HCLS Spain March 2019

A PREMIER CLINICAL TRIALS SPECIAL FOCUS: LOCAL CHAMPION: BETTING BIG ON
DESTINATION ONCOLOGY ESTEVE BIOSIMILARS

PAGE 39 PAGE 56 PAGE 15 PAGE 37
MATURING WITH GRACE
SPAIN
PAGE 25
MARCH 2019
STRAP IN HERE PLEASE
Strap subhead in here please
Acknowledgements
PharmaBoardroom is profoundly grateful to…
María Jesús Lamas Díaz, director of AEMPS
Enrique Ruiz Escudero, minister of health, Community of Madrid
Humberto Arnés, president, Farmaindustria
Francisco Fernández, director of communications, Farmaindustria
Ángel Luis Rodríguez de la Cuerda, secretary general, Association of

generics producers in Spain (AESEG)
Carlos Macaya, president, Spanish Heart Foundation (FEC)
Margarita Alfonsel, Spanish medical device association (FENIN)
Ion Arocena, Spanish biotech association (ASEBIO)
Press team of the Ministry of Health, Community of Madrid
for their continuous support, enthusiasm and encouragement in the

compilation of this report.
2 Healthcare & Life Sciences Review: Spain www.pharmaboardroom.com

HEALTHCARE & LIFE SCIENCES REVIEW
SPAIN
Timmo Andersen,
Boehringer
Ingelheim
Interview
20
CONTENTS
— March 2019
2 ACKNOWLEDGEMENTS
6 PREFACE
7-8 FOREWORDS
9 SNAPSHOT IN FIGURES
13 PHARMA INDUSTRY OVERVIEW INTERVIEW
Humberto Arnés, Farmaindustria
15 COMPANY FOCUS FEATURE Esteve
17 INDUSTRY SPOTLIGHT FEATURE Biotech
20 MNC INVESTMENTS INTERVIEW
Maturing with Timmo Andersen, Boehringer Ingelheim
Grace 22 MARKET TRENDS FEATURE
Cover story Spanish Mid-Caps’ Internationalization
25
25 MATURING WITH GRACE COVER STORY
27 Speedy Product Launches
30 Fragmentation and Devolution of Decision Making
Industry Spotlight: 34 Stagnation in the Generics Segment
Biotech 37 Betting Big on Biosimilars
Feature
17 39 A Premier Clinical Trials Destination
44 Magnificent Mid-Caps
45 Medtech: The Rise of Local Champions
46 Beyond the Family
48 A World Beating Healthcare Apparatus
52 PRIVATE HEALTHCARE FEATURE A Growing
Segment
The Healthcare & Life Sciences Review was produced
by PharmaBoardroom. 54 HOMEOPATHIC MEDICINES FEATURE
Boiron
Report Director: Mariuca Georgescu
Editorial Coordinator: Matthew Fsadni, Georgina Lott 55 PARTNERSHIPS AND COLLABORATIONS
Editorial Assistant: Joseph Kun INTERVIEW Ángel Fernández, MSD
Senior Editor: Louis Haynes
Editor: Patrick Burton
56 THERAPEUTIC FOCUS FEATURE Oncology
Report Publisher: Mariuca Georgescu, Laurent Pichotzki-Libano 58 GENERICS INTERVIEW Enrique Ordieres,
Graphic design: Miriam León Cinfa Group
For exclusive interviews and more info, please log onto 59 PUBLIC HEALTHCARE IN MADRID
www.pharmaboardroom.com or write to contact@focusreports.net. FEATURE Enrique Ruiz Escudero, Minister of
Copyright: All rights reserved. No part of this publication maybe reproduced in any Health of the Community of Madrid
form or by any means, whether electronic, mechanical or otherwise including photo-
copying, recording or any information storage or retrieval system without prior written 60 LOCAL SUCCESS STORY INTERVIEW
consent of Focus Reports. While every attempt is made to ensure the accuracy of the
Carlos Rubió, Laboratorios Rubió
information contained in this report, neither Focus Reports nor the authors accept any
liabilities forerrors and omissions. Opinions expressed in this report are not necessarily 62 DIGITALIZATION FEATURE Hospital IT
those of the authors.
Solutions
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Preface
Having largely recovered from the impact of the
global financial crisis and with several impressive
fundamentals in place, Spain once again stands as
one of Europe’s premier healthcare and life science
investment destinations.
These fundamentals include a revamped mar-
ket access process that puts the Iberian nation on
a par with France and Germany, a high-quality yet
affordable manufacturing base that has already
attracted big-ticket industrial investments from the
likes of Pfizer, Boehringer Ingelheim and Bayer, and
a budding reputation as one of the best clinical tri-
als destinations on the continent. Therefore, Spain,
the world’s tenth largest pharma market, can truly
be said to be maturing with grace.
Added to this, the Spanish can boast an advanced
healthcare system, increasingly embracing innova-
tive digital solutions and ranked the seventh best
on the planet by the WHO. This, in turn, is helping
Spaniards to live longer and Spain ranks second in
Europe for life expectancy and fourth globally, with
people in Madrid living longer than anywhere else
in Europe!
However, that is not to say that Spain is an easy
market to navigate. A highly fragmented and decen-
tralized healthcare system creates inconsistent mar-
ket access timeframes across the nation, with com-
panies having to negotiate with individual regions
and hospitals. Furthermore, considerable pricing
pressures abound, hitting the country’s generics
segment particularly hard.
Other topics touched on in this report include
Spain’s booming biotech scene, the internationali-
zation efforts of the country’s well-established mid-
cap firms, a private healthcare market growing in
both size and importance, and the nation’s expertise
in oncology.
Distinguished members of the healthcare and pharmaceutical sectors,

As the director of The Spanish Agency of Medicine and Health Products (AEMPS,
Agencia Española de Medicamentos y Productos Sanitarios), I am proud to introduce
the 2019 report of the Spanish Healthcare and Life Sciences Review a great opportunity
for the Spanish healthcare community to demonstrate to the world the strengths of our
universal healthcare system: something all Spaniards are proud of.
Within the world of pharmaceuticals over recent years we have seen unbelievable
advances in innovative treatments, especially in field of personalized medicine. This is
bringing about its own unique challenges for us to overcome, though also is offering
incredible benefits to the Spanish population.
Furthermore, Spain is a nation with an abundance of world class universities, hospitals
and research institutes, all backed by leading medical professionals. These, along with
the Royal Decree of 2015, has seen a large increase in clinical research that has positioned
the nation as a European and global leader in this regard. This not only adds value in
attracting investments from companies and fostering an innovative mindset, but also
gives patients priceless exposure to leading innovative treatments from around the globe.
Looking ahead, the rise of real-world evidence is bringing about a new age that is shap-
ing how we analyze and evaluate therapies from the initial clinical phase and throughout
a therapy´s time on the market. Our commitment at AEMPS is to ensure we are at the
forefront of utilizing this new wave of data so the people of Spain can continue to receive
the most innovative medicines possible in an efficient and rapid manner, while, above
all, ensuring the safety of all Spanish patients through a comprehensive evaluation and
analysis process of new technologies and medicines.
The Spain Healthcare and Life Sciences Review 2019 puts a deep focus on what trends
and regulations that are shaping the Spanish market, now and in the future. I invite the
local and international healthcare industry to better understand what makes Spain a
leader in delivering universal healthcare and how we are working to ensure this is the case
during the nation´s exciting future.
Warm Regards
María Jesús Lamas Díaz

Director of AEMPS

The biomedical research model that, at a global level leads the pharmaceutical industry, is
demonstrating its effectiveness. In the last decades it has made great advances in the most
serious diseases (from cancer to rheumatological diseases) and has managed to control
deadly diseases (such as AIDS), and even cure them (such as hepatitis C). We are now on
the cusp of a new and exciting era, that of gene and cellular therapies, with which so-called
precision medicine can be implemented through treatments for specific patient profiles,
which will generate remarkable progress in terms of health.
To a large extent, this is possible thanks to the constant evolution of this research model,
which is increasingly open, collaborative and international, and which is supported by the
cooperation of hospitals, universities and other public and private research centres and
with the participation of teams from around the world. In this way, a research network
comes together, one that enriches healthcare professionals (whose research work contrib-
utes to clinical activity), healthcare centres (which attract funds and improve the quality of
service), patients (the large beneficiaries) and the pharmaceutical industry, and thus mobi-
lising this framework and making it able to financially support the long and risky process
involved in developing a drug.
Spain plays an increasingly important role in this context. In 2017, the Spanish pharma-
ceutical industry beat its R&D investment record, after four consecutive years of growth,
and consolidated its leading position among the industrial sectors: more than 20% of the
R&D investment of the entire industry corresponds to the pharmaceutical sector. Such
investments add to both disruptive and incremental research, with companies positioned
to improve existing drugs to better meet the needs of doctors and patients.
On the other hand, almost half of the investment in R&D corresponds to contracts with
hospitals and Spanish public and private research centres, which makes the pharmaceutical
industry the great promoter of the biomedical research framework of the country.
All this is mobilised by about 200 companies, most of them with a long history in Spain
and all of varying sizes and profiles, which generate 40,500 high quality jobs (up to 200,000
if we add the indirect and induced jobs) and produce and export more than 25% of Spanish
high technology.
Spain’s commitment to the industry, added to the established tradition of public-private
collaboration, to the solidity and homogeneity of the National Health System, the highly
trained professionals and the growing involvement of patients, together with the support
of the Administration, is facilitating remarkable advances. One example is that Spain is
already an international benchmark in clinical trials. Spanish hospitals participate in three
out of every ten trials carried out in Europe and the participation in the first phases, the
most complex, grows every year. For many multinationals, Spain is already the second coun-
try, after the United States, with the largest volume of tests.
These data prove the strength of Spain in the field of biomedical research and its poten-
tial to gain greater prominence. The collaboration between the Government and the phar-
maceutical industry will be key in progressing even faster.
Humberto Arnés
Director General of Farmaindustria

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SNAPSHOT IN FIGURES
Macroeconomy
SPAIN SNAPSHOT
Source: CIA World Factbook

POPULATION: 49.3 MILLION (18TH IN WORLD)
TOTAL AREA: 505,370 KM2
UNEMPLOYMENT: 16.4%
GDP (PPP): USD 1.778 TRILLION (2017)

GDP PER CAPITA (PPP): USD 38,400 (2017)
GDP REAL GROWTH RATE: 3% (2017)
GDP (2005-2017)
Source: Tradingeconomics.com; Wold Bank

1700
1600
1500
1400
1300
1200
1100
0
2005 2006 2008 2010 2012 2014 2016 2017
EVOLUTION OF THE ANNUAL GDP OF SPAIN (2004-2017)
4.2 GDP GROWTH (%) Source: countryeconomy.com
3.7 3.8
3.2 3.4 3.3

3.0
1.1 1.4
0.0
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
-1.0
-1.7
-2.9
-3.6
SNAPSHOT IN FIGURES
Pharma Market
GROWTH OF THE PHARMACEUTICAL MARKET IN EACH AUTONOMOUS COMMUNITY
TOTAL NATIONAL ASTURIAS

CANTABRIA BASQUE COUNTRY
1.7% 100% 0.9% -0.4%

1.1% 1.6%
0.8% -1.2% NAVARRA
Growth (%PPG, GALICIA

-1.2% -1.0%
EUROS) -0.5%
CASTILLA AND LEON
Contribution to -1.9%
Growth (%, EUROS) 1.5% 4.7% ARAGON CATALONIA
LA RIOJA 0.0% 1.6%
0.1% 0.0% 14.3%
+0.5%
0.0%
+- 0.5% MADRID
VALENCIA
2.0%
EXTREMADURA CASTILLA LA MANCHA 2.5%
-0.5% 15.0% 0.9% BALEARIC ISLANDS
1.1% 2.7% 17.8%
1.5% 2.4% 3.0%
CANARY ISLANDS
0.3% 0.9% ANDALUSIA MURCIA
3.5% 38.3% 1.9% 3.6%
NATIONAL PHARMA SECTOR GROWTH (VOLUME AND VALUE)
MARKET RETAIL (MILLION UNITS, 2010-2017) MARKET RETAIL (MILLION EUROS, PVP, 2010-2017)
2010 1144 605 1749 2010 15659 5162 20621

+1.6% -6.8%
2011 1150 571 1722 2011 14403 5012 19415
-3.3% -6.2%
2012 1120 544 1664 2012 13385 4834 18219
Consumer
-2.4% -1.1%
Health
2013 1104 521 1625 2013 13147 4878 18026
Prescription
-0.2% +1.1%
2014 1097 524 1621 2014 13151 5080 18231
+4.4% +1.7%
2015 1149 543 1892 2015 13149 5393 18541
+3.3% +6.0%
2016 1186 561 1747 2016 13933 5727 19659
-0.9% +0.7%
2017 1175 556 1731 Source:
2017 14009 5791 19799

SNAPSHOT IN FIGURES
Leaderboards
TOP 20 PHARMA COMPANIES IN SPAIN (TOTAL MARKET)

% Market Share %PPG Previous Year % Market Share %PPG Previous Year
€ PVP (Sales Euros PVP) € PVP (Sales Euros PVP)
100.0% 1.3% 10 PFIZER 2.0% -10.4%

1 GLAXOSMITHKLINE 3.8% -2.7% 11 JANSSEN CILAG 1.9% -0.4%
2 CINFA 3.7% 2.8% 12 LILLY SAE 1.7% 5.5%
3 SANOFI-AVENTIS 3.5% -3.3% 13 STADA 1.6% 0.6%
4 MERCK SHARP DOHME 3.0% -2.6% 14 NORMON 1.6% 5.3%
5 BOEHRINGER ING ESP 2.6% 9.1% 15 FERRER 1.6% 1.1%
6 ASTRAZENECA 2.4% 2.1% 16 MENARINI 1.5% -0.6%
7 BAYER 2.3% 3.3% 17 NOVO NORDISK PHARM 1.4% 1.7%
8 NOVARTIS 2.1% 3.1% 18 ASTELLAS PHARMA 1.4% -1.5%
9 ESTEVE 2.1% 2.4% 19 KERN PHARMA 1.4% -1.3%
10 ALMIRALL S.A. 2.0% -9.9% 20 TOTAL OTHERS (2335) 56.2% 2.5%
MAT 04/2018 (last 12 months): April 2018 - May 2017

% PPG: Growth over the same period of the previous year % Market Share € PVP: percentage of market share based on sales euros public price Source: IQVIA

TOP 20 PHARMA COMPANIES IN SPAIN TOP 20 PHARMA COMPANIES IN SPAIN

(PRESCRIPTION MARKET) (CONSUMER HEALTH/OTC MARKET)
Source: IQVIA % Market Share %PPG Previous Year % Market Share %PPG Previous Year
Source: IQVIA € PVP (Sales Euros PVP)
€ PVP (Sales Euros PVP)
100.0% 1.2% 100.0% 1.7%

1 GLAXOSMITHKLINE 5.3% -2.7% 1 JOHNSON JOHNSON 4.4% 3.0%
2 MERCK SHARP DOHME 4.3% -2.6% 2 GSK CONS HEALTHCARE 3.3% 3.1%
3 SANOFI-AVENTIS 4.2% -3.9% 3 BAYER 3.2% 4.2%
4 CINFA 4.1% 1.8% 4 HARTMANN 3.0% -6.0%
5 BOEHRINGER ING ESP 3.6% 9.1% 5 CINFA 2.9% 6.2%
6 ASTRAZENECA 3.4% 2.1% 6 ISDIN 2.7% 2.6%
7 NOVARTIS 3.0% 3.1% 7 INDAS 2.6% -3.5%
8 PFIZER 2.8% -10.4% 8 RECKITT BENCKISER 2.4% -7.9%
9 JANSSEN CILAG 2.7% -0.4% 9 LACER 2.0% 1.6%
10 ESTEVE 2.7% 1.9% 10 SANOFI-AVENTIS 1.9% -0.2%
11 LILLY SAE 2.5% 5.5% 11 NESTLE HC 1.9% -2.8%
12 ALMIRALL S.A. 2.3% -12.8% 12 ABBOTT 1.7% 0.6%
13 NORMON 2.2% 4.8% 13 ESSITY SPAIN S.L 1.6% -3.2%
14 MENARINI 2.1% -1.4% 14 COLOPLAST 1.5% 5.6%
15 STADA 2.1% -0.1% 15 PROCTER GAMBLE 1.5% 1.5%
16 NOVO NORDISK PHARMA 2.0% 1.6% 16 URIACH-AQUILEA OTC 1.5% 2.7%
17 ASTELLAS PHARMA 2.0% -1.5% 17 ALMIRALL S.A. 1.4% 3.2%
18 BAYER 1.9% 2.6% 18 ZAMBON 1.4% 7.5%
19 KERN PHARMA 1.9% -2.0% 19 NUTRICIA S.A. 1.3% -4.5%
20 FERRER 1.8% 0.6% 20 AVENE 1.3% -5.5%
TOTAL OTHERS (309) 43.1% 3.5% TOTAL OTHERS (2206) 56.4% 2.7%
MAT 04/2018 (last 12 months): April 2018 - May 2017 MAT 04/2018 (last 12 months): April 2018 - May 2017
% PPG: Growth over the same period of the previous year % Market Share € % PPG: Growth over the same period of the previous year % Market Share €
PVP: percentage of market share based on sales euros public price PVP: percentage of market share based on sales euros public price


SNAPSHOT IN FIGURES
Healthcare
LEADING CAUSES OF DEATH
Chronic
Ischaemic heart obstructive
disease pulmonary
13.6% 7.1% disease (COPD)
Alzheimer
disease and other Lung cancer
6.9% dementias
14.6%
5% Stroke
Source: Health Europa
TOTAL SPENDING (PUBLIC AND PRIVATE) ON HEALTHCARE

