MSD AIA Forum - 2009 Brochure

1
MSD FORUM on
Access, Innovation and
Affordability of Medicines
Munich, 2007
Istanbul, 2008

3
CONTENTS
Introduction 4
Government Official/MSD Statements – Highlights 6
ACCESS TO MEDICINES 10
Access to Healthcare – a European Patient Perspective 12
Access to Healthcare – a Developing World Perspective 16
Access to Healthcare – Patients Empowerment 18
ACHAP – The African Comprehensive HIV/AIDS Partnerships 22
INNOVATION 24
Pharmaceutical Innovation in the 21st Century 26
What is the Future of Biopharmaceutical R&D? 28
What is the Future of the Pharmaceutical Business Model? 32
A New Golden Era in Vaccines? 34
The Functional Innovation System Model – Benchmarking Exercise 36
AFFORDABILITY OF MEDICINES 42
Healthcare Financing: What do Citizens Want? 44
Health Policy in Emerging Economies 46
What is the Future of our Healthcare Systems? 50
Competitiveness Strategies for Emerging Economies – The Link with Health Care 54
Corporate Responsibility 60

“How can we bring the best of medicine to each and every
person? We cannot rest till the way has been found, with our
help, to bring our finest achievements to everyone.”
George Merck
MSD Forum on
Access, Innovation and Affordability of Medicines
INTRODUCTION
4

5
At MSD1
, our business is discovering, developing and delivering
novel medicines and vaccines that can make a difference in
people‘s lives. We believe that we can bring value to the debate
about access, innovation and affordability of medicines, three
issues of utmost importance for our health and our future.
Medicines are at the crossroads of health, research and industri-
al policies. Therefore, our mission can only be achieved through
partnership with other key stakeholders in the health field.
With this in mind, in 2007, MSD launched a series of
annual conferences to provide a platform where patients,
physicians, governments, NGOs and the private sector can
exchange experiences and opinions on key health policy
issues. We have called this platform the Forum on Access,
Innovation and Affordability of Medicines, as these are the
three pillars of pharmaceutical policy.
The purpose of this brochure is to capture the outcome of
our discussions in Munich 2007 and Istanbul 2008.
ACCESS
For patients, rapid access to innovative therapy represents
the most important and immediate issue. Today, even in inte-
grated communities such as the European Union, patients of
different nationalities experience different levels of access
to healthcare. This can only change if patients are given a
1 MSD is known in the US as Merck & Co., Inc.. It is based in Whitehouse Station, NJ
more prominent role to ensure that our healthcare system is
built for, and remains at the service of patients.
INNOVATION
Pharmaceutical innovation is one of the major sources of
the longevity gains we have enjoyed in the last fifty years.
But pharmaceutical innovation does not happen by chance.
Before medicines can be made accessible and affordable,
they must first be invented. In the course of the last century,
only a few countries have achieved the creation of a fully
integrated pharmaceutical research & development plat-
form thanks to the right mix of policies and investments.
Traditionally, the world has relied upon these countries for
their pharmaceutical needs. Thanks to globalization, we are
now witnessing the emergence of new participants in the
race for innovation, as companies from emerging markets
are developing a research base in specific segments of the
pharmaceutical innovation pipeline.
AFFORDABILITY
On a daily basis we experience that even in economically
stable regions, the existing healthcare delivery models are
pushed to their limits. We need to develop innovative health-
care models to sustain and grow our social compact along
with citizens’ growing demands.
Further information can be accessed at
www.msd-forum.com

Government Official/MSD statements –
Highlights
6
“How can we ensure that we have the best innovation
platform in order to develop new medicines? Once
medicines are developed, how can we increase access
for the patients who need them? And how can we pay
for access to innovation?
These are the urgent issues that we, as patients, as
taxpayers and as innovators are facing today.”
Dr. Stefan J. Oschmann
President Europe, Middle East, Africa & Canada,
Merck & Co., Inc. (USA)
“Despite amazing progress and success, numerous
challenges remain. First, as we grow older, our health
problems shift to new research frontiers and challenges.
Second, new infectious diseases and epidemics continue
to appear globally. Third and most important, we do
have a huge collective effort to ensure that our knowledge
and technological prowess reach those in greatest need.
How we prepare today to respond to these growing
threats and issues will shape our future.”
Kenneth C. Frazier
Executive Vice President & President, Global Human
Health, Merck & Co., Inc. (USA)
Government Official/MSD Statements – Highlights

7
“Our investment program, “Bavaria 2020” will drive a
1.5 billion Euro investment. Today, MSD can already
build on an excellent infrastructure of universities,
clinics and research institutes in Bavaria. I warmly
invite you to make use of the contacts in the biotech and
the medical technology clusters and actively participate
in these networks.”
Emilia Müller
Bavarian Minister of Economic Affairs, Infrastructure,
Transport and Technology
“We all have the same vision and we all pursue
a common objective: to protect public health and to
provide patients with faster access to better and inno-
vative medicines. For this, pharmaceutical companies,
academia, clinical centres, small and medium sized
enterprises, patient organisations and public authorities,
including regulators, should all work closely together.
Only in this way we will be able to achieve the best
results possible towards our common objective.”
Dr. Martin Terberger
Head of Unit European Commission Enterprise and
Industry DG Pharmaceuticals Unit

8
Government Official/MSD Statements – Highlights
“Patient access to health is a priority for our government.
In the last couple of years we increased the resources in
this area and we still have a long way to go.”
Dr. Recep Akdag
Minister of Health of the Republic of Turkey
“The Health economy is one of the largest sectors in
Europe and will continue to grow. An ageing society,
continuous medical progress and the increasing public
demand for health provision and services provide us
with significant opportunities in the future. There is still
a lot to do to reduce the level of regulation which
hinders innova-tion from becoming effective earlier,
for the sake of the patient and for the sake of the future
of the healthcare system.”
Dr. Peter Lange
Head of Directorate General for “Life Sciences – Research
for Health” at the German Federal Ministry of Education
and Research

