Access to Medicine Index 2022 - METHODOLOGY
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Methodology for the 2022 Access to Medicine Index
Access to Medicine
Index 2022
METHODOLOGY
1
Methodology for the 2022 Access to Medicine Index ACKNOWLE DG E M E NTS The Access to Medicine Foundation would like to thank the following people and organisations for their contributions to this report. FU N D E RS UK Foreign, Commonwealth and Development Office The Dutch Ministry of Foreign Affairs Bill & Melinda Gates Foundation Wellcome Trust AXA Investment Managers EXPE RT REVI EW CO M M IT TE E Hans Hogerzeil (Chair) Emily Bleimund Githinji Gitahi Michela Gregory Fumie Griego Martha Gyansa-Lutterodt Dennis Ross-Degnan Alan Staple Fatima Suleman Klara Tisocki Prashant Yadav RESE ARCH TE AM E D ITO RIAL TE AM James Hazel Anna Massey Kasper Blom Eleanor Bley Griffiths Moy Bracken Rachel Jones Victorine de Milliano Myriam Diallo Sagal Hassan Camille Romero Emma Shiffman AD D ITI O NAL CO NTRI BUTORS We would like to thank the many other experts who contributed their views to the development of this methodology (see page 39). ACCESS TO M E D ICI N E FOU N DATIO N The Access to Medicine Foundation is an independent non-profit org- anisation based in the Netherlands. It aims to advance access to medi- cine in low- and middle-income countries by stimulating and guiding the pharmaceutical industry to play a greater role in improving access. Naritaweg 227-A 1043 CB, Amsterdam The Netherlands For questions about this report, please contact James Hazel, Research Programme Manager jhazel@accesstomedicinefoundation.org +31 (0) 20 215 35 35 2 www.accesstomedicineindex.org
Methodology for the 2022 Access to Medicine Index
Momentum for
improving access
must not be lost
The Covid-19 pandemic has exposed where the biggest fault- This will be the eighth edition of the Index, which was first
lines are in global access to medicine, and how much more published in 2008. It has a central role in ensuring that the
must be done to fix them. But it has also been a period of best of the industry thrives, highlighting best practice and
innovation and partnership, with the pharmaceutical indus- showing where more can – and should – be done. The Index
try showing just how quickly it can move to address a health- closely examines difficult issues like pricing, supply security,
care crisis. More widely, the pandemic has created a greater and reaching vulnerable populations. While Covid-19 is cer-
awareness of unequal access to healthcare and health prod- tainly within the scope of our analysis, this Index covers a
ucts faced by people all over the world. I fear that these total of 83 diseases and takes an in-depth look at access to
chronic issues will never go away if we do not harness this medicine to provide a clear picture of where we now stand.
momentum – and act now.
Previous indexes have shown worryingly short R&D pipelines
In so many ways, the corporate and public sectors have for Emerging Infectious Diseases. In addition, not enough was
stepped up since the pandemic began, developing new vac- being done to ensure affordability and access for the most
cines at unprecedented speeds while also tackling severe vulnerable populations. So, as we look to the future, I ask: has
strains to public health services. Yet we have still left the the pharmaceutical industry truly learned from this pandemic,
poorest populations last in line. Healthcare systems and med- or has Covid-19 won in setting back progress? The Index will
ical supply chains in lower-income countries have faced the illuminate the answers to these questions. The impetus must
biggest stresses, while the global distribution of vaccines has not be lost.
been far from equitable. There is much to celebrate, but also
much to improve.
Our current Access to Medicine Index came out in January
2021, and my team continues to use the data and the con-
clusions from the report to facilitate real change within
the pharmaceutical industry. The team has also now begun
work towards the 2022 Access to Medicine Index, and this
Methodology Report – which sets out the framework for the
next Index – is a major milestone along that path.
The 2022 Access to Medicine Index will evaluate the work of Jayasree K. Iyer
20 of the world’s largest pharmaceutical countries, assess- Executive Director
ing their efforts in addressing access to medicine in 108 low- Access to Medicine Foundation
and middle-income countries, whose populations have long
endured limited access to new or essential products.
3Methodology for the 2022 Access to Medicine Index
Table of contents
Acknowledgements 2 APPE N D ICES 38
Foreword 3 I Contributors to this report 39
About this report 5 IIA Diseases in scope for the 2022
Access to Medicine Index 40
EXECUTIVE SU M MARY 6 IIB Cancers in scope for the 2022
A vision for 2030: how this Index will shift pharma Access to Medicine Index 42
company practice 6 III The good practice standards framework for
capacity building 43
TH E 2022 ACCESS TO M E D ICI N E I N D EX 9 IV R&D priorities 44
Methodology 2021 9 V Ensuring the methodology considers issues
of sex and gender 47
REVI EWI NG TH E M ETHO DO LOGY 10 VI Definitions 48
How the Index distills access-to-medicine priorities VII References 51
for pharmaceutical companies 10
ANALY TI CAL FR AM EWO RK 12
2022 Index to put greater focus on measuring
outcomes 12
WHAT TH E I N D EX M E ASU RES 18
Company Scope 19
Disease Scope 20
Geographic Scope 24
Product Type Scope 26
HOW TH E I N D EX M E ASU RES 27
A Governance of Access 28
B Research & Development 30
C Product Delivery 32
LIST O F FI GU RES
Figure 1 Companies in scope of the 2022 Access to Medicine Index 6
Figure 2 2021 Methodology Review for the 2022 Access to Medicine Index 10
Figure 3 Analytical Framework for the 2022 Access to Medicine Index 13
Figure 4 Companies in scope of the 2022 Access to Medicine Index 19
Figure 5 Low- and middle-income countries shoulder the bulk of disease burdens 21
Figure 6 Defining the disease scope - screening protocol 22
Table 1 List of diseases, conditions and pathogens included in the 2
022 Access to Medicine Index 23
Figure 7 Countries included in the 2022 Access to Medicine Index – 108 Countries 24
Table 2 List of countries included in the 2022 Access to Medicine Index – 108 countries 25
4Methodology for the 2022 Access to Medicine Index
About this report
This report sets out the methodology for the 2022 Access Towards 2030
to Medicine Index, including its framework, scopes, prior- The UN has called for a decade of action in order to achieve
ity topics and indicators. It captures society’s expectations of the Sustainable Development Goals (SDGs) and universal
pharmaceutical companies regarding access to medicine in health coverage (UHC) by 2030, and the clock has already
low- and middle-income countries (LMICs). Using this meth- begun to tick. To reach that milestone, pharmaceutical com-
odology, the next Index will assess progress by 20 of the panies have a central role to play in developing the treat-
world’s largest pharmaceutical companies in making medi- ments needed by the more than 80% of the global popula-
cines, vaccines, diagnostics and other health products more tion who live in LMICs, and in improving products’ availability
accessible in LMICs. The Index is published every two years. across socioeconomic divides. The findings of the 2022 Index
will help illuminate where progress is already being made, and
where action is still required.