AS A PERCENTAGE OF GDP AT MARKET PRICES
Source: EFPIA FRANCE
GERMANY
12
11
10
ITALY
9
7
SPAIN
6 UK
2000 2010 2015 2016
TOTAL HEALTHCARE SPENDING IN SPAIN IN RELATION TO GDP (2010-2015)
27.5% 27.3% 26.4% 24.6% 25.2% 26.2% 27.8% 28.9% 30.0% 29.0%
Private
Healthcare
9.0% 9.0% 9.1% 9.1% 9.0% 9.1% 9.2%
Public 7.8% 7.8% 8.3%
Healthcare
% PIB
72.5% 72.7% 73.6% 75.4% 74.8% 73.8% 72.2% 71.1% 70.0% 71.0%
Source: OECD
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

LEADING FROM THE FRONT STRAP IN HERE PLEASE
Humberto Arnés, Farmaindustria Strap subhead in here please
ON A ROLL
Spain is picking up steam and on the rise. Now,

the pharmaceutical industry, headed by Humberto THE CHALLENGE IS HOW TO
Arnés, general director of Farmaindustria, the lead- RECONCILE THE SUSTAINABILITY
ing association in the sector, is looking to capitalize OF THE HEALTHCARE SYSTEMS IN
on the nation´s positive economic outlook and firm- EUROPE AND THE INTRODUCTION
ly position the country as a leading destination for OF INNOVATION INTO THE MARKET.
pharmaceutical players, both local and international
Spanish market. We had dramatically dropped behind

Humberto Arnés for both indicators during the crisis, and we are now
back in line with Italy or France.
FARMAINDUSTRIA
HCLS: What are some of the latest regulatory
changes worth highlighting within the Spanish
HCLS: How has the pharmaceutical industry pharmaceutical market?
benefited from Spain´s economic growth? HA: An important milestone in the Spanish phar-
HUMBERTO ARNÉS (HA): We have been through maceutical industry during the last years was the
difficult times from 2010 to 2015, as Spain was severe- Collaboration Agreement we signed with the govern-
ly hit by the Eurozone economic crisis. However, since ment in order to establish a predictable and steady
2015, the Spanish economy has been expanding at a framework for the pharma sector. The agreement
faster rate than other European member states such as sets out to match the growth of public expenditure
France, Germany and the UK. This is fantastic news for on medicines to that of GDP, as to enable the gov-
the pharmaceutical industry since, as a regulated sector ernment to meet its budgetary adjustment objectives
and one depending on state budget and funding, we while ensuring patients have access to the necessary
directly depend on the economy’s good health. medicines.
In fact, we have been constantly growing for the last If the expected expenditure threshold were to be
three years (2015-2017) leading to a growth rate of 2.7 exceeded due to the therapeutic needs of the society
percent of the total public pharmaceutical expenditure. exceeding the development of the economy, the gov-
In the two segments of the pharmaceutical industry – ernment and Farmaindustria are committed to come
the hospitals and retail market – growth varied to a cer- up with suitable solutions that will make it compatible,
tain extent. In the hospitals segment, growth was 3.3 including compensation from the industry. We are re-
percent, while retail sales grew by 2.2 percent. I cannot newing this agreement every year, and now we’re work-
think of any other European pharmaceutical market in ing with the government on a new agreement.
Europe with the same growth trajectory.
Two other important indicators reflected on the HCLS: Which models is Farmaindustria advocat-
positive change: the availability rate and the waiting ing in relation to innovation entering the Spanish
time. The availability rate reflects the amount of prod- market?
ucts approved by the EMA that are actually available HA: The challenge is how to reconcile the sustaina-
in Spain, and the waiting time reveals how long it bility of the healthcare systems in Europe and the in-
takes for a product approved by the EMA to reach the troduction of innovation into the market. We believe

STRAP IN HERE PLEASE LEADING FROM THE FRONT
Strap subhead in here please Humberto Arnés, Farmaindustria
the pharmaceutical industry by which all companies that

adhered to it will have to inform healthcare professionals
that transfers of value derived from their collaboration as
far as education, scientific-professional meetings and ser-
vices provision will be disclosed in an individual manner.
This evolution from the Code is endorsed by a
report released in April by the Spanish Data Protection
Agency which stated the legitimacy of the disclosure
on an individual basis is supported by the current
European legal framework (Directive 95/46/EC), so
that it will only be necessary to inform healthcare pro-
fessionals that each transfer of value will be disclosed
without being mandatory for the professional to sign
a previous individual consent. This makes Spain a pio-
neering country in this field.
that in Spain it is necessary to contemplate this chal-
lenge in a holistic way. HCLS: What is the importance of the pharmaceu-
Firstly, this can be done by preserving the current tical industry for Spain?
pharmaceutical model based on IP rights. When pat- HA: The pharmaceutical sector in Spain is very strate-
ents expire, national health systems can benefit from the gic. The sector directly employs over 40,000 people with
entry of generic medicines, which ultimately alleviate the more than 60 percent of our jobs going to post-gradu-
state’s purse. Secondly, we must preserve the competitive ates. Another striking point is that 21 percent of the
model of the market. Thirdly, smart pricing and payment entire industrial R&D investments are undertaken by
models such as discounts, risk sharing, etc. are already in the pharmaceutical industry, and it also constitutes a
place or explored. source of qualified, stable and diverse employments.
But ultimately the priority and the efforts should be
put on improving the efficiency of the healthcare sys-
tem. One way to improve the various inefficiencies of the THE SECTOR DIRECTLY EMPLOYS OVER
healthcare system is by measuring health outcomes and 40,000 PEOPLE WITH MORE THAN 50
the costs associated with each intervention to decide the PERCENT OF OUR JOBS GOING TO
most efficient intervention for every single case or patient. POST-GRADUATES.
At the moment we are working on a challenging
project with the International Consortium of Health One differential factor is also the fact that we are
Outcome Measurement (ICHOM) with three pilot pro- the main driving force in public R&D in biomedical
jects in three Spanish regions – Madrid, the Basque research. More than 47 percent of our R&D efforts are
Country and Galicia – to convey the importance of the in collaborative projects with R&D public centres in
value to measure healthcare outcomes and its associat- our country. As a result, Spain has a very strong and
ed costs. Even state-of-the-art technologies provide sav- important network of public and private R&D centres
ings to the system and are beneficial for the patients, the in bioscience. On a side note, Spain enjoys an important
health system, the industry and ultimately for medical network of public hospitals and one peculiarity is the
professionals because they have better tools to provide integration of primary and specialized care within the
solutions to their patients. network which facilitates clinical trials.
It is safe to say that there is no other sector provid-
HCLS: Can you elaborate more on the initiative ing the same value to society, because we provide health
on transparency? solutions to patients, secondly, we strongly contribute
HA: In 2016, the board of Farmaindustria gave the to the country’s R&D and economy and we are generat-
green light to an amendment of our Code of Practice of ing savings to the health system through innovations.

COMPANY FOCUS
Esteve
LAYING FOUNDATIONS
FOR THE FUTURE
Esteve has long been a family-run business, though in early 2018 they Staffan Schüberg
decided to make a daring, though calculated, move and positioned the ESTEVE
W
then CCO of Lundbeck, Staffan Schüberg, as their new CEO.
ith this hire, the group hails in a new companies that can help us increase and strengthen
strategy, aiming on “molding Esteve our geographical coverage by expanding or comple-
to what we view as its best fit within menting our current European footprint.”
the global pharmaceutical ecosystem. This geographic expansion is key for long term
This will be servicing high-end clients success as one of the main challenges that Schüberg
with APIs and specialty pharma and segregating out must overcome is that “Esteve has always had a global
generics arm of the business,” explains Schüberg. “We
are still strategizing on how to do this, for example,
through a joint venture or attracting venture capital
to increase the generics business size. In any case, this
branch must be grown and act on a global level to be
efficient, working on high volumes demanded by the
global generics market.”
As part of this R&D focused mindset, the compa-
ny will be focused “in neuroscience and gene therapy.
We have world-class experience here, and we see these
areas as highly attractive from a long-term commer-
cial perspective. Our deep knowledge allows us to rec-
ognize the emerging challenges and opportunities in
these areas, ultimately giving us a strategic advantage.”
To do this Schüberg will be active in the market as
he acknowledges that “a strong pipeline requires mul-
tiple shots on goal, and we now recognize the need
to complement our state-of-the-art R&D engine with
a state-of-the-art business development chassis that
can lead to more shots. Therefore, we are absolutely
in the market for possible acquisitions and mergers
with companies that represent a strong strategic fit
for Esteve.”
The next question is, what pieces fit the Esteve puz-
zle? Schüberg identifies three main avenues. “First,
companies with mid- to late-stage pipelines that align
with our core focus in neuroscience and gene thera-
py. Second, enterprises that have solid growth projec-
tions, but most importantly strong EBITDA. Finally,

COMPANY FOCUS
Esteve
ESTEVE
- NET REVENUES:
WE NOW RECOGNIZE THE NEED TO
COMPLEMENT OUR STATE-OF-THE-
803 MILLION ART R&D ENGINE WITH A STATE-OF-
- SALES OUTSIDE SPAIN: THE-ART BUSINESS DEVELOPMENT
73% CHASSIS THAT CAN LEAD TO MORE
- EMPLOYEES:
SHOTS. Staffan Schüberg ESTEVE
2,378
- R&D INVESTMENT: R&D strategy without a global presence. This results
81 MILLION in significant risk during the development phase with
smaller returns in the end because the commercial
- INDUSTRIAL FACILITIES IN opportunity is limited to certain regions. With a larger
EUROPE (3 SPAIN), ASIA geographic footprint, we will be able to truly maximize
(2 CHINA) AND AMERICA the potential of our innovative pipeline.”
(1 MÉXICO). The logical expansion is towards the US, as it “con-
servatively represents more than half of the global mar-
- SUBSIDIARIES: ket, so ignoring that region would be foolish. Every
PORTUGAL, ITALY, TURKEY, single successful global pharmaceutical company has
US a strong and meaningful US presence,” points out
Schüberg. This expansion for Esteve inevitably relates
- HQ: “back to our pipeline. We see a tremendous fit between
BARCELONA several of our development-stage therapies and the
unmet needs in the US market. Rather than spreading
- FOUNDED:
ourselves too thin, I view a meaningful US presence as
1929 critical to capitalizing on our R&D investments and
ultimately helping more patients.”

INDUSTRY SPOTLIGHT
Biotech
TEN YEARS IN
THE MAKING
Spain’s biotech scene is on the rise. In 2016 alone,
the nation had a total of 651 biotech companies,
with a total of 33 commencing operations in 2017.
Despite these quite modest numbers in comparison
to more well-established global biotech hubs, they
have been accompanied by some extremely en-
couraging exits.
I
n January this year, Stat-Dx “was sold for around association. Furthermore, in 2016, 66.8 percent of
USD 200 million to Qiagen” proudly high- all biotech companies had a focus on healthcare, the
lights Joël Jean-Mairet, general partner at lead- largest sector by a significant margin (second position
ing Spanish venture capital firm, Ysios Capital. was the Food Industry with 23.5 percent, and third,
“Another clear success was the sale of Cellerix which we Animal Health and Aquaculture with 20.8 percent).
reverse-merged with NYSE Euronext quoted Togenix The Spanish biotech sector is being led by CEO of
and sold it to Takeda for USD 520 million in July 2018”. ASEBIO, Ion Arocena, who understands the scene “did
The Spanish biotech sector is dominated by the not become a thriving sector overnight. Ten years ago,
region of Catalonia, with 23.3 percent of all biotech the right policies were put in place, there was money
companies, followed by Madrid at 18.7 percent, and being invested into research and that started to create
Andalusia with 16 percent, according to 2017 sta- the right conditions for the industry to develop”. As a
tistics from ASEBIO, the Spanish biotech industry result of this plan the “scientific production of Spain
BIOTECH COMPANIES
660
654 651
617 625 628 651
554
475 BIOTECH COMPANIES
33
BIOTECH COMPANIES STARTED
2009 2010 2011 2012 2013 2014 2015 2016
THEIR ACTIVITY IN 2017

INDUSTRY SPOTLIGHT
Biotech
TEN YEARS AGO, THE RIGHT POLICIES WERE PUT IN PLACE, THERE
WAS MONEY BEING INVESTED INTO RESEARCH AND THAT STARTED
TO CREATE THE RIGHT CONDITIONS FOR THE INDUSTRY TO
DEVELOP Ion Arocena ASEBIO
is highly competitive in terms of and this is not lost on Jordi Naval, gets Naval even
both quantity and quality, particu- CEO of Biocat, the Catalan Biotech more excited is
larly in the life sciences sector. We Cluster. He notes that “today, more the fact “the lev-
rank tenth worldwide in the area of than 60 percent of all the health- el of investment
biochemistry, genetics, molecular care and biotech innovation of over the last
biology, neuroscience and pharma- Spain is happening in Catalonia, few years has
cology and fifth in Europe, behind and Barcelona is where interna- increased sub-
ION AROCENA
Germany, the UK, France and Italy”. tional investors are really coming stantially. We
CEO, ASEBIO
As aforementioned, Catalonia is to look for breakthrough innova- have reached the
the leading player in the market, tions with a global reach”. What level of around
EUR 130 million invested yearly into
local companies having moved from
PERCENTAGE OF COMPANIES ACCORDING TO
BIOTECHNOLOGY AREA OF APPLICATION (2016)
EUR 50 million in 2014. Furthermore,
72 percent of all venture capital
Some companies have more than one are of application, what makes the total attracted by Catalan start-ups in the
differ from 100% sector this year (specifically EUR 42.7
FOOD INDUSTRY million of a total of EUR 60.9 million)
ANIMAL HEALTH
23.5% was through rounds of funding with
& AQUACULTUR
INDUSTRY international participants.”
20.8%
11.3% The importance of funding is also
AGRICULTURE not lost on former Minister of Finance
& FORESTY of Catalonia and current President
ENVIRONMENT of BIST, the Barcelona Institute of
17.4%
10.1% Science and Technology, Andreu Mas-
BIOTECH Colell, who points out that, “From
COMPANY 2007 to 2015, only two European
countries lowered the percentage of
GDP being allocated to R&D: Spain
and Finland. Fortunately, Catalonia
HUMAN HEALTH is competitive in the European
36.8% research ecosystem and has been able

INDUSTRY SPOTLIGHT
Biotech
DISTRIBUTION OF BIOTECHNOLOGY COMPANIES BY AUTONOMOUS REGIONS IN SPAIN (2017)
Catalonia is the autonomous region with the largest number of companies dedicated to biotechnology (23.3%),
followed by Madrid (18.7%), Andalusia (16.0%), Valencia (10%) and the Basque Country (8.8%)
8.8%
2.5% 0.8%
4.8% 2.5%
0.8%
< 2.4% 23.3%
3.5% 2.5%
2.4% - 3.2%
18.7%
3.2% - 8.3%
10.0%
> 8.3%
0-3% 0.8% 2.7%
1.1%
16.0%
2.2%
to partly compensate, with EU funds, for the decline of Arocena, knows that despite
Spanish funds. Catalonia compares well with countries the “fundamentals on which we
like Denmark, France or Austria in terms of EU funds (ASEBIO) can strengthen the
received per inhabitant. competitiveness of the Spanish
These funding rounds are an integral part of any biotech industry are solid what is
successful life sciences cluster and follow the grow- missing is long-term stable pol-
ing trend that “funding for research is increasing- icies…. Spain has identified cer-
ANDREU
ly outsourced to research organizations, university tain incentives for R&D activities, MAS-COLELL
labs, or start-ups. This is also happening among us in but the structure of such incen- president,
Catalonia”, explains Mas-Colell. tives can be definitely improved Barcelona Institute
of Science and
On a larger Spanish level this shift is also taking place, because most of the money that
Technology (BIST)
with the Spanish venture capital funding landscape companies receive are simply soft
being led by Ysios Capital, who in 2019 “are going to loans in the guise of ‘grants’…Our
launch a new fund focused exclusively on drug devel- main focus will be on how to tackle the weakness of the
opment... this will follow the new shift towards larger industry and face challenges such as the R&D incentives
funding rounds reaching tens of millions”, explains framework – e.g. grants – and access to capital which ulti-
Jean-Mairet. This is different to in the past, where mately enables companies to grow.”
“Historically, investment in Spain was drip fed to com- For Jean-Mairet, it is less about the pure act of attract-
panies…this is for early-stage companies, sometimes even ing capital, but more that “Spain must understand that
from scratch, gives us the opportunity to professionalize the driving force and key ingredient behind any suc-
the company from the very beginning.” cess will be top science. This will catalyse a new wave of
Now with the capital coming in and a plan in place, investment, not linearly, but exponentially, but again top
what is next to truly place Spain on the biotech map? science is the key for Spain in the future.”