9
“It is now well documented that improving the health of
our populations has a direct impact on economic growth,
which then positively feeds back into health status. Health
care investment is thus a crucial step in a virtuous circle
that ultimately improves our economic well-being and
pays for itself.”
Pat Cox
Former President of the European Parliament
“Can we really accept that male life expectancy is 12 years
shorter in Estonia and Latvia than in Sweden? That lung
cancer is twice more deadly in Hungary than in Finland?
Or that heart diseases will kill ten times more women in the
Slovak Republic than in France?
We need to look at a country’s general approach to health,
including health promotion and prevention policy. Regarding
pharmaceuticals, is it fair that patients in Poland or in Turkey
will only access innovative medicines years after patients
in Germany or the UK? Governments directly decide which
medicines are available and these delays cannot be justified
and need to be addressed.”
Jolanta Dickute
Group of the Alliance of Liberals and Democrats for Europe,
Lithuania

“We don‘t only want to have access to healthcare.
We want to have access to the best treatment.
We want to have access to the best quality
clinical outcomes.”
Dr. Albert Jovell,
President of the Spanish Patient Forum and
Director of the Patients‘ University
Access to Medicines
Access to Healthcare – a European
Patient Perspective
12

13
Healthcare is facing the most important social change
in history. We live in an increasing globalized world,
but we still think in very local terms. This has an im-
pact on how we perceive “access”. Today, we don‘t
only want to have access to healthcare. We want to
have access to the best treatment. We want to have
access to the best quality clinical outcomes.
Research shows that public trust in the government,
members of parliament and politicians is low. This is a grave
situation, because trust is required in order to effect the re-
quired changes and improvements that we want to see in our
healthcare systems and societies. The good news is that the
level of trust is rather high in the field of healthcare, espe-
cially for public hospitals, universities, doctors and scientists.
Everybody agrees that more money should be spent on
healthcare. However, when the question moves to the poten-
tial financing sources, which includes the creation of new
taxes, 82% of people surveyed respond “No new taxes: Get
the money from elsewhere.” This is the “NFMP phenomenon:
‘not from my pocketbook!’”
Health agencies are not consistent globally or even across
Europe and this might impair equitable access. For example,
access to PET scan (Positron Emission Tomography) is radi-
cally different between Norway (0 PET) and Denmark
(14 PETs) with the same population size. And Greece, with
twice the population of Denmark, only has 1 PET. Similar
access problems might arise with very different (and often
conservative) clinical practice guidelines from country to
country.
Dr. Albert Jovell

14
Patient-based innovation is focused on quality of life,
personalized treatments, long-term health outcomes, and
increased adherence. This can be achieved through solid
partnerships based on trust.
Patient organizations have a very big role to play to support
intermediation. The Spanish Patient Forum represents 16
different organizations, 609 patients‘ association for a total
of 267,528 members. Our slogan is, “Patients‘ voice in
democracy.”
Patients Decalogue
1. Contrasted quality information respecting the
plurality of the sources.
2.
Decisions focused on the patient.
3.
Respect for the values and autonomy of the
informed patient.
4.
Doctor-patient relationship based on
mutual respect and trust.
5.
Specific education and training on communication
skills for health professionals.
6.
Participation of the patients in the determination
of priorities in the health care system.
7.
Formal democratization of health-policy
decision-making process.

8.
Recognition of patients organisations as
agents of health policy.
9.
Improvement of patients knowledge of
their basic rights.
10. Guarantee of fulfilment of patients‘ basic rights.
Access to Medicines
Access to Healthcare – a European Patient Perspective Dr. Albert Jovell

15
The mission of the Spanish Patient Forum is to become
the reference for the representation of the organizations
that represent the interests of Spanish patients.
“My current obsession is trust. Public trust is in decline
and in times of changes, we need to focus on trust.
Trust is key for our future if we want to progress
as a society. We need partnerships, not confrontation.”
Dr. Albert Jovell,
President of the Spanish Patient Forum
Patients
R&D
Companies
Health
Professionals
Health
Authorities
Forum

“There are numerous resources to support
training and development of health staff, in
particular in the private sector. Well prepared
leaders and managers will source the right
inputs and ensure results are achieved.”
Dr. Ernest Darkoh,
Chairman of Broad Reach Healthcare
Access to Medicines
Access to Healthcare – a Developing World Perspective
Access to healthcare – A developing
world perspective
16

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Africa is home to 14% of the planet‘s population, but
disproportionately stuns us with heart-breaking stories and
statistics. The continent contains a mere 1.3% of the global
healthcare workforce, life expectancy is just 46 years, and
over 40% of the population lacks access to clean water.
Despite trillions of dollars in foreign aid, these statistics
have been remarkably stubborn. So it raises the question –
Is the situation as hopeless as is often portrayed?
We believe that there is much hope. Most of the challenges
we are facing related to healthcare in the developing world
can be addressed and there are proven solutions. However in
order to improve the productivity of our efforts, we need to
re-think the basic model of healthcare delivery that we have
invested in over the past half century- because it is critically
flawed.
I feel hopeful today because numerous proofs of concept
exist to provide the guiding lights for how we can rapidly
turn things around. There is not only opportunity to save
and improve lives but also to open and expand new markets
while creating badly needed jobs. Broad Reach Healthcare is
in the business of developing innovative large scale health
delivery systems and as such we are keen observers of good
practices that are redefining the landscape. The common
thread across these proofs of concept is that there was
courage to think and act outside the box.
Public private partnerships and recruitment of community
based institutions, structures and individuals provide a limit-
less pool of raw bodies and talent and bring as well critical
resources such as equipment, space, and high-end specialty
skills. Technology offers new avenues to link players together
and unlock further exciting possibilities such as improved
distribution logistics and telemedicine to allow penetration
of specialty services into rural areas.
Leadership, partnership, community involvement and
courage to act.
Dr. Ernest Darkoh, with Kenneth Frazier and Stefan Oschmann

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Access to Medicines
Access to Healthcare – Patients Empowerment
“
Our current health systems can be unfair, divisive and fail
to put the patients’ perspective first. We believe all patients
within the EU have a basic right to equal access to quality
medical treatment, regardless of where they live, their
status or their income.”
“
Health is inherent to the lives of every EU citizen, and health
equity is a major pillar in building Europe’s future. This is not
only about achieving the Lisbon agenda, but also crucially
about ensuring the European Social Model.”
Nicola Bedlington,
Executive Director, European Patients‘ Forum
Access to healthcare – Patients
Empowerment

