Access to Medicine Index 2018 - Access to Medicine Index 2018 Methodology Report 2017

 
Access to Medicine Index 2018 - Access to Medicine Index 2018 Methodology Report 2017
Access to Medicine Foundation

Access to Medicine
Index 2018
METHODOLOGY
       Access toREPORT
                 Medicine Index 2018
          Methodology Report 2017

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

          September 2017

                                                                               1
Access to Medicine Index 2018 - Access to Medicine Index 2018 Methodology Report 2017
Methodology for the 2018 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
Bill & Melinda Gates Foundation
The UK government
The Netherlands Ministry of Foreign Affairs

E XPE RT R E VI E W CO M M IT TE E
Hans Hogerzeil (Chair)
Sanne Frost-Helt
Fumie Griego
Suzanne Hill
Frasia Karua
Dennis Ross-Degnan
Dilip Shah
Yo Takatsuki
Joshua Wamboga
Prashant Yadav

TECH N I C AL SU BCO M M IT TE ES                   R ES E ARCH TE AM     E D ITO R IAL TE AM
Esteban Burrone                                     Danny Edwards         Anna Massey
Nick Chapman                                        Beth Boyer            Deirdre Cogan
Jennifer Dent                                       Clarke Cole
Michele Forzley                                     Luca Genovese
Warren Kaplan                                       Catherine Gray
Jillian Kohler                                      Nestor Papanikolaou
Niranjan Konduri                                    Tara Prasad
                                                    Stine Trolle
AD D ITI O NAL CO NTR I B UTO RS
We would like to thank the many other experts who contributed their
views to the development of this methodology (see page 56).

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 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 Danny Edwards,
Research Programme Manager
dedwards@accesstomedicinefoundation.org
+31 (0) 20 215 35 35
www.accesstomedicineindex.org

2
Access to Medicine Foundation

A good practice
framework

There is no simple blueprint for making medicine accessible       During ten years of research, we have identified real progress
to all who need them. Often, the poorest people must tackle       from the pharmaceutical industry and best practices in many
complex and changeable barriers before they can access the        areas linked to access: in R&D for neglected diseases, in new
health products they need. Nevertheless, huge strides are         business models that serve low-income populations, and in
being made on major global health challenges – eradicat-          a variety of maturing access initiatives that are making real
ing guinea worm, bringing out new medicines for tuberculo-        change. Yet in other areas, the pace of change remains slow,
sis and hepatitis C, vaccinating a generation of girls against    most notably in pricing.
cervical cancer. There are indeed tools and solutions availa-
ble that can take us a long way forward in improving access to    In 2018, we will publish a new update in our Index research.
medicine.                                                         We will be working in the meantime to show how this meth-
                                                                  odology report can be used to prioritise which actions com-
Our focus at the Access to Medicine Foundation is on the          panies should take. Pharmaceutical companies need willing
role of the pharmaceutical industry. My team and I pres-          and able partners to work with them to improve access and
ent here the current framework for pharmaceutical industry        to continue the slow-burning move away from the traditional
good practice regarding access to medicine in low- and mid-       pharma business model. We invite global health teams work-
dle-income countries, in the form of the metrics for the 2018     ing with and within companies, as well as investors, donors
Access to Medicine Index. They have been identified through       and governments, academics and NGOs to use this method-
our proven consensus-building model. We conducted a series        ology when working to develop healthy markets and healthy
of targeted stakeholder consultations to test and explore         populations.
society’s current expectations of pharmaceutical companies
in 2017.

Our discussions resulted in a tightly focused methodology
that efficiently identifies where companies have the greatest
potential to make change. In priority areas, the Index analysis
will also deepen. For example, in 2018, the Index R&D analy-
sis will match company pipelines against the urgent R&D pri-
orities set by WHO and others. The timely inclusion of cancer
in the scope of the Index reflects the view that a transac-       Jayasree K. Iyer
tional relationship is no longer enough. Companies must           Executive Director
also engage in improving the continuum of care for cancer         Access to Medicine Foundation
patients, and align with the growing prioritisation of cancer
care in low and middle income countries.

                                                                                                                                   3
Methodology for the 2018 Access to Medicine Index

Table of contents

Acknowledgements		                                   2   TECH N ICAL ARE AS
Message 			                                          3   A General Access to Medicine Management                 36
                                                         B Market Influence & Compliance                         37
EXECUTIVE SU M MARY		                                6   C Research & Development		                              38
                                                         D Pricing Manufacturing & Distribution                  39
I NTRO DUCTI O N                                         E Patents & Licensing		                                 40
Improving access to medicine in 2017                10   F Capacity Building		                                   41
                                                         G Product Donations		                                   42
REVI EWI NG TH E M ETHO DO LOGY
How the Index captures changes in the                    I N D ICATO RS PE R TECH N ICAL AREA
access-to-medicine landscape		                      12   A General Access to Medicine Management                 43
                                                         B Market Influence & Compliance                         44
KEY D ECISI O NS AN D D ISCUSSIONS                  14   C Research & Development		                              46
    ▶ C A N CER I N SCO PE                               D Pricing Manufacturing & Distribution                  49
How can the Access to Medicine Index bring cancer        E Patents & Licensing		                                 51
into its scope?		                                   15   F Capacity Building		                                   52
    ▶ PR I O R I T Y R& D                                G Product Donations		                                   54
What are pharmaceutical companies doing to answer
calls for urgently needed R&D?		                    17   APPE N D ICES
    ▶ ACCESS PL A N N I N G                              I.   Contributors to this report		                      56
Is it time for access planning to become standard        II. Priority countries for pricing and registration –
practice during development?		                      18        2018 update		                                      58
    ▶ A SSESSI N G I M PAC T                             III. Cancers in scope for the 2018 Access to
How should pharmaceutical companies assess the                Medicine Index		                                   61
impact of access initiatives?		                     19   IV. Good practice standards framework for the
    ▶ D O N AT I O NS                                         Capacity Building analysis		                       63
Can donation programmes provide sustainable              V. Priority diseases and pathogens for R&D analysis     64
access to medicine?		                               20   VI. ICD-10 coverage & (cancers only)
                                                              WHO EML relevance 		                               66
WHAT WE M E ASU RE                                       VII. References		                                       78
Company Scope		                                     22   VIII. Definitions and acronyms		                        79
Disease Scope		                                     24
Geographic Scope		                                  28
Product Type Scope		                                31

HOW TH E I N D EX M E ASU RES
The Analytical Framework: revealing the actions
that matter most for access 		                      34
Analytical framework		                              35