Continuity of framework enables clear trend analysis
Each Access to Medicine Index is the result of a two-year pro-
ANALYTICAL FRAMEWORK FOR
THE 2022 ACCESS TO MEDICINE INDEX
cess that begins with a review of the Index methodology.
Ahead of the previous Index, a comprehensive methodol-
A GOVERNANCE OF ACCESS 15% ogy review was carried out in 2019 which resulted in a tighter
2 priority topics, 7 indicators analytical framework with a greater focus on the pharmaceu-
B RESEARCH & DEVELOPMENT 30% tical industry’s core responsibilities on access (such as R&D,
3 priority topics, 7 indicators affordability, and intellectual property management).
In this cycle, for the upcoming eighth Access to Medicine
C PRODUCT DELIVERY 55% Index, a more targeted approach was taken when it came
9 priority topics, 17 indicators to reviewing the framework. A variety of experts were con-
sulted to introduce refinements to the methodological frame-
work, only where needed. This continuity within the method-
ology will facilitate clearer comparisons with data and infor-
mation from the previous Index, enabling more nuanced trend
analysis.
I N TH IS RE PO RT
Indicator review and stakeholder Analytical framework geared 14 priority topics, 31 indicators Four scopes of analysis
consultations The methodology toward trend analysis This meth- The 2022 Index will evaluate com- The 2022 Index will analyse how
review started with internal checks odology review prioritised conti- panies in 14 priority topics: areas 20 of the world’s largest pharma-
on indicators, data sets and analyt- nuity and the capacity for nuanced of behaviour where stakeholders ceutical companies are addressing
ical approaches, followed by exter- comparisons, with indicators agree that pharmaceutical compa- access to medicine in 108 low- and
nal consultations to identify the grouped into three Technical Areas: nies have the biggest potential and middle-income countries, looking
consensus view on where pharma- 1. Governance of Access responsibility to make change, such at 8 product types for 83 diseases,
ceutical companies can take action 2. Research & Development as product development, licensing conditions and pathogens.
toward goals for 2030. Page 9 3. Product Delivery Page 12 and pricing. Page 13 Page 18
Methodology for the 2022 Access to Medicine Index Methodology for the 2022 Access to Medicine Index Methodology for the 2022 Access to Medicine Index Methodology for the 2022 Access to Medicine Index Methodology for the 2022 Access to Medicine Index Methodology for the 2022 Access to Medicine Index
REVI EWI NG TH E M ETH O DO LOGY ANALY TICAL FR AM EWO RK WHAT WE M E ASU RE D ISE ASE SCO PE FIGURE 5 Low- and middle-income countries shoulder the bulk of WHAT WE M E ASU RE
disease burdens
How the Index distills access-to-medicine 2022 Index to put greater focus on measuring Disease Scope These four charts give an indication of how the diseases and conditions in
scope disproportionately affect people living in low- and middle-income
countries. Behind these numbers are millions of people who cannot rely on
Geographic Scope
priorities for pharmaceutical companies outcomes access to affordable, quality medicine.
Communicable diseases, DALYs
23 Communicable Diseases
Lower respiratory infections
This category includes the 10 Communicable Diseases (CDs) with the high- Enteric disease*
est DALY burdens in countries in scope, as well as diseases for which prod- HIV/AIDS
Malaria
uct gaps have been identified as priority R&D targets, such as emergent Tuberculosis
non-polio enteroviruses and ‘Disease X’, a WHO term to denote a currently Viral hepatitis (B and C)
Meningitis
Each Access to Medicine Index is the result of a two-year pro- Primary principles The Access to Medicine Index assesses the actions of phar- The full disease scope applies to all Technical Areas. COVID- unknown pathogen that could cause a serious international epidemic (as Sexually transmitted infections (STIs)**
The Access to Medicine Index measures the actions of phar- D E FI N I NG TH E G EOG R APH I C SCO PE
cess known as the ‘Index cycle’, which begins with a targeted The primary principles of the 2021 Methodology Review: STAKE HO LD E R OUTRE ACH FO R TH E 2022 ACCESS maceutical companies in relation to the set of diseases, con- 19 remains in scope and the Index will continue to track com- seen for COVID-19). The 2022 Index combines some prioritised diseases Measles maceutical companies in places where there is an urgent need
Pertussis
review of the Index methodology. The aim is to distil global 1 Ensure that the framework and indicator set clearly reflect TO M E D ICI N E I N D EX With more than 10 years of methodological development, 31 indicators ditions and pathogens confirmed by the Expert Review pany activity in this area during the period of analysis. For the that were previously separate under a single term (e.g., “enteric infections”
Tetanus
for better access to medicine. Three criteria have been used Step 1: Include all countries classified (according to World
priorities regarding access to medicine and to define how the core role for R&D-based pharmaceutical companies The Foundation has built stakeholder consensus on what the Index has evolved its framework and indicators through The Index’s methodological framework for 2022 streamlines Committee as critical priorities for improving access to 2022 Index, two new diseases (thalassemia and osteosar- now includes diarrhoeal diseases, typhoid and paratyphoid, and invasive non- 0 50M 100M 150M 200M to select countries for the 2022 Index (geographic scope): (1) Bank data) as low income or lower-middle income;
● Burden in countries in scope ● Burden in rest of world DALY (mn)
society expects pharmaceutical companies to contribute. The in access to medicine, and are responsive to the emerging we can expect from pharmaceutical companies on access to extensive dialogue between stakeholders. The result is a set the identification and confirmation of best practices and medicine. To define this priority list, the Foundation used coma) have been brought into scope for all Technical Areas. typhoidal salmonella). countries’ level of income (gross national income (GNI) per
emphasis is on defining ambitious, but achievable, actions for access needs in LMICs, thus incentivising change; medicine. Consultations have been carried out with global of ambitious yet achievable expectations for the behaviour of practices that, over the past decade, have proven to be data about disease burdens and incidence, together with The Index will follow products emerging from the pipeline capita); (2) level of development, and; (3) scale and scope Step 2: Include all countries defined (according to the UNDP’s