19
Patients play an increasingly role in setting policy
choices at the national and international levels. Is this
also true in emerging and transition economies?
Patients’ organisations have a major role to play as catalysts
for change. At local, regional, national, European and inter-
national level, they are the democratic and representative
voice of patients, and are entrusted by them to engage with
governments, the medical community, the corporate world,
and other members of civil society in promoting their rights
in relation to access to patient-centred, equitable healthcare.
From left to right:
Cristian Andriciuc, International Diabetes Federation
Nicola Bedlington, Executive Director, European Patients‘ Forum
Wayne Taylor, Helath Leadership Institute, Mc Master University, Canada

20
Access to Medicines
Access to Healthcare – Patients Empowerment
“Diabetes education should be considered an integral part of
diabetes prevention and care. Unfortunately this is not the
case in many countries of the world where diabetes educa-
tion is at best in its infancy or non-existent. The combina-
tion of lack of access to quality medical management and
diabetes education leads to poor clinical outcomes, reduced
quality of life and high health-related costs due to service
utilization and the costs of treatment.”
Cristian Andriciuc,
International Diabetes Federation
“Experiences in building patient groups in emerging countries“

21
“Our Vision is to foster high-quality, patient-centered and equitable
health care throughout the EU. Our Mission is to present a strong
and united patients’ voice. To deliver on our Vision and Mission, we
have Five Goals, namely: Equal Access, Patient Involvement, Patients’
perspective, Sustainable patient organisations, and Patient Unity.”
Nicola Bedlington,
Executive Director, European Patients‘ Forum
Training
Not Tokenism
Bill
of Rights
Research
Industry
the 3 P´s
Patient Empowerment –
the 3 P’s
Patient Advocacy
Partnerships
Patients Rights

“The Masa ARV program, which has received considerable
technical and financial support from ACHAP, has completely
changed the face of the epidemic in Botswana from a
very bleak picture in which mortality from AIDS was extremely
high, to one in which thousands of lives have been saved,
and tens of thousands of people have been helped to continue
living productive lives, contributing to the economic growth
of the country, and providing the needed support to their
dependents.”
Dr. Themba L. Moeti,
Managing Director ACHAP
ACHAP – The African Comprehensive
HIV/AIDS Partnerships
Access to Medicines
ACHAP – The African Comprehensive HIV/AIDS Partnerships
22

The African Comprehensive HIV/AIDS Partner-
ships is one of the most successful examples of
public-private partnerships that improve access
to essential health care services targeting key
development challenges.
About the ACHAP Program
Since doctors diagnosed the first case of AIDS in Botswa-
na in 1985, the disease has spread at a staggering rate.
According to the most recent estimates, 17.1 percent of
Botswana‘s 1.7 million people are HIV-positive, with young
adults and women hardest hit. In 2000, the Government of
Botswana, the Bill Melinda Gates Foundation and The
Merck Company Foundation established the African Com-
prehensive HIV/AIDS Partnerships (ACHAP) to support and
enhance Botswana‘s response to the HIV/AIDS epidemic
through a comprehensive approach to HIV/AIDS prevention,
care, treatment and support. The Merck Company Foundation
and the Gates Foundation each have committed $56.5 million
to the partnership and executives from both companies serve
on the ACHAP board. In addition, MSD is donating antiretro-
viral (ARV) medicines to Botswana‘s national ARV treatment
program, known as Masa, for the partnership‘s duration.
23
Dr. Themba L. Moeti
A physician training program
in Botswana.

“The successful pharmaceutical companies
in the next 30 years will be those that
understand where the science comes from
and make extraordinary efforts to bolster
academic partnerships.”
Dr. Mark J. Poznansky,
former President and Scientific Director,
Robarts Research Institute, Canada
Pharmaceutical Innovation in the
21st Century
26
Innovation
Pharmaceutical Innovation in the 21st Century

27
The success of pharmaceutical research and development
has been critically dependent on a series of tight and
effective partnerships. Just before the very beginning of the
RD pipeline, the discovery of new pathways and targets
has generally come from academic institutions (both public
and private), who then pass such discoveries to the pharma-
ceutical companies for development into safe and effec-
tive medicines. At the other end of the RD pipeline, the
successful uptake of new medicines is the result of similarly
strong partnerships between the pharmaceutical companies,
clinicians and medical opinion leaders.
The history of these partnerships shows that, as personalized
medicine becomes a reality, the pharmaceutical companies
will move towards novel business models where partner-
ships between academia and industry will become even
more crucial to the development of therapeutic innovation.
Dr. Mark J. Poznansky

“It is the first time in human history we can mimic the early
response to viral infections and steer the immune system
towards an anti viral response. This was not possible until now.”
Prof. Gunther Hartmann,
Director of the Institute of Clinical Pharmacology,
University of Bonn
What is the Future of
Biopharmaceutical RD?
28
Innovation
What is the Future of Biopharmaceutical RD?

Prof. Gunther Hartmann
Future of Research: RNA
What do you think will be one of the future developments in pharmaceutical research?
Hartmann: “In the class of therapeutic oligonucleotides, we now have new biopharmaceutical compounds with two distinct
functions. These functions are very relevant for the development of therapeutics: one is the RNA interference which enab-
les us to target certain genes and the other is the ability is to mimic viral infections. Both functions can be combined, for
example, in the treatment of tumors. It is also the first time we can mimic the early response to viral infections and steer the
immune system towards an anti-viral response. This was not possible until now. We‘ve been experimenting with this since
last year and there‘s a possibility that this will result in new therapeutics.”
How can we further proceed with clinical development?
Hartmann: “We believe that there‘s a strong need to do more early-on studies, especially phase 0 and phase 1 clinical trials
as well as exploratory clinical trial applications. This is essential to select the biomarkers and right molecules in order to
reduce the risk of failure in further clinical development phases.”
Design of combinatorial RNA oligonucleotides
TLR7
TLR9
TLR7
Plasmacytoid
dendritic cell
Myeloid
dendritic cell
Tumor cell
RIG-I
bcl-2
Apoptosis
Killer Killer
3p
3p
RNA interference
siRNA
TLR7 TLR8 TLR9
isRNA CpG DNA
RIG-I
3pRNA
Design of combinatorial RNA oligonucleotides
TLR7
TLR9
TLR7
Plasmacytoid
dendritic cell
Myeloid
dendritic cell
Tumor cell
RIG-I
bcl-2
Apoptosis
Killer Killer
3p
3p
RNA interference
siRNA
TLR7 TLR8 TLR9
isRNA CpG DNA
RIG-I
3pRNA
29
Source: Prof. Gunther Hartmann