4
Access to Medicine Foundation

LIST O F FI GU RES                                             LIST O F TAB LES
Figure 1. Analytical Framework for the 2018 Access             Table 1.   Analysis scopes for the 2018 Access
         to Medicine Index		                           8, 35              to Medicine Index		                               7
Figure 2. 2017 Methodology Review for the 2018                 Table 2. Companies included in the 2018 Access to
         Access to Medicine Index                        12               Medicine Index - 20 companies                    22
Figure 3. Cancers in scope for R&D: poorer countries           Table 3. List of diseases, conditions and pathogens
         shoulder large burdens                          15               included in the 2018 Access to Medicine Index 27
Figure 4. Market cap & revenue of companies listed             Table 4. List of countries included in the 2018 Access
         in the 2018 Access to Medicine Index            23               to Medicine Index – 106 countries                30
Figure 5. Breaking down the 2018 disease scope           24    Table 5. Priority countries		                               58
Figure 5a. Diseases and pathogens only in scope                Table 6. Exceptions to the priority country table           60
         for R&D		                                       24    Table 7.   Cancer types in scope and basis for inclusion
Figure 5b. Diseases and pathogens on independent                          for the R&D Technical Area                       61
         R&D priority lists		                            24    Table 8. Cancer types in scope and basis for inclusion
Figure 6. Low- and middle-income countries shoulder                       for product deployment analyses                  62
         the bulk of disease burdens                     25    Table 9. Inclusion and scoring criteria for capacity
Figure 7. Defining the disease scope –                                    building initiatives		                           63
         screening protocol		                            26    Table 10. Priority diseases and pathogens analysed in
Figure 8. Countries included in the 2018 Access to                        the Research & Development Technical Area 64
         Medicine Index - 106 Countries                  28    Table 11. Priority pathogens		                              65

                                                                                                                                5
Methodology for the 2018 Access to Medicine Index

Executive Summary

Globally, two billion people cannot access the medicine they          lytical scopes and the development of new measurements
need. Huge advances in global health are being made, and yet          where needed. Throughout this process, the team debated
new challenges continue to emerge. Among the many stake-              a range of issues with governments, multilateral organisa-
holders working to improve access, pharmaceutical companies           tions, research institutions, non-governmental organisations
have a critical role to play. In 2017, the Access to Medicine Foun-   (NGOs), investors, patient organisations, policy centers and
dation has built consensus on how pharmaceutical companies            pharmaceutical companies.
can address current global health priorities. This report descri-
bes the consensus-building process and how the latest cycle           Discussions covered specific questions relating to pharma-
has shaped the methodology for the 2018 Access to Medicine            ceutical company policy and practice, as well as broader per-
Index. The refined methodology has a tighter focus on where           spectives on the role for the industry regarding access. With
companies have the largest potential for impacting access.            the assistance of its formal committees of independent
                                                                      experts, the Index team balanced the viewpoints provided to
The Access to Medicine Index analyses 20 of the largest               identify workable ways forward. Strategic guidance was pro-
research-based pharmaceutical companies with products for             vided by the Foundation’s Expert Review Committee (ERC),
high-burden diseases in low- and middle-income countries.             an independent body of experts from, among others, WHO,
The Index ranks these companies according to their efforts            governments, NGOs, patient organisations, the industry, aca-
to improve access to medicine in these countries. It identifies       demia and investors.
best practices, highlights where progress is being made, and
uncovers where critical action is still required. In this way, the    Analysis scopes in 2018
Index provides both a guide and an incentive for pharmaceuti-         The 2018 Index will measure the same 20 companies as in
cal companies working to do more for people who lack access           2016, as they remain the largest R&D-based pharmaceuti-
to medicine.                                                          cal companies with the most relevant expertise and portfo-
                                                                      lios. Considering their size, resources, pipelines, portfolios and
In 2016, the Access to Medicine Index reported that pharma-           global reach, these companies have a critical role to play in
ceutical companies are getting more sophisticated in how              improving access to medicine. The majority have consistently
they get essential products to poor people. However, good             qualified for inclusion since 2008. Their efforts to improve
practice was found to be limited to a narrow range of prod-           access to medicine will be assessed across 106 low- and mid-
ucts and countries, and many opportunities to expand good             dle-income countries and in relation to 77 high-burden dis-
practice are yet to be acted upon.                                    eases, conditions and pathogens.

The Index methodology is updated every two years to take              69 indicators
account of new developments and emerging challenges in                The Index research team applied stricter standards than
access to medicine. Each methodology review is informed by            in 2015 for deciding when to retain, strengthen, merge or
a wide-ranging multi-stakeholder dialogue coordinated by the          remove a metric. As a result, the methodology has a tighter
Access to Medicine Foundation. For more than ten years, the           focus on where action by pharmaceutical companies has
Foundation has built stakeholder consensus on what we can             the greatest potential for improving access to medicine. It
expect from pharmaceutical companies.                                 provides a robust framework for efficiently tracking com-
                                                                      pany performance. The 2017 methodology comprises 69
Fine-grained review and consensus building                            indicators: four are mergers of pre-existing ones and 15 have
The Index research team began the 2017 review with a fine-            been removed. Five new indicators were developed in
grained evaluation of the 2016 indicators and data sets,              response to changes in global health priorities, including one
checking the robustness and continuing relevance of each              that specifically recognises R&D targeting priority R&D gaps
measure in turn. The outcomes led to adjustments to ana-              or needs, as identified by stakeholders such as WHO.

6
Access to Medicine Foundation

KE Y CHAN G ES

• Targeted analysis of priority R&D. WHO and others have            • Closer analysis of behaviours that facilitate access to
called for R&D to be urgently prioritised for specific diseases     medicine. The Access to Medicine Index measures four
in order to address urgent public health issues. The 2018           aspects of pharmaceutical company behaviour – transpar-
Index will analyse how companies are responding through an          ency, commitment, performance and innovation (referred to
assessment of R&D for priority diseases. More than half of          as Strategic Pillars). Their relative importance varies depend-
the disease scope (45 out of 77) have an identified priority        ing on the action in question, whether it is negotiating volun-
R&D gap or need, including for new diagnostic products, vac-        tary licenses, marketing activities or capacity building initia-
cines or medicines.                                                 tives, for example. For the first time, this variation has been
                                                                    captured in the Index’s analytical framework.
• Cancer is now in scope. Cancer incidence continues to rise
in low- and middle-income countries. These countries shoul-         • New metrics for capturing the quality and impact of
der a considerable proportion of the global cancer burden,          access initiatives. In 2018, the Index will take a deeper look at
and are increasingly prioritising cancer care in national health-   the quality of companies’ capacity building initiatives, by com-
care plans. In 2018, the Index will assess companies’ actions       paring them against a framework of good practice standards
to improve access to cancer control for the first time. Cancers     developed by the Index research team. The Index will also
that place a high burden on public health will be analysed in       expand its analysis of where and how companies monitor and
R&D, while cancer medicines on the latest WHO Model List of         measure the impact of their access-to-medicine activities.
Essential Medicines (2017) qualify for analyses of pricing, pat-
enting and donations practices.

