international

tinuing stakeholder consensus on the

As in 2022, the Index covers the 12

epidemic (as seen for COVID-19).

critical need for access to treatment.

pathogens included in the WHO’s

16 non-communicable diseases

20 neglected tropical diseases(2017). These are deemed a priority forThis category includes the 10 non-com-

As in 2022, the 2024 Index includes

efforts to curb antimicrobial resistancemunicable diseases with the highest

all WHO-classified neglected tropicalthrough the development of new and

DALY burdens in countries in scope

diseases.3 Yaws now includes othereffective antibacterial agents.4of the Index. It also includes cancer

endemic treponematoses (bejel andtypes with a high or disproportionate

pinta).

definitive priority pathogens list

FIGURE 6 Defining the disease scope
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 following protocol.
Which diseases qualify for inclusion?
Is the disease or condition suitable forpharmaceutical intervention?

no

Disease excluded

yes
Is the disease classified as a neglected
tropical disease by WHO?

yes

Disease includedno
Was the disease previously included in WHO
Global Health Observatory data as a maternalor newborn health condition?*no

yes

Cancer inclusion criteria
Disease included

incidence.
2. The ten cancer types with the highest incidence incountries in scope of the Index.

yes

Is the disease a cancer type?

1. The ten cancer types with the highest global

3. The five cancer types with the highest percentageof global incidence in countries in scope of thenoComparing DALY burdens in countries inscope, is the disease one of the ten communicable diseases or ten non-communicablediseases with the highest burden?

Index.
yes

The cancer types included in the 2022 Access to
Disease included

Medicine Index remain in scope.

noIs the disease one for which countries inscope carry a disproportionately high (≥95%)
proportion of the global DALY burden?

yes

Disease included

Exceptions: Alzheimer’s disease, bipolar affective
disorder and epilepsy were in scope of the 2022

noIs the disease an R&D priority identified in atleast one of six key R&D priority lists?**

yesIndex and have been retained due to stakeholder
Disease included

noconsensus. Endometriosis and ovarian anduterine cancer have also been retained to reflect
a greater focus on sex-linked barriers to acccess.

Disease excluded

Furthermore, osteosarcoma has been retained
as it is the most common primary malignant
bone tumour in children and young adults.

*As listed in the WHO methods and data
sources for global burden of disease
estimates 2000-2019**Policy Cures Research G-FINDER
neglected diseases, sexual and reproductive health, and emerging infectious diseases; WHO Prioritizing diseases forresearch and development in emergency
contexts, WHO Target Product Profiles
and WHO Priority Pathogen List.5-10

16

Methodology for the 2024 Access to Medicine Index

FIGURE 7 Low- and middle-income countries have a disproportionate share of global
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, who account for nearly 80% of the world’s
population. Behind these numbers are millions of people who cannot rely on access to affordable,
quality medicine.
Communicable diseases

Non-communicable diseases**

Lower respiratory infections

Cardiovascular diseases

Enteric infections

0

HIV/AIDS
Tuberculosis

COPD

Malaria

Diabetes mellitus

Viral hepatitis (B and C)

Depressive disorders

Meningitis

Migraine

Pertussis

Kidney diseases

Sexually transmitted infections (STIs)*

Anxiety disorders

Measles

Alzheimer's disease

Tetanus

AsthmaDiphtheria

Schizophrenia

Yellow fever

Epilepsy

Filoviral diseases

Bipolar affective disorder

Zika

100

200

300

400 500
mn DALYs

20

40

60

80 100mn DALYs

Sickle cell disease0● Burden in countries in scope● Burden in rest of world

20 40 60 80 100 120
mn DALYs

Thalassemia
Endometriosis
0● Burden in countries in scope● Burden in rest of world

Maternal and newborn health conditions

Neglected tropical diseases
Scabies and other ectoparasites

Preterm birth complications

DengueBirth asphyxia and birth trauma

Soil-transmitted helminthiasis

Other neonatal conditions

Lymphatic filariasis

Neonatal sepsis and infections

Schistosomiasis

Maternal haemorrhage

Taeniasis/cysticercosis

Hypertensive disorders of pregnancy

Onchocerciasis

Abortion and miscarriage

Food-borne trematodiases

Maternal sepsis

RabiesObstructed labour
0 10 20 30 40 50 60 70 80
mn DALYs

Leishmaniasis
Chagas disease
Trachoma● Burden in countries in scope● Burden in rest of world

Echinococcosis
Human African trypanosomiasis
Leprosy
Dracunculiasis
0

1

2

3

4
5
6
mn DALYs● Burden in countries in scope● Burden in rest of world*Excludes HIV/AIDS**The incidence for cancer types in scope
is found in Appendix IA on p. 40.

17

Methodology for the 2024 Access to Medicine Index
FIGURE 8 List of diseases, conditions and pathogens included in the

R&D priority*●

Buruli ulcer●●

Bunyaviral diseases●

Chagas disease●●

Coronaviral diseases●

Dengue and chikungunya

●

●

●

Dracunculiasis●●

Communicable diseases

Neglected tropical diseases

Diphteria●

Disease X***●

Echinococcosis

Emergent non-polio enteroviruses●

Food-borne trematodiases

●

●

●

●

Human African trypanosomiasis

●

●

●

●

●

Leishmaniasis

●

●

●

●

Leprosy

●

●

●

●

Lymphatic filariasis

●

●

●

●

Mycetoma, chromoblastomycosis

●

●

●

and other deep mycoses●

Onchocerciasis

●

●

●

Rabies●●Scabies and other ectoparasites

●

●

●

Schistosomiasis

●

●

●

●

Snakebite envenoming

●

●

●

●

Soil-transmitted helminthiasis

●

●

●

●

●
●

Enteric infections●

Filoviral diseases
Henipaviral diseases
HIV/AIDS●●

Leptospirosis
Lower respiratory infections●

Malaria●●

Measles●●

Meningitis●●

Pertussis●●

Rheumatic fever
Sexually transmitted infections

Stakeholder consensus**

MNH condition

WHO-identified NTD ortries in scope of the Index≥95% disease burden in coun-tries in scope of the Index

Top 10 DALY burden in coun-

Stakeholder consensus**

Arenaviral haemorrhagic fevers

R&D priority*

MNH condition

WHO-identified NTD ortries in scope of the Index≥95% disease burden in coun-tries in scope of the Index

Top 10 DALY burden in coun-

2024 Access to Medicine Index

●

●

●

(STIs)†●

Taeniasis/cysticercosis

Tetanus●

Tuberculosis

●

●

●

Viral hepatitis (B and C)

●

●

●

Yellow fever●●

Yaws and other endemic●●

treponematoses

●

Zika

Trachoma

Reproductive, maternal and newborn health conditions●

Non-communicable diseases●

Abortion and miscarriage●●

Birth asphyxia and birth trauma●●

Contraceptive methods

Alzheimer's disease●

Anxiety disorders●

Hypertensive disorders of

Asthma●pregnancy

●

●

●

●

●
●

●

Maternal haemorrhage

●

●

●

Maternal sepsis

●

●

●

Neonatal sepsis and infections

●

●

●

Obstructed labour●●

Other neonatal conditions●●

Bipolar affective disorder
Cancer‡●Cardiovascular diseases
Chronic obstructive pulmonary●

disease (COPD)
Depressive disorders●

Diabetes mellitus●

Preterm birth complications

Endometriosis●

Epilepsy●

Kidney diseases●

Migraine●●●

Priority pathogens§
Acinetobacter baumannii (carbapenem-resistant)Campylobacter spp. (fluoroquinolone-resistant)Enterobacteriaceae (carbapenem-resistant, 3rd generation

Schizophrenia●

Sickle cell disease●

Thalassemia●●

Blue text = Newly in scope for 2024 Access to Medicine Index

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)*Diseases, conditions and pathogens
indicated as R&D priorities on identified
lists published by Policy Cures Researchand WHO. 5-10**These diseases have been retained or
added due to specific access barriers,
amongst other reasons, as identified instakeholder engagement.
***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 19 cancer types. See Appendix
IB on p. 43 for more details.
§These will be collectively referred to as‘Other prioritised antibacterial-resistantinfections’ in the 2024 Access to Medicine
Index and categorised as one disease
under communicable diseases.

Salmonella spp. (fluoroquinolone-resistant)
Shigella spp. (fluoroquinolone-resistant)
Staphylococcus aureus (methicillin-resistant, vancomycin-intermediate andvancomycin-resistant)
Streptococcus pneumoniae (penicillin-non-susceptible)

18

Methodology for the 2024 Access to Medicine Index

WHAT WE M E ASU RE

Geographic scope
The Access to Medicine Index measures the actions of pharmaceutical companies
in places where there is an urgent need for better access to medicine. Four criteria
have been used to select countries for the geographic scope of the 2024 Index:(1) inclusion in the 2022 Index, (2) countries’ level of income (gross national income
per capita), (3) level of human development and (4) scale and scope of inequality.
Each country was assessed based on data from the World Bank, the United Nations
Development Programme (UNDP) and the United Nations Economic and Social
Council (ECOSOC).
The geographic scope of the 2024 Index covers 113 countries. Five new countries
have been added since the 2022 Index (Jamaica, Jordan, Lebanon, Marshall Islands
and Saint Lucia). All countries included in the 2022 Index have also been included inthis Index to enable the longitudinal tracking of efforts made by the pharmaceuticalcompanies in these countries. Countries included in the 2022 Index that no longer
qualify for inclusion under the below criteria (e.g., higher income level) weremaintained in the 2024 Index. These countries will remain in scope for six years tofacilitate longitudinal analysis and to prevent frequent switching out of countries.
D E FI N I N G TH E G EO G R APH I C SCO PE

Step 1:

Include all countries that were monitored in the previous Access to
Medicine Index.

Step 2:	Include countries classified as low-income or lower-middle-income
countries, according to the most recent World Bank income groupclassification (FY2024).11
Step 3:

Include all countries defined as having low or medium human development, according to the most recent UNDP Human Development Report(2021).12

Step 4: 	Include all high-development countries with a low inequality-adjusted
human development index, according to the most recent UNDP Human
Development Report (2021).12 This enables the Index to track higherincome countries with significant levels of inequality.
Step 5: 	Include all Least Developed Countries (LDCs) as defined by the mostrecent ECOSOC list (2021).13

FIGURE 9 113 countries are included in the 2024 Access to Medicine Index

World Bank income classification
Previously included
UNDP Human Development Index group
UNDP inequality-adjusted Human
Development Index
Not in scope
New inclusion

19

Methodology for the 2024 Access to Medicine Index

TABLE 2 List of countries included in the 2024 Access to Medicine Index

East Asia & PacificMiddle East & North Africa

Cambodia

LMIC

Algeria

LMIC

Mali

LIC

China

UMIC

Djibouti

LMIC

Mauritania

LMIC

Indonesia

UMIC

Egypt

LMIC

Mozambique

LIC

Kiribati

LMIC

Iran		LMIC

Namibia

UMIC

Korea, Dem. People’s Rep.

LIC

Iraq		

UMIC

Niger

LIC

Lao PDR

LMIC

JordanLMIC

Nigeria

LMIC

Marshall Islands

UMIC

LebanonLMIC

RwandaLIC

Micronesia, Fed. Sts.

LMIC

MoroccoLMICSão Tomé and Príncipe

LMIC

Mongolia

LMIC

Palestine, State of/West Bank Gaza UMIC

SenegalLMIC

Myanmar

LMIC

Syrian Arab Republic

LIC

Sierra Leone

LIC

Papua New Guinea

LMIC

Tunisia

LMIC

Somalia

LIC

Philippines

LMIC

Yemen, Rep.