Health Service Research
How could we improve the actual care of the individual patient?
Scriba: “There are numerous deficiencies in patient care worldwide. One main aspect is the underuse of pharmaceuticals.
This underuse of potentially useful medicines can be investigated through health service research. Health service research helps
discover the status of underuse in different therapeutic areas, analyze the mechanisms that lead to underuse and proposes
solutions to change that. There are numerous examples of underuse in several therapeutic areas, i.e. diabetes, hypertension,
osteoporosis. We should change this situation: Doctors want to improve the quality of service and the pharmaceutical industry
is seeking to increase the use of the right medication.”
Who should finance health service research?
Scriba: “In most countries, the funding of health service research by the government is deficient. However, research in this area is
very important. At the moment, it is sponsored and conducted by the pharmaceutical industry. In our workshop today, we came to
the conclusion that the funding should be outsourced from the industry and handed over to independent organizations. The reason
for such a move is to free health service research from potential criticism of conflict of interest with marketing activities.”
Innovation
What is the Future of Biopharmaceutical RD?
30

“Health Service Research needs support by sources
other than government. There is room for HSR programmes
to be supported by the pharmaceutical industry.”
Prof. Peter Christian Scriba,
Chairman of the Scientific Advisory Board of the
German Medical Association
Prof. Peter Christian Scriba
31

“We find that sustainable investing using our Environment,
Social and Governance framework, integrated with industry
structural themes and returns valuation, generates investment
outperformance.”
Andrew Howard,
Executive Director, Global Investment Research, Goldman Sachs International
“On the one hand, there is tremendous pressure on the industry
to come up with innovative, targeted drugs which require very
high RD costs. On the other hand, however, society is facing
increasing difficulty in paying for these high priced drugs.”
Martin Eijgenhuijsen,
Senior Portfolio Manager, ABP Investments
What is the Future of
the Pharmaceutical Business Model?
32
Innovation
What is the Future of the Pharmaceutical Business Model?

Evolution of the Companies‘ Evaluation:
GS Sustain
Goldman Sachs‘ Investment Research Team provides long-
term investment advice and ideas to their clients identifying
long term winners within sectors. The Investment Research
Team takes a very long term perspective on companies with
a view to identifying those companies that are in the stron-
gest position to be leaders in their industry for the long term.
Goldman Sachs‘ GS Sustain Research Team assesses com-
panies in three main areas: financial performance, industry
analysis, and environmental, social and governance perfor-
mance. The two former are rather traditional. However, the
third is a relatively new area within the financial community.
This movement started with investors focusing on the level of
corporate social responsibility of selected companies. Today, a
huge range of mainstream large fund managers are interested
in understanding how companies are managing their human
capital, their environmental risk, as well as corporate gover-
nance pressures.
The Pharma Futures Project
Pharma Futures is a scenario building project that has been
designed to create an on-going discussion between the
pharmaceutical industry and its owners (investors) on how to
respond to the concrete challenges the sector faces today in a
period of rapid transition. Pharma Futures has brought together
industry executives, and over 1 trillion euros of assets from the
investment community. Pharma Futures looked specifically at
RD, Pricing and Access and discussed how stakeholders can
respond to both shareholders and societal needs.
Global pharma at a turning point: Innovate or restructure
Source: Goldman Sachs Research
Large cap
pharma
Specialist
pharma
Japan
Generics
ESG
Patent risk
Innovation of
drug pipeline Barriers to
entry
Cash returns
Sustainable
investing
leaders
Global reach
Workshop discussion
33
Turning point
Themes
Winners
Returns have fallen
from 28% in 2001 to 21% in 2007E
Sales growth has slowed
from 8% pa in 2001 to 6% pa in 2007E
Sector has de-rated
from P/E 30x in 2001 to 15x in 2007E
MA; higher
RD spend
Unprecedented
level of patent
expiries
Tougher regulato-
ry environment
Changing
demographics
MA LBO
BRICs
potential
Generics
industry grows
Management
quality
Industry leadership
Financial
performance

A New Golden Era in Vaccines?
34
Innovation
A New Golden Era in Vaccines?
“The prospects for a new era of vaccine innovation will be
shaped not only by science and technology but also by the
political and economic environments in developed nations.
Any general economic decline that reduces public health
budgets for preventive medicine will negatively impact on
investment in vaccine RD and investment in increased
capacity.”
Prof. Lou Galambos,
Professor of History, Johns Hopkins University

35
Prof. Lou Galambos
Paradoxically, the golden era was followed by a series of
crisis that left the vaccine industry severely incapacitated
in its ability to innovate. The main crisis was triggered by
a “tragedy of the commons” scenario: Thanks to extremely
low prices exerted by public agencies (the largest purchasers
of vaccines) and successful liability cases, costs increased
faster than prices and vaccines became low-margin commo-
dities. This ultimately led to the decline of the US vaccine
industry, where only five major firms remained.
In following years, globalization and the monopsonic power
exerted by payers triggered a wave of mergers that changed
the vaccine industry, and the number of major vaccine produ-
cers in the world actually declined further.
In recent years, we have seen a renewal of the industrial and
innovative activity in the vaccine field. The sources of this
revival are not public or professional reform efforts. Instead,
the primary factor is the new science and technologies flow-
ing from the molecular genetic revolution and biotech.
“From 1945 through the 1970s, vaccines experienced a
golden era in innovation, production and distribution. This
golden era saw the introduction of nineteen new vaccines
against a wide range of infectious diseases. As a result,
decisive improvements were achieved in life expectancy
and morbidity throughout the world.”
Prof. Lou Galambos
This recent transition in the industry has swung the balance
in supply and to a lesser extent in innovation of vaccines
back toward Europe and away from the US. While North
America is still the largest single market for vaccines,
almost 90% of the world’s production now takes place in
Europe. Two-thirds of vaccine research and development
(RD) is now being conducted by European firms. Almost all
of the European investment in RD (22.5% of sales) comes
from the private sector, and almost all of it is focused on new
vaccines. If these developments continue, we may indeed
have a second golden age of vaccines.
However, any general economic decline that reduces public
health budgets for preventive medicine will negatively
impact on investment in vaccine RD and investment in
increased capacity.
In order to ensure a golden future in this wing of preventive
medicine, governments should continue to support the basic
science that has been the necessary foundation for success
in vaccine RD.
But the prospects for a new era of vaccine innovation will be
shaped not only by science and technology but also by the
political and economic environments in developed nations.