           Table 1. Analysis scopes for the 2018 Access to Medicine Index

           CO M PAN Y SCO PE                                        G EO G R APH I C SCO PE
           20 companies                                             106 low and middle-income countries
           • Selected based on a combination of market              • 31 low-income countries
           capitalisation and relevance of portfolio for            • 52 lower-middle-income countries
           access to medicine.                                      • 23 upper-middle-income countries

           D I S E A S E SCO PE                                     PRO D U C T T Y PE SCO PE
           77 diseases, conditions and pathogens                    8 types
           • 21 communicable diseases                               Medicines, microbicides, preventive vaccines,
           • 14 non-communicable diseases                           therapeutic vaccines, vector control products,
           • 20 neglected tropical diseases                         platform technologies, diagnostics, contraceptive
           • 10 maternal & neonatal health conditions               methods and devices.
           • 12 priority pathogens

                                                                                                                                       7
Methodology for the 2018 Access to Medicine Index

Figure 1. Analytical Framework for the 2018 Access to Medicine Index
The 2018 Access to Medicine Index analyses company behaviour using a                                The new approach to weighting the Strategic Pillars has been developed
framework of 69 indicators organised in seven Technical Areas. The frame-                           by the Foundation research team and tested both with an external expert in
work’s four pillars correspond to four aspects of behaviour. For the first time                     ranking analytics and the Index’s Expert Review Committee. Final weights
in 2018, the weight of each pillar now varies between the Technical Areas,                          of each Technical Area within the four pillars will be set during data analy-
giving a more sensitive reflection of where these behaviours matter most.                           sis, once new indicators have been confirmed as robust and can be fully inte-
                                                                                                    grated into the 2018 Framework. Target weights are indicated in the figure
In 2018, the target overall weights of the Strategic Pillars remain closely                         below.
aligned with the weights agreed in 2015 by the Expert Review Committee.
In 2015, these weights were: 15% for Commitments, 25% for Transparency,
50% for Performance and 10% for Innovation.

                                           Analytical Framework for the 2018 Access to Medicine Index

                                                                                4 STRATEGIC PILLARS
                                            Commitments    Transparency                       Performance                     Innovation
                                            13.3% (avg.)   23.2% (avg.)                       54.1% (avg.)                    9.4% (avg.)

                                     10%                                        General Access to Medicine Management

                                     10%                                        Market Influence & Compliance
                 7 TECHNICAL AREAS

                                     20%                                        Research & Development

                                     25%                                        Pricing, Manufacturing & Distribution

                                     15%                                        Patents & Licensing

                                     15%                                        Capacity Building

                                     5%                                         Product Donations

                                           Strategic Pillar weights: the target distrubution of pillar weights across Technical Areas in 2018

                                           Commitments                    Transparency                       Performance                                           Innovation

                                           13.3% (avg.)                   23.2% (avg.)                       54.1% (avg.)                                          9.4% (avg.)

8
Access to Medicine Foundation

The 2018 Access to
Medicine Index
Methodology 2017

                                       9
Methodology for the 2018 Access to Medicine Index

I NTRO DUCTI O N

Improving access to medicine in 2017

All people share the right to the highest attainable stand-           from globalisation,9 which could present a deeper crisis for
ard of health, as noted in the WHO Constitution. Yet access           global cooperation in areas such as health.
to medicine continues to be out of reach for an estimated
two billion people worldwide. Huge advances are being                 Progress is being made
made toward internationally agreed global health targets.             Nevertheless, during the same period, progress toward global
Nevertheless, new and complex health challenges continue to           health targets has continued, demonstrating that effective
emerge, demanding sustained commitment and deeper coop-               approaches are being developed and applied. For example,
eration from many different sides, as well as wider adoption          child mortality dropped by almost 50% between 1990 and
of proven solutions. Providing access depends on a complex            2013. There has been a 48% decline in AIDS-related deaths
range of factors and stakeholders.                                    since the peak of the HIV/AIDS epidemic in 2005,10 and more
                                                                      than half of all people living with HIV are accessing antiret-
Development aid for health has slipped since the first decade         roviral therapy.11 In 2015, 71% of countries had an NCD plan
of this century as government budgets have tightened. Aid             addressing cancer, up from 50% in 2010.12 In 2017, the WHO
grew only 0.1% between 2015 and 2016, compared to growth              World Health Assembly, endorsed a set of measures to
rates of up to 11.4% annually between 2000 and 2010.1 This            improve cancer control.13
slow-down is particularly concerning for low-income coun-
tries that rely heavily on aid to maintain the health of their        Breakthroughs in R&D continue to bring new promise. Direct-
populations.1 Yet, in many cases this gap is not being filled         acting antivirals mean country-by-country elimination of hep-
by recipient governments. In many countries in sub-Saha-              atitis C is a real possibility. Immunotherapy has become a
ran Africa and in low-income countries, government health             clinically validated treatment for many cancers,14 with mor-
expenditure as a percentage of GDP has also been in decline           tality from cancer dropping by 23% since 1991 in the United
in recent years.2                                                     States.15 Recent advances in gene-editing technology hold
                                                                      further promise for cancer control.16
While budget growth has slowed, crises and new trends have
posed further challenges to global health. For example, the           Cooperation to limit antimicrobial resistance (AMR) is also
Ebola outbreak in 2014 led to over 11,000 deaths in West              strengthening, with multiple initiatives starting up in recent
Africa.3 This was followed by the Zika outbreak in early 2015,        years, such as the Combating Antibiotic Resistant Bacteria
which quickly spiked to almost 3,500 suspected and con-               Biopharmaceutical Accelerator (CARB-X) and the Global
firmed cases in Central America in early 2016.4 Antimicrobial         Antibiotic Research and Development Partnership (GARDP) in
resistance is growing and already causes more than 700,000            the field of R&D. Numerous pharmaceutical companies have
deaths each year worldwide.5 Rapid urbanisation, worsen-              signalled their readiness to play a part in addressing AMR
ing diets, increasingly sedentary lifestyles and aging popu-          by signing the Davos Declaration on Antibiotic Resistance
lations are contributing to a rise in non-communicable dis-           and the Industry Roadmap for Progress on Combating
eases (NCDs).6 Climate change is expected to cause a quarter          Antimicrobial Resistance.17,18
of a million additional deaths per annum from malnutrition,
malaria, diarrhoea and heat stress between 2030 and 2050.7            Critical role for pharmaceutical companies
                                                                      In 2017, the need for all stakeholders to take action on access
Geopolitical and societal factors are also influencing the            to medicine remains clear, with each having their own appro-
shape of the global health landscape. The World Economic              priate role and responsibilities. Pharmaceutical companies
Forum has identified economic disparity and global govern-            control unique products that can greatly alleviate disease bur-
ance failures, the decline of trust in institutions, and persisting   dens; they also have the expertise to meet the need for new
gender inequalities as contributors to a fractured health land-       and adapted innovative products; the power to address the
scape.8 Some see these global risks as factors in a move away         affordability of those products; and the ability to strengthen

