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2 | 50 YEARS OF GLOBAL HEALTH PROGRESS
FOREWORDS
REFLECTING ON 50 YEARS OF HEALTH PROGRESS
STORIES OF PROGRESS
VACCINES:
Saving, protecting and enhancing lives
HIV/AIDS:
Overcoming one of the worst human pandemics
NEGLECTED TROPICAL DISEASES, MALARIA AND TUBERCULOSIS:
Thinking beyond traditional models
CANCER:
Persisting in research and innovation to deliver better patient outcomes
CARDIOVASCULAR DISEASE:
Innovating for longer and better lives
DIABETES:
Improving quality of life through management of a complex disease
HEPATITIS C:
Discovery to cure in 25 years
PRESENT TO FUTURE
COMMITMENT TO FUTURE PROGRESS
CONTENTS
4
7
23
24
32
42
54
64
72
80
87
98
Contents | 3
4 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Forewords | 5
IAN READ, PFIZER CHAIRMAN & CEO, IFPMA PRESIDENT
A desire for quality healthcare is something that unites all of us because a healthy society is essential to
ongoing global development. It creates stronger families and communities, enables more productive
and innovative workforces, and supports economic growth. That’s why patients and their needs have
been the IFPMA’s ‘north star’ for the last 50 years, and why they will continue to guide our efforts and
allocation of resources into the future.
During my 40 years in the pharmaceutical industry, I have been inspired by the monumental
advancements that have fundamentally altered the healthcare landscape. Today we benefit from
incredible medicines and vaccines that have:
turned fatal illnesses like HIV/AIDs into chronic conditions;
slowed disease progression for rheumatoid arthritis;
cured a disease such as hepatitis C;
helped to prevent previously widespread childhood illnesses such as rotavirus, chicken pox and
pneumococcal disease;
reduced mortality rates for cardiovascular and diabetes patients around the world, and;
revolutionized the care for some cancer patients with personalized therapies that have improved
outcomes and extended life.
While the pharmaceutical industry has been instrumental to this progress, none of it would have been
accomplished without partnership. From patient advocates to our biotech and academic partners to
local governments who help ensure access on the ground, innovation is only as good as the partnership
that supports it.
Last year I was incredibly proud to help launch Access Accelerated, a first-of-its-kind collaboration led by
more than 20 pharmaceutical companies, IFPMA, the World Bank and the Union of International Cancer
Control that is focused on improving access to treatment and care for non-communicable diseases in
low- and middle-income countries. We must continue to lean in to these types of endeavors that help
ensure the life-changing therapies we work so hard to develop reach those who need them most.
The next 50 years promises to deliver an even more exciting era of medical discovery. With more than
7,000 medicines in development around the world, we see the potential for additional breakthroughs
and cures that will transform millions of lives. As we continue on this journey, we must continue to build
trust around the vital role we play in improving global health. This is an obligation that I embrace, and I
know IFPMA will continue to lead us in this effort for years to come.
THOMAS CUENI, IFPMA DIRECTOR GENERAL
Health is vital for societal well-being and progress. While we may despair at health threats in the headlines
– dementia, antimicrobial resistance, pandemics – the truth is that we have lived through 50 years of
health progress.
The research-based biopharmaceutical industry has played its part in a network of research institutes,
government departments and donor organizations not only to deliver prevention and treatment, but to
strengthen health systems and to make universal health coverage a possibility.
Like any wave of progress, there are setbacks and mistakes have been made. One of the greatest was
in 1998 when 39 companies sued the South African government to stop legislation facilitating import of
lower priced medicines. The lawsuit became a symbol of industry’s insensitivity to the plight of patients
in sub-Saharan Africa.1 Profit, via patents and prices, were understood to be barriers to treatment until
the parties reached a then-revolutionary settlement. The court case led to major soul-searching among
pharmaceutical companies and resulted in government and industry working together to find solutions
for the epidemic — a precursor to the norm today.
From suing Nelson Mandela to becoming an active partner in delivering global health solutions, the
industry has evolved and learned. This needs to continue. We need to safeguard the progress made. And
we have to do even more.
We need to do more to reach all patients, regardless of economic circumstances. Investment in health
infrastructure, the ways services are delivered and the role of prevention must be part of the dialogue.
Today, more than half the world’s population have to pay for their medicines out of pocket.2 Improving
access for these people requires navigating a complex value chain. For example, there are often mark-ups
along the supply chain that make essential diabetes treatments unaffordable for many.3
Progress will be hampered as long as universal health coverage is not in place. We worry about the cost of
treatment – and prevention – but rarely tally the cost of not treating.
To do better, go further and faster we’ll need partnerships, of all kinds. More dialogue is a must, and that
we welcome.
As we live longer, the diseases of ageing raise a new set of questions. Climate change and conflict require
new ways of thinking about disease transmission and delivering care. And antimicrobial resistance poses a
real threat to global health security.
The last 50 years has seen companies move to greater global accountability. The next 50 will be about
further delivering on our purpose: putting patients first to deliver better health for everyone, everywhere.
FOREWORDS
6 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 7
REFLECTING ON
50 YEARS OF
GLOBAL HEALTH
PROGRESS
…THE THREATS OF SMALLPOX AND MALARIA WERE TOP OF MIND FOR THE
PUBLIC HEALTH COMMUNITY. The 21st World Health Assembly brought
public health actors together in Buenos Aires to explore the cooperation
with other organizations needed to tackle these challenges. Thanks to
global immunization campaigns, smallpox, one of the most devastating
diseases facing humanity, was eradicated in 1980. Malaria, despite the rate
of new cases falling by over a third between 2000 and 2015,4 remains one
of the world’s biggest killers. Elimination remains high on global public
health agenda.
…STUDIES OF CANCER IN NONHUMAN PRIMATES PROVIDED COMPELLING
NEW EVIDENCE FOR THE EXISTENCE OF A HUMAN CANCER VIRUS.5 Fifty years
later, experts’ understanding of the biology of cancer, and how to diagnose
and treat it, has advanced considerably. Cancer is now known to be a group
of over 100 different and complex diseases, all involving the uncontrolled
division of the body’s cells.6 Cutting-edge research is giving rise to new
treatments in the field of immunotherapy, which harnesses the immune
system to fight cancer from within.7 Improved understanding of cancer-
related genes means that doctors can use personalized medicine to target
the specific mutation that’s driving the cancer.8
IN 1968...
8 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 9
HEALTH ENABLES
HUMAN
DEVELOPMENT
AND PROSPERITY
Health is a most basic and essential asset not limited to any one agenda.
Poor health can limit opportunity and prevent the living of a full and
rewarding life.
Disease reinforces and worsens poverty. By some estimates, from 2011-2025, the
cumulative lost output in low- and middle-income countries (LMICs) from non-
communicable diseases (NCDs) was more than USD 7 trillion, making a powerful
economic case for effective prevention and intervention strategies.9
Individuals, communities, nations, and the global community benefit from good
health. Whether living free of disease through prevention programs, vaccines,
treatments and cures, or enjoying better quality of life living with and managing
diseases, health is the basis upon which successful, flourishing, and sustainable
societies develop. For instance, malaria eradication campaigns in Uganda are
associated with long-term improved education and livelihoods.10 AIDS treatment, care
and prevention has resulted in increased employment in sub-Saharan Africa.11
Health progress drives prosperity, wellbeing, enhanced livelihoods, economic
development, and equality.
SOCIAL IMPACTS OF IMPROVED HEALTH:
A MALARIA FREE AFRICA
WOULD MEAN...
POVERTY REDUCTION
25% MORE INCOME FOR HOUSEHOLDS
LABOUR PRODUCTIVITY
MORE PEOPLE IN PAID WORK
ECONOMIC GROWTH
1.3% ECONOMIC GROWTH (TOURISM, AGRICULTURE)
MORE CHILDREN IN EDUCATION
15% LESS SCHOOL ABSENTEEISM
BETTER SCHOOL PERFORMANCE
60% INCREASE IN SCHOOLCHILDREN LEARNING ABILITY
The last 50
years have seen
an increased
recognition that
access to health
is a right.
Mariângela Simão,
Assistant Director-General for
Access to Medicines, Vaccines and
Pharmaceuticals, World Health
Organization
THE
CONTRIBUTION
OF THE R&D-
BASED BIO-
PHARMACEUTICAL
INDUSTRY TO
GLOBAL HEALTH
PROGRESS
The International Federation of Pharmaceutical Manufacturers &
Associations (IFPMA) was created in 1968 with a mission to bring the
research & development (R&D)-based biopharmaceutical industry and the
health community together to tackle global health challenges. Fifty years
since, significant global health progress has been made.
The R&D-based biopharmaceutical industry (the industry) develops and provides
medicines and vaccines that improve the lives of patients worldwide. It has played
a unique and important part in delivering better health for millions of people across
the world.
Innovation is crucial, and the industry has contributed significantly to understanding
health challenges and developing solutions, investing USD 159 billion in R&D in 2017.12
The industry has learned that global health is about much more than medicines and
vaccines – it requires building and supporting strong health systems, developing
public health education, and strengthening standards and regulations. For innovations
to reach the people who need them, broader progress is needed, such as improved
diagnostic capabilities and better-informed healthcare providers. Partnership,
alongside innovation, is crucial to deliver on progress.
This report seeks to tell seven stories of progress over 50 years. Stories that
showcase advances, partnership, and challenges, and demonstrate not only unfinished
business, but also hope for the future. At the start of each story of progress, the reader
will find a personal story about how lives have been transformed, using the lens of
individual lives to represent the progress made and imagine the future. These are
illustrative only.
VACCINES: Saving, protecting and enhancing lives
HIV/AIDS: Overcoming one of the worst human pandemics
NEGLECTED TROPICAL DISEASE, MALARIA AND TUBERCULOSIS:
Thinking beyond traditional models
CANCER: Persisting in research and innovation to deliver better patient outcomes
CARDIOVASCULAR DISEASE: Innovating for longer and better lives
DIABETES: Improving quality of life through management of a complex disease
HEPATITIS C: Discovery to cure in 25 years
Future trends are also explored, what’s on the horizon and well beyond it.
10 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 11
A UNITED HEALTH ECOSYSTEM
Be it controlling NCDs, precision medicine for cancer or eliminating Neglected Tropical
Diseases (NTDs), health progress has been made possible by researchers in academia
and in industry understanding diseases and developing vaccines and medicines,
regulators incentivizing bringing of drugs to market, NGOs and foundations developing
programs to deliver medicines, financial institutions defining innovative funding
mechanisms, and healthcare providers training health workers. All are connected by
the drive to understand and respond to the needs of the patient.
The cycle of care, from prevention to treatment to quality of life and cure, is both
complex and highly personal. Health is impacted by a range of factors: from security
to sanitation, and from geography to genetics. The research-based biopharmaceutical
industry has played its part by bringing life-saving and life-prolonging medicines
and vaccines to individuals, improving both personal and public health outcomes.
Together, industry and others have reimagined how medicines make the journey from
lab to patient.
The industry’s contribution to global health challenges has evolved over 50 years –
enabled by a strong ethical code of practice. The way companies innovate and partner
with others has delivered numerous health benefits to individuals and societies.
Global health
progress relies
on all actors
sitting around the
table: activists,
governments,
technical groups
and industry.
David Heymann,
Professor, Infectious Disease
Epidemiology, London School
of Hygiene & Tropical Medicine
BUILDING TRUST
The importance of ethics and safety is reflected in the highly regulated
nature of the industry. In the early 20th century the industry was
dubbed ‘the ethical drug industry’, in reference to the safety and efficacy
requirements to which R&D-based biopharmaceutical manufacturers
adhere when bringing products to market.13 Today, ethics refers to much
broader values and principles.
Fairness, honesty, respect, and care are foundational to the success of the industry,
to broader global health progress and to patient outcomes. Progress requires an
environment that encourages risk-taking, exploration and innovation, which is made
possible through trust built upon proactive ethics.
IFPMA’s mission is based on the establishment and promotion of ethical principles for
the industry. The seeds of a shared ethos were planted in 1981, when the first IFPMA
Code of Practice was created as the foundation for global self-regulation.14 Updated
and revised over the decades, the code set the rules-based compliance framework for
clinical research and transparency, fees for services, support for continuing medical
education, training, interactions with patient organizations and physicians, and many
other areas. Many local and regional associations rely on the IFPMA code and guidance
for their own codes of conduct.
Progress was punctuated by other major global milestones: In 1988, the World Health
Organization (WHO) published its Ethical Criteria for Medicinal Drug Promotion;15 in
1996, the first WHO International Summit of National Bioethics Commissions was
held;16 in 2012, the Mexico City Principles for Voluntary Codes of Business Ethics in the
Biopharmaceutical Sector were endorsed by Asia-Pacific Economic Cooperation heads
of state, establishing a comprehensive ethical and integrity framework for the industry.
The current version of the IFPMA Code of Practice expands the scope beyond
marketing practices to cover all interactions with healthcare professionals, medical
institutions and patient organizations. Revision of the Code is ongoing. The revised
Code (effective January 2019) will be more principles-based and incorporate an
expanded understanding of ethics and business integrity.
The industry and partners continue to engage with emerging ethical challenges
presented by collaborative public health programs, including privacy, autonomy, and
equity. For example, the 2017 WHO Guidance on Ethical Issues in Public Health in set
out the first international framework for government, health workers, NGOs, and the
private sector to navigate these challenges.17
FOUNDATIONS
INVESTORS
REGULATORS
PHARMACISTS
INSURERS
HOSPITALS
PATIENTS
NGOs
DEVELOPMENT BANKS
NATIONAL HEALTHCARE SYSTEM
INTERNATIONAL MULTILATERAL INSTITUTIONS
HEALTHCARE PROVIDERS
RESEARCH-BASED BIOPHARMACEUTICAL
MANUFACTURERS
PUBLIC HEALTH DEPARTMENTS
HEALTH TECHNOLOGY PROVIDERS
ACADEMIA AND UNIVERSITIES
HEALTH WORKER ORGANIZATIONS
12 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 13
TRANSFORM AND
INNOVATE
Researching, developing, manufacturing, and improving medicines and
vaccines is at the heart of the industry’s contribution to health.
R&D – and improving the underlying understanding of diseases – is essential. This
has helped to take medicine from treatment based on controlling symptoms to
understanding diseases and causation, enabling more nuanced, targeted, and
systematic approaches across treatment, prevention, and care. For example,
advances in understanding the complex genetic, environment and lifestyle causes
of cardiovascular disease, and the effects of statins and anti-hypertensive drugs, has
paved the way for better and more effective treatment. Fifty years ago, doctors had few
tools to fight cancer, but through incremental advances and occasional breakthroughs,
many cancers that were once uniformly fatal are now generally treatable.
Every treatment or vaccine over the last 50 years has roots in the scientific advances
and breakthroughs made by others before. Industry tirelessly seeks out new
discoveries. Each vaccine or medicine takes years to develop and billions of dollars in
investment,18 with just one in 5,000 drug candidates making it all the way from drug
discovery to market.19 The development of a malaria vaccine is proving to be more
than a 30-year quest.20
Over the last 50 years, biotherapeutics (therapies derived from living organisms) have
become an integral part of modern medicine. Insulin was one of the first medicines
produced using biotechnological methods, and biotechnology is now used for diseases
including cancer, rheumatoid arthritis, heart disease and multiple sclerosis. The
Intellectual
property exists to
encourage innovation
and creativity,
which stimulate
improvements in our
quality of life, spur
economic growth
and address the
radical challenges
we confront such as
climate change, clean
energy, food security
and health.
Francis Gurry,
Director, World Intellectual
Property Organization25
PARTNER AND
ENGAGE
In 1968, actors of a given health system operated in siloes. Since then,
new approaches and more creative partnerships have emerged – whether
delivering healthcare more efficiently, effectively conducting research, or
strengthening the capacity of healthcare systems.26
In recognition of the complementarity of their research objectives and interests – and
to an extent the limits to public funding for research – there has been an upsurge in
academic-industrial collaboration.27 Combined, their unique contributions lead to
greater insights and innovation. Some partnerships rely on close collaboration, such as
research to jointly explore the new frontier of immunotherapy or conducting advanced
clinical trials requiring tight partnership between doctors, patients, and R&D-based
pharmaceutical manufacturers.28
Other collaborations adopt more radical approaches to improve patient outcomes.
For instance, 2000 saw the launch of Gavi, the vaccine alliance, a public–private
partnership committed to increasing access to immunization in poor countries.29 In
2002, The Global Fund was developed as a unique financing partnership between
governments, civil society, companies and people affected by the diseases they seek
to end: AIDS, TB and malaria.30 The London Declaration on Neglected Tropical Diseases
introduction of recombinant human erythropoietin into clinical practice in the 1980s
was a major breakthrough in the treatment of the anemia of patients with chronic
kidney disease.21 Understanding of biologics is crucial to the emerging practice of gene
therapy, whereby disease is treated or prevented through the addition or modification
of DNA. Decades in the making - first tested on humans in 1990, and informed by the
completion of the Human Genome Project in 1993 - gene therapy enables a deeper,
personalized and more precise approach to health. For example, gene therapy is used
to treat particular types of cancers by targeting specific cell mutations as well as curing
sickle cell disease by modifying stem cells.22
Intellectual property (IP) protection, typically granted in the form of patents and data
exclusivity, incentivizes investments to make advances and enables companies to
re-invest in their R&D capability. IP is a critical element of the innovation ecosystem,
alongside a science-based regulatory system and appropriate rewards and incentives.
IP can also help to create certainty in the overall business climate to usher in future
overall investments (including beyond the R&D-based biopharmaceutical industry).
This competitive research model has delivered many successes in previous decades,23
with industry and partners continuing to learn how to operate more effectively and
collaborate.24 IP has also contributed to the creation of the generics manufacturing
industry, enabling the R&D-based companies to focus on just that, R&D. IP has given
the industry the necessary confidence to invest in markets, accelerate the adoption of
technology, and increase patient access to a wider choice of medicines.
14 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 15
agreed in 2012, the largest mass drug administration in history, commits companies
as well as WHO, foundations, and others to work cooperatively to maintain and
expand drug donation programs to meet demand through 2020.31 Access Accelerated,
founded in 2017, brings together 23 biopharmaceutical companies, teaming up with
the World Bank, Union of International Cancer Control (UICC), and Boston University
to demonstrate that significant progress can be made in addressing the NCD epidemic
through cooperative action.32
Partnerships are crucial to improving patient access through strengthening health
systems: 90% of ‘essential’ medicines are generics, and yet not all reach patients.33
Without access to prevention support and quality health services, global health
progress will be uneven. Achieving universal health coverage (UHC) means ensuring all
people receive essential health care without risking financial hardship.
Achieving UHC is one of the targets under the Sustainable Development Goals (SDGs).
Partnerships contribute to this by training healthcare workers, building infrastructure
such as testing facilities, and delivering education to schools and community
organizations to promote prevention. For instance, UHC2030 brings together diverse
stakeholders to advocate for political commitment, strengthen dialogue and facilitate
knowledge sharing in order to strengthen health systems.34
These close partnerships could hardly have been imagined in previous decades.
If countries invest
in making progress
towards universal
health coverage, they
lay the foundation
for progress
towards ending
poverty, improving
gender equality,
decent work and
economic growth,
and more.
Tedros Adhanom Ghebreyesus,
Director General, WHO35
Progress is often depicted in terms of blockbuster headlines and global statistics. But it is important to recognize the people
behind the headlines: patients, researchers, doctors, health workers who have contributed to progress, often overcoming
huge odds to do so. Consider the tenacity of researchers such as Dr Joe Cohen, who worked as part of a team for almost
three decades to develop the first malaria vaccine,36 and Maysoun Shomali, who has dedicated 20 years of her career to
developing therapies for breast cancers resistant to other treatments.37
Faces of progress...