LIC

South Africa

UMIC

Samoa

LMIC

Solomon Islands

LMIC

South Asia

ThailandUMIC

Afghanistan

Timor-Leste

LMIC

Bangladesh

Tonga

UMIC

BhutanTuvalu

UMIC

Vanuatu

LMIC

Vietnam

LMIC

Europe & Central Asia

South Sudan

LIC

Sudan

LIC

LIC

Tanzania

LMIC

LMIC

Togo

LIC

LMIC

Uganda

LIC

India

LMIC

ZambiaLMIC

Maldives

UMIC

Zimbabwe

LMIC

Nepal

LMIC

PakistanLMIC

Sri Lanka

LMIC

Armenia

UMIC

KosovoUMIC

Sub-Saharan Africa

Kyrgyzstan

LMIC

AngolaLMIC

LIC

Low-income country

Moldova

UMIC

Benin

LMIC

LMIC

Lower-middle-income country

Tajikistan

LMIC

Botswana

UMIC

UMIC

Upper-middle-income country**

Turkmenistan

UMIC

Burkina Faso

LIC

HIC

High-income country**

UkraineLMIC

Burundi

LIC

World Bank Income classifications (FY2024)

Uzbekistan

LMIC

Cabo Verde

LMIC

Cameroon

LMIC

Latin America & Caribbean

Central African Republic

LIC

Belize

UMIC

Chad

LIC

Bolivia

LMIC

Comoros

LMIC

BrazilUMIC

Congo, Dem. Rep.

LIC

Colombia

UMIC

Congo, Rep.

LMIC

Dominican Republic

UMIC

Côte d’Ivoire

LMIC

Ecuador

UMIC

Equatorial Guinea

UMIC

El Salvador

UMIC

Eritrea

LIC

Guatemala

UMIC

Eswatini

LMIC

Guyana*HIC

Ethiopia

LIC

Haiti

LMIC

Gabon

UMIC

Honduras

LMIC

GambiaLIC

Jamaica

UMIC

Ghana

LMIC

MexicoUMIC

GuineaLMIC

Nicaragua

LMIC

Guinea-Bissau

LIC

Paraguay

UMIC

Kenya

LMIC

Peru

UMIC

Lesotho

LMIC

Saint Lucia

UMIC

Liberia

LIC

Suriname

UMIC

Madagascar

LIC

Venezuela

Unclassified

Malawi

LIC*Per the 2024 Index Methodology,
Guyana is included despite recently
receiving HIC classification. It will be
retained for six years, after which it will
be excluded from the country scope if it
does not meet other inclusion criteria.

**All UMICs and HICs in a low or medium
UNDP Human Development Index groupor with a low inequality-adjusted Human
Development Index were included.

20

Methodology for the 2024 Access to Medicine Index

WHAT WE M E ASU RE

Product scope
The product scope used in the 2024 Access to Medicine Index is deliberately­broad, in order to capture the wide-ranging product types available to supportthe ­prevention, diagnosis and treatment of relevant conditions and diseases incountries in scope of the Index. In 2024, as in the four previous iterations, the Index
continues to include the same eight product types in scope, as described below.
▶ Medicines
All medicines (both patented and non-patented) that directly treat a target­pathogen or disease process in scope are included, provided they meet inclusion
criteria. Medicines used only for symptomatic relief are not included▶ Microbicides
These include topical microbicides specifically intended to prevent HIV.
▶ Therapeutic vaccines
This covers vaccines intended to treat existing infections or diseases.
▶ Preventive vaccines
This covers vaccines intended to prevent infections.
▶ Diagnostics
This covers diagnostic tests designed for use in resource-limited settings (i.e.,
designed to be cheaper, faster, more reliable, easier to use in the field).
▶ Vector control products
These include pesticides, biological control compounds and vaccines targeting­animal reservoirs. Only chemical pesticides that are intended for global publichealth use and specifically aim to inhibit and kill vectors that transmit diseases
in scope of the Index are included. Likewise, only biological control interventions
that specifically aim to kill or control vectors associated with transmitting diseases
in scope of the Index are included. Only veterinary vaccines specifically designed
to prevent animal-to-human transmission of diseases covered by the Index are
included.
▶ Contraceptive methods and devices
This covers instruments, apparatuses, appliances, implants and other similaror related articles intended to be used for contraception (e.g., condoms or
diaphragms). It also includes combination products that deliver medicines (e.g.,
hormone-delivery contraceptive rings).
▶ Platform technologies
Only platform technologies that are specifically directed at meeting the needs ofpeople living in the countries covered by the Index are included. These comprise, forexample, general diagnostic platforms, adjuvants, immunomodulators and delivery
technologies and devices. Implants and platform technologies for ­reproductive
health are also included in this category. Platform technologies that have utility
for accelerating the development of health products for ‘Disease X’, a term usedby WHO to refer to currently unknown pathogens that could cause a serious­international epidemic, are also included.

21

Methodology for the 2024 Access to Medicine Index

How the Index measures
The 2024 Access to Medicine Index assesses company
behaviour using an analytical framework of 32 indicatorsorganised in three Technical Areas. The following pages set
out what each Technical Area measures and the rationale foreach indicator.
In this section:
I N D ICATO RS• Changes to the Methodology for the 2024 Index• Indicators per Technical Area and priority topic• Indicator rationales

22Methodology for the 2024 Access to Medicine Index

GOVE RNANCE O F ACCESS 			

15%

Overview of the Technical Area

Changes to the Methodology for the 2024 Index

To improve access to medicine both tangibly and sustainably,▶ In the Methodology for the 2024 Index there are sevenpharmaceutical companies must implement clear accessindicators, which is the same number as in the 2022 Index

strategies that focus on the long term. By enforcing rigorous

Methodology. However, significant updates have beenstandards of behaviour across their operations (including

made throughout the Technical Area; six out of sevenwith third-party contractors), companies can mitigate the risk

indicators have materially changed (including one mergerof practices that cause harm and undermine their efforts toimprove access to medicine.
The Governance of Access Technical Area looks at
how companies align their corporate strategies with theiraccess-to-medicine strategies, how they manage to achieve
their access-to-medicine goals and objectives, and how

and one new indicator).
▶ Two indicators from the 2022 Index Methodology havebeen merged into a single indicator, although what theindicator assesses has not changed. The merged indicatoris ‘GA2: Access-to-medicine strategy and outcomes’.
▶ Indicator ‘GA4: Responsible business practices’ has been

they incentivise managers to deliver on access-to-medicine

updated to ask for company policies on interactions withinitiatives. It also looks at how companies apply processes

healthcare professionals (HCPs) to include reference toto minimise the risk and occurence of non-compliant and/or

legitimate need for the interaction, as well as clarifying

corrupt behaviour, and the remedial actions companies takethe wording around expectations for publicly disclosing

when such breaches occur. Additionally, the Governance ofAccess Technical Area now looks at how companies measure
and report on patient reach.

information on transfers of value to HCPs.
▶ The wording of indicator ‘GA5: Ethics, risk and compliance’
has been updated to improve company understanding of
the information required and to look at ethical decisionmaking policies/frameworks.
▶ In the indicator ‘GA6: Incidence of breaches’, additional
analysis has been added to take into account publicly available evidence of remedial actions in the wake of a breach.
▶ ‘GA7: Trade policy: Intellectual property and accessto medicine’ has been updated to focus on company
intellectual property policies/statements, instead of theactions of the trade associations the companies belong to.
▶ A new indicator looking at the processes companies use
to measure and report on patient reach has been added
to the 2024 Index Methodology. This indicator is ‘GA8:
Measuring and reporting patient reach’.

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

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

GA1, GA2

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 strategy with measurable goals 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 publicly share their progress towards access-to-medicine goals.
2024 Indicator code

2024 Indicator text

Changes in 2024

Indicator rationale

GA1

Governance structures and incentives

Retained, with non-Assigning responsibility for access to medicine in

The company has a governance system that includes

material editorial

low- and middle-income countries (LMICs) at thedirect board-level responsibility and accountabilitychanges to indicatorhighest level of a company increases the chancefor its access-to-medicine initiatives. To facilitate

text.

that access-related objectives are given attention,effective implementation of the strategy, seniorremain on track and are achieved. Access-related

management (i.e., CEO and/or senior executives)

objectives and incentives encourage the CEO,and in-country operational managers have access-senior management and in-country/regional

to-medicine objectives and incentives to reward the

managers to perform towards achieving accesseffective delivery of initiatives that improve access togoals. Top-level responsibility is likely to trickle

medicine in countries, and for diseases, in scope of

down into the rest of the company, ensuring thethe Index.

prioritisation of access.

23

Methodology for the 2024 Access to Medicine Index

GOVE RNANCE O F ACCESS
2024 Indicator code

2024 Indicator text

Changes in 2024

Indicator rationale

GA2

Access-to-medicine strategy and outcomes

Merged with

An access-to-medicine strategy integrated in

The company has an access-to-medicine strategy

Indicator GA3.

the overall corporate strategy indicates that awhich it demonstrates is integrated within its

company considers access to medicine in LMICs tocorporate strategy and extends across the company’s

be relevant for its long-term growth, which makes

portfolio and pipeline, for diseases within scopeaccess to medicine more sustainable. The strategyof the Index. As part of the company’s access-to-should cover all products in the company’s portfolio

medicine strategy, it establishes and publicly shares

and all projects, particularly those deemed to be ofprogress on time-bound, measurable objectives,

significant public health importance.

goals, and targets related to improving access to
medicine in countries within scope of the Index, as

Public reporting of access-to-medicine outcomeswell as associated outcomes*.

informs external stakeholders of companies’
activities and progress, and enables accountability.

*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 to a country’s health system (such as the number ofhealthcare professionals trained).

GA3

Public disclosure of access-to-medicine outcomes

Merged with Indicator N/A

N/A

GA2 and removed as
standalone indicator.

Responsible business practices

Indicator(s)Corrupt behaviour and unethical marketing can have direct consequences for access to medicine, such as

GA4, GA5, GA6, GA7

the misdirection of national health budgets and promotion of the irrational use of medicines. Pharmaceuticalcompanies can limit misconduct by enforcing stringent ethics, risk and compliance processes across theiroperations, and with third parties, by modifying how they incentivise sales agents and by disclosing publicly how
they engage with healthcare professionals (HCPs). They should also implement policies to ensure they interact
ethically with HCPs, for example by setting limits on transfers of value (e.g., with fair market value assessments).
The Index expects companies to have in place controls to mitigate the risk of non-compliance for their operationsin LMICs. Companies should also be able to regulate the activities of contracted third parties. To assess theeffectiveness of controls, the Index checks for negative rulings and/or settlements with regards to unethicalmarketing, corruption, anti-competitive practices, and clinical trial misconduct in LMICs. In accordance with
their public standing, companies are expected to have intellectual property policies that are conducive to theinternational consensus on public health.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

GA4

Responsible business practices

Modified, with

Looking at responsible business practices provides

The company incentivises responsible business prac-material changes toinsights on where and how companies may influ-

tices by taking steps to decouple bonuses for sales

indicator text.

ence access in countries in scope of the Index, andagents* from sales volume targets only, evidencing

ensures greater transparency and accountability.

that sales targets are not set at the individual level
and that sales target bonuses represent a minimal

Decoupling sales agents’ financial rewards from theportion of overall compensation.

volume of medicine they sell removes the incentive
to engage in non-compliant behaviour (mis-sell,

The company has a clear public policy to ensure ethi-

oversell, or other undue influence) in order for thecal interactions with healthcare professionals (HCPs)

sales agent to obtain their compensation. This iswhich has provisions specifying the legitimate need

not only important to curb antimicrobial resistance,

for the interaction and limiting transfers of value**but also to prevent diversion of scarce resourcesin countries in scope of the Index. Additionally, thefrom health budgets and ensure appropriate accesscompany publicly discloses information about suchto medicine.

transfers of value in countries in scope of the Index,
where this is permitted by law.
*Including sales representative employees and third parties.
**Transfers could include payments for attending and/or
speaking at events, continuing medical education, promotional
activities, or other non-monetary benefits directed at HCPs.
Companies should have a process in place to determine
the legitimate need for HCP interactions and to ensure
fair market value at both payment per interaction level andcumulative/overall payments per HCP.

Public disclosure of transfers of value provide
accountability regarding the interactions between
companies and healthcare professionals, with theaim of, for example, curbing inappropriate incentives that can lead to irrational prescribing anddivert resources from already burdened healthcare
systems. It is also important for the appropriate useof company resources and managing external risks.

