FIRST INDEPENDENT TEN-YEAR ANALYSIS

Are pharmaceutical companies
making progress when it comes toglobal health?
MAY 2019

Access to Medicine Index – 10-year analysis

ACCESS TO MEDICINE FOUNDATIONThe Access to Medicine Foundation is an independent nonprofit organisation based in the Netherlands. It aims toadvance access to medicine in low- and middle-income countries by stimulating and guiding the pharmaceutical industry
to play a greater role in improving access to medicine. It has
published the Access to Medicine Index every two years since2008. In 2018, it published the first Antimicrobial Resistance
Benchmark.
ACKNOWLEDGEMENTS
The Foundation is grateful to Hans Hogerzeil, Niranjan Konduri
and Prashant Yadav for their thoughtful reviews of an earlier
draft of this study.
This acknowledgement is not intended to imply that the individuals mentioned endorse
conclusions or recommendations made in the published study. Decisions regarding theinclusion of feedback were made by the Access to Medicine Foundation.

AUTHORSADDITIONAL RESEARCHAlex Kong & Margo Warren

Beth Boyer

Danny Edwards

Myriam Diallo

Karrar Karrar

Nestor Papanikolaou

Jayasree K. Iyer

Camille Romero
Myla Swallow

EDITOR

Mariska van der Zee

Anna V. Massey
ADDRESS
Naritaweg 227A
1043 CB Amsterdam
The Netherlands
CONTACTOn behalf of the Access to Medicine Foundation,please contact
Anna V. Massey
amassey@accesstomedicinefoundation.org+ 31 (0) 20 2153 535
www.accesstomedicinefoundation.org
FUNDERSThis study was made possible with financial support from theBill & Melinda Gates Foundation, the Dutch Ministry of Foreign
Affairs and UK Aid.

2

Access to Medicine Foundation

Table of contents

5

OVERVIEW

5Context and scope

6

At a glance8

Key insights

10

Drivers of change

11

Toward 2030

14

GOVERNANCE & STRATEGY

Companies increasingly view and manage access to medicine as a
strategic issue
16

CONDUCT & COMPLIANCE

Misconduct continues, but companies are improving approaches
for managing compliance
18

RESEARCH & D E VE LO PM E NT

R&D for high-burden diseases surges, with gradual increase incompanies planning ahead to facilitate access.
26

NEGLEC TE D TRO PI C AL D I S E A S ES

Significant uptick in engagement in R&D and donations for NTDs
30

ACCESS TO S PECI FI C PRO D U C TS

Companies are only gradually increasing use of affordability strategies and voluntary licensing
36

IN - CO U NTRY ACCESS I N ITIATIVES

Companies are scaling up some on-the-ground activities
40

APPENDICES

3

Access to Medicine Index – 10-year analysis

4

Access to Medicine Foundation

First 10-year analysis ofpharmaceutical company
progress on global health
10-YEARS, 20 COMPANIES▶ This report analyses ten years of data to assess whether pharmaceutical companies are
doing more today for the 2 billion people worldwide who live without access to medicine.
▶ The data have been gathered since 2008 for the Access to Medicine Index, the most comprehensive, long-running independent survey of company behaviour on access to medicine.
▶ The 20 pharmaceutical companies evaluated in this report account for approximately 70%
of global pharmaceutical revenues. Global pharmaceutical sales are expected to reach USD
1.06 trillion by 2022.1 Emerging economies are expected to account for 25% of global spending on pharmaceuticals by 2020.2▶ The findings identify which activities are increasing, where gaps remain, and where standardpractice is improving. They cover strategy, R&D, pricing and licensing, among other areas.
▶The report provides a springboard for discussions on how the progress to date can be
expanded across the industry in order to achieve SDG 3 by 2030.
WHY NOWIn the era of modern medicine, many major milestones have been reached, from a near-eradication of polio globally to a reduction in new HIV infections by more than half since the peak of
the HIV/AIDS crisis.3 As the world works toward achieving the Sustainable Development Goals(SDGs) by 2030, continuing to expand access to medicine must be a top priority, particularlyaccess for people living in low- and middle-income countries (LMICs), which together accountfor 83% of all people alive today.4
Action is needed from many quarters, including from national governments, civil society andthe private sector. Pharmaceutical companies, as innovators and producers of medicines andvaccines, are key partners for advancing universal health coverage (UHC) and improving immunisation rates. They have a responsibility to develop real innovative treatments in priority areasand improve the availability of products to all people, regardless of socioeconomic standing.

SCOPE OF THE RESEARCHThis is the first independent ten-year report to assess how pharmaceutical companies are
responding to calls to improve global health. It is based on data that have been collected, verified and analysed by the Access to Medicine Foundation. It covers 20 of the world’s largest
research-based pharmaceutical companies, which the Foundation has tracked since 2008.
This analysis covers: (a) areas where pharmaceutical companies have a clear role andresponsibility to act; and (b) where action by pharmaceutical companies is critical for improving access to medicine. Much of the data were collated for the Access to Medicine Index, which
evaluates the 20 companies in seven areas of behaviour: strategy and governance, conductand compliance, R&D, pricing, licensing, capacity building and donations. The report assesses
absolute progress and the changing level of industry engagement since 2008, examining thenumbers of companies involved as well as key measures, such as the numbers of R&D projects
or voluntary licences. The analyses go back as far as data permit, and no earlier than 2008.**See Appendix for more information on data sources and themethodology for comparative analyses.

5Access to Medicine Index – 10-year analysis

Access to Medicine Foundation

AT A G L ANCEThe Access to Medicine
Index 2012

Are pharmaceutical companies making
progress when it comes to global health?
Bucket 1
Bucket 1
Two billion people world-

PHARMA CO M PAN I ES ARE G R ADUALLY

wide live on very low

CHANG I NG HOW TH E Y DO BUSI N ESS

incomes without access to

Several pharmaceutical companies are now doing

medicine or robust healthbusiness in new, inclusive ways that aim to reachsystems.

people on very low incomes. Plus, almost all com-

In 2018, a few inclusive business models are
running, with some being scaled up

17

The first Access to Medicine

access-to-medicine goals. Yet, only some compa-

run by 7 companies,

Index, published ten years

nies are tackling the risks of unethical sales behav-

with 8 models being scaled up.

ago, established a baseline

iour. Fewer companies consistently support inter-measure of what 20 of thenational trade agreements (i.e., TRIPS flexibilities)

12 best practices in capacity building,world’s largest R&D-based

designed to ensure the poorest people can benefit

run by 6 companies.

pharmaceutical companies

from medical innovation.

were doing to turn this situa-

17 companies now set goals and targets related
to access to medicine

9 companies are now reforming incentives forsales agents by decoupling bonuses from sales
incentives

Only 4 companies have consistently endorsed
at least one TRIPS flexibility since 201220 companies

18
10 inclusive business models,

2008 2010 2012 2014 2016 2018

Bucket 1

20 companies

panies now actively manage their progress toward

13

11

17

15

Bucket 2

The Access to Medicine
Index 2014

20companies
9

9

8

7

Bucket 2 2010 2012 2014 2016 2018

● 4 companies consistently endorsed at least
one TRIPS flexibility since 2012● 16 companies that have not consistently
given this level of endorsement2

Bucket 2

2014 2016 2018tion around.

show where progress has

H IV/AI DS AN D TU B E RCU LOSIS

been made, and indicate

R&D pipelines have grown markedly, due to an

where the main challenges

effective recipe for engaging pharmaceutical com-lie for the next decade.

panies in specific R&D challenges. Plus, five com-

Pipeline for priority diseases has more thandoubled since 2014. Now, 285 projects are inclinical development.

Pipelines for key diseases have grown, but not
for maternal and neonatal health conditions

The coverage of access plans for late-stage
R&D projects is largely unchanged

Since 2008, at least 171 new medicines havebeen approved. More than half targeting
non-communicable diseases

Bucket 2

Projects

Projects

388

Projects

90 for NTD
projects

No access plans

42.0%

FO R KE Y D ISE ASES SUCH AS MAL ARIA ,46.1%

R&D PI PE LI N ES G ROW, PARTI CU L ARLY
Data gathered since thenIn general, R&D activity continues to track com-118

mercial opportunities; more medicines for prof-

209

42 for HIV/AIDS

285

itable non-communicable diseases successfully
83% of all people alive today live inleft the pipeline than medicines for diseases of

the 106 countries covered by thispoverty.

2014

2018

research.2

USE O F ACCESS TACTICS I NCRE ASES ,BUT MANY PRO DUCTS ARE NOT YET

The number of licensed compounds for hepatitis C has risen to 7; for HIV/AIDS it is up to 22

COVE RE D
for improving access to health products: pricing,used more frequently than before and in pro-ac-

221

Bucket 2

cess ways. For example, access-oriented licensing
has expanded steadily since 2010, and a complete
suite of HIV/AIDS and hepatitis C treatments is
now available via voluntary licensing. In the future,
the use of these tools has potential to expand to
many more products in additional countries, somore people can benefit.
6

Bucket 3

2018

9

8

589

22

Bucket 2 2010 2012 2014 2016 2018

570

470

Projects 12
1000

800

447
230

2010 2012 2014 2016 2018280

2014 2016 2018
50

388

600

400

11

118
200

209

2014

285 in clinical development

112016 2018

Bucket 2

bonuses fromsales incentives
16

115 projects

25.2%2010 2018

HIV/AIDS
113 projects

9 MNH
2018

published every two years since 2008.
It covers seven areas of behaviour

tions. The analyses in this report goback as far as data permits within thisNo access plans
timeframe. The parameters of all data
In-house

Bucket 2
28.7%

Collaborativesets
have been controlled to ensurecomparability over time.
33.0% 13.0%

2010 2018

55 Malaria

2018

The Access to Medicine Index has been

licensing, capacity building and dona-

13

8
Access plans
90 NTD projects
In-house
Collaborative

Interpreting the figureslinked to access, including R&D, pricing,

10

2016

● 68 new approvals for communicable diseases,
4 companies consistently endorsed at least one TRIPS flexibility
NTDs and MNH* conditions
since 2012
● 103 new approvals for non-communicable diseases

Programmes
9 decouple

17 set goals and targets
2
related to access to
20142016 2018
medicine

31 Tuberculosis

0

285

13

20 companies*Maternal & neonatal health conditions

388 projects not in clinical development

18

11 use sales
targets only
No. of companies donating products for NTDs
has only slightly increased: 10 companies have16 structured donation programmes for NTDs

17
Projects
100

20 companies

Bucket 3

Products

7
4
21

2014

More products are now 15
covered by equitablepricing strategies: 447 products

Compounds

Pharmaceutical companies have three main tools
licensing and donations. All three tools are being

9 for MNH*

20 companies

Bucket 3

Supported by access plans

31 for TB

171
approvals

58.0%

55 for Malaria

process, to address access to successful projects.

53.9%

panies now systematically plan, as part of the R&D

24.8%

33.6%

23.0%

18.6%

7

Access to Medicine Index – 10-year analysis

SPRINGBOARD FOR DISCUSSION - KEY INSIGHTS

Access to medicine isincreasingly seen as
strategically importantSizeable leaps in companies'
engagement observed in someareas of activity

This report finds that access to medicine is widely recog-

In terms of companies’ engagement levels, the greatest pro-

nised today by pharmaceutical companies as a strategic issue.

gress is in the level of response to neglected tropical dis-Significantly, nearly all (17 out of 20) companies now have aeases (NTDs), HIV/AIDS, malaria and tuberculosis. These dis-strategy supported by goals and targets for addressing accesseases have been identified as the targets of urgently needed

to medicine. In 2010, eight companies had set access-related

R&D and as access priorities for global health since before thegoals.

scope of this study, when the groundwork for tackling access

There are several reasons for this shift. Firstly, the dual

as a global issue was being laid – first by civil society, then byburden of non-communicable and infectious diseases has

governments and donors. This groundwork focused on reduc-emerged as an urgent issue impacting healthcare systems

ing the burdens of NTDs, HIV/AIDS, malaria and tuberculosis,

in LMICs. This is driving up long-term demand for health-as well as the scale of child and maternal mortality.

care products and creating additional commercial opportuni-

For example, the pipeline for high-burden and priority dis-ties in LMICs for pharmaceutical companies. AstraZeneca andeases has more than doubled since 2014. For NTDs, the num-

Sanofi, among other companies, generate approximately 30%

ber of companies contributing to the development of newof revenues from emerging markets.5,6Secondly, pharmaceutical companies recognise that proac-

medicines, diagnostics or other products has increased fromtively addressing access is a way of managing the risks associ-ing products for NTDs has increased from eight to ten. The

ated with public opinion, increased regulation (e.g., disclosure

number of donation programmes for NTDs has reached 16,

requirements) and compulsory licensing.

up from 13 in 2010. Plus, nine companies that own (or havenine to 15 since 2010, while the number of companies donat-

Thirdly, the social licence to operate for pharmaceuti-

owned) patents for HIV/AIDS treatments have used intellec-

cal companies – i.e., society’s ongoing acceptance of a com-tual property (IP) rights flexibly to facilitate generic supply

pany’s way of doing business – rests on addressing access toin LMICs through voluntary licences or non-assert declara-

medicine for the people who need it, regardless of income.

tions. To date, IP rights have been used flexibly in this way for

The public sector increasingly emphasises the need for better29 compounds for two diseases: HIV/AIDS or hepatitis C. This

access to health products. Plus, changing societal values areincludes first- and second-line treatments, pangenotypic reg-

also having an impact on the ability of pharmaceutical compa-

imens and other products on the World Health Organization’s

nies to attract, retain and motivate employees.

Model List of Essential Medicines (WHO EML).

fig NTD 4

fig GS2

Figure 2. Since 2010, more company Boards now take

Figure 24. Since 2014, early-stage pipeline for NTDs has

direct responsibility for access to medicine

more than doubled
Projects
100

20 companies

19

14

13

9 have some form ofboard-level responsibility
11
672010 2012 2014 2016 2018

8

12

80

9

17

3 projects in other phases72

12 late-stage NTD projects

60

1211 have direct board-level
responsibility for access to
medicine

40

20

0

10

39

28

2014

2016 201872 early-stage NTD projects

Access to Medicine Foundation

Workable, scalable approaches
for good practice now present
in most areas of evaluation

Progress is concentrated amongfew companies, few diseases,
few countries

In most areas of practice, there is now a workable, scala-Progress is clearly evident in other areas of practice, although

ble approach for improving access to medicine that is being

generally confined to a few diseases or due to the actions of

implemented by one or more companies, including in volun-

just a few companies. Without the long-term involvement

tary licensing and access planning during R&D.

of a more diverse group of pharmaceutical companies, rad-Notably, since 2008, multiple companies have taken thestep of pioneering good practice in critical areas. For exam-

ical improvements in access to medicine will be difficult toachieve – and even harder to sustain.

ple, Novartis is the first to publicly commit to establishing

For example, in R&D, the 20 companies are now col-access plans for all innovative new medicines. Access plans

lectively developing more than twice as many medicines

can cover, for example, pricing, registration and supply. Merckand other products needed by people living in LMICs as in

KGaA became the first company to voluntarily disclose the2014. Yet in 2018, five companies were found to be carry-status of patents, in 2014. GSK was an early adopter of tiered

ing out 63% of the most urgently needed R&D projects (GSK,

pricing, notably for vaccines, and has operated a tiered pricing

Johnson & Johnson, Merck KGaA, Novartis and Sanofi).

approach for more than 20 years. Merck & Co., Inc. began its

Further, the industry’s engagement in such R&D is currently

donation programmes for onchocerciasis in 1987.

overwhelmingly focused on five high-burden and/or high-pri-Plus, seven companies are making efforts to develop andority diseases: malaria, HIV/AIDS, tuberculosis, Chagas diseasescale up commercial models that aim to include the poor-and leishmaniasis. Alongside closing the remaining innovation

est populations in their customer base. Several of these mod-(R&D) gaps, a parallel challenge going forward is to ensure

els focus on products for heart disease, diabetes and otherthat new products are delivered efficiently to the different

non-communicable diseases (NCDs), which are on the rise

populations that need access.

globally. These models can complement pricing, licensing andIn pricing, close to half (43%) of the products for the dis-donations initiatives to address the accessibility and afforda-

eases and conditions in scope are now covered by an equi-bility of health products for specific populations. Novartis, fortable pricing strategy (i.e., strategies that aim to address

example, has run its 'Healthy Family' programme since 2007,

affordability). Only 18% of products with such strategies meetwhich includes health camps tailored to local health priorities

all of the quality criteria assessed.* These robust strategies

and customs, focused on disease prevention, awareness andare concentrated in just a few companies: the majority (53%)

treatment, including essential medicines.

come from Boehringer Ingelheim, Gilead and Novartis.
Countries benefit from very different levels of attention,
depending on the area of activity. Low-income countries

Companies are running and scaling up a range of inclusive(LICs) and Least Developed Countries (LDCs) are often thebusiness models

focus of least attention, particularly when looking at registration filings and pricing strategies. For example, in 2018, theFoundation reported that 13/46 of the sub-Saharan Africancountries in scope had zero registration filings for new products targeting diseases and conditions deemed access priorities in these countries.** These 13 countries are mainly LICs,
and are home to more than 150 million people.2 Even in coun© Marshall Foster

tries such as Brazil, China and India, companies target theirprices to suit the poorest population segments to only a limited extent. Capacity-building initiatives are generally more

© Novo Nordisk

spread out, but the majority are still focused on middle-in-

Novo Nordisk has worked with faith-based organisations income and lower middle-income countries. For NTDs (theKenya to limit price mark-ups and developed ‘One-Stopfocus of most long-term structured donation programmes),

Diabetes Support Centres’ in Nigeria and Ghana.

donation programmes mirror patterns of disease distribution.

*Assessed by the Index, including whether
strategies determine different prices fordifferent populations within countries
and use socioeconomic factors to determine prices.

**Priority countries are defined by theFoundation per disease. They identify
countries with a greater need for accessto products, based on disease burden,
WHO data (2012), or IHME data (2015),

and adjusted for multi-dimensional inequality (UNDP, 2012).