16 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 17
50 YEARS OF GLOBAL
HEALTH PROGRESS
TRANSFORM AND INNOVATE
PARTNER AND ENGAGE
1968: Studies of cancer in nonhuman
primates provided compelling new evidence
that the Epstein-Barr virus, discovered four
years earlier, can lead to cancer in humans.38
1974: Expanded Programme on
Immunization (EPI) established to
develop and expand immunization
programs, initially targeting diphtheria,
whooping cough, tetanus, measles,
poliomyelitis, and tuberculosis,
towards the goal of providing universal
immunization for all children by 1990.40
2000: Adoption of the
Millennium Development Goals
(MDGs), a blueprint for meeting
the needs of the world’s poorest
with a focus on child mortality,
maternal health, HIV/AIDS,
malaria, and other diseases.53
1988: WHO publishes Ethical
Criteria for Medicinal Drug
Promotion, the first frame of
reference for judging proper
behavior in drug promotion.49
1988: Establishment of the
Global Polio Eradication Initiative,
which has contributed to the
99.9% reduction in global
incidence of polio.50
2000: Launch of Gavi,
the Vaccine Alliance, a
public–private global health
partnership committed
to increasing access to
immunization in poor
countries.54
1980: Worldwide vaccination programs
result in the eradication of smallpox, a
contagious virus with no known cure which
killed an estimated 300-500 million people
in the 20th century.43
1985: First manufactured insulin pen
launched, offering greater ease of use
and accuracy for patients versus the vial-
and-syringe method of insulin delivery.45
1981: First IFPMA Code of
Practice developed as the
foundation for industry’s global
self-regulation, setting ethical
and professional standards.44
2015: Sustainable Development
Goals (SDGs) adopted by world
leaders, setting out a global
sustainable development
agenda which emphasizes
collaboration across countries,
actors, and sectors for a
wide array of development
outcomes, health and wellbeing
prime among them.60
1977: The first angiotensin-
converting-enzyme (ACE)
inhibitor developed for the
treatment of hypertension,
is discovered.41
1971: Measles, mumps and rubella
(MMR) vaccine approved, providing
protection against three highly infectious
illnesses at the same time, via one shot.39
1987: The first antiretroviral (ARV)
drug is approved by the US FDA as
treatment for HIV, beginning a new
era of highly active ARV treatment.46
1996: A new class of combined
antiretroviral treatment, HAART, is
developed, leading to a 50% drop in
the number of AIDS-related deaths in
the U.S. and Europe in three years.52
2012: Signing of the London
Declaration on Neglected
Tropical Diseases: 14 billion
treatments pledged and
commitment to control,
eliminate or eradicate 10
debilitating NTDs responsible
for more than 90% of the
global neglected diseases
burden by 2020.57
2006: Human papilloma virus (HPV)
vaccine approved, which protects
from cervical cancer, a common
cancer among women under 35.55
2017: Launch of Access
Accelerated with 23 global
biopharmaceutical companies,
the World Bank, the Union of
International Cancer Control
(UICC), and Boston University
to combat NCDs globally.61
1987: First statin approved,
a key step in reducing
cardiovascular disease.48
2014: Development
of CAR-T cell
therapies -
programmed T cells
aim to hunt, bind
to, and eliminate
cancer cells.59
1987: Ivermectin developed
for parasitic infections in
animals and it is later found
an effective treatment for
river blindness and lymphatic
filariasis in humans, two
debilitating diseases which
affect the world’s poorest
populations.47
1989: Biotechnology
scientists identify the
previously unidentified virus
Hepatitis C, which is now
known to affect about 2% of
the world’s population.51
2011: Approval of direct-
acting antivirals (DAAs), called
protease inhibitors, which,
combined with interferon and
ribavirin, improve cure rates
among patients with the most
common hepatitis C genotype
to 70%.56
2012: First approval of
a TB drug in 40 years,
bedaquiline, unique in
that it interferes with
the enzyme required by
bacteria to replicate.58
2018: RTS,S malaria
vaccine introduced in pilot
immunization programs in
three African countries –
Kenya, Malawi, and Ghana.62
1978: First synthetic ‘human’ insulin
produced, the first human protein to be
manufactured through biotechnology,
enabling patients to avoid the allergic
reactions that insulin from cattle and
pigs could cause.42
18 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 19
BUILDING ON
SUCCESSES AND
SETBACKS
Progress is rarely a steady, straight line. Innovation tends to be messy,
unpredictable, and risky.
For instance, ivermectin was originally developed as a veterinary drug and was
subsequently found to be ideal for combatting two of the world’s most devastating
NTDs, river blindness and lymphatic filariasis in humans. The pneumococcal disease
conjugate vaccine from 1977 that protects against pneumonia was found to be
unsuccessful in children. Decades of development finally brought the breakthrough
PCV7 vaccine licensed in 2000.
Demographic shifts are altering disease burden and complicating progress: movement
of people from rural to urban areas and the growth of the middle class is associated
with reductions in infectious diseases, maternal and child illness, and malnutrition
while more young and middle-aged adults are suffering and dying from NCDs.63
Persistence and perseverance across the ecosystem have underpinned progress.
The industry, like all actors in global health, has needed to play the long game, and
breakthroughs have resulted from the work of many. For example, tackling the
global HIV/AIDS epidemic has relied on resolution to innovate and iteratively improve
antiretroviral treatments, as well as diligent research towards a vaccine.
Mistakes have been made. The industry has learned from these in order to move
forward. This includes the thalidomide tragedy in the 1960s, which resulted in more
structured drug regulations and the development of applications of the drug for
treatment of leprosy and certain cancers.64
The arc of progress since 1968 is evident when considering patient safety and
medicine quality – for instance, the raising of standards through post-marketing
safety surveillance (pharmacovigilance). The number of national pharmacovigilance
centers has increased from just 10 in 1968 to 67 by 2002,65 and legislation has been
passed in many geographies to ensure safe monitoring of medicines.66 Approaches
to pharmacovigilance have evolved from reacting to negative drug responses to
proactively addressing product safety throughout the clinical development process,
before and after approval. Recent product recalls emphasize the need for regulators
and companies to continue pharmacovigilance efforts through the generation and
capture of quality data, improved tools for analysis, and consistent communication of
benefits and risks.67
Advancing patient safety relies on combatting substandard and falsified products,
which damage patients and entire health systems.68 Vulnerable communities are most
affected, with one in 10 medical products circulating in LMICs being substandard or
falsified.69 Industry, multilaterals, and governments work to combat substandard and
falsified products through regulation and governance, building tools and technical
capacity to enforce quality standards in the manufacturing supply chain. For example,
R&D-based pharmaceutical manufacturers are teaming up with organizations offering
mobile-based medicine verification schemes for consumers.70
Patient safety and medicine quality must keep up with the evolution and globalization
of pharmaceutical supply chains, whereby products are manufactured, packaged,
and assembled in different countries, online pharmacies are growing rapidly, and new
business models have increasing operational complexity.
20 | 50 YEARS OF GLOBAL HEALTH PROGRESS
ENSURE HEALTHY LIVES AND
PROMOTE WELL-BEING FOR ALL
AT ALL AGES
Reflecting on 50 years of health progress | 21
PREVENTING DISEASE THROUGH
SAFE WATER AND SANITATION
FOR ALL
PROMOTING SUSTAINABLE
ENERGY FOR HEALTHY HOMES
AND LIVES
SUPPORTING HIGH-QUALITY
EDUCATION FOR ALL TO IMPROVE
HEALTH AND EQUALITY
FIGHTING GENDER INEQUITIES,
INCLUDING VIOLENCE AGAINST
WOMEN
PROMOTING HEALTH
EMPLOYMENT AS A DRIVER OF
INCLUSIVE ECONOMIC GROWTH
ENSURING EQUITABLE ACCESS
TO HEALTH SERVICES THROUGH
UNIVERSAL HEALTH COVERAGE
BASED ON STRONGER PRIMARY
CARE
PROMOTING RESPONSIBLE
CONSUMPTION OF MEDICINES
TO COMBAT ANTIBIOTIC
RESISTANCE
SUPPORTING THE RESTORATION
OF FISH STOCKS TO IMPROVE
SAFE AND DIVERSIFIED HEALTHY
DIETS
EMPOWERING STRONG LOCAL
INSTITUTIONS TO DEVELOP,
IMPLEMENT, MONITOR AND
ACCOUNT FOR AMBITIONS
NATIONAL SDG RESPONSES
PROMOTING NATIONAL R&D
CAPACITY AND MANUFACTURING
OF AFFORDABLE ESSENTIAL
MEDICAL PRODUCTS
FOSTERING HEALTHIER CITIES
THROUGH URBAN PLANNING FOR
CLEANER AIR AND SAFER AND
MORE ACTIVE LIVING
PROTECTING HEALTH FROM
CLIMATE RISKS, AND PROMOTING
HEALTH THROUGH LOW-CARBON
DEVELOPMENT
PROMOTING HEALTH AND
PREVENTING DISEASE
THROUGH HEALTHY NATURAL
ENVIRONMENTS
MOBILIZING PARTNERS TO
MONITOR AND ATTAIN THE
HEALTH-RELATED SDGS
PRIORITIZING THE HEALTH
NEEDS OF THE POOR
ADDRESSING THE CAUSES AND
CONSEQUENCES OF ALL FORMS OF
MALNUTRITION
In tackling the
health care
challenges of the
developing world,
we need to leave our
own ‘comfort zone’
and collaborate
with others, be it in
engaging on health
systems reform or
in partnerships to
bring medicines to
people in resource-
constrained settings.
Thomas Cueni,
Director General, IFPMA73
This 50 year milestone is as much an opportunity to look ahead as it is
to reflect back on progress. Whatever the future may bring – as we live
longer lives, as technology advances, and the world changes in ways we
can only partially understand (see ‘Present to Future’ section) – the world
depends on improved global health to continue to promote prosperity and
enable human progress.
The SDGs, launched in 2015, give greater visibility of the role of the private sector
in a shared societal agenda and emphasize the importance of collaboration across
countries, actors, and sectors for a wider array of development outcomes - health and
wellbeing prime among them. Meeting the highly ambitious 17 goals and 169 targets
by 2030 will require further scientific breakthroughs and strategic innovations.71
Health underpins the common view of the future we want, as articulated in the SDG
agenda for 2030, not only SDG 3 for good health and wellbeing. The R&D-based
biopharmaceutical industry is no stranger to multi-stakeholder partnership and looks
forward to continuing to deliver positive outcomes in collaboration.72
Based on WHO's 'Health in the SDG era' graphic
IN PURSUIT OF CONTINUED,
ACCELERATED PROGRESS
LOOKING AHEAD:
22 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF
PROGRESS
UNIVERSAL HEALTH COVERAGE:
THE FOUNDATION FOR PROGRESS
At the core of SDG 3 is the powerful concept of universal health coverage
(UHC): that patients, wherever they live, should be able to receive the
quality health services they need without suffering financial hardship.
Following a coordinated effort by the global health community in 2016, there is now a
global agreement on how progress towards UHC will be measured. The success of any
health initiative depends on achieving UHC.
Likewise, there is increasing recognition that strong, sound, financially sustainable
health systems generate a healthier and more productive society. One that can access
education and gain skills, enabling their participation in a dynamic global economy.
Health, in this sense, brings wealth.
UHC is also an opportunity for the R&D-based biopharmaceutical industry to redouble
its strong commitment to invest in it. Such investment can be multifaceted:
By discovering new medicines and vaccines to prevent and treat diseases;
By fostering innovation across the continuum of medical education, prevention,
treatment and care, including expanding patient access to quality medicines and
vaccines through innovative solutions;
By sharing its expertise and experience in technology solutions, training of health care
workers, human resources management, logistics and supply chain management,
health literacy, media and communications; and
By participating in multi-sectoral partnerships that encompass actors working on the
environment, transportation, information and communications, and education to
support countries to strengthen health systems, create innovative finance models and
build the bodies of evidence that will be crucial to implementing UHC.
Thanks to global efforts and a collective push, major progress on health service
coverage can be seen, especially in Africa.
Developing more public-private collaborations will enable healthcare companies to
deliver products and services more efficiently, and can accelerate progress towards
reaching UHC.
In the 21st century
people’s expectations
everywhere for
their health are
increasingly equal,
and as such, UHC
is an investment
that allows each
citizen access to
good quality services
without financial
compromise.
Tim Evans,
World Bank Group
24 | 50 YEARS OF GLOBAL HEALTH PROGRESS
VACCINES
Saving, protecting and enhancing lives
STORIES OF PROGRESS:
STORIES OF PROGRESS: Vaccines | 25
In 1796, Edward Jenner carried out what would become one of the most famous medical experiments
when he vaccinated James Phipps against smallpox. Today, vaccines are viewed as one of the most
effective and cost efficient medical technologies ever developed,74 resulting in the control, elimination
or near elimination of numerous infectious diseases.
Immunization saves between two and three million children’s lives per year.75 The continuing development of vaccine
science and growing partnerships for delivery have enabled the benefits of immunization to be realized across the globe,
dramatically decreasing the spread of infectious disease and supporting efforts to achieve global health security. However,
one in five children still miss out on routine life-saving immunization.76
SARA RECEIVES
VACCINATIONS
As a young child, Sara receives routine vaccinations:
polio, meningitis, rotavirus, hepatitis A, hepatitis B,
pneumonia, TDAP (typhoid, diphtheria and pertussis),
MMR (measles, mumps and rubella), BCG, yellow fever,
and Hib. She receives the HPV vaccine when she is 11.
In 1968, Sara would have received far fewer vaccines:
smallpox, polio, measles, mumps and DTP (for
diphtheria, tetanus and pertussis).
Sara hopes her children and grandchildren will benefit
from hoped-for vaccines to protect them from malaria
and HIV/AIDS.
Present Day...
Fifty years ago...
In the future...
TRANSFORMING LIVES
26 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: Vaccines | 27
50 YEARS OF
VACCINES
Research and development is, and always has been, at the heart of immunization
success. Germ theory – the identification of organisms that cause disease - has
been central to vaccine advances in the second half of the 20th century,77 with the
development of the first vaccines for smallpox, diphtheria, tetanus, anthrax, cholera,
plague, typhoid, TB, and polio.
As vaccine science continued to develop during the 20th century, improvements in
cell culture technologies welcomed in a second golden age of vaccines. Scientific
innovations at this time led to the creation of vaccines for measles, mumps, rubella,
hepatitis A and B, chicken pox, pneumonia, and influenza. Notable is the work of
Maurice Hilleman, who developed over 40 vaccines and eight of the 14 routinely
recommended today.78 Hilleman is credited with saving more lives than any other
medical scientist in the 20th century across his career.
Innovation also led to improved vaccine delivery technologies which have helped
reduce the global infectious disease burden. For example, advances in vaccine
thermostability has reduced the need for refrigeration and increased access to vaccines
globally.79 Development of delivery techniques such as microneedles and intradermal
devices has enhanced vaccine effectiveness and make it easier for health workers to
administer immunizations. Combination vaccines have been developed to reduce the
number of shots a child needs while maintaining the same level of protection, such as
the MMR combination vaccine licensed in 1971.80
In the 50 years since IFPMA was founded, smallpox has been eradicated and polio
nearly so across most of the world. Great strides have been made in reducing measles
infections. To date, vaccines have been developed to prevent 26 diseases, including
more recently developed vaccines for hepatitis B, hepatitis A, HPV and meningococcal
group B.81 IFPMA members have been at the forefront of science to achieve these
developments.
The eradication of
smallpox uniquely
combined product
innovation, process
innovation and policy
innovation – with
an unprecedented
level of stakeholder
collaboration.
Mariângela Simão,
WHO
1971: Measles, Mumps and Rubella vaccine approved, providing protection against
three highly infectious illnesses at the same time, via one shot.82
1974: The Expanded Programme on Immunization is established to develop and
expand immunization programs, initially targeting diphtheria, whooping cough,
tetanus, measles, poliomyelitis, and TB, towards the goal of providing universal
immunization for all children by 1990.83
1980: Worldwide vaccination programs result in the eradication of smallpox, a
contagious virus with no known cure, which killed an estimated 300-500 million people
in the 20th century.84
1986: Hepatitis B recombinant vaccine is licensed.85
1988: Establishment of the Global Polio Eradication Initiative, which has contributed
to the 99.9% reduction in global incidence of polio.86
1995: Hepatitis A vaccine is licensed.87
2000: Launch of Gavi, the Vaccine Alliance, a public–private global health partnership
committed to increasing access to immunization in poor countries.88
2000: Pneumococcal conjugate vaccine PCV7 is licensed, tackling one of the biggest
killers of children under five – pneumonia. This breakthrough vaccine improves earlier
versions that did not generate consistent immunity in children.89
2006: HPV vaccine approved in the US, providing protection from cervical cancer, a
common cancer among women under 35.90
2006: Approval of vaccine for rotavirus, the most common cause of diarrheal disease
among infants and young children.91
2012: Global Vaccine Action Plan adopted by World Health Assembly as a roadmap to
prevent millions of deaths by 2020 through equitable access to vaccines.92
2015: First dengue vaccine licenses obtained.93
2015: RTS,S vaccine became the first vaccine candidate to get approved for use
against malaria.94
2016: Americas region is the first region in the world to be declared measles-free.95
2017: The Coalition for Epidemic Preparedness Innovations launched to finance and
coordinate the development of new vaccines to prevent and contain infectious disease
epidemics and contribute to global health security.96
KEY MILESTONES
28 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: Vaccines | 29
ACHIEVING
ERADICATION OF
POLIO
The development of polio vaccines and the effort put into eradicating the disease
shows how innovations and partnerships can come together to eliminate a disease
across much of the world.
Polio is caused by a virus that reproduces in the gut from where it can spread to the
nervous system. In the pre-vaccine era, when poliovirus was the leading cause of
permanent disability in children, almost all children became infected by poliovirus,
with one in 200 susceptible individuals developing the paralyzing poliomyelitis.97
With effective vaccines available, health policymakers began to look at eradicating
polio.98 In 1974, the World Health Assembly recommended the oral polio vaccine
(OPV) as the vaccine of choice.99 In 1985, Rotary International launched their PolioPlus
program financially supporting the public health ambition to rid the world of polio.100
In 1988 the 41st World Health Assembly adopted a resolution for the worldwide
eradication of polio.101 The Global Polio Eradication Initiative (GPEI) brought national
governments, WHO, Rotary International, the US Centers for Disease Control and
Prevention, UNICEF and a number of key partners such as the Bill & Melinda Gates
Foundation (BMGF) together.102 Industry contribution, led by Sanofi Pasteur providing
almost 10 billion doses of OPV worldwide, including more than six billion doses to
UNICEF, has proven to be instrumental in taking polio to the brink of eradication. Since
GPEI was launched, the number of polio cases has fallen by over 99.9%.103 In 1994,
the Americas were certified polio-free, followed by the WHO Western Pacific Region
in 2000, the WHO European Region in 2002, and the WHO South-East Asia region in
2014.104 Poliovirus transmission levels are currently at the lowest point in history and
eradication is a realistic expectation.105
The infrastructure introduced to enable mass immunization has broader impacts in
strengthening delivery of health services. For example, in Nigeria medicines for malaria
are being delivered on a mass scale as part of the infrastructure for delivering the polio
vaccine.106 Evolving and strengthening this infrastructure can support access to a wider
range of medicines and vaccinations.
A SHIFT TO
LIFE COURSE
VACCINATION
- HUMAN
PAPILLOMA
VIRUS VACCINE
A more recent example of vaccine development is the development of the first ever
vaccine targeting cancer. The WHO defines the preventative, life-course approach as
one that aims at increasing effectiveness of interventions throughout a person’s life. It
addresses the causes and not the consequences of ill health at all stages of life.
As NCDs such as cancer, diabetes and Alzheimer’s disease become epidemic in the
ageing populations of both the developed and developing world, research is looking at
vaccines, which have previously been mainly seen as a solution to infectious diseases
for children. This perception can be damaging: In the US, more adults die of vaccine
preventable illnesses than children. Innovation in the industry is shifting to life-course
vaccines to target people’s needs throughout their life as and when they need them. A
life-course approach to immunization can help reduce disease burden, relieve pressure
on caregivers and allow older populations to not only benefit from the preventative
power of vaccines, but remain active members of the community.
The HPV vaccine provides the first great example of a shift in research and
development towards life-course vaccines. In 1976, Harald zur Hausen made the
connection between cervical cancers and infection with HPV (work for which he shared
a Nobel Prize in Medicine in 2008).107 It is estimated that cervical cancer affects more
than 500,000 women each year, 80% of whom live in the developing world.108 Screening
programs have been effective in early stage diagnosis to catch and treat cervical cancer,
but they have been less widely implemented in LMICs than in developed economies.
The HPV vaccine is ideally given to boys and girls at a young age to prevent cancer. In
2006, a quadrivalent (four-strain) vaccine was licensed followed by a bivalent (two-
strain) vaccine for girls in 2007 and in 2014 a nine-strain HPV vaccine was approved.
The impact of immunization on cervical and other HPV-related cancers will be evident
in the next decades – but a marked decrease in HPV infections, precancerous lesions
and genital warts is already dramatic in the vaccinated populations.109
30 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: Vaccines | 31
FUTURE
INNOVATION
Industry is committed to driving vaccine innovation to help achieve global health
security, prevent unnecessary disease and to address challenges presented by ageing
populations. Together, vaccine development and immunization programs can strive to
eliminate, contain, and prevent infectious diseases and NCDs.
The next phase of innovation will be driven by a greater understanding of pathogens and
immune responses as well as data and technology-led developments in research.
Smarter technologies will also play a big role in the development of vaccines in the
future. For example, vaccines that utilize messenger RNA (mRNA) are developing
quickly. They work by providing instructions to our cells to make whatever we need to
prevent disease, including antibodies. mRNA vaccines offer prompt and flexible design,
cost-optimized production, and safer administration.117 Other projects are underway to
bring vaccine adjuvants – which can improve vaccine efficacy by aiding its effect on the
immune system – to market.118 Today there are 264 vaccines in the pipeline in the US
alone, including a mix of life-course and infectious disease vaccines.119
Vaccines can also play a vital role in the fight against AMR, reducing infections and
limiting their transition, enabling less reliance on antibiotics as well as reducing the
inappropriate use of antibiotics for viral infections.
Vaccines remain the safest, most effective, and cost-effective medical technology ever
developed. They are deployed globally to all, regardless of gender or location. Global
vaccination programs have introduced key infrastructure to improve broader access to
medicines in the developing world. Vaccines also offer alternative solutions to life-course
diseases and an ageing population.