companies to take. 2 Enable the identification of best practice in all aspects of health technical experts, to take account of a diverse range pharmaceutical companies in improving access to medicine. successful, scalable and accepted by governments and other independent prioritisations, to pinpoint those for which (after market approval) and include them in its analyses of 18 Non-Communicable Diseases Non-communicable diseases, DALYs of inequality. Assessments for each country were based on Human Development Index) as having low or medium human
For this latest review, the Foundation continued to look access to medicine in order to facilitate broader uptake; of alternative viewpoints and technical expertise. Topics were The Methodology for the 2022 Index is based on a tight ana- stakeholders. This streamlining reflects the global health greater access to medicine is needed most. A review of the access strategies. This category includes the 10 Non-Communicable Diseases (NCDs) with data from the World Bank, the United Nations Development development;
Ischaemic heart disease
ahead to the 2030 deadline for achieving the Sustainable 3 Ensure all metrics are robust and can fairly compare a prioritised through internal analyses of data and indicators, lytical framework of three Technical Areas, and on 14 pri- community’s emphasis on access programmes that can Methodology for 2022 has set the disease scope for the 2022 the highest DALY burdens in countries in scope. For the first time, this list Stroke Programme (UNDP) and the United Nations Economic and
COPD
Development Goals, informed by the impacts of the COVID- range of companies against each other; independent reviews of the Index research during the pre- ority topics for corporate activity. In each area, the policies achieve both scale and sustainability. Index at 83 diseases, conditions and pathogens. All are in Previous iterations of the Index have focused on diseases includes thalassemia.1 It also includes cancer types with high or dispropor- Social Council (ECOSOC). Step 3: Include all high-development countries with a high
Diabetes mellitus
19 pandemic and building on the extensive strategic review 4 Preserve the capacity of the Index to track pharmaceutical vious period of analysis, and a review of developments in and practices of pharmaceutical companies are measured by Since the last iteration of the Index (2021), its number scope for all three Technical Areas. that mostly affect people in low- and middle-income coun- tionate incidences.2 Cancers in scope now include osteosarcoma, for which Migraine The 2022 Index has a geographic scope that covers 108 inequality-adjusted HDI ratio (HiHDI) as defined by the UN
Unipolar depressive disorders
of the Index methodology carried out in 2019, when the company activity on access to medicine over time; and access-to-medicine theory and practice. indicators that correspond to the core role they can play to of indicators has dropped from 33 to 31. Some have been tries (LMICs). The Index considers this to be a strong indica- treatments are included on the WHO’s Essential Medicines List. The Index countries. Two new countries have been added for the 2022 Inequality-Adjusted Human Development Index (this enables
Kidney diseases
Foundation engaged with more than 100 experts and organ- 5 Ensure the usefulness of the Index’s findings and analyses improve access. As previously, this role centres on the crea- refined, either to tailor a metric more closely to stakeholders’ Defining the disease scope tor that a low level of incentive to invest in pharmaceutical retains epilepsy, bipolar affective disorder and schizophrenia based on con- Alzheimer's disease Index (Algeria and Venezuela). The rest have been in scope the Index to track higher-income countries with significant
Anxiety disorders
isations. This led to an analytical framework with a tightened for governments, industry, investors, NGOs and other key I NTE RNAL I N D ICATO R ANALYSES EXPE RT REVI EW CO M M IT TE E tion and equitable delivery of health products while ensuring expectations of company behaviour, or to improve elements Some diseases are in scope of the Index because they impose R&D will limit the availability of suitable treatment options. tinuing stakeholder consensus on the critical need for access to treatment. 3,4 since 2018. With its two previous iterations covering the same levels of inequality); and
Asthma
structure and sharper analytical capacity. stakeholders in improving access to medicine. • Distribution analyses: Assessing the distribution of scores Throughout each Methodology Review, strategic guidance is responsible business practice and appropriate management such as data capture, comparison of companies or associated a high global disease burden despite the existence of effective In 2022, the Index retains its focus on these diseases and Hypertensive heart disease 106 countries, the Index can draw on the benefits of consist-
Epilepsy
The 2021 Methodology Review started with a series per indicator to check the spread of company behaviour in provided by the Expert Review Committee (ERC), an inde- of access. analyses. In addition, indicators may have been merged or treatments, or because they affect poorer populations dispro- (where data is available) will specifically include diseases in 20 Neglected Tropical Diseases ency and capacity in tracking the progress of pharmaceutical Step 4: Include all Least Developed Countries (LDCs) as
Schizophrenia
of internal checks on indicators, data sets and analytical Strict standards for developing indicators the 2021 Index. This indicates whether expectations of com- pendent body including experts from WHO, governments, removed in accordance with their relevance to access and/or portionately. To identify such diseases, the Foundation used which more than 95% of the global DALY burden is in coun- As previously, the 2022 Index includes all WHO-classified Neglected Tropical Bipolar affective disorder companies and their impacts in countries that face develop- defined by ECOSOC.
Endometriosis
approaches. This was followed by an external review to reaf- In 2021, the research team carried out a targeted review panies are fair (large clusters of low scores could indicate the industry, non-governmental organisations (NGOs), aca- Analytical focus for 2022 the industry’s role. All indicators for the 2022 Index are listed a screening protocol (see Figure xx). This is based on factors tries in scope. Diseases (NTDs).5 Five of these are especially prevalent in poorer regions ment and inequality-related constraints in access to medicine.