9

Access to Medicine Index – 10-year analysis

SPRINGBOARD FOR DISCUSSION - DRIVERS OF CHANGE

Three main factors are successful at driving pharmaceuticalcompany engagement
The uptake of good practice is uneven, with different fac-

1 Clear priorities endorsed by the international community oftors driving change. These can be commercial or regulatory;

experts in global health. For companies, a clear and agreed-take the form of market-shaping or de-risking initiatives; orbe clear priorities set by health organisations, donors and civil

upon agenda lowers the barrier to engagement.
2 Publicly funded de-risking or market-shaping mechanisms,

society, underpinned by public funding. Recent emphasis onwhich enable resource sharing and reduce uncertainty.

sustainable investing over past years has also influenced com-

3 Long-term and coordinated financial support from multiple

pany action. The Access to Medicine Index provides compa-

donors, and a sustained investment in health from national

nies and their stakeholders with a yardstick by which to meas-

governments, including to support healthy markets.

ure themselves against society’s expectations and identifies
best practices for companies to implement and improve upon.

This recipe is currently being used for only a few diseases

Where there is a sizeable global market, the main driverand conditions, such as NTDs, HIV/AIDS and child and mater-

for industry engagement is often commercial. This is likely

nal mortality. To cover the scale of the global disease burden,

the main reason NCDs such as diabetes consistently accountthe prospect of long-term, well-funded and high-level politi-

for the larger pipelines. Research-based pharmaceutical com-cal buy-in promises a wide range of committed partners frompanies generally view patent rights (and other related incen-

multiple sectors. Incentives are in place to stimulate compa-

tives such as data exclusivity) as a key incentive to innovate.

nies to work in areas where global priorities are already clear.

IP rights can lead to constraints on supply and affordability.

For example, Priority Review Vouchers (PRVs) issued by

Under this model, patent owners must consciously choose to

the US FDA offer companies an accelerated product review

manage IP rights responsibly to balance commercial decisions

process as a reward for developing products for neglectedthat leave the needs of the poorest unaddressed.

diseases. Advance market commitments and market-shap-

Global health experts emphasise the need for expand-ing mechanisms directly address the fragility and uncertainty

ing access to existing as well as new treatments for NCDs forof pharmaceutical markets for specific products or in cer-

people living in low- and middle-income countries. The cur-tain geographic regions as a means of encouraging compa-

rent pharmaceutical industry model offers a far weaker incen-

nies to enter markets and make products available. For exam-

tive for companies to engage in these markets.

ple, pooled procurement mechanisms used by organisations

Where there is only a weak or no commercial market, butsuch as Gavi, the Vaccine Alliance; the Pan American Healtha high disease burden, the most effective current recipe for

Organization (PAHO); and Unicef have helped to strengthen

engaging the pharmaceutical industry is as follows:

and provide security to the global vaccines market.

▶D R IVE RS I N AC TI O N
For NTDs, WHO has played a piv-

is another notable driver of R&D for

Product Development Partner-

New incentives are being devel-otal role in coordinating and driv-

prioritised diseases.

ships (PDPs) have proven success-oped for specific diseases or dis-ful at re-engaging pharmaceuticalease types. The Center for Epidemic

ing attention. The 2012 London
Declaration on NTDs provided a

HIV/AIDS, malaria and tuberculo-companies with R&D for poverty-re-Preparedness (CEPI) is address-

platform for public commitment,

sis have consistently had some oflated diseases. In a 2016 paper, theing the risk of emerging infectious

engagement and sharing progress

the largest pipelines of all communi-

Foundation identified nine bene-diseases such as Ebola and Zika.

from the pharmaceutical sector.

cable diseases examined. Combined,fits PDPs bring to efforts to ramp

Greater attention is being paid by

In 2012, 12 companies signed thethese diseases receive more thanup access.8 PDPs, such as thethe international community to the

London Declaration. Since then, thetwo thirds of total global neglected

Medicines for Malaria Venture andchallenge of NCDs. The 3rd UN

Foundation has noted more compa-

disease R&D funding and they havethe Drugs for Neglected Diseases

High-Level Meeting on NCDs wasnies engaging in NTD donations andbeen the strategic focus of multiple

initiative, primarily incentivise inno-

held in September 2018. The World

R&D. The Global Health Innovative

donors since the establishment ofvation for poverty-related diseases

Health Assembly agreed a resolu-

Technology Fund (GHIT), supported

the Millennium Development Goals

by facilitating financial risk-sharing

tion on cancer in 2017. The majority

by the Japanese government andin 2000 and of the Global Fund toacross public and private sectors.

of countries do now have a Nationalorganised with Astellas, Daiichi

Fight AIDS, Tuberculosis and Malaria

There are currently no PDPs target-

Cancer Control Plan (NCCP).9

Sankyo, Eisai, Shionogi and Takeda,

in 2002.

ing NCDs.

10

7

Access to Medicine Foundation

SPRINGBOARD FOR DISCUSSION – TOWARD 2030

Looking ahead to 2030: how to sustain and expand
pharmaceutical company engagement
New engagement mechanisms and incentives, as well as

essential NCD treatments. Such gaps must be formally priori-

action by pharmaceutical companies, have been heavily

tised by the global health community.

focused on NTDs, vaccines, HIV/AIDS, malaria and tuberculosis. Yet the scale of these developments does not match thePartnerships to strengthen health systems

scale of people’s need for better access to medicine, particu-

New kinds of ambitious partnerships are needed that address

larly in LDCs and low-income groups in middle-income coun-

countries’ specific needs at the health system level, prioritis-

tries. Looking ahead to 2030, to the achievement of SDG 3

ing the availability and affordability of health products. Theseand as new priorities are set for global health, pharmaceuticalpartnerships will need to be driven and owned by the publiccompany engagement must be sustained and expanded.

sector and be able to engage a diverse group of private sector
companies. All partners must commit to working in a trans-

Progress at scaleparently ethical manner.

The biggest challenge will be to make progress at scale andA core first task will be to jointly identify priorities, for

ensure different socioeconomic groups have access to health-example for underserved countries, as well as the roles andcare. This includes addressing the cost of healthcare andresponsibilities of the different actors including pharmaceuti-

prices for new medicines. Countries need support for theircal companies. For example, the role companies play in part-entire health systems as they work to establish universal

nerships for healthcare delivery should match their core com-

health coverage (UHC). Initiatives run in silos, bringing addi-

petencies and responsibilities: i.e., product innovation, supply

tional stresses to those systems. For example, budgets and(including manufacturing, production and delivery logistics),

capacities are stretched by the need to assess, establish andand fair pricing of health products.

maintain various initiatives.
One part of the solution will need to be the successful

Future investments in global health must be matched tothese new kinds of partnerships by: expanding access to lessscale-up and replication, to more countries and diseases, ofaffordable medicines; increasing both domestic and inter-

inclusive business models that explicitly aim to include people

national financing; and increasing the diversity of financ-with low incomes in the customer base. Ten such models areing sources. It is important that attention and funding does

currently running, including eight that have been scaled up

not shift away from current focuses until the goals that havesince launch to reach more people. While this is encouraging,already been set are actually achieved, including in the areas

there is no blueprint yet for expanding these models to meetof HIV/AIDS, malaria, tuberculosis and vaccines. At the samethe level of need across different diseases and populations.

time, pharmaceutical companies must make an internal cultural shift to be ready and able to dovetail their unique pipe-

Prioritising non-communicable diseases

lines and portfolios with a systems-level approach. Signs ofStarting in 2018, the UN and others increased their calls forthese shifts are already apparent in some companies.

action on NCDs, focusing on ensuring access to effective
treatments such as those on the WHO Model List of Essential

A more diverse group of companies at the table

Medicines. Currently, companies are addressing access to

Although companies are taking action, and the industry has

NCD treatments via stand-alone initiatives to strengthenincreased its involvement, the bulk of private sector engage-

healthcare infrastructure. The triggers for greater involve-

ment is being carried by just a few pharmaceutical compa-

ment by the pharmaceutical sector in improving access tonies. A retreat by just one of these companies could have a

NCD products will be clear priorities and a way of coordinat-

catastrophic effect on the progress made to date, not only foring and publicly tracking action.

addressing R&D priorities, but also for increasing and sustain-

For NCDs, it is important that access and affordability to

ing the supply of products to the people who need them. As

existing treatments are improved, particularly for people

new priorities are set for global health, a more diverse group

who need life-long treatment. However, the markets for NCDof companies must be brought to the table.

treatments in many LMICs are limited by issues with health-This report is a springboard for discussions on howcare infrastructure, access and affordability, among otherimprovements can be expanded across the pharmaceuticalfactors. As a result, few new NCD products are being devel-industry. Reaching the 2 billion people who still lack access

oped specifically with people in LMICs in mind. Many productto medicine worldwide is possible, provided we continue togaps and delivery challenges remain, such as the availability ofbuild on what has already been achieved and are prepared toheat-stable or long-acting treatments and broader access to

redraw and forge the path ahead.

11

Access to Medicine Index – 10-year analysis

12

Access to Medicine Foundation

10-year analysis:
findings in detail

14

GOVERNANCE & STRATEGY

Companies increasingly view and manage
access to medicine as a strategic issue
16

CONDUCT & COMPLIANCE

Misconduct continues, but companies are improving
approaches for managing compliance
18

RESEARCH & D E VE LO PM E NT

R&D for high-burden diseases surges, with
gradual increase in companies planning ahead
to facilitate access.
26

NEGLEC TE D TRO PI C AL D I S E A S ES

Significant uptick in engagement in R&D anddonations for NTDs
30

ACCESS TO S PECI FI C PRO D U C TS

Companies are only gradually increasing use ofaffordability strategies and voluntary licensing
36

IN - CO U NTRY ACCESS I N ITIATIVES

Companies are scaling up some on-the-ground
activities
40

APPENDICES

13

Access to Medicine Index – 10-year analysis

GOVE RNANCE & STR ATEGY

Companies increasingly view and manage
access to medicine as a strategic issue

As pharmaceutical companies search for new commercial

BOA R D - LE V EL R ESPO NSI B I LI T Y

opportunities in low- and middle-income countries (LMICs),

Ongoing shift to direct board-level responsibility forthey have a responsibility to also increase access to theiraccessproducts for people on lower incomes. To achieve this bal-

The success of an access-to-medicine strategy is closely

ance, companies must view and manage access to medi-

linked to how performance is measured, managed, moti-

cine as a strategic issue. This section looks at the compa-

vated and rewarded. This includes appropriate governancenies’ strategies for improving access to medicine, and at how

and accountability structures. Since 2010, the Foundation

responsibility for delivering on them has changed.

has examined whether companies discuss access to medicine at the board level. Discussions were taking place at more

ACCESS-TO - M ED I CI N E S T R AT EGY

than three quarters of companies in 2010, rising to all 20

What does a ‘good’ access strategy look like in 2018?

companies by 2014. Since then, there has been a continuing

Having a strategy for improving access to medicine increases

shift from such indirect board-level responsibility to assign-

a company’s chances of making long-term improvements ining direct responsibility to a named member of the board. In

this area. The Foundation has evaluated whether companies

2018, 11 companies were found to have board members thathave set measurable goals and targets for improving access,are directly responsible for how the company is addressing

underpinned by a clear rationale, since 2010. Since 2014, it

access to medicine (see Figure 2).

has also more directly assessed companies’ access-to-medicine strategies. The Foundation has found improvement inboth measures. The number of companies setting goals andtargets related to access, and now also implementing clear,
long-term strategies for improving access, has reached 17(see Figure 1). AbbVie, Astellas and Daiichi Sankyo are thethree exceptions. They engage in ad hoc approaches forincreasing access.
There is no one-size-fits-all strategy for improving access to
medicine. The Foundation identified several notable examples
in 2018. One is from Novartis: the Novartis Access framework
was implemented in 2015 and enables the company to tailor
its approach for reaching different segments of low-income to
middle-income populations, using a range of different accessmodels. These include differential pricing, structured donation programmes and non-exclusive voluntary licensing.
As another example, Johnson & Johnson uses an online
scorecard to report on access management. This scorecard
covers the company’s access-to-medicine initiatives since2016, listing goals, progress and other details, including quantitative and qualitative targets. The company publicly reports
on its access-to-medicine outcomes and sets specific goals
and measurable targets aligned with the United Nations
Sustainable Development Goals (SDGs).

14

Access to Medicine Foundation

Figure 1. Compared to 2010, 17 companies now set goals

Figure 2. Since 2010, more company Boards now takeand targets related to access to medicine

fig GS1b

direct responsibility for access to medicine

The chart shows the change, since 2010, in the number of companies withThis chart shows how the number of companies that assign board-levelapproaches for access to medicine underpinned by a clearly defined

responsibility for improving access to medicine has changed since 2010. By

rationale, supported by measurable goals and targets.

2014, all companies discussed access at the board level in some form.

20 companies

20 companies

17

17

15

8

fig GS2

9

AbbVie, Astellas
and Daiichi Sankyo
have not yet set
out an overarching access-to-medicine strategy, but havedeveloped approaches
for increasing access.

19

142010 2012 2014 2016 201899 have some form ofboard-level responsibility

17

11
6

17 set goals and targets
related to access to
medicine

137

11 have direct board-level
responsibility for access to
medicine2010 2012 2014 2016 201815

Access to Medicine Index – 10-year analysis

CO N DUCT & CO M PLIANCE

Misconduct continues, but companies
are improving approaches for managing
compliance
A combination of commercial incentives and weak regulatory

CO M PLI A N CE

systems can enable misconduct to take root and risk a neg-

Gradual shift away from sales-based incentives

ative impact on access to medicine. It is estimated that USD

Companies can implement a range of controls in order to455 billion was lost from global spending on global health inmitigate the risk of corruption and unethical marketing. The

2013 due to fraud, corruption or errors.1 Wherever pharma-

Foundation has been examining how companies audit compli-

ceutical companies operate, the Foundation expects them toance with their codes of conduct and standards of behaviour

uphold the same standards as in highly regulated countries

since 2012. Since then, the number of companies conduct-

and to take the initiative to expand policies and enforcement

ing audits has increased steadily, reaching all 20 companies inmechanisms to countries with weaker regulation. This section2016 (see Figure 3).

looks at evidence of breaches of laws or regulations relat-

The Foundation has also noted an increase in the number

ing to misconduct, as well as changes in how companies auditof companies reporting that they are decoupling incentives

compliance with codes of conduct and incentivise good ethi-

for sales agents from sales targets. One common alternative

cal conduct by sales agents.

is to reward technical knowledge rather than sales. By minimising the focus on sales volumes, there is less of a financial

CO N D U C T

trigger for sales agents to behave unethically, e.g., by oversell-

Addressing complianceing. Nine companies, up from two in 2014, now have incen-

The Foundation has sought to track evidence of breaches

tives that are no longer wholly linked to sales (see Figure 4).

of laws or regulations relating to marketing, corruption,

Roche and Takeda are the most recent companies to adopt

bribery and lobbying in low- and middle-income countries

non-sales-related targets for their sales personnel.

(LMICs). It looks for information about fines and settlements

Roche has incorporated non-financial metrics relat-

reached under national laws and regulations, as well as about

ing to diversity, sustainability and the environment in its

breaches of industry codes of conduct for good marketing

annual bonus plan. Takeda has implemented incentive pro-practice (this does not include ongoing cases or allegations).

grammes including incentives linked to technical and product

Since 2014, the Foundation has identified 12 such confirmed

knowledge.

breaches that occurred in LMICs, concerning multiple compa-

All companies can reform their incentives for sales staff bynies. Expert stakeholders have commented that the number

deepening the shift away from using only sales volume andis likely low when compared to such settlements in high-in-other sales-linked metrics as the basis for bonus calculations.

come countries because judicial and regulatory systems

The alternatives include using more long-term incentives andin many LMICs are weak, and misconduct is not reported,

incentives linked to access objectives or service level. When

not investigated or not prosecuted. In fact, most of theseit comes to auditing compliance, companies can work withbreaches were identified and prosecuted through high-in-

external auditing agents and expand audits to include morecome country legislation, such as the UK Bribery Act (UKBA),

countries and third parties. Taking a risk-based approach toand the Foreign Corrupt Practices Act (FCPA).

auditing is also recommended (i.e., conducting audits where
and when the risk of non-compliance is greater).

16

Access to Medicine Foundation

Figure 3. Compared to 2012, all companies now audit

Figure 4. Since 2014, small increase in companies

compliance with codes and standards

reforming incentives for sales agentsThe chart compares how many companies per year demonstrate that they

The chart compares, per year, how many companies are decoupling

audit compliance with codes of conduct and standards of behaviour. The

performance incentives from sales volumes for their sales agents.

number of companies reporting that they conduct such audits has increased

fig CC1

fig CC2

steadily since 2012. In 2018, all companies reported that they regularly audit
compliance with codes of conduct and standards of behaviour.

20 companies

20 companies

20

18

20

15

13

11
11 use sales
targets only

20 audit
compliance997

9 decouple
bonuses fromsales incentives

Corruption may be linked
to a misalignment of
incentives,2 including
how sales staff earn theirbonuses. It can also undermine rational prescribing
practices. This is why theFoundation encourages ashift away from using sales
volume as the basis forbonus calculations.