The Expanded Programme on Immunization initiated by the WHO in 1974 with the goal
of making vaccines available to all children.112
The founding of Gavi in 2000 by the BMGF, the World Bank, WHO, UNICEF and vaccine
manufacturers including Sanofi Pasteur, Pfizer, MSD, GSK, Novartis and Janssen.113
The creation of the Developing Countries Vaccine Manufacturers Network in 2000 with
the aim of protecting all people against infectious diseases by increasing the quality
and affordability of vaccines for all.114
The Global Vaccine Action Plan’s Decade of Vaccines, 2011-2020, endorsed by 194
member states with the aim of delivering universal access to immunization regardless
of where children were born, who they are or where they live.115
The Humanitarian Mechanism, launched in 2017 by WHO, UNICEF, Médecins Sans
Frontières and Save the Children, to enhance access to vaccinations for traditionally
‘left behind’ populations such as refugees and displaced people.116
IMMUNIZATION
FOR ALL
Today, vaccines are a key part of the ambition for UHC and the UN SDGs to help end
poverty, protect the planet, and ensure prosperity for all. Vaccines offer the opportunity
of truly global and equitable healthcare.
The resurgence of measles in some parts of the world today serves as a reminder of the
potential impacts of infectious diseases, which are easily preventable with vaccines.110
Immunization not only saves lives and improves health, it also unlocks the potential of
the community. A vaccinated community is healthier, stronger, and more productive.
Vaccination reduces the global burden of infectious disease; not only by protecting
vaccinated individuals, but by indirectly protecting unvaccinated individuals through
community protection or ‘herd protection’.111
However, without successful immunization programs and collaborations, the benefits
of vaccine innovation will not be fully realized. The new programmatic approach to
developing the recent dengue and malaria vaccines shows that, more than ever before,
industry needs to work hand-in-hand with governments, civil society, and global health
policymakers to enable the benefits of vaccination to extend to all. Several landmark
initiatives demonstrate the potential for such collaboration and impact, including:
Investment in
vaccines is critical
to address AMR.
Vaccines can prevent
illness and death
and eliminate the
need for the use of
antimicrobials in the
first place.
David Heymann,
London School of Hygiene
and Tropical Medicine
32 | 50 YEARS OF GLOBAL HEALTH PROGRESS
HIV/AIDS
Overcoming one of the worst
human pandemics
STORIES OF PROGRESS:
It has been 36 years since the world was first introduced to the term AIDS. With the first reported cases
of HIV/AIDS (human Immunodeficiency virus / acquired immune deficiency syndrome) in the 1980s, the
world faced a new and unknown virus.
The epidemic was defined by fear and death as HIV infection rates and AIDS-related deaths grew throughout the 1980s
and 1990s.120 As the global response ramped up, thanks to scientific advances and programs targeting those in need, 2005
marked a turning point as the number of AIDS related deaths peaked.121 Although patients in developed countries have
access to treatment and can expect near-normal lifespans, HIV/AIDS remains a particularly heavy burden in sub-Saharan
Africa, where it is the leading cause of death for adults.122
STORIES OF PROGRESS: HIV/AIDS | 33
ZAIN’S HIV/AIDS STORY
Zain was diagnosed, is able to manage his illness and
can expect a near normal lifespan, thanks to starting
combined antiretroviral (ARV) treatment early in the
course of the infection. He now takes a one-a-day pill.
In 1988, Zain would have had a life expectancy of just one
year from diagnosis and would not have had access to
combined ARV treatment.
Zain hopes a vaccine will prevent people like him being
infected with HIV and halt the spread of AIDS.
Present Day...
THIRTY years ago...
In the future...
TRANSFORMING LIVES
34 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: HIV/AIDS | 35
1982: The term AIDS is first used; tracking of disease begins in US.126
The HIV/AIDS epidemic is defined by scientific breakthroughs as well as transformative
partnerships and initiatives that controlled the epidemic through generations:
1984: The retrovirus that causes AIDS is identified.127
1987: The first antiretroviral (ARV) drug, azidothymidine, is approved by the FDA as
treatment for HIV.128
1996: 1996: Combined multi-drug ARV treatment is introduced, changing the course of
the HIV epidemic.129
1996: The Joint UN Programme on HIV and AIDS (UNAIDS) is established, serving as
the main advocate for accelerated global action on the epidemic.130
2001: UN Declaration of Commitment on HIV/AIDS calls for the respect of human
rights of people living with HIV.131
2002: The Global Fund to fight AIDS, Tuberculosis and Malaria (The Global Fund) is set
up, a public-private partnership to attract resources to fund prevention and treatment
in resources limited settings.132
2002: FDA approval of the first rapid home-use HIV testing kit providing results in
twenty minutes.133
2003: Launch of The President’s Emergency Plan for AIDS Relief, a US government
initiative to address the global HIV/AIDS epidemic.134
2003: Approval of new anti-HIV drug, enfuvirtide or T-20, the first in a new class of
drugs designed to prevent entry of the virus into human cells.135
KEY MILESTONES
Breakthrough innovations, notably antiretroviral (ARV) therapy, have had significant impact on confronting the epidemic
and enabling those infected with HIV to live long and healthy lives. Equally important have been partnerships to deliver
access to treatment, care, and education to those most affected around the world.
Patients diagnosed with AIDS in 1990 could expect to live only months, during which time they would be likely to contract a
number of other infections. Today, an HIV infected patient who receives ARV therapy may expect to live a normal lifespan.123
In fact, the HIV/AIDS death rate has dropped by 85% since 1991.124
The global response delivering improved patient outcomes for those with HIV/AIDS has also strengthened healthcare
systems and access more broadly, with knock-on effects of improving gender equality.
2006: The first one-a-day pill to treat HIV is approved in the US.136
2010: Medicines Patent Pool is founded, the first voluntary licensing and patent
pooling mechanism in public health, aiming to improve access to affordable and
appropriate HIV, hepatitis C and TB medicines.137
2012: The first medication to protect those who do not have HIV from infection, called
pre-exposure prophylaxis, is approved.138
2015: UNAIDS announces that the MDG target of 15 million people on life-saving HIV
treatment by 2015 has been met 9 months ahead of schedule.139
2015: Launch of the SDGs, which include a target to end the AIDS epidemic by 2030.140
AIDS RELATED DEATHS PER YEAR
NEW HIV INFECTIONS PER YEAR125
1990
1995
2000
2005
2010
2016
0
1m
2m
3m
4m
36 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: HIV/AIDS | 37
RESEARCH COLLABORATION
Partnerships have played a crucial role in supporting R&D advances for the treatment
of HIV/AIDS, bringing together academia, governments, and industry. The National
Cooperative Drug Discovery Group Programme for the Treatment of AIDS (NCDDG-
AIDS) is a collaboration platform established early in the epidemic. The AIDS Clinical
Trial Group (ACTG) supports clinical trials and laboratory studies in order to set
standards of care for HIV infection.148
TREATMENT FOR VULNERABLE GROUPS
A key challenge has been the development of pediatric ARV formulations. Initiatives
like the Pediatric HIV treatment Initiative (PHTI), The Global Accelerator for Pediatric
formulations (GAP-f) and the Collaborative Initiative for Pediatric HIV Education and
Research (Cipher) aim to close the treatment gap between adults and children.
In 2011, the Global Plan to eliminate new HIV infections among children by 2015 was
launched by organizations convened by the President’s Emergency Plan for AIDS Relief
and The Joint UN Programme on HIV and AIDS (UNAIDS).149 As part of this, companies
pledged funding for programs to ensure access to treatment for pregnant women and
maternal and family planning health services. Pledges included Johnson & Johnson
at USD 15 million,150 and more recently AstraZeneca with USD 10 million over five years
to cover HIV/AIDS.151 The number of children acquiring HIV infection declined from
360,000 in 2009152 to 160,000 in 2016.153
Mother to child transmission is preventable and has been virtually eliminated in the
developed world.154 Saving Mothers Giving Life155 - a public-private partnership between
USAID, MSD, and others - makes strategic investments to reduce deaths of mothers
with HIV. The International Partnerships for Microbicides, a partnership between civil
society, research-based pharmaceutical manufacturers, and research centers develops
HIV prevention products and other sexual and reproductive health technologies for
women with a focus on microbicides.156 Other public-private partnerships include
between ViiV Healthcare and the Pediatric European Network for the Treatment of
AIDS, which develops treatment strategies for children living with HIV including project
EPIICAL, a predictive in vitro platform to treat HIV-infected children, as well as those to
support research and build research and healthcare capacity in pediatrics HIV with the
Clinton Health Access Initiative, Amfar TREAT Asia and the International AIDS Society.157
People practicing intravenous drug use (IDU) remain disproportionately affected
by HIV, accounting for one in 10 new HIV infections worldwide.158 Harm reduction
strategies target IDU by focusing on explicit and peer-based education about the risk
of HIV from sharing injecting equipment, needle syringe programs, drug treatment
(especially opiate substitution treatment), and community development.
PARTNERING FOR DELIVERY
Diagnosis is as important to effective HIV/AIDS treatment as medicines. Currently, only
60% of people with HIV know their status.159 AmpliCare, a public-private partnership
PARTNERSHIPS
ADDRESS THE
FULL LIFECYCLE
OF HIV/AIDS,
DELIVERING CARE
TO THOSE WHO
NEED IT MOST
The HIV/AIDS crisis
triggered a level
of global solidarity
that had not been
seen before. We
must garner the
same support for
non-communicable
diseases.
Mariângela Simão,
WHO
Advances in R&D have transformed HIV from an untreatable and almost uniformly fatal
virus into a manageable, chronic condition. These innovations have extended the lives
of millions of people living with HIV. In the 30-plus years since the discovery of the HIV
virus, more than 30 medicines have been approved to treat the HIV infection. Over
time, medicines have improved in tolerability, efficacy, and convenience for patients.
A major breakthrough was the development of ARV therapy, which works by
preventing HIV from multiplying, reducing the viral load in the body and allowing
the immune system to keep it in check. The first generation of these therapies was
developed in the mid 1980s by Burroughs-Wellcome (now GSK) in collaboration with
the National Cancer Institute.141 Azidothymidine was the first ARV drug to be approved
by the US FDA as treatment for HIV.142
Since then, research has improved both understanding of the disease and its evolution,
simplifying the medication mechanism for patients.143
As understanding of the disease and the effects of ARV on patients grew, a
‘combination therapy’ approach emerged as far more effective than any single drug
treatment. So-called ‘cocktail’ approaches work by combining drugs in different
sequences. The adoption of HAART (highly active antiretroviral therapy) in 1996
inaugurated a new era in HIV treatment.144 The combination approach was quickly
incorporated into clinical practice and has since become the default therapeutic
approach.
Preventing transmission from mother to child also has huge implications for halting
the spread of HIV/AIDS and is another key focus area for R&D. Increased understanding
of ARV therapies allowed the use of treatment on pregnant mothers. Through
increased understanding of ARV therapies it was found that HIV positive mothers
adhering to ARV for several weeks or months before birth could eliminate the risk of
transmission to the baby through pregnancy, birth, and breastfeeding.145
A key challenge has been enhancing access to, and funding for treatment in resource-
scarce communities, including many of the geographies worst affected by the virus.
The development of less costly care regimens has allowed the extension of effective
treatment. For example, NNRTIs (non-nucleoside reverse transcriptase inhibitors) now
provide a lower cost option for LMICs and facilitated treatment expansion efforts.146
Newer classes of drugs include integrase inhibitors, today a recommended first-line
treatment in many cases, which work by preventing the virus from incorporating its
DNA into the host genome.147
R&D AND
INNOVATION:
FROM DEATH
SENTENCE
TO LIFETIME
TREATMENT FOR
PATIENTS
38 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: HIV/AIDS | 39
backed Medicines Patent Pool – and remains a key approach in improving access to
ARVs. ViiV Healthcare’s voluntary licensing approach, for example, enables accelerated
access to the innovative new HIV treatment, dolutegravir, across all LMICs, least
developed and Sub-Saharan African countries.1
Access to treatment grew in the 2000s. By 2006, 28% of those in need in sub-Saharan
Africa received treatment, compared to just 2% in 2003;164 2007 saw a 54% increase in
the number of people in LMICs receiving ARV therapy.165 There is a need for continued
progress in access for LMICs, alongside interventions in prevention, diagnosis and
broader health system strengthening.
STRENGTHENING HEALTH SYSTEMS
Caring for those living with HIV/AIDS extends beyond provision of treatment. Since
1999, the ‘Secure the Future’ initiative run by the Bristol Myers Squibb Foundation has
supported those living with HIV/AIDS in sub-Saharan Africa, with particular focus on
women and children and the links between cervical cancer and HIV.166 The Foundation
has invested USD 181 million to date, partnering with governments and NGOs to build
comprehensive care models through investments at a community level to support
outreach, home based care, and psycho-social support.
UNAIDS highlights the connection between HIV/AIDS responses and human rights.167
Education plays a crucial role in the fight against HIV and AIDS and stigma against
those living with it. It also promotes awareness of how to protect from AIDS,
encourages people to get tested and reduces discrimination against HIV-positive
people. GSK and ViiV Healthcare’s Positive Action programs tackle societal barriers
to addressing the global HIV epidemic such as stigma and discrimination, gaps in
education and sexual health services. The programs support community-based
organizations and NGOs to focus on populations worst affected by HIV such as women
and girls, adolescents, men who have sex with men, transgender people, incarcerated
individuals, sex-workers, and intravenous drug users.168
Botswana is an example where public-private partnerships have improved health
system capacity for treatment and prevention in a country with one of the highest
adult prevalence rates in the world. In 2000, MSD joined with BMGF and the
government of Botswana to form the African Comprehensive HIV/AIDS Partnerships
(ACHAP). ACHAP developed a comprehensive approach to increase prevention and
treatment of HIV/AIDS and care for those infected in support of the government of
Botswana’s response to the epidemic. The MSD Foundation and BMGF committed
to support ACHAP with USD 106.5 million. In addition, MSD donated its antiretroviral
medicines to Botswana’s national ARV treatment program for the duration of the
partnership. Botswana was among the first countries in sub-Saharan Africa to reach
universal access to treatment for HIV.1
Building on this progress, in 2016, ViiV announced an agreement to supply its latest HIV
medicine to support the government of Botswana’s national Treat All program, which
aims to ensure people living with HIV in the country get tested and receive treatment.
between Roche, the Clinton Foundation, USAID, and UNICEF aims to address barriers
that prevent early diagnosis of infants with a focus on sub-Saharan Africa.160 Roche has
redesigned its tests, developed a novel methodology for gathering and transporting
blood samples, as well as introducing SMS technology for test results. This has resulted
in expanded access to diagnosis in the remotest areas, where over six million infants
have been tested for HIV.
Despite the breakthroughs in treatment, by 2000, less than one million of the 34 million
people living with HIV/AIDS161 were accessing ARV therapy.162 In particular, many in
developing countries were left behind as treatments were not accessible.
In 2000, UNAIDS, WHO, Boehringer Ingelheim, BMS, Roche, GSK and MSD announced
a plan to improve access to treatment – the Accelerating Access Initiative (AAI). The
program, which concluded in 2012, applied preferential pricing to ARVs, opening the
door to a new future of access to ARV medicines in developing countries and laying the
foundation for future access to medicine initiatives.163
Many companies have made commitments reflecting the need for affordable
treatment options for the most affected countries. One mechanism to improve
access to ARVs is voluntary licensing agreements whereby the patent holder grants a
voluntary license over product patents in certain countries to generic manufacturers,
which enables them to develop, manufacture and sell generic versions of the licensed
product(s) in resource-limited settings. GSK gave the first voluntary license in 2001
for Retrovir, Epivir and Combivir in South Africa. Within a year there was a significant
increase in supply and reductions in ARV prices in the developing world. The scope and
approach to voluntary licensing agreements has continued to evolve – both directly
between patent-holding companies and generic manufacturers, and through the UN-
40 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: HIV/AIDS | 41
UNAIDS outlines the priority challenges for the next decade in their ambitious 90-90-90
targets for 2020:171
To get there, many look to industry and partners for additional pre-exposure options, a
cure or vaccine, and support closing the gap in treatment.
THE SEARCH FOR A CURE
While current treatments enable patients to live longer lives, the search for a cure
continues. Researchers have successfully lowered levels of the virus to undetectable
levels in certain children for a period of time,172 though there has not yet been a
confirmed case of an infant totally cured. AIDS researchers continue to improve our
understanding of how interventions can best impact infant immune system responses
to HIV. Many R&D eradication efforts focus on ‘flushing’ the HIV virus out of latently
infected cells, which are often seen as the major barrier to cure. This so called ‘shock
and kill’ technique works by ‘waking up’ inactive cells, forcing them to produce new
virus particles that are susceptible to current antiretroviral drugs. Several techniques
for this are in development with research ongoing into cytokine therapy, valproic acid,
and histone deacetylase inhibitors.173
VACCINE DEVELOPMENT
The development of a vaccine holds promise but has proven elusive due to the genetic
diversity of the virus and its ability to rapidly mutate.174 The International AIDS Vaccine
Initiative brings together public and private actors to research, design and develop
vaccine candidates.175 Researchers are optimistic that a vaccine will be found in our
lifetime. For example, Johnson & Johnson is working to develop a mosaic-based
vaccine is yielding encouraging results from clinical studies and is progressing to the
next phase of clinical development.176
CLOSING THE FUNDING GAP
Of the 37 million people globally living with HIV, 21 million have access to ARV therapy
– and more year-on-year. Yet, millions still lack access to therapy, many in LMICs. It
is estimated that just 12 million of the 25 million living with HIV/AIDS in Africa receive
ARV therapy.177 UNAIDS estimates the funding gap for HIV in LMICs over the 2015
to 2020 period stands at USD 26 billion, and it looks to public and private partners
to ensure the gains in R&D innovation do not exclude those in need of existing or
older treatments.178 Individual R&D-based pharmaceutical manufacturers – through
licensing, pricing initiatives and various partnerships – continue to seek to improve
access for LMICs, alongside critically needed interventions in prevention, diagnosis
and broader health system strengthening. Only a holistic approach will ensure critical
treatments are available to all people in need.
of all people living with
HIV know their HIV status
of all people receiving ARV
therapy will have viral
suppression
of all people diagnosed
with HIV infection receive
sustained ARV therapy
90%
90%
90%
Ending the AIDS epidemic by 2030, as set out in SDG target 3.3, will only be achieved
with innovation and multi-sector partnerships.169
Despite the array of effective HIV prevention tools such as male and female condoms,
pre-exposure prophylaxis, voluntary male circumcision, and behavior change
interventions (e.g. the use of clean needles), 1.8 million people became newly infected
with HIV in 2016.170
2030: THE END
OF THE AIDS
EPIDEMIC?
42 | 50 YEARS OF GLOBAL HEALTH PROGRESS
NEGLECTED TROPICAL DISEASES,
MALARIA AND TUBERCULOSIS
Thinking beyond traditional models
STORIES OF PROGRESS:
NTDs, malaria, and TB carry significant social and economic burdens, despite the fact that many of these
diseases can be effectively controlled, and in many cases, eliminated. Because these diseases
disproportionately affect vulnerable people, mainly in LMICs, they do not receive the same level of attention
as other diseases.
These diseases worsen and reinforce poverty, persisting in populations with limited access to adequate sanitation or medical care
and in close contact with infectious vectors and domestic animals and livestock.
Women, children, and HIV/AIDS sufferers are most likely to be infected by NTDs. Women are particularly likely to be affected due to
gendered roles which expose them to transmission, such as caring for sick children, cleaning of materials likely to carry infection, or
collecting water.179 The majority of malaria deaths are in children under five and one million children catch TB each year. Sick children
miss out on school, illness reduces families’ earnings, and diseases are a huge burden on already fragile healthcare systems.
STORIES OF PROGRESS: NTDs, Malaria and Tuberculosis | 43
NISHA’S EXPERIENCE WITH
LYMPHATIC FILARIASIS, A
NEGLECTED TROPICAL DISEASE
Nisha receives treatment for the disease through
donations received as part of the London Declaration.
In 1998, Nisha might not have had access to treatment
and would have lived with this debilitating disease all of
her life.
Nisha hopes that partnerships will continue to provide
access to treatment for everyone suffering from lymphatic
filariasis (LF), enabling it to be eradicated globally.
Present Day...
TWENTY years ago...
In the future...
TRANSFORMING LIVES
44 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: NTDs, Malaria and Tuberculosis | 45
INNOVATIVE
RESEARCH
MODELS
A central challenge for this group of diseases is the lack of competitive markets for
vaccines and medicines in the LMICs where the diseases are most prevalent. In spite of
these challenges, R&D-based biopharmaceutical companies are working to accelerate
the elimination or control of these diseases through the discovery of new treatments
and interventions through innovative mechanisms, including product development
partnerships (PDPs), IP sharing and open innovation, and programs to expand access
in endemic countries.
Companies foster R&D by sharing IP assets, compound libraries, access to research
facilities, hosting scientists and providing training. Additionally, the private sector has
transferred technology and built technical expertise to develop, manufacture, register
and distribute products. The Tres Cantos Open Lab Foundation allows independent
researchers to access GSK facilities, resources, and expertise to advance research into
TB, malaria and kinetoplastid infections.180 Similarly, the Novartis Institute for Tropical
Disease is a collaborative research centre, where academic institutions such as the
University of Singapore and non-profits such as the TB Alliance work together with
Novartis scientists to develop new therapies.181 WIPO Re:Search is a global consortium
of over 100 companies, academia, research centers, non-profits and government
agencies that facilitates sharing of know-how, technologies, and bridge research
gaps.182 To date, 95 research collaborations have been established through WIPO
Re:Search by BIO Ventures for Global Health.183
Innovative collaborations have tremendous potential to advance progress towards
new drugs and diagnostics addressing neglected diseases. 90% of NTD related
programs in which IFPMA members are active are collaborative efforts which involve
over 50 organizations, including universities, NGOs, and public and private sector
institutes.184
The first of its kind in Japan, the Global Health Innovative Technology (GHIT) Fund, is a partnership between the BMGF,
the Japanese government, pharmaceutical companies, the Wellcome Trust and UNDP.185 The fund invests and manages a
portfolio of development partnerships, mobilizing Japanese and international pharmaceutical companies and academic
organizations to get new medicines, vaccines, and diagnostic tools to people afflicted by NTDs.