Sickle cell disorders
firm the consensus view among stakeholders on the appropri- of the analytical framework, scopes and indicators. Each of that expectations may be too high) and the extent of room demia and investors. The ERC met to review proposals for The analytical framework for 2022 has a tight structure, with from page XX onwards. such as: the prioritisation of the disease by organisations such (particularly rural areas) of low-income countries. Thalassemia
0 50M 100M 150M 200M
ate role for pharmaceutical companies in improving access to the indicators of the 2022 Access to Medicine Index was for improvement. Outcomes inform refinements to indica- the scope, structure and analytical approach of the 2022 31 indicators grouped into three Technical Areas: as Policy Cures Research and the World Health Organization The 2022 Index also brings into scope three diseases that
● Burden in countries in scope ● Burden in rest of world DALY (mn)
medicine in low- and middle-income countries (LMICs). The reviewed through quantitative and qualitative analyses for tors and scoring guidelines. Index, making recommendations where the consensus view is 1 Governance of Access KE Y CHAN G ES I N 2022 (WHO) for improving access to medicine; global and/or coun- exclusively affect women and girls (linked to biological sex). 10 Reproductive, Maternal and Newborn Health
resulting consensus was translated into a set of metrics for robustness, response quality, the potential for longitudinal • Response rate analyses: Assessing company response rates unclear or where uncertainty exists in areas of measurement, 2 Research & Development • The Index will modify the weighting of its three Technical try-level disease burdens; and the relevance of pharmaceu- According to a review of data from GBD 2019 and from the Conditions FIGURE 7 Countries included in the 2022 Access to Medicine Index – 108 Countries
assessing how far the world’s largest pharmaceutical com- analysis and the potential for companies to improve access. and quality regarding each data request in the 2021 Index. before endorsing the final methodology. 3 Product Delivery Areas, decreasing the weighting of Governance of tical intervention. The 2022 Index disease scope has been Global Cancer Observatory (GLOBOCAN 2020)1,2, endometri- To recognise the importance of reproductive, maternal and child health, Neglected tropical diseases, DALYs
panies are meeting society’s expectations. The result is the The Foundation uses strict standards for deciding when to This confirms whether questions are clear and whether For the 2022 Index, analytical criteria for each indicator have Access to 15% (from 20%) and increasing Research and updated according to the most recent Global Burden of osis and ovarian and uterine cancer have comparably higher the Index has since 2014 included contraceptives and nine Maternal and
Scabies and other ectoparasites
methodology for the 2022 Access to Medicine Index. merge or remove a metric. These include the consensus view companies can feasibly gather data for each question. Expert Review Committee for the 2022 Index been refined to ensure like-for-like comparison. This could Development to 30% (from 25%). Disease Study (GBD 2019), which also provides country-level incidence rates and/or DALY burdens than other sex-linked Neonatal Health Conditions.1 Additionally the term Maternal and Neonatal Dengue
on the relevance of the measured behaviour, and the clarity • Correlation analyses: Indicator-level assessments of score Hans Hogerzeil (Chair) University of Groningen relate, for example, to the approaches of companies in simi- • A shifting of weight between Technical Areas puts greater data on disability-adjusted life years (DALYs). This meas- diseases. Including these in 2022 will increase the capacity of Health conditions has been updated to Reproductive, Maternal and Newborn Soil-transmitted helminthiasis
Foodborne trematodiases
and degree of consensus regarding the industry’s role. correlations, which help diagnose less relevant indicators Emily Bleimund U.S. Department of Health and lar country contexts and/or where external market incentives focus on indicators that measure outcomes, rather than ure is commonly used to measure the burden of disease in a the Index to assess the unmet needs of women and girls living Health Conditions. Taeniasis/cysticercosis
and can reveal or confirm positive or negative relationships Human Services (such as pooled procurement mechanisms) resemble each those that measure policies and processes. population. The WHO defines one DALY as “one lost year of in LMICs with sex-linked diseases. Schistosomiasis
Lymphatic filariasis
FIGURE 2 2021 Methodology Review for the 2022 Access to Medicine Index between related areas of company behaviour. Githinji Gitahi Amref Health Africa other. This change will enable the 2022 Index to make a more • The Index will include two new countries but maintains healthy life” to account for the gap between a given popula- 12 Priority Pathogens Onchocerciasis
• Qualitative indicator review: A battery of qualitative assess- Michela Gregory Director, ESG Services at NEI nuanced comparison of access approaches deployed by com- longstanding consistency in its geographic scope. This tion’s ideal health situation, and the actual situation. As in 2020, the Index covers the 12 pathogens included in the WHO’s Leishmaniasis
Rabies
Access to Methodology ments of each indicator including clarity of the expecta- Investments panies in different markets and territories. reflects the recent economic shifts and inequality issues definitive priority pathogens list (2017). These are deemed a priority for
Trachoma
Medicine for the tions and role for companies, continuing relevance to access Fumie Griego International Federation of which can hinder access in such countries. efforts to curb antimicrobial resistance through the development of new Chagas disease
Index 2021 2022 Index
Echinococcosis
26 January to medicine, potential for longitudinal comparisons and the Pharmaceutical Manufacturers Three Technical Areas • The 2022 Index newly includes osteosarcoma and thalas- and effective antibacterial agents.6 For tuberculosis, multidrug resistance
Human African trypanosomiasis Legend: Basis for inclusion*
‘change-making’ potential of each indicator. & Associations Stakeholders have confirmed three key areas (Technical semia in its disease scope, based on stakeholder consensus is a significant issue among patients, making it a critical priority for Leprosy ● World Bank income classification
Final methodology adjustments Dracunculiasis ● UN Human Development Index
Stakeholder engagement to confirm core role for pharma Dennis Ross-Degnan Harvard Medical School and Areas) in which pharmaceutical companies have responsibility and the disproportionate burden of these diseases in coun- pharmaceutical efforts. Because of this, the 2022 Index evaluates it not as
following ERC endorsement 0 2M 4M 6M 8M 10M ● UN Inequality-Adjusted Human
These tests were used to detect and eliminate the risk of Harvard Pilgrim Health Care and ability to influence access to medicine in low- and middle- tries in scope. a pathogen but as a communicable disease. ● Burden in countries in scope ● Burden in rest of world DALY (mn) Development Index
● ECOSOC LDC List
JANUARY SEPTEMBER redundant measures, to pinpoint opportunities for enhancing Institute income countries (LMICs). The Technical Areas are divided • In assessing supply chains, the Index will look more closely
● New inclusion
2021 2021
Indicator and data checks data and to identify where scoring guidelines could be tight- Alan Staple The Clinton Health Access Initiative into 14 priority topics. The Index weights each one according at the process of technology transfer and put more empha- Maternal & neonatal health conditions, mortality
*Classification at the time of the 2018 Access to Medicine
ened. During the indicator review, topics were identified for Fatima Suleman University of KwaZulu-Natal to its perceived importance in improving access to medicine. sis on this area.