22012 2014 2016 20182014 2016 201817

Access to Medicine Index – 10-year analysis

RESE ARCH & D EVE LO PM E NT

R&D for high-burden diseases surges, with
gradual increase in companies planning ahead
to facilitate access
The Foundation regularly analyses pharmaceutical compa-

marginally; some projects were discontinued, while others

nies’ R&D pipelines for specific diseases, conditions and path-gained market approval (see Figure 6).

ogens. These comprise the most pressing access priorities for

Notably, projects targeting NTDs have more than doubled,

people living in low- and middle-income countries (LMICs),

from 38 projects to 90. These projects have little commer-

as defined by the Access to Medicine Foundation throughcial potential, as the people affected by these diseases gen-consultation with experts working in global health. People

erally live on very low incomes and/or have limited access toin LMICs face more than 80% of the global burden of these

healthcare. The increase in NTD R&D can largely be attributed

diseases.1

to efforts led by the World Health Organization (WHO) andThis section examines how the number of R&D projects

product development partnerships (PDPs), such as the Drugs

targeting these diseases and conditions has changed overfor Neglected Diseases initiative (DNDi), which have coordi-

time, the number of companies involved in the different R&D

nated and driven attention for pharmaceutical R&D targetingareas and whether companies are now more likely to plan

NTDs (read more on page 24). The growth is mostly focusedahead to facilitate access to successful R&D projects. Thison three related diseases: leishmaniasis, Chagas disease andsection also looks at which products have reached the market

human African trypanosomiasis. Caused by related proto-in the past decade.

zoan parasites, these three diseases have been the subject offocused attention from the global health community since at

R& D PI PELI N E SIZE

least 2009, when DNDi launched its Chagas Clinical Research

R&D pipeline has doubled since 2014

Platform.2 Many NTDs have seen sustained company activity

Since 2014, a set of 47 diseases and conditions has consist-over the years (see Figure 8).

ently qualified for the Index analysis. These include: communi-

Looking at these same diseases and conditions (as in

cable diseases (infectious diseases), such as HIV/AIDS, malaria

Figure 6), there were generally more companies engaged

and tuberculosis; neglected tropical diseases (NTDs), includ-in pharmaceutical R&D in 2018 than in previous years (seeing parasitic infections such as sleeping sickness (human

Figure 7). HIV/AIDS is an exception, with fewer compa-

African trypanosomiasis) and river blindness (onchocerciasis);nies that are engaging, and a growth in R&D projects. Some

non-communicable diseases (NCDs), such as diabetes melli-companies have left this space, while others, such as Gileadtus, heart disease and stroke; as well as maternal and neona-and GSK (working through ViiV Healthcare with Pfizer andtal health conditions, such as maternal haemorrhage and pre-Shionogi), have specialised.

term birth complications. The pipeline for this set of 47 dis-

There is a range of reasons why the number of companies

eases and conditions has more than doubled since 2014: fromengaging in R&D per disease may fluctuate. These include

327 projects to 673 (see Figure 5). The sharpest increase has

acquisitions and divestments, investigatory candidates yield-

been in the number of projects for NCDs (see page 18 foring promising or poor results and new or discontinued

more information). If successful, products for NCDs have thepartnerships.

greatest commercial potential.
In 2018, cancer and a number of additional communicable diseases were newly included in the Foundation’s analysis. Cancer alone brought a further doubling of the pipeline,
to 1,314 projects.
To break down this analysis further, the Foundation has
pulled out changes in pipeline size for specific diseases andconditions since 2014: HIV/AIDS, malaria, tuberculosis, NTDs
and maternal and neonatal health conditions (see Figure6). Most of these pipelines have increased. Projects targeting maternal and neonatal health conditions have decreased18

Access to Medicine Foundation

Figure 5. Since 2014, the pipeline for high-burden and

Figure 6. Since 2014, pipelines for key diseases haveneglected diseases and conditions has more than doubled

grown, but not for maternal and neonatal health conditions

The chart compares the number of R&D projects in company pipelines for

The chart shows the change in pipeline size for key diseases or conditions

47 high-burden or neglected diseases and conditions in 2014 and 2018. The

between 2014 and 2018. The increase in R&D projects for NTDs is apipeline has more than doubled in size.

response to increasing global attention coordinated by WHO.

fig
fig RD2a

fig RD1

Projects
100

Projects

90 target NTDs

1000

800
388

600

400

388 projects not in clinical development

42 target HIV/AIDS
11

118
200

0

55 target malaria

50

31 target tuberculosis

285

209

2014

285 in clinical development

9 target maternal & neonatal
health conditions

0

2018

2014

2018

Figure 7. Compared to 2010, more companies are now

Figure 8. Since 2010, clear uptick in NTD R&D engagement

involved in R&D for key diseases and areas

for leishmaniasis, Chagas disease and HAT

The chart shows the change in the number of companies engaged in R&D

The chart shows the change in the numbers of companies engaged in R&D

for key diseases or conditions between 2010 and 2018. Pipelines forfor specific NTDs in scope since 2010. The strongest increases are in R&D
Data importmaternal & neonatal health conditions were first comprehensively assessed
for leishmaniasis, Chagas disease, onchocerciasis and human African

figtrypanosomiasis
RD 3a(HAT), which have been prioritised by the global health

12 target tuberculosis
11 target malaria

2016

Neglected tropical disease2018

15 companies targetingneglected tropicaldiseases15

2012

Companies

2014

community.

2010

in 2014. Across most areas, company engagement has increased. In HIV/fig
AIDS, some companies have left while others have specialised.
fig RD2b

Buruli ulcer 2 0 0 0 0 Companies active in R&D
Chagas disease 5 7 7 10 14
Dengue 4 5 5 8 7Dracunculiasis 0 0 0 1 0
Fascioliasis 0 0 0 0 1
Human African trypanosomiasis 6 8 4 3 10

10Leishmaniasis 5 7 5 9 14

7 target HIV/AIDS
6 target maternal &neonatal healthconditions

5

Leprosy 0 0 0 1 1
Lymphatic filariasis 0 5 4 4 4Onchocerciasis 1 3 1 7 7Schistosomiasis 3 1

1

2 2

0 companies

Soil-transmitted helminthiasis 0 1

1

2

1

1-4 companies

1 0 0 05-10 companies

Yaws 0 0 0 0 0>10 companies

Trachoma 1

0
2010

2014

2018

Data import19

Access to Medicine Index – 10-year analysis
R& D FO R N CDS

since at least 2014, with a small increase in pipeline size andHigh numbers of projects for non-communicable diseases

few projects reaching the market. The total number of such

Most high-income countries offer healthy markets for new

projects currently in the pipeline is 29 (see Figure 11). In 2018,

pharmaceutical products targeting NCDs such as heart dis-

there were fewer companies engaged in this type of R&D

ease, diabetes and respiratory conditions. R&D projects forthan in 2014; just three companies (GSK, Johnson & Johnson

NCDs have consistently accounted for the largest propor-

and Sanofi) account for 21 out of 29 projects. The 29 paedi-tion of the R&D pipeline identified by the Index, despite theatric medicines currently in the pipeline include: three new

Index analysing similar numbers of NCDs and communica-

water-dispersible formulations for tuberculosis from Sanofi,

ble diseases with each iteration. As noted earlier in this study,

which will be easier for children to swallow; four new paediat-

the R&D pipeline for the 47 diseases and conditions consist-

ric indications of HIV/AIDS medicines from GSK; and a child-

ently in scope more than doubled between 2014 and 2018,

friendly formulation of the tuberculosis medicine bedaquiline(Sirturo®) from Johnson & Johnson.

with projects for NCDs accounting for more than half of thisincrease (57%). During the same period, the number of companies evaluated that engage in R&D for NCDs in scope since

PR I O R I T Y R& D

2014 has remained stable: now at 18 companies out of 20

R&D for priority product gaps increases; many gaps remain(see Figure 10). Almost all of the companies (19/20) are cur-unaddressed

rently active in R&D for cancer care, and nearly three quarters

Diseases can have an effective cure available and still face(14) are active in R&D targeting diabetes (see figure 9). Of the

product gaps – for example, the development of a single-dose

171 new medicine approvals identified since 2008, 60% (103)oral treatment for syphilis would enable governments to bringare for NCDs.

this disease quickly under control during outbreaks. WHO and

NCDs account for a rising burden of disease in most LMICs,

Policy Cures Research, an independent R&D-focused policya trend that is predicted to continue.3 Experts in the global

group, have published lists of the most urgently needed newhealth community have emphasised the need for expanding access to existing and effective treatments for NCDs,

products – here termed priority product gaps.5-9
The Foundation first examined R&D targeting priority

especially those listed on the WHO EML. However, pharma-

product gaps in 2016. It looked at 22 diseases with 84 prior-ceutical companies have a responsibility to ensure that new

ity product gaps. It found companies taking action for 18/22

NCD products can also be made available and accessible toof these diseases and targeting 31/84 gaps, with 151 projects

these populations. However, low- and middle-income coun-in total (see Figure 12). In 2018, looking at the same set of dis-try (LMIC) markets are often viewed as less lucrative, due toeases and product gaps, the Foundation identified an addi-

the perception of regulatory challenges and reduced ability oftional 44 R&D projects (now 195 in total for 36/84 gaps).

patients in these countries to pay, for example. As a result, it

These projects include diagnostics for schistosomiasis,

is likely that new NCD products are not being routinely devel-

medicines for the treatment of shigellosis and a number of

oped where R&D product gaps exist for those living in LMICs

vector control products. Most new projects since 2016 target– for example, heat-stable formulations, additional oral oncol-

leishmaniasis, malaria, Chagas disease, human African trypa-

ogy medicines and long-acting versions of treatments fornosomiasis and tuberculosis. Product gaps that remain untar-

chronic diseases.

geted by the companies in scope include single-dose oral

There is evidence that some companies take the uniqueburden of NCDs for LMICs into account, considering the economic- and health-related consequences of these diseases inthese countries. However, few provide evidence of detailed
approaches to adapt or innovate NCD products specificallyfor those living in LMICs, leaving critical needs, such as forheat-stable medicines and vaccines, unaddressed.
PA ED I AT R I C R& D

Small numbers of medicines being adapted for children
Many health products are not particularly well suited fortreating children, for example, because they do not have a sufficiently low dosage, because they are difficult for children to
swallow, or they were never tested in paediatric populations.
Adapting medicines for children is a specific type of R&D.
Particular needs for adaptive R&D were highlighted in 2006
when WHO identified serious gaps in research and several
barriers to access, and indicated how to overcome them.4 The
number of medicines being developed or adapted for children
by the companies in scope has remained relatively constant20

treatments for syphilis and preventive vaccines for NTDs suchas Buruli ulcer and trachoma.

access plans
2016
29
2018
28

33
38

15
21

38
26

Access to Medicine Foundation

Figure 9. Since 2012, non-communicable diseases have

Figure 10. Since 2014, most companies have engaged inremained as the focus of R&D engagement

NCD research; R&D projects for NCDs have nearly tripled

The chart shows the numbers of companies engaged in pharmaceutical R&D

The charts show how many companies engaged in R&D for 10 non-commu-

fig RD NCD a/b
nicable diseases (NCDs) since 2014, as well as the corresponding number offig

for non-communicable diseases since 2012. For most diseases, the level of

R&D engagement has remained fairly constant. The uptick in R&D for kidney

R&D projects. The number of R&D projects has nearly tripled.

diseases is likely because they affect large populations in high-income
countries.
fig RD 3b

2016

2018

2012

Non-communicable disease2014

20 companies

Asthma 6 6 7 7

17Companies active in R&D

5 4

Ischaemic heart disease 9 3 4 8

315 300

18 companies
engaged in R&D for
NCDs

Diabetes mellitus 15 13 15 14
1

400

18

COPD 6 4 7 6
Epilepsy 1

Projects

200

0 companies

Kidney diseases 4 2 9 10

1-4 companies

Stroke 7 3 2 3

5-10 companies

Unipolar depressive disorders 4 1 4 4>10 companies

117 R&D projects
for NCDs
2014 2018

100

117

2014 2018

0

Figure 11. Since 2014, the number of medicines being

Figure 12. Since 2016, priority R&D has increased

developed or adapted for children remains low

The figure compares the number of R&D projects in 2016 and 2018 that

The charts show the changing level of engagement by pharmaceuticalfig RD 4a/b

companies in adapting medicines for children, as well as the number ofprojects. Although there are more medicines being adapted now than in
2014, the overall numbers remain low.

figtarget
RD5a set of 84 priority product gaps defined by WHO and Policy Cures

Research. The number of projects has increased, now targeting 36 out of 84
gaps, but still leaving many unaddressed.

Projects
2014
2018
Companies engaged in R&D for NCDs
200

20 companies

Projects

40

17

18

195

Y-Axis: 20 companies
Pointer to 2018:150"18 companies engaged in R&D for NCDs"
151

29
11

10

2014 201810 companies
23 R&D projects
adapting/developing
for children
medicines forchildren

23

30

20

10

2014 2018

195 R&D projects
targeting priority
product gaps
2014
2018
R&D projects for NCDs

100

0

50

0

117

315

Y-Axis: Projects
Pointer to 2014: "117 R&D projects for NCDs"
2016

2018

21

Access to Medicine Index – 10-year analysis
VACCI N ES R& D

ACCESS PL A NS

Industry focuses on diseases common to high-income

Coverage of late-stage R&D projects with access planscountries

remains constant

Vaccines are important products in preventing the further

New medicines and other life-saving products must be

spread of both communicable and neglected tropical dis-made rapidly available to people who need them, wherevereases. However, the abundance of some infections such as

they live. This requires advance planning before new prod-

pneumonia in both high-income countries and LMICs can play

ucts are approved for sale. Access plans can include registra-a critical role in shifting the industry’s focus. Broadly, theretion targets based on need, pricing commitments or licensing

has been little movement in or out of R&D for preventive vac-arrangements that will accelerate the speed at which prod-cines among the companies in scope. In 2014, ten compa-

ucts become accessible. The Foundation examines whether

nies were developing at least one vaccine candidate, while incompanies are planning ahead in this way, and what these

2018, nine companies were involved in this space (see Figure

access plans look like.

15). Similarly, there has been a slight reduction in the num-Over the past ten years, various initiatives have been

ber of vaccine projects in the pipeline, from 86 in 2014 to 74

established to engage pharmaceutical companies in R&D forin 2018 (see Figure 15), when holding the disease scope con-global health, drawing on public and private funds to pool

stant from 2014 onward. Many diseases for which preventive

risks and share benefits. PDPs, for example, facilitate financial

vaccines have been identified as priority R&D product gaps

risk-sharing for R&D and systematically ensure access plans

have seen either a stagnation or consolidation of companies

are developed early in product development.

and/or projects between 2014 and 2018 (see Figures 13 andIn 2014, the Foundation looked at access plans for projects

14). Of note, GSK acquired Novartis’ vaccine business in 2015,

developed in partnership (40% of such R&D projects exam-and has consistently been found to be developing a compara-

ined in 2014 were being developed through partnerships). It

tively high number of R&D projects for urgently needed vac-reported that 16% of all collaborative R&D projects were sup-cines, along with Johnson & Johnson and Sanofi.

ported by access plans.

While HIV/AIDS, malaria and tuberculosis have been the

In 2016 and 2018, data were also collected on accesssubjects of intense scrutiny from global health organisations

plans for projects being carried out in-house. In 2018, theand funding, few companies have been active in developing

Foundation reported that close to a third of all projects are

vaccines for these diseases. This is in stark contrast to com-being developed with other organisations, and 16% of all pro-panies’ efforts to develop vaccines for lower respiratory infec-

jects have an access plan. When looking solely at late-stage

tions and meningitis, which tend to have promising market

R&D projects (from Phase II onwards) in 2018, just 19% of

potential in high-income countries. Less lucrative diseases,

projects were found to be supported by access plans.

in particular the NTDs and infections caused by drug-resist-

For late-stage communicable and NTD projects, the pro-ant bacteria, have received almost no attention in the last six

portion of late-stage projects with access plans has not signif-

years from companies in scope with regards to vaccines R&D,

icantly increased since 2016 (see Figure 16). However, therewith the exception of dengue. Dengue vaccines are likely tohas been a small rise in the number of collaborative projects

have some commercial incentive because dengue is endemic

targeting these disease types that also have access plans inin at least 100 countries, some of which have higher market

place (from 33 to 37).

potential.10 Where there are R&D vaccine projects in other

During this period, five companies have establishedneglected areas, one or two companies are often responsi-

new processes for considering access for all R&D projects

ble for sustaining this activity. For example, Eisai is the solefor high-burden and neglected diseases (GSK, Johnson &company developing a Chagas disease vaccine, and Takeda

Johnson, Merck KGaA, Novartis and Takeda). Novartis goes ais the sole company developing a vaccine for chikungunya.

step further, committing to developing access strategies for

Currently, GSK and Pfizer are actively developing Group B

all new medicine launches including biosimilars.

Streptococcus vaccines. A vaccine for these pathogens is

GSK pioneered good practice in this area, starting in 2014

urgently needed but does not yet exist.

by systematically incorporating access plans into researchcontracts for projects targeting tuberculosis, malaria and
NTDs that are developed at its Tres Cantos Open Laboratory
Foundation (TCOLF) in Spain.

22

Access to Medicine Foundation

Figure 13. Since 2014, the number of companies developing

Figure 14. Since 2014, companies have focused efforts tovaccines for key diseases has remained consistently low

develop new vaccines in a few diseases

The chart shows the number of companies active in R&D to develop new

The chart shows the number of vaccine R&D projects targeting diseases thatR&D for NTDs has remained limited.

lower respiratory infections, meningitis and diarrhoeal diseases.

Buruli ulcer 0 0 0 Companies
Chagas disease 1 1 1 active in R&D
Dengue 3 3 3Human African trypanosomiasis 0 0 0

Neglected tropical diseases

Buruli ulcer 0 0 0 Vaccine
Chagas disease 1 1 1 projects
Dengue 3 3 3Human African trypanosomiasis 0 0 0
Leishmaniasis 1 0 0
Onchocerciasis 0 0 0
Schistosomiasis 0 0 0
Soil-transmitted helminthiasis 0 0 0

Leishmaniasis 1 0 0
Onchocerciasis 0 0 0
Schistosomiasis 0 0 0
Soil-transmitted helminthiasis 0 0 0
Trachoma 0 0 0
Diarrhoeal diseases 4 4 4
HIV/AIDS 3 3 3Lower respiratory infections 9 9 6

Lower respiratory infections 33 27 29
Malaria 4 3 3
Meningitis 14 13 7

Malaria 3 1 2
Meningitis 6 6 3
Tuberculosis 3 2 2Tuberculosis 3 2 2Viral hepatitis C (genotypes 4-6) 0 0 0
Maternal & neonatal
Neonatal sepsis 0 2 2
health conditions(Group B Streptococcus)

Viral hepatitis C (genotypes 4-6) 0 0 0
Maternal & neonatal
Neonatal sepsis 1 2 2
health conditions(Group B Streptococcus)
Companies active in R&D

0

1-2

3-4

5-6

Trachoma 0 0 0
Diarrhoeal diseases 14 8 11
HIV/AIDS 3 3 5Communicable diseases

Communicable diseases

2018

2014

Neglected tropical diseases

2016

2018

2016

2014

fig RD vaccines
3
fig RD vaccines
2
vaccines for diseases that are designated as priorities. Since 2014, vaccines
are designated as priorities since 2014. This type of R&D is concentrated in
RULI ULCER>6

Vaccine projects

0

1-5

6-10

11-15

>15

0 companies

Figure 15. Since 2014, company engagement 1-2
in companiesFigure 16. Since 2016, the coverage of access plans for late-stage

3-4 companies
R&D1abfor diseases in scope has remained
projects is largely unchanged
fig RDvaccine
vaccines
5-6 companies

relatively constant

The charts compare the percentages of late-stage R&D projects for communicable>6 companies
and neglected tropical diseases in scope with access plans in 2016 and 2018. They
The charts compare how many companies are developing vaccines
for diseases in scope and the number of corresponding R&D

also show the proportion of projects being carried out through partnerships or

projects. Both measures have decreased slightly since 2014.

in-house.