The Functional Innovation System
Model – Benchmarking Exercise
Innovation
The Functional Innovation System Model – Benchmarking Exercise
“Innovation requires a multi-stakeholder engagement, where each
stakeholder contributes on one end and benefits on the other. To
succeed, an innovation model is based on the active participation
of government, academia, industry, and civil society.

Turkey, Poland, and Hungary share a bold vision and positive
attitude when it comes to innovation in life sciences. Realizing
the vision will require a balanced investment in both knowledge
creation through government funding and better market
conditions for the private sector to translate knowledge into
innovation.”
Borys Chabursky,
President Founder, SHI consulting
36

Expanded Functional Innovation Systems Model
37
Innovation is a process of realizing improvements by introdu-
cing new ideas that add increased value, either to the custo-
mer or the producer, providing an overall economic, social
and environmental impact. Innovation correlates with wealth
across countries. Being the foundation of the knowledge-
based economy, innovation is a major driver of wealth in
today’s global economy.
The process of innovation constitutes a virtual cycle of activi-
ties, which is predicated on the balance between knowledge
creation on one end, and improved market conditions for
innovation output on the other. Innovation requires a multi-
stakeholder (i.e. government, academia, industry, NGO)
engagement, where each stakeholder contributes on one end
and benefits on the other.
Ultimately, success is rooted in the market. However, govern-
ments play a vital role in supporting effective policies
and at times funding to promote full commercialization
potential at several stages, including the support of research
innovation, mitigating risk of business investments in research
and development, and providing a market for new technologies.
Policy
Health
Impact
Products Process
Healthcare
Delivery
Health Policy
Priority-setting
Health Economics
Quality Research
Health Policy
Development Testing
Engagement of
Policymakers
Development of
Practice
Guidelines
Technology
Development
Commercialization
of Discovery
Dissemination
Training
Adoption
of New
Practices
Enabling
Discovery
Oucomes,
Comparative Health
Services Research
Model
Discovery
Practice
Products
The creation of diagnostics, drugs and
devices that target diseases, improve
patient outcomes and reduce the burden
of care on the health system.
Process
Innovation driven by the need for constant
improvements in how the healthcare systems
is organized, how health professionals
are trained and interact with one another,
and how patients access technologies and
services.
Policy
Both enables technology and
delivery solutions and establishes
a receptive environment of their uptake.
Developed by SHI Consulting in collaboration with Research Canada.
Innovation in health is not only inclusive of health technoligies, but also accounts for health policy and health delivery, wich are represented as
three interlinking rings, with health impact at the core, as the impetus for innovation an dthe standard by which success is measured.

38
The Functional Innovation System Model serves as an
ideal framework for the individual assessment of emerging
countries for a comparative analysis both to each other and
to global benchmarks to identify opportunities where cluster
policies can play a role in enhancing regional innovation.
This model is adapted from Research Canada’s model for
health science innovation, developed in partnership with SHI
Consulting.
In this study, SHI Consulting utilized the Functional Innovation
System (FIS) as a model to characterize and assess progress
in Turkey, Poland, and Hungary. SHI Consulting also presented
innovation characteristics from Ireland, China, and India for
comparison purposes. For a full presentation of the study,
please go to www.msd-forum.com.
Turkey
– Turkey has an ambitious vision and positive attitude when
it comes to innovation in life sciences. Realizing its vision
will require a balanced investment in both knowledge
creation and market favorability. Growing investments
in government-funded RD should be complemented by
increasing the involvement of the private sector.
– Overall, Turkey needs to build on its bold vision and
positive attitude to capitalize on the intrinsic potential
of its healthcare market. Developing a world-class life
sciences knowledge economy is within reach.
Poland
– Having developed a reasonable life science research and
development base through historic central economic
planning, Poland now needs to protect and grow this base
in a market economy environment: this entails a renewal
in commitment to the sector, and the creation of favorable
market conditions to encourage the private sector to
shoulder the investment in RD.
– A sub-optimal access to innovative health products and an
under-funded healthcare system are preventing the
innovative biopharmaceutical industry from sharing, with
the public sector, the cost of investment in RD.
Hungary
– Hungary’s relatively favorable market conditions (compa
red with the rest of central and eastern Europe), combined
with a fairly developed legacy life science RD base, has
positioned the country on a path of innovation in life
sciences.
– Hungary has a strong history in pharmaceutical research
and has placed emphasis on recruiting multinational
biopharmaceutical companies to enhance RD capacity
and create employment opportunities.
Innovation

– Improving IP generation and enabling small and emerging
biotechnology companies to secure greater access to
resources (e.g. providing capital, business support) will
strengthen the innovation base.
– Hungary is supplementing the strong manufacturing base
with RD capacity, by recruiting RD operations from
large biopharmaceutical companies. It will be important
for Hungary to promote interactions between public RD
base and industry players.
Who are the Stakeholders in Innovations?
Innovation, in knowledge-based economy, is not exclusive to industry and the business sector; rather it requires a multi-sector engagement, where
each stakeholder contributes on one end and benefits on the other.
Non-
Government
Organisations
(NGO´s)
Government
Industry
Academia
Impact
–
Growth: Leverage areas of com-
petitive advantage
–
Responsibilty: Participation in
social development
–
Innovation: Engage shared
resources from stakeholders
across the value chain
–
Prosperity: Shared rewards from
measurable outcomes
Bring
–
Regional/national represen-
tation
– Regulatory policy
Gain
–
ROI for RD programs
–
Improved socioeconomics
outcomes
Bring
–
Patients and resources
–
Delivery capacity
Gain
–
Scientific capacity
–
Improved socioeconomics
outcomes
Bring
–
Cost-effective capacity
–
Novel resources/expertise
Gain
–
Growth in markets
– Focus on profit
Bring
–
Research expertise
–
Innovative ideas
–
Access to IP
Gain
–
Translational research
–
Improved access to innova-
tive treatment
39