An innovative public-private partnership
PARTNERING FOR
DELIVERY
In many cases, methods to prevent, diagnose and treat these diseases are known.
Much harder, yet equally essential to eradication, is ensuring access to interventions.
This is where innovative partnerships are important.
Many R&D-based pharmaceutical companies have committed to drug donations until
diseases are eliminated. The progress realized through these global donation efforts
demonstrates the power of strategic collaboration in reducing the impact of NTDs on
health and society.
Partnerships and collaborative efforts such as The London Declaration on Neglected
Tropical Diseases (The London Declaration), USAID Neglected Tropical Diseases
Programme, Medicines for Malaria Venture (MMV) and the Stop TB Partnership bring
together public, private, and civil society actors to improve access to treatments,
capacity building and policy advocacy. These are essential to end these diseases.
The success of drug distribution campaigns relies on an integrated treatment approach.
In the past, many countries conducted separate treatment campaigns for individual
diseases. Now, many programs provide treatments for several diseases at the same
time. For example, a national program can treat all children in a region for intestinal
worms, onchocerciasis and LF in a single school visit. These large-scale campaigns also
offer an opportunity to reach people with other health interventions and can support
country progress towards stronger health systems and UHC.186
46 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: NTDs, Malaria and Tuberculosis | 47
2003: The term ‘neglected tropical diseases’ is coined by Peter Hotez and colleagues to
counterbalance the attention given to HIV/AIDS, TB and malaria.192
2007: First Global Partners’ Meeting on NTDs held at WHO headquarters in Geneva,
bringing together over 200 public and private institutions dedicated to contributing their
time, efforts, and resources to control neglected tropical diseases.193
2009-13: USAID launches Neglected Tropical Diseases Initiative committing USD 350 million
to deliver integrated NTD treatment to 300 million people in Africa, Asia, and Latin America.194
2012: WHO NTD Roadmap sets targets and milestones to control, prevent, eliminate, and
eradicate NTDs.195
2012: The London Declaration on Neglected Tropical Diseases (The London Declaration):
14 billion treatments pledged and commitment to control, eliminate or eradicate 10
debilitating NTDs responsible for more than 90% of the burden by 2020.196
2013: Development of high-quality diethylcarbamazine citrate tablets for treatment of
LF, with a formulation suitable for worldwide distribution.197
2015: The number of people requiring treatment and care for neglected tropical diseases
falls 21% since 2010, to 1.6 billion people.198
2016: Approval of new child-friendly chewable tablet formulation for children infected by
intestinal worms (soil-transmitted helminthiasis).199
2017: Clinical trial results show efficacy and safety of fexinidazole, the first oral
monotherapy for Human African Trypanosomiasis, which could avoid the need for
lumbar puncture and for systematic hospitalization of patients.200
2017: NTD Summit (Geneva): half-way to The London Declaration, which has been
awarded the title of ‘biggest donation’ ever by Guinness World Records.201
WHO LIST OF
UPDATED 2017
NEGLECTED TROPICAL DISEASES
PROTOZA
Chagas Disease
Human African trypanosomiasis
(sleeping sickness)
Leishmaniasis
ADDED IN 2017
Mycetoma, chromoblastomycosis
and other deep mycoses
Scabies and other ectoparasites
Snakebite envenoming
BACTERIA
Buruli Ulcer
Leprosy (Hansen’s disease)
Trachoma
Yaws (Endemic
treponematoses)
VIRUSES
Dengue and Chikungunya
Rabies
HELMINTH
Dracunculiasis (guinea-worm disease)
Echinococcosis
Foodborne trematodiases
Lymphatic filariasis
Onchocerciasis (river blindness)
Schistosomiasis
Soil-transmitted helminthiases
Taeniasis/Cysticercosis
One in seven people suffer from an NTD,202 with the vast majority of cases in LMICs
where parasites, bacteria and viruses thrive in subtropical climates. NTDs are painful
and can blind, disfigure, and cause severe and permanent disabilities. Disfiguring
NTDs such as Buruli ulcer, yaws, and leprosy are frequently associated with stigma,
increasing the burden of disease.
Progress has been made in eradicating NTDs with the elimination of some diseases
in certain geographies. A notable milestone was the discovery that ivermectin for
parasitic infections could be used to treat river blindness and lymphatic filariasis (LF)
in humans. There was no market as those infected were too poor to pay, so MSD made
an open-ended commitment to give away as much of the drug as necessary until
river blindness is eliminated.203 Similar commitments followed. In 2017 the Japanese
pharmaceutical company Eisai renewed its pledge to donate diethylcarbamazine until
the global elimination of LF is achieved.204 GSK has donated eight billion tablets of
albendazole to date to prevent LF and control intestinal worms and has also pledged
to donate albendazole to every country that needs it until LF is eliminated. Lymphatic
filariasis transmission has now been eliminated in 11 countries including China, Costa
Rica, Egypt, South Korea, Sri Lanka, and Thailand.205
The Drugs for Neglected Diseases Initiative (DNDi) works in partnership with industry,
research institutions and the public sector on the most neglected diseases. This
includes Human African Trypanosomiasis (HAT), leishmaniosis and Chagas disease,
which fall outside the scope of market-driven R&D.206 USAID Neglected Tropical
Diseases Programme delivers integrated NTD treatment to 300 million people in Africa,
Asia and Latin America and reached two billion treatments by 2016.207
The breakthrough
global collaborative
effort to control
river blindness
responded to the
links between
disease and rural
development and
for the first time
recognized health as
an investment with a
positive return.
Tim Evans,
World Bank Group
1971: Benznidazole introduced for the treatment of Chagas disease.187
1975: Development of albendazole for treatment of parasitic worm infections
including cysticercosis.188
1986: Approval of clofazimine to treat leprosy, a key constituent of multidrug therapy
(MDT) alongside rifampicin and dapsone.189
1987: Development of ivermectin (also known as Mectizan®) for parasitic infections in animals
and finds it can be used to treat river blindness in humans and LF. Established the Mectizan®
Donation Programme to provide ivermectin to all who needed it, for as long as needed.190
1998: Azithromycin begins to be prevalently used as a first-line response for eliminating
blinding trachoma.191
NEGLECTED
TROPICAL
DISEASES
KEY MILESTONES
48 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: NTDs, Malaria and Tuberculosis | 49
1972: Chinese scientist Tu Youyou discovers artemisinin, a cornerstone of malaria
treatment.
1979: Clinical trials of artemisinin published.218
1985: First large-scale trials of insecticide treated nets.219
1992: The RTS,S malaria vaccine enters clinical trials.220
1998: Launch of the Roll Back Malaria Partnership.221
MALARIA
KEY MILESTONES
In addition to the donations by MSD, GSK and Eisai, a number of other programs focus
on the elimination of particular NTDs:
Bayer works with WHO to tackle Chagas disease and African Sleeping Sickness, both of
which are completely curable in the early stages with drugs.208
Pfizer partners with the International Trachoma Initiative - an independent NGO
dedicated to eliminating trachoma - to donate antibiotics and work with agencies to
implement the WHO recommended SAFE (Surgery, Antibiotics, Facial Cleanliness, and
Environmental improvements) strategy for trachoma control.209
Merck KGaA works to fight schistosomiasis in Africa through its ‘One Merck for
Schistosomiasis’ program, which includes the development of a pediatric formulation
of praziquantel via a consortium of partners to treat children younger than 6 years old
and the development of innovative schistosomiasis diagnostics in association with the
current efforts of the BMGF.210
Johnson & Johnson co-founded Children Without Worms to tackle soil-transmitted
helminthiases through interventions including mass drug treatment and preventative
chemotherapy.211
Sanofi has initiated partnerships to address HAT including with the WHO to donate
existing drugs and with DNDi to develop a new oral treatment.
Novartis, through partnering with WHO, has committed to deliver Multi Drug Therapy
for leprosy to 1.3 million people by 2020.212
More and more countries are eliminating these diseases. River blindness and Chagas
disease have been eliminated from several countries in the Americas.213 Morocco,
Cambodia and the Lao People’s Democratic Republic have eliminated trachoma as a
public health problem.214 In 2015, India was the first country to be declared yaws-free.215
Progress has been enabled by the large-scale donation of medicines. In 2015, nearly
a billion people received donated treatments for at least one NTD.216 The London
Declaration is a flagship partnership for driving control or elimination of NTDs. The
industry is delivering on its promise of 14 billion donated treatments (USD 7 billion
worth of medicine) over 10 years. Millions of health workers and community volunteers
have been trained, strengthening health systems in the poorest communities to ensure
appropriate treatment and care. The London Declaration has been awarded the title of
‘biggest donation’ ever by Guinness World Records (April 2017). By 2020, nearly USD 18
billion worth of medicines will have been distributed, the largest medicine donation the
world has ever seen.
Preventative chemotherapy is one of the interventions deployed by the WHO,
involving administering six medicines in seven different combinations, to combat at
least five NTDs. Since the integrated approach began in 2008, 14 previously endemic
countries have been declared free of at least one NTD that is receptive to preventive
chemotherapy.217
1999: The Medicines for Malaria Venture launched to develop antimalarials for the
most vulnerable populations.222
2000: The UN General Assembly adopts the MDGs, setting a target to halt and begin
reversing malaria incidence by 2015.223
2001: The first artemisinin-based combination therapy (ACT) is brought to the
global market.224
2002: Launch of The Global Fund, the world’s largest financier of anti-AIDS, TB,
and malaria programs.225
2008: Launch of Global Malaria Action Plan, the first comprehensive blueprint for
global malaria control and elimination.226
2009: Launch of the first high-quality ACT formulated especially for children.227
2015: The RTS,S vaccine is the first malaria vaccine candidate to receive positive
scientific opinion from the European Medicines Agency (EMA).228
2015: WHO reports that since 2010, 60 countries have reported mosquito resistance
to at least one insecticide class and of these, 50 reported resistance to two or more
insecticide classes.229
2017: Regulatory application submitted for tafenoquine, the first new medicine for the
radical cure (prevention of relapse) of P vivax malaria in patients aged 16 and older in
more than 60 years.230
2018: RTS,S vaccine introduced in pilot immunization programs in three African
countries – Kenya, Malawi, and Ghana.231
50 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: NTDs, Malaria and Tuberculosis | 51
1970: First outbreak of drug-resistant TB in the US.
1993: WHO declares TB ‘a global emergency’ with deaths from TB higher than any
previous year.
2002: Launch of Global Fund to fight HIV/AIDS, TB, and Malaria.
2005: The number of deaths annually from TB peaks worldwide at 2 million.
2010: Launch of the Gene Xpert molecular test for TB,243 a rapid test which is endorsed
by WHO and hailed as a major breakthrough.
2012: The first approval of a TB drug in 40 years, bedaquiline, unique in that it
interferes with the enzyme required by bacteria to replicate.244
2014: Approval of delamanid, for active multidrug resistant TB, which is added to the
WHO’s essential medicines list.245
2015: WHO launches the ‘End TB’ strategy with the goal of ending the TB epidemic
by 2035.246
2018: (March) Delhi TB Summit; (September) First ever UN High-level meeting on TB in
New York City.
TUBERCULOSIS
KEY MILESTONES
Although TB has long been preventable and curable. it is the ninth leading cause of
death worldwide and the biggest infectious killer, above HIV.247 In 2015, 10.4 million
cases (one million children) and 1.8 million deaths (170,000 children, not including
those with HIV) occurred from TB.248 LICs and LMICs see 95% of TB deaths.249
An estimated 53 million lives have been saved through TB diagnosis and treatment
between 2000 and 2016.250 Drugs included in first-line TB treatments were developed
more than 30 years ago. Current treatments for multi-drug TB require patients to take
multiple antibiotics for nine to 24 months or longer, are complicated to administer,
and have significant adverse effects. Many patients stop their drugs before the bacteria
have been destroyed, which can further encourage drug resistance. Shortening
treatment regimens is a priority.
Malaria is caused by parasites transmitted from the bites of infected mosquitoes.
Malaria costs the African economy more than USD 12 billion every year.232 In countries
with high malaria rates, economic growth is slowed by 1.3%.233 Malaria control is
increasingly recognized as an important tool for poverty reduction - households in
Africa lose up to 25% of their income to the disease.
Between 2000 and 2015, the rate of new cases of malaria fell by 37% globally.234
Since 2000, eight countries have eliminated malaria and many others have reduced
transmission to low levels.235 However, malaria remains one of the world’s biggest killers.
Treatments have helped reduce malaria deaths. The current WHO-recommended
first-line treatment for malaria, artemisinin, was discovered in in 1972 by Tu Youyou, a
Chinese scientist who was awarded a Nobel Prize in 2015 for her discovery. Artemisinin
is particularly effective when combined with other medicines in artemisinin-based
combination therapy (ACT), which the standard treatment for malaria today. Novartis
started producing it in the late 1990s and began marketing it in the 2000s. Alongside
the discovery of novel treatments, continuous investment in R&D is needed for new
pediatric formulations given that children and pregnant women are most at risk of
contracting malaria. In 2009, Novartis, in partnership with The Medicines for Malaria
Venture (MMV), launched the first dispersible ACT formulated for babies and children.236
New drugs to treat and prevent malaria in children are in development by the likes
of Merck KGaA, who leverage the screening of compound libraries to identify new
candidates.237
MMV is one of the most well-known PDPs, launched in 1999 to develop antimalarials
for vulnerable populations. In 2008, MMV in partnership with Sanofi and DNDi,
launched the first anti-malarial drug resulting from a public-private partnership:
a fixed-dose combination of artesunate and amodiaquine which enables better
adherence to treatment and reduces the risk of resistance by avoiding selective use
of a specific component.238 MMV also works with GSK to develop tafenoquine to cure
relapsing P. vivax malaria, submitted for regulatory approval in both the US and
Australia in 2017. If approved, tafenoquine would be the first new medicine for the
prevention of relapse of P vivax malaria in more than 60 years.239
Control of malaria will be significantly aided by the development of a vaccine. After
more than 30 years of research, GSK, along with partners Programme for Appropriate
Technology in Health, Malaria Vaccine Initiative and the BMGF, is close to bringing
a vaccine to endemic countries. RTS,S is the first, and to date, only vaccine to show
partial protection against malaria among young children. The vaccine is being made
available from 2018 through routine immunization programs to young children in
Ghana, Kenya and Malawi.240
The industry recognizes that the elimination of malaria requires action in a number of
different areas, not just treatments and vaccines but increasing access to antimalarials,
equipping hospitals, supporting improved sanitation, training of health workers, and the
strengthening of health systems. Ensuring access to vector control tools such as bed nets
is fundamental to reducing cases of malaria. RBM is a global platform for coordinated
action, with 500 members including the private sector, NGOs, community organizations,
foundations, and research institutions. So far 70 campaigns distributed free treated bed-
nets to all households in areas with malaria since 2000.
The disease does not stand still. Antimalarial resistance is a real and growing threat
to hard won progress. For the first time in 10 years, global malaria cases are no longer
falling, driven in part by drug resistance.242 New funding mechanisms and tools such
as advanced mosquito surveillance using genetic sequencing will be needed to ensure
the world does not see a resurgence of the disease.
History has shown
that with malaria
there is no standing
still—we move
forward or risk
resurgence.
Bill Gates,
Bill and Melinda Gates Foundation241
52 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: NTDs, Malaria and Tuberculosis | 53
THE PATH TO
ERADICATION
Despite progress, much remains to be done to meet SDG target 3.3 to end epidemics
of TB, malaria and NTDs by 2030. The challenge consists of two missions: delivering
health services for prevention and those living with diseases and eliminating
transmission by addressing resistance and vaccine development.
Neglected diseases thrive in areas that lack adequate sanitation. About 2.4 billion
people do not have access to adequate washing facilities. Hygiene can reduce
transmission of the bacterial infection that causes trachoma. Breeding sites for
mosquitoes are reduced through improved water management, limiting transmission
of mosquito borne diseases. Protecting freshwater resources can prevent transmission
of schistosomiasis. Improving access to water, sanitation, and hygiene (WASH) will be
crucial to combat NTDs, as set out in the WHO’s strategy in 2015.254
Climate change, growing megacities, and conflict present a challenge to meeting
control and elimination targets. Overcrowding and poor hygiene and sanitation
facilitate the spread of diseases. It is expected that climate change will increase the
malaria burden in several regions of the world, particularly densely populated tropical
highlands. An increase in NTD cases (including dengue fever and Chagas disease)
in southern Europe is likely due to changing climate. Given the projected growth in
the size of the world’s population by 2030, more people will be living in areas at risk
of neglected diseases, putting further strain on overstretched health systems and
program budgets. War and refugee zones can increase exposure and susceptibility
to infection. New approaches must deliver interventions in less time, provide flexible
funding, and empower communities to administer care when external support is
unavailable.
These diseases are not restricted to LMICs; many are found among the poor living in
G20 nations. Estimates suggest that 12 million people in the US live with at least one
poverty-related neglected or emerging disease.255 NTDs can only be eradicated if all in
wealthier nations receive the treatment and care they need.
Comorbidity also remains a challenge. HIV patients are at greater risk of TB and
malaria. The risk of death in co-infected individuals is twice that of HIV infected
individuals without TB.256 There is a need to find new and improved treatments and
interventions to tackle this joint disease burden.
Tackling sub-standard drugs and vaccines development remain critical to addressing
drug resistance, given that antimalarials and antibiotics are the most commonly
reported sub-standard or falsified products.257 These medicines are at best ineffective,
and at worst, can result in death. They also contribute to AMR and drug-resistant
infections and reduce patient confidence. Drug resistance presents a major challenge
to eradicating TB and malaria. The need for ongoing innovation and a robust pipeline
for treatment will become more urgent as strains become resistant to traditional
treatments.
The inadequacy of current diagnosis has challenged efforts to contain the spread of
TB and forms a core component of the WHO’s End TB strategy. Janssen, a company
of Johnson & Johnson, has partnered with the non-profit FIND to increase access to
molecular diagnostics tools for TB case detection and multi-drug resistant TB (MDR-TB)
diagnosis.251
Drug resistance is another growing threat. Each year, there are roughly half a million
new cases of MDR-TB, many of them transmissible. Breakthroughs by Johnson &
Johnson and Otsuka have recently emerged: two new medicines (bedaquiline and
delamanid) have been approved for the treatment of MDR-TB under programmatic
conditions in numerous countries, with both added to the WHO’s Essential Medicines
List. A priority is getting these new treatments to patients by broadening sustainable
and responsible access.
Other resource sharing programs include Eli Lilly’s technology transfer program,
which began in 2003 to provide R&D-based pharmaceutical manufacturers in MDR-TB
‘hot spots’ (China, India, Russia and South Africa) with trademarks, technology and
know-how.252 The BIO Ventures for Global Health partnership hub which brokered
discussions between the Centre for World Health & Medicine (CHWM) and GSK, both
work on methionine aminopeptidases (MetAP) as a drug target for TB. GSK tests
identifying inhibitors of MetAP had disappointed and CWHM consequently placed its
MetAP inhibitor on hold to avoid repeating experiments, saving money and time.253
The PreDICT-TB Consortium, a public-private consortium, is working to overcome
the barrier of inaccurate prediction of clinical effectiveness by currently available
laboratory methods in order to speed up the identification of the most effective
combination of new drugs.
The TB Drug Accelerator is an effective example of pre-competitive collaboration and resource sharing, through which the
expertise of partner organizations is leveraged to speed the development of medicines. The TB Drug Accelerator, launched
in August 2012, is a BMGF sponsored discovery consortium of nine pharmaceutical companies (GSK, AbbVie, AstraZeneca,
Bayer, Eisai, Eli Lilly, MSD, Sanofi, and J&J) and major academic organizations to speed up discovery and development of
novel compounds against TB. Through early-stage TB research collaboration, it aims to develop five new pre-clinical drug
candidates with treatment-shortening potential within five years, and proof-of-concept for a one-month three-drug regimen
within 10 years. Members have opened up access to TB compound libraries to enable collaborative screening and data
sharing. The TB Drug Accelerator aligns asset progression across portfolios so that members work to accelerate the most
deserving discovery programs, regardless of where the drug originated, to avoid duplication. Coordinating previously siloed
research teams and sharing knowledge of fundamental biology, screening capability and drug discovery resources has led to
faster development timelines.
pre-competitive collaboration
There a number
of new medicines
and diagnostics in
the pipeline, which
may change the
perspective for these
neglected tropical
diseases and hopefully
allow us to go
further towards
eliminating or near
eliminating these
diseases by 2030.