20 companies

Projects

86 vaccine R&D
projects
10

fig RD6 overhaul

100

86
74

75

No access plans

In-house

In-house

2016
50

9
25

2014 2018

112 projects

Collaborative
25.2%

115 projects

2018
9 companies
engaged in
vaccine R&D

2014 2018

Access plans

25.0%

Collaborative

28.7%
33.0%

33.0%
23.2%

13.0%
18.8%

0

100%

0

25.2

24.8

28.7

33.6

33.0

23.0

23

Access to Medicine Index – 10-year analysis
M A R KE T A PPROVA L S

At least 171 new medicines receive approval in past decade▶NEW MECHANISM TO ACCELERATE REGISTRATIONThe Foundation has examined new medicine approvals by

The European Medicines Agency, in cooperation with WHO,the 20 companies for 76 of the 77 diseases, conditions andoffers a pathway known as Article 58 that facilitates thepathogens in scope examined in the 2018 Access to Medicine

approval of medicines and vaccines that are particularly

Index.* It was found that at least 171 new medicines received

needed by people living outside the EU. Some products thatapproval, mainly for NCDs (see Figure 17).

have been successfully submitted to this process include:

This analysis looked at new medicine approvals per appli-• RTS,S (Mosquirix™), a preventive vaccine for P. falciparum

cant from the European Medicines Agency (EMA), US Foodmalaria developed by GSK in partnership with PATH’sand Drug Administration (FDA), and Japan’s Pharmaceuticals

Malaria Vaccine Initiative, for use in children aged 6 weeks

and Medical Devices Agency (PMDA) since 2008. Vaccines

to 17 months.

and diagnostics are not included, nor are biological agents,• Chlorhexidine digluconate antiseptic gel (Umbipro™),

due to a lack of sufficient data.

developed by GSK in partnership with Save the Children for

The majority of new medicines (103) are for NCDs, mainly

the prevention of umbilical cord infections in newborns.

diabetes mellitus, cardiovascular conditions and chronic• Oral fexinidazole, developed by Sanofi in partnership with

obstructive pulmonary disorder (COPD). Most of the remain-

DNDi as the first all-oral treatment for human African trypa-

ing new medicine approvals target communicable diseases

nosomiasis (see page 26).

(62), mainly HIV/AIDS and viral hepatitis (see Figure 18). Veryfew are for maternal and neonatal health conditions or NTDs
(five and one, respectively). The only NTD medicine to receive▶WHAT IS LIKELY TO COME OUT OF THE PIPELINE NEXT?

an approval since 2008 from the 20 companies was a chew-

At least 220 R&D projects from the 20 companies are inable form of mebendazole (Vermox™ Chewable) developed

Phase III clinical development, or have been submitted for

by Johnson & Johnson to allow for easier administration

approval by a stringent regulatory authority, for 76 of the 77

to children. Notably, a new powder formulation of ritonavir(Norvir®, AbbVie, 2017) and dispersible artemether/lumefan-

diseases, conditions and pathogens examined in the 2018

trine (Coartem® Dispersible, Novartis, 2009), have also been

• Two Phase III preventive vaccine candidates for Ebola: one

approved since 2008, both also for children.

each from Johnson & Johnson and Merck & Co., Inc.

Recent approvals include new antiretrovirals for HIV/AIDS,

Access to Medicine Index,* including, as of 6 May 2019:• Cabotegravir/rilpivirine, a combination dual long-acting

such as dolutegravir/rilpivirine (Juluca ), developed in part-

injectable being developed by ViiV Healthcare and Johnson

nership by Johnson & Johnson and ViiV Healthcare, as well as& Johnson for the treatment of HIV, has been submitted forglecaprevir/pibrentasvir (Mavyret™), a pangenotypic hepati-

approval by the FDA.

tis C treatment developed by AbbVie. The 20 companies have

• Oral semaglutide, being developed by Novo Nordisk forreceived approval for at least 12 fixed-dose combination HIV/diabetes mellitus type 2. It belongs to a class of antidiabetic

AIDS medicines from 2008 to 2018.

agents that are currently only available as injectables requir-®

Out of the 20 companies, 19 have received one or more

ing refrigeration. Novo Nordisk has submitted this medicine

approvals for new medicines targeting diseases or conditions

for approval by the FDA.

in scope (see Figure 19). The exception is Merck KGaA; it has• Heat-stable carbetocin, Ferring Pharmaceuticals’ propri-

gained approvals in this time period, but for diseases out of

etary and investigational compound for the prevention ofscope of this analysis, such as cancer and multiple sclerosis.

postpartum haemorrhage, is being developed to address

Merck & Co., Inc. leads a group of seven companies that haveheat-stability issues with the current first-line treatment

had 12 or more medicines approved.

oxytocin. Merck & Co., Inc. is collaborating with Ferring
Pharmaceuticals and WHO through its Merck for Mothers

New medicines supported by access initiatives

Initiative to advance this compound and ensure affordability

Of the newly approved products analysed, at least 52 haveand sustainability. Ferring Pharmaceuticals is now seeking

an access initiative (i.e., an equitable pricing strategy, non-ex-

registrations for this medicine.

clusive voluntary licence or structured donation programme).
For example, Gilead’s tenofovir disoproxil fumarate (Viread®)• An ultra-long-acting injectable form of paliperidone pal-for HIV/AIDS has an equitable pricing strategy in 23 countries

Johnson, that could help patients living with schizophrenia

where pricing is considered a priority** and has a voluntarythrough as few as two injections a year.

licence that covers 116 countries. Other examples are:• Eisai’s perampanel (Fycompa®) for epilepsy, which has equi-• Esketamine, an antidepressant with a new mechanism of

mitate, in Phase III of clinical development by Johnson &action from Johnson & Johnson. Esketamine was approved

table pricing strategies that include prices set for different

by the FDA in March 2019 for the treatment of treat-population groups within a country (intra-country pricing).

ment-resistant depression in adults. Johnson & Johnson• Johnson & Johnson’s bedaquiline (Sirturo®) for tuberculo-

continues to investigate esketamine in treating majorsis, which has an equitable pricing strategy with per-coun-depression with imminent risk for suicide in adults andtry prices and a structured donation programme.
• Gilead’s sofosbuvir (Sovaldi®) for hepatitis C, which has equitable pricing strategies that include intra-country pricing.
24

children.
*Cancer was excluded as the Index did notcover cancer products until 2018.

**Priority countries are disease-specific subsets of countries with a particular need for access to relevant products.
See appendix.

Access to Medicine Foundation

Figure 17. Since 2008, at least 171 new medicines have

Figure 18. Since 2008, more medicines have been

received approval from the EMA, FDA and/or PMDA

approved for diabetes mellitus and HIV/AIDS than other

Since 2008, the 20 companies evaluated have received approval from thediseases

EMA, FDA and/or PMDA for at least 171 new medicines for diseases and

The figure shows the number of new medicines gaining EMA, FDA and/or

conditions that are especially important to public health in low- and

fig RD8bPMDA market approval since 2008 per disease/condition. Nearly half target

middle-income countries. Most are for NCDs,* with very few for NTDs or

diabetes mellitus or HIV/AIDS.*

maternal and neonatal health conditions.

No. of companies

fig RD7

62 new medicines
for communicablediseases in scope

171
approvals
103 fornon-communicablediseases

Diabetes mellitus 51

11

HIV/AIDS 34

9

Cardiovascular risk management** 22

12

5
for maternal &neonatal healthconditions
1
for neglected
tropical diseases

COPD 16

4

Viral hepatitis (B and C) 16

6

Lower respiratory infections 7

3

Kidney diseases 5

2

Contraceptive methods 5

1

Epilepsy 5

2

Asthma 4

3

Schizophrenia 3

2

Diarrhoeal diseases 2

2

Two new malaria medicines
have been approved: dispersible artemether/lumefantrine(Coartem® Dispersible, Novartis, 2009) and tafenoquine(Krintafel™, GSK, 2018).

Malaria 2
Tuberculosis 2
Unipolar depressive disorder 2
Meningitis 1

2
2
2
1

Soil-transmitted helminthiasis 1

1

0

10

20

30

40

50

Approvals since 2008 (new medicines, EMA/FDA/PMDA)

Disease category
Number of new medicines/indications (FDA/PMDA)
Communicable Diseases
61
Maternal & Neonatal Health Conditions
5
Neglected Tropical Diseases
1
Non-Communicable Diseases
105

RD

Total (to put in middle)

Figure 19. Since 2008, 19 companies have received
approvals for at least 171 medicines for diseases andconditions in scope

figTheRD8a
figure shows how many new medicines targeting diseases andconditions in scope* each company has received approvals for from the EMA,
FDA and/or PMDA since 2008.

171

Total

Merck & Co., Inc. 8
Boehringer Ingelheim 2

11

19

13

15

Gilead 15

15
6

Johnson & Johnson 8

115

AstraZeneca 13

13

Takeda 12
Novartis 2

12
10

12

Novo Nordisk 993

Daiichi Sankyo 5

8

GSK 1 7

8

AbbVie 772

Astellas 3

5Bayer 55

Eisai 5

5

Eli Lilly 5
1

Bristol-Myers Squibb 4
Pfizer 2

5

All five contraceptive methods approved as new drugs
since 2008 were developedby Bayer.

Sanofi 52554ViiV Healthcare 4
Roche 1
0

4
8
5

10

15

1

20

Approvals since 2008 (new medicines, EMA/FDA/PMDA)*Cancer was excluded as the Index did notcover cancer products until 2018.

**Cardiovascular risk management
includes hypertensive heart disease,ischaemic heart disease and stroke.

● Communicable diseases● Non-communicable diseases● Contraceptives● Neglected tropical diseases

ViiV Healthcare is a pharmaceutical company run in partnership by GSK, Pfizer
and Shionogi (78.3%, 11.7% and 10% shareholders, respectively in 2018) that specialises in developing innovative treatments
for HIV/AIDS.

25

Access to Medicine Index – 10-year analysis

N EG LECTE D TROPICAL D ISEASES

Significant uptick in engagement in R&D anddonations for NTDs

The term ‘neglected tropical diseases’ (NTDs) was coined in

products. Nevertheless, in 2010, nine of the companies eval-

2003 to refer to a group of diseases that primarily affect peo-uated were working on at least one R&D project target-

ple living in the world’s poorest communities.1 Many NTDs

ing an NTD in scope (see Figure 21). In 2018, fifteen compa-

are caused by worms or other parasites, and they can lead tonies were found to be developing projects for the 14 NTDs

blindness, or disfiguring and painful swellings or ulcers. NTDs

that have been in scope since 2010. Seven companies havecan keep children out of school and adults out of work andnewly started working on R&D for these NTDs since 2010,

contribute to cycles of poverty.

while one, Eli Lilly, has since stopped. Novo Nordisk, though

The World Health Organization (WHO) has played a central

not active in R&D for NTDs, donated a licence to its small

and pivotal role in coordinating and driving attention towardmolecule compound library to the National Center for DrugNTDs, particularly since 2008. Before this, individual phar-

Screening (NCDS) in Shanghai, China in 2008 to identify new

maceutical companies (most notably Merck & Co., Inc.) werecandidates for NTDs.

actively donating NTD treatments, while others were carrying

All four Japanese companies tracked by the Foundation

out R&D, often through the Special Programme for Research(Astellas, Daiichi Sankyo, Eisai and Takeda) are now active

and Training in Tropical Diseases (TDR), active since thein R&D for NTDs (see Figure 22). Eisai is the only Japanese

1980s and currently sponsored by UNICEF, UN Development

company that was active in NTD research between the first

Programme, World Bank and WHO. In 2012, WHO set global

Index in 2008 and the 2012 London Declaration on NTDs.

targets for controlling, eliminating and eradicating NTDs

Astellas and Takeda entered the field after this point. Daiichi

by 2020, published in its NTD Roadmap.2 Inspired by the

Sankyo entered after 2014, following the formation of the

Roadmap, a broad range of partners including 14 pharmaceu-

Global Health Innovative Technology Fund (GHIT) in 2013.

tical companies endorsed the 2012 London Declaration on

GHIT funds R&D for neglected diseases. All four of theseNTDs, a multi-lateral public commitment to bringing ten NTDs

Japanese companies are GHIT partners. At the 2016 Ise-

under control by 2020.3 Today, 20 diseases are categorised by

Shima Summit, the G7 leaders committed to furthering R&D

WHO as being NTDs. This section examines how companies’

for NTDs, for example, by adopting policies to encourage

engagement in donations and R&D for NTDs has increased

product development and by promoting public-private part-since 2010.

nerships such as GHIT.

D O N AT I O NS

Marginally more companies now donate for NTDs
Since 2010, two additional companies have established structured donation programmes aimed at NTDs (see Figure 20).
The number of structured donations programmes with products for NTDs has also slightly increased, from 13 to 16. In the
majority of cases, all donation programmes for NTDs can besupported by commitments to continue donating until thediseases have been eradicated or eliminated. In 2012, 12 companies analysed by the Index signed the London Declaration
on NTDs.
R ESE A RCH & D E V ELO PM EN T

Increase in company R&D activity for NTDs
NTDs predominantly affect people with little or no ability to
pay for treatment. As a result, there is often little commercial incentive for pharmaceutical companies to develop new26

Access to Medicine Foundation

Figure 20. Since 2010, the number of companies donating products

Figure 21. Since 2010, more companies are now

for NTDs has only slightly increased

engaged in R&D for NTDs

The chart shows how many companies were engaged in donations for NTDs before and

The chart compares how many companies were active in R&D

after the 2012 London Declaration on NTDs. Since 2010, this number has only marginallyfor NTDs in 2010 with the number of companies active in 2018.

figincreased.
NTD 1a/b
In 2018, six companies were found to have committed to donating medicines

fig NTD 2a

until eradication/elimination targets are met, for nine NTDs. Companies have been
donating medicines for NTDs for many years. Some programmes go back as far as the
1980s.

20 companies

Programmes

16

8

10

13 structured donation
programmesfor NTDs
10 with structured
donation programmesfor NTDs

2010 2018

20 companies

20

15

15

13
10

9

15 active in R&D
for NTDs

5

2010 201802010 2018

Figure 22. Since 2010, most companies active in NTD R&D
have expanded to more diseases
The figure shows how many of the 14 NTDs defined in 2010 each company
was targeting compared with 2018. More companies are now active in thismost companies have expanded their activity to more NTDs.
figspace,
NTDand2b

2010

2018

Astellas3 4 NTDs targeted
0 3 per company

AstraZeneca

0 3

Bayer

0 4

Boehringer Ingelheim

0 0Bristol-Myers Squibb

0 4

Daiichi Sankyo

0 2

Eisai

1

Eli Lilly

1 0

Gilead0 0

AbbVie

5

GSK

4 3

Johnson & Johnson

0 7

Merck & Co., Inc.

4 5

Merck KGaA

2 6

Novartis

4 5

Novo Nordisk

0 0

fig RD2a

Pfizer

6 4

0 NTDsRoche

0 0

1-3 NTDs

Sanofi

2 6

4-6 NTDs

Takeda0 3>6 NTDs

27

Access to Medicine Index – 10-year analysis

R&D pipeline for NTDs has doubled since 2014
The Foundation began examining pipelines in detail for NTDs

▶Which new NTD projects are moving close to the market?

in 2014. There are now more than twice as many NTD projects as in 2014, rising from 38 to 90 projects (see Figure 23).

SA N O FI

Since 2014, WHO has defined three additional diseases (sca-Fexinidazole for the treatment of human Africanbies and other ectoparasites; mycetoma, chromoblastomy-

trypanosomiasis

cosis and other deep mycoses; and snakebite envenoming)

This medicine received a positive opinion from the EMA in

as NTDs; only three out of the 90 projects target these more2018 as the first complete oral treatment for human African

recently defined NTDs.

trypanosomiasis (HAT, or sleeping sickness). It has since been

The number of projects in late stages of development tar-registered in the Democratic Republic of Congo. It treats thegeting NTDs has grown slightly since 2014, while the num-strain of HAT known as g-HAT, which accounts for 97% of

ber in early stages has more than doubled (see Figure 24).

reported cases. Untreated, g-HAT is almost always fatal.4 This

This increase in early stage R&D is encouraging, but due topromising new medicine had a success rate* of >90% in Phasethe high failure rate of pharmaceutical R&D, many of these

II/III clinical trials.5 It could replace the current first-line treat-

additional early-stage projects will likely not make it to clini-

ment for g-HAT, which must be administered intravenously by

cal testing.

skilled medical professionals.

As noted on page 16, the increase in engagement for NTDs
is centred on diseases that have been prioritised by the global

TA KEDA

health community. There are more companies involved in

Live-attenuated tetravalent dengue vaccine (DENVax)

R&D for Chagas disease, leishmaniasis, onchocerciasis, lym-

Currently undergoing Phase III clinical testing, this could

phatic filariasis and human African trypanosomiasis than the

become the second dengue vaccine, after Sanofi’s Dengvaxia®,

other 15 NTDs. All five of these diseases were named prior-

to reach the market; it has already demonstrated immuno-

ity targets in the 2012 London Declaration and have been the

genicity against all four serotypes of dengue virus.6 Treatment

focus of the Drugs for Neglected Diseases initiative (DNDi).

for dengue is currently limited to supportive care, withSince 2014, the majority of R&D projects for NTDs have

untreated cases of severe dengue leading to mortality rates of

involved an external partner, for example, through a PDP (seegreater than 20%. There are as many as 390 million estimatedFigure 25).

dengue infections a year.7

Pipelines have been consistently empty for some NTDs
since at least 2014: Buruli ulcer, dracunculiasis, trachoma andBAY ERyaws. Dracunculiasis and yaws have relatively effective treat-

Fast-disintegrating nifurtimox (Lampit®) for treatingments available, and donation programmes are running. Buruli

Chagas disease in children

ulcer and trachoma also have effective treatments available,

These fast-disintegrating tablets have been successfully tested

yet new products need to be developed, including vaccines

in Phase I and Phase III studies in children and adults, mak-and affordable, reliable diagnostics, as well as new medicines

ing Chagas medication easier for all patients, especially young

with shorter courses of treatment to improve effectiveness.

children, to use. It is expected to reach the market starting in

For R&D, WHO and Policy Cures Research have published

2020, with Bayer stating that it aims to register the product inlists of the most urgently needed new products – termed

endemic countries with high disease burdens and to apply forpriority product gaps – including for NTDs (see Appendix).