40
How Do We Build Innovation Clusters?
The innovation cycle builds around sector strengths, attracting a critical mass of innovators, implementers and regulators to form an integrated
innovation cluster or ecosystem; any gaps or disruptions in the cycle (e.g., in market conditions) will prevent continuity, and impact progress at the
level of other components (e.g., research and development).
Innovation
Quadrant 1: Development
Development is a high-risk and high-cost stage
where promising technologies undergo proof-of
consept validation studies to determine wheter
they warrant commercialization. Innovators
require technical, financal and enrepreneurial
support to navigate their technologies success-
fully through the commercialization process.
Quadrant 2: Research
Research excellence is the key to knowledge
creation and serves as the foundation of the
system of innovation.
Quadrant 3: Market Validation
Market Validation describes the process
of turning an innovation into a marketable
product. Key functions in this quadrant include
evaluation by regulatory agencies, business
development activities, and developing indus-
trial manufacturing and marketing capacity to
ensure products reach the global maretplace.
Quadrant 4: Delivery
Delivery is the culmination of the innovation
system. During this stage, innovative products
must meet the needs of the end-users.
M
a
r
k
e
t
Validation
D
e
v
e
l
o
pment Rese
a
r
c
h
Deli
v
e
r
y
Commercialization:
Go/No-go Path to Market,
Proof-of-Concept Studies
Industrialization:
Manufacturing, Marketing,
Support Industries
Innovation:
Four Pillars of Research:
Discovery, Clinical, Health Ser-
vices, Population Health
Technology Validation:
Early-stage Largescale
Clinical Trials
Delivery Impact:
Consumers, Care, Providers,
Health Systems
Product
Business Development:
Regulatory Approval Licensing
Market
Conditions
Push
Pull
Knowledge
Creation
Thematic focus (e.g. particular
industries or sectors)
Achieving success in innovation requires
a vision and strategy that facilitates
communication among stakeholder to effectively
coordinate resources and activities across the FIS.

Overall Comparison of the Six Characterized Countries
Turkey can and should mobilize quickly ans effectively to translate the bold vision it has established for its life science knowledge economy and
take advantage of its inherent market size. The build-up of both the RD base and improvement in market conditions must go hand-in-hand.
41
“Innovation is the foundation of the knowledge-based economy
and a major driver of wealth in today’s global economy.”
Borys Chabursky,
President Founder, SHI Consulting
Push
(High)
Pull
(High)
Poland
Turkey
India
China
Hungary
Ireland
Vision
Established
Emerging
Limited
Vision is clear implementation-focused strategy
that achieves coordination among the compo-
nents of the FIS to realize achievable goals.
Push
factors include: research infrastructure,
highly-skilled workforce, investment in
scientific discovery, early-stage risk capital,
and commercialization support.
Pull
factors include: regulatory frameworks, venture
capital, industrialization support, and access
to local and global markets.

“This study clearly shows that, first, for gaining
acceptance for reform proposals in health care,
information about citizen preferences is crucial,
and second, one size does not fit all.”
Prof. Peter Zweifel,
University of Zurich
Healthcare Financing:
What do Citizens Want?
44
Healthcare Financing: What do Citizens Want?

45
Prof. Peter Zweifel
“I would like to convey the idea to you today that we
should take due account of citizens‘ preferences.”
Policy makers, payers and providers assume that citizens all
want the same thing from their healthcare system. Is this
“one size fits all” approach really what citizens want or are
they in fact more willing to adopt a choice-based system
than their own government? Surveys of citizens in Germany,
Switzerland and The Netherlands show that citizens are in
fact ready to take the concept of patient-centered health-
care to a new level and may lead the way for modern policy
making.
First, citizens‘ preferences can be expressed in “willingness-
to-pay” values. Second, market experiments, in particular of
the “discreet choice” type, can be used to derive those va-
lues. Third, by running this type of study, we show that there
is a significant level of preference heterogeneity regarding
healthcare provision in the three countries under study.
Evidence shows that not only are neighbouring countries
quite different in their preferences with regard to the
provision of health services, but also that there are impor-
tant differences within countries. “That doesn‘t square too
well with the quest for uniform, national solutions that our
elected politicians cherish so much.”

“Economic evaluation has the potential to improve the
efficient allocation of scarce health care resources and
can substantiate the appropriateness of reimbursement
decisions. However, international cost-effectiveness
evidence is not relevant and a number of local factors
limit the full utilization of economic evaluations in CEE
countries.”

Dr. Zoltán Kaló,
Director, Health Economics Research Centre (HERC)
Health Policy in Emerging Economies
46
46

Health care resources are
limited
Without reimbursement
patients cannot get access
to life-saving technologies
Return on RD investments
is reduced, innovative
therapies are more expensive
Reimbursement of innovative
technologies is a challenge
for health care systems
Local purchasing power is lower than in developed countries
and new pharmaceuticals are relatively expensive compared
to other health care services.
In CEE countries the value of innovation is often not reco-
gnized by health care decision-makers. This is primarily due to
the concern about high budget impact and a false interpreta-
tion of cost-effectiveness (cost-savings are expected).
Reimbursement of innovative medical technologies is a great
challenge for payers in CEE countries. Although burden of
diseases is significant, availability of health care resources is
fairly limited.
Budget impact and local cost-effectiveness analyses
can substantiate the appropriateness of reimbursement
decisions. However consistent and fair decisions are
not yet the norm.
47
Dr. Zoltán Kaló,
Director, Health Economics Research Centre (HERC),
Eötvös Loránd University, President, Hungarian Health
Economics Association ISPOR Hungary Chapter
Health Policy in Central-Eastern European
countries
Health care resources are even more restricted in CEE coun-
tries, than in developed countries. Public resources are nee-
ded to boost the economy. In former communist countries the
health care sector (especially hospital care) is still oversized.

48
Slovenia Health Care System
Slovenia experiences similar trends as other countries:
increased constrains on the financial capacity of its health
system are compounded by the growing need for health
care.
Solutions lie in knowledge activation, that is translation
of knowledge into practice. The full implementation of our
medical knowledge should be our priority, even before the
implementation of new technologies.
We need to increase the involvement of citizens and patients,
empower the management of health care and make full use
of existing, modern ICTs in the way health care information
is processed and managed.
Dorjan Maruši , International Health Systems Advisor,
Former State Secretary, Ministry of Health Slovenia
“Responsible and careful management of the well being of
the population is an essential function of the government.
Evolution is in the nature of health care systems. The ideal
health care system is still to be built!”
Dorjan Maruši ,
International Health Systems Advisor,
Former State Secretary, Ministry of Health Slovenia

“The link between health and wealth has been solidly established. European
countries are getting older and have no other choice but to ensure that their
aging population remains healthy. Without a full deployment of innovation in
health care, the costs of illness will be horrendous and put a major drag on
European economies. Who will pay is a major question.”
Jim Attridge
Imperial College, London
49

“Our research shows that there is quite a lot of value
lost in healthcare systems. There is a lot of inefficiency
and potentially a lot of waste in the system. If we
manage to reallocate resources to limit the amount of
waste, there is not necessarily a need to increase
healthcare budgets.”
Panos Kanavos,
Senior Lecturer in International Health Policy,
London School of Economics
What is the Future of our
Healthcare Systems?
50
What is the Future of our Healthcare Systems?