MNC INVESTMENTS
Timmo Andersen, Boehringer Ingelheim
THE GERMANS
BETTING BIG
ON SPAIN
Attracting investment from multinational compa-
nies is always a competitive process. However,
Spain’s positive economic growth and world-class
personnel have attracted the eyes of German giant,
Boehringer Ingelheim, explains Timmo Andersen,
former general manager of BI Spain and newly ap-
pointed head of Europe, Australia and Canada.
didn’t run away in the fact of price cuts and have been
one of the most resilient parts of the national economy.
Timmo Andersen
BOEHRINGER WE WERE ONE OF THE FEW INDUSTRIES
INGELHEIM THAT DIDN’T RUN AWAY IN THE FACT OF
PRICE CUTS AND HAVE BEEN ONE OF THE
MOST RESILIENT PARTS OF THE NATIONAL
HCLS: To what extent has the Spanish pharma
ECONOMY.
industry rebounded from the dark days of the fi-
nancial crisis? HCLS: The company is investing EUR 130 mil-
TIMMO ANDERSEN (TA): Overall the Spanish lion on a new facility and extension in Sant Cugat
pharma industry has exhibited great resilience in the del Vallès. What benefits will this big-ticket invest-
aftermath of the financial crisis. Back in 2009, the local ment deliver?
industry suffered a massive blow, which really set the TA: Boehringer Ingelheim already manufactures am-
clock back: forced price reductions, sluggish market poules products such as Nolotil at the Sant Cugat del
access, and even products being ejected from the reim- Vallès complex where we currently employ some 900
bursement list. Thankfully, though, recent years have personnel. What the new investment will accomplish is
been characterized by a good sense of partnership be- the integration of the production of Respimat, the car-
tween the PP-led government and the industry, where- tridge and the applicator of a medication for the treat-
by we have witnessed controlled growth in-line with or ment of respiratory diseases, which will be distributed
just above the GDP rate. worldwide. This is a very strategic product that will
In contrast to the political turbulence in Spain marked give us sustainability for the next 15 or so years. Right
by a series of inconclusive elections, the operating envi- now, we have some very mature products like ampoules
ronment in the pharma market has been one of great being manufactured in Catalonia, so the time is right
consistency and continuity. I think it is fair to say that for an upgrade that makes our Spanish operations
there has been a great mutual understanding between more forward looking. All in all, this is an immensely
the government and private enterprise over the ena- exciting development and will involve the creation of a
bling conditions needed for business to thrive. I believe further 250-300 jobs.
the Ministries of Health and of Industry both properly We’ve also been making a series of other high-profile
acknowledged the value that the pharma industry con- investments locally. Three years ago we decided to estab-
tributes locally in terms of quality job creation and tech- lish one of our global IT support centres here. The ini-
nological prowess. We were one of the few industries that tial idea was to put in place a classic, low-value support

MNC INVESTMENTS
Timmo Andersen, Boehringer Ingelheim
the trust the market places in us by investing in jobs

creation wherever we can afford it.
You also have to bear in mind, shifts in global supply
chains in line with our “From Volume to Value” cor-
porate strategy. For highly strategic projects like flag-
AMONG EUROPEAN ship research sites or biosimilars production facilities,
the tendency within Boehringer Ingelheim is increas-
COUNTRIES, SPAIN
ingly to perform those tasks out in the heavyweight
STANDS AS ONE markets of tomorrow such as China. When you look at
OF OUR MOST our global sales ratios, Europe is gradually losing some
HIGH-PROFILE of its relevance. However, among European countries,
INVESTMENT Spain stands as one of our most high-profile invest-
DESTINATIONS. ment destinations.
HCLS: What are the challenges and opportuni-

operation of 60 people, but over time that workforce ties within the Spanish pharma market?
has been increased to 400 and handles the global devel- TA: Right now, market access is acceptable compared
opment innovation and maintenance of Boehringer to many of the other European member states many of
Ingelheim’s IT platforms. It other words, it has become which have public health systems that are experiencing
a centre of excellence charged with driving the com- severe financial pressures. There is therefore much to
pany’s embracement of digital disruption. Meanwhile, be optimistic about and I think the Spanish affiliate’s
we’ve established two of our global regulatory affairs successful results and performance over a sustained pe-
centres (for mature products and documentation riod reflect that confidence.
respectively) as well as a third dedicated to supporting I am concerned, however, about the long-term impli-
new product registrations. cations of some of the Spanish market’s structural
anomalies such as the pricing of generics in Spain.
HCLS: Why is it that Boehringer Ingelheim is Because everything has been working well so far and
betting so big on Spain? Spain is emerging nicely from the big dip, there is per-
TA: Spain offers a unique constellation of factors. haps a sense of complacency around properly dealing
One of the main pulling points, however, relates to with this issue. The brute reality, however, is that in
the great pool of skilled human capital. If you look at most markets generic erosion works well in freeing up
the macroeconomic parameters, Spain is afflicted with money to invest in innovation. Right now, the phar-
exceedingly high youth unemployment. However, the macists and retailers are content because of the higher
country simultaneously possesses some of the best margins, but the moment will come when expenditure
business universities, technical schools and hospitals. on innovation reaches a ceiling.
This means that it is very easy to source affordable, but Then there is the devolution of decision making to
high-quality talent. If you consider the cost-quality ra- regional and sub regional levels. Up until now, this has
tios, manufacturing in Spain is significantly cheaper worked because we negotiate with the full range of
than it would be in Switzerland or our home country stakeholders from the regional authorities and com-
of Germany, and yet we can still produce top notch, re- munities down to the hospitals. Everyone receives a
liable products suitable for export all around the globe. percentage or concession that they feel is acceptable.
There is also a social dimension. We are a German The danger is that, over time, this can spin out of con-
company, but with a very European identity and fla- trol and result in a loss of transparency and predicta-
vour. We strive to become part of the fabric of the bility. Maintaining predictability is critical. If there’s
socio-economic identity of the markets where we con- one thing that global management boards like less
duct a high-performance business. Spain falls into this than being below budget it is wildly fluctuating results
category. It is a good market for us and we seek to repay and uncertainty.

MARKET TRENDS
Spanish Mid-Caps’ Internationalization
THE GRASS IS
ALWAYS GREENER
Despite the Spanish economy and pharmaceutical market’s
steady growth, many local players are understanding the lim-
itations and risks of operating within a single market. There-
fore, these small to mid-cap local companies are taking the
T
next logical steps in their growth; internationalization.
his international movement for many companies has

only just began, though for Uriach, the Spanish OTC
company of the year in 2018. “The financial crisis in
2008 pushed the company to broaden its horizons
outside of Spain in order to survive. At the
beginning of these renovations, we were an
EUR 35 million business fully concentrated
in Spain. In the space of five years, we have
reached over EUR 100 million in healthcare
turnover across four countries,” highlights
CEO Orial Segarra “We are becoming a
ORIAL mid-sized European company and increas-
SEGARRA ing our presence in new markets through
CEO, Uriach
joint ventures and acquisitions. Of course,
the crisis was not comfortable, but it made
the company stronger in a sense. To last
over 180 years, an organization must be
adaptable; something that is embedded in
the DNA of Uriach”
Historically, thanks to cultural and lin-
guistic ties, Latin America has been the
CARLOS
RUBIÓ first international step for many of these
executive president, Spanish players. This was no different for
Laboratorios Rubió Laboratiorios Rubío who commenced
operations within the LATAM region in AT THE BEGINNING OF THESE
1982. Now, VP Carlos Rubió sees new RENOVATIONS, WE WERE AN
opportunities in similar regions as “third EUR 35 MILLION BUSINESS FULLY
world countries have an appetite for “clas-
CONCENTRATED IN SPAIN. IN THE
sic therapies,” which gives us an opportuni-
SPACE OF FIVE YEARS, WE HAVE
ty to grow. We really are based in Spain, but
act in a global sense, adapting our products
REACHED OVER EUR 100 MILLION
to intentional regulations and guidelines.” IN HEALTHCARE TURNOVER
IGNACIO
VEGA This has seen the company’s internation- ACROSS FOUR COUNTRIES
president, Cardiva al footprint increase and become a larger Orial Segarra URIACH
piece of their revenue pie. Nevertheless,

MARKET TRENDS
Spanish Mid-Caps’ Internationalization
Rubió understands that the company’s in the UK, Germany, France, Nordics,
“growth in the US and other markets Spain and Portugal, while in the mean-
will need an increase in our manufactur- time building relationships to soon
ing capability, since more than 50 per- move into Eastern Europe and other
cent of the units we manufacture are for countries.”
international sales, and we will start this Another local medical device player
new project next year.” also shares this view to grow abroad, and
Cardiva, led by president Ignacio Vega
aims “to expand in many countries in
WE REALLY ARE BASED order to minimize the risks inherent in
IN SPAIN, BUT ACT IN A focusing on only one country. Currently,
GLOBAL SENSE, ADAPTING between 35 and 40 percent of the Málaga
OUR PRODUCTS TO plant’s production goes to exports, but
INTERNATIONAL REGULATIONS our future goal is that this percentage
AND GUIDELINES. rises to 90 percent.” As a result of this
impressive growth, the company is “now
Carlos Rubió LABORATORIOS RUBIÓ
investing a lot of money in our Málaga
However, despite links to the LATAM plant because we have grown so quick-
region, the big pie for many players is ly, and we need larger facilities. Our
the European Union, due to its proxim- investments will double the production
ity and similarities in regulation. Xavier capacity of the plant. Each day we export
Carbonell, after taking the reigns as more and more products, and this is our
CEO of the previously family-run med- priority.”
ical device player, Palex Group, moved
to position the company firmly within
the international space when the group CURRENTLY, BETWEEN 35 AND
“acquired a company with radio-fre- 40 PERCENT OF THE MÁLAGA
quency identification (RFID) technology PLANT’S PRODUCTION GOES
around seven years ago. We have invested TO EXPORTS, BUT OUR
a lot of money to develop our own sys- FUTURE GOAL IS THAT THIS
tems using this system, SmartCabinet® PERCENTAGE RISES TO 90
and SmartKanban@, and we see our PERCENT. Ignacio Vega CARDIVA
self-developed products as our future. We
are now dealing on the other side and are Along with this Málaga plant, the
distributing to Germany, the UK, Malta, group also has a site in Barcelona,
France, Italy and the Gulf Countries.” though Cardiva has taken this interna-
Furthermore, Carbonell is positioning tional strategy a step further, and in the
Palex Group as a gateway to Europe for early 2000s, “made a move into China
players outside the EU. In this way they with the acquisition of a manufactur-
have recently “struck up a joint venture ing plant near Shanghai,” points out
with JIMRO (Otsuka Medical Device Vega “Our Chinese facility – due to the
Company) to act as the exclusive distrib- comparatively lower labor costs – acts
uting partner in Europe for their large as our main manufacturing hub, after
medical device business arm. This will which the products are transferred to
over time incorporate their new technol- our Málaga facility which hosts the
ogies and we are currently distributing automated part of our production.”

COVER STORY
Maturing with Grace
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TO SEE YOU EXCITED
ABOUT PURSUING
YOUR DREAMS
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cutting edge treatments for disabling conditions and rare diseases,
as well as treatments for everyday illnesses. On all 5 continents around the world,
we want to encourage you to live life fully.
TO LIVE… AND TO DREAM.
Spain
MATURING WITH GRACE
With Spain now squarely on the road to economic recovery an analogous growth trajectory,” confides Humberto Arnés,
following the ravages of the global financial crisis, multi- the director general of Farmaindustria, Spain’s leading
national pharmaceutical companies are seeing the coun- pharmaceutical industry association.
try as a top-tier investment destination once more thanks Timmo Andersen, senior vice president and head of Eu-
to a much-improved market access scenario, high quality, rope, Canada and Australia at Boehringer Ingelheim very
but affordable manufacturing capabilities and an enviable much concurs. “Spain is a great country to be operating in
clinical research base. Gone are many of the forced price at this moment. Growth in the local pharmaceuticals market
reductions and ejections from the reimbursement list that is outpacing much of the rest of the national economy at
coincided with the implementation of successive austerity around three to four percent and moreover this is happen-
programs. Instead Spain today stands proud as the tenth ing on a consistent basis,” he enthuses.
largest pharma market in the world with a valuation of some A visible improvement to the market access context has
EUR 26.15 billion (USD 29.55 billion) in 2017 according naturally been a decisive factor in this turnaround in in-
to BMI. vestor confidence. “In addition to market growth, two other
“Overall the Spanish life sciences sector has exhibited important indicators reflect positive change: product avail-
great resilience having initially endured quite a hammering: ability and the timeframe taken for a product approved by
for the past three years, the overall value of pharmaceutical the EMA to reach the Spanish market. We had dramatically
sales in the hospital segment expanded at a rate of 3.3 per- dropped behind for both indicators during the crisis, but
cent while retail sales increased 2.2 percent... I genuinely are thankfully now back in line with markets such as Italy,
cannot think of any other European market that has enjoyed France and Germany,” explains Arnés.

COVER STORY
Maturing with Grace
Many country managers of orig- European internationalization

inator drug MNCs now perceive strategies. “Practically any drug
the Spanish life sciences space to maker worth its salt that is look-
be competitive again within its ing to build a strong reputation in
region. “I actually would go as far Europe must position themselves
as to say that Spain has attained a in the EU-5, and that includes
satisfactory level of market access: being in Spain,” argues Sergio
HUMBERTO comparing the percentage of Serra Ripol, managing director of SERGIO
ARNÉS RODRÍGUEZ
drugs approved by the Ministry of Tillotts’ local affiliate. “The fun-
director general, CEO, Pfizer
Farmaindustria
Health and the time frame it takes damentals of this market are pret-
to gain full market access for inno- ty compelling: a positive economic
vative medicines, we can now con- swing, rising GDP, sectoral growth,
clude that Spain sits amongst the an increasing envelope of life sci-
more efficient European markets,” ence investments backed by large
affirms Ángel Fernández, president volume of KOLs and medical pro-
and managing director of MSD fessionals that are world-renowned
Spain and Portugal. within their therapeutic area, and
The strong performance that to cap it all off, a universal health-
ÁNGEL many affiliates are registering is care system that is one of the best FERNANDO
FERNÁNDEZ also serving to pep up investor sen- in the world in some aspects!” ÁLVAREZ
president & director timent. “Expectations for the local Indeed, examples abound of rela- country manager
general, MSD Spain & Portugal,
market are riding high. A few years tive newcomers to Europe making Allergan
ago, our affiliate actually won an it a priority to establish on-the-
award internally for being the most dynamic market ground footprints in Spain. “Purely
within Allergan’s entire international division and we from the market size perspective, Spain represents an
have been registering double-digit growth every year, attractive option commercially and then there are a
which is rather unprecedented and simply not nor- whole host of additional positives such as the robust
mal for a settled, Western European market,” radiates healthcare apparatus, operating frameworks that
Allergan’s director general for Iberia, Fernando Álvarez. reward innovation and the sheer maturity of the clinical
Little wonder, then, that more and more multina- community,” reasons Ramón Villamarín Valdenebro,
tional pharma firms are contemplating presence on the general manager of Japanese discovery-based pharma
Spanish market as a necessary and logical step in their outfit, Shionogi.
The “Pact” that Holds Firm
An important milestone in the evolution of the Spanish pharmaceutical sector has been the signing of an annually re-
newed “collaboration agreement” between industry and government so as to keep interests on all sides – manufacturers,
patients and payers – aligned and harmonious. “It is absolutely no exaggeration to credit this ‘stability protocol’ with
enabling drug developers to weather post-crisis austerity and with helping to create a predictable and steady framework
for the pharma sector to do business,” reflects Pfizer CEO, Sergio Rodríguez.
“The agreement essentially sets out to match the growth of public expenditure on medicines to that of GDP, so as to
enable the government to meet its budgetary adjustment objectives while ensuring patients continue to gain access to
the necessary medicines. If the expected expenditure threshold were to be exceeded due to the therapeutic needs of
the society exceeding the development of the economy, the government and Farmaindustria are committed to coming
up with suitable solutions that will make it compatible, including compensation from the industry,” expounds Farmain-
dustria’s Humberto Arnés.

COVER STORY
Maturing with Grace
“Being here is great for a compa- Laboratorios Combix, subsidiary of

ny like ours that is embarking on Zydus Group.
a learning curve. We already have a
140-year history, though a majority
of this is solely in Japan. We under-
stand that the entire global market SPEEDY PRODUCT LAUNCHES
is changing, and this is happen-
SERGIO SERRA ing now; therefore, we must adapt Participants in the Spanish market RAMÓN
VILLAMARÍN
managing director, to these shifts first-hand, so we certainly tend to paint a picture of a
Tillots Pharma general manager,
can learn throughout the journey. jurisdiction that is broadly welcom- Shionogi
Maintaining a direct presence in ing towards innovative medicine
Spain crucially enables us to accomplish this,” he adds. and ready to cater for ambitious
Gujarati generics player, Zydus Cadila, has been product launch tempos. “I think that Spain has become
pursuing a similar logic. “In the European context, very professional in rewarding novel innovation. From
Spain constitutes a very mature and strategically sig- a regulatory adjudication standpoint, we detect a real
nificant market where practically all the major firms shift towards conducting technical assessments, rath-
are present. It therefore follows suit that the two affil- er than merely comparing new treatments to what
iates that our Group maintains to date on the conti- already exists within the marketplace. Innovation is
nent should be located in Spain and France,” reveals really being evaluated on an individual basis, which is
Juan Luis Fernández Balaguer, general manager of excellent news for genuine innovators just so long as
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COVER STORY
Maturing with Grace
they can adequately demonstrate added value,” posits Big Ticket Infrastructural Investments
Shionogi’s Ramón Villamarín Valdenebro.
Allergan’s Fernando Álvarez wholeheartedly agrees, Against an alluring backdrop, big name
pointing to highly innovative “needle movers” (i.e. game pharma brands are now starting to
changing products) that his company has managed to spend heavily on in-country manufac-
turing, development and shared servi-
successfully introduce to the local market including ce facilities. Boehringer Ingelheim, for
Ozurdex®, which offers a novel solution to combat ret- its part, has chosen to situate key glo-
ina swelling caused by conditions such as diabetic mac- bal functionalities in Spain, including
ular edema, and CoolSculpting®, a groundbreaking an IT support centre as well as three
regulatory affairs centres. Furthermore,
cryolipolysis-based technique for reducing stubborn fat BERNARDO in June 2017, the company announced
without surgical intervention. Being able to achieve this KANAHUATI a EUR 130 million (USD 150 million)
was likewise contingent upon proof of value delivery. “In — investment in its Sant Cugat del Vallès
CEO, Bayer manufacturing facility in Catalonia.
the Spanish market, products must be more sophisticat-
ed and encompass a larger spread of requirements, not Noting the rationale behind these
only the needs of the doctors, but equally of the system big-ticket Spanish investments, BI’s
Timmo Andersen points out that,
as a whole and patients. Efficiency must work alongside “Spain has exceedingly high youth
results, not just one or the other. That’s why we are so unemployment. However, the coun-
attentive to compiling evidence such as pharmaco-eco- try simultaneously possesses some of
the best business universities, techni-
nomic reports that indicate economic impact, as well as cal schools and hospitals. This means
the optimization of care processes,” he reveals. that it is very easy to source affordable,
TIMMO but high-quality talent.” He continues,
ANDERSEN “manufacturing in Spain is significantly
— cheaper than it would be in Switzer-
senior vice land or our home country of Germany,
president and and yet we can still produce top notch,
head Europe, reliable products suitable for export all
Canada and around the globe.”
Australia,
Boehringer Another German pharma heavywei-
Ingelheim ght, Bayer, has been following suit
pursuing heavy capital injections into
upgrading its hardware and rendering Spain a keystone
of its global supply chain infrastructure. “If we take a look
at the numbers for 2017, for example, overall, we inves-
ted EUR 33 million (USD 38 million), EUR 13 million (USD
15 million) of which we invested in infrastructure, among
other projects, improving plant quality and updating office
spaces. The remaining EUR 20 million (USD 23 million) was
invested in R&D,” recounts CEO, Bernardo Kanahuati. Its
API plant in in La Felguera in Asturias produces the entire
group’s acetylsalicylic acid, the active component of Aspi-
rin. The company’s production plant in Alcalá de Henares,
Madrid, meanwhile, constitutes the sole Bayer plant to
produce soft gelatin capsules and doubles up as an impor-
tant site for innovating new encapsulation technologies.
In a similar vein, Pfizer’s production plant in San Sebastián

de los Reyes, Madrid, is notable for being the only Pfi-
zer plant in the world that manufactures, packages and
distributes recombinant products for the treatment of
hemophilia A and B. “This is a critical facility because we
distribute products manufactured in this plant to 15,000
patients spread 75 different countries,” explains CEO,
Sergio Rodríguez.