10
Access to Medicine Foundation

supply chains and support healthcare infrastructures. When
pharmaceutical companies take positive action, it can have a
profound effect on people’s lives.                                    Over the past ten years, the Access to Medicine Index has identified increas-
                                                                      ing engagement by pharmaceutical companies in access to medicine.
In 2016, the Access to Medicine Index reported that pharma-
ceutical companies are getting more sophisticated in how
they get products to poor people, and are addressing global           For example, the disease scope has been adjusted in line with
health priorities for example in R&D. However, good practice          changing views on which diseases should be prioritised for
was found to be limited to a narrow range of products and             improving access to medicine. In 2008, the Index focused
countries, and many opportunities to expand good practice             mainly on Neglected Tropical Diseases (NTDs) as defined by
are yet to be acted upon.                                             WHO, expanding to include high-burden diseases including
                                                                      NCDs in 2010. The latest refinement in this direction is the
The work of the Access to Medicine Foundation                         inclusion of cancer in the 2018 Access to Medicine Index.
The Access to Medicine Index analyses 20 of the top
research-based pharmaceutical companies with products for             The geographic scope has also been refined, to ensure it
high-burden diseases in low- and middle-income countries.             covers countries where greater access to medicine is needed
The Index ranks these companies according to their efforts to         most. Many countries have moved into higher World Bank
improve access to medicine. It identifies best practices, high-       classifications over the lifespan of the Index: 72% of the
lights where progress is being made, and uncovers where crit-         world’s poor now live in middle-income countries.19 To adapt
ical action is still required. In this way, the Index provides both   to these demographic changes, the 2014 Index adopted
an incentive and a guide for pharmaceutical companies to do           measures of human development and inequality in its country
more for people who still lack access to medicine.                    inclusion framework, to bring some higher income countries
                                                                      with low levels of equality into the Index scope.
Over the past decade, the Access to Medicine Foundation has
developed a robust process for building consensus among a             The 2018 Access to Medicine Index
wide range of stakeholders on what society expects of phar-           In 2017 the Foundation has completed the 6th review of its
maceutical companies regarding access to medicine in low-             methodology for the Access to Medicine Index. The 2018
and middle-income countries. These expectations are then              Access to Medicine Index will measure the same 20 compa-
translated into metrics that form the basis of the methodol-          nies as in 2016. Considering their size, resources, pipelines,
ogy for the Access to Medicine Index.                                 portfolios and global reach, these companies have a criti-
                                                                      cal role to play in improving access to medicine. The refined
The Index methodology is updated every two years in                   methodology comprises 69 indicators, covers 106 countries
line with developments in access to medicine following a              and 77 diseases, conditions and pathogens. The Foundation
wide-ranging multi-stakeholder dialogue coordinated by the            will now begin the process of data collection, verification,
Access to Medicine Foundation. The dialogue draws together            scoring and analysis, before publishing the next Access to
the views of NGOs, governments, the industry and multi-lat-           Medicine Index in late 2018. The Foundation will also use this
eral organisations, in order to build consensus on how and            latest methodology to provide guidance to pharmaceuti-
where pharmaceutical companies can and should be improv-              cal companies on where the priorities now lie, and how they
ing access to medicine.                                               match with the many solutions and practices identified in pre-
                                                                      vious iterations of the Index.
How the Index has responded to global challenges
As a result, the Index methodology has evolved continually
since the first Access to Medicine Index was publishd in 2008.

                                                                                                                                                 11
Methodology for the 2018 Access to Medicine Index

REVI EWI NG TH E M ETHODOLOGY

How the Index captures changes in the
access-to-medicine landscape

Each Access to Medicine Index is the result of a two-year pro-           CO M M IT TE E CO N SU LTATI O N S
cess known as the ‘Index cycle’, which begins with a targeted            Throughout each Methodology Review, formal committees
review of the Index methodology. The aim is to confirm the               support the Index team. Summaries of discussions and deci-
global priorities regarding access to medicine and define how            sions are provided in the next section. Recommendations
society expects pharmaceutical companies to contribute.                  for specific areas of the Index are provided by Technical
The emphasis is on defining ambitious, but achievable actions            Subcommittees of specialists in different aspects of access
for companies to take. For this latest review, the Foundation            to medicine. Strategic guidance is provided by the Expert
drew on more than a decade of experience in building con-                Review Committee (ERC), an independent body of experts,
sensus on where pharmaceutical companies can take action,                including from WHO, governments, patient organisations, the
before translating it into robust metrics. The result is the             industry, non-governmental organisations (NGOs), academia
methodology for the 2018 Access to Medicine Index.                       and investors. The ERC met twice to review proposals for the
                                                                         scope, structure and analytical approach of the 2018 Index
The process for the methodology review has been developed                and to ratify the final methodology.
over six Index cycles. It includes a series of internal checks on
indicators, data sets, measures of behaviour and on analyti-             Expert Review Committee in 2018
cal approaches. This is followed by an external review, during           Hans Hogerzeil (Chair)            University of Groningen
which the consensus view is sought between a range of                    Sanne Frost-Helt                  Denmark Ministry of Foreign Affairs*
stakeholders on specific access topics and the role for phar-            Fumie Griego                      International Federation of Pharma-
maceutical companies, as well as on the analytical scopes and            		                                ceutical Industry Associations
the appropriate weights for the areas measured by the Index.             Suzanne Hill                      World Health Organization
                                                                         Frasia Karua                      Amref Health Africa
The primary principles of the Methodology Review are: (1)                Dennis Ross-Degnan                Harvard Medical School
that all metrics are robust and data can efficiently and fea-            Dilip Shah                        Indian Pharmaceutical
sibly be collected; (2) that the Index is responsive to chang-           		                                Association
ing access needs; and (3) that all metrics are relevant to the           Yo Takatsuki                      BMO Global Asset Management
appropriate role for pharmaceutical companies in improving               Joshua Wamboga                    International Alliance of Patients’
access to medicine.                                                      		                                Organizations
                                                                         Prashant Yadav                    Harvard Medical School