51
Trends in healthcare financing, reform and
cost containment
Healthcare systems are faced with tremendous pressures
due to a demographic shift towards an ageing population, in-
creasing levels of chronic diseases and a constant supply of
innovative, but expensive, technologies. Adding to the chal-
lenge, the financing needs of public pension plans are set
to increase dramatically in the coming decades thus leaving
governments with very little budgetary room to manoeuvre.
This unprecedented situation puts payers and financing
actors in a bind and explains some of the “reformania” that
one can experience in the healthcare budget area. Just in the
last 10 years, healthcare financing has increasingly shifted
towards budget rationing and an attempt toward “evidence-
based” purchasing. The challenge underpinning this latter
shift is how can we prove the value of new healthcare
technologies and interventions even before they are allowed
on the market? Some of the methods currently used are not
robust enough and thus are not providing the expected level
of quality evidence that could inform policy making that
should aim at balancing budgetary decisions and a high level
of healthcare.
Despite a strong incentive to improve efficiency, healthcare
systems, in particular in Europe, are faced with a number of
challenges that prevent necessary structural and organiza-
tional reforms. Institutional inertia, rent-seeking behaviours,
and inability to apply evidence-based reforms often lead well
intended efforts to drive efficiencies from the system into
higher expenditures and poor quality of care.
Trend in Health Care Financing,
Reform and Cost Containment
Paradigm shift in OECD countries: 1970s–2010
1970s–1980s 1990s–2010
1980s–1990s
Command
and control
measures
Budget
setting
Budget shifting,
rationing,
evidence-based
purchasing
Source: European Observatory on Health Care Systems
Prof. Panos Kanavos (left)
Jim Attridge, Esra Doganay,
Prof. Panos Kanavos

52
Future of health systems – Taking an ecological
view of our health
“Healthcare 2.0” is a world where there is an expectation of
user-generated content (similar to the Web 2.0 movement in
the Internet), as well as an expectation of social responsibi-
lity which translates into individuals taking an active role in
their healthcare. Our health is not anymore the product of a
“system” or “industry” that treats diseases, but health is co-
produced by each person, the environment in which they find
themselves and the health system with which they interact.
Health and environmental sustainability are two forces that
are strongly interlinked. In the last 10 years, US airlines had
to purchase about 350 million gallons more of jet fuel just to
accommodate the increasing weight of individuals. Healthy
behaviours, such as an increase in walking or cycling, are
good for the environment. Bicycling programs, measuring
daily physical activity with pedometers and promoting mass
transit all help reduce the carbon footprint and promote
individual health.
Until today, our healthcare systems have been based on the
assumption that people would conform to such systems.
There is no other part of society that would survive with a
model where the consumer has to conform to the supplier.
In order to be successful in a time of growing demands and
limited resources, we need to build healthcare systems that
conform to their users.
Understanding people and their needs will help us
develop healthcare systems that strongly engage the
consumer.
What is the Future of our Healthcare Systems?
Dr. Jonathan T. Lord

53
Dr. W. Brian Healy Prof. Panos Kanavos
Workshop reports

“From tax advantages for both the company and the
researchers to direct financial support, the 2008
RD law provides significant incentives for locating
Research Development activities in Turkey.”

Mehmet Gökay Üstün,
Head of Project, Investment Support Promotion Agency of Turkey (ISPAT)
Competitiveness Strategies for
Emerging Economies – The Link with
Health Care
54
Competitiveness Strategies for Emerging Economies – The Link with Health Care

55
Mehmet Gökay Üstün,
Head of Project, Investment Support Promotion
Agency of Turkey (ISPAT)
“The Investment Climate in Turkey is Sunny”
Turkey offers significant investment opportunities in a rich
economic and cultural environment. Turkey is the 15th
largest economy in the world and the 6th largest compared
to EU countries. It has the youngest population compared to
the EU countries. Turkey is the 2nd largest producer of glass
sheet and the 11th largest iron and steel producer in the
world (3rd compared to the EU countries). Its proportion of
women in academic positions is higher than the EU average.
It is the 8th most visited holiday destination in the world.
Turkey has a dynamic and attractive economy in a geographic
location that provides easy access to 1.34 billion persons.
Turkey has made great strides in structural reforms in order
to attract foreign direct investments. The 2008 RD law is
one example among many.
Strengthening upward trend in FDI Inflows
25
20
15
10
5
0
2002 2003 2004 2005 2006 2007 2008*
FDI Flow
Billion USD
1.1
1.8
2.8
8.8
20.2
22.0
7.6
*Year to date as of June **As of June
25
20
15
10
5
0
2001 2002 2003 2004 2005 2006 2007 2008**
Number of Companies with International
Capital (Cumulative)
thousand
5.1 5.6
6.7
8.8
11.7
15.7
20.5
18.7

56
In addition to the core hospital, each Bio City includes
between 250,000 and 1,000,000 square feet of biomedical
research space, as well as the funding, both for-profit and
non-profit, to support early-, mid- and late-stage research
projects and companies that locate within the Bio City.
Each Bio City project is structured as an international public-
private partnership. Top partners in the government, acade-
mic, and commercial spheres, with proven track records in
execution, have already committed to the project.
Becoming the Leader in Emerging Markets
Healthcare
Established by a consortium of investors, entrepreneurs
and foundations, the Bio City Development Company aims
at developing super-specialist healthcare and associated
biomedical research and development facilities in high-
growth emerging markets.
By 2012, from Dubai to Shanghai, the Global Bio City
Network will include 2500 of the highest quality tertiary
care hospital beds across emerging markets. Located on
eight campuses, or “Bio Cities”, each specialist hospital
is to be partnered with a major Western academic/clinical
partner and will be the “hub” medical centre for the host
country or city.
“It is not the strongest of the species that survives,
nor the most intelligent … but the one most responsive
to change.”
Charles Darwin