Dirk Engels,
Director of Neglected Tropical
Diseases, WHO258
FOREWORDS
REFLECTING ON 50 YEARS OF HEALTH PROGRESS
STORIES OF PROGRESS
VACCINES:
Saving, protecting and enhancing lives
HIV/AIDS:
Overcoming one of the worst human pandemics
NEGLECTED TROPICAL DISEASES, MALARIA AND TUBERCULOSIS:
Thinking beyond traditional models
CANCER:
Persisting in research and innovation to deliver better patient outcomes
CARDIOVASCULAR DISEASE:
Innovating for longer and better lives
DIABETES:
Improving quality of life through management of a complex disease
HEPATITIS C:
Discovery to cure in 25 years
PRESENT TO FUTURE
COMMITMENT TO FUTURE PROGRESS
CONTENTS
4
7
23
24
32
42
54
64
72
80
87
98
Contents | 3
4 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Forewords | 5
IAN READ, PFIZER CHAIRMAN & CEO, IFPMA PRESIDENT
A desire for quality healthcare is something that unites all of us because a healthy society is essential to
ongoing global development. It creates stronger families and communities, enables more productive
and innovative workforces, and supports economic growth. That’s why patients and their needs have
been the IFPMA’s ‘north star’ for the last 50 years, and why they will continue to guide our efforts and
allocation of resources into the future.
During my 40 years in the pharmaceutical industry, I have been inspired by the monumental
advancements that have fundamentally altered the healthcare landscape. Today we benefit from
incredible medicines and vaccines that have:
turned fatal illnesses like HIV/AIDs into chronic conditions;
slowed disease progression for rheumatoid arthritis;
cured a disease such as hepatitis C;
helped to prevent previously widespread childhood illnesses such as rotavirus, chicken pox and
pneumococcal disease;
reduced mortality rates for cardiovascular and diabetes patients around the world, and;
revolutionized the care for some cancer patients with personalized therapies that have improved
outcomes and extended life.
While the pharmaceutical industry has been instrumental to this progress, none of it would have been
accomplished without partnership. From patient advocates to our biotech and academic partners to
local governments who help ensure access on the ground, innovation is only as good as the partnership
that supports it.
Last year I was incredibly proud to help launch Access Accelerated, a first-of-its-kind collaboration led by
more than 20 pharmaceutical companies, IFPMA, the World Bank and the Union of International Cancer
Control that is focused on improving access to treatment and care for non-communicable diseases in
low- and middle-income countries. We must continue to lean in to these types of endeavors that help
ensure the life-changing therapies we work so hard to develop reach those who need them most.
The next 50 years promises to deliver an even more exciting era of medical discovery. With more than
7,000 medicines in development around the world, we see the potential for additional breakthroughs
and cures that will transform millions of lives. As we continue on this journey, we must continue to build
trust around the vital role we play in improving global health. This is an obligation that I embrace, and I
know IFPMA will continue to lead us in this effort for years to come.
THOMAS CUENI, IFPMA DIRECTOR GENERAL
Health is vital for societal well-being and progress. While we may despair at health threats in the headlines
– dementia, antimicrobial resistance, pandemics – the truth is that we have lived through 50 years of
health progress.
The research-based biopharmaceutical industry has played its part in a network of research institutes,
government departments and donor organizations not only to deliver prevention and treatment, but to
strengthen health systems and to make universal health coverage a possibility.
Like any wave of progress, there are setbacks and mistakes have been made. One of the greatest was
in 1998 when 39 companies sued the South African government to stop legislation facilitating import of
lower priced medicines. The lawsuit became a symbol of industry’s insensitivity to the plight of patients
in sub-Saharan Africa.1 Profit, via patents and prices, were understood to be barriers to treatment until
the parties reached a then-revolutionary settlement. The court case led to major soul-searching among
pharmaceutical companies and resulted in government and industry working together to find solutions
for the epidemic — a precursor to the norm today.
From suing Nelson Mandela to becoming an active partner in delivering global health solutions, the
industry has evolved and learned. This needs to continue. We need to safeguard the progress made. And
we have to do even more.
We need to do more to reach all patients, regardless of economic circumstances. Investment in health
infrastructure, the ways services are delivered and the role of prevention must be part of the dialogue.
Today, more than half the world’s population have to pay for their medicines out of pocket.2 Improving
access for these people requires navigating a complex value chain. For example, there are often mark-ups
along the supply chain that make essential diabetes treatments unaffordable for many.3
Progress will be hampered as long as universal health coverage is not in place. We worry about the cost of
treatment – and prevention – but rarely tally the cost of not treating.
To do better, go further and faster we’ll need partnerships, of all kinds. More dialogue is a must, and that
we welcome.
As we live longer, the diseases of ageing raise a new set of questions. Climate change and conflict require
new ways of thinking about disease transmission and delivering care. And antimicrobial resistance poses a
real threat to global health security.
The last 50 years has seen companies move to greater global accountability. The next 50 will be about
further delivering on our purpose: putting patients first to deliver better health for everyone, everywhere.
FOREWORDS
6 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 7
REFLECTING ON
50 YEARS OF
GLOBAL HEALTH
PROGRESS
…THE THREATS OF SMALLPOX AND MALARIA WERE TOP OF MIND FOR THE
PUBLIC HEALTH COMMUNITY. The 21st World Health Assembly brought
public health actors together in Buenos Aires to explore the cooperation
with other organizations needed to tackle these challenges. Thanks to
global immunization campaigns, smallpox, one of the most devastating
diseases facing humanity, was eradicated in 1980. Malaria, despite the rate
of new cases falling by over a third between 2000 and 2015,4 remains one
of the world’s biggest killers. Elimination remains high on global public
health agenda.
…STUDIES OF CANCER IN NONHUMAN PRIMATES PROVIDED COMPELLING
NEW EVIDENCE FOR THE EXISTENCE OF A HUMAN CANCER VIRUS.5 Fifty years
later, experts’ understanding of the biology of cancer, and how to diagnose
and treat it, has advanced considerably. Cancer is now known to be a group
of over 100 different and complex diseases, all involving the uncontrolled
division of the body’s cells.6 Cutting-edge research is giving rise to new
treatments in the field of immunotherapy, which harnesses the immune
system to fight cancer from within.7 Improved understanding of cancer-
related genes means that doctors can use personalized medicine to target
the specific mutation that’s driving the cancer.8
IN 1968...
8 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 9
HEALTH ENABLES
HUMAN
DEVELOPMENT
AND PROSPERITY
Health is a most basic and essential asset not limited to any one agenda.
Poor health can limit opportunity and prevent the living of a full and
rewarding life.
Disease reinforces and worsens poverty. By some estimates, from 2011-2025, the
cumulative lost output in low- and middle-income countries (LMICs) from non-
communicable diseases (NCDs) was more than USD 7 trillion, making a powerful
economic case for effective prevention and intervention strategies.9
Individuals, communities, nations, and the global community benefit from good
health. Whether living free of disease through prevention programs, vaccines,
treatments and cures, or enjoying better quality of life living with and managing
diseases, health is the basis upon which successful, flourishing, and sustainable
societies develop. For instance, malaria eradication campaigns in Uganda are
associated with long-term improved education and livelihoods.10 AIDS treatment, care
and prevention has resulted in increased employment in sub-Saharan Africa.11
Health progress drives prosperity, wellbeing, enhanced livelihoods, economic
development, and equality.
SOCIAL IMPACTS OF IMPROVED HEALTH:
A MALARIA FREE AFRICA
WOULD MEAN...
POVERTY REDUCTION
25% MORE INCOME FOR HOUSEHOLDS
LABOUR PRODUCTIVITY
MORE PEOPLE IN PAID WORK
ECONOMIC GROWTH
1.3% ECONOMIC GROWTH (TOURISM, AGRICULTURE)
MORE CHILDREN IN EDUCATION
15% LESS SCHOOL ABSENTEEISM
BETTER SCHOOL PERFORMANCE
60% INCREASE IN SCHOOLCHILDREN LEARNING ABILITY
The last 50
years have seen
an increased
recognition that
access to health
is a right.
Mariângela Simão,
Assistant Director-General for
Access to Medicines, Vaccines and
Pharmaceuticals, World Health
Organization
THE
CONTRIBUTION
OF THE R&D-
BASED BIO-
PHARMACEUTICAL
INDUSTRY TO
GLOBAL HEALTH
PROGRESS
The International Federation of Pharmaceutical Manufacturers &
Associations (IFPMA) was created in 1968 with a mission to bring the
research & development (R&D)-based biopharmaceutical industry and the
health community together to tackle global health challenges. Fifty years
since, significant global health progress has been made.
The R&D-based biopharmaceutical industry (the industry) develops and provides
medicines and vaccines that improve the lives of patients worldwide. It has played
a unique and important part in delivering better health for millions of people across
the world.
Innovation is crucial, and the industry has contributed significantly to understanding
health challenges and developing solutions, investing USD 159 billion in R&D in 2017.12
The industry has learned that global health is about much more than medicines and
vaccines – it requires building and supporting strong health systems, developing
public health education, and strengthening standards and regulations. For innovations
to reach the people who need them, broader progress is needed, such as improved
diagnostic capabilities and better-informed healthcare providers. Partnership,
alongside innovation, is crucial to deliver on progress.
This report seeks to tell seven stories of progress over 50 years. Stories that
showcase advances, partnership, and challenges, and demonstrate not only unfinished
business, but also hope for the future. At the start of each story of progress, the reader
will find a personal story about how lives have been transformed, using the lens of
individual lives to represent the progress made and imagine the future. These are
illustrative only.
VACCINES: Saving, protecting and enhancing lives
HIV/AIDS: Overcoming one of the worst human pandemics
NEGLECTED TROPICAL DISEASE, MALARIA AND TUBERCULOSIS:
Thinking beyond traditional models
CANCER: Persisting in research and innovation to deliver better patient outcomes
CARDIOVASCULAR DISEASE: Innovating for longer and better lives
DIABETES: Improving quality of life through management of a complex disease
HEPATITIS C: Discovery to cure in 25 years
Future trends are also explored, what’s on the horizon and well beyond it.
10 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 11
A UNITED HEALTH ECOSYSTEM
Be it controlling NCDs, precision medicine for cancer or eliminating Neglected Tropical
Diseases (NTDs), health progress has been made possible by researchers in academia
and in industry understanding diseases and developing vaccines and medicines,
regulators incentivizing bringing of drugs to market, NGOs and foundations developing
programs to deliver medicines, financial institutions defining innovative funding
mechanisms, and healthcare providers training health workers. All are connected by
the drive to understand and respond to the needs of the patient.
The cycle of care, from prevention to treatment to quality of life and cure, is both
complex and highly personal. Health is impacted by a range of factors: from security
to sanitation, and from geography to genetics. The research-based biopharmaceutical
industry has played its part by bringing life-saving and life-prolonging medicines
and vaccines to individuals, improving both personal and public health outcomes.
Together, industry and others have reimagined how medicines make the journey from
lab to patient.
The industry’s contribution to global health challenges has evolved over 50 years –
enabled by a strong ethical code of practice. The way companies innovate and partner
with others has delivered numerous health benefits to individuals and societies.
Global health
progress relies
on all actors
sitting around the
table: activists,
governments,
technical groups
and industry.
David Heymann,
Professor, Infectious Disease
Epidemiology, London School
of Hygiene & Tropical Medicine
BUILDING TRUST
The importance of ethics and safety is reflected in the highly regulated
nature of the industry. In the early 20th century the industry was
dubbed ‘the ethical drug industry’, in reference to the safety and efficacy
requirements to which R&D-based biopharmaceutical manufacturers
adhere when bringing products to market.13 Today, ethics refers to much
broader values and principles.
Fairness, honesty, respect, and care are foundational to the success of the industry,
to broader global health progress and to patient outcomes. Progress requires an
environment that encourages risk-taking, exploration and innovation, which is made
possible through trust built upon proactive ethics.
IFPMA’s mission is based on the establishment and promotion of ethical principles for
the industry. The seeds of a shared ethos were planted in 1981, when the first IFPMA
Code of Practice was created as the foundation for global self-regulation.14 Updated
and revised over the decades, the code set the rules-based compliance framework for
clinical research and transparency, fees for services, support for continuing medical
education, training, interactions with patient organizations and physicians, and many
other areas. Many local and regional associations rely on the IFPMA code and guidance
for their own codes of conduct.
Progress was punctuated by other major global milestones: In 1988, the World Health
Organization (WHO) published its Ethical Criteria for Medicinal Drug Promotion;15 in
1996, the first WHO International Summit of National Bioethics Commissions was
held;16 in 2012, the Mexico City Principles for Voluntary Codes of Business Ethics in the
Biopharmaceutical Sector were endorsed by Asia-Pacific Economic Cooperation heads
of state, establishing a comprehensive ethical and integrity framework for the industry.
The current version of the IFPMA Code of Practice expands the scope beyond
marketing practices to cover all interactions with healthcare professionals, medical
institutions and patient organizations. Revision of the Code is ongoing. The revised
Code (effective January 2019) will be more principles-based and incorporate an
expanded understanding of ethics and business integrity.
The industry and partners continue to engage with emerging ethical challenges
presented by collaborative public health programs, including privacy, autonomy, and
equity. For example, the 2017 WHO Guidance on Ethical Issues in Public Health in set
out the first international framework for government, health workers, NGOs, and the
private sector to navigate these challenges.17
FOUNDATIONS
INVESTORS
REGULATORS
PHARMACISTS
INSURERS
HOSPITALS
PATIENTS
NGOs
DEVELOPMENT BANKS
NATIONAL HEALTHCARE SYSTEM
INTERNATIONAL MULTILATERAL INSTITUTIONS
HEALTHCARE PROVIDERS
RESEARCH-BASED BIOPHARMACEUTICAL
MANUFACTURERS
PUBLIC HEALTH DEPARTMENTS
HEALTH TECHNOLOGY PROVIDERS
ACADEMIA AND UNIVERSITIES
HEALTH WORKER ORGANIZATIONS
12 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 13
TRANSFORM AND
INNOVATE
Researching, developing, manufacturing, and improving medicines and
vaccines is at the heart of the industry’s contribution to health.
R&D – and improving the underlying understanding of diseases – is essential. This
has helped to take medicine from treatment based on controlling symptoms to
understanding diseases and causation, enabling more nuanced, targeted, and
systematic approaches across treatment, prevention, and care. For example,
advances in understanding the complex genetic, environment and lifestyle causes
of cardiovascular disease, and the effects of statins and anti-hypertensive drugs, has
paved the way for better and more effective treatment. Fifty years ago, doctors had few
tools to fight cancer, but through incremental advances and occasional breakthroughs,
many cancers that were once uniformly fatal are now generally treatable.
Every treatment or vaccine over the last 50 years has roots in the scientific advances
and breakthroughs made by others before. Industry tirelessly seeks out new
discoveries. Each vaccine or medicine takes years to develop and billions of dollars in
investment,18 with just one in 5,000 drug candidates making it all the way from drug
discovery to market.19 The development of a malaria vaccine is proving to be more
than a 30-year quest.20
Over the last 50 years, biotherapeutics (therapies derived from living organisms) have
become an integral part of modern medicine. Insulin was one of the first medicines
produced using biotechnological methods, and biotechnology is now used for diseases
including cancer, rheumatoid arthritis, heart disease and multiple sclerosis. The
Intellectual
property exists to
encourage innovation
and creativity,
which stimulate
improvements in our
quality of life, spur
economic growth
and address the
radical challenges
we confront such as
climate change, clean
energy, food security
and health.
Francis Gurry,
Director, World Intellectual
Property Organization25
PARTNER AND
ENGAGE
In 1968, actors of a given health system operated in siloes. Since then,
new approaches and more creative partnerships have emerged – whether
delivering healthcare more efficiently, effectively conducting research, or
strengthening the capacity of healthcare systems.26
In recognition of the complementarity of their research objectives and interests – and
to an extent the limits to public funding for research – there has been an upsurge in
academic-industrial collaboration.27 Combined, their unique contributions lead to
greater insights and innovation. Some partnerships rely on close collaboration, such as
research to jointly explore the new frontier of immunotherapy or conducting advanced
clinical trials requiring tight partnership between doctors, patients, and R&D-based
pharmaceutical manufacturers.28
Other collaborations adopt more radical approaches to improve patient outcomes.
For instance, 2000 saw the launch of Gavi, the vaccine alliance, a public–private
partnership committed to increasing access to immunization in poor countries.29 In
2002, The Global Fund was developed as a unique financing partnership between
governments, civil society, companies and people affected by the diseases they seek
to end: AIDS, TB and malaria.30 The London Declaration on Neglected Tropical Diseases
introduction of recombinant human erythropoietin into clinical practice in the 1980s
was a major breakthrough in the treatment of the anemia of patients with chronic
kidney disease.21 Understanding of biologics is crucial to the emerging practice of gene
therapy, whereby disease is treated or prevented through the addition or modification
of DNA. Decades in the making - first tested on humans in 1990, and informed by the
completion of the Human Genome Project in 1993 - gene therapy enables a deeper,
personalized and more precise approach to health. For example, gene therapy is used
to treat particular types of cancers by targeting specific cell mutations as well as curing
sickle cell disease by modifying stem cells.22
Intellectual property (IP) protection, typically granted in the form of patents and data
exclusivity, incentivizes investments to make advances and enables companies to
re-invest in their R&D capability. IP is a critical element of the innovation ecosystem,
alongside a science-based regulatory system and appropriate rewards and incentives.
IP can also help to create certainty in the overall business climate to usher in future
overall investments (including beyond the R&D-based biopharmaceutical industry).
This competitive research model has delivered many successes in previous decades,23
with industry and partners continuing to learn how to operate more effectively and
collaborate.24 IP has also contributed to the creation of the generics manufacturing
industry, enabling the R&D-based companies to focus on just that, R&D. IP has given
the industry the necessary confidence to invest in markets, accelerate the adoption of
technology, and increase patient access to a wider choice of medicines.
14 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 15
agreed in 2012, the largest mass drug administration in history, commits companies
as well as WHO, foundations, and others to work cooperatively to maintain and
expand drug donation programs to meet demand through 2020.31 Access Accelerated,
founded in 2017, brings together 23 biopharmaceutical companies, teaming up with
the World Bank, Union of International Cancer Control (UICC), and Boston University
to demonstrate that significant progress can be made in addressing the NCD epidemic
through cooperative action.32
Partnerships are crucial to improving patient access through strengthening health
systems: 90% of ‘essential’ medicines are generics, and yet not all reach patients.33
Without access to prevention support and quality health services, global health
progress will be uneven. Achieving universal health coverage (UHC) means ensuring all
people receive essential health care without risking financial hardship.
Achieving UHC is one of the targets under the Sustainable Development Goals (SDGs).
Partnerships contribute to this by training healthcare workers, building infrastructure
such as testing facilities, and delivering education to schools and community
organizations to promote prevention. For instance, UHC2030 brings together diverse
stakeholders to advocate for political commitment, strengthen dialogue and facilitate
knowledge sharing in order to strengthen health systems.34
These close partnerships could hardly have been imagined in previous decades.
If countries invest
in making progress
towards universal
health coverage, they
lay the foundation
for progress
towards ending
poverty, improving
gender equality,
decent work and
economic growth,
and more.
Tedros Adhanom Ghebreyesus,
Director General, WHO35
Progress is often depicted in terms of blockbuster headlines and global statistics. But it is important to recognize the people
behind the headlines: patients, researchers, doctors, health workers who have contributed to progress, often overcoming
huge odds to do so. Consider the tenacity of researchers such as Dr Joe Cohen, who worked as part of a team for almost
three decades to develop the first malaria vaccine,36 and Maysoun Shomali, who has dedicated 20 years of her career to
developing therapies for breast cancers resistant to other treatments.37
Faces of progress...