WHO prequalification. An estimated 6-7 million people world-

As reported in the 2018 Access to Medicine Index, 27 gaps

wide are infected with Trypanosoma cruzi, the protozoan para-

for NTDs (out of 41 in total) are currently not targeted bysite responsible for Chagas disease.8

the companies in scope, with gaps for diagnostics getting
the least attention overall. All companies are encouraged toassess how their R&D expertise, resources and IP assets canbe applied in the global push to fight NTDs.

28*Success rate was defined by the study’s authors as
patients being alive, having no evidence of trypanosomes
in any body fluid, not requiring rescue medication andhaving a white blood cell count of 20 or fewer cells per
microLitre of cerebrospinal fluid.

Access to Medicine Foundation

Figure 23. Since 2014, R&D projects for NTDs have more

Figure 24. Since 2014, early-stage pipeline for NTDs has

than doubled

more than doubled

The figure compares the numbers of R&D projects targeting NTDs since

The figure shows the proportion of the NTD pipeline that is in either early or

2014. Since then, the number of projects has reached 90. Only threelate stages of development each year. The proportion of projects in early

projects target a disease newly defined as an NTD since 2014 by WHO (newfig NTD 4stages has more than doubled.

fig NTD 3
in scope).

Projects

Projects

100

3 for NTDs new in scope since 2014
87

80

100

3 projects in other phases
12

80

72
60

40

1 for NTDs new in scope since 2014

60

12

51
40

38

87 for NTDs in scope since 2014

20

0

20

2014

2016

12 late-stage NTD projects

0

2018

10

39

28

2014

72 early-stage NTD projects

2016 2018

Figure 25. Since 2014, R&D for NTDs consistently driven bypartnerships
The figure compares the numbers of NTD R&D projects each year that are
being conducted in partnerships (i.e., are collaborative). Collaborative
projects consistently account for the highest proportion. Projects that are
fig
NTD 5

being developed by more than one company are counted more than once.

Projects
100

15

80

72

15 in-houseprojects

60

14
40

20

0

11

37

72 collaborative
projects

27

2014

2016

2018

fig RD 3a29

Access to Medicine Index – 10-year analysis

ACCESS TO SPECI FIC PRODUCTS

Companies are only gradually increasinguse of affordability strategies and voluntary
licensing
Whether medicines, vaccines and other products reach theRegistration in practice remains limited

people who need them depends on the strategic choices

While commitments are gradually strengthening, this hascompanies make to support availability and affordability. The

yet to translate into a significant change in registration prac-

three main tools available to a pharmaceutical company fortice. In 2014, the Foundation reported that 16 companies filed

improving access to specific products are: equitable pric-

more than 50% of their products for registration in more thaning strategies, voluntary licensing and product donations.

half of the 106 LMICs in scope. In 2016, the Foundation rede-This section looks at how companies’ use of equitable pric-

fined its approach to assessing registration filings: to assess

ing and licensing in low- and middle-income countries (LMICs)

filings in countries designated as ‘priorities’ for specific dis-has changed over time (their use of donations in relation toeases and conditions (these designations are based on factors

neglected tropical diseases is summarised on page 24). This

such as disease burden and income inequality – an average ofsection also looks at three further areas of practice – regis-

13 countries are designated as priorities for each disease andtration filings, support for the Doha Declaration on the TRIPS

condition). In 2016 and again in 2018, the Foundation found

Agreement and Public Health and patent transparency – asthat less than a quarter of companies’ newest products werethese practices act as key enablers for others, such as pro-being widely registered in priority countries (2016: 22% filed

curers and generic medicine manufacturers, to also improvein >50% of priority countries, n=160; 2018: 21% filed in >50%

access to specific products.

of priority countries, n=187).

R EG IS T R AT I O N FI LI N GS

file a product for registration in a specific market. For exam-

Registration commitments become more specificple, companies may be deterred due to competing products

Registration is the first step to making a product available in a

already on the market, unclear local regulatory requirements

country. The Foundation has tracked how companies commit

or health authorities which lack specific capacities for pro-

to filing to register new products in LMICs.

cessing registration dossiers. Political instability, conflict orThere are a variety of reasons why a company may not

Between 2012 and 2014, 13 companies strengthened

economic sanctions can also play a role. The WHO prequali-

or expanded their commitments to registering products infication system, WHO Collaborative Registration Procedure

LMICs. For example, Roche improved the timeframe within

and the African Medicines Regulatory Harmonization (AMRH)

which it commits to registering its products, and Novartis pro-

programme are already providing support for registration.

vided a more specific commitment to registering products in

The newly created African Medicines Agency (AMA) may alsocountries in Africa.

help expedite the registration process across the continent.

Since 2014, the Foundation has also assessed the detail ofcompanies’ registration commitments, using three quality criteria (see Figure 26). It finds that companies’ commitments
to registering products are gradually getting more detailed;there is an upward trend in two out of the three areas,
although still only small proportions of companies meet thesequality criteria. Currently, only three companies (Gilead, GSK
and Takeda) explicitly state that their commitments cover the
majority of their products.

30

Access to Medicine Foundation

Figure 26. Since 2014, commitments to registering products have gradually become more
specificfi PD
1

The first chart shows the number of companies that have made general registration commitments, comparing 2014
and 2018. The three remaining charts each show how many companies have made commitments that meet one of
the three quality criteria looked for in this analysis. There is some movement toward making more detailed
commitments.
20 companies

13

20 companies

20 companies

20 companies

14
11
6
3

2014 2018

Companies with generalcommitments to registering products widely.

2014 2018

Companies with registration commitmentsthat apply in at least one
low-income or sub-Saharan African country.

52014 2018

Companies with registration commitments that
include a pledge to register products within
12 months of first global
launch.

432014 2018

Companies with registration commitments that
apply to the majority of its
portfolio.

▶KE Y TE R M S

Registration filings: where

Patent transparency: when

Equitable pricing strategies:

Voluntary licensing agree-

a product is filed for regis-

a patent expires in a coun-

where affordability is taken

ments or non-assert dec-

tration for sale in a country.

try. This makes clear which

into account by the phar-larations: licences give per-Companies bear the primary

products are covered by pat-maceutical company when

mission to generic medicine

responsibility to file for reg-ents in specific territories, giv-

determining prices for differ-

manufacturers to develop

istration; without registra-ing guidance on, for exam-

ent population segments.

and manufacture versions oftion, the product cannot usu-

ple, where generic versions

on-patent products underally be imported, marketed or

could potentially enter new

transparent and access-distributed.

markets.

friendly terms. Non-assert
declarations pledge not toenforce patents in certain
territories or under certain
conditions.

31

Access to Medicine Index – 10-year analysis
SU PPO RT FO R T R I PS FLE XI B I LI T I ES

LI CENSI N GCompany support for the Doha Declaration remains

Slow but steady increase in voluntary licensing

conservative

In 2018, the Foundation reported that the pharmaceutical

Since at least 2012, companies have continued to take a con-industry continues to move slowly towards a more access-ori-

servative stance on the Agreement on Trade-Related Aspects

ented approach to managing IP. In this context, ‘access-ori-of Intellectual Property Rights (TRIPS) and the subsequent

ented’ refers to whether a company voluntarily licenses its

Doha Declaration on the TRIPS Agreement and Public Healthproducts on terms that facilitate access, or uses other mech-(Doha Declaration). In that time, the level of endorsement has

anisms to provide flexibility (i.e., non-assert declarations andshifted among the companies, with some withdrawing pub-non-filing or enforcement pledges).

lic support and others newly supporting the Doha Declaration

The Foundation has found consistent growth since 2010

and at least one TRIPS flexibility. Some companies provide

in the number of compounds covered by voluntary licences

a limited degree of endorsement of the Doha Declaration,or non-assert declarations (when products that are no longer

under specific restricted conditions. Four companies (Eisai,

under patent are also included). In 2018, this had grown to

GSK, Johnson & Johnson and Merck KGaA) have consistently

29 compounds (see Figure 29). In 2014, the first products for

publicly supported the Doha Declaration and at least one

a disease other than HIV/AIDS were licensed (for hepatitis C

TRIPS flexibility since 2012 (see Figure 27).

treatments). Licensing today remains confined to these two

In 2018, half of the companies (10) evaluated do not publicly support the Doha Declaration and at least one TRIPS

diseases.
Since 2012, the Medicines Patent Pool (MPP) has become

flexibility. AstraZeneca has set itself apart, acknowledging

the main driving force behind quality, proactive voluntarythat countries are free to determine what constitutes a ‘pub-

licensing in the pharmaceutical industry (see Figure 30). The

lic health emergency’. Merck KGaA acknowledges that it is theFoundation has consistently found that the transparency andright of countries – provided certain criteria are met, such as

flexibility of terms and conditions is highest when the MPP is

engagement with the patent rights-holder – to determine theinvolved. In 2018, seven companies were found to be involved

grounds for issuing compulsory licences.

in licensing activities: AbbVie, Boehringer Ingelheim, BristolMyers Squibb, Gilead, GSK, Johnson & Johnson and Merck &PAT EN T T R A NSPA R EN CY

Co., Inc. Compared to 2012, only AbbVie is new to this group

Sizeable leap in patent transparency supports procure-(Roche was in this group in 2012 but is no longer counted asment decisions

the patent on its licensed product has since expired).

How pharmaceutical companies manage their IP impacts theavailability and affordability of medicines, particularly in how
they facilitate generic medicine manufacturers in bringing
cheaper versions into new markets. Transparency about thepatents companies hold is one element of a responsible IP
strategy.
Broadly speaking, information about the status of patents
should be available and accessible from country-level patentoffices. However, this is often not the case in LMICs, where▶Which compounds are available for licensing?

the capacities of regulatory systems can be constrained. As a

Pro-access licences have been negotiated and applied toresult, a lack of certainty can arise about which patents are in

a complete suite of HIV/AIDS and hepatitis C medicines,

force and where. Critically, this can have a detrimental effectincluding first- and second-line therapies and products on

on procurement decisions. Procurers may opt for lower-risk

the WHO Model List of Essential Medicines (WHO EML).

strategies that avoid the supply of generics to countries

Through licences, all first-line WHO pangenotypic regi-

where patent status is ambiguous, potentially adding unnec-

mens for hepatitis C can now be made available in coun-

essary costs. Conversely, patent transparency gives procur-

tries in scope through generic supply. Many licensed com-

ers greater confidence when procuring generic alternatives topounds were approved for use in the last 10 years. Novelpatented products. The Foundation assesses whether compa-

patented products for HIV/AIDS and hepatitis C have beennies disclose patent status, regardless of product type, check-the primary candidates for the use of non-exclusive volun-

ing for information such as patent number, expiry date andtary licences.

jurisdiction.
In recent years, the Foundation has seen a striking shift
in the level of transparency about the patents pharmaceutical companies hold (see Figure 28). Merck KGaA was the firstcompany to make such disclosures, in 2014. Today, 17 companies make some level of disclosure about the patents they
hold.

32

Access to Medicine Foundation

Figure 27. Since 2012, four companies have consistently

Figure 28. Since 2010, publicly disclosing patentpublicly endorsed the Doha Declaration and at least one

has become new industry standard
figinformation
PD2

TRIPS flexibility

The chart shows how many companies publish at least some information

The chart shows the proportion of companies that have consistently publicly

about patent statuses. The first company to take this step was Merck KGaA,

supported the Doha Declaration and at least one TRIPS flexibility since 2012.

followed by AstraZeneca, Novo Nordisk and Gilead in 2016. By 2018, patent

On average, ten companies have been found by each successive Index reporttransparency could be said to have become standard practice.

fig
give this level of support, with the group of companies changing from year
fig PD9 tonew

20 companies

to year.

4 companies have consistently
endorsed at least one
TRIPS flexibility since 201217 disclose patent
information17

16 companies disclose patent infor0

20
companies0

mation through the Pat-INFORMED
online database, an initiative coordi-

16 companies
have not.

1

4

nated between IFPMA and WIPO.
AstraZeneca and Gilead self-publish

2010 2012 2014 2016 2018

patent information online.

Figure 29. Since 2010, number of licensed compounds has

Figure 30. Compared to 2012, more companies are

steadily increased

licensing medicines through the Medicines Patent Pool

The chart shows, at two-year intervals, a cumulative total of the number of

The chart shows how many companies engage in voluntary licensing throughproducts that have been granted non-exclusive voluntary licence agreements

the Medicines Patent Pool (MPP) in 2018 compared with in 2012. The MPPor were subject to non-assert declarations. There has been a steady addition

is now the main driving force for continued engagement, and is consistently

fig PD6altof new compounds since 2010 (when products now off patent are also

fig PD5

associated with a push for more access-oriented licence terms.

counted).
Number of 30
Data importcompounds
7
7 hepatitis C
Figure labels and data
25 4 companies have consistently endorsed at least4
compounds
one TRIPS flexibility since 2012 4
16 companies have not 2
16 22
20
21
21
22 HIV/AIDS
compounds
17

20 companies

15

10

12
6

5
0

2
5

1
2010

2012

2014 2016

2 with other licences or
non-assert declarations
5 engage in voluntary
licensing through MPP

2012 20182018

Table 1. Compounds currently with licences or non-assert declarations
The table shows the on-patent products with valid licences or non-assert declarations belonging to companies in scope. All compounds are used
to treat either HIV/AIDS or hepatitis C. This table does not include licence agreements or declarations that have expired.
CompoundCompany

Disease
HIV/AIDS

HCV

AbbVie●●Bristol-Myers Squibb●●

Gilead●Abacavir, Dolutegravir (adult and paediatric)

GSK (ViiV)●

Raltegravir (paediatric)

Merck & Co., Inc.

●

Nevirapine XR

Boehringer Ingelheim●

Darunavir

Johnson & Johnson●

LICENCES NEGOTIATED VIA MEDICINES PATENT POOL

Lopinavir, Ritonavir (adult and paediatric), Glecaprevir,
Pibrentasvir
Atazanavir, Daclatasvir
Cobicistat, Elvitegravir, Emtricitabine, Tenofovir Disoproxil
Fumarate, Tenofovir Alafenamide, Bictegravir

NON-ASSERT DECLARATIONSPRIVATELY AGREED LICENCES

Sofosbuvir, Ledipasvir, Velpatasvir, Voxilaprevir

GileadRilpivirine

Johnson & Johnson

●
●

33

Access to Medicine Index – 10-year analysis
PR I CI N G

Increase in pricing strategies meeting key criteria

Tackling inequity means tailoring strategies to specific

In 2014 and again in 2016, one third of products evaluatedcommunities

were covered by an equitable pricing strategy (see Figure

Whether a product is ‘affordable’ depends on who is paying –31). In 2018, this increased by 10% to 43% (447 out of 1,036

whether it is a patient and who that patient is, or whether it isproducts).

another stakeholder in the local healthcare system. In LMICs,

More products are now meeting all of the criteria used by

up to 70% of spending on medicines is made out of pocket.1

the Index to assess the depth of pricing strategies, increas-

Many people rely heavily on privately funded health services.

ing from 5% in 2016 to 18% in 2018 (see Figure 32). The

Governments and insurance companies do not always coverFoundation began gathering data on these criteria in 2016.

the full cost of treatment. Even in middle-income countries

This notable shift indicates that companies are beginning(MICs), many millions of people living in poverty still face suchto think more strategically about how to improve affordabil-

issues.

ity for people in LMICs. However, more progress is required toSince at least 2014, almost all companies evaluated (18 out
of 20) have been using equitable pricing strategies in someform. To qualify as ‘equitable’, a strategy cannot comprise dis-reach a higher proportion of products in scope of the Index,
as 57% still lack any form of equitable pricing strategies.
To improve affordability, companies must take account ofcounting alone; strategies must include concrete steps forsocioeconomic factors affecting the target population seg-

assessing the affordability of discounted prices.

ments when setting prices, including disease burden, health-The Index examines two types of equitable pricing strategies: inter-country strategies, where prices are set at thecare financing and healthcare infrastructure.
There are models of good practice for companies to adopt.

national level based on, e.g., GDP or GNI per capita; andIn 2018, three companies provided evidence that they use

intra-country strategies, where different prices are set within

specific tools when determining prices for different pop-a country for different population segments, e.g., to reflectulations. For example, AstraZeneca assesses an individu-

differences between the private and public sectors. Intra-

al’s ability to pay based on a variety of socioeconomic fac-country strategies are considered to be more sensitive totors in Brazil; Takeda has developed a tool for assessing peo-

the ability to pay of a greater range of populations, especiallyple’s ability to pay for products for Hodgkin’s Lymphoma

when universal health coverage is not in place.

and inflammatory bowel disease in countries including thePhilippines; and Novartis uses a framework to determine pricesegmentation and develop patient access programmes forcountries in scope.

34

Access to Medicine Foundation

Figure 31. Compared to 2014, equitable pricing strategies
are applied to more products
The chart shows the increasing use of equitable pricing strategies over time.
The proportion of products with equitable pricing strategies has grown fromfig PD3

33% to 43% since 2014.

Products
1200

589

1000

589 products
not covered

570

800
470
600

447

400

200

0

230

2014

447 products covered byequitable pricing strategies

280

2016

2018

Figure 32. Since 2016, coverage of needs-based pricing strategies has remained limited
The top figure breaks down the coverage of equitable pricing strategies in 2016, showing how many products’
strategies meet all key criteria looked for by the Foundation. The lower figure shows the same breakdown in 2018,
when more products are attached to equitable pricing strategies, and more strategies meet all criteria, although 57%
of all products examined still lack any form of equitable pricing strategies.