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Methodology for the 2024 Access to Medicine Index

GOVE RNANCE O F ACCESS
2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

GA5

Ethics, risk and compliance

Modified, with

Corruption can inhibit access to medicine, so it is

The company has one or more policies in place tomaterial changes toessential for companies to implement good ethics,

mitigate the risk of non-compliance in its operations

indicator text.

risk and compliance policies and procedures toin low- and middle-income countries (LMICs) –reduce this risk. Such policies and procedures aim

including by affiliated third parties – covering areas

to prevent non-compliant activities, which cansuch as ethical marketing, anti-corruption and clinicalnegatively affect access by undermining confidence

trials. The company also has country- or region-in the pharmaceutical sector, diverting scarcespecific procedures* in place to operationalise theresources from health budgets, impacting prices

policies, taking into account country- or region-and limiting the availability of medicines in thespecific risks. In addition, the company has a policy

public sector.

or framework in place to guide and promote ethicaldecision-making among employees.
*The Index looks for procedures such as fraud-specific risk
assessment, country or region risk-based assessments andprocesses to ensure third-party compliance.

GA6

Incidence of breaches

Modified, with

Breaches of codes/regulations/laws can under-

The company has not been found to be the subject

material changes tomine confidence in the pharmaceutical sector,of negative legal rulings or settled legal cases forindicator text.

divert scarce resources from health budgets,

unethical marketing practices, corrupt practices, anti-

impact prices and limit the availability of medicinescompetitive practices, or misconduct in clinical trials

in the public sector. Such civil, criminal and regu-

in countries within scope of the Index during the past

latory infractions provide information about thetwo years. In the event of such a ruling or settlement,

quality of a company’s compliance systems andthere is publicly available evidence that the company

responses to unethical or illegal behaviour.

has taken remedial actions (including cooperation
with authorities) and steps designed to ensure theThough cases of breaches may not be identified

breach does not occur in future.

by such regulatory or law enforcement entities in
LMICs and not exposed publicly, they do occur.
Therefore, the Index assesses whether companies
have been the subject of breaches in countries inscope of the Index involving unethical marketing
practices, corrupt practices, anti-competitive
practices, or misconduct in clinical trials.
Remedial actions following a breach, as wellas actions designed to ensure breaches do notreoccur, are important to demonstrate companies
are accepting responsibility for the breach and areworking to guarantee adherence to good businesspractices.

GA7

Trade policy: Intellectual property and access to

Modified, with

Where a company applies an IP strategy which

medicinematerial changes todoes not operate in accordance with the inter-

The company employs an intellectual property (IP)indicator text.

national consensus on IP standards (through, forstrategy conducive to creating access to medicine.

example, exerting pressure on governments not toThis is in accordance with the rights of national

incorporate provisions from the Doha Declaration

governments to deploy IP systems flexibly, as definedon the TRIPS flexibilities within national legisla-by the international framework on IP (i.e., the Dohation), there can be a knock-on negative impact to

Declaration on the TRIPS Agreement and Publicaccess to medicine in those countries. The Index

Health). This is evidenced by the company having

looks at a company’s public IP policy, and thea publicly available IP policy or statement which

extent to which that policy aligns with the prin-discloses explicit support for, and is in line with, theciples embodied within the Doha Declaration on

principles embodied within the Doha Declaration on

TRIPS and Public Health.

TRIPS and Public Health.

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Methodology for the 2024 Access to Medicine Index

GOVE RNANCE O F ACCESS
Measuring and reporting patient reachIndicator(s)Measuring and reporting patient reach numbers helps to identify gaps in access to medicine to allow for better

GA8

allocation of resources. Companies are expected to publicly publish a methodology explaining how they calculatepatient reach, as well as patient reach numbers, outcomes and improvements.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

GA8

Measuring and reporting patient reach

New indicator.

Implementing policies and processes to define,The company has a process in place for measuring

measure, and report on the numbers of patientspatient reach that:reached by a company’s products promotesa)		Is publicly available in terms of underlying

transparency, accountability, and corporate social

methodology (equation/metrics/assumptions/

responsibility. By measuring and reporting on

limitations);

patient reach, companies and their partners canb) extends across the company’s portfolio, fordiseases within scope of the Index;c)		covers all countries within scope of the Index,

identify gaps in access, address disparities, andbetter allocate resources to improve health equity
and the lives of underserved populations.

where the company’s products are sold;d) regularly reports resulting patient reach numbers
publicly;e) incorporates clear goals and objectives to measureand improve* patient reach and associated healthoutcomes over time, and can demonstrate such
improvements.
*Improvement in patient reach does not necessarily mean anincrease in patients receiving a product (for example, where thegoal of a product is elimination or eradication of a disease).

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Methodology for the 2024 Access to Medicine Index

RESE ARCH AN D D EVE LO PM E NT 			

30%

Overview of the Technical Area

Changes to the Methodology for the 2024 Index

Large research-based pharmaceutical companies play a▶ Seven indicators remain in the R&D Technical Area in thesignificant role not only in developing new medicines and2024 Index Methodology. Two out of seven indicators inother lifesaving products needed in low- and middle-income

this Technical Area have materially changed.

countries (LMICs), but also in bringing them to market.

▶ Within the 2024 Index pipeline analysis, ‘RD1b: Other

Planning during drug development to improve access is

R&D projects’ has been reworded to reflect that the Index

needed to make such new products rapidly available tonot only assesses R&D pipeline projects that are definedpeople who need them, wherever they live.

as addressing a ‘public health need’ (e.g., by targeting aThis Technical Area analyses in-house and collaborative
research and development (R&D) activity that aims todevelop or adapt products for diseases, conditions and path-

new population), but all R&D projects that are addressing
diseases or conditions in scope of the Index (that are notdeemed priority R&D under RD1a).

ogens in scope of the Index, and in response to the needs of▶ For the 2024 Index, the indicator ‘RD3b: Access planning

people living in LMICs. It also examines whether companies

for other R&D projects’ has been changed to now assessplan sufficiently during the development of their products toaccess plans for all other R&D pipeline projects, beyond

make sure those that are successful become swiftly acces-

those that address an R&D priority gap. Access planssible in LMICs, and the extent to which they engage in R&D

for late-stage projects (from Phase II onwards) that arecapacity building.

included under indicator RD1b will be assessed under thisindicator.
▶ The scope of the ‘RD2: Planning for access: Framework’
indicator has been expanded to evaluate whether companies make a public commitment to access planning in
LMICs for pipeline candidates from Phase II onwards (e.g.,on their website).

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

RD1a, RD1b, RD4

public health needs in LMICs, where products are suitable for those populations. Companies can do this either
in-house or 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.5-10
Additionally, the Index tracks product development for other diseases in scope for which R&D priorities
have not yet been independently assessed (such as non-communicable diseases), as these diseases cause adisproportionately high burden in LMICs. Companies are also expected to disaggregate and disclose the resources
they dedicate to such R&D.

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Methodology for the 2024 Access to Medicine Index

RESE ARCH AN D D EVE LO PM E NT 		2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

RD1a

R&D pipeline: Prioritised diseases

Retained, with noLarge research-based companies have the capacity,

The company engages in the development ofchanges to indicatorthrough R&D, to help address public healthproducts that target priority product gaps identified

text.

needs in LMICs for identified priorities. They areby global health research organisations.* This

well positioned to ensure that these products

includes innovative and adaptive R&D and in-houseprogress through the pipeline, even if there is little

and collaborative R&D.

commercial incentive. Additionally, companies
should ensure that new product developments*Currently, the Index categorises R&D priorities using lists
from WHO and Policy Cures Research.

specifically address access barriers in LMICs by:
1.		Creating new formulations to improve stability,
administration or adherence (e.g., heat-stable
formulations, dispersible oral formulations,long-acting formulations, new fixed-dose
combinations).
2.		Inclusion of special populations as it pertains
to clinical research (e.g., pregnant/lactating
individuals, children (<12 years), the elderly andimmunocompromised).
3.		Significantly improving the administrative
burden, or total healthcare costs of existingproducts (e.g., require fewer hospital/clinic
visits, long acting injectables, self-administeredformulations).
4.		Carrying out clinical trials in countries in scopeof the Index.

RD1b

R&D pipeline: Other diseases

Retained, with non-The company engages in R&D (both innovative

The company engages in the development ofmaterial editorial

and adaptive) for all other diseases in scope of

products for other diseases in scope of the Indexchanges to indicatorthe Index (for which global health stakeholders

beyond the R&D priorities identified by global healthtext.

have not formally identified priority product gaps).

research organisations.* This includes innovative andAdditionally, companies should ensure that new

adaptive R&D.

product developments specifically address accessbarriers in LMICs by:*Currently, the Index categorises R&D priorities using lists
from WHO and Policy Cures Research.

1.		Creating new formulations to improve stability,
administration or adherence (e.g., heat-stable
formulations, dispersible oral formulations,long-acting formulations, new fixed-dose
combinations).
2.		Inclusion of special populations as it pertains
to clinical research (e.g., pregnant/lactating
individuals, children (<12 years), the elderly andimmunocompromised).
3.		Significantly improving the administrative
burden, or total healthcare costs of existingproducts (e.g., require fewer hospital/clinic
visits, long acting injectables, self-administeredformulations).
4.		Carrying out clinical trials in countries in scopeof the Index.

RD4

Disclosure of resources dedicated to R&D

Retained, with non-Public disclosure of R&D investments can be used

The company publicly discloses the resourcesmaterial editorial

to identify and prioritise areas of limited financial

dedicated to its R&D activities conducted in-housechanges to indicator

investment, where additional investment from theand/ or in collaboration for diseases within scope oftext.

public and private sector are needed. This can help

the Index.

promote transparency of R&D funding across thevalue chain and build understanding about thecapital needed to bring different types of products,from different therapeutic areas, to market.

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Methodology for the 2024 Access to Medicine Index

RESE ARCH AN D D EVE LO PM E NT 		
Access planning

Indicator(s)Planning for access helps pharmaceutical companies ensure they take public health needs into account duringRD2, RD3a, RD3b

product development. Such planning can help those in LMICs to gain access to products more rapidly andaffordably following their market entry. When companies establish a structured process to develop access plans,
this can help such planning become standard practice. Companies are expected to develop plans for all pipeline
projects from Phase II of clinical development onwards.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

RD2

Planning for access: Framework

Modified, with

By establishing a structured framework and

The company ensures it plans for equitable accessmaterial changes toapproach to develop access plans for all productfor all products it develops successfully (bothindicator text.

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

RD3ain-house and collaboratively) for people in LMICs,

a company increases the likelihood of developing

and demonstrates a systematic approach to accesslong-term access plans as early in the process as

for all R&D projects, which is applied from Phase

possible. When a company publicly commits to

II of clinical development onwards. The company

a systematic approach to access planning duringmakes public commitments addressing its systematic

R&D, this can help to ensure accountability, and canapproach to access planning for LMICs.

reinforce existing efforts.

Planning for access: Project-specific plans for

Retained, with noAdvance access planning is particularly critical forprioritised diseases

changes to indicator

R&D projects developed to address key productThe company ensures that all R&D projects for

text.

gaps relevant to patients in LMICs. Companies

diseases prioritised by WHO and Policy Cures

should ensure these products quickly reach the

Research are supported by detailed commitments

people who need them by planning for accessand strategies to improve access to products induring clinical development (starting from Phase

countries within scope of the Index.

II). To increase the impact on public health, thecompany’s access plans should go beyond filing forregistration and consider affordability and aspects
such as supply and demand planning, partneringwith an access-oriented organisation, equitablepricing, WHO prequalification, post-trial access,technology transfers, product donations, patent
waivers and non-exclusive voluntary licensing.
Also, where applicable, companies should ensure
inclusion of special populations, such as pregnant
and breastfeeding individuals, children, and theelderly, in clinical research.