COVER STORY
Maturing with Grace
“We’ve witnessed somewhat of a paradigm shift impressed in the efficient manner

in terms of the process for evaluating the benefits of in which it successfully launched
new therapies,” confirms Baltasar Lobato, partner its revolutionary oncological prod-
for the health & life sciences advisory practice of EY. uct for renal cancer, Cabometyx, in
“Traditionally the main customers for pharmaceuti- under a year. “Bringing a sophisticat-
cal companies were doctors and the emphasis was on ed product like Cabometyx to mar-
comparative medicinal value and clinical performance. ket in a mere nine months is testa-
Nowadays, as the healthcare provider looks more and ment to our rapid reaction speeds, GUILLERMO
CASTILLO
more towards sustainability, they are tilting towards the agile biotech-style mindset and an
managing director,
best treatment in terms of overall end outcomes and accommodating contextual envi- Ipsen
cost and therefore companies must negotiate directly ronment… Drug developers often
with payers. As a consequence, the traditional network bemoan the complexities of bringing portfolios to stag-
of large sales teams is giving way to smaller market access nating European markets, but we have managed to buck
teams including pharmaco-economists talking specifi- this trend by proving that it is possible to speedily and effi-
cally to government officials.” ciently execute product launches. I personally believe that
Certainly, the rewards for companies that go about it the secret is properly understanding the operational land-
in the right way can be considerable. Many of the MNCs scape and the needs of the target health system,” recounts
are boasting remarkably good product launch rhythms Guillermo Castillo, managing director of Ipsen Iberia.
in Spain. Pfizer has introduced five new innovations to “We very much hope that our experience in launch-
market in 2018 alone, while French mid-cap, Ipsen, has ing Cabometyx can serve as a showcase example of the

COVER STORY
Maturing with Grace
possibilities within Europe to introduce innovation of the unique features of the market is the fragmentation
despite the severe financial constraints on health sys- linked to the country’s 17 autonomous regions; each of
tems. Being very transparent and upfront in terms of which leverages its own jurisdiction over the organiza-
pharmaco-economics, we commenced negotiations sub- tion and delivery of health services within the territory,”
mitting the dossier in December and received approval observes Tillotts’ Sergio Serra Ripol. “This might well
from the Spanish authorities in March. It was the first bring some advantages, as it allows the health system to
time in my entire professional career that I had a process stand closer to the end user and deliver tailored solu-
surpass the infrastructure required to actually roll out tions, but it definitely poses a market access challenge
the project!” he remembers. for the industry and even more so for smaller specialty
outfit like ours,” he laments.
FRAGMENTATION AND DEVOLUTION OF SPAIN IS ONE OF THE MOST

DECISION MAKING DECENTRALIZED COUNTRIES IN THE EU
Sergio Serra Ripol TILLOTTS
That’s not to suggest, however, that Spanish market
access is all sweetness and light. One complicating quirk “Although the national approval time is relatively
of the Spanish system is the seemingly inordinate powers quick, practical access can be impeded by this territori-
vested in regional authorities. “Spain is one of the most al fragmentation,” concedes MSD’s Ángel Fernández.
decentralized countries in the EU and consequently one “In my opinion, there are simply too many bodies – too
many moving parts – that are making individual anal-
yses. The danger is that hurdles created by national,
regional, and hospital processes create demanding bar-
riers to entry which then lose the benefits of offering all
patients equal access to health innovations.”
Indeed, “there is ample evidence to suggest that
excessive dilution of decision-making powers is breed-
ing inequality and distorting the balanced incor-
poration of science and innovation,” notes Bayer’s
CEO, Bernardo Kanahuati. Certainly, wild disparities
between healthcare expenditure and provision can be
witnessed across the different geographical zones. For
instance, the Basque Country, Principality of Asturias
and Community of Navarre spend over 30 percent
more on health per capita than the region of Andalusia.
Meanwhile, according to the European Observatory
on Health Systems and Policies, the proportion of
patients on waiting lists is up to five times greater in
some regions than in others. Patients in regions like
Catalonia and Castilla-La Mancha wait on average
more than 160 days for surgery, compared to less than
50 days in other autonomous regions.
Dr Josep Tabernero director of the Vall d´Hebron
Institute of Oncology and head of the Medical Oncology
Department at Vall d’Hebron University Hospital, adds
that the continuum of care is stronger in the larger
regions. He notes that “Smaller regions often need help

COVER STORY
Maturing with Grace

COVER STORY
Maturing with Grace
with patients in terms of special an ‘access’ market, meaning that companies typically
diagnostics, whereas larger com- devote more resources to market access than in other
munities often have better facilities countries, even with a similar size,” he adds.
to offer optimal treatments. In the So, what practical strategies can companies deploy to
larger regions, the continuum of navigate this anomaly? “It all starts with mapping out
care is good because primary care and establishing a standard profile for each region… We
is good, and there is good interac- can speak of a minimum and a maximum bandwidth
DR JOSEP tion between the primary care and when talking about approval timeframes. Regions dis-
TABERNERO
the hospitals.” play massive discrepancies and a local solution is need-
director, Vall d’Hebron These differences also play them- ed to solve a local problem: some are tremendously
Institute of Oncology
selves out when it comes to the ther- advanced in what they are doing and others are lag-
apies on offer, especially ones with gards. Therefore, we have to be flexible enough to adjust
a limited patient group. “The European Commission to their capabilities and the underlying infrastructure
has approved some 53 orphan drugs, but only 18 are on the ground. One local fix that Ipsen has come up
securely reimbursed here in Spain across all the regions. with – and many companies of our size are doing the
Moreover, even if the regions approve the drug and agree same – is to combine the positions of the access and key
on the reimbursement, then the individual hospitals may account manager into a single job under which the hold-
still think differently,” regrets José Manuel Rigueiro, gener accountable for everything that is happening in these
eral manager of Actelion. “This is why Spain is essentially areas of responsibility,” discloses Guillermo Castillo.
ESTIMATED HEALTHCARE EXPENDITURE (2015)
MADRID CATALONIA ANDALUSIA

12,481 14,705 12,842
ESTIMATED HC EXPENDITURE ESTIMATED HC EXPENDITURE ESTIMATED HC EXPENDITURE
TOTAL EUR MIL TOTAL EUR MIL TOTAL EUR MIL
PRIVATE 4,543 5,002 3,667

EXPENDITURE (36.4%) (34%) (28.6%)
EUR MIL
BREAKDOWN INSUR: 1,630 (35.9%) INSUR: 1,511 (30.2%) INSUR: 923 (25.2%)
OOP: 2,913 (64.1%) OOP: 3,491 (69.8%) OOP: 2,743 (74.8%)
PUBLIC EXPENDITURE 6,951 7,625 8,760

EUR MIL (55.7%) (49.3%) (68.3%)
EXPENDITURE PER CAPITA

EUR
1,996 2,014 1,641
PRIVATE 713 689 495
PUBLIC 1,283 1,325 1,145
Source: Fundación IDIS - https://www.fundacionidis.com/es

COVER STORY
Maturing with Grace
Andalusian exceptionalism
Despite the fragmented nature of the Spanish healthcare “The Andalusian tendering system creates a break in the
system, many of the country’s autonomous communities market in such a way that it is very difficult to work in both
have similar procedures for the reimbursement of drugs. Andalusia and the rest of the country. The fragmentation
However, the one region that sticks out is Andalusia, the is not good as many companies are then forced to choo-
most populous autonomous community in Spain, and its se which market they will work in”
unique tendering model.
Despite the pricing pressures being placed upon compa-
The issue is that “many of the companies winning these nies in Andalusia, it remains a region in which companies
tenders have no infrastructure in Spain. They are only here continue to work, making up “20 percent of the Spanish
to make margins of cents,” explains Enrique Ordieres, generics market,” according to Joachim Teubner, gene-
president of Cinfa Group, one of the largest local general manager of Aristo Pharma. “This tender system is a
rics players. “The government is obviously happy with the concept Aristo has experience in within the Netherlands
pricing, but they need to look beyond that and see that and Germany and we also are taking part in this southern
local generics players are offering more than just cheap region of Spain.”
drugs. The problem is many key stakeholders lack this
long-term vision and are just looking at the short-term However, change could be on the way. Recently, Andalu-
impact of spending on their next budget. The case of sia has sworn in a new administration, with Jesus Aguirre
tenders in Andalusia has created a bad attitude towards named as the community’s new Minister of Health and
generics. They must recognize the value of the generics Family. Prior to the election, Aguirre was extremely vocal
market in bringing production facilities, investments and in speaking out against the tendering system of medici-
employment. We are creating an ecosystem for Spain nes, even stating once the previous government had the
and saving money for the payer in the meantime”. tendering system approved through constitutional court
that “a battle has been lost, but not the war.” This is an
For other players, such as Laboratorios Combix, they excellent sign for patients and pharmacists who have re-
“used to make one-third of our sales in Andalusia region, peatedly asked the government to change this policy as
but we decided to remain in the rest of Spain,” points patients were unable to access the same medicines as the
out general manager, Juan Luis Fernández Balaguer. rest of Spain.
reorganizing and transforming our market access capa-

AT ALL ADMINISTRATIVE LEVELS, IT IS EASY bilities with a focus on the major needs of key stake-
IN PRACTICE TO ENGAGE IN DIALOGUE holders in the system. Essentially, we are assigning our
WITH THE AUTHORITIES IN SPAIN market access personnel to clusters of regional markets
Paolo Cionini LEO PHARMA that exhibit similar characteristics, so they can work in
“It all starts with gaining the situational intelligence. more than one state, rather our having to maintain 17
To operate your business effectively under these cir- separate teams for each of Spain’s autonomous com-
cumstances, it is critically important to understand munities,” says Fernando Álvarez.
each of the local markets, while gradually building the Others, however, believe that the impact of the
relationships with key opinion leaders. Once you have regional dimension can be overstated. Paolo Cionini,
amassed this know-how there are still human, logisti- vice president for Europe South and country manager
cal and technical difficulties to surmount if you are a for Spain and Portugal at LEO Pharma, notices paral-
small or mid-size firm. I remember a delay of around lels with the devolved authorities in Italy. “It may look
six months in the effective commercialization of one quite daunting to begin with, but Spain is actually a
of our products in one specific small region, due to a little less complicated because there is more fluidity. At
mere technical particularity in their IT prescription sys- all administrative levels, it is easy in practice to engage
tem, which we should have probably identified earlier,” in dialogue with the authorities in Spain which in turn
admits Tillots’ Sergio Serra Ripol. makes it comparatively simple to identify common
Allergan, meanwhile, has come up with its own for- solutions and conclude deals.”
mula to surmount the onerous resource requirements “Just because this arrangement is working more
to deal with this level of complexity. “We have been or less now, doesn’t necessarily mean that it will be

COVER STORY
Maturing with Grace
sustainable in the long run though,” is based “on dialogue and collaboration with nation-
warns Timmo Andersen. “Up until al and regional administrations which are responsible
now, the drug makers have been for health competencies. We consider it essential to
negotiating with the full range of facilitate patients’ access to innovative drugs, ensuring
stakeholders from the national the sustainability and equity of the system.” This has
authorities and regional commu- allowed the company to “recently launch Flutiform
nities all the way down to individ- K-haler®, a new drug for the treatment of asthma. In
JAVIER ual hospitals. Everyone receives a the area of analgesia, we are aiming to obtain reim-
ALVARADO
percentage or concession that they bursement of an inhaled analgesic for the relief of acute
general manager, feel is acceptable. The danger, how- pain in the field of medical emergency.”
Mundipharma
ever, is that, over time, this can spin
out of control and result in a loss of
transparency and predictability.”
This relation building approach has been key for STAGNATION IN THE GENERICS SEGMENT
Mundipharma, headed by general Manager, Javier
Alvarado. He acknowledges that the “Spanish pharma- Another peculiarity is Spain’s sluggish generics mar-
ceutical market has managed to maintain a favorable ket. “The generics market is growing at 4.5 percent but
level of access to innovative medicines by maintaining still, the penetration for the sector is relatively low at
control of pharmaceutical expenditure that guarantees approximately 42 percent of units sold and 24 percent
the sustainability of the system.” Therefore, his strategy of total sales revenue. In a healthy market, the pene-
tration in value should be around 40 percent,” attests
Combix’s Juan Luis Fernández Balaguer.
“To be honest, we are slightly worried about the cur-
rent situation, because the Spanish generics market
GENERICS PENETRATION IN THE EU5

COUNTRIES (%)
(2016)
UK
29% GERMANY
30.8%
FRANCE
19.6%
SPAIN ITALY
22.1% 56.1%
Source: EFPIA

COVER STORY
Maturing with Grace
EVOLUTION OF THE PHARMA MARKET - GENERICS AND BRANDS
(MILLION UNITS) Generics (MILLION EUROS, PVP)

Brands
3.6%
-1.0%
1.4%
0.8%
3194
540 3058 3083
533 40% 21%
538
1.5% 0.1% 3.4% 1.2% 12138
808 809 60% 11990 79%
796 11582
MAT/7/16 MAT/7/17 MAT/7/18 MAT/7/16 MAT/7/17 MAT/7/18

Source: IQVIA
has stagnated and not grown at patent expiration and go to the private market with a
a decent rate for quite some time low price,” reasons Ángel Luis Rodríguez de la Cuerda,
now. The primary cause of this lack AESEG’s secretary general.
of penetration is the absence of a
clear price differential between the
reference medicine and the generic
product, which is mandated by leg-
ENRIQUE islation. According to Spanish law,
ORDIERES once a drug comes off patent, the
president, originator and generic are priced
Laboratorios Cinfa
equally, which thoroughly distorts
the market dynamics. In fact, if
you rewind a decade to prior to the
implementation of such rules, we
were instantly achieving around 70
percent generics penetration when
a drug came off patent. Now we are
lucky if we reach 10 to 15 percent!”
argues Enrique Ordieres, president
ÁNGEL LUIS
RODRÍGUEZ DE of CINFA.
LA CUERDA For this reason, the Trade
secretary general, Association of Generic Producers
AESEG
(AESEG) has been vigorously lob-
bying for the abolition of this stip-
ulation. “We consider the regulatory framework in
force to greatly disadvantage our members and create
artificial imperfections within the marketplace. Even
many originator drug developers could be interested
in reversing these decisions because not all are hap-
py to have to lower the price from the first day of the

COVER STORY
Maturing with Grace
Not only is a stalled generics mar-

ket bad news for the national health
system in terms of squandered
cost savings that could otherwise
have been reinvested into financing
innovative medicine, but also it is
unfair for the generics players who
CARLOS JUAN LUIS JOAQUÍN RAÚL DÍAZ- contribute so much to the nation-
TEIXEIRA FERNÁNDEZ RODRIGO POCH VARELA
BALAGUER al economy. “Let’s not forget that of
CEO, TEVA Iberia head, Sandoz managing director,
general manager, Kern Pharma
every ten generics consumed local-
Laboratorios Combix ly, seven are produced in Spain and
this something that brings a lot in
Additional hurdles are also apparent. “While it is terms of GDP growth,” reminds Teixeira. “The Spanish
mandatory by law for doctors to prescribe treatments by generics industry, despite its difficulties, has saved
Non-proprietary Name, not all the 17 regions implement Spain EUR 20 billion (USD 23 billion) over the past
it in an orthodox manner, leading to a situation whereby two decades and the government needs to realize that
in some autonomous communities, penetration is very the opportunity for us to save them even more exists,”
high, and in others it is very low,” reflects Carlos Teixeira, reinforces Enrique Ordieres.
CEO of TEVA in Spain and Portugal. All of this also colors the composition and make-up
of the local generics landscape. “Our main competition
in Spain is not only coming from international compa-
nies, but also from national generics companies. Out
of the five most important generics players in Spain,
three of them are national companies. This is a unique
market in Europe. To differentiate ourselves against
these local competitors we are compelled to maintain a
strong patient focus,” muses Joaquín Rodrigo, general
director Iberia of Sandoz.
The homegrown Spanish players are equally forced
to tweak their business models. “Our generic products
are the same as our competition and are offered at the
same price. Therefore, we must in some way differenti-
ate ourselves in our interactions with the health commu-
nity and be smarter and more agile; a challenging task
in a saturated generic ecosystem,” elucidates Joachim
Teubner, general manager of Aristo Pharma.
“I believe that the significant pricing pressures being
applied will necessitate a lot of consolidation in the
generics field and companies that are not back integrat-
ed with self-manufacturing, will not survive. Already
we see the market beginning to shrink and numer-
ous M&As,” he notes, while pointing out that the fact
Aristo manufactures its own products in Spain, via its
production arm, Medinsa, means the company “can
offer attractive prices in an agile manner, which is well
aligned with the competitive and low-margin nature of
the Spanish generics business.”