Preterm labour and birth complications Index period of analysis. Updated country income and
discussion during the next phase of stakeholder dialogue. Klara Tisocki World Health Organization (WHO) Birth asphyxia and trauma development classifications are available through the
Amsterdam Series Expert Review
Other neontal conditions World Bank and UNDP data.
What can we learn from Comittee Meeting Prashant Yadav INSEAD and Center for Global
COVID-19 to solve chronic issues 23 June Neonatal sepsis and infections
Development Maternal haemorrhage Due to scaling, countries may not be visible on the map
in access to health in LMICs?
Hypertensive disorders of pregnancy (e.g., Tuvalu)
16 June
Maternal sepsis
Footnotes on p.24 Abortion and miscarriage
*At time of ERC meetings Obstructed labour
0 200k 400k 600k 800k 1M
10 11 12 20 ● Burden in countries in scope ● Burden in rest of world DALY (mn)
21 24
55Methodology for the 2022 Access to Medicine Index
EXECUTIVE SU M MARY
A vision for 2030: how this Index will shift
pharma company practice
This report sets out the analytical framework for the next lies. Millions more children have gone without timely vaccina-
Access to Medicine Index, the longest-running assessment of tions since the pandemic began. The shortages of medicines
pharmaceutical industry action to improve access to medi- caused by disruptions to supply chains also affect those living
cine. It builds on the previous Index methodology, which was with non-communicable diseases, including diabetes and
published in March 2020 when the world was waking up to cancer. These groups are especially dependent on receiving a
the threat of COVID-19. steady supply of treatment.
Governments, philanthropic foundations and multi-lateral The pandemic has also reduced access to medicine in more
agencies pivoted quickly to devote funding and resources to indirect ways. With the closure of health facilities and restric-
the pandemic. The private sector also responded vigorously, tions on travel, many pregnant women have lost access to the
ramping up programmes to develop new vaccines, diagnostics obstetric and/or neonatal treatments they may require. This
and treatments, while working to minimise disruption to sup- puts them at grave risk, and jeopardises gains made over the
ply chains. The COVID-19 pandemic has provided a case study past decade in maternal and infant mortality rates.
for the role played by the pharmaceutical industry in develop-
ing and delivering health products, and exposed the vast and
complex network of supply chains and logistics that factories,
clinics and pharmacies depend upon.
The UN has called for a decade of action to achieve its
Sustainable Development Goals (SDGs) and universal health
coverage (UHC) by 2030. The pandemic is demonstrat-
ing in real time how access to medicine can be achieved – or FIG 1 Companies in scope of the 2022 Access to Medicine Index
blocked. Even though vaccines now exist that could end the
Market cap 2020
Company Name Country
pandemic, price, patents, and national stockpiling are among (bn USD)
the factors that influence which populations are served first. AbbVie Inc USA 186,681
The tough lessons from the pandemic should provide a Astellas Pharma Inc JPN 31,067
wake-up call for changing the way healthcare is delivered. Yet AstraZeneca plc GBR 135,160
there is a clear risk that the world could soon return to ‘busi- Bayer AG DEU 63,404
ness as usual’ when it comes to delivering access to medicine. Boehringer Ingelheim GmbH DEU n/a
Bristol Myers Squibb Co USA 136,580
Fall-out continues from the pandemic Daiichi Sankyo Co, Ltd JPN 60,019
Furthermore, the COVID-19 pandemic is not over; action Eisai Co, Ltd JPN 20,849
is still required to curb this pandemic and prepare for the Eli Lilly & Co USA 195,068
future by building strong and responsive health systems. The Gilead Sciences Inc USA 80,940
COVID-19 pandemic has triggered far-reaching consequences GlaxoSmithKline plc GBR 86,525
for global health, disrupting a vast range of programmes Johnson & Johnson USA 433,237
designed to increase access to medicine. Screening and Merck & Co, Inc USA 190,309
treatment for tuberculosis, malaria and HIV/AIDS have been Merck KGaA DEU 73,652
interrupted; so have programmes and activities that target Novartis AG CHE 201,943
neglected tropical diseases (NTDs) and sexual and reproduc- Novo Nordisk A/S DNK 172,363
tive health. Such disruptions can have a ripple effect on devel- Pfizer Inc USA 192,793
opment gains: for example, by putting women and girls at risk Roche Holding AG CHE 292,984
of unwanted pregnancies and impacting their ability to attend Sanofi FRA 118,723
school, join the workforce and help provide for their fami- Takeda Pharmaceutical Co, Ltd JPN 55,422
6Methodology for the 2022 Access to Medicine Index
A vision for 2030 What changes are we working to achieve?
To achieve the SDGs and UHC by 2030 despite the impact To achieve the SDGs and UHC by 2030 despite the impact of
of COVID-19, the pharmaceutical industry must complete COVID-19, the pharmaceutical industry must complete a shift
a shift in how it addresses access to medicine. Namely, it in how it addresses access to medicine:
must approach access to medicine systematically and at
scale, ensuring that healthcare products are delivered to the Governance of Access by 2030
right people via initiatives tailored to local needs and health • Access-to-medicine is fully integrated into commercial
systems. strategy, including oversight, incentives and accountability
This has been confirmed in 2021 by the Access to Medicine from HQ to in-country operations.