RD3bPlanning for access: Project-specific plans for

Modified, with

To ensure successful products can be madeother diseases

material changes toavailable swiftly and widely, R&D projects require

The company ensures that all its R&D projects

indicator text.

advance access planning. Companies should ensure

targeting diseases in scope of the Index (beyond

these products are quick to reach the people

those identified as R&D priorities by WHO and Policy

who need them by planning for access during

Cures Research) are supported by detailed plans toclinical development (starting from Phase II). To

improve access to products in countries within scope

strengthen the potential impact on public health,of the Index.

the company’s access plans should go beyond
filing for registration and consider affordability
and aspects such as supply and demand planning,
partnering with an access-oriented organisation,
equitable pricing, WHO prequalification, post-trial
access, technology transfers, product donations,patent waivers and non-exclusive voluntary
licensing. Also, where applicable, companies should
ensure inclusion of special populations, such as
pregnant and breastfeeding individuals, children
and the elderly, in clinical research.

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Methodology for the 2024 Access to Medicine Index

RESE ARCH AN D D EVE LO PM E NT
Building R&D capacity

Indicator(s)Pharmaceutical companies have the expertise and ability to support the continuing development of R&D sectors

RD6

in LMICs. Companies can engage in relevant activities, such as increasing clinical trial capacity (beyond their own
interests and/or pipelines) or setting up research networks, to build local R&D capacity and support the development of research skills. In turn, this can enable local researchers to address relevant health needs and priorities.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

RD6

Capacity building in R&D

Retained, with non-For the development of medicines that can treat

The company increases local capacity for healthmaterial editorial

local diseases, meet local needs, and correspondresearch (including clinical trial capacity) and productchanges to indicator

to disease patterns in countries in scope, it isdevelopment by undertaking R&D capacity-building

text.

important to support local R&D. Companies needinitiatives in partnership with local universities and/to be incentivised to take action for building local

or public sector research organisations in LMICs.

R&D capacity that goes beyond their own interests

These initiatives address local R&D capacity needs,

and/or pipeline, as they have expertise in R&D thatpriorities and/or skills gaps in countries in scope

they can share locally.

of the Index. The Index assesses whether these
initiatives meet Good Practice Standards (GPS).**I.e., has good governance structures in place; initiative goalsalign with, or support, institutional goals; measures outcomes;
and has long-term aims/aims for sustainability.

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Methodology for the 2024 Access to Medicine Index

PRO DUCT D E LIVE RY			

55%

Overview of the Technical Area

Changes to the Methodology for the 2024 Index

Choices that pharmaceutical companies make regarding▶ In the 2024 Index Methodology there are 18 indicators in

the delivery of their products strongly influence countries’

the Product Delivery Technical Area, compared to 17 in theefforts to achieve Universal Health Coverage. As a first step,2022 Index Methodology. Ten indicators in this Technicalcompanies must register their products for sale where they

Area have materially changed (with two new indicators

are needed, so that they can be made swiftly available toand one merger).

populations in need. Companies can then deploy three main

▶ The main shift in this Technical Area is the increased focus

access strategies that have the greatest potential for impact

on capturing patient reach in the three access strategy indi-on the supply and affordability of medicine: equitable accesscators (‘PP3: Access strategies: Supranationally procured

and pricing strategies, responsible intellectual property (IP)products,’ ‘PP4: Access strategies: Healthcare practitioner-­management and product donations.

administered products’ and ‘PP5: Access strategies: Self-

This Technical Area assesses how companies improveadministered products’). PP4 and PP5 have now each beenaccess to their products through a variety of mechanisms,

split into part ‘a’ and ‘b’, signifying the relative importanceincluding registration, pricing strategies, responsible IP man-of both the quality of the access strategy (part a) and out-

agement, inclusive business models and product donations. It

comes of the strategy, including patient reach (part b). PP3

also examines how companies design and measure outcomes

will remain as one indicator but has also been modified toof their access strategies and tailor their tools to boost

include measurement of patient reach and outcomes.

access. Further, it captures how companies leverage their▶ Analysis in ‘PBM1: Inclusive business models’ has been

expertise and resources to address significant local barriers

modified to expand the target population addressed andto access. Such barriers might include gaps in local healthcare

to focus analysis on models offering company products

infrastructure, poorly functioning supply chains and/or weakquality assurance systems.

instead of building capacity of separate models.
▶ ‘PQ1: Ensuring continuous supply’ has been modified tocollect additional data on company efforts to support
manufacturing capacity in low- and middle-income
countries (LMICs).
▶ Under ‘PR1: Registration,’ mechanisms to facilitate­registration, will be newly considered for analysis.
▶ PP2a has been modified to include public commitments toadhere to international standards.
▶ ‘PPL4: Access-oriented licensing’ and ‘PPL5: Licensing:Geographic scope’ have been merged into a single
indicator, ‘PPL4: Quality and geographic coverage ofaccess-oriented licensing.’

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

PR1look at how widely pharmaceutical companies file to register their newest products in countries in scope andmake them available for patients’ use in these countries. Companies are expected to prioritise registration incountries with a high burden of disease, and to aim for registration in LMICs within 12 months of first global
regulatory approval by, for example, the European Medicines Agency, Food and Drug Administration, or JapanesePharmaceuticals and Medical Devices Agency. Where applicable, companies can engage in Collaborative
Registration Procedures (CRP), among other mechanisms, to facilitate widespread registration in LMICs.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PR1

Registration performance

Modified, with

Filing to register products in LMICs is a critical step

The company broadly files to register its most recently

material changes toto enable more widespread access in these coun-launched* products that target diseases in scope ofindicator text.

tries, especially in those with high disease bur-the Index, in countries with the highest disease burden.

dens. Companies should engage with international

The company provides evidence of engaging withorganisations and regulators to facilitate inter-mechanisms to facilitate registration, such as WHO

national regulatory reliance. Participating in joint

Collaborative Registration Procedure, where applicable.

assessments and other procedures can also help*’Most recently launched’ refers to the date that the productwas first approved to be marketed anywhere globally. The
Index analyses information for up to ten of the company’s
most recently launched products, depending on the size of thecompany’s portfolio.

build capacity of regulatory authorities in LMICs,
thus facilitating and accelerating the registrationof products.

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Methodology for the 2024 Access to Medicine Index

PRO DUCT D E LIVE RY
Equitable access strategies and outcomes

Indicator(s)Equitable access means no one is left behind, with everyone in LMICs – including lower-income groups with

PP3, PP4a, PP4b, PP5a, PP5blimited ability to pay – able to benefit from products. Companies are expected to apply access strategies to key
products across LMICs, 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 by integrating payers’ ability to pay for a product into theirpricing approach.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PP3

Access strategies: Supranational products

Modified, withThis indicator evaluates products for which

The company applies access strategies to its supra-material changes tocompanies engage with market-shaping and/nationally procured products* and extends thoseindicator text.

or pooled procurement organisations, such as

strategies to countries in scope of the Index which

UNICEF; Gavi, the Vaccine Alliance; and the Global

do not qualify for the procurement agreements.

Fund to Fight AIDS, Tuberculosis and Malaria, toThis is evidenced by:increase access. Importantly, it also assesses thea) an access strategy to supply the product through aextent to which companies consider access tosupranational procurement agreement;b) an access strategy for a country outside of the

products for countries which do not qualify forsuch support.

procurement agreement that demonstrates how
relevant payer(s)’ ability to pay is considered, andhow additional strategies improve the affordability
and availability of the product for the different
segments of the country’s population across thefull income pyramid. The company’s strategy
demonstrates goals aimed at improving patients’
health outcomes and tracks the progress** of theaccess strategy to ensure that goals are achieved.
This is evidenced by:i) methods to define the total eligible patient
population***;ii) evidence of patient reach during the period ofanalysis;iii) evidence of how the strategy has progressed**,and future plans for advancing the strategy.
*Products for which international pooled procurement,
advance market commitments, market-shaping facilities andsignificant public funding and donor support exist. These
products include vaccines and products indicated for thetreatment of HIV, tuberculosis, malaria, neglected tropicaldiseases, and reproductive health.
**An increase in the number of patients reached, or
elimination/eradication targets achieved.
***Eligibility is defined as the patients that have been diagnosed or identified by a healthcare professional as suitable
recipients of the product based on the licensed indication.
Note: Companies that do not market these products will nothave this indicator applied to them.

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Methodology for the 2024 Access to Medicine Index

PRO DUCT D E LIVE RY2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PP4aAccess strategy quality: Healthcare practitioner-

Modified, with

Companies have an important role in supporting

administered products

material changes togovernments to achieve universal health coverage

The company takes into consideration both theindicator text.

by improving the reach of products across therelevant payer(s)’ ability to pay and the demographic*

income pyramid. Companies should carefully

characteristics of a country to determine its accessdetermine different payer(s)’ ability to pay, taking

strategy, aiming to improve the affordability andsocioeconomic into account. Products that needavailability of its healthcare practitioner-administered

the oversight of a healthcare practitioner for

products** and increase reach among patients acrossadministration are likely to be more complex andthe income pyramid.

require more sophisticated health systems forThis is evidenced by:administration and ongoing care. Companies maya) an access strategy that demonstrates how thetherefore choose to also partner with organisations

relevant payer(s)’ ability to pay for the different

to build capacity and/or strengthen health systems.

segments of the population is considered and any

Companies can choose to use a mix of strategies

additional strategies*** to complement pricing

to maximise their product reach: intra-country

strategies;

segmentation, licensing and donations.

b) initiatives to strengthen health systems and build
capacity to ensure the continuum of care for the
product.
*The characteristics of a population such as age, sex, income
level, education level, employment, etc.
**Products that often require either hospital administrationof the product or the attention of a skilled healthcare
professional during administration.
***For example, patient assistance programmes, donations,
voluntary licensing, technology transfer etc.
Note: Companies that do not market these products will nothave this indicator applied to them.

PP4b

Access strategy outcomes: Healthcare

New indicator.

To determine the success of their accesspractitioner-administered products

strategies, companies should have goals in place

The company demonstrates it has a process in place

to increase access to patients across the income

to monitor the performance of the access strategy

pyramid. Successful strategies should be evidenced

for its health practitioner-administered products

by an increase in patient numbers (or a decrease

aimed at reaching patients across the income

when eradication is the goal) both to date andpyramid. The company’s strategy demonstrates goals

along with future projections.

aimed at improving patients’ health outcomes andtracks the progress* of the access strategy to ensurethat goals are achieved.
This is evidenced by:a) methods to define the total eligible patient population** and patient reach;b) evidence of patient reach during the period ofanalysis;c) evidence of how the strategy has progressed*, andfuture plans for advancing the strategy.
*An increase in the number of patient of patients reached, or
elimination/eradication targets achieved.
**Eligibility is defined as the patients that have been diagnosed or identified by a healthcare professional as suitable
recipients of the product based on the licensed indication.
Note: Companies that do not market these products will nothave this indicator applied to them.

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Methodology for the 2024 Access to Medicine Index

PRO DUCT D E LIVE RY2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PP5a

Access strategy quality: self-administered

Modified, with

Companies have an important role in supporting

products

material changes togovernments to achieve universal health coverage

The company takes into consideration both the rel-indicator text.

by improving the reach of products across theevant payer(s)’ ability to pay and the demographic*

income pyramid. Companies should carefully

characteristics of a country to determine its accessdetermine different payer(s)’ ability to pay, taking

strategy, aiming to improve the affordability and avail-socioeconomic factors into account. Companies

ability of its self-administered products and increase

can choose to use a mix of strategies to maximise

reach among patients across the income pyramid.

their product reach: intra-country segmentation,
licensing and donations.

This is evidenced by an access strategy that demonstrates how all the relevant payer(s)’ ability to pay forthe different segments of the population is considered and any additional strategies** to complement
pricing strategies.
*The characteristics of a population such as age, sex, income
level, education level, employment, etc.
**For example, patient assistance programmes, donations,
voluntary licensing, technology transfer etc.

PP5b

Access strategy outcomes: self-administered

New indicator.