16 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 17
50 YEARS OF GLOBAL
HEALTH PROGRESS
TRANSFORM AND INNOVATE
PARTNER AND ENGAGE
1968: Studies of cancer in nonhuman
primates provided compelling new evidence
that the Epstein-Barr virus, discovered four
years earlier, can lead to cancer in humans.38
1974: Expanded Programme on
Immunization (EPI) established to
develop and expand immunization
programs, initially targeting diphtheria,
whooping cough, tetanus, measles,
poliomyelitis, and tuberculosis,
towards the goal of providing universal
immunization for all children by 1990.40
2000: Adoption of the
Millennium Development Goals
(MDGs), a blueprint for meeting
the needs of the world’s poorest
with a focus on child mortality,
maternal health, HIV/AIDS,
malaria, and other diseases.53
1988: WHO publishes Ethical
Criteria for Medicinal Drug
Promotion, the first frame of
reference for judging proper
behavior in drug promotion.49
1988: Establishment of the
Global Polio Eradication Initiative,
which has contributed to the
99.9% reduction in global
incidence of polio.50
2000: Launch of Gavi,
the Vaccine Alliance, a
public–private global health
partnership committed
to increasing access to
immunization in poor
countries.54
1980: Worldwide vaccination programs
result in the eradication of smallpox, a
contagious virus with no known cure which
killed an estimated 300-500 million people
in the 20th century.43
1985: First manufactured insulin pen
launched, offering greater ease of use
and accuracy for patients versus the vial-
and-syringe method of insulin delivery.45
1981: First IFPMA Code of
Practice developed as the
foundation for industry’s global
self-regulation, setting ethical
and professional standards.44
2015: Sustainable Development
Goals (SDGs) adopted by world
leaders, setting out a global
sustainable development
agenda which emphasizes
collaboration across countries,
actors, and sectors for a
wide array of development
outcomes, health and wellbeing
prime among them.60
1977: The first angiotensin-
converting-enzyme (ACE)
inhibitor developed for the
treatment of hypertension,
is discovered.41
1971: Measles, mumps and rubella
(MMR) vaccine approved, providing
protection against three highly infectious
illnesses at the same time, via one shot.39
1987: The first antiretroviral (ARV)
drug is approved by the US FDA as
treatment for HIV, beginning a new
era of highly active ARV treatment.46
1996: A new class of combined
antiretroviral treatment, HAART, is
developed, leading to a 50% drop in
the number of AIDS-related deaths in
the U.S. and Europe in three years.52
2012: Signing of the London
Declaration on Neglected
Tropical Diseases: 14 billion
treatments pledged and
commitment to control,
eliminate or eradicate 10
debilitating NTDs responsible
for more than 90% of the
global neglected diseases
burden by 2020.57
2006: Human papilloma virus (HPV)
vaccine approved, which protects
from cervical cancer, a common
cancer among women under 35.55
2017: Launch of Access
Accelerated with 23 global
biopharmaceutical companies,
the World Bank, the Union of
International Cancer Control
(UICC), and Boston University
to combat NCDs globally.61
1987: First statin approved,
a key step in reducing
cardiovascular disease.48
2014: Development
of CAR-T cell
therapies -
programmed T cells
aim to hunt, bind
to, and eliminate
cancer cells.59
1987: Ivermectin developed
for parasitic infections in
animals and it is later found
an effective treatment for
river blindness and lymphatic
filariasis in humans, two
debilitating diseases which
affect the world’s poorest
populations.47
1989: Biotechnology
scientists identify the
previously unidentified virus
Hepatitis C, which is now
known to affect about 2% of
the world’s population.51
2011: Approval of direct-
acting antivirals (DAAs), called
protease inhibitors, which,
combined with interferon and
ribavirin, improve cure rates
among patients with the most
common hepatitis C genotype
to 70%.56
2012: First approval of
a TB drug in 40 years,
bedaquiline, unique in
that it interferes with
the enzyme required by
bacteria to replicate.58
2018: RTS,S malaria
vaccine introduced in pilot
immunization programs in
three African countries –
Kenya, Malawi, and Ghana.62
1978: First synthetic ‘human’ insulin
produced, the first human protein to be
manufactured through biotechnology,
enabling patients to avoid the allergic
reactions that insulin from cattle and
pigs could cause.42
18 | 50 YEARS OF GLOBAL HEALTH PROGRESS
Reflecting on 50 years of health progress | 19
BUILDING ON
SUCCESSES AND
SETBACKS
Progress is rarely a steady, straight line. Innovation tends to be messy,
unpredictable, and risky.
For instance, ivermectin was originally developed as a veterinary drug and was
subsequently found to be ideal for combatting two of the world’s most devastating
NTDs, river blindness and lymphatic filariasis in humans. The pneumococcal disease
conjugate vaccine from 1977 that protects against pneumonia was found to be
unsuccessful in children. Decades of development finally brought the breakthrough
PCV7 vaccine licensed in 2000.
Demographic shifts are altering disease burden and complicating progress: movement
of people from rural to urban areas and the growth of the middle class is associated
with reductions in infectious diseases, maternal and child illness, and malnutrition
while more young and middle-aged adults are suffering and dying from NCDs.63
Persistence and perseverance across the ecosystem have underpinned progress.
The industry, like all actors in global health, has needed to play the long game, and
breakthroughs have resulted from the work of many. For example, tackling the
global HIV/AIDS epidemic has relied on resolution to innovate and iteratively improve
antiretroviral treatments, as well as diligent research towards a vaccine.
Mistakes have been made. The industry has learned from these in order to move
forward. This includes the thalidomide tragedy in the 1960s, which resulted in more
structured drug regulations and the development of applications of the drug for
treatment of leprosy and certain cancers.64
The arc of progress since 1968 is evident when considering patient safety and
medicine quality – for instance, the raising of standards through post-marketing
safety surveillance (pharmacovigilance). The number of national pharmacovigilance
centers has increased from just 10 in 1968 to 67 by 2002,65 and legislation has been
passed in many geographies to ensure safe monitoring of medicines.66 Approaches
to pharmacovigilance have evolved from reacting to negative drug responses to
proactively addressing product safety throughout the clinical development process,
before and after approval. Recent product recalls emphasize the need for regulators
and companies to continue pharmacovigilance efforts through the generation and
capture of quality data, improved tools for analysis, and consistent communication of
benefits and risks.67
Advancing patient safety relies on combatting substandard and falsified products,
which damage patients and entire health systems.68 Vulnerable communities are most
affected, with one in 10 medical products circulating in LMICs being substandard or
falsified.69 Industry, multilaterals, and governments work to combat substandard and
falsified products through regulation and governance, building tools and technical
capacity to enforce quality standards in the manufacturing supply chain. For example,
R&D-based pharmaceutical manufacturers are teaming up with organizations offering
mobile-based medicine verification schemes for consumers.70
Patient safety and medicine quality must keep up with the evolution and globalization
of pharmaceutical supply chains, whereby products are manufactured, packaged,
and assembled in different countries, online pharmacies are growing rapidly, and new
business models have increasing operational complexity.
20 | 50 YEARS OF GLOBAL HEALTH PROGRESS
ENSURE HEALTHY LIVES AND
PROMOTE WELL-BEING FOR ALL
AT ALL AGES
Reflecting on 50 years of health progress | 21
PREVENTING DISEASE THROUGH
SAFE WATER AND SANITATION
FOR ALL
PROMOTING SUSTAINABLE
ENERGY FOR HEALTHY HOMES
AND LIVES
SUPPORTING HIGH-QUALITY
EDUCATION FOR ALL TO IMPROVE
HEALTH AND EQUALITY
FIGHTING GENDER INEQUITIES,
INCLUDING VIOLENCE AGAINST
WOMEN
PROMOTING HEALTH
EMPLOYMENT AS A DRIVER OF
INCLUSIVE ECONOMIC GROWTH
ENSURING EQUITABLE ACCESS
TO HEALTH SERVICES THROUGH
UNIVERSAL HEALTH COVERAGE
BASED ON STRONGER PRIMARY
CARE
PROMOTING RESPONSIBLE
CONSUMPTION OF MEDICINES
TO COMBAT ANTIBIOTIC
RESISTANCE
SUPPORTING THE RESTORATION
OF FISH STOCKS TO IMPROVE
SAFE AND DIVERSIFIED HEALTHY
DIETS
EMPOWERING STRONG LOCAL
INSTITUTIONS TO DEVELOP,
IMPLEMENT, MONITOR AND
ACCOUNT FOR AMBITIONS
NATIONAL SDG RESPONSES
PROMOTING NATIONAL R&D
CAPACITY AND MANUFACTURING
OF AFFORDABLE ESSENTIAL
MEDICAL PRODUCTS
FOSTERING HEALTHIER CITIES
THROUGH URBAN PLANNING FOR
CLEANER AIR AND SAFER AND
MORE ACTIVE LIVING
PROTECTING HEALTH FROM
CLIMATE RISKS, AND PROMOTING
HEALTH THROUGH LOW-CARBON
DEVELOPMENT
PROMOTING HEALTH AND
PREVENTING DISEASE
THROUGH HEALTHY NATURAL
ENVIRONMENTS
MOBILIZING PARTNERS TO
MONITOR AND ATTAIN THE
HEALTH-RELATED SDGS
PRIORITIZING THE HEALTH
NEEDS OF THE POOR
ADDRESSING THE CAUSES AND
CONSEQUENCES OF ALL FORMS OF
MALNUTRITION
In tackling the
health care
challenges of the
developing world,
we need to leave our
own ‘comfort zone’
and collaborate
with others, be it in
engaging on health
systems reform or
in partnerships to
bring medicines to
people in resource-
constrained settings.
Thomas Cueni,
Director General, IFPMA73
This 50 year milestone is as much an opportunity to look ahead as it is
to reflect back on progress. Whatever the future may bring – as we live
longer lives, as technology advances, and the world changes in ways we
can only partially understand (see ‘Present to Future’ section) – the world
depends on improved global health to continue to promote prosperity and
enable human progress.
The SDGs, launched in 2015, give greater visibility of the role of the private sector
in a shared societal agenda and emphasize the importance of collaboration across
countries, actors, and sectors for a wider array of development outcomes - health and
wellbeing prime among them. Meeting the highly ambitious 17 goals and 169 targets
by 2030 will require further scientific breakthroughs and strategic innovations.71
Health underpins the common view of the future we want, as articulated in the SDG
agenda for 2030, not only SDG 3 for good health and wellbeing. The R&D-based
biopharmaceutical industry is no stranger to multi-stakeholder partnership and looks
forward to continuing to deliver positive outcomes in collaboration.72
Based on WHO's 'Health in the SDG era' graphic
IN PURSUIT OF CONTINUED,
ACCELERATED PROGRESS
LOOKING AHEAD:
22 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF
PROGRESS
UNIVERSAL HEALTH COVERAGE:
THE FOUNDATION FOR PROGRESS
At the core of SDG 3 is the powerful concept of universal health coverage
(UHC): that patients, wherever they live, should be able to receive the
quality health services they need without suffering financial hardship.
Following a coordinated effort by the global health community in 2016, there is now a
global agreement on how progress towards UHC will be measured. The success of any
health initiative depends on achieving UHC.
Likewise, there is increasing recognition that strong, sound, financially sustainable
health systems generate a healthier and more productive society. One that can access
education and gain skills, enabling their participation in a dynamic global economy.
Health, in this sense, brings wealth.
UHC is also an opportunity for the R&D-based biopharmaceutical industry to redouble
its strong commitment to invest in it. Such investment can be multifaceted:
By discovering new medicines and vaccines to prevent and treat diseases;
By fostering innovation across the continuum of medical education, prevention,
treatment and care, including expanding patient access to quality medicines and
vaccines through innovative solutions;
By sharing its expertise and experience in technology solutions, training of health care
workers, human resources management, logistics and supply chain management,
health literacy, media and communications; and
By participating in multi-sectoral partnerships that encompass actors working on the
environment, transportation, information and communications, and education to
support countries to strengthen health systems, create innovative finance models and
build the bodies of evidence that will be crucial to implementing UHC.
Thanks to global efforts and a collective push, major progress on health service
coverage can be seen, especially in Africa.
Developing more public-private collaborations will enable healthcare companies to
deliver products and services more efficiently, and can accelerate progress towards
reaching UHC.
In the 21st century
people’s expectations
everywhere for
their health are
increasingly equal,
and as such, UHC
is an investment
that allows each
citizen access to
good quality services
without financial
compromise.
Tim Evans,
World Bank Group
24 | 50 YEARS OF GLOBAL HEALTH PROGRESS
VACCINES
Saving, protecting and enhancing lives
STORIES OF PROGRESS:
STORIES OF PROGRESS: Vaccines | 25
In 1796, Edward Jenner carried out what would become one of the most famous medical experiments
when he vaccinated James Phipps against smallpox. Today, vaccines are viewed as one of the most
effective and cost efficient medical technologies ever developed,74 resulting in the control, elimination
or near elimination of numerous infectious diseases.
Immunization saves between two and three million children’s lives per year.75 The continuing development of vaccine
science and growing partnerships for delivery have enabled the benefits of immunization to be realized across the globe,
dramatically decreasing the spread of infectious disease and supporting efforts to achieve global health security. However,
one in five children still miss out on routine life-saving immunization.76
SARA RECEIVES
VACCINATIONS
As a young child, Sara receives routine vaccinations:
polio, meningitis, rotavirus, hepatitis A, hepatitis B,
pneumonia, TDAP (typhoid, diphtheria and pertussis),
MMR (measles, mumps and rubella), BCG, yellow fever,
and Hib. She receives the HPV vaccine when she is 11.
In 1968, Sara would have received far fewer vaccines:
smallpox, polio, measles, mumps and DTP (for
diphtheria, tetanus and pertussis).
Sara hopes her children and grandchildren will benefit
from hoped-for vaccines to protect them from malaria
and HIV/AIDS.
Present Day...
Fifty years ago...
In the future...
TRANSFORMING LIVES
26 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: Vaccines | 27
50 YEARS OF
VACCINES
Research and development is, and always has been, at the heart of immunization
success. Germ theory – the identification of organisms that cause disease - has
been central to vaccine advances in the second half of the 20th century,77 with the
development of the first vaccines for smallpox, diphtheria, tetanus, anthrax, cholera,
plague, typhoid, TB, and polio.
As vaccine science continued to develop during the 20th century, improvements in
cell culture technologies welcomed in a second golden age of vaccines. Scientific
innovations at this time led to the creation of vaccines for measles, mumps, rubella,
hepatitis A and B, chicken pox, pneumonia, and influenza. Notable is the work of
Maurice Hilleman, who developed over 40 vaccines and eight of the 14 routinely
recommended today.78 Hilleman is credited with saving more lives than any other
medical scientist in the 20th century across his career.
Innovation also led to improved vaccine delivery technologies which have helped
reduce the global infectious disease burden. For example, advances in vaccine
thermostability has reduced the need for refrigeration and increased access to vaccines
globally.79 Development of delivery techniques such as microneedles and intradermal
devices has enhanced vaccine effectiveness and make it easier for health workers to
administer immunizations. Combination vaccines have been developed to reduce the
number of shots a child needs while maintaining the same level of protection, such as
the MMR combination vaccine licensed in 1971.80
In the 50 years since IFPMA was founded, smallpox has been eradicated and polio
nearly so across most of the world. Great strides have been made in reducing measles
infections. To date, vaccines have been developed to prevent 26 diseases, including
more recently developed vaccines for hepatitis B, hepatitis A, HPV and meningococcal
group B.81 IFPMA members have been at the forefront of science to achieve these
developments.
The eradication of
smallpox uniquely
combined product
innovation, process
innovation and policy
innovation – with
an unprecedented
level of stakeholder
collaboration.
Mariângela Simão,
WHO
1971: Measles, Mumps and Rubella vaccine approved, providing protection against
three highly infectious illnesses at the same time, via one shot.82
1974: The Expanded Programme on Immunization is established to develop and
expand immunization programs, initially targeting diphtheria, whooping cough,
tetanus, measles, poliomyelitis, and TB, towards the goal of providing universal
immunization for all children by 1990.83
1980: Worldwide vaccination programs result in the eradication of smallpox, a
contagious virus with no known cure, which killed an estimated 300-500 million people
in the 20th century.84
1986: Hepatitis B recombinant vaccine is licensed.85
1988: Establishment of the Global Polio Eradication Initiative, which has contributed
to the 99.9% reduction in global incidence of polio.86
1995: Hepatitis A vaccine is licensed.87
2000: Launch of Gavi, the Vaccine Alliance, a public–private global health partnership
committed to increasing access to immunization in poor countries.88
2000: Pneumococcal conjugate vaccine PCV7 is licensed, tackling one of the biggest
killers of children under five – pneumonia. This breakthrough vaccine improves earlier
versions that did not generate consistent immunity in children.89
2006: HPV vaccine approved in the US, providing protection from cervical cancer, a
common cancer among women under 35.90
2006: Approval of vaccine for rotavirus, the most common cause of diarrheal disease
among infants and young children.91
2012: Global Vaccine Action Plan adopted by World Health Assembly as a roadmap to
prevent millions of deaths by 2020 through equitable access to vaccines.92
2015: First dengue vaccine licenses obtained.93
2015: RTS,S vaccine became the first vaccine candidate to get approved for use
against malaria.94
2016: Americas region is the first region in the world to be declared measles-free.95
2017: The Coalition for Epidemic Preparedness Innovations launched to finance and
coordinate the development of new vaccines to prevent and contain infectious disease
epidemics and contribute to global health security.96
KEY MILESTONES
28 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: Vaccines | 29
ACHIEVING
ERADICATION OF
POLIO
The development of polio vaccines and the effort put into eradicating the disease
shows how innovations and partnerships can come together to eliminate a disease
across much of the world.
Polio is caused by a virus that reproduces in the gut from where it can spread to the
nervous system. In the pre-vaccine era, when poliovirus was the leading cause of
permanent disability in children, almost all children became infected by poliovirus,
with one in 200 susceptible individuals developing the paralyzing poliomyelitis.97
With effective vaccines available, health policymakers began to look at eradicating
polio.98 In 1974, the World Health Assembly recommended the oral polio vaccine
(OPV) as the vaccine of choice.99 In 1985, Rotary International launched their PolioPlus
program financially supporting the public health ambition to rid the world of polio.100
In 1988 the 41st World Health Assembly adopted a resolution for the worldwide
eradication of polio.101 The Global Polio Eradication Initiative (GPEI) brought national
governments, WHO, Rotary International, the US Centers for Disease Control and
Prevention, UNICEF and a number of key partners such as the Bill & Melinda Gates
Foundation (BMGF) together.102 Industry contribution, led by Sanofi Pasteur providing
almost 10 billion doses of OPV worldwide, including more than six billion doses to
UNICEF, has proven to be instrumental in taking polio to the brink of eradication. Since
GPEI was launched, the number of polio cases has fallen by over 99.9%.103 In 1994,
the Americas were certified polio-free, followed by the WHO Western Pacific Region
in 2000, the WHO European Region in 2002, and the WHO South-East Asia region in
2014.104 Poliovirus transmission levels are currently at the lowest point in history and
eradication is a realistic expectation.105
The infrastructure introduced to enable mass immunization has broader impacts in
strengthening delivery of health services. For example, in Nigeria medicines for malaria
are being delivered on a mass scale as part of the infrastructure for delivering the polio
vaccine.106 Evolving and strengthening this infrastructure can support access to a wider
range of medicines and vaccinations.
A SHIFT TO
LIFE COURSE
VACCINATION
- HUMAN
PAPILLOMA
VIRUS VACCINE
A more recent example of vaccine development is the development of the first ever
vaccine targeting cancer. The WHO defines the preventative, life-course approach as
one that aims at increasing effectiveness of interventions throughout a person’s life. It
addresses the causes and not the consequences of ill health at all stages of life.
As NCDs such as cancer, diabetes and Alzheimer’s disease become epidemic in the
ageing populations of both the developed and developing world, research is looking at
vaccines, which have previously been mainly seen as a solution to infectious diseases
for children. This perception can be damaging: In the US, more adults die of vaccine
preventable illnesses than children. Innovation in the industry is shifting to life-course
vaccines to target people’s needs throughout their life as and when they need them. A
life-course approach to immunization can help reduce disease burden, relieve pressure
on caregivers and allow older populations to not only benefit from the preventative
power of vaccines, but remain active members of the community.
The HPV vaccine provides the first great example of a shift in research and
development towards life-course vaccines. In 1976, Harald zur Hausen made the
connection between cervical cancers and infection with HPV (work for which he shared
a Nobel Prize in Medicine in 2008).107 It is estimated that cervical cancer affects more
than 500,000 women each year, 80% of whom live in the developing world.108 Screening
programs have been effective in early stage diagnosis to catch and treat cervical cancer,
but they have been less widely implemented in LMICs than in developed economies.
The HPV vaccine is ideally given to boys and girls at a young age to prevent cancer. In
2006, a quadrivalent (four-strain) vaccine was licensed followed by a bivalent (two-
strain) vaccine for girls in 2007 and in 2014 a nine-strain HPV vaccine was approved.
The impact of immunization on cervical and other HPV-related cancers will be evident
in the next decades – but a marked decrease in HPV infections, precancerous lesions
and genital warts is already dramatic in the vaccinated populations.109
30 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: Vaccines | 31
FUTURE
INNOVATION
Industry is committed to driving vaccine innovation to help achieve global health
security, prevent unnecessary disease and to address challenges presented by ageing
populations. Together, vaccine development and immunization programs can strive to
eliminate, contain, and prevent infectious diseases and NCDs.
The next phase of innovation will be driven by a greater understanding of pathogens and
immune responses as well as data and technology-led developments in research.
Smarter technologies will also play a big role in the development of vaccines in the
future. For example, vaccines that utilize messenger RNA (mRNA) are developing
quickly. They work by providing instructions to our cells to make whatever we need to
prevent disease, including antibodies. mRNA vaccines offer prompt and flexible design,
cost-optimized production, and safer administration.117 Other projects are underway to
bring vaccine adjuvants – which can improve vaccine efficacy by aiding its effect on the
immune system – to market.118 Today there are 264 vaccines in the pipeline in the US
alone, including a mix of life-course and infectious disease vaccines.119
Vaccines can also play a vital role in the fight against AMR, reducing infections and
limiting their transition, enabling less reliance on antibiotics as well as reducing the
inappropriate use of antibiotics for viral infections.
Vaccines remain the safest, most effective, and cost-effective medical technology ever
developed. They are deployed globally to all, regardless of gender or location. Global
vaccination programs have introduced key infrastructure to improve broader access to
medicines in the developing world. Vaccines also offer alternative solutions to life-course
diseases and an ageing population.