Figure 2. 2017 Methodology Review for the 2018 Access to Medicine Index

                                                                    ERC Meeting I               ERC Meeting II
                                                                    June 2017                   July 2017                Methodology
     Index 2016                                                                                                          for 2018 Index
     Sept 15 2016                                                                                                        Sept 2017

                                            Company        Scopes            Resolving              Final adjust-
                        Indicator and
                                            feedback on    and metrics       specific               ments following
                        data checks
                                            2016 Index     discussions       questions              ratification

                       INTERNAL            EXTERNAL REVIEWS & CONSENSUS BUILDING                    FINALISATION
                       REVIEWS

                                                                         *At time of ERC meetings

12
Access to Medicine Foundation

I NTE R NAL R E VI E W O F I N D I C ATO RS AN D DATA              CO N S E N SUS B U I LD I N G AN D D IALO G U E
The Foundation reviewed each of the indicators of the 2016         The Foundation has built stakeholder consensus on what we
Access to Medicine Index for robustness, response quality and      can expect from pharmaceutical companies for more than
the potential for companies to improve access to medicine          a decade. While disagreement persists in key areas, such as
through a series of quantitative and qualitative analyses:         pricing and the management of intellectual property, overall
• Distribution analyses. Assessing the distribution of scores      the depth of consensus on the appropriate role for pharma-
 per indicator to check the spread of company behaviour in         ceutical companies has grown. In 2017, the Foundation’s pro-
 the 2016 Index. This indicates whether expectations of com-       cess of consensus building has once again underpinned meth-
 panies are fair (large clusters of low scores may indicate        odological changes for the 2018 Access to Medicine Index.
 expectations may be too high) and the extent of room for          The Foundation strives to ensure that the consultation pro-
 improvement. Outcomes inform refinements to indicators            cess is wide-ranging, independent, transparent and includes
 and scoring guidelines.                                           the engagement of key global health experts.
• Response rate analyses: Assessing company response rates
 to each data point requested in the 2016 Index. This con-         Review and engagement process
 firms whether questions are clear and whether companies           The stakeholder dialogue was targeted toward priority areas
 can feasibly gather data per question; it can also indicate the   and topics identified by the Foundation’s research team for
 relevance companies assign per question and/or their will-        discussion with experts. Topics were prioritised through:
 ingness to disclose information.                                  internal analyses of data and indicators, independent reviews
• Correlation analyses: Indicator-level assessments of score       of the Index research during the 2015-16 period of analysis,
 correlations, which help diagnose less relevant indicators,       and a review of developments in access-to-medicine theory
 and can reveal or confirm positive or negative relationships      and practice. The Foundation team also engaged with the
 between related areas of company behaviour.                       companies measured by the 2016 Index and its associated
• Qualitative indicator review: A battery of qualitative assess-   data-collection processes.
 ments of each indicator, including clarity of expectations
 and role for companies, continuing relevance to access to         The Foundation’s research team then reached out to a broad
 medicine, potential for longitudinal comparisons and the          range of experts through a targeted stakeholder engage-
 ‘change-making’ potential of each indicator.                      ment exercise. Experts were identified from relevant organi-
                                                                   sations, through a review of the literature, and recommenda-
These tests were used to identify where scoring guidelines         tions from other stakeholders. The research team engaged
could be tightened, detect and eliminate the risk of redun-        with experts and stakeholders from a wide range of back-
dant measures, and pinpoint opportunities for enhancing data       grounds to ensure alternative viewpoints and technical exper-
quality. In 2017, the Foundation applied stricter standards for    tise were incorporated. This included discussions with repre-
deciding when to merge or remove a metric. These standards         sentatives of multilateral organisations, research institutions,
were linked to: the relevance of the measured behaviour to         NGOs, investors, and companies (see Appendix).
access to medicine; clarity regarding the industry’s role; and
the degree of consensus among stakeholders regarding how           The Foundation used the views gathered to inform its pro-
companies should behave. During the indicator review, topics       posals for modifications to the methodology. These propos-
were identified for discussion during the next phase of con-       als were discussed in detail with the Index’s Technical Sub-
sensus building and stakeholder dialogue.                          Committees and ERC. The recommendations and strategic
                                                                   guidance provided by the ERC in particular helped to identify
                                                                   ways forward where disagreement or uncertainty existed in
                                                                   areas of measurement.

                                                                                                                                        13
Methodology for the 2018 Access to Medicine Index

REVI EWI NG TH E M ETHODOLOGY

Key decisions and discussions

Discussions held during the method-                 In this section:
ology review were wide-ranging and
rich. In many cases, there was align-                ▶ C A N CER I N SCO PE
ment on the behaviours that the 2018                How can the Access to Medicine Index bring cancer into its scope?
Access to Medicine Index should meas-
ure and how. In others, it was difficult to          ▶ PR I O R I T Y R& D
find consensus. In these cases, the Index           What are pharmaceutical companies doing to answer calls for
team, with its Technical Subcommittees              urgently needed R&D?
and Expert Review Committee, iden-
tified workable ways forward, balanc-                ▶ ACCESS PL A N N I N G
ing the evidence and viewpoints gath-               Is it time for access planning to become standard practice during
ered. This section highlights discussions           development?
where the appropriate decision was
contested, or where discussions led to               ▶ A SSESSI N G I M PAC T
new areas of measurement.                           How should pharmaceutical companies assess the impact of access
                                                    initiatives?

                                                     ▶ D O N AT I O NS
                                                    Can donation programmes provide sustainable access to medicine?

14
Access to Medicine Foundation

 ▶ C A N CER I N SCO PE
HOW CAN TH E ACCESS TO M E D ICI N E I N D EX B RI NG CANCE R I NTO ITS SCO PE?