57
Stanford University
Provost
VC Business
Affairs CFO
President
School of
Earth Sciences
School of
Engineering
School of
Law
School of
Education
School of
Medicine
School of
Humanities
Sciences
Graduate
School of
Business
IAP
IAP
IAP IAP
IAP
IAP
IAP
2 IAPs
3 IAPs
3 IAPs
10 IAPs 15 IAPs
Entrepreneurial
Programs
Office of
Technology Licencing
Vice Provost,
Dean of Research
Entrepreneurial
Programs
Entrepreneurial
Programs
Entrepreneurial
Programs
Executive
Education
Continuing
Education
Linear
Accelerator
Center
3 IAPs
IAP = Industrial Affiliate Program
Dr. Jullien Gaer,
Chairman Bio City Development Company, Hong Kong

58
Domestic conditions are key:
–
Identify the research capabilities where the potential for
excellence in specific areas is possible.
–
Develop management capabilities, especially in the field
of translational research
–
Develop the regional and social infrastructure
–
Identify leaders and champions
–
Specify the nature of the private sector engagement
and involvement
– Create a sense of urgency to help emerge a culture
of change
Values are critical drivers:
– Be comfortable with high levels of uncertainty
–
Develop a tolerance for ‘bad news’
–
See failure as a ‘positive’ metric
–
Don’t try to get it perfect the first time: Build for
iteration, not for perfection
–
Understand the motivations of stakeholders and
aligning incentives
–
People are the most important intellectual property
– Build social and professional networks to ensure
sustainability and scalability
–
Share risks and rewards (collective sense of ‘ownership’)
– Commercialization is a ‘body contact’ sport
Suggestions:
– Build models of cross disciplinary research collaborations
– Build boundary spanning organizations and programs
that are integrative
–
Find ways to connect academia and industry early
(pre-transaction)
– Think of ROI as return on involvement, not just return on
investment
– Celebrate your successes. They become your ‘role models’
Building the Innovation Cluster of San Diego – Lessons Learned
With a 20 year history and tremendous success, the innovation cluster in San Diego, California offers valuable learning
opportunities for emerging markets wishing to develop their innovative base.

59
Greg Horowitt,
Director and Co-Founder of Global CONNECT,
University of California, San Diego, USA
“A strategic innovation policy needs to focus on collaborations
and the government has to get involved early on: Any
country that wishes to develop a strong research base needs
cross disciplinary research collaborations, integrative
programs and organizations, strong and early engagement
with the research-based industries. You are seeking not just
a return on investment, but a Return On Involvement. And
don’t forget to celebrate your successes: they become your
role models!”
Greg Horowitt, Director and Co-Founder of Global CONECT,
University of California, San Diego, USA

Corporate Responsibility
Franz-Beckenbauer-Foundation
60
Franz-Beckenbauer-Foundation

61
There are many reasons one should help other people; chief
among them is personal gratitude for one‘s own health. The-
refore I founded the Franz Beckenbauer Foundation 25 years
ago after retiring from professional soccer. The Franz Becken-
bauer Foundation‘s goal is to provide financial and emoti-
onal support to people with mental or physical disabilities
caused through no fault of their own. Our means are directed
towards a well-defined purpose. Decisions about which
groups, which projects or which persons shall be supported
are made quickly and without unnecessary bureaucracy. Hel-
ping people in need and being committed to the protection
of our close environment are the ambitions of my foundation
and of our donors. In order to reach this goal, we need strong
partners to help us provide efficient relief. MSD‘s philanthro-
py is very similar to that of the Franz Beckenbauer Foundati-
on. MSD supports initiatives that address social needs and
are consistent with its overall mission to enhance the health
and well-being of people around the world. That is why I
would like to thank MSD for their support, also on behalf of
the people we are able to help.
Kenneth C. Frazier, Stefan J. Oschmann Franz Beckenbauer

“The Merck Manual, which is published in 18 languages
and updated periodically, has served as the most important
reference book for many physicians in the medical world.
We are honored to donate 4500 copies of the Merck
Manual to the Ministry of Health of the Republic of Turkey
to support the access of Turkish physicians to reliable
medical information”.
Dr. Stefan Oschmann,
President Europe, Middle-East, Africa Canada, Merck Co., Inc. (USA)
MSD donates 4500 copies of the Merck
Manual
MSD donates 4500 copies of the Merck Manual
62

63
On the day before the MSD Forum on Access, Innovation
and Affordability of Medicines, MSD donated 4500 copies
of the latest edition of the Merck Manual for Diagnosis and
Therapy, which had just been translated an published in
Turkish.
Through this donation, MSD continues a century-old traditi-
on. The Merck Manual is recognized as the most important
and the best-selling medical reference book for physicians.
Turkish Health Minister Dr. Recep Akdag hosted the dona-
tion ceremony at his office in, Ankara, where Dr. Stefan
Oschmann, President of Europe, Middle East, Africa and
Canada (EMEAC) handed to him the first edition of the
donation.
“The Merck Manual is well known to Turkish physicians and
I am delighted to receive such a meaningful donation on
behalf of his Ministry”, said Dr. Recep Akdag.
Dr. Recep Akdag further said that he was quite familiar with
the Merck Manual. “I remember well from my university
years that I referred to the Merck Manual as a student in the
Faculty of Medicine”, said Dr. Akdag.
From left to right:
Dr. Stefan J. Oschmann
President Europe, Middle East, Africa Canada, Merck Co., Inc.
Dr. Recep Akdag
Minister of Health of the Republic of Turkey
Mete Husemoglu,
VP Managing Director, Merck Sharp Dohme Turkey
Faik Somer,
Senior VP Regional Director, CEE-MEA, Merck Co., Inc. (USA)

The Rolli-Gang
Rolli-Gang
64

65
The Rolli-Gang is a vocal group of young, differently abled
people. Founded by the musician and teacher René Vollmar
at the Munich Country School for Handicapped Students in
2001, the “Rolli-Gang” shows what people with handicaps
can achieve. Their music is full of life, positive, hopeful and
their message is: “There is no problem that can‘t be solved.”
Within the last five years they have given many concerts,
for example at the World Youth Day 2005 in Cologne, at
the Soccer World Championship 2006 in Munich and at the
Soccer World Championship of differently abled people in
Munich in 2006.
The Rolli-Gang

66
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Gestaltung:
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/
medienkeller
2009
IMPRESSUM:
Boris Azaïs
Andreas Marmsoler
MSD
RBSC-2009-D-AIA
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