2016

Products
pricedequitably (33%)
280

850
products

280...including withprice differentiation
within countries (11%)
95... and covering
at least onepriority country*(7%)
61

95

61

...and with at least one
socioeconomic factor
taken into account (5%).
44570
No equitablepricing strategy

2018

Products
pricedequitably (43%)
447

1,036
products

447...including withprice differentiation
within countries (30%)
317... and covering
at least onepriority country*(22%)
226

317

226

...and with at least one
socioeconomic factor
taken into account (18%).
189

589
No equitablepricing strategy*Priority countries have been identified by
the Foundation as having among the highest burdens for the disease in question,
based on WHO data (2012), or IHME data
(2015), and adjusted for multi-dimensional
inequality (UNDP, 2012).

35

Access to Medicine Index – 10-year analysis

I N - COU NTRY ACCESS I N ITIATIVES

Companies are scaling up some on-the-ground
activities

Hundreds of millions of people worldwide live on very low

I N CLUSI V E B USI N ESS M O D EL S

incomes, and have no access to the robust health systems

Use of inclusive business models appears to be expanding

needed in order for health products to be deployed, pre-The Foundation has identified inclusive business models

scribed and administered efficiently. These people can neither

since 2014, when it first evaluated innovative business mod-afford nor access the medicines they need. This section looks

els and captured six such models. The number of models

at two ways in which pharmaceutical companies can directly

has remained more or less constant since then, and in 2018,

address these barriers for specific populations and communi-

the Index identified five companies with six inclusive busi-

ties: inclusive business models and capacity building.

ness models that had been scaled up or newly launched sinceAn ‘inclusive’ business model is one that explicitly aims

the 2016 Index. Five of these are pre-existing models that are

to include people on very low incomes in its customer base.

being expanded with the aim of reaching more people. These

Inclusive models are either cost-neutral or, ideally, commer-are encouraging signs that inclusive business models can be,

cially sustainable. Such models can complement pricing,

and are, successful and sustained long-term. Table 1 sets out

licensing and donations initiatives to address the accessibility

the ten inclusive business models identified by the Index since

and affordability of health products for specific populations.

2014 that are currently running. The longest-running mod-Capacity-building activities may include training for health-els are Novartis’ Health Family programme, which started incare providers, such as nurses, or programmes to reduce

2007, and Novo Nordisk’s Base of the Pyramid programme,

stock-outs and other supply chain issues. Large pharma-

which started in 2010. Eight of these models have beenceutical companies have the expertise and the capacity toscaled up since they first started.

strengthen local health systems, provided initiatives are carried out with appropriate partners. Companies’ initiatives are
expected to address local needs, have processes in place to
avoid conflicts of interest, have clear goals and objectives,
measure outcomes and/or impact and aim for sustainable

Through GAP, Roche is expanding

models and long-term impact.

access to the plasma separation
card for HIV viral load testing. GAPOver the past ten years, on-the-ground initiatives haveis being run with UNAIDS, theevolved as global health priorities have shifted. There is now a

Clinton Health Access Initiative

greater emphasis on expanding access to essential medicines(CHAI), the President’s Emergency

for NCDs and on strengthening in-country capacity to sus-

Plan for AIDS relief (PEPFAR) andtain this expansion. In some cases, companies are working to

the Global Fund.

scale up existing projects deemed to be a success. However,© F. Hoffmann-La Roche 2018

in recent years, the global health community has identified
a need for companies to report publicly on outcomes and to
begin to measure the true impact of such projects. Impact

Eli Lilly’s LEAP builds capacity ofmeasurement is now recognised as key for achieving broader

primary care physicians to manage

and more rapid access. Some companies, such as Novartis

patients’ diabetes. The LEAP modeland Novo Nordisk, publicly report on the results of theirprovides training for primary careefforts and several others have recently made commitments

physicians in China to increase theirto doing so.

confidence and skills in managing
diabetes across all stages of thedisease. The programme currently© Eli Lilly

36

targets the middle class in China.

Access to Medicine Foundation

Table 2. Companies are running and scaling up a range of inclusive business models
The table sets out inclusive business models highlighted by the Index since 2014 that areeither still running or being scaled up. In 2018, the Index identified five companies with six
inclusive business models that had been scaled up or newly launched since the 2016 Index.

StartedCompany

Programme

Model

Scope or scale up since launch

Eli Lilly

Lilly Expanding Access for

Lilly Expanding Access for People (LEAP) builds

Scale up: to 14 provinces in China; from 13 2015

People (LEAP)

capacity in diabetes care.

in 2016

Live Well

Live Well social enterprise model builds and sup-Scale up: to 20 communities in Zambia,

ports local distributor networks.

from four in 2016

The programme offers zero-interest, no-collateral

Runs in 11 cities in Punjab, India

2012

Community-level meetings and educational health

Scale up: to multiple communities across2013

programmes run by healthcare professionals, as

India in 2016

GSK
Merck & Co., Inc.

Programme Sambhav

in:

2015

loans for eligible patients with hepatitis C and a disease management option.
Merck KGaA

Suswastha*well as products based on needs in its target areas
and with adapted price bands.
Curafa™

Curafa™ programme establishes local primary

Runs in five counties in Kenya (new)2018

healthcare centres.
Novartis

ComHIPComHIP programme enables people with hyperten- Scale up: to three districts in Ghana, fromsion to access diagnosis and care at the commu-

2015

two in 2016

nity level.
Healthy Family

Health camps focused on disease prevention,

Scale up: to at least four countries

awareness and treatment, tailored to local health(Cameroon, India, Kenya and Vietnam),priorities and customs, including a wide range offrom one, India, in 2007

2007

essential medicines.
Novartis AccessNovo Nordisk

Base of the Pyramid

Novartis Access uses portfolio approach to address Scale up: to three additional countries
affordability for products for non-communicable(Pakistan, Rwanda and Uganda), from two

diseases.

in 2016 (Ethiopia and Kenya)

Project to improve diabetes care for the working

Scale up: to five countries (Ghana, India,

2015

2010

poor by providing training to healthcare profession- Kenya, Nigeria and Senegal) in 2013
als, patient education to improve self-management,
and addressing a stable, affordable supply of insulin.
Roche

Global Access Program

Roche Global Access Program provides better

Scale up: to 82 countries and more prod-access to diagnostic testing for HIV/AIDS in 82

ucts for HIV/AIDS testing; and to hepati-countries.

tis C testing2015*Since the acquisition of Merck KGaA’s consumer health businessby Procter & Gamble in 2018, Suswastha is no longer a Merck KGaA
initiative.

37

Access to Medicine Index – 10-year analysis
FO CUS O N A FR I C A

Capacity building and inclusive business models concen-

Novartis Healthy Family runs

trated in sub-Saharan Africa

programmes in Cameroon, India,

Seven of the ten inclusive business models are operating in

Kenya and Vietnam, with a focus on

one or more sub-Saharan African countries. These include

prevention, awareness andmodels with a focus on enhancing early diagnosis, estab-treatment. Programmes are tailoredlishing primary healthcare centres, improving last mile sup-to local health priorities andply chains and providing low cost medicines. These initiatives

customs and include a wide range

generally focus on one or a few countries, usually LMICs.

of essential medicines.

The Index first noted an increase in company interest and© Nguyen Tran Hung for Novartis AG

strategic initiatives in African countries in 2014: nine companies (AstraZeneca, Bayer, GSK, Merck and Co. Inc., Merck
KGaA, Novartis, Novo Nordisk, Takeda and Sanofi) reported

A Senegalese healthworker checks

strategically tailoring or re-focusing their activities in sub-Sa-

stock levels as part of an initiative toharan Africa. These activities included, for example, establish-

improve stock management, part ofing new business units or strategies focused on the continent,

the Merck & Co., Inc. ‘Informed Pushstrengthening companies’ physical presence in Africa (by, e.g.,

Model’. This model removes thesetting up legal entities, local offices, subsidiaries or affiliates),burden of tracking and ordering

expanding into more African countries, investing in local man-inventory from pharmacies by using

ufacturing capacity, engaging in new research partnerships or

logistics operators to regularly

setting up new access programmes that target underserved© IntraHealth International

populations and address local challenges.

deliver and track supplies to ensuresufficient stock.

African countries are also the focus of companies’ efforts
to build capacities in local healthcare systems and supply

With PATH (a global health NGO),

chains. These initiatives are diverse. As an example, Takeda

Novo Nordisk implemented its No

works with the Kenyan Ministry of Health and other part-

Empty Shelves project in 2014 toners to ensure more people can access cancer care services.

assess supply chain strengths andIn Ghana, Merck KGaA is working with partners including thebottlenecks, as well as availability

government to establish a new local vaccine manufacturing

and affordability of essential

plant. Capacity building efforts are critical for advancing uni-

medicines and technologies (EMTs).

versal health coverage (UHC).

Data were collected in healthCompanies generally invest in capacity building in markets© Path/Carissa Vados

where they have a strategic or commercial interest. In thefacilities and pharmacies in Senegal
to identify access barriers.

2018 Access to Medicine Index analysis (covering 106 countries, mainly LMICs, including 50 of the 54 countries in Africa),

In Nampula, Mozambique, aKenya has the most capacity-building initiatives, followed byhealthworker uses GSK’s mVacciNa-

South Africa and then China. Overall, the Index identified andtion mobile technology to improveanalysed 141 capacity building initiatives in African countries.

patient-record keeping. GSK’s

The Index only analysed initiatives that meet local needs formVacciNation programme started in

specific capacities. Only one country in Africa in this analysis

Mozambique, where GSK tested(Equatorial Guinea) has no initiative that qualified for analysis.

whether mobile technologies canhelp increase childhood immunisa© GSK

tion, in partnership with the Ministryof Health.

38

Access to Medicine Foundation

Table 3. Capacity building initiatives identified as best practices in 2018
The table sets out the capacity building initiatives identified in the 2018 Access to Medicine Index as best practices,each of which is currently running in at least one African country from the companies in scope. There are 12 initiatives
from six companies, in three areas of capacity building. These best practices are typically initiatives that have beentested and proven, and some examples include initiatives that have been successfully scaled up from pilots.
Company

2018 Best PracticeStarted in:

Currently active in:

Africa NCD Open Lab: A notable number of collaborations with

2014

Sub-Saharan Africa, including Cameroon, Ethiopia,

R& D

GSK

African institutions to assess, support and improve NCD research.

Ghana, Kenya, Malawi, Mozambique, Nigeria, South
Africa, Tanzania and Uganda

Johnson &Ugandan Academy for Health Innovation and Impact: A public

Johnsoninstitute that supports the development of scientists in Africa andTakedaR&D AtM Employee Fellowship Program: Employee fellowship pro- 2016

2015

Ugandaconducts its own research.
Haiti, Kenya and Tanzania

gramme that enters long-term engagements with selected NGOs.
S U PPLY CH A I N

GSKmVacciNation: A successfully scaled-up mobile technology plat-

2012

Mozambique, Nigeria and Tanzania

2013

Senegal2009

Nigeria, Pakistan and Zambia

2014

Kenya and Senegal

form that tracks vaccine stock data in remote locations.
Merck & Co., Inc.

Informed Push Model: Model removes the burden of tracking andordering inventory from pharmacies by using logistics operators toregularly deliver and track supplies to ensure sufficient stock.

Novartis

SMS for Life 2.0: Enhanced mobile technology supply chain management system now utilising new technologies and expanding tocountries and a wider range of products.

Novo Nordisk

No Empty Shelves: Partnership to assess supply chain strengths
and bottlenecks, as well as availability and affordability of essential
medicines and technologies (EMTs).

Novo Nordisk

The Base of the Pyramid (BoP): Initiative to improve access to dia- 2012

Ghana, Kenya, Nigeria and Senegal

betes care reaches three new countries.
H E A LT H SYST E M ST R E N GT H E N I N G

GSK

GSK and Save the Children partnership: A wide range of pro-2013

28 countries: Benin, Burkina Faso, Cambodia,

jects through a global partnership with Save the Children, with the

Côte D’Ivoire, Dominican Republic, DRC, Ethiopia,

stated aim of helping one million children access needed medicine

Guatemala, Haiti, Honduras, India, Kenya, Liberia,

and vaccines.

Mali, Mexico, Myanmar, Niger, Nigeria, Senegal,
Sierra Leone, South Africa, Sri Lanka, Sudan, Syria,
Togo, Uganda, Vietnam and Yemen

Johnson &The New Horizons: Advancing Pediatric HIV Collaborative:

JohnsonCollaborative initiative aimed at advancing paediatric HIV/AIDS

South Africa, Swaziland, Uganda, Zambia andcare, particularly for those failing treatment.

Zimbabwe. Additionally, in collaboration with2013

9 countries: Ethiopia, Kenya, Lesotho, Rwanda,

Right to Care, Janssen, owned by parent company
Johnson & Johnson, supported drug resistanceworkshops in Malawi (2016 and 2017), Mozambique(2016) and Nigeria (2018).
Merck & Co., Inc.

Merck for Mothers/MSD for Mothers: A USD 500 million, 10-year

2011

More than 30 countries, with a particularly strong

initiative to design scalable solutions to help end preventablefocus on several countries in scope of the Index

maternal deaths.

including Ethiopia, India, Mexico, Senegal, Tanzania,
Uganda and Zambia.

Novartis

Strengthening care at the community level:

2007

Cameroon, Kenya, India and Vietnam (Healthy-Healthy Family

Family)-Community Health Educator Replication CHER II program

Kenya (CHER II)-Health Express, Jian Kang Kuai Che (JKKC)

China (Health Express , JKKC)In the past 10 years, Novartis has run initiatives alongside government health ministries and local NGOs to ensure it tailors healthcare activities to local needs.

39

Access to Medicine Index – 10-year analysis

APPE N D IX I

Methodology for this report

The Access to Medicine Index is the longest-run-areas. In some areas, it was not possible to pro-be published (e.g., the period of analysis for thening research programme at the Access tovide a more complete picture of the area of anal-

2018 Access to Medicine Index extended from 1

Medicine Foundation. The first Index was pub-ysis due to these kinds of external constraints on

June 2016 to 31 May 2018). An exception to thislished in 2008. Since then, it has been publishedthe collection of data.

timeframe was for the analysis of new medi-

every two years as a relative ranking of twenty

Where possible for each iteration of thecine approvals, for which approvals of new med-of the largest global research-based pharma-

Access to Medicine Index, data validation using

icines by the European Medicines Agency (EMA),

ceutical companies, based on their policies andexternal published sources was performed to

US Food and Drug Administration (FDA) andpractices to improve access to medicine in low-

verify company submissions. Additionally, com-

Japanese Pharmaceuticals and Medical Devices

and middle-income countries.

panies were invited to fact check certain num-

Agency (PMDA) were assessed between 1

bers and statements in this report (e.g., mar-January 2008 and 31 December 2018.

The Index methodology is developed througha process that systematically draws together

ket approvals since 2008) prior to publication to

the views of NGOs, governments, investors, theensure accuracy.

Maintaining the disease scope of the Index
The disease scope of the Index is updated every

pharmaceutical industry and multi-lateral organisations to build a consensus, ratified by the

Identifying data points for longitudinal analysis

two years to reflect the evolving disease bur-Expert Review Committee for the Index, on how

The framework of indicators the Index employs

dens and priorities unique to low- and middle-in-

and where pharmaceutical companies can andto assess companies was reviewed to identify

come countries (LMICs), then ratified by anshould be improving access to medicine.

data points that were measured across succes-

Expert Review Committee comprised of a range

sive iterations of the Index without change. Thisof expert stakeholders. In 2008, the Access toreport incorporate the data collected acrossproduced a subset of consistent data points

Medicine Index primarily focused on NTDs as

multiple iterations of the Access to Medicine

that would allow for longitudinal trend iden-

defined by WHO, expanding to include high-bur-Index by the Access to Medicine Foundation,tification. Where data points were not meas-den diseases including non-communicable dis-using various methods to establish trends inured across all iterations of the Index, the ear-eases (NCDs) in 2010. The latest major addi-

access-to-medicine activities from the phar-liest available point of measurement possibletion to the disease scope was the inclusion of amaceutical industry over the past ten years.

was used. Where a narrower timeframe of com-group of cancers in the 2018 Access to Medicine

These methods, and their associated limita-

parison is used, this is indicated in the text. For

Index.

tions, are detailed in this section. A more exten-

example, engagement in neglected tropical dis-

To facilitate longitudinal trend analysis insive detailing of how the Index assesses dataeases (NTDs) product donations has been meas-

this report, the disease scope was held constantand compares companies, and any associatedured since 2010, as has engagement in NTD

when possible to allow for consistency in dif-

limitations which may also apply to this study,

research and development. Refinements in theferent analyses throughout the report, as indi-

can be found in the 2017 Access to Medicine

analysis and evaluation of equitable pricing werecated in the text. This is particularly of note inIndex Methodology and on pages 229 and 230

made in 2014, and in 2016; progress and regressareas of the report that focus on the breadthin Appendix IX of the 2018 Access to Medicine

in this area can only be compared when taking

and depth of company activity in certain dis-

Index.1,2

these changes into account. An analysis of com-ease areas (such as the R&D section), where thepany internal control frameworks was intro-

2014 Access to Medicine Index disease scope

Data availability

duced in 2018 and is therefore an example of awas held constant for much of the analysis.

The quality of data obtained from companies

set of data points not included within this anal-

Osteoarthritis, in scope in 2014, was removed

varies, especially with regards to commerciallyysis, as progress or regress could not be shown

from this analysis as this disease was excluded

sensitive data. Some data were provided underover time.

from the disease scope from 2016 onwards.