COVER STORY
Maturing with Grace
Procare Health: Bringing Clinical Data to Natural Medicines

Clinical evidence is a hallmark of the woman.” Furthermore, the company is working with the
classic pharmaceutical model. Yann “California Nanosystem Institute of the University of UCLA
Gaslain, CEO of Procare Health, a Ca- for the development of an innovative Cervix on a chip, a
talonia-based company focused on technology they have developed for other organs. We will
women’s health, is bringing this clini- then be able to conduct experiments on real tissue, rather
cal concept to natural products that than the traditional model via animals or plates. In turn,
have never been tested in this way. The results will be more accurate and allow us to measure the
problem for Gaslain is that “many key side-effects in real time, as a preliminary step to expensive
YANN opinion leaders still see the idea of na- but necessary clinical programs.”
GASLAIN tural products being clinically proven to
— be a foreign concept. To counter this This innovation has allowed the company to establish an
CEO, Procare we must work with them to open their exciting international footprint in a short period of time.
Health minds. We are open to discussing this Gaslain notes that Procare already has partnerships with
information in a constructive manner.” “Shionogi in Italy for Papilocare and Libicare, Gedeon Ri-
chter in Eastern Europe and Besins Healthcare for Latin
This strong R&D focus has led to strong results since the America.” The next step is to enter the US market, though
company was founded in 2012, backed by the star pro- this still requires talks with the FDA. If positive the com-
duct Papilocare “the only product that helps women ma- pany “will set up a legal US entity and look to possibly
nage the HPV virus, the leading cause of cervical cancer in partner with a local distributor,” explains Gaslain.
Meanwhile other players, like especially for establishing an OTC base and have even
Kern Pharma, have been resorting managed to launch a sports supplement line,” candidly
to diversifications as a way to spread details managing director, Raúl Díaz-Varela.
risk and mitigate exposure. “Even
though we are mainly a generics
company, we consider it prudent to
hedge risk and cover other growth BETTING BIG ON BIOSIMILARS
JOACHIM
TEUBNER possibilities in the market. We
general manager,
envisage challenges in the future, Some of the more sophisticated generics companies are
Aristo Pharma Iberica so we knew we had to be prepared, thus already beginning to look beyond the prevailing

COVER STORY
Maturing with Grace
local market woes and start vesting involve the whole value chain right
their hopes in the embryonic bio- from the beginning and to shape the
similars segment. “It is clear that the biosimilars ecosystem hence our con-
generics market has matured and tribution to the establishment of a
lost some impetus, so the growth dedicated Spanish biosimilars associ-
momentum lies more with biosimi- ation (BioSim),” adds Rodrigo.
lars. With patents beginning to expire “At the moment, we have 39
REGINA on wide range of biologic therapies approved biosimilars in the EU IGNASI BIOSCA
MÚZQUIZ we are detecting a palpable increase belonging to 15 molecules, while
CEO, Reig Jofre
director general, in interest in biosimilars,” acknowl- in Spain we have 26, which is main-
BioSim
edges Joaquín Rodrigo of Sandoz. ly due to the time lapse between the
Sandoz, in fact, enjoys the distinc- EU authorization and the confirmation of the Spanish
tion of being the first company to commercialize a bio- Agency approval, patent expiry dates or the particu-
similar in Europe including Spain, namely the growth lar interests of each marketing authorization holder,”
hormone Omnitrope and is intent on maintaining its remarks Regina Múzquiz, director general of BioSim.
first mover advantage in this field so has been playing a
lead role in preparing the groundwork locally. “It is vital
that we avoid the mistakes Spain made when generics IT IS VITAL THAT WE AVOID THE
were first introduced to the market, such as misconcep- MISTAKES SPAIN MADE WHEN GENERICS
tions and false perceptions of products. The idea is to WERE FIRST INTRODUCED TO THE
MARKET Joaquín Rodrigo SANDOZ
Quite a few big name local entities are now belatedly

getting on the bandwagon. Kern Pharma, for example,
has signed an eye-catching partnership with Celltrion
to bring such molecules to market. Meanwhile Reig
Jofre has joined forces with the biotech, LeanBio, to set
up a new entity called Syna Therapeutics. “This pro-
ject is international so we would sell wherever we detect
demand, whether in Spain or indeed the rest of Europe.
We need to fine-tune the model but the industry will
undoubtedly grow. It is a model that cannot be avoid-
ed. For the rest of the world, it makes sense from a pure
access perspective. Many countries have not had access
to certain biologics because they were too expensive.
Biosimilars are the answer to that,” confidently declares
Reig Jofre CEO Ignasi Biosca.
Others, however, have noticed the relatively low local
penetration rates in the areas in which biosimilars are
currently present in Spain such as oncology, where they
register around a mere five to eight percent, far below
their potential.
Despite the biosimilar market needing a clearer direc-
tion, the country has witnessed its own innovation in
the area. Cinfa recently developed and achieved EMA
approval for a biosimilar therapy, Pelmeg® before sell-
ing the business arm, Cinfa Biotech, to Mundipharma.

COVER STORY
Maturing with Grace
This, for Mundipharma’s Javier Alvarado, is “strategi- more than 20 percent of the almost
cally very important for us. We have strengthened our 4,000 clinical studies carried out
position as a leader in biosimilars with the acquisition. each year in Europe and is vying
This expands our biosimilar platform beyond commer- with the UK to become the preferred
cial excellence to development. We are confident that our second choice destination within
entry into this market will open the door for yet more the EU27 after Germany,” attests
success. Furthermore, for Alvarado, it allows the compa- Ion Arocena, CEO of the Spanish
ny to play an important role in creating accessibility for Biotech Association (ASEBIO). MARIETA
JIMÉNEZ
innovative therapies; “an essential factor in guaranteeing Many multinationals have been
president and
the sustainability of the healthcare system.” unequivocal about ramping up their general manager,
in-country R&D presence. “Within Merck
the last two years, we have signed
agreements with two leading research institutes and
A PREMIER CLINICAL TRIALS DESTINATION two leading universities. We are conducting some 55
clinical studies and are working hard to convince HQ to
Innovative drug developers have few such concerns. On invest even more into Spain’s clinical operations, spe-
the contrary, they have become increasingly enthused by cifically phase I and phase II studies,” declares Marieta
Spain’s prowess as a clinical trials venue and R&D hub. Jiménez, president and general manager of Merck.
“Spain seems to be going through a golden age for clin- Meanwhile MSD has been investing heavily in the
ical research: right now the country is participating in creation of the MEDINA research centre of excellence,

COVER STORY
Maturing with Grace
Navigating A Distinctive Pharmacy Landscape

Spain has half the population of Germany but a similar number of pharmacies – around 22,000 – pre-
senting significant challenges for distributors and sales forces who are unable to physically visit every
location.

For HRA Pharma, a specialist in emergency contraceptives, maintaining good relationships with this
dense network of pharmacies is crucial to their overall goal of protecting women’s health, especially
as Spain has some of the lowest contraception usage rates in the EU. Inés Barata Correia, the com-
pany’s managing director for Spain and Portugal, explains that “We are working on building a way for
INÉS BARATA
people to feel comfortable and not ashamed when visiting pharmacies... We have to identify and best
CORREIRA educate these pharmacies as they are the primary point of sale.”
—
managing direc- To achieve this mindset shift in Spanish consumers, HRA has had to utilize innovative marketing stra-
tor for Spain and tegies. Barata Correia notes that “The myth around these types of products is that the pharmacies do
Portugal, HRA not want to sell them. However, 95 percent of sales come from the pharmacies. Therefore, to overco-
me this false perception, we went to the Ministry of Health to present a new campaign for the cate-
gory: a video with the objective of starting a conversation about emergency contraception.” She continues, “Our aim is
to clear the air and educate the public about the importance of this area in women’s health. Our first and most important
priority is to organize training programs for the pharmacies on emergency contraceptives. Pharmacies are a vital point
of contact to get the right message across and ensure that consumers feel at ease throughout the purchasing process.”

SNAPSHOT IN FIGURES
Clinical Trials
CLINICAL STUDIES CONDUCTED BY AUTONOMOUS COMMUNITY (2017)
Source: Farmaindustria - AEMPS - Spanish (% OF NATIONAL TOTAL)

Registry of Clinical Research - Clinical-
CANTABRIA
Trials.gov - InvestInSpain.org ASTURIAS BASQUE COUNTRY
1.7% 1.5% 3%
GALICIA NAVARRA
5.9% 1.8%
LA RIOJA
0.1%
CASTILLA AND LEON CATALONIA
3.3% ARAGON
27.1%
1.7%
MADRID
BALEARIC ISLANDS
23.3% 1.7%
VALENCIA
EXTREMADURA CASTILLA LA MANCHA 11.9%

1% 1.3%
MURCIA
CANARY ISLANDS
1.4% 3.3%
ANDALUSIA
12.4%
CLINICAL TRIALS STARTED IN EUROPE GROWTH OF CLINICAL STUDIES IN SPAIN

IN 2017
PERCENTAGE CHANGE (1997-2015)
9
1 ,60 48,12%
00 818
1,0 8
92
791
6
65 60
9
705
0
46 43
9 7
42 6 602
33 4
28
534 539 640
FRANCE
UK
GERMANY
ITALY
BELGIUM
THE NETHERLANDS
DENMARK
SWITZERLAND
SWEDEN
SPAIN
1997 2001 2002 2009 2010 2015 2016

Source: Farmaindustria - AEMPS -
Spanish Registry of Clinical Research - Source: Farmaindustria - AEMPS - Spanish Registry of Clinical Research -
ClinicalTrials.gov - InvestInSpain.org ClinicalTrials.gov - InvestInSpain.org

COVER STORY
Maturing with Grace
which possesses a collection of over What though, makes Spain such an appealing propo-
190,000 cultures of fungi and bac- sition for this type of activity relative to its peers? “The
teria being used to test new antibi- country’s many excellent researchers, practitioners, cli-
otics. “We are proud to say that the nicians and the presence of large health infrastructures,
foundation boasts the largest sample give it an edge as well as the deep talent pools of exper-
library in the world… At the end of tise in therapeutic areas like cardiology and oncology,”
the day, we consider Spain is a top claims Bayer’s Bernardo Kanahuati.
JORDI NAVAL worldwide clinical research platform Spain is also comparatively fast in approving the
CEO, Biocat and some 80 percent of MSD trials different stages of clinical trials while the size of the
are executed in some shape or form market means you can generally access the patient
here,” admits Ángel Fernández. groups you require: For example, in the investigation of
Some globally renowned, star products have also Tanezumab, a molecule against chronic pain, Spain is
been conceived in Spain. “One of Ipsen’s Spanish affil- the second country in the world, only behind the United
iate’s main claims to fame has actually been its part in States, in the number of patients recruited,” opines
the creation of champion product, Somatuline, used Pfizer’s Sergio Rodríguez.
for the treatment of neuroendocrine (NET) tumors and
the hormonal disorder Acromegaly. Somatuline, which
was launched in the US three years ago and continues to WE CAN DEPEND UPON AND PLACE OUR
undergo sequential innovation, was originally developed TRUST IN SPANISH RESEARCHERS AND
here at the local site,” laughs Guillermo Castillo. THE COST COMES IN SUBSTANTIALLY
CHEAPER THAN OTHER SOPHISTICATED
MARKETS SUCH AS FRANCE AND
GERMANY Carlos Teixeira TEVA
The affordability differential also counts of course.

“The tradeoff between efficiency, cost and reliability
works out: we can depend upon and place our trust in
Spanish researchers and the cost comes in substantial-
Passionate about improving the lives ly cheaper than other sophisticated markets such as
of patients France and Germany,” shrewdly calculates TEVA’s Carlos
Teixeira. “A full preclinical to post clinical program can
be carried out in Catalonia for half the cost or less than
in other key regions in Europe, the UK, or the US,” agrees
Jordi Naval, CEO of the Catalan Bio-Region (Biocat).
Simultaneously the existence of a fully-fledged bio-
tech hub situated in Catalonia has helped to keep the
quality of clinical research high. “Today, more than 60
percent of all the healthcare and biotech innovation of
Spain is happening in and around Barcelona and there
is a comprehensive professional ecosystem in place to
support life sciences activities right along the value
chain encompassing R&D, training, regulatory, CMO,
licensing, IP and much more besides,” points out Naval.
Even the funding landscape is much more evolved than
hitherto. “Between 2015 and 2017, Catalan start-ups in
Contact Tillotts Pharma Spain on: esinfo@tillotts.com
Telephone: +34 93 178 59 79 the healthcare sector attracted EUR 340 million (USD
392 million) in investment, three times more than in

COVER STORY
Maturing with Grace
the 2013-2015 period. The capital

Sights Set on Success
raised through rounds of invest-
Spain’s ophthalmology market is Eu- ment with international partici-
rope’s fifth largest but low levels of pants has also doubled in recent
eyecare awareness among the gene- years, from EUR 85 million (USD
ral public and a constrained healthca- 98 million) in 2013 to 2015 to EUR
re budget mean that new market en-
trants may find it difficult to navigate.
211 million (USD 243 million) in
2016 to 2018,” he discloses. JOÉL JEAN-
MAIRET
Ana Fernández, Spain country mana- “Historically, venture capital
ger of French ophthalmologic specia- (VC) investment in Spain was drip general partner,
ANA Ysios Capital
FERNÁNDEZ list Laboratoires Théa, explains that
“Generally speaking, there was a low
fed to life science pioneers, though
— but we have been noticing a deci-
country awareness of eye health, retinal disea-
manager, ses and glaucoma in Spain – with the sive shift towards larger funding rounds reaching tens
Laboratoires exception of dry eye – until 2012. Be- of millions for early-stage companies and sometimes
Théa fore that point, Spain’s national heal-
even from scratch. Furthermore the ‘build-to-buy
th system reimbursed all treatments
for eye care totally. When someone had an issue with strategy,’ when investors invest in off-balance R&D for
their eyes, they went directly to their doctor who refe- a company, with the option of acquiring the company
rred them to a specialist. However, in 2012 artificial tears later on is becoming much more common and is testa-
were de-reimbursed and it became an OTC market. For
ment to the maturing of the ecosystem,” believes Joël
dry eye products, pharmacies started to play a larger
role in the recommendation of those products.” Jean-Mairet, general partner at Ysios Capital.
Fernández continues, “Health Authorities take ophthal-

mology seriously but we, as an industry, also need to
remember that they have serious budgetary constraints.
There needs to be greater industry-government colla-
boration to find solutions... There needs to be a more
holistic view, beyond the molecule itself.”
Théa, present in Spain since 1996 as the group’s first

affiliate outside of its native France, has been able to
find success in the Spanish market and Théa Spain now
stands as the company’s third most significant global
affiliate in terms of revenue. Fernández ascribes this
success to the company’s longstanding commitment to
Spain and sole focus on the ophthalmologic niche. She
posits that “We are competing with both big local pla-
yers as well as the huge international companies. For
these big companies, ophthalmology is a relatively small
part of their business, but for us it is everything. We are
100 percent dedicated to ophthalmology. This helps us
make a difference due to our expertise and our passion
for ophthalmology but also because of how seriously
we take building partnerships with research and training
programs within ophthalmology.” Morning
Fernández concludes, “Nowadays there are many com-
After Pill
panies active in ophthalmology, but 22 years ago, when
Théa Spain was established, this was not the case. When
ophthalmologists see the Théa brand, they recognize the
difference. We have expertise in ophthalmology with a
low employee turnover rate, so ophthalmologists see the
same sales reps and can build relationships with them.”