To determine the success of their access strategies

products

companies should have goals in place to increase

The company demonstrates it has a process in place

access to patients across the income pyramid.

to monitor the performance of the access strategy

Successful strategies should be evidenced by an

for its self-administered products aimed at reaching

increase in patient numbers (or a decrease when

patients across the income pyramid. The company’s

eradication is the goal) both to date and along withstrategy demonstrates goals aimed at improving

future projections.

patients’ health outcomes and tracks the progress*of the access strategy to ensure that goals areachieved.
This is evidenced by:a) methods to define the total eligible patient population** and patient reach.
b) evidence of patient reach during the period ofanalysis.
c) evidence of how the strategy has progressed*, andfuture plans for advancing the strategy.
*An increase in the number of patient of patients reached orelimination/eradication targets achieved.
**Eligibility is defined as the patients that have been diagnosed or identified by a healthcare professional as suitable
recipients of the product based on the licensed indication.
Note: Companies which do not market these products will nothave this indicator applied to them.

Intellectual property strategy

Indicator(s)Responsible, transparent management of intellectual property (IP) can stimulate R&D by third-party research-

PPL1, PPL2, PPL3

ers. 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 newmarkets and the decision-making of international procurers. Companies are expected to publish patent statuses
and implement patent filing/enforcement policies to mitigate the risk that patent protections will limit R&D andproduct availability and affordability.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PPL1

Patent filing and enforcement

Retained, with non-Clarity about where patents are to be filed,

The company publicly commits to not file for (ormaterial editorial

or will be enforced, gives greater certainty to

enforce) patents relating to diseases in scope inchanges to indicator

international drug procurers and generic medicine

Least Developed Countries, low-income countries,

text.

manufacturers when planning the manufacture

and in a subset of lower-middle-income countries

and/or supply of generic products.

and upper-middle-income countries.

34

Methodology for the 2024 Access to Medicine Index

PRO DUCT D E LIVE RY2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PPL2

Patent status disclosure

Retained, with non-Transparency is part of the social contract that

The company publicly discloses the patent statusmaterial editorial

underlies the patent system. When transparencyof its products for diseases in scope of the Index, inchanges to indicatoris standard, this supports procurement agencies tocountries within scope.

text.

make important decisions about which products
to supply. Companies should have a transparent
approach for all relevant therapeutic areas andproduct types, including biologics.
Companies should disclose detailed informationon the status of their patents, including the natureof the patent, filing date, grant number, grant dateand jurisdiction.

PPL3

IP sharing

Retained, with non-

When a company shares its intellectual property

The company provides evidence of sharing its IP

material editorial

on terms conducive to increasing access, this(such as molecule libraries, patented compounds,changes to indicator

can accelerate R&D efforts and help to makeprocesses and technologies) with research institu-

text.

new products available to populations in need intions and neglected disease drug discovery initiatives

LMICs. Such potential for access is optimised when(such as World Intellectual Property Organizationcompanies share their more valuable assets, such

Re:Search, Medicines for Malaria Venture, Coronaas those more likely to accelerate product entry

accelerated R&D in Europe) that are developing

into the market.

products for diseases and countries in scope of theIndex.

Licensing quality

Indicator(s)Non-exclusive voluntary licensing supports the market entry of alternative manufacturers of patented products,

PPL4

in turn supporting a more secure supply of products and enhancing affordability through increased competition.
Pharmaceutical companies 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. Additionally, a broad range of countries should be included within thegeographic scope of the licence to ensure widespread access for people living in LMICs.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PPL4

Quality and geographic coverage of access-Merged with

Licences allow generic medicine manufacturers

oriented licensing

Indicator PPL5.

to enter markets where a large research-based

The company grants access-oriented, transparent,

pharmaceutical company might not be distributing

non-exclusive voluntary licences which include

a product already, resulting in access to genericclauses that facilitate affordability and supply ofversions of the patented medicine. Access-oriented

quality products. The company includes a broad

terms provide generic medicine manufacturers

range of countries within the geographic scopewith additional flexibility (in manufacturing and/of its licences, from a range of country income

or distribution processes, for example) supportingclassifications.*

them to optimise affordability and supply. Qualityof these terms is assessed according to the context*Low-income countries, lower-middle income countries andupper-middle income countries in scope as defined by theWorld Bank country classification by income level.

of the licence (type of product, indication, etc).
Including more countries in a licence will increase
the potential for that licence to make an impact
on public health. Often, the terms of voluntary
licences exclude entire populations of middleincome countries. To increase access to medicine
and its benefits for public health, voluntary licences
should include those populations with proven need.

PPL5

Licensing: Geographic scope

Merged with

N/A

Indicator PPL4.

N/A

35

Methodology for the 2024 Access to Medicine Index

PRO DUCT D E LIVE RY
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 opportunity
to access the medicines they need. Pharmaceutical companies supplying such products are expected to publicly
commit to remaining engaged until established elimination, eradication and control goals are reached. Companies
must also be able to respond rapidly to requests for ad hoc donations, taking steps to ensure that their products
reach the end user.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PP2aAccess strategies: Ad hoc donations

Modified, with

Ad hoc donations can fill critical resourcing gaps

The company has public policies and supply

material changes towhen health systems are under strain. When

processes* in place to ensure ad hoc donations**

indicator text.

donations are made ad hoc in humanitarian

are carried out rapidly in response to expressedsituations (e.g., conflicts, natural disasters), theyneed. Efforts are made - in house and/or via partner

should be made rapidly in response to expressedorganisations - to monitor delivery of donations toneed. Companies should also monitor donations toensure that they reach the patient.

ensure that they reach the patient so that products
are not damaged, sold, misused, or redirected.

*These policies and processes should align with the latest
WHO guidelines for medicine donations.
**A donation 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

Retained, with non-Long-term donation programmes can be a route

programmesmaterial editorial

to increased access to medicine for those with

The company engages in long-term, sustainablechanges to indicator

limited ability to pay. They play a specific role inproduct donation programmes for neglected tropicaltext.

elimination, eradication and control programmes

diseases, where goals of elimination, eradication andwhere there is a limited ability to pay for products.

control are possible and realistic.* It publicly commits

Public disclosure of a commitment with no time

to remaining engaged in these donation programmes

limit indicates a company’s intention to continue

for as long as needed to support the achievement of

donating products for as long as needed to support

such goals.

the achievement of public health goals.

*These goals are aligned with the World Health Organization’s
2021-2030 Roadmap for Neglected Tropical Diseases

Inclusive business models

Indicator(s)To achieve Universal Health Coverage, companies must develop and implement inclusive business models that

PBM1

address access needs for their products, reaching the most vulnerable groups. These models specifically address
the access needs of populations that may not be reached by existing business models due to social, economic or
health factors. In addition to positive patient outcomes (e.g., increased affordability and awareness), these models
can benefit a company through access to new markets, increased earnings and innovations that are transferrable
to other contexts.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PBM1

Inclusive business models

Modified, with

Companies should develop and implement

The company develops and implements inclu-

material changes toinclusive business models to address access issues

sive business models that aim to provide its prod-

indicator text.

for populations in LMICs that are overlooked byucts to populations in LMICs that have been under-

existing business models. Inclusive business models

served or unserved, by existing business models.*

can bring benefits to patients and business alike,

These models work in partnership to address access

improving health outcomes, strengthening supply

issues and have long-term plans for scalability and tochains, increasing affordability and expandingachieve a sustainable source of revenue in the longmarkets.

term. Outcomes of these models are measured overtime.
*This can include vulnerable populations that are at a higher
risk of facing barriers to accessing medicines due to social,economic and/or health considerations.

36

Methodology for the 2024 Access to Medicine Index

PRO DUCT D E LIVE RY
Quality and supply

Indicator(s)Inefficiencies and weaknesses in supply chains (whether in procurement processes, delivery logistics, storage

PQ1, PQ2, PCB2

or at other stages) can have a stark impact on the accessibility, availability and quality of medicines. To identify
bottlenecks and improve capacity for good supply chain management in 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.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PQ1

Ensuring continuous supply

Modified, with

Ensuring continuous supply and preventing the risk

The company has mechanisms in place to improvematerial changes toof stockouts means patients who need essential

supply chain efficiency and takes informed action toindicator text.

medicines can continue to access high-quality

ensure uninterrupted supply. The company uses the

products.

following mechanisms to make products available insufficient quantities in a timely manner in LMICs:a) The company has a system in place and works with
relevant stakeholders (e.g., government agencies,
distributors, hospitals, warehouses, wholesalers, orother relevant networks) to communicate about
issues that may affect the supply chain.
b) The company manages a buffer stock of relevant,finished products.
c) The company works with several active pharmaceutical ingredient (API) suppliers, holds API buffer
stocks and/or produces in-house APIs.
d) The company works to enhance local supply
capacities and strengthen supply chains.*e) The company transfers technology (e.g., for API,vaccine adjuvant and/or drug product) to manufacturers to improve manufacturing capacity andavailability in LMICs* and/or manufactures relevant
products in LMICs.
*Analysis is based on submission in PCB1 and PCB2.

PQ2

Reporting substandard and falsified medical

Retained, with non-Reporting confirmed cases of SF medical products

products

material editorial

in a timely manner to the relevant authority is

The company has a policy or procedure for reportingchanges to indicator

important from a public health point of view,

confirmed cases of substandard and falsified (SF)text.

allowing withdrawal from the market quickly.

medical products in countries in scope of the

SF medical products can cause harm and death.

Index to relevant stakeholders (national regulatory

Pharmaceutical companies have a responsibility toauthorities and WHO Rapid Alert)* in a timely

ensure access to quality products and to mitigate

manner**. This prioritises the minimisation of harm

the risk of harm by sharing information with healthto public health.

authorities rapidly.

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

The Index looks at specific policies or proceduresin place that require a company to consistently
report confirmed SF cases in a timely manner.
Some stakeholders argue that it is good practicefor companies to alert relevant authorities as soon
as they suspect a case.

37

Methodology for the 2024 Access to Medicine Index

PRO DUCT D E LIVE RY2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PCB2

Capacity building in supply chain management

Retained, with non-An inefficient supply chain can significantly impact

A company undertakes supply chain capacity building

material editorial

access to medicine. It can increase the risk ofinitiatives in countries within scope of the Index inchanges to indicator

low-quality, substandard/falsified medicines andpartnership with local stakeholders (e.g., ministries

text.

stockouts. Companies have a role in supportingof health and public procurement, logistics andstrong, resilient supply chains which also benefit

distribution agencies) with the aim of improving the

products beyond their own portfolios.

affordability, accessibility and quality of products,
including products outside of its own portfolio. The
Index assesses whether these initiatives meet Good
Practice Standards (GPS).**I.e., guided by clear, measurable goals and/or objectives;
measures outcomes; has long-term aims/aims forsustainability.

Local manufacturing

Indicator(s)Making medicines locally can help to reduce costs and improve supply, but quality must be guaranteed. When

PCB1

pharmaceutical companies work with third-party manufacturers in LMICs, they can take steps to ensure local
staff have the 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 bringbroader value in terms of quality manufacturing to build local capacity beyond that needed for their own products
and portfolios.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PCB1

Capacity building in manufacturing

Retained, with non-Companies have a role in supporting local manu-

A company undertakes manufacturing capacity

material editorial

facturing outside of their own plants, contribut-

building initiatives in partnership with third-party/changes to indicator

ing to the quality manufacturing of other prod-

unaffiliated local manufacturers or other external

text.

ucts. Local manufacturing can bring medicines toparties (e.g., universities) in LMICs. These initiatives

market in LMICs more quickly, and can simplify

address local manufacturing capacity needs, priorities

supply chains.

and/or skill gaps in countries in scope of the Index.
The Index assesses whether these initiatives meet
Good Practice Standards (GPS).**I.e., guided by clear, measurable goals and/or objectives; measures outcomes; has long-term aims/aims forsustainability.

Health system strengthening

Indicator(s)Robust health systems must be in place for products to be deployed, prescribed and administered safely

PCB3

and effectively. Such systems may include infrastructure, trained health professionals, diagnostic capacity,
data management and the means to reduce stigma. Although health system strengthening is not a central
responsibility of pharmaceutical companies, their expertise and capacity can be used to help support efforts
made by other partners. Companies must manage conflicts of interest and monitor outcomes.