The Expanded Programme on Immunization initiated by the WHO in 1974 with the goal
of making vaccines available to all children.112
The founding of Gavi in 2000 by the BMGF, the World Bank, WHO, UNICEF and vaccine
manufacturers including Sanofi Pasteur, Pfizer, MSD, GSK, Novartis and Janssen.113
The creation of the Developing Countries Vaccine Manufacturers Network in 2000 with
the aim of protecting all people against infectious diseases by increasing the quality
and affordability of vaccines for all.114
The Global Vaccine Action Plan’s Decade of Vaccines, 2011-2020, endorsed by 194
member states with the aim of delivering universal access to immunization regardless
of where children were born, who they are or where they live.115
The Humanitarian Mechanism, launched in 2017 by WHO, UNICEF, Médecins Sans
Frontières and Save the Children, to enhance access to vaccinations for traditionally
‘left behind’ populations such as refugees and displaced people.116
IMMUNIZATION
FOR ALL
Today, vaccines are a key part of the ambition for UHC and the UN SDGs to help end
poverty, protect the planet, and ensure prosperity for all. Vaccines offer the opportunity
of truly global and equitable healthcare.
The resurgence of measles in some parts of the world today serves as a reminder of the
potential impacts of infectious diseases, which are easily preventable with vaccines.110
Immunization not only saves lives and improves health, it also unlocks the potential of
the community. A vaccinated community is healthier, stronger, and more productive.
Vaccination reduces the global burden of infectious disease; not only by protecting
vaccinated individuals, but by indirectly protecting unvaccinated individuals through
community protection or ‘herd protection’.111
However, without successful immunization programs and collaborations, the benefits
of vaccine innovation will not be fully realized. The new programmatic approach to
developing the recent dengue and malaria vaccines shows that, more than ever before,
industry needs to work hand-in-hand with governments, civil society, and global health
policymakers to enable the benefits of vaccination to extend to all. Several landmark
initiatives demonstrate the potential for such collaboration and impact, including:
Investment in
vaccines is critical
to address AMR.
Vaccines can prevent
illness and death
and eliminate the
need for the use of
antimicrobials in the
first place.
David Heymann,
London School of Hygiene
and Tropical Medicine
32 | 50 YEARS OF GLOBAL HEALTH PROGRESS
HIV/AIDS
Overcoming one of the worst
human pandemics
STORIES OF PROGRESS:
It has been 36 years since the world was first introduced to the term AIDS. With the first reported cases
of HIV/AIDS (human Immunodeficiency virus / acquired immune deficiency syndrome) in the 1980s, the
world faced a new and unknown virus.
The epidemic was defined by fear and death as HIV infection rates and AIDS-related deaths grew throughout the 1980s
and 1990s.120 As the global response ramped up, thanks to scientific advances and programs targeting those in need, 2005
marked a turning point as the number of AIDS related deaths peaked.121 Although patients in developed countries have
access to treatment and can expect near-normal lifespans, HIV/AIDS remains a particularly heavy burden in sub-Saharan
Africa, where it is the leading cause of death for adults.122
STORIES OF PROGRESS: HIV/AIDS | 33
ZAIN’S HIV/AIDS STORY
Zain was diagnosed, is able to manage his illness and
can expect a near normal lifespan, thanks to starting
combined antiretroviral (ARV) treatment early in the
course of the infection. He now takes a one-a-day pill.
In 1988, Zain would have had a life expectancy of just one
year from diagnosis and would not have had access to
combined ARV treatment.
Zain hopes a vaccine will prevent people like him being
infected with HIV and halt the spread of AIDS.
Present Day...
THIRTY years ago...
In the future...
TRANSFORMING LIVES
34 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: HIV/AIDS | 35
1982: The term AIDS is first used; tracking of disease begins in US.126
The HIV/AIDS epidemic is defined by scientific breakthroughs as well as transformative
partnerships and initiatives that controlled the epidemic through generations:
1984: The retrovirus that causes AIDS is identified.127
1987: The first antiretroviral (ARV) drug, azidothymidine, is approved by the FDA as
treatment for HIV.128
1996: 1996: Combined multi-drug ARV treatment is introduced, changing the course of
the HIV epidemic.129
1996: The Joint UN Programme on HIV and AIDS (UNAIDS) is established, serving as
the main advocate for accelerated global action on the epidemic.130
2001: UN Declaration of Commitment on HIV/AIDS calls for the respect of human
rights of people living with HIV.131
2002: The Global Fund to fight AIDS, Tuberculosis and Malaria (The Global Fund) is set
up, a public-private partnership to attract resources to fund prevention and treatment
in resources limited settings.132
2002: FDA approval of the first rapid home-use HIV testing kit providing results in
twenty minutes.133
2003: Launch of The President’s Emergency Plan for AIDS Relief, a US government
initiative to address the global HIV/AIDS epidemic.134
2003: Approval of new anti-HIV drug, enfuvirtide or T-20, the first in a new class of
drugs designed to prevent entry of the virus into human cells.135
KEY MILESTONES
Breakthrough innovations, notably antiretroviral (ARV) therapy, have had significant impact on confronting the epidemic
and enabling those infected with HIV to live long and healthy lives. Equally important have been partnerships to deliver
access to treatment, care, and education to those most affected around the world.
Patients diagnosed with AIDS in 1990 could expect to live only months, during which time they would be likely to contract a
number of other infections. Today, an HIV infected patient who receives ARV therapy may expect to live a normal lifespan.123
In fact, the HIV/AIDS death rate has dropped by 85% since 1991.124
The global response delivering improved patient outcomes for those with HIV/AIDS has also strengthened healthcare
systems and access more broadly, with knock-on effects of improving gender equality.
2006: The first one-a-day pill to treat HIV is approved in the US.136
2010: Medicines Patent Pool is founded, the first voluntary licensing and patent
pooling mechanism in public health, aiming to improve access to affordable and
appropriate HIV, hepatitis C and TB medicines.137
2012: The first medication to protect those who do not have HIV from infection, called
pre-exposure prophylaxis, is approved.138
2015: UNAIDS announces that the MDG target of 15 million people on life-saving HIV
treatment by 2015 has been met 9 months ahead of schedule.139
2015: Launch of the SDGs, which include a target to end the AIDS epidemic by 2030.140
AIDS RELATED DEATHS PER YEAR
NEW HIV INFECTIONS PER YEAR125
1990
1995
2000
2005
2010
2016
0
1m
2m
3m
4m
36 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: HIV/AIDS | 37
RESEARCH COLLABORATION
Partnerships have played a crucial role in supporting R&D advances for the treatment
of HIV/AIDS, bringing together academia, governments, and industry. The National
Cooperative Drug Discovery Group Programme for the Treatment of AIDS (NCDDG-
AIDS) is a collaboration platform established early in the epidemic. The AIDS Clinical
Trial Group (ACTG) supports clinical trials and laboratory studies in order to set
standards of care for HIV infection.148
TREATMENT FOR VULNERABLE GROUPS
A key challenge has been the development of pediatric ARV formulations. Initiatives
like the Pediatric HIV treatment Initiative (PHTI), The Global Accelerator for Pediatric
formulations (GAP-f) and the Collaborative Initiative for Pediatric HIV Education and
Research (Cipher) aim to close the treatment gap between adults and children.
In 2011, the Global Plan to eliminate new HIV infections among children by 2015 was
launched by organizations convened by the President’s Emergency Plan for AIDS Relief
and The Joint UN Programme on HIV and AIDS (UNAIDS).149 As part of this, companies
pledged funding for programs to ensure access to treatment for pregnant women and
maternal and family planning health services. Pledges included Johnson & Johnson
at USD 15 million,150 and more recently AstraZeneca with USD 10 million over five years
to cover HIV/AIDS.151 The number of children acquiring HIV infection declined from
360,000 in 2009152 to 160,000 in 2016.153
Mother to child transmission is preventable and has been virtually eliminated in the
developed world.154 Saving Mothers Giving Life155 - a public-private partnership between
USAID, MSD, and others - makes strategic investments to reduce deaths of mothers
with HIV. The International Partnerships for Microbicides, a partnership between civil
society, research-based pharmaceutical manufacturers, and research centers develops
HIV prevention products and other sexual and reproductive health technologies for
women with a focus on microbicides.156 Other public-private partnerships include
between ViiV Healthcare and the Pediatric European Network for the Treatment of
AIDS, which develops treatment strategies for children living with HIV including project
EPIICAL, a predictive in vitro platform to treat HIV-infected children, as well as those to
support research and build research and healthcare capacity in pediatrics HIV with the
Clinton Health Access Initiative, Amfar TREAT Asia and the International AIDS Society.157
People practicing intravenous drug use (IDU) remain disproportionately affected
by HIV, accounting for one in 10 new HIV infections worldwide.158 Harm reduction
strategies target IDU by focusing on explicit and peer-based education about the risk
of HIV from sharing injecting equipment, needle syringe programs, drug treatment
(especially opiate substitution treatment), and community development.
PARTNERING FOR DELIVERY
Diagnosis is as important to effective HIV/AIDS treatment as medicines. Currently, only
60% of people with HIV know their status.159 AmpliCare, a public-private partnership
PARTNERSHIPS
ADDRESS THE
FULL LIFECYCLE
OF HIV/AIDS,
DELIVERING CARE
TO THOSE WHO
NEED IT MOST
The HIV/AIDS crisis
triggered a level
of global solidarity
that had not been
seen before. We
must garner the
same support for
non-communicable
diseases.
Mariângela Simão,
WHO
Advances in R&D have transformed HIV from an untreatable and almost uniformly fatal
virus into a manageable, chronic condition. These innovations have extended the lives
of millions of people living with HIV. In the 30-plus years since the discovery of the HIV
virus, more than 30 medicines have been approved to treat the HIV infection. Over
time, medicines have improved in tolerability, efficacy, and convenience for patients.
A major breakthrough was the development of ARV therapy, which works by
preventing HIV from multiplying, reducing the viral load in the body and allowing
the immune system to keep it in check. The first generation of these therapies was
developed in the mid 1980s by Burroughs-Wellcome (now GSK) in collaboration with
the National Cancer Institute.141 Azidothymidine was the first ARV drug to be approved
by the US FDA as treatment for HIV.142
Since then, research has improved both understanding of the disease and its evolution,
simplifying the medication mechanism for patients.143
As understanding of the disease and the effects of ARV on patients grew, a
‘combination therapy’ approach emerged as far more effective than any single drug
treatment. So-called ‘cocktail’ approaches work by combining drugs in different
sequences. The adoption of HAART (highly active antiretroviral therapy) in 1996
inaugurated a new era in HIV treatment.144 The combination approach was quickly
incorporated into clinical practice and has since become the default therapeutic
approach.
Preventing transmission from mother to child also has huge implications for halting
the spread of HIV/AIDS and is another key focus area for R&D. Increased understanding
of ARV therapies allowed the use of treatment on pregnant mothers. Through
increased understanding of ARV therapies it was found that HIV positive mothers
adhering to ARV for several weeks or months before birth could eliminate the risk of
transmission to the baby through pregnancy, birth, and breastfeeding.145
A key challenge has been enhancing access to, and funding for treatment in resource-
scarce communities, including many of the geographies worst affected by the virus.
The development of less costly care regimens has allowed the extension of effective
treatment. For example, NNRTIs (non-nucleoside reverse transcriptase inhibitors) now
provide a lower cost option for LMICs and facilitated treatment expansion efforts.146
Newer classes of drugs include integrase inhibitors, today a recommended first-line
treatment in many cases, which work by preventing the virus from incorporating its
DNA into the host genome.147
R&D AND
INNOVATION:
FROM DEATH
SENTENCE
TO LIFETIME
TREATMENT FOR
PATIENTS
38 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: HIV/AIDS | 39
backed Medicines Patent Pool – and remains a key approach in improving access to
ARVs. ViiV Healthcare’s voluntary licensing approach, for example, enables accelerated
access to the innovative new HIV treatment, dolutegravir, across all LMICs, least
developed and Sub-Saharan African countries.1
Access to treatment grew in the 2000s. By 2006, 28% of those in need in sub-Saharan
Africa received treatment, compared to just 2% in 2003;164 2007 saw a 54% increase in
the number of people in LMICs receiving ARV therapy.165 There is a need for continued
progress in access for LMICs, alongside interventions in prevention, diagnosis and
broader health system strengthening.
STRENGTHENING HEALTH SYSTEMS
Caring for those living with HIV/AIDS extends beyond provision of treatment. Since
1999, the ‘Secure the Future’ initiative run by the Bristol Myers Squibb Foundation has
supported those living with HIV/AIDS in sub-Saharan Africa, with particular focus on
women and children and the links between cervical cancer and HIV.166 The Foundation
has invested USD 181 million to date, partnering with governments and NGOs to build
comprehensive care models through investments at a community level to support
outreach, home based care, and psycho-social support.
UNAIDS highlights the connection between HIV/AIDS responses and human rights.167
Education plays a crucial role in the fight against HIV and AIDS and stigma against
those living with it. It also promotes awareness of how to protect from AIDS,
encourages people to get tested and reduces discrimination against HIV-positive
people. GSK and ViiV Healthcare’s Positive Action programs tackle societal barriers
to addressing the global HIV epidemic such as stigma and discrimination, gaps in
education and sexual health services. The programs support community-based
organizations and NGOs to focus on populations worst affected by HIV such as women
and girls, adolescents, men who have sex with men, transgender people, incarcerated
individuals, sex-workers, and intravenous drug users.168
Botswana is an example where public-private partnerships have improved health
system capacity for treatment and prevention in a country with one of the highest
adult prevalence rates in the world. In 2000, MSD joined with BMGF and the
government of Botswana to form the African Comprehensive HIV/AIDS Partnerships
(ACHAP). ACHAP developed a comprehensive approach to increase prevention and
treatment of HIV/AIDS and care for those infected in support of the government of
Botswana’s response to the epidemic. The MSD Foundation and BMGF committed
to support ACHAP with USD 106.5 million. In addition, MSD donated its antiretroviral
medicines to Botswana’s national ARV treatment program for the duration of the
partnership. Botswana was among the first countries in sub-Saharan Africa to reach
universal access to treatment for HIV.1
Building on this progress, in 2016, ViiV announced an agreement to supply its latest HIV
medicine to support the government of Botswana’s national Treat All program, which
aims to ensure people living with HIV in the country get tested and receive treatment.
between Roche, the Clinton Foundation, USAID, and UNICEF aims to address barriers
that prevent early diagnosis of infants with a focus on sub-Saharan Africa.160 Roche has
redesigned its tests, developed a novel methodology for gathering and transporting
blood samples, as well as introducing SMS technology for test results. This has resulted
in expanded access to diagnosis in the remotest areas, where over six million infants
have been tested for HIV.
Despite the breakthroughs in treatment, by 2000, less than one million of the 34 million
people living with HIV/AIDS161 were accessing ARV therapy.162 In particular, many in
developing countries were left behind as treatments were not accessible.
In 2000, UNAIDS, WHO, Boehringer Ingelheim, BMS, Roche, GSK and MSD announced
a plan to improve access to treatment – the Accelerating Access Initiative (AAI). The
program, which concluded in 2012, applied preferential pricing to ARVs, opening the
door to a new future of access to ARV medicines in developing countries and laying the
foundation for future access to medicine initiatives.163
Many companies have made commitments reflecting the need for affordable
treatment options for the most affected countries. One mechanism to improve
access to ARVs is voluntary licensing agreements whereby the patent holder grants a
voluntary license over product patents in certain countries to generic manufacturers,
which enables them to develop, manufacture and sell generic versions of the licensed
product(s) in resource-limited settings. GSK gave the first voluntary license in 2001
for Retrovir, Epivir and Combivir in South Africa. Within a year there was a significant
increase in supply and reductions in ARV prices in the developing world. The scope and
approach to voluntary licensing agreements has continued to evolve – both directly
between patent-holding companies and generic manufacturers, and through the UN-
40 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: HIV/AIDS | 41
UNAIDS outlines the priority challenges for the next decade in their ambitious 90-90-90
targets for 2020:171
To get there, many look to industry and partners for additional pre-exposure options, a
cure or vaccine, and support closing the gap in treatment.
THE SEARCH FOR A CURE
While current treatments enable patients to live longer lives, the search for a cure
continues. Researchers have successfully lowered levels of the virus to undetectable
levels in certain children for a period of time,172 though there has not yet been a
confirmed case of an infant totally cured. AIDS researchers continue to improve our
understanding of how interventions can best impact infant immune system responses
to HIV. Many R&D eradication efforts focus on ‘flushing’ the HIV virus out of latently
infected cells, which are often seen as the major barrier to cure. This so called ‘shock
and kill’ technique works by ‘waking up’ inactive cells, forcing them to produce new
virus particles that are susceptible to current antiretroviral drugs. Several techniques
for this are in development with research ongoing into cytokine therapy, valproic acid,
and histone deacetylase inhibitors.173
VACCINE DEVELOPMENT
The development of a vaccine holds promise but has proven elusive due to the genetic
diversity of the virus and its ability to rapidly mutate.174 The International AIDS Vaccine
Initiative brings together public and private actors to research, design and develop
vaccine candidates.175 Researchers are optimistic that a vaccine will be found in our
lifetime. For example, Johnson & Johnson is working to develop a mosaic-based
vaccine is yielding encouraging results from clinical studies and is progressing to the
next phase of clinical development.176
CLOSING THE FUNDING GAP
Of the 37 million people globally living with HIV, 21 million have access to ARV therapy
– and more year-on-year. Yet, millions still lack access to therapy, many in LMICs. It
is estimated that just 12 million of the 25 million living with HIV/AIDS in Africa receive
ARV therapy.177 UNAIDS estimates the funding gap for HIV in LMICs over the 2015
to 2020 period stands at USD 26 billion, and it looks to public and private partners
to ensure the gains in R&D innovation do not exclude those in need of existing or
older treatments.178 Individual R&D-based pharmaceutical manufacturers – through
licensing, pricing initiatives and various partnerships – continue to seek to improve
access for LMICs, alongside critically needed interventions in prevention, diagnosis
and broader health system strengthening. Only a holistic approach will ensure critical
treatments are available to all people in need.
of all people living with
HIV know their HIV status
of all people receiving ARV
therapy will have viral
suppression
of all people diagnosed
with HIV infection receive
sustained ARV therapy
90%
90%
90%
Ending the AIDS epidemic by 2030, as set out in SDG target 3.3, will only be achieved
with innovation and multi-sector partnerships.169
Despite the array of effective HIV prevention tools such as male and female condoms,
pre-exposure prophylaxis, voluntary male circumcision, and behavior change
interventions (e.g. the use of clean needles), 1.8 million people became newly infected
with HIV in 2016.170
2030: THE END
OF THE AIDS
EPIDEMIC?
42 | 50 YEARS OF GLOBAL HEALTH PROGRESS
NEGLECTED TROPICAL DISEASES,
MALARIA AND TUBERCULOSIS
Thinking beyond traditional models
STORIES OF PROGRESS:
NTDs, malaria, and TB carry significant social and economic burdens, despite the fact that many of these
diseases can be effectively controlled, and in many cases, eliminated. Because these diseases
disproportionately affect vulnerable people, mainly in LMICs, they do not receive the same level of attention
as other diseases.
These diseases worsen and reinforce poverty, persisting in populations with limited access to adequate sanitation or medical care
and in close contact with infectious vectors and domestic animals and livestock.
Women, children, and HIV/AIDS sufferers are most likely to be infected by NTDs. Women are particularly likely to be affected due to
gendered roles which expose them to transmission, such as caring for sick children, cleaning of materials likely to carry infection, or
collecting water.179 The majority of malaria deaths are in children under five and one million children catch TB each year. Sick children
miss out on school, illness reduces families’ earnings, and diseases are a huge burden on already fragile healthcare systems.
STORIES OF PROGRESS: NTDs, Malaria and Tuberculosis | 43
NISHA’S EXPERIENCE WITH
LYMPHATIC FILARIASIS, A
NEGLECTED TROPICAL DISEASE
Nisha receives treatment for the disease through
donations received as part of the London Declaration.
In 1998, Nisha might not have had access to treatment
and would have lived with this debilitating disease all of
her life.
Nisha hopes that partnerships will continue to provide
access to treatment for everyone suffering from lymphatic
filariasis (LF), enabling it to be eradicated globally.
Present Day...
TWENTY years ago...
In the future...
TRANSFORMING LIVES
44 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: NTDs, Malaria and Tuberculosis | 45
INNOVATIVE
RESEARCH
MODELS
A central challenge for this group of diseases is the lack of competitive markets for
vaccines and medicines in the LMICs where the diseases are most prevalent. In spite of
these challenges, R&D-based biopharmaceutical companies are working to accelerate
the elimination or control of these diseases through the discovery of new treatments
and interventions through innovative mechanisms, including product development
partnerships (PDPs), IP sharing and open innovation, and programs to expand access
in endemic countries.
Companies foster R&D by sharing IP assets, compound libraries, access to research
facilities, hosting scientists and providing training. Additionally, the private sector has
transferred technology and built technical expertise to develop, manufacture, register
and distribute products. The Tres Cantos Open Lab Foundation allows independent
researchers to access GSK facilities, resources, and expertise to advance research into
TB, malaria and kinetoplastid infections.180 Similarly, the Novartis Institute for Tropical
Disease is a collaborative research centre, where academic institutions such as the
University of Singapore and non-profits such as the TB Alliance work together with
Novartis scientists to develop new therapies.181 WIPO Re:Search is a global consortium
of over 100 companies, academia, research centers, non-profits and government
agencies that facilitates sharing of know-how, technologies, and bridge research
gaps.182 To date, 95 research collaborations have been established through WIPO
Re:Search by BIO Ventures for Global Health.183
Innovative collaborations have tremendous potential to advance progress towards
new drugs and diagnostics addressing neglected diseases. 90% of NTD related
programs in which IFPMA members are active are collaborative efforts which involve
over 50 organizations, including universities, NGOs, and public and private sector
institutes.184
The first of its kind in Japan, the Global Health Innovative Technology (GHIT) Fund, is a partnership between the BMGF,
the Japanese government, pharmaceutical companies, the Wellcome Trust and UNDP.185 The fund invests and manages a
portfolio of development partnerships, mobilizing Japanese and international pharmaceutical companies and academic
organizations to get new medicines, vaccines, and diagnostic tools to people afflicted by NTDs.