Cancer is one of the world’s leading causes of death, and now          comparing evidence gathered during the 2015 review, with
accounts for 1 in 6 deaths worldwide.20 Clearly, cancer is a pri-      new developments and viewpoints on cancer prioritisation
ority global health issue. However, providing good cancer care         and the opportunities for pharma companies.
is an almost uniquely complex challenge, requiring prevention,
screening, diagnosis, referral, treatment and palliative care,         Cancer incidence continues to rise in low- and middle-income
among other steps. In poorer countries, the necessary infra-           countries, with such countries shouldering a large propor-
structure and resources for delivering this care are typically         tion of the burden (see figure 3).22 Three further medicines
weak or limited. Although the majority of countries have a             have been added to the WHO EML (in 2017).23 In the same
national cancer control plan (NCCP) in place, in poorer coun-          period, R&D activity for cancer treatment has expanded rap-
tries, the necessary infrastructure and resources for deliver-         idly, and the global oncology market is now expected to grow
ing cancer care are typically weak or limited. China, India and        by almost a third to USD 150 billion by 2020.24
Brazil, for example, have relatively strong
health systems that are better equipped for the
management of cancer, while countries such               Figure 3. Cancers in scope for R&D: poorer countries shoulder
as Kenya and South Africa do not yet meet                		           large burdens
basic infrastructure requirements for cancer             The 2018 Index will analyse company pipelines for 17 cancer types. These have been
treatment.21                                             selected based on their incidence either globally or in countries in scope. For most of
                                                         these cancer types, more than 50% of the incidence is in the 106 low- and middle-income
Cancer has not previously been included in the           countries in the scope of the Index.
scope of the Access to Medicine Index. When
                                                                               Lung
its inclusion was last discussed, in 2015, stake-
                                                                             Breast
holders expressed contrasting views: for exam-
                                                                           Stomach
ple, that the need for greater action to improve
                                                                               Liver
cancer control had triggered WHO to add 16
                                                                         Colorectal
cancer medicines to its Model List of Essential
                                                                            Cervical
Medicines (WHO EML); that there is a need to
                                                                      Oesophageal
stimulate companies to address the affordabil-
                                                                           Prostate
ity of cancer medicines in countries with con-
                                                                        Leukaemia
strained finances; that companies can only play
                                                                     Lip, oral cavity
a limited role in improving cancer support sys-
                                                          Non-Hodgkin lymphoma
tems; that the Index should instead prioritise
                                                            Brain, nervous system
diseases with a more critical need for access
                                                                            Bladder
to treatment, including typical childhood kill-
                                                                        Gallbladder
ers with known and effective treatments on the
                                                                     Other pharynx
market.                                                               Nasopharynx
                                                                    Kaposi sarcoma
During the 2017 Methodology Review, the
                                                                                        0             0.5              1             1.5               2
research team once again examined whether
                                                                                        ● Incidence in countries in scope                  Incidence (mn)
cancer should be brought into the Index scope,                                          ● Global incidence rate

                                                                                                                                                     15
Methodology for the 2018 Access to Medicine Index

At the 2017 WHO World Health Assembly, delegates agreed               pharmaceutical companies can build capacity at all levels of
a resolution on cancer prevention and control, urging greater         health services across the cancer continuum of care in low-
efforts to “promote the availability and affordability of qual-       and middle-income countries. Furthermore, the companies
ity, safe and effective medicines (for cancer), in particular,        share an opportunity to increase access to affordable medi-
but not limited to, those on the WHO Model List of Essential          cine. Together, these companies produce 34 of the 46 unique
Medicines (WHO EML).25                                                cancer medicines on the WHO EML (2015).

In 2017, the Access to Medicine Foundation carried out a
first study of how pharmaceutical companies are address-
ing cancer control. It found that 16 companies were engaged
in 129 diverse initiatives in low- and middle-income coun-
tries.26 The range and volume of initiatives indicates that

D ECI S I O N : C AN CE R I S I N SCO PE FO R TH E 2018 I N D E X

On reviewing new developments with stakeholders, and with             type in low-resource settings. The cancers in scope for R&D
strategic guidance from the Expert Review Committee, the              are selected based on global incidence, on incidence in coun-
Foundation decided to include cancer for the first time in the        tries in the scope of the Index, and where the burden was dis-
scope of the Access to Medicine Index in 2018. In its analy-          proportionately high in low- and middle-income countries
sis, the Index will acknowledge where possible the context
of national cancer care systems. The 2018 Index will examine          When it comes to registered products, an external prioriti-
27 cancer types: 17 in the R&D Technical Area, and 19 in the          sation does exist. Cancers in scope for product deployment
Technical Areas relating to pricing, patenting and donations          are selected based on whether there are relevant registered
(see Appendix). Nine cancers are in both sets. In Capacity            products on the WHO EML (2017), highlighted in the recent
Building, the Index will include all initiatives related to cancer.   cancer resolution as those needing particular focus when
                                                                      considering availability and affordability. This focuses the
Bringing cancers into scope for R&D highlighted a signifi-            analysis on a subset of cancer products identified by WHO as
cant omission in the global health landscape: an absence of           essential for the treatment of cancer.
prioritisation regarding cancer-care research needs in low-
and middle-income countries. Therefore a proxy was needed;            The decision to include cancer in the 2018 Index scope is
incidence was highlighted as the most robust indication of            described in more detail in Cancer Control 2017 (by the
whether further R&D was needed to treat a particular cancer           International Network for Cancer Treatment and Research).

16
Access to Medicine Foundation

 ▶ PR I O R I T Y R& D
WHAT ARE PHARMACEUTICAL CO M PAN I ES DO I NG TO ANSWE R CALLS FO R U RG E NTLY N E E D E D R&D?