COVER STORY
Maturing with Grace
Moreover these successes have all Pharma has not covered and play
emerged despite the virtual absence to their strengths. As Oriol Segarra
of public funding for R&D. “The of Uriach notes, “filling a glass with
overall public spending on R&D big stones will create holes for small
is only 1.2 percent of GDP com- pebbles to fit in. Big Pharma compa-
pared to the average 2.3 percent nies may have areas that fall under
throughout Europe or countries the radar which can be taken advan-
GIJS JOCHEMS like Germany and the UK which tage of by smaller outfits.” CARLOS RUBIÓ
general manager, are well over 3 percent. Part of the For family-owned Laboratorios executive president,
Promega challenge with funding comes from Rubió, their strategy revolves around Laboratorios Rubió
the issue that one-third of the GDP close interaction with healthcare
expenditure for R&D is in the form practitioners and shrewd acquisi-
of low-interest loans. It is impossible tions of products at different stages
for a researcher to pay back the loan of their life cycle. Executive President
when he does not have a model of Carlos Rubió explains that, “We are
revenue; basic research only works always looking for the next move.
with direct investment,” argues For example, we licensed a product
Gijs Jochems, general manager of that was previously been licensed STAFFAN
ORIAL SEGARRA
Promega, a company specializing in to Bayer, and within two years had SCHÜBERG
CEO, Uriach
molecular biology, protein analysis doubled the sales. This is all based CEO, Esteve
and expression, which itself had to around a close-knit interaction with
reconfigure its business model in the wake of a sharp doctors, and this is a strategy we look
decline in public financing for R&D. for with our international partners abroad. Furthermore,
we see growth by acquiring or licensing products at the
end of their life cycle. This means they do not require an
abundance of marketing as they are already well known,
MAGNIFICENT MID-CAPS yet we can focus on these treatments, while other com-
panies would rather concentrate on their new launches.”
Spain’s high-performance midcaps have hit upon a Spanish champion Esteve, also family-owned, is also
variety of strategies whereby they target niches that Big prioritizing opportunities that may have slipped the
Una compañía innovadora al servicio de los pacientes

An innovative company improving the lives of patients

COVER STORY
Maturing with Grace
Complete Cleanroom Solutions

One element of the bio and pharma- achieve with our expertise in that sector and, specifically,
ceutical value chain that almost all pla- in blow fill seals processes.”
yers involved in R&D or manufacturing
require is cleanroom technology. With Espina outlines COMSA’s holistic approach to cleanroom
pricing pressures abounding, clean- solutions thusly: “We have a specialized R&D team that is
room service providers are increasingly centred around new technologies, specifically in heating,
having to bring a more complete packa- ventilation, and air conditioning (HVAC). That includes
ge to the table to offer value for money. HVAC sterilization via peroxide as well as lean and mainte-
CARLOS
nance systems. Our role is not only to bring the solution to
ESPINA One such specialist is COMSA Clean- partners when using HVAC, but also provide the required
— room Technology, the annual revenues maintenance along the way and post-completion.”
managing of which skyrocketed from EUR 20 mi-
director, llion (USD 23 million) in 2016 to EUR 45 He continues, “Our overriding goal is to be the main project
COMSA million (USD 52 million) in 2018 thanks contractor and manager; meaning a general contractor for
Cleanroom to a rollout of more consolidated clean- civil works, black utilities and pharmaceutical installation
Technology
room services. Carlos Espina, the com- for clean utilities. These services entail architecture, medi-
pany’s managing director explains that, cinal gases, purified water, HVAC and production equip-
“Under current market conditions the pharmaceutical in- ment among others. In other words, we provide complete
dustry is all about big value. This is what we are aiming to turnkey solutions for the pharmaceutical industry!”
attention of larger entities. New CEO Staffan Schüberg association, “plays a fundamen-
asserts that “If Esteve is to continue to grow, we must tal role as a strategic partner of the
focus on smaller opportunities that Big Pharma may Spanish economy and the health
overlook.” Schüberg also notes the importance of stra- system and is key for its advance-
tegic acquisitions for a company of Esteve’s size. “We rec- ment and transformation.”
ognize that a strong pipeline requires multiple shots on Alongside the usual multination-
goal, and we now recognize the need to complement our al players such as Phillips, Siemens,
state-of-the-art R&D engine with a state-of-the-art busi- Medtronic and B Braun, all of MARGARITA
ALFONSEL
ness development chassis that can lead to more shots,” whom are present in the Spanish
he states. “To do this, we are absolutely in the market for medical device sector, Spain has general secretary,
Fenin
possible acquisitions and mergers with companies that seen a significant rise of local play-
represent a strong strategic fit for Esteve. We are looking ers acting both as distributors and
for potential partners with mid- to late-stage pipelines as innovators of their own in-house designed products.
that align with our core focus in neuroscience and gene One such player is Cardiva, which “began life as a
therapy, solid growth projections and strong EBITDA, distributor, primarily for the US company Medtronic,
or could help us expand or complement our current focused only on northern Spain. In 1990, Cardiva made
European footprint.” an agreement with a Scottish company and began dis-
tributing all over Spain,” explains Ignacio Vega, the
company’s president. “During the 1990s, we realized
that focusing solely on distribution would always be
MEDTECH: THE RISE OF LOCAL CHAMPIONS limiting to our growth aspirations, with the continu-
al consolidation, mergers and acquisitions of smaller
The Spanish medical device market was valued at manufacturing companies making it a very unstable
around USD 4.5 billion in 2015 and is projected to reach market. Therefore, we began to look at investing in our
USD 5.6 billion by 2019 according to Emergo, a consul- own manufacturing facilities. We found a small family
tancy. This industry, according to Margarita Alfonsel, company in Málaga, southern Spain, which had been
general secretary of Fenin, the Spanish medical device developing products for surgical use for J&J.”

COVER STORY
Maturing with Grace
This initial investment was fol- portfolio of products” expresses

lowed by the acquisition of a man- Carlos Ibares Sanz, Cardiva’s direc-
ufacturing plant near Shanghai, tor of corporate negotiations. “In
which acts as the group’s main man- terms of manufacturing, we want
ufacturing hub, as well as a factory to consolidate what we already pro-
in Barcelona. With substantial reve- duce as well as expanding capacity.
nue growth, Cardiva is now investing With the upgrades to our Málaga
IGNACIO VEGA a large sum into the Málaga plant to facility, we are now able to manu- CARLOS IBARES
SANZ
president, Cardiva match the company’s international facture Class III medical devices.”
director of corporate
aspirations. According to Vega, these Ibares also believes that future negotiations, Cardiva
“investments will double the pro- growth will come from internation-
duction capacity of the plant. Each day we export more al expansion. “The next step is to
and more products, and this is our priority. We want to look for partners in other countries that could devel-
expand in many countries in order to minimize the risks op as Cardiva has in Spain,” he opines. Furthermore,
inherent in focusing on only one country. Currently, Cardiva sees R&D as a key step in this process, with the
between 35 and 40 percent of the Málaga plant’s pro- overriding long-term objective of wanting to be “dis-
duction goes to exports, but our future goal is for this ruptive with one of our own technologies!”
percentage to rise to 90 percent.”
These plant upgrades also fulfill another “key priority
of being able to offer medical professionals a complete BY CONTROLLING EVERY STAGE OF
PRODUCTION AND COMMERCIALIZATION,
WE CAN OFFER MORE TO HOSPITALS
THAN BIG COMPANIES Ignacio Vega CARDIVA
Dedicated Despite Cardiva’s dramatic rise, Vega and Ibares are
to life still wary of the common challenge facing all medical
device players: pricing. Vega highlights the need “to
reduce costs in order to increase our activities in areas
such as manufacturing.” To surmount this challenge,
At Laboratorios Combix,
Combix
part of the Zydus Cadila group he suggests that, “by controlling every stage of produc-
(a world leader in generics tion and commercialization, we can offer more to hos-
manufacturing) we work to offer pitals than big companies. Big companies have prob-
you effective solutions in all the
main therapeutic areas. lems building relationships with hospitals and, at the
end of the day, their concerns are primarily financial.”
At Laboratorios Combix,
Combix
we dedicate our efforts
to making life easier.
BEYOND THE FAMILY
Another local player to boom in recent years is the

Barcelona-based Palex Group. The group, which had
been family-run throughout its history, appointed an
LABORATORIOS COMBIX, S.L. external CEO, Xavier Carbonell, in 2008 and revenues
Calle Badajoz, 2, edificio 2
28223 Pozuelo de Alarcón, Madrid have since tripled, sitting at roughly EUR 150 million
T: 91 490 42 53
F: 91 490 31 89
(USD 173 million) in 2018. This according to Carbonell,
www.combix.es
was triggered by a decision “around four years ago when
the company was turning over around EUR 100 million

COVER STORY
Maturing with Grace
(USD 115 million) annually. I was asked by the family Carbonell, “will over time begin to
to construct a business plan for the following five years, include JIMRO’s new technologies.
so I came up with two cases. The first was to continue We are currently distributing in the
on our current pathway, being a family-owned company. UK, Germany, France, the Nordics,
The second was a much more aggressive approach and Spain and Portugal, while in the
was ultimately chosen, built around investment from meantime building relationships to
a VC fund. At that time the Spanish market was filled soon move into Eastern Europe and
with companies struggling financially. We could have let other countries.” XAVIER
CARBONELL
them fade out, but instead we decided to acquire these Palex’s strong distribution foot-
CEO, Palex Group
smaller entities and grow our network across Spain. print is, however, only the founda-
Furthermore, we made acquisitions of larger groups that tion for Carbonell’s true goal: devel-
had their own portfolio that was different to ours. This oping products utilizing in-house
not only allowed us to grow in size, but also increase the R&D. To do this, Palex has its “own R&D department
size of the product range that we offer to the medical and business development team that is working to find
community and to patients.” innovative solutions. Though investing this money is
Carbonell also highlights the success of a shift in one thing, the critical part is how we work, and this
Palex’s positioning towards becoming the exclusive dis- must be smart and targeted.” This has led to the reali-
tribution partner for companies without a footprint in zation that two areas must be targeted, “Firstly, neuro-
Europe, such as the joint venture (JV) struck with JIMRO vascular, and our knowledge from the cardiovascular
AF_Prensa_Bayer_1715x117mm.pdf 1 21/11/18 15:25
(Otsuka Medical Device Company). This JV according to sector will assist us in this. Secondly, robotics, which

COVER STORY
Maturing with Grace
we believe has huge potential.” Carbonell will be look- as Japan, the Netherlands, the UK
ing to target the European and LATAM regions, as the and the USA. Meanwhile, Spain
company already “understands that from our distrib- rates as one of Europe’s best per-
utor background the regulations in each market are formers in terms of life expectancy,
vastly different. Therefore, we are working hard to find ranking fourth globally and second
the perfect partners, and thus far we have made some on the continent, with its capital
encouraging progress.” city, Madrid, distinguished for pos-
sessing the highest life expectancy in JUAN SANABRIA
Europe at 85.2 years! general manager
That is not to imply, though, that Iberia, Philips
A WORLD BEATING HEALTHCARE the national health system does
APPARATUS not face considerable sustainabili-
ty question marks after years of budgetary constraints
Alongside Spain’s flourishing biotech and industrial and rising demographic and epidemiological pressures.
fabric, the country’s stellar healthcare system also holds Although in practice, the weight of health in the econo-
significant additional appeal for potential life sciences my has been reduced, falling below the symbolic line of
investors. The achievements in this domain are wide- six percent of GDP. Meanwhile more than 17 percent of
ly appreciated: The Spanish healthcare system perfor- the population is over 65 and aging while a massive 80
mance is ranked as seventh globally by the World Health percent of the health system’s cost constitutes respond-
AAFFPRENSA GENERICO ARYSTO 85.725X117.475mm V3 ENG.pdf
Organization (WHO), beating illustrious countries such 1 9/1/19
ing 9:57
to chronic illness.
LOGICALLY, THE SOLUTION IS TO

RETHINK HEALTHCARE PROVISION IN
WHICH PATIENTS CAN ACCESS ALL
THEIR TREATMENT NEEDS IN THE MOST
EFFICIENT WAY POSSIBLE
Enrique Ruiz Escudero MINISTER OF HEALTH,
COMMUNITY OF MADRID
“The country was on a good trajectory until the global

financial crisis and although the investment level start-
ed to recover after 2013, we have still not reached the
pre-crisis levels. Capital public investment remains low
and the obsolescence of systems remains high. At the
end of 2016, 24 percent of CT scanners were all more
than ten years old, 33 percent of image-guided therapy
systems were over 10, and 60 percent of x-ray systems,”
warns Juan Sanabria, general manager of the Iberian
cluster of Philips Healthcare, one of the leading special-
ists in medtech and healthcare integration solutions.
“Logically, the solution is to rethink healthcare pro-
vision in which patients can access all their treatment
needs in the most efficient way possible. Naturally, we
must increase the number of resources allocated to
chronic disease and with regard to specialization and
patient treatment, there will be a greater need to meet

COVER STORY
Maturing with Grace
individual needs,” proposes Enrique Ruiz Escudero, shift in focus motivated by chronic-
minister of health for the Madrid community. ity, dependence, fragility and social
Interestingly, Spanish stakeholders have been at the support,” he adds.
forefront of trailblazing the concept of the “liquid hos- The model being contemplated
pital,” which envisions the virtual and physical expan- and trialed by a number of pioneer-
sion of healthcare provision beyond the parameters of ing entities, including Sant Joan de
the traditional centralized hospital structure. The aim Déu Hospital in Barcelona, “com-
is to leverage connectivity, telemedicine, the Internet of bines architectural advantages and ÁNGEL
NAVARRO
Things (IoT) along with social media to co-opt patients, clinical functionality thanks to an
families and society into the management of disease. enlightened infrastructure design president, Azierta
“A liquid hospital (H2.0) is essentially a deeper and that takes into account health man-
broader care ecosystem that adds to the traditional hos- agement and relates spaces to their
pital (H1.0) to the point that whereby it becomes pres- surroundings, transcending the static building that
ent in the medical, family and greater social reality,” quickly becomes obsolete and instead generating dynam-
explains a spokesman for the Daedalus Project of the ic spaces, prepared to change their use, adapt and grow
Public Health System of Andalusia (SSPA). “As such, it in a sustainable manner according to emergent socio-de-
heralds the disappearance of barriers and distances, the mographic needs,” notes Ángel Navarro , president of the
development of precision medicine, the availability of science and health consultancy, Azierta.
digital mechanisms to inform the decision making of “We are striving to re-conceptualize health manage-
professionals and patients as well as a transformational ment, a new area in which we offer expert consultancy

COVER STORY
Maturing with Grace
ESSENTIALLY, WE ARE STRIVING TO INTEGRATE MORE TECHNOLOGY INTO

THE SERVICES WE PROVIDE, WHICH IS IMPERATIVE IF WE ARE TO CONTINUE
DELIVERING SUCH STRONG RESULTS FOR OUR CLIENTS Ángel Navarro AZIERTA
in model designs, optimizing access to innovative prod- “Health spaces have evolved since the mid-20th centu-
ucts and technologies, whilst at the same time working ry, adapting to different distribution patterns generated
to design new infrastructures related to health, such as by functional demands. Looking ahead, the role of the
dynamic hospitals and monographic units for patients,” expert is being re-molded to be placed at the service of
explains Navarro. “Essentially, we are striving to inte- the citizen rather than the centre; diagnostic resources
grate more technology into the services we provide, are unceasingly centralized while disease management
which is imperative if we are to continue delivering such and delivery of care is dispersed to the most appropriate
strong results for our clients. The digital transforma- and efficient level which, in some instances, may even
tion of the healthcare sector is a trend we need to pay be within the patient’s own home,” confirms Gonzalo
attention to, as this will revolutionize the entire value Rodríguez, president of the engineering specialist, TSYA
chain of health provision as well as the modus operandi International.
of the pharma industry.” Sant Joan de Déu hospital, for instance, is working on
The sheer radicalism of these initiatives should not be the creation of a portal where patients and their fami-
underestimated for they predict the de-centreing of the lies can gain access to health test results without having
role of the physician and the empowerment of patients to leave the home. Even more importantly, the portal
and their support networks as opposed to the hierar- also plans to incorporate a broad range of telemedicine
chical, top-down doctor-patient relationship of old. services. These encompass online consultation, real
Prevention: The Key to a Healthy Heart
In 1993, Dr Carlos Macaya received the case, but my suspicion is it may well have something
worldwide recognition as a cardiovas- to do with salt intake.” Macaya explains, “Both nations,
cular surgeon after he operated on after all, consume large quantities of fish. Though we are
the heart of Mother Teresa, known in nominally host to the healthy Mediterranean diet, the
the Roman Catholic Church as Saint reality is more complex: younger generations of Spa-
Teresa of Calcutta. Nowadays, Maca- niards are increasingly opting for unhealthy fast food.”
ya is president of the Spanish Heart Furthermore, Macaya believes “Good and efficient com-
Foundation (FEC), professor of Car- munication is necessary to eliminate misconceptions (wi-
DR CARLOS
diology at the Faculty of Medicine of thin the cardiovascular field), such as the general belief
MAYACA the Complutense University of Madrid that men die more from cardiovascular disease when the
— and director of the Cardiology Service reality is different: Spanish women die five percent more
at the San Carlos Clinical Hospital. than men from cardiovascular diseases.”
Cardiovascular disease in Spain, like in nearly all develo- Now, Macaya is leading a new charge with the main
ped nations, continues to be the leading killer, accoun- purpose of the FEC, as stipulated in its statute, “to pro-
ting for 29.17 percent of deaths, according to the latest mote education, the prevention and research of car-
report from the National Institute of Statistics, ahead of diovascular health in civil society, the encouragement
cancer (27.50 percent) and diseases of the respiratory and dissemination of cardio-healthy life habits for the
system (11.4 percent). Around 120,000 people die every Spanish population.” Macaya maintains that “If cardio-
year in Spain from cardiovascular complications. vascular disease is the leading cause of death and it
can be prevented by more than 80 percent in terms
Despite these results, “interestingly Spain is second of premature deaths, it is clear that it is tremendously
only to Japan in terms of having the highest prevalence necessary to act in the field of prevention, and this is
of hypertension. There is much debate over why this is our mission.”