2024 Indicator code

2024 Indicator

Changes in 2024

Indicator rationale

PCB3

Health system strengthening

Retained, with non-While health systems are the primary responsibility

With measures in place to mitigate or prevent

material editorialof governments, companies can provide support.

conflicts of interest, a company works in partnerships

changes to indicator

Well-functioning health systems promote better– including with local stakeholders – to undertake

text.

diagnosis, pharmacovigilance, disease surveillance

health system strengthening initiatives that address

and overall treatment. They are critical for

local needs in countries in scope of the Index. Suchsustainable access to medicine.

initiatives work in a coordinated way with otherparties, complementing the local health system, withoutcomes clearly monitored. The Index assesses
whether these initiatives meet Good PracticeStandards (GPS).**I.e., guided by clear, measurable goals and/or objectives;
measures outcomes; publicly discloses outcomes; has longterm aims/achieves integration within the local health system

38Methodology for the 2024 Access to Medicine Index

AppendicesIA 	Diseases in scope of the 2024 Access to Medicine
IndexIB 	Cancers in scope of the 2024 Access to Medicine
IndexII 	The Good Practice Standards framework forcapacity building
III 	R&D prioritiesIV 	Ensuring the Methodology considers issues of sex
and genderV 	Definitions
VI 	References

39

Methodology for the 2024 Access to Medicine Index

APPE N D IX IA

Diseases in scope of the 2024 Access to Medicine Index
Diseases are included based on their burden of disability-

products for cardiovascular diseases (including statins,adjusted life years (DALYs) in countries in scope, WHOantihypertensives, antiarrhythmics and anticoagulants) willclassifications and the relevance of pharmaceuticalbe included under a clearer rationale. DALY burden andinterventions. The disease scope for the 2024 Index has

mortality data was collected from the Institute for Healthdecreased from 83 to 81 diseases, conditions and pathogens.

Metrics and Evaluation’s 2019 Global Burden of Disease study

There are two fewer diseases than in the 2022 Access to(GBD 2019) and are presented as totals for countries in scope

Medicine Index due to the combination of hypertensive

and disaggregated by sex where possible.1 Incidence data forheart disease, ischaemic heart disease and stroke into

cancer types was collected from GLOBOCAN 2020.2

cardiovascular diseases. The reason for this change is that

FIGURE 10 Diseases, conditions and pathogens in scope of the 2024 Access to Medicine Index
Disease burden in DALYs% DALYs% DALYs(countries in scope)(female)(male)

Alzheimer's disease14,121,433

60

40

Anxiety disorders

21,079,626

61

39

Asthma17,228,459

50

50Bipolar affective disorder

5,736,709

51

49

Cancer*DALY not applicable

N/A

N/A

Cardiovascular diseases

297,986,563

43

57

Chronic obstructive pulmonary disease (COPD)

59,365,204

43

57

Depressive disorders

35,512,221

61

39

Diabetes mellitus

53,461,951

49

51

Endometriosis

1,820,882

1000Epilepsy

10,908,201

45

55

Kidney diseases

33,437,603

47

53

Migraine

32,094,478

62

38

Schizophrenia

11,268,674

46

54

Sickle cell disease

5,720,857

60

40

Thalassemia

3,811,736

63

37

N O N - CO M M U N I C AB LE D I S E A S ES (16)Total incidence (countries in scope)% incidence (female)% incidence (male)

Bladder

207,694

24

76

Brain, nervous system

189,928

45

55

Breast1,211,993

100

0Cervical

496,792

100

0Colorectal

955,869

44

56

Gallbladder

79,43865

35

Head and neck628,126

25

75

Kaposi sarcoma

27,740

33

67

Leukaemia

262,842

43

57

Liver

675,942

29

71

Lung

1,203,383

33

67

Non-Hodgkin lymphoma

268,963

43

57

Oesophageal

488,88733

67

Osteosarcoma

Incidence not available in globocan 2020

N/A

N/A

Ovarian

193,455

100

0Prostate

492,398

0100

Stomach721,890

33

67

Thyroid368,668

77

23

Uterine182,174

100

0

C A N CE R T Y PE S I N SCO PE (19)**The 19 cancer types are collectively
counted as one non-communicabledisease.

40

Methodology for the 2024 Access to Medicine Index

Disease burden in DALYs% DALYs% DALYs(countries in scope)(female)(male)CO M M U N I C AB LE D I S E A S ES (23 + 12 PR I O R IT Y PATH O G E N S**)
Arenaviral haemorrhagic fevers

DALY not available in GBD 2019

N/A

N/A

Bunyaviral diseases

DALY not available in GBD 2019

N/A

N/A

Coronaviral diseases

DALY not available in GBD 2019

N/A

N/A

Diphtheria

365,636

48

52

Disease X

N/A

N/A

N/A

Emergent non-polio enteroviruses

DALY not available in GBD 2019

N/A

N/A

Enteric infections

94,536,740

48

52

Filoviral diseases***

195,39454

46

Henipaviral diseases

DALY not available in GBD 2019

N/A

N/A

HIV/AIDS

45,406,645

52

48

Leptospirosis

DALY not available in GBD 2019

N/A

N/A

Lower respiratory infections

88,276,785

48

52

Malaria

46,424,214

49

51

Measles

6,994,415

49

51

Meningitis

16,005,996

45

55

Other prioritised antibacterial-resistant infections**

DALY not available in GBD 2019

N/A

N/A

Pertussis

10,122,828

54

46

Rheumatic fever

DALY not available in GBD 2019

N/A

N/A

Sexually transmitted infections (STIs)

8,335,093

49

51

Tetanus2,309,409

45

55

Tuberculosis

46,045,180

37

63

Viral hepatitis (B and C)

27,963,181

27

73

Yellow fever

287,110

28

72

Zika

263

45

55

Buruli ulcer

DALY not available in GBD 2019

N/A

N/A

Chagas disease245,559

41

59

Dengue and chikungunya†

2,349,463

47

53

Dracunculiasis

1

54

46

Echinococcosis

98,50351

49

Food-borne trematodiases

747,283

39

61

Human African trypanosomiasis

82,61248

52

Leishmaniasis

692,733

42

58

Leprosy

28,67836

64

Lymphatic filariasis

1,613,541

19

81

Mycetoma, chromoblastomycosis and other deep mycoses

DALY not available in GBD 2019

N/A

N/A

Onchocerciasis

1,230,270

47

53

Rabies780,126

30

70

Scabies and other ectoparasites

4,636,790

49

51

Schistosomiasis

1,614,937

52

48

Snakebite envenoming

DALY not available in GBD 2019

N/A

N/A

Soil-transmitted helminthiasis

1,946,535

58

42

Taeniasis/cysticercosis‡

1,151,503

54

46

Trachoma

180,125

52

48

Yaws and other endemic treponematoses

DALY not available in GBD 2019

N/A

N/A

N EG LEC TE D TRO PI C AL D I S E A S ES (20)**Collectively, these will be referred
to as communicable diseases in the2024 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 2024 Access to Medicine Index

Disease burden in DALYs% DALYs% DALYs(countries in scope)(female)(male)R E PRO D U C TIVE , MATE R NAL AN D N E WBO R N H E ALTH (10)Abortion and miscarriage

1,114,569

100

0Birth asphyxia and birth trauma

51,991,484

42

58

Contraceptive methods

DALY not applicable

N/A

N/A

Hypertensive disorders of pregnancy

1,780,833

100

0Maternal haemorrhage

3,040,655

100

0Maternal sepsis

1,045,195

100

0Neonatal sepsis and infections

23,883,067

45

55

Obstructed labour

986,019

100

0

Other neonatal conditions

33,024,628

45

55

Preterm birth complications

64,631,489

43

57

42

Methodology for the 2024 Access to Medicine Index

APPE N D IX I B

Cancers in scope of the 2024 Access to Medicine Index
Cancer remains in scope for the 2024 Index. The 19 cancer

As in the methodologies for the 2018, 2021 and 2022

types in scope for the 2022 Index have been retained. The

Indexes, products for the management of pain andlatest data on cancer incidence does not show evidence that

supportive treatments (e.g., antiemetics) are not included.

additional cancer types should be included.

TABLE 3 Cancer types in scope and basis for inclusion

Cancer types in scope (19)Ten cancer types

Ten cancer types

Five cancer types where

Included inwith the highestwith the highest

countries in scope2022 Accessglobal incidence

incidence inaccount for highest %to Medicine

rates

countries in scopeof global incidence

Index

Bladder●Brain, nervous system●

Breast2,261,419

1,211,993

Cervical

604,127

496,792

Colorectal

1,931,590

955,869

Gallbladder
Head and neck*

●
82%

●
69%

931,931

628,126

Kaposi sarcoma

●
●

81%

Leukaemia

●
●

Liver

905,677

675,942Lung

2,206,771

1,203,383

75%

●
●

Non-Hodgkin lymphoma
Oesophageal●●
604,100

488,887

81%●

Osteosarcoma●

Ovarian●

Prostate

1,414,259

492,398●

Stomach1,089,103

721,890●

Thyroid

586,202368,668●

Uterine*Includes all head and neck cancers in
GLOBOCAN 2020: nasopharynx, lip, oralcavity, salivary glands, larynx, oropharynx
and hypopharynx cancer.

●

43

Methodology for the 2024 Access to Medicine Index

APPE N D IX I I

The Good Practice Standards framework for capacity buildingThis framework has been developed to convey stakeholders’slightly different stakeholder expectations for inclusion criteria.

expectations for good practice in capacity building, with all

Initiatives that meet all inclusion criteria are assessedcompany capacity building initiatives measured against thisagainst the Foundation’s Good Practice Standards (GPS).

framework.

The GPS differ slightly per capacity building subtheme but all

There are three basic inclusion criteria that all initiatives

centre around four topics: governance, goals and objectives,must meet: 1) be active during the period of analysis, 2) takeoutcomes, and sustainability. Companies are assessed based

place in a country/countries in scope of the Index and 3)

on a maximum of five initiatives per subtheme, with higher-

address local needs. Beyond these general criteria, the chart

performing companies having more initiatives that meet allis divided into four subthemes of capacity building, each withGPS.

FIGURE 11 Good Practice Standards framework for capacity building
The flowchart provides a guide to the criteria by which company initiatives
are included for analysis in the Index and the Good Practice Standards (GPS)by which they are analysed. The chart is broken down by subtheme ofcapacity building, each with slightly different expectations for analysis.

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 fromanalysisNo

Yes

Does the initiative address
local needs?
Yes

Which subtheme?
R&D

Manufacturing

Initiative done inpartnership with local No
university and/or publicresearch institution

Initiative builds
capacity of third-party,
unaffiliatedmanufacturers orworks with external
parties such as local
universities (i.e.,
in-house capacity
building is excluded).

Yes

No

Supply Chain

Health System Strengthening

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

Initiative done in partnership including local
stakeholders

Yes

Yes
Initiative has processes in place to mitigate
or prevent conflict of interest

Partnership has good
governance structures in
place

No

Yes
Initiative has clearly defined, measurable
goals and/or objectives

Yes

No

No

Yes
Outcomes of initiatives measuredNo

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

Outcomes of initiatives
measured

Outcomes of
initiatives measured

Outcomes of
initiatives measured

Partnership has good governancestructures in place

Initiative has long-term
aims/
aims for sustainability

Initiative has
long-term aims/
aims for sustainability

Initiative has long-term
aims/
aims for sustainability

Initiative has long-term aims/aims toachieve integration within the healthsystemDS2

Initiative publicly discloses outcomes

44

Methodology for the 2024 Access to Medicine Index

APPE N D IX I I I

R&D priorities

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

Rift Valley fever (RVF)

●

●

●

●

●

●

●

Severe fever with thrombocytopenia syndrome (SFTS)

●

●

●

●

●

●

Bunyaviral diseases (other thanCCHF, RVF or SFTS)

●

●

●

●

●

●

●

●

Buruli ulcer

●

●

●

●

●

●

Chagas disease

●

●

●

●

Contraceptive methods

●

●

●

Middle East respiratory syndrome
coronavirus (MERS-CoV)

●

●

●

●

●

●

●

Severe acute respiratory syndrome (SARS)

●

●

●

●

●

●

●

Coronavirus disease 2019
(COVID-19)

●

●

●

●

●

●

●

Highly pathogenic coronaviraldiseases (other than MERS-CoV,SARS and COVID-19)

●

●

●

●

●

●

Chikungunya

●

●

●

●

●

Dengue●●●●Cholera

●

●

●

●

●

Cryptosporidiosis

●

●

●

●

●

CancerCoronaviral diseases

Dengue and Chikungunya

Enteric infections

HPV-related cervical cancer

●
●

●
●

●

●

●
●

●

●

●

Enteroaggregative E. coli (EAEC)
infections

●

●

●

●

●

●

Rotaviral gastroenteritis

●

●

●

●

●

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

●

●

●

●

●

Non-typhoidal S. enterica (NTS)

●

●

●

●

●

●

●

●

●

● Gap identified

Definition: Product gap
identified for the disease,condition or pathogen on
one or more of the R&D
priority lists.