There are many diseases without adequate or effective treat-               Stakeholders were clear that companies could be expected to
ments available, or where the products are not sufficiently tai-           act and incentivised to do more in this low-incentive space.
lored to meet the needs of people living in low- and middle-
income countries. Pharmaceutical companies have much to                    Following these discussions, the Foundation identified and
add in this space: addressing such ‘product gaps’ is a core                reviewed published, independently defined lists of prior-
expertise of the industry. However, there is a mismatch in                 ity product gaps and research needs. Such prioritisations can
incentives. Commercial incentives remain a primary driver for              stimulate R&D by providing guidance and directing resources
pharmaceutical R&D. The product gaps and research needs                    to where they are most needed. The Index offers an addi-
that matter more to people living in low- and middle-income                tional incentive in the form of recognition for R&D that tar-
countries and less to people in wealthier countries typically              gets these priorities. The Index team found R&D prior-
offer little or no commercial incentive to engage in pharma-               ity lists defined by global health stakeholders, such as WHO,
ceutical R&D.                                                              for a range of Communicable Diseases, Neglected Tropical
                                                                           Diseases and Maternal & Neonatal Health Conditions.
Despite this, companies can and do engage in R&D with                      However, no priority list has yet been developed to iden-
less commercial promise, for example through collaborative                 tify R&D needs within the field of Non-Communicable
models such as Product Development Partnerships (PDPs),                    Diseases (NCDs). On reaching out to stakeholders, it was rec-
which can facilitate risk- and expertise-sharing. As a first anal-         ognised that very limited work has been done in this field.
ysis in this space, the 2016 Access to Medicine Index looked               Stakeholders identified the absence of an external prioritisa-
at whether pharmaceutical companies were addressing ‘high-                 tion list for NCDs as a significant concern that needed to be
need, low-incentive’ product gaps. It found that 31 out of 84              addressed by the global health community.
of the gaps analysed were being addressed by one or more
companies, largely through partnerships, and through a com-                The prioritisation lists identified by the Index team define spe-
bined total of 151 projects. This analysis compared companies’             cific product gaps that are disproportionately needed by pop-
pipelines with priority product gaps identified by Policy Cures            ulations in low- and middle-income countries, as well as gaps
Research (G-FINDER) for diseases already included in the                   linked to potential global health threats, such as emerging
Index disease scope.27                                                     infectious diseases and pathogens that have developed anti-
                                                                           biotic resistance. To address the lack of a prioritisation list for
During the 2017 methodology review, the Foundation sought                  NCDs, stakeholders endorsed the Index team’s proposition to
to expand this analysis to draw in a more comprehensive                    include R&D projects for NCDs that demonstrably address a
range of diseases where a pressing research need or                        need specific to populations in low- and middle-income
product gap had been identified. In discussions with stake-                countries.
holders, emerging infectious diseases such as Ebola and Zika
were cited as diseases that were not within the Index scope,
but where R&D was of critical value – and where companies
have shown clear evidence of engagement.

D ECI S I O N : E XPAN D D I S E A S E SCO PE TO C APTU R E I N D USTRY R ES PO N S ES TO R& D PR I O R ITI ES CU R R E NTLY I D E NTI FI E D

The disease scope has been expanded to include all diseases,               The five lists are:
conditions and pathogens with an identified product gap on
the five independently compiled lists of product gaps and                  • G-FINDER neglected diseases, products and technologies
R&D needs that are deemed priorities for public health. The                  (2017);27
aim is to provide a complete analysis of how the companies                 • G-FINDER reproductive health areas, products and technol-
in scope are addressing such R&D priorities. This analysis will              ogies (2014);28
aid global health stakeholders in understanding where R&D                  • WHO R&D Blueprint (2017);29
is taking place, and recognise and encourage companies to                  • WHO Initiative for Vaccine Research gaps (2017)30
address all priority gaps on these lists.                                  • WHO pathogen priority list for R&D of new antiobiotics
                                                                             (2017)31

                                                                                                                                                17
Methodology for the 2018 Access to Medicine Index

 ▶ PL A N N I N G FO R ACCESS
IS IT TI M E FO R ACCESS PL AN N I NG TO B ECO M E STAN DARD PR ACTI CE DU RI NG PRO DUCT
D EVE LO PM E NT ?

Pharmaceutical companies start working on their market                      Views among stakeholders have since shifted; the con-
access strategies while products are still in development.                  sensus now is that companies should apply the lessons
Their aim is to secure strong market positions for new prod-                they have learned from access planning in PDPs and bring
ucts, and they generally target markets with high potential                 them in-house. Indeed, companies in many cases already
profitability. It is less common for companies to also plan for             do so. Looking only at late-stage R&D projects, the 2016
access for populations in less profitable markets during devel-             Index showed that 41% of projects conducted by compa-
opment. These access plans aim to make successful innova-                   nies in-house had associated access provisions. Importantly,
tions rapidly available for patients in low- and middle-income              expanding this expectation would capture companies’ plans
countries, and at affordable prices and support their rapid                 for more projects targeting NCDs. These projects typically
uptake.                                                                     happen in-house, rather than in collaboration. Given the
                                                                            increasing burden of NCDs in low-and middle income coun-
During the methodology review, the Foundation’s research                    tries, the need for companies to also make new NCD products
team asked stakeholders to consider whether companies can                   rapidly accessible is growing.
be expected to step up their access-planning and integrate it
more deeply into their businesses. Is it time for access plan-              On the question of timing (i.e., when access planning should
ning to become standard practice during development?                        take place), stakeholders tended to agree that broad com-
                                                                            mitments – e.g., to ensure the affordability of the product on
In the 2016 Index, access provisions were expected only when                approval – can be made very early in development. However,
they were part of collaborative research projects, usually with             they were also clear that, in most cases, it is not possible to
PDPs. During previous methodology reviews, the stakeholder                  develop detailed access provisions tailored to local contexts
view was that access planning was more likely in such part-                 until at least phase II clinical development.
nerships than in projects conducted by companies in-house.
The 2014 Index showed 39% of projects carried out in collab-
oration had plans for access in place, rising to 51% in the 2016
Index.

D ECI S I O N : B ROAD E R M E A SU R E M E NT O F ACCESS PROVI S I O N S

Stakeholders agreed that it was now time to broaden the                     This means it will now look more comprehensively at access
focus of the Index’s measurement of access provisions: that                 provisions for R&D projects targeting NCDs. Regarding
companies can now be expected to plan for access for all pro-               timing, the 2018 Index will expect advance planning for access
spective products that are needed in low- and middle-income                 for projects from phase II. This provides a clearer expectation
countries. Following this shift, the Index adjusted its measure             and point of focus for early consideration of access.
to recognise all access provisions, whether for R&D carried
out in partnership or in-house.

18
Access to Medicine Foundation

 ▶ A SSESSI N G I M PAC T
HOW CAN TH E I N D EX M E ASU RE TH E I M PACT O F ACCESS I N ITIATIVES?