Foundation through its stakeholder dialogue, which it holds • Results of access initiatives are monitored and shared
every two years to verify the consensus view on pharma’s publicly.
core role in improving access to medicine. A key step in the • Business is conducted in an ethical and responsible manner.
methodology review for the next Access to Medicine Index,
this latest dialogue builds on the extensive strategic review Research & Development by 2030
carried out in 2019, when the Foundation engaged with more • Pharmaceutical R&D responds to the needs of people in
than 100 experts and organisations. This led to an analytical low- and middle-income countries.
framework with a tightened structure and sharper analytical • Companies’ access plans for registration, supply and
capacity. affordability are systematically developed during R&D, from
Each Access to Medicine Index assesses 20 of the world’s at least Phase II of clinical development.
largest R&D-based pharmaceutical companies on their
actions to improve access to medicine for people living in the Product Delivery by 2030
low- and middle-income countries measured by the Index, • Access is prioritised for products viewed as essen-
which are home to more than 80% of all people alive today. It tial to public health, particularly where there are few
examines companies on their policies and practices in strat- manufacturers.
egy, compliance, R&D, pricing and product delivery. The 20 • New products are quickly and widely registered in low-and
companies in scope account for more than half of global middle-income countries.
pharmaceutical revenue. Considering their pipelines, port- • LMICs can rely on a steady and sufficient supply of quality
folios, resources and global reach, these companies have a products.
unique capacity to develop the health products that people in • Payers and patients can afford the health products they
LMICs need, and to improve the availability of these products need, including people at the base of the income pyramid.
across socioeconomic divides. • Alternative manufacturers are enabled to supply qual-
ity products, competing on price, to countries where pat-
ent-holding companies do not plan to supply directly.
• Health systems are supported through partnerships includ-
ing local stakeholders and in line with local needs.
7Methodology for the 2022 Access to Medicine Index
How the Index drives change
As a tool to drive change, the Index identifies best practice, The next Index will be published in 2022. It will cover:
tracks progress and shows where critical action is needed to • 20 of the world’s largest pharmaceutical companies;
improve access to medicine. It evaluates companies in areas • 31 metrics covering the core role for pharma on access to
where they have the biggest potential and responsibility to medicine in strategy, compliance, R&D, pricing and product
make change, and identifies what is working where and why, delivery;
in order to provide blueprints to expand good practice. By • 108 low- and middle-income countries (LMICs) where bet-
ranking companies every two years, it spurs them to com- ter access to medicine is most urgently needed; and
pete and collaborate on priority access-to-medicine topics. It • 83 diseases, conditions and pathogens that disproportion-
shows which companies are leading the way, as better per- ately impact people in LMICs.
formers rise in the ranking.
KE Y ANALY TI CAL TH E M ES FO R 2022
• Progress toward the SDGs and UHC. The methodol-
ogy review introduced discrete refinements to the analyt-
ical framework while maintaining consistency with previ-
ous analytical approaches. Indicators have been modified
to ensure like-for-like comparisons are more precise. As a
result, the 2022 Index will continue to track progress, while ANALYTICAL FRAMEWORK FOR THE 2022 ACCESS TO MEDICINE INDEX
making more sensitive comparisons of how pharmaceutical
companies use their access approaches in different markets Indicators
3 TECHNICAL AREAS 14 PRIORITY TOPICS per topic
and territories around the world.
Responsible business practices 4
A GOVERNANCE OF ACCESS 15%
• Pandemic preparedness and response. The previous Index, Governance and strategy 3
published in January 2021, found that most pathogens pos-
Access planning 3
ing pandemic concerns were unaddressed by R&D. In 2022, B RESEARCH & DEVELOPMENT 30%
the Index will assess whether this has changed, as part of a
broader assessment of the industry’s level of pandemic pre-
Product development 3
paredness. Importantly, it will also examine companies’ agil-
ity in ramping up manufacturing and deployment to make
COVID-19 products available to all countries, and particu-
Building R&D capacity 1
larly, assessing pricing and supply commitments, identify-
Equitable access strategies 3
C PRODUCT DELIVERY 55%
ing best practices and exploring where and how the indus-
try fell short.
Intellectual property strategy 3
• Continuous supply. Pharmaceutical companies are newly
Quality and supply 3
conscious of how quickly demand for new products can
surge. The 2022 Index will assess the measures compa-
Licensing quality 2
nies are putting in place to respond to urgent need, includ-
ing through partnerships and/or by sharing technology with Product donations 2
smaller companies, generic medicine manufacturers and
Registration 1
research institutes. It will also assess the measures compa- Inclusive business models 1
nies took to ensure the supply of existing health products Local manufacturing 1
and protect pre-existing access commitments. Health systems strengthening 1
8Methodology for the 2022 Access to Medicine Index
The 2022 Access to
Medicine Index
Methodology 2021
The Access to Medicine Index is the product of a two-year
cycle known as the Index cycle, which starts with a review
of the Index methodology. The aim of the review is to distill
global priorities regarding access to medicine and define how
society expects pharmaceutical companies to contribute.
In this section:
REVI EWI NG TH E M ETHO DO LOGY
The 2022 Methodology Review started with a series of inter-
nal checks on indicators, data sets and analytical approaches.
This was followed by an external review to confirm the con-
sensus view among stakeholders on where pharmaceutical
companies should take action in the coming decade.
STAKE HO LD E R CO NSE NSUS
To achieve the SDGs and UHC by 2030 despite the impact
of COVID-19, the pharmaceutical industry must complete a
shift in how it addresses access to medicine. Namely, it must
approach access to medicine systematically and at scale,
ensuring that healthcare products are delivered to the right
people via initiatives tailored to local needs and health sys-
tems. This has been confirmed in 2021 by the Access to
Medicine Foundation through its stakeholder dialogue, which
it holds every two years to verify the consensus view on phar-
ma’s core role in improving access to medicine.
ANALY TICAL FR AM EWO RK
The 2022 Access to Medicine Index is based on a refined ana-
lytical framework of three Technical Areas, and 14 priority
topics for corporate activity.