● Specific gap

Definition: Specific R&D
need or product gap
identified, e.g., for a newroute of administration to
be developed or specificserotypes to be targeted.

●●

Shigellosis

Emergent non-polio
enteroviruses (including
EV71, D68)

Blue text = priority R&D
product gap newly inscope for the 2024 Index.

●

Enterotoxigenic E. coli (ETEC)
infections

Giardiasis (lambliasis)

WHO Priority Pathogen List●

WHO Prefered ProductCharacteristics●

WHO Prioritizing diseases for
R&D in emergency contexts

Policy Cures Research G-FINDER
Emerging Infectious Diseases

Policy Cures Research G-FINDER
Sexual & Reproductive Health

Policy Cures Research G-FINDER
Neglected Diseases

Devices (for reproductive
health only)●

Microbicides

Diagnostics●

Crimean-Congo haemorrhagic
fever (CCHF)

Lassa fever
Bunyaviral diseases

Vaccines (therapeutic)

Arenaviral haemorrhagic
fevers (other than Lassa fever)

Vaccines (preventative)

Specific disease target

Medicines

Disease

Vector control products

TABLE 4 Priority diseases, conditions and pathogens●●● Included on priority
R&D list.

45

●

●

●

●

●

●

●

Filoviral diseases (other than EVD
or MVD)

●

●

●

●

●

●

Nipah virus (NiV) infection

●

●

●

●

●

●

●

Henipaviral diseases (other thanNiV infection)

●

●

●

●

●

●

●

HIV/AIDS

●

●

●

●

Human African
trypanosomiasis

●

●

●

●

●

●

Hypertensive disorders ofpregnancy

Pre-eclampsia and eclampsia

●

●
●

●

●

●

●

●

●

Leprosy

●

●

●

●

●

●

●

●

●

Lower respiratory infections●●

Leishmaniasis

Leptospirosis●

Pneumococcal disease(S. pneumoniae)●

Influenza●●

Respiratory syncytial virus (RSV)
disease●●Lymphatic filariasis(elephantiasis)

●

●

●

●

Malaria (P. falciparum)

●

●

●

●

●

●

●

Malaria (P. vivax)

●

●

●

●

●

●

●

Malaria (other strains than P.
falciparum or P. vivax)

●

●

●

●

●

●

Maternal haemorrhage

Postpartum haemorrhage●

Meningitis

Meningitis (N. meningitidis)

Malaria

●
●

●

●
●

Meningitis (C. neoformans)●

Mycetoma, chromoblastomycosis and other deep
mycoses

Mycetoma●●●

Histoplasmosis

●

●

●

Neonatal sepsis

Group B Streptococcus

Rheumatic fever●●

Schistosomiasis (bilharzia)●

Blue text = priority R&D
product gap newly inscope for the 2024 Index.

●

●

●

●

●

●

Group A Streptococcus

Scabies

Sexually transmitted
infections (STIs)●●

River blindness(onchocerciasis)

Chlamydia

●
●

●

●

●

●

●

●

●

●

●

●

●

●
●

Gonorrhoea

●

●

●

●

●

●

●

Herpes simplex virus type 2(HSV-2) infection

●

●

●

●

●

●

●

Human T-cell lymphotropic virus
type 1 (HTLV-1) infection

●

●

●

●

●

●

Syphilis

●

●

●

●

●

●

Sexually transmitted infections(other than chlamydia, gonorrhoea, syphilis or HSV-2 or HTLV-1
infections)

●

●

●

●

●

●

● Gap identified

Definition: Product gap
identified for the disease,condition or pathogen on
one or more of the R&D
priority lists.

● Specific gap

Definition: Specific R&D
need or product gap identified, e.g., for a new routeof administration to be
developed or specificserotypes to be targeted.

WHO Priority Pathogen List

WHO Prioritizing diseases for
R&D in emergency contexts●●

WHO Prefered ProductCharacteristics

Policy Cures Research G-FINDER
Emerging Infectious Diseases

●

●

●

Policy Cures Research G-FINDER
Sexual & Reproductive HealthDiagnostics●●

Henipaviral diseases

Policy Cures Research G-FINDER
Neglected Diseases

Vaccines (therapeutic)●

Marburg virus disease (MVD)

Devices (for reproductive
health only)

Vaccines (preventative)

Ebola virus disease (EVD)

Vector control products

Specific disease target

Filoviral diseases

Microbicides

Disease

Medicines

Methodology for the 2024 Access to Medicine Index● Included on priority
R&D list.

46

●
●

Tapeworm infection(taeniasis/cysticercosis)●●

Tuberculosis
Viral hepatitis (B and C)

●
●

●
●

●
●

●

Hepatitis B●

Hepatitis C

●

●

●

●

Zika virus disease●●●

Trachoma

●
●

●

●

●

●

●

●

●

●

●

●
●

●

●

●
●

Acinetobacter baumannii(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, vancomycin-intermediate and vancomycin-resistant)●

Streptococcus pneumoniae(penicillin-non-susceptible)

Blue text = priority R&D
product gap newly inscope for the 2024 Index.

●
●

●
●

Disease X*
Other prioritised
antibacterial-resistantinfections

WHO Priority Pathogen List

Roundworm infection (ascariasis)
Snakebite envenoming

WHO Prefered ProductCharacteristics●

WHO Prioritizing diseases for
R&D in emergency contexts

Whipworm infection (trichuriasis)

Policy Cures Research G-FINDER
Emerging Infectious Diseases●

Policy Cures Research G-FINDER
Sexual & Reproductive Health●

Policy Cures Research G-FINDER
Neglected Diseases

Strongyloidiasis and other roundworm infections (excl. ascariasis)

Devices (for reproductive
health only)●

Vector control products●

Microbicides

Vaccines (preventative)

Hookworm infection(ancylostomiasis/necatoriasis)

Diagnostics

Specific disease target

Soil transmitted
helminthiasis

Vaccines (therapeutic)

Disease

Medicines

Methodology for the 2024 Access to Medicine Index● Gap identified

Definition: Product gap
identified for the disease,condition or pathogen on
one or more of the R&D
priority lists.

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

●● Specific gap

Definition: Specific R&D
need or product gap identified, e.g., for a new routeof administration to be
developed or specificserotypes to be targeted.

●● Included on priority
R&D list.

47

Methodology for the 2024 Access to Medicine Index

APPE N D IX IV

Ensuring the Methodology considers issues of sex and gender
To ensure access to medicine and health products, accessvulval, penile and vaginal cancer.2 Breast, cervical andplans and strategies also need to address barriers to access­prostate cancer types remain included in the disease scopethat lie beyond affordability, sustainable supply, and theon the basis of high incidence both globally and in countries

strength of a health system. The lived experience of patientsin scope of the Index.

can have a significant impact on their ability to access essential• The Index continues to assess companies’ inclusive businesshealthcare, as well as the type of healthcare they need. For

models which address access issues for individuals who

example, the socioeconomic status or age of a patient, or thecannot access products through existing business models.

prevalence of certain diseases where they live, need to be

These inclusive business models exemplify company efforts

considered. Critically, many patients face barriers to accessto embed vulnerable groups into the way they design, sell,that are rooted in sex and gender.

and deliver products by considering social, economic andBiological characteristics related to an individual’s sex

health factors that impede access. In considering these(e.g., hormones, anatomical differences, immune responses,

factors, inclusive business models can also address accessgenetics) as well as gender-related factors (e.g., societal
expectations, stigma and differences in exposure to risk

barriers related to sex and gender.
• In R&D, pregnant and lactating populations have been­factors) can influence the likelihood of contracting a diseasehistorically excluded from clinical trials for non-obstetricand how it presents itself.

conditions. Safety concerns as well as ethical and legal

Moreover, sex and gender often influence crucial elements

considerations are often cited as reasons for their exclu-

of access – such as the safety and efficacy of medicines, thesion.14 As a result, the safety profiles and appropriate doses

opportunity to access quality care in a safe environment, andof many products are unknown for these populations. In

access to information about treatment and prevention of dis-line with the World Health Organization’s call to action,ease – making it critical to consider these two factors whenthe Index will, where applicable, assess the fair inclusion ofaddressing barriers to access.

those who are pregnant and lactating in clinical trials.15

Governments, civil society groups, and non-governmentalorganisations (NGOs) play a key role in addressing how issues
pertaining to sex and gender are considered in healthcaredelivery. However, pharmaceutical companies are also a vitalpiece of the puzzle. From the way they conduct research, tothe way they deliver products to the patient, efforts can bemade by pharmaceutical companies to uncover and address
access barriers related to sex and gender.
In evaluating pharmaceutical companies’ actions toimprove access to medicine, continual effort is made by theFoundation to explore how analysis and reporting can include
gender - and sex- related issues more comprehensively. The
approach for the 2024 Index Methodology is laid out below:• For each review of the Index Methodology, the Foundation
examines the sex-disaggregated epidemiological data toconsider the inclusion of additional diseases or conditions
that have a disproportionate burden on either sex. The latest
analysis did not find any additional diseases or conditions
that needed to be included based on our methodologicalapproach. The current disease scope considers diseases
for which the burden is disproportionately high (more than70%) for either females or males, such as maternal healthconditions and endometriosis. Assessment of the sexlinked cancer types (both globally and in countries in scopeof the Index) previously led the Index to include uterine
and ovarian cancer, as these have a significantly higher
incidence than other sex-linked cancers such as testicular,

48

Methodology for the 2024 Access to Medicine Index

APPE N D IX V

Definitions
Terms defined below are tailored toAccess-to-medicine strategy

Ad hoc donation

the objectives and methodology of the

A strategy specifically intended to

A donation of products for which there

Access to Medicine Index and should be

improve access to medicine, thatis no clear, defined long-term strategy

understood within the context of thisincludes all the typical elements of ato control, eliminate or eradicate areport.

strategy (for example, a clear rationale,disease. This may include a company

targets, objectives and expected

donating a range of medicines based

Access plansoutcomes). In low- and middle- incomeon the explicit needs of a country.

Plans to ensure that access needs incountries where the company operates,

Donations made during emergency

low- and middle-income countries

the strategy may apply to a defined set

situations, such as conflicts and natural

are taken into consideration duringof diseases, products or therapeutic

disasters, are also included here.

the R&D stage. Access plans can beareas, or ideally to the whole pipeline

developed in-house or in collaboration.

and portfolio.

They can include commitments andAffordability
This refers to the payer’s ability to pay

strategies, as well as more concrete

Active pharmaceutical ingredient

for a product (whether or not they

access provisions, such as specific(API)

are the end user) – see ‘payers’ formeasures developed in partnership

The active pharmaceutical component

definition. Affordability is one of thewith other organisations that canof a medicine that causes its intended

key dimensions for access to medicine.

enforce accountability. Potential

effects. Some medicines, such as

The Programme takes this into accountcomponents of an access plan include

combination therapies, have multiple

when assessing pricing strategies forregistration commitments, equitable

active ingredients that target multiple

relevant products. A product’s afforda-

pricing strategies, sufficient supply

disease pathways and/or symptoms.

bility depends on different factors,

commitments, and applying for World

The inactive ingredients of a medicine

including socioeconomic, demographic

Health Organization prequalification.

are referred to as excipients.

and healthcare system characteristics,

Access plans facilitate availability,

which should be considered by phar-affordability and supply for patients

Adaptive R&D

maceutical companies when setting thein countries within the scope of the

R&D adaptations of existing/registeredprice of the products.