The pressure to show that initiatives to improve access to             Discussions held during the Foundation’s 2017 Methodology
medicine actually work is growing, particularly as pharmaceu-          Review confirmed that such moves are viewed as a step in
tical companies are expanding their engagement in access ini-          the right direction. Stakeholders see value in pharmaceuti-
tiatives in low- and middle-income countries. Governments,             cal companies working with third parties and each other to
NGOs, patient groups and communities increasingly expect               develop and fine tune their approaches to impact measuring,
to see a measureable impact. The companies themselves                  as well as in sharing information about their results and suc-
also seek a greater understanding of what works and what               cesses. However, there is still no agreement among stake-
doesn’t, to demonstrate and build on success and avoid                 holders on how to best define impact, or on the most appro-
repeating past failures.                                               priate models for assessing the impact of pharmaceutical
                                                                       companies’ access initiatives. Stakeholders have also high-
The increasing focus on impact measuring started with the              lighted risks that stem from confusion between outcome and
global development community, driven by several economic               impact measurements.
and political factors. For example, many funding agencies
have reduced or retargeted their development budgets, while            Stakeholders argued for transparency regarding impact meas-
major donors have pushed hard for greater demonstration of             urement, specifically in terms of companies sharing informa-
‘value for money’. At the same time, there is a growing public         tion about their approaches and whether they work, as well
perception that five decades of development assistance – in            as the results of their evaluations, so that a wider community
time, money and other resources – have not led to the hoped-           of actors can learn from them.
for effects. This perception has put pressure on donors, and
consequently other actors in international development such            In 2016, the Index evaluated whether companies or their
as NGOs, academia and the private sector, to do a better job           partners carry out impact assessments for donation pro-
of demonstrating clear, tangible results that can be under-            grammes. When the measure was developed in 2015, these
stood by both their peers and the general public.                      programmes were identified through stakeholder consulta-
                                                                       tion as the most likely focus of impact measurement. A study
Several pharmaceutical companies have already started to               from Boston University has since confirmed this position;33 it
announce, plan and carry out impact assessments of their               found that 31 out of 47 published evaluations related to dona-
access initiatives. For example, University College London             tion programmes. However, many stakeholders and pharma-
recently carried out a study of Novo Nordisk’s Base of the             ceutical companies now expect more; impact assessments are
Pyramid projects. This initiative aims to facilitate access to         now viewed as possible and potentially instructive in a variety
diabetes care for people in work, but on low incomes, in cer-          of access initiatives, from inclusive business models, to health
tain low- and middle-income countries.32 Boston University             systems strengthening activities.
has started a programme that aims to measure the impact of
initiatives associated with Access Accelerated: an industry ini-
tiative to prevent NCDs and improve access to care in low-
and lower-middle income countries.

TH E D ECI S I O N : I N D E X TO LO O K FO R B ROAD E R E FFO RTS TO E VALUATE I M PAC T

For the 2018 Index, companies’ efforts to evaluate impact will         nise those companies taking steps and making plans to meas-
also be measured in the Technical Areas of General Access              ure impact, share information about the variety of ways they
to Medicine Management and Capacity Building, as well as               engage in this work, including with third parties, and credit
in Product Donations. More specifically, the Index will recog-         those companies that take steps to publish the results.

                                                                                                                                       19
Methodology for the 2018 Access to Medicine Index

▶ D O N AT I O NS
CAN DO NATI O N PROG R AM M ES PROVI D E SUSTAI NAB LE ACCESS TO M E D I CI N E?

The donation of pharmaceutical products can help to ensure                     access to pharmaceuticals is better guaranteed through
that the poorest populations – people with no ability to pay                   models such as equitable pricing or licensing than through
– are able to access the medicines they need. Donations con-                   donations. Such approaches emphasise affordability for
tinue to demonstrate particular value during humanitarian                      payers and encourage low- and middle-income country gov-
emergencies, when healthcare infrastructure is damaged and                     ernments to invest in their health systems. At the same time,
populations are especially vulnerable. Donations have become                   equitable pricing and licensing can provide companies with a
a core component of global efforts to eliminate, eradicate                     return on their investments as an incentive to remaining in a
and control neglected tropical diseases, which predominantly                   given market longer-term.
affect the poorest populations across the world.
                                                                               Stakeholders agree that donation programmes remain an
Recently, however, some have raised concerns regarding the                     appropriate approach for improving access to medicine in
long-term sustainability of product donations. For example,                    certain contexts, particularly for reaching the poorest and
Médecins Sans Frontières recently rejected an offer of pneu-                   most vulnerable populations. There is also a critical difference
mococcal vaccine donations calling instead for the vaccine                     between programmes that aim for disease eradication and
to be sold at a discounted price.34 The organisation’s ration-                 those where eradication cannot be seen as a goal (i.e., pro-
ale is that donation programmes are vulnerable to changing                     grammes targeteing chronic diseases). Where donations are
priorities within companies, while market-based approaches                     deemed appropriate, the consensus view is that programmes
are more likely to last.34 Other commentators have noted that                  must include assessments of how access can be sustainable
donations can disrupt market incentives for generic compe-                     in the long-term. This means companies working with govern-
tition,35 and emphasised the importance of taking long-term                    ments to establish plans to ensure recipient populations can
sustainability into account when donating products, especially                 continue to access treatments for as long as they are needed,
for those targeting chronic diseases.36                                        even after donation programmes end. Once again, sustainable
                                                                               approaches are especially pressing where patients suffer from
During the 2017 Methodology Review, the Foundation found a                     chronic diseases.
growing consensus among stakeholders that sustainable

TH E D ECI S I O N : G R E ATE R E M PHA S I S O N SUSTAI NAB I LIT Y PL AN N I N G ; R E D U CE D W E I G HT
FO R PRO D U C T D O NATI O N S OV E R ALL

Following these discussions, the research team carried out a                   implemented in a sustainable manner, with a view to the long-
close examination of the Product Donations Technical Area                      term needs of the populations they serve. Finally, the Index
with the sustainability of access in mind. This led to a reduc-                will differentiate between programmes targeting communi-
tion in the overall weight of the Technical Area, from 10% to                  cable diseases and those targeting NCDs, recognising that
5% of companies’ final Index score.                                            NCD programmes cannot aim for disease eradication and/or
The Index will also apply a more stringent standard regard-                    elimination.
ing the quality of donation programmes; companies are now
expected to ensure donations programmes are designed and

20
Access to Medicine Foundation

What the Index
measures

The Access to Medicine Index assesses company policies and
behaviour regarding specific diseases and product types and
in a specific geographic scope. The following pages set out
the rationale for these analytical scopes and how they have
been defined.

In this section:

CO M PAN Y SCO PE
20 companies
• Selected based on a combination of market capitalisation
  and relevance of portfolio for access to medicine.

D I S E A S E SCO PE
77 diseases, conditions and pathogens
• 21 Communicable Diseases
• 14 Non-Communicable Diseases
• 20 Neglected Tropical Diseases
• 10 Maternal & Neonatal Health Conditions
• 12 Priority Pathogens

G EO G R APH I C SCO PE
106 Low and middle-income countries
• 31 Low-Income Countries (LICs)
• 52 Lower-Middle-Income countries (LMICs)
• 23 Upper-Middle-Income Countries (UMICs)

PRO D U C T T Y PE SCO PE
Medicines, microbicides, preventive vaccines, therapeutic vac-
cines, vector control products, platform technologies, diag-
nostics, contraceptive methods and devices.

                                                               21
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