The analytical framework comprises 31 indicators grouped
into three Technical Areas:
1. Governance of Access
2. Research & Development
3. Product Delivery
99Methodology for the 2022 Access to Medicine Index
REVI EWI NG TH E M ETHODOLOGY
How the Index distills access-to-medicine
priorities for pharmaceutical companies
Each Access to Medicine Index is the result of a two-year pro- Primary principles
cess known as the ‘Index cycle’, which begins with a targeted The primary principles of the 2021 Methodology Review:
review of the Index methodology. The aim is to distil global 1 Ensure that the framework and indicator set clearly reflect
priorities regarding access to medicine and to define how the core role for R&D-based pharmaceutical companies
society expects pharmaceutical companies to contribute. The in access to medicine, and are responsive to the emerging
emphasis is on defining ambitious, but achievable, actions for access needs in LMICs, thus incentivising change;
companies to take. 2 Enable the identification of best practice in all aspects of
For this latest review, the Foundation continued to look access to medicine in order to facilitate broader uptake;
ahead to the 2030 deadline for achieving the Sustainable 3 Ensure all metrics are robust and can fairly compare a
Development Goals, informed by the impacts of the COVID- range of companies against each other;
19 pandemic and building on the extensive strategic review 4 Preserve the capacity of the Index to track pharmaceutical
of the Index methodology carried out in 2019, when the company activity on access to medicine over time; and
Foundation engaged with more than 100 experts and organ- 5 Ensure the usefulness of the Index’s findings and analyses
isations. This led to an analytical framework with a tightened for governments, industry, investors, NGOs and other key
structure and sharper analytical capacity. stakeholders in improving access to medicine.
The 2021 Methodology Review started with a series
of internal checks on indicators, data sets and analytical Strict standards for developing indicators
approaches. This was followed by an external review to reaf- In 2021, the research team carried out a targeted review
firm the consensus view among stakeholders on the appropri- of the analytical framework, scopes and indicators. Each of
ate role for pharmaceutical companies in improving access to the indicators of the 2022 Access to Medicine Index was
medicine in low- and middle-income countries (LMICs). The reviewed through quantitative and qualitative analyses for
resulting consensus was translated into a set of metrics for robustness, response quality, the potential for longitudinal
assessing how far the world’s largest pharmaceutical com- analysis and the potential for companies to improve access.
panies are meeting society’s expectations. The result is the The Foundation uses strict standards for deciding when to
methodology for the 2022 Access to Medicine Index. merge or remove a metric. These include the consensus view
on the relevance of the measured behaviour, and the clarity
and degree of consensus regarding the industry’s role.
FIGURE 2 2021 Methodology Review for the 2022 Access to Medicine Index
Access to Methodology
Medicine for the
Index 2021 2022 Index
26 January
Stakeholder engagement to confirm core role for pharma Final methodology adjustments
following ERC endorsement
JANUARY SEPTEMBER
2021 2021
Indicator and data checks
Amsterdam Series Expert Review
What can we learn from Comittee Meeting
COVID-19 to solve chronic issues 23 June
in access to health in LMICs?
16 June
*At time of ERC meetings
10Methodology for the 2022 Access to Medicine Index
STAKE HO LD E R OUTRE ACH FO R TH E 2022 ACCESS
TO M E D ICI N E I N D EX
The Foundation has built stakeholder consensus on what
we can expect from pharmaceutical companies on access
to medicine. As in previous years, consultations have been
carried out with global health technical experts to ensure a
diverse range of viewpoints and technical expertise are incor-
porated. This included global health donors, international
organisations, investors, low- and middle-income country
governments and regulators, NGOs, pharmaceutical indus-
try organisations, product development partnerships (PDPs)
and research and academic institutions. The Foundation also
engaged with companies evaluated in the Index.
I NTE RNAL I N D I CATO R ANALYSES EXPE RT REVI EW CO M M IT TE E
• Distribution analyses: Assessing the distribution of scores Throughout each Methodology Review, strategic guidance is
per indicator to check the spread of company behaviour in provided by the Expert Review Committee (ERC), an inde-
the 2021 Index. This indicates whether expectations of com- pendent body including experts from WHO, governments,
panies are fair (large clusters of low scores could indicate the industry, non-governmental organisations (NGOs), aca-
that expectations may be too high) and the extent of room demia and investors. The ERC met to review proposals for
for improvement. Outcomes inform refinements to indica- the scope, structure and analytical approach of the 2022
tors and scoring guidelines. Index, making recommendations where the consensus view is
• Response rate analyses: Assessing company response rates unclear or where uncertainty exists in areas of measurement,
and quality regarding each data request in the 2021 Index. before endorsing the final methodology.
This confirms whether questions are clear and whether
companies can feasibly gather data for each question. Expert Review Committee for the 2022 Index
• Correlation analyses: Indicator-level assessments of score Hans Hogerzeil (Chair) University of Groningen
correlations, which help diagnose less relevant indicators Emily Bleimund U.S. Department of Health and
and can reveal or confirm positive or negative relationships Human Services
between related areas of company behaviour. Githinji Gitahi Amref Health Africa
• Qualitative indicator review: A battery of qualitative assess- Michela Gregory Director, ESG Services at NEI
ments of each indicator including clarity of the expecta- Investments
tions and role for companies, continuing relevance to access Fumie Griego International Federation of
to medicine, potential for longitudinal comparisons and the Pharmaceutical Manufacturers
‘change-making’ potential of each indicator. & Associations
Martha Gyansa-Lutterodt Ministry of Health, Ghana
These tests were used to detect and eliminate the risk of Dennis Ross-Degnan Harvard Medical School and
redundant measures, to pinpoint opportunities for enhancing Harvard Pilgrim Health Care
data and to identify where scoring guidelines could be tight- Institute
ened. During the indicator review, topics were identified for Alan Staple The Clinton Health Access Initiative
discussion during the next phase of stakeholder dialogue. Fatima Suleman University of KwaZulu-Natal
Klara Tisocki World Health Organization (WHO)
Prashant Yadav INSEAD and Center for Global
Development
11Methodology for the 2022 Access to Medicine Index
ANALY TI CAL FR AM EWO RK
2022 Index to put greater focus on measuring
outcomes
With more than 10 years of methodological development, 31 indicators
the Index has evolved its framework and indicators through The Index’s methodological framework for 2022 streamlines
extensive dialogue between stakeholders. The result is a set the identification and confirmation of best practices and
of ambitious yet achievable expectations for the behaviour of practices that, over the past decade, have proven to be
pharmaceutical companies in improving access to medicine. successful, scalable and accepted by governments and other
The Methodology for the 2022 Index is based on a tight ana- stakeholders. This streamlining reflects the global health
lytical framework of three Technical Areas, and on 14 pri- community’s emphasis on access programmes that can
ority topics for corporate activity. In each area, the policies achieve both scale and sustainability.
and practices of pharmaceutical companies are measured by Since the last iteration of the Index (2021), its number
indicators that correspond to the core role they can play to of indicators has dropped from 33 to 31. Some have been
improve access. As previously, this role centres on the crea- refined, either to tailor a metric more closely to stakeholders’
tion and equitable delivery of health products while ensuring expectations of company behaviour, or to improve elements
responsible business practice and appropriate management such as data capture, comparison of companies or associated
of access. analyses. In addition, indicators may have been merged or
removed in accordance with their relevance to access and/or
Analytical focus for 2022 the industry’s role. All indicators for the 2022 Index are listed
The analytical framework for 2022 has a tight structure, with from page 28 onwards.