An innovative public-private partnership
PARTNERING FOR
DELIVERY
In many cases, methods to prevent, diagnose and treat these diseases are known.
Much harder, yet equally essential to eradication, is ensuring access to interventions.
This is where innovative partnerships are important.
Many R&D-based pharmaceutical companies have committed to drug donations until
diseases are eliminated. The progress realized through these global donation efforts
demonstrates the power of strategic collaboration in reducing the impact of NTDs on
health and society.
Partnerships and collaborative efforts such as The London Declaration on Neglected
Tropical Diseases (The London Declaration), USAID Neglected Tropical Diseases
Programme, Medicines for Malaria Venture (MMV) and the Stop TB Partnership bring
together public, private, and civil society actors to improve access to treatments,
capacity building and policy advocacy. These are essential to end these diseases.
The success of drug distribution campaigns relies on an integrated treatment approach.
In the past, many countries conducted separate treatment campaigns for individual
diseases. Now, many programs provide treatments for several diseases at the same
time. For example, a national program can treat all children in a region for intestinal
worms, onchocerciasis and LF in a single school visit. These large-scale campaigns also
offer an opportunity to reach people with other health interventions and can support
country progress towards stronger health systems and UHC.186
46 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: NTDs, Malaria and Tuberculosis | 47
2003: The term ‘neglected tropical diseases’ is coined by Peter Hotez and colleagues to
counterbalance the attention given to HIV/AIDS, TB and malaria.192
2007: First Global Partners’ Meeting on NTDs held at WHO headquarters in Geneva,
bringing together over 200 public and private institutions dedicated to contributing their
time, efforts, and resources to control neglected tropical diseases.193
2009-13: USAID launches Neglected Tropical Diseases Initiative committing USD 350 million
to deliver integrated NTD treatment to 300 million people in Africa, Asia, and Latin America.194
2012: WHO NTD Roadmap sets targets and milestones to control, prevent, eliminate, and
eradicate NTDs.195
2012: The London Declaration on Neglected Tropical Diseases (The London Declaration):
14 billion treatments pledged and commitment to control, eliminate or eradicate 10
debilitating NTDs responsible for more than 90% of the burden by 2020.196
2013: Development of high-quality diethylcarbamazine citrate tablets for treatment of
LF, with a formulation suitable for worldwide distribution.197
2015: The number of people requiring treatment and care for neglected tropical diseases
falls 21% since 2010, to 1.6 billion people.198
2016: Approval of new child-friendly chewable tablet formulation for children infected by
intestinal worms (soil-transmitted helminthiasis).199
2017: Clinical trial results show efficacy and safety of fexinidazole, the first oral
monotherapy for Human African Trypanosomiasis, which could avoid the need for
lumbar puncture and for systematic hospitalization of patients.200
2017: NTD Summit (Geneva): half-way to The London Declaration, which has been
awarded the title of ‘biggest donation’ ever by Guinness World Records.201
WHO LIST OF
UPDATED 2017
NEGLECTED TROPICAL DISEASES
PROTOZA
Chagas Disease
Human African trypanosomiasis
(sleeping sickness)
Leishmaniasis
ADDED IN 2017
Mycetoma, chromoblastomycosis
and other deep mycoses
Scabies and other ectoparasites
Snakebite envenoming
BACTERIA
Buruli Ulcer
Leprosy (Hansen’s disease)
Trachoma
Yaws (Endemic
treponematoses)
VIRUSES
Dengue and Chikungunya
Rabies
HELMINTH
Dracunculiasis (guinea-worm disease)
Echinococcosis
Foodborne trematodiases
Lymphatic filariasis
Onchocerciasis (river blindness)
Schistosomiasis
Soil-transmitted helminthiases
Taeniasis/Cysticercosis
One in seven people suffer from an NTD,202 with the vast majority of cases in LMICs
where parasites, bacteria and viruses thrive in subtropical climates. NTDs are painful
and can blind, disfigure, and cause severe and permanent disabilities. Disfiguring
NTDs such as Buruli ulcer, yaws, and leprosy are frequently associated with stigma,
increasing the burden of disease.
Progress has been made in eradicating NTDs with the elimination of some diseases
in certain geographies. A notable milestone was the discovery that ivermectin for
parasitic infections could be used to treat river blindness and lymphatic filariasis (LF)
in humans. There was no market as those infected were too poor to pay, so MSD made
an open-ended commitment to give away as much of the drug as necessary until
river blindness is eliminated.203 Similar commitments followed. In 2017 the Japanese
pharmaceutical company Eisai renewed its pledge to donate diethylcarbamazine until
the global elimination of LF is achieved.204 GSK has donated eight billion tablets of
albendazole to date to prevent LF and control intestinal worms and has also pledged
to donate albendazole to every country that needs it until LF is eliminated. Lymphatic
filariasis transmission has now been eliminated in 11 countries including China, Costa
Rica, Egypt, South Korea, Sri Lanka, and Thailand.205
The Drugs for Neglected Diseases Initiative (DNDi) works in partnership with industry,
research institutions and the public sector on the most neglected diseases. This
includes Human African Trypanosomiasis (HAT), leishmaniosis and Chagas disease,
which fall outside the scope of market-driven R&D.206 USAID Neglected Tropical
Diseases Programme delivers integrated NTD treatment to 300 million people in Africa,
Asia and Latin America and reached two billion treatments by 2016.207
The breakthrough
global collaborative
effort to control
river blindness
responded to the
links between
disease and rural
development and
for the first time
recognized health as
an investment with a
positive return.
Tim Evans,
World Bank Group
1971: Benznidazole introduced for the treatment of Chagas disease.187
1975: Development of albendazole for treatment of parasitic worm infections
including cysticercosis.188
1986: Approval of clofazimine to treat leprosy, a key constituent of multidrug therapy
(MDT) alongside rifampicin and dapsone.189
1987: Development of ivermectin (also known as Mectizan®) for parasitic infections in animals
and finds it can be used to treat river blindness in humans and LF. Established the Mectizan®
Donation Programme to provide ivermectin to all who needed it, for as long as needed.190
1998: Azithromycin begins to be prevalently used as a first-line response for eliminating
blinding trachoma.191
NEGLECTED
TROPICAL
DISEASES
KEY MILESTONES
48 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: NTDs, Malaria and Tuberculosis | 49
1972: Chinese scientist Tu Youyou discovers artemisinin, a cornerstone of malaria
treatment.
1979: Clinical trials of artemisinin published.218
1985: First large-scale trials of insecticide treated nets.219
1992: The RTS,S malaria vaccine enters clinical trials.220
1998: Launch of the Roll Back Malaria Partnership.221
MALARIA
KEY MILESTONES
In addition to the donations by MSD, GSK and Eisai, a number of other programs focus
on the elimination of particular NTDs:
Bayer works with WHO to tackle Chagas disease and African Sleeping Sickness, both of
which are completely curable in the early stages with drugs.208
Pfizer partners with the International Trachoma Initiative - an independent NGO
dedicated to eliminating trachoma - to donate antibiotics and work with agencies to
implement the WHO recommended SAFE (Surgery, Antibiotics, Facial Cleanliness, and
Environmental improvements) strategy for trachoma control.209
Merck KGaA works to fight schistosomiasis in Africa through its ‘One Merck for
Schistosomiasis’ program, which includes the development of a pediatric formulation
of praziquantel via a consortium of partners to treat children younger than 6 years old
and the development of innovative schistosomiasis diagnostics in association with the
current efforts of the BMGF.210
Johnson & Johnson co-founded Children Without Worms to tackle soil-transmitted
helminthiases through interventions including mass drug treatment and preventative
chemotherapy.211
Sanofi has initiated partnerships to address HAT including with the WHO to donate
existing drugs and with DNDi to develop a new oral treatment.
Novartis, through partnering with WHO, has committed to deliver Multi Drug Therapy
for leprosy to 1.3 million people by 2020.212
More and more countries are eliminating these diseases. River blindness and Chagas
disease have been eliminated from several countries in the Americas.213 Morocco,
Cambodia and the Lao People’s Democratic Republic have eliminated trachoma as a
public health problem.214 In 2015, India was the first country to be declared yaws-free.215
Progress has been enabled by the large-scale donation of medicines. In 2015, nearly
a billion people received donated treatments for at least one NTD.216 The London
Declaration is a flagship partnership for driving control or elimination of NTDs. The
industry is delivering on its promise of 14 billion donated treatments (USD 7 billion
worth of medicine) over 10 years. Millions of health workers and community volunteers
have been trained, strengthening health systems in the poorest communities to ensure
appropriate treatment and care. The London Declaration has been awarded the title of
‘biggest donation’ ever by Guinness World Records (April 2017). By 2020, nearly USD 18
billion worth of medicines will have been distributed, the largest medicine donation the
world has ever seen.
Preventative chemotherapy is one of the interventions deployed by the WHO,
involving administering six medicines in seven different combinations, to combat at
least five NTDs. Since the integrated approach began in 2008, 14 previously endemic
countries have been declared free of at least one NTD that is receptive to preventive
chemotherapy.217
1999: The Medicines for Malaria Venture launched to develop antimalarials for the
most vulnerable populations.222
2000: The UN General Assembly adopts the MDGs, setting a target to halt and begin
reversing malaria incidence by 2015.223
2001: The first artemisinin-based combination therapy (ACT) is brought to the
global market.224
2002: Launch of The Global Fund, the world’s largest financier of anti-AIDS, TB,
and malaria programs.225
2008: Launch of Global Malaria Action Plan, the first comprehensive blueprint for
global malaria control and elimination.226
2009: Launch of the first high-quality ACT formulated especially for children.227
2015: The RTS,S vaccine is the first malaria vaccine candidate to receive positive
scientific opinion from the European Medicines Agency (EMA).228
2015: WHO reports that since 2010, 60 countries have reported mosquito resistance
to at least one insecticide class and of these, 50 reported resistance to two or more
insecticide classes.229
2017: Regulatory application submitted for tafenoquine, the first new medicine for the
radical cure (prevention of relapse) of P vivax malaria in patients aged 16 and older in
more than 60 years.230
2018: RTS,S vaccine introduced in pilot immunization programs in three African
countries – Kenya, Malawi, and Ghana.231
50 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: NTDs, Malaria and Tuberculosis | 51
1970: First outbreak of drug-resistant TB in the US.
1993: WHO declares TB ‘a global emergency’ with deaths from TB higher than any
previous year.
2002: Launch of Global Fund to fight HIV/AIDS, TB, and Malaria.
2005: The number of deaths annually from TB peaks worldwide at 2 million.
2010: Launch of the Gene Xpert molecular test for TB,243 a rapid test which is endorsed
by WHO and hailed as a major breakthrough.
2012: The first approval of a TB drug in 40 years, bedaquiline, unique in that it
interferes with the enzyme required by bacteria to replicate.244
2014: Approval of delamanid, for active multidrug resistant TB, which is added to the
WHO’s essential medicines list.245
2015: WHO launches the ‘End TB’ strategy with the goal of ending the TB epidemic
by 2035.246
2018: (March) Delhi TB Summit; (September) First ever UN High-level meeting on TB in
New York City.
TUBERCULOSIS
KEY MILESTONES
Although TB has long been preventable and curable. it is the ninth leading cause of
death worldwide and the biggest infectious killer, above HIV.247 In 2015, 10.4 million
cases (one million children) and 1.8 million deaths (170,000 children, not including
those with HIV) occurred from TB.248 LICs and LMICs see 95% of TB deaths.249
An estimated 53 million lives have been saved through TB diagnosis and treatment
between 2000 and 2016.250 Drugs included in first-line TB treatments were developed
more than 30 years ago. Current treatments for multi-drug TB require patients to take
multiple antibiotics for nine to 24 months or longer, are complicated to administer,
and have significant adverse effects. Many patients stop their drugs before the bacteria
have been destroyed, which can further encourage drug resistance. Shortening
treatment regimens is a priority.
Malaria is caused by parasites transmitted from the bites of infected mosquitoes.
Malaria costs the African economy more than USD 12 billion every year.232 In countries
with high malaria rates, economic growth is slowed by 1.3%.233 Malaria control is
increasingly recognized as an important tool for poverty reduction - households in
Africa lose up to 25% of their income to the disease.
Between 2000 and 2015, the rate of new cases of malaria fell by 37% globally.234
Since 2000, eight countries have eliminated malaria and many others have reduced
transmission to low levels.235 However, malaria remains one of the world’s biggest killers.
Treatments have helped reduce malaria deaths. The current WHO-recommended
first-line treatment for malaria, artemisinin, was discovered in in 1972 by Tu Youyou, a
Chinese scientist who was awarded a Nobel Prize in 2015 for her discovery. Artemisinin
is particularly effective when combined with other medicines in artemisinin-based
combination therapy (ACT), which the standard treatment for malaria today. Novartis
started producing it in the late 1990s and began marketing it in the 2000s. Alongside
the discovery of novel treatments, continuous investment in R&D is needed for new
pediatric formulations given that children and pregnant women are most at risk of
contracting malaria. In 2009, Novartis, in partnership with The Medicines for Malaria
Venture (MMV), launched the first dispersible ACT formulated for babies and children.236
New drugs to treat and prevent malaria in children are in development by the likes
of Merck KGaA, who leverage the screening of compound libraries to identify new
candidates.237
MMV is one of the most well-known PDPs, launched in 1999 to develop antimalarials
for vulnerable populations. In 2008, MMV in partnership with Sanofi and DNDi,
launched the first anti-malarial drug resulting from a public-private partnership:
a fixed-dose combination of artesunate and amodiaquine which enables better
adherence to treatment and reduces the risk of resistance by avoiding selective use
of a specific component.238 MMV also works with GSK to develop tafenoquine to cure
relapsing P. vivax malaria, submitted for regulatory approval in both the US and
Australia in 2017. If approved, tafenoquine would be the first new medicine for the
prevention of relapse of P vivax malaria in more than 60 years.239
Control of malaria will be significantly aided by the development of a vaccine. After
more than 30 years of research, GSK, along with partners Programme for Appropriate
Technology in Health, Malaria Vaccine Initiative and the BMGF, is close to bringing
a vaccine to endemic countries. RTS,S is the first, and to date, only vaccine to show
partial protection against malaria among young children. The vaccine is being made
available from 2018 through routine immunization programs to young children in
Ghana, Kenya and Malawi.240
The industry recognizes that the elimination of malaria requires action in a number of
different areas, not just treatments and vaccines but increasing access to antimalarials,
equipping hospitals, supporting improved sanitation, training of health workers, and the
strengthening of health systems. Ensuring access to vector control tools such as bed nets
is fundamental to reducing cases of malaria. RBM is a global platform for coordinated
action, with 500 members including the private sector, NGOs, community organizations,
foundations, and research institutions. So far 70 campaigns distributed free treated bed-
nets to all households in areas with malaria since 2000.
The disease does not stand still. Antimalarial resistance is a real and growing threat
to hard won progress. For the first time in 10 years, global malaria cases are no longer
falling, driven in part by drug resistance.242 New funding mechanisms and tools such
as advanced mosquito surveillance using genetic sequencing will be needed to ensure
the world does not see a resurgence of the disease.
History has shown
that with malaria
there is no standing
still—we move
forward or risk
resurgence.
Bill Gates,
Bill and Melinda Gates Foundation241
52 | 50 YEARS OF GLOBAL HEALTH PROGRESS
STORIES OF PROGRESS: NTDs, Malaria and Tuberculosis | 53
THE PATH TO
ERADICATION
Despite progress, much remains to be done to meet SDG target 3.3 to end epidemics
of TB, malaria and NTDs by 2030. The challenge consists of two missions: delivering
health services for prevention and those living with diseases and eliminating
transmission by addressing resistance and vaccine development.
Neglected diseases thrive in areas that lack adequate sanitation. About 2.4 billion
people do not have access to adequate washing facilities. Hygiene can reduce
transmission of the bacterial infection that causes trachoma. Breeding sites for
mosquitoes are reduced through improved water management, limiting transmission
of mosquito borne diseases. Protecting freshwater resources can prevent transmission
of schistosomiasis. Improving access to water, sanitation, and hygiene (WASH) will be
crucial to combat NTDs, as set out in the WHO’s strategy in 2015.254
Climate change, growing megacities, and conflict present a challenge to meeting
control and elimination targets. Overcrowding and poor hygiene and sanitation
facilitate the spread of diseases. It is expected that climate change will increase the
malaria burden in several regions of the world, particularly densely populated tropical
highlands. An increase in NTD cases (including dengue fever and Chagas disease)
in southern Europe is likely due to changing climate. Given the projected growth in
the size of the world’s population by 2030, more people will be living in areas at risk
of neglected diseases, putting further strain on overstretched health systems and
program budgets. War and refugee zones can increase exposure and susceptibility
to infection. New approaches must deliver interventions in less time, provide flexible
funding, and empower communities to administer care when external support is
unavailable.
These diseases are not restricted to LMICs; many are found among the poor living in
G20 nations. Estimates suggest that 12 million people in the US live with at least one
poverty-related neglected or emerging disease.255 NTDs can only be eradicated if all in
wealthier nations receive the treatment and care they need.
Comorbidity also remains a challenge. HIV patients are at greater risk of TB and
malaria. The risk of death in co-infected individuals is twice that of HIV infected
individuals without TB.256 There is a need to find new and improved treatments and
interventions to tackle this joint disease burden.
Tackling sub-standard drugs and vaccines development remain critical to addressing
drug resistance, given that antimalarials and antibiotics are the most commonly
reported sub-standard or falsified products.257 These medicines are at best ineffective,
and at worst, can result in death. They also contribute to AMR and drug-resistant
infections and reduce patient confidence. Drug resistance presents a major challenge
to eradicating TB and malaria. The need for ongoing innovation and a robust pipeline
for treatment will become more urgent as strains become resistant to traditional
treatments.
The inadequacy of current diagnosis has challenged efforts to contain the spread of
TB and forms a core component of the WHO’s End TB strategy. Janssen, a company
of Johnson & Johnson, has partnered with the non-profit FIND to increase access to
molecular diagnostics tools for TB case detection and multi-drug resistant TB (MDR-TB)
diagnosis.251
Drug resistance is another growing threat. Each year, there are roughly half a million
new cases of MDR-TB, many of them transmissible. Breakthroughs by Johnson &
Johnson and Otsuka have recently emerged: two new medicines (bedaquiline and
delamanid) have been approved for the treatment of MDR-TB under programmatic
conditions in numerous countries, with both added to the WHO’s Essential Medicines
List. A priority is getting these new treatments to patients by broadening sustainable
and responsible access.
Other resource sharing programs include Eli Lilly’s technology transfer program,
which began in 2003 to provide R&D-based pharmaceutical manufacturers in MDR-TB
‘hot spots’ (China, India, Russia and South Africa) with trademarks, technology and
know-how.252 The BIO Ventures for Global Health partnership hub which brokered
discussions between the Centre for World Health & Medicine (CHWM) and GSK, both
work on methionine aminopeptidases (MetAP) as a drug target for TB. GSK tests
identifying inhibitors of MetAP had disappointed and CWHM consequently placed its
MetAP inhibitor on hold to avoid repeating experiments, saving money and time.253
The PreDICT-TB Consortium, a public-private consortium, is working to overcome
the barrier of inaccurate prediction of clinical effectiveness by currently available
laboratory methods in order to speed up the identification of the most effective
combination of new drugs.
The TB Drug Accelerator is an effective example of pre-competitive collaboration and resource sharing, through which the
expertise of partner organizations is leveraged to speed the development of medicines. The TB Drug Accelerator, launched
in August 2012, is a BMGF sponsored discovery consortium of nine pharmaceutical companies (GSK, AbbVie, AstraZeneca,
Bayer, Eisai, Eli Lilly, MSD, Sanofi, and J&J) and major academic organizations to speed up discovery and development of
novel compounds against TB. Through early-stage TB research collaboration, it aims to develop five new pre-clinical drug
candidates with treatment-shortening potential within five years, and proof-of-concept for a one-month three-drug regimen
within 10 years. Members have opened up access to TB compound libraries to enable collaborative screening and data
sharing. The TB Drug Accelerator aligns asset progression across portfolios so that members work to accelerate the most
deserving discovery programs, regardless of where the drug originated, to avoid duplication. Coordinating previously siloed
research teams and sharing knowledge of fundamental biology, screening capability and drug discovery resources has led to
faster development timelines.
pre-competitive collaboration
There a number
of new medicines
and diagnostics in
the pipeline, which
may change the
perspective for these
neglected tropical
diseases and hopefully
allow us to go
further towards
eliminating or near
eliminating these
diseases by 2030.
Dirk Engels,
Director of Neglected Tropical
Diseases, WHO258