The findings of this longitudinal progress

Information used in the development of

For this reason, the figures presented indata are provided under NDA, it is reported on

this progress report extends between the start

this report often cannot be directly comparedin aggregate. If aggregate reporting is not pos-of the period of analysis for the 2010 Index

with analogous figures in the 2018 Access tosible, these data are excluded from the analy-(January 2008) to the close of the period of

Medicine Index, as they only include a subset ofsis. For example, the content of R&D contracts,

analysis for the 2018 Index (May 2018). The 2010

disease data. In general, trends were establishedearly-stage research and investment informa-and 2012 iterations of the Index were basedusing a fixed disease scope, as described in eachtion may be revealed more cautiously by compa-

on fiscal years. From the 2014 Index onwards,

section of the report. This scope varies between

nies. This variation can be an obstacle to finding

the period of analysis was fixed to 1 June of

and within sections, but mainly, the 2014 dis-and reporting reliable, industry-wide trends andthe year in which one Index was published to 31

ease scope was utilised in the R&D and NTDs

specific relationships and conclusions in certain

May of the year in which the next Index was tosections of the report, and the 2018 diseasenon-disclosure agreements (NDAs). Where40

Access to Medicine Foundation

scope was utilised in the product deployment

picture of how companies are pricing prod-

2018 were included for analysis if they tar-section of the report. However, some excep-

ucts across a larger portfolio. This approach

geted a disease in scope: the diseases and condi-

tions to this approach exist, as noted later in thisis also intended to maintain consistency with

tions looked at by the 2018 Access to Medicine

methodology.

other Foundation publications in which the same

Index, with the exception of cancer. Cancer wascharts are shown.

excluded from the registration analysis to ensureSpecific approaches

that the overview of products brought to mar-

Most of the analyses conducted for this report

Analysis of compounds licensed

ket by the 20 companies in scope since 2008

follow the previously mentioned approaches.

To accurately capture the net number of com-aligned closely to the Index disease scopes from

This section includes specific approaches taken

pounds licensed since 2010, the Foundation val-

previous cycles, and to aid comparison. The 2014

for some of the more complex data sets and theidated previously reported Index data points

Index disease scope was predominantly used inunique limitations related to these analyses.

by reviewing external information pertaining

the R&D analyses of this report.

to specific compounds retrieved from both the

For this analysis, only new medicines were

Medicines Patent Pool as well as the Research

included, and only new approvals for the four

deployment technical areas

Handbook on Intellectual Property Licensing.3,4

Japanese companies were referred to when

Similar to how the disease scope has changed

Individual compounds owned by companies in

examining PMDA approvals, as direct compari-between iterations of the Index, the geographic

scope of the Index that have non-assert declara-

son between American/European and Japanese

scope has expanded or narrowed with each pub-tions or non-exclusive voluntary licences applied

approvals before and during the period of anal-

lication to best capture the countries whereare included. Some companies may own theysis was not always possible. This analysis

greater access to medicine is needed most.

rights to products with multiple compounds, forthus shows an incomplete portrayal of all newSome countries have moved into higher World

example a double- or triple-combination ther-approvals in the past ten years but allows for the

Bank classifications over the timespan of theapy. In these cases, each individual compound

analysis and presentation of the trends for what

Index to date, while some upper middle-income

is included in the analysis. The net number of

information is available.

countries have been added in more recent iter-

compounds also includes those with patents

Additionally, the number of new market

ations of the Index as a reflection of high lev-or agreements that have since expired, evenapprovals that have access initiatives in placeels of socioeconomic inequality in these coun-

though those licences or agreements are no

was limited by factors including incomplete

tries. Between the 2016 and 2018 iterations of

longer needed. These compounds are included

information regarding equitable pricing strate-

the Index, for example, three countries (Georgia,

for analysis to demonstrate the total instances

gies for older products, the analytical framework

Jamaica and Panama) were removed and twoof action from companies in scope of the Index

for which was substantially changed in the 2014

countries (Tonga and Tunisia) were newly

since 2010.

Index, and regarding what access initiatives were

Disease and country comparability in productin place for some newer formulations of existing

included to reflect changes in inequality measurements and World Bank classifications.

Market approval analysis

medicines. This led to the reporting of a more

For the purposes of assessing products devel-

conservative value of new medicines with accessment technical areas of this report relate tooped by the 20 companies examined by the

initiatives from 2008 to 2018.

the geographical, disease, product and com-Index that have received market approval, thepany scopes determined by the Expert Review

FDA’s Approved Drug Products with Therapeutic

Committee (ERC) during the methodology

Equivalence Evaluations (referred to as ‘thereview process and as published in the 2017

Orange Book’) and lists of approved products

Access to Medicine Index Methodology. For thisby the EMA and PMDA were utilised.5-7 The con-analysis, the disease and country scopes weretents of the Orange Book exclude vaccines andnot held constant, as the product deployment

some therapeutic biological agents that can betechnical areas measure the proportion of equi-found in the FDA Center for Drug Evaluationtable pricing strategies across company port-

and Research’s List of Licensed Biologicalfolios over time. Even when removing newly

Products with Reference Product Exclusivity andin-scope products due to disease scope expan-

Biosimilarity or Interchangeability Evaluations

sions from the analysis, the increase in the per-(referred to as ‘the Purple Book’).8

The outputs analysed in the product deploy-centage of products with equitable pricing strat-

Medicines that received an approval from one

egies remains notable. This analysis is thus

or more of these stringent regulatory authori-intended to provide a more comprehensive

ties between 1 January 2008 and 31 December

41

Access to Medicine Index – 10-year analysis

APPE N D IX I I

References

OV E RV I E W

CO M PLI A N CE

11

9 WHO. Global Priority List of Antibiotic ResistantBacteria to Guide Research, Discovery and Development

EvaluatePharma® World Preview 2017,

Gee J, Button M. The Financial Cost of Healthcareof New Antibiotics.; 2017. http://www.cdc.gov/drugre-

Outlook to 2022.; 2017. www.evaluate.com/

Fraud 2015.; 2015. https://www.pianoo.nl/sites/default/

sistance/threat-report-2013/. Accessed October 22,

PharmaWorldPreview2017. Accessed February 21, 2019.

files/documents/documents/thefinancialcostofhealth-2018.

carefraud-september2015.pdf. Accessed January 15,
2 IFPMA. The Pharmaceutical Industry and Global

2019.

Health, Facts and Figures 2017. https://www.ifpma.

dengue/epidemiology/index.html. Accessed January 21,

org/wp-content/uploads/2017/02/IFPMA-Facts-And-

2 Genovese L, Edwards D. Why It Matters -Figures-2017.pdf. Accessed February 21, 2019.

Pharmaceutical Compliance, Anti-Corruption and Accessto Medicine.; 2017. https://accesstomedicinefounda-

3 UNAIDS warns that progress is slowing and time istion.org/media/uploads/downloads/5bc5edf40595e_

running out to reach the 2020 HIV targets | UNAIDS.

Compliance_Anti-corruption_Access-to-Medicine_Why_

http://www.unaids.org/en/resources/presscentre/

It_Matters_L_Genovese_D_Edwards.pdf. Accessedpressreleaseandstatementarchive/2018/july/miles-

January 16, 2019.

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4 World Development Indicators | DataBank.
https://databank.worldbank.org/data/reports.aspx?source=2&series=SP.POP.TOTL&country=. Accessed
February 21, 2019.
5 AstraZeneca. What Science Can Do - AstraZeneca
Annual Report and Form 20-F Information 2017.;
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6 Sanofi. Form 20-F 2017.; 2017. https://www.sanofi.
com/-/media/Project/One-Sanofi-Web/Websites/
Global/Sanofi-COM/Home/en/investors/docs/
S-Z/Sanofi-20-F-2017-EN-PDF-e-accessible_01.pdf.
Accessed February 25, 2019.
7 Chapman N, Doubell A, Oversteegen L, et al.
Neglected Disease Research and Development: Reaching
New Heights Policy Cures Research 2018 | G-FINDER.
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uploads/2019/01/Y11_G-FINDER_Full_report_Reaching_
new_heights.pdf. Accessed February 21, 2019.
8 Cole CB, Iyer JK. Ensuring Sustained Incentives for
Pharmaceutical Companies to Develop Medicine for the
Poor.; 2016. https://accesstomedicinefoundation.org/
media/uploads/downloads/5bc5edfd5372e_2016-Ensuring-sustained-incentives-for-pharma-to-develop-medicine-for-the-poor.pdf. Accessed February 21,
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9 International Cancer Control Partnership. www.
iccp-portal.org. Accessed April, 2017.

10 Epidemiology | Dengue | CDC. https://www.cdc.gov/
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ical diseases – the present and the future. Tidsskr Den
Nor legeforening. 2018. doi:10.4045/tidsskr.17.0678
2 World Health Organization. Accelerating Work to
Overcome the Global Impact of Neglected Tropical1

Access to Medicine Index 2018.; 2018. https://access-Diseases - A Roadmap for Implementation.; 2012.

tomedicinefoundation.org/publications/2018-ac-https://unitingtocombatntds.org/wp-content/

cess-to-medicine-index. Accessed January 16, 2019.

uploads/2017/11/who_ntd_roadmap.pdf. Accessed
February 22, 2019.

2 Chagas Platform – DNDi. https://www.dndi.org/
strengthening-capacity/chagas-platform/. Accessed

3 The London Declaration on Neglected TropicalJanuary 16, 2019.

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3 Islam SMS, Purnat TD, Phuong NTA, Mwingiraeases. Published 2012. Accessed October 22, 2018.

U, Schacht K, Fröschl G. Non-communicable diseases (NCDs) in developing countries: a sympo-

4 WHO. Trypanosomiasis, human African (sleeping sick-

sium report. Global Health. 2014;10:81. doi:10.1186/

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detail/trypanosomiasis-human-african-(sleeping-sickness). Published 2018. Accessed January 16, 2019.

4 WHO | Intergovernmental Working Group on Public
Health, Innovation and Intellectual Property (IGWG).

5 Mesu VKBK, Kalonji WM, Bardonneau C, et al.

WHO. 2012. https://www.who.int/phi/igwg/en/.

Oral fexinidazole for late-stage African Trypanosoma

Accessed January 16, 2019.

brucei gambiense trypanosomiasis: a pivotal multicentre, randomised, non-inferiority trial. Lancet (London,

5 Chapman N, Doubell A, Oversteegen L, et al. G-Finder

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2017 - Neglected Disease Research and Development:

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Reflecting on a Decade of Global Investment.; 2017.
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6 Sáez-Llorens X, Tricou V, Yu D, et al. Immunogenicity

Accessed October 22, 2018.

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6 Pablo Alzate Granados J, Chowdhary V, Gonzalez

Asia and Latin America: 18-month interim data from

Ramirez L, et al. Reproductive Health: R&D for thea phase 2, randomised, placebo-controlled study.

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Lancet Infect Dis. 2018;18(2):162-170. doi:10.1016/

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2018.
7 WHO. Dengue and severe dengue. https://www.who.
7 WHO. WHO Research and Development Blueprint.

int/news-room/fact-sheets/detail/dengue-and-se-

Geneva; 2017. http://www.who.int/csr/research-and-de-vere-dengue. Published 2018. Accessed January 16,

velopment/en/. Accessed October 22, 2018.

2019.

8 WHO Initiative for Vaccine Research. Disease-specific

8 WHO. Chagas disease (American trypanosomiasis).

areas of work. 2017. http://www.who.int/immunization/

https://www.who.int/news-room/fact-sheets/detail/research/development/en/. Accessed October 22, 2018.

chagas-disease-(american-trypanosomiasis). Published2018. Accessed February 28, 2019.

42

Access to Medicine Foundation

APPE N D IX I I I

List of figures

PRO D U C T D E PLOY M E NT
1

Figure 1

Compared to 2010, 17 companies now set goals and targets related to access to medicine

13

Figure 2

Since 2010, more company Boards now take direct responsibility for access to medicine

6, 13

Global Burden of Disease Health Financing

Figure 3

Compared to 2012, all companies now audit compliance with codes and standards

15

Collaborator Network J, Campbell M, Chapin A, etFigure 4

Since 2014, small increase in companies reforming incentives for sales agents15

al. Evolution and patterns of global health financ-Figure 5

Since 2014, the pipeline for high-burden and neglected diseases and conditions has

ing 1995-2014: development assistance for health,more than doubled

17

Figure 6

Since 2014, pipelines for key diseases have grown, but not for maternal and neonatal

England). 2017;389(10083):1981-2004. doi:10.1016/

Figure 7

Compared to 2010, more companies are now involved in R&D for key diseases and areas

17

S0140-6736(17)30874-7

Figure 8

Since 2010, clear uptick in NTD R&D engagement for leishmaniasis, Chagas disease and HAT

17

Figure 9

Since 2012, non-communicable diseases have remained as the focus of R&D engagement

19

and government, prepaid private, and out-of-pocket
health spending in 184 countries. Lancet (London,

M E T H O D O LO GY
1Access to Medicine Foundation. Access to Medicine

Index Methodology (2017).; 2017. www.accesstomedicineindex.org. Accessed October 23, 2018.
2 Access to Medicine Index 2018.; 2018. https://accesstomedicinefoundation.org/publications/2018-access-to-medicine-index. Accessed January 16, 2019.
3 Licence Overview – MPP. https://medicinespatentpool.org/what-we-do/global-licence-overview/.
Accessed February 26, 2019.
4 de Werra J, ed. Research Handbook on Intellectual
Property Licensing. Edward Elgar Publishing Limited;2013.
5 Center for Drug Evaluation and Research. DrugApprovals and Databases - Approved Drug Products with
Therapeutic Equivalence Evaluations (Orange Book).
https://www.fda.gov/Drugs/InformationOnDrugs/
ucm129662.htm. Accessed February 26, 2019.
6 Download medicine data | European Medicines
Agency. https://www.ema.europa.eu/en/medicines/
download-medicine-data. Accessed February 26, 2019.
7 List of Approved Products | Pharmaceuticals andMedical Devices Agency. https://www.pmda.go.jp/english/review-services/reviews/approved-information/
drugs/0002.html. Accessed February 26, 2019.
8 Center for Drug Evaluation and Research. Biosimilars- Purple Book: Lists of Licensed Biological Productswith Reference Product Exclusivity and Biosimilarity orInterchangeability Evaluations. https://www.fda.gov/

health conditions

17

Figure 10 Since 2014, most companies have engaged in NCD research; R&D projects for NCDs
have nearly tripled19

Figure 11 Since 2014, the number of medicines being developed or adapted for children remains low

19

Figure 12 Since 2016, priority R&D has increased

19

Figure 13 Since 2014, the number of companies developing vaccines for key diseases has remained
consistently low
Figure 14 Since 2014, companies have focused efforts to develop new vaccines in a few diseases

21
21

Figure 15 Since 2014, company engagement in vaccine R&D for diseases in scope hasremained relatively constantFigure 16 Since 2016, the coverage of access plans for late-stage projects is largely unchanged

21
21

Figure 17 Since 2008, at least 171 new medicines have received approval from the
EMA, FDA and/or PMDA

23

Figure 18 Since 2008, more medicines have been approved for diabetes mellitus and HIV/AIDS
than other diseases

23

Figure 19 Since 2008, 19 companies have received approvals for at least 171 medicines fordiseases and conditions in scope

23

Figure 20 Since 2010, the number of companies donating products for NTDs has only slightly increased 25
Figure 21 Since 2010, more companies are now engaged in R&D for NTDs

25

Figure 22 Since 2010, most companies active in NTD R&D have expanded to more diseases

25

Figure 23 Since 2014, R&D projects for NTDs have more than doubled
Figure 24 Since 2014, early-stage pipeline for NTDs has more than doubled

27
6, 27

Figure 25 Since 2014, R&D for NTDs consistently driven by partnerships

27

Figure 26 Since 2014, commitments to registering products have gradually become more specific29

Figure 27 Since 2012, four companies have consistently publicly endorsed the Doha Declaration
and at least one TRIPS flexibility

31

Figure 28 Since 2010, publicly disclosing patent information has become new industry standard

31

Figure 29 Since 2010, number of licensed compounds has steadily increased

31

Table 131

Compounds currently with licences or non-assert declarations

Figure 30 Compared to 2012, more companies are licensing medicines through the Medicines Patent Pool31
Figure 31 Compared to 2014, equitable pricing strategies are applied to more products

33

Figure 32 Since 2016, coverage of needs-based pricing strategies has remained limited

33

Table 2Companies are running and scaling up a range of inclusive business models

35

Table 3

Capacity building initiatives identified as best practices in 201837

Table 4Market cap & revenue of companies listed in the 2018 Access to Medicine Index

42

Table 5

Diseases, conditions and pathogens in scope of the 2018 Access to Medicine Index

43

Table 6Countries in scope of the 2018 Access to Medicine Index

45

Table 7

Priority countries

46

Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedand Approved/
ApprovalApplications /TherapeuticBiologicApplications/
Biosimilars/ucm411418.htm. Accessed February 26,
2019.

43

Access to Medicine Index – 10-year analysis

APPE N D IX IV

Pharmaceutical companies in scope
The Access to Medicine Index assesses 20 of the world’s largest research-2018. The Access to Medicine Foundation recognises that generic com-

based pharmaceutical companies on their policies and practices to improve

panies play a significant role in access to medicine, particularly in low- andaccess to medicine for people living in low- and middle-income countries.

middle-income countries. Generic medicines marketed by the 20 research-Considering their size, resources, pipelines, portfolios and global reach,based companies or any of their generic medicine subsidiaries in whichthese companies have a critical role to play in improving access to medi-

they have more than 50% ownership are included for analysis.

cine. The Index has measured these companies for 12 years, meaning theirperformance can be tracked over time. Pharmaceutical companies that
exclusively produce generic medicines remain excluded from the Index in

Table 4. Market cap & revenue of companies listed in the 2018 Access to Medicine Index
Market Cap Revenue
Company

TickerCountry(bn USD)(bn USD)
25.638
AbbVie

AbbVie Inc.

ABBV

USA

101.76

Astellas Pharma Inc.

4503

JPN

29.98 Astellas
12.148
PharmaAstraZeneca plc

AZN

GBR

69.3

23.002
AstraZeneca

Bayer AG

BAYN

DEU

86.46

49.273
Bayer

Boehringer Ingelheim GmbH

N/A

DEU

N/A
Boehringer 16.698
Ingelheim

Bristol-Myers Squibb Co.

BMY

USA

97.67
19.427
Bristol-Myers
Squibb

Daiichi Sankyo Co. Ltd.

4568

JPN

14.54

8.455
DaiichiSankyoEisai Co. Ltd.

4523

JPN

17.06

4.62 Eisai

Eli Lilly & Co.