COVER STORY
Maturing with Grace
time-monitoring and tele-rehabil- anatomy and genome information, which are allowing
itation programs through which faster and more accurate diagnoses and, therefore, per-
doctors and patients can interact sonalized treatments,” he continues.
via webcam without the need for GE Healthcare, for its part, is experimenting with its
physical consultation at the clinic very own concept of “hospital command & control cen-
— thus doing away with unneces- tre,” borrowing from other disciplines like the aviation
sary displacements and opening the sector. “Having started in the US and a first of its kind
LUIS CAMPO door to a considerably more person- in Europe, the Command Centre strives to transform
CEO, Spain & alized follow-up of the patient. how care is delivered and organized. Utilizing artificial
Portugal, GE “What you’re seeing is the liquid intelligence, it will provide a clear, instant, and real-
Healthcare
hospital flattening the walls of the time overview and help staff make quick and informed
hospital and enticing the discipline decisions on how to best manage patient care. Staff
of disease management to include patients and fami- will monitor a wall of analytics that constantly pulls
lies, through multiple digital technology-based mech- in streams of real-time data from the multiple sys-
anisms – from tablets and smartphones to wearable tems and advanced algorithms will help staff to antic-
devices – and their respective formats: blogs, social net- ipate and resolve bottlenecks in care delivery before
works, apps, webcasting and much more,” confides one they occur, recommending actions to enable faster,
analyst at the Instituto para el Desarrollo e Integración more responsive patient care and better allocation of
de la Sanidad (IDIS). resources,” recounts the company’s CEO for Spain and
“Digital technology is rapidly becoming the main Portugal, Luis Campo.
facilitator of health integration between levels of care,
between the hospital and the home, and even between
different hospital centres and the clinical units within
the same hospital… applying connectivity to all areas of
health care is no longer optional in the society in which
we live,” muses Philips’ Sanabria.
Accelerate Your
IT IS CLEAR THAT THE FUTURE SUCCESS Antibody Development
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ALGORITHMS SO THAT ALL THIS BIG DATA
OF PERSONAL AND CLINICAL HEALTH Fc Receptors
IN THE CLOUD PROVIDES KNOWLEDGE Human /mouse ADCC & ADCP
BOTH FOR THE INDIVIDUAL HEALTH Immune Checkpoints
OUTCOMES OF EACH PATIENT AND FOR PD-1, TIGIT, CTLA-4, LAG-3, GITR, 4-1BB,
THE RESULTS OF POPULATION HEALTH OX-40, etc...
Juan Sanabria PHILIPS
T Cell Activation
“It is clear that the future success of modern health-
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“Philips already has solutions to manage combined Email: esp_custserv@promega.com
information, for example, of imaging tests, pathological

PRIVATE HEALTHCARE
A Growing Segment
OPEN FOR
NEGOTIATIONS
The Spanish healthcare system is universal. “In principle, this univer-

sality would eliminate the need for a private health system,” explains
Carlos Rus Palacios, general secretary of ASPE, the private hospital
and private healthcare association. “However,” continues Rus Palaci-
os, “private healthcare exists, serving more than 12 million people and
I
represents more than 30 percent of healthcare activity in Spain.”
n terms of innovation, “over latest technologies which can only

the last 12 years, most tech- be found in private health centres.”
nological innovation has “In many health systems, citizens GIUSEPE
been coming from the pri- with higher financial status enroll in CHIERICATTI
vate sector,” points out Dr Juan private insurance schemes in order GENERAL MANAGER, CHIESI
Abarca Cidon, president of HM to reach access to what is not offered
Hospitales, a leading local private by the public system. Contrarily, in
healthcare provider “During the Spain, we have a public excellent
crisis years, the public sector was healthcare system, which complete-
severely impacted, and investments ly covers all beneficiaries. The pri-
in this area have suffered. I believe vate system is not a fragmentation
that there needs to be an agreement of healthcare in Spain; there con-
between the government and pri- tinues to be a link between the two
vate sector to better facilitate inno- sides,” underlines Fernando Prados
vation collaboration in order to Roa, deputy minister of health at
allow more patients access to the SERMAS, the Madrid system of
NUMBER OF PRIVATE AND PUBLIC HOSPITALS IN SPAIN
PUBLIC
HOSPITALS
356 799
45% 55%
PRIVATE CARLOS RUS

HOSPITALS PALACIOS
443
GENERAL MANAGER, ASPE
Source: OECD

PRIVATE HEALTHCARE
A Growing Segment
healthcare centres. “Around 20 to 25 percent of our activity is done with our

supervision but performed by private management. This allows for homog-
enization since our indexes are similar, patient satisfaction is high, but also
allows for transparency,” elaborates Enrique Ruiz Escudero, minister of
health for the community of Madrid.
Several companies are using the private sector’s openness to innovation
to their advantage. Chiesi recently struck an agreement with HM Hospitales
for the provision of Holoclar®, the first stem cell product to be approved by
the EMA. Giuseppe Chiericatti, general manager of Chiesi Spain, notes that
“since Holoclar® is not reimbursed by the Spanish Health Service, we signed
an agreement with HM Hospitales to make the drug available to patients in
Spain. Signing agreements with the private sector will an important part of
making innovative therapies available to patients in the future.”
This, along with Chiesi’s work in public healthcare has generated “sus-
tained, double digit growth in the last few years, not something to take for
granted in Southern Europe. Moreover, we anticipate that we will exceed
the EUR 100 million (USD 115 million) mark in 2019,” notes Chiericatti,
DR JUAN ABARCA who now has aspirations to focus on the launch of innovative rare disease
CIDÓN products in Spain. To do this he is “open to discussing innovative ways to
PRESIDENT, HM HOSPITALES increase the availability of rare disease therapies. This may be through novel
risk sharing arrangements such as pay-per-performance.”
PRIVATE HEALTHCARE SPENDING IN RELATION TO TOTAL HEALTHCARE SPENDING IN

SELECTED OECD COUNTRIES, 2015
PRIVATE HEALTHCARE SPENDING IN SPAIN ACCOUNTS FOR 29.0% OF TOTAL HEALTHCARE SPENDING,
RANKING ABOVE THE OECD AVERAGE AND MAJOR NEIGHBOURING COUNTRIES.
36.0%
Source: OECD, Health Data 2017
33.8% (november 2017)
30.0%
29.0%
27.1%
25.1%
24.4%
22.5% 21.1%
20.3%
19.3%
17.6%
16.3%
15.9% 15.5%
L LY CE DS K Y
D
GA ND N RIA IUM UK N H CD
RL
AN U LA AI ITA ST LG AN AN WE
DE EC
CZ BLIC ENM
AR AN OE
ITZ
E
PO
RT PO SP AU BE FR
TH
ERL S
P U D G E RM
SW NE RE

HOMEOPATHIC MEDICINES
Boiron
CHANGING THE
NARRATIVE
In late 2018, new minister of health, María Luisa Carcedo, made the move to blacklist thousands
of alternative medicines in a bid to crackdown on products considered to have “no scientific
basis.” This move was so aggressive, her along with Minister of Science and Innovation, Pedro
Duque, stated that “Public and private establishments that include pseudo-therapies will not be
T
able to call themselves health centres.”
he project, named Health Protection new health solutions.”

Plan Against Pseudo-therapies, is To catalyze this process
divided into four main lines of action, Barriga and his team “made
with this plan has drawing heavy scru- an important change in
tiny towards a group of treatments that have been understanding our target in
utilized for decades: homeopathic medicines. As terms of professionals; that
a result, the homeopathic producers of any prod- is, doctors of patients for
EDUARDO
ucts on a list of 2008 medicines, have until April whom our treatments can BARRIGA
2019 to prove that their remedies clinically work. be most beneficial and what general manager,
Leading the fight against the new wave of criti- is the right way to approach Boiron
cism is global homeopathic leader, Boiron, head- them. We want to build
ed in Spain by general manager, Eduardo Barriga. closer connections with both modern pharma-
The French-based company works heavily in cies and physicians with a new medical approach,
generating clinical data to back up their claims, more global and integrative, who advise and are
though Barriga feels, “there is heavy criticism [of more interactive with their patients.”
homeopathic medicine] in Spain which is unde- These pharmacies for the homeopathic mar-
served. Spain is a market where the homeopathic ket are key as “these pharmacies have a greater
regulations were previously not aligned with that dedication to patients by offering advice and
of the EU, but they are heading in the direction are open to new, natural therapies. As a result,
of being regulated in the same way. As the market we work directly with 5,000 specific pharma-
leader, we want to be regulated in the spirit of the cies who are positioning themselves to become,
European laws.” what I believe, will be the pharmacy model of the
future,” highlights Barriga.
The real question is what is the potential of the
IT IS IMPERATIVE THAT homeopathic market in Spain considering the
STAKEHOLDERS HAVE AN OPEN market conditions? Firstly, “For the last five years,
MIND TO HOMEOPATHY natural therapies have been growing in Spain and
Europe by double-digit figures,” explains Barriga,
For Barriga, “it is imperative that stakehold- and he is quite optimistic for the future, believing
ers have an open mind to homeopathy and for if Spain “can apply what has been done success-
those who have yet to consider the added value fully in markets where homeopathy is valued, like
of homeopathy in their medical offerings; open France, the dynamics here can reach the same lev-
your mind, your patients are looking for these el within the next five years.”

PARTNERSHIPS AND COLLABORATIONS
Ángel Fernández, MSD
LOCAL COLLABORATION;
GLOBAL AMBITION
Ángel Fernández, president and managing director of American giant, MSD, highlights the increasing need
for collaboration and partnerships for multinationals operating in the Spanish pharma market.
HCLS: What are MSD’s most sig- the market is not to work singular-
nificant co-marketing agreements ly, but with other players to inject
and collaborations in Spain? value back to the country. Ángel
ÁNGEL FERNÁNDEZ (AF): In Fernández
terms of content, our manufactur-
MSD
ing and marketing agreement with THROUGH
Rovi could be argued to be the most CO-MARKETING
comprehensive. Just about a decade throughout Spain. Hurdles creat-
AGREEMENTS SUCH AS
ago MSD transferred its manufac- ed by national, regional, and hos-
turing facility in Alcalá de Henares
THIS, WE ARE BETTER pital processes create demanding
to Rovi, and since then we continue EQUIPPED TO EMBED barriers to entry which then lose
to be their primary partner. This, OURSELVES WITHIN THE the benefits of offering all patients
in some senses, reflects a trend to- SPANISH MARKET AND equal access to health innovations.
wards outsourcing that can be seen CONTRIBUTE THROUGH We are moving away from the
right across Big Pharma. Nowadays MORE THAN JUST THE tradition of large-scale teams of
they export our products, produce MSD ORGANIZATION sales representatives to instead
and supply products to us, and have ALONE. having a souped-up market access
added three MSD products to their division, which emphasizes com-
portfolio. This is a very important HCLS: How would you de- munication and collaboration
partnership in terms of quality con- scribe the ease of market access with industry players. These out-
trol, quality assurance, etc. In that in Spain? come-driven strategies we are har-
sense we have additional commer- AF: Looking at the percentage of nessing aim to establish new agree-
cial collaboration agreements with drugs approved by the Ministry of ments to aid in making the current
Almirall Ferrer and Faes. Health and the time it takes to gain healthcare system more sustaina-
full market access, Spain falls in the ble. We have reconfigured the for-
HCLS: How important are these more efficient side of the European mula – we must keep a common
agreements to your success in markets – the situation here is not denominator while still working
Spain? the worst nor the best, but overall on an individual basis with each
AF: Through co-marketing agree- still impressive. This being said, region. Our strategy hinges upon
ments such as this, we are better there continues to be room for im- being flexible and agile enough to
equipped to embed ourselves within provement. Although the national be able to deliver bespoke solutions
the Spanish market and contribute approval time is relatively quick, in different parts of the country.
through more than just the MSD practical access is hindered by the We have got to a stage where we are
organization alone. It is the genes of territory fragmentation by the 17 now comfortable with drawing up
our operation in this country to play regions. There are too many bod- and implementing on-the-ground
an active role within the community. ies – too many moving parts – that market access fixes in each of the
We assume that the way to operate in are making individual analyses different autonomous regions.

THERAPEUTIC FOCUS
Oncology
MAKING WAVES:
PROMOTING ONCOLOGICAL
INNOVATION
In recent times, the global push for personalised medicine has been headlined by oncology, with the rise
of CAR-T immune oncology therapy which stimulates the patient’s antibodies so that their own “army”
can act against the tumour. This was first made available by Novartis, though now other companies, such
as Gilead, are getting in on the act. Spain is currently looking to bring this approach to the market with
new Minister of Health María Luisa Carcedo, announcing the national health system’s plan to finance No-
N
vartis’ Kymriah® treatment in December 2018.
evertheless, this therapy does come at This cost will only increase as the paradigm of can-
a high cost, therefore, Novartis “have cer shifts towards chronic patients, with “even those
worked together with local authorities who are cured having to be treated. In addition, we
to establish a price that is sustainable for have cured survivors and they have side effects from
the national health system,” explains Marta Moreno, therapies, sometimes psychological or social side-ef-
director of market access and institutional relations fects.” As a result, the overall costs on treatment are
at Novartis Oncology Spain. “We have finally agreed heavily impacting healthcare systems, indicated by
on an innovative payment model based on health out- the startling statistical fact that “ten years ago, the
comes,” she adds. cost was USD 3,000-4,000. Nowadays, if you treat
Other companies are also experiencing fruitful times the patient for eleven months the estimated figure
in Spain in regard to their oncology portfolio. Ángel totals USD 300,000-400,000 in the US.” Furthermore,
Fernández, president and managing director of MSD Tabernero, believes there will be an upward trend of
Spain and Portugal, sees their “strategic areas for future cancer patients as “Essentially the prevalence of inci-
development and most important sectors [as] vaccines dence is increasing because we are living longer.” This
and oncology, specifically immune-oncology.” This according to him is due to several factors, such as
approach is backed by Guillermo Castillo, managing tobacco and alcohol consumption, obesity, sun radi-
director of Ipsen Spain, as “Oncology accounts for the ation, as well as the fact we are now “aware that some
largest portion of Ipsen’s local revenue at 83 percent.” of cancers are also related to viral infections such as
Despite the high costs of oncology treatment, Josep HPB, HIV and hepatitis.”
Tabernero, director of the Vall D’Hebron Institute A characteristic of the Spanish healthcare ecosys-
of Oncology and president of the European Society tem is fragmentation of the healthcare market into
of Medical Oncology, believes the “strong reaction the 17 autonomous communities and this create its
towards rising drug costs is only to delay full reim- unique sets of circumstances. “The model of reim-
bursement of patient treatments. Once the EMA bursement should be adjusted according to regional
approves the drug, the price is set by the Ministry of parameters” explains Tabernero “what is being called
Health. But that doesn’t mean you secure immediate as geographically-adapted value-based reimburse-
reimbursement. Governments often delay reimbursement.” Additionally, the level of care is also impact-
ment because they don’t have the budget. Combating ed, “with smaller regions often needing help with
cancer and prevention is expensive, but the drugs only patients in terms of special diagnostics, and then
account for 27-30 percent of the cost. The rest is pri- larger communities often have better facilities to
mary care and hospitals etc.” offer optimal treatments.”

THERAPEUTIC FOCUS
Oncology
Ruth Vera, president of the Oncology:

Spanish Society of Medical The Biggest Piece of the Clinical Trials Pie
Oncology (SEOM), sees these
regional differences as a press- Spain’s clinical research prowess is growing and lead-
ing issue. “Due to the regional- ing the charge in this area is the field of oncology,
ism of Spain there is a significant making up 36.8 percent of all trials in the country,
RUTH VERA
difference between hospitals well ahead of second placed cardiovascular with 8.1
president, Spanish in different parts of the coun- percent. Tabernero believes this is backed by “several
Society of Medical try,” she notes. “To prevent this good centres in Spain that focus on fundamental can-
Oncology (SEOM)
increasingly large gap it is impor- cer research” but most importantly the centre he heads,
tant that the government takes the Vall D’Hebron Insitute of “one of the three leading
action as soon as possible as in two years there could oncology centres in Europe…that adopts a purely trans-
be a major divide.” lational research model and harnesses multidisciplinary
For Vera, this regional approach also impacts teams to both accelerate and advance personalized and
market access of drugs as “some medicines that are targeted therapies against cancer.”
approved in Spain at the national level should be avail- This has resulted in the centre’s core workload
able across the country but are not in certain regions.” being allocated towards clinical trials, and at the Vall
However, despite the complications of having to deal D’Hebron hospital there are “around 1,200 patients
with regional bodies for reimbursement, oncology with solid tumours in clinical trials, this representing
is leading the way in regard in the hospital market, 35 percent of the patients that need any kind of system-
making up 23.8 percent of annual overall spending, ic treatment; 40 percent of these patients are enrolled in
and with the amount being spent 16.8 percent more phase one, 30 percent in phase two, and 30 percent in
in 2017 compared to 2016 according to IQVIA data. phase three studies.”
THERAPEUTIC AREAS WITH THE MOST INVESTMENT
HAEMATOLOGY
NEUROSCIENCE 6.6% OTHER
6.7%
13.6%
RESPIRATORY
4.3% OTHER
4.1%
REUMATOLOGY CARDIOVASCULAR PAIN
4.9% 8.1% 2.3%
PSYCHIATRY
ANTI- 2.2%
ENDOCRINOLOGY
INFECTIVE
3.6% METABOLISM
7.1% 1.8%
IMMUNOLOGY OPHTHALMOLOGY
3.7% 1.7%
DIGESTIVE
1.5%
ONCOLOGY
36.8%
Source: Farmaindustria - AEMPS - Spanish Registry of Clinical Research - ClinicalTrials.gov - InvestInSpain.org

GENERICS
Enrique Ordieres, Cinfa Group
A ‘MUST’ FOR THE FUTURE

OF SPANISH HEALTHCARE
Enrique
Spain’s generics market has stagnated over recent years and penetration rates are Ordieres
some of the lowest in Europe. Enrique Ordieres, president of the leading generics CINFA GROUP
player, Cinfa Group, gives his voice to possible solutions in this challenging situation.
HCLS: What are top of your priorities? generic drugs are manufactured in Spain, so all the ge-
ENRIQUE ORDIERES (EO): The Spanish gener- nerics players are bringing investments and offering
ics market has stagnated and not grown at a decent rate Spaniards good jobs.
for quite some time. In fact, the penetration rate of ge-
nerics in Spain is much lower than in other European
nations. All the generics players need to work together GENERICS ARE A ‘MUST’ FOR THE
now to show just how important the role of the sector FUTURE OF SPANISH HEALTHCARE.
is when it comes to establishing a sustainable health-
care ecosystem. We must drive this message home HCLS: Do you feel the current conditions of the
across the entire value chain towards key stakeholders generics market are sustainable in the long term?
– authorities, patients and medical professionals – be- EO: The government is obviously happy with gener-
cause generics are a ‘must’ for the future of Spanish ics pricing, but they need to look beyond that and see
healthcare. that local generics players are offering more than just
cheap drugs. The problem is many key stakeholders
HCLS: What is the main challenge impacting the lack this long-term vision and are just looking at the
Spanish generics ecosystem? short-term impact of spending on their next budget.
EO: First of all, we need the support of the govern- Legislation is also hurting the industry, as generics
ment, not only at central level, but in each autonomous companies do not have the opportunity to differentiate
community. They must make important decisions to themselves. Once a drug comes off patent, the originator
develop the generics market across the country and and generic are priced equally, obviously making mar-
really value what we are doing. The Spanish generics ket penetration near impossible. In fact, if you look back
industry, despite its difficulties, has saved Spain 20 bil- 10 years, we were instantly achieving around 70 percent
lion EUR over the last 20 years and the governments generics penetration when a drug came off patent. Now
need to see that the opportunity for us to save them we are lucky if we reach 10 to 15 percent. This is extreme-
even more exists. On top of that, 70 percent of all these ly low compared to other European nations.
CINFA GROUP SNAPSHOT