31 indicators grouped into three Technical Areas:
1 Governance of Access KE Y CHAN G ES I N 2022
2 Research & Development • The Index will modify the weighting of its three Technical
3 Product Delivery Areas, decreasing the weighting of Governance of Access
For the 2022 Index, analytical criteria for each indicator have to 15% (from 20%) and increasing Research & Development
been refined to ensure like-for-like comparison. This could to 30% (from 25%).
relate, for example, to the approaches of companies in simi- • A shifting of weight between Technical Areas puts greater
lar country contexts and/or where external market incentives focus on indicators that measure outcomes, rather than
(such as pooled procurement mechanisms) resemble each those that measure policies and processes.
other. This change will enable the 2022 Index to make a more • The Index will include two new countries but maintains
nuanced comparison of access approaches deployed by com- longstanding consistency in its geographic scope. This
panies in different markets and territories. reflects the recent economic shifts and inequality issues
which can hinder access in such countries.
Three Technical Areas • The 2022 Index newly includes osteosarcoma and thalas-
Stakeholders have confirmed three key areas (Technical semia in its disease scope, based on stakeholder consensus
Areas) in which pharmaceutical companies have responsibility and the disproportionate burden of these diseases in coun-
and ability to influence access to medicine in low- and middle- tries in scope.
income countries (LMICs). The Technical Areas are divided • In assessing supply chains, the Index will look more closely
into 14 priority topics. The Index weights each one according at the process of technology transfer and put more empha-
to its perceived importance in improving access to medicine. sis on this area.
12Methodology for the 2022 Access to Medicine Index
FIGURE 3 Analytical Framework for the 2022 Access to Medicine Index
The 2022 Access to Medicine Index analyses company behaviour using a framework of 31 indi-
cators organised in three Technical Areas. In line with previous Index methodology reviews, the
emphasis has increased
ANALYTICAL on R&D and FOR
FRAMEWORK product
THEdelivery
2022strategies
ACCESS such
TOasMEDICINE
pricing and INDEX
licensing.
Indicators
3 TECHNICAL AREAS 14 PRIORITY TOPICS per topic
Responsible business practices 4
A GOVERNANCE OF ACCESS 15%
Governance and strategy 3
Access planning 3
B RESEARCH & DEVELOPMENT 30%
Product development 3
Building R&D capacity 1
Equitable access strategies 3
C PRODUCT DELIVERY 55%
Intellectual property strategy 3
Quality and supply 3
Licensing quality 2
Product donations 2
Registration 1
Inclusive business models 1
Local manufacturing 1
Health systems strengthening 1
13Methodology for the 2022 Access to Medicine Index
GOVE RNANCE O F ACCESS 15%
To improve access to medicine both tangibly and sustaina- Changes in 2022
bly, pharmaceutical companies must implement clear access • The 2022 Index looks at access-related governance struc-
strategies that focus on the long term. By enforcing rigor- tures including monitoring and incentives for top-level staff.
ous standards of behaviour across their operations (including • It assesses whether a company’s strategies cover all thera-
with third-party contractors), companies can mitigate the risk peutic areas, which may yield a wider range of access initia-
of practices that cause harm and undermine their efforts to tives for consideration.
improve access from occurring. • It examines companies’ limit-setting policies around trans-
This Technical Area looks at how companies plan, govern fers of value likely to influence the behaviour of health-
and manage the achievement of their objectives for increas- care professionals (HCPs) in countries in scope (e.g., pay-
ing access to medicine, and at how they apply processes to ments to attend and/or speak at events, to continue
minimise the occurrence and risks of non-compliant and/ medical education and other non-monetary benefits).
or corrupt behaviour. It evaluates companies’ strategies for • It looks at how companies monitor risks around non-com-
access, considering whether these align with corporate strat- pliance at the national level with laws and standards on eth-
egies. It also looks at how companies measure and incentivise ical marketing, anti-corruption and clinical trial governance.
progress towards their objectives for access.
PRIO RIT Y TO PI CS AN D EXPECTATIONS FOR CO M PANY B E HAVIOU R
Governance & strategy Indicator(s)
To ensure that they implement access strategies successfully, pharmaceutical companies must establish struc- GA1, GA2, GA3
tures for governance and management. By assigning responsibility and offering incentives at the highest level, com-
panies can increase the likelihood of prioritising, maintaining and achieving access-related objectives. Companies
are expected to develop and implement a clear, long-term strategy to improve access to medicine. Such a strat-
egy should not remain isolated from the main business of the company; it should seek to align with commercial con-
cerns. Companies should share publicly their progress towards strategic goals. Considerations around access to
medicine should not be limited to a few areas but incorporated systematically into all R&D projects and all commer-
cialisation/market-access strategies, specifically in relation to LMICs.
Responsible business practices
Corrupt behaviour and unethical marketing can have direct consequences for access to medicine, such as the misdi- GA4, GA5, GA6, GA7
rection of national health budgets and promotion of the irrational use of medicines. Pharmaceutical companies can
limit misconduct by enforcing stringent compliance processes across their operations and with third parties, and by
modifying how they incentivise sales agents and disclosing publicly how they engage with healthcare professionals.
They can also implement policies to ensure they interact ethically with healthcare professionals, for example by set-
ting 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 operations in LMICs; these should include monitor-
ing and auditing processes. Companies should also be able to regulate the activities of contracted third parties. To
assess the effectiveness of controls, the Index checks for negative rulings and/or settlements with regards to unethi-
cal marketing, corruption, anti-competitive behaviour (whether or not related to intellectual property) and clinical
trial misconduct in LMICs. In accordance with their public standing, companies are expected to have IP policies that
are conducive to the international consensus on public health.
For indicators and their full rationales, see p.28-29
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