LLY

USA

81.2
Eli Lilly and21.222
Company

Gilead Sciences Inc.

GILD

USA

94.34 Gilead30.39
Sciences

GlaxoSmithKline plc

GSK

GBR

94.68 GlaxoSmithKline
34.307

Johnson & Johnson

JNJ

USA

313.43
Jonhnson &71.89
JohnsonMerck & Co., Inc.

MRK

USA

162.3139.807Merck& Co.

Merck KGaA

MRK

DEU

45.47

15.828Merck
KGaA

Novartis AG

NOVN

CHE

191.3848.52
Novartis

Novo Nordisk A/SNOVO B

DNK

92.13

15.841
Novo
Nordisk

Pfizer Inc.

PFE

USA

197.1

52.82
PfizerRoche Holding AG

ROG

CHE

198.0949.626
Roche

104.7

35.632
Sanofi

SanofiSAN

FRA

Takeda Pharmaceutical Co. Ltd.

4502

JPN

32.76
14.843 Co.
TakedaPharmaceutical0*Source: Bloomberg terminal 2017**Exchange rate 31 Dec 2016 vs USD, from oanda.com

44

50

100

● Market Cap (bn USD)
● Revenue (bn USD)

150

200

250

300

350

Access to Medicine Foundation

APPE N D IX V

Disease scope of the 2018 Access to Medicine Index
Diseases are included based on their global burden of disability-adjusted

this list are deemed by WHO as priority R&D targets for new and effec-

life years (DALYs)1, other WHO classifications and the relevance of phar-tive antibiotics active against the pathogens themselves and the diseases

maceutical interventions. Index diseases are defined according to the WHOthey cause. This WHO priority pathogens list does not define specific prod-

International Classification of Diseases, 10th Revision (ICD-10) codes. The

ucts needed. R&D projects targeting these pathogens are grouped underdisease scope for the 2018 Index has expanded from 51 to 77 diseases,‘Other prioritised antibiotic-bacterial infections’ in figures and tables. DALY

conditions and pathogens. Cancer is now in scope. 12 pathogens have beenburden and mortality data was collected from WHO’s 2015 Global Healthbrought into the disease scope for the 2018 Index R&D analysis. These

Estimates (GHE).

have been identified by the WHO priority pathogens list. Pathogens on

Table 5. Diseases, conditions and pathogens in scope of the 2018 Access to Medicine Index
N O N - CO M M U N I C AB LE D I S E A S ES (14)TOTAL DALYS (LI C S & M I C S)

Anxiety disorders

17,637,255

Asthma22,489,628

Bipolar affective disorder
Cancer6,542,313
DALY not applicable

Chronic obstructive pulmonary disease (COPD)

59,841,914

Diabetes mellitus

53,660,514

Epilepsy

12,610,507

Hypertensive heart disease

17,053,619

Ischaemic heart disease

137,803,915

Kidney diseases

30,361,404

Migraine

19,608,650

Schizophrenia

11,707,269

Stroke113,999,836

Unipolar depressive disorders

40,359,896

CO M M U N I C AB LE D I S E A S ES* (2 1)

TOTAL DALYS (LI C S & M I C S)

Arenaviral haemorrhagic fevers (including Lassa fever)

N/A

Coronaviruses (including MERS-CoV and SARS-CoV)

N/A

Crimean-Congo haemorrhagic fever (CCHF)
Diarrhoeal diseases
Filoviral diseases (Ebola and Marburg)
Henipaviral diseases (including Nipah virus)
HIV/AIDS
Leptospirosis

N/A
83,764,595
N/A
N/A
59,213,043
N/A

Lower respiratory infections

131,150,237

Malaria

38,491,119

Measles

12,264,045

Meningitis**22,781,461

Other prioritised antibiotic-resistant bacterial infections
Pertussis

N/A
5,950,007

Rheumatic fever

N/A

Rift Valley fever (RVF)

N/A

Severe fever with thrombocytopenia syndrome (SFTS)
Sexually transmitted infections (STIs)***N/A
10,092,695

Tetanus4,662,932

Tuberculosis

54,332,361

Viral hepatitis (B and C)†

24,703,328

Zika

N/A

45

Access to Medicine Index – 10-year analysis
N EG LEC TE D TRO PI C AL D I S E A S ES (20)

TOTAL DALYS (LI C S & M I C S)

Buruli ulcer

DALY not available in GHE 2016

Chagas disease191,781

Dengue and chikungunya

2,575,517

Dracunculiasis

DALY not available in GHE 2018

Echinococcosis

607,742

Food-borne trematodiases

DALY not available in GHE 2015

Human African trypanosomiasis

371,657

Leishmaniasis

1,346,249

Leprosy

484,820

Lymphatic filariasis

2,069,423

Mycetoma, chromoblastomycosis and other deep mycoses

DALY not available in GHE 2019

Onchocerciasis

1,135,571

Rabies1,654,232

Scabies and other ectoparasites

DALY not available in GHE 2020

Schistosomiasis

3,478,062

Snakebite envenoming

DALY not available in GHE 2021

Soil transmitted helminthiasis

4,179,035

Taeniasis/cysticercosis

1,846,098

Trachoma

275,741

Yaws
MATE R NAL AN D N EO NATAL H E ALTH CO N D ITI O N S (10)DALY not available in GHE 2017
TOTAL MORTALIT Y (LICS & MICS)

Abortion

30,886Birth asphyxia and birth trauma

726,826

Contraceptive methods

Mortality not applicable

Hypertensive disorders of pregnancy

46,270Maternal haemorrhage

82,447

Maternal sepsis
Neonatal sepsis and infections

17,399342,069

Obstructed labour

23,020

Other neonatal conditions

208,149

Preterm birth complications

768,639

Green text = newly in scope for the 2018 Index
Exclusions: none in 2018
* The 11 communicable diseases with the highest DALY burdens in countries in scope ofthe 2018 Index, plus 10 further diseases and 12 pathogens (grouped under ‘other prioritised antibiotic-resistant bacterial infections’) that have been identified as R&D priorities.
Neglected tropical diseases, while also communicable, are highlighted separately throughout the Index.
** Projects targeting cryptococcal meningitis are included for the analysis of specified
R&D priorities.
*** Includes chlamydia, genital herpes, gonorrhoea, syphilis and trichomoniasis.
† Includes acute hepatitis (B and C) and cirrhosis caused by hepatitis (B and C).

R E FE R E N CE
1 World Health Organization. Global
Health Estimates 2015: Disease
burden by Cause, Age, Sex, by Country
and by Region, 2000-2015. 2016.
http://www.who.int/healthinfo/
global_burden_disease/estimates/en/
index2.html

46

Access to Medicine Foundation

APPE N D IX VICountries in scope of the 2018 Access to Medicine Index
The geographic scope for the 2018 Access to Medicine Index comprises

receive a score of less than 0.6 on the UN Inequality-Adjusted Human

106 countries. All countries defined by the World Bank as low income orDevelopment Index are included.2 This measure takes account of how

lower middle-income are included.1 All countries defined by the UNDP as

health, education and income are distributed within each country. Finally,

either low or medium human development are included.2 This ensures thatall Least Developed Countries (LDCs), as defined by the Committee forseveral central measures of human development (life expectancy, edu-

Development Policy of the UN Economic and Social Council (ECOSOC), arecation and standard of living) are taken into account. All countries that

included.3

Table 6. Countries in scope of the 2018 Access to Medicine Index
Country

Classification

E A ST A S IA & PACI FI C
Cambodia

LMIC

China

HiHDI

Indonesia

LMIC

Kiribati

LMIC

Korea, Dem. People’s Rep.

LIC

El Salvador

LMIC

Chad

LIC

Guatemala

LMIC

Comoros

LIC

GuyanaMHDC

Congo, Dem. Rep.

Haiti

Congo, Rep.

Honduras

LMIC

Côte d’Ivoire

LMIC

MexicoHiHDI

Equatorial Guinea

MHDC

Nicaragua

LMIC

EritreaParaguay

MHDC

Ethiopia

Peru

HiHDI

Gabon

HiHDI

Lao PDR

LMIC

Micronesia, Fed. Sts.

LMIC

Suriname

MongoliaLMIC

M I D D LE E A ST & N O RTH AFR I C AMyanmar

LMIC

Djibouti

LMIC

Papua New Guinea

LMIC

Egypt, Arab Rep.

LMIC

Philippines

LMIC

Iran

HiHDI

Samoa

LMIC

Iraq

MHDC

Solomon Islands

LMIC

Morocco

LMIC

Timor-Leste

LMIC

Palestine, State of/West Bank Gaza LMIC

Thailand

HiHDI

Syrian Arab Republic

LMIC■ Tonga

LMIC■ Tunisia

LMIC

TuvaluLDC

Yemen, Rep.

LMIC

Vanuatu

LMIC

VietnamLMIC

SO UTH A S IAE U RO PE & CE NTR AL A S IA

Afghanistan

LIC

Bangladesh

LMIC

Armenia

LMIC

BhutanLMIC

Kosovo

LMIC

India

LMIC

Kyrgyz Republic

LMIC

Maldives

HiHDI

Moldova

LMIC

Nepal

LIC

Tajikistan

LMIC

Pakistan

LMIC

Turkmenistan

MHDC

Sri Lanka

LMIC

Ukraine

LMIC

Uzbekistan

LMIC

SU B -SAHAR AN AFR I C A

L ATI N AM E R I C A & C AR I B B E AN

Angola

LHDC

Benin

LIC

BelizeHiHDI

Botswana

Bolivia

LMIC

Burkina Faso

LIC

BrazilHiHDI

BurundiLIC

Colombia

HiHDI

Cabo Verde

LMIC

Dominican Republic

HiHDI

Cameroon

LMIC

Ecuador

HiHDI

Central African Republic■ New inclusion
New inclusions: Tonga & Tunisia (LMICs)
Exclusions: Jamaica (HiHDI >0.6),
Panama (HiHDI >0.6), & Georgia (UMIC)R E FE R E N CE S
1 The World Bank. World Bank Country
and Lending Groups – World Bank
Data Help Desk. https://datahelpdesk.
worldbank.org/knowledgebase/arti-

LIC

LIC

MHDC

LIC

CL A SS I FI C AT I O N K E Y
Key
LIC
Low-income country
LMIC Lower middle-income country
LDC
Least Developed Country
LHDC Low Human Development
MHDC Medium Human Development Country
HiHDI High Human Development
Country with high inequality

cles/906519-world-bank-country-andlending-groups. Accessed April 30, 2017.
2 UNDP. Human Development Index.
http://hdr.undp.org/en/composite/
HDI. Accessed April 30, 2017

LMIC

LIC
LIC
MHDC

Gambia, The

LIC

Ghana

LMIC

GuineaLIC

Guinea-Bissau

LIC

Kenya

LMIC

Lesotho

LMIC

Liberia

LIC

Madagascar

LIC

Malawi

LIC

Mali
Mauritania

LIC
LMIC

Mozambique
Namibia

LIC
MHDC

Niger

LIC

Nigeria

LMIC

RwandaSão Tomé and Principe

LIC
LMIC

Senegal

LIC

Sierra Leone

LIC

SomaliaSouth Africa

LIC
MHDC

South Sudan

LIC

Sudan

LMIC

Swaziland

LMIC

Tanzania

LIC

Togo

LIC

UgandaLIC

ZambiaLMIC

Zimbabwe

LIC

Data Source
World BankWorld BankECOSOC (UN Economic and Social Council)
Country UNDP- UN Human Development Index (HDI)
UNDP- UN Human Development Index (HDI)
UNDP- UN Human Development Index (HDI)

3 LDCs at a Glance | Development Policy& Analysis Division. https://www.
un.org/development/desa/dpad/least-developed-country-category/ldcs-ataglance.html.
Accessed April 30, 2017.

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Access to Medicine Index – 10-year analysis
Per disease, the set of priority countries includes five low-income countries

For diseases that were in scope in 2016, the priority countries are(World Bank defined) in order to ensure the Index evaluates pricing strate-unchanged. For diseases that are newly in scope, the most current data

gies directed towards poorer countries.

(WHO, 2015; IHME, 2015; UNDP, 2015) has been used to determine the pri-

Where data gaps exist, countries are automatically included. If a country has

ority countries.

one of the highest DALY burdens for a disease, but its inequality coefficientis unknown or where DALY data for a country does not exist, it is included asa priority country. For example, for Kosovo and Tuvalu, no DALY data is avail-

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Timor Leste
Togo
Tonga
TuvaluUgandaVanuatu
Vietnam
ZambiaZimbabwe

Solomon Islands
SomaliaSouth Africa
South Sudan
Sri Lanka
Sudan
Suriname
Tanzania
Thailand

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Disease/conditionNon-communicableAnxiety disorders
AsthmaBipolar affective disorder
Cancer (all except Kaposi Sarcoma)
Cancer (Kaposi sarcoma)• •Chronic obstructive pulmonary disease
Diabetes mellitus
Epilepsy
Hypertensive heart disease
Ischaemic heart disease
Kidney diseases
Migraine
Schizophrenia
StrokeUnipolar depressive disorders
Communicable
Chlamydia• •Diarrhoeal diseases• •Genital herpes• •Gonorrhoea• •HIV/AIDS• • •Lower respiratory infections• •Malaria• •Measles•
Meningitis• •Pertussis• •Syphilis• •Tetanus•Trichomoniasis• •Tuberculosis•
Viral hepatitis B•
Viral hepatitis C• •Neglected tropical
Buruli ulcer•
Chagas disease•
Chikungunya•••
Dengue•Dracunculiasis
Human African trypanosomiasis• •Leishmaniases• •Leprosy•
Lymphatic filariasis• •Mycetoma, chromoblastomycosis and other deep mycoses
Onchocerciasis•
Rabies•Scabies and other ectoparasites• •Schistosomiasis•
Snakebite envenoming•
Soil-transmitted helminthiases
Trachoma• •Yaws•
Maternal & neonatal
Abortion•
Birth asphyxia and birth trauma• •Contraceptive methods• •Hypertensive disorders of pregnancy•
Maternal haemorrhage•
Maternal sepsis•
Neonatal sepsis and infections•
Obstructed labour•
Other neonatal conditions•
Prematurity and low birth weight
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Iran, Islamic Rep.
Kenya
Kiribati
Korea, Dem. Rep.
KosovoLao PDR
Liberia
Madagascar
Malawi
Maldives
Mali
Mauritania
MexicoMicronesia, Fed. Sts.
Mozambique
Myanmar
Nepal
Niger
Nigeria
PakistanPapua New Guinea
Peru
Philippines
São Tomé & Principe
Senegalable for any diseases in scope.

Access to Medicine Foundation

APPE N D IX VI I

For each disease and condition in the scope of the 2018 Index, the Index has a

Priority countries have been identified as having one of the highest burdens

defined list of ‘priority countries’. These defined lists of countries are used forfor the disease in question, based on WHO data (2012), or IHME data (2015),

certain indicators in the Technical Area Pricing, Manufacturing & Distribution.

and adjusted for multi-dimensional inequality (UNDP, 2012).

Table 7. Priority countries

Afghanistan
AngolaBangladesh
Benin
Bolivia
BrazilBurkina Faso
BurundiCambodia
Cameroon
Central African Rep.
Chad
China
Colombia
Comoros
Congo, Dem. Rep.
Congo, Rep.
Côte d’Ivoire
EcuadorEgypt, Arab Rep.
El Salvador
Equatorial Guinea
Ethiopia
Gabon
Ghana
GuatemalaGuineaHaiti
Honduras
India
Indonesia

Priority countries for the 2018 Access to Medicine Index

This table shows the priority countries identified for each disease/condition – dots denote priority

Disease/condition

country status. Individual priority

Non-communicableAnxiety disorders
AsthmaBipolar affective disorder
Cancer (all except Kaposi Sarcoma)
Cancer (Kaposi sarcoma)
Chronic obstructive pulmonary disease
Diabetes mellitus
Epilepsy
Hypertensive heart disease
Ischaemic heart disease
Kidney diseases
Migraine
Schizophrenia
StrokeUnipolar depressive disorders
Communicable
Chlamydia
Diarrhoeal diseases
Genital herpes
Gonorrhoea
HIV/AIDS
Lower respiratory infections
Malaria
Measles
Meningitis
Pertussis
Syphilis
TetanusTrichomoniasis
Tuberculosis
Viral hepatitis B
Viral hepatitis C
Neglected tropical
Buruli ulcer
Chagas disease
Chikungunya
DengueDracunculiasis
Human African trypanosomiasis
Leishmaniases
Leprosy
Lymphatic filariasis

country lists exist for viral hepatitis(B and C) and the sexually transmitted infections included in the scopeof the 2018 Index (chlamydia, genital herpes, gonorrhoea, syphilis andtrichomoniasis). Countries in thescope of the 2018 Index that havenot been designated as priority
countries for any disease/condition
are not included in this table.
For certain neglected tropical diseases and maternal and neonatal
health conditions, where DALY data
was not available, other criteria
were used. Other criteria were also
used to identify priority countries
for cancer, to ensure alignment
with the inclusion of cancer in the2018 Index. Where DALY data was
not used, Kosovo and Tuvalu are nolonger listed as priority countries,
unless identified based on the alternative criteria noted below.

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Schistosomiasis
Snakebite envenoming• •Soil-transmitted helminthiases•
Trachoma
Yaws•
Maternal & neonatal
Abortion
Birth asphyxia and birth trauma•
Contraceptive methods
Hypertensive disorders of pregnancy• •Maternal haemorrhage•
Maternal sepsis•
Neonatal sepsis and infections• •Obstructed labour• •Other neonatal conditions• •Prematurity and low birth weight
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Access to Medicine Index – 10-year analysis

Disclaimer
The report is intended to be for information
purposes only and is not intended as promotional material in any respect. The material is notintended as an offer or solicitation for the purchase or sale of any financial instrument. The
report is not intended to provide accounting, legal
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Whilst based on information believed to be reliable, no guarantee can be given that it is accurate orcomplete.
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herein has been obtained from sources which we
believe to be reliable, but we do not guarantee its
accuracy or completeness. All opinions expressedherein are subject to change without notice.
© 2019 Access to Medicine Foundation - All rights
reserved
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The Access to Medicine Foundation is independently
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