Programme.

medicines, or other health products inscope that may address an unmet need

Budget impact

Access strategy (product specific)

in countries in scope of the Programme.

An estimated measure of the cost of

The range of mechanisms a company

This can include adding new indications,

treatment with a given therapy for acan implement to provide access to

new target patient populations (e.g.,given number of patients in a specificits product for a specific group of

infants/children, pregnant and lactating

population.

patients within a country. An accesspeople), environmental conditions (e.g.,

strategy can be composed of different

heat-resistant formulations) or new

Buffer stockelements, including pricing strategies

formulations (e.g., oral formulations).

A reserve or surplus quantity of essen-

and additional initiatives to improvetial materials, components, or finished

the affordability and availability of theAdditional access initiatives

products that a company maintains as a

product. Access strategies with theInitiatives, other than pricing, thatsafeguard against potential disruptions

biggest potential impact in terms ofimprove the availability and affordability

in the supply chain.

equitable access are those that aim toof the products with the aim of increas-

promote affordable access to medicine

ing the number of patients reached.

Capacity building

for all income groups of the population

Such initiatives may include, but are

The company forms partnerships

by considering the ability to pay of the

not limited to, non-exclusive voluntarywith local stakeholders to develop

payer, and by taking healthcare systems’

licensing, donations, private–public andand strengthen skills, resources orneeds and characteristics into account.

private-private partnerships, patient

processes in LMICs (e.g., by training

assistance programmes, non-assertof staff or obtaining equipment anddeclarations, technology transfer andother necessary resources). The Index

health system strengthening initiatives.

assesses capacity building across four
subthemes: R&D, manufacturing, supply
chains and health system strengthening.
49

Methodology for the 2024 Access to Medicine Index

Conflict of interest

Equitable pricing strategy

Good manufacturing practice (GMP)

When the commercial interests of a

A targeted pricing strategy which aims

A system employed to ensure thatcompany are at odds with, or perceived

to improve access to medicine for those

products are consistently produced

to be at odds with, the interests ofin need by considering the relevant pay-

and controlled according to

the partnership, the partner (i.e., local

er’s ability to pay, and by taking health-appropriate quality standards. Withinstakeholders), or the health and well-care systems’ needs and characteristics

pharmaceutical production this serves

being of the population the partnership

into account.

to minimise risks such as unexpected

intends to help.

contamination, incorrect labelling
Ethical marketingor incorrect dosing of the active

Country or region risk-based

Promotional activities that are aimed at

ingredient. GMP covers all aspects

assessment

the general public, patients, healthcareof pharmaceutical production (e.g.,

An assessment to help a pharmaceuticalprofessionals/students and opinion

starting materials, premises, equipment,

company to evaluate the risk of non-leaders in such a way that transparency,

training and personal hygiene of staff)

compliance with ethical marketing,integrity, accuracy, clarity and complete-and includes processes that provide

anti-corruption, and clinical trial

ness of information can be ensured.

documented proof that correct

standards in LMICs. This type ofprocedures are consistently followed

assessment examines the country- or

Fair market value assessment

at each step of the manufacturing

region-specific legal and regulatory

Assessment that defines the appro-

process. GMP guidelines are establishedenvironment, cultural and social factors,

priateness of payments made to

and overseen by regulatory agencies inas well as economic and political

healthcare professionals (HCPs). These

individual countries or regions, as wellconditions that may influence theprovide structure to ensure ethicalas the World Health Organization.

company’s compliance risks.

interactions between the pharmaceutical industry and HCPs they engage with.

Demographic factors

Good Practice Standards (GPS)A set of standards developed by theCharacteristics of a population such as

Falsified medical products

Foundation that are used to assess

age, sex, income level, education level,

Medical products that deliberately/company capacity building initiatives

employment, etc.

fraudulently misrepresent their identity,that meet all inclusion criteria. Higher-

composition or source.

performing companies have more

16

Disability-adjusted life year (DALY)

capacity building initiatives that meet

A measure of disease burden that

Fraud-specific risk assessment

combines disease-associated mortality

An assessment that identifies potential

and morbidity. It is the sum of therisks of fraud within a pharmaceutical

Healthcare practitioner-administerednumber of years of life lost (YLLs) andcompany’s operations in LMICs. This

products

years lived with disability (YLDs). DALYs

type of assessment considers the

Products that typically require either

allow the comparison of disease burden

vulnerabilities and weaknesses within

hospital administration of the productacross different populations and healththe company’s operations, which couldor the continued attention of a skilledconditions across time. One DALY

be exploited by employees, contractors,

healthcare professional for administra-equals one lost year of healthy life.

or third-party service providers totion, such as an intravenously adminis-

commit fraud.

tered oncology medicine.

The finished dosage form of a medicine

Good governance structures

Innovative R&D

obtained at the end of the manufactur-

The structures put in place to estab-

The development of medicines,

ing process, (e.g., the tablet, capsule, orlish clear roles, responsibilities andtherapeutic and preventive vaccines,

solution containing the API(s), generally,

decision-making processes for accessdiagnostics, vector control products andbut not necessarily, in association withinitiatives. These structures also include

microbicides which have not previously

one or more other ingredients). Also

systems of communication whereby

been approved for use.

referred to as a finished drug product,

information about processes, decisions

finished product or formulation.

and outcomes of initiatives are regularly

all GPS.

Drug productconveyed to the relevant stakeholders.

50Methodology for the 2024 Access to Medicine Index

Long-term donation programmes

Out-of-pocket payment

Post-trial accessA donation of products for which a

Payments made by people at the time

The continued provision of an inves-defined strategy exists as to the type,of getting any type of service provided

tigational product or comparator tovolume, duration and destination of

by any type of healthcare provider.

clinical trial participants following the

donated products. These programmes

They include cost-sharing (the partend of the clinical trial in which they

are longer than five years and aim to

not covered by a third party like anparticipated when continued treatment

control, eliminate or eradicate a disease.

insurer) and informal payments, but

is beneficial.

For analysis, the Index focuses onthey exclude insurance premiums.

long-term donation programmes for

Out-of-pocket payments exclude any

Priority R&D

neglected tropical diseases.

reimbursement by a third party, such

R&D that addresses product gaps

as the government, a health insurance

resulting from a lack of effective or

National regulatory authority

fund or a private insurance company.

suitable products to treat, prevent or

A national regulatory agency

In the Programme’s context, out-of-

detect certain diseases, conditions andresponsible for ensuring that products

pocket payments relate to payments

pathogens in countries within scope

released for public distribution

made for medicines or other healthof the Programme. Product gaps may(normally pharmaceuticals andproducts in scope.

be medicines, vaccines, diagnostics,

19

biological products, such as vaccines

medical devices or vector control

and medical devices including test

Patient assistance programmes

products. These product gaps arekits) are evaluated properly and meet

Programmes initiated by pharmaceuti-

defined as being those listed in a seriesinternational standards of quality, safety

cal companies which provide financialof six priority lists developed by theand efficacy.17

assistance or free-of-charge medicines

World Health Organization and Policy

for a defined patient population with

Cures Research, an independent R&D-

limited ability to pay.

focused policy group.

to control, approve and determine

Patient reachSelf-administered products

pricing and reimbursement of medicinal

The number of people benefitting

Products which patients can typically

products in a country.

from access to a company’s product(s),take or administer themselves for

National reimbursement authority
Governmental bodies with the authority

which can be demonstrated through,regular usage without needing a skilled

Non-assert declarations

for example, annual sales volume

healthcare worker. These products

A commitment by a rights holder not

divided by volume per patient or the

may or may not be prioritised by

to enforce certain patents in a defined

estimated number of patients reachedgovernments or by the global healthgroup of countries. This allows a genericby a particular access strategy, initiative,

community (e.g., treatments forversion of a patent-protected productor partnership. The Index evaluates a

non-communicable diseases such as

to be produced and/or commercialised

company’s overall process for defining,diabetes, stroke and heart disease).

in those countries.18

measuring, and reporting on patientreach, as well as product-specific exam-

Substandard medical products

Non-exclusive voluntary licences

ples of patient reach in the context of

Also called ‘out of specification’, these

Licences which enable – on a non-access strategies.

are authorised medical products

exclusive basis, and according to thethat fail to meet either their quality

terms of the licence agreed –thePayersmanufacture and supply of generic

Entities, including individuals, private

versions of patented medicines by other

health insurers, governments, andSupranationally procured products

manufacturers.

international organisations, which are

Products for which international

responsible for funding and facilitating

pooled procurement, advance market

medical services. The entities varycommitments, market-shaping facilities

based on the healthcare system’s

and significant public funding and donor

financial structure.

support exist. These products include

standards or specifications, or both.16

vaccines and products indicated for
Period of analysis

the treatment of HIV, tuberculosis,

For the 2024 Index, the time period for

malaria, neglected tropical diseases andwhich data will be analysed covers the

reproductive health.

company’s activities between 1 June
2022 and 31 May 2024.

51

Methodology for the 2024 Access to Medicine Index

Technology transfer
A pharmaceutical company transfers
knowledge, tools and/or technology
necessary for producing a specificproduct (e.g., medicine, vaccine) toa manufacturer. Technology transfer
can improve the supply and availabilityof products, while also building
manufacturing capacity that canbe applied to other manufacturing
processes.
Vulnerable populations
People at greater risk of facing barriers
to accessing medicines due to social,economic and/or health considerations.
The World Health Organization(WHO) Collaborative Registration
Procedure (CRP)
A procedure launched by the WHOthat aims to expedite registration ofprequalified finished pharmaceuticalproducts. It accelerates registration
through improved information sharing
between the WHO prequalification
system and national regulatory
authorities. By leveraging assessment
and inspection outputs alreadyproduced by WHO prequalification,and thereby eliminating duplicative
regulatory work, it speeds up in-country
registration of quality-assured
products and contributes to their wider
availability.20

52

Methodology for the 2024 Access to Medicine Index

APPE N D IX VI

References
1

Institute for Health Metrics and
Evaluation. Global Burden of Disease(GBD) Results. 2019. Accessed June 7,
2023. https://vizhub.healthdata.org/
gbd-results/.
2 Global Cancer Observatory. Cancer
Today. 2020. Accessed June 7,
2023. https://gco.iarc.fr/today/
online-analysis-table.
3 World Health Organization. Control
of Neglected Tropical Diseases.
Accessed June 7, 2021. https://www.
who.int/data/gho/data/themes/
neglected-tropical-diseases.
4 World Health Organization.
Prioritization of Pathogens to Guide
Discovery, Research and Developmentof New Antibiotics for Drug-ResistantBacterial Infections, Including
Tuberculosis. 2017. Accessed June
7, 2023. https://apps.who.int/iris/handle/10665/311820.
5 Policy Cures Research G-FINDER.
Neglected Disease R&D Scope. 2023.
Accessed August 24, 2023. https://
gfinder.policycuresresearch.org/staticContent/pdf/G-FINDER_ND_R%26D_
scope.pdf.
6 Policy Cures Research G-FINDER.
Sexual and Reproductive Health R&D
Scope. 2023. Accessed August 24,
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Emerging Infectious Disease R&D
Scope. 2023. Accessed August 24,
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Prioritizing diseases for research anddevelopment in emergency contexts.
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Preferred Product Characteristics(PPCs). Accessed August 30, 2023.
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product-and-delivery-research/ppcs.
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new antibiotics. Accessed August 30,
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item/27-02-2017-who-publishes-listof-bacteria-for-which-new-antibioticsare-urgently-needed.
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blogs.worldbank.org/opendata/
new-world-bank-group-country-classifications-income-level-fy24.
12 United Nations Development
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Report 2021-2022. 2022.
Accessed June 7, 2023.
https://hdr.undp.org/content/
human-development-report-2021-22.

13 United Nations Department of
Economic and Social Affairs. LDCs at a
Glance. 2021. Accessed June 7, 2023.
https://www.un.org/development/
desa/dpad/least-developed-country-category/ldcs-at-a-glance.html.
14 Smith DD, Pippen JL, Adesomo AA,
Rood KM, Landon MB, Costantine
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