• Portfolio of more than 4,500 products and more than 1 billion generic drug units marketed since
they were launched in 1998.
• 1st manufacturer in Spain for units of drugs dispensed in retail pharmacies - one out of every five
generic drugs dispensed in Spain is produced by Cinfa
• Present in more than 55 countries all over the world
• Consists of six companies: Cinfa Laboratories, Natural Santé, Sakura Italia, Orliman, Cyndea
Pharma and 3P Biopharmaceuticals

PUBLIC HEALTHCARE IN MADRID
Enrique Ruiz Escudero, Minister of Health of the Community of Madrid
BEHIND THE HIGHEST LIFE

EXPECTANCY IN EUROPE
Madrid is famous for its football, food and art, though now it can boast to be the city with the
highest life expectancy in Europe at 85.2 years. Moreover, Spain as a whole is one of Europe’s
E
best performers in terms of life expectancy, ranking fourth globally and second in the continent.
xplanations for this include the Spanish healthcare system as perfect.

predilection for a ‘Mediterranean diet’ Significant economic dispar-
(rich in olive oil, fruit and vegetables), ities exist between Spain’s 17
one of the lowest mortality rates for regions, the healthcare sys-
heart disease in the world, the sixth low- tem is decentralized – lack-
est rate of suicide in the OECD (Organisation for ing universal patient records
Economic Co-operation and Development), and and the uptake of digital
good-quality universal healthcare. solutions and new technol- ENRIQUE
RUIZ
Enrique Ruiz Escudero, the Community of ogies can be extremely slow. ESCUDERO
Madrid’s Minister of Health, asserts that the Despite these nationwide minister of health,
healthcare available in Madrid – Spain’s geograph- issues, Ruiz Escudero feels community
of Madrid
ic, cultural and economic centre and at the heart that Madrid has been able to
of one of the country’s wealthiest regions – is of forge ahead in healthcare by
an especially high quality and density. He notes embracing an innovative management model and
that “Madrid has 6.5 million citizens and we have opening up to public-private collaboration. He
a network of 34 hospitals, 430 health centres and explains, “Our management model allows for col-
71,000 staff, including 16,000 doctors… The total laboration between the public and private sector.
Community budget is more than EUR 19 billion Around 20 to 25 percent of our activity is done
and the Madrid MoH represents 41 percent of this with our supervision but with private manage-
– highlighting the strength and the importance of ment. This allows for homogenization since our
healthcare here.” indexes are similar, patient satisfaction is high but
also allows transparency in each process. It keeps
us in constant check.”
WE ARE THE REGION WITH THE A highly developed transport network, rated as
HIGHEST LIFE EXPECTANCY IN EUROPE one of Europe’s best, also contributes to Madrid’s
AND THIS FORCES US TO STAY ON health. Ruiz Escudero points out that, “it takes
OUR TOES, ALWAYS INNOVATING AND one and a half hours to drive across the region; our
MAKING SURE THAT WE MAINTAIN THE transport network helps make our urgent and pri-
BEST MANAGEMENT POSSIBLE. mary care incredibly fast.”
Enrique Ruiz Escudero Ruiz Escudero concludes, “Madrileños feel
MINISTER OF HEALTH, COMMUNITY OF MADRID proud of their health and it’s a value that defines
Given the city’s ageing population, whether this us… We are the region with the highest life expec-
elevated level of healthcare spending is sustainable tancy in Europe and this forces us to stay on our
is open to debate. Moreover, it would be unwise toes, always innovating and making sure that we
to paint the Madrilenian and, indeed the Spanish maintain the best management possible.”

LOCAL SUCCESS STORY
TIME TO
DIVERSIFY
For local companies in any market, the spreading of
risk is key within the ultra-competitive pharmaceu-
tical landscape. Carlos Rubió, executive president
of Laboratorios Rubió, acknowledges this fact and
is on a mission to broaden the company’s portfolio
and international footprint.
Carlos Rubió
LABORATORIOS
RUBIÓ
HCLS: What are your main priorities today?

CARLOS RUBIÓ (CR): We need to increase the
size of the company, and we are looking to do this as HCLS: Your portfolio is quite diverse. How do
quickly as possible. We are always looking for collabo- you choose the areas you are present?
rations or joint ventures to help accelerate the process. CR: In the mid ’90s we were present in some 20 ther-
We have been to foreign markets across the globe, such apeutic areas, though after discussions with medical
as Japan and the Nordics, to look for this potential professionals, we streamlined our business approach
growth. Furthermore, we are openly searching for any from 2005 until 2010, and now we are present in
possible acquisitions that make sense. nephrology, urology/andrology, CNS, rheumatology,
cardiovascular and also in a minor way in gynecology
HCLS: The company has grown 47 percent in and oncology. Moreover, we are also launching a food
sales over the last five years. What has been the rea- for special medical purpose in nephology in January
son behind this? 2019. We have established a level of credibility with
CR: This has been due mainly to our experience in de- specialists and been able to convey new medicines and
livering new concepts and ideas to the domestic market. therapeutic concepts.
On the international scene, the products that inno- Furthermore, are working on a Liposcale® test,
vative companies didn’t see fit to bring to Spain were which is is an advanced lipoprotein test based on 2D
mainly in niche areas. Therefore, our products that Nuclear Magnetic Resonance (NMR) that determines
were filling this gap in Spain, also had little compe- the size and number of lipoprotein particles for the
tition in the international space compared to main- main types (VLDL, LDL and HDL) and also each sub-
stream products. In this regard, we have experienced type size and concentration, determining its categori-
good growth abroad over recent times by just merely zation by nine sizes: large, medium and small particles
being present on the international scene. For example, of each main type. Cardiology, endocrinology, neph-
Resincalcio was released in 1968 and did not have any rology, angiology and vascular surgery, neurology or
competition in Spain until 2009, and we now have it lipidology are the specialties that could benefit from
registered in 12 countries, while Rubifen, a CNS prod- diagnosis management, risk evaluation perspective,
uct, is found in some 25 nations. therapeutic efficacy and patient follow-up.

LOCAL SUCCESS STORY
and will be launched next year. Additionally, we have

a list of projects in the future with the US as the main
target, and we will continue to only do what we know
best; niche products in the field of generics. This will
see the US increase our international sales significantly.
And our international movement has grown since
our first movement into Latin American in 1982. Many
products third world nations can not afford, as the first
world shifts towards the use of biologics. Therefore,
these third world countries have an appetite for “clas-
sic therapies,” which gives us an opportunity to grow.
We really are based in Spain, but act in a global sense,
adapting our products to intentional regulations and
guidelines.
Our growth in the US and other markets will need an
increase in our manufacturing capability, since more
than 50 percent of the units we manufacture are for
international sales, and we will start this new project
next year.
HCLS: The company is looking for portfolio pur-

chases. Where are you looking to make these moves?
This technology concept is more well known in the CR: Mostly inside Spain, though we see future moves
US, but really has not come to the European market. to be within other European markets.
The research has been done with our partners, Biosfer We are always looking for the next move. For exam-
Teslab. We are now conducting clinical trials in Spain ple, we licensed a product that was previously been
and are looking for partners to conduct the same tests licensed to Bayer, and within two years had doubled the
in regions such as the Nordics. sales. This is all based around a close-knit interaction
with doctors, and this is a strategy we look for within
HCLS: How important are these partnerships for our international partners abroad. Furthermore, we see
a company like Laboratorios Rubió? growth by acquiring or licensing products at the end of
CR: We are always looking to partner with research their life cycle. This means they do not require an abun-
centers at the early stages, within Spain or the interna- dance of marketing as they are already well known, yet
tional market. Obviously, once we go into the commer- we can focus on these treatments, while other compa-
cial phase, we are looking to set up distribution part- nies would rather concentrate on their new launches.
nerships with larger pharmaceutical companies with a
good diagnostic division and market reach. HCLS: What do you see in the future for the
We already have established some 50 partners through- company?
out our history, from locals to big multinationals, and CR: We will continue to be a strong player and grow
the type of relationship we set up depends on size and towards our target of EUR 60 million revenue annually.
the partners companies therapeutic focus. This allows This will be by developing our own products, growing
use to grow our product range and diversify our risk. our niche areas, entering new license agreement and
partnerships, and above all, interacting with doctors
HCLS: How is the company focused towards and patients. This brings about its own complexities
the US? for a company of our size, though it allows us to under-
CR: At the moment, we are registering one product stand the market better and diversify and spread risk
in the US, and it has already past the FDA inspection within the sensitive Spanish market.

DIGITALIZATION
Hospital IT solutions
AT A DISRUPTION
POINT
With cost pressures mounting, Spain is increasingly
turning towards digital solutions to maintain the high
levels of care provided by its healthcare system.
As Ángeles Delgado,
president for Spain
and Portugal at
Japanese ICT firm
Fujitsu notes, Spain has a very
banking, the budget expenditure
on IT ranges anywhere between
five and six percent,” she points
out. “Unfortunately, in healthcare,
we see that of the overall budget,
efficient healthcare system which only 1.2 percent is allocated to IT –
spends less than those of France, a shift in mindset is needed within
ÁNGELES FERNANDO
Germany, and Switzerland, but the industry. There is no room left
DELGADO PRADOS ROA
is still well aligned with the to cut costs in clinics and hospi- president, Fujitsu deputy minister of
European average. Spain is one tals and increasing demands can- Spain and Portugal health, community
of the top three countries global- not be met without upgrading the of Madrid
ly with the highest life expectan- system. Now is the time to invest
cy and most health issues in the – the only way forward is through
country can be dealt with at the digital technology.” Understandably, Delgado sees
primary care level which accounts Fujitsu as the ideal provider of
for about 14.3 percent of expend- this technology, the company
iture. However, Spain is at a point SPAIN IS AT A POINT OF having already struck a deal with
of disruption in which the health- DISRUPTION IN WHICH SERMAS, the Madrid hospital
care system is facing big challeng- THE HEALTHCARE network, to provide complete IT
es; the solution to which has to be SYSTEM IS FACING solutions for healthcare institu-
technology.” BIG CHALLENGES; tions across the Spanish capital.
Delgado feels that there needs She asserts that, “SERMAS is one
THE SOLUTION TO
to be a greater allocation of pub- of the most successful healthcare
lic funds towards IT solutions in WHICH HAS TO BE services in Spain. They have always
healthcare. “Looking at other indus- TECHNOLOGY. been very open to technology and
tries like telecommunications and Ángeles Delgado FUJITSU they have had good experiences in

DIGITALIZATION
Hospital IT solutions
the past working with Fujitsu.” Delgado continues, IT system to link healthcare across the entire system,
“There is now one single service to handle IT for all of which is something we lack at the moment. This will
SERMAS’ hospitals, which means managing the net- help to achieve a more complete integration between
works, servers, and access. SERMAS sees Fujitsu as a institutions including hospitals, primary care centres
partner with end-to-end capabilities and the neces- and urgent care centres. Due to the rapidly changing
sary level of investment to walk through the future.” nature of technology, many institutions have their
Fernando Prados Roa, deputy minister of health own IT systems, therefore, the aim is to unite the cen-
for the Community of Madrid explains the rationale tres in this regard to establish stronger collaboration
behind the deal thusly. “We are working to create an networks of data exchange.”

INDEX
Including advertisers
Advertisers
COMPANY NAME PAGE

Actelion 32 Laboratorios Rubió 22, 23, 38, 44, 60, 61
Allergan 26, 28, 33, 35 LEO Pharma 4, 33
Aristo Pharma 33, 36, 37, 48 Merck 39
Association of Generics Producers in Spain MSD 26, 30, 39, 42, 55, 56
(AESEG) 2, 35 Mundipharma 34, 38, 44
Azierta 49, 50 Novartis 56
Barcelona Institute of Science and Technology Palex 23, 31, 46, 47
(BIST) 18, 19
Pfizer 5, 26, 28, 29, 42
Bayer 5, 28, 30, 42, 44, 47, 61
Philips Healthcare 48, 51
Boehringer Ingelheim 5, 20, 21, 25, 28, 33, 34
Procare Health 37
Boiron 36, 54
Promega 44, 51
Cardiva 22, 23, 29, 39, 45, 46
Reig Jofre 38
Catalonia Bio and Health Tech 4
Sandoz 28, 36, 38
Catalonia Bio-Region (Biocat) 18, 42
Shionogi 26, 27, 28, 37, 40
Chiesi 34, 52, 53
Spanish Agency of Medicine and Health Products
Cinfa 27, 33, 35, 38, 58 (AEMPS) 2, 6
COMSA Cleanroom Technology 45, Spanish Biosimilars Association (BioSim) 38
Esteve 15, 16, 44, 45 Spanish Biotech Association
EY 4, 29 (ASEBIO) 2, 17, 18, 19, 39
Farmaindustria 2, 7, 13, 14, 25, 26 Spanish Heart Foundation (FEC) 2, 50
FEDHEMO 4 Spanish Medical Device Association (FENIN) 2, 45
FEDIFAR 4 Spanish Private Health Alliance (ASPE) 52
Fujitsu 62, 63 Spanish Society of Medical Oncology (SEOM) 57
GE Healthcare 51 TEVA 36, 42
HM Hospitales 52, 53 Tillotts 26, 30, 42
HRA Pharma 40, 43 Uriach 22, 44
Ipsen 24, 29, 32, 42, 56 Vall d’Hebron Institute of Oncology 30, 32, 56, 57
Kern Pharma 36, 37, 38 Ysios Capital 4, 17, 19, 43
Laboratoires Théa 30, 43 Zydus Cadila 27, 46
Laboratorios Combix 27, 33, 34, 36, 46
Photo © cover, page 4: Meninas Madrid Gallery. Nº 11. Antonio AZZATO (Red mirror) 2018. Plaza de la Independencia, 1. | Photo © page 2: Room XX, Palais des Nations. Miquel Barceló. Flickr: Tom Page | Photo
© page 13-14: Barcelona, Spain. Pixabay. Public domain. | Photo © page 17-18: Torre, 2017. Juan Navarro Baldeweg | Photo © page 20-21: Abstract composition M131. Jesús Perea. Limited by Saatchi Art. | Photo
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Manuel Broto Gimeno | Photo © page 62-63: Barcelona, Commercial Building. Flickr: Detlef Schobert.
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HCLS Spain March 2019

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A PREMIER CLINICAL TRIALS SPECIAL FOCUS: LOCAL CHAMPION: BETTING BIG ON

DESTINATION ONCOLOGY ESTEVE BIOSIMILARS

MATURING WITH GRACE

María Jesús Lamas Díaz, director of AEMPS

Enrique Ruiz Escudero, minister of health, Community of Madrid

Humberto Arnés, president, Farmaindustria

Francisco Fernández, director of communications, Farmaindustria

Ángel Luis Rodríguez de la Cuerda, secretary general, Association of

Carlos Macaya, president, Spanish Heart Foundation (FEC)

Margarita Alfonsel, Spanish medical device association (FENIN)

Ion Arocena, Spanish biotech association (ASEBIO)

Press team of the Ministry of Health, Community of Madrid

for their continuous support, enthusiasm and encouragement in the

2 Healthcare & Life Sciences Review: Spain www.pharmaboardroom.com

www.pharmaboardroom.com Healthcare & Life Sciences Review: Spain 3

JOIN THE CONVERSATION

AMPLIFIED CONTENT IN BRIEF

Read the interview

Read the interview

Read the article

PAOLO CIONINI @pharmaboardroom

4 Healthcare & Life Sciences Review: Spain www.pharmaboardroom.com

Distinguished members of the healthcare and pharmaceutical sectors,

María Jesús Lamas Díaz

6 Healthcare & Life Sciences Review: Spain www.pharmaboardroom.com

www.pharmaboardroom.com Healthcare & Life Sciences Review: Spain 7

We are present in more countries than anyone else.

We speak directly with healthcare leaders and

We are ready to share their insights and experiences

Source: CIA World Factbook

TOTAL AREA: 505,370 KM2

GDP (PPP): USD 1.778 TRILLION (2017)

Source: Tradingeconomics.com; Wold Bank

EVOLUTION OF THE ANNUAL GDP OF SPAIN (2004-2017)

4.2 GDP GROWTH (%) Source: countryeconomy.com

3.2 3.4 3.3

GROWTH OF THE PHARMACEUTICAL MARKET IN EACH AUTONOMOUS COMMUNITY

TOTAL NATIONAL ASTURIAS

1.7% 100% 0.9% -0.4%

Growth (%PPG, GALICIA

NATIONAL PHARMA SECTOR GROWTH (VOLUME AND VALUE)

2010 1144 605 1749 2010 15659 5162 20621

10 Healthcare & Life Sciences Review: Spain www.pharmaboardroom.com

TOP 20 PHARMA COMPANIES IN SPAIN (TOTAL MARKET)

100.0% 1.3% 10 PFIZER 2.0% -10.4%

MAT 04/2018 (last 12 months): April 2018 - May 2017

TOP 20 PHARMA COMPANIES IN SPAIN TOP 20 PHARMA COMPANIES IN SPAIN

100.0% 1.2% 100.0% 1.7%

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LEADING CAUSES OF DEATH

TOTAL SPENDING (PUBLIC AND PRIVATE) ON HEALTHCARE

2000 2010 2015 2016

TOTAL HEALTHCARE SPENDING IN SPAIN IN RELATION TO GDP (2010-2015)

12 Healthcare & Life Sciences Review: Spain www.pharmaboardroom.com

Spain is picking up steam and on the rise. Now,

Spanish market. We had dramatically dropped behind

www.pharmaboardroom.com Healthcare & Life Sciences Review: Spain 13

the pharmaceutical industry by which all companies that

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16 Healthcare & Life Sciences Review: Spain www.pharmaboardroom.com

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18 Healthcare & Life Sciences Review: Spain www.pharmaboardroom.com